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
Open accessAbstract
PURPOSE In SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986 ), maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation. We report overall survival (OS) after a 7-year follow-up, a clinically relevant time point and the longest follow-up for any poly(ADP-ribose) polymerase inhibitor in the first-line setting. METHODS This double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib (n = 260) or placebo (n = 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end point, was conducted after a 7-year follow-up. RESULTS The median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to 0.76; P = .0004 [ P < .0001 required to declare statistical significance]). At 7 years, 67.0% of olaparib patients versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not received a first subsequent treatment (Kaplan-Meier estimates). The incidence of myelodysplastic syndrome and acute myeloid leukemia remained low, and new primary malignancies remained balanced between treatment groups. CONCLUSION Results indicate a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term follow-up.
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In patients with BRCA-associated late-stage ovarian cancer, use of PARPi maintenance therapy reduces the five-year risk of disease recurrence or death by 70% over placebo.
“In patients with BRCAassociated late-stage ovarian cancer, use of PARPi maintenance therapy reduces the five-year risk of disease recurrence or death by 70% over placebo [2].”
From Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue (2023) · cites this paper as [2]
The Introduction (page unavailable) reports a progression-free survival hazard ratio of 0.30 for maintenance olaparib versus placebo in the primary analysis, and 0.33 after five years of follow-up. Those figures support an approximately 70% reduction in the hazard of progression or death, not a 70% reduction in the cumulative risk at five years. The trial studied olaparib specifically in patients with newly diagnosed advanced, BRCA-mutated ovarian cancer who had responded to platinum chemotherapy; it does not establish the claim for PARP inhibitors generally. (LLM, conf=0.88)
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- Authors
- DiSilvestro, P., Banerjee, S., Colombo, N., Scambia, G., Kim, B.-G., Oaknin, A., Friedlander, M., Lisyanskaya, A., Floquet, A., Leary, A., Sonke, G. S., Gourley, C., Oza, A., González-Martín, A., Aghajanian, C., Bradley, W., Mathews, C., Liu, J., McNamara, J., Lowe, E. S., Ah-See, M.-L., Moore, K. N., & on behalf of the SOLO1 Investigators
- Affiliations
- Women & Infants Hospital of Rhode Island (US)
- Royal Marsden NHS Foundation Trust (GB)
- European Institute of Oncology (IT)
- Agostino Gemelli University Polyclinic (IT)
- Samsung Medical Center (KR)
- Vall d'Hebron Hospital Universitari (ES)
- UNSW Sydney (AU)
- City Clinical Oncology Center (RU)
- Institut Bergonié (FR)
- Institut Gustave Roussy (FR)
- The Netherlands Cancer Institute (NL)
- Edinburgh Cancer Research (GB)
- Princess Margaret Cancer Centre (CA)
- Clínica Universidad de Navarra, Madrid, Spain
- Memorial Sloan Kettering Cancer Center (US)
- Froedtert Hospital (US)
- Dana-Farber Cancer Institute (US)
- AstraZeneca (United Kingdom) (GB)
- AstraZeneca (United States) (US)
- OU Health Stephenson Cancer Center (US)
- Corresponding author
- DiSilvestro, Paul
- ORCID
- DiSilvestro, Paul
- Banerjee, Susana
- Colombo, Nicoletta
- Scambia, Giovanni
- Kim, Byoung-Gie
- Oaknin, Ana
- Friedlander, Michael
- Lisyanskaya, Alla
- Floquet, Anne
- Leary, Alexandra
- Sonke, Gabe S.
- Gourley, Charlie
- Oza, Amit
- González-Martín, Antonio
- Aghajanian, Carol
- Bradley, William
- Mathews, Cara
- Liu, Joyce
- Lowe, Elizabeth S.
- Ah-See, Mei-Lin
- Moore, Kathleen N.
- Venue
- Journal of Clinical Oncology
- Published
- 2023-01-20
- Volume
- 41
- Issue
- 3
- Pages
- 609-617
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC9870219
- OpenAlex
- W4295078726
- Cited by
- 511
- References
- 19
- Citations by year
- 2026: 118 · 2025: 147 · 2024: 140 · 2023: 99 · 2022: 7
- FWCI
- 41.12
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Journal of Clinical Oncology (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (publishedVersion, other-oa)
- BOA (University of Milano-Bicocca) (submittedVersion, cc-by-nc-nd)
- Funders
- AstraZeneca
- Sanofi
- NRG Oncology
- National Cancer Institute (P30CA008748)
- Topics
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › BRCA gene mutations in cancer
- Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
- Keywords
- olaparib, maintenance therapy, advanced ovarian cancer, BRCA1 mutation, BRCA2 mutation, PARP inhibitors, overall survival, long-term follow-up, platinum-based chemotherapy, myelodysplastic syndrome, acute myeloid leukemia
- MeSH terms
- Poly(ADP-ribose) Polymerase Inhibitors, Antineoplastic Agents, Female, Follow-Up Studies, Humans, Mutation, Neoplasm Recurrence, Local, Ovarian Neoplasms, Phthalazines, Piperazines, Maintenance Chemotherapy
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