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.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Northwestern University, Chicago, IL, USA. lacoutum@mskcc.org
Mario E
ME
Lacouture
Edith P
EP
Mitchell
Bilal
B
Piperdi
Madhavan V
MV
Pillai
Heather
H
Shearer
Nicholas
N
Iannotti
Feng
F
Xu
Mohamed
M
Yassine
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D018450:Disease Progression; D003875:Drug Eruptions / Q000209:etiology / Q000517:prevention & control*; D004643:Emollients / Q000627:therapeutic use; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077544:Panitumumab; D011292:Premedication; D011788:Quality of Life; D013473:Sunscreening Agents / Q000627:therapeutic use
D000911:Antibodies, Monoclonal; D003879:Dermatologic Agents; D004643:Emollients; D005938:Glucocorticoids; D013473:Sunscreening Agents; D000077544:Panitumumab; D066246:ErbB Receptors