A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01)

Keun-Wook Lee, Chi Hoon Maeng, Tae-You Kim, Dae Young Zang, Yeul Hong Kim, In Gyu Hwang, Sang Cheul Oh, Joo Seop Chung, Hong Suk Song, Jin Won Kim, Su Jin Jeong, Jae Yong Cho, Keun-Wook Lee, Chi Hoon Maeng, Tae-You Kim, Dae Young Zang, Yeul Hong Kim, In Gyu Hwang, Sang Cheul Oh, Joo Seop Chung, Hong Suk Song, Jin Won Kim, Su Jin Jeong, Jae Yong Cho

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01224652.

© AlphaMed Press; the data published online to support this summary is the property of the authors.

Figures

Figure 1.
Figure 1.
Progression‐free survival. Abbreviations: CI, confidence interval; HR, hazard ratio; PFS, progression‐free survival.
Figure 2.
Figure 2.
Overall survival. Abbreviations: CI, confidence interval; HR, hazard ratio; OS, overall survival.
Figure 3.
Figure 3.
Consolidated Standards of Reporting Trials diagram. Abbreviations: CR, complete response; ITT, intention‐to‐treat.

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