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Overall Survival Results From the POLO Trial: A Phase III Study of Active Maintenance Olaparib Versus Placebo for Germline BRCA-Mutated Metastatic Pancreatic Cancer
Open accessAbstract
PURPOSE: The phase III POLO study demonstrated significant progression-free survival (PFS) benefit for active olaparib maintenance therapy versus placebo for patients with metastatic pancreatic adenocarcinoma and a germline BRCA mutation. Here, we report the final analysis of overall survival (OS) and other secondary end points. PATIENTS AND METHODS: Patients with a deleterious or suspected deleterious germline BRCA mutation whose disease had not progressed after ≥ 16 weeks of first-line platinum-based chemotherapy were randomly assigned 3:2 to active maintenance olaparib (300 mg twice daily) or placebo. The primary end point was PFS; secondary end points included OS, time to second disease progression or death, time to first and second subsequent cancer therapies or death, time to discontinuation of study treatment or death, and safety and tolerability. RESULTS: In total, 154 patients were randomly assigned (olaparib, n = 92; placebo, n = 62). No statistically significant OS benefit was observed (median 19.0 v 19.2 months; hazard ratio [HR], 0.83; 95% CI, 0.56 to 1.22; P = .3487). Kaplan-Meier OS curves separated at approximately 24 months, and the estimated 3-year survival after random assignment was 33.9% versus 17.8%, respectively. Median time to first subsequent cancer therapy or death (HR, 0.44; 95% CI, 0.30 to 0.66; P < .0001), time to second subsequent cancer therapy or death (HR, 0.61; 95% CI, 0.42 to 0.89; P = .0111), and time to discontinuation of study treatment or death (HR, 0.43; 95% CI, 0.29 to 0.63; P < .0001) significantly favored olaparib. The HR for second disease progression or death favored olaparib without reaching statistical significance (HR, 0.66; 95% CI, 0.43 to 1.02; P = .0613). Olaparib was well tolerated with no new safety signals. CONCLUSION: Although no statistically significant OS benefit was observed, the HR numerically favored olaparib, which also conferred clinically meaningful benefits including increased time off chemotherapy and long-term survival in a subset of patients.
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“longer follow up data did not demonstrate a similar improvement in overall survival (OS) compared to patients who received placebo alone following platinum-based therapy88.”
From Pancreatic cancer: Advances and challenges (2023) · cites this paper as [88]
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Metadata
- Authors
- Kindler, H. L., Hammel, P., Reni, M., Van Cutsem, E., Macarulla, T., Hall, M. J., Park, J. O., Hochhauser, D., Arnold, D., Oh, D.-Y., Reinacher-Schick, A., Tortora, G., Algül, H., O'Reilly, E. M., Bordia, S., McGuinness, D., Cui, K., Locker, G. Y., & Golan, T.
- Affiliations
- University of Chicago (US)
- Université Paris-Saclay (FR)
- IRCCS Ospedale San Raffaele (IT)
- University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium
- Vall d'Hebron Hospital Universitari (ES)
- Fox Chase Cancer Center (US)
- Samsung Medical Center (KR)
- University College London (GB)
- Asklepios Klinik Altona (DE)
- Seoul National University (KR)
- St Josef-Hospital, Ruhr University Bochum, Bochum, Germany
- Università Cattolica del Sacro Cuore (IT)
- TUM Klinikum (DE)
- Memorial Sloan Kettering Cancer Center (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- AstraZeneca (United Kingdom) (GB)
- AstraZeneca (United States) (US)
- Tel Aviv University (IL)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2022-12-01
- Volume
- 40
- Issue
- 34
- Pages
- 3929-3939
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC10476841
- OpenAlex
- W4285386328
- Cited by
- 244
- References
- 39
- Citations by year
- 2026: 60 · 2025: 68 · 2024: 59 · 2023: 48 · 2022: 9
- FWCI
- 19.25
- Type
- journal article
- Language
- en
- Update notices
- correction (2024-04-30)
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- Lirias (KU Leuven) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- American Society of Clinical Oncology
- Alnylam Pharmaceuticals
- Celgene
- FibroGen
- Array BioPharma
- Boston Scientific Corporation
- Merck KGaA
- Taiho Pharmaceutical
- Exelixis
- Novocure
- Les Laboratories Pierre Fabre
- Halozyme
- Mylan
- Constellation Pharmaceuticals
- BeiGene
- Incyte
- MacroGenics
- Eisai
- Astellas Pharma
- European Society for Medical Oncology
- Servier
- Swedish Orphan Biovitrum
- Ipsen
- Sirtex Medical
- Aptitude Health
- National Institutes of Health (CA008748)
- Genentech
- EMD Serono
- Chugai Pharmaceutical
- National Cancer Institute (CA008748, P30- 17 CA008748, P30CA008748)
- Daiichi Sankyo Europe
- Topics
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › BRCA gene mutations in cancer
- Keywords
- olaparib, maintenance therapy, germline BRCA mutation, metastatic pancreatic adenocarcinoma, PARP inhibitors, overall survival, progression-free survival, platinum-based chemotherapy, secondary malignancies, PARP inhibitor resistance, treatment discontinuation, safety and tolerability
- MeSH terms
- Adenocarcinoma, Female, Germ Cells, Humans, Neoplasm Recurrence, Local, Ovarian Neoplasms, Pancreatic Neoplasms, Phthalazines, Piperazines, Disease Progression
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