Radiotherapy and adjuvant trastuzumab in operable breast cancer: Tolerability and adverse event data from the NCCTG phase III trial N9831

Michele Y. Halyard, Thomas M. Pisansky, Amylou C. Dueck, Vera Suman, Lori Pierce, Larry Solin, Larry Marks, Nancy Davidson, Silvana Martino, Peter Kaufman, Leila Kutteh, Shaker R. Dakhil, Edith A. Perez

Research output: Contribution to journalArticle

127 Scopus citations

Abstract

Purpose: To assess whether trastuzumab (H) with radiotherapy (RT) increases adverse events (AEs) after breast-conserving surgery or mastectomy. Patients and Methods: Patients with early-stage resected human epidermal growth factor receptor 2 (HER-2) -positive breast cancer (BC) were randomly assigned to doxorubicin (A) and cyclophosphamide (C), followed by weekly paclitaxel (T; AC-T-H or AC-TH-H). RT criteria (with or without nodal RT) were postlumpectomy breast or (optional) postmastectomy chest wall. RT of internal mammary nodes was prohibited. RT commenced within 5 weeks after T, concurrently with H. Analysis included 1,503 irradiated patients for RT-associated AEs across treatment arms. Rates of cardiac events (CEs) with and without RT were compared within arms. Results: No significant differences among arms were found in incidence of acute skin reaction, pneumonitis, dyspnea, cough, dysphagia, or neutropenia. A significant difference occurred in incidence of leukopenia, with higher rates for AC-T-H versus AC-T (odds ratio = 1.89; 95% CI, 1.25 to 2.88). At a median follow-up of 3.7 years (range, 0 to 6.5 years), RT with H did not increase relative frequency of CEs regardless of treatment side. The cumulative incidence of CEs with AC-T-H was 2.7% with or without RT. With AC-TH-H, the cumulative incidence was 1.7% v 5.9% with or without RT, respectively. Conclusion: Concurrent adjuvant RT and H for early-stage BC was not associated with increased acute AEs. Further follow-up is required to assess late AEs.

Original languageEnglish (US)
Pages (from-to)2638-2644
Number of pages7
JournalJournal of Clinical Oncology
Volume27
Issue number16
DOIs
StatePublished - Jun 1 2009

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Halyard, M. Y., Pisansky, T. M., Dueck, A. C., Suman, V., Pierce, L., Solin, L., Marks, L., Davidson, N., Martino, S., Kaufman, P., Kutteh, L., Dakhil, S. R., & Perez, E. A. (2009). Radiotherapy and adjuvant trastuzumab in operable breast cancer: Tolerability and adverse event data from the NCCTG phase III trial N9831. Journal of Clinical Oncology, 27(16), 2638-2644. https://doi.org/10.1200/JCO.2008.17.9549