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Abstract
Introduction The introduction of poly-ADP ribose polymerase inhibitors in ovarian cancer has demonstrated significantly improved progression free survival in four randomized controlled clinical trials in patients with platinum sensitive relapsed ovarian cancer. While overall survival data remain immature, this real world evidence study sets a baseline for future evaluation of poly-ADP ribose polymerase inhibitors.
Methods A retrospective chart review was undertaken to investigate real world survival outcomes across 13 National Health Service Trusts in England, Wales, and Scotland. Patients were included if they had platinum sensitive relapsed high grade serous ovarian cancer and had responded to secondline platinum based chemotherapy. Clinical data were collected retrospectively from electronic prescribing records and chart notes. The index date for overall survival analysis was defined as the later of (1) day 1 of the final secondline platinum based treatment or (2) date of response to secondline treatment. The primary objective was overall survival from the index date. Secondary objectives included progression free survival and overall survival by subsequent line of treatment. BRCA mutation status was collected where available. Quality of life questionnaires were not assessed within this study.
Results 233 patients were identified who met the study inclusion criteria. Patient characteristics were consistent with other published data, with a median age of 61 years (range 35–85). Sensitivity analysis of the primary objective demonstrated that the earliest point poly-ADP ribose polymerase inhibitors may be initiated (following completion of secondline chemotherapy) is associated with a median overall survival of 19.8 months. Secondline median overall survival and progression free survival from the index date were 19.3±2.4 months and 7.3±1.2 months, respectively. 144 patients were treated with thirdline chemotherapy with median overall survival and progression free survival from the index date (either date of last cycle of thirdline treatment or date of response to thirdline treatment) of 8.3±2.6 and 4.4±1.8 months, respectively.
Conclusion Overall survival was shown to be shorter in this real world study compared with randomized clinical trials, and underlines the differences in clinical outcomes of patients in a real life setting. This baseline real world study has demonstrated poor survival outcomes in this patient group prior to availability of poly-ADP ribose polymerase inhibitors.
- ovarian cancer
- fallopian tube neoplasms
- peritoneal neoplasms
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Footnotes
Contributors All authors were involved in the development of the study protocol and objectives, and review and writing of the manuscript.
Funding This work was supported by AstraZeneca.
Competing interests TM, JR, and OC are employees of AstraZeneca UK Ltd, a biopharmaceutical company who manufactures treatments for ovarian cancer. RL declares advisory board work for and travel grants from AstraZeneca and Tesaro. RM reports consultancy work for Merck, Tesaro, and Clovis Oncology, serving on speaker’s bureau for Roche and Tesaro, and has received travel grants from AstraZeneca and Tesaro. RJ reports advisory board work for Tesaro and Clovis Oncology and travel grants from AstraZeneca, Pharma Mar, and Tesaro. RMG reports advisory board work for AstraZeneca, Tesaro, Clovis, Immunogen, and Sotio; funding to attend conferences from AstraZeneca, Tesaro, and Roche; and research funding from Boehringer Ingelheim and Lilly/Ignyta. RMG is also the national coordinating investigator for the OREO trial (AstraZeneca) and First trial (Tesaro), and is the site principal investigator for the ORZORA trial (AstraZeneca) as well as other trials sponsored by Tesaro, Clovis, Immunogen, and Pfizer. EH reports advisory board work for Roche and Tesaro. MH has undertaken advisory work for Roche, Clovis Oncology, Amgen, Tesaro, and AstraZeneca.
Patient consent for publication Not required.
Ethics approval Ethics approval came through the National Health Service ‘Service Evaluation’ from each individual National Health Service trust. Data were pseudonymised at source and gathered retrospectively, meaning no patient consent was required. This study was performed in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data may be obtained from a third party and are not publicly available. Pseudonymised chart notes (ie, the data) are the property of the relevant hospital trust, and may be requested from them through liaison with the corresponding author, RL (ORCID iD: 0000-0003-1544-8396). Conditions for reuse are subject to the request. Additional information (eg, protocols, statistical analysis plans) may be requested from enquiries@svmpharma.com.