[Phase II clinical trial on gemcitabine in the treatment of stage IIIB-IV non-small cell lung cancer].
OBJECTIVE
To evaluate the efficacy and safety of domestic Gemcitabine in the treatment of patients with stage IIIB approximately IV non-small cell lung cancer (NSCLC).


METHODS
124 NSCLC patients were randomized into three groups: Group A: single drug group, 40 cases, gemcitabine 1 000 mg/m(2) + NS 100 ml or 200 ml was infused within 30 approximately 60 minutes on D1, 8 and 15, with 28 days taken as one cycle. Group B: combined treatment group, 36 cases, in addition to the above protocol, cisplatin 30 mg/m(2) was infused within 60 approximately 120 min, on D1, 2 and 3. Group C: combined control group: 39 cases, the protocol applied was the same as group B except domestic gemcitabine being replaced by imported gemzar. The efficacy and side effects of treatment were evaluated after 8 weeks of treatment.


RESULTS
115 patients could be evaluated for response rate. PR was observed in 9/40 (22.5%) of group A, 15/36 (41.6%) in group B and 15/39 (38.36%) in group C. There was no significant difference of PR rates between group B and group C (P = 0.552). 117 patients who received the second cycle of treatment were evaluated for toxicity. The incidence of grade III approximately IV nausea, vomiting and loss of appetite was much higher in group B. Hematological toxicity of groups B and C was higher than that of group A. There was no significant difference between groups B and C.


CONCLUSIONS
The efficacy and incidence of side effects between domestic gemcitabine and the imported gemzar are similar.
Liu
Shu-jun
SJ
Peking University School of Oncology, Beijing Cancer Hospital, Beijing 100036, China.
Di
Li-jun
LJ
Wang
Jie
J
Li
Rong
R
Yang
Lan
L
Sun
Hong
H
Zhang
Mao-hong
MH
Li
Li
L
Liu
Ji-wei
JW
Gao
Ya-jie
YJ
Sun
Hui
H
Xu
Guang-wei
GW
D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D000093542:Gemcitabine
D003841:Deoxycytidine; D000093542:Gemcitabine