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乳腺癌新辅助化疗的前世与今生

2018-01-27 曹守波 肿瘤资讯

新辅助化疗可以使乳腺癌患者获得快速的病理缓解,其在世界范围内的应用逐年增加。越来越多的证据表明,新辅助化疗与较高的局部复发率密切相关,并且未有明确证据表明其能给患者带来生存获益,这也使得专家们重新考虑新辅助化疗在乳腺癌治疗中的地位,最新的研究对这一问题进行了详细解读,相关研究发表在BMJ杂志。

新辅助化疗可以使乳腺癌患者获得快速的病理缓解,其在世界范围内的应用逐年增加。越来越多的证据表明,新辅助化疗与较高的局部复发率密切相关,并且未有明确证据表明其能给患者带来生存获益,这也使得专家们重新考虑新辅助化疗在乳腺癌治疗中的地位,最新的研究对这一问题进行了详细解读,相关研究发表在BMJ杂志。

乳腺癌是女性最常见的恶性肿瘤,在2014年,英国女性中新发和死亡的乳腺癌患者分别为55000和11000例,而早期乳腺癌的传统治疗方式包括手术、放疗和全身化疗。新辅助化疗作为乳腺癌的一种新的治疗方式开始于20世纪末,其主要目的是缩小肿瘤的体积。它主要有以下4方面优势:首先,它可以使不可切除的肿瘤变为可切除;其次,增加保乳的机会;对于局部晚期并发高远处转移风险的患者,术前全身治疗被期望可以改善患者的生存时间;新辅助化疗可以观察到肿瘤的缩小和成像变化,并且能够对临床疗效进行快速评价。此外,新辅助化疗还有助于检测新药在体内的有效率,而这些药物有可能被用作辅助治疗。

最新一项多中心调查研究显示,约有7-27%新发乳腺癌患者会接受新辅助化疗,按照全世界范围每年新发乳腺癌170万例计算,接受新辅助化疗的乳腺癌患者会有12-46万。尽管数据支持新辅助化疗可以使患者获得快速缓解,然而新辅助化疗后的保乳手术会导致更高的局部复发率,即使在早期应用全身治疗的情况下,新辅助化疗也并未给患者带来更多的生存获益。尽管原发肿瘤反应是评价某种特殊治疗方式对预后影响的重要指标,而在评价新型化疗方案时,它却很难真实反映患者的总体生存获益情况。因此,新辅助化疗对新化疗方案检测的帮助也非常有限。对于40-80%的患者而言,新辅助化疗延长了肿瘤在乳房的停留时间,也会使手术更难,因为化疗后肿瘤不易触及,腋窝淋巴结也相对不明显。本文将从以下五点对新辅助化疗进行详细阐述。

1. 缩小瘤体,使手术成为可能

当乳腺癌患者表现为肿块较大、技术上很难切除时,新辅助化疗可以缩小肿块的体积,使得手术成为可能。然而,这些患者中许多都伴有远处转移,对于该类患者,手术的目的仅仅是控制症状,因为它能加重患者的无远处转移生存时间,这是新辅助化疗的一个罕见指证。

2. 保乳,局部复发和总生存

对比新辅助化疗和辅助化疗疗效的临床试验发现,二者对于患者生存获益情况的改善并无明显差异。在接受新辅助化疗后,仅有16.6%的乳腺癌患者可以最终从乳房切除术转变为保乳手术,但是这些患者的局部复发率明显更高,而这一结果在一项纳入超过4500例乳腺癌患者的meta分析中也得到证实。另外,即使是在高强度化疗 (紫杉醇和蒽环类药物) 的情况下,保乳率也仅仅提高了29%。

3. 新辅助化疗与辅助化疗

新辅助化疗使得体内评估患者的临床疗效成为可能,而这主要是依赖于一项假设,即原发肿瘤的特征和生物学行为可以提示转移发生的可能,新辅助化疗的疗效可以预测术后辅助化疗的疗效。而最近的临床试验结果对这一假设提出了挑战。

首先,病理完全缓解是指无肉眼可见的残余肿瘤细胞,而传统的病理学很难做到检测所有可视细胞。随机试验数据显示,即使有明显的病理完全缓解,原始瘤床未完全切除也会导致局部复发率增高。其次,尽管在某些研究中,病理完全缓解可以作为评价患者预后的一个指标,而它作为评价不同治疗方案乳腺癌预后的指标还有待商榷。比如,Cortazar等人发现,病理完全缓解发生率的升高并未改善患者的总生存时间。

此外,如果原发肿瘤与转移生物学行为相似的话,在新辅助化疗过程疗效评价为病理完全缓解的患者在术后辅助阶段也应该会有类似的临床疗效。如果是这样的话,这些患者的预后应该更好,因为在术后辅助化疗阶段他们的肿瘤负荷更小。目前,新靶向药物的临床实验越来越多地在新辅助治疗中开展,如果它们不能达到改善患者病理完全缓解的目的,他们很有可能就会被弃用。这种做法是不对的,因为这些药物可能仅在术后辅助治疗阶段给患者带来生存获益,这时候的肿瘤负荷相对较小。例如,在新辅助治疗阶段,相比于雌激素受体阴性的患者,trastuzumab对受体阳性患者获益程度更小,然而在辅助治疗阶段,trastuzumab对受体阴性和阳性患者的获益情况并无明显差别。如果辅助治疗的研究结果并未在第一时间公布,很有可能会把受体阳性的患者剔除掉,使得他们不能从trastuzumab辅助治疗获益。

最后,目前对病理完全缓解的解释可能存在缺陷,明显的是,新辅助化疗后的组织病理学评估往往与患者临床预后和生物学行为相关程度小。随着影像学和病理技术的提高,有助于识别隐匿的肿瘤细胞,进而对病理完全缓解进行重新定义。

4. 较大体积肿瘤在患者体内停留的时间

即使是在最好新辅助化疗药物治疗的情况下,病理完全缓解率仅为39%,部分缓解和疾病稳定的可达48%,12%患者对治疗并无反应。根据RECIST标准,疾病稳定允许患者肿瘤最大径增幅小于20%,而在最佳治疗的情况下,仍有60%患者将会携带高度恶性化疗耐药细胞而继续存活。即使是最终产生病理完全缓解的患者,较大的瘤体也会在完全缓解之前继续在体内存留数月,这也可能会导致额外的手术延迟。

5. 新辅助化疗很难使手术切除更为精细

新辅助化疗后,软组织和弥漫的残余肿瘤之间缺乏清晰的边界,这会降低局部手术切除的精确度,这也可能是局部复发率增高的原因之一。另外一方面,如果患者首先接受手术治疗的话,多数情况下,肿瘤可以立马被切除,由于医生可以触及瘤体边缘,也使得手术变得相对简单。

点评

由于新的临床试验数据与目前广泛使用的新辅助化疗的临床实践相矛盾,使得我们不得不重新思考新辅助化疗在乳腺癌治疗中的角色。新辅助化疗仅适用于适合保乳边缘以及有可能对新辅助化疗产生疗效的肿瘤患者。即使在这样的情况下,也应该与患者共同决定,交代清楚包括缺乏生存获益以及更高的局部复发风险在内的所有优缺点以及不确定性。

原始出处:

Rethinking neoadjuvant chemotherapy for breast cancer.
http://www.bmj.com/content/360/bmj.j5913

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    2018-02-12 天涯183

    非常好的文章.学习了.很收益

    0

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    2018-02-04 天涯183

    非常好的文章.学习了

    0

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    2018-01-30 三生有幸9135

    学习一下谢谢分享

    0

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    2018-01-28 秀红

    太全了

    0

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    2018-01-28 飛歌

    学习了很有用不错

    0

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    2018-01-27 有备才能无患

    新辅助化疗可以使乳腺癌患者获得快速的病理缓解.其在世界范围内的应用逐年增加.越来越多的证据表明.新辅助化疗与较高的局部复发率密切相关.并且未有明确证据表明其能给患者带来生存获益.这也使得专家们重新考虑新辅助化疗在乳腺癌治疗中的地位.最新的研究对这一问题进行了详细解读.相关研究发表在BMJ杂志.

    0

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    2018-01-27 天涯183

    非常好的文章.学习了

    0

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