Phase II study of cetuximab plus S-1/cisplatin therapy in Japanese patients with advanced gastric cancer.
OBJECTIVE
We evaluated the efficacy and safety of first-line S-1 plus cisplatin in combination with cetuximab for Japanese patients with advanced gastric cancer, including gastroesophageal junction adenocarcinoma.


METHODS
This open-label, single arm, multicenter, phase 2 trial was conducted to assess first-line cetuximab plus S-1 plus cisplatin for advanced gastric cancer. A total of 40 patients from 10 centers were enrolled. Cetuximab was administered weekly, with the initial infusion at 400 mg/m2 and then 250 mg/m2 each subsequent week. S-1 plus cisplatin chemotherapy was concomitantly conducted in a 5-week cycle: S-1 (40-60 mg, adjusted for body surface area) was given twice daily for 3 consecutive weeks, followed by a 2-week rest period, and cisplatin (60 mg/m2) was given on day 8 of each cycle for a maximum of 8 cycles. Treatment continued until the occurrence of radiographically confirmed progressive disease, unacceptable toxicity or withdrawal of consent. The primary endpoint was the best overall response. Secondary endpoints included progression-free survival and safety.


RESULTS
A total of 40 patients were evaluable. One patient (2.5%) had a complete response; 15 patients (37.5%) had a partial response. The observed overall response rate according to the independent review committee was 40.0% (95% confidence interval, 24.9-56.7; P = 0.7043 [one-sided null hypothesis: overall response rate ≤ 43%]); median PFS was 5.6 months (95% confidence intervals, 4.2-8.3). No adverse events leading to death were reported during the study, and no specific safety concerns were observed.


CONCLUSIONS
Overall, the addition of cetuximab to S-1 plus cisplatin was well tolerated in patients with advanced gastric cancer but provided no additional clinical benefit in this study. ClinicalTrials.gov identifier: NCT01388790.
['Yamaguchi|Kensei|K|0000-0001-6887-5709', 'Fuse|Nozomu|N|', 'Komatsu|Yoshito|Y|', 'Fujii|Hirofumi|H|', 'Hironaka|Shuichi|S|', 'Omuro|Yasushi|Y|', 'Muro|Kei|K|', 'Yasui|Hirofumi|H|', 'Ueda|Shinya|S|', 'Nishina|Tomohiro|T|', 'Watanabe|Morihiro|M|', 'Ohtsu|Atsushi|A|']
D000230:Adenocarcinoma D000328:Adult D000368:Aged D000971:Antineoplastic Combined Chemotherapy Protocols D000068818:Cetuximab D002945:Cisplatin D004334:Drug Administration Schedule D004338:Drug Combinations D005260:Female D006801:Humans D007564:Japan D008297:Male D008875:Middle Aged D010094:Oxonic Acid D012074:Remission Induction D013274:Stomach Neoplasms D005641:Tegafur D016896:Treatment Outcome
cetuximab S-1 cisplatin stomach neoplasms tegafur-gimeracil-oteracil