Randomized CLIO/BGOG-ov10 trial of olaparib monotherapy versus physician's choice chemotherapy in relapsed ovarian cancer

• Published in: Gynecologic oncology Vol. 165; no. 1; pp. 14 - 22
• Main Authors: Vanderstichele, Adriaan, Loverix, Liselore, Busschaert, Pieter, Van Nieuwenhuysen, Els, Han, Sileny N., Concin, Nicole, Callewaert, Tiene, Olbrecht, Siel, Salihi, Rawand, Berteloot, Patrick, Neven, Patrick, Lambrechts, Diether, Van Gorp, Toon, Vergote, Ignace
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2022
• Subjects: Chemotherapy; Olaparib; Ovarian cancer; PARPi; Randomized; Recurrence; Recurrence; Chemotherapy; Olaparib; Randomized; PARPi; Ovarian cancer
• DOI: 10.1016/j.ygyno.2022.01.034
• ISSN: 0090-8258

Comparison of olaparib (OLA) monotherapy versus chemotherapy in patients with platinum-sensitive (PSOC) or platinum-resistant ovarian cancer (PROC). Patients with measurable disease and ≥ 1 prior line of chemotherapy (CT) were randomized 2:1 to OLA (300 mg tablets, BID) or physician's choice CT.: for PSOC: Carboplatin-Pegylated-Liposomal-Doxorubicin (PLD) or Carboplatin-Gemcitabine; for PROC: PLD, Topotecan, Paclitaxel or Gemcitabine. 160 patients (60 with PSOC and 100 with PROC) were randomized 2:1 to OLA (n = 107) or CT (n = 53). Baseline characteristics were similar between both arms. Overall objective response rate (ORR) for OLA and CT were similar (24.3% (26/107) and 28.3% (15/53), respectively). Clinical benefit rate (≥ 12 weeks) was similar with 54.2% (58/107) and 56.6% (30/53), respectively. In PSOC, ORR was 35.0% (14/40) and 65.0% (13/20) for OLA and CT (p = 0.053); in PROC, ORR was 17.9% (12/67) and 6.1% (2/33) for OLA and CT (p = 0.134). ORR in heavily pretreated PROC (>4 prior lines) was 22.9% (8/35) with OLA versus 0% (0/14) for CT. ORR of 35.7% (5/14) and 13.2% (7/53) was observed in BRCA-mutated and -wildtype PROC cases, respectively. Median PFS in PROC was not significantly different with 2.9 months (95% CI 2.8–5.1 in the OLA group versus 3.8 months (95% CI 3.0–6.4) in the CT group (hazard ratio [HR] 1.11 [95% CI 0.72–1.78]; log-rank p = 0.600). OLA monotherapy showed overall an equal response rate in relapsed ovarian cancer compared with CT. In PROC, ORR and TFST tended to be higher with OLA than with CT. In heavily pretreated patients (four lines or more) with PROC disease, OLA treatment seemed to be more effective than CT. •Phase II randomized study of olaparib monotherapy versus chemotherapy in recurrent ovarian cancer•Objective response rate was overall similar in the total study (n = 160) for olaparib and chemotherapy•In platinum-sensitive disease the response rate was numerically higher with chemotherapy•Progression free survival, clinical benefit rate and overall survival were overall not significantly different.•In platinum-resistant ovarian cancer with ≥4 prior lines, olaparib seemed to be more effective than chemotherapy.