Radiotherapy and Adjuvant Trastuzumab in Operable Breast Cancer: Tolerability and Adverse Event Data From the NCCTG Phase III Trial N9831
Autor: | Michele Y. Halyard, Nancy E. Davidson, Lawrence B. Marks, Vera J. Suman, L. J. Solin, Lori J. Pierce, Silvana Martino, Edith A. Perez, Shaker R. Dakhil, Leila A. Kutteh, Peter A. Kaufman, Thomas M. Pisansky, Amylou C. Dueck |
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Jazyk: | angličtina |
Rok vydání: | 2009 |
Předmět: |
Oncology
Adult Cancer Research medicine.medical_specialty Time Factors Paclitaxel medicine.medical_treatment Breast Neoplasms Neutropenia Adenocarcinoma Antibodies Monoclonal Humanized Mastectomy Segmental Risk Assessment Young Adult Breast cancer Trastuzumab Internal medicine Antineoplastic Combined Chemotherapy Protocols Original Reports medicine Odds Ratio Humans Cyclophosphamide Mastectomy Aged business.industry Cancer Antibodies Monoclonal Middle Aged medicine.disease United States Surgery Radiation therapy Treatment Outcome Tolerability Chemotherapy Adjuvant Doxorubicin Female Radiotherapy Adjuvant Breast disease business medicine.drug |
Popis: | 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. |
Databáze: | OpenAIRE |
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