A feasibility study of postoperative chemotherapy with S-1 and cisplatin (CDDP) for stage III/IV gastric cancer (CCOG 1106).
BACKGROUND
The standard of care for stage II/III gastric cancer in Japan is D2 dissection followed by adjuvant S-1 monotherapy. Outcome of patients with stage III disease remains unsatisfactory, calling for a more intensive adjuvant chemotherapy regimen, for which evidence in advanced/metastatic cancer research suggests S-1/cisplatin (CDDP) as a candidate. Although S-1/CDDP was poorly tolerated postoperatively in the previous trial, compliance was dramatically improved by insertion of one cycle of S-1 monotherapy, which delayed administration of CDDP by 6 weeks.


METHODS
A feasibility study of post-gastrectomy S-1/CDDP was performed. Patients with stage III/IV gastric cancer were eligible. The first cycle of chemotherapy consisted of S-1 monotherapy, and intensive antiemetic drugs were prescribed when patients were administered CDDP. The primary endpoint was the completion rate of four cycles of S-1/CDDP. The secondary endpoints were the relative dose intensity, safety, progression-free survival time and overall survival time. Several criteria to skip, postpone or reduce the dose had been predetermined.


RESULTS
Between 2010 and 2011, 33 patients were enrolled. Four patients had stage IIIA disease, 7 patients had stage IIIB disease, 11 patients had stage IIIC disease, and 11 patients had stage IV disease. The completion rate of the protocol treatment was 60.6%. The relative dose intensity of S-1 was 77.3% and that of CDDP was 72.3%.


CONCLUSIONS
The protocol-specified delay in the administration of CDDP dramatically improved the relative drug intensity in the postoperative adjuvant setting, although the completion rate did not reach the expected level.
Department of Surgery, Konan Kosei Hospital, Konan, Japan.
Keisuke
K
Kurimoto
Kiyoshi
K
Ishigure
Yoshinari
Y
Mochizuki
Akiharu
A
Ishiyama
Takanori
T
Matsui
Seiji
S
Ito
Hiroshi
H
Nakayama
Nobutake
N
Tanaka
Daisuke
D
Kobayashi
Junichi
J
Sakamoto
Akimasa
A
Nakao
Yasuhiro
Y
Kodera
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011182:Postoperative Care; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005641:Tegafur / Q000008:administration & dosage; D055815:Young Adult
D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin