Ngoi Natalie Y L, Choi Chel Hun, Zhu Junxian, Lim Diana, Tan Tuan Zea, Sun Haoyang, Heong Valerie, Ow Samuel G W, Chay Wen Yee, Kim Hee Seung, Lim Yi Wan, Lim Siew Eng, Goss Geraldine, Goh Jeffrey C, Kim Jae-Weon, Friedlander Michael, Tai Bee Choo, Kim Kidong, Tan David S P
Department of Haematology-Oncology, National University Cancer Institute, Singapore, Singapore.
Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Clin Cancer Res. 2025 Sep 15;31(18):3907-3915. doi: 10.1158/1078-0432.CCR-25-0201.
The optimal treatment of recurrent ovarian clear cell carcinoma (rOCCC) remains unknown. This is the first randomized trial to compare durvalumab with chemotherapy in rOCCC.
MOCCA is a randomized, phase 2 trial conducted in Singapore, Korea, and Australia. Eligible patients had rOCCC with recurrence after platinum-based chemotherapy, Eastern Cooperative Oncology Group performance status ≤2, and no prior immune checkpoint blockade. Patients were randomly assigned (2:1) to durvalumab (1,500 mg every 4 weeks) or chemotherapy. Patients progressing on chemotherapy were allowed to cross over to durvalumab. The primary outcome was progression-free survival. Secondary outcomes included overall survival, objective response rates, and safety.
Forty-eight eligible women were assigned to durvalumab (N = 31) or chemotherapy (N = 17). The median progression-free survival was 7.6 [95% confidence interval (CI), 7.0-16.0] and 14.0 (95% CI, 7.0-32.9) weeks with durvalumab and chemotherapy, respectively (HR = 1.6; 95% CI, 0.8-3.0; P = 0.92). The median overall survival was 37.9 (95% CI, 21.7-143.0) and 40.6 (95% CI, 25.0-not reached) weeks, respectively (HR = 1.5; 95% CI, 0.7-3.3; P = 0.85). The difference in objective response rates between the groups was not statistically significant (durvalumab 9.7% vs. physician's choice chemotherapy 18.8%; difference -9.1%; 95% CI, -31.3% to 12.9%; P = 0.83). Fewer all-grade (35.5% vs. 68.8%) and high-grade (9.7% vs. 31.3%) treatment-related adverse events were observed for durvalumab. PD-L1 combined positive score (CPS)+ was observed in 28.9% (CPS ≥1%) and 10.5% (CPS ≥10%) of patients. PIK3CA mutations were associated with time to progression on durvalumab ≥12 weeks [relative risk (mutated vs. wild-type) 2.83; 95% CI, 1.16-14.17].
Durvalumab was well-tolerated but did not improve efficacy outcomes compared with chemotherapy in rOCCC.
复发性卵巢透明细胞癌（rOCCC）的最佳治疗方案仍不明确。这是第一项比较度伐利尤单抗与化疗用于rOCCC治疗的随机试验。
MOCCA是一项在新加坡、韩国和澳大利亚开展的随机2期试验。符合条件的患者为铂类化疗后复发的rOCCC患者，东部肿瘤协作组体能状态≤2，且既往未接受过免疫检查点阻断治疗。患者被随机分配（2:1）至度伐利尤单抗组（每4周1500mg）或化疗组。化疗进展的患者可交叉至度伐利尤单抗组。主要结局为无进展生存期。次要结局包括总生存期、客观缓解率和安全性。
48名符合条件的女性被分配至度伐利尤单抗组（N = 31）或化疗组（N = 17）。度伐利尤单抗组和化疗组的中位无进展生存期分别为7.6周[95%置信区间（CI），7.0 - 16.0]和14.0周（95% CI，7.0 - 32.9）（风险比[HR] = 1.6；95% CI，0.8 - 3.0；P = 0.92）。中位总生存期分别为37.9周（95% CI，21.7 - 143.0）和40.6周（95% CI，25.0 - 未达到）（HR = 1.5；95% CI，0.7 - 3.3；P = 0.85）。两组间客观缓解率的差异无统计学意义（度伐利尤单抗组9.7% vs. 医生选择的化疗组18.8%；差异 -9.1%；95% CI，-31.3%至12.9%；P = 0.83）。度伐利尤单抗组观察到的所有级别（35.5% vs. 68.8%）和高级别（9.7% vs. 31.3%）治疗相关不良事件较少。28.9%（CPS≥1%）和10.5%（CPS≥10%）的患者检测到PD-L1联合阳性评分（CPS）+。PIK3CA突变与度伐利尤单抗治疗≥12周的疾病进展时间相关[相对风险（突变型vs.野生型）2.83；95% CI，1.16 - 14.17]。
度伐利尤单抗耐受性良好，但与化疗相比，在rOCCC中并未改善疗效结果。
