N083E (Alliance): long-term outcomes of patients treated in a pilot phase II study of docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy for early-stage HER2-positive breast cancer

Roberto A. Leon-Ferre, Edith A. Perez, David W. Hillman, Celyne Bueno, Alejandra T. Perez, Beiyun Chen, Robert B. Jenkins, Donald W. Northfelt, David B. Johnson, Robert L. Carolla, Robin T. Zon, Alvaro Moreno-Aspitia

Research output: Contribution to journalArticle

Abstract

Background: The addition of lapatinib (L) to trastuzumab (T) was previously found to be synergistic in preclinical models and in the neoadjuvant setting. Prior to the results of the ALTTO trial, this study assessed the safety and feasibility of adding L to the standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen in early-stage HER2-positive breast cancer (HER2+ BC). Methods: In this single-arm, 2-stage, phase II study, patients with stages I–III HER2+ BC received TCH plus L at 1000 mg daily for a total of 12 months. The primary endpoint was the safety and tolerability, including the rate of diarrhea. Secondary endpoints included adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety. Results: Thirty eligible patients were enrolled. Median follow-up is 5.3 years. Diarrhea was the most common AE with 50% Grade (G)1/2 and 43% G3 diarrhea. However, it was responsive to dose reduction of L (750 mg) and institution of anti-diarrheal medications. Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment. Conclusion: TCHL was a tolerable regimen at a starting L dose of 750 mg PO daily when given concurrently with chemotherapy.

Original languageEnglish (US)
Pages (from-to)613-622
Number of pages10
JournalBreast cancer research and treatment
Volume182
Issue number3
DOIs
StatePublished - Aug 1 2020

Keywords

  • Adjuvant
  • Breast cancer
  • Gastrointestinal
  • HER2 cardiac
  • Lapatinib
  • Tolerability

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Leon-Ferre, R. A., Perez, E. A., Hillman, D. W., Bueno, C., Perez, A. T., Chen, B., Jenkins, R. B., Northfelt, D. W., Johnson, D. B., Carolla, R. L., Zon, R. T., & Moreno-Aspitia, A. (2020). N083E (Alliance): long-term outcomes of patients treated in a pilot phase II study of docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy for early-stage HER2-positive breast cancer. Breast cancer research and treatment, 182(3), 613-622. https://doi.org/10.1007/s10549-020-05709-z