Olaparib as Treatment Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer: Phase III SOLO3 Study Final Overall Survival Results
Olaparib treatment significantly improved objective response rate (primary end point) and progression-free survival versus nonplatinum chemotherapy in patients with BRCA-mutated platinum-sensitive relapsed ovarian cancer in the open-label phase III SOLO3 trial (ClinicalTrials.gov identifier: NCT02282020). We report final overall survival (OS; prespecified secondary end point), post hoc OS analysis by number of previous chemotherapy lines, and exploratory BRCA reversion mutation analysis. Two hundred sixty-six patients were randomly assigned 2:1 to olaparib tablets (300 mg twice daily; n = 178) or physician's choice of single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan; n = 88). OS was similar with olaparib versus chemotherapy (hazard ratio [HR], 1.07 [95% CI, 0.76 to 1.49]; <i>P</i> = .71, median 34.9 and 32.9 months, respectively, full analysis set). OS with olaparib was favorable in patients with two previous chemotherapy lines (HR, 0.83 [olaparib <i>v</i> chemotherapy] [95% CI, 0.51 to 1.38]; median 37.9 <i>v</i> 28.8 months); however, a potential detrimental effect was seen in patients with at least three previous chemotherapy lines (HR, 1.33 [95% CI, 0.84 to 2.18]; median 29.9 <i>v</i> 39.4 months). BRCA reversion mutations might have contributed to this finding. No patient randomly assigned to olaparib with a BRCA reversion mutation detected at baseline (6 of 170 [3.5%]) achieved an objective tumor response.
Authors
- Charles A. Leath (ORCID: https://orcid.org/0000-0002-4034-6845)
- Ricardo Villalobos-Valencia (ORCID: https://orcid.org/0000-0001-5669-7132)
- Joo‐Hyun Nam (ORCID: https://orcid.org/0000-0001-8300-6974)
- Natalia Lukashchuk (ORCID: https://orcid.org/0009-0006-6678-0072)
- Radoslaw Madry (ORCID: https://orcid.org/0000-0002-2795-4168)
- Giovanni Scambia (ORCID: https://orcid.org/0000-0002-9503-9041)
- Elizabeth Lowe (ORCID: https://orcid.org/0000-0003-3573-7208)
- Carlos Hernández (ORCID: https://orcid.org/0000-0002-5006-7997)
- Mei-Lin Ah-See (ORCID: https://orcid.org/0009-0004-5528-8926)
- Jae‐Weon Kim (ORCID: https://orcid.org/0000-0003-1835-9436)
- Mariusz Bidziński (ORCID: https://orcid.org/0000-0003-4767-6369)
- David Cibula (ORCID: https://orcid.org/0000-0001-6387-9356)
- Dave Carter (ORCID: https://orcid.org/0000-0003-3503-7615)
- Richard T. Penson (ORCID: https://orcid.org/0000-0002-8091-8588)
- Sang Young Ryu
- Nicoletta Colombo (ORCID: https://orcid.org/0000-0003-2225-715X)
- Paulo Mora (ORCID: https://orcid.org/0000-0003-1756-3320)
Institutions
- Università Cattolica del Sacro Cuore (IT)
- AstraZeneca (United Kingdom) (GB)
- Poznan University of Medical Sciences (PL)
- Harvard University (US)
- Charles University (CZ)
- Asan Medical Center (KR)
- Seoul National University Hospital (KR)
- University of Alabama at Birmingham (US)
- Massachusetts General Hospital (US)
- Korea Institute of Radiological and Medical Sciences (KR)
- AstraZeneca (United States) (US)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- European Institute of Oncology (IT)
- University of Milano-Bicocca (IT)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2024-12-13
- DOI
- https://doi.org/10.1200/jco.24.00933
- Citations
- 5
- Primary Topic
- PARP inhibition in cancer therapy
- Type
- article
- Field-Weighted Citation Impact
- 1.41