Orr R K
Division of Surgical Oncology, The Marshfield Clinic, Wisconsin 54449, USA.
Ann Surg Oncol. 1999 Jan-Feb;6(1):109-16. doi: 10.1007/s10434-999-0109-1.
Because of the general acceptance of the NSABP B-04 study, prophylactic axillary node dissection for women with clinically negative axillae is considered diagnostic, but not therapeutic, by many oncologists. Nevertheless, several authors have shown that B-04 did not include enough patients to exclude a small survival advantage.
A Bayesian meta-analysis of the available literature was performed comparing standard treatment to standard treatment without axillary node dissection. Six randomized controlled trials were identified, consisting of nearly 3000 patients and spanning four decades.
All six trials showed that prophylactic axillary node dissection improved survival, ranging from 4% to 16%, corresponding to a risk reduction of 7%-46%. Combining the six trials showed an average survival benefit of 5.4% (95% CI = 2.7-8.0%, probability of survival benefit > 99.5%). Adjusting for biases in the individual studies did not alter the conclusions, nor did subset analysis of Stage I patients.
Axillary node dissection improves survival in women with operable breast cancer. Nevertheless, two important limitations of this analysis are noteworthy. Few of the patients in the six trials had T1a tumors, so extrapolation of these results to this subset (and those with nonpalpable tumors) may be inappropriate. Essentially no patients in the six trials were treated with adjuvant therapy, as contrasted to current clinical practice. It is possible that the risk reduction seen in this meta-analysis may be diminished in patients receiving adjuvant chemotherapy. Despite these limitations, this study suggests that axillary dissection should be performed in most women with palpable tumors for diagnostic, as well as therapeutic, purposes.
由于NSABP B - 04研究已被广泛接受,许多肿瘤学家认为,对于腋窝临床阴性的女性患者,预防性腋窝淋巴结清扫具有诊断意义,但不具有治疗意义。然而,一些作者指出,B - 04研究纳入的患者数量不足以排除存在微小生存优势的可能性。
对现有文献进行贝叶斯荟萃分析,比较标准治疗与未进行腋窝淋巴结清扫的标准治疗。共识别出6项随机对照试验,涉及近3000名患者,跨越4个十年。
所有6项试验均表明,预防性腋窝淋巴结清扫可提高生存率,幅度为4%至16%,相当于风险降低7% - 46%。综合这6项试验显示,平均生存获益为5.4%(95%置信区间 = 2.7 - 8.0%,生存获益概率>99.5%)。对各研究中的偏倚进行校正并未改变结论,对I期患者的亚组分析结果同样如此。
腋窝淋巴结清扫可提高可手术乳腺癌女性患者的生存率。然而,该分析存在两个值得注意的重要局限性。这6项试验中几乎没有患者患有T1a肿瘤,因此将这些结果外推至该亚组(以及肿瘤不可触及的患者)可能并不合适。与当前临床实践形成对比的是,这6项试验中基本上没有患者接受辅助治疗。在接受辅助化疗的患者中,本荟萃分析中观察到的风险降低可能会减弱。尽管存在这些局限性,但本研究表明,对于大多数可触及肿瘤的女性患者,应进行腋窝清扫,以达到诊断和治疗目的。