title: Long-term Outcome of an Organ Preservation Program After Neoadjuvant Treatment for Rectal Cancer.
abstract: The aim of this study was to establish the oncological and functional results of organ preservation with a watch-and-wait approach (W&W) and selective transanal endoscopic microsurgery (TEM) in patients with a clinical complete or near-complete response (cCR) after neoadjuvant chemoradiation for rectal cancer.
  
  
  
  Between 2004 and 2014, organ preservation was offered if response assessment with digital rectal examination, endoscopy, and MRI showed (near) cCR. Watch-and-wait was offered for cCR, and two options were offered for near cCR: TEM or reassessment after three months. Follow-up included endoscopy and MRIs every three months during the first year, and every six months thereafter. Long-term outcome was assessed with Kaplan-Meier curves. Functional outcome was assessed with colostomy-free survival and Vaizey incontinence score (0 = perfect continence, 24 = totally incontinent).
  
  
  
  One hundred patients were included, with median follow-up of 41.1 months. Sixty-one had cCR at initial response assessment. Thirty-nine had near cCR, of whom 24 developed cCR at the second assessment and 15 patients underwent TEM (9 ypT0, 1 ypT1, 5 ypT2). Fifteen patients developed a local regrowth (12 luminal, 3 nodal), all salvageable and within 25 months. Five patients developed metastases, and five patients died. Three-year overall survival was 96.6% (95% confidence interval [CI] = 89.9% to 98.9%), distant metastasis-free survival was 96.8% (95% CI = 90.4% to 99.0%), local regrowth-free survival was 84.6% (95% CI = 75.8% to 90.5%), and disease-free survival was 80.6% (95% CI = 70.9% to 87.4%). Colostomy-free survival was 94.8% (95% CI = 88.0% to 97.8%), with a good continence after watch-and-wait (Vaizey = 3.4, SD = 3.9) and moderate after TEM (Vaizey = 9.7, SD = 5.1).
  
  
  
  Organ preservation appears oncologically safe for selected rectal cancer patients with a cCR or near cCR after neoadjuvant chemoradiation when applying strict selection criteria and frequent follow-up, including endoscopy and MRI. The low colostomy rate and the good long-term functional outcome warrant discussing this option with the patient as an alternative to major surgery.
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Milou H
authors: MH
authors: Martens
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Monique
authors: M
authors: Maas
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Luc A
authors: LA
authors: Heijnen
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Doenja M J
authors: DM
authors: Lambregts
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Jeroen W A
authors: JW
authors: Leijtens
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Laurents P S
authors: LP
authors: Stassen
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Stephanie O
authors: SO
authors: Breukink
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Christiaan
authors: C
authors: Hoff
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Eric J
authors: EJ
authors: Belgers
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Jarno
authors: J
authors: Melenhorst
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Rob
authors: R
authors: Jansen
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Jeroen
authors: J
authors: Buijsen
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Ton G M
authors: TG
authors: Hoofwijk
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB).
authors: Regina G H
authors: RG
authors: Beets-Tan
authors: Department of Surgery (MHM, LAH, LPSS, SOB, JM), Department of Radiology (MHM, MM, LAH, DMJL), GROW School for Oncology and Developmental Biology (MHM, LAH, JB, RGHBT, GLB), and Department of Medical Oncology (RJ), Maastricht University Medical Center, Maastricht, the Netherlands; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands (JWAL); Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands (CH); Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands (EJB, TGMH); Department of Radiotherapy, Maastro Radiation Clinic, Maastricht, the Netherlands (JB); Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands (MM, DMJL, RGHBT); Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands (GLB) g.beets@nki.nl.
authors: Geerard L
authors: GL
authors: Beets
mesh_terms: D000368:Aged; D059186:Chemoradiotherapy, Adjuvant; D003125:Colostomy; D051517:Digital Rectal Examination; D018572:Disease-Free Survival; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000000981:diagnostic imaging*; D059351:Organ Sparing Treatments; D012004:Rectal Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate; D013997:Time Factors; D000067369:Transanal Endoscopic Microsurgery; D016896:Treatment Outcome; D057832:Watchful Waiting