Randomized phase II study of two schedules of carboplatin and gemcitabine for stage IIIB and IV advanced non-small cell lung cancer (JACCRO LC-01 study).
Słowa kluczowe
Abstrakcyjny
BACKGROUND
Gemcitabine combined with carboplatin (CG) is one of the regimens used widely for advanced non-small cell lung cancer. Improvement in its toxicity may result in good clinical outcomes.
METHODS
A new schedule of gemcitabine and carboplatin (CG8) was compared with the standard one (CG1). Both are 3-weekly regimens, but carboplatin is administered on day 1 in CG1 and on day 8 in CG8.
RESULTS
The response rate of CG1 was 29.2%, which was higher than that of CG8 (22.2%). Median survival times in CG1 and CG8 were 348 and 455.5 days, respectively. Grade ≥3 leukopenia, thrombocytopenia and anemia were observed in 56.0, 72.0 and 36.0% of patients with CG1 and in 33.3, 25.9 and 14.8% of patients with CG8, respectively. Whereas grade ≥3 elevation of asparatate aminotransferase, alanine aminotransferase and alkaline phosphatase was seen mainly in CG8, grade ≥3 non-hematologic toxicities such as febrile neutropenia, infection, appetite loss, diarrhea and eruption were observed only in CG1.
CONCLUSIONS
CG1 is superior in response rate, but CG8 shows improved toxicities and a tendency of prolonged survival.
