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Clinical Trial
. 2011 Dec 10;29(35):4633-40.
doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.

Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer

Monique Maas  1 , Regina G H Beets-Tan, Doenja M J Lambregts, Guido Lammering, Patty J Nelemans, Sanne M E Engelen, Ronald M van Dam, Rob L H Jansen, Meindert Sosef, Jeroen W A Leijtens, Karel W E Hulsewé, Jeroen Buijsen, Geerard L Beets
Affiliations
Clinical Trial

Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer

Monique Maas et al. J Clin Oncol. .

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 [cCR]) 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.

Trial registration: ClinicalTrials.gov NCT00939666.

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