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The intensity of posttreatment surveillance of patients with rectal cancer managed by a watch-and-wait approach can be safely reduced if patients achieve and maintain a clinical complete response within the first 3 years of initiation of that approach, a retrospective, multicenter registry study suggests.
“The risk of local regrowth or distant metastases after a clinical complete response to neoadjuvant chemoradiotherapy after nonoperative management of rectal cancer remains an important drawback for the widespread uptake of watch and wait in clinical practice,” Laura Fernandez, MD, Champalimaud Clinical Center, Lisbon, and colleagues observe.
“Conditional survival analysis estimates suggest that patients who sustain a clinical complete response for 3 years have 5% or lower risk of developing a local regrowth and a less than 2% risk of developing systemic recurrence thereafter,” the investigators emphasize.
Achieving a complete clinical recovery and sustaining it for 1 year is the “most relevant protective factor” for patients with rectal cancer and places them in an “excellent prognostic stage,” Fernandez said in a press statement.
The study was published online Dec. 11 in The Lancet Oncology.
A watch-and-wait database
A total of 793 patients were identified from the International Watch and Wait Database, a large registry of patients who experience a clinical complete response after neoadjuvant chemotherapy and who are managed by a watch-and-wait strategy. The registry includes data from 47 clinics in 15 countries.
The main outcome measures were the probability of patients remaining free of local regrowth and distant metastasis for an additional 2 years after sustaining a clinical complete response for 1, 3, and 5 years after the start of watch-and-wait management.
Among patients who had sustained clinical complete response for 1 year, the probability of remaining local regrowth–free for an additional 2 years – in other words, for a total of 3 years – was 88.1%.
Local regrowth–free survival rates were in the high 90 percentages after sustaining a clinical response for 3 years and for 5 years.
“Similar results were observed for distant metastasis–free survival,” Dr. Fernandez and colleagues continue. For example, 2-year conditional distant metastasis–free survival rates among patients who remained free of distant metastasis from the time the decision was made to initiate watch-and-wait management for 1 year was 93.8%; for 3 years, it was 97.8%; and for 5 years, it was 96.6%, the investigators report.
The only risk factors identified in the study for local regrowth over time was baseline clinical tumor stage and total dose of radiotherapy received.
However, after patients have achieved and sustained a complete clinical response for 1 year, known risk factors for local regrowth, such as disease stage before any treatment and the dose of radiation received by the patient, “seem to become irrelevant,” said Dr. Fernandez.
The authors say that after a patient sustains a clinical complete response for more than 3 years, it is unlikely that intensive surveillance for the detection of local regrowth would be required.
Indeed, they suggest that those who have no sign of regrowth or distant metastases at 3 years post treatment could probably be followed in established follow-up programs for rectal cancer patients who are treated with standard therapy, including radical resection.
Study limitations
Asked for comment, Joshua Smith, MD, PhD, a colorectal surgeon with the Memorial Sloan Kettering Cancer Center, New York, cautioned that there are real limitations to retrospective data as used for the current analysis, including the heterogeneity of the definitions of a clinical complete response. The investigators also tried to assess response to treatment both before and after 2010. Before 2010, intrarectal ultrasound was used to stage rectal cancer; currently, MRI is used.
There was also heterogeneity of the radiation used across the study interval. All of these factors must be taken into consideration when interpreting the investigators’ conclusions, Smith cautioned. Nevertheless, he also noted that the group is very sophisticated and that the article was well written and, in his view, not terribly overstated. “I just would be cautious with what they are saying that after 3 years, you do not need to be as strict with your surveillance,” Dr. Smith told this news organization.
“I think we still have some patients with local regrowth after that period of time, so I wouldn’t say we’re out of the woods after 3 years – I think we still have to follow these patients very closely,” he emphasized.
“The data clearly show that the longer a patient doesn’t have a local regrowth, the lower their chances are that they will develop local regrowth,” Dr. Smith said.
The study also provides clinicians with data to discuss with potential watch-and-wait candidates, he added. “The decision we make should really depend on the patient – what their goals are and what their quality-of-life perspective is,” Dr. Smith said. More definitive data on patient outcomes are expected soon from the Organ Preservation in Rectal Adenocarcinoma (OPRA) Trial.
That trial prospectively evaluates the watch-and-wait approach. Results should reflect not only what surgeons can anticipate with respect to local regrowth and distant metastases, but it should also determine the real organ preservation rate – an important endpoint of the watch-and-wait approach.
“I think it will be a paradigm-changing trial,” Dr. Smith predicted.
The study was funded by the European Registration of Cancer Care, among others organizations. Dr. Fernandez has disclosed no relevant financial relationships. Dr. Smith has served as a clinical advisor to Guardant Health.
A version of this article first appeared on Medscape.com.
The intensity of posttreatment surveillance of patients with rectal cancer managed by a watch-and-wait approach can be safely reduced if patients achieve and maintain a clinical complete response within the first 3 years of initiation of that approach, a retrospective, multicenter registry study suggests.
“The risk of local regrowth or distant metastases after a clinical complete response to neoadjuvant chemoradiotherapy after nonoperative management of rectal cancer remains an important drawback for the widespread uptake of watch and wait in clinical practice,” Laura Fernandez, MD, Champalimaud Clinical Center, Lisbon, and colleagues observe.
“Conditional survival analysis estimates suggest that patients who sustain a clinical complete response for 3 years have 5% or lower risk of developing a local regrowth and a less than 2% risk of developing systemic recurrence thereafter,” the investigators emphasize.
Achieving a complete clinical recovery and sustaining it for 1 year is the “most relevant protective factor” for patients with rectal cancer and places them in an “excellent prognostic stage,” Fernandez said in a press statement.
The study was published online Dec. 11 in The Lancet Oncology.
A watch-and-wait database
A total of 793 patients were identified from the International Watch and Wait Database, a large registry of patients who experience a clinical complete response after neoadjuvant chemotherapy and who are managed by a watch-and-wait strategy. The registry includes data from 47 clinics in 15 countries.
The main outcome measures were the probability of patients remaining free of local regrowth and distant metastasis for an additional 2 years after sustaining a clinical complete response for 1, 3, and 5 years after the start of watch-and-wait management.
Among patients who had sustained clinical complete response for 1 year, the probability of remaining local regrowth–free for an additional 2 years – in other words, for a total of 3 years – was 88.1%.
Local regrowth–free survival rates were in the high 90 percentages after sustaining a clinical response for 3 years and for 5 years.
“Similar results were observed for distant metastasis–free survival,” Dr. Fernandez and colleagues continue. For example, 2-year conditional distant metastasis–free survival rates among patients who remained free of distant metastasis from the time the decision was made to initiate watch-and-wait management for 1 year was 93.8%; for 3 years, it was 97.8%; and for 5 years, it was 96.6%, the investigators report.
The only risk factors identified in the study for local regrowth over time was baseline clinical tumor stage and total dose of radiotherapy received.
However, after patients have achieved and sustained a complete clinical response for 1 year, known risk factors for local regrowth, such as disease stage before any treatment and the dose of radiation received by the patient, “seem to become irrelevant,” said Dr. Fernandez.
The authors say that after a patient sustains a clinical complete response for more than 3 years, it is unlikely that intensive surveillance for the detection of local regrowth would be required.
Indeed, they suggest that those who have no sign of regrowth or distant metastases at 3 years post treatment could probably be followed in established follow-up programs for rectal cancer patients who are treated with standard therapy, including radical resection.
Study limitations
Asked for comment, Joshua Smith, MD, PhD, a colorectal surgeon with the Memorial Sloan Kettering Cancer Center, New York, cautioned that there are real limitations to retrospective data as used for the current analysis, including the heterogeneity of the definitions of a clinical complete response. The investigators also tried to assess response to treatment both before and after 2010. Before 2010, intrarectal ultrasound was used to stage rectal cancer; currently, MRI is used.
There was also heterogeneity of the radiation used across the study interval. All of these factors must be taken into consideration when interpreting the investigators’ conclusions, Smith cautioned. Nevertheless, he also noted that the group is very sophisticated and that the article was well written and, in his view, not terribly overstated. “I just would be cautious with what they are saying that after 3 years, you do not need to be as strict with your surveillance,” Dr. Smith told this news organization.
“I think we still have some patients with local regrowth after that period of time, so I wouldn’t say we’re out of the woods after 3 years – I think we still have to follow these patients very closely,” he emphasized.
“The data clearly show that the longer a patient doesn’t have a local regrowth, the lower their chances are that they will develop local regrowth,” Dr. Smith said.
The study also provides clinicians with data to discuss with potential watch-and-wait candidates, he added. “The decision we make should really depend on the patient – what their goals are and what their quality-of-life perspective is,” Dr. Smith said. More definitive data on patient outcomes are expected soon from the Organ Preservation in Rectal Adenocarcinoma (OPRA) Trial.
That trial prospectively evaluates the watch-and-wait approach. Results should reflect not only what surgeons can anticipate with respect to local regrowth and distant metastases, but it should also determine the real organ preservation rate – an important endpoint of the watch-and-wait approach.
“I think it will be a paradigm-changing trial,” Dr. Smith predicted.
The study was funded by the European Registration of Cancer Care, among others organizations. Dr. Fernandez has disclosed no relevant financial relationships. Dr. Smith has served as a clinical advisor to Guardant Health.
A version of this article first appeared on Medscape.com.
The intensity of posttreatment surveillance of patients with rectal cancer managed by a watch-and-wait approach can be safely reduced if patients achieve and maintain a clinical complete response within the first 3 years of initiation of that approach, a retrospective, multicenter registry study suggests.
“The risk of local regrowth or distant metastases after a clinical complete response to neoadjuvant chemoradiotherapy after nonoperative management of rectal cancer remains an important drawback for the widespread uptake of watch and wait in clinical practice,” Laura Fernandez, MD, Champalimaud Clinical Center, Lisbon, and colleagues observe.
“Conditional survival analysis estimates suggest that patients who sustain a clinical complete response for 3 years have 5% or lower risk of developing a local regrowth and a less than 2% risk of developing systemic recurrence thereafter,” the investigators emphasize.
Achieving a complete clinical recovery and sustaining it for 1 year is the “most relevant protective factor” for patients with rectal cancer and places them in an “excellent prognostic stage,” Fernandez said in a press statement.
The study was published online Dec. 11 in The Lancet Oncology.
A watch-and-wait database
A total of 793 patients were identified from the International Watch and Wait Database, a large registry of patients who experience a clinical complete response after neoadjuvant chemotherapy and who are managed by a watch-and-wait strategy. The registry includes data from 47 clinics in 15 countries.
The main outcome measures were the probability of patients remaining free of local regrowth and distant metastasis for an additional 2 years after sustaining a clinical complete response for 1, 3, and 5 years after the start of watch-and-wait management.
Among patients who had sustained clinical complete response for 1 year, the probability of remaining local regrowth–free for an additional 2 years – in other words, for a total of 3 years – was 88.1%.
Local regrowth–free survival rates were in the high 90 percentages after sustaining a clinical response for 3 years and for 5 years.
“Similar results were observed for distant metastasis–free survival,” Dr. Fernandez and colleagues continue. For example, 2-year conditional distant metastasis–free survival rates among patients who remained free of distant metastasis from the time the decision was made to initiate watch-and-wait management for 1 year was 93.8%; for 3 years, it was 97.8%; and for 5 years, it was 96.6%, the investigators report.
The only risk factors identified in the study for local regrowth over time was baseline clinical tumor stage and total dose of radiotherapy received.
However, after patients have achieved and sustained a complete clinical response for 1 year, known risk factors for local regrowth, such as disease stage before any treatment and the dose of radiation received by the patient, “seem to become irrelevant,” said Dr. Fernandez.
The authors say that after a patient sustains a clinical complete response for more than 3 years, it is unlikely that intensive surveillance for the detection of local regrowth would be required.
Indeed, they suggest that those who have no sign of regrowth or distant metastases at 3 years post treatment could probably be followed in established follow-up programs for rectal cancer patients who are treated with standard therapy, including radical resection.
Study limitations
Asked for comment, Joshua Smith, MD, PhD, a colorectal surgeon with the Memorial Sloan Kettering Cancer Center, New York, cautioned that there are real limitations to retrospective data as used for the current analysis, including the heterogeneity of the definitions of a clinical complete response. The investigators also tried to assess response to treatment both before and after 2010. Before 2010, intrarectal ultrasound was used to stage rectal cancer; currently, MRI is used.
There was also heterogeneity of the radiation used across the study interval. All of these factors must be taken into consideration when interpreting the investigators’ conclusions, Smith cautioned. Nevertheless, he also noted that the group is very sophisticated and that the article was well written and, in his view, not terribly overstated. “I just would be cautious with what they are saying that after 3 years, you do not need to be as strict with your surveillance,” Dr. Smith told this news organization.
“I think we still have some patients with local regrowth after that period of time, so I wouldn’t say we’re out of the woods after 3 years – I think we still have to follow these patients very closely,” he emphasized.
“The data clearly show that the longer a patient doesn’t have a local regrowth, the lower their chances are that they will develop local regrowth,” Dr. Smith said.
The study also provides clinicians with data to discuss with potential watch-and-wait candidates, he added. “The decision we make should really depend on the patient – what their goals are and what their quality-of-life perspective is,” Dr. Smith said. More definitive data on patient outcomes are expected soon from the Organ Preservation in Rectal Adenocarcinoma (OPRA) Trial.
That trial prospectively evaluates the watch-and-wait approach. Results should reflect not only what surgeons can anticipate with respect to local regrowth and distant metastases, but it should also determine the real organ preservation rate – an important endpoint of the watch-and-wait approach.
“I think it will be a paradigm-changing trial,” Dr. Smith predicted.
The study was funded by the European Registration of Cancer Care, among others organizations. Dr. Fernandez has disclosed no relevant financial relationships. Dr. Smith has served as a clinical advisor to Guardant Health.
A version of this article first appeared on Medscape.com.