Biomarker · Gene alteration

TP53 mutation

Somatic TP53 mutations detected by sequencing of tumor tissue or marrow; used mainly as a prognostic and risk-stratification marker across solid and hematologic malignancies.

CI-BIO-00000034TP53 graph →NCIt C118396

Also calledTP53-mutated · p53 mutation · TP53-mutant

Derived

Associated cancers (26)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Malignant Neoplasm	21	21	—	—	0 / 1 / 0 / 19 / 1
Malignant Breast Neoplasm	15	5	10	—	0 / 11 / 1 / 2 / 1
Chronic Lymphocytic Leukemia	7	1	6	—	1 / 6 / 0 / 0 / 0
Malignant Ovarian Neoplasm	7	4	3	—	0 / 5 / 2 / 0 / 0
Gastric Carcinoma

Derived

Drugs with predictive evidence (24)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
MDM2 Inhibitor AMGMDS3	17	1	16	D	1 / 16	Malignant Neoplasm
CisplatinSmall Molecule	9	4	5	B	3 / 5	Gastric Carcinoma, Malignant Gastric Neoplasm,

Curated evidence

Predictive evidence items (52)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–50 of 52 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
TP53 Mutation8
Alemtuzumab

Regulatory

Approvals mentioning the linked drugs (444)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

openfda

Clinical trials

Active trials (1,111)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 558 recruiting · 287 active phase 3 · 5,094 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 851–900 of 1,111 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT07025239	QL1706 Injection Plus Bevacizumab and XELOX vs Placebo Plus Bevacizumab and XELOX as First-Line Treatment of Unresectable Metastatic Colorectal Cancer	not yet recruiting	Phase 3

Literature

Linked publications (58)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–25 of 58 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Clinical impact of clonal and subclonal TP53, SF3B1, BIRC3, NOTCH1, and ATM mutations in chronic lymphocytic leukemia.
· Blood · 2016 · PMID 26837699 · validated civic_curation pubmed
TP53 mutation and survival in chronic lymphocytic leukemia.
· J Clin Oncol · 2010 · PMID 20697090 · validated civic_curation pubmed
Recurrent mutations refine prognosis in chronic lymphocytic leukemia.
· Leukemia · 2015 · PMID 24943832 · validated civic_curation pubmed
Pooled Analysis of the Prognostic and Predictive Effects of TP53 Comutation Status Combined With KRAS or EGFR Mutation in Early-Stage Resected Non-Small-Cell Lung Cancer in Four Trials of Adjuvant Chemotherapy.
· J Clin Oncol · 2017 · PMID 28453411

TP53 Wildtype6
Chemotherapy	Esophageal Carcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID906 Patients with p53 wild type (as defined by low expression and/or wild-type tp53 gene) had a higher response rate to chemotherapy-based treatment (total major response [MR]: risk ratio [RR] = 1.09, 95 … (full text at CIViC) PMID 23515910 · Zhang et al., 2013 · Open in CIViC	civic
RG7112	Leukemia	Predictive	B	Supports Sensitivity Response	3	accepted	EID2965 Phase I Trial of RG7112 in 116 heavily pretreated patients with AML, ALL, CML, CLL, sCLL demonstrated sustained clinical improvement and induction of TP53 target genes in subset of patients with wild … (full text at CIViC) PMID 26459177 · Andreeff et al., 2016 · Open in CIViC	civic
Adjuvant Chemotherapy	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID1149 Pooled analysis of TP53 mutations (exons 5-8) from 4 randomized trials (IALT, JBR10, CALGB-9633 and ANITA, 1209 patients, median follow-up 5.5 years) of platinum-based adjuvant chemotherapy (ACT) vers… (full text at CIViC) PMID 26899019 · Ma et al., 2016 · Open in CIViC	civic
Capecitabine + Cetuximab + OxaliplatinCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID875 In this retrospective biomarker analysis of the EXPERT-C trial, patients with TP53 wild-type status had a statistically significant better progression free survival (PFS) (89.3% vs 65.0% at 5 years; h… (full text at CIViC) PMID 24957073 · Sclafani et al., 2014 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	accepted	EID2964 MDM2 Inhibitor screen in a panel of 260 cancer cell lines with well characterized TP53 status shows that only cancer cell lines with unaltered TP53 may be sensitive to MDM2 Inhibitor. PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic
Rebemadlin	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	accepted	EID2963 MDM2 Inhibitor Nutlin-3a induced senescence in presence of functional TP53 in murine primary fibroblasts, oncogenically transformed fibroblasts, and fibrosarcoma cell lines. Cells lacking functional T… (full text at CIViC) PMID 17671205 · Efeyan et al., 2007 · Open in CIViC	civic

TP53 R273C2
Cisplatin + Etoposide + MitomycinCombination	Gastric CarcinomaALIAS	Predictive	C	Does Not Support Sensitivity Response	3	accepted	EID2292 A female patient taking part in a 25 patient gastric cancer trial was diagnosed at age 46, and received preoperative high dose chemotherapy (HDCT). Japanese Society for Gastric Cancer Response Score w… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID4881 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 Inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 Inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic

TP53 Y220C2
Cisplatin + Etoposide + MitomycinCombination	Gastric CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID2306 A male patient taking part in a 25 patient gastric cancer trial was diagnosed at age 50, harbored a TP53 mutation and received preoperative high dose chemotherapy (HDCT). Japanese Society for Gastric … (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID4884 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 Inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 Inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic

TP53 R175H4
EAP Protocol	Gastric CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	—	accepted	EID2310 In a study of 25 patients with advanced gastric cancer, mutations in TP53 were identified in 32% of primary tumors. TP53 mutations were associated with an improved response to preoperative treatment o… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
Doxorubicin	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	3	accepted	EID319 Breast tumors in a mouse model with R172H mutation (homologous to human R175H) are more responsive to doxorubicin than breast tumors with wild type TP53. PMID 22698404 · Jackson et al., 2012 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID4880 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID10074 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic

TP53 Deleterious Mutation4
RG7112	Leukemia	Predictive	B	Supports Resistance	3	accepted	EID2966 Phase I Trial of MDM2 inhibitor RG7112 in 116 patients with AML, ALL, CML, CLL, sCLL demonstrated sustained clinical improvement and induction of TP53 target genes in subset of patients with wild type… (full text at CIViC) PMID 26459177 · Andreeff et al., 2016 · Open in CIViC	civic
Adjuvant Chemotherapy	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID1148 Pooled analysis of TP53 mutations (exons 5-8) from 4 randomized trials (IALT, JBR10, CALGB-9633 and ANITA) of platinum-based adjuvant chemotherapy (ACT) versus observation (OBS). Patients with TP53wt … (full text at CIViC) PMID 26899019 · Ma et al., 2016 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID2967 MDM2 Inhibitor screen in a panel of 260 cancer cell lines with well characterized TP53 status shows that only cancer cell lines with unaltered TP53 may be sensitive to MDM2 Inhibitor AMGMDS3, while th… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic
Rebemadlin	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID2968 MDM2 Inhibitor Nutlin-3a induced senescence in presence of functional TP53 in murine primary fibroblasts, oncogenically transformed fibroblasts, and fibrosarcoma cell lines. TP53 mutant cells lacking … (full text at CIViC) PMID 17671205 · Efeyan et al., 2007 · Open in CIViC	civic

TP53 Overexpression2
Cisplatin + Etoposide + MitomycinCombination	Malignant Gastric Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID2799 In a Phase II trial of 25 patients with metastaic gastric cancer, patients received preoperative high dose chemotherapy (HDCT) consisting of etoposide, cisplatin and mitomycin. Patients with greater t… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
Carboplatin + CisplatinSubstitutes	Malignant Ovarian Neoplasm	Predictive	B	Supports Resistance	3	accepted	EID3013 In a study involving patients with invasive ovarian carcinoma who had undergone surgery, a subset of 73 patients were classified via response to platinum-based chemotherapy as sensitive or resistant/r… (full text at CIViC) PMID 11595686 · Reles et al., 2001 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	May 14, 1996	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	May 14, 1996	openfda
Doxorubicin	US FDA	—	Efficacy supplement 2015-04-16 (see label)	approved	Apr 16, 2015	openfda
Doxorubicin	US FDA	—	Efficacy supplement 2008-06-10 (see label)	approved	Jun 10, 2008	openfda
Doxorubicin	US FDA	—	Efficacy supplement 2007-05-17 (see label)	approved	May 17, 2007	openfda
Doxorubicin	US FDA	—	Efficacy supplement 2005-01-28 (see label)	approved	Jan 28, 2005	openfda
Doxorubicin	US FDA	—	Efficacy supplement 2004-10-27 (see label)	approved	Oct 27, 2004	openfda
Doxorubicin	US FDA	—	Efficacy supplement 2003-05-08 (see label)	approved	May 8, 2003	openfda
Doxorubicin	US FDA	—	Efficacy supplement 1999-06-28 (see label)	approved	Jun 28, 1999	openfda
Doxorubicin	US FDA	Malignant Ovarian Neoplasm	Ovarian cancer: After failure of platinum-based chemotherapy	approved	Nov 17, 1995	openfda
Doxorubicin	US FDA	AIDS-Related Kaposi Sarcoma	AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy	approved	Nov 17, 1995	openfda
Doxorubicin	US FDA	Multiple Myeloma	Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy	approved	Nov 17, 1995	openfda
Doxorubicin	US FDA	—	for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma	approved	Dec 23, 1987	openfda
Doxorubicin	US FDA	Malignant Breast Neoplasm	as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer	approved	Dec 23, 1987	openfda
Etoposide	US FDA	Malignant Testicular Neoplasm	Refractory testicular cancer	approved	Feb 13, 2026	openfda
Etoposide	US FDA	Lung Small Cell Carcinoma	Small cell lung cancer	approved	Feb 13, 2026	openfda
Etoposide	US FDA	—	Refractory testicular tumors, in combination with other chemotherapeutic drugs.	approved	May 17, 1996	openfda
Etoposide	US FDA	Lung Small Cell Carcinoma	Small cell lung cancer, in combination with cisplatin, as first-line treatment.	approved	May 17, 1996	openfda
Etoposide	US FDA	Lung Small Cell Carcinoma	VePesid (etoposide) is indicated in the management of: Small Cell Lung Cancer— VePesid Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.	approved	Dec 30, 1986	openfda
Methotrexate	US FDA	—	Efficacy supplement 2024-10-23 (see label)	approved	Oct 23, 2024	openfda
Methotrexate	US FDA	—	Efficacy supplement 2024-10-23 (see label)	approved	Oct 23, 2024	openfda
Methotrexate	US FDA	Mycosis Fungoides	Treatment of adults with mycosis fungoides	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) • Treatment of adults with severe psoriasis	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) • Treatment of adults with severe psoriasis	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Non-Hodgkin Lymphoma	Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Non-Hodgkin Lymphoma	Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Mycosis Fungoides	Treatment of adults with mycosis fungoides	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Non-Hodgkin Lymphoma	Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) • Treatment of adults with severe psoriasis	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) • Treatment of adults with severe psoriasis	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Mycosis Fungoides	Treatment of adults with mycosis fungoides	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Mycosis Fungoides	Treatment of adults with mycosis fungoides	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Non-Hodgkin Lymphoma	Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Efficacy supplement 2021-03-29 (see label)	approved	Mar 29, 2021	openfda
Methotrexate	US FDA	—	. Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy	approved	Apr 25, 2017	openfda
Methotrexate	US FDA	—	. Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy	approved	Apr 25, 2017	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen	approved	Apr 25, 2017	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen	approved	Apr 25, 2017	openfda
Methotrexate	US FDA	—	Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy • Limitation of Use Rasuvo is not indicated for the treatment of neoplastic diseases	approved	Jul 10, 2014	openfda
Methotrexate	US FDA	—	Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy • . • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy • . Limitation of Use Otrexup is not indicated for the treatment of neoplastic diseases	approved	Oct 11, 2013	openfda
Methotrexate	US FDA	—	Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy • . • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy • . Limitation of Use Otrexup is not indicated for the treatment of neoplastic diseases	approved	Oct 11, 2013	openfda
Methotrexate	US FDA	—	Efficacy supplement 1988-04-07 (see label)	approved	Apr 7, 1988	openfda
Methotrexate	US FDA	Head and Neck Squamous Cell Carcinoma	o Treatment of adults with squamous cell carcinoma of the head and neck as a single agent.	approved	Aug 10, 1959	openfda
Methotrexate	US FDA	—	o Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. • Treatment of adults with rheumatoid arthritis (RA). • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). • Treatment of adults with severe psoriasis.	approved	Aug 10, 1959	openfda
Methotrexate	US FDA	Malignant Breast Neoplasm	o Treatment of adults with breast cancer as part of a combination chemotherapy regimen.	approved	Aug 10, 1959	openfda
Methotrexate	US FDA	Osteosarcoma	o Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen.	approved	Aug 10, 1959	openfda