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Annals of Oncology Advance Access published online on May 2, 2006
Annals of Oncology, doi:10.1093/annonc/mdl084
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© 2006 European Society for Medical Oncology
Received January 12, 2006
Revised March 15, 2006
Accepted March 17, 2006

original article

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 1, L. Z. Wang 2, L. S. Tham 1, W. P. Yong 1, M. Boyer 3, H. L. Lim 1, H. S. Lee 4, M. Millward 3, S. Liang 5, P. Beale 3, S. C. Lee 1, and B. C. Goh 2 *

1 Cancer Therapeutics Research Group, Department of Haematology-Oncology, National University Hospital, Singapore
2 Cancer Therapeutics Research Group, Department of Haematology-Oncology, National University Hospital, Singapore; Department of Pharmacology, National University Hospital, Singapore
3 Cancer Therapeutics Research Group, Sydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
4 Department of Pharmacology, National University Hospital, Singapore
5 Clinical Trials & Epidemiology Research Unit, Ministry of Health, Singapore

* To whom correspondence should be addressed.
B. C. Goh, E-mail: gohbc{at}nuh.com.sg


  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 Cmaxgemcitabine 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.

Keywords: gemcitabine; non-small cell lung cancer; pharmacokinetics.
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