The DOI matches its Crossref record; 17 of the 17 references it cites were found in a registry or an index.
Individual Fluorouracil Dose Adjustment Based on Pharmacokinetic Follow-Up Compared With Conventional Dosage: Results of a Multicenter Randomized Trial of Patients With Metastatic Colorectal Cancer
Abstract
Purpose: A phase III, multicenter, randomized study compared conventional dosing of fluorouracil (FU) plus folinic acid with pharmacokinetically guided FU dose adjustment in terms of response, tolerability, and survival. Patients and Methods: Two hundred eight patients with measurable metastatic colorectal cancer were randomly assigned to one of two arms: arm A (104 patients; 96 assessable), in which the FU dose was calculated based on body-surface area; and arm B (104 patients; 90 assessable), in which the FU dose was individually determined using pharmacokinetically guided adjustments. The initial regimen was 1,500 mg/m 2 FU plus 200 mg/m 2 folinic acid infusion during a continuous 8-hour period administered once weekly. FU doses were adjusted weekly in arm B based on a single-point measurement of FU plasma concentrations at steady state until the therapeutic range (targeted area under the curve 20-25 mg·h·L−1) previously established in other studies was reached. Results: An intent-to-treat analysis of the 208 patients showed the objective response rate was 18.3% in arm A and 33.7% in arm B (P = .004). Median overall survival was 16 months in arm A and 22 months in arm B (P = .08). The mean FU dose throughout treatment was 1,500 mg/m 2/wk in arm A and 1,790 ± 386 mg/m 2/wk (range, 900 to 3,300 mg/m 2/wk) in arm B. Toxic adverse effects were significantly more frequent and severe in arm A compared with arm B (P = .003). Conclusion: Individual FU dose adjustment based on pharmacokinetic monitoring resulted in significantly improved objective response rate, a trend to higher survival rate, and fewer grade 3/4 toxicities. These results support the value of pharmacokinetically guided management of FU dose in the treatment of metastatic colorectal patients.
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IMAMURA, Y., MUKOHARA, T., SHIMONO, Y., FUNAKOSHI, Y., CHAYAHARA, N., TOYODA, M., KIYOTA, N., TAKAO, S., KONO, S., NAKATSURA, T., et al. (2015) · Oncology Reports · doi:10.3892/or.2015.3767 · Cited by 845
Effects of systemic chemotherapy on the liver
Ramadori, G., & Cameron, S. (2010) · Annals of Hepatology · doi:10.1016/s1665-2681(19)31651-5 · Cited by 132
Rathore, M., Zhang, W., Wright, M., Bhattacharya, R., Fan, F., Vaziri-Gohar, A., Winter, J., Wang, Z., Markowitz, S. D., Willis, J., et al. (2022) · Molecular Cancer Research · doi:10.1158/1541-7786.mcr-21-0633 · Cited by 14
Metadata
- Authors
- Gamelin, E., Delva, R., Jacob, J., Merrouche, Y., Raoul, J. L., Pezet, D., Dorval, E., Piot, G., Morel, A., & Boisdron-Celle, M.
- Venue
- Journal of Clinical Oncology
- Published
- 2008-05-01
- Volume
- 26
- Issue
- 13
- Pages
- 2099-2105
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2142287269
- Cited by
- 346
- References
- 17
- FWCI
- 7.24
- Type
- journal article
- Language
- en
- Open access
- closed
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- Gamelin, E., Delva, R., Jacob, J., Merrouche, Y., Raoul, J. L., Pezet, D., Dorval, E., Piot, G., Morel, A., & Boisdron-Celle, M. (2008). Individual Fluorouracil Dose Adjustment Based on Pharmacokinetic Follow-Up Compared With Conventional Dosage: Results of a Multicenter Randomized Trial of Patients With Metastatic Colorectal Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2007.13.3934
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