Phase II trial of low-dose gemcitabine in prolonged infusion and cisplatin for advanced non-small cell lung cancer.
OBJECTIVE
To evaluate the efficacy and safety of the combination of gemcitabine at a low dose of 250 mg/m(2) in 6h prolonged infusion with cisplatin in chemonaive patients with advanced non-small cell lung cancer (NSCLC).


METHODS
Fifty-eight chemonaive patients with stage IIIB or IV NSCLC were included, 39 males and 19 females, with a median age 61 years (range 28-73). Thirty-four (58.6%) patients had adenocarcinoma, 18 (31.0%) squamous cell, and 6 (10.4%) others. Seventeen (29.3%) had stage IIIB and 41 (70.7%) stage IV. Treatment consisted of 250 mg/m(2) gemcitabine in a 6h infusion on days 1 and 8, and cisplatin at 75 mg/m(2) on day 2 of a 3-week cycle. A total of 219 chemotherapy cycles were administered, with a median of 4 cycles per patient (range 1-6).


RESULTS
Of the 58 patients enrolled, all were evaluated for toxicity and 56 assessed for response. The overall response rate was 39.3% (95% confidence interval, 26.5-52.1%) with complete and partial responses of 3.6 and 35.7%, respectively. The median time to disease progression was 5.5 months (95% CI, 4.3-6.7 months), and median overall survival time was 10.5 months (95% CI, 8.5-12.5 months). One-year survival rate was 41.4%. Hematologic toxicity was fairly mild, and grades 3-4 hematologic toxicities consisted of neutropenia in 18.9% of patients, thrombocytopenia in 10.3%, and anemia in 6.9%. No patients required platelet transfusions, no bleeding episodes were recorded, and three patients received packed red blood cells (RBC) transfusions. The main nonhematologic toxicities included grade 3 nausea/vomiting in 27.6% of patients, grade 1-2 alopecia in 63.8%, and grade 1-2 skin rash in 17.3 %.


CONCLUSIONS
Low-dose gemcitabine in 6h prolonged infusion plus cisplatin is effective in NSCLC treatment. Toxicity, especially myelosuppression, is remarkably mild.
Xiong
Jian Ping
JP
Department of Oncology, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, China. jpxiong@medmail.com.cn
Feng
Miao
M
Qiu
Feng
F
Xu
Jun
J
Tao
Qing Song
QS
Zhang
Ling
L
Xiang
Xiao Jun
XJ
Zhong
Lu Xing
LX
Yu
Feng
F
Ma
Xu Tian
XT
Gong
Wang Yong
WY
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000037:antagonists & inhibitors*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine