Randomized phase III study comparing the efficacy and safety of irinotecan plus S-1 with S-1 alone as first-line treatment for advanced gastric cancer (study GC0301/TOP-002).
Randomized phase III study comparing the efficacy and safety of irinotecan plus S-1 with S-1 alone as first-line treatment for advanced gastric cancer (study GC0301/TOP-002).
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DOI：
10.1007/s10120-011-0009-5
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发表时间：
2011-03
期刊：
影响因子：
7.4
通讯作者：
Sakata, Yuh
中科院分区：
文献类型：
--
作者：
Narahara, Hiroyuki;Iishi, Hiroyasu;Imamura, Hiroshi;Tsuburaya, Akira;Chin, Keisho;Imamoto, Haruhiko;Esaki, Taito;Furukawa, Hiroshi;Hamada, Chikuma;Sakata, Yuh
在I/II期研究中，盐酸伊立替康和S-1（一种口服氟嘧啶）作为单药治疗晚期胃癌显示出抗肿瘤活性。伊立替康和S-1（IRI-S）联合治疗对晚期胃癌也有活性。本研究旨在比较IRI-S与S-1单药治疗在晚期或复发性胃癌患者中的疗效和安全性。患者被随机分配至口服S-1（80 mg/m2，每日一次，每6周一次，持续28天）或口服S-1（80 mg/m2，每日一次，每5周一次，持续21天）+伊立替康（80 mg/m2，每5周一次，第1天和第15天静脉输注）（IRI-S）。主要终点是总生存期。次要终点包括治疗失败时间、1年和2年生存率、应答率和安全性。IRI-S与S-1单药治疗的中位生存时间分别为12.8与10.5个月（P = 0.233），至治疗失败时间分别为4.5与3.6个月（P = 0.157），1年生存率分别为52.0与44.9%。IRI-S的缓解率显著高于S-1单药治疗（41.5% vs. 26.9%，P = 0.035）。IRI-S组中性粒细胞减少和腹泻发生率更高，但可管理。接受IRI-S治疗的患者在与S-1单药治疗相似的相对剂量强度下接受了更多疗程的治疗。尽管IRI-S的中位生存期长于S-1单药治疗，且耐受性良好，但在本研究中并未显示出显著的优效性。
Irinotecan hydrochloride and S-1, an oral fluoropyrimidine, have shown antitumor activity against advanced gastric cancer as single agents in phase I/II studies. The combination of irinotecan and S-1 (IRI-S) is also active against advanced gastric cancer. This study was conducted to compare the efficacy and safety of IRI-S versus S-1 monotherapy in patients with advanced or recurrent gastric cancer. Patients were randomly assigned to oral S-1 (80 mg/m2 daily for 28 days every 6 weeks) or oral S-1 (80 mg/m2 daily for 21 days every 5 weeks) plus irinotecan (80 mg/m2 by intravenous infusion on days 1 and 15 every 5 weeks) (IRI-S). The primary endpoint was overall survival. Secondary endpoints included the time to treatment failure, 1- and 2-year survival rates, response rate, and safety. The median survival time with IRI-S versus S-1 monotherapy was 12.8 versus 10.5 months (P = 0.233), time to treatment failure was 4.5 versus 3.6 months (P = 0.157), and the 1-year survival rate was 52.0 versus 44.9%, respectively. The response rate was significantly higher for IRI-S than for S-1 monotherapy (41.5 vs. 26.9%, P = 0.035). Neutropenia and diarrhea occurred more frequently with IRI-S, but were manageable. Patients treated with IRI-S received more courses of therapy at a relative dose intensity similar to that of S-1 monotherapy. Although IRI-S achieved longer median survival than S-1 monotherapy and was well tolerated, it did not show significant superiority in this study.
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影响因子：
45.3
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