庚铂一线治疗不能手术胃癌217例临床报告

Clinical Study of Sunpla as First-line Treatment for Inoperable Gastric Cancer

目的:确定庚铂单药治疗的安全性和有效性;比较庚铂、醛氢叶酸钙和5-氟脲嘧啶联合方案与顺铂、醛氢叶酸钙和5-氟脲嘧啶联合方案一线治疗不能手术的胃癌的有效性和安全性。方法:本试验采用多中心、开放式、前瞻性、随机对照研究,217例经病理组织学确诊的胃腺癌患者参加本次试验且均签署知情同意书,其中,单药组(单用庚铂,简称A组)50例,联合治疗组(庚铂+醛氢叶酸钙+5-氟脲嘧啶,简称B组)83例,联合对照组(顺铂+醛氢叶酸钙+5-氟脲嘧啶,简称C组)84例。每3周为一疗程,治疗1～3个疗程。结果:B组可评价疗效79例,在第二周期末无完全缓解者,部分缓解18例,稳定44例,进展17例,总有效率为22.78%。C组可评价疗效82例,在第二周期末无完全缓解,部分缓解17例,稳定47例,进展18例,总有效率为20.73%。两组比较有效率无显著性差异(P=0.8131)。A组可评价疗效者47例,完全缓解1例,部分缓解6例,稳定25例,进展15例,单药有效率达到14.90%。结论:庚铂在胃癌治疗上,单药疗效与文献报道一致,与醛氢叶酸钙和5-氟脲嘧啶联合方案与顺铂对照联合方案的疗效相当;庚铂的主要不良反应是恶心呕吐和食欲下降,血液学检查为白细胞和中性粒细胞减少,试验过程中未见严重的肝、肾毒性。

Objective： To evaluate the safely and efficacy of sunpla as a single agent therapy for the treatment of inoperable gastric cancer and to compare the safety and efficacy of sunpla vs. cisplatin combined with Calcium Folinate and 5-Fluorouracil for the treatment of inoperable gastric cancer as first-line treatment. Methods： A randomized, multi-central, open and prospective controlled clinical trial was carried out. A total of 217 patients （pts） with gastric cancer confirmed by histopathology were enrolled in the study, and all of them have signed the written informed consent. Fifty pts were allocated to single-drug arm （single use of sunpla, A arm）, 83 were assigned to combination treatment arm （sumpla＋Calcium Folinate＋5-Fluorouracil,B arm）, 84 pts were allocated to combination controlled arm （eisplatin＋Calcium Folinate＋5-Fluoroaracil, C arm）. Every treatment cycle included three weeks, and 1 to 3 cycles was given for each pt. Results： At the end of the second treatment cycle in the B arm. there was no CR pts among the 79 evaluable pts, with 18 PR pts, 44 SD pts and 17 PD pts, The total response rate was 22.78%. At the end of the second treatment cycle in the C arm, there were no CR pts among the 82 evaluable pts, with 17 PR pts, 47 SD pts and 18 PD pts. The total response rate was 20.73%. The response rate between the two arms had no significant difference （P=0.8131）. Among the 47 evaluable pts in the A arm. there were 1 CR, 6 PR, 25 SD and 15 PD. The response rate for single use of the sunpla was 14.90%. Conclusions： The efficacy of sunpla as a single-agent therapy in the treatment of gastric cancer was in accordance with certain reports, and there is no significant difference between sunpla vs. cisplatin combined with Calcium Folinate and 5-Fluorouracil. The major adverse events are nausea, vomiting, anorexia and digestive tract reaction. The abnormalities of laboratory examination are leucopenia and neutropenia. No serious hepatonephrotoxicity has been observed during the trial.