Clinical trial · Observational

The Correlation Between HRD Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer

The Correlation Between Homologous Recombination Deficiency Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer

NCT06242392CI-TRIAL-00073644unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Clinicopathological data were collected from ovarian cancer patients treated with PARP inhibitors, with follow-up imaging conducted before and after treatment. The efficacy was evaluated according to RECIST criteria, comparing the correlation between different HRD statuses and the efficacy of PARP inhibitors in ovarian cancer.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Ovarian Neoplasms	Ovarian Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
homologous recombination deficiency	Genetic	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
effective group
description
The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria, patients who were evaluated as complete remission, partial remission and stable disease were included in the effective group. Patients assessed as having progressive disease were included in the treatment-refractory group.
interventionNames
1. Genetic: homologous recombination deficiency
label
ineffective group
description
The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria. Patients assessed as having progressive disease were included in the ineffective group.
interventionNames
1. Genetic: homologous recombination deficiency

Primary outcomes (1)

measure
Efficacy of PARP inhibitors in the treatment of ovarian cancer

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients diagnosed with ovarian cancer (any histological type) and possessing complete pathological hematoxylin and eosin (HE) stained slides and paraffin-embedded tissue blocks.
* Patients must be 18 years of age or older.
* Patients should not have concurrent multiple primary cancers.
* Patients must undergo an MRI or CT scan prior to starting treatment.
* According to RECIST (Response Evaluation Criteria In Solid Tumors) criteria, patients must have at least one measurable lesion.
* Participants must provide informed consent, voluntarily cooperate with clinical follow-up, and sign an informed consent form.

Exclusion Criteria:

* Patients who do not have accessible tumor tissue required for Homologous Recombination Deficiency (HRD) testing.
* Patients whose clinical records are incomplete, making it impossible to effectively compare treatment efficacy.
* Patients who are lost to follow-up and for whom subsequent treatment outcomes cannot be tracked.

References

Publications (6)

BACKGROUNDMiller RE, Leary A, Scott CL, Serra V, Lord CJ, Bowtell D, Chang DK, Garsed DW, Jonkers J, Ledermann JA, Nik-Zainal S, Ray-Coquard I, Shah SP, Matias-Guiu X, Swisher EM, Yates LR. ESMO recommendations on predictive biomarker testing for homologous recombination deficiency and PARP inhibitor benefit in ovarian cancer. Ann Oncol. 2020 Dec;31(12):1606-1622. doi: 10.1016/j.annonc.2020.08.2102. Epub 2020 Sep 28. PMID 33004253
BACKGROUNDVergote I, Gonzalez-Martin A, Ray-Coquard I, Harter P, Colombo N, Pujol P, Lorusso D, Mirza MR, Brasiuniene B, Madry R, Brenton JD, Ausems MGEM, Buttner R, Lambrechts D; European experts' consensus group. European experts consensus: BRCA/homologous recombination deficiency testing in first-line ovarian cancer. Ann Oncol. 2022 Mar;33(3):276-287. doi: 10.1016/j.annonc.2021.11.013. Epub 2021 Dec 1. PMID 34861371
BACKGROUNDLheureux S, Gourley C, Vergote I, Oza AM. Epithelial ovarian cancer. Lancet. 2019 Mar 23;393(10177):1240-1253. doi: 10.1016/S0140-6736(18)32552-2. PMID 30910306
BACKGROUNDDoig KD, Fellowes AP, Fox SB. Homologous Recombination Repair Deficiency: An Overview for Pathologists. Mod Pathol. 2023 Mar;36(3):100049. doi: 10.1016/j.modpat.2022.100049. Epub 2023 Jan 10. PMID 36788098
BACKGROUNDRay-Coquard I, Pautier P, Pignata S, Perol D, Gonzalez-Martin A, Berger R, Fujiwara K, Vergote I, Colombo N, Maenpaa J, Selle F, Sehouli J, Lorusso D, Guerra Alia EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marme F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361. PMID 31851799
BACKGROUNDMoore KN, du Bois A. Homologous recombination deficiency testing in first-line ovarian cancer. Ann Oncol. 2022 Mar;33(3):231-233. doi: 10.1016/j.annonc.2021.12.013. Epub 2022 Jan 8. No abstract available.