PMID- 19349549 OWN - NLM STAT- MEDLINE DCOM- 20090611 LR - 20220408 IS - 1527-7755 (Electronic) IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 27 IP - 16 DP - 2009 Jun 1 TI - Radiotherapy and adjuvant trastuzumab in operable breast cancer: tolerability and adverse event data from the NCCTG Phase III Trial N9831. PG - 2638-44 LID - 10.1200/JCO.2008.17.9549 [doi] AB - 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. FAU - Halyard, Michele Y AU - Halyard MY AD - Mayo Clinic Scottsdale, Scottsdale, AZ 85259, USA. mhalyard@mayo.edu FAU - Pisansky, Thomas M AU - Pisansky TM FAU - Dueck, Amylou C AU - Dueck AC FAU - Suman, Vera AU - Suman V FAU - Pierce, Lori AU - Pierce L FAU - Solin, Larry AU - Solin L FAU - Marks, Larry AU - Marks L FAU - Davidson, Nancy AU - Davidson N FAU - Martino, Silvana AU - Martino S FAU - Kaufman, Peter AU - Kaufman P FAU - Kutteh, Leila AU - Kutteh L FAU - Dakhil, Shaker R AU - Dakhil SR FAU - Perez, Edith A AU - Perez EA LA - eng GR - U10 CA052352/CA/NCI NIH HHS/United States GR - U10 CA037417/CA/NCI NIH HHS/United States GR - U10 CA060276/CA/NCI NIH HHS/United States GR - CA-52352/CA/NCI NIH HHS/United States GR - CA-35195/CA/NCI NIH HHS/United States GR - U10 CA037404/CA/NCI NIH HHS/United States GR - CA-25224/CA/NCI NIH HHS/United States GR - CA-60276/CA/NCI NIH HHS/United States GR - U10 CA035272/CA/NCI NIH HHS/United States GR - U10 CA035101/CA/NCI NIH HHS/United States GR - P30 CA015083/CA/NCI NIH HHS/United States GR - CA-63826/CA/NCI NIH HHS/United States GR - CA-35415/CA/NCI NIH HHS/United States GR - CA-35269/CA/NCI NIH HHS/United States GR - U10 CA035269/CA/NCI NIH HHS/United States GR - CA-37404/CA/NCI NIH HHS/United States GR - U10 CA063848/CA/NCI NIH HHS/United States GR - U10 CA035195/CA/NCI NIH HHS/United States GR - CA-35103/CA/NCI NIH HHS/United States GR - CA-63848/CA/NCI NIH HHS/United States GR - U10 CA035415/CA/NCI NIH HHS/United States GR - U10 CA063849/CA/NCI NIH HHS/United States GR - CA-37417/CA/NCI NIH HHS/United States GR - CA-35272/CA/NCI NIH HHS/United States GR - CA-35101/CA/NCI NIH HHS/United States GR - U10 CA025224/CA/NCI NIH HHS/United States GR - CA-15083/CA/NCI NIH HHS/United States GR - CA-63849/CA/NCI NIH HHS/United States GR - N01 CA015083/CA/NCI NIH HHS/United States GR - U10 CA035103/CA/NCI NIH HHS/United States PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural DEP - 20090406 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 80168379AG (Doxorubicin) RN - 8N3DW7272P (Cyclophosphamide) RN - P188ANX8CK (Trastuzumab) RN - P88XT4IS4D (Paclitaxel) SB - IM CIN - J Clin Oncol. 2009 Dec 1;27(34):e239; author reply e240-1. PMID: 19884526 MH - Adenocarcinoma/drug therapy/radiotherapy/surgery/*therapy MH - Adult MH - Aged MH - Antibodies, Monoclonal/*administration & dosage MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Breast Neoplasms/drug therapy/radiotherapy/surgery/*therapy MH - Chemotherapy, Adjuvant MH - Cyclophosphamide/administration & dosage MH - Doxorubicin/administration & dosage MH - Female MH - Humans MH - *Mastectomy MH - *Mastectomy, Segmental MH - Middle Aged MH - Odds Ratio MH - Paclitaxel/administration & dosage MH - Radiotherapy, Adjuvant/adverse effects MH - Risk Assessment MH - Time Factors MH - Trastuzumab MH - Treatment Outcome MH - United States MH - Young Adult PMC - PMC2690390 COIS- Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. EDAT- 2009/04/08 09:00 MHDA- 2009/06/12 09:00 PMCR- 2010/06/01 CRDT- 2009/04/08 09:00 PHST- 2009/04/08 09:00 [entrez] PHST- 2009/04/08 09:00 [pubmed] PHST- 2009/06/12 09:00 [medline] PHST- 2010/06/01 00:00 [pmc-release] AID - JCO.2008.17.9549 [pii] AID - 79549 [pii] AID - 10.1200/JCO.2008.17.9549 [doi] PST - ppublish SO - J Clin Oncol. 2009 Jun 1;27(16):2638-44. doi: 10.1200/JCO.2008.17.9549. Epub 2009 Apr 6.