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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 RA
Wang LZ
Tham LS
Yong WP
Boyer M
Lim HL
Lee HS
Millward M
Liang S
Beale P
Lee SC
Goh BC
Source :
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2006 Jul; Vol. 17 (7), pp. 1128-33. Date of Electronic Publication: 2006 May 02.
Publication Year :
2006

Abstract

Background: Intracellular gemcitabine triphosphate (dFdCTP) levels can be optimised by administering gemcitabine at a fixed dose rate infusion.<br />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/m(2) over 75 min (arm A) or gemcitabine 1000 mg/m(2) 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.<br />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 microM +/- 17.2 microM and 35,079 +/- 18,216 microM*min respectively and in arm B, 41.2 +/- 13.9 microM and 32 249 +/- 11 267 microM*min respectively. dFdCTP saturation was reached in Arm B but not in Arm A.<br />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.

Details

Language :
English
ISSN :
0923-7534
Volume :
17
Issue :
7
Database :
MEDLINE
Journal :
Annals of oncology : official journal of the European Society for Medical Oncology
Publication Type :
Academic Journal
Accession number :
16670205
Full Text :
https://doi.org/10.1093/annonc/mdl084