IMPORTANCE Chemoradiotherapy (CRT), followed by surgery, is the recommended approach for stage II and III rectal cancer. While CRT decreases the risk of local recurrence, it does not improve survival and leads to poorer functional outcomes than surgery alone. Therefore, new approaches to better select patients for CRT are important. OBJECTIVE To conduct a phase 2 study to evaluate the safety and feasibility of using magnetic resonance imaging (MRI) criteria to select patients with "good prognosis" rectal tumors for primary surgery. DESIGN, SETTING, AND PARTICIPANTS Prospective nonrandomized phase 2 study at 12 high-volume colorectal surgery centers across Canada. From September 30, 2014, to October 21, 2016, a total of 82 patients were recruited for the study. Participants were patients newly diagnosed as having rectal cancer with MRI-predicted good prognosis rectal cancer. The MRI criteria for good prognosis tumors included distance to the mesorectal fascia greater than 1 mm; definite T2, T2/early T3, or definite T3 with less than 5 mm of extramural depth of invasion; and absent or equivocal extramural venous invasion. INTERVENTIONS Patients with rectal cancer with MRI-predicted good prognosis tumors underwent primary surgery. MAIN OUTCOMES AND MEASURES The primary outcome was the proportion of patients with a positive circumferential resection margin (CRM) rate. Assuming a 10% baseline probability of a positive CRM, a sample size of 75 was estimated to yield a 95% CI of ±6.7%. RESULTS Eighty-two patients (74% male) participated in the study. The median age at the time of surgery was 66 years (range, 37-89 years). Based on MRI, most tumors were midrectal (65% [n = 53]), T2/early T3 (60% [n = 49]), with no suspicious lymph nodes (63% [n = 52]). On final pathology, 91% (n = 75) of tumors were T2 or greater, 29% (n = 24) were node positive, and 59% (n = 48) were stage II or III. The positive CRM rate was 4 of 82 (4.9%; 95% CI, 0.2%-9.6%). CONCLUSIONS AND RELEVANCE The use of MRI criteria to select patients with good prognosis rectal cancer for primary surgery results in a low rate of positive CRM and suggests that CRT may not be necessary for all patients with stage II and III rectal cancer.
Approximately one third of physicians treating cancer patients are not aware of what decision aids are, and only 24% are currently using decision aids in clinical practice. Strategies to increase physician awareness about decision aids and to implement these tools into clinical practice are important.
BACKGROUND:
Although the body of evidence supporting nonoperative management for rectal cancer has been accumulating, there has been little systematic investigation to explore how physicians and patients value the tradeoffs between oncologic and functional outcomes after abdominal perineal resection and nonoperative management.
OBJECTIVE:
The purpose of this study was to elicit patient and physician preferences for nonoperative management relative to abdominal perineal resection in the setting of low rectal cancer.
DESIGN:
We conducted a standardized interviews of patients and a cross-sectional survey of physicians.
SETTINGS:
Patients from 1 tertiary care center and physicians from across Canada were included.
PATIENTS:
The study involved 50 patients who were previously treated for rectal cancer and 363 physicians who treat rectal cancer.
INTERVENTIONS:
Interventions included standardized interviews using the threshold technique with patients and surveys mailed to physicians.
MAIN OUTCOMES MEASURES:
We measured absolute increase risk in local regrowth and absolute decrease in overall survival that patients and physicians would accept with nonoperative management relative to abdominal perineal resection.
RESULTS:
Patients were willing to accept a 20% absolute increase for local regrowth (ie, from 0% to 20%) and a 20% absolute decrease in overall survival (ie, from 80% to 60%) with nonoperative management relative to abdominal perineal resection, whereas physicians were willing to accept a 5% absolute increase for local regrowth (ie, from 0% to 5%) and a 5% absolute decrease in overall survival (ie, from 80% to 75%) with nonoperative management relative to abdominal perineal resection.
LIMITATIONS:
Data were subject to response bias and generalizable to only a select group of patients with low rectal cancer.
CONCLUSIONS:
Offering nonoperative management as an option to patients, even if oncologic outcomes are not equivalent, may be more consistent with the values of patients in this setting. See Video Abstract at http://links.lww.com/DCR/A688.
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