Phase II study of carboplatin combined with biweekly docetaxel for advanced non-small cell lung cancer.
BACKGROUND
The combination of carboplatin and docetaxel has been considered one of the standard treatments for advanced non-small cell lung cancer (NSCLC). To investigate a safer and more convenient schedule for outpatient, we conducted a phase II study to evaluate the efficacy and the safety of carboplatin plus biweekly docetaxel for advanced NSCLC.


METHODS
Patients with stage IIIB, IV, or postoperative recurrent NSCLC with good performance status were administered docetaxel at a dose of 35 mg/m on days 1 and 15 and carboplatin at an area under the curve (AUC) of 6 on day 1 every 4 weeks for at least three cycles.


RESULTS
Fifty patients were treated with median of three cycles (range 1-6). Grade 3/4 toxicities included neutropenia in 18 patients (36%), thrombocytopenia in 4 patients (8%), and anemia in 10 patients (20%). No patient experienced febrile neutropenia. Nonhematological toxicities were also mild to moderate, and there were no treatment-related deaths. The overall response rate was 30%, and the disease control rate was 70%. Among the elderly population, 54% of patients achieved partial response. Median progression-free survival was 4.8 months, and median overall survival was 11.8 months.


CONCLUSIONS
Biweekly docetaxel plus carboplatin has a similar efficacy and lower toxicity compared with a standard triweekly regimen of docetaxel plus carboplatin, which is a suitable regimen for outpatients, including elderly patients.
Ishimoto
Osamu
O
Tohoku Lung Cancer Clinical Study Group, Sendai Kousei Hospital, Aobaku, Sendai, Miyagi, Japan.
Sugawara
Shunichi
S
Inoue
Akira
A
Ishida
Takashi
T
Munakata
Mitsuru
M
Koinumaru
Sadahiro
S
Hasegawa
Yukihiro
Y
Suzuki
Toshiro
T
Miki
Hiroshi
H
Saijo
Yasuo
Y
Nukiwa
Toshihiro
T
D000328:Adult; D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology*; D009367:Neoplasm Staging; D012307:Risk Factors; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin