Yen Tina W F, Hunt Kelly K, Mirza Nadeem Q, Thomas Eva S, Singletary S Eva, Babiera Gildy V, Meric-Bernstam Funda, Buchholz Thomas A, Feig Barry W, Ross Merrick I, Ames Frederick C, Theriault Richard L, Kuerer Henry M
Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
Cancer. 2004 Mar 1;100(5):942-9. doi: 10.1002/cncr.20085.
To date, the impact of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-24 trial reported in 1999 on the use of tamoxifen after surgery for ductal carcinoma in situ (DCIS) is unknown. The current study was designed to evaluate the impact of NSABP B-24 on current practices at a comprehensive cancer center.
The records of 350 consecutive patients with DCIS who were treated at the authors' institution between July 1999 and June 2002 were obtained from a prospective database and analyzed. Whether patients were offered tamoxifen, whether patients accepted tamoxifen, and the associated reasons were recorded along with tamoxifen-related side effects and patient compliance with therapy. Clinical and pathologic factors were evaluated for their impact on recommendations regarding tamoxifen. Differences were assessed by chi-square analysis.
Of the 350 patients, 73 were excluded because of evidence of invasive carcinoma on final pathology review. Of the remaining 277 patients, 166 patients (60%) were offered tamoxifen, and 90 patients (54%) chose to take tamoxifen. Of 111 patients who were not offered tamoxifen, 39 patients (35%) had documented explanations, which included bilateral mastectomy (n = 25 patients), medical reasons (n = 10 patients), and already received tamoxifen for other reasons at the time of diagnosis (n = 4 patients). Of 94 patients who received tamoxifen, 20 patients (21%) discontinued use because of side effects or complications. Tamoxifen was more likely to be recommended for women who underwent segmental resection compared with women who underwent total mastectomy (P = 0.002) and for women with smaller pathologic DCIS tumors (P = 0.001). In addition, these two factors were interrelated.
Physicians and patients remain cautious regarding the use of tamoxifen after local treatment for DCIS. The current findings have implications for current trials evaluating aromatase inhibitors and other chemopreventive agents for this disease.
迄今为止,1999年报道的国家乳腺与肠道外科辅助治疗项目(NSABP)B-24试验对原位导管癌(DCIS)术后使用他莫昔芬的影响尚不清楚。本研究旨在评估NSABP B-24对一家综合癌症中心当前治疗实践的影响。
从前瞻性数据库中获取并分析了1999年7月至2002年6月期间在作者所在机构接受治疗的350例连续DCIS患者的记录。记录患者是否被提供他莫昔芬、是否接受他莫昔芬及其相关原因,以及与他莫昔芬相关的副作用和患者的治疗依从性。评估临床和病理因素对他莫昔芬推荐的影响。通过卡方分析评估差异。
在350例患者中,73例因最终病理检查发现浸润性癌而被排除。在其余277例患者中,166例(60%)被提供他莫昔芬,90例(54%)选择服用他莫昔芬。在111例未被提供他莫昔芬的患者中,39例(35%)有书面解释,其中包括双侧乳房切除术(25例)、医学原因(10例)以及诊断时因其他原因已接受他莫昔芬治疗(4例)。在94例接受他莫昔芬治疗的患者中,20例(21%)因副作用或并发症而停药。与接受全乳切除术的女性相比,接受局部切除术的女性更有可能被推荐使用他莫昔芬(P = 0.002),且病理DCIS肿瘤较小的女性更有可能被推荐使用他莫昔芬(P = 0.001)。此外,这两个因素相互关联。
对于DCIS局部治疗后使用他莫昔芬,医生和患者仍持谨慎态度。当前的研究结果对目前评估芳香化酶抑制剂和其他化学预防药物治疗该疾病的试验具有启示意义。