Tegafur-uracil plus gemcitabine combination chemotherapy in patients with advanced non-small cell lung cancer previously treated with platinum.
BACKGROUND
An open-label, single-arm prospective study was conducted to evaluate the efficacy and toxicity of the combination of gemcitabine and tegafur-uracil (UFT) in patients with advanced nonsmall-cell lung cancer (NSCLC) after the failure of previous platinum-containing regimens.


METHODS
Patients with advanced NSCLC received 200 mg/m2 of UFT twice daily from day 1 through 14 plus 900 mg/m2 of gemcitabine per day via intravenous injection on days 8 and 15. This regimen was repeated every 3 or 4 weeks.


RESULTS
A total of 40 patients were enrolled. Eleven patients (28%; 95% confidence interval [CI], 15-44%) achieved a partial response. The median progression-free survival, median overall survival, and 1-year survival rate were 4.0 months (95% CI, 3.3-6.7 months), 12.6 months (95% CI, 7.0-22.3 months), and 51% (95% CI, 33-66%), respectively. The most common grade 3 or 4 toxicity was neutropenia (38%; 95% CI, 23-54%) and the rate of grade 3 or 4 nonhematologic toxicity remained at less than 5%. A multivariate Cox model showed that adenocarcinoma, nonsmoking history, and good performance status predicted better survival.


CONCLUSIONS
Combination chemotherapy with UFT and gemcitabine showed a promising effectiveness and acceptable toxicity for patients with platinum-resistant NSCLC.
Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan. tseto@nk-cc.go.jp
Takashi
T
Seto
Takeharu
T
Yamanaka
Makiko
M
Nakano
Mayuko
M
Ota
Riichiroh
R
Maruyama
Tatsuro
T
Okamoto
Hiroshi
H
Wataya
Kazutsugu
K
Uematsu
Nobuhiko
N
Seki
Kenji
K
Eguchi
Hiroshi
H
Semba
Yukito
Y
Ichinose
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D007564:Japan / Q000453:epidemiology; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D012189:Retrospective Studies; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000627:therapeutic use; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage / Q000627:therapeutic use
D009944:Organoplatinum Compounds; D005641:Tegafur; D014498:Uracil