Hereditary Leiomyomatosis and Renal Cell Cancer

Mendelian MONDO:0007888 Pathograph 10 Show in embeddings browser hereditary cancer-predisposing syndrome

Hereditary leiomyomatosis and renal cell cancer (HLRCC) is an autosomal dominant cancer predisposition syndrome caused by germline loss-of-function variants in FH at 1q42-q43, encoding the tricarboxylic-acid-cycle enzyme fumarate hydratase. Carriers develop multiple cutaneous leiomyomas and, in women, early and numerous uterine leiomyomas; a subset develop an aggressive type 2 papillary or collecting-duct renal cell carcinoma that metastasizes at small primary size and dominates prognosis. HLRCC is the clearest human example of a metabolic enzyme acting as a classical tumor suppressor: the germline allele is heterozygous, tumors show loss of the wild-type allele, and measured fumarate hydratase activity is very low or absent in tumor tissue. What makes the syndrome mechanistically distinctive is that the oncogenic signal is the accumulated substrate rather than the energetic deficit. Fumarate builds up to concentrations at which it competitively inhibits the 2-oxoglutarate-dependent dioxygenase superfamily — stabilizing hypoxia-inducible factor in normoxia ("pseudohypoxia") and blocking TET- and Jumonji-mediated demethylation — and, uniquely among the oncometabolites, additionally reacts covalently with cysteine thiols, succinating KEAP1 and de-repressing NRF2 antioxidant signalling. The same FH gene has a second, entirely different phenotype in the biallelic state: homozygous or compound heterozygous FH mutation causes recessive fumarate hydratase deficiency, a severe infantile encephalopathy, so the number of damaged alleles inherited determines which of two unrelated diseases results.

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1
Inheritance
7
Pathophys.
3
Phenotypes
2
Hypotheses
1
Gaps
10
Pathograph
1
Genes
3
Medical Actions
1
Trials
1
References
👪

Inheritance

1
Autosomal dominant HP:0000006
HLRCC segregates as an autosomal dominant tumor predisposition. Cutaneous and uterine leiomyomas are highly penetrant; renal cell carcinoma affects a minority of carriers but accounts for most of the mortality. The contrast with the recessive disorder caused by biallelic FH mutation is instructive and is stated explicitly in the original mapping paper.
Autosomal dominant inheritance Penetrance: INCOMPLETE Expressivity: VARIABLE
Show evidence (3 references)
PMID:11865300 SUPPORT Human Clinical
"Thus, heterozygous and homozygous or compound heterozygous mutants have very different clinical phenotypes."
States the dose-dependent divergence between the dominant tumor predisposition and the recessive metabolic disease, which is the inheritance claim made here.
PMID:20301430 SUPPORT Other
"Each child of an individual with FH tumor predisposition syndrome has a 50% chance of inheriting the FH pathogenic variant."
GeneReviews Genetic Counseling section: the transmission risk to offspring. Evidence source is OTHER because GeneReviews is an expert-authored review rather than a primary study.
PMID:20301430 SUPPORT Other
"It is not possible to precisely predict the likelihood of manifestations, age of onset, severity and type of features, or rate of disease progression in offspring who inherit the FH pathogenic variant."
GeneReviews Genetic Counseling section, and the direct basis for the VARIABLE expressivity and INCOMPLETE penetrance recorded here — the source states explicitly that outcome in a carrier is not predictable.

Mechanistic Hypotheses

2
Pseudohypoxic HIF Activation Drives FH-Deficient Tumorigenesis
hif_pseudohypoxia_driver CANONICAL
Evidence balance 1 support
The long-standing reading of HLRCC: competitive inhibition of the HIF prolyl hydroxylases by accumulated fumarate stabilizes HIF in normoxia, and the resulting constitutive hypoxia programme is what transforms the FH-null cell. The human evidence for this arm is observational — HIF overexpression correlates with biallelic FH loss in HLRCC-associated renal cancer.
Show evidence (1 reference)
PMID:16098467 SUPPORT Human Clinical
"We demonstrate that FH inhibition, together with elevated intracellular fumarate, coincides with HIF upregulation."
The human tumor observation on which the pseudohypoxia-driver reading of HLRCC rests.
KEAP1 Succination and NRF2 Dysregulation Drives FH-Deficient Tumorigenesis
nrf2_succination_driver ALTERNATIVE
Evidence balance 1 support
The competing reading, specific to the fumarate lesion: the transforming event is covalent succination of KEAP1 and consequent constitutive NRF2 antioxidant signalling, not HIF stabilization. Mouse genetics is the strongest evidence and it removes HIF from the causal path — Fh1-associated renal cyst formation proceeds without HIF, and deleting Hif-1alpha made cysts worse rather than better. This entry does not adjudicate between the two readings; see the HUMAN_MODEL_MISMATCH discussion below.
Show evidence (1 reference)
PMID:22014577 SUPPORT Model Organism
"Using a mouse model, we provide genetic evidence that Fh1-associated cyst formation is Hif independent, as is striking upregulation of antioxidant signaling pathways revealed by gene expression profiling."
Genetic evidence placing cyst formation outside the HIF axis, which is what makes this an alternative to rather than a complement of the pseudohypoxia reading. Evidence source is MODEL_ORGANISM.
?

Discussions and Knowledge Gaps

1
Does the HIF-independent, KEAP1-succination/NRF2 mechanism established in Fh1-deficient mouse kidney account for tumorigenesis in human HLRCC, where HIF overexpression is the observed correlate of biallelic FH loss?
HUMAN MODEL MISMATCH OPEN hlrcc_human_model_fidelity_of_nrf2_branch
The two branches point in different therapeutic directions and the evidence for them is of different kinds. The human evidence is observational — HIF overexpression correlates with biallelic FH loss in human renal cancer — and supports the pseudohypoxia reading. The evidence that removes HIF from the causal path is genetic but murine: Fh1-associated cyst formation proceeds without HIF, and deleting Hif-1alpha made cysts worse. Neither result settles the human case, and a correlation in human tumors cannot discriminate driver from marker. Curators should not present either branch as the established human mechanism, and should keep the model-derived claim tagged MODEL_ORGANISM.
Proposed experiments
Succination burden versus HIF target output in matched human HLRCC tumors
succination_versus_hif_in_human_hlrcc_tumors
Quantify S-(2-succinyl)cysteine burden, NRF2 target-gene output and HIF target-gene output in the same human HLRCC renal tumors and matched leiomyomas, testing whether one branch tracks tumor grade and behaviour while the other does not.

Pathophysiology

7
Germline FH First-Hit Inactivation
A heterozygous loss-of-function variant in FH is present constitutionally. Leiomyomatosis-associated alleles are predicted to produce absent or truncated protein, or to substitute or delete highly conserved residues, and fumarate hydratase activity is already measurably reduced in lymphoblastoid cells from carriers — so the heterozygous state is not biochemically silent even though it is clinically a susceptibility rather than a disease.
FH hgnc:3700 HUGO Gene Nomenclature Committee (hgnc) Relation: this pathophysiological event involves this gene This pathophysiological event involves decreased FH (hgnc:3700). hgnc:3700 is a gene from the HUGO Gene Nomenclature Committee. ↓ DECREASED
Genetic context FH hgnc:3700 HUGO Gene Nomenclature Committee (hgnc) Relation: this genetic context concerns this gene This genetic context concerns FH (hgnc:3700). hgnc:3700 is a gene from the HUGO Gene Nomenclature Committee. variant_origin: GERMLINE allelic_hit_role: FIRST_HIT allelic_event: PATHOGENIC_VARIANT zygosity: HETEROZYGOUS functional_impact_category: LOSS_OF_FUNCTION
Constitutional heterozygous FH loss of function; alleles predict absent or truncated protein or substitution of highly conserved residues.
Show evidence (2 references)
PMID:11865300 SUPPORT Human Clinical
"Leiomyomatosis-associated mutations are predicted to result in absent or truncated protein, or substitutions or deletions of highly conserved amino acids."
Characterizes the germline allelic spectrum that constitutes the first hit.
PMID:11865300 SUPPORT Human Clinical
"Activity of fumarate hydratase is reduced in lymphoblastoid cells from individuals with leiomyomatosis."
Demonstrates measurable enzyme reduction in the constitutional heterozygous state, supporting the claim that heterozygosity is not biochemically silent.
Somatic FH Second-Hit Inactivation and Biallelic Loss
Tumors in FH carriers predominantly show functional inactivation of the retained wild-type allele, and measured fumarate hydratase activity in tumor tissue is very low or absent — the biallelic state that distinguishes tumor from surrounding carrier tissue. This is the node at which HLRCC hands over from the inherited-predisposition mechanism to the oncometabolite mechanism: only in the biallelic cell does fumarate reach the concentrations at which it acts as a signalling molecule.
Genetic context FH hgnc:3700 HUGO Gene Nomenclature Committee (hgnc) Relation: this genetic context concerns this gene This genetic context concerns FH (hgnc:3700). hgnc:3700 is a gene from the HUGO Gene Nomenclature Committee. variant_origin: GERMLINE_AND_SOMATIC allelic_hit_role: BIALLELIC_INACTIVATION allelic_event: LOSS_OF_HETEROZYGOSITY functional_impact_category: LOSS_OF_FUNCTION
Combined inherited and acquired inactivation leaving the tumor cell without functional fumarate hydratase.
fumarate hydratase activity GO:0004333 Gene Ontology (GO) Relation: this pathophysiological event involves this molecular function This pathophysiological event involves fumarate hydratase activity (GO:0004333), qualified as loss of function. GO:0004333 is a molecular function from the Gene Ontology. ⇓ LOSS OF FUNCTION
Show evidence (2 references)
PMID:16098467 SUPPORT Human Clinical
"These tumors predominantly exhibit functional inactivation of the remaining wild-type allele, implicating FH inactivation as a tumor-promoting event."
Direct evidence for the second hit and the resulting biallelic state in human FH-associated renal cancer.
PMID:11865300 SUPPORT Human Clinical
"This enzyme acts as a tumor suppressor in familial leiomyomata, and its measured activity is very low or absent in tumors from individuals with leiomyomatosis."
Confirms near-complete loss of enzyme activity in tumor as opposed to carrier tissue.
Fumarate Accumulation
Fumarate, the substrate of the missing enzyme, accumulates within the FH-null cell. It is a structural analogue of 2-oxoglutarate and, at these concentrations, competes with it; it is also an electrophile that reacts with cysteine thiols. Both properties are exploited downstream, and they are chemically independent of each other.
tricarboxylic acid cycle GO:0006099 Gene Ontology (GO) Relation: this pathophysiological event involves this biological process This pathophysiological event involves decreased tricarboxylic acid cycle (GO:0006099). GO:0006099 is a biological process from the Gene Ontology. ↓ DECREASED
Show evidence (1 reference)
PMID:16098467 SUPPORT In Vitro
"We demonstrate that FH inhibition, together with elevated intracellular fumarate, coincides with HIF upregulation."
Establishes elevated intracellular fumarate as the consequence of enzyme loss and links it to the downstream signalling readout.
Fumarate-Mediated Dioxygenase Inhibition
Fumarate acts as a competitive inhibitor of the HIF prolyl hydroxylases and, by the same active-site competition, of other 2-oxoglutarate-dependent dioxygenases including the TET 5-methylcytosine hydroxylases and Jumonji histone demethylases. This is the rate-limiting signalling step of the oncometabolite mechanism in HLRCC.
2-oxoglutarate-dependent dioxygenase activity GO:0016706 Gene Ontology (GO) Relation: this pathophysiological event involves this molecular function This pathophysiological event involves decreased 2-oxoglutarate-dependent dioxygenase activity (GO:0016706). GO:0016706 is a molecular function from the Gene Ontology. ↓ DECREASED
Show evidence (1 reference)
PMID:16098467 SUPPORT In Vitro
"Further, we show that fumarate acts as a competitive inhibitor of HPH."
The direct biochemical demonstration of competitive inhibition that defines this node.
Pseudohypoxic HIF Stabilization in FH-Null Cells
Unhydroxylated HIF-alpha escapes VHL recognition and accumulates in normoxia, driving the hypoxia transcriptional programme. HIF overexpression correlates with biallelic FH loss in human renal cancer. Whether this is the transforming event or an accompanying marker is genuinely unsettled, and this entry curates it as one of two competing readings rather than as the mechanism.
cellular response to decreased oxygen levels GO:0036294 Gene Ontology (GO) Relation: this pathophysiological event involves this biological process This pathophysiological event involves increased cellular response to decreased oxygen levels (GO:0036294). GO:0036294 is a biological process from the Gene Ontology. ↑ INCREASED
Show evidence (1 reference)
PMID:16098467 SUPPORT Human Clinical
"Individuals with hemizygous germline fumarate hydratase (FH) mutations are predisposed to renal cancer."
Anchors the pseudohypoxia observation to the human renal cancer predisposition this entry describes.
KEAP1 Succination and NRF2 Activation
Fumarate covalently modifies cysteine residues on KEAP1 to form S-(2-succinyl)cysteine, abrogating KEAP1's ability to repress NRF2 and leaving the antioxidant transcriptional programme constitutively active. Mouse genetics places this branch outside the HIF axis: Fh1-associated renal cyst formation is HIF-independent, and deleting Hif-1alpha exacerbated rather than prevented cysts. This is a model-derived claim and is marked as such.
cellular response to oxidative stress GO:0034599 Gene Ontology (GO) Relation: this pathophysiological event involves this biological process This pathophysiological event involves increased cellular response to oxidative stress (GO:0034599). GO:0034599 is a biological process from the Gene Ontology. ↑ INCREASED
Show evidence (1 reference)
PMID:22014577 SUPPORT Model Organism
"Mechanistic analysis revealed that fumarate modifies cysteine residues within the Kelch-like ECH-associated protein 1 (KEAP1), abrogating its ability to repress the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2)-mediated antioxidant response pathway, suggesting a role for Nrf2 dysregulation..."
Establishes the succination branch and its NRF2 output in an Fh1-deficient mouse. Evidence source is MODEL_ORGANISM; the human equivalence is an open question recorded in this entry's discussions.
Leiomyomatosis and Aggressive Renal Cell Carcinoma
The clinical output: multiple cutaneous leiomyomas, early and numerous uterine leiomyomas often leading to hysterectomy in the third or fourth decade, and — in a minority of carriers — a type 2 papillary or collecting-duct renal cell carcinoma notable for metastasizing while the primary is still small. The multiplicity of the leiomyomas is the signature of independent second hits across a primed tissue; the renal tumor is rarer because fewer renal cells complete the second hit, but it determines prognosis.
Show evidence (2 references)
PMID:11865300 SUPPORT Human Clinical
"We previously mapped a gene that predisposes to multiple fibroids, cutaneous leiomyomata and renal cell carcinoma to chromosome 1q42.3-q43 (refs 4-6)."
Defines the three-component tumor spectrum of the syndrome as originally mapped.
PMID:22014577 SUPPORT Other
"Hereditary leiomyomatosis and renal cell carcinoma (HLRCC) is an inherited cancer syndrome in which affected individuals are at risk of developing benign cutaneous and uterine leiomyomas, renal cysts, and aggressive collecting duct and Type 2 papillary renal cell carcinomas (pRCC)"
Documents the renal histology and its aggressiveness. Evidence source is OTHER because this sentence is the paper's introductory characterization of the syndrome rather than its own experimental result.

Pathograph

Use the checkboxes to hide or show graph categories. Hover nodes for evidence and cross-linked metadata.
Pathograph: causal mechanism network for Hereditary Leiomyomatosis and Renal Cell Cancer Interactive directed graph showing how pathophysiology mechanisms, phenotypes, genetic factors and variants, experimental models, environmental triggers, and treatments relate through causal and linked edges.

Phenotypes

3
Multiple Cutaneous Leiomyomas Dermatologic HP:0007437 Human Phenotype Ontology (HP) Relation: this clinical feature is this phenotype This clinical feature is Multiple cutaneous leiomyomas (HP:0007437). HP:0007437 is a phenotype from the Human Phenotype Ontology.
Show evidence (2 references)
PMID:11865300 SUPPORT Human Clinical
"We previously mapped a gene that predisposes to multiple fibroids, cutaneous leiomyomata and renal cell carcinoma to chromosome 1q42.3-q43 (refs 4-6)."
Names multiple cutaneous leiomyomata as a defining component of the mapped phenotype.
PMID:20301430 SUPPORT Other
"Cutaneous leiomyomata appear as skin-colored to light brown papules or nodules distributed across the trunk and extremities and occasionally on the face, and are usually noted in the second to fourth decades of life, increasing in size and number with age."
GeneReviews Clinical Characteristics section, giving the appearance, distribution and onset window of the cutaneous lesion, and its progressive accumulation with age — the visible signature of independent second hits across the skin over time.
Uterine Leiomyoma Reproductive HP:0000131 Human Phenotype Ontology (HP) Relation: this clinical feature is this phenotype This clinical feature is Uterine leiomyoma (HP:0000131). HP:0000131 is a phenotype from the Human Phenotype Ontology.
Show evidence (2 references)
PMID:11865300 SUPPORT Human Clinical
"We previously mapped a gene that predisposes to multiple fibroids, cutaneous leiomyomata and renal cell carcinoma to chromosome 1q42.3-q43 (refs 4-6)."
Names multiple uterine fibroids as part of the inherited predisposition mapped to the FH locus. The sentence used previously here described sporadic fibroids in general and said nothing about the syndrome.
PMID:20301430 SUPPORT Other
"Uterine leiomyomata tend to be numerous and large; mean age at diagnosis is ~30 years, with most females experiencing irregular or heavy menstruation and pelvic pain."
GeneReviews Clinical Characteristics section, giving the mean age at diagnosis and the symptom burden — the reason many carriers reach myomectomy or hysterectomy in early adulthood.
Papillary Renal Cell Carcinoma Renal HP:0006766 Human Phenotype Ontology (HP) Relation: this clinical feature is this phenotype This clinical feature is Papillary renal cell carcinoma (HP:0006766). HP:0006766 is a phenotype from the Human Phenotype Ontology.
Show evidence (2 references)
PMID:22014577 SUPPORT Other
"Hereditary leiomyomatosis and renal cell carcinoma (HLRCC) is an inherited cancer syndrome in which affected individuals are at risk of developing benign cutaneous and uterine leiomyomas, renal cysts, and aggressive collecting duct and Type 2 papillary renal cell carcinomas (pRCC)"
Specifies the renal histological subtypes seen in HLRCC. Evidence source is OTHER because this is the paper's background characterization.
PMID:20301430 SUPPORT Other
"Renal tumors are usually unilateral, solitary, and aggressive. They are associated with poor survival due to clinical aggressiveness and propensity to metastasize despite small primary tumor size. The median age of detection is approximately 40 years."
GeneReviews Clinical Characteristics section. This is the clinically decisive sentence of the entry: unlike the multifocal cutaneous and uterine lesions, the renal tumor is usually solitary yet metastasizes while small, which is why surveillance is imaging-based and annual rather than triggered by symptoms.
🧬

Genetic Associations

1
FH
Gene: FH hgnc:3700 HUGO Gene Nomenclature Committee (hgnc) Relation: this disease-associated gene is this gene This disease-associated gene is FH (hgnc:3700). hgnc:3700 is a gene from the HUGO Gene Nomenclature Committee. relationship_type: CAUSATIVE
Show evidence (1 reference)
PMID:11865300 SUPPORT Human Clinical
"Mutations in FH also occur in the recessive condition fumarate hydratase deficiency, and some parents of people with this condition are susceptible to leiomyomata."
Documents the allelic relationship between the dominant tumor syndrome and the recessive metabolic disease at the same locus.
💊

Medical Actions

3
Systemic Therapy for FH-Deficient Renal Cell Carcinoma
Action: PharmacotherapyNCI Thesaurus (NCIT) Relation: this treatment is this clinical intervention This treatment is Pharmacotherapy (NCIT:C15986). NCIT:C15986 is a clinical intervention from the NCI Thesaurus. NCIT:C15986
Agent: erlotinib NCIT:C65530 NCI Thesaurus (NCIT) Relation: this treatment uses this therapeutic agent This treatment uses erlotinib (NCIT:C65530). NCIT:C65530 is a therapeutic agent from the NCI Thesaurus. bevacizumab NCIT:C2039 NCI Thesaurus (NCIT) Relation: this treatment uses this therapeutic agent This treatment uses bevacizumab (NCIT:C2039). NCIT:C2039 is a therapeutic agent from the NCI Thesaurus.
The renal tumor is the arm that determines prognosis, and it is managed differently from sporadic renal cell carcinoma. Beyond surgery, GeneReviews names two systemic combinations as potentially beneficial: erlotinib plus bevacizumab, and cabozantinib plus nivolumab. The erlotinib/bevacizumab pairing is mechanistically coherent with this entry's pathophysiology — an anti-VEGF antibody targeting the pseudohypoxic, HIF-driven angiogenic output of the FH-null cell, combined with EGFR blockade. Note the source's own hedging ("may be beneficial"); this is not curated as established efficacy.
Mechanism Target:
INHIBITS Pseudohypoxic HIF Stabilization in FH-Null Cells — Bevacizumab neutralizes VEGF, the principal angiogenic output of the stabilized HIF complex, acting downstream of the untreatable metabolic lesion rather than on it. This targets the pseudohypoxia branch specifically and is therefore contingent on that branch being the driver — an open question recorded in this entry's mechanistic_hypotheses.
Show evidence (1 reference)
PMID:20301430 SUPPORT Other
"In addition, treatment with erlotinib plus bevacizumab or cabozantinib plus nivolumab may be beneficial for kidney tumors."
GeneReviews Management section, naming both systemic combinations. The hedged "may be beneficial" is preserved rather than upgraded.
Renal Surveillance and Surgery
Action: NephrectomyNCI Thesaurus (NCIT) Relation: this treatment is this clinical intervention This treatment is Nephrectomy (NCIT:C15284). NCIT:C15284 is a clinical intervention from the NCI Thesaurus. NCIT:C15284
Because the renal tumor metastasizes at small size, surveillance is annual thin-slice MRI from childhood rather than symptom-triggered imaging, and surgery uses wide margins. Referral to a surgeon familiar with the syndrome is specified, reflecting that nephron-sparing norms for sporadic renal tumors do not transfer here.
Mechanism Target:
INHIBITS Leiomyomatosis and Aggressive Renal Cell Carcinoma — Surveillance and wide-margin resection act on the consequence node by detecting and removing the renal tumor before dissemination; they do not alter the germline lesion or prevent further second hits.
Show evidence (2 references)
PMID:20301430 SUPPORT Other
"annual MRI with 1- to 3-mm slices through the kidneys from age eight years; prompt follow up for suspicious renal lesions"
GeneReviews Management section, giving the surveillance modality, slice thickness and starting age. The unusually early start and fine slices follow directly from the tumor metastasizing while small.
PMID:20301430 SUPPORT Other
"Total or partial nephrectomy with wide margins may be carefully considered in some settings."
GeneReviews Management section on the surgical approach. The wide-margin qualifier distinguishes this from standard nephron-sparing surgery for sporadic renal tumors.
Symptomatic Management of Cutaneous and Uterine Leiomyomas
Action: Therapeutic ProcedureNCI Thesaurus (NCIT) Relation: this treatment is this clinical intervention This treatment is Therapeutic Procedure (NCIT:C49236). NCIT:C49236 is a clinical intervention from the NCI Thesaurus. NCIT:C49236
The benign lesions are treated for symptom burden rather than cancer risk: cutaneous leiomyomas by excision or ablation with pharmacological options for the characteristic pain, and uterine fibroids medically or surgically. GeneReviews attaches an important caveat to fibroid surgery — histology must distinguish atypical smooth muscle neoplasm from leiomyosarcoma.
Show evidence (2 references)
PMID:20301430 SUPPORT Other
"Treatment of cutaneous leiomyomas can include surgical excision, carbon dioxide laser, cryotherapy, or electrodessication."
GeneReviews Management section, listing the cutaneous treatment options.
PMID:20301430 SUPPORT Other
"histologic examination to differentiate between atypical smooth muscle neoplasm and leiomyosarcoma should be performed in those undergoing surgery"
GeneReviews Management section. This is a safety caveat rather than a treatment: fibroid surgery in an FH carrier must not assume the lesion is benign.
🔬

Diagnosis

2
Molecular Genetic Testing for Heterozygous FH Variants
The diagnosis is established by identifying a heterozygous germline FH pathogenic variant. The zygosity in that sentence is load-bearing: a heterozygous variant establishes this tumor predisposition syndrome, whereas biallelic FH variants cause the recessive metabolic disease fumarate hydratase deficiency, which is a different disorder with a different GeneReviews chapter.
Genetic Testing NCIT:C15709 NCI Thesaurus (NCIT)
Results: A heterozygous germline pathogenic FH variant establishes the diagnosis and makes at-risk relatives eligible for predictive testing and early renal surveillance.
Show evidence (1 reference)
PMID:20301430 SUPPORT Other
"Diagnosis of FH tumor predisposition syndrome is established in a proband with a heterozygous pathogenic variant in FH identified by molecular genetic testing."
GeneReviews Diagnosis/Testing section, stating the confirmatory test and the heterozygous zygosity that separates this syndrome from recessive fumarate hydratase deficiency.
Predictive Testing of At-Risk Relatives
Cascade testing is framed by GeneReviews as serving two purposes: starting surveillance early in carriers, and sparing non-carriers the cost and burden of lifelong renal imaging.
Genetic Testing NCIT:C15709 NCI Thesaurus (NCIT)
Results: Identifies which at-risk relatives require early renal surveillance and which can be discharged from it.
Show evidence (1 reference)
PMID:20301430 SUPPORT Other
"It is appropriate to clarify the genetic status of apparently asymptomatic at-risk relatives of an affected individual by molecular genetic testing for the familial FH pathogenic variant in order to identify as early as possible those who would benefit from early surveillance and treatment and..."
GeneReviews Evaluation of Relatives at Risk, giving both the case for cascade testing and the de-escalation rationale for non-carriers.
🔬

Clinical Trials

1
NCT02495103 PHASE_II TERMINATED
Terminated phase I/II trial of vandetanib plus metformin in HLRCC-associated and SDH-associated kidney cancer, pairing the two oncometabolite-driven renal cancer syndromes in one metabolic-therapy arm.
Target Phenotypes: Papillary renal cell carcinoma HP:0006766 Human Phenotype Ontology (HP) Relation: this clinical trial targets this phenotype This clinical trial targets Papillary renal cell carcinoma (HP:0006766). HP:0006766 is a phenotype from the Human Phenotype Ontology.
Show evidence (1 reference)
clinicaltrials:NCT02495103 SUPPORT Human Clinical
"For Phase II, people 18 and over with advanced hereditary leiomyomatosis and renal cell cancer (HLRCC), succinate dehydrogenase renal cell carcinoma (SDH-RCC), or advanced papillary renal cell carcinoma not related to a hereditary syndrome"
Registry record defining an HLRCC-specific phase II cohort. The trial terminated, so it evidences that the combination was studied in HLRCC, not that it is efficacious.
{ }

Source YAML

click to show
name: Hereditary Leiomyomatosis and Renal Cell Cancer
creation_date: "2026-08-23T00:00:00Z"
category: Mendelian
categories:
- Hereditary Cancer Syndrome
- Cancer Predisposition Syndrome
- Inborn Error of Metabolism
parents:
- hereditary cancer-predisposing syndrome
disease_term:
  preferred_term: hereditary leiomyomatosis and renal cell cancer
  term:
    id: MONDO:0007888
    label: hereditary leiomyomatosis and renal cell cancer
synonyms:
- HLRCC
- multiple cutaneous and uterine leiomyomatosis
- MCUL
- Reed syndrome
description: >-
  Hereditary leiomyomatosis and renal cell cancer (HLRCC) is an autosomal
  dominant cancer predisposition syndrome caused by germline loss-of-function
  variants in FH at 1q42-q43, encoding the tricarboxylic-acid-cycle enzyme
  fumarate hydratase. Carriers develop multiple cutaneous leiomyomas and, in
  women, early and numerous uterine leiomyomas; a subset develop an aggressive
  type 2 papillary or collecting-duct renal cell carcinoma that metastasizes at
  small primary size and dominates prognosis. HLRCC is the clearest human example
  of a metabolic enzyme acting as a classical tumor suppressor: the germline
  allele is heterozygous, tumors show loss of the wild-type allele, and measured
  fumarate hydratase activity is very low or absent in tumor tissue. What makes
  the syndrome mechanistically distinctive is that the oncogenic signal is the
  accumulated substrate rather than the energetic deficit. Fumarate builds up to
  concentrations at which it competitively inhibits the 2-oxoglutarate-dependent
  dioxygenase superfamily — stabilizing hypoxia-inducible factor in normoxia
  ("pseudohypoxia") and blocking TET- and Jumonji-mediated demethylation — and,
  uniquely among the oncometabolites, additionally reacts covalently with
  cysteine thiols, succinating KEAP1 and de-repressing NRF2 antioxidant
  signalling. The same FH gene has a second, entirely different phenotype in the
  biallelic state: homozygous or compound heterozygous FH mutation causes
  recessive fumarate hydratase deficiency, a severe infantile encephalopathy, so
  the number of damaged alleles inherited determines which of two unrelated
  diseases results.
inheritance:
- name: Autosomal dominant
  inheritance_term:
    preferred_term: Autosomal dominant inheritance
    term:
      id: HP:0000006
      label: Autosomal dominant inheritance
  penetrance: INCOMPLETE
  expressivity: VARIABLE
  description: >-
    HLRCC segregates as an autosomal dominant tumor predisposition. Cutaneous and
    uterine leiomyomas are highly penetrant; renal cell carcinoma affects a
    minority of carriers but accounts for most of the mortality. The contrast
    with the recessive disorder caused by biallelic FH mutation is instructive
    and is stated explicitly in the original mapping paper.
  evidence:
  - reference: PMID:11865300
    reference_title: "Germline mutations in FH predispose to dominantly inherited uterine fibroids, skin leiomyomata and papillary renal cell cancer."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      Thus, heterozygous and homozygous or compound heterozygous mutants have
      very different clinical phenotypes.
    explanation: >-
      States the dose-dependent divergence between the dominant tumor
      predisposition and the recessive metabolic disease, which is the
      inheritance claim made here.
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      Each child of an individual with FH tumor predisposition syndrome has a
      50% chance of inheriting the FH pathogenic variant.
    explanation: >-
      GeneReviews Genetic Counseling section: the transmission risk to
      offspring. Evidence source is OTHER because GeneReviews is an
      expert-authored review rather than a primary study.
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      It is not possible to precisely predict the likelihood of manifestations,
      age of onset, severity and type of features, or rate of disease
      progression in offspring who inherit the FH pathogenic variant.
    explanation: >-
      GeneReviews Genetic Counseling section, and the direct basis for the
      VARIABLE expressivity and INCOMPLETE penetrance recorded here — the source
      states explicitly that outcome in a carrier is not predictable.
pathophysiology:
- name: Germline FH First-Hit Inactivation
  conforms_to: "germline_two_hit_tumor_predisposition#Constitutional First-Hit Tumor Suppressor Inactivation"
  description: >-
    A heterozygous loss-of-function variant in FH is present constitutionally.
    Leiomyomatosis-associated alleles are predicted to produce absent or
    truncated protein, or to substitute or delete highly conserved residues, and
    fumarate hydratase activity is already measurably reduced in lymphoblastoid
    cells from carriers — so the heterozygous state is not biochemically silent
    even though it is clinically a susceptibility rather than a disease.
  role: trigger
  biological_scale: MOLECULAR
  gene:
    preferred_term: FH
    modifier: DECREASED
    term:
      id: hgnc:3700
      label: FH
  genetic_context:
    gene:
      preferred_term: FH
      term:
        id: hgnc:3700
        label: FH
    variant_origin: GERMLINE
    allelic_hit_role: FIRST_HIT
    allelic_events:
    - PATHOGENIC_VARIANT
    zygosity: HETEROZYGOUS
    functional_impact_category: LOSS_OF_FUNCTION
    description: >-
      Constitutional heterozygous FH loss of function; alleles predict absent or
      truncated protein or substitution of highly conserved residues.
  evidence:
  - reference: PMID:11865300
    reference_title: "Germline mutations in FH predispose to dominantly inherited uterine fibroids, skin leiomyomata and papillary renal cell cancer."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      Leiomyomatosis-associated mutations are predicted to result in absent or
      truncated protein, or substitutions or deletions of highly conserved amino
      acids.
    explanation: >-
      Characterizes the germline allelic spectrum that constitutes the first hit.
  - reference: PMID:11865300
    reference_title: "Germline mutations in FH predispose to dominantly inherited uterine fibroids, skin leiomyomata and papillary renal cell cancer."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      Activity of fumarate hydratase is reduced in lymphoblastoid cells from
      individuals with leiomyomatosis.
    explanation: >-
      Demonstrates measurable enzyme reduction in the constitutional
      heterozygous state, supporting the claim that heterozygosity is not
      biochemically silent.
  downstream:
  - target: Somatic FH Second-Hit Inactivation and Biallelic Loss
    description: >-
      A somatic event removing the wild-type allele is required before enzyme
      activity falls low enough for fumarate to accumulate to signalling
      concentrations.

- name: Somatic FH Second-Hit Inactivation and Biallelic Loss
  conforms_to: "germline_two_hit_tumor_predisposition#Biallelic Tumor Suppressor Inactivation in a Susceptible Cell"
  description: >-
    Tumors in FH carriers predominantly show functional inactivation of the
    retained wild-type allele, and measured fumarate hydratase activity in tumor
    tissue is very low or absent — the biallelic state that distinguishes tumor
    from surrounding carrier tissue. This is the node at which HLRCC hands over
    from the inherited-predisposition mechanism to the oncometabolite mechanism:
    only in the biallelic cell does fumarate reach the concentrations at which it
    acts as a signalling molecule.
  role: central_effector
  biological_scale: CELLULAR
  genetic_context:
    gene:
      preferred_term: FH
      term:
        id: hgnc:3700
        label: FH
    variant_origin: GERMLINE_AND_SOMATIC
    allelic_hit_role: BIALLELIC_INACTIVATION
    allelic_events:
    - LOSS_OF_HETEROZYGOSITY
    functional_impact_category: LOSS_OF_FUNCTION
    description: >-
      Combined inherited and acquired inactivation leaving the tumor cell without
      functional fumarate hydratase.
  molecular_functions:
  - preferred_term: fumarate hydratase activity
    term:
      id: GO:0004333
      label: fumarate hydratase activity
    modifier: LOSS_OF_FUNCTION
  evidence:
  - reference: PMID:16098467
    reference_title: "HIF overexpression correlates with biallelic loss of fumarate hydratase in renal cancer: novel role of fumarate in regulation of HIF stability."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      These tumors predominantly exhibit functional inactivation of the
      remaining wild-type allele, implicating FH inactivation as a
      tumor-promoting event.
    explanation: >-
      Direct evidence for the second hit and the resulting biallelic state in
      human FH-associated renal cancer.
  - reference: PMID:11865300
    reference_title: "Germline mutations in FH predispose to dominantly inherited uterine fibroids, skin leiomyomata and papillary renal cell cancer."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      This enzyme acts as a tumor suppressor in familial leiomyomata, and its
      measured activity is very low or absent in tumors from individuals with
      leiomyomatosis.
    explanation: >-
      Confirms near-complete loss of enzyme activity in tumor as opposed to
      carrier tissue.
  downstream:
  - target: Fumarate Accumulation
    description: >-
      With the enzyme absent, its substrate accumulates to concentrations orders
      of magnitude above physiological.

- name: Fumarate Accumulation
  conforms_to: "oncometabolite_dioxygenase_inhibition#Oncometabolite Accumulation"
  description: >-
    Fumarate, the substrate of the missing enzyme, accumulates within the
    FH-null cell. It is a structural analogue of 2-oxoglutarate and, at these
    concentrations, competes with it; it is also an electrophile that reacts with
    cysteine thiols. Both properties are exploited downstream, and they are
    chemically independent of each other.
  role: amplifier
  biological_scale: MOLECULAR
  biological_processes:
  - preferred_term: tricarboxylic acid cycle
    term:
      id: GO:0006099
      label: tricarboxylic acid cycle
    modifier: DECREASED
  evidence:
  - reference: PMID:16098467
    reference_title: "HIF overexpression correlates with biallelic loss of fumarate hydratase in renal cancer: novel role of fumarate in regulation of HIF stability."
    supports: SUPPORT
    evidence_source: IN_VITRO
    snippet: >-
      We demonstrate that FH inhibition, together with elevated intracellular
      fumarate, coincides with HIF upregulation.
    explanation: >-
      Establishes elevated intracellular fumarate as the consequence of enzyme
      loss and links it to the downstream signalling readout.
  downstream:
  - target: Fumarate-Mediated Dioxygenase Inhibition
    description: >-
      Accumulated fumarate competes with 2-oxoglutarate at the active site of
      the dioxygenase superfamily.
  - target: KEAP1 Succination and NRF2 Activation
    description: >-
      Fumarate additionally succinates cysteine residues, a covalent
      modification unrelated to its competitive inhibition.

- name: Fumarate-Mediated Dioxygenase Inhibition
  conforms_to: "oncometabolite_dioxygenase_inhibition#Competitive Inhibition of 2-Oxoglutarate-Dependent Dioxygenases"
  description: >-
    Fumarate acts as a competitive inhibitor of the HIF prolyl hydroxylases and,
    by the same active-site competition, of other 2-oxoglutarate-dependent
    dioxygenases including the TET 5-methylcytosine hydroxylases and Jumonji
    histone demethylases. This is the rate-limiting signalling step of the
    oncometabolite mechanism in HLRCC.
  role: central_effector
  biological_scale: MOLECULAR
  molecular_functions:
  - preferred_term: 2-oxoglutarate-dependent dioxygenase activity
    term:
      id: GO:0016706
      label: 2-oxoglutarate-dependent dioxygenase activity
    modifier: DECREASED
  evidence:
  - reference: PMID:16098467
    reference_title: "HIF overexpression correlates with biallelic loss of fumarate hydratase in renal cancer: novel role of fumarate in regulation of HIF stability."
    supports: SUPPORT
    evidence_source: IN_VITRO
    snippet: >-
      Further, we show that fumarate acts as a competitive inhibitor of HPH.
    explanation: >-
      The direct biochemical demonstration of competitive inhibition that
      defines this node.
  downstream:
  - target: Pseudohypoxic HIF Stabilization in FH-Null Cells
    description: >-
      Loss of prolyl hydroxylation prevents VHL-dependent degradation of
      HIF-alpha under normal oxygen tension.
    hypothesis_groups:
    - hif_pseudohypoxia_driver

- name: Pseudohypoxic HIF Stabilization in FH-Null Cells
  conforms_to: "oncometabolite_dioxygenase_inhibition#Pseudohypoxic HIF Stabilization"
  description: >-
    Unhydroxylated HIF-alpha escapes VHL recognition and accumulates in normoxia,
    driving the hypoxia transcriptional programme. HIF overexpression correlates
    with biallelic FH loss in human renal cancer. Whether this is the
    transforming event or an accompanying marker is genuinely unsettled, and this
    entry curates it as one of two competing readings rather than as the
    mechanism.
  role: effector
  biological_scale: CELLULAR
  biological_processes:
  - preferred_term: cellular response to decreased oxygen levels
    term:
      id: GO:0036294
      label: cellular response to decreased oxygen levels
    modifier: INCREASED
  evidence:
  - reference: PMID:16098467
    reference_title: "HIF overexpression correlates with biallelic loss of fumarate hydratase in renal cancer: novel role of fumarate in regulation of HIF stability."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      Individuals with hemizygous germline fumarate hydratase (FH) mutations are
      predisposed to renal cancer.
    explanation: >-
      Anchors the pseudohypoxia observation to the human renal cancer
      predisposition this entry describes.
  downstream:
  - target: Leiomyomatosis and Aggressive Renal Cell Carcinoma
    description: >-
      Constitutive hypoxia-response transcription supports the vascular and
      metabolic phenotype of the resulting tumors.

- name: KEAP1 Succination and NRF2 Activation
  conforms_to: "oncometabolite_dioxygenase_inhibition#KEAP1 Succination and NRF2 Antioxidant Pathway Activation"
  description: >-
    Fumarate covalently modifies cysteine residues on KEAP1 to form
    S-(2-succinyl)cysteine, abrogating KEAP1's ability to repress NRF2 and
    leaving the antioxidant transcriptional programme constitutively active.
    Mouse genetics places this branch outside the HIF axis: Fh1-associated renal
    cyst formation is HIF-independent, and deleting Hif-1alpha exacerbated rather
    than prevented cysts. This is a model-derived claim and is marked as such.
  role: adaptive_escape
  biological_scale: MOLECULAR
  biological_processes:
  - preferred_term: cellular response to oxidative stress
    term:
      id: GO:0034599
      label: cellular response to oxidative stress
    modifier: INCREASED
  evidence:
  - reference: PMID:22014577
    reference_title: "Renal cyst formation in Fh1-deficient mice is independent of the Hif/Phd pathway: roles for fumarate in KEAP1 succination and Nrf2 signaling."
    supports: SUPPORT
    evidence_source: MODEL_ORGANISM
    snippet: >-
      Mechanistic analysis revealed that fumarate modifies cysteine residues
      within the Kelch-like ECH-associated protein 1 (KEAP1), abrogating its
      ability to repress the Nuclear factor (erythroid-derived 2)-like 2
      (Nrf2)-mediated antioxidant response pathway, suggesting a role for Nrf2
      dysregulation in FH-associated cysts and tumors.
    explanation: >-
      Establishes the succination branch and its NRF2 output in an Fh1-deficient
      mouse. Evidence source is MODEL_ORGANISM; the human equivalence is an open
      question recorded in this entry's discussions.
  downstream:
  - target: Leiomyomatosis and Aggressive Renal Cell Carcinoma
    description: >-
      Constitutive antioxidant signalling supports survival of FH-null cells.
    hypothesis_groups:
    - nrf2_succination_driver

- name: Leiomyomatosis and Aggressive Renal Cell Carcinoma
  conforms_to: "germline_two_hit_tumor_predisposition#Early-Onset, Multifocal, and Bilateral Tumor Spectrum"
  description: >-
    The clinical output: multiple cutaneous leiomyomas, early and numerous
    uterine leiomyomas often leading to hysterectomy in the third or fourth
    decade, and — in a minority of carriers — a type 2 papillary or
    collecting-duct renal cell carcinoma notable for metastasizing while the
    primary is still small. The multiplicity of the leiomyomas is the signature
    of independent second hits across a primed tissue; the renal tumor is rarer
    because fewer renal cells complete the second hit, but it determines
    prognosis.
  role: consequence
  biological_scale: ORGANISM
  evidence:
  - reference: PMID:11865300
    reference_title: "Germline mutations in FH predispose to dominantly inherited uterine fibroids, skin leiomyomata and papillary renal cell cancer."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      We previously mapped a gene that predisposes to multiple fibroids,
      cutaneous leiomyomata and renal cell carcinoma to chromosome 1q42.3-q43
      (refs 4-6).
    explanation: >-
      Defines the three-component tumor spectrum of the syndrome as originally
      mapped.
  - reference: PMID:22014577
    reference_title: "Renal cyst formation in Fh1-deficient mice is independent of the Hif/Phd pathway: roles for fumarate in KEAP1 succination and Nrf2 signaling."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      Hereditary leiomyomatosis and renal cell carcinoma (HLRCC) is an inherited
      cancer syndrome in which affected individuals are at risk of developing
      benign cutaneous and uterine leiomyomas, renal cysts, and aggressive
      collecting duct and Type 2 papillary renal cell carcinomas (pRCC)
    explanation: >-
      Documents the renal histology and its aggressiveness. Evidence source is
      OTHER because this sentence is the paper's introductory characterization of
      the syndrome rather than its own experimental result.
phenotypes:
- category: Dermatologic
  name: Multiple Cutaneous Leiomyomas
  description: >-
    Multiple firm skin-coloured to brown papules and nodules arising from arrector
    pili smooth muscle, often painful and frequently the first sign of the
    syndrome.
  phenotype_term:
    preferred_term: Multiple cutaneous leiomyomas
    term:
      id: HP:0007437
      label: Multiple cutaneous leiomyomas
  evidence:
  - reference: PMID:11865300
    reference_title: "Germline mutations in FH predispose to dominantly inherited uterine fibroids, skin leiomyomata and papillary renal cell cancer."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      We previously mapped a gene that predisposes to multiple fibroids,
      cutaneous leiomyomata and renal cell carcinoma to chromosome 1q42.3-q43
      (refs 4-6).
    explanation: >-
      Names multiple cutaneous leiomyomata as a defining component of the
      mapped phenotype.
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      Cutaneous leiomyomata appear as skin-colored to light brown papules or
      nodules distributed across the trunk and extremities and occasionally on
      the face, and are usually noted in the second to fourth decades of life,
      increasing in size and number with age.
    explanation: >-
      GeneReviews Clinical Characteristics section, giving the appearance,
      distribution and onset window of the cutaneous lesion, and its progressive
      accumulation with age — the visible signature of independent second hits
      across the skin over time.
- category: Reproductive
  name: Uterine Leiomyoma
  description: >-
    Uterine fibroids that are numerous, symptomatic and of early onset relative
    to sporadic fibroids, commonly leading to myomectomy or hysterectomy in young
    adulthood.
  phenotype_term:
    preferred_term: Uterine leiomyoma
    term:
      id: HP:0000131
      label: Uterine leiomyoma
  evidence:
  - reference: PMID:11865300
    reference_title: "Germline mutations in FH predispose to dominantly inherited uterine fibroids, skin leiomyomata and papillary renal cell cancer."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      We previously mapped a gene that predisposes to multiple fibroids,
      cutaneous leiomyomata and renal cell carcinoma to chromosome 1q42.3-q43
      (refs 4-6).
    explanation: >-
      Names multiple uterine fibroids as part of the inherited predisposition
      mapped to the FH locus. The sentence used previously here described
      sporadic fibroids in general and said nothing about the syndrome.
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      Uterine leiomyomata tend to be numerous and large; mean age at diagnosis
      is ~30 years, with most females experiencing irregular or heavy
      menstruation and pelvic pain.
    explanation: >-
      GeneReviews Clinical Characteristics section, giving the mean age at
      diagnosis and the symptom burden — the reason many carriers reach
      myomectomy or hysterectomy in early adulthood.
- category: Renal
  name: Papillary Renal Cell Carcinoma
  description: >-
    Type 2 papillary (or collecting-duct) renal cell carcinoma; typically
    unilateral and solitary but biologically aggressive, with a propensity to
    metastasize at small size that governs surveillance and surgical policy.
  phenotype_term:
    preferred_term: Papillary renal cell carcinoma
    term:
      id: HP:0006766
      label: Papillary renal cell carcinoma
  evidence:
  - reference: PMID:22014577
    reference_title: "Renal cyst formation in Fh1-deficient mice is independent of the Hif/Phd pathway: roles for fumarate in KEAP1 succination and Nrf2 signaling."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      Hereditary leiomyomatosis and renal cell carcinoma (HLRCC) is an inherited
      cancer syndrome in which affected individuals are at risk of developing
      benign cutaneous and uterine leiomyomas, renal cysts, and aggressive
      collecting duct and Type 2 papillary renal cell carcinomas (pRCC)
    explanation: >-
      Specifies the renal histological subtypes seen in HLRCC. Evidence source
      is OTHER because this is the paper's background characterization.
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      Renal tumors are usually unilateral, solitary, and aggressive. They are
      associated with poor survival due to clinical aggressiveness and
      propensity to metastasize despite small primary tumor size. The median age
      of detection is approximately 40 years.
    explanation: >-
      GeneReviews Clinical Characteristics section. This is the clinically
      decisive sentence of the entry: unlike the multifocal cutaneous and
      uterine lesions, the renal tumor is usually solitary yet metastasizes
      while small, which is why surveillance is imaging-based and annual rather
      than triggered by symptoms.
genetic:
- name: FH
  gene_term:
    preferred_term: FH
    term:
      id: hgnc:3700
      label: FH
  relationship_type: CAUSATIVE
  notes: >-
    FH at 1q42.3-q43 encodes fumarate hydratase. Heterozygous germline
    loss-of-function variants cause HLRCC; biallelic germline variants instead
    cause the recessive metabolic disease fumarate hydratase deficiency.
  evidence:
  - reference: PMID:11865300
    reference_title: "Germline mutations in FH predispose to dominantly inherited uterine fibroids, skin leiomyomata and papillary renal cell cancer."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      Mutations in FH also occur in the recessive condition fumarate hydratase
      deficiency, and some parents of people with this condition are susceptible
      to leiomyomata.
    explanation: >-
      Documents the allelic relationship between the dominant tumor syndrome and
      the recessive metabolic disease at the same locus.
discussions:
- discussion_id: hlrcc_human_model_fidelity_of_nrf2_branch
  prompt: >-
    Does the HIF-independent, KEAP1-succination/NRF2 mechanism established in
    Fh1-deficient mouse kidney account for tumorigenesis in human HLRCC, where
    HIF overexpression is the observed correlate of biallelic FH loss?
  kind: HUMAN_MODEL_MISMATCH
  status: OPEN
  attaches_to:
  - pathophysiology#KEAP1 Succination and NRF2 Activation
  - pathophysiology#Pseudohypoxic HIF Stabilization in FH-Null Cells
  rationale: >-
    The two branches point in different therapeutic directions and the evidence
    for them is of different kinds. The human evidence is observational — HIF
    overexpression correlates with biallelic FH loss in human renal cancer — and
    supports the pseudohypoxia reading. The evidence that removes HIF from the
    causal path is genetic but murine: Fh1-associated cyst formation proceeds
    without HIF, and deleting Hif-1alpha made cysts worse. Neither result
    settles the human case, and a correlation in human tumors cannot
    discriminate driver from marker. Curators should not present either branch
    as the established human mechanism, and should keep the model-derived claim
    tagged MODEL_ORGANISM.
  proposed_experiments:
  - experiment_id: succination_versus_hif_in_human_hlrcc_tumors
    name: Succination burden versus HIF target output in matched human HLRCC tumors
    description: >-
      Quantify S-(2-succinyl)cysteine burden, NRF2 target-gene output and HIF
      target-gene output in the same human HLRCC renal tumors and matched
      leiomyomas, testing whether one branch tracks tumor grade and behaviour
      while the other does not.
treatments:
- name: Systemic Therapy for FH-Deficient Renal Cell Carcinoma
  description: >-
    The renal tumor is the arm that determines prognosis, and it is managed
    differently from sporadic renal cell carcinoma. Beyond surgery, GeneReviews
    names two systemic combinations as potentially beneficial: erlotinib plus
    bevacizumab, and cabozantinib plus nivolumab. The erlotinib/bevacizumab
    pairing is mechanistically coherent with this entry's pathophysiology — an
    anti-VEGF antibody targeting the pseudohypoxic, HIF-driven angiogenic output
    of the FH-null cell, combined with EGFR blockade. Note the source's own
    hedging ("may be beneficial"); this is not curated as established efficacy.
  therapeutic_modality: SMALL_MOLECULE
  treatment_term:
    preferred_term: Pharmacotherapy
    term:
      id: NCIT:C15986
      label: Pharmacotherapy
    therapeutic_agent:
    - preferred_term: erlotinib
      term:
        id: NCIT:C65530
        label: Erlotinib
    - preferred_term: bevacizumab
      term:
        id: NCIT:C2039
        label: Bevacizumab
  target_mechanisms:
  - target: Pseudohypoxic HIF Stabilization in FH-Null Cells
    treatment_effect: INHIBITS
    description: >-
      Bevacizumab neutralizes VEGF, the principal angiogenic output of the
      stabilized HIF complex, acting downstream of the untreatable metabolic
      lesion rather than on it. This targets the pseudohypoxia branch
      specifically and is therefore contingent on that branch being the driver —
      an open question recorded in this entry's mechanistic_hypotheses.
  evidence:
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      In addition, treatment with erlotinib plus bevacizumab or cabozantinib
      plus nivolumab may be beneficial for kidney tumors.
    explanation: >-
      GeneReviews Management section, naming both systemic combinations. The
      hedged "may be beneficial" is preserved rather than upgraded.
- name: Renal Surveillance and Surgery
  notes: >-
    Curated under `treatments:` as a management intervention, not as a claim
    that imaging or biochemistry is itself therapeutic. In a two-hit
    predisposition syndrome the second hit cannot be prevented, so the only
    available lever is stage at detection: surveillance is the intervention
    that converts an unavoidable tumor into a resectable one. Where a
    `target_mechanisms` link is present it points at the clinical-outcome node
    for that reason, and never at an upstream mechanistic node.
  description: >-
    Because the renal tumor metastasizes at small size, surveillance is annual
    thin-slice MRI from childhood rather than symptom-triggered imaging, and
    surgery uses wide margins. Referral to a surgeon familiar with the syndrome
    is specified, reflecting that nephron-sparing norms for sporadic renal
    tumors do not transfer here.
  therapeutic_modality: SURGERY
  treatment_term:
    preferred_term: Nephrectomy
    term:
      id: NCIT:C15284
      label: Nephrectomy
  target_mechanisms:
  - target: Leiomyomatosis and Aggressive Renal Cell Carcinoma
    treatment_effect: INHIBITS
    description: >-
      Surveillance and wide-margin resection act on the consequence node by
      detecting and removing the renal tumor before dissemination; they do not
      alter the germline lesion or prevent further second hits.
  evidence:
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      annual MRI with 1- to 3-mm slices through the kidneys from age eight
      years; prompt follow up for suspicious renal lesions
    explanation: >-
      GeneReviews Management section, giving the surveillance modality, slice
      thickness and starting age. The unusually early start and fine slices
      follow directly from the tumor metastasizing while small.
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      Total or partial nephrectomy with wide margins may be carefully considered
      in some settings.
    explanation: >-
      GeneReviews Management section on the surgical approach. The wide-margin
      qualifier distinguishes this from standard nephron-sparing surgery for
      sporadic renal tumors.
- name: Symptomatic Management of Cutaneous and Uterine Leiomyomas
  description: >-
    The benign lesions are treated for symptom burden rather than cancer risk:
    cutaneous leiomyomas by excision or ablation with pharmacological options
    for the characteristic pain, and uterine fibroids medically or surgically.
    GeneReviews attaches an important caveat to fibroid surgery — histology must
    distinguish atypical smooth muscle neoplasm from leiomyosarcoma.
  therapeutic_modality: SURGERY
  treatment_term:
    preferred_term: Therapeutic Procedure
    term:
      id: NCIT:C49236
      label: Therapeutic Procedure
  evidence:
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      Treatment of cutaneous leiomyomas can include surgical excision, carbon
      dioxide laser, cryotherapy, or electrodessication.
    explanation: >-
      GeneReviews Management section, listing the cutaneous treatment options.
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      histologic examination to differentiate between atypical smooth muscle
      neoplasm and leiomyosarcoma should be performed in those undergoing
      surgery
    explanation: >-
      GeneReviews Management section. This is a safety caveat rather than a
      treatment: fibroid surgery in an FH carrier must not assume the lesion is
      benign.
diagnosis:
- name: Molecular Genetic Testing for Heterozygous FH Variants
  description: >-
    The diagnosis is established by identifying a heterozygous germline FH
    pathogenic variant. The zygosity in that sentence is load-bearing: a
    heterozygous variant establishes this tumor predisposition syndrome, whereas
    biallelic FH variants cause the recessive metabolic disease fumarate
    hydratase deficiency, which is a different disorder with a different
    GeneReviews chapter.
  diagnosis_term:
    preferred_term: Genetic Testing
    term:
      id: NCIT:C15709
      label: Genetic Testing
  results: >-
    A heterozygous germline pathogenic FH variant establishes the diagnosis and
    makes at-risk relatives eligible for predictive testing and early renal
    surveillance.
  evidence:
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      Diagnosis of FH tumor predisposition syndrome is established in a proband
      with a heterozygous pathogenic variant in FH identified by molecular
      genetic testing.
    explanation: >-
      GeneReviews Diagnosis/Testing section, stating the confirmatory test and
      the heterozygous zygosity that separates this syndrome from recessive
      fumarate hydratase deficiency.
- name: Predictive Testing of At-Risk Relatives
  description: >-
    Cascade testing is framed by GeneReviews as serving two purposes: starting
    surveillance early in carriers, and sparing non-carriers the cost and burden
    of lifelong renal imaging.
  diagnosis_term:
    preferred_term: Genetic Testing
    term:
      id: NCIT:C15709
      label: Genetic Testing
  results: >-
    Identifies which at-risk relatives require early renal surveillance and
    which can be discharged from it.
  evidence:
  - reference: PMID:20301430
    reference_title: "FH Tumor Predisposition Syndrome."
    supports: SUPPORT
    evidence_source: OTHER
    snippet: >-
      It is appropriate to clarify the genetic status of apparently
      asymptomatic at-risk relatives of an affected individual by molecular
      genetic testing for the familial FH pathogenic variant in order to
      identify as early as possible those who would benefit from early
      surveillance and treatment and to reduce costly screening procedures in
      those who have not inherited the pathogenic variant.
    explanation: >-
      GeneReviews Evaluation of Relatives at Risk, giving both the case for
      cascade testing and the de-escalation rationale for non-carriers.
mechanistic_hypotheses:
- hypothesis_group_id: hif_pseudohypoxia_driver
  hypothesis_label: Pseudohypoxic HIF Activation Drives FH-Deficient Tumorigenesis
  status: CANONICAL
  description: >-
    The long-standing reading of HLRCC: competitive inhibition of the HIF prolyl
    hydroxylases by accumulated fumarate stabilizes HIF in normoxia, and the
    resulting constitutive hypoxia programme is what transforms the FH-null
    cell. The human evidence for this arm is observational — HIF overexpression
    correlates with biallelic FH loss in HLRCC-associated renal cancer.
  evidence:
  - reference: PMID:16098467
    reference_title: "HIF overexpression correlates with biallelic loss of fumarate hydratase in renal cancer: novel role of fumarate in regulation of HIF stability."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      We demonstrate that FH inhibition, together with elevated intracellular
      fumarate, coincides with HIF upregulation.
    explanation: >-
      The human tumor observation on which the pseudohypoxia-driver reading of
      HLRCC rests.
- hypothesis_group_id: nrf2_succination_driver
  hypothesis_label: KEAP1 Succination and NRF2 Dysregulation Drives FH-Deficient Tumorigenesis
  status: ALTERNATIVE
  description: >-
    The competing reading, specific to the fumarate lesion: the transforming
    event is covalent succination of KEAP1 and consequent constitutive NRF2
    antioxidant signalling, not HIF stabilization. Mouse genetics is the
    strongest evidence and it removes HIF from the causal path — Fh1-associated
    renal cyst formation proceeds without HIF, and deleting Hif-1alpha made
    cysts worse rather than better. This entry does not adjudicate between the
    two readings; see the HUMAN_MODEL_MISMATCH discussion below.
  evidence:
  - reference: PMID:22014577
    reference_title: "Renal cyst formation in Fh1-deficient mice is independent of the Hif/Phd pathway: roles for fumarate in KEAP1 succination and Nrf2 signaling."
    supports: SUPPORT
    evidence_source: MODEL_ORGANISM
    snippet: >-
      Using a mouse model, we provide genetic evidence that Fh1-associated cyst
      formation is Hif independent, as is striking upregulation of antioxidant
      signaling pathways revealed by gene expression profiling.
    explanation: >-
      Genetic evidence placing cyst formation outside the HIF axis, which is
      what makes this an alternative to rather than a complement of the
      pseudohypoxia reading. Evidence source is MODEL_ORGANISM.
references:
- reference: PMID:20301430
  title: "FH Tumor Predisposition Syndrome."
  tags:
  - GeneReviews
clinical_trials:
- name: NCT02495103
  phase: PHASE_II
  status: TERMINATED
  description: >-
    Terminated phase I/II trial of vandetanib plus metformin in HLRCC-associated
    and SDH-associated kidney cancer, pairing the two oncometabolite-driven
    renal cancer syndromes in one metabolic-therapy arm.
  target_phenotypes:
  - preferred_term: Papillary renal cell carcinoma
    term:
      id: HP:0006766
      label: Papillary renal cell carcinoma
  evidence:
  - reference: clinicaltrials:NCT02495103
    reference_title: Phase I/II Trial of Vandetanib in Combination With Metformin in Subjects With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: >-
      For Phase II, people 18 and over with advanced hereditary leiomyomatosis and renal cell cancer (HLRCC), succinate dehydrogenase renal cell carcinoma (SDH-RCC), or advanced papillary renal cell carcinoma not related to a hereditary syndrome
    explanation: >-
      Registry record defining an HLRCC-specific phase II cohort. The trial
      terminated, so it evidences that the combination was studied in HLRCC, not
      that it is efficacious.
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References & Deep Research

References

1
FH Tumor Predisposition Syndrome.
No top-level findings curated for this source.