Originally published as JCO Early Release 10.1200/JCO.2008.17.9549 on April 6 2009

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Radiotherapy and Adjuvant Trastuzumab in Operable Breast Cancer: Tolerability and Adverse Event Data From the NCCTG Phase III Trial N9831

From the Mayo Clinic Scottsdale, Scottsdale, AZ; Mayo Clinic and Mayo Foundation, Rochester, MN; Southwest Oncology Group Operations Office, San Antonio, TX; Eastern Cooperative Oncology Group Data Management Office, Brookline, MA; Cancer and Leukemia Group B Data Management Center, Durham, NC; Cedar Rapids Oncology Project, Community Clinical Oncology Program, Cedar Rapids, IA; Wichita Community Clinical Oncology Program, Wichita, KS; and Mayo Clinic Jacksonville, Jacksonville, FL.

Corresponding author: Michele Halyard, MD, Mayo Clinic Scottsdale, 13400 East Shea Blvd, Scottsdale, AZ 85259; e-mail: mhalyard{at}mayo.edu.

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.

Supported in part by Public Health Service Grants No. CA-25224, CA-37404, CA-15083, CA-63826, CA-52352, CA-63849, CA-35195, CA-35272, CA-60276, CA-35269, CA-37417, CA-63848, CA-35101, CA-35415, and CA-35103.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00005970.

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