Lessons learned: Irinotecan could not be proven noninferior to paclitaxel as a second-line treatment for patients with metastatic or recurrent gastric cancer.The failure to demonstrate noninferiority may have been a result of insufficient patient enrollment.Both agents were tolerable but showed different toxicity profiles.
Background: This phase III study compared the efficacy and safety of paclitaxel versus irinotecan in patients with metastatic or recurrent gastric cancer (MRGC) who had experienced disease progression following first-line chemotherapy.
Methods: Patients were randomized to receive either paclitaxel (70 mg/m2; days 1, 8, 15, every 4 weeks) or irinotecan (150 mg/m2 every other week). The primary endpoint was progression-free survival (PFS).
Results: This study was stopped early due to low accrual rate. A total of 112 patients were enrolled; 54 were allocated to paclitaxel and 58 to irinotecan. Median PFS for the paclitaxel and irinotecan groups was 3.5 and 2.1 months, respectively (hazard ratio [HR], 1.27; 95% confidence interval [CI], 0.86-1.88; p = .234). Noninferiority of irinotecan to paclitaxel was not proved because the upper boundary of the 95% CI (1.88) exceeded the predefined upper margin of noninferiority (1.32). Median overall survival (OS) was 8.6 months in the paclitaxel group and 7.0 months in the irinotecan group (HR, 1.39; 95% CI, 0.91-2.11; p = .126). Among toxicities greater than or equal to grade 3, neutropenia (11.5%) was the most common, followed by peripheral neuropathy (7.7%) in the paclitaxel group, and neutropenia (34.5%) followed by nausea, vomiting, and anemia (8.6%, respectively) in the irinotecan group.
Conclusion: Although paclitaxel showed numerically longer PFS and OS compared with irinotecan, this was statistically insignificant. Both irinotecan and paclitaxel are valid second-line treatment options in MRGC.
经验获取
• 就作为转移性或复发性胃癌患者的二线治疗而言,无法证明伊立替康不劣于紫杉醇。
• 未能证明非劣性可能是由于患者招募人数不足所导致的结果。
• 虽然这两种药物都具有耐受性,但是,它们显示出了不同的毒性特征。
摘要
背景。本次 III 期研究比较了紫杉醇与伊立替康在经过一线治疗之后出现疾病进展的转移性或复发性胃癌 (MRGC) 患者中的有效性和安全性。
方法。患者随机接受紫杉醇(70 mg/m2;在每 4 周的第 1 天、第 8 天、第 15 天给药)或伊立替康(150 mg/m2,每隔一周给药)治疗。主要终点是无进展生存期 (PFS)。
结果。本研究因招募率低而提前终止。一共入组了 112 名患者;54 名患者分配至紫杉醇组,58 名患者分配至伊立替康组。紫杉醇组和伊立替康组的中位 PFS 分别为 3.5 个月和 2.1 个月 [风险比 (HR),1.27;95% 置信区间 (CI),0.86–1.88;p = 0.234]。由于 95% CI 的上限 (1.88) 超过了非劣性的预定义上限 (1.32),因此,未能证明伊立替康不劣于紫杉醇。紫杉醇组和伊立替康组的中位总生存期 (OS) 分别为 8.6 个月和 7.0 个月(HR,1.39;95% CI,0.91–2.11;p = 0.126)。在 3 级或以上的毒性中,紫杉醇组最常见的是嗜中性粒细胞减少症 (11.5%), 其次是周围神经病变 (7.7%);伊立替康组最常见的是嗜中性粒细胞减少症 (34.5%), 其次是恶心、呕吐和贫血(分别为 8.6%)。
结论。尽管紫杉醇在数字上显示出比伊立替康更长的 PFS 和 OS,但是,这在统计上并不显著。伊立替康和紫杉醇都是 MRGC 的有效二线治疗选择。
Trial registration: ClinicalTrials.gov NCT01224652.
© AlphaMed Press; the data published online to support this summary is the property of the authors.