Author(s)

Dina A. Salem, Dina R. Ibrahim^*, Ahmed Ezzat, Azza M. Adel

Department of Clinical Oncology and Nuclear Medicine, Faculty of Medicine, Ain-Shams University, Cairo, Egypt.

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.

Non-Small Cell Lung Cancer, Gemcitabine, Fixed-Dose Rate, Toxicities

Salem, D. , Ibrahim, D. , Ezzat, A. and Adel, A. (2015) Fixed Dose Rate versus Standard Dose Rate Infusion of Gemcitabine and Cisplatin in Advanced Stage Non-Small Cell Lung Cancer. Journal of Cancer Therapy, 6, 45-52. doi: 10.4236/jct.2015.61007.