The guideline was developed through the RAND/UCLA Appropriateness Method, where members of an independent, multidisciplinary expert panel rate the appropriateness of different treatment approaches for different clinical scenarios based on a systematic review of published research. Experts in oncology, gastroenterology and internal medicine rated more than 200 unique scenarios combining risk factors that influence treatment decisions with potentially appropriate treatment modalities. Panelists individually scored each scenario on a nine-point scale that assessed the anticipated benefit versus harm for an average patient in that situation. Ratings from the 10-member panel were aggregated into three categories for the Clinical Practice Statement; therapeutic options were labeled as Appropriate for median panel ratings of seven to nine without disagreement, May Be Appropriate for median ratings of four to six or if there was disagreement, and Rarely Appropriate for median ratings of one to three without disagreement.

Scenarios and treatment recommendations were grouped into four sections, including (1) neoadjuvant and (2) adjuvant therapies used in conjunction with rectal surgery as well as non-operative management approaches for (3) medically inoperable patients and (4) patients who refuse radical rectal surgery.


For neoadjuvant therapy, panelists rated five treatment options, stratified by three patient characteristics: risk classification based on disease stage (intermediate-risk, moderately-high-risk or high-risk disease), distance from the tumor to the anal verge and distance from the tumor to the mesorectal fascia.

Neoadjuvant chemoradiation was rated Appropriate for all scenarios, while neoadjuvant brachytherapy alone was rated Rarely Appropriate across all scenarios. Neoadjuvant chemotherapy alone was rated May Be Appropriate for intermediate- and moderately-high-risk patients with non-threatened mesorectal fascia and Rarely Appropriate for the other scenarios. Forgoing neoadjuvant therapy was rated potentially appropriate only for cases with higher tumors situated far from the mesorectal fascia, where there would be no concern for positive margins following surgery.

Goodman explained the importance of radiation in treatment sequencing for tumors situated closer to the anal verge. "Tumors that sit lower in the rectum are in a more narrow part of the pelvis and therefore tend to have a higher risk of positive margins. Lower tumors also have a somewhat higher rate of lymph node metastasis. In these cases, radiation therapy is particularly important to help reduce the risk of local recurrence following surgery by shrinking the tumor, which helps surgeons resect more cleanly, and by eliminating micro-metastatic disease that may remain in pelvic lymph nodes not removed during surgery," she said.

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