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乳腺导管原位癌的临床试验

Clinical Trials for Ductal Carcinoma In Situ of the Breast.

作者信息

Han Michelle S, Khan Seema A

机构信息

Department of Surgery, Northwestern University, 250 E. Superior Street, Suite 4-420, Chicago, IL, 60611, USA.

Prentice Women's Hospital, Northwestern University, 250 E. Superior Street, Suite 4-420, Chicago, IL, 60611, USA.

出版信息

J Mammary Gland Biol Neoplasia. 2018 Dec;23(4):293-301. doi: 10.1007/s10911-018-9413-3. Epub 2018 Sep 11.

Abstract

Ductal carcinoma in situ (DCIS) of the breast is a non-obligatory precursor to invasive breast carcinoma, with a variable natural history and biological potential for progression to invasive disease. Over the past 30 years, clinical trials have applied the therapeutic principles used for invasive carcinoma to treat DCIS (surgery, with or without breast radiotherapy, and post-operative endocrine therapy), with excellent survival outcomes, and in-breast recurrence rates that range from 0.5 to 1% annually. However, half of such recurrences are again in-situ lesions, and intensive therapy is likely not necessary for all patients. Current clinical research is focused on a better characterization of the potential of individual lesions to progress to invasive disease, and to identify women who would do well with lesser treatment. Three ongoing trials in the United States and Europe randomize women to active surveillance (with or without endocrine therapy) versus usual treatment with surgery and radiotherapy. The use of pre-operative endocrine therapy has been evaluated in a recently completed trial of letrozole use in postmenopausal women with DCIS; and in on-going trials of tamoxifen, used either orally, or as a 4-hydroxytamoxifen gel formulation for application to the breast skin. This review summaries the major past and current clinical trials of DCIS, and the likely trajectories of DCIS management in the near future.

摘要

乳腺导管原位癌(DCIS)是浸润性乳腺癌的一种非必然前驱病变,其自然病程多变,进展为浸润性疾病的生物学潜能各异。在过去30年里,临床试验已将用于浸润性癌的治疗原则应用于DCIS的治疗(手术,联合或不联合乳腺放疗,以及术后内分泌治疗),取得了出色的生存结果,且乳腺内复发率为每年0.5%至1%。然而,此类复发中有一半再次为原位病变,并非所有患者都可能需要强化治疗。当前的临床研究聚焦于更好地描述个体病变进展为浸润性疾病的潜能,并识别那些接受较少治疗就能取得良好效果的女性。美国和欧洲正在进行的三项试验将女性随机分为主动监测(联合或不联合内分泌治疗)与手术及放疗的常规治疗组。术前内分泌治疗的应用已在一项最近完成的来曲唑用于绝经后DCIS女性的试验中得到评估;同时也在进行关于他莫昔芬的试验,他莫昔芬既可以口服,也可以制成4-羟基他莫昔芬凝胶制剂用于乳腺皮肤涂抹。本综述总结了DCIS过去和当前的主要临床试验,以及DCIS管理在不久的将来可能的发展方向。

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