Abstract
1094 Background: Lap has single agent activity against BM in patients (pts) with HER2+ (ErbB2+) BC. Lap + Cap increases response rate, time to progression, and progression-free survival when compared with Cap alone in pts with refractory HER2+ BC. An exploratory analysis of the latter study (EGF100151) showed fewer pts on Lap + Cap developed BM at first relapse compared with Cap alone. The LEAP and ATU were designed to provide access to Lap before commercial availability and were initiated after EGF100151 enrollment was halted. Eligibility requirements for these programs were similar to EGF100151, i.e., pts had disease progression following prior taxane, anthracycline, and trastuzumab therapy. Although data were not formally collected via case report forms, we surveyed LEAP and ATU sites to ascertain the percent of pts with progressive BM at entry and response to Lap + Cap. Methods: LEAP/ATU sites that enrolled 15 or more pts were queried to provide data via worksheets or narratives regarding progressive BM upon entry, presence of tumor-related neurological signs and symptoms (NSS), steroid use, prior Cap exposure, and improvements in NSS and CNS response. Results: 58 sites (48 LEAP and 10 ATU sites) were surveyed. 138 of 1189 (12%) pts presented with progressive BM at entry. Unconfirmed CNS response to Lap + Cap in the 138 pts were as follows: complete response (CR) 3 (2%), partial response (PR) 22 (16%), stable disease (SD) 65 (47%), progressive disease (PD) 19 (14%), unknown 29 (21%). 42% of pts with progressive BM at entry received Cap before LEAP or ATU; 36% of pts with CR or PR in the CNS received prior Cap. Investigators reported improvement in NSS in 25% of pts with BM. Conclusions: Exploratory data from the LEAP and ATU programs have clear limitations, however, they suggest that Lap + Cap provides clinical benefit to pts with progressive BM from HER2+ BC. Prospective studies evaluating lap + chemotherapy in this pt population are ongoing. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration GlaxoSmithKline Exelixis, GlaxoSmithKline, Novartis, Pfizer GlaxoSmithKline GlaxoSmithKline GlaxoSmithKline
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
