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Data from a U.K. registry reveal that 86% of Barrett’s esophagus patients achieve complete remission of high-grade dysplasia after radiofrequency ablation, with only 9% reporting adverse events.
"The safety and short-term efficacy of radiofrequency ablation as a minimally invasive intervention for premalignant dysplastic Barrett’s esophagus are now beyond debate," wrote Dr. Rehan J. Haidry and his coauthors in the July issue of Gastroenterology (doi: 10.1053/j.gastro.2013.03.045).
Indeed, radiofrequency ablation (RFA) "has provided clinicians in specialist centers a valuable adjunct to more established surgical treatments."
Dr. Haidry, of the National Medical Laser Centre at University College London, and his colleagues analyzed data from the U.K. National Halo RFA Registry, founded in 2008 to audit outcomes of all patients undergoing ablation using the Halo device for high-grade dysplasia and early cancer in Barrett’s esophagus.
The cohort included 335 patients (mean age, 68.1 years); 81% were men and 100% were white.
Dr. Haidry calculated that the median number of RFA treatments was 2 (range, 1-6), and they took place over a median period of 11.6 months. The mean length of Barrett’s esophagus to be ablated was 5.8 cm. In all, 72% of patients were classed as having high-grade dysplasia, 24% as having low-grade dysplasia, and 4% as having intramucosal cancer.
About half the patients (49%) underwent endoscopic resection before starting RFA.
The researchers then combed the records for evidence of the primary outcomes of this analysis: complete reversal of high-grade dysplasia and complete reversal of all dysplasia 12 months from the index RFA treatment.
They found that at 1 year post RFA, 86% of patients had achieved complete reversal of high-grade dysplasia, and 81% showed complete reversal of all dysplasia.
Nevertheless, the authors also found 12 cases of recurrent neoplasia after "apparently successful" ablation, occurring at a mean 8 months after completion of the protocol.
Additionally, "5.1% have progressed to invasive disease at their most recent follow-up biopsy," the authors wrote.
Looking at the safety profile of RFA, the investigators uncovered one case of perforation in a patient who was treated with a 34-mm balloon (since removed from the market, according to the researchers), and 30 cases (9%) of stricturing, all of which were managed endoscopically.
The authors conceded several limitations to this "real world" analysis of what they called "the largest series to date of patients with early Barrett’s neoplasia undergoing RFA."
For example, "the proposed protocol states that all patients should undergo ablation every 3 months until the 12-month period, at which point the end-of-protocol biopsy defines treatment success or failure," wrote Dr. Haidry.
"Within the confines of varied practice nationwide and diversity in resources, these strict timelines were difficult to achieve."
Moreover, "although the durability of favorable response appears promising, our median follow-up time of 19 months is short," added the authors, noting that two late relapses occurred more than 4 years after "apparently successful" ablation.
"This highlights the importance of long-term follow-up of these patients."
The researchers disclosed that one of their coauthors has financial ties to the makers of the Halo device. The work was supported by the Cancer Research UK (CRUK) University College London Early Cancer Medicine Centre, and was conducted at a facility sponsored by the U.K. Department of Health.
Ablation of Barrett’s esophagus may be a “game changer” for high-risk patients with Barrett’s esophagus: It provides the potential of changing the management of this precancerous condition from surveillance for early cancer to prevention. We need to confirm several factors, however, to determine if ablation is both effective and practical, especially as compared with surveillance. In particular, does it decrease the risk of important endpoints such as cancer or cancer death; is the decrease in cancer risk durable; and can it decrease the need for alternative strategies (e.g., repeated endoscopies for surveillance)?
The two articles recently published in Gastroenterology ( "Dutch study confirms RFA for Barrett's durable at 5 years," "One-third recur after RFA in Barrett's esophagus") provide insights into the durability of ablation, after the initial successful elimination of Barrett’s esophagus. Reported from three different multicenter groups, from three different countries, the somewhat disparate results provide a greater understanding of ablation outcomes. Together, the studies indicate that:
- P Most patients have durable eradication of their dysplasia; thus, ablation is a reasonable long-term strategy for high-risk patients (e.g., patients with high-grade dysplasia).
- P There is a low but significant risk of recurrent metaplasia and dysplasia. In a study from the United Kingdom, among 208 patients who achieved remission, only 9% in follow-up had recurrent intestinal metaplasia by the end of follow-up; but of those with recurrence, 47% had recurrent dysplasia. The study from the Netherlands found recurrent esophageal metaplasia in only 6% of their 54 patients; among these patients, one had low-grade dysplasia, one had high-grade dysplasia, and one had a small cancer. In contrast, the U.S. Multicenter Consortium found that, among patients who were in remission by 24 months, 20% developed recurrent metaplasia within 1 year and 33% had metaplasia after 2 years. These findings suggest that continued endoscopic surveillance is required until better predictors of risk are available.
- P The differences in results between the centers suggest we can learn more about how to optimize outcomes. Comparative trials are needed to confirm the optimum methods for both ablation and postablation acid suppression, which differed somewhat between the centers.
Douglas A. Corley, M.D., Ph.D., is in the division of research, Kaiser Permanente Northern California, Oakland, and Kaiser Permanente San Francisco Medical Center. He reported no conflicts of interest.
Ablation of Barrett’s esophagus may be a “game changer” for high-risk patients with Barrett’s esophagus: It provides the potential of changing the management of this precancerous condition from surveillance for early cancer to prevention. We need to confirm several factors, however, to determine if ablation is both effective and practical, especially as compared with surveillance. In particular, does it decrease the risk of important endpoints such as cancer or cancer death; is the decrease in cancer risk durable; and can it decrease the need for alternative strategies (e.g., repeated endoscopies for surveillance)?
The two articles recently published in Gastroenterology ( "Dutch study confirms RFA for Barrett's durable at 5 years," "One-third recur after RFA in Barrett's esophagus") provide insights into the durability of ablation, after the initial successful elimination of Barrett’s esophagus. Reported from three different multicenter groups, from three different countries, the somewhat disparate results provide a greater understanding of ablation outcomes. Together, the studies indicate that:
- P Most patients have durable eradication of their dysplasia; thus, ablation is a reasonable long-term strategy for high-risk patients (e.g., patients with high-grade dysplasia).
- P There is a low but significant risk of recurrent metaplasia and dysplasia. In a study from the United Kingdom, among 208 patients who achieved remission, only 9% in follow-up had recurrent intestinal metaplasia by the end of follow-up; but of those with recurrence, 47% had recurrent dysplasia. The study from the Netherlands found recurrent esophageal metaplasia in only 6% of their 54 patients; among these patients, one had low-grade dysplasia, one had high-grade dysplasia, and one had a small cancer. In contrast, the U.S. Multicenter Consortium found that, among patients who were in remission by 24 months, 20% developed recurrent metaplasia within 1 year and 33% had metaplasia after 2 years. These findings suggest that continued endoscopic surveillance is required until better predictors of risk are available.
- P The differences in results between the centers suggest we can learn more about how to optimize outcomes. Comparative trials are needed to confirm the optimum methods for both ablation and postablation acid suppression, which differed somewhat between the centers.
Douglas A. Corley, M.D., Ph.D., is in the division of research, Kaiser Permanente Northern California, Oakland, and Kaiser Permanente San Francisco Medical Center. He reported no conflicts of interest.
Ablation of Barrett’s esophagus may be a “game changer” for high-risk patients with Barrett’s esophagus: It provides the potential of changing the management of this precancerous condition from surveillance for early cancer to prevention. We need to confirm several factors, however, to determine if ablation is both effective and practical, especially as compared with surveillance. In particular, does it decrease the risk of important endpoints such as cancer or cancer death; is the decrease in cancer risk durable; and can it decrease the need for alternative strategies (e.g., repeated endoscopies for surveillance)?
The two articles recently published in Gastroenterology ( "Dutch study confirms RFA for Barrett's durable at 5 years," "One-third recur after RFA in Barrett's esophagus") provide insights into the durability of ablation, after the initial successful elimination of Barrett’s esophagus. Reported from three different multicenter groups, from three different countries, the somewhat disparate results provide a greater understanding of ablation outcomes. Together, the studies indicate that:
- P Most patients have durable eradication of their dysplasia; thus, ablation is a reasonable long-term strategy for high-risk patients (e.g., patients with high-grade dysplasia).
- P There is a low but significant risk of recurrent metaplasia and dysplasia. In a study from the United Kingdom, among 208 patients who achieved remission, only 9% in follow-up had recurrent intestinal metaplasia by the end of follow-up; but of those with recurrence, 47% had recurrent dysplasia. The study from the Netherlands found recurrent esophageal metaplasia in only 6% of their 54 patients; among these patients, one had low-grade dysplasia, one had high-grade dysplasia, and one had a small cancer. In contrast, the U.S. Multicenter Consortium found that, among patients who were in remission by 24 months, 20% developed recurrent metaplasia within 1 year and 33% had metaplasia after 2 years. These findings suggest that continued endoscopic surveillance is required until better predictors of risk are available.
- P The differences in results between the centers suggest we can learn more about how to optimize outcomes. Comparative trials are needed to confirm the optimum methods for both ablation and postablation acid suppression, which differed somewhat between the centers.
Douglas A. Corley, M.D., Ph.D., is in the division of research, Kaiser Permanente Northern California, Oakland, and Kaiser Permanente San Francisco Medical Center. He reported no conflicts of interest.
Data from a U.K. registry reveal that 86% of Barrett’s esophagus patients achieve complete remission of high-grade dysplasia after radiofrequency ablation, with only 9% reporting adverse events.
"The safety and short-term efficacy of radiofrequency ablation as a minimally invasive intervention for premalignant dysplastic Barrett’s esophagus are now beyond debate," wrote Dr. Rehan J. Haidry and his coauthors in the July issue of Gastroenterology (doi: 10.1053/j.gastro.2013.03.045).
Indeed, radiofrequency ablation (RFA) "has provided clinicians in specialist centers a valuable adjunct to more established surgical treatments."
Dr. Haidry, of the National Medical Laser Centre at University College London, and his colleagues analyzed data from the U.K. National Halo RFA Registry, founded in 2008 to audit outcomes of all patients undergoing ablation using the Halo device for high-grade dysplasia and early cancer in Barrett’s esophagus.
The cohort included 335 patients (mean age, 68.1 years); 81% were men and 100% were white.
Dr. Haidry calculated that the median number of RFA treatments was 2 (range, 1-6), and they took place over a median period of 11.6 months. The mean length of Barrett’s esophagus to be ablated was 5.8 cm. In all, 72% of patients were classed as having high-grade dysplasia, 24% as having low-grade dysplasia, and 4% as having intramucosal cancer.
About half the patients (49%) underwent endoscopic resection before starting RFA.
The researchers then combed the records for evidence of the primary outcomes of this analysis: complete reversal of high-grade dysplasia and complete reversal of all dysplasia 12 months from the index RFA treatment.
They found that at 1 year post RFA, 86% of patients had achieved complete reversal of high-grade dysplasia, and 81% showed complete reversal of all dysplasia.
Nevertheless, the authors also found 12 cases of recurrent neoplasia after "apparently successful" ablation, occurring at a mean 8 months after completion of the protocol.
Additionally, "5.1% have progressed to invasive disease at their most recent follow-up biopsy," the authors wrote.
Looking at the safety profile of RFA, the investigators uncovered one case of perforation in a patient who was treated with a 34-mm balloon (since removed from the market, according to the researchers), and 30 cases (9%) of stricturing, all of which were managed endoscopically.
The authors conceded several limitations to this "real world" analysis of what they called "the largest series to date of patients with early Barrett’s neoplasia undergoing RFA."
For example, "the proposed protocol states that all patients should undergo ablation every 3 months until the 12-month period, at which point the end-of-protocol biopsy defines treatment success or failure," wrote Dr. Haidry.
"Within the confines of varied practice nationwide and diversity in resources, these strict timelines were difficult to achieve."
Moreover, "although the durability of favorable response appears promising, our median follow-up time of 19 months is short," added the authors, noting that two late relapses occurred more than 4 years after "apparently successful" ablation.
"This highlights the importance of long-term follow-up of these patients."
The researchers disclosed that one of their coauthors has financial ties to the makers of the Halo device. The work was supported by the Cancer Research UK (CRUK) University College London Early Cancer Medicine Centre, and was conducted at a facility sponsored by the U.K. Department of Health.
Data from a U.K. registry reveal that 86% of Barrett’s esophagus patients achieve complete remission of high-grade dysplasia after radiofrequency ablation, with only 9% reporting adverse events.
"The safety and short-term efficacy of radiofrequency ablation as a minimally invasive intervention for premalignant dysplastic Barrett’s esophagus are now beyond debate," wrote Dr. Rehan J. Haidry and his coauthors in the July issue of Gastroenterology (doi: 10.1053/j.gastro.2013.03.045).
Indeed, radiofrequency ablation (RFA) "has provided clinicians in specialist centers a valuable adjunct to more established surgical treatments."
Dr. Haidry, of the National Medical Laser Centre at University College London, and his colleagues analyzed data from the U.K. National Halo RFA Registry, founded in 2008 to audit outcomes of all patients undergoing ablation using the Halo device for high-grade dysplasia and early cancer in Barrett’s esophagus.
The cohort included 335 patients (mean age, 68.1 years); 81% were men and 100% were white.
Dr. Haidry calculated that the median number of RFA treatments was 2 (range, 1-6), and they took place over a median period of 11.6 months. The mean length of Barrett’s esophagus to be ablated was 5.8 cm. In all, 72% of patients were classed as having high-grade dysplasia, 24% as having low-grade dysplasia, and 4% as having intramucosal cancer.
About half the patients (49%) underwent endoscopic resection before starting RFA.
The researchers then combed the records for evidence of the primary outcomes of this analysis: complete reversal of high-grade dysplasia and complete reversal of all dysplasia 12 months from the index RFA treatment.
They found that at 1 year post RFA, 86% of patients had achieved complete reversal of high-grade dysplasia, and 81% showed complete reversal of all dysplasia.
Nevertheless, the authors also found 12 cases of recurrent neoplasia after "apparently successful" ablation, occurring at a mean 8 months after completion of the protocol.
Additionally, "5.1% have progressed to invasive disease at their most recent follow-up biopsy," the authors wrote.
Looking at the safety profile of RFA, the investigators uncovered one case of perforation in a patient who was treated with a 34-mm balloon (since removed from the market, according to the researchers), and 30 cases (9%) of stricturing, all of which were managed endoscopically.
The authors conceded several limitations to this "real world" analysis of what they called "the largest series to date of patients with early Barrett’s neoplasia undergoing RFA."
For example, "the proposed protocol states that all patients should undergo ablation every 3 months until the 12-month period, at which point the end-of-protocol biopsy defines treatment success or failure," wrote Dr. Haidry.
"Within the confines of varied practice nationwide and diversity in resources, these strict timelines were difficult to achieve."
Moreover, "although the durability of favorable response appears promising, our median follow-up time of 19 months is short," added the authors, noting that two late relapses occurred more than 4 years after "apparently successful" ablation.
"This highlights the importance of long-term follow-up of these patients."
The researchers disclosed that one of their coauthors has financial ties to the makers of the Halo device. The work was supported by the Cancer Research UK (CRUK) University College London Early Cancer Medicine Centre, and was conducted at a facility sponsored by the U.K. Department of Health.
FROM GASTROENTEROLOGY
Major finding: At 1 year post radiofrequency ablation for Barrett’s esophagus, 86% of patients had achieved complete reversal of high-grade dysplasia, and 81% complete reversal of all dysplasia.
Data source: The U.K. National Halo RFA Registry.
Disclosures: The researchers disclosed that one of their coauthors has financial ties to the makers of the Halo device. The work was supported by the Cancer Research UK (CRUK) University College London Early Cancer Medicine Centre, and was conducted at a facility sponsored by the U.K. Department of Health.