晚期胃癌维持化疗的生存分析

Survival of Advanced Gastric Cancer Patients Treated with Maintenance Chemotherapy

目的探讨晚期胃癌一线化疗后继续卡培他滨维持治疗对患者生存期的影响及其安全性。方法：02例初治晚期胃癌患者,以氟尿嘧啶类/奥沙利铂方案化疗4~8周期,达疾病控制患者分别进入维持组或观察组,维持组以卡培他滨单药化疗(1.0 g/m2,口服2次/日,d1~14,3周重复)直至疾病进展或出现不可耐受的毒性,观察组单纯随访。结果 102例患者经一线化疗后,客观缓解率41.2%,疾病控制率77.5%。达到疾病控制患者共79例,其中44例进入维持组,35例进入观察组,随访期间两组客观有效率差异无统计学意义(P>0.05)。维持组中位无进展生存时间7.8月,观察组5.8月,两组比较差异有统计学意义(P<0.05),维持组中位总生存时间17.1月,较观察组13.4月有所延长(P=0.041)。不良反应情况,维持组在手足综合征的发生上高于观察组(P<0.05),但仅1例患者停药,余经处理均可耐受;其他不良反应,包括骨髓抑制、恶心呕吐、腹泻、肝肾功能异常、外周神经毒性、口腔炎等,两组差异均无统计学意义(P>0.05)。结论氟尿嘧啶类/奥沙利铂方案一线化疗达疾病控制后以卡培他滨维持治疗能够延长晚期胃癌患者无进展生存期和总生存期。

Objective To investigate the survival and safety of capecitabine maintenance chemotherapy after the first-line fluorouracil/oxaliplatin chemotherapy for patients with advanced gastric cancer(AGC).Methods A total of 102 initial treatment AGC patients accepted the combined chemotherapy of fluorouracil/oxaliplatin for 4-8 cycles.The patients who responded to the therapy were assigned to either the group with capecitabine maintenance chemotherapy (1.0 g/m2 po bid d1-dl4,repeated every 3 weeks) or the observation group with follow-up.The maintenance therapy was continued until disease progression or intolerable toxicity.Results The response rate(RR) and disease control rate(DCR) after the first-line fluorouracil/oxaliplatin chemotherapy were 41.2％ and 77.5％,respectively.Among the 79 patients who responded to the combined therapy,44 patients entered the maintenance group and 35 patients entered the observation group.During the follow-up,the differences of RR and DCR between two groups were not significant (P＞ 0.05).The median progression free survival (mPFS) in maintenance group (7.8 months) was longer than that in observation group (5.8 months)(P＜0.05).The median overall survival (mOS) were 17.1 and 13.4 months in maintenance group and observation group respectively,with significant difference (P=0.041).As for the adverse events,the incidence rate of hand-foot syndrome in maintenance group was higher than that in observation group (P＜0.05),but only one patient discontinued treatment.The differences of other adverse events,such as myelosuppression,nausea and vomiting,diarrhea,hepatorenal dysfunction,peripheral neurovirulence and stomatitis,were not significant between two groups (P＞0.05).Conclusion Capecitabine maintenance chemotherapy could prolong progression free survival and overall survival in AGC patients who respond to first-line fluorouracil/ oxaliplatin chemotherapy.