Dutch study confirms RFA for Barrett's durable at 5 years

At 5 years after radiofrequency ablation for Barrett’s esophagus, 93% of patients remained in complete, sustained remission.

That’s the finding from a Netherlands cohort with the "longest duration of follow-up of patients undergoing RFA for BE containing high-grade intraepithelial neoplasia and/or early-stage cancer," wrote Dr. K. Nadine Phoa and coauthors. The study, for the July issue of Gastroenterology, was published online April 1.

The investigators cautioned, however, that "both cancer recurrences occurred after almost 5 years of follow-up," demonstrating the need for long-term monitoring in this population (doi: 10.1053/j.gastro.2013.03.046).

Dr. Phoa, of the Academic Medical Center in Amsterdam, and her colleagues looked at data from four distinct consecutive cohort studies: AMC-I, which was the first pilot study of circumferential RFA using the HALO360 ablation device; AMC-II, the second, prospective study of the device; EURO-I, the first European multicenter RFA trial; and AMC-IV, a prospective, randomized, multicenter trial of the device.

Of the 55 patients who underwent one of the included trials and were treated at Dr. Phoa’s institution (45 men; mean age, 65 years), 72% underwent endoscopic resection before the first RFA treatment, either piecemeal or en bloc.

After RFA, complete remission of neoplasia and/or complete remission of intestinal metaplasia was achieved in 54 of 55 patients; of the 54 patients, 8 withdrew during follow-up due to unrelated death, comorbidity, or emigration, leaving 46 patients with a median follow-up of 61 months and six endoscopies for analysis.

The investigators found that among these, sustained complete remission of neoplasia and complete remission of intestinal metaplasia were maintained in 43 of 46 patients (93%; 95% confidence interval, 82.5-97.8).

Among the 3 patients who did have recurrence, one was 71 years old and initially presented with early-stage cancer and multifocal high-grade intraepithelial neoplasia. At the 5-year visit, a "small area with columnar mucosa with low-grade intraepithelial neoplasia was discovered," wrote the authors, and "18 months after argon plasma coagulation, no endoscopic or histological evidence of residual BE was found."

The second case was an 81-year-old patient with baseline early-stage cancer and residual BE with high-grade intraepithelial neoplasia. During the patient’s fifth endoscopy, at 52 months post RFA, "a 6-mm lesion was seen and radically removed en bloc by endoscopic resection-cap technique," the authors wrote.

"Histological evaluation showed a radically resected mucosal cancer without evidence of lymph-vascular invasion," they added, and at 3 and 9 months post resection, no endoscopic or histologic evidence of neoplasia was found.

Finally, the third case of recurrence was seen in a 62-year-old patient with baseline early-stage cancer and high-grade intraepithelial neoplasia, who, at the 5-year visit, had an elevated Barrett’s island containing carcinoma 2 cm above the neo-squamocolumnar junction.

"The lesion was radically removed en bloc by endoscopic resection-cap technique," wrote the authors, and as in the case of the prior two lesions, 3 months later, "no endoscopic or histological evidence of neoplasia or intestinal metaplasia was found."

Taking into account these three cases, the authors performed a Kaplan-Meier analysis and found a recurrence-free proportion of 90% of patients after 5 years.

According to the authors, even though remission was reestablished in all 3 patients who recurred, "this study also demonstrates how small and subtle recurrences can be."

Indeed, "even a minimal area of residual Barrett’s might be at risk for malignant progression, and this emphasizes the importance of a dedicated treatment protocol and careful endoscopic inspection to ensure complete eradication of all Barrett’s epithelium."

One of Dr. Phoa’s coauthors disclosed financial relationships with BÂRRX Medical, maker of the HALO device, and other pharmaceutical and device makers. The researchers wrote that BÂRRX Medical also supported this study.

At 5 years after radiofrequency ablation for Barrett’s esophagus, 93% of patients remained in complete, sustained remission.

That’s the finding from a Netherlands cohort with the "longest duration of follow-up of patients undergoing RFA for BE containing high-grade intraepithelial neoplasia and/or early-stage cancer," wrote Dr. K. Nadine Phoa and coauthors. The study, for the July issue of Gastroenterology, was published online April 1.

The investigators cautioned, however, that "both cancer recurrences occurred after almost 5 years of follow-up," demonstrating the need for long-term monitoring in this population (doi: 10.1053/j.gastro.2013.03.046).

Dr. Phoa, of the Academic Medical Center in Amsterdam, and her colleagues looked at data from four distinct consecutive cohort studies: AMC-I, which was the first pilot study of circumferential RFA using the HALO360 ablation device; AMC-II, the second, prospective study of the device; EURO-I, the first European multicenter RFA trial; and AMC-IV, a prospective, randomized, multicenter trial of the device.

Of the 55 patients who underwent one of the included trials and were treated at Dr. Phoa’s institution (45 men; mean age, 65 years), 72% underwent endoscopic resection before the first RFA treatment, either piecemeal or en bloc.

After RFA, complete remission of neoplasia and/or complete remission of intestinal metaplasia was achieved in 54 of 55 patients; of the 54 patients, 8 withdrew during follow-up due to unrelated death, comorbidity, or emigration, leaving 46 patients with a median follow-up of 61 months and six endoscopies for analysis.

The investigators found that among these, sustained complete remission of neoplasia and complete remission of intestinal metaplasia were maintained in 43 of 46 patients (93%; 95% confidence interval, 82.5-97.8).

Among the 3 patients who did have recurrence, one was 71 years old and initially presented with early-stage cancer and multifocal high-grade intraepithelial neoplasia. At the 5-year visit, a "small area with columnar mucosa with low-grade intraepithelial neoplasia was discovered," wrote the authors, and "18 months after argon plasma coagulation, no endoscopic or histological evidence of residual BE was found."

The second case was an 81-year-old patient with baseline early-stage cancer and residual BE with high-grade intraepithelial neoplasia. During the patient’s fifth endoscopy, at 52 months post RFA, "a 6-mm lesion was seen and radically removed en bloc by endoscopic resection-cap technique," the authors wrote.

"Histological evaluation showed a radically resected mucosal cancer without evidence of lymph-vascular invasion," they added, and at 3 and 9 months post resection, no endoscopic or histologic evidence of neoplasia was found.

Finally, the third case of recurrence was seen in a 62-year-old patient with baseline early-stage cancer and high-grade intraepithelial neoplasia, who, at the 5-year visit, had an elevated Barrett’s island containing carcinoma 2 cm above the neo-squamocolumnar junction.

"The lesion was radically removed en bloc by endoscopic resection-cap technique," wrote the authors, and as in the case of the prior two lesions, 3 months later, "no endoscopic or histological evidence of neoplasia or intestinal metaplasia was found."

Taking into account these three cases, the authors performed a Kaplan-Meier analysis and found a recurrence-free proportion of 90% of patients after 5 years.

According to the authors, even though remission was reestablished in all 3 patients who recurred, "this study also demonstrates how small and subtle recurrences can be."

Indeed, "even a minimal area of residual Barrett’s might be at risk for malignant progression, and this emphasizes the importance of a dedicated treatment protocol and careful endoscopic inspection to ensure complete eradication of all Barrett’s epithelium."

One of Dr. Phoa’s coauthors disclosed financial relationships with BÂRRX Medical, maker of the HALO device, and other pharmaceutical and device makers. The researchers wrote that BÂRRX Medical also supported this study.

At 5 years after radiofrequency ablation for Barrett’s esophagus, 93% of patients remained in complete, sustained remission.

That’s the finding from a Netherlands cohort with the "longest duration of follow-up of patients undergoing RFA for BE containing high-grade intraepithelial neoplasia and/or early-stage cancer," wrote Dr. K. Nadine Phoa and coauthors. The study, for the July issue of Gastroenterology, was published online April 1.

The investigators cautioned, however, that "both cancer recurrences occurred after almost 5 years of follow-up," demonstrating the need for long-term monitoring in this population (doi: 10.1053/j.gastro.2013.03.046).

Dr. Phoa, of the Academic Medical Center in Amsterdam, and her colleagues looked at data from four distinct consecutive cohort studies: AMC-I, which was the first pilot study of circumferential RFA using the HALO360 ablation device; AMC-II, the second, prospective study of the device; EURO-I, the first European multicenter RFA trial; and AMC-IV, a prospective, randomized, multicenter trial of the device.

Of the 55 patients who underwent one of the included trials and were treated at Dr. Phoa’s institution (45 men; mean age, 65 years), 72% underwent endoscopic resection before the first RFA treatment, either piecemeal or en bloc.

After RFA, complete remission of neoplasia and/or complete remission of intestinal metaplasia was achieved in 54 of 55 patients; of the 54 patients, 8 withdrew during follow-up due to unrelated death, comorbidity, or emigration, leaving 46 patients with a median follow-up of 61 months and six endoscopies for analysis.

The investigators found that among these, sustained complete remission of neoplasia and complete remission of intestinal metaplasia were maintained in 43 of 46 patients (93%; 95% confidence interval, 82.5-97.8).

Among the 3 patients who did have recurrence, one was 71 years old and initially presented with early-stage cancer and multifocal high-grade intraepithelial neoplasia. At the 5-year visit, a "small area with columnar mucosa with low-grade intraepithelial neoplasia was discovered," wrote the authors, and "18 months after argon plasma coagulation, no endoscopic or histological evidence of residual BE was found."

The second case was an 81-year-old patient with baseline early-stage cancer and residual BE with high-grade intraepithelial neoplasia. During the patient’s fifth endoscopy, at 52 months post RFA, "a 6-mm lesion was seen and radically removed en bloc by endoscopic resection-cap technique," the authors wrote.

"Histological evaluation showed a radically resected mucosal cancer without evidence of lymph-vascular invasion," they added, and at 3 and 9 months post resection, no endoscopic or histologic evidence of neoplasia was found.

Finally, the third case of recurrence was seen in a 62-year-old patient with baseline early-stage cancer and high-grade intraepithelial neoplasia, who, at the 5-year visit, had an elevated Barrett’s island containing carcinoma 2 cm above the neo-squamocolumnar junction.

"The lesion was radically removed en bloc by endoscopic resection-cap technique," wrote the authors, and as in the case of the prior two lesions, 3 months later, "no endoscopic or histological evidence of neoplasia or intestinal metaplasia was found."

Taking into account these three cases, the authors performed a Kaplan-Meier analysis and found a recurrence-free proportion of 90% of patients after 5 years.

According to the authors, even though remission was reestablished in all 3 patients who recurred, "this study also demonstrates how small and subtle recurrences can be."

Indeed, "even a minimal area of residual Barrett’s might be at risk for malignant progression, and this emphasizes the importance of a dedicated treatment protocol and careful endoscopic inspection to ensure complete eradication of all Barrett’s epithelium."

One of Dr. Phoa’s coauthors disclosed financial relationships with BÂRRX Medical, maker of the HALO device, and other pharmaceutical and device makers. The researchers wrote that BÂRRX Medical also supported this study.