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

R. A. Soo, L. Z. Wang, L. S. Tham, W. P. Yong, M. Boyer, H. L. Lim, H. S. Lee, M. Millward, S. Liang, P. Beale, S. C. Lee, B. C. Goh

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38 Citations (Scopus)

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.

Original languageEnglish
Article numberPMID 16670205
Pages (from-to)1128-1133
Number of pages6
JournalAnnals of Oncology
Volume17
Issue number7
DOIs
Publication statusPublished - Jul 2006
Externally publishedYes

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