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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)

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Affiliated Author(s)
송홍석
Alternative Author(s)
Song, Hong Suk
Journal Title
Oncologist.
ISSN
1549-490X
Issued Date
2019
Abstract
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%) wa 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. The Oncologist 2019;24:18–e24
Department
Dept. of Internal Medicine (내과학)
Publisher
School of Medicine (의과대학)
Citation
Keun‐Wook Lee et al. (2019). 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). Oncologist., 24(1), 18-e24. doi: 10.1634/theoncologist.2018-0142
Type
Article
ISSN
1549-490X
DOI
10.1634/theoncologist.2018-0142
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41760
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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