Safety and Feasibility of Using Magnetic Resonance Imaging Criteria to Identify Patients With "Good Prognosis" Rectal Cancer Eligible for Primary Surgery The Phase 2 Nonrandomized QuickSilver Clinical Trial

被引：83

作者：

Kennedy, Erin D. ^{[1
,2
,3
]}

Simunovic, Marko ^{[4
]}

Jhaveri, Kartik ^{[5
,6
]}

Kirsch, Richard ^{[7
]}

Brierley, Jim ^{[8
,9
]}

Drolet, Sebastien ^{[10
]}

Brown, Carl ^{[11
]}

Vos, Patrick M. ^{[12
]}

Xiong, Wei ^{[13
]}

MacLean, Tony ^{[14
]}

Kanthan, Selliah ^{[15
]}

Stotland, Peter ^{[16
]}

Raphael, Simon ^{[17
]}

Chow, Gil ^{[18
]}

O'Brien, Catherine A. ^{[19
]}

Cho, Charles ^{[20
]}

Streutker, Cathy ^{[21
]}

Wong, Raimond ^{[22
]}

Schmocker, Selina ^{[1
]}

Liberman, Sender ^{[23
]}

Reinhold, Caroline ^{[24
]}

Kopek, Neil ^{[25
]}

Marcus, Victoria ^{[26
]}

Bouchard, Alexandre ^{[27
]}

Lavoie, Caroline ^{[28
]}

Morin, Stanislas ^{[29
]}

Perigny, Martine ^{[30
]}

Wright, Ann ^{[10
]}

Neumann, Katerina ^{[31
]}

Clarke, Sharon ^{[32
]}

Patil, Nikhilesh G. ^{[33
]}

Arnason, Thomas ^{[34
]}

Williams, Lara ^{[35
]}

McLeod, Robin ^{[2
,3
]}

Brown, Gina ^{[36
]}

Mathieson, Alex ^{[37
]}

Pooni, Amandeep ^{[1
]}

Baxter, Nancy N. ^{[2
,3
,38
,39
]}

机构：

[1] Mt Sinai Hosp, Div Gen Surg, Dept Surg, Toronto, ON, Canada

[2] Univ Toronto, Dept Surg, Toronto, ON, Canada

[3] Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada

[4] McMaster Univ, Fac Hlth Sci, Dept Surg, Hamilton, ON, Canada

[5] Univ Hlth Network, Mt Sinai Hosp, Joint Dept Med Imaging, Toronto, ON, Canada

[6] Univ Toronto, Womens Coll Hosp, Toronto, ON, Canada

[7] Mt Sinai Hosp, Dept Pathol & Lab Med, Toronto, ON, Canada

[8] Princess Margaret Canc Ctr, Dept Radiat Oncol, Toronto, ON, Canada

[9] Univ Toronto, Dept Radiat Oncol, Toronto, ON, Canada

[10] Laval Univ, Dept Surg, Ctr Hosp Univ CHU Quebec, Quebec City, PQ, Canada

[11] St Pauls Hosp, Providence Hlth Care, Dept Surg, Vancouver, BC, Canada

[12] St Pauls Hosp, Providence Hlth Care, Dept Radiol, Vancouver, BC, Canada

[13] St Pauls Hosp, Dept Pathol & Lab Med, Vancouver, BC, Canada

[14] Univ Calgary, Foothills Med Ctr, Dept Surg, Calgary, AB, Canada

[15] Univ Saskatchewan, Dept Surg, Saskatoon, SK, Canada

[16] North York Gen Hosp, Dept Surg, Toronto, ON, Canada

[17] North York Gen Hosp, Dept Pathol & Lab Med, Toronto, ON, Canada

[18] North York Gen Hosp, Dept Med Imaging, Toronto, ON, Canada

[19] Univ Hlth Network, Dept Surg, Toronto, ON, Canada

[20] Southlake Reg Hlth Ctr, Dept Radiat Oncol, Newmarket, ON, Canada

[21] St Michaels Hosp, Dept Pathol & Lab Med, Toronto, ON, Canada

[22] McMaster Univ, Juravinski Canc Ctr, Dept Radiat Oncol, Hamilton, ON, Canada

[23] MUHC, Dept Surg, Montreal Gen Hosp, Montreal, PQ, Canada

[24] MUHC, Dept Diagnost Radiol, Montreal Gen Hosp, Montreal, PQ, Canada

[25] MUHC, Dept Radiat Oncol, Montreal Gen Hosp, Montreal, PQ, Canada

[26] MUHC, Dept Pathol & Lab Med, Montreal Gen Hosp, Montreal, PQ, Canada

[27] Laval Univ, CHU Quebec, Dept Surg, Quebec City, PQ, Canada

[28] Laval Univ, CHU Quebec, Dept Radiat Oncol, Quebec City, PQ, Canada

[29] Laval Univ, CHU Quebec, Dept Med Imaging, Quebec City, PQ, Canada

[30] Laval Univ, CHU Quebec, Dept Pathol & Lab Med, Quebec City, PQ, Canada

[31] Queen Elizabeth 2 Hlth Sci Ctr, Dept Surg, Halifax, NS, Canada

[32] Queen Elizabeth 2 Hlth Sci Ctr, Dept Diagnost Radiol, Halifax, NS, Canada

[33] Queen Elizabeth 2 Hlth Sci Ctr, Dept Radiat Oncol, Halifax, NS, Canada

[34] Queen Elizabeth 2 Hlth Sci Ctr, Dept Pathol & Lab Med, Halifax, NS, Canada

[35] Ottawa Hosp, Dept Surg, Ottawa, ON, Canada

[36] Natl Hlth Serv NHS Fdn Trust, Royal Marsden Hosp, Dept Radiol, Surrey, England

[37] Mem Univ, Dept Surg, Eastern Hlth Author, St John, NF, Canada

[38] St Michaels Hosp, Div Gen Surg, Li Ka Shing Knowledge Inst, Toronto, ON, Canada

[39] Sunnybrook Hlth Sci Ctr, Inst Clin Evaluat Sci, Toronto, ON, Canada

来源：

JAMA ONCOLOGY | 2019年 / 5卷 / 07期

关键词：

COURSE PREOPERATIVE RADIOTHERAPY; TOTAL MESORECTAL EXCISION; QUALITY-OF-LIFE; POSTOPERATIVE CHEMORADIOTHERAPY; MRC CR07; PREFERENCES; CHEMORADIATION; MULTICENTER; THERAPY; IMPACT;

D O I：

10.1001/jamaoncol.2019.0186

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

IMPORTANCE Chemoradiotherapy (CRT), followed by surgery, is the recommended approach for stage II and III rectal cancer. While CRT decreases the risk of local recurrence, it does not improve survival and leads to poorer functional outcomes than surgery alone. Therefore, new approaches to better select patients for CRT are important. OBJECTIVE To conduct a phase 2 study to evaluate the safety and feasibility of using magnetic resonance imaging (MRI) criteria to select patients with "good prognosis" rectal tumors for primary surgery. DESIGN, SETTING, AND PARTICIPANTS Prospective nonrandomized phase 2 study at 12 high-volume colorectal surgery centers across Canada. From September 30, 2014, to October 21, 2016, a total of 82 patients were recruited for the study. Participants were patients newly diagnosed as having rectal cancer with MRI-predicted good prognosis rectal cancer. The MRI criteria for good prognosis tumors included distance to the mesorectal fascia greater than 1 mm; definite T2, T2/early T3, or definite T3 with less than 5 mm of extramural depth of invasion; and absent or equivocal extramural venous invasion. INTERVENTIONS Patients with rectal cancer with MRI-predicted good prognosis tumors underwent primary surgery. MAIN OUTCOMES AND MEASURES The primary outcome was the proportion of patients with a positive circumferential resection margin (CRM) rate. Assuming a 10% baseline probability of a positive CRM, a sample size of 75 was estimated to yield a 95% CI of +/- 6.7%. RESULTS Eighty-two patients (74% male) participated in the study. The median age at the time of surgery was 66 years (range, 37-89 years). Based on MRI, most tumors were midrectal (65% [n = 53]), T2/early T3 (60% [n = 49]), with no suspicious lymph nodes (63% [n = 52]). On final pathology, 91% (n = 75) of tumors were T2 or greater, 29% (n = 24) were node positive, and 59% (n = 48) were stage II or III. The positive CRM rate was 4 of 82 (4.9%; 95% CI, 0.2%-9.6%). CONCLUSIONS AND RELEVANCE The use of MRI criteria to select patients with good prognosis rectal cancer for primary surgery results in a low rate of positive CRM and suggests that CRT may not be necessary for all patients with stage II and III rectal cancer.

引用

页码：961 / 966

页数：6

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