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Clinical study of TS-1 therapy for inoperable and recurrent gastric cancer

机译：TS-1治疗临床研究无法操作和复发性胃癌

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The clinical efficacy and safety of TS-1 therapy were studied retrospectively in patients with inoperable and recurrent gastric cancer. The subjects were 45 patients who were treated with TS-1 for more than 4 weeks at our center between May 1999 and July 2002. The objective overall response rate was 32% (14/44; 95% confidence interval, CI, 19-48). The response rate in the chemo-naive patients was 44% (11/25; 95% CI, 24-65), and that in the patients with previous chemotherapy was 16% (3/19; 95% CI, 3.4-40). Although doses or durations of TS-1 administration were reduced in 22 patients (reduction group) due to adverse effects or poor performance status, they achieved a fairly high response rate of 38% (8/21). For primary lesions, the response rate was 30% (8/27). The prevalence of adverse reactions with a grade of 3 or 4 was 36%. However, the prevalence of each grade 3 or 4 adverse effect was relatively low, at 13% for neutropenia, and around 5% for anorexia, nausea, vomiting, and diarrhea. The median administration period was 10 weeks (4-47 weeks) in all patients and 11 weeks (6-47 weeks) in the reduction group. The relative dose intensity was 0.89 in all patients and 0.81 in the reduction group. In patients who were treated until August 2001, the median survival time (MST) was 13 months with 1-year and 2-year survival rates of 53% and 14%, respectively. These results were similar to those reported in the phase II study for the new drug approval. This study demonstrated the reproducible activity and safety of TS-1 in practice.
机译：回顾性和经常性胃癌患者的临床疗效和TS-1治疗的临床疗效和安全性。受试者是45名患者，在1999年5月和2002年5月在我们的中心在我们的中心治疗了40周。客观的总体反应率为32％（14/44; 95％的置信区间，CI，19-48 ）。化疗患者的反应率为44％（11/25; 95％CI，24-65），并在先前化疗患者中为16％（3/19; 95％CI，3.4-40） 。虽然22例患者（减少组）减少了TS-1给药的剂量或持续时间，但由于不利影响或性能状况不佳，它们的效率相当高的响应率（8/21）。对于初级病变，响应率为30％（8/27）。等级3或4的不良反应的患病率为36％。然而，每个级别3或4级不良反应的患病率相对较低，中性粒细胞率为13％，厌食症，恶心，呕吐和腹泻约为5％。所有患者的中位给药期为10周（4-47周），还原组11周（6-47周）。所有患者的相对剂量强度为0.89，还原组中0.81。在患者患者到2001年8月，中位存活时间（MST）为13个月，1年和2年生存率分别为53％和14％。这些结果与第二阶段据报道的新药物批准的研究结果类似。本研究证明了在实践中可重复的TS-1的活性和安全性。

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