Document Detail


Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer.
MedLine Citation:
PMID:  20142600     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: Panitumumab, a fully human monoclonal antibody targeting the epidermal growth factor receptor (EGFR), is approved in the United States and Europe for the treatment of refractory metastatic colorectal cancer (mCRC). Skin toxicities are the most common adverse events with EGFR inhibitors. This is the first study designed to examine differences between pre-emptive and reactive skin treatment for specific skin toxicities in patients with mCRC for any EGFR inhibitor. PATIENTS AND METHODS: Patients receiving panitumumab-containing therapy were randomly assigned 1:1 to pre-emptive or reactive treatment (after skin toxicity developed). Pre-emptive treatment included use of skin moisturizers, sunscreen, topical steroid, and doxycycline. The primary end point of the study was the incidence of protocol-specified >or= grade 2 skin toxicities during the 6-week skin treatment period. Quality of life (QOL) was assessed with the Dermatology Life Quality Index (DLQI). RESULTS: Of 95 enrolled patients, 48 received pre-emptive treatment, and 47 received reactive treatment. The incidence of protocol-specified >or= grade 2 skin toxicities during the 6-week skin treatment period was 29% and 62% for the pre-emptive and reactive groups, respectively. Mean DLQI score change from baseline to week 3 was 1.3 points and 4.2 points in the pre-emptive and reactive groups, respectively. CONCLUSION: The pre-emptive skin treatment regimen was well tolerated. The incidence of specific >or= grade 2 skin toxicities during the 6-week skin treatment period was reduced by more than 50% in the pre-emptive group compared with the reactive group. Patients in the pre-emptive group reported less QOL impairment than patients in the reactive group.
Authors:
Mario E Lacouture; Edith P Mitchell; Bilal Piperdi; Madhavan V Pillai; Heather Shearer; Nicholas Iannotti; Feng Xu; Mohamed Yassine
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-02-08
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  28     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-03-09     Completed Date:  2010-04-07     Revised Date:  2010-09-22    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1351-7     Citation Subset:  IM    
Affiliation:
Northwestern University, Chicago, IL, USA. lacoutum@mskcc.org
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal / administration & dosage,  adverse effects*
Antineoplastic Combined Chemotherapy Protocols / adverse effects
Colorectal Neoplasms / drug therapy*
Dermatologic Agents / therapeutic use*
Disease Progression
Drug Eruptions / etiology,  prevention & control*
Emollients / therapeutic use
Female
Follow-Up Studies
Glucocorticoids / therapeutic use
Humans
Male
Middle Aged
Premedication*
Quality of Life
Receptor, Epidermal Growth Factor / antagonists & inhibitors*
Sunscreening Agents / therapeutic use
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Dermatologic Agents; 0/Emollients; 0/Glucocorticoids; 0/Sunscreening Agents; 0/panitumumab; EC 2.7.10.1/Receptor, Epidermal Growth Factor
Comments/Corrections
Comment In:
J Clin Oncol. 2010 Sep 20;28(27):e474; author reply e475-6   [PMID:  20585089 ]
Curr Oncol Rep. 2010 Jul;12(4):223-5   [PMID:  20437117 ]

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