Gemcitabine/carboplatin in patients with metastatic non-small-cell lung cancer: phase II study of 28-day and 21-day schedules.
Clin Lung Cancer
; 7(3): 202-7, 2005 Nov.
Article
in En
| MEDLINE
| ID: mdl-16354316
ABSTRACT
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. PATIENTS ANDMETHODS:
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).CONCLUSION:
Gemcitabine/carboplatin demonstrated efficacy comparable to other platinum agent doublets. Either schedule can be recommended, as differences in survival between groups were not significant.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Antineoplastic Combined Chemotherapy Protocols
/
Carboplatin
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Carcinoma, Non-Small-Cell Lung
/
Deoxycytidine
/
Lung Neoplasms
Type of study:
Clinical_trials
/
Prognostic_studies
Limits:
Adult
/
Aged
/
Aged80
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Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Clin Lung Cancer
Journal subject:
NEOPLASIAS
Year:
2005
Document type:
Article
Affiliation country:
United States
Publication country:
EEUU
/
ESTADOS UNIDOS
/
ESTADOS UNIDOS DA AMERICA
/
EUA
/
UNITED STATES
/
UNITED STATES OF AMERICA
/
US
/
USA