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/m2 three times every 4 weeks or daily oral S-1 (80 mg/m2) for 2 weeks plus paclitaxel (50 mg/m2) 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.
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Acknowledgments
We thank the non-profit organization Epidemiological and Clinical Research Information Network (ECRIN) for the partial support of this work.
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Morita 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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Nakanishi, K., Kobayashi, D., Mochizuki, Y. et al. 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). Int J Clin Oncol 21, 557–565 (2016). https://doi.org/10.1007/s10147-015-0919-z
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DOI: https://doi.org/10.1007/s10147-015-0919-z