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前哨淋巴结活检在学术性综合癌症中心成为乳腺癌标准治疗方法的情况。

Emergence of sentinel node biopsy in breast cancer as standard-of-care in academic comprehensive cancer centers.

作者信息

Edge Stephen B, Niland Joyce C, Bookman Michael A, Theriault Richard L, Ottesen Rebecca, Lepisto Eva, Weeks Jane C

机构信息

Roswell Park Cancer Institute, Buffalo, NY 14263, USA.

出版信息

J Natl Cancer Inst. 2003 Oct 15;95(20):1514-21. doi: 10.1093/jnci/djg076.

Abstract

BACKGROUND

Ongoing clinical trials are addressing the accuracy and safety of sentinel node biopsy (SNB) in the treatment of breast cancer; however, SNB is already increasingly being used in clinical practice. This study examined the extent and time trends of the use of SNB in stage I and II breast cancer patients.

METHODS

Clinical data were collected from stage I and II (tumor size < or =5.0 cm) breast cancer patients (n = 3003) who were treated at five comprehensive cancer centers between July 1, 1997, and December 31, 2000. Axillary surgery was classified as SNB alone, SNB + axillary node dissection (AND), AND alone, or none. Patterns of use of axillary surgery were summarized as the percentage of patients receiving each surgery type. The statistical significance of time trends for the use of SNB alone was analyzed by logistic regression models. All statistical tests were two-sided.

RESULTS

Overall, SNB alone was used in 13% of patients, SNB + AND in 22%, AND alone in 59%, and no axillary surgery in 6%. Use of SNB alone was statistically significantly associated with breast-conserving surgery of both smaller (< or =2 cm) and larger tumors (2-5 cm) (P<.001 for both associations). For stage I cancer patients treated with breast-conserving surgery (n = 1763), use of SNB increased statistically significantly over the study period, from 8% in 1997 to 9%, 14%, 15%, 22%, 42%, and 58% for the next six consecutive 6-month time intervals, respectively. After controlling for center, age, and comorbidity, the odds ratio for the use of SNB alone was 2.30 (95% confidence interval = 1.88 to 2.82) for each 6-month interval (P<.001).

CONCLUSIONS

Widespread use of SNB outside the clinical trial setting suggests that oncologists at cancer centers in our study have accepted SNB as standard-of-care for the treatment of breast cancer. This acceptance, if it occurs in other cancer centers and community practice, may affect accrual and generalizability of ongoing clinical trials of SNB.

摘要

背景

正在进行的临床试验正在探讨前哨淋巴结活检(SNB)在乳腺癌治疗中的准确性和安全性;然而,SNB已越来越多地应用于临床实践。本研究调查了I期和II期乳腺癌患者中SNB的使用程度和时间趋势。

方法

收集了1997年7月1日至2000年12月31日期间在五个综合癌症中心接受治疗的I期和II期(肿瘤大小≤5.0 cm)乳腺癌患者(n = 3003)的临床数据。腋窝手术分为单纯SNB、SNB +腋窝淋巴结清扫(AND)、单纯AND或未进行腋窝手术。腋窝手术的使用模式总结为接受每种手术类型的患者百分比。通过逻辑回归模型分析单纯使用SNB的时间趋势的统计学意义。所有统计检验均为双侧检验。

结果

总体而言,单纯使用SNB的患者占13%,SNB + AND的患者占22%,单纯AND的患者占59%,未进行腋窝手术的患者占6%。单纯使用SNB与较小(≤2 cm)和较大(2 - 5 cm)肿瘤的保乳手术在统计学上显著相关(两种关联的P均<0.001)。对于接受保乳手术的I期癌症患者(n = 1763),在研究期间,SNB的使用在统计学上显著增加,从1997年的8%分别增加到接下来连续六个6个月时间间隔的9%、14%、15%、22%、42%和58%。在控制了中心、年龄和合并症后,每6个月时间间隔单纯使用SNB的优势比为2.30(95%置信区间 = 1.88至2.82)(P<0.001)。

结论

在临床试验环境之外广泛使用SNB表明,我们研究中的癌症中心的肿瘤学家已将SNB接受为乳腺癌治疗的标准治疗方法。如果这种接受情况发生在其他癌症中心和社区实践中,可能会影响正在进行的SNB临床试验的入组和普遍性。

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