Donker Mila, Slaets Leen, van Tienhoven Geertjan, Rutgers Emiel J Th
*Dit onderzoek werd eerder gepubliceerd in The Lancet Oncology (2014;15:1303-10) met als titel 'Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial'. Afgedrukt met toestemming.
Ned Tijdschr Geneeskd. 2015;159:A9302.
To investigate whether axillary radiotherapy (ART) in patients with primary breast cancer and a tumour-positive sentinel node results in a similar axillary tumour recurrence rate compared with axillary lymph node dissection (ALND), and whether ART results in lower morbidity.
Randomised, multicentre non-inferiority trial.
Patients with breast cancer ≤ 5 cm without clinical signs of lymph node metastases but with a tumour-positive sentinel node were randomised between ALND or ART. The primary endpoint was the 5-year axillary recurrence rate. Secondary endpoints were disease-free survival, overall survival, morbidity (lymphoedema and shoulder function) and quality of life. (www.clinicaltrials.gov, study number NCT00014612.)
Between 2001 and 2010, 1425 patients with a tumour-positive sentinel node were included, 744 of whom had been randomised to ALND and 681 to ART. After a median follow-up period of 6.1 years, the 5-year axillary recurrence rate was 0.43% after ALND and 1.19% after ART; the difference was not statistically significant. The primary analysis was underpowered due to the low number of axillary recurrences. At 5 years the disease-free survival rate was 86.9% after ALND and 82.7% after ART. Overall survival was 93.3% and 92.5% respectively. Lymphoedema was noted significantly more often after ALND than after ART at 1 year, 3 years and 5 years. There were no significant differences in shoulder function or quality of life.
Both ART and ALND produce very low axillary recurrence rates in patients with breast cancer ≤ 5 cm and a tumour-positive sentinel node. ART results in significantly less lymphoedema than ALND.
研究原发性乳腺癌且前哨淋巴结肿瘤阳性患者接受腋窝放疗（ART）与腋窝淋巴结清扫术（ALND）相比，腋窝肿瘤复发率是否相似，以及ART是否导致更低的发病率。
随机、多中心非劣效性试验。
乳腺癌≤5cm且无临床淋巴结转移征象但前哨淋巴结肿瘤阳性的患者被随机分为接受ALND或ART。主要终点是5年腋窝复发率。次要终点是无病生存期、总生存期、发病率（淋巴水肿和肩部功能）及生活质量。（www.clinicaltrials.gov，研究编号NCT00014612。）
在2001年至2010年期间，纳入了1425例前哨淋巴结肿瘤阳性患者，其中744例被随机分配至ALND组，681例被分配至ART组。中位随访期6.1年后，ALND组的5年腋窝复发率为0.43%，ART组为1.19%；差异无统计学意义。由于腋窝复发例数少，主要分析效能不足。5年时，ALND组的无病生存率为86.9%，ART组为82.7%。总生存率分别为93.3%和92.5%。在1年、3年和5年时，ALND组淋巴水肿的发生率显著高于ART组。肩部功能或生活质量方面无显著差异。
对于乳腺癌≤5cm且前哨淋巴结肿瘤阳性的患者，ART和ALND的腋窝复发率均非常低。与ALND相比，ART导致的淋巴水肿显著更少。
