The prognosis of patients with recurrent or persistent ovarian clear cell carcinoma: Results from a randomized phase III study (JGOG3017/GCIG).

Abstract

5515 Background: There are currently no concise data on prognosis in patients with recurrent or persistent clear cell carcinoma (CCC). The JGOG3017/GCIG was a randomized phase III trial to compare paclitaxel plus carboplatin (TC) to CPT-11 plus cisplatin (CPT-P) for stage I to IV CCC patients who have been diagnosed by central pathological review (CPR). A total of 619 patients were eligible for efficacy analyses. The aim of this study was to investigate prognosis of these patients with recurrent or persistent CCC. Methods: We estimated median and restricted mean survival time (RMST) of post-progression survival (PPS) of patients with recurrent or persistent CCC by platinum sensitivity, treatment arm, crossover chemotherapy, primary stage, residual tumor, performance status and ethnicity. PPS rates at 6, 12, 18 and 24-month were also calculated. Results: Among the 619 patients, the recurrence rate of stages was as follows: 6.3% (6/96) in stage IA/IB, 14.6% (46/315) in stage IC, and 54.8% (114/208) in stage II- Ⅳ. The recurrence rate of surgical situations was as follows: 19.4% (106/544) in complete surgery, 75% (27/36) in optimal, and 84.6% (33/39) in suboptimal. Overall, 166 of 619 patients had recurrent disease. The median PPS were 14.0 months (95% confidence interval [CI], 12.6 – 17.9) for all patients, 13.5 months (95% CI, 11.4 – 19.6) in the TC group (n=77) and 14.4 months (95% CI, 11.0 - 18.8) in the CPT-T group (n=89), with no significant difference between the two groups (hazard ratio, 1.02; 95% CI, 0.71 - 1.47, log-rank P = 0.898). The RMST of PPS for all patients was 14.6 months (95% CI, 13.3 - 15.8). Median PPS for patients with platinum-resistant (44.6%, n=74) and platinum-sensitive (53.0%, n=88) disease were 10.9 months (95% CI, 8.9 - 13.3) and 18.8 months (95% CI, 15.0 - 28.7) (HR, 1.88; 95% CI, 1.30-2.72, p<0.001), respectively. Conclusions: The median PPS of patients with platinum-resistant recurrence was significantly shorter than that of patients with platinum-sensitive recurrence. Data on PPS in patients with recurrent CCC that will be the basis of a future clinical trial in such patients were obtained.