Durvalumab versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinoma (MOCCA/APGOT-OV2/GCGS-OV3): A Multicenter, Randomized, Phase 2 Trial.

This is the first randomized trial to compare durvalumab with chemotherapy in rOCCC.

这是首个比较durvalumab与化疗在复发性卵巢透明细胞癌（rOCCC）中的随机试验。

patients_and_methods

MOCCA is a randomized, phase 2 trial conducted in Singapore, Korea, and Australia.

MOCCA 是在新加坡、韩国和澳大利亚进行的一项随机、二期临床试验。

Eligible patients had rOCCC with recurrence after platinum-based chemotherapy, Eastern Cooperative Oncology Group performance status ≤2, and no prior immune checkpoint blockade.

符合条件的患者为接受过铂类化疗后复发的 rOCCC 患者，东部肿瘤协作组体能状态评分≤2，且之前未接受过免疫检查点阻断治疗。

Patients were randomly assigned (2:1) to durvalumab (1,500 mg every 4 weeks) or chemotherapy.

患者按2:1的比例随机分配接受durvalumab（每4周1,500毫克）或化疗。

Patients progressing on chemotherapy were allowed to cross over to durvalumab.

在化疗过程中病情进展的患者允许转为接受durvalumab治疗。

The primary outcome was progression-free survival. Secondary outcomes included overall survival, objective response rates, and safety.

主要结果是无进展生存期。次要结果包括总生存期、客观缓解率和安全性。

Results

Forty-eight eligible women were assigned to durvalumab (N = 31) or chemotherapy (N = 17).

共有48名符合条件的女性被分配到durvalumab组（N=31）或化疗组（N=17）。

The median progression-free survivalwas 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).

中位无进展生存期分别为使用durvalumab和化疗的7.6周（95%置信区间，7.0-16.0周）和14.0周（95%置信区间，7.0-32.9周）（风险比HR = 1.6；95%置信区间，0.8-3.0；P = 0.92）。

The median overall survivalwas 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).

中位总生存期分别为37.9周（95%置信区间，21.7-143.0周）和40.6周（95%置信区间，25.0-未达到），分别对应durvalumab和化疗（风险比HR = 1.5；95%置信区间，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).

两组之间的客观缓解率差异不具有统计学意义（durvalumab 9.7% 对比 医生选择的化疗 18.8%；差异 -9.1%；95% 置信区间，-31.3% 至 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.

观察到durvalumab的全等级（35.5% 对比 68.8%）和高等级（9.7% 对比 31.3%）治疗相关不良事件较少

PD-L1 combined positive score (CPS)+ was observed in 28.9% (CPS ≥1%) and 10.5% (CPS ≥10%) of patients.

PD-L1联合阳性评分（CPS）+ 在 28.9%（CPS ≥1%）和 10.5%（CPS ≥10%）的患者中观察到。

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].

PIK3CA突变与接受durvalumab治疗≥12周的进展时间相关[相对风险（突变型vs.野生型）2.83; 95% 置信区间, 1.16-14.17]。

Conclusions

Durvalumab was well-tolerated but did not improve efficacy outcomes compared with chemotherapy in rOCCC.

在rOCCC中，与化疗相比，Durvalumab耐受性良好，但并未改善疗效结果。