Journal of Cancer Therapy, 2015, 6, 45-52 Published Online January 2015 in SciRes. http://www.scirp.org/journal/jct http://dx.doi.org/10.4236/jct.2015.61007 How to cite this paper: Salem, D.A., Ibrahim, D.R., Ezzat, A. and Adel, A.M. (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. http://dx.doi.org/10.4236/jct.2015.61007 Fixed Dose Rate versus Standard Dose Rate Infusion of Gemcitabine and Cisplatin in Advanced Stage Non-Small Cell Lung Cancer 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 Email: * diabdina@hotmail.com Received 19 November 2014; revised 20 December 2014; accepted 31 December 2014 Academic Editor: Fumihiko Hirai, National Kyushu Cancer Center, Japan Copyright © 2015 by authors and Scientific Research Publishing Inc. This work is licensed under the Creative Commons Attribution International License (CC BY). http://creativecommons.org/licenses/by/4.0/ Abstract Background: Comparing the efficacy and safety of gemcitabine at a fixed-dose rate (FDR) infusion (10 mg/m 2 /min) with the standard dose rate infusion in patients with locally advanced and me- tastatic 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/m 2 on days 1 and 8 given as a 30-min infusion (Arm A) or at a rate of 10 mg/m 2 /min (Arm B). Cisplatin 75 mg/m 2 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. Keywords Non-Small Cell Lung Cancer, Gemcitabine, Fixed-Dose Rate, Toxicities * Corresponding author.