[Randomized study of thalidomide combined with vinorelbine and cisplatin chemotherapy for the treatment of advanced non-small cell lung cancer].
OBJECTIVE
To evaluate the efficacy, median time to progression (TTP), quality of life and toxicity in the patients with advanced non-small cell lung cancer (NSCLC), treated with thalidomide plus vinorelbine and cisplatin (NP) or NP alone.


METHODS
Sixty six patients with advanced NSCLC were divided randomly into two groups, the trial and control groups. The trial group was treated with vinorelbine 25 approximately 30 mg/m(2) i.v. on D1 and D8, cisplatin 70 approximately 80 mg/m(2) i.v. on D1 (NP regimen), and thalidomide 200 mg orally and daily from D1. The control group received vinorelbine and cisplatin as above described.


RESULTS
Of 66 assessable patients, the overall response rate was 51.5% in the trial group and 36.4% in the control group (P = 0.22). The median TTP was 6.0 months for the trial group, and 3.6 months for the control group (P < 0.001). The score of quality of life in trial group was higher than that in the control group, but no significant difference was observed between the two groups (P > 0.05). There were no significant differences in toxicities between the two groups (P > 0.05).


CONCLUSIONS
NP regimen combined with thalidomide can significantly prolong the median time to tumor progression in patients with advanced NSCLC. Thalidomide may have a synergic activity with NP regimen without increased toxicities.
Gu
Ai-qin
AQ
Department of Pneumology, Shanghai Chest Hospital of Jiaotong Uniyersity, Shanghai 200030, China.
Han
Bao-hui
BH
Zhang
Xue-yan
XY
Shen
Jie
J
Qi
Da-jiang
DJ
Xiong
Li-wen
LW
Xin
Yu
Y
Song
Yi-yi
YY
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D004357:Drug Synergism; D001068:Feeding and Eating Disorders / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011788:Quality of Life; D012074:Remission Induction; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine; D014839:Vomiting / Q000139:chemically induced
D013792:Thalidomide; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine