Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials.
Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials.
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乳房切除术和腋窝手术后放射疗法对10年复发和20年乳腺癌死亡率的影响：在22项随机试验中对8135名女性的单个患者数据的荟萃分析。
DOI：
10.1016/s0140-6736(14)60488-8
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发表时间：
2014-06-21
期刊：
影响因子：
168.9
通讯作者：
Darby, S.
中科院分区：
文献类型：
--
作者：
McGale, P.;Taylor, C.;Correa, C.;Cutter, D.;Duane, F.;Ewertz, M.;Gray, R.;Mannu, G.;Peto, R.;Whelan, T.;Wang, Y.;Wang, Z.;Darby, S.
先前的荟萃分析显示，在所有结节阳性的女性中，术后放射治疗可以降低复发和乳腺癌死亡率的风险。然而，只有一到三个阳性淋巴结的女性的益处尚不确定。我们的目标是评估这些女性在乳房切除和腋窝清扫后接受放射治疗的效果。我们对1964-86年间随机分配到治疗组的8135名妇女的个人数据进行了荟萃分析，在22项试验中，乳腺癌切除和腋窝手术后对胸壁和区域淋巴结进行放射治疗，与相同手术但不进行放射治疗相比。随访10年，复发率为10年，死亡率为2009年1月1日。分析按试验、个人随访年份、入院年龄和病理结节状态进行分层。3786名女性腋窝清扫至少达到II级，并有零个、一到三个或四个或更多阳性结节。所有患者都接受了包括胸壁、锁骨上或腋窝(或两者)以及内乳房链的放射治疗。对于700例腋窝清扫且无阳性结节的患者，放疗对局部复发(双侧显著水平[2p]和gt；0·1)、总复发率(比率[RR]，照射与未照射比较，1·06，95%CI 0·76-1·48，2p>；0·1)或乳腺癌死亡率(RR 1·18，95%CI 0·89-1·55，2p>；0·1)无显著影响。对腋窝清扫1~3个阳性结节的1 314例患者，放疗降低了局部复发(2p<；0·00001)、总复发率(RR 0·68，95%CI 0·57~0·82，2p=0·00006)和乳腺癌死亡率(RR 0·80，95%CI 0·67~0·95，2p=0·01)。在这13 14名妇女中，1 133人参加了两个试验组的系统治疗(环磷酰胺、甲氨蝶呤、氟尿嘧啶或他莫昔芬)的试验，对她们来说，放疗再次降低了局部复发(2p<；0·00001)、总复发率(RR 0·67，95%CI 0·55~0·82，2p=0·00009)和乳腺癌死亡率(RR 0·78，95%CI 0·-0·94，2p=0·01)。对于腋窝清扫且有4个以上阳性结节的患者，放疗降低了局部复发(2p<；0·00001)、总复发率(RR为0·79，95%CI为0·69~0·90，2p=0·0003)和乳腺癌死亡率(RR为0·87，95%CI为0·77~0·99，2p=0·04)。在乳房切除和腋窝清扫后，即使在给予系统治疗的情况下，在这些试验中，有一到三个阳性淋巴结的女性，放射治疗可以降低复发和乳腺癌死亡率。对于今天在许多国家复发风险较低的女性来说，由于更有效的放射治疗，绝对收益可能较小，但比例收益可能较大。英国癌症研究、英国心脏基金会、英国医学研究理事会。
Postmastectomy radiotherapy was shown in previous meta-analyses to reduce the risks of both recurrence and breast cancer mortality in all women with node-positive disease considered together. However, the benefit in women with only one to three positive lymph nodes is uncertain. We aimed to assess the effect of radiotherapy in these women after mastectomy and axillary dissection. We did a meta-analysis of individual data for 8135 women randomly assigned to treatment groups during 1964–86 in 22 trials of radiotherapy to the chest wall and regional lymph nodes after mastectomy and axillary surgery versus the same surgery but no radiotherapy. Follow-up lasted 10 years for recurrence and to Jan 1, 2009, for mortality. Analyses were stratified by trial, individual follow-up year, age at entry, and pathological nodal status. 3786 women had axillary dissection to at least level II and had zero, one to three, or four or more positive nodes. All were in trials in which radiotherapy included the chest wall, supraclavicular or axillary fossa (or both), and internal mammary chain. For 700 women with axillary dissection and no positive nodes, radiotherapy had no significant effect on locoregional recurrence (two-sided significance level [2p]>0·1), overall recurrence (rate ratio [RR], irradiated vs not, 1·06, 95% CI 0·76–1·48, 2p>0·1), or breast cancer mortality (RR 1·18, 95% CI 0·89–1·55, 2p>0·1). For 1314 women with axillary dissection and one to three positive nodes, radiotherapy reduced locoregional recurrence (2p<0·00001), overall recurrence (RR 0·68, 95% CI 0·57–0·82, 2p=0·00006), and breast cancer mortality (RR 0·80, 95% CI 0·67–0·95, 2p=0·01). 1133 of these 1314 women were in trials in which systemic therapy (cyclophosphamide, methotrexate, and fluorouracil, or tamoxifen) was given in both trial groups and, for them, radiotherapy again reduced locoregional recurrence (2p<0·00001), overall recurrence (RR 0·67, 95% CI 0·55–0·82, 2p=0·00009), and breast cancer mortality (RR 0·78, 95% CI 0·64–0·94, 2p=0·01). For 1772 women with axillary dissection and four or more positive nodes, radiotherapy reduced locoregional recurrence (2p<0·00001), overall recurrence (RR 0·79, 95% CI 0·69–0·90, 2p=0·0003), and breast cancer mortality (RR 0·87, 95% CI 0·77–0·99, 2p=0·04). After mastectomy and axillary dissection, radiotherapy reduced both recurrence and breast cancer mortality in the women with one to three positive lymph nodes in these trials even when systemic therapy was given. For today's women, who in many countries are at lower risk of recurrence, absolute gains might be smaller but proportional gains might be larger because of more effective radiotherapy. Cancer Research UK, British Heart Foundation, UK Medical Research Council.