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House barely passes ACA repeal/replace bill
A few additional tweaks to the American Health Care Act helped garner just enough Republican votes to pass the first phase of the party’s three-part effort to repeal and replace the Affordable Care Act.
The bill passed May 4 by a 217-213 margin, with one Republican member not voting. The vote came after a false start in March when House Speaker Paul Ryan (R-Wisc.) canceled consideration because Republicans could not muster enough votes to pass it. All votes in favor of the bill came from GOP members, while all House Democrats plus 20 Republicans voted against passage.
Two amendments helped to make the bill palatable enough to gain enough votes for passage. New amendments from Rep. Gary Palmer (R-Ala.) and Rep. Fred Upton (R-Mich.) targeted high-risk pools. They were added to an April amendment from Rep. Tom MacArthur (R-N.J.) that would allow states to seek waivers for coverage of the essential health benefits and from community rating provisions to allow for higher premiums for those who are sicker or older.
The American Health Care Act (H.R. 1629) in its amended form has not been yet been scored by the Congressional Budget Office (CBO) to determine its effects on the federal budget. However, an earlier CBO analysis of the original, unamended bill predicted an estimated 58 million people would be uninsured by 2026, compared with 28 million under the Affordable Care Act. It is also predicting large premium increases for some groups of patients.
A CBO score is required of all legislation because, under Senate rules, anything that adds to the budget must be offset by additional revenue-generating provisions or cuts elsewhere in the federal budget. The bill, if passed and sent to the president’s desk for signature, is at minimum budget neutral if not deficit reducing.
The amended AHCA was roundly rejected by most physician organizations, including the American Medical Association and many specialty societies.
“The bill passed by the House today will result in millions of Americans losing access to quality, affordable health insurance and those with preexisting health conditions face the possibility of going back to the time when insurers could charge them premiums that made access to coverage out of the question,” AMA President Andrew Gurman, MD, said in a statement. “The AMA urges the Senate and the Administration to work with physician, patient, hospital, and other provider groups to craft bipartisan solutions so all American families can access affordable and meaningful coverage, while preserving the safety net for vulnerable patients.”
House Minority Leader Nancy Pelosi (D-Calif.), in addition to criticizing the bill for its predicted effects in increasing premiums and decreasing coverage for those with preexisting conditions, called out the bill for being nothing more than a means to help cover the cost of a separate tax bill when she described the AHCA as providing “tax cuts for the rich at the expense of health insurance for tens of millions of working families across America” during the debate prior to passage. “Trumpcare is a billionaire’s tax cut disguised as a health care bill.”
Speaker Ryan continued to highlight the continual coverage issues that have been growing in the individual health insurance marketplace, spotlighting Iowa, where insurer Medica has announced that it will likely discontinue providing coverage in 2018, leaving most counties in the state with no option to purchase coverage following the announced withdrawal of Aetna and Wellmark Blue Cross Blue Shield.
“This is a crisis,” Speaker Ryan said during the debate. “What protection is Obamacare if there is no health care plan to purchase in your state? This is the direction Obamacare is rapidly heading.”
In helping to get the AHCA barely over the final hurdle, the Palmer amendment creates an “invisible risk-sharing program” under which the federal government would subsidize insurers to the tune of $15 billion over 9 years. The program would allow insurers to make a prospective determination of who might be a cost-intensive user and move them to the high-risk pool with the federal funding joining insurer funding to help pay for coverage. The amendment also would change the ACA’s reinsurance provisions, which retroactively reimburse insurers for high-utilizing customers.
Neither invisible risk sharing nor retroactive reinsurance are “inherently superior at reducing premiums,” according to an April 12 blog post by the journal Health Affairs. “Premium reductions depend entirely on how much funding the program receives in relation to the risks being insured. Rep. Palmer’s amendment leaves all the critical details of this new, invisible program unspecified, making it hard to generate precise estimate.”
Authors Mark Hall, senior fellow at Brookings Institute, and Nicholas Bagely, law professor at the University of Michigan, Ann Arbor, note that the funding in the amendment “is no more than 2% of total premiums in the market.”
The Upton amendment would add an additional $8 billion in funding for high-risk pools, bringing the total amount potentially available to help cover people with preexisting conditions to $123 billion.
Analysis from Avalere finds that the funding specifically allocated to assist those with preexisting conditions ($23 billion, including the additional $8 billion from the Upton amendment) “will only cover 110,000 individuals with preexisting, chronic condition. If states were to allocate all the other funds [available in the AHCA] toward providing insurance to people with preexisting conditions ... 600,000 with preexisting chronic conditions could be covered.” The analysis notes approximately “2.2 million enrollees in the individual market today have some sort of preexisting chronic condition.”
“Given the amount of funding in the bill, the program can only afford a few small states to opt into medical underwriting,” Caroline Pearson, senior vice president at Avalere, said in a statement. “If any large states receive a waiver, many chronically ill individuals could be left without access to insurance.”
Because the AHCA focuses solely on reforming revenue-related aspects of the ACA and was passed using budget reconciliation procedures, it will need only a simple majority to pass the Senate. However, keeping the bill budget neutral will make it difficult to pass in its current form, even though Republicans hold 52 of the chamber’s 100 seats.
Phase two of the repeal and replace plan will be a full examination of federal regulations and phase three, which will require at least 60 votes in the Senate, will be changes to other provisions in the health care law that are not directly revenue generating. President Donald Trump in the past has suggested that this will include his goals of opening the sale of insurance across state lines and other key priorities.
A few additional tweaks to the American Health Care Act helped garner just enough Republican votes to pass the first phase of the party’s three-part effort to repeal and replace the Affordable Care Act.
The bill passed May 4 by a 217-213 margin, with one Republican member not voting. The vote came after a false start in March when House Speaker Paul Ryan (R-Wisc.) canceled consideration because Republicans could not muster enough votes to pass it. All votes in favor of the bill came from GOP members, while all House Democrats plus 20 Republicans voted against passage.
Two amendments helped to make the bill palatable enough to gain enough votes for passage. New amendments from Rep. Gary Palmer (R-Ala.) and Rep. Fred Upton (R-Mich.) targeted high-risk pools. They were added to an April amendment from Rep. Tom MacArthur (R-N.J.) that would allow states to seek waivers for coverage of the essential health benefits and from community rating provisions to allow for higher premiums for those who are sicker or older.
The American Health Care Act (H.R. 1629) in its amended form has not been yet been scored by the Congressional Budget Office (CBO) to determine its effects on the federal budget. However, an earlier CBO analysis of the original, unamended bill predicted an estimated 58 million people would be uninsured by 2026, compared with 28 million under the Affordable Care Act. It is also predicting large premium increases for some groups of patients.
A CBO score is required of all legislation because, under Senate rules, anything that adds to the budget must be offset by additional revenue-generating provisions or cuts elsewhere in the federal budget. The bill, if passed and sent to the president’s desk for signature, is at minimum budget neutral if not deficit reducing.
The amended AHCA was roundly rejected by most physician organizations, including the American Medical Association and many specialty societies.
“The bill passed by the House today will result in millions of Americans losing access to quality, affordable health insurance and those with preexisting health conditions face the possibility of going back to the time when insurers could charge them premiums that made access to coverage out of the question,” AMA President Andrew Gurman, MD, said in a statement. “The AMA urges the Senate and the Administration to work with physician, patient, hospital, and other provider groups to craft bipartisan solutions so all American families can access affordable and meaningful coverage, while preserving the safety net for vulnerable patients.”
House Minority Leader Nancy Pelosi (D-Calif.), in addition to criticizing the bill for its predicted effects in increasing premiums and decreasing coverage for those with preexisting conditions, called out the bill for being nothing more than a means to help cover the cost of a separate tax bill when she described the AHCA as providing “tax cuts for the rich at the expense of health insurance for tens of millions of working families across America” during the debate prior to passage. “Trumpcare is a billionaire’s tax cut disguised as a health care bill.”
Speaker Ryan continued to highlight the continual coverage issues that have been growing in the individual health insurance marketplace, spotlighting Iowa, where insurer Medica has announced that it will likely discontinue providing coverage in 2018, leaving most counties in the state with no option to purchase coverage following the announced withdrawal of Aetna and Wellmark Blue Cross Blue Shield.
“This is a crisis,” Speaker Ryan said during the debate. “What protection is Obamacare if there is no health care plan to purchase in your state? This is the direction Obamacare is rapidly heading.”
In helping to get the AHCA barely over the final hurdle, the Palmer amendment creates an “invisible risk-sharing program” under which the federal government would subsidize insurers to the tune of $15 billion over 9 years. The program would allow insurers to make a prospective determination of who might be a cost-intensive user and move them to the high-risk pool with the federal funding joining insurer funding to help pay for coverage. The amendment also would change the ACA’s reinsurance provisions, which retroactively reimburse insurers for high-utilizing customers.
Neither invisible risk sharing nor retroactive reinsurance are “inherently superior at reducing premiums,” according to an April 12 blog post by the journal Health Affairs. “Premium reductions depend entirely on how much funding the program receives in relation to the risks being insured. Rep. Palmer’s amendment leaves all the critical details of this new, invisible program unspecified, making it hard to generate precise estimate.”
Authors Mark Hall, senior fellow at Brookings Institute, and Nicholas Bagely, law professor at the University of Michigan, Ann Arbor, note that the funding in the amendment “is no more than 2% of total premiums in the market.”
The Upton amendment would add an additional $8 billion in funding for high-risk pools, bringing the total amount potentially available to help cover people with preexisting conditions to $123 billion.
Analysis from Avalere finds that the funding specifically allocated to assist those with preexisting conditions ($23 billion, including the additional $8 billion from the Upton amendment) “will only cover 110,000 individuals with preexisting, chronic condition. If states were to allocate all the other funds [available in the AHCA] toward providing insurance to people with preexisting conditions ... 600,000 with preexisting chronic conditions could be covered.” The analysis notes approximately “2.2 million enrollees in the individual market today have some sort of preexisting chronic condition.”
“Given the amount of funding in the bill, the program can only afford a few small states to opt into medical underwriting,” Caroline Pearson, senior vice president at Avalere, said in a statement. “If any large states receive a waiver, many chronically ill individuals could be left without access to insurance.”
Because the AHCA focuses solely on reforming revenue-related aspects of the ACA and was passed using budget reconciliation procedures, it will need only a simple majority to pass the Senate. However, keeping the bill budget neutral will make it difficult to pass in its current form, even though Republicans hold 52 of the chamber’s 100 seats.
Phase two of the repeal and replace plan will be a full examination of federal regulations and phase three, which will require at least 60 votes in the Senate, will be changes to other provisions in the health care law that are not directly revenue generating. President Donald Trump in the past has suggested that this will include his goals of opening the sale of insurance across state lines and other key priorities.
A few additional tweaks to the American Health Care Act helped garner just enough Republican votes to pass the first phase of the party’s three-part effort to repeal and replace the Affordable Care Act.
The bill passed May 4 by a 217-213 margin, with one Republican member not voting. The vote came after a false start in March when House Speaker Paul Ryan (R-Wisc.) canceled consideration because Republicans could not muster enough votes to pass it. All votes in favor of the bill came from GOP members, while all House Democrats plus 20 Republicans voted against passage.
Two amendments helped to make the bill palatable enough to gain enough votes for passage. New amendments from Rep. Gary Palmer (R-Ala.) and Rep. Fred Upton (R-Mich.) targeted high-risk pools. They were added to an April amendment from Rep. Tom MacArthur (R-N.J.) that would allow states to seek waivers for coverage of the essential health benefits and from community rating provisions to allow for higher premiums for those who are sicker or older.
The American Health Care Act (H.R. 1629) in its amended form has not been yet been scored by the Congressional Budget Office (CBO) to determine its effects on the federal budget. However, an earlier CBO analysis of the original, unamended bill predicted an estimated 58 million people would be uninsured by 2026, compared with 28 million under the Affordable Care Act. It is also predicting large premium increases for some groups of patients.
A CBO score is required of all legislation because, under Senate rules, anything that adds to the budget must be offset by additional revenue-generating provisions or cuts elsewhere in the federal budget. The bill, if passed and sent to the president’s desk for signature, is at minimum budget neutral if not deficit reducing.
The amended AHCA was roundly rejected by most physician organizations, including the American Medical Association and many specialty societies.
“The bill passed by the House today will result in millions of Americans losing access to quality, affordable health insurance and those with preexisting health conditions face the possibility of going back to the time when insurers could charge them premiums that made access to coverage out of the question,” AMA President Andrew Gurman, MD, said in a statement. “The AMA urges the Senate and the Administration to work with physician, patient, hospital, and other provider groups to craft bipartisan solutions so all American families can access affordable and meaningful coverage, while preserving the safety net for vulnerable patients.”
House Minority Leader Nancy Pelosi (D-Calif.), in addition to criticizing the bill for its predicted effects in increasing premiums and decreasing coverage for those with preexisting conditions, called out the bill for being nothing more than a means to help cover the cost of a separate tax bill when she described the AHCA as providing “tax cuts for the rich at the expense of health insurance for tens of millions of working families across America” during the debate prior to passage. “Trumpcare is a billionaire’s tax cut disguised as a health care bill.”
Speaker Ryan continued to highlight the continual coverage issues that have been growing in the individual health insurance marketplace, spotlighting Iowa, where insurer Medica has announced that it will likely discontinue providing coverage in 2018, leaving most counties in the state with no option to purchase coverage following the announced withdrawal of Aetna and Wellmark Blue Cross Blue Shield.
“This is a crisis,” Speaker Ryan said during the debate. “What protection is Obamacare if there is no health care plan to purchase in your state? This is the direction Obamacare is rapidly heading.”
In helping to get the AHCA barely over the final hurdle, the Palmer amendment creates an “invisible risk-sharing program” under which the federal government would subsidize insurers to the tune of $15 billion over 9 years. The program would allow insurers to make a prospective determination of who might be a cost-intensive user and move them to the high-risk pool with the federal funding joining insurer funding to help pay for coverage. The amendment also would change the ACA’s reinsurance provisions, which retroactively reimburse insurers for high-utilizing customers.
Neither invisible risk sharing nor retroactive reinsurance are “inherently superior at reducing premiums,” according to an April 12 blog post by the journal Health Affairs. “Premium reductions depend entirely on how much funding the program receives in relation to the risks being insured. Rep. Palmer’s amendment leaves all the critical details of this new, invisible program unspecified, making it hard to generate precise estimate.”
Authors Mark Hall, senior fellow at Brookings Institute, and Nicholas Bagely, law professor at the University of Michigan, Ann Arbor, note that the funding in the amendment “is no more than 2% of total premiums in the market.”
The Upton amendment would add an additional $8 billion in funding for high-risk pools, bringing the total amount potentially available to help cover people with preexisting conditions to $123 billion.
Analysis from Avalere finds that the funding specifically allocated to assist those with preexisting conditions ($23 billion, including the additional $8 billion from the Upton amendment) “will only cover 110,000 individuals with preexisting, chronic condition. If states were to allocate all the other funds [available in the AHCA] toward providing insurance to people with preexisting conditions ... 600,000 with preexisting chronic conditions could be covered.” The analysis notes approximately “2.2 million enrollees in the individual market today have some sort of preexisting chronic condition.”
“Given the amount of funding in the bill, the program can only afford a few small states to opt into medical underwriting,” Caroline Pearson, senior vice president at Avalere, said in a statement. “If any large states receive a waiver, many chronically ill individuals could be left without access to insurance.”
Because the AHCA focuses solely on reforming revenue-related aspects of the ACA and was passed using budget reconciliation procedures, it will need only a simple majority to pass the Senate. However, keeping the bill budget neutral will make it difficult to pass in its current form, even though Republicans hold 52 of the chamber’s 100 seats.
Phase two of the repeal and replace plan will be a full examination of federal regulations and phase three, which will require at least 60 votes in the Senate, will be changes to other provisions in the health care law that are not directly revenue generating. President Donald Trump in the past has suggested that this will include his goals of opening the sale of insurance across state lines and other key priorities.
VIDEO: Incoming AATS president outlines goals
BOSTON – Strengthening member engagement is a top goal for incoming AATS President Duke E. Cameron, MD.
In this video, Dr. Cameron, of Massachusetts General Hospital, Boston, shared his objectives as the next AATS leader and the direction he envisions for the specialty over the next 100 years. Dr. Cameron also discussed his hope for new online educational efforts and the importance of physician collaboration with other health professionals.
On Twitter @legal_med
BOSTON – Strengthening member engagement is a top goal for incoming AATS President Duke E. Cameron, MD.
In this video, Dr. Cameron, of Massachusetts General Hospital, Boston, shared his objectives as the next AATS leader and the direction he envisions for the specialty over the next 100 years. Dr. Cameron also discussed his hope for new online educational efforts and the importance of physician collaboration with other health professionals.
On Twitter @legal_med
BOSTON – Strengthening member engagement is a top goal for incoming AATS President Duke E. Cameron, MD.
In this video, Dr. Cameron, of Massachusetts General Hospital, Boston, shared his objectives as the next AATS leader and the direction he envisions for the specialty over the next 100 years. Dr. Cameron also discussed his hope for new online educational efforts and the importance of physician collaboration with other health professionals.
On Twitter @legal_med
AT THE AATS ANNUAL MEETING
Point/Counterpoint: Should all suspected mucinous cystic neoplasms be resected?
Dr. Pawlik is a pretty clever guy and a strong adversary. Mucinous cystic neoplasm is literally the only topic in hepato-pancreato-biliary surgery he has not written about – yet.1
But I will argue that all suspected mucinous cystic neoplasms (MCNs) should be surgically removed. Reasons include: the natural history of a benign MCN in a typical 45-year-old remains unknown, clinical features are not always reliable, and it’s difficult to distinguish benign from malignant neoplasms without surgery.
Although many MCNs are benign when resected, all have malignant potential.
The prevalence of cancer at time of diagnosis with an MCN is fairly low, about 15%. This means most of these cysts are benign when resected. However, discrimination between benign and malignant is difficult without surgery, and the degree of epithelial dysplasia at time of resection ranges from mild to severe with invasive carcinoma.
When cancer is present, patients tend to do poorly. In one study where 44 out of 344 patients developed invasive cancer, the group with cancer had a 3-year overall survival rate of 59%.2
In addition, aspiration of cyst fluid is often of limited utility. It is poor at distinguishing whether a cyst is benign or malignant. For example, in a series of 55 patients with MCNs that underwent fine-needle aspiration of cyst epithelium, 71% of assays were nondiagnostic.3 So this diagnostic test is very insensitive and may miss at least half of cancers – another point in favor of surgical resection for all MCNs.
It is true that evidence in the literature associates certain clinical factors with a higher risk for malignancy in suspected MCNs. These include male gender, larger cysts, and location in the pancreatic head or neck or larger cyst diameter and presence of nodules.2,4 However, use of clinical features is not perfect.
In another study, of 163 resected MCNs, those with invasive cancer were often – but not always – larger than 4 cm with nodules.5 These same series revealed that those with invasive cancer were often, but again not always, larger than 4 cm.
We see this in our practice as well – that a large cyst or presence of nodules is not a foolproof indicator of malignancy. We had a 38-year-old woman with a large cyst and nodules who did not have cancer. In contrast, a 45-year-old woman at our institution presented with small cysts and no cancer on fine-needle aspiration. However, final pathology in her case revealed high-grade dysplasia.
Also, we only know what happens to cysts that have been resected. We know nothing about duration or other best practices for following patients who do not undergo surgery. For this reason, we really don’t know what these tumors will do if left alone.
Surgery is curative and carries a pretty low risk. Following resection, these patients do well. We’re talking about curative operations.
Dr. Katz is an Associate Professor, Department of Surgical Oncology, Division of Surgery at the University of Texas MD Anderson Cancer Center in Houston. He is also Chief of the Pancreas Surgery Service at MD Anderson. Dr. Katz noted he was asked to provide the pro side of the argument, and he may not necessarily uphold these positions in his own practice. Dr. Katz had no relevant financial disclosures.
References:
1. Dr. Pawlik’s list of selected publications: http://pathology.jhu.edu/liver/pawlik.cfm.
2. JAMA Surg. 2017;152:19-25.
3. Cancer. 2017;125:169-77.
4. Pancreas. 2011;40:67-71.
5. Ann Surg. 2008;247:571-9.
Some mucinous cystic neoplasms can be safely followed.
Data in the literature suggest some of these suspected mucinous cystic neoplasms can be followed; surgery may not be indicated solely because “as surgeons we tend to take all masses out” and because operative complications occur. Therefore, resection is not a benign procedure.
Dr. Katz, you were done before you got started. The evidence shows that some of the MCNs can be followed rather than resected.
Most of the published studies focus on IPMN, but I think the topic of MCNs is becoming increasingly important; they follow IPMNs as the second most common type of cystic neoplasms. So we’re going to be finding more small MCNs. In this debate, we are not talking about an 8-cm MCN, but rather what do we do when we see a 2- to 3-cm MCN. Do these patients all need to undergo resection?
What Dr. Katz is concerned about is that we are going to miss a cancer. We should operate on all patients because – at least as Dr. Katz’s argues – the surgery can always be done without complications.
However, even at the very, very experienced centers, morbidity was 30%-50%, and a pancreatic fistula developed for 1 in 10 patients. So it’s not a benign procedure.1
As surgeons, we tend to take every mass out. Although operative mortality is low, it is still in a measurable range, 1%-2%, and that is even at expert centers. Many of these small cysts are being found at smaller and community hospitals, and undue morbidity and mortality may weigh more heavily in these settings.2
Rather than “being a hammer and seeing everything as a nail,” we need a more rational approach. For example, we should identify a subgroup that will the most benefit from resection.
Investigators from Memorial Sloan Kettering Cancer Center reported that certain clinical factors identify patients at higher risk for mortality, such as nodules.3 Patients with invasive cancer almost all had nodules. And all patients with invasive cancer without nodules had a tumor larger than 4 cm.
Maybe using both presence of nodules and size is the right approach to identifying underling malignancy in suspected MCNs. Again, size is important, as is male gender, presence of solid nodules, and duct dilatation.4
We are arguing whether all MCNs should be resected. I’m positing that many 2-cm to 3-cm MCNs can be followed. There is only a small chance they will grow over time, and it’s unlikely they are harboring a malignancy.
Dr. Pawlik is Chair of Surgery at the Ohio State Wexner Medical Center in Columbus. He is also the Urban Meyer III and Shelley Meyer Chair for Cancer Research at Ohio State. He has no disclosures.
References
1. HPB (Oxford). 2007;9:8-15.
2. Diagnosis and Management of Cystic Lesions of the Pancreas. Diagnostic and Therapeutic Endoscopy Volume 2011 (2011), Article ID 478913.
3. JAMA Surg. 2017;152:19-25.
4. Ann Surg. 2006;244:572-82.
This Point/Counterpoint feature is based on comments Dr. Katz and Dr. Pawlik made during a debate at AHPBA 2017, the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
Dr. Pawlik is a pretty clever guy and a strong adversary. Mucinous cystic neoplasm is literally the only topic in hepato-pancreato-biliary surgery he has not written about – yet.1
But I will argue that all suspected mucinous cystic neoplasms (MCNs) should be surgically removed. Reasons include: the natural history of a benign MCN in a typical 45-year-old remains unknown, clinical features are not always reliable, and it’s difficult to distinguish benign from malignant neoplasms without surgery.
Although many MCNs are benign when resected, all have malignant potential.
The prevalence of cancer at time of diagnosis with an MCN is fairly low, about 15%. This means most of these cysts are benign when resected. However, discrimination between benign and malignant is difficult without surgery, and the degree of epithelial dysplasia at time of resection ranges from mild to severe with invasive carcinoma.
When cancer is present, patients tend to do poorly. In one study where 44 out of 344 patients developed invasive cancer, the group with cancer had a 3-year overall survival rate of 59%.2
In addition, aspiration of cyst fluid is often of limited utility. It is poor at distinguishing whether a cyst is benign or malignant. For example, in a series of 55 patients with MCNs that underwent fine-needle aspiration of cyst epithelium, 71% of assays were nondiagnostic.3 So this diagnostic test is very insensitive and may miss at least half of cancers – another point in favor of surgical resection for all MCNs.
It is true that evidence in the literature associates certain clinical factors with a higher risk for malignancy in suspected MCNs. These include male gender, larger cysts, and location in the pancreatic head or neck or larger cyst diameter and presence of nodules.2,4 However, use of clinical features is not perfect.
In another study, of 163 resected MCNs, those with invasive cancer were often – but not always – larger than 4 cm with nodules.5 These same series revealed that those with invasive cancer were often, but again not always, larger than 4 cm.
We see this in our practice as well – that a large cyst or presence of nodules is not a foolproof indicator of malignancy. We had a 38-year-old woman with a large cyst and nodules who did not have cancer. In contrast, a 45-year-old woman at our institution presented with small cysts and no cancer on fine-needle aspiration. However, final pathology in her case revealed high-grade dysplasia.
Also, we only know what happens to cysts that have been resected. We know nothing about duration or other best practices for following patients who do not undergo surgery. For this reason, we really don’t know what these tumors will do if left alone.
Surgery is curative and carries a pretty low risk. Following resection, these patients do well. We’re talking about curative operations.
Dr. Katz is an Associate Professor, Department of Surgical Oncology, Division of Surgery at the University of Texas MD Anderson Cancer Center in Houston. He is also Chief of the Pancreas Surgery Service at MD Anderson. Dr. Katz noted he was asked to provide the pro side of the argument, and he may not necessarily uphold these positions in his own practice. Dr. Katz had no relevant financial disclosures.
References:
1. Dr. Pawlik’s list of selected publications: http://pathology.jhu.edu/liver/pawlik.cfm.
2. JAMA Surg. 2017;152:19-25.
3. Cancer. 2017;125:169-77.
4. Pancreas. 2011;40:67-71.
5. Ann Surg. 2008;247:571-9.
Some mucinous cystic neoplasms can be safely followed.
Data in the literature suggest some of these suspected mucinous cystic neoplasms can be followed; surgery may not be indicated solely because “as surgeons we tend to take all masses out” and because operative complications occur. Therefore, resection is not a benign procedure.
Dr. Katz, you were done before you got started. The evidence shows that some of the MCNs can be followed rather than resected.
Most of the published studies focus on IPMN, but I think the topic of MCNs is becoming increasingly important; they follow IPMNs as the second most common type of cystic neoplasms. So we’re going to be finding more small MCNs. In this debate, we are not talking about an 8-cm MCN, but rather what do we do when we see a 2- to 3-cm MCN. Do these patients all need to undergo resection?
What Dr. Katz is concerned about is that we are going to miss a cancer. We should operate on all patients because – at least as Dr. Katz’s argues – the surgery can always be done without complications.
However, even at the very, very experienced centers, morbidity was 30%-50%, and a pancreatic fistula developed for 1 in 10 patients. So it’s not a benign procedure.1
As surgeons, we tend to take every mass out. Although operative mortality is low, it is still in a measurable range, 1%-2%, and that is even at expert centers. Many of these small cysts are being found at smaller and community hospitals, and undue morbidity and mortality may weigh more heavily in these settings.2
Rather than “being a hammer and seeing everything as a nail,” we need a more rational approach. For example, we should identify a subgroup that will the most benefit from resection.
Investigators from Memorial Sloan Kettering Cancer Center reported that certain clinical factors identify patients at higher risk for mortality, such as nodules.3 Patients with invasive cancer almost all had nodules. And all patients with invasive cancer without nodules had a tumor larger than 4 cm.
Maybe using both presence of nodules and size is the right approach to identifying underling malignancy in suspected MCNs. Again, size is important, as is male gender, presence of solid nodules, and duct dilatation.4
We are arguing whether all MCNs should be resected. I’m positing that many 2-cm to 3-cm MCNs can be followed. There is only a small chance they will grow over time, and it’s unlikely they are harboring a malignancy.
Dr. Pawlik is Chair of Surgery at the Ohio State Wexner Medical Center in Columbus. He is also the Urban Meyer III and Shelley Meyer Chair for Cancer Research at Ohio State. He has no disclosures.
References
1. HPB (Oxford). 2007;9:8-15.
2. Diagnosis and Management of Cystic Lesions of the Pancreas. Diagnostic and Therapeutic Endoscopy Volume 2011 (2011), Article ID 478913.
3. JAMA Surg. 2017;152:19-25.
4. Ann Surg. 2006;244:572-82.
This Point/Counterpoint feature is based on comments Dr. Katz and Dr. Pawlik made during a debate at AHPBA 2017, the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
Dr. Pawlik is a pretty clever guy and a strong adversary. Mucinous cystic neoplasm is literally the only topic in hepato-pancreato-biliary surgery he has not written about – yet.1
But I will argue that all suspected mucinous cystic neoplasms (MCNs) should be surgically removed. Reasons include: the natural history of a benign MCN in a typical 45-year-old remains unknown, clinical features are not always reliable, and it’s difficult to distinguish benign from malignant neoplasms without surgery.
Although many MCNs are benign when resected, all have malignant potential.
The prevalence of cancer at time of diagnosis with an MCN is fairly low, about 15%. This means most of these cysts are benign when resected. However, discrimination between benign and malignant is difficult without surgery, and the degree of epithelial dysplasia at time of resection ranges from mild to severe with invasive carcinoma.
When cancer is present, patients tend to do poorly. In one study where 44 out of 344 patients developed invasive cancer, the group with cancer had a 3-year overall survival rate of 59%.2
In addition, aspiration of cyst fluid is often of limited utility. It is poor at distinguishing whether a cyst is benign or malignant. For example, in a series of 55 patients with MCNs that underwent fine-needle aspiration of cyst epithelium, 71% of assays were nondiagnostic.3 So this diagnostic test is very insensitive and may miss at least half of cancers – another point in favor of surgical resection for all MCNs.
It is true that evidence in the literature associates certain clinical factors with a higher risk for malignancy in suspected MCNs. These include male gender, larger cysts, and location in the pancreatic head or neck or larger cyst diameter and presence of nodules.2,4 However, use of clinical features is not perfect.
In another study, of 163 resected MCNs, those with invasive cancer were often – but not always – larger than 4 cm with nodules.5 These same series revealed that those with invasive cancer were often, but again not always, larger than 4 cm.
We see this in our practice as well – that a large cyst or presence of nodules is not a foolproof indicator of malignancy. We had a 38-year-old woman with a large cyst and nodules who did not have cancer. In contrast, a 45-year-old woman at our institution presented with small cysts and no cancer on fine-needle aspiration. However, final pathology in her case revealed high-grade dysplasia.
Also, we only know what happens to cysts that have been resected. We know nothing about duration or other best practices for following patients who do not undergo surgery. For this reason, we really don’t know what these tumors will do if left alone.
Surgery is curative and carries a pretty low risk. Following resection, these patients do well. We’re talking about curative operations.
Dr. Katz is an Associate Professor, Department of Surgical Oncology, Division of Surgery at the University of Texas MD Anderson Cancer Center in Houston. He is also Chief of the Pancreas Surgery Service at MD Anderson. Dr. Katz noted he was asked to provide the pro side of the argument, and he may not necessarily uphold these positions in his own practice. Dr. Katz had no relevant financial disclosures.
References:
1. Dr. Pawlik’s list of selected publications: http://pathology.jhu.edu/liver/pawlik.cfm.
2. JAMA Surg. 2017;152:19-25.
3. Cancer. 2017;125:169-77.
4. Pancreas. 2011;40:67-71.
5. Ann Surg. 2008;247:571-9.
Some mucinous cystic neoplasms can be safely followed.
Data in the literature suggest some of these suspected mucinous cystic neoplasms can be followed; surgery may not be indicated solely because “as surgeons we tend to take all masses out” and because operative complications occur. Therefore, resection is not a benign procedure.
Dr. Katz, you were done before you got started. The evidence shows that some of the MCNs can be followed rather than resected.
Most of the published studies focus on IPMN, but I think the topic of MCNs is becoming increasingly important; they follow IPMNs as the second most common type of cystic neoplasms. So we’re going to be finding more small MCNs. In this debate, we are not talking about an 8-cm MCN, but rather what do we do when we see a 2- to 3-cm MCN. Do these patients all need to undergo resection?
What Dr. Katz is concerned about is that we are going to miss a cancer. We should operate on all patients because – at least as Dr. Katz’s argues – the surgery can always be done without complications.
However, even at the very, very experienced centers, morbidity was 30%-50%, and a pancreatic fistula developed for 1 in 10 patients. So it’s not a benign procedure.1
As surgeons, we tend to take every mass out. Although operative mortality is low, it is still in a measurable range, 1%-2%, and that is even at expert centers. Many of these small cysts are being found at smaller and community hospitals, and undue morbidity and mortality may weigh more heavily in these settings.2
Rather than “being a hammer and seeing everything as a nail,” we need a more rational approach. For example, we should identify a subgroup that will the most benefit from resection.
Investigators from Memorial Sloan Kettering Cancer Center reported that certain clinical factors identify patients at higher risk for mortality, such as nodules.3 Patients with invasive cancer almost all had nodules. And all patients with invasive cancer without nodules had a tumor larger than 4 cm.
Maybe using both presence of nodules and size is the right approach to identifying underling malignancy in suspected MCNs. Again, size is important, as is male gender, presence of solid nodules, and duct dilatation.4
We are arguing whether all MCNs should be resected. I’m positing that many 2-cm to 3-cm MCNs can be followed. There is only a small chance they will grow over time, and it’s unlikely they are harboring a malignancy.
Dr. Pawlik is Chair of Surgery at the Ohio State Wexner Medical Center in Columbus. He is also the Urban Meyer III and Shelley Meyer Chair for Cancer Research at Ohio State. He has no disclosures.
References
1. HPB (Oxford). 2007;9:8-15.
2. Diagnosis and Management of Cystic Lesions of the Pancreas. Diagnostic and Therapeutic Endoscopy Volume 2011 (2011), Article ID 478913.
3. JAMA Surg. 2017;152:19-25.
4. Ann Surg. 2006;244:572-82.
This Point/Counterpoint feature is based on comments Dr. Katz and Dr. Pawlik made during a debate at AHPBA 2017, the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
Adjunctive rifampicin doesn’t improve any outcome in S. aureus bacteremia
VIENNA – When given in conjunction with an antibiotic, rifampicin didn’t improve treatment response or mortality in patients with Staphylococcus aureus bacteremia, either in an overall analysis or in any of 18 subgroups.
The only hints of benefit associated with the drug were decreases in treatment failure and recurrence, but the numbers needed to treat were excessive (29 and 26, respectively). They didn’t translate into any long-term survival benefit and couldn’t balance out other findings that rifampicin increased drug interactions and complicated treatment, Guy Thwaites, MD, said at the European Conference on Clinical Microbiology and Infectious Diseases.
He presented the results of the randomized, placebo-controlled ARREST (Adjunctive Rifampicin to Reduce Early Mortality From Staphylococcus aureus bacteremia) study. ARREST was conducted at 29 sites in the United Kingdom. It enrolled 758 adults with proven S. aureus bacteremia who were already on standard antibiotic therapy and switched them to either adjunctive rifampicin or placebo for 2 weeks. Clinicians could choose rifampicin in either 600 mg or 900 mg, oral or IV formulations, once or twice daily doses.
Patients were followed with clinical assessments and blood cultures for 12 weeks and for overall mortality for 102 weeks. The primary endpoint was bacteriologically confirmed treatment failure or recurrence by week 12.
Patients were a mean of 65 years old. Most infections (64%) were community acquired, with the remainder associated with a stay in a health care facility, and 6% were methicillin resistant. Serious comorbidities were common, including cancer (17%), chronic lung disease (12%), kidney disease (18%), and diabetes (30%).
The largest portion of infections (40%) had a deep focus, including native cardiac valve or joint, prosthetic cardiac valve or implant, and deep tissue infections. Other sites of infection were indwelling lines, skin/soft tissue, surgical sites, pneumonia, and urinary tract. For 18%, no specific focus was ever established.
Rifampicin was initiated a mean of 68 hours after main antibiotic therapy. Most patients (86%) received it orally, in the 900-mg dose (78%). The mean rifampicin treatment duration was 13 days.
Treatment failure rates through week 12 were practically identical for rifampicin and placebo (17.5% vs. 18.9%) in the overall analysis. Clinical failure or recurrence through week 12 was also similar for rifampicin and placebo (21.4% vs. 22.9%). Dr. Thwaites didn’t present all 18 subgroup analyses but said the results were similar no matter how patients were divided.
There was no significant difference in 12-week mortality for rifampicin vs. placebo (15.7% vs. 14.8%). There were 112 deaths, 56 in each group. Of these, 28 were directly related to the S. aureus infection. There was no difference in long-term survival measured at 102 weeks.
When an independent endpoint review committee examined some of the composite endpoints separately, it determined that rifampicin did confer a significant advantage in both bacterial and clinical recurrence. However, 29 patients needed to be treated to avoid a bacteriologic recurrence and 26 to avoid a clinical recurrence. Two cases of rifampicin resistance developed.
One-quarter of the group experienced serious adverse events. Dr. Thwaites didn’t review these but said they were evenly distributed between the groups. He also said that rifampicin was associated with an increase in drug-drug interactions, some of which required changing the backbone antibiotic.
There was a small, but nonsignificant, increase in acute kidney injury in the rifampicin group.
The study was funded by the National Institute of Health Research in the United Kingdom. Dr. Thwaites had no financial disclosures.
[email protected]
On Twitter @alz_gal
VIENNA – When given in conjunction with an antibiotic, rifampicin didn’t improve treatment response or mortality in patients with Staphylococcus aureus bacteremia, either in an overall analysis or in any of 18 subgroups.
The only hints of benefit associated with the drug were decreases in treatment failure and recurrence, but the numbers needed to treat were excessive (29 and 26, respectively). They didn’t translate into any long-term survival benefit and couldn’t balance out other findings that rifampicin increased drug interactions and complicated treatment, Guy Thwaites, MD, said at the European Conference on Clinical Microbiology and Infectious Diseases.
He presented the results of the randomized, placebo-controlled ARREST (Adjunctive Rifampicin to Reduce Early Mortality From Staphylococcus aureus bacteremia) study. ARREST was conducted at 29 sites in the United Kingdom. It enrolled 758 adults with proven S. aureus bacteremia who were already on standard antibiotic therapy and switched them to either adjunctive rifampicin or placebo for 2 weeks. Clinicians could choose rifampicin in either 600 mg or 900 mg, oral or IV formulations, once or twice daily doses.
Patients were followed with clinical assessments and blood cultures for 12 weeks and for overall mortality for 102 weeks. The primary endpoint was bacteriologically confirmed treatment failure or recurrence by week 12.
Patients were a mean of 65 years old. Most infections (64%) were community acquired, with the remainder associated with a stay in a health care facility, and 6% were methicillin resistant. Serious comorbidities were common, including cancer (17%), chronic lung disease (12%), kidney disease (18%), and diabetes (30%).
The largest portion of infections (40%) had a deep focus, including native cardiac valve or joint, prosthetic cardiac valve or implant, and deep tissue infections. Other sites of infection were indwelling lines, skin/soft tissue, surgical sites, pneumonia, and urinary tract. For 18%, no specific focus was ever established.
Rifampicin was initiated a mean of 68 hours after main antibiotic therapy. Most patients (86%) received it orally, in the 900-mg dose (78%). The mean rifampicin treatment duration was 13 days.
Treatment failure rates through week 12 were practically identical for rifampicin and placebo (17.5% vs. 18.9%) in the overall analysis. Clinical failure or recurrence through week 12 was also similar for rifampicin and placebo (21.4% vs. 22.9%). Dr. Thwaites didn’t present all 18 subgroup analyses but said the results were similar no matter how patients were divided.
There was no significant difference in 12-week mortality for rifampicin vs. placebo (15.7% vs. 14.8%). There were 112 deaths, 56 in each group. Of these, 28 were directly related to the S. aureus infection. There was no difference in long-term survival measured at 102 weeks.
When an independent endpoint review committee examined some of the composite endpoints separately, it determined that rifampicin did confer a significant advantage in both bacterial and clinical recurrence. However, 29 patients needed to be treated to avoid a bacteriologic recurrence and 26 to avoid a clinical recurrence. Two cases of rifampicin resistance developed.
One-quarter of the group experienced serious adverse events. Dr. Thwaites didn’t review these but said they were evenly distributed between the groups. He also said that rifampicin was associated with an increase in drug-drug interactions, some of which required changing the backbone antibiotic.
There was a small, but nonsignificant, increase in acute kidney injury in the rifampicin group.
The study was funded by the National Institute of Health Research in the United Kingdom. Dr. Thwaites had no financial disclosures.
[email protected]
On Twitter @alz_gal
VIENNA – When given in conjunction with an antibiotic, rifampicin didn’t improve treatment response or mortality in patients with Staphylococcus aureus bacteremia, either in an overall analysis or in any of 18 subgroups.
The only hints of benefit associated with the drug were decreases in treatment failure and recurrence, but the numbers needed to treat were excessive (29 and 26, respectively). They didn’t translate into any long-term survival benefit and couldn’t balance out other findings that rifampicin increased drug interactions and complicated treatment, Guy Thwaites, MD, said at the European Conference on Clinical Microbiology and Infectious Diseases.
He presented the results of the randomized, placebo-controlled ARREST (Adjunctive Rifampicin to Reduce Early Mortality From Staphylococcus aureus bacteremia) study. ARREST was conducted at 29 sites in the United Kingdom. It enrolled 758 adults with proven S. aureus bacteremia who were already on standard antibiotic therapy and switched them to either adjunctive rifampicin or placebo for 2 weeks. Clinicians could choose rifampicin in either 600 mg or 900 mg, oral or IV formulations, once or twice daily doses.
Patients were followed with clinical assessments and blood cultures for 12 weeks and for overall mortality for 102 weeks. The primary endpoint was bacteriologically confirmed treatment failure or recurrence by week 12.
Patients were a mean of 65 years old. Most infections (64%) were community acquired, with the remainder associated with a stay in a health care facility, and 6% were methicillin resistant. Serious comorbidities were common, including cancer (17%), chronic lung disease (12%), kidney disease (18%), and diabetes (30%).
The largest portion of infections (40%) had a deep focus, including native cardiac valve or joint, prosthetic cardiac valve or implant, and deep tissue infections. Other sites of infection were indwelling lines, skin/soft tissue, surgical sites, pneumonia, and urinary tract. For 18%, no specific focus was ever established.
Rifampicin was initiated a mean of 68 hours after main antibiotic therapy. Most patients (86%) received it orally, in the 900-mg dose (78%). The mean rifampicin treatment duration was 13 days.
Treatment failure rates through week 12 were practically identical for rifampicin and placebo (17.5% vs. 18.9%) in the overall analysis. Clinical failure or recurrence through week 12 was also similar for rifampicin and placebo (21.4% vs. 22.9%). Dr. Thwaites didn’t present all 18 subgroup analyses but said the results were similar no matter how patients were divided.
There was no significant difference in 12-week mortality for rifampicin vs. placebo (15.7% vs. 14.8%). There were 112 deaths, 56 in each group. Of these, 28 were directly related to the S. aureus infection. There was no difference in long-term survival measured at 102 weeks.
When an independent endpoint review committee examined some of the composite endpoints separately, it determined that rifampicin did confer a significant advantage in both bacterial and clinical recurrence. However, 29 patients needed to be treated to avoid a bacteriologic recurrence and 26 to avoid a clinical recurrence. Two cases of rifampicin resistance developed.
One-quarter of the group experienced serious adverse events. Dr. Thwaites didn’t review these but said they were evenly distributed between the groups. He also said that rifampicin was associated with an increase in drug-drug interactions, some of which required changing the backbone antibiotic.
There was a small, but nonsignificant, increase in acute kidney injury in the rifampicin group.
The study was funded by the National Institute of Health Research in the United Kingdom. Dr. Thwaites had no financial disclosures.
[email protected]
On Twitter @alz_gal
Key clinical point:
Major finding: Treatment failure was nearly identical with rifampicin and placebo (17.5% vs. 18.9%).
Data source: A placebo-controlled trial enrolling 758 adults.
Disclosures: The study was funded by the National Institute of Health Research in the United Kingdom. Dr. Thwaites had no financial disclosures.
NSCLC Was a Key Focus of General Thoracic Session
The initial results of a phase III randomized trial comparing lobectomy to segmentectomy for small, peripheral non–small cell lung cancer (NSCLC) were presented by Kenji Suzuki, MD, of the Juntendo University Hospital, Japan.
Segmentectomy and lobectomy both proved feasible techniques for early-stage NSCLC. However, segmentectomy did not appear to be less invasive than lobectomy with regard to blood loss or the frequency of air leak, according to Dr. Suzuki.
A total of 1,106 patients (554 in lobectomy arm; 552 in segmentectomy arm) were enrolled between August 2009 and October 2014. There were 22 patients whose mode of surgery was converted from segmentectomy to lobectomy in the segmentectomy arm, resulting in 576 lobectomies and 530 segmentectomies. 
“The aim of the trial is to confirm the non-inferiority in overall survival (OS) of segmentectomy, compared with lobectomy,” said Dr. Suzuki.
Surgical complications were evaluated by the mode of surgery with an intention-to-treat analysis. As to a mode of surgery, segmentectomy was categorized into simple and complex in terms of technical difficulty; resection of the right or left S6, the left superior, and the lingular segment were defined as simple, because these procedures are easy and common.
Operative mortality was 0% in both groups. Postoperative complications, including pneumonia were not significantly different between the two groups. However, there was a significant difference in the rate of air leak detected: 3.8% in Group A and 6.5% in Group B (with no broncho-pleural fistulas being found).
Multivariate analysis showed that pack-year (PY) smoking greater than 20 vs. none was a significant predictor of postoperative complications. Significant predictors of pulmonary complications, including alveolar fistula and empyema, were typical segmentectomy (vs. lobectomy); and PY greater than 20 vs. none.
“The primary analysis of this study is planned for 2020,” said Dr. Suzuki. Those results should help to determine whether segmentectomy should be considered the standard of treatment, compared to lobectomy.
Previous research has shown that a wedge resection (WR) may be superior to stereotactic body radiation therapy (SBRT) for patients with early-stage non–small cell lung cancer (NSCLC). However, the role that the quality of the WR plays in improved outcomes is unknown, according to Seth Krantz, MD, of the NorthShore University Health System who presented the results of a database analysis of patients within the National Cancer Database (NCDB) with clinical T1-T2, N0, M0 NSCLC patients who were treated with either WR or SBRT from 2005-2012. These patients were analyzed for surgical quality markers, predictors of lymph node assessment and pathologic upstaging, and overall survival. Quality markers included the number of nodes examined and margins status.
Of more than 7,000 WR patients included (44%) had 0 LNs examined; 37% had 1-5 examined, and nearly 17% had more than 5 nodes examined. Significant predictors of having at least 5 nodes examined included younger age, fewer comorbidities, T2 tumors, and obtaining negative margins. Negative margins were obtained in the vast majority of WR patients.
“Our study confirms that nationwide, while most patients undergoing wedge resection for early stage disease receive a margin negative resection, fewer than 20% of patients had more than five lymph nodes assessed, and nearly half had no lymph nodes assessed. Pathologic assessment of lymph nodes was associated with improved long-term survival and greater utilization of adjuvant chemotherapy. Furthermore, the benefit of a wedge resection compared to SBRT, was significantly affected by the extent of lymph node assessment. 
If patients are going to be offered a wedge resection for early stage non-small cell lung cancer, every effort should be made to perform a pathologic assessment of regional lymph nodes,” Dr. Krantz concluded.
Patients at high risk for non–small cell lung cancer (NSCLC) metastases were found to have a significant rate of unsuspected lymph node metastases upon endosonographic assessment, even in the presence of radiologically normal mediastinal lymph nodes, according to a study reported by Pravachan Hegde, MD, of the University of Montreal.
A total of 22 out of 161 patients with radiologically normal mediastinum were found to be positive on combined EBUS/EUS staging. “Given the significant rate of unsuspected lymph node metastases, combined endosonographic lymph node staging should be routinely performed in staging of NSCLC in high risk patients even in the presence of radiologically normal mediastinal lymph nodes,” Dr. Hedge concluded.
The initial results of a phase III randomized trial comparing lobectomy to segmentectomy for small, peripheral non–small cell lung cancer (NSCLC) were presented by Kenji Suzuki, MD, of the Juntendo University Hospital, Japan.
Segmentectomy and lobectomy both proved feasible techniques for early-stage NSCLC. However, segmentectomy did not appear to be less invasive than lobectomy with regard to blood loss or the frequency of air leak, according to Dr. Suzuki.
A total of 1,106 patients (554 in lobectomy arm; 552 in segmentectomy arm) were enrolled between August 2009 and October 2014. There were 22 patients whose mode of surgery was converted from segmentectomy to lobectomy in the segmentectomy arm, resulting in 576 lobectomies and 530 segmentectomies.
“The aim of the trial is to confirm the non-inferiority in overall survival (OS) of segmentectomy, compared with lobectomy,” said Dr. Suzuki.
Surgical complications were evaluated by the mode of surgery with an intention-to-treat analysis. As to a mode of surgery, segmentectomy was categorized into simple and complex in terms of technical difficulty; resection of the right or left S6, the left superior, and the lingular segment were defined as simple, because these procedures are easy and common.
Operative mortality was 0% in both groups. Postoperative complications, including pneumonia were not significantly different between the two groups. However, there was a significant difference in the rate of air leak detected: 3.8% in Group A and 6.5% in Group B (with no broncho-pleural fistulas being found).
Multivariate analysis showed that pack-year (PY) smoking greater than 20 vs. none was a significant predictor of postoperative complications. Significant predictors of pulmonary complications, including alveolar fistula and empyema, were typical segmentectomy (vs. lobectomy); and PY greater than 20 vs. none.
“The primary analysis of this study is planned for 2020,” said Dr. Suzuki. Those results should help to determine whether segmentectomy should be considered the standard of treatment, compared to lobectomy.
Previous research has shown that a wedge resection (WR) may be superior to stereotactic body radiation therapy (SBRT) for patients with early-stage non–small cell lung cancer (NSCLC). However, the role that the quality of the WR plays in improved outcomes is unknown, according to Seth Krantz, MD, of the NorthShore University Health System who presented the results of a database analysis of patients within the National Cancer Database (NCDB) with clinical T1-T2, N0, M0 NSCLC patients who were treated with either WR or SBRT from 2005-2012. These patients were analyzed for surgical quality markers, predictors of lymph node assessment and pathologic upstaging, and overall survival. Quality markers included the number of nodes examined and margins status.
Of more than 7,000 WR patients included (44%) had 0 LNs examined; 37% had 1-5 examined, and nearly 17% had more than 5 nodes examined. Significant predictors of having at least 5 nodes examined included younger age, fewer comorbidities, T2 tumors, and obtaining negative margins. Negative margins were obtained in the vast majority of WR patients.
“Our study confirms that nationwide, while most patients undergoing wedge resection for early stage disease receive a margin negative resection, fewer than 20% of patients had more than five lymph nodes assessed, and nearly half had no lymph nodes assessed. Pathologic assessment of lymph nodes was associated with improved long-term survival and greater utilization of adjuvant chemotherapy. Furthermore, the benefit of a wedge resection compared to SBRT, was significantly affected by the extent of lymph node assessment.
If patients are going to be offered a wedge resection for early stage non-small cell lung cancer, every effort should be made to perform a pathologic assessment of regional lymph nodes,” Dr. Krantz concluded.
Patients at high risk for non–small cell lung cancer (NSCLC) metastases were found to have a significant rate of unsuspected lymph node metastases upon endosonographic assessment, even in the presence of radiologically normal mediastinal lymph nodes, according to a study reported by Pravachan Hegde, MD, of the University of Montreal.
A total of 22 out of 161 patients with radiologically normal mediastinum were found to be positive on combined EBUS/EUS staging. “Given the significant rate of unsuspected lymph node metastases, combined endosonographic lymph node staging should be routinely performed in staging of NSCLC in high risk patients even in the presence of radiologically normal mediastinal lymph nodes,” Dr. Hedge concluded.
The initial results of a phase III randomized trial comparing lobectomy to segmentectomy for small, peripheral non–small cell lung cancer (NSCLC) were presented by Kenji Suzuki, MD, of the Juntendo University Hospital, Japan.
Segmentectomy and lobectomy both proved feasible techniques for early-stage NSCLC. However, segmentectomy did not appear to be less invasive than lobectomy with regard to blood loss or the frequency of air leak, according to Dr. Suzuki.
A total of 1,106 patients (554 in lobectomy arm; 552 in segmentectomy arm) were enrolled between August 2009 and October 2014. There were 22 patients whose mode of surgery was converted from segmentectomy to lobectomy in the segmentectomy arm, resulting in 576 lobectomies and 530 segmentectomies.
“The aim of the trial is to confirm the non-inferiority in overall survival (OS) of segmentectomy, compared with lobectomy,” said Dr. Suzuki.
Surgical complications were evaluated by the mode of surgery with an intention-to-treat analysis. As to a mode of surgery, segmentectomy was categorized into simple and complex in terms of technical difficulty; resection of the right or left S6, the left superior, and the lingular segment were defined as simple, because these procedures are easy and common.
Operative mortality was 0% in both groups. Postoperative complications, including pneumonia were not significantly different between the two groups. However, there was a significant difference in the rate of air leak detected: 3.8% in Group A and 6.5% in Group B (with no broncho-pleural fistulas being found).
Multivariate analysis showed that pack-year (PY) smoking greater than 20 vs. none was a significant predictor of postoperative complications. Significant predictors of pulmonary complications, including alveolar fistula and empyema, were typical segmentectomy (vs. lobectomy); and PY greater than 20 vs. none.
“The primary analysis of this study is planned for 2020,” said Dr. Suzuki. Those results should help to determine whether segmentectomy should be considered the standard of treatment, compared to lobectomy.
Previous research has shown that a wedge resection (WR) may be superior to stereotactic body radiation therapy (SBRT) for patients with early-stage non–small cell lung cancer (NSCLC). However, the role that the quality of the WR plays in improved outcomes is unknown, according to Seth Krantz, MD, of the NorthShore University Health System who presented the results of a database analysis of patients within the National Cancer Database (NCDB) with clinical T1-T2, N0, M0 NSCLC patients who were treated with either WR or SBRT from 2005-2012. These patients were analyzed for surgical quality markers, predictors of lymph node assessment and pathologic upstaging, and overall survival. Quality markers included the number of nodes examined and margins status.
Of more than 7,000 WR patients included (44%) had 0 LNs examined; 37% had 1-5 examined, and nearly 17% had more than 5 nodes examined. Significant predictors of having at least 5 nodes examined included younger age, fewer comorbidities, T2 tumors, and obtaining negative margins. Negative margins were obtained in the vast majority of WR patients.
“Our study confirms that nationwide, while most patients undergoing wedge resection for early stage disease receive a margin negative resection, fewer than 20% of patients had more than five lymph nodes assessed, and nearly half had no lymph nodes assessed. Pathologic assessment of lymph nodes was associated with improved long-term survival and greater utilization of adjuvant chemotherapy. Furthermore, the benefit of a wedge resection compared to SBRT, was significantly affected by the extent of lymph node assessment.
If patients are going to be offered a wedge resection for early stage non-small cell lung cancer, every effort should be made to perform a pathologic assessment of regional lymph nodes,” Dr. Krantz concluded.
Patients at high risk for non–small cell lung cancer (NSCLC) metastases were found to have a significant rate of unsuspected lymph node metastases upon endosonographic assessment, even in the presence of radiologically normal mediastinal lymph nodes, according to a study reported by Pravachan Hegde, MD, of the University of Montreal.
A total of 22 out of 161 patients with radiologically normal mediastinum were found to be positive on combined EBUS/EUS staging. “Given the significant rate of unsuspected lymph node metastases, combined endosonographic lymph node staging should be routinely performed in staging of NSCLC in high risk patients even in the presence of radiologically normal mediastinal lymph nodes,” Dr. Hedge concluded.
McChrystal Spoke on the Need for a New Kind of Team
Monday’s Honored Guest Lecturer Gen. Stanley A. McChrystal, a retired four-star general, and former commander of U.S. and International Security Assistance Forces in Afghanistan, and of the Joint Special Operations Command, spoke on the transforming nature of leadership and teams.
His address, “Team of Teams – Rules of Engagement for a Complex World,” discussed how old organizational frameworks with a centralized leadership and silos of responsibility, similar to the standard organization charts that everyone is familiar with, are no longer sufficiently functional and efficient in a changing world. He stated how the world is not just complicated, but complex, and the nature of complexity means that it cannot be predicted and a rapid, adaptive response is necessary.He highlighted his experiences in Iraq where a terrorist group, rather than using a hierarchical organization such as Al Queda, organically developed a highly adaptable and diffuse structure, which allowed them to have their leaders taken out without heavily impacting their ability to grow and rapidly respond. It wasn’t until the U.S. military under his leadership emulated such a diffuse response and geared up their efforts many-fold, that the anti-terrorism effort began to succeed.
The cascade through the chain of command just wasn’t fast enough.“We had entered an environment where we had to resynchronize the organization every 24 hours. The entire organization.” So he established a daily conference call not just among the leadership but, instead, “connected everybody, all at the same time. We started by ordering 400 people to be on it and in a very short period of time it became 7,500, and went from 30 minutes to 90 minutes a day,” he said. And despite the fact that some people would call this ‘crazy,’ he said. “I’ll tell you it’s the most efficient thing I’ve ever been a part of in my life. In those 90 minutes, everyone in the organization got shared contextual understanding of what we were doing, what we were trying to do, and what we could do.” Leaders need to create an environment for a new kind of organization to grow.
Monday’s Honored Guest Lecturer Gen. Stanley A. McChrystal, a retired four-star general, and former commander of U.S. and International Security Assistance Forces in Afghanistan, and of the Joint Special Operations Command, spoke on the transforming nature of leadership and teams.
His address, “Team of Teams – Rules of Engagement for a Complex World,” discussed how old organizational frameworks with a centralized leadership and silos of responsibility, similar to the standard organization charts that everyone is familiar with, are no longer sufficiently functional and efficient in a changing world. He stated how the world is not just complicated, but complex, and the nature of complexity means that it cannot be predicted and a rapid, adaptive response is necessary.He highlighted his experiences in Iraq where a terrorist group, rather than using a hierarchical organization such as Al Queda, organically developed a highly adaptable and diffuse structure, which allowed them to have their leaders taken out without heavily impacting their ability to grow and rapidly respond. It wasn’t until the U.S. military under his leadership emulated such a diffuse response and geared up their efforts many-fold, that the anti-terrorism effort began to succeed.
The cascade through the chain of command just wasn’t fast enough.“We had entered an environment where we had to resynchronize the organization every 24 hours. The entire organization.” So he established a daily conference call not just among the leadership but, instead, “connected everybody, all at the same time. We started by ordering 400 people to be on it and in a very short period of time it became 7,500, and went from 30 minutes to 90 minutes a day,” he said. And despite the fact that some people would call this ‘crazy,’ he said. “I’ll tell you it’s the most efficient thing I’ve ever been a part of in my life. In those 90 minutes, everyone in the organization got shared contextual understanding of what we were doing, what we were trying to do, and what we could do.” Leaders need to create an environment for a new kind of organization to grow.
Monday’s Honored Guest Lecturer Gen. Stanley A. McChrystal, a retired four-star general, and former commander of U.S. and International Security Assistance Forces in Afghanistan, and of the Joint Special Operations Command, spoke on the transforming nature of leadership and teams.
His address, “Team of Teams – Rules of Engagement for a Complex World,” discussed how old organizational frameworks with a centralized leadership and silos of responsibility, similar to the standard organization charts that everyone is familiar with, are no longer sufficiently functional and efficient in a changing world. He stated how the world is not just complicated, but complex, and the nature of complexity means that it cannot be predicted and a rapid, adaptive response is necessary.He highlighted his experiences in Iraq where a terrorist group, rather than using a hierarchical organization such as Al Queda, organically developed a highly adaptable and diffuse structure, which allowed them to have their leaders taken out without heavily impacting their ability to grow and rapidly respond. It wasn’t until the U.S. military under his leadership emulated such a diffuse response and geared up their efforts many-fold, that the anti-terrorism effort began to succeed.
The cascade through the chain of command just wasn’t fast enough.“We had entered an environment where we had to resynchronize the organization every 24 hours. The entire organization.” So he established a daily conference call not just among the leadership but, instead, “connected everybody, all at the same time. We started by ordering 400 people to be on it and in a very short period of time it became 7,500, and went from 30 minutes to 90 minutes a day,” he said. And despite the fact that some people would call this ‘crazy,’ he said. “I’ll tell you it’s the most efficient thing I’ve ever been a part of in my life. In those 90 minutes, everyone in the organization got shared contextual understanding of what we were doing, what we were trying to do, and what we could do.” Leaders need to create an environment for a new kind of organization to grow.
Game over: VTE is a risk in obese, sedentary teens
MONTREAL – It’s well known that airplane passengers, condemned to sit for endless hours in the claustrophobic cabins of the unfriendly skies, are at increased risk for venous thromboembolic events (VTEs). Less well documented, however, is the VTE risk encountered by overweight or obese teens who while their hours away playing video games.
“This is becoming a sedentary-type risk factor,” said Mira A. Kohorst, MD, from the division of pediatric hematology-oncology at the Mayo Clinic in Rochester, Minn.
Dr. Kohorst and her colleagues reported on a small but troubling trend of VTE episodes that they observed in teen boys over the last few years. They refer to obesity, sedentary lifestyle, and gaming as “the new thrombophilia cocktail in adolescent males.”
The reported incidence of pediatric VTE ranges from 0.7 to 4.9 per 100,000 person years, considerably lower than the 1 in 1000 estimated incidences reported in adults. But, thanks to the growing incidence of obesity in children, which more than doubled from 1980 to 2012 and quadrupled in teens age 12-19 years from 5% to 21%, youngsters appear to be catching up in the VTE department, the investigators reported.
“Given the direct mortality rate of 2% [that is] associated with VTE and risk for postthrombotic syndrome of 26%, it is important to understand underlying modifiable risk factors,” they wrote.
To do this, they retrospectively reviewed records of children who presented with VTE in their center.
All play, no exercise
The authors described three cases, including that of an 18-year old boy with a body mass index (BMI) of 37 kg/m2, putting him squarely in the obese category. This lad, who spent 12 or more hours a day playing video games and was sedentary at other times as well, presented with bilateral pulmonary emboli and an associated right lower lobe infarction. Testing for thrombophilia showed that he was heterozygous for factor V Leiden but did not have other coagulation abnormalities. He was started on enoxaparin (Lovenox) and then transitioned to apixaban (Eliquis) for a total of 6 months of thromboprophylaxis. He was counseled about modifying his lifestyle and did not have a recurrence after 14 months of follow-up.
A similarly sedentary 17-year old male with an even higher BMI (39 kg/m2) presented with bilateral basilar pulmonary emboli and infarctions in association with a left femoral deep vein thrombosis. This patients also had factor V Leiden heterozygosity and the May-Thurner (iliac vein compression) syndrome. He was treated for a total of 6 months with warfarin followed by rivaroxaban (Xarelto) and was counseled about lifestyle changes but was unable to lose weight. Eight months after completing therapy, he had a second extensive deep vein thrombosis, this time in his right leg, and was restarted on rivaroxaban.
The third patient, a morbidly obese (BMI 56 kg/m2) 13-year-old boy, presented with left lower lobe pulmonary embolism following 3 weeks of immobility caused by the Guillain-Barré syndrome. As in the other cases, he confessed to a sedentary lifestyle and a predilection for gaming. His father had previously developed a line-associated thrombus. The family declined thrombophilia testing. The patient received 3 months of enoxaparin. He has not been followed since discontinuing therapy.
Move it, kid!
The risk of VTE in adolescent boys, especially obese and extreme gamers who spend most of their waking hours in a chair staring at a screen, is similar to that for adolescent girls who use oral contraceptives, Dr. Kohorst and her colleagues said.
“Many case reports link prolonged ‘gaming’ to thrombosis and fatal pulmonary emboli. Additionally, prolonged television viewing has become a documented risk factor for mortality from pulmonary emboli,” the investigators wrote.
They recommend that clinicians ask adolescents about their gaming and TV-watching habits and encourage them to become more active to lower their risk for VTE.
The study was internally supported. Dr. Kohorst and colleagues reported no relevant disclosures.
MONTREAL – It’s well known that airplane passengers, condemned to sit for endless hours in the claustrophobic cabins of the unfriendly skies, are at increased risk for venous thromboembolic events (VTEs). Less well documented, however, is the VTE risk encountered by overweight or obese teens who while their hours away playing video games.
“This is becoming a sedentary-type risk factor,” said Mira A. Kohorst, MD, from the division of pediatric hematology-oncology at the Mayo Clinic in Rochester, Minn.
Dr. Kohorst and her colleagues reported on a small but troubling trend of VTE episodes that they observed in teen boys over the last few years. They refer to obesity, sedentary lifestyle, and gaming as “the new thrombophilia cocktail in adolescent males.”
The reported incidence of pediatric VTE ranges from 0.7 to 4.9 per 100,000 person years, considerably lower than the 1 in 1000 estimated incidences reported in adults. But, thanks to the growing incidence of obesity in children, which more than doubled from 1980 to 2012 and quadrupled in teens age 12-19 years from 5% to 21%, youngsters appear to be catching up in the VTE department, the investigators reported.
“Given the direct mortality rate of 2% [that is] associated with VTE and risk for postthrombotic syndrome of 26%, it is important to understand underlying modifiable risk factors,” they wrote.
To do this, they retrospectively reviewed records of children who presented with VTE in their center.
All play, no exercise
The authors described three cases, including that of an 18-year old boy with a body mass index (BMI) of 37 kg/m2, putting him squarely in the obese category. This lad, who spent 12 or more hours a day playing video games and was sedentary at other times as well, presented with bilateral pulmonary emboli and an associated right lower lobe infarction. Testing for thrombophilia showed that he was heterozygous for factor V Leiden but did not have other coagulation abnormalities. He was started on enoxaparin (Lovenox) and then transitioned to apixaban (Eliquis) for a total of 6 months of thromboprophylaxis. He was counseled about modifying his lifestyle and did not have a recurrence after 14 months of follow-up.
A similarly sedentary 17-year old male with an even higher BMI (39 kg/m2) presented with bilateral basilar pulmonary emboli and infarctions in association with a left femoral deep vein thrombosis. This patients also had factor V Leiden heterozygosity and the May-Thurner (iliac vein compression) syndrome. He was treated for a total of 6 months with warfarin followed by rivaroxaban (Xarelto) and was counseled about lifestyle changes but was unable to lose weight. Eight months after completing therapy, he had a second extensive deep vein thrombosis, this time in his right leg, and was restarted on rivaroxaban.
The third patient, a morbidly obese (BMI 56 kg/m2) 13-year-old boy, presented with left lower lobe pulmonary embolism following 3 weeks of immobility caused by the Guillain-Barré syndrome. As in the other cases, he confessed to a sedentary lifestyle and a predilection for gaming. His father had previously developed a line-associated thrombus. The family declined thrombophilia testing. The patient received 3 months of enoxaparin. He has not been followed since discontinuing therapy.
Move it, kid!
The risk of VTE in adolescent boys, especially obese and extreme gamers who spend most of their waking hours in a chair staring at a screen, is similar to that for adolescent girls who use oral contraceptives, Dr. Kohorst and her colleagues said.
“Many case reports link prolonged ‘gaming’ to thrombosis and fatal pulmonary emboli. Additionally, prolonged television viewing has become a documented risk factor for mortality from pulmonary emboli,” the investigators wrote.
They recommend that clinicians ask adolescents about their gaming and TV-watching habits and encourage them to become more active to lower their risk for VTE.
The study was internally supported. Dr. Kohorst and colleagues reported no relevant disclosures.
MONTREAL – It’s well known that airplane passengers, condemned to sit for endless hours in the claustrophobic cabins of the unfriendly skies, are at increased risk for venous thromboembolic events (VTEs). Less well documented, however, is the VTE risk encountered by overweight or obese teens who while their hours away playing video games.
“This is becoming a sedentary-type risk factor,” said Mira A. Kohorst, MD, from the division of pediatric hematology-oncology at the Mayo Clinic in Rochester, Minn.
Dr. Kohorst and her colleagues reported on a small but troubling trend of VTE episodes that they observed in teen boys over the last few years. They refer to obesity, sedentary lifestyle, and gaming as “the new thrombophilia cocktail in adolescent males.”
The reported incidence of pediatric VTE ranges from 0.7 to 4.9 per 100,000 person years, considerably lower than the 1 in 1000 estimated incidences reported in adults. But, thanks to the growing incidence of obesity in children, which more than doubled from 1980 to 2012 and quadrupled in teens age 12-19 years from 5% to 21%, youngsters appear to be catching up in the VTE department, the investigators reported.
“Given the direct mortality rate of 2% [that is] associated with VTE and risk for postthrombotic syndrome of 26%, it is important to understand underlying modifiable risk factors,” they wrote.
To do this, they retrospectively reviewed records of children who presented with VTE in their center.
All play, no exercise
The authors described three cases, including that of an 18-year old boy with a body mass index (BMI) of 37 kg/m2, putting him squarely in the obese category. This lad, who spent 12 or more hours a day playing video games and was sedentary at other times as well, presented with bilateral pulmonary emboli and an associated right lower lobe infarction. Testing for thrombophilia showed that he was heterozygous for factor V Leiden but did not have other coagulation abnormalities. He was started on enoxaparin (Lovenox) and then transitioned to apixaban (Eliquis) for a total of 6 months of thromboprophylaxis. He was counseled about modifying his lifestyle and did not have a recurrence after 14 months of follow-up.
A similarly sedentary 17-year old male with an even higher BMI (39 kg/m2) presented with bilateral basilar pulmonary emboli and infarctions in association with a left femoral deep vein thrombosis. This patients also had factor V Leiden heterozygosity and the May-Thurner (iliac vein compression) syndrome. He was treated for a total of 6 months with warfarin followed by rivaroxaban (Xarelto) and was counseled about lifestyle changes but was unable to lose weight. Eight months after completing therapy, he had a second extensive deep vein thrombosis, this time in his right leg, and was restarted on rivaroxaban.
The third patient, a morbidly obese (BMI 56 kg/m2) 13-year-old boy, presented with left lower lobe pulmonary embolism following 3 weeks of immobility caused by the Guillain-Barré syndrome. As in the other cases, he confessed to a sedentary lifestyle and a predilection for gaming. His father had previously developed a line-associated thrombus. The family declined thrombophilia testing. The patient received 3 months of enoxaparin. He has not been followed since discontinuing therapy.
Move it, kid!
The risk of VTE in adolescent boys, especially obese and extreme gamers who spend most of their waking hours in a chair staring at a screen, is similar to that for adolescent girls who use oral contraceptives, Dr. Kohorst and her colleagues said.
“Many case reports link prolonged ‘gaming’ to thrombosis and fatal pulmonary emboli. Additionally, prolonged television viewing has become a documented risk factor for mortality from pulmonary emboli,” the investigators wrote.
They recommend that clinicians ask adolescents about their gaming and TV-watching habits and encourage them to become more active to lower their risk for VTE.
The study was internally supported. Dr. Kohorst and colleagues reported no relevant disclosures.
FROM ASPHO 2017
Key clinical point: Obesity and a sedentary lifestyle are risk factors for venous thromboembolic events in teens, as well as adults.
Major finding: Teen boys who were obese and spent much of their day playing video games presented with VTE.
Data source: Retrospective review and case series.
Disclosures: The study was internally supported. Dr. Kohorst and colleagues reported no relevant disclosures.
Mastectomy unnecessary for some breast cancer recurrences
LAS VEGAS – Although mastectomy is the standard of care for tumor recurrence following lumpectomy and whole breast irradiation, a second lumpectomy with partial breast irradiation is a sound alternative under certain circumstances, according to Manjeet Chadha, MD, professor of radiation oncology and director of the department of radiation oncology at Icahn School of Medicine at Mount Sinai, New York.
It depends on whether the new lesion is a true recurrence, or simply another primary tumor. In the absence of a genetic footprint to compare the two, Dr. Chadha and her colleagues use several of what she called “soft criteria” to make the call and counsel women.
True ipsilateral recurrence of an aggressive tumor tends to happen early, and in the same quadrant. However, if breast cancer recurs more than 3 years after treatment of the primary tumor and in a different quadrant, and if the patient is negative for BRCA mutation, and if the new growth is small, localized on MRI, histologically different from the primary tumor, and likely to be resected with clean margins, Dr. Chadha said she is comfortable offering a second lumpectomy and partial breast radiation – usually multicatheter brachytherapy – to women who do not want a mastectomy.
“Second cancer in a previously irradiated breast is not an uncommon clinical entity. Based on patient preference, the option of repeat breast conservation and reirradiation may be offered selectively as an alternative to mastectomy,” followed by systemic therapy, she said at the annual meeting of the American Society of Breast Surgeons.
“I think all of us across the country are discussing presentations like this in tumor boards,” but it’s not always offered as an option. Sometimes, “the mindset of the treating surgeon is ‘oh, this breast has had radiation; I can’t give radiation again.’ Clearly, whole breast reirradiation is not recommended,” but it seems possible based on a growing body of literature to differentiate new primaries with new biology from true recurrences, and to treat them safely with breast conserving surgery and partial irradiation, she said.
The largest series to date of salvage lumpectomy with multicatheter brachytherapy followed 217 women for a median of 3.9 years. Median tumor size was 1.2 cm. The 5-year local control rate – effectively, the mastectomy-free survival – was 94.4%, and the overall survival was 88.7%, which mirrors the success of first-time lumpectomy with whole breast irradiation, and lends support to the notion that some recurrences are, in fact, entirely new disease. The European team reported excellent or good cosmetic results in 85% of women (Radiother Oncol. 2013 Aug;108[2]:226-31).
The series used high-dose radiation. Dr. Chadha said she and her colleagues have had similar success with low-dose multicatheter brachytherapy, with similarly good aesthetic results. To avoid cosmetic impact, however, she noted it’s important to work with radiation oncologists “mindful of the nuances of what’s needed,” including how far to separate the skin from the radiation.
Brachytherapy has the most support in the literature, but external beam therapy is also an option. “Whatever technique you use, the delineation of the target and the geometric coverage of the lumpectomy cavity [must be] complete in all cases,” she said.
Dr. Chadha had no financial conflicts of interest.
LAS VEGAS – Although mastectomy is the standard of care for tumor recurrence following lumpectomy and whole breast irradiation, a second lumpectomy with partial breast irradiation is a sound alternative under certain circumstances, according to Manjeet Chadha, MD, professor of radiation oncology and director of the department of radiation oncology at Icahn School of Medicine at Mount Sinai, New York.
It depends on whether the new lesion is a true recurrence, or simply another primary tumor. In the absence of a genetic footprint to compare the two, Dr. Chadha and her colleagues use several of what she called “soft criteria” to make the call and counsel women.
True ipsilateral recurrence of an aggressive tumor tends to happen early, and in the same quadrant. However, if breast cancer recurs more than 3 years after treatment of the primary tumor and in a different quadrant, and if the patient is negative for BRCA mutation, and if the new growth is small, localized on MRI, histologically different from the primary tumor, and likely to be resected with clean margins, Dr. Chadha said she is comfortable offering a second lumpectomy and partial breast radiation – usually multicatheter brachytherapy – to women who do not want a mastectomy.
“Second cancer in a previously irradiated breast is not an uncommon clinical entity. Based on patient preference, the option of repeat breast conservation and reirradiation may be offered selectively as an alternative to mastectomy,” followed by systemic therapy, she said at the annual meeting of the American Society of Breast Surgeons.
“I think all of us across the country are discussing presentations like this in tumor boards,” but it’s not always offered as an option. Sometimes, “the mindset of the treating surgeon is ‘oh, this breast has had radiation; I can’t give radiation again.’ Clearly, whole breast reirradiation is not recommended,” but it seems possible based on a growing body of literature to differentiate new primaries with new biology from true recurrences, and to treat them safely with breast conserving surgery and partial irradiation, she said.
The largest series to date of salvage lumpectomy with multicatheter brachytherapy followed 217 women for a median of 3.9 years. Median tumor size was 1.2 cm. The 5-year local control rate – effectively, the mastectomy-free survival – was 94.4%, and the overall survival was 88.7%, which mirrors the success of first-time lumpectomy with whole breast irradiation, and lends support to the notion that some recurrences are, in fact, entirely new disease. The European team reported excellent or good cosmetic results in 85% of women (Radiother Oncol. 2013 Aug;108[2]:226-31).
The series used high-dose radiation. Dr. Chadha said she and her colleagues have had similar success with low-dose multicatheter brachytherapy, with similarly good aesthetic results. To avoid cosmetic impact, however, she noted it’s important to work with radiation oncologists “mindful of the nuances of what’s needed,” including how far to separate the skin from the radiation.
Brachytherapy has the most support in the literature, but external beam therapy is also an option. “Whatever technique you use, the delineation of the target and the geometric coverage of the lumpectomy cavity [must be] complete in all cases,” she said.
Dr. Chadha had no financial conflicts of interest.
LAS VEGAS – Although mastectomy is the standard of care for tumor recurrence following lumpectomy and whole breast irradiation, a second lumpectomy with partial breast irradiation is a sound alternative under certain circumstances, according to Manjeet Chadha, MD, professor of radiation oncology and director of the department of radiation oncology at Icahn School of Medicine at Mount Sinai, New York.
It depends on whether the new lesion is a true recurrence, or simply another primary tumor. In the absence of a genetic footprint to compare the two, Dr. Chadha and her colleagues use several of what she called “soft criteria” to make the call and counsel women.
True ipsilateral recurrence of an aggressive tumor tends to happen early, and in the same quadrant. However, if breast cancer recurs more than 3 years after treatment of the primary tumor and in a different quadrant, and if the patient is negative for BRCA mutation, and if the new growth is small, localized on MRI, histologically different from the primary tumor, and likely to be resected with clean margins, Dr. Chadha said she is comfortable offering a second lumpectomy and partial breast radiation – usually multicatheter brachytherapy – to women who do not want a mastectomy.
“Second cancer in a previously irradiated breast is not an uncommon clinical entity. Based on patient preference, the option of repeat breast conservation and reirradiation may be offered selectively as an alternative to mastectomy,” followed by systemic therapy, she said at the annual meeting of the American Society of Breast Surgeons.
“I think all of us across the country are discussing presentations like this in tumor boards,” but it’s not always offered as an option. Sometimes, “the mindset of the treating surgeon is ‘oh, this breast has had radiation; I can’t give radiation again.’ Clearly, whole breast reirradiation is not recommended,” but it seems possible based on a growing body of literature to differentiate new primaries with new biology from true recurrences, and to treat them safely with breast conserving surgery and partial irradiation, she said.
The largest series to date of salvage lumpectomy with multicatheter brachytherapy followed 217 women for a median of 3.9 years. Median tumor size was 1.2 cm. The 5-year local control rate – effectively, the mastectomy-free survival – was 94.4%, and the overall survival was 88.7%, which mirrors the success of first-time lumpectomy with whole breast irradiation, and lends support to the notion that some recurrences are, in fact, entirely new disease. The European team reported excellent or good cosmetic results in 85% of women (Radiother Oncol. 2013 Aug;108[2]:226-31).
The series used high-dose radiation. Dr. Chadha said she and her colleagues have had similar success with low-dose multicatheter brachytherapy, with similarly good aesthetic results. To avoid cosmetic impact, however, she noted it’s important to work with radiation oncologists “mindful of the nuances of what’s needed,” including how far to separate the skin from the radiation.
Brachytherapy has the most support in the literature, but external beam therapy is also an option. “Whatever technique you use, the delineation of the target and the geometric coverage of the lumpectomy cavity [must be] complete in all cases,” she said.
Dr. Chadha had no financial conflicts of interest.
EXPERT ANALYSIS FROM ASBS 2017
Could refractory T-ALL be daratumumab’s next frontier?
MONTREAL – Daratumumab may do for patients with T-cell acute lymphoblastic leukemia (T-ALL) what it has done for those with multiple myeloma. That, at least, is the hope of a team of investigators who are conducting preclinical studies and planning human trials of the CD38 inhibitor in leukemia.
“We believe daratumumab significantly inhibits disease progression as shown in our different [patient-derived xenograft] models,” said Karen L. Bride, MD, of Children’s Hospital of Philadelphia.
The Food and Drug Administration approved daratumumab (Darzalex) in November 2015 for the treatment of patients with multiple myeloma who had received at least three prior lines of therapy. They then amended the approval last fall to “at least one prior medicine.”
When added to a standard regimen of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma in the phase III CASTOR trial, daratumumab reduced the risk of disease progression or death by 61% with little increase in toxicity.
The drug is believed to work against multiple myeloma through both an on-target (anti-CD38) mechanism, and through off-target promotion of increases in T-helper cells, cytotoxic T-lymphocytes, T-cell function response, and T-cell receptor clonality (Blood. 2016 Jan. doi: 10.1182/blood-2015-12-687749).
CD38 in T-ALL
Dr. Bride and her colleagues hope to bring daratumumab’s anti-CD38 action to bear on relapsed or refractory T-ALL.
“One of the reasons this is particularly challenging is that we find T-ALL is clinically and genetically heterogeneous,” she said. “With a number of different genetic mutations that have been identified, there are certainly some potentially targetable pathways. However, finding an appropriate target that can be broadly applicable is still needed.”
CD38 may be one such target. It is expressed at relatively high levels on both T-ALL and B-precursor ALL blasts but at only low levels on normal immune cells.
The investigators first used flow cytometry to measure CD38 levels in samples from 10 patients with early T-cell precursor (ETP) T-ALL and 11 with non-ETP disease, both at diagnosis and after 1 month of induction chemotherapy. CD38 expression was detectable in all of the samples and did not change significantly after chemotherapy, suggesting that CD38 was indeed a valid target in T-ALL.
They then grafted primary ALL blasts from patients with ETP-ALL and non-ETP-ALL into mice and randomly assigned them to be treated for 3 to 5 weeks with daratumumab or to serve as controls. The mice were initially treated after they developed more than 1% of peripheral blood blasts.
Daratumumab-treated models had significant reductions in disease burden as measured by blasts in both peripheral blood (P = .0112) and spleen (P = .0003).
There were six responses to daratumumab in the seven treated mice grafted with ETP-ALL and no cases of toxicity. Among the eight mice with non-ETP ALL, however, there was only one response, and five animals became moribund roughly 1 hour after injection.
The investigators could not find an explanation for these reactions either on necropsy or pathology studies.
“We hypothesized that there was potentially massive tumor lysis syndrome being experienced by the mice, and, as a consequence, they were becoming moribund,” Dr. Bride said.
In subsequent experiments, they have begun introducing the drug within 5 days of adoptive transfer, prior to full engraftment. This is akin to treating during a minimal residual disease phase, she said.
Despite the observed but unexplained toxicities in some animals, “our data are promising enough that we’re hopeful that we will open a phase I/II trial of daratumumab starting next year,” Dr. Bride said.
Not so fast
However, a pediatric hematologist/oncologist who was not involved in the study said in an interview that Dr. Bride and her colleagues would be wise not to proceed too quickly into human trials, at least until the potential toxicities of daratumumab in T-ALL have been more fully elucidated.
“I found it very striking that the mice responded the way they did, and that was just from receiving the drug. So, there is something else that’s going on, and I think it behooves them to investigate further. It’s not that I’m skeptical about the activity of the drug; I just don’t want studies to be shut down because the investigators didn’t have the best trial design,” said Valerie I. Brown, MD.
Dr. Brown, director of experimental therapeutics at Penn State Health Milton S. Hershey (Penn.) Medical Center, was a comoderator of the session where Dr. Bride presented the study findings.
Asked about her response to Dr. Brown’s comments in an interview, Dr. Bride said that “because of the success of daratumumab in humans already, I think I’m a bit less worried about this agent. You can’t necessarily translate exactly across diseases, but I do think it’s very promising, and I don’t think [the toxicity] is a reason to pull back.”
The study was supported by grants from the Leukemia and Lymphoma Society and the National Institutes of Health. Janssen donated the daratumumab. Dr. Bride and Dr. Brown reported no conflicts of interest to disclose.
MONTREAL – Daratumumab may do for patients with T-cell acute lymphoblastic leukemia (T-ALL) what it has done for those with multiple myeloma. That, at least, is the hope of a team of investigators who are conducting preclinical studies and planning human trials of the CD38 inhibitor in leukemia.
“We believe daratumumab significantly inhibits disease progression as shown in our different [patient-derived xenograft] models,” said Karen L. Bride, MD, of Children’s Hospital of Philadelphia.
The Food and Drug Administration approved daratumumab (Darzalex) in November 2015 for the treatment of patients with multiple myeloma who had received at least three prior lines of therapy. They then amended the approval last fall to “at least one prior medicine.”
When added to a standard regimen of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma in the phase III CASTOR trial, daratumumab reduced the risk of disease progression or death by 61% with little increase in toxicity.
The drug is believed to work against multiple myeloma through both an on-target (anti-CD38) mechanism, and through off-target promotion of increases in T-helper cells, cytotoxic T-lymphocytes, T-cell function response, and T-cell receptor clonality (Blood. 2016 Jan. doi: 10.1182/blood-2015-12-687749).
CD38 in T-ALL
Dr. Bride and her colleagues hope to bring daratumumab’s anti-CD38 action to bear on relapsed or refractory T-ALL.
“One of the reasons this is particularly challenging is that we find T-ALL is clinically and genetically heterogeneous,” she said. “With a number of different genetic mutations that have been identified, there are certainly some potentially targetable pathways. However, finding an appropriate target that can be broadly applicable is still needed.”
CD38 may be one such target. It is expressed at relatively high levels on both T-ALL and B-precursor ALL blasts but at only low levels on normal immune cells.
The investigators first used flow cytometry to measure CD38 levels in samples from 10 patients with early T-cell precursor (ETP) T-ALL and 11 with non-ETP disease, both at diagnosis and after 1 month of induction chemotherapy. CD38 expression was detectable in all of the samples and did not change significantly after chemotherapy, suggesting that CD38 was indeed a valid target in T-ALL.
They then grafted primary ALL blasts from patients with ETP-ALL and non-ETP-ALL into mice and randomly assigned them to be treated for 3 to 5 weeks with daratumumab or to serve as controls. The mice were initially treated after they developed more than 1% of peripheral blood blasts.
Daratumumab-treated models had significant reductions in disease burden as measured by blasts in both peripheral blood (P = .0112) and spleen (P = .0003).
There were six responses to daratumumab in the seven treated mice grafted with ETP-ALL and no cases of toxicity. Among the eight mice with non-ETP ALL, however, there was only one response, and five animals became moribund roughly 1 hour after injection.
The investigators could not find an explanation for these reactions either on necropsy or pathology studies.
“We hypothesized that there was potentially massive tumor lysis syndrome being experienced by the mice, and, as a consequence, they were becoming moribund,” Dr. Bride said.
In subsequent experiments, they have begun introducing the drug within 5 days of adoptive transfer, prior to full engraftment. This is akin to treating during a minimal residual disease phase, she said.
Despite the observed but unexplained toxicities in some animals, “our data are promising enough that we’re hopeful that we will open a phase I/II trial of daratumumab starting next year,” Dr. Bride said.
Not so fast
However, a pediatric hematologist/oncologist who was not involved in the study said in an interview that Dr. Bride and her colleagues would be wise not to proceed too quickly into human trials, at least until the potential toxicities of daratumumab in T-ALL have been more fully elucidated.
“I found it very striking that the mice responded the way they did, and that was just from receiving the drug. So, there is something else that’s going on, and I think it behooves them to investigate further. It’s not that I’m skeptical about the activity of the drug; I just don’t want studies to be shut down because the investigators didn’t have the best trial design,” said Valerie I. Brown, MD.
Dr. Brown, director of experimental therapeutics at Penn State Health Milton S. Hershey (Penn.) Medical Center, was a comoderator of the session where Dr. Bride presented the study findings.
Asked about her response to Dr. Brown’s comments in an interview, Dr. Bride said that “because of the success of daratumumab in humans already, I think I’m a bit less worried about this agent. You can’t necessarily translate exactly across diseases, but I do think it’s very promising, and I don’t think [the toxicity] is a reason to pull back.”
The study was supported by grants from the Leukemia and Lymphoma Society and the National Institutes of Health. Janssen donated the daratumumab. Dr. Bride and Dr. Brown reported no conflicts of interest to disclose.
MONTREAL – Daratumumab may do for patients with T-cell acute lymphoblastic leukemia (T-ALL) what it has done for those with multiple myeloma. That, at least, is the hope of a team of investigators who are conducting preclinical studies and planning human trials of the CD38 inhibitor in leukemia.
“We believe daratumumab significantly inhibits disease progression as shown in our different [patient-derived xenograft] models,” said Karen L. Bride, MD, of Children’s Hospital of Philadelphia.
The Food and Drug Administration approved daratumumab (Darzalex) in November 2015 for the treatment of patients with multiple myeloma who had received at least three prior lines of therapy. They then amended the approval last fall to “at least one prior medicine.”
When added to a standard regimen of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma in the phase III CASTOR trial, daratumumab reduced the risk of disease progression or death by 61% with little increase in toxicity.
The drug is believed to work against multiple myeloma through both an on-target (anti-CD38) mechanism, and through off-target promotion of increases in T-helper cells, cytotoxic T-lymphocytes, T-cell function response, and T-cell receptor clonality (Blood. 2016 Jan. doi: 10.1182/blood-2015-12-687749).
CD38 in T-ALL
Dr. Bride and her colleagues hope to bring daratumumab’s anti-CD38 action to bear on relapsed or refractory T-ALL.
“One of the reasons this is particularly challenging is that we find T-ALL is clinically and genetically heterogeneous,” she said. “With a number of different genetic mutations that have been identified, there are certainly some potentially targetable pathways. However, finding an appropriate target that can be broadly applicable is still needed.”
CD38 may be one such target. It is expressed at relatively high levels on both T-ALL and B-precursor ALL blasts but at only low levels on normal immune cells.
The investigators first used flow cytometry to measure CD38 levels in samples from 10 patients with early T-cell precursor (ETP) T-ALL and 11 with non-ETP disease, both at diagnosis and after 1 month of induction chemotherapy. CD38 expression was detectable in all of the samples and did not change significantly after chemotherapy, suggesting that CD38 was indeed a valid target in T-ALL.
They then grafted primary ALL blasts from patients with ETP-ALL and non-ETP-ALL into mice and randomly assigned them to be treated for 3 to 5 weeks with daratumumab or to serve as controls. The mice were initially treated after they developed more than 1% of peripheral blood blasts.
Daratumumab-treated models had significant reductions in disease burden as measured by blasts in both peripheral blood (P = .0112) and spleen (P = .0003).
There were six responses to daratumumab in the seven treated mice grafted with ETP-ALL and no cases of toxicity. Among the eight mice with non-ETP ALL, however, there was only one response, and five animals became moribund roughly 1 hour after injection.
The investigators could not find an explanation for these reactions either on necropsy or pathology studies.
“We hypothesized that there was potentially massive tumor lysis syndrome being experienced by the mice, and, as a consequence, they were becoming moribund,” Dr. Bride said.
In subsequent experiments, they have begun introducing the drug within 5 days of adoptive transfer, prior to full engraftment. This is akin to treating during a minimal residual disease phase, she said.
Despite the observed but unexplained toxicities in some animals, “our data are promising enough that we’re hopeful that we will open a phase I/II trial of daratumumab starting next year,” Dr. Bride said.
Not so fast
However, a pediatric hematologist/oncologist who was not involved in the study said in an interview that Dr. Bride and her colleagues would be wise not to proceed too quickly into human trials, at least until the potential toxicities of daratumumab in T-ALL have been more fully elucidated.
“I found it very striking that the mice responded the way they did, and that was just from receiving the drug. So, there is something else that’s going on, and I think it behooves them to investigate further. It’s not that I’m skeptical about the activity of the drug; I just don’t want studies to be shut down because the investigators didn’t have the best trial design,” said Valerie I. Brown, MD.
Dr. Brown, director of experimental therapeutics at Penn State Health Milton S. Hershey (Penn.) Medical Center, was a comoderator of the session where Dr. Bride presented the study findings.
Asked about her response to Dr. Brown’s comments in an interview, Dr. Bride said that “because of the success of daratumumab in humans already, I think I’m a bit less worried about this agent. You can’t necessarily translate exactly across diseases, but I do think it’s very promising, and I don’t think [the toxicity] is a reason to pull back.”
The study was supported by grants from the Leukemia and Lymphoma Society and the National Institutes of Health. Janssen donated the daratumumab. Dr. Bride and Dr. Brown reported no conflicts of interest to disclose.
Key clinical point: CD38 may be a valid target for therapy against relapsed/refractory T-cell acute lymphoblastic leukemia.
Major finding: Six of seven models of early T-precursor T-ALL responded to daratumumab injections.
Data source: In vitro and in vivo studies evaluating the potential of daratumumab for treatment of T-ALL.
Disclosures: The study was supported by grants from the Leukemia and Lymphoma Society and the National Institutes of Health. Janssen donated the daratumumab. Dr. Bride and Dr. Brown reported having no conflicts of interest.
Elder abuse: Strong social support prevents associated psychopathology
SAN FRANCISCO – Victims of elder abuse who have perceived strong social support from family or friends are “completely inoculated” against the otherwise dramatically increased risk of trauma-related psychopathology that pertains to mistreated seniors who lack such support, according to Ron Acierno, PhD.
Dr. Acierno, professor of nursing at the Medical University of South Carolina in Charleston, presented 8-year follow-up data from the National Elder Mistreatment Study, the largest study of elder abuse ever conducted in the United States.
The National Elder Mistreatment Study involved 5,777 randomly selected community-dwelling older adults who, in 2008, participated in structured interviews assessing whether they had experienced physical, psychological, sexual, or neglectful mistreatment. The study made headlines by documenting an unexpectedly high 11% rate of elder mistreatment within the previous 12 months (Am J Public Health. 2010 Feb;100[2]:292-7).
Eight years later, Dr. Acierno and his coinvestigators were able to recontact 173 of the original 684 abused elders, as well as 602 nonabused controls for structured interviews assessing their current mental health. At that point, the participants averaged 84.9 years of age.
Striking differences in mental health status based on elder abuse history were documented. The prevalences of depression, generalized anxiety disorder, and posttraumatic stress disorder were 13%, 7%, and 8%, respectively, in the elder abuse group, compared with 5%, 1%, and 1% in the nonabused controls. Of the group subjected to abuse 8 years earlier, 40% were categorized at follow-up as “in poor health,” compared with 23% of controls.
More importantly, high social support essentially erased the elder abuse group’s increased risk (see graphic), Dr. Acierno said.
The National Elder Mistreatment Study was funded by the National Institute of Justice, the National Institute on Aging, and the Archstone Foundation. Dr. Acierno reported having no financial conflicts.
SAN FRANCISCO – Victims of elder abuse who have perceived strong social support from family or friends are “completely inoculated” against the otherwise dramatically increased risk of trauma-related psychopathology that pertains to mistreated seniors who lack such support, according to Ron Acierno, PhD.
Dr. Acierno, professor of nursing at the Medical University of South Carolina in Charleston, presented 8-year follow-up data from the National Elder Mistreatment Study, the largest study of elder abuse ever conducted in the United States.
The National Elder Mistreatment Study involved 5,777 randomly selected community-dwelling older adults who, in 2008, participated in structured interviews assessing whether they had experienced physical, psychological, sexual, or neglectful mistreatment. The study made headlines by documenting an unexpectedly high 11% rate of elder mistreatment within the previous 12 months (Am J Public Health. 2010 Feb;100[2]:292-7).
Eight years later, Dr. Acierno and his coinvestigators were able to recontact 173 of the original 684 abused elders, as well as 602 nonabused controls for structured interviews assessing their current mental health. At that point, the participants averaged 84.9 years of age.
Striking differences in mental health status based on elder abuse history were documented. The prevalences of depression, generalized anxiety disorder, and posttraumatic stress disorder were 13%, 7%, and 8%, respectively, in the elder abuse group, compared with 5%, 1%, and 1% in the nonabused controls. Of the group subjected to abuse 8 years earlier, 40% were categorized at follow-up as “in poor health,” compared with 23% of controls.
More importantly, high social support essentially erased the elder abuse group’s increased risk (see graphic), Dr. Acierno said.
The National Elder Mistreatment Study was funded by the National Institute of Justice, the National Institute on Aging, and the Archstone Foundation. Dr. Acierno reported having no financial conflicts.
SAN FRANCISCO – Victims of elder abuse who have perceived strong social support from family or friends are “completely inoculated” against the otherwise dramatically increased risk of trauma-related psychopathology that pertains to mistreated seniors who lack such support, according to Ron Acierno, PhD.
Dr. Acierno, professor of nursing at the Medical University of South Carolina in Charleston, presented 8-year follow-up data from the National Elder Mistreatment Study, the largest study of elder abuse ever conducted in the United States.
The National Elder Mistreatment Study involved 5,777 randomly selected community-dwelling older adults who, in 2008, participated in structured interviews assessing whether they had experienced physical, psychological, sexual, or neglectful mistreatment. The study made headlines by documenting an unexpectedly high 11% rate of elder mistreatment within the previous 12 months (Am J Public Health. 2010 Feb;100[2]:292-7).
Eight years later, Dr. Acierno and his coinvestigators were able to recontact 173 of the original 684 abused elders, as well as 602 nonabused controls for structured interviews assessing their current mental health. At that point, the participants averaged 84.9 years of age.
Striking differences in mental health status based on elder abuse history were documented. The prevalences of depression, generalized anxiety disorder, and posttraumatic stress disorder were 13%, 7%, and 8%, respectively, in the elder abuse group, compared with 5%, 1%, and 1% in the nonabused controls. Of the group subjected to abuse 8 years earlier, 40% were categorized at follow-up as “in poor health,” compared with 23% of controls.
More importantly, high social support essentially erased the elder abuse group’s increased risk (see graphic), Dr. Acierno said.
The National Elder Mistreatment Study was funded by the National Institute of Justice, the National Institute on Aging, and the Archstone Foundation. Dr. Acierno reported having no financial conflicts.
AT THE ANXIETY AND DEPRESSION CONFERENCE 2017
Key clinical point:
Major finding: Having a strong social support network virtually eliminated the otherwise sharply increased risk of trauma-related psychopathology in victims of elder abuse.
Data source: An 8-year follow-up report on the mental health status of participants in the largest study of elder mistreatment in US history.
Disclosures: The National Elder Mistreatment Study was funded by the National Institute of Justice, the National Institute on Aging, and the Archstone Foundation. The presenter reported having no financial conflicts.