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Sub-category:
Metastatic Breast Cancer
Category:
Breast Cancer--Metastatic Breast Cancer
Meeting:
2008 ASCO Annual Meeting
Session Type and Session Title:
General Poster Session, Breast Cancer — Metastatic
Abstract No:
1094
Citation:
J Clin Oncol 26: 2008 (May 20 suppl; abstr 1094)
Author(s):
F. Boccardo, B. Kaufman, J. Baselga, V. Dieras, J. Link, M. A. Casey, A. Fittipaldo, C. Oliva, D. Zembryki, S. D. Rubin
Abstract:
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.
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):
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1. Evaluation of lapatinib (Lap) plus capecitabine (Cap) in patients with brain metastases (BM) from HER2+ breast cancer (BC) enrolled in the Lapatinib Expanded Access Program (LEAP) and French Authorisation Temporaire d'Utilisation (ATU).
Meeting:
2008 ASCO Annual Meeting
Presenter:
Francesco Boccardo, MD
Session:
Breast Cancer — Metastatic
(General Poster Session)
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Other Abstracts in this Sub-Category:
Abstracts by F. Boccardo :
Presentations by F. Boccardo :
Educational Book Manuscripts by F. Boccardo :
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