National Surgical Adjuvant Breast and Bowel Project Operations and Biostatistics Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.
J Clin Oncol. 2010 Sep 1;28(25):3929-36. doi: 10.1200/JCO.2010.28.2491. Epub 2010 Aug 2.
PURPOSE: Sentinel lymph node resection (SNR) may reduce morbidity while providing the same clinical utility as conventional axillary dissection (AD). National Surgical Adjuvant Breast and Bowel Project (NSABP) B-32 is a randomized phase III trial comparing SNR immediately followed by AD (SNAD) to SNR and subsequent AD if SN is positive. We report the definitive patient-reported outcomes (PRO) comparisons. PATIENTS AND METHODS: Eligible patients had clinically node-negative, operable invasive breast cancer. The PRO substudy included all SN-negative participants enrolled May 2001 to February 2004 at community institutions in the United States (n = 749; 78% age > or = 50; 87% clinical tumor size < or = 2.0 cm; 84% lumpectomy; 87% white). They completed questionnaires presurgery, 1 and 2 to 3 weeks postoperatively, and every 6 months through year 3. Arm symptoms, arm use avoidance, activity limitations, and quality of life (QOL) were compared with intent-to-treat two-sample t-tests and repeated measures analyses. RESULTS: Arm symptoms were significantly more bothersome for SNAD compared with SNR patients at 6 months (mean, 4.8 v 3.0; P < .001) and at 12 months (3.6 v 2.5; P = .006). Longitudinally, SNAD patients were more likely to experience ipsilateral arm and breast symptoms, restricted work and social activity, and impaired QOL (P < or = .002 all items). From 12 to 36 months, fewer than 15% of either SNAD or SNR patients reported moderate or greater severity of any given symptom or activity limitation. CONCLUSION: Arm morbidity was greater with SNAD than with SNR. Despite considerable fears about complications from AD for breast cancer, this study demonstrates that initial problems with either surgery resolve over time.
目的:前哨淋巴结切除术(SNR)可以减少发病率,同时提供与常规腋窝清扫术(AD)相同的临床效用。美国国家外科辅助乳腺和肠道项目(NSABP)B-32 是一项随机 III 期临床试验,比较了 SN 阴性后立即进行 AD(SNAD)与 SN 阴性后如果 SN 阳性则进行 AD 的 SNR。我们报告了明确的患者报告结果(PRO)比较。
患者和方法:符合条件的患者患有临床淋巴结阴性、可手术的浸润性乳腺癌。PRO 子研究包括所有 SN 阴性的参与者,这些参与者于 2001 年 5 月至 2004 年 2 月在美国社区机构入组(n = 749;78%年龄≥50 岁;87%临床肿瘤大小≤2.0 cm;84%乳房切除术;87%白人)。他们在术前、术后 1 天和 2 至 3 周以及术后 3 年内每 6 个月完成问卷。采用意向治疗两样本 t 检验和重复测量分析比较手臂症状、手臂使用回避、活动受限和生活质量(QOL)。
结果:与 SNR 患者相比,SNAD 患者在 6 个月(平均 4.8 对 3.0;P<.001)和 12 个月(3.6 对 2.5;P=.006)时手臂症状更令人困扰。纵向看,SNAD 患者更有可能出现同侧手臂和乳房症状、限制工作和社会活动以及降低 QOL(所有项目 P≤.002)。从 12 到 36 个月,SNAD 或 SNR 患者中不到 15%的人报告有任何给定症状或活动受限的中度或更严重程度。
结论:与 SNR 相比,SNAD 导致的手臂发病率更高。尽管对乳腺癌 AD 并发症存在相当大的担忧,但本研究表明,两种手术的最初问题会随着时间的推移而解决。
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