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Abstract：
BACKGROUND: The combination of a fluoropyrimidine [5-fluorouracil (5-FU), capecitabine, or S-1] with a platinum analog (cisplatin or oxaliplatin) is the most widely accepted first-line chemotherapy regimen for metastatic or recurrent advanced gastric cancer (AGC), based on the results of clinical trials. However, there is little evidence to guide chemotherapy for elderly patients with AGC because of under-representation of this age group in clinical trials. Thus, the aim of this study is to determine the optimal chemotherapy regimen for elderly patients with AGC by comparing the efficacies and safeties of combination therapy versus monotherapy as first-line chemotherapy.
METHODS: This study is a randomized, controlled, multicenter, phase III trial. A total of 246 elderly patients (≥70 years old) with metastatic or recurrent AGC who have not received previous palliative chemotherapy will be randomly allocated to a combination therapy group or a monotherapy group. Patients randomized to the combination therapy group will receive fluoropyrimidine plus platinum combination chemotherapy (capecitabine/cisplatin, S-1/cisplatin, capecitabine/oxaliplatin, or 5-FU/oxaliplatin), and those randomized to the monotherapy group will receive fluoropyrimidine monotherapy (capecitabine, S-1, or 5-FU). The primary outcome is the overall survival of patients in each treatment group. The secondary outcomes include progression-free survival, response rate, quality of life, and safety.
CONCLUSIONS: We are conducting this pragmatic trial to determine whether elderly patients with AGC will obtain the same benefit from chemotherapy as younger patients. We expect that this study will help guide decision-making for the optimal treatment of elderly patients with AGC.
METHODS: This study is a randomized, controlled, multicenter, phase III trial. A total of 246 elderly patients (≥70 years old) with metastatic or recurrent AGC who have not received previous palliative chemotherapy will be randomly allocated to a combination therapy group or a monotherapy group. Patients randomized to the combination therapy group will receive fluoropyrimidine plus platinum combination chemotherapy (capecitabine/cisplatin, S-1/cisplatin, capecitabine/oxaliplatin, or 5-FU/oxaliplatin), and those randomized to the monotherapy group will receive fluoropyrimidine monotherapy (capecitabine, S-1, or 5-FU). The primary outcome is the overall survival of patients in each treatment group. The secondary outcomes include progression-free survival, response rate, quality of life, and safety.
CONCLUSIONS: We are conducting this pragmatic trial to determine whether elderly patients with AGC will obtain the same benefit from chemotherapy as younger patients. We expect that this study will help guide decision-making for the optimal treatment of elderly patients with AGC.
摘要：
■氟嘧啶[5-氟尿嘧啶（5-FU），卡培他滨,或S-1]与铂类似物（顺铂或奥沙利铂）是转移性或复发性晚期胃癌（AGC）最广泛接受的一线化疗方案，根据临床试验的结果.然而,由于该年龄组在临床试验中的代表性不足,因此几乎没有证据指导老年AGC患者的化疗.因此，本研究的目的是通过比较联合治疗与单药治疗作为一线化疗的疗效和安全性,确定老年AGC患者的最佳化疗方案.
■这项研究是一项随机研究，控制,多中心，第三阶段试验。共有246例转移性或复发性AGC患者（≥70岁），先前未接受姑息性化疗，将被随机分配到联合治疗组或单一治疗组。随机分配到联合治疗组的患者将接受氟嘧啶加铂类联合化疗（卡培他滨/顺铂，S-1/顺铂,卡培他滨/奥沙利铂，或5-FU/奥沙利铂），那些随机分配到单药治疗组的患者将接受氟嘧啶单药治疗（卡培他滨，S-1或5-FU)。主要结果是每个治疗组患者的总生存期。次要结果包括无进展生存期，响应率,生活质量,和安全。
■我们正在进行这项务实的试验，以确定患有AGC的老年患者是否会从化疗中获得与年轻患者相同的益处。我们希望这项研究将有助于指导老年AGC患者的最佳治疗决策。
■这项研究是一项随机研究，控制,多中心，第三阶段试验。共有246例转移性或复发性AGC患者（≥70岁），先前未接受姑息性化疗，将被随机分配到联合治疗组或单一治疗组。随机分配到联合治疗组的患者将接受氟嘧啶加铂类联合化疗（卡培他滨/顺铂，S-1/顺铂,卡培他滨/奥沙利铂，或5-FU/奥沙利铂），那些随机分配到单药治疗组的患者将接受氟嘧啶单药治疗（卡培他滨，S-1或5-FU)。主要结果是每个治疗组患者的总生存期。次要结果包括无进展生存期，响应率,生活质量,和安全。
■我们正在进行这项务实的试验，以确定患有AGC的老年患者是否会从化疗中获得与年轻患者相同的益处。我们希望这项研究将有助于指导老年AGC患者的最佳治疗决策。
