Real-world clinical and molecular profile of ovarian cancer patients treated with Olaparib: study protocol and design of the OC-REAL India multicentre ambispective observational study

Narayanankutty Warrier; Ghanashyam Biswas; Dipanjan Panda; Anita Ramesh; Devang Sarvaiya; Sucheta Mehta; Senthilnathan Mohanasundaram; Jaideep Gogtay

doi:10.18203/2349-3933.ijam20263724

Authors

Narayanankutty Warrier
Ghanashyam Biswas
Dipanjan Panda
Anita Ramesh
Devang Sarvaiya Cipla Ltd., Peninsula Business Park, Ganapatrao Kadam Marg, Lower Parel West, Mumbai, Maharashtra 400013
Sucheta Mehta
Senthilnathan Mohanasundaram
Jaideep Gogtay

DOI:

https://doi.org/10.18203/2349-3933.ijam20263724

Keywords:

Ovarian cancer, PARP, Olaparib, maintenance therapy, BRCA, HRD, Real-world evidence, Targeted therapy

Abstract

Background: Globally, ovarian cancer (OC) is the eighth most common cancer among women, accounting for an estimated 3.7% of all cases and 4.7% of cancer-related deaths. Approximately 20-25% of OC cases harbour germline BRCA1/2 mutations, while homologous recombination deficiency (HRD) has emerged as an important therapeutic biomarker. Poly (ADP-ribose) polymerase (PARP) inhibitors, such as Olaparib, have demonstrated significant clinical benefit as maintenance therapy in patients with BRCA-mutated or HRD-positive OC. However, real-world Indian data on the clinical and molecular characteristics of patients receiving Olaparib remain limited. The objective of the study was to evaluate the clinical, molecular, and treatment profile of OC patients receiving Olaparib maintenance therapy.

Methods: This ambispective, cross-sectional, multicentre, non-interventional, real-world evidence study aims to enrol 250 Indian OC patients initiated on Olaparib maintenance therapy. Data will be captured electronically at a baseline visit using an electronic data capture (EDC) system. Variables include demographics, comorbidities, family cancer history, histopathology, surgical and treatment history, BRCA mutation and HRD status, CA-125 levels at diagnosis and prior to Olaparib initiation, and details of maintenance therapy.

Conclusions: OC-REAL India study will provide real-world insights into Indian OC patients on Olaparib, including demographics, pathology, and BRCA/HRD mutation prevalence. Findings aim to support personalized treatment and improve clinical outcomes. As this is an ongoing study, the results are expected to be published after completion of the study.

Trial registration: The study was registered with the Clinical Trials Registry-India (CTRI; Registration No. CTRI/2025/08/092561)

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References

Caruso G, Weroha SJ, Cliby W. Ovarian cancer: a review. JAMA. 2025;334(14):1278-91. DOI: https://doi.org/10.1001/jama.2025.9495

Cancer Research UK. Ovarian cancer statistics, 2026. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer#heading-Zero. Accessed on 22 May 2026.

Wang L, Zhang Q, Wang X, Dong Z, Liu S, Wang Q, et al. Therapeutic landscape of ovarian cancer: recent advances and emerging therapies. Biomark Res. 2025;13(1):103. DOI: https://doi.org/10.1186/s40364-025-00818-7

Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-63. DOI: https://doi.org/10.3322/caac.21834

International Agency for Research on Cancer. Cancer Today. Available at: https://gco.iarc.who.int/today/en/dataviz/pie?mode=cancer&types=0&sexes=2&populations=356. Accessed on 22 May 2026.

Shaik B, Zafar T, Balasubramanian K, Gupta SP. An overview of ovarian cancer: molecular processes involved and development of target-based chemotherapeutics. Curr Top Med Chem. 2021;21(4):329-46. DOI: https://doi.org/10.2174/1568026620999201111155426

Mindovix. Understanding omental cancer: a comprehensive overview. Available at: https://mindovix.com/articles/understanding-omental-cancer-overview. Accessed on 22 May 2026.

Li X, Li Z, Ma H, Li X, Zhai H, Li X, et al. Ovarian cancer: diagnosis and treatment strategies. Oncol Lett. 2024;28:441. DOI: https://doi.org/10.3892/ol.2024.14574

De Oliveira LRLB, Horvat N, Andrieu PIC, Panizza PSB, Cerri GG, Viana PCC. Ovarian cancer staging: what the surgeon needs to know. Br J Radiol. 2021;94(1125):20210091. DOI: https://doi.org/10.1259/bjr.20210091

Ghose A, McCann L, Makker S, Uma M, Sri VNG, Jayaraj E, et al. Diagnostic biomarkers in ovarian cancer: advances beyond CA125 and HE4. Ther Adv Med Oncol. 2024;16:17588359241233225. DOI: https://doi.org/10.1177/17588359241233225

Renz M, Friedlander M, Berek JS. Cancer of the ovary, fallopian tube, and peritoneum: 2025 update. Int J Gynecol Obstet. 2025;171(1):6-35. DOI: https://doi.org/10.1002/ijgo.70282

Berek JS, Matias-Guiu X, Creutzberg C, Fotopoulou C, Gaffney D, Kehoe S, et al. FIGO staging of endometrial cancer: 2023. Int J Gynecol Obstet. 2023;162:383-94. DOI: https://doi.org/10.1002/ijgo.14923

Shah B, Hussain M, Seth A. Homologous recombination deficiency in ovarian and breast cancers: biomarkers, diagnosis, and treatment. Curr Issues Mol Biol. 2025;47:1807-21. DOI: https://doi.org/10.20944/preprints202504.0229.v1

Wu J, Mamidi TKK, Zhang L, Hicks C. Delineation of the germline and somatic mutation interaction landscape in triple-negative and non-triple-negative breast cancer. Int J Genomics. 2020;2020:2641370. DOI: https://doi.org/10.1155/2020/2641370

Gupta S, Rajappa S, Advani S, Agarwal A, Aggarwal S, Goswami C, et al. Prevalence of BRCA1 and BRCA2 mutations among patients with ovarian, primary peritoneal, and fallopian tube cancer in India: a multicenter cross-sectional study. JCO Glob Oncol. 2021;7:849-61. DOI: https://doi.org/10.1200/GO.21.00051

Mangogna A, Munari G, Pepe F, Maffii E, Giampaolino P, Ricci G, et al. Homologous recombination deficiency in ovarian cancer: from the biological rationale to current diagnostic approaches. J Pers Med. 2023;13:284. DOI: https://doi.org/10.3390/jpm13020284

Miller RE, Elyashiv O, El-Shakankery KH, Ledermann JA. Ovarian cancer therapy: homologous recombination deficiency as a predictive biomarker of response to PARP inhibitors. Onco Targets Ther 2022;15:1105-17. DOI: https://doi.org/10.2147/OTT.S272199

Jiang B, Shang Y, Zhang X, He W, Hua H, Ye F, et al. The prognostic and predictive value of homologous recombination deficiency in gastrointestinal cancer. Oncologist. 2025;30(6):oyaf141. DOI: https://doi.org/10.1093/oncolo/oyaf141

McGrail DJ, Li Y, Smith RS, Feng B, Dai H, Hu L, et al. Widespread BRCA1/2-independent homologous recombination defects are caused by alterations in RNA-binding proteins. Cell Rep Med. 2023;4:101255. DOI: https://doi.org/10.1016/j.xcrm.2023.101255

Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, et al. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384:2394-405. DOI: https://doi.org/10.1056/NEJMoa2105215

Che H, Wang LW, Ye XY, He X. Olaparib research update: mechanism, structure, and clinical trials. Med Chem Res. 2025;34:535-48. DOI: https://doi.org/10.1007/s00044-025-03375-8

DiSilvestro P, Banerjee S, Colombo N, Scambia G, Kim BG, Oaknin A, et al. Overall survival with maintenance olaparib at a 7-year follow-up in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation: the SOLO1/GOG 3004 trial. J Clin Oncol. 2023;41:609-17. DOI: https://doi.org/10.1200/JCO.22.01549

Azribi F, Abdou E, Dawoud E, Ashour M, Kamal A, Al Sayed M, et al. Prevalence of BRCA1 and BRCA2 pathogenic sequence variants in ovarian cancer patients in the Gulf region: the PREDICT study. BMC Cancer. 2021;21:1280. DOI: https://doi.org/10.1186/s12885-021-09094-8

Ali AT, Al-Ani O, Al-Ani F. Epidemiology and risk factors for ovarian cancer. Prz Menopauzalny. 2023;22:93-104. DOI: https://doi.org/10.5114/pm.2023.128661

Sindiani A, Obeidat B, Hamadeh L, Alghazo S, Al-Mohtaseb A, Alshdaifat E. A descriptive study of the clinico-pathological and surgical characteristics of patients with primary epithelial ovarian cancer: a cross-sectional study. Ann Med Surg (Lond). 2020;59:254-7. DOI: https://doi.org/10.1016/j.amsu.2020.09.043

Kheiri SA, Kunna A, Babiker AY, Alsuhaibani SA, Ahmed RY, Alsammani MA. Histopathological pattern and age distribution of malignant ovarian tumors among Sudanese women. Open Access Maced J Med Sci. 2018;6:237-41. DOI: https://doi.org/10.3889/oamjms.2018.067

Vedpathak SG, Nayak VRK. Retrospective study of clinico-pathological features of ovarian tumors. Int J Reprod Contracept Obstet Gynecol. 2018;7:618-22. DOI: https://doi.org/10.18203/2320-1770.ijrcog20180182

MedPage Today. Nulliparity linked to higher risk of clear cell and endometrioid ovarian tumors. Available at: https://www.medpagetoday.com/resource-centers/focus-ovarian-cancer/nulliparity-linked-higher-risk-clear-cell--endometrioid-ovarian-tumors/1780. Accessed on 22 May 2026.

International Agency for Research on Cancer. Patients with cancer and a history of diabetes or cardiovascular disease are at higher risk of all-cause and cancer-specific mortality. Available at: https://www.iarc.who.int/news-events/patients-with-cancer-and-a-history-of-diabetes-or-cardiovascular-disease-are-at-higher-risk-of-all-cause-and-cancer-specific-mortality/. Accessed on 22 May 2026.

Wang T, Read SH, Moino D, Ayoubi Y, Chern JY, Tworoger SS. Tobacco smoking and survival following a diagnosis of ovarian cancer. Cancer Epidemiol Biomarkers Prev. 2022;31:1376-82. DOI: https://doi.org/10.1158/1055-9965.EPI-21-1327

Garg R, Singh S, Rani R, Agrawal M, Rajvanshi R. A clinicopathological study of malignant ovarian tumors in India. J South Asian Feder Menopause Soc. 2014;2:9-11. DOI: https://doi.org/10.5005/jp-journals-10032-1024

Yogambal M, Arunalatha P, Chandramouleeswari K, Palaniappan V. Ovarian tumours: incidence and distribution in a tertiary referral center in South India. IOSR J Dent Med Sci. 2014;13:74-80. DOI: https://doi.org/10.9790/0853-13237480

Kamal S, Kumar M. Clinicopathological analysis of ovarian tumors in a tertiary care hospital. Int J Acad Med Pharm. Available at: http://www.academicmed.org. Accessed on 22 May 2026.

Hossain N, Ft K, Ms M. Clinico-pathological features and treatment outcome of malignant epithelial ovarian tumours. Bangladesh Med Res Counc Bull. 2020;46:115-9. DOI: https://doi.org/10.3329/bmrcb.v46i2.49021

Ataseven B, Chiva LM, Harter P, Gonzalez-Martin A, du Bois A. FIGO stage IV epithelial ovarian, fallopian tube and peritoneal cancer revisited. Gynecol Oncol. 2016;142:597-607. DOI: https://doi.org/10.1016/j.ygyno.2016.06.013

Gersekowski K, Na R, Alsop K, Delahunty R, Goode EL, Cunningham JM, et al. Risk factors for ovarian cancer by BRCA status: a collaborative case-only analysis. Cancer Epidemiol Biomarkers Prev. 2024;33:586-93. DOI: https://doi.org/10.1158/1055-9965.EPI-23-0984

Sekine M, Enomoto T, Arai M, Hiroki D, Hiroyuki N, Takeshi I, et al. Differences in age at diagnosis of ovarian cancer for each BRCA mutation type in Japan: optimal timing to carry out risk-reducing salpingo-oophorectomy. J Gynecol Oncol. 2022;33(4):e46. DOI: https://doi.org/10.3802/jgo.2022.33.e46

Ren L, Yao R, Hou T, Liu C, Zhao F, Chen X, et al. Pan-cancer analysis of homologous recombination deficiency and homologous recombination repair-associated gene alterations in solid tumors from a large Asian cohort. BMC Cancer. 2025;25:14267. DOI: https://doi.org/10.1186/s12885-025-14267-w

Fiegl H, Schnaiter S, Reimer DU, Leitner K, Nardelli P, Tsibulak I, et al. BRCA loss of function including BRCA1 DNA-methylation, but not BRCA-unrelated homologous recombination deficiency, is associated with platinum sensitivity. Clin Epigenetics. 2024;16:171. DOI: https://doi.org/10.1186/s13148-024-01781-0

Zhao S, Zhang M, Zhu X, Xing J, Zhou J, Yin X. The potential regulatory role of RNA methylation in ovarian cancer. RNA Biol. 2023;20:207-18. DOI: https://doi.org/10.1080/15476286.2023.2213915

Wei Q, Yang D, Liu X, Zhao H, Yang Y, Xu J, et al. Exploration of the role of m6A RNA methylation regulators in malignant progression and clinical prognosis of ovarian cancer. Front Genet. 2021;12:650554. DOI: https://doi.org/10.3389/fgene.2021.650554

Murai J, Pommier Y. BRCAness, homologous recombination deficiencies, and synthetic lethality. Cancer Res. 2023;83(8):1173-4. DOI: https://doi.org/10.1158/0008-5472.CAN-23-0628

Charkhchi P, Cybulski C, Gronwald J, Wong FO, Narod SA, Akbari MR. CA125 and ovarian cancer: a comprehensive review. Cancers (Basel). 2020;12(12):3730. DOI: https://doi.org/10.3390/cancers12123730

Poveda A, Lheureux S, Colombo N, Cibula D, Lindemann K, Weberpals J, et al. Olaparib maintenance monotherapy in platinum-sensitive relapsed ovarian cancer patients without a germline BRCA1/BRCA2 mutation: OPINION primary analysis. Gynecol Oncol. 2022;164(3):498-504. DOI: https://doi.org/10.1016/j.ygyno.2021.12.025

Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/BRCA2 mutation (SOLO2/ENGOT-Ov21): final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021;22(5):620-31. DOI: https://doi.org/10.1097/OGX.0000000000000962

Indian Council of Medical Research. Consensus document for management of epithelial ovarian cancer. New Delhi: Indian Council of Medical Research; Available at: https://www.icmr.gov.in/icmrobject/custom_data/pdf/resource-guidelines/Ovarian_Cancer.pdf. Accessed on 21 May 2026.