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SAN FRANCISCO – Five-year survival rates for 41 patients with locoregionally advanced esophageal cancer who underwent induction chemotherapy and definitive chemoradiotherapy were 53% for patients with a clinical complete response who avoided surgery, 33% for patients with suspected residual disease, and 41% for patients with suspected residual disease who were able to undergo surgery.
The multicenter phase II Radiation Therapy Oncology Group (RTOG) 0246 trial suggests that the organ-preserving strategy of selective esophageal resection after definitive chemoradiation can be an effective approach, Dr. Stephen Swisher said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).
Forty-one of the 43 patients enrolled with nonmetastatic resectable esophageal cancer had enough data to be included in the final analysis. Thirty-seven patients completed both induction chemotherapy and definitive chemoradiotherapy. Four patients died from problems associated with treatment (10%), two related to induction chemotherapy, one related to chemoradiation, and one related to surgery.
The overall 5-year survival rate after a median follow-up of 6.7 years was 37% in an intention-to-treat analysis, which is similar to results of trials of other treatment modalities for locoregionally advanced esophageal cancer, he said. Patients with a clinical complete response to chemoradiotherapy had a median survival of 66 months, compared with 15 months for all patients with suspected residual disease and 36 months for patients with suspected residual disease who were able to undergo surgery, reported Dr. Swisher of the University of Texas M.D. Anderson Cancer Center, Houston, and his associates.
During enrollment in 2003-2006, 15 patients came from the M.D. Anderson Cancer Center; 18 other sites contributed 1-3 patients each. Twenty-nine patients had adenocarcinomas (73%). Pretreatment clinical stages were T3 or greater in 31 patients (76%) and N1 in 29 patients (71%).
All underwent two cycles of induction chemotherapy with 5-fluorouracil (5-FU), cisplatin, and paclitaxel, followed by concurrent chemoradiation and daily 5-FU with cisplatin over the first 5 days.
After definitive chemoradiation, patients underwent chest and abdominal imaging to look for residual locoregional disease using CT scans, esophageal ultrasound, and optional PET scans. Those with no suspected residual disease were observed and monitored for recurrence every 3 months for the first 6 months, then every 6 months for the next 18 months, and then yearly. Patients with suspected residual disease were considered for immediate surgery.
Ultimately, 21 patients (51% of the total) underwent surgery: 17 had selective esophagectomies due to suspected residual cancer; 1 patient with a clinical complete response after chemoradiotherapy requested surgery; and 3 patients who were thought to have clinical complete responses underwent salvage esophagectomies due to recurrent cancer 5-15 months after chemoradiotherapy.
Besides the 17 patients with suspected residual cancer who underwent surgery, 4 others with a noncomplete response to chemoradiotherapy did not have esophagectomies because of metastatic disease in 3 patients and inoperable local disease in 1 patient.
The investigators previously reported preliminary results showing an overall 1-year survival rate of 71% in the study.
The meeting was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Dr. Swisher reported having no financial disclosures.
On Twitter @sherryboschert
This study provides a start toward "what we should be doing in cancer service delivery," which is creating a customized or tailored approach to delivery of services, Dr. Donald Low said. Eliminating esophagectomy when feasible is "probably appropriate, considering the historical perspective of bad outcomes in esophageal resection."
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Courtesy of the American Society of Clinical Oncology
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The RTOG 0246 trial addresses an important clinical issue and looks at a new approach of neoadjuvant therapy and selective surgery. One of the study’s strengths is that surveillance was very scheduled and orchestrated – there was a branch point at which the decision was made to have or not have surgery. How that surveillance would fit into real-world practice is unclear and important to consider, he said. The long-term follow-up is another strength of the study.
On the other hand, it has several weaknesses. A large number of participating centers yielded a relatively limited number of study participants: 79% of the centers contributed fewer than two patients, and only the M.D. Anderson center contributed more than three patients. The cancers were mostly adenocarcinomas, but the study included some squamous cell cancers and esophageal or esophagogastric junction tumors – a mixed presentation that makes analysis of results more complex. There were no stage-by-stage comparisons of results, and the study included everything from T2 N0 to T3 N1 stage disease.
In addition, there was no reliable current methodology for accurately identifying complete pathological response without surgical resection. "Remember, that’s the important issue, because at some point you have to sit down with a physiologically intact person and give an impression as to whether they’ve had a complete response," he said.
Dr. Donald Low is head of the section on general thoracic surgery and thoracic oncology at Virginia Mason Medical Center, Seattle. This is a portion of his discussion of Dr. Swisher’s study at the meeting. Dr. Low has received honoraria from Boston Scientific.
This study provides a start toward "what we should be doing in cancer service delivery," which is creating a customized or tailored approach to delivery of services, Dr. Donald Low said. Eliminating esophagectomy when feasible is "probably appropriate, considering the historical perspective of bad outcomes in esophageal resection."
|
Courtesy of the American Society of Clinical Oncology
|
The RTOG 0246 trial addresses an important clinical issue and looks at a new approach of neoadjuvant therapy and selective surgery. One of the study’s strengths is that surveillance was very scheduled and orchestrated – there was a branch point at which the decision was made to have or not have surgery. How that surveillance would fit into real-world practice is unclear and important to consider, he said. The long-term follow-up is another strength of the study.
On the other hand, it has several weaknesses. A large number of participating centers yielded a relatively limited number of study participants: 79% of the centers contributed fewer than two patients, and only the M.D. Anderson center contributed more than three patients. The cancers were mostly adenocarcinomas, but the study included some squamous cell cancers and esophageal or esophagogastric junction tumors – a mixed presentation that makes analysis of results more complex. There were no stage-by-stage comparisons of results, and the study included everything from T2 N0 to T3 N1 stage disease.
In addition, there was no reliable current methodology for accurately identifying complete pathological response without surgical resection. "Remember, that’s the important issue, because at some point you have to sit down with a physiologically intact person and give an impression as to whether they’ve had a complete response," he said.
Dr. Donald Low is head of the section on general thoracic surgery and thoracic oncology at Virginia Mason Medical Center, Seattle. This is a portion of his discussion of Dr. Swisher’s study at the meeting. Dr. Low has received honoraria from Boston Scientific.
This study provides a start toward "what we should be doing in cancer service delivery," which is creating a customized or tailored approach to delivery of services, Dr. Donald Low said. Eliminating esophagectomy when feasible is "probably appropriate, considering the historical perspective of bad outcomes in esophageal resection."
|
Courtesy of the American Society of Clinical Oncology
|
The RTOG 0246 trial addresses an important clinical issue and looks at a new approach of neoadjuvant therapy and selective surgery. One of the study’s strengths is that surveillance was very scheduled and orchestrated – there was a branch point at which the decision was made to have or not have surgery. How that surveillance would fit into real-world practice is unclear and important to consider, he said. The long-term follow-up is another strength of the study.
On the other hand, it has several weaknesses. A large number of participating centers yielded a relatively limited number of study participants: 79% of the centers contributed fewer than two patients, and only the M.D. Anderson center contributed more than three patients. The cancers were mostly adenocarcinomas, but the study included some squamous cell cancers and esophageal or esophagogastric junction tumors – a mixed presentation that makes analysis of results more complex. There were no stage-by-stage comparisons of results, and the study included everything from T2 N0 to T3 N1 stage disease.
In addition, there was no reliable current methodology for accurately identifying complete pathological response without surgical resection. "Remember, that’s the important issue, because at some point you have to sit down with a physiologically intact person and give an impression as to whether they’ve had a complete response," he said.
Dr. Donald Low is head of the section on general thoracic surgery and thoracic oncology at Virginia Mason Medical Center, Seattle. This is a portion of his discussion of Dr. Swisher’s study at the meeting. Dr. Low has received honoraria from Boston Scientific.
SAN FRANCISCO – Five-year survival rates for 41 patients with locoregionally advanced esophageal cancer who underwent induction chemotherapy and definitive chemoradiotherapy were 53% for patients with a clinical complete response who avoided surgery, 33% for patients with suspected residual disease, and 41% for patients with suspected residual disease who were able to undergo surgery.
The multicenter phase II Radiation Therapy Oncology Group (RTOG) 0246 trial suggests that the organ-preserving strategy of selective esophageal resection after definitive chemoradiation can be an effective approach, Dr. Stephen Swisher said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).
Forty-one of the 43 patients enrolled with nonmetastatic resectable esophageal cancer had enough data to be included in the final analysis. Thirty-seven patients completed both induction chemotherapy and definitive chemoradiotherapy. Four patients died from problems associated with treatment (10%), two related to induction chemotherapy, one related to chemoradiation, and one related to surgery.
The overall 5-year survival rate after a median follow-up of 6.7 years was 37% in an intention-to-treat analysis, which is similar to results of trials of other treatment modalities for locoregionally advanced esophageal cancer, he said. Patients with a clinical complete response to chemoradiotherapy had a median survival of 66 months, compared with 15 months for all patients with suspected residual disease and 36 months for patients with suspected residual disease who were able to undergo surgery, reported Dr. Swisher of the University of Texas M.D. Anderson Cancer Center, Houston, and his associates.
During enrollment in 2003-2006, 15 patients came from the M.D. Anderson Cancer Center; 18 other sites contributed 1-3 patients each. Twenty-nine patients had adenocarcinomas (73%). Pretreatment clinical stages were T3 or greater in 31 patients (76%) and N1 in 29 patients (71%).
All underwent two cycles of induction chemotherapy with 5-fluorouracil (5-FU), cisplatin, and paclitaxel, followed by concurrent chemoradiation and daily 5-FU with cisplatin over the first 5 days.
After definitive chemoradiation, patients underwent chest and abdominal imaging to look for residual locoregional disease using CT scans, esophageal ultrasound, and optional PET scans. Those with no suspected residual disease were observed and monitored for recurrence every 3 months for the first 6 months, then every 6 months for the next 18 months, and then yearly. Patients with suspected residual disease were considered for immediate surgery.
Ultimately, 21 patients (51% of the total) underwent surgery: 17 had selective esophagectomies due to suspected residual cancer; 1 patient with a clinical complete response after chemoradiotherapy requested surgery; and 3 patients who were thought to have clinical complete responses underwent salvage esophagectomies due to recurrent cancer 5-15 months after chemoradiotherapy.
Besides the 17 patients with suspected residual cancer who underwent surgery, 4 others with a noncomplete response to chemoradiotherapy did not have esophagectomies because of metastatic disease in 3 patients and inoperable local disease in 1 patient.
The investigators previously reported preliminary results showing an overall 1-year survival rate of 71% in the study.
The meeting was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Dr. Swisher reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Five-year survival rates for 41 patients with locoregionally advanced esophageal cancer who underwent induction chemotherapy and definitive chemoradiotherapy were 53% for patients with a clinical complete response who avoided surgery, 33% for patients with suspected residual disease, and 41% for patients with suspected residual disease who were able to undergo surgery.
The multicenter phase II Radiation Therapy Oncology Group (RTOG) 0246 trial suggests that the organ-preserving strategy of selective esophageal resection after definitive chemoradiation can be an effective approach, Dr. Stephen Swisher said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).
Forty-one of the 43 patients enrolled with nonmetastatic resectable esophageal cancer had enough data to be included in the final analysis. Thirty-seven patients completed both induction chemotherapy and definitive chemoradiotherapy. Four patients died from problems associated with treatment (10%), two related to induction chemotherapy, one related to chemoradiation, and one related to surgery.
The overall 5-year survival rate after a median follow-up of 6.7 years was 37% in an intention-to-treat analysis, which is similar to results of trials of other treatment modalities for locoregionally advanced esophageal cancer, he said. Patients with a clinical complete response to chemoradiotherapy had a median survival of 66 months, compared with 15 months for all patients with suspected residual disease and 36 months for patients with suspected residual disease who were able to undergo surgery, reported Dr. Swisher of the University of Texas M.D. Anderson Cancer Center, Houston, and his associates.
During enrollment in 2003-2006, 15 patients came from the M.D. Anderson Cancer Center; 18 other sites contributed 1-3 patients each. Twenty-nine patients had adenocarcinomas (73%). Pretreatment clinical stages were T3 or greater in 31 patients (76%) and N1 in 29 patients (71%).
All underwent two cycles of induction chemotherapy with 5-fluorouracil (5-FU), cisplatin, and paclitaxel, followed by concurrent chemoradiation and daily 5-FU with cisplatin over the first 5 days.
After definitive chemoradiation, patients underwent chest and abdominal imaging to look for residual locoregional disease using CT scans, esophageal ultrasound, and optional PET scans. Those with no suspected residual disease were observed and monitored for recurrence every 3 months for the first 6 months, then every 6 months for the next 18 months, and then yearly. Patients with suspected residual disease were considered for immediate surgery.
Ultimately, 21 patients (51% of the total) underwent surgery: 17 had selective esophagectomies due to suspected residual cancer; 1 patient with a clinical complete response after chemoradiotherapy requested surgery; and 3 patients who were thought to have clinical complete responses underwent salvage esophagectomies due to recurrent cancer 5-15 months after chemoradiotherapy.
Besides the 17 patients with suspected residual cancer who underwent surgery, 4 others with a noncomplete response to chemoradiotherapy did not have esophagectomies because of metastatic disease in 3 patients and inoperable local disease in 1 patient.
The investigators previously reported preliminary results showing an overall 1-year survival rate of 71% in the study.
The meeting was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Dr. Swisher reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ASCO GASTROINTESTINAL CANCERS SYMPOSIUM
Major finding: Five-year survival rates after definitive chemoradiotherapy were 53% with complete clinical responses to definitive chemoradiotherapy, 33% for those with noncomplete responses, and 41% for patients in the latter group who were able to undergo esophagectomy.
Data source: Prospective multicenter trial of selective surgery following definitive chemoradiotherapy in 41 patients with advanced locoregional esophageal cancer.
Disclosures: Dr. Swisher reported having no financial disclosures.
