TITLE:
Fixed Dose Rate versus Standard Dose Rate Infusion of Gemcitabine and Cisplatin in Advanced Stage Non-Small Cell Lung Cancer
AUTHORS:
Dina A. Salem, Dina R. Ibrahim, Ahmed Ezzat, Azza M. Adel
KEYWORDS:
Non-Small Cell Lung Cancer, Gemcitabine, Fixed-Dose Rate, Toxicities
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.6 No.1,
January
8,
2015
ABSTRACT: Background: Comparing the
efficacy and safety of gemcitabine at a fixed-dose rate (FDR) infusion (10 mg/m2/min)
with the standard dose rate infusion in patients with locally advanced and metastatic
non-small squamous cell carcinoma (NSCLC). Methods: The study randomized 60
patients with confirmed diagnosis of NSCLC to receive gemcitabine at a dose of
1000 mg/m2 on days 1 and 8 given as a 30-min infusion (Arm A) or at
a rate of 10 mg/m2/min (Arm B). Cisplatin 75 mg/m2 was
administered intravenously on day 2 in both arms. Results: No difference in
overall response rate (46.6% versus 43.3%). Median time to progression for Arm
A was 7 months (95% CI, 6.207 - 7.793 months), versus 6 months for Arm B (95%
CI, 4.990 - 7.010 months). Median survival time was comparable [12 months (95%
CI, 8.588 - 15.412 months) versus 11 months (95% CI, 9.066 - 12.934 months)]
respectively. Two-year survival (18% versus 11%, p = 0.38) was detected. No treatment related deaths
occurred. Main hematological toxicities were grade I and II neutropenia, in
36.7% and 53.3% respectively (p = 0.044). Grade III anemia was observed in 10% and
6.7% in both arms respectively (p = 0.024). Grade I and II nausea and vomiting was
observed in 50% and 46.7%. Conclusions: FDR gemcitabine in combination with
cisplatin had equivalent efficacy and more severe hematologic toxicities
compared to the standard 30-min gemcitabine infusion with cisplatin in patients
with advanced NSCLC.