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BMC Cancer
Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Research article

Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer

Authors: Guoxiu Wang, Jiuda Zhao, Yan Song, Wen Zhang, Yongkun Sun, Aiping Zhou, Jing Huang, Feng Du, Lin Yang

Published in: BMC Cancer | Issue 1/2018

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Abstract

Background

S-1 plus oxaliplatin(SOX) has been demonstrated to be effective and well tolerated for patients with metastatic gastric cancer. We conducted this phase II study to evaluate the feasibility of SOX as adjuvant chemotherapy for gastric cancer after curative resection.

Methods

Adjuvant chemotherapy consisted of six to eight cycles of S-1 plus oxaliplatin. Oxaliplatin was administered intravenously at a dose of 130 mg/m2 on day 1. S-1 was administered orally at a dose of 70 mg/m2 daily from day 1 to 14 of a 3-week cycle. A total of 58 patients were enrolled in this study. The primary end point of the trial was the treatment completion rate for six cycles. Secondary endpoints were safety, 1-year and 3-year of disease free survival (DFS) and overall survival (OS).

Results

A total of 58 patients were enrolled and 54 patients have been analysed. The completion rate of six cycles was 72.2%. Grade 4 toxicities included neutropenia (1.9%) and thrombocytopenia (3.7%). Grade 3 toxicities included leukopenia (5.6%), neutropenia (24.1%), thrombocytopenia (13.0%), nausea (7.4%), vomiting 13.0%), and diarrhea (13.0%). There was no grade 3 or higher peripheral sensory neuropathy and treatment-related death. The median follow-up time was 42.4 months. 1-year and 3-year DFS rate were 85.2 and 75.9%, respectively.1-year and 3-year OS were 98.1 and 85.2%, respectively.

Conclusion

Adjuvant chemotherapy for GC with S-1 plus oxaliplatin is safe and feasible in Chinese patients. The optimal dose of oxaliplatin and optimal cycles of treatment still need to be further investigated.

Trial registration

clinicaltrials.gov identifier NCT01542294. Trial registration date: 03/02/2012.
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Metadata
Title
Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer
Authors
Guoxiu Wang
Jiuda Zhao
Yan Song
Wen Zhang
Yongkun Sun
Aiping Zhou
Jing Huang
Feng Du
Lin Yang
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4480-9

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