[ASCO-GI 2015]直肠癌不再需要手术治疗?—J. J. Smith博士访谈

作者:  J.J.Smith   日期:2015/1/21 15:20:40  浏览量:28831

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编者按:2015胃肠癌症研讨会1月17日下午的日程中,Jesse Joshua Smith 博士就“直肠癌辅助治疗后临床完全缓解的患者观察等待/非手术治疗”的研究做口头报告。报告结束后,《肿瘤瞭望》前方记者就这一议题采访了Smith 博士。

  “直肠癌患者新辅助治疗后密切观察等待或直肠手术的回顾性分析结果(摘要509)”显示,I-III期直肠癌患者在辅助治疗后获得了临床完全缓解(cCR),不立即行直肠手术,而是采取“观察和等待”的方法可使一部分患者达到良好的效果。

 

  研究速览

 

  在73例未手术的患者中,54例(74%)患者的肿瘤缩小,最终没有行直肠手术,而19例(26%)患者肿瘤再次生长,但这种肿瘤再生是可管理的,2人局部切除后保留了直肠,其余17例患者接受了直肠切除术。对照组的72例患者接受标准直肠手术,获得了病理完全缓解(PCR)。

 

  非手术管理组(NOM)四年总生存期的概率为91%,手术组为95%,非手术组有6例患者死于癌症,手术组是4例患者,差异没有统计学意义(P=0.4713)。两组的远处复发率也差不多。数据表明NOM方法并不会降低治疗效果,且大多数患者能保留直肠。特定疾病相关的生存差异也没有统计学意义(P=0.2374)。不行直肠手术可以显著提高患者的生活质量,减少肠道受损和降低性功能的风险。

 

  J. J. Smith博士访谈

 

  研究中以何标准选择“观察与等待”/非手术方法治疗的患者?患者需要接受新辅助化疗,然后对其进行临床评估,一般采用直肠指检(DRE)、MRI成像等方法。

 

  非手术治疗组的效果如何?

 

  在辅助放化疗结束后,患者获得了临床完全缓解,对于那些不行肛门切除术保留器官的患者,他们的治疗效果能比得上行标准直肠手术的患者吗?

 

  在4年总生存期两组的结果是一样的。非手术组中,74%的患者肿瘤没有再次生长,26%的患者肿瘤再生长,这些的重新生长的肿瘤手术治疗后获得了良好效果。而在标准手术组,根治性的直肠切除术会导致手术并发症,比如性功能障碍和肛门功能障碍,显著影响患者的生存质量。但是,数据表明,手术组的患者新辅助治疗后达到临床完全缓解(pCR),然后进行标准的手术切除,患者获得病理完全缓解,样本里没有发现肿瘤细胞。

 

  非手术治疗的长期安全性?

 

  研究的数据证明新辅助治疗后非手术治疗的良好效果。但是还需要进一步的试验证明,在下一项的临床研究中,患者将被随机分配到不同的新辅助化疗方案组,在患者达到临床完全缓解后,对这部分患者密切观察不进行手术切除,这项试验将证明非手术的方法长期安全性。

 

  患者接受新辅助治疗后获得临床完全缓解,那么cCR能否可以准确地预测pCR?在手术组,一些临床完全缓解的患者手术后,没有发现肿瘤细胞,所以cCR和pCR之间存在相关性。

 

访谈原文

 

  Oncology Frontier: Dr. Smith, What are the standards by which patients are selected for “watch-and-wait” or non-operative approach?

 

  《肿瘤瞭望》:史密斯博士,您以何标准选择“观察与等待”/非手术方法治疗的患者?

 

  J. J. Smith: So they have to end the Chemotherapy and then evaluate it, clinically with the digital?rectal exam (DRE). In addition, the imaging (usually that is an MRI) could be used to find   rectal tumor in different places, but there are institutionally MRI adopted after digital?rectal exam.

 

  Smith博士:患者需要接受新辅助化疗,然后对其进行临床评估,一般采用直肠指检(DRE)、MRI成像等方法。

 

  Oncology FrontierAccording to your study, after achieving a complete clinical response with chemoradiation alone, whether the oncologic outcomes for patients who preserve their organ are comparable to ones undergo standard rectal surgery?

 

  《肿瘤瞭望》:根据您的研究,在辅助放化疗结束后,患者获得了临床完全缓解,对于那些不行肛门切除术保留器官的患者,他们的治疗效果能比得上行标准直肠手术的患者吗?

 

  J. J. Smith: Yes, we found no difference in overall survival, 4 years, compared non-operation arm with the pathologic complete response (pCR) of the patient undergone rectal resection. I think it the patient are able to achieve clinical complete response with careful and form consent, they agree between the non surgery option and the patients (74%) could preserve the organ safely, even there a local tumor re-growth (26%), those patients (we saw 26% patients have local tumor re-growth) could be savaged safely with the surgery operation which was total mesorectal excision (TME), All cases, and that seems to be safe, the OS was no different. There are still significant morbidities with rectal surgery. Because there data suggest people who achieve clinical complete response(cCR)and then undergo resection , there are no tumor cells found in the specimen.

 

  There is an argument the patients truly have robust response, tumor disappears, can be observed was the morbidity which include the sexual dysfunction and anal dysfunction, if there is low tumor sometimes they have to adopt pioneer resection, in addition some of the rectal surgery(like low entire resection) they still preserve may have to develop morbidity. So that is significant apact on patients in all their life.

 

  Smith博士:是的,在4年总生存期两组的结果是一样的。非手术组74%患者的肿瘤没有再次生长,26%的患者肿瘤再生长,这些的重新生长的肿瘤手术后获得了良好效果。而在标准手术组,根治性的直肠切除术会导致手术并发症,比如性功能障碍和肛门功能障碍,显著影响患者的生存质量。数据表明,手术组的患者新辅助治疗后达到临床完全缓解,然后进行标准的手术切除,患者获得病理完全缓解,样本里没有发现肿瘤细胞。

 

  Oncology FrontierIs your new line of thinking universally embraced?

 

  《肿瘤瞭望》:你的新的思路已经普遍接受吗?

 

  J. J. Smith: Look at the data carefully, I think this data suggest it is a promising approach .but we need prospect trial to confirm the finding. The next step we actually a trial which is more dense to show trial, patients will be randomized to different new adjuvant?chemotherapy regimens and assess them. If they have cCR, they can be managed none operative section. I think that will answer whether it is safe for long term.

 

  Smith博士:研究的数据证明新辅助治疗后非手术治疗良好效果。但是还需要进一步的试验证明,在下一项的临床研究中,患者将被随机分配到不同的新辅助化疗方案组,在患者达到临床完全缓解后,对这部分患者密切观察不进行手术切除,这项试验将证明非手术的方法长期安全性。

 

  Oncology FrontierFor patients underwent neoadjuvant therapy, does clinical complete response(cCR)can accurately predict pathologic complete response (pCR)?

 

  《肿瘤瞭望》:患者接受新辅助治疗后获得临床完全缓解,那么cCR能否可以准确地预测PCR?

 

  J. J. Smith: as I mentioned, there some patients that achieve cCR undergone resection and no tumor cell was found, so there is correlation between cCR and pCR.

 

 

  Smith博士:研究中,在手术组,一些临床完全缓解的患者手术后,没有发现肿瘤细胞,所以cCR和pCR之间存在相关性。

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直肠癌手术治疗直肠癌新辅助治疗2015胃肠癌症研讨会ASCO GI 2015

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