培训课件--胃癌辅助化疗临床试验解读.pptVIP

DISCUSSION DISCUSSION S-1单药辅助化疗在ⅢB期胃癌患者中未达到统计学差异，而且还看到单药S-1与单纯手术比较，远处转移发生率也无差异，这说明针对分期较晚、肿瘤负荷量较大的患者，单药尚不足以预防复发和远处转移；而XELOX辅助化疗在预防局部复发、腹膜和远处转移中与对照组比较均有显著差异 DISCUSSION 通过分析ACTS-GC与CLASSIC实验，可以得出结论：分期较晚（IIIB期）、术后复发转移风险高的病人更多考虑联合化疗，II期患者可以考虑XELOX或S-1辅助治疗，同时要结合患者的不良事件及对持续治疗时间的耐受性。 DISCUSSION 6.关于S-1用于胃癌术后辅助化疗的使用期限存在争议，目前有看法认为：术后辅助化疗应用时间不应该长于用于一线姑息化疗同方案的中位PFS，单药S-1在胃癌一线姑息化疗的中位PFS大约4个月，因此S-1用于胃癌术后辅助化疗的合适时间应当为4-6个月，使用时间过长会增加额外的毒性反应并导致生存期缩短，这个需要进一步开展三期临床试验来证实。 DISCUSSION 7.ACTS-GC试验（包括CLASSIC试验）并未设置关于胃癌病理分型（如Lauren分型）的亚组分析，对于恶性程度较高且分期较晚的这部分胃癌术后患者（易于早期复发和转移），如弥漫型III期胃癌患者术后的治疗，仍需进一步设计试验来证实？ DISCUSSION 8.如何避免对化疗原发耐药的患者术后化疗的伤害？ 谢谢！ Adjuvant Chemotherapy for Gastric Cancer with S-1, an Oral Fluoropyrimidine  --ACTS-GC Introduction Meta-analyses have shown that adjuvant chemotherapy is effective in treating gastric cancer.However, the effectiveness of specific regimens has not been verified in large clinical trials. Background Advanced gastric cancer can respond to S-1, an oral fluoropyrimidine. We tested S-1 as adjuvant chemotherapy in patients with curatively resected gastric cancer. METHODS Patients in Japan with stage II or III gastric cancer who underwent gastrectomy with extended (D2) lymph-node dissection were randomly assigned to undergo surgery followed by adjuvant therapy with S-1 or to undergo surgery only. METHODS In the S-1 group, administration of S-1 was started within 6 weeks after surgery and continued for 1 year. The treatment regimen consisted of 6-week cycles in which, in principle, 80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks. The primary end point was overall survival. Eligibility Criteria The criteria for eligibility were histologically proven gastric cancer of stage II , IIIA, or IIIB; D2 or more extensive lymph-node dissection with R0 surgery ; no hepatic, peritoneal, or d