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

Rutger C. H. Stijns*, Eelco J. R. de Graaf, Cornelis J. A. Punt, Iris D. Nagtegaal, Joost J. M. E. Nuyttens, Esther van Meerten, Pieter J. Tanis, Ignace H. J. T. de Hingh, George P. van der Schelling, Yair Acherman, Jeroen W. A. Leijtens, Andreas J. A. Bremers, Geerard L. Beets, Christiaan Hoff, Cornelis Verhoef, Corrie A. M. Marijnen, Johannes H. W. de Wilt, Guus M. J. Bokkerink, Annemieke Cats, Pascal G. DoorneboschRoy S. Dwarkasing, Heidi Rutten, Albert J. ten Tije, Mike Stephen Tromp, Erik Schoon, Mareille Verseveld, Jeroen Buijsen, CARTS Study Group

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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 cT1-3NOMO 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 cT1-3NOMO 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 studywas 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.

Original languageEnglish
Pages (from-to)47-54
Number of pages8
JournalJAMA Surgery
Volume154
Issue number1
DOIs
Publication statusPublished - Jan 2019

Keywords

  • QUALITY-OF-LIFE
  • TOTAL MESORECTAL EXCISION
  • ANTERIOR RESECTION SYNDROME
  • LOCAL EXCISION
  • POSTOPERATIVE CHEMORADIOTHERAPY
  • NEOADJUVANT CHEMORADIATION
  • COLORECTAL-CANCER
  • CLINICAL-TRIALS
  • OPEN-LABEL
  • MULTICENTER

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