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Sub-category:
Multidisciplinary Treatment
Category:
Colon and Rectum
Meeting:
2009 Gastrointestinal Cancers Symposium
Session Type and Session Title:
General Session III: Cancers of the Colon and Rectum: Multidisciplinary Treatment
General Poster Session F
Abstract No:
291
Author(s):
M. E. Lacouture, E. P. Mitchell, H. Shearer, N. Iannotti, B. Piperdi, M. V. Pillai, F. Xu, M. Yassine
Abstract:
Introduction: Pmab is a fully human monoclonal antibody targeting the EGFR approved in the US and Europe for the tx of refractory mCRC. STs are the most common adverse events with anti-EGFR inhibitors. This is the first prospective study of pmab for mCRC that examined the differences between pre-emptive (P) and reactive (R) skin tx for specific ST. Methods: Pts receiving pmab-containing therapy were randomized 1:1 to P (ST tx 24 hrs prior to 1st pmab dose, daily through week 6) or R (after ST developed). ST tx included use of skin moisturizers, sunscreen (PABA free, SPF > 15, UVA/UVB protection), topical steroid (1% hydrocortisone cream), and doxycycline (100 mg BID). The primary endpoint of the study was the incidence of specific > grade 2 STs during the 6-week skin tx period. QOL was assessed with the Dermatology Life Quality Index (DLQI) at screening, weeks 2-7, and follow-up. The DLQI is a validated, 10 question QOL assessment tool that is scored on a scale of 0 to 30, with higher scores indicating more QOL impairment. This analysis reports the final results for the primary endpoint and an exploratory analysis of QOL for P vs R tx groups. Results: Of 95 enrolled pts, 48 received P, and 47 received R. Results on the primary endpoint, key safety, and QOL are shown (table). Conclusions: In this study, the skin treatment regimen was well tolerated, and the incidence of specific > grade 2 STs during the 6-week skin tx period was reduced by more than 50% in the P group compared with the R group. Pts in the P group reported improved QOL, especially around week 3 when the median time to first > grade 2 ST of interest was reached in the R skin treatment group.
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Results | Pre-Emptive
Skin
Treatment
(n=48) |
Reactive
Skin
Treatment
(n=47) | |
Mean (SD) pmab doses-n | 6.8 (4.8) | 6.7 (5.8) |
Incidence of protocol-specified ≥ grade 2 ST
during the 6-week skin treatment period-% | 29 | 62 |
Incidence of protocol-specified grade 2 ST
during the 6-week skin treatment period-% (95% CL)* | 23 (11, 35) | 40 (26, 54) |
Incidence of protocol-specified grade 3 ST
during the 6-week skin treatment period-% (95% CL)* | 6 (0, 13) | 21 (10, 33) |
Median (95% CL) time to first ≥ grade 2 ST of
interest-weeks | NR | 2.7 (2.1, 6.3) | |
Incidence of ≥ grade 3 adverse events-n (%) | 29 (60) | 38 (81) |
Mean (SD) DLQI change from baseline to
week 3-points | 1.3 (2.6) | 4.2 (5.8) |
Mean (SD) DLQI change from baseline to
week 7-points | 2.0 (2.8) | 2.6 (4.4) | | *There were no grade 4 or 5 protocol specified ST during the 6 week skin treatment period. NR = not reached |
Faculty Disclosures
Abstract Disclosures
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by M. E. Lacouture:
Presentations by M. E. Lacouture:
Educational Book Manuscripts by M. E. Lacouture:
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