Phase II multi-institutional prospective randomized trial comparing S-1 plus paclitaxel with paclitaxel alone as second-line chemotherapy in S-1 pretreated gastric cancer (CCOG0701)

• Published in: International journal of clinical oncology 2016-06, Vol.21 (3), p.557-565
• Main Authors: Nakanishi, Koki, Kobayashi, Daisuke, Mochizuki, Yoshinari, Ishigure, Kiyoshi, Ito, Seiji, Kojima, Hiroshi, Ishiyama, Akiharu, Fujitake, Shinichi, Shikano, Toshio, Morita, Satoshi, Kodera, Yasuhiro
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer Research; Chemotherapy; Chemotherapy, Adjuvant; Clinical outcomes; Clinical trials; Disease-Free Survival; Drug Combinations; Female; Gastric cancer; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Oncology; Original Article; Oxonic Acid - administration & dosage; Oxonic Acid - adverse effects; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Prospective Studies; Retreatment; Stomach Neoplasms - drug therapy; Surgical Oncology; Survival Rate; Tegafur - administration & dosage; Tegafur - adverse effects
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-015-0919-z

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.