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PURPOSE This phase III, multicenter, randomized, open-label study investigated the efficacy and safety of nivolumab versus chemotherapy (gemcitabine [GEM] or pegylated liposomal doxorubicin [PLD]) in patients with platinum-resistant ovarian cancer. MATERIALS AND METHODS Eligible patients had platinum-resistant epithelial ovarian cancer, received ≤ 1 regimen after diagnosis of resistance, and had an Eastern Cooperative Oncology Group performance score of ≤ 1. Patients were randomly assigned 1:1 to nivolumab (240 mg once every 2 weeks [as one cycle]) or chemotherapy (GEM 1000 mg/m2 for 30 minutes [once on days 1, 8, and 15] followed by a week's rest [as one cycle], or PLD 50 mg/m2 once every 4 weeks [as one cycle]). The primary outcome was overall survival (OS). Secondary outcomes included progression-free survival (PFS), overall response rate, duration of response, and safety. RESULTS Patients (n = 316) were randomly assigned to nivolumab (n = 157) or GEM or PLD (n = 159) between October 2015 and December 2017. Median OS was 10.1 (95% CI, 8.3 to 14.1) and 12.1 (95% CI, 9.3 to 15.3) months with nivolumab and GEM or PLD, respectively (hazard ratio, 1.0; 95% CI, 0.8 to 1.3; P = .808). Median PFS was 2.0 (95% CI, 1.9 to 2.2) and 3.8 (95% CI, 3.6 to 4.2) months with nivolumab and GEM or PLD, respectively (hazard ratio, 1.5; 95% CI, 1.2 to 1.9; P = .002). There was no statistical difference in overall response rate between groups (7.6% v 13.2%; odds ratio, 0.6; 95% CI, 0.2 to 1.3; P = .191). Median duration of response was numerically longer with nivolumab than GEM or PLD (18.7 v 7.4 months). Fewer treatment-related adverse events were observed with nivolumab versus GEM or PLD (61.5% v 98.1%), with no additional or new safety risks. CONCLUSION Although well-tolerated, nivolumab did not improve OS and showed worse PFS compared with GEM or PLD in patients with platinum-resistant ovarian cancer.

5524 Background: Patients with persistent cervical cancer after definitive radiotherapy/concurrent chemoradiotherapy (RT/CCRT) have a poor prognosis. Salvage hysterectomy (HT) is potentially curative, but eligibility criteria therefor have not been determined. Methods: Part 1) Retrospective review of patients with persistent cervical cancer treated with definitive RT/CCRT at 35 institutions of the Japanese Clinical Oncology Group (JCOG) from 2005–2014. Differences between a salvage HT group and a systemic chemotherapy (CT) group after definitive RT/CCRT for residual tumor were evaluated. Clinical variables influencing a salvage HT treatment decision were evaluated using logistic regression analysis. Part 2) Questionnaire-based survey conducted by JCOG gynecologic oncologists assessing treatment choice for patients with residual cervical disease after definitive RT/CCRT. Patients with residual cervical tumor before, during and after definitive RT/CCRT were surveyed for 86 conditions and appropriate candidates for salvage HT were evaluated using heat map analysis. Results: Part 1) We identified 298 patients who underwent salvage HT or systemic CT. Median overall survival was 3.8 and 0.9 year in the HT and CT groups, respectively (HR 0.4341, 95% CI 0.336-0.559, p < 0.01). FIGO stage and lymph node metastasis at initial treatment, performance status (PS) at diagnosis of residual cervical tumor and parametrial invasion of residual cervical tumor significantly influenced a salvage HT treatment decision. Part 2) Heat map analysis showed that surveyed variables segregated into 3 groups: i) in favor of salvage HT, ii) in favor of systemic CT, and iii) either. Conditions such as FIGO stage IB-IIB, PS of 0-1, residual tumor < 4 cm, no parametrial invasion and no residual lymph node metastasis were included in group i, in favor of salvage HT. Conclusions: Eligibility criteria could be determined based on the results of the current study, and a prospective clinical trial evaluating the survival benefit of salvage HT for residual cervical tumor after definitive RT/CCRT is being planned by JCOG.

5527Background: Patients with persistent cervical cancer after definitive radiotherapy/concurrent chemoradiotherapy (RT/CCRT) have a poor prognosis. Salvage hysterectomy (HT) is considered curative...

TPS5603Background: Patients with metastatic or recurrent CC who are not amenable to curative treatment with surgery or radiation have a poor prognosis, and systemic chemotherapy is regarded as a st...

5503 Background: The superiority of chemotherapy regimens employing a taxane plus a platinum agent over standard therapy with doxorubicin plus cisplatin (AP) was recently demonstrated for advanced or recurrent endometrial cancer. This multicenter phase III trial evaluated the clinical benefit of taxane plus platinum agent regimens as adjuvant chemotherapy compared with AP for endometrial cancer patients at high risk of recurrence after surgery. Methods: Endometrial cancer patients having a high risk of recurrence and postoperative residual disease < 2 cm were randomly assigned (1:1:1) with stratification by FIGO stage and histologic grade to receive 6 cycles of doxorubicin (60 mg/m2) plus cisplatin (50 mg/m2) on day 1 (AP), docetaxel (70 mg/m2) plus cisplatin (60 mg/m2) on day 1 (DP) or paclitaxel (180 mg/m2) plus carboplatin (AUC 6.0 mg/mL x minute) on day 1 (TC) every 3 weeks as adjuvant chemotherapy. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), adverse events, and tolerability. Results: From November 2006 to January 2011, 788 patients were enrolled from 118 institutions in Japan and were eligible for evaluation. The proportion of patients receiving 6 cycles was 80% for AP, 83% for DP, and 76% for TC, and tolerability of the regimens showed no significant difference. After a median follow-up period of 7.0 years, there was no statistical difference of PFS (P=0.1246) or OS (P=0.6734) among the 3 groups. The 5-year PFS rate was 74.9% for AP, 80.9% for DP, and 74.7% for TC, while the 5-year OS rates were 84.3%, 89.3%, and 88.4%, respectively. Conclusions: There was no significant difference of survival among patients receiving AP, DP, or TC as adjuvant chemotherapy for endometrial cancer. Since each regimen showed adequate tolerability, taxane plus platinum agent regimens may be a reasonable alternative to AP. Clinical trial information: UMIN000000522.