A multicenter phase II study of the efficacy and safety of docetaxel plus cisplatin in Asian chemonaïve patients with metastatic or locally advanced non-small cell lung cancer.
OBJECTIVE
To evaluate the efficacy and safety of docetaxel-cisplatin in patients with metastatic or locally advanced non-small cell lung cancer (NSCLC).


METHODS
Chemotherapy-naïve patients with histologically confirmed TNM stage III or IV NSCLC were recruited from 12 Asian trial centers. Patients received docetaxel (75 mg/m2) and cisplatin (75 mg/m2) every 3 weeks for 6 cycles.


RESULTS
130 of 146 patients were evaluable for efficacy (60% stage IV). Three complete and 58 partial responses were observed (overall response rate: 46.9%; 95% CI: 38.3-55.5%). Median time to progression was 6.9 months and median survival was 14.0 months; 1-year survival was 59.5%. Grade 3/4 neutropenia, thrombocytopenia and anemia occurred in 69.2%, 6.2% and 18.5% of patients, respectively. Grade 3/4 vomiting was observed in 13.7% and grade 3/4 neurosensory effects were observed in 2.7% of patients. There was one case of treatment-related death due to sepsis.


CONCLUSIONS
Docetaxel-cisplatin is an effective and well-tolerated treatment in Asian patients with NSCLC.
Ho
James C M
JC
Department of Medicine, Queen Mary Hospital, University of Hong Kong, Pokfulam, Hong Kong, China.
Tan
E H
EH
Leong
S S
SS
Wang
C H
CH
Sun
Y
Y
Li
R
R
Wahid
M I A
MI
Jusuf
A
A
Liao
M
M
Guan
Z
Z
Handoyo
P
P
Huang
J S
JS
Chan
V
V
Luna
G
G
Tsang
K W T
KW
Lam
W K
WK
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001208:Asia; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D015996:Survival Rate; D043823:Taxoids
D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel; D002945:Cisplatin