替吉奥单药治疗非小细胞肺癌

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替吉奥对非亚裔晚期非小细胞肺癌疗效好
　　4月20日：美国华盛顿大学医学院Govindan等人报告一项多中心Ⅱ期临床研究称：对于化疗过的非亚裔晚期NSCLC患者，使用S-1单药的耐受性良好，而且疗效可与其他已批准的药物想媲美。该报告发表在2011年2月15日的《JThoracOncol》在线版上。

　　S1是一种新型的口服氟脲嘧啶制剂，在日本NSCLC患者中已显示有一定疗效，且耐药性良好。研究人员从美国21个中心入组了57例晚期NSCLC患者，都是只接受过一次化疗。对所有患者予S-1(30mg/m2，q12h，连续14天后休息7天)化疗，直至符合停药标准为止。主要的研究终点为客观缓解率。

　　根据独立评估结果，研究结果如下：客观缓解率和疾病稳定率分别是7.1%和48.2%，疾病控制率为55.3%。无进展生存期2.9个月，中位总生存7.3个月，1年的生存率为31.6%。各组织学亚型患者生存期没有明显的差异。患者对S-1的耐受性良好，最常见的因治疗引起的不良反应有恶心(54%)和腹泻(49%)。

毕业 · 发表于 2011-10-8 20:05:40

不知道效果到底如何？能否进脑？是否可以考虑与别的药物联用？

老马 · 发表于 2011-10-8 23:06:16

（替吉奥）是一种氟尿嘧啶衍生物口服抗癌剂，它包括替加氟（FT）和以下两类调节剂：吉美嘧啶（CDHP）及奥替拉西（Oxo）。其三种组分的作用如下：FT是5-Fu的前体药物，具有优良的口服生物利用度，能在活体内转化为5-Fu。CDHP能够抑制在二氢嘧啶脱氢酶作用下从FT释放出来的5-Fu的分解代谢，有助于长时间血中和肿瘤组织中5-Fu有效深度，从而取得与5-Fu持续静脉输注类似的疗效。Oxo能够阻断5-Fu的磷酸化，口服给药之后，Oxo在胃肠组织中具有很高的分布浓度，从而影响5-Fu在胃肠道的分布，进而降低5－Fu毒性的作用。替吉奥与5-Fu相比具有以下优势：①能维持较高的血药浓度并提高抗癌活性；②明显减少药毒性；③给药方便。　　在日本，替吉奥于1999年被批准用来治疗晚期胃癌，2001年被批准用来治疗头颈部癌症，2003年被批准用来治疗结直肠癌，2004年被批准用来治疗非小细胞肺癌。多年的临床应用证明，替吉奥是安全有效的抗癌药物。据统计，日本目前晚期胃癌的化疗，有80%以上的病例使用替吉奥，治疗有效率（CR+PR）可达44.6%。

Michaelfung · 发表于 2011-10-25 21:34:09

Background: S-1 is an oral, fixed-dose combination product comprised of tegafur (FT), a prodrug of 5-FU, and 2 modulators of 5-FU metabolism: gimeracil (CDHP) and oteracil (Oxo). S-1 is designed to provide oral delivery of 5-FU while reducing the rate of degradation of 5-FU and its conversion in the gastrointestinal tract to its toxic phosphorylated metabolite. Studies conducted in Japan have demonstrated antitumor activity of S-1 in patients with NSCLC. Methods: Patients with advanced NSCLC (stage IIIB/IV) who had received prior first-line combination chemotherapy and had measurable disease received S-1 30 mg/m2 orally bid for 2 weeks followed by a 7-day recovery period, repeated every 3 weeks. The trial had a 3-stage design: 30 patients evaluable for efficacy in stage 1; an additional 20 patients in stage 2 if ≥ 3/30 (10%) patients had a confirmed response (RECIST) in stage 1; and progression to stage 3 if ≥ 8/50 (16%) patients had a confirmed response in stage 2. Results: A total of 57 patients were enrolled in 2 stages at 21 sites and received a median of 3.0 cycles of therapy. Baseline characteristics were: 61.4% men; mean age = 63.2 years (range: 44-85); 22.8% ECOG = 0, 77.2% ECOG = 1; 45.6% adenocarcinoma, 31.6% squamous cell, 12.3% large cell, 14.0% other. Prior first-line regimens were primarily platinum-based (93%). Among 50 evaluable patients, 4 (8.0%) patients had confirmed PR and 27 (54.0%) had SD (independent assessment). Median duration of response was 6.0 months (95% CI: 3.8, 18.8). Median PFS was 2.9 months (95% CI: 1.7, 4.1). MST was 7.3 months (95% CI: 6.0, 9.7). At least 1 grade 3 or higher adverse drug reaction (ADR) occurred in 49.1% of patients. The most frequent grade 3 ADRs (occurring in > 10% of patients) were diarrhea (21.1%) and fatigue (12.3%). ADRs resulting in treatment discontinuation included fatigue (5.3%), rash/dermatitis (5.3%), and decreased creatinine clearance (3.5%). Conclusions: Although this study did not meet the predefined tumor response target to proceed to stage 3, median PFS and overall survival estimates were comparable to those observed with pemetrexed and docetaxel when used as second-line treatment of patients with NSCLC. Its effectiveness should be evaluated in a larger study.

这个和上面是同一个临床试验，这个是2010年的，最后的结果经过独立评估后做了少许修改。

我看了一些日本的数据，感觉日本人的数据不可信，但美国人做的数据可信度可能高一些