Gemcitabine/carboplatin in patients with metastatic non-small-cell lung cancer: phase II study of 28-day and 21-day schedules.
BACKGROUND
The combination of gemcitabine/carboplatin is active and is widely used for advanced non-small-cell lung cancer (NSCLC). The optimum schedule for the administration of these agents is not currently known. This study compared 2 different combinations of carboplatin/gemcitabine to identify a schedule with a superior therapeutic index.


METHODS
The 28-day schedule used gemcitabine 1,100 mg/m2 on days 1 and 8 plus carboplatin to an area under the curve (AUC) of 5 on day 8. The 21-day schedule used gemcitabine 1,000 mg/m2 on days 1 and 8 plus carboplatin to an AUC of 5 on day 1.


RESULTS
Four hundred ninety-nine chemotherapy-naive patients with stage IIIB NSCLC (with malignant pleural effusion) or stage IV NSCLC were accrued. Grade 3/4 toxicities with the 28-day and 21-day schedules were anemia (4.8% and 6.9% of cycles, respectively), neutropenia (9.1% and 10.7% of cycles, respectively), and thrombocytopenia (8% and 14.4% of cycles, respectively). Thirty-four patients (13.2%) received blood transfusions with the 28-day regimen, as did 43 (20%) with the 21-day regimen, and no bleeding episodes occurred. Overall response rates were 22.8% with the 28-day schedule and 32.6% with the 21-day schedule (P=0.0338). Median survival and 1-year and 2-year survival rates were 9.8 months, 38.6%, and 15.7%, respectively, with the 28-day schedule and 12 months, 49.1%, and 15.8%, respectively, with the 21-day schedule (P=0.5098).


CONCLUSIONS
Gemcitabine/carboplatin demonstrated efficacy comparable to other platinum agent doublets. Either schedule can be recommended, as differences in survival between groups were not significant.
Obasaju
Coleman K
CK
Eli Lilly and Company, Indianapolis, IN 46285, USA. cobasaju@lilly.com
Ye
Zhishen
Z
Bloss
Leslie P
LP
Monberg
Matthew J
MJ
Curiel
Rafael E
RE
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; 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*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine