Please use this identifier to cite or link to this item: https://doi.org/10.1093/annonc/mdl084
Title: A multicentre randomised phase II study of carboplatin in combination with gemcitabine at standard rate or fixed dose rate infusion in patients with advanced stage non-small-cell lung cancer
Authors: Soo, R.A. 
Wang, L.Z. 
Tham, L.S.
Yong, W.P. 
Boyer, M.
Lim, H.L.
Lee, H.S.
Millward, M.
Liang, S.
Beale, P.
Lee, S.C. 
Goh, B.C.
Keywords: Gemcitabine
Non-small cell lung cancer
Pharmacokinetics
Issue Date: Jul-2006
Citation: Soo, R.A., Wang, L.Z., Tham, L.S., Yong, W.P., Boyer, M., Lim, H.L., Lee, H.S., Millward, M., Liang, S., Beale, P., Lee, S.C., Goh, B.C. (2006-07). A multicentre randomised phase II study of carboplatin in combination with gemcitabine at standard rate or fixed dose rate infusion in patients with advanced stage non-small-cell lung cancer. Annals of Oncology 17 (7) : 1128-1133. ScholarBank@NUS Repository. https://doi.org/10.1093/annonc/mdl084
Abstract: Background: Intracellular gemcitabine triphosphate (dFdCTP) levels can be optimised by administering gemcitabine at a fixed dose rate infusion. Patients and methods: Patients with chemonaive advanced non-small cell lung cancer (NSCLC) were randomised to receive gemcitabine at a fixed dose rate gemcitabine 750 mg/m2 over 75 min (arm A) or gemcitabine 1000 mg/m2 over 30 min (arm B) on days 1 and 8 every three week cycle. Carboplatin at AUC of 5 was administered in both treatment arms on day 1 of each cycle. End points were activity, tolerability and pharmacokinetics of plasma and intracellular gemcitabine. Results: 76 patients were randomised. Response rate was 34 % in arm A and 42% in arm B. Toxicity and quality of life scores were similar for both treatment arms. Mean plasma Cmax gemcitabine and mean dFdCTP AUC in arm A was 20.8 μM ± 17.2 μM and 35 079 ± 18 216 μM*min respectively and in arm B, 41.2 ± 13.9 μM and 32 249 ± 11 267 μM*min respectively. dFdCTP saturation was reached in Arm B but not in Arm A. Conclusion: The saturability of dFdCTP accumulation in Arm A suggests optimal delivery of gemcitabine is achieved using fixed rate infusion compared to 30-min infusion. Fixed dose rate gemcitabine is active and feasible, supporting the concept of fixed dosing rate of gemcitabine in advanced NSCLC. However, this entails a longer infusion time with associated higher costs involved. © 2006 European Society for Medical Oncology.
Source Title: Annals of Oncology
URI: http://scholarbank.nus.edu.sg/handle/10635/105570
ISSN: 09237534
DOI: 10.1093/annonc/mdl084
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