Originally published as JCO Early Release 10.1200/JCO.2008.20.0139 on March 30 2009

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Feasibility Trial of Partial Breast Irradiation With Concurrent Dose-Dense Doxorubicin and Cyclophosphamide in Early-Stage Breast Cancer

From the Departments of Radiation Oncology and Molecular Radiation Sciences, Surgery, and Oncology, the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and the Johns Hopkins University School of Medicine, Baltimore, MD.

Corresponding author: Richard Zellars, MD, Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins, 401 N Broadway, Suite 1440, Baltimore, MD 21231; e-mail: zellari{at}jhmi.edu.

Purpose Anthracyclines and concurrent whole-breast irradiation result in prohibitive cutaneous toxicity. We hypothesized that anthracycline-based chemotherapy and concurrent partial breast irradiation (PBI) is safe and conducted a single-arm feasibility trial testing this hypothesis with dose-dense doxorubicin and cyclophosphamide (ddAC).

Patients and Methods Women with T1-2, N0-1 breast cancer with 3 mm lumpectomy margins received PBI (40.5 Gy, 15 daily 2.7-Gy fractions) concurrently with the first two of four cycles of ddAC (60 and 600 mg/m² of doxorubicin and cyclophosphamide, respectively, every 14 days with colony-stimulating support). Primary end points were local and systemic toxicity. Additional systemic therapy was given at the physician's discretion.

Results Twenty-seven patients enrolled between November 2004 and January 2007, but two patients did not receive protocol therapy (one found with additional local disease and one withdrew consent). Twenty-five women completed all planned PBI. Four (16%) of 25 did not complete all ddAC (febrile neutropenia [FN], n = 2; diverticulitis and neutropenia, n = 1; and social/economic reasons, n = 1). Four among the remaining 21 who completed all ddAC had a cycle delayed (FN, n = 1; acute respiratory illness, n = 1; foot blisters, n = 1; perianal dermatitis, n = 1). There was no grade 3 to 4 anemia or thrombocytopenia. Grade 3 nonhematologic toxicities (none grade 4) occurred in 28% (seven of 25) of patients (nausea/vomiting, n = 3; stomatitis, n = 2; contralateral breast abscess, n = 1; fatigue, n = 1; and cough/bronchospasms, n = 1). The observed rate of grade 2 skin toxicity was 0% (0 of 25; one-sided 95% CI, 0% to 11%).

Conclusion PBI with concurrent ddAC is feasible, and local/systemic toxicity is acceptable. Larger studies are warranted to assess long-term locoregional control and late toxicities.

Supported by the Breast Cancer Research Foundation.

Presented at the 49th Annual Meeting of the American Society for Therapeutic Radiology and Oncology, October 28-November 1, 2007, Los Angeles, CA.

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

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