Patients with rectal cancer responsive to neoadjuvant therapy may forgo surgery
Nonoperative “watch-and-wait” management may be a viable strategy for certain patients with rectal cancer who demonstrate a complete clinical response to neoadjuvant therapy, according to study results published in Surgical Oncology.
Radical resection is considered standard treatment for many patients with rectal cancer. However, this surgery may result in quality-of-life issues such as incontinence, urinary/sexual dysfunction and the need for a colostomy bag, as well as the risk for anastomotic leak, a potentially fatal complication.
“In previous retrospective series, we have seen that a nonoperative management may be feasible in patients who are older, have a number of comorbidities or are unable to undergo a prostatectomy,” study author Stephen J. Nurkin, MD, MS, FACS, associate professor of surgery at Roswell Park Comprehensive Cancer Center, said in an interview with HemOnc Today. “Based on this, we decided to look at this in a prospective manner, collecting a database of patients who were interested in nonoperative management, if they did obtain a complete clinical response.”
In the retrospective analysis, Nurkin and colleagues identified 29 patients (mean age, 67 years; 55.2% women) with rectal cancer treated at Roswell Park Comprehensive Cancer Center between 2012 and 2016 who opted to forego surgery in favor of nonoperative management after achieving complete clinical response following various neoadjuvant treatments.
All patients received neoadjuvant long course chemoradiotherapy. Seven underwent initial induction FOLFOX chemotherapy followed by chemoradiation, and 11 underwent consolidation chemotherapy after chemoradiation.
The researchers reported follow-up results every 3 to 4 months for the first 2 years and conducted physical exams, carcinoembryonic antigen evaluations, repeat lower endoscopy, and CT of the chest/abdomen/pelvis every 6 months. After 2 years, researchers followed patients every 4 to 6 months.
At median follow-up of 27.6 months (range, 5.5-64.5), 79% of the patients remained cancer-free. Six patients (21%) experienced recurrences (one local, one local and distant, and four distant). Five of these patients were candidates for salvage surgery. One patient died of causes not related to rectal cancer.
Researchers observed no clinically significant differences in local, distant or synchronous recurrence related to patient characteristics, tumor stage, treatment regimen or pathology.
At 1 year, the local recurrence rate was 0.95 (95% CI, 0.72-0.99), the distant recurrence rate was 0.89 (95% CI, 0.69-0.96) and the rate of any recurrence was 0.89 (95% CI, 0.69-0.96).
At 3 years, the local recurrence rate was 0.87 (95% CI, 0.54-0.97), the distant recurrence rate was 0.76 (95% CI, 0.49-0.9) and the rate of any recurrence was 0.68 (95% CI, 0.4-0.85).
The researchers cited limitations to their study, including the use of various treatment strategies and relatively short-term follow-up.
Nurkin said he believes these findings raise awareness of and support data on nonoperative management of rectal cancer.
“We’re getting more and more systemic options, and we have more effective therapies that are clearly leading to better response rates in these types of tumors,” Nurkin told HemOnc Today. “We also now have more effective therapies that are clearly reading to more response rates in these types of tumors.”
‘Watch and wait’
Nurkin said the first step in nonoperative management is to determine whether it is suitable for the patient. After patients with stage II or III rectal cancer have undergone chemoradiation and adjuvant therapy, Nurkin said he evaluates them through sigmoidoscopy and endoscopic evaluation to determine their response.
"If there's no evidence of ulcer or stricture, as long as endoscopically we’re not seeing any evidence of a residual tumor, we still offer the standard of care, which is surgical resection,” Nurkin said. “Then we also discuss nonoperative management with them, if they’re interested in what that entails.”
Typically, nonoperative management includes endoscopic evaluation with sigmoidoscopy at least three times a year, he said. Additionally, patients receive endoscopic ultrasound or MRI at least twice a year, to assess for possible lymph node recurrences outside the rectal wall.
“That’s the surveillance we do for 2 years and, after that, we open up those intervals a bit more, so the scopes are not as frequent,” he said. “We do find that most of the time, if these patients recur, they usually recur within a 2-year timeframe.”
Nonoperative management is not for all patients, Nurkin said, noting that clinicians should discuss the risks vs. benefits of this option with their patients. He added that appropriate candidates for nonoperative management should be willing and able to comply with intensive surveillance.
“This is still fairly experimental, and we do not have large data sets and large randomized controlled trials showing that this is safe for all,” he said. – by Jennifer Byrne
For more information:
Stephen J. Nurkin, MD, MS, FACS, can be reached at firstname.lastname@example.org.
Disclosures: Nurkin reports no relevant disclosures. Please see the study for all other authors’ relevant financial disclosures.