Annual Meeting Proceedings II - Newly Released Abstracts for
Annual Meeting Proceedings II - Newly Released Abstracts for
Annual Meeting Proceedings II - Newly Released Abstracts for
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BREAST CANCER—HER2/ER<br />
LBA671 Oral Abstract Session, Sun, 8:00 AM-11:00 AM<br />
Open-label phase <strong>II</strong>I randomized controlled trial comparing taxane-based chemotherapy<br />
(Tax) with lapatinib (L) or trastuzumab (T) as first-line therapy <strong>for</strong> women<br />
with HER2� metastatic breast cancer: Interim analysis (IA) of NCIC CTG<br />
MA.31/GSK EGF 108919.<br />
Karen A. Gelmon, Frances Boyle, Bella Kaufman, David Huntsman, Alexey Manikhas, Angelo Di Leo,<br />
Miguel Martin, Lee Steven Schwartzberg, Susan Faye Dent, Susan Ellard, Katia Sonia Tonkin,<br />
Yasir M. Nagarwala, Kathleen I. Pritchard, Timothy Joseph Whelan, Dora Nomikos,<br />
Judy-Anne W. Chapman, Wendy Parulekar; British Columbia Cancer Agency-Vancouver Cancer Centre,<br />
Vancouver, BC, Canada; Mater Hospital, North Sydney, Australia; Chaim Sheba Medical Center, Tel<br />
Hashomer, Israel; British Columbia Cancer Agency, Vancouver, BC, Canada; City Clinical Oncological<br />
Dispensary, St. Petersburg, Russia; Sandro Pitigliani Medical Oncology Unit, Prato, Italy; Hospital<br />
Universitario Gregorio Maranon, Madrid, Spain; The West Clinic, Memphis, TN; The Ottawa Hospital<br />
Cancer Centre, Ottawa, ON, Canada; Cancer Centre <strong>for</strong> Southern Interior, Kelowna, BC, Canada; Cross<br />
Cancer Institute, Edmonton, AB, Canada; GlaxoSmithKline Oncology, Collegeville, PA; Sunnybrook Odette<br />
Cancer Centre, University of Toronto, Toronto, ON, Canada; Juravinski Cancer Centre at Hamilton Health<br />
Sciences, Hamilton, ON, Canada; NCIC Clinical Trials Group, Kingston, ON, Canada; NCIC Clinical<br />
Trials Group, Queen’s University, Kingston, ON, Canada<br />
Background: The relative efficacy of L vs T when combined with Tax chemotherapy in the first-line setting<br />
of metastatic breast cancer (BC) is unknown. Methods: MA.31 compares Tax-based therapy, paclitaxel<br />
80mg/m 2 wkly or docetaxel 75mg/m 2 3 wkly <strong>for</strong> 24 wks in combination with L or T. The L dose was 1,250<br />
mg po daily with Tax followed by 1,500 mg daily (LTax/L). After a loading dose, the T dose was 2 mg/kg<br />
wkly or 6 mg/kg 3 wkly � Tax followed by T 6 mg/kg 3 wkly (TTax/T). Stratification was by prior<br />
neo/adjuvant HER2 therapy, prior neo/adjuvant Tax, planned Tax (paclitaxel vs docetaxel), and liver<br />
metastases. The primary endpoint is ITT progression-free survival (PFS), defined as time from randomization<br />
to objective progressive disease based on RECIST criteria or death from any cause. The protocolspecified<br />
IA was per<strong>for</strong>med after observing 333 PFS events; the trial was to stop if the 2-sided p-value from<br />
the stratified log-rank test was less than 0.03. The NCIC CTG’s independent DSMC reviewed IA results and<br />
recommended disclosure because the superiority boundary was crossed. A secondary analysis utilized<br />
central laboratory-confirmed HER2 � status. Results: Between July 17 2008 and Dec 1 2011, 652 pts were<br />
accrued. Data from 636 pts (525 HER2 centrally confirmed) were included in the IA with clinical cutoff date<br />
of Nov 7 2011 and database lock of Apr 13 2012. Median follow-up was 13.6 mos, 12.9 mos <strong>for</strong> LTax/L<br />
pts and 14.0 mos <strong>for</strong> TTax/T patients. In the ITT analysis, PFS was inferior with LTax/L compared to<br />
TTax/T hazard ratio (HR) �1.33; 95% CI 1.06-1.67; p�0.01. LTax/L had median PFS 8.8 mos (95% CI<br />
8.3-10.6) compared to TTax/T 11.4 mos (95% CI 10.8-13.7). PFS in the centrally confirmed HER2� had<br />
HR 1.48 (95%CI 1.15-1.92; p�0.003) (LTax/L to TTax/T). No difference in overall survival was detected<br />
(LTax/L to TTax/T) HR� 1.1 (95% CI 0.75-1.61; p�0.62). More grade 3-4 diarrhea and rash was observed<br />
with LTax/L (p�0.001). Conclusions: LTax/L therapy is associated with a shorter PFS compared to TTax/T<br />
as first line therapy <strong>for</strong> HER2� metastatic BC. ClinicalTrials.gov: NCT00667251. CCSRI grant: 021039.<br />
Supported by GlaxoSmithKline.<br />
© 2012 American Society of Clinical Oncology. Reprinted with permission.