Lancet. 2014 Jun 21;383(9935):2127-35. doi: 10.1016/S0140-6736(14)60488-8. Epub 2014 Mar 19.
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.
之前的荟萃分析表明，对于所有淋巴结阳性疾病患者，包括仅 1 至 3 个阳性淋巴结的患者，术后辅助放疗可降低复发风险和乳腺癌死亡率。但是，在仅 1 至 3 个阳性淋巴结的患者中，放疗的获益并不确定。我们旨在评估在这些患者接受乳房切除术和腋窝清扫术后放疗的效果。
我们对 22 项临床试验中的 8135 名女性进行了个体数据的荟萃分析，这些女性在 1964 年至 1986 年期间被随机分配至接受乳房切除术和腋窝手术后胸部和区域淋巴结放疗的治疗组和相同手术但未接受放疗的对照组。随访时间为复发 10 年和截至 2009 年 1 月 1 日的死亡率。分析按试验、个体随访年份、入组年龄和病理淋巴结状态分层。
3786 名女性接受了至少 II 级腋窝清扫术，并且淋巴结无转移、1 至 3 个阳性淋巴结或 4 个或更多阳性淋巴结。所有患者均参加了包含胸部、锁骨上或腋窝（或两者）和内乳链放疗的试验。对于 700 名无阳性淋巴结的腋窝清扫术患者，放疗对局部区域复发（双侧显著性水平[2p]>0.1）、总体复发（放疗与未放疗的比率[RR]，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。对于 1314 名接受腋窝清扫术和 1 至 3 个阳性淋巴结的患者，放疗降低了局部区域复发（2p<0.00001）、总体复发（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）。这些 1314 名患者中有 1133 名参加了接受两组系统性治疗（环磷酰胺、甲氨蝶呤和氟尿嘧啶或他莫昔芬）的试验，对于这些患者，放疗再次降低了局部区域复发（2p<0.00001）、总体复发（RR 0.67，95%CI 0.55-0.82，2p=0.00009）和乳腺癌死亡率（RR 0.78，95%CI 0.64-0.94，2p=0.01）。对于 1772 名接受腋窝清扫术和 4 个或更多阳性淋巴结的患者，放疗降低了局部区域复发（2p<0.00001）、总体复发（RR 0.79，95%CI 0.69-0.90，2p=0.0003）和乳腺癌死亡率（RR 0.87，95%CI 0.77-0.99，2p=0.04）。
在这些试验中，对于接受乳房切除术和腋窝清扫术的女性，无论是否接受系统性治疗，放疗均降低了 1 至 3 个阳性淋巴结患者的复发和乳腺癌死亡率。对于当今许多国家复发风险较低的女性，绝对获益可能较小，但由于放疗效果更好，相对获益可能更大。
英国癌症研究中心、英国心脏基金会、英国医学研究理事会。
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