S-l combined with cisplatin plus concurrent chemoradiotherapy versus cisplatin plus concurrent chemoradiotherapy for Chinese patients with advanced gastric cancer: a multi-centre randomized controlled trial.
BACKGROUND
This study aimed to investigate the safety and efficacy of S-l combined with cisplatin plus concurrent chemoradiotherapy (SCCC) versus cisplatin plus concurrent chemoradiotherapy (CCC) for Chinese patients with advanced gastric cancer (AGC).


METHODS
Between April 2008 and June 2010, 144 eligible patients with AGC were included and divided randomly into 2 groups. Seventy-two patients in the SCCC group received with S-1 on days 1-14 of a 21-day cycle, 24-h cisplatin infusion (70 mg/m(2) on day 1) every 4 weeks for 2 cycles, and concurrent chemoradiotherapy (30-Gy radiotherapy over 4 weeks) beginning on day 1. The other 72 patients in the CCC group were administered cisplatin and concurrent chemoradiotherapy as for SCCC. The primary outcome was overall survival. Secondary outcomes were progression-free survival and adverse events.


RESULTS
The median overall survival durations were 11.7 months (range 1.7-29.7 months) and 9.5 months (range 1.2-25.4 months) in SCCC and CCC groups, respectively (P = 0.041). The median progression-free survival durations were 10.6 months for SCCC (range 1.3-24.7 months) and 8.8 months (range 0.7-22.3 months) for CCC (P = 0.046). The toxicity profile was similar in both groups.


CONCLUSIONS
In summary, SCCC showed more promising safety and efficacy than CCC in Chinese patients with AGC. In addition, the toxicities were also acceptable in both groups.
Department of Surgery, Fourth Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.
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Chen
Department of Oncology, Third Affiliated Hospital of Harbin Medical University, No. 150 Haping Road, Nangang District, Harbin, 150081, Heilongjiang, China.
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Li
Department of Oncology, Third Affiliated Hospital of Harbin Medical University, No. 150 Haping Road, Nangang District, Harbin, 150081, Heilongjiang, China.
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Sun
Department of Oncology, Third Affiliated Hospital of Harbin Medical University, No. 150 Haping Road, Nangang District, Harbin, 150081, Heilongjiang, China.
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Y
Liu
Department of Oncology, Third Affiliated Hospital of Harbin Medical University, No. 150 Haping Road, Nangang District, Harbin, 150081, Heilongjiang, China.
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S
Liu
Department of Oncology, Third Affiliated Hospital of Harbin Medical University, No. 150 Haping Road, Nangang District, Harbin, 150081, Heilongjiang, China. marong1521@163.com.
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Ma
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D044466:Asian People; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage*; D013274:Stomach Neoplasms / Q000401:mortality / Q000628:therapy*; D005641:Tegafur / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin
Advanced gastric cancer; Chemoradiotherapy; Cisplatin; Randomized controlled trial; S-l