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)
DC Field | Value | Language |
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dc.contributor.author | Lee K.-W. | - |
dc.contributor.author | Maeng C.H. | - |
dc.contributor.author | Kim T.-Y. | - |
dc.contributor.author | Zang D.Y. | - |
dc.contributor.author | Kim Y.H. | - |
dc.contributor.author | Hwang I.G. | - |
dc.contributor.author | Oh S.C. | - |
dc.contributor.author | Chung J.S. | - |
dc.contributor.author | Song H.S. | - |
dc.contributor.author | Kim J.W. | - |
dc.contributor.author | Jeong S.J. | - |
dc.contributor.author | Cho J.Y. | - |
dc.date.available | 2020-06-26T09:20:06Z | - |
dc.date.issued | 201810 | - |
dc.identifier.issn | 1569-8041 | - |
dc.identifier.issn | 1569-8041 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/41185 | - |
dc.description.abstract | Background: Although emerging treatments have been introduced to patients with metastatic or recurrent gastric cancer (MRGC) as second-line therapy, paclitaxel or irinotecan are still viable options. This phase III study compared the efficacy and safety of paclitaxel versus irinotecan in patients with MRGC who failed to 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 biweekly). 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, of which 54 were allocated to paclitaxel, and 58 to irinotecan. Median PFS of paclitaxel or irinotecan group were 3.5 and 2.1 months, respectively [hazard ratio (HR) 1.27; 95% confidence interval (CI), 0.86-1.88; p = 0.234]. Non-inferiority of irinotecan to paclitaxel was not proven according to the predefined upper margin of non-inferiority (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 = 0.126). There was no difference in response rate (p = 0.783) between paclitaxel (15.8%) and irinotecan (13.6%). Among toxicities of ≥ grade 3, neutropenia (11.5%) was the most common toxicity, 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. Conclusions: 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. | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.title | 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) | - |
dc.type | Conference | - |
dc.identifier.doi | 10.1093/annonc/mdy282.064 | - |
dc.citation.conferenceName | 43rd ESMO Congress | - |
dc.citation.conferencePlace | 독일 | - |
dc.citation.endPage | viii229 | - |
dc.citation.startPage | viii228 | - |
dc.citation.title | Annals of oncology : official journal of the European Society for Medical Oncology | - |
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