Phase I/II study of 3-week cycle cisplatin-gemcitabine in advanced non-small cell lung cancer.
BACKGROUND
The combination of cisplatin and gemcitabine is one of the most active chemotherapy regimens against non-small cell lung cancer. However, the optimum schedule for this combination has not been determined. This study was performed to determine the maximum tolerated dose of gemcitabine combined with cisplatin in a 3-week cycle regimen and to observe safety and efficacy for Japanese patients with advanced non-small cell lung cancer.


METHODS
80 mg/m(2) of cisplatin on day 1 and escalated doses of gemcitabine on days 1 and 8 were administered every 3 weeks to patients with previously untreated, advanced non-small cell lung cancer. The initial dose of gemcitabine was 1000 mg/m(2) and was escalated in 250 mg/m(2) increments.


RESULTS
Twenty-four patients were enrolled between March and December 2000. In total, 64 courses were given. The main toxicities were neutropenia, thrombocytopenia and hepatotoxicity. The maximum tolerated dose was determined to be 1500 mg/m(2) of gemcitabine combined with 80 mg/m(2 )of cisplatin. Nine of 24 patients (37.5%) achieved a partial response.


CONCLUSIONS
This study demonstrates that the combination of cisplatin and gemcitabine repeated every three weeks is tolerable for Japanese patients with advanced non-small cell lung cancer. We determined 1250 mg/m(2) of gemcitabine combined with 80 mg/m(2 )of cisplatin to be the recommended dose.
Kusaba
Hitoshi
H
Division of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan.
Tamura
Tomohide
T
Shimoyama
Tatsu
T
Hotta
Katsuyuki
K
Inoue
Akira
A
Nokihara
Hiroshi
H
Ueda
Yutaka
Y
Akiyama
Yoshiko
Y
Yamamoto
Noboru
N
Sekine
Ikuo
I
Kunitoh
Hideo
H
Ohe
Yuichiro
Y
Kodama
Tetsuro
T
Saijo
Nagahiro
N
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine