突破性研究!NEJM、ASCO同时发布:约70%的常见乳腺癌不需要化疗
2018/06/07
化疗是很多癌症患者需要经历的考验,虽然很大程度上能够预防癌转移和复发,但是却面临着包括脱发、呕吐等在内的毒副作用。近日,《New England Journal of Medicine》期刊发表了一项具有里程碑意义的研究,让大家重新思考“癌症患者是否需要接受化疗”这一选择题。数据显示,基于肿瘤基因测序,大多数最常见的早期乳腺癌患者可以不需要化疗过程!


“通过这项研究,约70%的患有最常见乳腺癌类型的病人可以安全地避免痛苦的化疗过程。” 文章作者、芝加哥洛约拉大学Chicago Stritch医学院肿瘤研究系主任、Loyola医学肿瘤学家Kathy Albain表示,“对于多数患者及医生而言,不明确的日子已经一去不复返了。”

这一突破性研究于6月3日在ASCO2018年会上同时公布。


DOI: 10.1056/NEJMoa1804710

基因检测给“肿瘤复发”概率打分

Kathy Albain团队采用一种研究多年的基因检测——21-gene breast cancer assay,囊括患者乳腺肿瘤样本中的21个基因,以确定它们的表达水平。研究人员依据这一检测结果给肿瘤“复发概率”进行0-100的打分。分数越高,癌症复杂的概率越高(患者生存率可能越低)。很显然,得分较高的乳腺癌患者接受化疗,他们的癌症复发风险会显著降低。

在此之前,医生和患者面临的挑战是:如果患者的“复发概率”趋于中间值,该怎么办(接受化疗的益处是否大于它的副作用和毒性)?先前的研究已经表明,10分以下的患者不需要接受化疗,而25分以上的患者则需要接受化疗。

“重新界定”化疗与否

现在,Kathy Albain团队重点分析了大多数处于11-25分的女性患者。

他们共招募了10273名患有常见乳腺癌类型的女性患者(激素受体阳性、HER-2阴性且未扩散至淋巴结),其中有69%(6711)的患者在21-gene测试中取得了11-25分。

这些患者被随机分配接受两种治疗方案:先化疗后激素治疗、仅激素治疗。研究人员会记录患者治疗期间包括无癌、局部复发、远端转移以及整体生存率等指标。

结果显示,对于11-25分的女性患者(尤其是50-75岁),化疗组和未化疗组之间并没有显著差异。对于50岁以下的患者而言,当基因检测分数≤15时,两种治疗方案同样没有明显区别。对于更年轻、基因检测得分在16-25之间的患者,接受化疗的效果比不接受略好。

“这项研究会对病人和医生产生巨大的影响。它会大大增加那些在不影响治疗结果的情况下放弃化疗的患者数量。” Kathy Albain表示道。

责编:艾曼

参考资料:

Landmark study finds more breast cancer patients can safely forgo chemotherapy

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  • Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer

    BACKGROUND The recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score. METHODS We performed a prospective trial involving 10,273 women with hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, axillary node–negative breast cancer. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease–free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death). RESULTS Endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease–free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P=0.26). At 9 years, the two treatment groups had similar rates of invasive disease–free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local–regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease–free survival varied with the combination of recurrence score and age (P=0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25. CONCLUSIONS Adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-receptor–positive, HER2-negative, axillary node–negative breast cancer who had a midrange 21-gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger. (

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