Randomized phase II trial of first-line treatment with tailored irinotecan and S-1 therapy versus S-1 monotherapy for advanced or recurrent gastric carcinoma (JFMC31-0301)
Randomized phase II trial of first-line treatment with tailored irinotecan and S-1 therapy versus S-1 monotherapy for advanced or recurrent gastric carcinoma (JFMC31-0301)
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DOI：
10.1097/cad.0b013e328345b509
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发表时间：
2011-07-01
影响因子：
2.3
通讯作者：
Saji, Shigetoyo
中科院分区：
文献类型：
--
作者：
Komatsu, Yoshito;Takahashi, Yutaka;Saji, Shigetoyo
伊立替康的药代动力学在个体之间存在显着差异。本研究旨在比较定制伊立替康和 S-1 疗法与 S-1 单一疗法对晚期/复发性胃癌患者的治疗效果。晚期/复发性胃癌患者被随机分配接受定制的伊立替康和 S-1（A 组）治疗或单独 S-1 治疗（B 组）。 A 组接受 S-1（80-120 mg/m(2)/天）治疗 14 天，第 1 天和第 15 天使用伊立替康。初始伊立替康剂量 75 mg/m(2)（0 级）根据早期疗程中的毒性进行了调整。在 B 组中，单独施用 S-1（80-120 毫克/天）28 天，随后 14 天不进行治疗。 95 名患者被随机分配（A 组 48 名患者，B 组 47 名患者）。 A 组（48 名患者中的 12 名）原发肿瘤的缓解率为 25.0%（48 名患者中的 12 名），B 组（47 名患者中的 7 名）原发肿瘤的缓解率为 25.0%，而根据实体瘤缓解评估标准的缓解率为 27.8%（36 名患者中的 10 名）和 21.9%（32 名患者中的 7 名）。血液学毒性、厌食和腹泻在 A 组中更为常见，但两组的 3-4 级毒性相似。这些发现表明定制的伊立替康和 S-1 疗法对于胃癌的有用性。抗癌药物 22:576-583 (C) 2011 Wolters Kluwer Health |利平科特·威廉姆斯和威尔金斯。
The pharmacokinetics of irinotecan vary markedly between individuals. This study sought to compare tailored irinotecan and S-1 therapy with S-1 monotherapy for the treatment of patients with advanced/recurrent gastric cancer. Patients with advanced/recurrent gastric cancer were randomized to receive tailored irinotecan and S-1 (arm A) therapy or S-1 therapy alone (arm B). Arm A received S-1 (80-120 mg/m(2)/day) for 14 days, with irinotecan on days 1 and 15. The initial irinotecan dose of 75 mg/m(2) (level 0) was adjusted for toxicity during an earlier course. In arm B, S-1 (80-120 mg/day) was administered alone for 28 days, followed by 14 days without therapy. Ninety-five patients were randomized (48 patients to arm A and 47 patients to arm B). The response rate of the primary tumor (Japanese criteria) was 25.0% in arm A (12 of 48 patients) and 14.9% in arm B (seven of 47 patients), whereas the response rates according to Response Evaluation Criteria In Solid Tumors were 27.8% (10 of 36) versus 21.9% (seven of 32). Hematological toxicity, anorexia, and diarrhea were significantly more common in arm A, but both arms had similar grades 3-4 toxicities. These findings suggest the usefulness of tailored irinotecan and S-1 therapy for gastric cancer. Anti-Cancer Drugs 22:576-583 (C) 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.