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Title of Journal: Int J Clin Oncol

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Abbravation: International Journal of Clinical Oncology

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Springer Japan

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DOI

10.1016/0315-0860(80)90024-5

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ISSN

1437-7772

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Phase II multiinstitutional prospective randomize

Authors: Koki Nakanishi Daisuke Kobayashi Yoshinari Mochizuki Kiyoshi Ishigure Seiji Ito Hiroshi Kojima Akiharu Ishiyama Shinichi Fujitake Toshio Shikano Satoshi Morita Yasuhiro Kodera
Publish Date: 2015/11/07
Volume: 21, Issue: 3, Pages: 557-565
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Abstract

Gastric cancer patients who developed progression during S1based firstline chemotherapy or had recurrence during postoperative adjuvant chemotherapy by S1 were randomly assigned to receive secondline treatment either by weekly administration of paclitaxel at 80 mg/m2 three times every 4 weeks or daily oral S1 80 mg/m2 for 2 weeks plus paclitaxel 50 mg/m2 given on days 1 and 8 every 3 weeks S1 plus paclitaxel The primary endpoint was progressionfree survival PFS at 4 months after the initiation of treatmentA total of 78 patients were eligible for efficacy analyses—40 were assigned to the paclitaxel group and 38 to the S1 plus paclitaxel group PFS at 4 months was similar between the groups 50  for paclitaxel vs 55  for S1 plus paclitaxel P = 0641 There were no differences between the groups either in progressionfree survival 46 vs 46 months respectively P = 0526 overall survival 100 vs 100 months respectively P = 0464 or overall response rate 27 vs 22  respectively P = 0767 The incidences of grade 3 or 4 hematological and nonhematological toxicities were also equivalent between the two groups 25 vs 26  and 24 vs 26  respectivelyMorita has received grants and personal fees from Taiho Pharmaceutical Company grants and personal fees from Bristol Myers Squib outside the submitted work Kodera has received grants and personal fees from Taiho Pharmaceutical Company grants and personal fees from Bristol Meyers Squib grants from Nippon Kayaku outside the submitted work


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