Koki Nakanishi1, Daisuke Kobayashi2, Yoshinari Mochizuki1, Kiyoshi Ishigure3, Seiji Ito4, Hiroshi Kojima5, Akiharu Ishiyama6, Shinichi Fujitake7, Toshio Shikano8, Satoshi Morita9, Yasuhiro Kodera10. 1. Department of Surgery, Komaki City Hospital, Komaki, Japan. 2. Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. kobadai@med.nagoya-u.ac.jp. 3. Department of Surgery, Konan Kosei Hospital, Konan, Japan. 4. Department of Gastroenterological Surgery, Aichi Cancer Center, Nagoya, Japan. 5. Department of Surgery, Aichi Cancer Center Hospital, Nagoya, Japan. 6. Department of Surgery, Okazaki City Hospital, Okazaki, Japan. 7. Department of Surgery, Nishio Municipal Hospital, Nishio, Japan. 8. Department of Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan. 9. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 10. Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
Abstract
BACKGROUND: The aim of this study was to explore whether a combination of S-1 and paclitaxel offers any benefit over paclitaxel alone to patients pretreated by S-1. METHODS:Gastric cancer patients who developed progression during S-1-based first-line chemotherapy or had recurrence during postoperative adjuvant chemotherapy by S-1 were randomly assigned to receive second-line treatment either by weekly administration of paclitaxel at 80 mg/m(2) three times every 4 weeks or daily oral S-1 (80 mg/m(2)) for 2 weeks plus paclitaxel (50 mg/m(2)) given on days 1 and 8, every 3 weeks (S-1 plus paclitaxel). The primary endpoint was progression-free survival (PFS) at 4 months after the initiation of treatment. RESULTS: A total of 78 patients were eligible for efficacy analyses-40 were assigned to the paclitaxel group and 38 to the S-1 plus paclitaxel group. PFS at 4 months was similar between the groups (50 % for paclitaxel vs 55 % for S-1 plus paclitaxel, P = 0.641). There were no differences between the groups either in progression-free survival (4.6 vs 4.6 months, respectively, P = 0.526), overall survival (10.0 vs 10.0 months, respectively, P = 0.464), or overall response rate (27 vs 22 %, respectively, P = 0.767). The incidences of grade 3 or 4 hematological and non-hematological toxicities were also equivalent between the two groups (25 vs 26 % and 24 vs 26 %, respectively). CONCLUSIONS: No benefit of S-1 administration beyond progression was shown when paclitaxel was selected as the key drug for second-line chemotherapy.
RCT Entities:
BACKGROUND: The aim of this study was to explore whether a combination of S-1 and paclitaxel offers any benefit over paclitaxel alone to patients pretreated by S-1. METHODS:Gastric cancerpatients who developed progression during S-1-based first-line chemotherapy or had recurrence during postoperative adjuvant chemotherapy by S-1 were randomly assigned to receive second-line treatment either by weekly administration of paclitaxel at 80 mg/m(2) three times every 4 weeks or daily oral S-1 (80 mg/m(2)) for 2 weeks plus paclitaxel (50 mg/m(2)) given on days 1 and 8, every 3 weeks (S-1 plus paclitaxel). The primary endpoint was progression-free survival (PFS) at 4 months after the initiation of treatment. RESULTS: A total of 78 patients were eligible for efficacy analyses-40 were assigned to the paclitaxel group and 38 to the S-1 plus paclitaxel group. PFS at 4 months was similar between the groups (50 % for paclitaxel vs 55 % for S-1 plus paclitaxel, P = 0.641). There were no differences between the groups either in progression-free survival (4.6 vs 4.6 months, respectively, P = 0.526), overall survival (10.0 vs 10.0 months, respectively, P = 0.464), or overall response rate (27 vs 22 %, respectively, P = 0.767). The incidences of grade 3 or 4 hematological and non-hematological toxicities were also equivalent between the two groups (25 vs 26 % and 24 vs 26 %, respectively). CONCLUSIONS: No benefit of S-1 administration beyond progression was shown when paclitaxel was selected as the key drug for second-line chemotherapy.
Authors: Peter C Thuss-Patience; Albrecht Kretzschmar; Dmitry Bichev; Tillman Deist; Axel Hinke; Kirstin Breithaupt; Yasemin Dogan; Bernhard Gebauer; Guido Schumacher; Peter Reichardt Journal: Eur J Cancer Date: 2011-10 Impact factor: 9.162
Authors: Jung Hun Kang; Soon Il Lee; Do Hyoung Lim; Keon-Woo Park; Sung Yong Oh; Hyuk-Chan Kwon; In Gyu Hwang; Sang-Cheol Lee; Eunmi Nam; Dong Bok Shin; Jeeyun Lee; Joon Oh Park; Young Suk Park; Ho Yeong Lim; Won Ki Kang; Se Hoon Park Journal: J Clin Oncol Date: 2012-03-12 Impact factor: 44.544
Authors: Charles S Fuchs; Jiri Tomasek; Cho Jae Yong; Filip Dumitru; Rodolfo Passalacqua; Chanchal Goswami; Howard Safran; Lucas Vieira Dos Santos; Giuseppe Aprile; David R Ferry; Bohuslav Melichar; Mustapha Tehfe; Eldar Topuzov; John Raymond Zalcberg; Ian Chau; William Campbell; Choondal Sivanandan; Joanna Pikiel; Minori Koshiji; Yanzhi Hsu; Astra M Liepa; Ling Gao; Jonathan D Schwartz; Josep Tabernero Journal: Lancet Date: 2013-10-03 Impact factor: 79.321
Authors: J Kim; C-L Sun; B Mailey; C Prendergast; A Artinyan; S Bhatia; A Pigazzi; J D I Ellenhorn Journal: Ann Oncol Date: 2009-07-21 Impact factor: 32.976
Authors: Emil Ter Veer; Nadia Haj Mohammad; Gert van Valkenhoef; Lok Lam Ngai; Rosa M A Mali; Martijn G H van Oijen; Hanneke W M van Laarhoven Journal: Cancer Metastasis Rev Date: 2016-09 Impact factor: 9.264