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Original Investigation
January 2019

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

Author Affiliations
  • 1Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands
  • 2Department of Surgery, IJsselland Hospital, Capelle aan de Ijssel, the Netherlands
  • 3Department of Medical Oncology, Academic Medical Centre, Amsterdam, the Netherlands
  • 4Department of Pathology, Radboud University Medical Centre, Nijmegen, the Netherlands
  • 5Department of Radiation Oncology, Erasmus Medical Centre, Rotterdam, the Netherlands
  • 6Department of Oncology, Erasmus Medical Centre Cancer Institute, Rotterdam, the Netherlands
  • 7Department of Surgery, Academic Medical Centre, Amsterdam, the Netherlands
  • 8Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands
  • 9Department of Surgery, Amphia Hospital, Breda, the Netherlands
  • 10Department of Surgery, Medical Centre Slotervaart, Amsterdam, the Netherlands
  • 11Department of Surgery, Laurentius Hospital, Roermond, the Netherlands
  • 12Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands
  • 13Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, the Netherlands
  • 14Department of Surgical Oncology, Erasmus Medical Centre, Rotterdam, the Netherlands
  • 15Department of Radiotherapy, Leiden University Medical Centre, Leiden, the Netherlands
JAMA Surg. 2019;154(1):47-54. doi:10.1001/jamasurg.2018.3752
Key Points

Question  Is neoadjuvant chemoradiotherapy followed by local excision a feasible alternative to conventional total mesorectal excision?

Finding  In this phase II feasibility study of 55 patients, organ preservation was achieved in 35 patients (64%) with acceptable long-term oncological outcomes and health-related quality of life. However, most patients experienced a certain degree of functional impairment.

Meaning  Organ preservation may be a feasible alternative to total mesorectal excision for patients with a desire for organ preservation.

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.

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