TY - JOUR
T1 - RC0639
T2 - Phase II study of paclitaxel, trastuzumab, and lapatinib as adjuvant therapy for early stage HER2-positive breast cancer
AU - Moreno-Aspitia, Alvaro
AU - Dueck, Amylou C.
AU - Ghanem-Cañete, Ismael
AU - Patel, Tejal
AU - Dakhil, Shaker
AU - Johnson, David
AU - Franco, Sandra
AU - Kahanic, Stephen
AU - Colon-Otero, Gerardo
AU - Tenner, Kathleen S.
AU - Rodeheffer, Richard
AU - McCullough, Ann E.
AU - Jenkins, Robert B.
AU - Palmieri, Frances M.
AU - Northfelt, Donald
AU - Perez, Edith A.
N1 - Funding Information:
Acknowledgments Palmieri F, Dueck A, Johnson B, et al. Cardiac Safety of Lapatinib Given Concurrently with Paclitaxel and Trast-uzumab as Part of Adjuvant Therapy for Patients with HER2? Breast Cancer: Pilot Data from the Mayo Clinic Cancer Research Consortium Trial RC0639. Cancer Res 2009; 69(24 Suppl):3086. Preliminary reports from this study were presented at the Thirty-Second Annual CTRC-AACR San Antonio Breast Cancer Symposium Dec 10-13, 2009; San Antonio, TX (abstract 3086). Study conduct was partially funded by Mayo Clinic and GlaxoSmithKline, Inc (GSK). GSK did not contribute to the drafting or completion of this manuscript.
PY - 2013/4
Y1 - 2013/4
N2 - Lapatinib adds to the efficacy of trastuzumab in preclinical models and also in the neo-adjuvant setting. This study assesses the safety and feasibility of adding lapatinib to paclitaxel and trastuzumab (THL) as part of the adjuvant therapy for HER2-positive breast cancer (HER2+ BC). In this single-arm phase II study, patients with stages I-III HER2+ BC received standard anthracycline-based chemotherapy followed by weekly taxane, with concurrent standard trastuzumab, plus daily lapatinib for a total of 12 months. The primary endpoint was symptomatic congestive heart failure, secondary endpoints included overall safety. A total of 109 eligible patients were enrolled. Median follow-up is 4.3 years. No patients experienced congestive heart failure while on treatment. Mean left ventricular ejection fraction at baseline and at the end of THL were 63.6 % (N = 109, SD = 5.7) and 59.8 % (N = 98, SD = 8.1), respectively [mean change -3.95 % (N = 98, SD = 8.3), p < 0.001]. One hundred and two patients initiated post-AC treatment; of them, 31 % experienced grade 3 (no G4) diarrhea with lapatinib at 750 mg/day. The addition of lapatinib to paclitaxel and trastuzumab following AC does not add cardiac toxicity. Lapatinib dose of 750 mg/day in combination with standard chemotherapy plus trastuzumab has acceptable overall tolerability.
AB - Lapatinib adds to the efficacy of trastuzumab in preclinical models and also in the neo-adjuvant setting. This study assesses the safety and feasibility of adding lapatinib to paclitaxel and trastuzumab (THL) as part of the adjuvant therapy for HER2-positive breast cancer (HER2+ BC). In this single-arm phase II study, patients with stages I-III HER2+ BC received standard anthracycline-based chemotherapy followed by weekly taxane, with concurrent standard trastuzumab, plus daily lapatinib for a total of 12 months. The primary endpoint was symptomatic congestive heart failure, secondary endpoints included overall safety. A total of 109 eligible patients were enrolled. Median follow-up is 4.3 years. No patients experienced congestive heart failure while on treatment. Mean left ventricular ejection fraction at baseline and at the end of THL were 63.6 % (N = 109, SD = 5.7) and 59.8 % (N = 98, SD = 8.1), respectively [mean change -3.95 % (N = 98, SD = 8.3), p < 0.001]. One hundred and two patients initiated post-AC treatment; of them, 31 % experienced grade 3 (no G4) diarrhea with lapatinib at 750 mg/day. The addition of lapatinib to paclitaxel and trastuzumab following AC does not add cardiac toxicity. Lapatinib dose of 750 mg/day in combination with standard chemotherapy plus trastuzumab has acceptable overall tolerability.
KW - Adjuvant
KW - Breast cancer
KW - Gastrointestinal
KW - HER2 cardiac
KW - Lapatinib
KW - Tolerability
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U2 - 10.1007/s10549-013-2469-2
DO - 10.1007/s10549-013-2469-2
M3 - Article
C2 - 23479422
AN - SCOPUS:84879420364
SN - 0167-6806
VL - 138
SP - 427
EP - 435
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
IS - 2
ER -