编者按:2017年的ASCO年会上,来自北京大学肿瘤医院顾晋教授团队的研究成果“直肠癌新辅助放化疗后临床完全缓解的等待观察疗法的可行性与安全性”进行了壁报展示(摘要号3610)。该研究是一项开放性、多中心、前瞻性的临床研究,具有较强的临床意义,我们特邀主要研究者顾晋教授为我们详细解读这项临床研究的背景、研究设计、主要结果和临床意义。
The feasibility and efficiency of wait and see policy for patients with
complete clinical response following neoadjuvant therapy in rectal cancer:
A prospective cohort study from China. First Author: Jin Gu, Peking University Cancer Hospital, Beijing, China
Background:?It has been reported that non-operative treatment (wait and see) is feasible for the selected rectal cancer cases with a complete clinical response (cCR) following neoadjuvant therapy (NT). The aim of this study is to determine whether "wait and see" policy is efficient for the cCR patients in China.?Methods:?We designed a prospective cohort study in China (ChiCTR-TRC-12002488). From Jul 2012 to August 2016, totally 45 patients with locally advanced rectal cancer who were cCR following NT were enrolled in the study; within whom, 32 patients were assigned to wait and see group, and the remaining 13 patients were assigned to surgery group (intent-to-treat grouping).?Results:?The median follow-up time was 24 months (range: 3-51). Of the patients who were followed up more than 12 months (n=37), 8 patients developed tumor progression (7 in wait and see group and 1 in surgery group, respectively). In the wait and see group, the local regrowth took an account of 23.1% (6/26), while the distant metastasis rate was 3.8% (1/26). In the surgery group, there were 23.1% (3/13) of patients who has residual cancer confirmed by postoperative pathological assessment. All the patients with tumor regrowth underwent radical surgery and no body died of cancer.?Conclusions:?Wait and see policy has an acceptable safety and efficiency, it may become an alternative treatment for the patients who were cCR following NT. Clinical trial information: ChiCTR-TRC-12002488.
顾晋教授
直肠癌是中国发病率快速上升的恶性肿瘤,严重威胁人民群众的身体健康。低位直肠癌给患者造成的伤害最大,不仅手术的风险高、创伤大,而且手术切除肛门之后还需终身佩戴造口袋,严重影响患者的生活质量。近年来普遍开展的针对中低位直肠癌的新辅助放化疗有效地降低了局部复发率,提高了手术保留肛门的比例,然而放化疗的毒性反应和不良后果也日益显现,保留肛门后排便功能障碍的比例也相当高。低位直肠癌有无可能通过非手术的方法治愈?这是当前国内外学者普遍关注的热点问题。以巴西学者Habr-Gama为首的研究人员发现,约1/4的放化疗后的患者出现临床完全缓解,即肿瘤“消失”,这部分患者即使不作手术复发率也不超过20%,这些发现给直肠癌的治疗带来了新的希望。北京大学肿瘤医院顾晋教授率领的科研团队在国内率先开展了针对低位直肠癌的非手术疗法的研究。
顾晋教授及其团队成员对于经过新辅助放化疗后临床完全缓解的患者,设计了一整套符合中国国情的随诊方案,并且对于肿瘤进展的患者量身定制了个体化的治疗方案。具体地说,如果新辅助放化疗后患者达到了临床完全缓解的标准,则患者有权选择接受根治性手术或者接受等待观察疗法。如果选择等待观察疗法,则严格按照规定的随访间隔长期随访,发现肿瘤进展立即处理。
该研究目前共纳入患者45例,等待观察组32例,手术组13例。经过长期随访,等待观察组局部复发率23.1%,远处转移率3.8%;手术组局部复发率0,远处转移率15.4%;两组患者总体肿瘤进展率相当。该研究目前尚未终止,相信随着更多患者入组以及随访时间的延长,会有更具说服力的结果问世。
课题组证实了该方案的可行性与安全性,肿瘤进展率控制在较低水平,为广大低位直肠癌患者免去了手术的烦恼,保留了肛门和正常排便功能,极大改善了患者的生活质量,相信该研究成果将给多的中国直肠癌患者带来更大的福音。