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Non-operative Management Following Concurrent Chemoradiotherapy for Rectal Cancer

同步化放療後於直腸癌患者之非手術治療

摘要


Purpose. Neoadjuvant chemoradiotherapy combined with total mesorectal excision has become the standard of care for most rectal cancers. A clinically complete response may develop following concurrent chemoradiotherapy. The potential clinical effectiveness of non-operative management is highlighted by pathologic response rates from neoadjuvant trials. This is of concern for elderly patients and for those with significant medical comorbidities. Another potential concern is the perceived reduction in quality of life with a permanent stoma. Therefore, we performed a retrospective study to evaluate the results of non-operative management after chemoradiotherapy, especially in clinically incomplete response patients with non-operative management. Methods. Patients with stage II or III rectal cancer, treated between January 1, 2009 and December 31, 2017, were included in a retrospective study. Clinical data were acquired from computer databases and information concerning survival from the outpatient department follow-up and/or telephone questionnaire. Patients with nonmetastatic rectal cancer treated by neoadjuvant chemoradiation therapy, including 50.4 Gy and concomitant 5-fluorouracil and leucovorin or capecitabine, were assessed for tumor response six to eight weeks after chemoradiation therapy completion. Complete and incomplete clinical responses were defined based on clinical, image and endoscopic findings. After fully informed the patient and families about the risk of non-operative management, both groups of patients have adopted the policy of no surgery with a surveillance program. Results. Ten of 20 patients experienced a clinically complete response at initial assessment after chemoradiotherapy (50%). Median follow-up time was 38.2 months. Two patients (20%) experienced local recurrence (median recurrence time, 20.0 months). Two patients (20%) experienced systemic recurrence. (median recurrence time, 8.0 months). By contrast, patients that experienced a clinically incomplete response had higher systemic recurrence (40%, median recurrence time, 11.0 months). Conclusion. The local recurrence rate in clinically complete response patients is similar to previous study. The optimal tools and follow-up interval for assessing a clinically complete response remain to be determined. Although non-operative management is a promising, innovative approach in previous study, it should not be adopted into routine care until it has been proven to be an equivalent or superior treatment approach in multicenter prospective clinical trials.

並列摘要


目的:術前化放療合併全直腸系膜切除術已成為大多數直腸癌的治療標準。同步放化療後可能會出現完全臨床反應。術前化放療後的病理反應率突顯了非手術治療的潛在臨床效果。因此我們進行了一項回顧性研究,以評估同步放化療後非手術治療的結果,尤其是針對不完全臨床反應的患者。方法:本文為一項回顧性研究,包含2009年1月1日至2017年12月31日期間接受治療的II期或III期直腸癌患者。從醫院資料庫中獲取臨床數據,並從門診追蹤及電話調查中獲取生存率的訊息。在術前化放療完成8週後,對接受術前化放療(包括放射治療劑量50.4 Gy和伴隨的5-fluorouracil和leucovorin或capecitabine)治療的非轉移性直腸癌患者的腫瘤反應進行評估。根據臨床、影像和內視鏡檢查結果確定臨床反應。在充分告知病患惡性腫瘤progress的風險後,病患仍以門診理學檢查、大腸鏡及影像學密切追蹤。結果:20名患者中有10名在化放療後的初始評估中經歷了完全臨床反應(50%)。追蹤時間的平均數為38.2個月。2名患者(20%)經歷了局部復發(平均復發時間為20.0個月)。2名患者(20%)出現全身性復發(平均復發時間為8.0個月)。相比之下,不完全臨床反應的患者有更高的全身復發率(40%,平均複發時間為11.0個月)。結論:完全臨床反應患者的局部復發率與以前的研究相似。評估完全臨床反應的最佳工具和回診時間間隔尚待確定。儘管在之前的研究中非手術治療是一種有前途的創新方法,但除非在多中心前瞻性臨床試驗中被證明是等效或優越的治療方法,否則不應將其用於常規治療。

參考文獻


Benson, A.B., et al., Rectal cancer. Journal of the National Comprehensive Cancer Network, 2012. 10(12): p. 1528-1564.
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