Primary chemoradiation therapy followed by intensive surveillance for complete clinical responders

Investigators in England performed the Oncological Outcomes after Clinical Complete Response in Patients with Rectal Cancer trial.[23] This was a propensity-score−matched cohort analysis. At a tertiary medical center in Manchester, 228 patients who chose watchful waiting from 2011 to 2013 after a complete clinical response to preoperative chemoradiation therapy were combined with 98 patients from a registry of three neighboring medical centers who chose watchful waiting after chemoradiation therapy beginning in 2005. A clinical complete response was considered in the absence of residual ulceration, stenosis, or mass within the rectum during digital rectal examination and endoscopic examination 8 weeks or more after completion of concurrent chemoradiation therapy. The only positive findings consistent with a complete clinical response during clinical or endoscopic examination were whitening of the mucosa and telangiectasia. Classification of complete clinical response required normal radiological imaging of the mesorectum and pelvis. Complete clinical responders (n = 129) were compared with a cohort of patients treated similarly who underwent surgery for complete resection (n = 228). Compared with all patients who underwent surgery, patients who chose watch and wait had tumors with an earlier T stage and N stage and that were less likely to be poorly differentiated. Patients managed by watch and wait underwent a more intensive follow-up protocol consisting of outpatient digital rectal examination; MRI (every 4–6 months in the first 2 years); examination under anesthesia or endoscopy; computed tomography scan of the chest, abdomen, and pelvis; and at least two carcinoembryonic antigen measurements in the first 2 years. The optimal follow-up has not been determined.For patients who have a complete clinical response to therapy, it is reasonable to consider a watch-and-wait approach with intensive surveillance instead of immediate surgical resection.

Investigators in England performed the Oncological Outcomes after Clinical Complete Response in Patients with Rectal Cancer trial.[23] This was a propensity-score−matched cohort analysis. At a tertiary medical center in Manchester, 228 patients who chose watchful waiting from 2011 to 2013 after a complete clinical response to preoperative chemoradiation therapy were combined with 98 patients from a registry of three neighboring medical centers who chose watchful waiting after chemoradiation therapy beginning in 2005. A clinical complete response was considered in the absence of residual ulceration, stenosis, or mass within the rectum during digital rectal examination and endoscopic examination 8 weeks or more after completion of concurrent chemoradiation therapy. The only positive findings consistent with a complete clinical response during clinical or endoscopic examination were whitening of the mucosa and telangiectasia. Classification of complete clinical response required normal radiological imaging of the mesorectum and pelvis. Complete clinical responders (n = 129) were compared with a cohort of patients treated similarly who underwent surgery for complete resection (n = 228). Compared with all patients who underwent surgery, patients who chose watch and wait had tumors with an earlier T stage and N stage and that were less likely to be poorly differentiated. Patients managed by watch and wait underwent a more intensive follow-up protocol consisting of outpatient digital rectal examination; MRI (every 4–6 months in the first 2 years); examination under anesthesia or endoscopy; computed tomography scan of the chest, abdomen, and pelvis; and at least two carcinoembryonic antigen measurements in the first 2 years. The optimal follow-up has not been determined.For patients who have a complete clinical response to therapy, it is reasonable to consider a watch-and-wait approach with intensive surveillance instead of immediate surgical resection.

After a median follow-up of 33 months, 44 (34%) of the 129 patients who chose watchful waiting had a local recurrence, and 36 patients had a salvage resection.

Investigators in England performed the Oncological Outcomes after Clinical Complete Response in Patients with Rectal Cancer trial.[23] This was a propensity-score−matched cohort analysis. At a tertiary medical center in Manchester, 228 patients who chose watchful waiting from 2011 to 2013 after a complete clinical response to preoperative chemoradiation therapy were combined with 98 patients from a registry of three neighboring medical centers who chose watchful waiting after chemoradiation therapy beginning in 2005. A clinical complete response was considered in the absence of residual ulceration, stenosis, or mass within the rectum during digital rectal examination and endoscopic examination 8 weeks or more after completion of concurrent chemoradiation therapy. The only positive findings consistent with a complete clinical response during clinical or endoscopic examination were whitening of the mucosa and telangiectasia. Classification of complete clinical response required normal radiological imaging of the mesorectum and pelvis. Complete clinical responders (n = 129) were compared with a cohort of patients treated similarly who underwent surgery for complete resection (n = 228). Compared with all patients who underwent surgery, patients who chose watch and wait had tumors with an earlier T stage and N stage and that were less likely to be poorly differentiated. Patients managed by watch and wait underwent a more intensive follow-up protocol consisting of outpatient digital rectal examination; MRI (every 4–6 months in the first 2 years); examination under anesthesia or endoscopy; computed tomography scan of the chest, abdomen, and pelvis; and at least two carcinoembryonic antigen measurements in the first 2 years. The optimal follow-up has not been determined.For patients who have a complete clinical response to therapy, it is reasonable to consider a watch-and-wait approach with intensive surveillance instead of immediate surgical resection.

In the paired-cohort analysis, the 3-year non-regrowth DFS rate for all patients was 83% (95% CI, 76%–88%): 88% (95% CI, 75%–94%) for the watch-and-wait group and 78% (95% CI, 63%–87%) for the surgical resection group (log-rank P = .022).

Investigators in England performed the Oncological Outcomes after Clinical Complete Response in Patients with Rectal Cancer trial.[23] This was a propensity-score−matched cohort analysis. At a tertiary medical center in Manchester, 228 patients who chose watchful waiting from 2011 to 2013 after a complete clinical response to preoperative chemoradiation therapy were combined with 98 patients from a registry of three neighboring medical centers who chose watchful waiting after chemoradiation therapy beginning in 2005. A clinical complete response was considered in the absence of residual ulceration, stenosis, or mass within the rectum during digital rectal examination and endoscopic examination 8 weeks or more after completion of concurrent chemoradiation therapy. The only positive findings consistent with a complete clinical response during clinical or endoscopic examination were whitening of the mucosa and telangiectasia. Classification of complete clinical response required normal radiological imaging of the mesorectum and pelvis. Complete clinical responders (n = 129) were compared with a cohort of patients treated similarly who underwent surgery for complete resection (n = 228). Compared with all patients who underwent surgery, patients who chose watch and wait had tumors with an earlier T stage and N stage and that were less likely to be poorly differentiated. Patients managed by watch and wait underwent a more intensive follow-up protocol consisting of outpatient digital rectal examination; MRI (every 4–6 months in the first 2 years); examination under anesthesia or endoscopy; computed tomography scan of the chest, abdomen, and pelvis; and at least two carcinoembryonic antigen measurements in the first 2 years. The optimal follow-up has not been determined.For patients who have a complete clinical response to therapy, it is reasonable to consider a watch-and-wait approach with intensive surveillance instead of immediate surgical resection.

The 3-year OS rate was 96% (95% CI, 88%–98%) in the watch-and-wait group versus 87% (95% CI, 77%–93%) for the surgical resection group (log-rank P = .015).

Investigators in England performed the Oncological Outcomes after Clinical Complete Response in Patients with Rectal Cancer trial.[23] This was a propensity-score−matched cohort analysis. At a tertiary medical center in Manchester, 228 patients who chose watchful waiting from 2011 to 2013 after a complete clinical response to preoperative chemoradiation therapy were combined with 98 patients from a registry of three neighboring medical centers who chose watchful waiting after chemoradiation therapy beginning in 2005. A clinical complete response was considered in the absence of residual ulceration, stenosis, or mass within the rectum during digital rectal examination and endoscopic examination 8 weeks or more after completion of concurrent chemoradiation therapy. The only positive findings consistent with a complete clinical response during clinical or endoscopic examination were whitening of the mucosa and telangiectasia. Classification of complete clinical response required normal radiological imaging of the mesorectum and pelvis. Complete clinical responders (n = 129) were compared with a cohort of patients treated similarly who underwent surgery for complete resection (n = 228). Compared with all patients who underwent surgery, patients who chose watch and wait had tumors with an earlier T stage and N stage and that were less likely to be poorly differentiated. Patients managed by watch and wait underwent a more intensive follow-up protocol consisting of outpatient digital rectal examination; MRI (every 4–6 months in the first 2 years); examination under anesthesia or endoscopy; computed tomography scan of the chest, abdomen, and pelvis; and at least two carcinoembryonic antigen measurements in the first 2 years. The optimal follow-up has not been determined.For patients who have a complete clinical response to therapy, it is reasonable to consider a watch-and-wait approach with intensive surveillance instead of immediate surgical resection.

The 3-year colostomy-free survival rate was 74% (95% CI, 64%–82%) for the watch-and-wait group and 47% (95% CI, 37%–57%; log-rank P < .0001) for the surgical group.

In the OPRA study (NCT02008656), 324 patients with stage II/III rectal cancer were randomly assigned to receive either induction chemotherapy followed by chemoradiation therapy or chemoradiation therapy followed by consolidation chemotherapy. Patients had the potential to omit surgery based on response assessment.[24,25] While the optimal surveillance regimen for patients undergoing nonoperative management is still under active study, the regimen in the OPRA trial involved periodic surveillance with digital rectal examination, sigmoidoscopy, and MRI. Digital rectal examination and flexible sigmoidoscopy were performed every 4 months for the first 2 years from the time of assessment of response, and every 6 months for the following 3 years. Rectal MRI was performed every 6 months for the first 2 years and yearly for the following 3 years. Patients could have additional assessments if clinically indicated.The optimal follow-up for these patients has not been determined. For patients who have a complete clinical response to therapy, nonoperative management with intensive surveillance instead of immediate surgical resection is a standard-of-care approach.

In the OPRA study (NCT02008656), 324 patients with stage II/III rectal cancer were randomly assigned to receive either induction chemotherapy followed by chemoradiation therapy or chemoradiation therapy followed by consolidation chemotherapy. Patients had the potential to omit surgery based on response assessment.[24,25] While the optimal surveillance regimen for patients undergoing nonoperative management is still under active study, the regimen in the OPRA trial involved periodic surveillance with digital rectal examination, sigmoidoscopy, and MRI. Digital rectal examination and flexible sigmoidoscopy were performed every 4 months for the first 2 years from the time of assessment of response, and every 6 months for the following 3 years. Rectal MRI was performed every 6 months for the first 2 years and yearly for the following 3 years. Patients could have additional assessments if clinically indicated.The optimal follow-up for these patients has not been determined. For patients who have a complete clinical response to therapy, nonoperative management with intensive surveillance instead of immediate surgical resection is a standard-of-care approach.

The 5-year DFS rate was 71% (95% CI, 64%–79%) and the total mesorectal excision–free survival rate was 39% (95% CI, 32%–48%) in the patients who received induction chemotherapy followed by chemoradiation therapy. The 5-year DFS rate was 69% (95% CI, 62%–77%) and the total mesorectal excision–free survival rate was 54% (95% CI, 46%–62%) in the patients who received chemoradiation therapy followed by consolidation chemotherapy.[24][Level of evidence B1]