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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.
- 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.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Antineoplastic Combined Chemotherapy Protocols pharmacokinetics
Area Under Curve
Carboplatin adverse effects
Carcinoma, Non-Small-Cell Lung metabolism
Deoxycytidine administration & dosage
Deoxycytidine adverse effects
Deoxycytidine pharmacokinetics
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Humans
Infusions, Intravenous
Lung Neoplasms metabolism
Male
Middle Aged
Neoplasm Staging
Quality of Life
Gemcitabine
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Carboplatin administration & dosage
Carcinoma, Non-Small-Cell Lung drug therapy
Deoxycytidine analogs & derivatives
Lung Neoplasms drug therapy
Subjects
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