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11 november 2011: Bron: ©American Society of Clinical Oncology

Wanneer bij patiënten met endeldarmkanker - rectumkanker een volledige remissie wordt bereikt door een combinatiebehandeling van chemo en bestraling - radiotherapie lijkt een operatie niet nodig and lijkt een wait-and-see beleid voldoende. Dit blijkt uit de resultaten van een Nederlandse studie uitgevoerd in Maastricht. Een kleinschalige gerandomiseerde studie bij totaal 41 patienten met niet uitgezaaide rectumkanker. Deze studie bevestigt een grotere studie, waarvan de resultaten werden gepresenteerd al weer in 2006. Zie onderaan dit artikel abstract van die studie met ook toegang tot het volledige studierapport.

Van de recente studie uit Maastricht waren dit de resultaten:

Resultaten: Eenentwintig patiënten met aantoonbare rectumkanker werden opgenomen in de wait-and-see groep. Gemiddelde follow-up was 25 ± 19 maanden. 1 patiënt ontwikkelde een lokaal recidief zonder verdere uitzaaiingen en werd daaraan succesvol geopereerd. De andere 20 patiënten waren nog steeds in leven na 2 jaar zonder ziekte symptomen. De controle groep bestond uit 20 patiënten met een aantoonbare complete remissie en kregen alsnog een operatie. Deze groep patienten hadden een gemiddelde follow-up van 35 ± 23 maanden. Voor deze patiënten bleek de 2-jaars ziektevrije overleving en algehele overleving respectievelijk 93% en 91%, 

In de controlegroep, hadden 9 patiënten na de operatie een permanente stoma nodig en 11 een tijdelijke stoma. De helft van de patiënten ondervonden geen complicaties na een operatie, maar zeven patiënten hadden ernstige complicaties, zoals naadlekkage, intra-abdominale abcessen, en respiratoir falen. 1 patient overleed tijdens de studieduur aan de complicaties veroorzaakt door de operatie. 1 patient overleed aan de kanker zelf tijdens de studieduur.

In de wait-and-see-groep, was de 2-jaars ziektevrije overleving 89% (95% betrouwbaarheidsinterval [BI], 43% tot 98%), en de twee-jaars overleving was 100%.

In de controle groep was 2-jaar ziektevrije overleving 93% (95% BI, 59% tot 99%) en de totale overleving was 91% (95% BI, 59% tot 99%). De verschillen waren niet significant verschillend tussen de twee studiegroepen.

Hier het abstract van deze studie waarover u contact op kunt nemen met: 

  1. Corresponding author: Geerard L. Beets, MD, PhD, Maastricht University Medical Center, PO Box 5800, Maastricht, the Netherlands 6202 AZ; e-mail: g.beets@mumc.nl.

A wait-and-see policy with strict selection criteria, up-to-date imaging techniques, and follow-up is feasible and results in promising outcome at least as good as that of patients with a complete remission after surgery

Wait-and-See Policy for Clinical Complete Responders After Chemoradiation for Rectal Cancer

  1. Monique Maas,
  2. Regina G.H. Beets-Tan,
  3. Doenja M.J. Lambregts,
  4. Guido Lammering,
  5. Patty J. Nelemans,
  6. Sanne M.E. Engelen,
  7. Ronald M. van Dam,
  8. Rob L.H. Jansen,
  9. Meindert Sosef,
  10. Jeroen W.A. Leijtens,
  11. Karel W.E. Hulsewé,
  12. Jeroen Buijsen and
  13. Geerard L. Beets

+ Author Affiliations

  1. Monique Maas, Regina G.H. Beets-Tan, Doenja M.J. Lambregts, Sanne M.E. Engelen, Ronald M. van Dam, Rob L.H. Jansen, and Geerard L. Beets, Maastricht University Medical Center; Patty J. Nelemans, Maastricht University; Guido Lammering and Jeroen Buijsen, Maastro Clinic, Maastricht; Meindert Sosef, Atrium Medical Center, Heerlen; Jeroen W.A. Leijtens, Laurentius Hospital, Roermond; and Karel W.E. Hulsewé, Orbis Medical Center, Sittard, the Netherlands.
  1. Corresponding author: Geerard L. Beets, MD, PhD, Maastricht University Medical Center, PO Box 5800, Maastricht, the Netherlands 6202 AZ; e-mail: g.beets@mumc.nl.

Abstract

Purpose Neoadjuvant chemoradiotherapy for rectal cancer can result in complete disappearance of tumor and involved nodes. In patients without residual tumor on imaging and endoscopy (clinical complete response ) a wait-and-see-policy (omission of surgery with follow-up) might be considered instead of surgery. The purpose of this prospective cohort study was to evaluate feasibility and safety of a wait-and-see policy with strict selection criteria and follow-up.

Patients and Methods Patients with a cCR after chemoradiotherapy were prospectively selected for the wait-and-see policy with magnetic resonance imaging (MRI) and endoscopy plus biopsies. Follow-up was performed 3 to 6 monthly and consisted of MRI, endoscopy, and computed tomography scans. A control group of patients with a pathologic complete response (pCR) after surgery was identified from a prospective cohort study. Functional outcome was measured with the Memorial Sloan-Kettering Cancer Center (MSKCC) bowel function questionnaire and Wexner incontinence score. Long-term outcome was estimated by using Kaplan-Meier curves.

Results Twenty-one patients with cCR were included in the wait-and-see policy group. Mean follow-up was 25 ± 19 months. One patient developed a local recurrence and had surgery as salvage treatment. The other 20 patients are alive without disease. The control group consisted of 20 patients with a pCR after surgery who had a mean follow-up of 35 ± 23 months. For these patients with a pCR, cumulative probabilities of 2-year disease-free survival and overall survival were 93% and 91%, respectively.

Conclusion A wait-and-see policy with strict selection criteria, up-to-date imaging techniques, and follow-up is feasible and results in promising outcome at least as good as that of patients with a pCR after surgery. The proposed selection criteria and follow-up could form the basis for future randomized studies.

Footnotes

  • Received June 20, 2011.
  • Accepted July 25, 2011.

Stage 0 rectal cancer disease is associated with excellent long-term results irrespective of treatment strategy. Surgical resection may not lead to improved outcome in this situation and may be associated with high rates of temporary or definitive stoma construction and unnecessary morbidity and mortality rates.

Ann Surg. 2004 October; 240(4): 711–718.
PMCID: PMC1356472
Copyright © 2004 Lippincott Williams & Wilkins, Inc.
Operative Versus Nonoperative Treatment for Stage 0 Distal Rectal Cancer Following Chemoradiation Therapy
Long-term Results
Angelita Habr-Gama, MD,* Rodrigo Oliva Perez, MD,* Wladimir Nadalin, MD, Jorge Sabbaga, MD, Ulysses Ribeiro, Jr, MD, Afonso Henrique Silva e Sousa, Jr, MD,* Fábio Guilherme Campos, MD,* Desidério Roberto Kiss, MD,* and Joaquim Gama-Rodrigues, MD
From the *Colorectal Surgery Division, Department of Gastroenterology, †Radiotherapy Division, Department of Radiology, and ‡Surgery of Alimentary Tract Division, Department of Gastroenterology, University of São Paulo School of Medicine, São Paulo, Brazil.
Objective:
Report overall long-term results of stage 0 rectal cancer following neoadjuvant chemoradiation and compare long-term results between operative and nonoperative treatment.
Methods:
Two-hundred sixty-five patients with distal rectal adenocarcinoma considered resectable were treated by neoadjuvant chemoradiation (CRT) with 5-FU, Leucovorin and 5040 cGy. Patients with incomplete clinical response were referred to radical surgical resection. Patients with incomplete clinical response treated by surgery resulting in stage p0 were compared to patients with complete clinical response treated by nonoperative treatment. Statistical analysis was performed using χ2, Student t test and Kaplan-Meier curves.
Results:
Overall and disease-free 10-year survival rates were 97.7% and 84%. In 71 patients (26.8%) complete clinical response was observed following CRT (Observation group). Twenty-two patients (8.3%) showed incomplete clinical response and pT0N0M0 resected specimens (Resection group). There were no differences between patient's demographics and tumor's characteristics between groups. In the Resection group, 9 definitive colostomies and 7 diverting temporary ileostomies were performed. Mean follow-up was 57.3 months in Observation Group and 48 months in Resection Group. There were 3 systemic recurrences in each group and 2 endorectal recurrences in Observation Group. Two patients in the Resection group died of the disease. Five-year overall and disease-free survival rates were 88% and 83%, respectively, in Resection Group and 100% and 92% in Observation Group.
Conclusions:
Stage 0 rectal cancer disease is associated with excellent long-term results irrespective of treatment strategy. Surgical resection may not lead to improved outcome in this situation and may be associated with high rates of temporary or definitive stoma construction and unnecessary morbidity and mortality rates.

 


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