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 |
---|---|---|
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 | 2019-03-08T06:38:17Z | - |
dc.date.issued | 2019-01 | - |
dc.identifier.issn | 1083-7159 | - |
dc.identifier.issn | 1549-490X | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/3169 | - |
dc.description.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. © AlphaMed Press; the data published online to support this summary is the property of the authors. | - |
dc.format.extent | 7 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | Wiley-Blackwell | - |
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 | Article | - |
dc.identifier.doi | 10.1634/theoncologist.2018-0142 | - |
dc.identifier.bibliographicCitation | Oncologist, v.24, no.1, pp 18 - 24 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.wosid | 000455119900006 | - |
dc.identifier.scopusid | 2-s2.0-85054806347 | - |
dc.citation.endPage | 24 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 18 | - |
dc.citation.title | Oncologist | - |
dc.citation.volume | 24 | - |
dc.type.docType | Article in Press | - |
dc.publisher.location | 미국 | - |
dc.subject.keywordPlus | 2ND-LINE CHEMOTHERAPY | - |
dc.subject.keywordPlus | SUPPORTIVE CARE | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | PLUS | - |
dc.subject.keywordPlus | FLUOROURACIL | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | CISPLATIN | - |
dc.subject.keywordPlus | DOCETAXEL | - |
dc.subject.keywordPlus | FAILURE | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
84, Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea (06974)02-820-6194
COPYRIGHT 2019 Chung-Ang University All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.