Radiotherapy and Adjuvant Trastuzumab in Operable Breast Cancer: Tolerability and Adverse Event Data From the NCCTG Phase III Trial N9831
Radiotherapy and Adjuvant Trastuzumab in Operable Breast Cancer: Tolerability and Adverse Event Data From the NCCTG Phase III Trial N9831
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DOI：
10.1200/jco.2008.17.9549
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发表时间：
2009-06-01
影响因子：
45.3
通讯作者：
Perez, Edith A.
中科院分区：
文献类型：
--
作者：
Halyard, Michele Y.;Pisansky, Thomas M.;Perez, Edith A.
PurposeTo assess whether trastuzumab（H）with radiotherapy（RT）increases adverse events（AE）after breast-serving surgery or mastectomy.Patients and MethodsPatients with early stage removed 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标准（伴或不伴淋巴结RT）为乳房肿瘤切除术后乳房或（可选）乳房切除术后胸壁。禁止内乳淋巴结RT。RT在T后5周内开始，与H同时进行。分析包括各治疗组中1，503例接受放疗的患者的RT相关AE。心脏事件（CE）的发生率与RT和不RT进行了比较arms.ResultsNo显着差异，发现在急性皮肤反应，肺炎，呼吸困难，咳嗽，吞咽困难，或中性粒细胞减少症的发生率。白细胞减少症的发生率存在显著差异，AC-T- H组的发生率高于AC-T组（比值比= 1.89; 95% CI，1.25 - 2.88）。在中位随访3.7年（范围：0 - 6.5年）时，RT + H未增加CE的相对频率，无论治疗侧如何。与AC-TH-H，累积发病率为1.7%v 5.9%与或不RT，respectively. ConclusionConcurrentadjuvant RT和H早期BC与急性AE增加无关。需要进一步随访以评估晚期AE。J Clin Oncol 27：2638-2644. (C)2009年美国临床肿瘤学会
PurposeTo assess whether trastuzumab (H) with radiotherapy (RT) increases adverse events (AEs) after breast-conserving surgery or mastectomy.Patients and MethodsPatients 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.ResultsNo 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.ConclusionConcurrent adjuvant RT and H for early-stage BC was not associated with increased acute AEs. Further follow-up is required to assess late AEs. J Clin Oncol 27: 2638-2644. (C) 2009 by American Society of Clinical Oncology