Estape J, Grau J J, Lcobendas F, Curto J, Daniels M, Viñolas N, Pera C
Oncological Coordination Unit, Clinic Hospital, Barcelona, Spain.
Ann Surg. 1991 Mar;213(3):219-21. doi: 10.1097/00000658-199103000-00006.
Seventy consecutive patients were entered in a two-arm randomized trial after surgical resection for locally advanced gastric cancer. In the first arm, 37 patients were included as a control group, receiving no further treatment after surgery. In the second arm, 33 patients were treated with adjuvant chemotherapy consisting of mitomycin C (MMC), 20 mg/m2 administered intravenously once every 6 weeks for four consecutive cycles. All patients in both arms were followed in the same way for 5 years. At 5 years 23 of 37 patients in the control arm and 7 of 33 patients in the treatment arm were dead because of relapse. Actuarial survival curve was statistically significant in favor of patients given adjuvant MMC (p less than 0.001). After 10 years follow-up, 31 of 37 patients in the control arm and 16 out of 33 patients in the treatment arm were dead because of relapse, the statistical differences continuing in the actuarial survival curve in favor of treated patients (p less than 0.01). The best advantages of adjuvant treatment were observed in the T3N0M0 stage. The most frequent relapse site was the peritoneal cavity and the relapse pattern shows special decrease in liver metastases in treated patients. Toxicity was acute and mild. No delayed toxicity or second malignancies were observed. These data suggest that adjuvant MMC after resected surgery of gastric cancer is a successful treatment and its effects are still evident after 10 years of follow-up.
70例局部进展期胃癌患者在手术切除后进入双臂随机试验。第一组,37例患者作为对照组,术后不再接受进一步治疗。第二组,33例患者接受辅助化疗,化疗方案为丝裂霉素C(MMC),20mg/m²,每6周静脉注射1次,连续4个周期。两组所有患者均以相同方式随访5年。5年后,对照组37例患者中有23例、治疗组33例患者中有7例因复发死亡。精算生存曲线在接受辅助MMC治疗的患者中具有统计学意义(p<0.001)。随访10年后,对照组37例患者中有31例、治疗组33例患者中有16例因复发死亡,精算生存曲线的统计学差异持续存在,有利于接受治疗的患者(p<0.01)。辅助治疗的最佳优势在T3N0M0期观察到。最常见的复发部位是腹腔,治疗患者的复发模式显示肝转移有特别减少。毒性为急性且轻微。未观察到延迟毒性或第二原发性恶性肿瘤。这些数据表明,胃癌切除术后辅助MMC治疗是一种成功的治疗方法,其效果在随访10年后仍然明显。