The TME Trial After a Median Follow-up of 6 Years

Peeters, Koen; Marijnen, Corrie A.M.; Nagtegaal, Irıs D.; Kranenbarg, E. Klein; Putter, Hein; Wiggers, Theo; Rutten, H.J.T.; Påhlman, Lars; Glimelius, Bengt; Leer, J.W.H.; Velde, Cornelis J.H. van de

doi:10.1097/01.sla.0000257358.56863.ce

Cited by 1,027 publications

(253 citation statements)

References 34 publications

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“…The rate of LR after ISR varies from 0% to 22.7%, lower than that after APR (10–57%) for mid or low rectal cancer 27, 31, 67. Neoadjuvant CRT affects the down‐sizing of tumor and down‐staging of disease, and is often used as a standard strategy to avoid a positive CRM and LR in rectal cancer patients 68, 69, 70, 71, 72. However, some questions remain as to whether neoadjuvant CRT should be more widely applied for patients who would undergo ISR.…”

Section: Discussionmentioning

confidence: 99%

“…However, some questions remain as to whether neoadjuvant CRT should be more widely applied for patients who would undergo ISR. CRT is associated with higher surgical complications,68, 69 a negative impact on anal function,45, 70 and sexual disorder,71 and has no clear survival benefit 72. In Japan, preoperative neoadjuvant CRT has not been routinely carried out for resectable T1, T2 and T3 tumors regardless of the presence or absence of lymph node metastasis.…”

Section: Discussionmentioning

confidence: 99%

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Intersphincteric resection for very low rectal cancer: A review of the updated literature

Shirouzu

Murakami

Akagi

2017

Annals of Gastroent Surgery

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Intersphincteric resection (ISR) has rapidly increased worldwide including laparoscopic surgery. However, there are some concerns for the definition of ISR, surgical technique, oncological outcome, anal function, and quality of life (QoL). The aim of the present study is to evaluate those issues. A review of this surgical technique was carried out by searching English language literature of the PubMed online database and appropriate articles were identified. With regard to open‐ISR, the morbidity rate ranged from 7.5% to 38.3%, with lower mortality rates. Local recurrence rates varied widely from 0% to 22.7%, with a mean follow‐up duration of 40–94 months. Disease‐free and overall 5‐year survival rates were 68–86% and 76–97%, respectively. Those outcomes were equivalent to laparoscopic‐ISR. Surgical and oncological outcomes of ISR were generally acceptable. However, accurate evaluation of anal function and QoL was difficult because of a lack of standard assessment of various patient‐related factors. The surgical and oncological outcomes after ISR seem to be acceptable. The ISR technique seems to be valid as an alternative to abdominoperineal resection in selected patients with a very low rectal cancer. However, both necessity for ISR and expectations of QoL impairment as a result of functional disorder should be fully discussed with patients before surgery.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Intersphincteric resection for very low rectal cancer: A review of the updated literature

Shirouzu

Murakami

Akagi

2017

Annals of Gastroent Surgery

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“…61 However, whereas a number of other studies investigating the effectiveness of preoperative RT or postoperative RT in patients with rectal cancer staged as T1-3 have demonstrated improvements in local control of disease, overall survival was not shown to be significantly affected. 38,62,63 Preliminary results from a study of patients with stage II/III rectal cancer comparing short course preoperative RT with a postoperative approach which included chemoRT in selected patients (ie, those with a positive CRM following resection) and no RT in patients without evidence of residual disease following surgery indicated that patients in the preoperative RT arm had significantly lower local recurrence rates and a 5% absolute improvement in 3-year disease-free survival (DFS) (P=0.03). 64 Currently, however, short course RT for the treatment of rectal cancer is not widely practiced in the U.S.…”

Section: Ms-7mentioning

confidence: 99%

Positive lymph node retrieval ratio optimises patient staging in colorectal cancer

et al. 2009

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These guidelines are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no representations nor warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. These guidelines are copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. ©2009. 6. General. This Agreement contains the entire agreement between NCCN and you relating to its subject matter. No amendment, change, or modification of this Agreement shall be binding on either party unless mutually agreed to by the parties in writing. If any provision of this Agreement is held to be invalid or unenforceable by a court of competent jurisdiction, the validity and enforceability of the remaining provisions shall not be affected thereby. This Agreement will be governed by and construed in accordance with the laws of the Commonwealth of Pennsylvania without giving any effect to the conflict of law provisions thereof, and each party agrees to submit to personal jurisdiction in the federal and state courts of Pennsylvania and waives any objection to venues in said courts. This Agreement will not be governed by the United Nations Conventions of Contracts for the International Sale of goods, the application of which is expressly excluded. You agree that the Guidelines will not be shipped, transferred or exported into any country or used in any manner prohibited by the United States Export Administration Act, or any other export laws, restrictions. This Agreement will terminate automatically upon failure by you to comply with its terms. NCCN MAKES NO WARRANTIES CONCERNING THE GUIDELINES OR ANY ELECTRONIC DELIVERY MEDIA SUPPLIED BY NCCN, WHICH ARE PROVIDED "AS IS." NCCN DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NCCN DOES NOT WARRANT THE ACCURACY OR COMPLETENESS OF THE GUIDELINES AND DOES NOT WARRANT OR GUARANTEE OR MAKE ANY REPRESENTATION REGARDING THE USE OR THE RESULTS OF THE USE OF THE GUIDELINES. IN NO EVENT SHALL NCCN OR ITS MEMBERS BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE LICENSE GRANTED UNDER THIS AGREEMENT OR USE OF THE GUIDELINES INCLUDING, WITHOUT LIMITATION, LOSS OF LIFE, LOSS OF DATA, LOSS OF INCOME OR PROFIT, OR OTHER LOSSES SUSTAINED AS A RESULT OF INJURY TO ANY PERSON, OR LOSS OR DAMAGE TO PROPERTY, OR CLAIMS OF THIRD PARTIES, EVEN IF NCCN HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. SOME JURISDICTION...

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“…For example, rectal cancer has a well-established tendency to recur locally; however, the combination of total mesorectal excision and optimal chemoradiotherapy has reduced rates to < 10% in modern series. [58][59][60][61] Existing evidence on the pattern of recurrence after curative resection of colorectal cancer is limited to retrospective audits, [62][63][64] and data from high-quality randomised controlled trials are lacking. Trials of adjuvant therapies for colon and rectal cancer reveal certain information on patterns of recurrence, but these are by definition limited to more advanced-stage cancers requiring such treatments.…”

Section: Introductionmentioning

confidence: 99%

A randomised controlled trial to assess the cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent

Mant

Gray

Pugh

et al. 2017

Health Technol Assess

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Background Intensive follow-up after surgery for colorectal cancer is common practice but lacks a firm evidence base. Objective To assess whether or not augmenting symptomatic follow-up in primary care with two intensive methods of follow-up [monitoring of blood carcinoembryonic antigen (CEA) levels and scheduled imaging] is effective and cost-effective in detecting the recurrence of colorectal cancer treatable surgically with curative intent. Design Randomised controlled open-label trial. Participants were randomly assigned to one of four groups: (1) minimum follow-up (n = 301), (2) CEA testing only (n = 300), (3) computerised tomography (CT) only (n = 299) or (4) CEA testing and CT (n = 302). Blood CEA was measured every 3 months for 2 years and then every 6 months for 3 years; CT scans of the chest, abdomen and pelvis were performed every 6 months for 2 years and then annually for 3 years. Those in the minimum and CEA testing-only arms had a single CT scan at 12–18 months. The groups were minimised on adjuvant chemotherapy, gender and age group (three strata). Setting Thirty-nine NHS hospitals in England with access to high-volume services offering surgical treatment of metastatic recurrence. Participants A total of 1202 participants who had undergone curative treatment for Dukes’ stage A to C colorectal cancer with no residual disease. Adjuvant treatment was completed if indicated. There was no evidence of metastatic disease on axial imaging and the post-operative blood CEA level was ≤ 10 µg/l. Main outcome measures Primary outcome Surgical treatment of recurrence with curative intent. Secondary outcomes Time to detection of recurrence, survival after treatment of recurrence, overall survival and quality-adjusted life-years (QALYs) gained. Results Detection of recurrence During 5 years of scheduled follow-up, cancer recurrence was detected in 203 (16.9%) participants. The proportion of participants with recurrence surgically treated with curative intent was 6.3% (76/1202), with little difference according to Dukes’ staging (stage A, 5.1%; stage B, 7.4%; stage C, 5.6%; p = 0.56). The proportion was two to three times higher in each of the three more intensive arms (7.5% overall) than in the minimum follow-up arm (2.7%) (difference 4.8%; p = 0.003). Surgical treatment of recurrence with curative intent was 2.7% (8/301) in the minimum follow-up group, 6.3% (19/300) in the CEA testing group, 9.4% (28/299) in the CT group and 7.0% (21/302) in the CEA testing and CT group. Surgical treatment of recurrence with curative intent was two to three times higher in each of the three more intensive follow-up groups than in the minimum follow-up group; adjusted odds ratios (ORs) compared with minimum follow-up were as follows: CEA testing group, OR 2.40, 95% confidence interval (CI) 1.02 to 5.65; CT group, OR 3.69, 95% CI 1.63 to 8.38; and CEA testing and CT group, OR 2.78, 95% CI 1.19 to 6.49. Survival A Kaplan–Meier survival analysis confirmed no significant difference between arms (log-rank p = 0.45). The baseline-adjusted Cox proportional hazards ratio comparing the minimum and intensive arms was 0.87 (95% CI 0.67 to 1.15). These CIs suggest a maximum survival benefit from intensive follow-up of 3.8%. Cost-effectiveness The incremental cost per patient treated surgically with curative intent compared with minimum follow-up was £40,131 with CEA testing, £43,392 with CT and £85,151 with CEA testing and CT. The lack of differential impact on survival resulted in little difference in QALYs saved between arms. The additional cost per QALY gained of moving from minimum follow-up to CEA testing was £25,951 and for CT was £246,107. When compared with minimum follow-up, combined CEA testing and CT was more costly and generated fewer QALYs, resulting in a negative incremental cost-effectiveness ratio (–£208,347) and a dominated policy. Limitations Although this is the largest trial undertaken at the time of writing, it has insufficient power to assess whether or not the improvement in detecting treatable recurrence achieved by intensive follow-up leads to a reduction in overall mortality. Conclusions Rigorous staging to detect residual disease is important before embarking on follow-up. The benefit of intensive follow-up in detecting surgically treatable recurrence is independent of stage. The survival benefit from intensive follow-up is unlikely to exceed 4% in absolute terms and harm cannot be absolutely excluded. A longer time horizon is required to ascertain whether or not intensive follow-up is an efficient use of scarce health-care resources. Translational analyses are under way, utilising tumour tissue collected from Follow-up After Colorectal Surgery trial participants, with the aim of identifying potentially prognostic biomarkers that may guide follow-up in the future. Trial registration Current Controlled Trials ISRCTN41458548. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 32. See the NIHR Journals Library website for further project information.

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The TME Trial After a Median Follow-up of 6 Years

Cited by 1,027 publications

References 34 publications

Intersphincteric resection for very low rectal cancer: A review of the updated literature

Intersphincteric resection for very low rectal cancer: A review of the updated literature

Positive lymph node retrieval ratio optimises patient staging in colorectal cancer

A randomised controlled trial to assess the cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent

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