Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Department of Gastroenterology/Digestive Oncology, University Hospitals Leuven & KU Leuven, Leuven, 3000, Belgium.
Future Oncol. 2022 Jun;18(20):2465-2473. doi: 10.2217/fon-2022-0093. Epub 2022 May 10.
Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI); durvalumab, an anti-PD-L1 antibody, in patients with gastric/gastroesophageal junction cancer. Accumulating evidence indicates that ICIs combined with FLOT chemotherapy improve clinical outcomes in patients with advanced or metastatic cancer. We describe the rationale for and the design of MATTERHORN, a randomized, double-blind, placebo-controlled, phase III study investigating the efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy followed by adjuvant durvalumab monotherapy in patients with resectable gastric/gastroesophageal junction cancer. The planned sample size is 900 patients, the primary end point is event-free survival and safety and tolerability will be evaluated. Clinical trial registration: NCT04592913 (ClinicalTrials.gov).
可切除的胃/胃食管交界癌的标准治疗包括手术和新辅助-辅助 5-氟尿嘧啶-亚叶酸钙-奥沙利铂-多西紫杉醇（FLOT）化疗。早期临床研究支持进一步开发免疫检查点抑制剂（ICI）；抗 PD-L1 抗体 durvalumab 在胃/胃食管交界癌患者中的临床应用。越来越多的证据表明，ICI 联合 FLOT 化疗可改善晚期或转移性癌症患者的临床结局。我们描述了 MATTERHORN 的原理和设计，这是一项随机、双盲、安慰剂对照的 III 期研究，旨在评估新辅助-辅助 durvalumab 和 FLOT 化疗联合辅助 durvalumab 单药治疗可切除胃/胃食管交界癌患者的疗效和安全性。计划样本量为 900 例患者，主要终点是无事件生存，安全性和耐受性将进行评估。临床试验注册：NCT04592913（ClinicalTrials.gov）。
