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

Abstract

for the CARTS Study Group 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 PARTICIPANTSIn 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 MEASURESThe primary study outcome of the study was the number of ypT0-1 specimens by performing TEM. Secondary outcome parameters were locoregional recurrences and HRQL. RESULTSOf 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 RELEVANCEIn 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.

Radiation Therapy for Rectal Cancer: Executive Summary of an ASTRO Clinical Practice Guideline

“…Ideal candidates are those with distally (<8-10 cm from the anal verge) located invasive tumors, favorable histology, and size <4 cm. [54][55][56] In such cases, it is critical that LE is performed by surgeons experienced with transanal LE techniques, preferably at centers with experienced multidisciplinary teams. It is important to note, however, TME conversion after LE for ypT2-3 may lead to major complications and poor functional outcomes.…”

Local Resection of Rectal Cancer after Neoadjuvant Therapy: A New Trend for Organ Preservation

“…Stijns (14) reported on the functional results of patients with successful organ preservation in the CARTS study. They found that 50% of the patients had major LARS.…”

Mesorectal radiotherapy for early stage rectal cancer: A novel target volume

“…In early stage tumours (C)RT can lead to OP in more than 50% when combined with local excision [13][14][15][16]. Unfortunately, this (C)RT can be accompanied by toxicity, morbidity and even mortality [14,15,17]. However, all available data on toxicity and mortality, are based on conventional radiotherapy techniques, with large treatment volumes, including large elective LN regions.…”