J Natl Cancer Inst Monogr. 2001(30):5-15.
Our goal was to provide health-care providers, patients, and the general public with an assessment of currently available data regarding the use of adjuvant therapy for breast cancer.
The participants included a non-Federal, non-advocate, 14-member panel representing the fields of oncology, radiology, surgery, pathology, statistics, public health, and health policy as well as patient representatives. In addition, 30 experts in medical oncology, radiation oncology, biostatistics, epidemiology, surgical oncology, and clinical trials presented data to the panel and to a conference audience of 1000.
The literature was searched with the use of MEDLINE for January 1995 through July 2000, and an extensive bibliography of 2230 references was provided to the panel. Experts prepared abstracts for their conference presentations with relevant citations from the literature. Evidence from randomized clinical trials and evidence from prospective studies were given precedence over clinical anecdotal experience.
The panel, answering predefined questions, developed its conclusions based on the evidence presented in open forum and the scientific literature. The panel composed a draft statement, which was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately after its release at the conference and was updated with the panel's final revisions. The statement is available at http://consensus.nih.gov.
The panel concludes that decisions regarding adjuvant hormonal therapy should be based on the presence of hormone receptor protein in tumor tissues. Adjuvant hormonal therapy should be offered only to women whose tumors express hormone receptor protein. Because adjuvant polychemotherapy improves survival, it should be recommended to the majority of women with localized breast cancer regardless of lymph node, menopausal, or hormone receptor status. The inclusion of anthracyclines in adjuvant chemotherapy regimens produces a small but statistically significant improvement in survival over non-anthracycline-containing regimens. Available data are currently inconclusive regarding the use of taxanes in adjuvant treatment of lymph node-positive breast cancer. The use of adjuvant dose-intensive chemotherapy regimens in high-risk breast cancer and of taxanes in lymph node-negative breast cancer should be restricted to randomized trials. Ongoing studies evaluating these treatment strategies should be supported to determine if such strategies have a role in adjuvant treatment. Studies to date have included few patients older than 70 years. There is a critical need for trials to evaluate the role of adjuvant chemotherapy in these women. There is evidence that women with a high risk of locoregional tumor recurrence after mastectomy benefit from postoperative radiotherapy. This high-risk group includes women with four or more positive lymph nodes or an advanced primary cancer. Currently, the role of postmastectomy radiotherapy for patients with one to three positive lymph nodes remains uncertain and should be tested in a randomized controlled trial. Individual patients differ in the importance they place on the risks and benefits of adjuvant treatments. Quality of life needs to be evaluated in selected randomized clinical trials to examine the impact of the major acute and long-term side effects of adjuvant treatments, particularly premature menopause, weight gain, mild memory loss, and fatigue. Methods to support shared decision-making between patients and their physicians have been successful in trials; they need to be tailored for diverse populations and should be tested for broader dissemination.
我们的目标是为医疗保健提供者、患者及公众提供一份关于乳腺癌辅助治疗现有数据的评估。
参与者包括一个由14名成员组成的非联邦、非倡导性小组，成员代表肿瘤学、放射学、外科、病理学、统计学、公共卫生和卫生政策领域，以及患者代表。此外，30名医学肿瘤学、放射肿瘤学、生物统计学、流行病学、外科肿瘤学和临床试验方面的专家向该小组及1000名会议听众展示了数据。
利用MEDLINE检索了1995年1月至2000年7月的文献，并向该小组提供了一份包含2230篇参考文献的详尽书目。专家们为其会议发言准备了摘要，并引用了文献中的相关内容。随机临床试验的证据和前瞻性研究的证据优先于临床轶事经验。
该小组回答预先设定的问题，根据在公开论坛上展示的证据和科学文献得出结论。该小组撰写了一份声明草案，全文宣读后分发给专家和听众征求意见。此后，该小组解决了相互冲突的建议，并在会议结束时发布了一份修订声明。该小组在会议结束后的几周内完成了修订的定稿。声明草案在会议发布后立即在万维网上公布，并根据该小组的最终修订进行了更新。该声明可在http://consensus.nih.gov上获取。
该小组得出结论，关于辅助激素治疗的决策应基于肿瘤组织中激素受体蛋白的存在情况。辅助激素治疗应仅提供给肿瘤表达激素受体蛋白的女性。由于辅助多药化疗可提高生存率，因此应建议大多数局限性乳腺癌女性进行辅助多药化疗，无论其淋巴结、绝经或激素受体状态如何。在辅助化疗方案中加入蒽环类药物相较于不含蒽环类药物的方案，在生存率方面有小幅但具有统计学意义的提高。目前关于紫杉烷在淋巴结阳性乳腺癌辅助治疗中的应用，现有数据尚无定论。在高危乳腺癌中使用辅助剂量密集化疗方案以及在淋巴结阴性乳腺癌中使用紫杉烷应仅限于随机试验。应支持正在进行的评估这些治疗策略的研究，以确定这些策略在辅助治疗中是否有作用。迄今为止的研究纳入的70岁以上患者很少。迫切需要进行试验以评估辅助化疗在这些女性中的作用。有证据表明，乳房切除术后局部区域肿瘤复发风险高的女性可从术后放疗中获益。这一高危组包括有四个或更多阳性淋巴结或原发性癌症进展期的女性。目前，乳房切除术后放疗对有一至三个阳性淋巴结患者的作用仍不确定，应在随机对照试验中进行检验。个体患者对辅助治疗风险和益处的重视程度各不相同。需要在选定的随机临床试验中评估生活质量，以检查辅助治疗的主要急性和长期副作用的影响，特别是过早绝经、体重增加、轻度记忆力减退和疲劳。在试验中，支持患者与其医生之间共同决策的方法已取得成功；需要针对不同人群进行调整，并应进行测试以实现更广泛的传播。
