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Official Newspaper of the American College of Surgeons
Factor XI inhibitor trims DVTs after knee replacement surgery
SAN FRANCISCO – Reducing factor XI levels with the experimental antisense oligonucleotide FXI-ASO lowered venous thromboembolism rates after total knee arthroplasty without increasing bleeding in a phase II study.
Venous thromboembolism (VTE) rates were 30% among controls (21/69) on enoxaparin (Lovenox) 40 mg, compared with 27% for patients (36/134) given FXI-ASO 200 mg and 4% for those (3/71) given FXI-ASO 300 mg. Low-dose FXI-ASO was noninferior to enoxaparin (P = .59), while the high-dose regimen was superior (P < .001).
A 4% VTE rate “has never ever been seen before in patients undergoing knee surgery,” Dr. Harry Büller said during the late-breaking abstract session at the annual meeting of the American Society of Hematology.
The strategy of targeting factor XI is based on the understanding that patients with factor XI deficiency (plasma levels < 20% of normal) have a reduced risk of deep vein thrombosis (DVT). Experimental data in mice and primates also suggest that reducing factor XI attenuates thrombosis without excess bleeding.
Among the 300 patients in the open-label study, major or clinically relevant bleeding occurred in 3% of both FXI-ASO groups and 8% of the enoxaparin group (P = .09).
The findings provide the first evidence in humans that the factor XI intrinsic pathway is one of the drivers of postoperative thrombosis and support the concept that thrombosis and hemostasis can be dissociated, said Dr. Büller of the Academic Medical Center, Amsterdam.
“FXI-ASO is a promising new investigational antithrombotic agent and I believe you are witnessing the birth of a new class of antithrombotic agents,” he concluded.
During a press conference, Dr. Büller confided to reporters that he felt like a boy in a candy store, finally able to reveal the superb study findings.
Dr. Robert Flaumenhaft of Harvard Medical School, Boston, was far less effusive in an editorial that accompanied the simultaneous publication of the study in the New England Journal of Medicine.
“Do these finding prove that reduction in factor XI levels inhibits thrombosis without affecting bleeding? The conservative answer is no,” he wrote.
Dr. Flaumenhaft observed that the incidence of clinically relevant bleeding is relatively low after knee arthroplasty, even when patients receive anticoagulants, and that this safety outcome did not differ significantly between the enoxaparin and 300-mg FXI-ASO groups.
“These results also do not make a compelling case for the clinical use of the factor XI antisense oligonucleotide over anticoagulants that are currently used for prophylaxis in patients undergoing knee arthroplasty,” he wrote.
Central to this argument are issues of convenience and questions regarding reversibility. Treatment began 36 days before surgery and was associated with a high incidence of adverse events at the injection site and factor XI levels remained about 60% lower 70 days after initiation of therapy.
The half-life of FXI-ASO is about 22 days, “which in the classical setting in terms of bleeding could be seen as something of a disadvantage,” Dr. Büller told reporters. “But if we do the next study and it shows to be safe, it turns into an advantage” … because there is the possibility of giving FXI-ASO once every 3 weeks.
Dr. Flaumenhaft closed the editorial by acknowledging that the study challenges “the current paradigm” regarding the primary mechanism responsible for fibrin formation during thrombosis. “The striking observation that reducing factor XI levels prevents thrombosis after knee arthroplasty provides the best clinical evidence to date that the intrinsic pathway is essential for thrombus formation,” he wrote.
The study was conducted at 19 centers in five countries and randomly assigned 300 patients scheduled for elective primary unilateral total-knee arthroplasty to daily enoxaparin 40 mg or three doses of FXI-ASO. The protocol was amended early on to exclude a 100-mg FXI-ASO dose.
FXI-ASO 200 mg or 300 mg was given subcutaneously beginning 36 days before surgery on days 1, 3, 5, 8, 15, 22, and 29, and 6 hours postoperatively, with a final dose on day 39.
Enoxaparin 40 mg was given subcutaneously once daily, beginning the evening before or 6-8 hours after surgery, according to investigator preference, and was continued for at least 8 days postoperatively.
The primary efficacy point was a composite of asymptomatic DVT, detected by venography, and confirmed symptomatic VTE.
At baseline, the average factor XI level was 1.23 units/mL in the enoxaparin group, 1.20 U/mL in the 200-mg group, and 1.16 U/mL in the 300-mg group.
In patients with an average factor XI level of 0.2 U/mL or less, the incidence of the primary efficacy outcome was 5%.
Isis Pharmaceuticals funded the study. Dr. Büller disclosed ties with Isis, Daiichi-Sankyo, Bayer Healthcare, Pfizer, and Bristol-Myers Squibb. Dr. Flaumenhaft reported having no disclosures.
SAN FRANCISCO – Reducing factor XI levels with the experimental antisense oligonucleotide FXI-ASO lowered venous thromboembolism rates after total knee arthroplasty without increasing bleeding in a phase II study.
Venous thromboembolism (VTE) rates were 30% among controls (21/69) on enoxaparin (Lovenox) 40 mg, compared with 27% for patients (36/134) given FXI-ASO 200 mg and 4% for those (3/71) given FXI-ASO 300 mg. Low-dose FXI-ASO was noninferior to enoxaparin (P = .59), while the high-dose regimen was superior (P < .001).
A 4% VTE rate “has never ever been seen before in patients undergoing knee surgery,” Dr. Harry Büller said during the late-breaking abstract session at the annual meeting of the American Society of Hematology.
The strategy of targeting factor XI is based on the understanding that patients with factor XI deficiency (plasma levels < 20% of normal) have a reduced risk of deep vein thrombosis (DVT). Experimental data in mice and primates also suggest that reducing factor XI attenuates thrombosis without excess bleeding.
Among the 300 patients in the open-label study, major or clinically relevant bleeding occurred in 3% of both FXI-ASO groups and 8% of the enoxaparin group (P = .09).
The findings provide the first evidence in humans that the factor XI intrinsic pathway is one of the drivers of postoperative thrombosis and support the concept that thrombosis and hemostasis can be dissociated, said Dr. Büller of the Academic Medical Center, Amsterdam.
“FXI-ASO is a promising new investigational antithrombotic agent and I believe you are witnessing the birth of a new class of antithrombotic agents,” he concluded.
During a press conference, Dr. Büller confided to reporters that he felt like a boy in a candy store, finally able to reveal the superb study findings.
Dr. Robert Flaumenhaft of Harvard Medical School, Boston, was far less effusive in an editorial that accompanied the simultaneous publication of the study in the New England Journal of Medicine.
“Do these finding prove that reduction in factor XI levels inhibits thrombosis without affecting bleeding? The conservative answer is no,” he wrote.
Dr. Flaumenhaft observed that the incidence of clinically relevant bleeding is relatively low after knee arthroplasty, even when patients receive anticoagulants, and that this safety outcome did not differ significantly between the enoxaparin and 300-mg FXI-ASO groups.
“These results also do not make a compelling case for the clinical use of the factor XI antisense oligonucleotide over anticoagulants that are currently used for prophylaxis in patients undergoing knee arthroplasty,” he wrote.
Central to this argument are issues of convenience and questions regarding reversibility. Treatment began 36 days before surgery and was associated with a high incidence of adverse events at the injection site and factor XI levels remained about 60% lower 70 days after initiation of therapy.
The half-life of FXI-ASO is about 22 days, “which in the classical setting in terms of bleeding could be seen as something of a disadvantage,” Dr. Büller told reporters. “But if we do the next study and it shows to be safe, it turns into an advantage” … because there is the possibility of giving FXI-ASO once every 3 weeks.
Dr. Flaumenhaft closed the editorial by acknowledging that the study challenges “the current paradigm” regarding the primary mechanism responsible for fibrin formation during thrombosis. “The striking observation that reducing factor XI levels prevents thrombosis after knee arthroplasty provides the best clinical evidence to date that the intrinsic pathway is essential for thrombus formation,” he wrote.
The study was conducted at 19 centers in five countries and randomly assigned 300 patients scheduled for elective primary unilateral total-knee arthroplasty to daily enoxaparin 40 mg or three doses of FXI-ASO. The protocol was amended early on to exclude a 100-mg FXI-ASO dose.
FXI-ASO 200 mg or 300 mg was given subcutaneously beginning 36 days before surgery on days 1, 3, 5, 8, 15, 22, and 29, and 6 hours postoperatively, with a final dose on day 39.
Enoxaparin 40 mg was given subcutaneously once daily, beginning the evening before or 6-8 hours after surgery, according to investigator preference, and was continued for at least 8 days postoperatively.
The primary efficacy point was a composite of asymptomatic DVT, detected by venography, and confirmed symptomatic VTE.
At baseline, the average factor XI level was 1.23 units/mL in the enoxaparin group, 1.20 U/mL in the 200-mg group, and 1.16 U/mL in the 300-mg group.
In patients with an average factor XI level of 0.2 U/mL or less, the incidence of the primary efficacy outcome was 5%.
Isis Pharmaceuticals funded the study. Dr. Büller disclosed ties with Isis, Daiichi-Sankyo, Bayer Healthcare, Pfizer, and Bristol-Myers Squibb. Dr. Flaumenhaft reported having no disclosures.
SAN FRANCISCO – Reducing factor XI levels with the experimental antisense oligonucleotide FXI-ASO lowered venous thromboembolism rates after total knee arthroplasty without increasing bleeding in a phase II study.
Venous thromboembolism (VTE) rates were 30% among controls (21/69) on enoxaparin (Lovenox) 40 mg, compared with 27% for patients (36/134) given FXI-ASO 200 mg and 4% for those (3/71) given FXI-ASO 300 mg. Low-dose FXI-ASO was noninferior to enoxaparin (P = .59), while the high-dose regimen was superior (P < .001).
A 4% VTE rate “has never ever been seen before in patients undergoing knee surgery,” Dr. Harry Büller said during the late-breaking abstract session at the annual meeting of the American Society of Hematology.
The strategy of targeting factor XI is based on the understanding that patients with factor XI deficiency (plasma levels < 20% of normal) have a reduced risk of deep vein thrombosis (DVT). Experimental data in mice and primates also suggest that reducing factor XI attenuates thrombosis without excess bleeding.
Among the 300 patients in the open-label study, major or clinically relevant bleeding occurred in 3% of both FXI-ASO groups and 8% of the enoxaparin group (P = .09).
The findings provide the first evidence in humans that the factor XI intrinsic pathway is one of the drivers of postoperative thrombosis and support the concept that thrombosis and hemostasis can be dissociated, said Dr. Büller of the Academic Medical Center, Amsterdam.
“FXI-ASO is a promising new investigational antithrombotic agent and I believe you are witnessing the birth of a new class of antithrombotic agents,” he concluded.
During a press conference, Dr. Büller confided to reporters that he felt like a boy in a candy store, finally able to reveal the superb study findings.
Dr. Robert Flaumenhaft of Harvard Medical School, Boston, was far less effusive in an editorial that accompanied the simultaneous publication of the study in the New England Journal of Medicine.
“Do these finding prove that reduction in factor XI levels inhibits thrombosis without affecting bleeding? The conservative answer is no,” he wrote.
Dr. Flaumenhaft observed that the incidence of clinically relevant bleeding is relatively low after knee arthroplasty, even when patients receive anticoagulants, and that this safety outcome did not differ significantly between the enoxaparin and 300-mg FXI-ASO groups.
“These results also do not make a compelling case for the clinical use of the factor XI antisense oligonucleotide over anticoagulants that are currently used for prophylaxis in patients undergoing knee arthroplasty,” he wrote.
Central to this argument are issues of convenience and questions regarding reversibility. Treatment began 36 days before surgery and was associated with a high incidence of adverse events at the injection site and factor XI levels remained about 60% lower 70 days after initiation of therapy.
The half-life of FXI-ASO is about 22 days, “which in the classical setting in terms of bleeding could be seen as something of a disadvantage,” Dr. Büller told reporters. “But if we do the next study and it shows to be safe, it turns into an advantage” … because there is the possibility of giving FXI-ASO once every 3 weeks.
Dr. Flaumenhaft closed the editorial by acknowledging that the study challenges “the current paradigm” regarding the primary mechanism responsible for fibrin formation during thrombosis. “The striking observation that reducing factor XI levels prevents thrombosis after knee arthroplasty provides the best clinical evidence to date that the intrinsic pathway is essential for thrombus formation,” he wrote.
The study was conducted at 19 centers in five countries and randomly assigned 300 patients scheduled for elective primary unilateral total-knee arthroplasty to daily enoxaparin 40 mg or three doses of FXI-ASO. The protocol was amended early on to exclude a 100-mg FXI-ASO dose.
FXI-ASO 200 mg or 300 mg was given subcutaneously beginning 36 days before surgery on days 1, 3, 5, 8, 15, 22, and 29, and 6 hours postoperatively, with a final dose on day 39.
Enoxaparin 40 mg was given subcutaneously once daily, beginning the evening before or 6-8 hours after surgery, according to investigator preference, and was continued for at least 8 days postoperatively.
The primary efficacy point was a composite of asymptomatic DVT, detected by venography, and confirmed symptomatic VTE.
At baseline, the average factor XI level was 1.23 units/mL in the enoxaparin group, 1.20 U/mL in the 200-mg group, and 1.16 U/mL in the 300-mg group.
In patients with an average factor XI level of 0.2 U/mL or less, the incidence of the primary efficacy outcome was 5%.
Isis Pharmaceuticals funded the study. Dr. Büller disclosed ties with Isis, Daiichi-Sankyo, Bayer Healthcare, Pfizer, and Bristol-Myers Squibb. Dr. Flaumenhaft reported having no disclosures.
AT ASH 2014
Key clinical point: Reducing factor XI levels with FXI-ASO was effective in preventing VTE in patients undergoing knee arthroplasty and appeared safe with respect to bleeding risk.
Major finding: The primary VTE endpoint occurred in 4% of patients on FXI-ASO 300 mg, 27% on FXI-ASO 200 mg, and 30% on enoxaparin.
Data source: Open-label, parallel-group phase II study of 300 patients undergoing primary unilateral total-knee arthroplasty.
Disclosures: Isis Pharmaceuticals funded the study. Dr. Büller disclosed ties with Isis, Daiichi-Sankyo, Bayer Healthcare, Pfizer, and Bristol-Myers Squibb. Dr. Flaumenhaft reported having no disclosures.
Feds open ACA special enrollment period during tax season
Medicare officials are giving consumers another chance to enroll in health insurance this year.
On Feb. 20, the agency opened a special enrollment period, running from March 15 through April 30, for individuals who are just finding out about the tax penalty for failing to purchase health insurance.
“We recognize that this is the first tax filing season where consumers may have to pay a fee or claim an exemption for not having health insurance coverage,” Marilyn Tavenner, Administrator of Centers for Medicare & Medicaid Services, said in a statement. “Our priority is to make sure consumers understand the new requirement to enroll in health coverage and to provide those who are not aware or did not understand the requirement with an opportunity to enroll in affordable coverage this year.”
The special enrollment period is an extra chance to sign up for 2015 coverage, but it won’t spare anyone from paying the penalty for not having insurance in 2014. That will cost consumers $95 per adult or 1% of income, whichever is greater. But if they sign up for 2015 coverage, they can avoid paying the higher penalty of $325 per adult or 2% of income, whichever is greater. They will still have to pay a fee for any months when they didn’t have coverage in 2015.
The special enrollment period is limited to individuals who live in states that use the federal insurance marketplace. They are eligible if they are currently not enrolled for 2015 through the marketplace, attest that they paid a fee on their 2014 tax return for not having coverage in that year, and attest that they first understood the implications of the penalty after the end of open enrollment in connection with preparing their taxes.
CMS estimates that 2%-4% of taxpayers will pay the penalty for not having coverage in 2014.
Medicare officials are giving consumers another chance to enroll in health insurance this year.
On Feb. 20, the agency opened a special enrollment period, running from March 15 through April 30, for individuals who are just finding out about the tax penalty for failing to purchase health insurance.
“We recognize that this is the first tax filing season where consumers may have to pay a fee or claim an exemption for not having health insurance coverage,” Marilyn Tavenner, Administrator of Centers for Medicare & Medicaid Services, said in a statement. “Our priority is to make sure consumers understand the new requirement to enroll in health coverage and to provide those who are not aware or did not understand the requirement with an opportunity to enroll in affordable coverage this year.”
The special enrollment period is an extra chance to sign up for 2015 coverage, but it won’t spare anyone from paying the penalty for not having insurance in 2014. That will cost consumers $95 per adult or 1% of income, whichever is greater. But if they sign up for 2015 coverage, they can avoid paying the higher penalty of $325 per adult or 2% of income, whichever is greater. They will still have to pay a fee for any months when they didn’t have coverage in 2015.
The special enrollment period is limited to individuals who live in states that use the federal insurance marketplace. They are eligible if they are currently not enrolled for 2015 through the marketplace, attest that they paid a fee on their 2014 tax return for not having coverage in that year, and attest that they first understood the implications of the penalty after the end of open enrollment in connection with preparing their taxes.
CMS estimates that 2%-4% of taxpayers will pay the penalty for not having coverage in 2014.
Medicare officials are giving consumers another chance to enroll in health insurance this year.
On Feb. 20, the agency opened a special enrollment period, running from March 15 through April 30, for individuals who are just finding out about the tax penalty for failing to purchase health insurance.
“We recognize that this is the first tax filing season where consumers may have to pay a fee or claim an exemption for not having health insurance coverage,” Marilyn Tavenner, Administrator of Centers for Medicare & Medicaid Services, said in a statement. “Our priority is to make sure consumers understand the new requirement to enroll in health coverage and to provide those who are not aware or did not understand the requirement with an opportunity to enroll in affordable coverage this year.”
The special enrollment period is an extra chance to sign up for 2015 coverage, but it won’t spare anyone from paying the penalty for not having insurance in 2014. That will cost consumers $95 per adult or 1% of income, whichever is greater. But if they sign up for 2015 coverage, they can avoid paying the higher penalty of $325 per adult or 2% of income, whichever is greater. They will still have to pay a fee for any months when they didn’t have coverage in 2015.
The special enrollment period is limited to individuals who live in states that use the federal insurance marketplace. They are eligible if they are currently not enrolled for 2015 through the marketplace, attest that they paid a fee on their 2014 tax return for not having coverage in that year, and attest that they first understood the implications of the penalty after the end of open enrollment in connection with preparing their taxes.
CMS estimates that 2%-4% of taxpayers will pay the penalty for not having coverage in 2014.
VIDEO: Ask patients about metal-on-metal hip implants
MAUI, HAWAII – Rheumatologists and other providers need to ask patients if they’ve had metal-on-metal hip implants.
That goes for hip resurfacing – which by definition is metal on metal – as well as actual metal-on-metal hips. Signs of trouble can be as subtle as mental status changes, and they go well beyond the traditional issues with worn-out artificial joints.
During a video interview at the 2015 Rheumatology Winter Clinical Symposium, Dr. Bill Bugbee, an orthopedic surgeon and professor at the University of California, San Diego, explained the problems and the warning signs for which physicians should watch.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MAUI, HAWAII – Rheumatologists and other providers need to ask patients if they’ve had metal-on-metal hip implants.
That goes for hip resurfacing – which by definition is metal on metal – as well as actual metal-on-metal hips. Signs of trouble can be as subtle as mental status changes, and they go well beyond the traditional issues with worn-out artificial joints.
During a video interview at the 2015 Rheumatology Winter Clinical Symposium, Dr. Bill Bugbee, an orthopedic surgeon and professor at the University of California, San Diego, explained the problems and the warning signs for which physicians should watch.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MAUI, HAWAII – Rheumatologists and other providers need to ask patients if they’ve had metal-on-metal hip implants.
That goes for hip resurfacing – which by definition is metal on metal – as well as actual metal-on-metal hips. Signs of trouble can be as subtle as mental status changes, and they go well beyond the traditional issues with worn-out artificial joints.
During a video interview at the 2015 Rheumatology Winter Clinical Symposium, Dr. Bill Bugbee, an orthopedic surgeon and professor at the University of California, San Diego, explained the problems and the warning signs for which physicians should watch.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT RWCS 2015
More cancer patients surviving longer, but age-based disparities remain
Survival rates overall for cancer patients are higher now than 20 years ago, though younger patients are faring significantly better than older ones for many types of cancer, according to investigators.
The findings were published online Feb. 19 in JAMA Oncology.
Furthermore, racial disparities in survival persist for most cancer sites, wrote Chenjie Zeng and associates at Vanderbilt University, Nashville, Tenn.
Using data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program, the researchers calculated survival rates for just over a million patients diagnosed with cancer of the colon or rectum, breast, prostate, lung, liver, pancreas or ovary over the time span from 1990 to 2009. Survival rates were obtained for each cancer site; results were grouped in 5-year cohorts by diagnosis date, and further broken down by race, sex, and age group (20-49, 50-64, 65-74, and 75-85 years at time of diagnosis).
Hazard ratios for cancer-specific death were obtained by comparing all later 5-year cohorts to the 1990-1994 group. Adjusted HRs for patients aged 50-64 years diagnosed with cancer in 2005-2009 compared with those diagnosed in 1990-1994 were 0.57 for colon or rectal cancer, 0.48 for breast cancer, 0.61 for liver cancer, and 0.32 for prostate cancer. By contrast, the oldest patients (aged 75-85 years) had HRs of 0.88, 0.88, 0.76, and 0.65, respectively, for these cancer sites. Age-related findings were less pronounced for lung and pancreatic cancers, Ms. Zeng and associates said (JAMA Oncology 2015 Feb. 19 [doi:10.1001/jamaoncol.2014.161]).
African Americans had a greater increase in prostate cancer survival than did whites or Asians; ovarian cancer survival, however, was reduced for African Americans but improved among whites over the study period. Overall survival rates were poorer for all cancer sites for African Americans when compared to whites, with racial disparities in screening and care a potential factor.
Some of the age-related survival differences may be attributed to younger patients’ being able to take greater advantage of newer therapies, since the largest age-related survival gap occurred for cancer sites with greater treatment advances (breast, colorectal, and prostate cancers), Ms. Zeng and associates said.
Study limitations included inability to exclude potential confounders such as socioeconomic status, lifestyle choices, and comorbidities, as well as oversampling of urban and foreign-born individuals in the study population, the researchers noted.
Survival rates overall for cancer patients are higher now than 20 years ago, though younger patients are faring significantly better than older ones for many types of cancer, according to investigators.
The findings were published online Feb. 19 in JAMA Oncology.
Furthermore, racial disparities in survival persist for most cancer sites, wrote Chenjie Zeng and associates at Vanderbilt University, Nashville, Tenn.
Using data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program, the researchers calculated survival rates for just over a million patients diagnosed with cancer of the colon or rectum, breast, prostate, lung, liver, pancreas or ovary over the time span from 1990 to 2009. Survival rates were obtained for each cancer site; results were grouped in 5-year cohorts by diagnosis date, and further broken down by race, sex, and age group (20-49, 50-64, 65-74, and 75-85 years at time of diagnosis).
Hazard ratios for cancer-specific death were obtained by comparing all later 5-year cohorts to the 1990-1994 group. Adjusted HRs for patients aged 50-64 years diagnosed with cancer in 2005-2009 compared with those diagnosed in 1990-1994 were 0.57 for colon or rectal cancer, 0.48 for breast cancer, 0.61 for liver cancer, and 0.32 for prostate cancer. By contrast, the oldest patients (aged 75-85 years) had HRs of 0.88, 0.88, 0.76, and 0.65, respectively, for these cancer sites. Age-related findings were less pronounced for lung and pancreatic cancers, Ms. Zeng and associates said (JAMA Oncology 2015 Feb. 19 [doi:10.1001/jamaoncol.2014.161]).
African Americans had a greater increase in prostate cancer survival than did whites or Asians; ovarian cancer survival, however, was reduced for African Americans but improved among whites over the study period. Overall survival rates were poorer for all cancer sites for African Americans when compared to whites, with racial disparities in screening and care a potential factor.
Some of the age-related survival differences may be attributed to younger patients’ being able to take greater advantage of newer therapies, since the largest age-related survival gap occurred for cancer sites with greater treatment advances (breast, colorectal, and prostate cancers), Ms. Zeng and associates said.
Study limitations included inability to exclude potential confounders such as socioeconomic status, lifestyle choices, and comorbidities, as well as oversampling of urban and foreign-born individuals in the study population, the researchers noted.
Survival rates overall for cancer patients are higher now than 20 years ago, though younger patients are faring significantly better than older ones for many types of cancer, according to investigators.
The findings were published online Feb. 19 in JAMA Oncology.
Furthermore, racial disparities in survival persist for most cancer sites, wrote Chenjie Zeng and associates at Vanderbilt University, Nashville, Tenn.
Using data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program, the researchers calculated survival rates for just over a million patients diagnosed with cancer of the colon or rectum, breast, prostate, lung, liver, pancreas or ovary over the time span from 1990 to 2009. Survival rates were obtained for each cancer site; results were grouped in 5-year cohorts by diagnosis date, and further broken down by race, sex, and age group (20-49, 50-64, 65-74, and 75-85 years at time of diagnosis).
Hazard ratios for cancer-specific death were obtained by comparing all later 5-year cohorts to the 1990-1994 group. Adjusted HRs for patients aged 50-64 years diagnosed with cancer in 2005-2009 compared with those diagnosed in 1990-1994 were 0.57 for colon or rectal cancer, 0.48 for breast cancer, 0.61 for liver cancer, and 0.32 for prostate cancer. By contrast, the oldest patients (aged 75-85 years) had HRs of 0.88, 0.88, 0.76, and 0.65, respectively, for these cancer sites. Age-related findings were less pronounced for lung and pancreatic cancers, Ms. Zeng and associates said (JAMA Oncology 2015 Feb. 19 [doi:10.1001/jamaoncol.2014.161]).
African Americans had a greater increase in prostate cancer survival than did whites or Asians; ovarian cancer survival, however, was reduced for African Americans but improved among whites over the study period. Overall survival rates were poorer for all cancer sites for African Americans when compared to whites, with racial disparities in screening and care a potential factor.
Some of the age-related survival differences may be attributed to younger patients’ being able to take greater advantage of newer therapies, since the largest age-related survival gap occurred for cancer sites with greater treatment advances (breast, colorectal, and prostate cancers), Ms. Zeng and associates said.
Study limitations included inability to exclude potential confounders such as socioeconomic status, lifestyle choices, and comorbidities, as well as oversampling of urban and foreign-born individuals in the study population, the researchers noted.
FROM JAMA ONCOLOGY
Key clinical point: Cancer survival rates improved less for older than younger patients in a large longitudinal study.
Major finding: All age groups showed improved survival for all cancers with the exception of ovarian cancer, but differences were greater for younger ages.
Data source: Longitudinal analysis of 20 years of data from 1.02 million cancer patients in nine population-based National Cancer Institute registries.
Disclosures: This study was supported by the National Institutes of Health and by funds from Vanderbilt University’s Ingram Professorship and Anne Potter Wilson Chair. Ms. Zeng received support from the Vanderbilt International Scholarship Program. The authors reported no conflicts of interest.
Teamwork key to head and neck cancer management
PARIS – Successful head and neck cancer management can be achieved only if a multidisciplinary approach is taken, experts emphasized at a recent international conference on anticancer treatment.
Because of its very location and complex anatomy, squamous cell cancer of the head and neck (SCCHN) is a difficult tumor to treat, Dr. Jean-Pierre Lefebvre of Centre Oscar Lambret in Lille, France, explained. Two-thirds of tumors are diagnosed at a late stage and often require a combination of therapeutic approaches and thus “combined toxicities.” Patients also frequently have comorbid illnesses that can affect their compliance and tolerance to treatments.
“There is only one solution: a multidisciplinary approach at any time of the management,” Dr. Lefebvre said.
The multidisciplinary approach requires a tight-knit team of imaging specialists; biologists and pathologists; anesthesiologists and surgeons; medical and radiation oncologists; nurses, general practitioners, and other support professions, such as dentists, dietitians, psychologists, speech and physical therapy specialists; and of course, the patients themselves.
Dr. Lefebvre noted that it was vital to provide patients with good information about their disease and its treatment, from the time of diagnosis to explain the various management decisions made by the multidisciplinary team and likely outcomes of the recommended interventions.
The primary goals of treatment are to control disease above the clavicles and to ensure survival, Dr. Lefebvre observed. Other treatment goals include preserving organ function, controlling symptoms, and creating a minimal impact on a patient’s quality of life by providing treatments that offer minimal long-term toxicity, good tolerability, and perhaps most important, good patient satisfaction.
Selecting treatment can be challenging and cannot be done without a multidisciplinary decision. The two main pathways are a surgery-based or radiotherapy-based treatment, but within each there are multiple options and combinations that need careful consideration on a case-by-case basis.
“It’s not a cookbook decision,” agreed Dr. Jan B. Vermorken, emeritus professor of oncology at Antwerp University Hospital, Belgium, who discussed the systemic treatment of head and neck cancer in a separate lecture. He agreed that head and neck cancer treatment is a multidisciplinary challenge that needs to balance the efficacy and tolerability of treatment on an individual basis, and always while considering the patient’s preferences.
“Patients can be very well informed,” Dr. Vermorken noted and suggested that clinicians need to be prepared to help patients understand the information that they find themselves in order to be able to counter any misinformation they might have found.
“There is no treatment without side effects,” Dr. Vermorken stressed. “When there are no side effects, [the treatment] doesn’t work. So you have to warn patients there are always side effects of the treatment they will be given.”
In addition to the importance of the multidisciplinary team in the management of head and neck cancer, understanding the biology of the disease and using systemic treatment are important for treatment, he said. Recent advances in this area include the recognition of the human papillomavirus as a risk factor for and strong predictor of survival in oropharyngeal cancer, and the role of epidermal growth factor receptor to enable targeting with anti-EGFR drugs, such as cetuximab (Erbitux). Systemic treatment for locally advanced disease includes concurrent chemoradiotherapy (CCRT), bioradiotherapy (BRT) with cetuximab and sequential chemotherapy (induction chemotherapy followed by CCRT or BRT).
In most cases of locally advanced SCCHN, the recommended chemotherapy of choice is high-dose cisplatin, given every 3 weeks. Although alternatives to this have been proposed – such as lowering the dose of cisplatin or using carboplatin or cetuximab instead – they have been insufficiently studied and many questions remain unanswered at the moment.
As for the treatment of recurrent or metastatic SCCHN, if it is resectable, then this would be followed by radiotherapy or CCRT. In patients deemed fit enough to handle the regimen, a combination of a platinum agent, 5-fluorouracil (5-FU) and cetuximab) is a new standard first-line regimen, although the role of maintenance cetuximab is unclear.
Better chemotherapy partners for cetuximab or alternatives for anti-EGFR–targeting agents are under investigation. This includes using docetaxel (Taxotere) instead of 5-FU with cetuximab or using lapatinib (Tykerb), afatinib (Gilotrif) or dacomitinib to block multiple human epidermal growth factor receptors or a variety of monoclonal antibodies to try to overcome resistance to anti-EGFR drugs.
Reactivation of immune surveillance by blocking the PD-1 pathway with drugs such as nivolumab (Opdivo) and pembrolizumab (Keytruda) seems to be a promising approach for treating head and neck cancer and is under investigation in other tumors, including non–small cell lung cancer, triple-negative breast cancer, and melanoma, Dr. Vermorken said.Dr. Lefebvre has acted as a consultant to Merck Serono and Sanofi. Dr. Vermorken has participated in advisory boards of AstraZeneca; Boehringer Ingelheim; Debiopharm; Genentech; Merck Serono; Merck, Sharp & Dohme; Oncolytics Biotech; Pierre Fabre; and Vaccinogen; and received lecturer fees from Merck Serono.
PARIS – Successful head and neck cancer management can be achieved only if a multidisciplinary approach is taken, experts emphasized at a recent international conference on anticancer treatment.
Because of its very location and complex anatomy, squamous cell cancer of the head and neck (SCCHN) is a difficult tumor to treat, Dr. Jean-Pierre Lefebvre of Centre Oscar Lambret in Lille, France, explained. Two-thirds of tumors are diagnosed at a late stage and often require a combination of therapeutic approaches and thus “combined toxicities.” Patients also frequently have comorbid illnesses that can affect their compliance and tolerance to treatments.
“There is only one solution: a multidisciplinary approach at any time of the management,” Dr. Lefebvre said.
The multidisciplinary approach requires a tight-knit team of imaging specialists; biologists and pathologists; anesthesiologists and surgeons; medical and radiation oncologists; nurses, general practitioners, and other support professions, such as dentists, dietitians, psychologists, speech and physical therapy specialists; and of course, the patients themselves.
Dr. Lefebvre noted that it was vital to provide patients with good information about their disease and its treatment, from the time of diagnosis to explain the various management decisions made by the multidisciplinary team and likely outcomes of the recommended interventions.
The primary goals of treatment are to control disease above the clavicles and to ensure survival, Dr. Lefebvre observed. Other treatment goals include preserving organ function, controlling symptoms, and creating a minimal impact on a patient’s quality of life by providing treatments that offer minimal long-term toxicity, good tolerability, and perhaps most important, good patient satisfaction.
Selecting treatment can be challenging and cannot be done without a multidisciplinary decision. The two main pathways are a surgery-based or radiotherapy-based treatment, but within each there are multiple options and combinations that need careful consideration on a case-by-case basis.
“It’s not a cookbook decision,” agreed Dr. Jan B. Vermorken, emeritus professor of oncology at Antwerp University Hospital, Belgium, who discussed the systemic treatment of head and neck cancer in a separate lecture. He agreed that head and neck cancer treatment is a multidisciplinary challenge that needs to balance the efficacy and tolerability of treatment on an individual basis, and always while considering the patient’s preferences.
“Patients can be very well informed,” Dr. Vermorken noted and suggested that clinicians need to be prepared to help patients understand the information that they find themselves in order to be able to counter any misinformation they might have found.
“There is no treatment without side effects,” Dr. Vermorken stressed. “When there are no side effects, [the treatment] doesn’t work. So you have to warn patients there are always side effects of the treatment they will be given.”
In addition to the importance of the multidisciplinary team in the management of head and neck cancer, understanding the biology of the disease and using systemic treatment are important for treatment, he said. Recent advances in this area include the recognition of the human papillomavirus as a risk factor for and strong predictor of survival in oropharyngeal cancer, and the role of epidermal growth factor receptor to enable targeting with anti-EGFR drugs, such as cetuximab (Erbitux). Systemic treatment for locally advanced disease includes concurrent chemoradiotherapy (CCRT), bioradiotherapy (BRT) with cetuximab and sequential chemotherapy (induction chemotherapy followed by CCRT or BRT).
In most cases of locally advanced SCCHN, the recommended chemotherapy of choice is high-dose cisplatin, given every 3 weeks. Although alternatives to this have been proposed – such as lowering the dose of cisplatin or using carboplatin or cetuximab instead – they have been insufficiently studied and many questions remain unanswered at the moment.
As for the treatment of recurrent or metastatic SCCHN, if it is resectable, then this would be followed by radiotherapy or CCRT. In patients deemed fit enough to handle the regimen, a combination of a platinum agent, 5-fluorouracil (5-FU) and cetuximab) is a new standard first-line regimen, although the role of maintenance cetuximab is unclear.
Better chemotherapy partners for cetuximab or alternatives for anti-EGFR–targeting agents are under investigation. This includes using docetaxel (Taxotere) instead of 5-FU with cetuximab or using lapatinib (Tykerb), afatinib (Gilotrif) or dacomitinib to block multiple human epidermal growth factor receptors or a variety of monoclonal antibodies to try to overcome resistance to anti-EGFR drugs.
Reactivation of immune surveillance by blocking the PD-1 pathway with drugs such as nivolumab (Opdivo) and pembrolizumab (Keytruda) seems to be a promising approach for treating head and neck cancer and is under investigation in other tumors, including non–small cell lung cancer, triple-negative breast cancer, and melanoma, Dr. Vermorken said.Dr. Lefebvre has acted as a consultant to Merck Serono and Sanofi. Dr. Vermorken has participated in advisory boards of AstraZeneca; Boehringer Ingelheim; Debiopharm; Genentech; Merck Serono; Merck, Sharp & Dohme; Oncolytics Biotech; Pierre Fabre; and Vaccinogen; and received lecturer fees from Merck Serono.
PARIS – Successful head and neck cancer management can be achieved only if a multidisciplinary approach is taken, experts emphasized at a recent international conference on anticancer treatment.
Because of its very location and complex anatomy, squamous cell cancer of the head and neck (SCCHN) is a difficult tumor to treat, Dr. Jean-Pierre Lefebvre of Centre Oscar Lambret in Lille, France, explained. Two-thirds of tumors are diagnosed at a late stage and often require a combination of therapeutic approaches and thus “combined toxicities.” Patients also frequently have comorbid illnesses that can affect their compliance and tolerance to treatments.
“There is only one solution: a multidisciplinary approach at any time of the management,” Dr. Lefebvre said.
The multidisciplinary approach requires a tight-knit team of imaging specialists; biologists and pathologists; anesthesiologists and surgeons; medical and radiation oncologists; nurses, general practitioners, and other support professions, such as dentists, dietitians, psychologists, speech and physical therapy specialists; and of course, the patients themselves.
Dr. Lefebvre noted that it was vital to provide patients with good information about their disease and its treatment, from the time of diagnosis to explain the various management decisions made by the multidisciplinary team and likely outcomes of the recommended interventions.
The primary goals of treatment are to control disease above the clavicles and to ensure survival, Dr. Lefebvre observed. Other treatment goals include preserving organ function, controlling symptoms, and creating a minimal impact on a patient’s quality of life by providing treatments that offer minimal long-term toxicity, good tolerability, and perhaps most important, good patient satisfaction.
Selecting treatment can be challenging and cannot be done without a multidisciplinary decision. The two main pathways are a surgery-based or radiotherapy-based treatment, but within each there are multiple options and combinations that need careful consideration on a case-by-case basis.
“It’s not a cookbook decision,” agreed Dr. Jan B. Vermorken, emeritus professor of oncology at Antwerp University Hospital, Belgium, who discussed the systemic treatment of head and neck cancer in a separate lecture. He agreed that head and neck cancer treatment is a multidisciplinary challenge that needs to balance the efficacy and tolerability of treatment on an individual basis, and always while considering the patient’s preferences.
“Patients can be very well informed,” Dr. Vermorken noted and suggested that clinicians need to be prepared to help patients understand the information that they find themselves in order to be able to counter any misinformation they might have found.
“There is no treatment without side effects,” Dr. Vermorken stressed. “When there are no side effects, [the treatment] doesn’t work. So you have to warn patients there are always side effects of the treatment they will be given.”
In addition to the importance of the multidisciplinary team in the management of head and neck cancer, understanding the biology of the disease and using systemic treatment are important for treatment, he said. Recent advances in this area include the recognition of the human papillomavirus as a risk factor for and strong predictor of survival in oropharyngeal cancer, and the role of epidermal growth factor receptor to enable targeting with anti-EGFR drugs, such as cetuximab (Erbitux). Systemic treatment for locally advanced disease includes concurrent chemoradiotherapy (CCRT), bioradiotherapy (BRT) with cetuximab and sequential chemotherapy (induction chemotherapy followed by CCRT or BRT).
In most cases of locally advanced SCCHN, the recommended chemotherapy of choice is high-dose cisplatin, given every 3 weeks. Although alternatives to this have been proposed – such as lowering the dose of cisplatin or using carboplatin or cetuximab instead – they have been insufficiently studied and many questions remain unanswered at the moment.
As for the treatment of recurrent or metastatic SCCHN, if it is resectable, then this would be followed by radiotherapy or CCRT. In patients deemed fit enough to handle the regimen, a combination of a platinum agent, 5-fluorouracil (5-FU) and cetuximab) is a new standard first-line regimen, although the role of maintenance cetuximab is unclear.
Better chemotherapy partners for cetuximab or alternatives for anti-EGFR–targeting agents are under investigation. This includes using docetaxel (Taxotere) instead of 5-FU with cetuximab or using lapatinib (Tykerb), afatinib (Gilotrif) or dacomitinib to block multiple human epidermal growth factor receptors or a variety of monoclonal antibodies to try to overcome resistance to anti-EGFR drugs.
Reactivation of immune surveillance by blocking the PD-1 pathway with drugs such as nivolumab (Opdivo) and pembrolizumab (Keytruda) seems to be a promising approach for treating head and neck cancer and is under investigation in other tumors, including non–small cell lung cancer, triple-negative breast cancer, and melanoma, Dr. Vermorken said.Dr. Lefebvre has acted as a consultant to Merck Serono and Sanofi. Dr. Vermorken has participated in advisory boards of AstraZeneca; Boehringer Ingelheim; Debiopharm; Genentech; Merck Serono; Merck, Sharp & Dohme; Oncolytics Biotech; Pierre Fabre; and Vaccinogen; and received lecturer fees from Merck Serono.
EXPERT ANALYSIS FROM ICACT 2015
Uterine cancer low in myomectomy with power morcellation
The prevalence of uterine cancer was 0.09% among women who underwent myomectomy with electric power morcellation, according to the results of a large database study, lower than for women who underwent myomectomy without power morcellation.
But the prevalence of uterine cancer increased with age, the researchers reported on Feb. 19 in JAMA Oncology.
“Given that older women are at the greatest risk for pathologic abnormalities, electric power morcellation should be approached with caution in patients older than 50 years undergoing myomectomy,” Dr. Jason D. Wright and his colleagues at Columbia University, New York, wrote (JAMA Oncol. 2015 Feb.19).
Electric power morcellation facilitates the excision of uterine leiomyoma in minimally invasive surgery. Its use has received increased scrutiny after a patient underwent hysterectomy with electric power morcellation for presumed benign leiomyoma that was, in fact, a uterine sarcoma, which was disseminated. The case has prompted an evaluation of electric power morcellation safety in performance of hysterectomy and myomectomy.
The Food and Drug Administration also entered the debate last year, issuing a safety alert for electric power morcellators in November and warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”
The Columbia University researchers examined the prevalence of cancers and precancerous abnormalities of the uterus in women who underwent myomectomy from 2006 to 2012 using administrative data from the Perspective database.
Among 38,557 women who underwent myomectomy without electric power morcellation, uterine cancer prevalence was 0.19% or 1 in 528, and prevalence of any pathologic abnormality was 0.67% or 1 in 150.
For women who underwent the procedure with electric power morcellation, uterine cancer prevalence was 0.09% or 1 in 1,073, and prevalence of any pathologic abnormality was 0.43% or 1 in 230.
Age was the strongest risk factor for uterine cancer and other abnormalities.
Comparing women aged 50-59 years to women 60 years and older who had myomectomy without morcellation, the prevalence of uterine cancer increased from 0.62% to 3.40%. In women who had power morcellation, the prevalence of uterine cancer was 0.97% in women aged 50-59 years and 0% in those 60 years or older.
The researchers reported similar trends for endometrial hyperplasia and overall adverse pathologic findings.
The researchers reported having no financial disclosures.
Most systematic literature reviews and large studies have focused on hysterectomy patients, overlooking myomectomy patients, according to a commentary by Dr. Ceana Nezhat. Worldwide, thousands of myomectomies are performed in reproductive-age women to preserve and enhance fertility. The impact of tissue disruption at the time of myomectomy by any method carries a small risk of intraperitoneal dissemination of occult malignant tissue. Studies on the prevalence of malignant and premalignant uterine lesions in younger patients are needed to better understand the risks tumor dissemination during myomectomy by any method, he wrote.
“The FDA black box warning on power morcellators must not cause a reversal to laparotomy or increase in the number of hysterectomies for uterine tumors,” Dr. Nezhat wrote.
“The report by Wright et al. opens the door to the use of administrative data. However, there are significant differences between administrative data and clinical registries to measure outcome and surgical quality,” Dr. Nezhat wrote. An earlier report based on clinical data found that electric power morcellation was associated with substantially higher risk of abdominopelvic recurrence and lower disease-free survival than suggested by the Wright study, he wrote.
Using administrative data is much less expensive than maintaining prospective registries. Developing strategies to combine clinical data, including final pathology reports and long-term results, with administrative data will help in improving surgical quality, as well as aid in counseling patients based on scientific research, according to Dr. Nezhat.
Dr. Ceana Nezhat is a minimally invasive surgeon at the Atlanta Center for Minimally Invasive Surgery and Reproductive Medicine. These remarks were part of an editorial accompanying the report (JAMA Oncol. 2015 Feb. 19). Dr. Nezhat is a consultant for Karl Storz Endoscopy, a medical adviser to Plasma Surgical, and serves on the Scientific Advisory Board of SurgiQuest.
Most systematic literature reviews and large studies have focused on hysterectomy patients, overlooking myomectomy patients, according to a commentary by Dr. Ceana Nezhat. Worldwide, thousands of myomectomies are performed in reproductive-age women to preserve and enhance fertility. The impact of tissue disruption at the time of myomectomy by any method carries a small risk of intraperitoneal dissemination of occult malignant tissue. Studies on the prevalence of malignant and premalignant uterine lesions in younger patients are needed to better understand the risks tumor dissemination during myomectomy by any method, he wrote.
“The FDA black box warning on power morcellators must not cause a reversal to laparotomy or increase in the number of hysterectomies for uterine tumors,” Dr. Nezhat wrote.
“The report by Wright et al. opens the door to the use of administrative data. However, there are significant differences between administrative data and clinical registries to measure outcome and surgical quality,” Dr. Nezhat wrote. An earlier report based on clinical data found that electric power morcellation was associated with substantially higher risk of abdominopelvic recurrence and lower disease-free survival than suggested by the Wright study, he wrote.
Using administrative data is much less expensive than maintaining prospective registries. Developing strategies to combine clinical data, including final pathology reports and long-term results, with administrative data will help in improving surgical quality, as well as aid in counseling patients based on scientific research, according to Dr. Nezhat.
Dr. Ceana Nezhat is a minimally invasive surgeon at the Atlanta Center for Minimally Invasive Surgery and Reproductive Medicine. These remarks were part of an editorial accompanying the report (JAMA Oncol. 2015 Feb. 19). Dr. Nezhat is a consultant for Karl Storz Endoscopy, a medical adviser to Plasma Surgical, and serves on the Scientific Advisory Board of SurgiQuest.
Most systematic literature reviews and large studies have focused on hysterectomy patients, overlooking myomectomy patients, according to a commentary by Dr. Ceana Nezhat. Worldwide, thousands of myomectomies are performed in reproductive-age women to preserve and enhance fertility. The impact of tissue disruption at the time of myomectomy by any method carries a small risk of intraperitoneal dissemination of occult malignant tissue. Studies on the prevalence of malignant and premalignant uterine lesions in younger patients are needed to better understand the risks tumor dissemination during myomectomy by any method, he wrote.
“The FDA black box warning on power morcellators must not cause a reversal to laparotomy or increase in the number of hysterectomies for uterine tumors,” Dr. Nezhat wrote.
“The report by Wright et al. opens the door to the use of administrative data. However, there are significant differences between administrative data and clinical registries to measure outcome and surgical quality,” Dr. Nezhat wrote. An earlier report based on clinical data found that electric power morcellation was associated with substantially higher risk of abdominopelvic recurrence and lower disease-free survival than suggested by the Wright study, he wrote.
Using administrative data is much less expensive than maintaining prospective registries. Developing strategies to combine clinical data, including final pathology reports and long-term results, with administrative data will help in improving surgical quality, as well as aid in counseling patients based on scientific research, according to Dr. Nezhat.
Dr. Ceana Nezhat is a minimally invasive surgeon at the Atlanta Center for Minimally Invasive Surgery and Reproductive Medicine. These remarks were part of an editorial accompanying the report (JAMA Oncol. 2015 Feb. 19). Dr. Nezhat is a consultant for Karl Storz Endoscopy, a medical adviser to Plasma Surgical, and serves on the Scientific Advisory Board of SurgiQuest.
The prevalence of uterine cancer was 0.09% among women who underwent myomectomy with electric power morcellation, according to the results of a large database study, lower than for women who underwent myomectomy without power morcellation.
But the prevalence of uterine cancer increased with age, the researchers reported on Feb. 19 in JAMA Oncology.
“Given that older women are at the greatest risk for pathologic abnormalities, electric power morcellation should be approached with caution in patients older than 50 years undergoing myomectomy,” Dr. Jason D. Wright and his colleagues at Columbia University, New York, wrote (JAMA Oncol. 2015 Feb.19).
Electric power morcellation facilitates the excision of uterine leiomyoma in minimally invasive surgery. Its use has received increased scrutiny after a patient underwent hysterectomy with electric power morcellation for presumed benign leiomyoma that was, in fact, a uterine sarcoma, which was disseminated. The case has prompted an evaluation of electric power morcellation safety in performance of hysterectomy and myomectomy.
The Food and Drug Administration also entered the debate last year, issuing a safety alert for electric power morcellators in November and warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”
The Columbia University researchers examined the prevalence of cancers and precancerous abnormalities of the uterus in women who underwent myomectomy from 2006 to 2012 using administrative data from the Perspective database.
Among 38,557 women who underwent myomectomy without electric power morcellation, uterine cancer prevalence was 0.19% or 1 in 528, and prevalence of any pathologic abnormality was 0.67% or 1 in 150.
For women who underwent the procedure with electric power morcellation, uterine cancer prevalence was 0.09% or 1 in 1,073, and prevalence of any pathologic abnormality was 0.43% or 1 in 230.
Age was the strongest risk factor for uterine cancer and other abnormalities.
Comparing women aged 50-59 years to women 60 years and older who had myomectomy without morcellation, the prevalence of uterine cancer increased from 0.62% to 3.40%. In women who had power morcellation, the prevalence of uterine cancer was 0.97% in women aged 50-59 years and 0% in those 60 years or older.
The researchers reported similar trends for endometrial hyperplasia and overall adverse pathologic findings.
The researchers reported having no financial disclosures.
The prevalence of uterine cancer was 0.09% among women who underwent myomectomy with electric power morcellation, according to the results of a large database study, lower than for women who underwent myomectomy without power morcellation.
But the prevalence of uterine cancer increased with age, the researchers reported on Feb. 19 in JAMA Oncology.
“Given that older women are at the greatest risk for pathologic abnormalities, electric power morcellation should be approached with caution in patients older than 50 years undergoing myomectomy,” Dr. Jason D. Wright and his colleagues at Columbia University, New York, wrote (JAMA Oncol. 2015 Feb.19).
Electric power morcellation facilitates the excision of uterine leiomyoma in minimally invasive surgery. Its use has received increased scrutiny after a patient underwent hysterectomy with electric power morcellation for presumed benign leiomyoma that was, in fact, a uterine sarcoma, which was disseminated. The case has prompted an evaluation of electric power morcellation safety in performance of hysterectomy and myomectomy.
The Food and Drug Administration also entered the debate last year, issuing a safety alert for electric power morcellators in November and warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”
The Columbia University researchers examined the prevalence of cancers and precancerous abnormalities of the uterus in women who underwent myomectomy from 2006 to 2012 using administrative data from the Perspective database.
Among 38,557 women who underwent myomectomy without electric power morcellation, uterine cancer prevalence was 0.19% or 1 in 528, and prevalence of any pathologic abnormality was 0.67% or 1 in 150.
For women who underwent the procedure with electric power morcellation, uterine cancer prevalence was 0.09% or 1 in 1,073, and prevalence of any pathologic abnormality was 0.43% or 1 in 230.
Age was the strongest risk factor for uterine cancer and other abnormalities.
Comparing women aged 50-59 years to women 60 years and older who had myomectomy without morcellation, the prevalence of uterine cancer increased from 0.62% to 3.40%. In women who had power morcellation, the prevalence of uterine cancer was 0.97% in women aged 50-59 years and 0% in those 60 years or older.
The researchers reported similar trends for endometrial hyperplasia and overall adverse pathologic findings.
The researchers reported having no financial disclosures.
FROM JAMA ONCOLOGY
Key clinical point: Among women who underwent myomectomy, the prevalence of cancers was low but increased with age.
Major finding: Rates of uterine cancers for women who underwent myomectomy with and without electric power morcellation were 0.09% and 0.19%, respectively.
Data source: The nationwide database study retrospectively analyzed 41,777 women who underwent myomectomy in 496 U.S. hospitals.
Disclosures: The researchers reported having no financial disclosures.
Jacobson Promising Investigator Award Nominations due March 27
The American College of Surgeons (ACS) Surgical Research Committee is accepting nominations for the eleventh Joan L. and Julius H. Jacobson II Promising Investigator Award, to be conferred in 2015. This award recognizes outstanding surgeons engaged in research, advancing the art and science of surgery, and demonstrating early promise of significant contribution to the practice of surgery and the safety of surgical patients.
Surgeons who are at the “tipping point” of their research careers with a track record indicative of early promise and potential will receive special consideration. Well-established surgeon-scientists are ineligible for this award. To be considered for the award this year, submissions must be received no later than March 27.For complete details on award criteria and nomination procedures, visit the Jacobson Promising Investigator Award section on the ACS website at https://www.facs.org/quality%20programs/about/cqi/Jacobson. For additional information, contact Carla Manosalvas, Administrator, Committees and Educational Programs Division of Research and Optimal Patient Care, at [email protected].
The American College of Surgeons (ACS) Surgical Research Committee is accepting nominations for the eleventh Joan L. and Julius H. Jacobson II Promising Investigator Award, to be conferred in 2015. This award recognizes outstanding surgeons engaged in research, advancing the art and science of surgery, and demonstrating early promise of significant contribution to the practice of surgery and the safety of surgical patients.
Surgeons who are at the “tipping point” of their research careers with a track record indicative of early promise and potential will receive special consideration. Well-established surgeon-scientists are ineligible for this award. To be considered for the award this year, submissions must be received no later than March 27.For complete details on award criteria and nomination procedures, visit the Jacobson Promising Investigator Award section on the ACS website at https://www.facs.org/quality%20programs/about/cqi/Jacobson. For additional information, contact Carla Manosalvas, Administrator, Committees and Educational Programs Division of Research and Optimal Patient Care, at [email protected].
The American College of Surgeons (ACS) Surgical Research Committee is accepting nominations for the eleventh Joan L. and Julius H. Jacobson II Promising Investigator Award, to be conferred in 2015. This award recognizes outstanding surgeons engaged in research, advancing the art and science of surgery, and demonstrating early promise of significant contribution to the practice of surgery and the safety of surgical patients.
Surgeons who are at the “tipping point” of their research careers with a track record indicative of early promise and potential will receive special consideration. Well-established surgeon-scientists are ineligible for this award. To be considered for the award this year, submissions must be received no later than March 27.For complete details on award criteria and nomination procedures, visit the Jacobson Promising Investigator Award section on the ACS website at https://www.facs.org/quality%20programs/about/cqi/Jacobson. For additional information, contact Carla Manosalvas, Administrator, Committees and Educational Programs Division of Research and Optimal Patient Care, at [email protected].
Apply by April 3 for ACS Clinical Scholars in Residence Program
The application period for the American College of Surgeons (ACS) two-year on-site Clinical Scholars in Residence Fellowship in surgical outcomes research, health services research, and health care policy for positions starting in 2016 opened January 1, 2015. Applicants must be U.S. citizens who have completed two years of clinical training and are able to obtain two years of program funding from their home institution or other granting agency. Applicants must be members in good standing of the ACS. The application deadline is April 3, 2015.
The Clinical Scholar in Residence will have the opportunity to work in multiple areas within the ACS Division of Research and Optimal Patient Care to advance the College’s quality improvement initiatives and to perform research relevant to ongoing ACS projects. Participants will also earn a master’s degree during their two years. The Clinical Scholar will be mentored in clinical, statistical, and health services research. Since the ACS Clinical Scholars in Residence Program began in 2005, the participants have gone on to have successful careers in this field.
Clinical Scholars in Residence dates:
Application deadline: April 3, 2015
Interview notification: May 1, 2015
Interview Process: May 1–31, 2015
Notification of appointment: June 12, 2015
Starting date: July 1, 2016
View more information on the Clinical Scholars in Residence Program on the ACS website at www.facs.org/ropc/clinicalscholars.html. If you have additional questions, contact the ACS Clinical Scholars in Residence Program at [email protected].
The application period for the American College of Surgeons (ACS) two-year on-site Clinical Scholars in Residence Fellowship in surgical outcomes research, health services research, and health care policy for positions starting in 2016 opened January 1, 2015. Applicants must be U.S. citizens who have completed two years of clinical training and are able to obtain two years of program funding from their home institution or other granting agency. Applicants must be members in good standing of the ACS. The application deadline is April 3, 2015.
The Clinical Scholar in Residence will have the opportunity to work in multiple areas within the ACS Division of Research and Optimal Patient Care to advance the College’s quality improvement initiatives and to perform research relevant to ongoing ACS projects. Participants will also earn a master’s degree during their two years. The Clinical Scholar will be mentored in clinical, statistical, and health services research. Since the ACS Clinical Scholars in Residence Program began in 2005, the participants have gone on to have successful careers in this field.
Clinical Scholars in Residence dates:
Application deadline: April 3, 2015
Interview notification: May 1, 2015
Interview Process: May 1–31, 2015
Notification of appointment: June 12, 2015
Starting date: July 1, 2016
View more information on the Clinical Scholars in Residence Program on the ACS website at www.facs.org/ropc/clinicalscholars.html. If you have additional questions, contact the ACS Clinical Scholars in Residence Program at [email protected].
The application period for the American College of Surgeons (ACS) two-year on-site Clinical Scholars in Residence Fellowship in surgical outcomes research, health services research, and health care policy for positions starting in 2016 opened January 1, 2015. Applicants must be U.S. citizens who have completed two years of clinical training and are able to obtain two years of program funding from their home institution or other granting agency. Applicants must be members in good standing of the ACS. The application deadline is April 3, 2015.
The Clinical Scholar in Residence will have the opportunity to work in multiple areas within the ACS Division of Research and Optimal Patient Care to advance the College’s quality improvement initiatives and to perform research relevant to ongoing ACS projects. Participants will also earn a master’s degree during their two years. The Clinical Scholar will be mentored in clinical, statistical, and health services research. Since the ACS Clinical Scholars in Residence Program began in 2005, the participants have gone on to have successful careers in this field.
Clinical Scholars in Residence dates:
Application deadline: April 3, 2015
Interview notification: May 1, 2015
Interview Process: May 1–31, 2015
Notification of appointment: June 12, 2015
Starting date: July 1, 2016
View more information on the Clinical Scholars in Residence Program on the ACS website at www.facs.org/ropc/clinicalscholars.html. If you have additional questions, contact the ACS Clinical Scholars in Residence Program at [email protected].
Submit nominations for Surgical Volunteerism, Humanitarian Awards
The American College of Surgeons (ACS) is accepting nominations for the 2015 Surgical Volunteerism Award(s) and Surgical Humanitarian Award, made possible in part through grant support from Pfizer, Inc. All nominations for the awards, which celebrate the power of humanitarian outreach, must be received by Friday, February 27. College members hold the awards in high esteem and have been inspired by the memorable stories shared by the extraordinary surgeons who have been recipients of the awards. The 2014 recipient of the Surgical Volunteerism International Award, Robert Bach, MD, FACS, North Haven, ME, said, “I think it is a wonderful thing you are doing, promoting giving back, as my experience in Nicaragua has been one of the most rewarding aspects of my life. To quote St. Francis of Assisi, ‘It is in giving that we receive.’ We always take away more than we give. I would also say that the one-to-one relationships that we form in helping our colleagues abroad teach us how to do and live with less. The experience of receiving the award at the Clinical Congress enabled me to meet surgeons with similar interests, take practical courses of value on the field, and feel honored by a highly respected organization.”
Submit nominations online at http://web2.facs.org/ogb. Go to the ACS website for more details about the awards at https://www.facs.org/member-services/volunteer.
The American College of Surgeons (ACS) is accepting nominations for the 2015 Surgical Volunteerism Award(s) and Surgical Humanitarian Award, made possible in part through grant support from Pfizer, Inc. All nominations for the awards, which celebrate the power of humanitarian outreach, must be received by Friday, February 27. College members hold the awards in high esteem and have been inspired by the memorable stories shared by the extraordinary surgeons who have been recipients of the awards. The 2014 recipient of the Surgical Volunteerism International Award, Robert Bach, MD, FACS, North Haven, ME, said, “I think it is a wonderful thing you are doing, promoting giving back, as my experience in Nicaragua has been one of the most rewarding aspects of my life. To quote St. Francis of Assisi, ‘It is in giving that we receive.’ We always take away more than we give. I would also say that the one-to-one relationships that we form in helping our colleagues abroad teach us how to do and live with less. The experience of receiving the award at the Clinical Congress enabled me to meet surgeons with similar interests, take practical courses of value on the field, and feel honored by a highly respected organization.”
Submit nominations online at http://web2.facs.org/ogb. Go to the ACS website for more details about the awards at https://www.facs.org/member-services/volunteer.
The American College of Surgeons (ACS) is accepting nominations for the 2015 Surgical Volunteerism Award(s) and Surgical Humanitarian Award, made possible in part through grant support from Pfizer, Inc. All nominations for the awards, which celebrate the power of humanitarian outreach, must be received by Friday, February 27. College members hold the awards in high esteem and have been inspired by the memorable stories shared by the extraordinary surgeons who have been recipients of the awards. The 2014 recipient of the Surgical Volunteerism International Award, Robert Bach, MD, FACS, North Haven, ME, said, “I think it is a wonderful thing you are doing, promoting giving back, as my experience in Nicaragua has been one of the most rewarding aspects of my life. To quote St. Francis of Assisi, ‘It is in giving that we receive.’ We always take away more than we give. I would also say that the one-to-one relationships that we form in helping our colleagues abroad teach us how to do and live with less. The experience of receiving the award at the Clinical Congress enabled me to meet surgeons with similar interests, take practical courses of value on the field, and feel honored by a highly respected organization.”
Submit nominations online at http://web2.facs.org/ogb. Go to the ACS website for more details about the awards at https://www.facs.org/member-services/volunteer.
Submit abstracts online for 2015 ACS Clinical Congress
The electronic abstract submission site is now available to receive research and video abstracts for the 2015 ACS Clinical Congress, October 4−8 in Chicago, IL.
The deadline for abstract submissions is 5:00 pm, CST, on Monday, March 2. Submissions can be made via the ACS website at abstracts.facs.org. Revisions may be made until the deadline. No revisions or submissions will be accepted after the deadline. For more information, contact [email protected] for oral or poster abstract submissions, and [email protected] for video-based education submissions.
The electronic abstract submission site is now available to receive research and video abstracts for the 2015 ACS Clinical Congress, October 4−8 in Chicago, IL.
The deadline for abstract submissions is 5:00 pm, CST, on Monday, March 2. Submissions can be made via the ACS website at abstracts.facs.org. Revisions may be made until the deadline. No revisions or submissions will be accepted after the deadline. For more information, contact [email protected] for oral or poster abstract submissions, and [email protected] for video-based education submissions.
The electronic abstract submission site is now available to receive research and video abstracts for the 2015 ACS Clinical Congress, October 4−8 in Chicago, IL.
The deadline for abstract submissions is 5:00 pm, CST, on Monday, March 2. Submissions can be made via the ACS website at abstracts.facs.org. Revisions may be made until the deadline. No revisions or submissions will be accepted after the deadline. For more information, contact [email protected] for oral or poster abstract submissions, and [email protected] for video-based education submissions.