培美曲塞联合顺铂二线治疗未手术晚期胃癌病人的临床观察

    Clinical observation of the second-line chemotherapy of pemetrexed combined with cisplatin in the treatment of unresectable advanced gastric cancer

    • 摘要:
      目的评价培美曲塞联合顺铂二线治疗未手术晚期胃癌病人的疗效及不良反应,并比较是否采用二线化疗对生存时间的影响。
      方法选取63例一线化疗失败的晚期未手术胃癌病人。34例同意化疗者作为观察组,给予培美曲塞联合顺铂方案二线治疗至少两个周期,计算有效率(RR)和疾病控制率(DCR),并评价不良反应。另29例拒绝化疗作为对照组,给予最佳支持治疗。随访无进展生存时间-2(PFS-2)和总生存时间(OS)。
      结果观察组中,34例均可评价近期疗效,完全缓解1例,部分缓解8例,稳定10例,进展15例,RR为26.5%,DCR为55.9%。主要不良反应为1~2级的骨髓抑制、乏力和恶心呕吐。3~4级不良反应仅见白细胞减少,其中3级发生率为8.8%,4级为3.0%。病人均无发热、肾功能异常及化疗相关性死亡事件发生。观察组PFS-2为3.3个月。观察组及对照组OS分别为10.8个月(95%CI:7.5~14.1月)及5.8月(95%CI:2.6~9.0月),差异有统计学意义(P < 0.01)。
      结论培美曲塞联合顺铂二线治疗晚期未手术胃癌的疗效较好,且不良反应轻、耐受性好。与最佳支持治疗相比,二线化疗能明显延长病人生存时间。

       

      Abstract:
      ObjectiveTo evaluate the efficacy and adverse reaction of the second-line chemotherapy of pemetrexed combined with cisplatin(PemCis) in the treatment of unresectable advanced gastric cancer(AGC), and analyze the survival time of patients with second-line chemotherapy.
      MethodsSixty-three patients with unresectable AGC, who failed to the first-line chemotherapy, were divided into the observation group(34 cases treated with second-line chemotherapy of PemCis for two cycles at least) and control group(29 cases treated with best supportive care).The response rate(RR) and disease control rate(DCR) in observation group were calculated to evaluate the adverse reaction.The progression-free survival time-2(PFS-2) and overall survival(OS) in two groups were followed up.
      ResultsThe short-term efficacy in observation group was evaluated, the complete remission in 1 case, partial remission in 8 cases, stability in 10 cases and progress in 15 cases were identified, and the RR and DCR were 26.5%, and 55.9%, respectively.The major side effects in observation group were grade 1-2 bone marrow suppression, fatigue, nausea and vomiting, the eucopenia was grade 3-4 toxic reaction, and the incidence rate of grade 3 and 4 were 8.8% and 3.0%, respectively.No fever, renal dysfunction or chemotherapy-related death in all patients was identified.The PFS-2 of the observation group was 3.3 months.The OS in observation group and control group were 10.8 months(95%CI:7.5 to 14.1 months) and 5.8 months(95%CI:2.6 to 9.0 months), respectively, and the difference of which was statistically significant(P < 0.01).
      ConclusionsThe second-line treatment with PemCis for unresectable AGC has good effect and tolerance, which can significantly prolong the survival time of patients compared with supportive care.

       

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