直肠癌新辅助治疗后原发肿瘤病理完全缓解者的外科治疗

Surgical management of patients with pathologic complete response in the primary tumor after neoadjuvant chemotherapy for rectal cancer

目的：总结中、低位直肠癌新辅助治疗后原发肿瘤达病理完全缓解（ pCR）者的临床病理特点，探讨合理的治疗措施。方法回顾性分析1994年1月至2013年12月间，中国医学科学院肿瘤医院收治的局部晚期中、低位直肠癌经新辅助治疗后原发肿瘤达pCR的52例患者的临床资料，患者术前临床分期为Ⅱ期（ cT3～4N0期）10例，Ⅲ期（ cT3～4N＋期）42例。新辅助治疗后，临床完全缓解（cCR）10例（19．2％）。结果51例患者接受根治性手术，其中5例（9．8％）病理证实淋巴结内仍可见转移癌；1例cCR患者行经肛门局部切除术。全组患者术后并发症的发生率为21．2％。中位随访时间为23．6个月，随访期间仅1例患者出现骨转移，1例患者影像学发现肠系膜及腹膜后淋巴结肿大，无肿瘤特异性死亡病例。全组患者的2年无病生存率和总生存率分别为96．2％和100％。结论根治性手术是直肠癌新辅助治疗后pCR患者的主要治疗手段。局部切除或临床单纯观察需十分谨慎，目前仅适合于患者身体条件无法耐受根治性手术或保肛意愿强烈、拒绝根治性手术以及在临床试验中进行。

Objective To summarize and analyze the clinicopathological features and surgical management of patients with pathologic complete response （ pCR ） in the primary tumor after neoadjuvant chemotherapy for rectal cancer, and to explore the rational treatment of this entity. Methods Clinical data of fifty-two patients with locally advanced mid-low rectal cancer admitted to the Cancer Institute and Hospital, Chinese Academy of Medical Sciences from January 1994 to December 2013 were retrospectively analyzed. They were treated with neoadjuvant chemotherapy and achieved pathological complete response in the primary tumor. The preoperative clinical staging were stage Ⅱ （ cT3~4N0） in 10 cases and stage Ⅲ（ cT3~4N＋） in 42 cases. After the neoadjuvant therapy, 10 cases achieved clinical complete response （cCR） （19.2%）. Results Radical surgery was performed in 51 patients. Among them, five patients （9.8%） had pathological lymph node metastasis. One cCR patient underwent transanal local excision. The postoperative complication rate was 21. 2%. During a median follow-up of 23. 6 months, only one patient developed bone metastasis and another one had enlarged mesenteric and retroperitoneal lymph nodes detected by imaging.All the patients were alive by the last follow-up. The 2-year disease-free survival rate was 96.2%and overall survival rate was 100%. Conclusions Radical surgery remains the standard therapy for cCR patients with rectal cancer after neoadjuvant chemotherapy. Local excision and “wait and see” should be recommended with great caution and limited to patients who cannot tolerate or refuse radical surgery with a strong demanding for sphincter saving, or applied in clinical trials.