Phase II study of the combination of gemcitabine and nedaplatin for advanced non-small-cell lung cancer.
We examined the efficacy and safety of the combination of gemcitabine and nedaplatin in patients with untreated advanced non-small-cell lung cancer. Thirty-four patients (24 men and 10 women) with a mean age of 69 years (range, 39-75 years) were treated every 3 weeks with gemcitabine (1,000 mg/m(2) on days 1 and 8) and nedaplatin (100 mg/m(2) on day 1). Four patients had stage IIIB disease and 30 patients had stage IV disease. None of the 33 patients achieved a complete response, but 10 achieved a partial response, for a response rate of 30.3% (95% confidence interval, 15.6-48.7%). One patient could not be evaluated for response because only one course of chemotherapy had been administered due to grade 3 eruption. The median survival time was 9.0 months (range, 1-17 months). Grades 3-4 hematological toxicities included leukopenia in 47% of patients, neutropenia in 62%, thrombocytopenia in 56%, and anemia in 44%. Grades 3-4 nonhematological toxicities included nausea and vomiting in 6% of patients, diarrhea in 3%, and hepatic dysfunction in 9%. There were no treatment-related deaths. The dose intensities were 89.6% and 86.7%, respectively, of the planned doses of gemcitabine and nedaplatin. Our results suggest that the combination of gemcitabine and nedaplatin is an acceptable treatment for patients with previously untreated advanced non-small-cell lung cancer.
Shirai
Takao
T
The First Department of Internal Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Tokyo 142-8666, Japan. alicelov@t.toshima.ne.jp
Hirose
Takashi
T
Noda
Munehide
M
Ando
Kouichi
K
Ishida
Hiroo
H
Hosaka
Takamichi
T
Ozawa
Tetsuzi
T
Okuda
Kentarou
K
Ohnishi
Tsukasa
T
Ohmori
Tohru
T
Horichi
Naoya
N
Adachi
Mitsuru
M
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D012189:Retrospective Studies; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D009944:Organoplatinum Compounds; D003841:Deoxycytidine; C053989:nedaplatin; D012264:Ribonucleotide Reductases; D000093542:Gemcitabine