[Randomized phase II trial to compare S-1 and S-1/PSK for advanced or recurrent gastric cancer-lessons from the results].
BACKGROUND
This is a randomized phase II trial to evaluate non-inferiority of progression-free surviva(l PFS) by comparing S-1 and S-1/PSK for advanced or recurrent gastric cancer. Sample size was calculated to be 120. However, the trial was terminated because of slow accrual. This exploratory analysis was done by collecting the minimum data.


RESULTS
Only 8 patients were enrolled. Four patients were randomly assigned to S-1 and the others to S-1/PSK. Performance status was 0 in all 8 patients. Median age was 64. Median overall survival was 13.7 months in all 8 patients, 8 . 9 months in S-1 group, and 13 . 7 months in S-1/PSK group.


CONCLUSIONS
When considering PS 0 in 8 patients enrolled, an overall survival was comparable to that observed in S-1 group of other phase III trials. Standard chemotherapy for advanced gastric cancer was changed to S-1/CDDP by SPIRITS phase III trial which was presented just after this trial was initiated, which would be a major cause of slow accrual. When conducting phase III trial, we should carefully determine design and standard arm by considering on-going phase III trial.
Dept. of Gastrointestinal Surgery, Kanagawa Cancer Center.
Takaki
T
Yoshikawa
Akira
A
Tsuburaya
Zenichiro
Z
Saze
Toru
T
Aoyama
Shinichi
S
Hasegawa
Akira
A
Kanemoto
Masanori
M
Terashima
Hideaki
H
Tahara
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010094:Oxonic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D011509:Proteoglycans / Q000008:administration & dosage / Q000627:therapeutic use*; D012008:Recurrence; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage / Q000627:therapeutic use*
D004338:Drug Combinations; D011509:Proteoglycans; C079198:S 1 (combination); D005641:Tegafur; C010770:polysaccharide-K; D010094:Oxonic Acid