A non-interventional, multicenter study to assess prevalence of BRCA1 and BRCA2 mutation among ovarian, primary peritoneal, and fallopian tube cancer patients in India.

Rohit Kodagali AstraZeneca Pharma India Ltd., Bengaluru, India info_outline Rohit Kodagali, Sudeep Gupta, Senthill J Rajappa, Suresh Hariram Advani, Amit Agarwal, Shyam Aggarwal, Chanchal Goswami, Palanki Satya Dattatreya, Devavrat Arya, Shekhar Patil

Authors Rohit Kodagali AstraZeneca Pharma India Ltd., Bengaluru, India info_outline Rohit Kodagali, Sudeep Gupta, Senthill J Rajappa, Suresh Hariram Advani, Amit Agarwal, Shyam Aggarwal, Chanchal Goswami, Palanki Satya Dattatreya, Devavrat Arya, Shekhar Patil Organizations AstraZeneca Pharma India Ltd., Bengaluru, India, Department of Medical Oncology, Breast Disease Management Group, Tata Memorial Centre (TMC), Mumbai, India, Indo American Cancer Hospital and Research Institute, Hyderabad, India, Jaslok Hopsital and Research Centre, Mumbai, India, B L Kapur Memorial Hospital, Delhi, India, Sir Ganga Ram Hospital, New Delhi, India, B.P. Poddar Hospital and Medical Research Ltd, Kolkata, India, Omega Hospital, Hyderabad, India, Fortis International Oncology Center, Moida, India, HCG Cancer Center, Bengaluru, India Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Background: BRCA1 and BRCA2 are tumour suppressor genes. 1,2 Functional BRCA proteins regulate cell growth and prevent abnormal cell division that might lead to tumour development. Approximately 17% (Range 3 – 27 %) of ovarian cancer patients worldwide have a BRCA mutation. 3 This study aimed to estimate the prevalence of germline BRCA mutations among previously and newly diagnosed ovarian, primary peritoneal or fallopian tube cancer patients in India. Methods: This is a non-interventional, cross-sectional, multicenter, prospective, observational study conducted at 15 sites from different geographical regions across India. The study targets to enroll 240 patients over 6 months. The calculated sample size for this study is 228, assuming 5 % precision and a dropout rate of 10 %. The study enrolled females with new or previous diagnosis of ovarian, primary peritoneal, or fallopian tube cancer. No study medication was administered as a part of study procedure. Results: In the interim analysis performed on the first 100 enrolled patients, 22% of Ovarian, primary peritoneal or fallopian tube cancer patients were found to be BRCA1/BRCA2 mutation positive (CI 0.1433-0.3139). 52% of these enrolled patients were found to have serous histopathology, 23.1% of which were found to be BRCA1/2 positive. The percentage of BRCA1/2 mutation status in patients who had a family history of ovarian or breast cancer was found to be 66.7% and 62.5% respectively. Conclusions: In this study, the prevalence of BRCA1 and BRCA2 mutations among patients with ovarian, primary peritoneal and fallopian tube cancer patients in the first 100 patients enrolled was found to be 22%. References: 1. Vos S, et al. Crit Rev Oncol Hematol. 2018 Jul;127:29-41; 2. Solodskikh SA et al. Mutat Res. 2019 Jan;813:51-57; 3. Alsop K, et al. J Clin Oncol. 2012;30(21):2655-2663.