NATIONAL HARBOR, Maryland (EGMN) – Age 50 years or older, initial clinical tumor size greater than 5 cm, and pathologic tumor response to neoadjuvant chemotherapy were significant independent predictors of locoregional failure in women who underwent neoadjuvant chemotherapy in two large breast cancer trials.

Investigators presented these results from a 10-year follow-up study of 2,961 patients in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and NSABP B-27 trials at the 2010 Breast Cancer Symposium.

Dr. Eleftherios P. Mamounas of Aultman Hospital in Canton, Ohio, and his colleagues reported the 10-year incidence of local or regional failure based on type of surgery was 12.3% in patients who had mastectomies and 10.3% in those who had lumpectomies plus chemotherapy. The incidence of local failure was 8.9% in the mastectomy group and 8.1% in the lumpectomy plus chemotherapy group. The incidence of regional failure was 3.4% and 2.2%, respectively.

In a multivariate analysis based on 318 locoregional failure events in all 2,961 patients, the overall significant predictors of locoregional failure included age 50 years or older (hazard ratio 0.79, P = .04), clinical tumor size greater than 5 cm (HR 1.52, P = .0005), and positive clinical nodal status (HR 1.64, P less than .0001). In addition, being node negative without pathologic complete response (HR 1.65, P less than .001) or node positive with pathologic complete response (HR 2.77, P less than 0.001) were significant predictors as well.

The lack of data on predictors of locoregional failure after neoadjuvant chemotherapy has raised questions about whether to use radiation therapy and when to perform sentinel node biopsies in these patients, said Dr. Mamounas.

He also presented data on locoregional failure in lumpectomy patients and mastectomy patients separately, for the purpose of developing separate treatment nomograms for each procedure. A majority of the locoregional failures in the lumpectomy patients were in-breast recurrences. In mastectomy patients, rates of chest wall recurrence were inversely correlated to pathologic nodal response, Dr. Mamounas said.

“The effect of age (in lumpectomy patients), clinical tumor size (in mastectomy patients), and clinical nodal status at locoregional failure appears to diminish with increasing pathologic response in the breast and axillary nodes,” said Dr. Mamounas.

The neoadjuvant chemotherapy regimens were one of two: doxorubicin and cyclophosphamide (AC) for four cycles, or the AC regimen for four cycles followed by four cycles of neoadjuvant/adjuvant docetaxel. Patients in the B-27 trial received tamoxifen in addition to their neoadjuvant chemotherapy. Lumpectomy patients were treated with radiation, but mastectomy patients were not.

The independent predictors were incorporated into two nomograms: one for mastectomy and one for lumpectomy plus breast radiation, Dr. Mamounas explained. Additional studies are planned to include treatment effects in the development and validation of the nomograms, he said.

Dr. Mamounas disclosed serving as a consultant for Eli Lilly & Co. and receiving honoraria from AstraZeneca and Sanofi-Aventis.

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

马里兰州国家海港(EGMN)——两项大型乳腺癌临床试验表明，年龄≥50岁、初始临床肿瘤大小>5 cm、肿瘤对新辅助化疗的病理学反应是行新辅助化疗的女患者局部区域治疗失败的显著独立预测因子。

 

以上结果是由俄亥俄州坎顿市Aultman医院的Eleftherios P. Mamounas博士及其同事对美国乳腺与肠道外科辅助治疗研究组(NSABP) B-18试验和B-27试验中的2,961例患者随访10年得出。这两项试验中的新辅助化疗方案为以下两种之一：4个疗程的阿霉素+环磷酰胺(AC)；4个疗程的AC治疗序贯以4个疗程的多西紫杉醇新辅助/辅助治疗。B-27试验中的患者接受他莫昔芬联合新辅助化疗；行肿块切除术患者接受放疗治疗，但行乳房切除术患者则不然。

 

经分析发现，行乳房切除术患者10年局部或区域治疗失败率为12.3%，行肿块切除术加化疗者为10.3%，这两种术式的局部治疗失败率分别为8.9%和8.1%，区域治疗失败率分别为3.4%和2.2%。肿块切除术患者中大多数局部区域治疗失败为乳腺内复发，行乳房切除术患者的胸壁复发率与淋巴结病理学反应呈负相关。对318例局部区域治疗失败事件进行多变量分析发现，局部区域治疗失败的显著预测因子包括：年龄≥50岁[风险比(HR) 0.79, P=0.04]、临床肿瘤大小>5 cm (HR 1.52, P =0.0005)以及临床淋巴结阳性(HR 1.64, P <0.0001)。另外，淋巴结阴性、未达到病理学完全缓解(HR 1.65, P <0.001)或淋巴结阳性、达到病理学完全缓解(HR 2.77, P<0.001)也是显著预测因子。

 

随着乳腺和腋下淋巴结病理学反应的增加，这些因素——年龄(对于肿块切除术患者)、临床肿瘤大小(对于乳房切除术患者)及局部区域治疗失败时的临床淋巴结状态——的影响似乎会减小。

 

Mamounas博士披露担任礼来公司的顾问，并收到阿斯利康公司和赛诺菲-安万特公司的酬金。

 

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