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Previous Volume 355:2733-2743 December 28, 2006 Number 26 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Muss, H. B. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

ABSTRACT

Background Lapatinib, a tyrosine kinase inhibitor of human epidermal growth factor receptor type 2 (HER2, also referred to as HER2/neu) and epidermal growth factor receptor (EGFR), is active in combination with capecitabine in women with HER2-positive metastatic breast cancer that has progressed after trastuzumab-based therapy. In this trial, we compared lapatinib plus capecitabine with capecitabine alone in such patients.

Methods Women with HER2-positive, locally advanced or metastatic breast cancer that had progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab were randomly assigned to receive either combination therapy (lapatinib at a dose of 1250 mg per day continuously plus capecitabine at a dose of 2000 mg per square meter of body-surface area on days 1 through 14 of a 21-day cycle) or monotherapy (capecitabine alone at a dose of 2500 mg per square meter on days 1 through 14 of a 21-day cycle). The primary end point was time to progression, based on an evaluation by independent reviewers under blinded conditions.

Results The interim analysis of time to progression met specified criteria for early reporting on the basis of superiority in the combination-therapy group. The hazard ratio for the independently assessed time to progression was 0.49 (95% confidence interval, 0.34 to 0.71; P<0.001), with 49 events in the combination-therapy group and 72 events in the monotherapy group. The median time to progression was 8.4 months in the combination-therapy group as compared with 4.4 months in the monotherapy group. This improvement was achieved without an increase in serious toxic effects or symptomatic cardiac events.

Conclusions Lapatinib plus capecitabine is superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab. (ClinicalTrials.gov number, NCT00078572 [ClinicalTrials.gov] .)

Source Information

From Allegheny General Hospital, Pittsburgh (C.E.G.); GlaxoSmithKline, Greenford, United Kingdom (J.F.); US Oncology, Sedona, AZ (D.L.); Nottingham University Hospitals, Nottingham, United Kingdom (S.C.); Centre Régional de Lutte contre le Cancer Val d'Aurelle, Montpellier, France (C.G.R.); Centrum Onkologii Klinika Nowotworów Piersi i Chirurgii, Warsaw, Poland (T.P.); Zaklad Opieki Zdrowotnej MSWiA, Olsztyn, Poland (A.J.-G.); Ireland Cooperative Oncology Research Group, Dublin (J.C.); Mount Medical Centre, Perth, Australia (A.C.); Chaim Sheba Medical Center, Tel-Hashomer, Israel (B.K.); Errikos Dynan Hospital, Athens (D.S.); Centre René Gauducheau, Saint Herblain, France (M.C.); Broomfield Hospital, Chelmsford, United Kingdom (N.D.); GlaxoSmithKline, Collegeville, PA (M.B., S.D.R., S.S.); GlaxoSmithKline, Middlesex, United Kingdom (C.O.); and Western General Hospital, Edinburgh (D.C.).

Address reprint requests to Dr. Geyer at the Allegheny Cancer Center, Allegheny General Hospital, 320 E. North Ave., 5th Floor, Pittsburgh, PA 15212, or at cgeyer{at}wpahs.org.

Full Text of this Article

Related Letters:

Lapatinib plus Capecitabine in Breast Cancer
Sonpavde G., Geyer C. E., Forster J., Cameron D.
Extract | Full Text | PDF  
N Engl J Med 2007; 356:1471-1472, Apr 5, 2007. Correspondence

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