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
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) | ||
---|---|---|---|
O | P | O vs P | |
Upfront surgery | NR | 15.3 | 0.31 (0.21–0.46) |
Interval surgery | 33.6 | 9.8 | 0.37 (0.24–0.58) |
Residual disease | 29.4 | 11.3 | 0.44 (0.25–0.77) |
No residual disease | NR | 15.3 | 0.33 (0.23–0.46) |
Clinical CR*‡ | NR | 15.3 | 0.34 (0.24–0.47) |
Clinical PR†‡ | 30.9 | 8.4 | 0.31 (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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