Maintenance olaparib after platinum-based chemotherapy in patients (pts) with newly diagnosed advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): Efficacy by surgical and tumor status in the Phase III SOLO1 trial.

Authors

null

Cara Amanda Mathews

Women & Infants Hospital, Providence, RI

Cara Amanda Mathews , Kathleen N. Moore , Nicoletta Colombo , Giovanni Scambia , Byoung-Gie Kim , Ana Oaknin , Michael Friedlander , Alla Sergeevna Lisyanskaya , Anne Floquet , Alexandra Leary , Gabe S. Sonke , Charlie Gourley , Susana N. Banerjee , Amit M. Oza , Antonio González-Martín , Carol Aghajanian , William Hampton Bradley , Elizabeth S. Lowe , Ralph Bloomfield , Paul Disilvestro

Organizations

Women & Infants Hospital, Providence, RI, Stephenson Cancer Center at the University of Oklahoma, Oklahoma City, OK, University of Milan-Bicocca and Istituto Europeo di Oncologia, Milan, Italy, Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Rome, Italy, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, Prince of Wales Clinical School, University of New South Wales, and Royal Hospital for Women, Sydney, Australia, St Petersburg City Oncology Dispensary, St Petersburg, Russia, Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, Bordeaux, France, Gustave-Roussy Cancer Campus, Villejuif, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, France, The Netherlands Cancer Institute, Amsterdam, Netherlands, Cancer Research UK Edinburgh Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, United Kingdom, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, United Kingdom, Princess Margaret Cancer Centre, Toronto, ON, Canada, MD Anderson Cancer Center, Madrid, Spain, Memorial Sloan Kettering Cancer Center, New York, NY, Froedtert and the Medical College of Wisconsin, Milwaukee, WI, AstraZeneca, Gaithersburg, MD, AstraZeneca, Cambridge, United Kingdom

Research Funding

Pharmaceutical/Biotech Company

Background: In SOLO1 (NCT01844986), maintenance olaparib significantly improved progression-free survival (PFS) vs placebo (HR 0.30; 95% CI 0.23–0.41; Moore et al. N Engl J Med 2018) in pts with newly diagnosed advanced OC and a BRCAm. This analysis evaluates olaparib efficacy by timing of surgery, presence of residual tumor following surgery and response status after completion of chemotherapy in SOLO1. Methods: Pts underwent cytoreductive surgery and were in clinical complete response (CR) or partial response (PR) after platinum-based chemotherapy. Pts were stratified by response and received olaparib tablets 300 mg twice daily or placebo. Investigator-assessed PFS and objective response were assessed using modified RECIST v1.1. Results: 260 pts were randomized to olaparib and 131 to placebo; one pt did not receive placebo. Median follow-up was 41 months in both arms. 63% and 35% of pts underwent upfront and interval surgery, 21% and 76% had residual and no residual macroscopic disease after surgery, and 74% and 26% entered the study in clinical CR and PR (based on electronic case report form [eCRF] data). PFS was significantly improved regardless of the timing of surgery, residual disease status after surgery or response after platinum-based chemotherapy (Table). In pts with baseline radiologic evidence of disease (n=80; eCRF), the objective response rate was 43% for olaparib (CR, 28%) and 23% for placebo (CR, 12%). Conclusions: Maintenance olaparib improved outcomes compared with placebo in pts with newly diagnosed advanced OC and a BRCAm, regardless of surgical or tumor status. Clinical trial information: NCT01844986

Median PFS, months
HR (95% CI)
OPO vs P
Upfront surgeryNR15.30.31 (0.21–0.46)
Interval surgery33.69.80.37 (0.24–0.58)
Residual disease29.411.30.44 (0.25–0.77)
No residual diseaseNR15.30.33 (0.23–0.46)
Clinical CR*NR15.30.34 (0.24–0.47)
Clinical PR†‡30.98.40.31 (0.18–0.52)

*NED and a normal CA-125 level. ≥30% decrease in tumor volume or NED after chemotherapy but an abnormal CA-125 level. By eCRF. NED, no radiologic evidence of disease; NR, not reached; O, olaparib; P, placebo

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT01844986

Citation

J Clin Oncol 37, 2019 (suppl; abstr 5541)

DOI

10.1200/JCO.2019.37.15_suppl.5541

Abstract #

5541

Poster Bd #

364

Abstract Disclosures