Feasibility trial of partial breast irradiation with concurrent dose-dense doxorubicin and cyclophosphamide in early-stage breast cancer
Zellars RC et al. - In a study to determine whether anthracycline-based chemotherapy and concurrent partial breast irradiation (PBI) are safe, it was shown that PBI with concurrent dose-dense doxorubicin and cyclophosphamide (ddAC) is feasible, and local/systemic toxicity is acceptable. 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 2 of 4 cycles of ddAC (60 and 600 mg/m2 of doxorubicin and cyclophosphamide, respectively, every 14 days with colony-stimulating support).
- Primary endpoints were local and systemic toxicity.
- Additional systemic therapy was given at the physician's discretion.
Results- 27 pts enrolled, but 2 pts did not receive protocol therapy (1 found with additional local disease and 1 withdrew consent).
- 25 women completed all planned PBI.
- 4 (16%) of 25 did not complete all ddAC (febrile neutropenia [FN], n=2; diverticulitis and neutropenia, n=1; and social/economic reasons, n=1).
- 4 of 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% (7 of 25) of pts (nausea/vomiting, n=3; stomatitis, n=2; contralateral breast abscess, n=1; fatigue, n=1; and cough/bronchospasms, n=1).
- observed rate of ≥ grade 2 skin toxicity was 0% (0 of 25).
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