度伐鲁单抗对比医师选择的化疗方案用于复发性卵巢透明细胞腺癌（MOCCA/APGOT-OV2/GCGS-OV3）：一项多中心、随机、2期试验
Durvalumab versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinoma (MOCCA/APGOT-OV2/GCGS-OV3): A Multicenter, Randomized, Phase 2 Trial.
作者信息
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
机构信息
Department of Haematology-Oncology, National University Cancer Institute, Singapore, Singapore.
Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
出版信息
Clin Cancer Res. 2025 Sep 15;31(18):3907-3915. doi: 10.1158/1078-0432.CCR-25-0201.
PURPOSE
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.
PATIENTS AND METHODS
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.
RESULTS
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].
CONCLUSIONS
Durvalumab was well-tolerated but did not improve efficacy outcomes compared with chemotherapy in rOCCC.
目的
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。
患者与方法
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。
结果
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]。
结论
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。
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