Patients with rectal cancer who sustained clinical complete response after neoadjuvant chemoradiotherapy for 1 year with a watch-and-wait strategy seemed to have low risk for local regrowth and distant metastases during the next 2 years, researchers reported.
In the study of 793 patients with clinical complete response being managed by watch-and-wait strategy at 47 clinics in 15 countries, the probability of remaining free of local regrowth for 2 additional years after 1 year of clinical complete response was 88.1%, according to Rodrigo Perez, PhD, of Hospital Alemao Oswaldo Cruz in Sao Paulo, Brazil, and colleagues.
This increased to 97.3% if clinical complete response was sustained for 3 years, and to 98.6% if sustained for 5 years, they stated in the Lancet Oncology.
Results suggest that the intensity of surveillance for watch-and-wait patients may be reduced, according to the authors, who wrote that "intensive surveillance of the rectum for the detection of local regrowth after sustaining a clinical complete response for more than 3 years is unlikely to be required."
Similarly, the probability of having no distant metastasis also increased with the duration of clinical complete response. The probability of 2 additional years of distant-free survival was 93.8% for those who sustained clinical complete response 1 year and increased to more than 95% at 3 years (97.8%) and at 5 years (96.6%).
The only significant factor for local regrowth identified in the study were baseline cT stage (cT3-4 vs cT1-2, hazard ratio 1.73, 95% CI 1.15-2.61, P=0.0083) and total radiotherapy dose (greater than 50.4 Gy vs <50.4, HR 0.60, 95% CI 0.00-0.84, P=0.0035).
Perez and colleagues conducted a conditional survival modelling study using the International Watch & Wait Database. Adult patients enrolled in the retrospective study were undergoing a surveillance strategy from 1991 to 2015.
The authors explained that "Clinical complete response was defined as the presence of white scars and telangiectasias, and the absence of any irregularity, mass, ulceration, or stenosis during clinical assessment. In addition, only patients with radiological imaging consistent with complete tumour regression (including the absence of metastatic lymph nodes) were included in the study."
David Liska, MD, of the Cleveland Clinic, said that his institution is using this watch-and-wait approach more now than it did several years ago. Based on the number of studies being published about the watch-and-wait approach in rectal cancer, it seems that utilization of the approach is also increasing elsewhere, he said.
"Current surveillance practices are not standardized across institutions, including the ones that participated in this study," said Liska, who was not involved in the study. "However, many of the surveillance protocols described in the literature, similar to ours here at Cleveland Clinic, are rather intensive, including frequent endoscopic examination, blood tests, MRIs, and CT scans."
The point of this intensive regimen is to make sure that if the cancer recurs it can be caught early, but these tests can be expensive and cause anxiety for patients, he noted.
"If further studies confirm that recurrence after 3 years is very rare, we could hopefully observe our watch-and-wait patients with a less intensive surveillance regimen," Liska said.
Indeed, the criteria used to define both clinical complete response and surveillance strategies for a watch-and-wait approach varied by institution in the study, and included the possibility of patients with near complete or full clinical complete responses being grouped together.
However, Perez and colleagues noted that if this did occur it might better reflect a real-world clinical practice "as identifying patients with full clinical complete response according to strict criteria takes a substantial amount of time" and "identification of full clinical complete response is usually retrospective."
Still, this makes the results less generalizable, Liska said, adding that some studies have shown that following chemoradiation, recurrences can occur even more than 5 years after completing treatment.
"It will, therefore, be important to continue monitoring outcomes from large series of watch-and-wait patients for more than 5 years, and, ideally, also have studies that directly compare different surveillance regimens before finalizing recommendations regarding the intensity and duration of surveillance," he stated. "Regardless of the specific surveillance regimen chosen, it is critically important to have a multidisciplinary team of experts direct the selection of patients, treatments, and surveillance regimens in order for a watch-and-wait approach in rectal cancer to achieve optimal outcomes."
Disclosures
Perez and a co-author disclosed relevant relationships with Johnson & Johnson, Medtronics, Merck, Merck Sharpe & Dohme, and Roche.
Liska disclosed no relevant relationships with industry.
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