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Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy.
J Clin Oncol 2006; 24(33):5194-200JC

Abstract

PURPOSE

To characterize the efficacy and safety of palifermin in reducing the incidence of oral mucositis (OM) and diarrhea when administered to patients with metastatic colorectal cancer (CRC) receiving fluorouracil/leucovorin (FU/LV) chemotherapy.

PATIENTS AND METHODS

Patients (N = 64) were randomly assigned to receive either placebo or palifermin (40 microg/kg for 3 consecutive days) before each of two consecutive cycles of chemotherapy with FU/LV. The incidence of OM and diarrhea, safety, disease progression, and survival were evaluated.

RESULTS

Thirty-six patients received placebo and 28 patients received palifermin. The incidence of WHO grade 2 or higher OM was lower in patients who received palifermin compared with placebo (29% v 61% in cycle 1; 11% v 47% in cycle 2). FU dose reductions in the second chemotherapy cycle were more frequent in the placebo group (31%) than in the palifermin group (14%). Investigators reported lower mucositis scores and patients reported less severe symptoms with palifermin. There were no statistically significant differences in the incidence or severity of diarrhea or in overall survival between the groups. Overall, palifermin was safe and well tolerated.

CONCLUSION

Palifermin administered at the indicated dosing regimen (40 microg/kg for 3 consecutive days) before chemotherapy was well tolerated and resulted in a statistically significant and clinically meaningful reduction in the incidence of WHO grade 2 or higher OM in patients with metastatic CRC.

Authors+Show Affiliations

Premiere Oncology, John Wayne Cancer Institute, St John's Health Center, Santa Monica, CA 90404, USA. lrosen@premiereoncology.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17075109

Citation

Rosen, Lee S., et al. "Palifermin Reduces the Incidence of Oral Mucositis in Patients With Metastatic Colorectal Cancer Treated With Fluorouracil-based Chemotherapy." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 24, no. 33, 2006, pp. 5194-200.
Rosen LS, Abdi E, Davis ID, et al. Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy. J Clin Oncol. 2006;24(33):5194-200.
Rosen, L. S., Abdi, E., Davis, I. D., Gutheil, J., Schnell, F. M., Zalcberg, J., ... Clarke, S. (2006). Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 24(33), pp. 5194-200.
Rosen LS, et al. Palifermin Reduces the Incidence of Oral Mucositis in Patients With Metastatic Colorectal Cancer Treated With Fluorouracil-based Chemotherapy. J Clin Oncol. 2006 Nov 20;24(33):5194-200. PubMed PMID: 17075109.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy. AU - Rosen,Lee S, AU - Abdi,Ehtesham, AU - Davis,Ian D, AU - Gutheil,John, AU - Schnell,Frederick M, AU - Zalcberg,John, AU - Cesano,Alessandra, AU - Gayko,Urte, AU - Chen,Mon-Gy, AU - Clarke,Stephen, Y1 - 2006/10/30/ PY - 2006/11/1/pubmed PY - 2006/12/19/medline PY - 2006/11/1/entrez SP - 5194 EP - 200 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J. Clin. Oncol. VL - 24 IS - 33 N2 - PURPOSE: To characterize the efficacy and safety of palifermin in reducing the incidence of oral mucositis (OM) and diarrhea when administered to patients with metastatic colorectal cancer (CRC) receiving fluorouracil/leucovorin (FU/LV) chemotherapy. PATIENTS AND METHODS: Patients (N = 64) were randomly assigned to receive either placebo or palifermin (40 microg/kg for 3 consecutive days) before each of two consecutive cycles of chemotherapy with FU/LV. The incidence of OM and diarrhea, safety, disease progression, and survival were evaluated. RESULTS: Thirty-six patients received placebo and 28 patients received palifermin. The incidence of WHO grade 2 or higher OM was lower in patients who received palifermin compared with placebo (29% v 61% in cycle 1; 11% v 47% in cycle 2). FU dose reductions in the second chemotherapy cycle were more frequent in the placebo group (31%) than in the palifermin group (14%). Investigators reported lower mucositis scores and patients reported less severe symptoms with palifermin. There were no statistically significant differences in the incidence or severity of diarrhea or in overall survival between the groups. Overall, palifermin was safe and well tolerated. CONCLUSION: Palifermin administered at the indicated dosing regimen (40 microg/kg for 3 consecutive days) before chemotherapy was well tolerated and resulted in a statistically significant and clinically meaningful reduction in the incidence of WHO grade 2 or higher OM in patients with metastatic CRC. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/17075109/Palifermin_reduces_the_incidence_of_oral_mucositis_in_patients_with_metastatic_colorectal_cancer_treated_with_fluorouracil_based_chemotherapy_ L2 - http://ascopubs.org/doi/full/10.1200/JCO.2005.04.1152?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -