Peng Zhi, Wei Jia, Wang Feng, Ying Jieer, Deng Yanhong, Gu Kangsheng, Cheng Ying, Yuan Xianglin, Xiao Juxiang, Tai Yanfei, Wang Linna, Zou Jianjun, Zhang Yanqiao, Shen Lin
Department of GI Oncology, Beijing Cancer Hospital, Beijing, P.R. China.
Department of Oncology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, P.R. China.
Clin Cancer Res. 2021 Jun 1;27(11):3069-3078. doi: 10.1158/1078-0432.CCR-20-4691. Epub 2021 Mar 25.
Capecitabine plus oxaliplatin (CAPOX) is one of the standard first-line treatments for unresectable, advanced, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Camrelizumab shows promising antitumor activity in advanced or metastatic G/GEJ adenocarcinoma in a phase I study. We reported the outcomes of cohort 1 in a multicenter, open-label, phase II trial, which assessed camrelizumab in combination with CAPOX followed by camrelizumab plus apatinib as a first-line combination regimen for advanced or metastatic G/GEJ adenocarcinoma.
Systemic treatment-naïve patients with EGFR2-negative advanced or metastatic G/GEJ adenocarcinoma received initial camrelizumab plus CAPOX for 4-6 cycles, and patients without progressive disease were administrated subsequent camrelizumab plus apatinib. Primary endpoint was objective response rate (ORR).
All 48 enrolled patients comprised the efficacy and safety analysis population. The ORR was 58.3% [95% confidence interval (CI), 43.2-72.4] with this combination regimen. Median duration of response was 5.7 months (95% CI, 4.4-8.3). Median overall survival was 14.9 months (95% CI, 13.0-18.6), and median progression-free survival was 6.8 months (95% CI, 5.6-9.5), respectively. The most common grade ≥3 treatment-related adverse events (>10%) were decreased platelet count (20.8%), decreased neutrophil count (18.8%), and hypertension (14.6%). Treatment-related death occurred in 1 patient (2.1%) due to abnormal hepatic function and interstitial lung disease.
Camrelizumab combined with CAPOX followed by camrelizumab plus apatinib demonstrated encouraging antitumor activity and manageable toxicity as first-line therapy for patients with advanced or metastatic G/GEJ adenocarcinoma.
卡培他滨联合奥沙利铂（CAPOX）是不可切除的晚期或转移性胃癌或胃食管交界（G/GEJ）腺癌的标准一线治疗方案之一。卡瑞利珠单抗在一项I期研究中显示出在晚期或转移性G/GEJ腺癌中具有有前景的抗肿瘤活性。我们报告了一项多中心、开放标签的II期试验中第1队列的结果，该试验评估了卡瑞利珠单抗联合CAPOX，随后使用卡瑞利珠单抗加阿帕替尼作为晚期或转移性G/GEJ腺癌的一线联合治疗方案。
初治的EGFR2阴性晚期或转移性G/GEJ腺癌患者接受初始卡瑞利珠单抗联合CAPOX治疗4 - 6个周期，无疾病进展的患者随后接受卡瑞利珠单抗加阿帕替尼治疗。主要终点为客观缓解率（ORR）。
所有48例入组患者构成疗效和安全性分析人群。该联合治疗方案的ORR为58.3%[95%置信区间（CI），43.2 - 72.4]。中位缓解持续时间为5.7个月（95%CI，4.4 - 8.3）。中位总生存期为14.9个月（95%CI，13.0 - 18.6），中位无进展生存期分别为6.8个月（95%CI，5.6 - 9.5）。最常见的≥3级治疗相关不良事件（>10%）为血小板计数减少（20.8%）、中性粒细胞计数减少（18.8%）和高血压（14.6%）。1例患者（2.1%）因肝功能异常和间质性肺病发生治疗相关死亡。
卡瑞利珠单抗联合CAPOX，随后使用卡瑞利珠单抗加阿帕替尼作为晚期或转移性G/GEJ腺癌患者的一线治疗方案，显示出令人鼓舞的抗肿瘤活性和可管理的毒性。
