Phase II study of docetaxel plus cisplatin as a second-line combined therapy in patients with advanced gastric carcinoma.
BACKGROUND
We conducted a pilot phase II study to evaluate the efficacy and safety of docetaxel and cisplatin as a combination second-line therapy for advanced gastric cancer.


METHODS
Between 2000 and 2003, 30 patients were enrolled into this study. Chemotherapy consisted of 60 mg/m2 of docetaxel followed by 60 mg/m2 of cisplatin. This regimen was repeated at least three times at 3-week intervals.


RESULTS
The overall response rate was 26.7%. The median time to disease progression was 4.5 months. The median survival time was 13 months from the start of the first-line therapy and 6 months from the second-line therapy. With respect to toxicity, the major adverse effect was leukopenia, which reached grades 3-4 in 26.7%. Non-hematological toxicities were usually moderate, and no deaths were attributable to the adverse effects of the drugs.


CONCLUSIONS
This combination therapy was effective as a second-line treatment for advanced gastric cancer with acceptable toxic side-effects.
Kunisaki
Chikara
C
Department of Surgery, Gastroenterological Center, Yokohama City University, Graduate School of Medicine, Yokohama, Japan. s0714@med.yokohama-cu.ac.jp
Imada
Toshio
T
Yamada
Roppei
R
Hatori
Shinsuke
S
Ono
Hidetaka
H
Otsuka
Yuichi
Y
Matsuda
Goro
G
Nomura
Masato
M
Akiyama
Hirotoshi
H
Kubo
Akira
A
Shimada
Hiroshi
H
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D013274:Stomach Neoplasms / Q000188:drug therapy*; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin