Paul DiSilvestro1, Nicoletta Colombo2, Giovanni Scambia3, Byoung-Gie Kim4, Ana Oaknin5, Michael Friedlander6, Alla Lisyanskaya7, Anne Floquet8, Alexandra Leary9, Gabe S Sonke10, Charlie Gourley11, Susana Banerjee12, Amit Oza13, Antonio González-Martín14, Carol A Aghajanian15, William H Bradley16, Cara A Mathews1, Joyce Liu17, Elizabeth S Lowe18, Ralph Bloomfield19, Kathleen N Moore20. 1. Women & Infants Hospital, Providence, RI. 2. European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), University of Milan-Bicocca, Milan, Italy. 3. Fondazione Policlinico Universitario A Gemelli, IRCCS, Università Cattolica, Rome, Italy. 4. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. 5. Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain. 6. University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, New South Wales, Australia. 7. St Petersburg City Oncology Dispensary, St Petersburg, Russia. 8. Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, France. 9. Gustave-Roussy Cancer Campus, Villejuif, France. 10. The Netherlands Cancer Institute, Amsterdam, the Netherlands. 11. Cancer Research UK Edinburgh Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, United Kingdom. 12. The Royal Marsden National Health Service Foundation Trust and Institute of Cancer Research, London, United Kingdom. 13. Princess Margaret Cancer Centre, Toronto, Ontario, Canada. 14. Clínica Universidad de Navarra, Madrid, Spain. 15. Memorial Sloan-Kettering Cancer Center, New York, NY. 16. Froedtert and the Medical College of Wisconsin, Milwaukee, WI. 17. Dana-Farber Cancer Institute, Boston, MA. 18. AstraZeneca, Gaithersburg, MD. 19. AstraZeneca, Cambridge, United Kingdom. 20. Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK.
Abstract
PURPOSE: In SOLO1, maintenance olaparib (300 mg twice daily) significantly improved progression-free survival (PFS) for patients with newly diagnosed BRCA1- and/or BRCA2-mutated advanced ovarian cancer compared with placebo (hazard ratio [HR], 0.30; 95% CI, 0.23 to 0.41; median not reached v 13.8 months). We investigated PFS in SOLO1 for subgroups of patients based on preselected baseline factors. PATIENTS AND METHODS: Investigator-assessed PFS subgroup analyses of SOLO1 included clinical response after platinum-based chemotherapy (complete [CR] or partial response [PR]), surgery type (upfront or interval surgery), disease status after surgery (residual or no gross residual disease), and BRCA mutation status (BRCA1 or BRCA2). Additionally, we evaluated PFS in patients with stage III disease who underwent upfront surgery and had no gross residual disease. We also report objective response rate. RESULTS: The risk of disease progression or death was reduced with olaparib compared with placebo by 69% (HR, 0.31; 95% CI, 0.21 to 0.46) and 63% (HR, 0.37; 95% CI, 0.24 to 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 to 0.77) and 67% (HR, 0.33; 95% CI, 0.23 to 0.46) in patients with residual or no residual disease after surgery; 66% (HR, 0.34; 95% CI, 0.24 to 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 to 0.52); and 59% (HR, 0.41; 95% CI, 0.30 to 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a BRCA1 or BRCA2 mutation, respectively. CONCLUSION:Patients with newly diagnosed advanced ovarian cancer achieve substantial benefit from maintenance olaparib treatment regardless of baseline surgery outcome, response to chemotherapy, or BRCA mutation type.
RCT Entities:
PURPOSE: In SOLO1, maintenance olaparib (300 mg twice daily) significantly improved progression-free survival (PFS) for patients with newly diagnosed BRCA1- and/or BRCA2-mutated advanced ovarian cancer compared with placebo (hazard ratio [HR], 0.30; 95% CI, 0.23 to 0.41; median not reached v 13.8 months). We investigated PFS in SOLO1 for subgroups of patients based on preselected baseline factors. PATIENTS AND METHODS: Investigator-assessed PFS subgroup analyses of SOLO1 included clinical response after platinum-based chemotherapy (complete [CR] or partial response [PR]), surgery type (upfront or interval surgery), disease status after surgery (residual or no gross residual disease), and BRCA mutation status (BRCA1 or BRCA2). Additionally, we evaluated PFS in patients with stage III disease who underwent upfront surgery and had no gross residual disease. We also report objective response rate. RESULTS: The risk of disease progression or death was reduced with olaparib compared with placebo by 69% (HR, 0.31; 95% CI, 0.21 to 0.46) and 63% (HR, 0.37; 95% CI, 0.24 to 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 to 0.77) and 67% (HR, 0.33; 95% CI, 0.23 to 0.46) in patients with residual or no residual disease after surgery; 66% (HR, 0.34; 95% CI, 0.24 to 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 to 0.52); and 59% (HR, 0.41; 95% CI, 0.30 to 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a BRCA1 or BRCA2 mutation, respectively. CONCLUSION:Patients with newly diagnosed advanced ovarian cancer achieve substantial benefit from maintenance olaparib treatment regardless of baseline surgery outcome, response to chemotherapy, or BRCA mutation type.
Authors: F Guffanti; M F Alvisi; A Anastasia; F Ricci; M Chiappa; A Llop-Guevara; V Serra; R Fruscio; A Degasperi; S Nik-Zainal; M R Bani; M Lupia; R Giavazzi; E Rulli; G Damia Journal: Br J Cancer Date: 2021-11-03 Impact factor: 7.640
Authors: Ahmed Ebada Salem; Gabriel C Fine; Matthew F Covington; Bhasker R Koppula; Richard H Wiggins; John M Hoffman; Kathryn A Morton Journal: Cancers (Basel) Date: 2022-06-18 Impact factor: 6.575
Authors: Ana Oaknin; Amit M Oza; Domenica Lorusso; Carol Aghajanian; Andrew Dean; Nicoletta Colombo; Johanne I Weberpals; Andrew R Clamp; Giovanni Scambia; Alexandra Leary; Robert W Holloway; Margarita Amenedo Gancedo; Peter C Fong; Jeffrey C Goh; David M O'Malley; Deborah K Armstrong; Susana Banerjee; Jesus García-Donas; Elizabeth M Swisher; Terri Cameron; Lara Maloney; Sandra Goble; Jonathan A Ledermann; Robert L Coleman Journal: Cancer Med Date: 2021-09-21 Impact factor: 4.452
Authors: Pratibha S Binder; Yassar M Hashim; James Cripe; Tommy Buchanan; Abigail Zamorano; Suwanna Vangveravong; David G Mutch; William G Hawkins; Matthew A Powell; Dirk Spitzer Journal: BMC Cancer Date: 2022-03-12 Impact factor: 4.638