A feasibility study of postoperative chemotherapy with S-1 and cisplatin (CDDP) for gastric carcinoma (CCOG0703).
BACKGROUND
The outcome of stage III gastric cancer patients treated by D2 dissection followed by adjuvant chemotherapy with S-1 remains unsatisfactory. Moreover, some patients with a preoperative diagnosis of stage II/III turn out to be stage IV after surgical exploration, and a standard postoperative treatment for this population has not been established.


METHODS
A feasibility study of postoperative S-1/cisplatin (CDDP) was performed with patients who underwent gastrectomy for what turned out to be a stage IV gastric cancer. The primary endpoint of the trial was the relative dose intensity during five courses of S-1/CDDP. Several criteria to skip, postpone, or reduce the dose had been predetermined.


RESULTS
Between 2007 and 2009, 31 patients were accrued, including 19 patients who were positive for peritoneal washing cytology, 6 with peritoneal seeding, 5 with metastasis to the paraaortic nodes, and 4 with other distant metastases. Only 7 patients completed five cycles as planned (median, two cycles). The median relative dose intensities of S-1 and CDDP were 37% and 40%, respectively. Causes of treatment failure were failure to fulfill criteria for starting a new course within 5 weeks of the last administration of S-1 in 7, patient refusal in 6, disease recurrence/progression in 4, need to reduce dose by two levels in 4, and two successive skips of CDDP in 3 patients. The median progression-free survival time of all patients was 363 days.


CONCLUSIONS
Although promising in the neoadjuvant and advanced/metastatic setting, S-1/CDDP is too toxic as a postgastrectomy treatment for Japanese patients.
Kodera
Yasuhiro
Y
Department of Surgery II, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
Ishiyama
Akiharu
A
Yoshikawa
Takaki
T
Kinoshita
Takashi
T
Ito
Seiji
S
Yokoyama
Hiroyuki
H
Mochizuki
Yoshinari
Y
Ito
Hiroaki
H
Tsuburaya
Akira
A
Sakamoto
Junichi
J
Nakao
Akimasa
A
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000627:therapeutic use*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005743:Gastrectomy; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011182:Postoperative Care; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin
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