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对绝经后早期乳腺癌女性进行减肥干预

 SIBCS 2020-08-27

  肥胖与乳腺癌结局不良密切相关。

  2020年2月21日,美国乳腺癌研究基金会、英国《自然》旗下《乳腺癌》在线发表加拿大多伦多大学、西奈山医院、渥太华大学、渥太华医院、麦克马斯特大学、朱拉文斯基医院、蒙特利尔大学、戴尔豪斯大学、美国哈佛大学医学院、达纳法伯癌症研究所、华盛顿大学医学院的LISA研究报告,对术后标准化体重减轻生活方式电话干预能否影响乳腺癌结局进行了调查。该研究由安大略临床肿瘤学协作组发起,由诺华提供资助。

  • LISA: Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer (NCT00463489)

  • SPONSOR: Ontario Clinical Oncology Group (OCOG)

  • COLLABORATOR: Novartis Pharmaceuticals

  该多中心随机对照三期临床研究计划于2007年8月~2009年12月从美国和加拿大12家医院入组体重指数≥24kg/m²的早期(T1-3、N0-3、M0)激素受体阳性乳腺癌术后来曲唑辅助治疗女性,按1∶1的比例随机分为两组:对照组单纯邮寄教学材料,干预组通过2年内19次电话进行标准化饮食、体力活动、行为等生活方式干预,以实现体重减轻10%。通过生存曲线,对主要结局无病生存和次要结局总体生存进行比较。

  结果,原计划入组2150例,由于诺华中途停止提供资助,故仅入组338例。其中,生活方式干预组171例、对照组167例。两组患者入组时体重指数以及其他特征相似。

  经过中位8年随访,干预组与对照组相比:

  • 半年体重减轻:5.3%比0.6%

  • 一年体重减轻:5.5%比0.6%

  • 两年体重减轻:3.7%比0.4%

  • 发病死亡人数:22例比30例

  • 发病死亡比例:12.9%比18.0%

  • 发病死亡风险:0.71(95%置信区间:0.41~1.24,P=0.23)

  • 全因死亡人数:9例比10例

  • 全因死亡比例:5.3%比6.0%

  • 全因死亡风险:0.86(95%置信区间:0.35~2.14,P=0.74)

  因此,该研究结果表明,虽然诺华中途停止提供资助减少了样本量,但是与生活方式干预对无病生存潜在有益影响的假设相符,为完成正在进行的生活方式干预影响乳腺癌结局随机对照研究提供了证据。

NPJ Breast Cancer. 2020 Feb 21. [Epub ahead of print]

The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer.

Pamela J. Goodwin, Roanne J. Segal, Michael Vallis, Jennifer A. Ligibel, Gregory R. Pond, André Robidoux, Brian Findlay, Julie R. Gralow, Som D. Mukherjee, Mark Levine, Kathleen I. Pritchard.

University of Toronto, Toronto, ON, Canada; University of Ottawa, Ottawa, ON, Canada; McMaster University, Hamilton, ON, Canada; Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada; Dalhousie University, Halifax, NS, Canada; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA; University of Washington School of Medicine, Seattle, WA, USA.

Obesity has been associated with poor breast cancer (BC) outcomes. We investigated whether a standardized, telephone-based weight loss lifestyle intervention in the adjuvant setting would impact BC outcomes. We conducted a multicenter trial randomizing women 1:1 to mail-based educational material alone (control) or combined with a standardized, telephone-based lifestyle intervention that focused on diet, physical activity, and behavior and involved 19 calls over 2 years to achieve up to 10% weight loss. In all, 338 (of 2150 planned) T1-3, N0-3, M0 hormone receptor positive BC patients with body mass index (BMI)≥24kg/m² receiving adjuvant letrozole were randomized (enrolment ended due to funding loss). The primary outcome was disease-free survival (DFS); secondary outcome was Overall Survival (OS). At 8 years' median follow-up, in a planned analysis, DFS and OS were compared using the Kaplan-Meier method. Baseline BMI and other characteristics were similar between study arms. In all, 22 of 171 (12.9%) in the lifestyle intervention arm versus 30 of 167 (18.0%) in the education had DFS events; the hazard ratio (HR) was 0.71 (95% confidence interval [CI]: 0.41-1.24, p=0.23). Although loss of funding reduced sample size, we view these hypothesis generating results as compatible with our hypothesis of a potential beneficial effect of a lifestyle intervention on DFS. They provide support for completion of ongoing randomized controlled trials of the effect of lifestyle interventions in BC outcomes.

DOI: 10.1038/s41523-020-0149-z


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