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Feasibility trial of partial breast irradiation with concurrent dose-dense doxorubicin and cyclophosphamide in early-stage breast cancer.

AbstractPURPOSE:
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 > or = 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 > or = 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.
AuthorsRichard C Zellars, Vered Stearns, Deborah Frassica, Fariba Asrari, Theodore Tsangaris, Lee Myers, Shirley DiPasquale, Julie R Lange, Lisa K Jacobs, Leisha A Emens, Deborah K Armstrong, John H Fetting, Elizabeth Garrett-Mayer, Nancy E Davidson, Antonio C Wolff
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 27 Issue 17 Pg. 2816-22 (Jun 10 2009) ISSN: 1527-7755 [Electronic] United States
PMID19332718 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Doxorubicin
  • Cyclophosphamide
Topics
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Breast Neoplasms (diagnosis, drug therapy)
  • Combined Modality Therapy
  • Cyclophosphamide (therapeutic use)
  • Dose-Response Relationship, Drug
  • Doxorubicin (therapeutic use)
  • Early Detection of Cancer
  • Feasibility Studies
  • Female
  • Humans
  • Radiotherapy, Adjuvant
  • Treatment Outcome

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