Background

To compare irinotecan-alone, paclitaxel-alone, and each combination chemotherapy with S-1 in patients with advanced gastric cancer (AGC) that is refractory to S-1 or S-1 plus cisplatin (SP).

Methods

Patients with AGC after first-line chemotherapy with S-1 or SP, or patients during adjuvant chemotherapy or within 26 weeks after adjuvant chemotherapy completion with S-1 with confirmed disease progression were eligible. Patients were randomly divided into four groups based on treatment: irinotecan-alone (irinotecan; 150 mg/m², day 1, q14 days), paclitaxel-alone (paclitaxel; 80 mg/m², days 1, 8, 15, q28 days), S-1 plus irinotecan (irinotecan; 80 mg/m², days 1, 15, S-1; 80 mg/m², days 1–21, q35 days), and S-1 plus paclitaxel (paclitaxel; 50 mg/m², day1, 8, S-1; 80 mg/m², days 1–14, q21 days). The primary endpoint was overall survival (OS) and secondary endpoints were progression-free survival (PFS), response rate, and safety.

Results

From July 2008 to March 2012, 127 patients were enrolled. No difference in median OS was observed in the irinotecan vs. paclitaxel groups or in the monotherapy groups vs. the S-1 combination therapy groups. Median PFS was longer in the paclitaxel group compared with the irinotecan group (4.1 vs. 3.6 months, p = 0.035), although no difference was observed when comparing monotherapy vs. S-1 combination. The most common grade 3 to 4 hematological adverse events were neutropenia with no difference in incidence rate across the treatment groups.

Conclusions

There was no difference in OS between irinotecan and paclitaxel no in OS prolongation of S-1 combination therapy in second-line chemotherapy.

中文翻译：

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CPT-11 与 PTX 对比每种联合化疗与 S-1 治疗 S-1 或 S-1 加 CDDP 难治的晚期胃癌的随机 II 期研究：OGSG0701

背景

比较单用伊立替康、单用紫杉醇和每种联合化疗与 S-1 在 S-1 或 S-1 加顺铂 (SP) 难治的晚期胃癌 (AGC) 患者中的比较。

方法

S-1 或 SP 一线化疗后 AGC 患者，或辅助化疗期间或 S-1 辅助化疗完成后 26 周内已确认疾病进展的患者符合条件。患者根据治疗被随机分为四组：单用伊立替康（irinotecan; 150 mg/m ² , day 1, q14 days），单用紫杉醇（paclitaxel; 80 mg/m ² , days 1, 8, 15, q28天）、S-1 加伊立替康（伊立替康；80 mg/m ²，第 1、15 天，S-1；80 mg/m ²，第 1-21 天，q35 天）和 S-1 加紫杉醇（紫杉醇； 50 mg/m ²，第1、8天，S-1；80 mg/m ²，第 1-14 天，第 21 天）。主要终点是总生存期（OS），次要终点是无进展生存期（PFS）、反应率和安全性。

结果

2008 年 7 月至 2012 年 3 月，共招募了 127 名患者。伊立替康组与紫杉醇组或单药治疗组与 S-1 联合治疗组的中位 OS 均未观察到差异。与伊立替康组相比，紫杉醇组的中位 PFS 更长（4.1 个月与 3.6 个月，p  = 0.035），但在比较单药治疗与 S-1 组合时没有观察到差异。最常见的 3 至 4 级血液学不良事件是中性粒细胞减少症，各治疗组的发生率没有差异。

结论

伊立替康和紫杉醇在二线化疗中 S-1 联合治疗的 OS 延长方面没有差异。