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

Maas M et al.

Journal of Clinical Oncology. 2011 Dec 10; 29(35):4633-4640

https://doi.org/10.1200/JCO.2011.37.7176PMID:22067400

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.

Maas M¹,
Beets-Tan RG ,
Lambregts DM ,
Lammering G ,
Nelemans PJ ,
Engelen SM ,
van Dam RM ,
Jansen RL ,
Sosef M ,
Leijtens JW ,
Hulsewé KW ,
Buijsen J ,
Beets GL

Affiliations

¹ Maastricht University Medical Center, the Netherlands

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There has been much interest in limiting therapy in patients with rectal cancer, but most of this has related to defining patients in whom radiation therapy is not needed. This article provides some perspective on another approach -- in defining a group of patients in whom surgical resection may not be needed.Surgical resection has been deemed necessary in all patients in the treatment of rectal cancer. This study, along with an earlier Brazilian study by Habr-Gama et al. {1}, provides the possibility of not performing surgery in a select group of patients treated with primary radiation therapy and chemotherapy. This study is certainly not definitive, but it does provide additional information to suggest that a watch-and-wait policy may be appropriate in the proper clinical setting. It is likely that, in the future, there will be further clarification of patients who do not need surgery, radiation therapy or chemotherapy but can be treated with just one or two of those modalities.

References

Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results.
Habr-Gama A et al.
Ann Surg 2004 Oct; 4(240):711-7; discussion 717-8
PMID: 15383798