Dataset Information

Long-term Oncological and Functional Outcomes of Chemoradiotherapy Followed by Organ-Sparing Transanal Endoscopic Microsurgery for Distal Rectal Cancer: The CARTS Study.

ABSTRACT:

Importance

Treatment of rectal cancer is shifting toward organ preservation aiming to reduce surgery-related morbidity. Short-term outcomes of organ-preserving strategies are promising, but long-term outcomes are scarce in the literature.

Objective

To explore long-term oncological outcomes and health-related quality of life (HRQL) in patients with cT1-3N0M0 rectal cancer who underwent neoadjuvant chemoradiotherapy (CRT) followed by transanal endoscopic microsurgery (TEM).

Design, setting, and participants

In this multicenter phase II feasibility study, patients with cT1-3N0M0 rectal cancer admitted to referral centers for rectal cancer throughout the Netherlands between February 2011 and September 2012 were prospectively included. These patients were to be treated with neoadjuvant CRT followed by TEM in case of good response. An intensive follow-up scheme was used to detect local recurrences and/or distant metastases. Data from validated HRQL questionnaires and low anterior resection syndrome questionnaires were collected. Data were analyzed from February 2011 to April 2017.

Main outcomes and measures

The primary study outcome of the study was the number of ypT0-1 specimens by performing TEM. Secondary outcome parameters were locoregional recurrences and HRQL.

Results

Of the 55 included patients, 30 (55%) were male, and the mean (SD) age was 64 (39-82) years. Patients were followed up for a median (interquartile range) period of 53 (39-57) months. Two patients (4%) died during CRT, 1 (2%) stopped CRT, and 1 (2%) was lost to follow-up. Following CRT, 47 patients (85%) underwent TEM, of whom 35 (74%) were successfully treated with local excision alone. Total mesorectal excision was performed in 16 patients (4 with inadequate responses, 8 with completion after TEM, and 4 with salvage for local recurrence). The actuarial 5-year local recurrence rate was 7.7%, with 5-year disease-free and overall survival rates of 81.6% and 82.8%, respectively. Health-related quality of life during follow-up was equal to baseline, with improved emotional well-being in patients treated with local excision (mean score at baseline, 72.0; 95% CI, 67.1-80.1; mean score at follow-up, 86.9; 95% CI, 79.2-94.7; P = .001). Major, minor, and no low anterior resection syndrome was experienced in 50%, 28%, and 22%, respectively, of patients with successful organ preservation.

Conclusions and relevance

In early-stage rectal cancer (cT1-3N0M0), CRT enables organ preservation with additional TEM surgery in approximately two-thirds of patients with good long-term oncological outcome and HRQL. This multimodality treatment triggers a certain degree of bowel dysfunction, and one-third of patients still undergo radical surgery and are overtreated by CRT.

SUBMITTER: Stijns RCH

PROVIDER: S-EPMC6439861 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Transanal endoscopic microsurgery (TEM) is a minimally invasive technique that is increasingly being used to treat early rectal cancer (T1/T2). We studied the outcomes of TEM for rectal cancer at our institution looking at the indication, recurrence rate, need for further radical surgery, 30-day and 12-month mortality and complication rate. We performed a retrospective analysis of prospectively collected data of cases between 2008 and 2012: 110 TEM procedures were performed during this period: 40 were confirmed rectal cancers and 70 were benign. We analysed the data for the 40 patients with confirmed rectal cancer. Thirty (75 %) of the subjects were male with a mean age of 71?±?10 years (range 49-90 years) and 19 (48 %) patients were ASA 3 and 4. Nineteen (48 %) of cancers were pT1, eighteen (45 %) were pT2, two (5 %) were pT3 and one was yPT0. Mean specimen size was 66?±?20 mm (range 33-120 mm) with a mean polyp size of 41?±?24 mm (range 18-110 mm). The mean cancer size was 24?±?13 mm (range 2-50 mm). Average distance from the anal verge was 70?±?37 mm (range 10-150 mm), and the mean operating time was 72?±?22 min (range 40-120 min), with an average blood loss of 28?±?15 ml (range 10-50ml). Median hospital stay was 2?±?1 days (range 1-7 days). Complete excision (R0) was achieved in 37 (93 %) patients. Minor post-operative complications included urinary retention in two and pyrexia in three patients. There were no 30-day or 12-month mortalities. Mean follow-up was 13?±?11 months, range (3-40 months) Local recurrence occurred in two (5 %) patients, both underwent redo TEM. Twelve (30 %) patients underwent laparoscopic radical resections (seven AR and five APER) post-TEM. Post-operative histology confirmed pT0N0 in 7/12 patients. Three were lymph node-positive (T0N1), one was pT3N1 and the fifth was pT3N2. TEM is associated with quicker recovery, shorter hospital stay and fewer complications than radical surgery. It is a good alternative to radical surgery in early rectal cancer, especially for high-risk patients. Recurrent tumours can be treated with redo TEM.

Project description:Transanal endoscopic microsurgery (TEM) for the treatment of early-stage rectal cancer has attracted attention due to its advantages of reduced surgical trauma, fewer complications, low operative mortality, rapid postoperative recovery and short hospital stay. However, there are still significant controversies regarding TEM for the treatment of rectal cancer, mainly related to the prognosis associated with this method.This study sought to compare the efficacy of transanal endoscopic microsurgery (TEM) and total mesorectal excision (TME) for the treatment of T1 rectal cancer.We searched the Cochrane Library, PubMed, Embase and CNKI databases. Based on the Cochrane Handbook for Systematic Reviews, we screened the trials, evaluated the quality and extracted the data.One randomized controlled trial (RCT) and six non-randomized controlled clinical trials (CCTs) were included in the meta-analysis (a total of 860 rectal cancer patients were included; 303 patients were treated with TEM, and 557 patients were treated with TME). Analysis revealed that all seven studies reported local recurrence rates, and there was a significant difference between the TEM and TME groups [odds ratio (OR) = 4.62, 95% confidence interval (CI) (2.03, 10.53), P = 0.0003]. A total of five studies reported distant metastasis rates, and there was no significant difference between the TEM and TME groups [OR = 0.74, 95%CI (0.32, 1.72), P = 0.49]. A total of six studies reported postoperative overall survival of the patients, and there was no significant difference between the TEM and TME groups [OR = 0.87, 95%CI(0.55, 1.38), P = 0.55]. In addition, two studies reported the postoperative disease-free survival rates of patients, and there was no significant difference between the TEM and TME groups [OR = 1.12, 95%CI (0.31, 4.12), P = 0.86].For patients with T1 rectal cancer, the distant metastasis, overall survival and disease-free survival rates did not differ between the TEM and TME groups, although the local recurrence rate after TEM was higher than that after TME.

Project description:BackgroundOlder patients with early-stage rectal cancer are under-represented in clinical trials and, therefore, little high-quality data are available to guide treatment in this patient population. The TREC trial was a randomised, open-label feasibility study conducted at 21 centres across the UK that compared organ preservation through short-course radiotherapy (SCRT; 25 Gy in five fractions) plus transanal endoscopic microsurgery (TEM) with standard total mesorectal excision in adults with stage T1-2 rectal adenocarcinoma (maximum diameter ≤30 mm) and no lymph node involvement or metastasis. TREC incorporated a non-randomised registry offering organ preservation to patients who were considered unsuitable for total mesorectal excision by the local colorectal cancer multidisciplinary team. Organ preservation was achieved in 56 (92%) of 61 non-randomised registry patients with local recurrence-free survival of 91% (95% CI 84-99) at 3 years. Here, we report acute and long-term patient-reported outcomes from this non-randomised registry group.MethodsPatients considered by the local colorectal cancer multidisciplinary team to be at high risk of complications from total mesorectal excision on the basis of frailty, comorbidities, and older age were included in a non-randomised registry to receive organ-preserving treatment. These patients were invited to complete questionnaires on patient-reported outcomes (the European Organisation for Research and Treatment of Cancer Quality of Life [EORTC-QLQ] questionnaire core module [QLQ-C30] and colorectal cancer module [QLQ-CR29], the Colorectal Functional Outcome [COREFO] questionnaire, and EuroQol-5 Dimensions-3 Level [EQ-5D-3L]) at baseline and at months 3, 6, 12, 24, and 36 postoperatively. To aid interpretation, data from patients in the non-randomised registry were compared with data from those patients in the TREC trial who had been randomly assigned to organ-preserving therapy, and an additional reference cohort of aged-matched controls from the UK general population. This study is registered with the ISRCTN registry, ISRCTN14422743, and is closed.FindingsBetween July 21, 2011, and July 15, 2015, 88 patients were enrolled onto the TREC study to undergo organ preservation, of whom 27 (31%) were randomly allocated to organ-preserving therapy and 61 (69%) were added to the non-randomised registry for organ-preserving therapy. Non-randomised patients were older than randomised patients (median age 74 years [IQR 67-80] vs 65 years [61-71]). Organ-preserving treatment was well tolerated among patients in the non-randomised registry, with mild worsening of fatigue; quality of life; physical, social, and role functioning; and bowel function 3 months postoperatively compared with baseline values. By 6-12 months, most scores had returned to baseline values, and were indistinguishable from data from the reference cohort. Only mild symptoms of faecal incontinence and urgency, equivalent to less than one episode per week, persisted at 36 months among patients in both groups.InterpretationThe SCRT and TEM organ-preservation approach was well tolerated in older and frailer patients, showed good rates of organ preservation, and was associated with low rates of acute and long-term toxicity, with minimal effects on quality of life and functional status. Our findings support the adoption of this approach for patients considered to be at high risk from radical surgery.FundingCancer Research UK.