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Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5.
J Clin Oncol. 2010 Dec 10; 28(35):5182-7.JC

Abstract

PURPOSE

Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid-based topical keratolytic agent (ULABTKA) may prevent HFS.

PATIENTS AND METHODS

A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m(2) per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD.

RESULTS

The percentage of patients with moderate/severe HFS symptoms was not different between groups, being 13.6% in the ULABTKA arm and 10.2% in the placebo arm (P = .768 by Fisher's exact test). The odds ratio was 1.37 (95% CI, 0.37 to 5.76). Cycle 1 CTCAE skin toxicity was higher in the ULABTKA arm but not significantly so (33% v 27%; P = .82). No significant differences were observed in other toxicities between groups.

CONCLUSION

These data do not support the efficacy of a ULABTKA cream for preventing HFS symptoms in patients receiving capecitabine.

Authors+Show Affiliations

Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA.No 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 availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21060036

Citation

Wolf, Sherry L., et al. "Placebo-controlled Trial to Determine the Effectiveness of a Urea/lactic Acid-based Topical Keratolytic Agent for Prevention of Capecitabine-induced Hand-foot Syndrome: North Central Cancer Treatment Group Study N05C5." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 28, no. 35, 2010, pp. 5182-7.
Wolf SL, Qin R, Menon SP, et al. Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. J Clin Oncol. 2010;28(35):5182-7.
Wolf, S. L., Qin, R., Menon, S. P., Rowland, K. M., Thomas, S., Delaune, R., Christian, D., Pajon, E. R., Satele, D. V., Berenberg, J. L., & Loprinzi, C. L. (2010). Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 28(35), 5182-7. https://doi.org/10.1200/JCO.2010.31.1431
Wolf SL, et al. Placebo-controlled Trial to Determine the Effectiveness of a Urea/lactic Acid-based Topical Keratolytic Agent for Prevention of Capecitabine-induced Hand-foot Syndrome: North Central Cancer Treatment Group Study N05C5. J Clin Oncol. 2010 Dec 10;28(35):5182-7. PubMed PMID: 21060036.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. AU - Wolf,Sherry L, AU - Qin,Rui, AU - Menon,Smitha P, AU - Rowland,Kendrith M,Jr AU - Thomas,Sachdev, AU - Delaune,Robert, AU - Christian,Diana, AU - Pajon,Eduardo R,Jr AU - Satele,Daniel V, AU - Berenberg,Jeffrey L, AU - Loprinzi,Charles L, AU - ,, Y1 - 2010/11/08/ PY - 2010/11/10/entrez PY - 2010/11/10/pubmed PY - 2011/1/21/medline SP - 5182 EP - 7 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J. Clin. Oncol. VL - 28 IS - 35 N2 - PURPOSE: Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid-based topical keratolytic agent (ULABTKA) may prevent HFS. PATIENTS AND METHODS: A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m(2) per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. RESULTS: The percentage of patients with moderate/severe HFS symptoms was not different between groups, being 13.6% in the ULABTKA arm and 10.2% in the placebo arm (P = .768 by Fisher's exact test). The odds ratio was 1.37 (95% CI, 0.37 to 5.76). Cycle 1 CTCAE skin toxicity was higher in the ULABTKA arm but not significantly so (33% v 27%; P = .82). No significant differences were observed in other toxicities between groups. CONCLUSION: These data do not support the efficacy of a ULABTKA cream for preventing HFS symptoms in patients receiving capecitabine. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/21060036/Placebo_controlled_trial_to_determine_the_effectiveness_of_a_urea/lactic_acid_based_topical_keratolytic_agent_for_prevention_of_capecitabine_induced_hand_foot_syndrome:_North_Central_Cancer_Treatment_Group_Study_N05C5_ L2 - http://ascopubs.org/doi/full/10.1200/JCO.2010.31.1431?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -