Heidi Splete

WASHINGTON (EGMN) – Of 400 United States physicians surveyed online, 95% said they have received flu vaccinations for the 2010-2011 flu season or plan to do so, according to data collected by the National Foundation for Infectious Diseases.

These results are encouraging, because they show that more physicians are practicing what they preach about flu vaccination, Dr. William Schaffner, president of the NFID, said at a press conference on influenza.

“I am optimistic that we are becoming a culture of prevention,” Dr. Schaffner said.

“Plenty of flu vaccine is anticipated for this year,” along with a plentiful supply of antiviral medication, he emphasized, and vaccines are available at pharmacies as well as doctors’ offices.

“Flu vaccination is the best way to protect yourself against the flu,” said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. Every year thousands of Americans die from influenza, he said. For the 2010-2011 flu season, the CDC recommends universal vaccination for everyone aged 6 months and older. Several vaccination options are available, including a flu shot, a nasal spray, and a high-dose vaccine for older adults, Dr. Frieden said.

Dr. Daniel Jernigan, deputy director of the influenza division in the CDC’s National Center for Immunization and Respiratory Diseases, said that this year’s vaccine contains antibodies against three flu viruses: influenza B, influenza A (H3N2), and influenza A (H1N1). Approximately 119 million doses of 2010-2011 flu vaccine already have been distributed in the United States, with a total of 160 million doses anticipated, Dr. Jernigan said. There is no need for a separate H1N1 vaccine this year, he noted.

So far this year, the H3N2 virus has been the most commonly seen, said Dr. Jernigan. Although children were disproportionately affected by the 2009 H1N1 virus, “When H3N2 is dominant, we see more illness in children and older adults,” he said.

Another important reason to vaccinate children is that they are incredibly efficient at spreading the flu – to their peers, family members, and other close contacts, said Dr. Judith S. Palfrey, past president of the American Academy of Pediatrics.

“Pediatricians can play a critical role,” Dr. Palfrey emphasized. “In a recent NFID consumer survey of mothers, nearly 7 in 10 mothers said their child’s pediatrician was the first person they would turn to for information about influenza and vaccination.”

Dr. Palfrey added that children under 9 years of age who have never been vaccinated against the flu should receive two doses this year, given at about four weeks apart. One dose is sufficient for previously vaccinated children, she said. A complete algorithm for childhood vaccination is available at the American Academy of Pediatrics website.

More information about this year’s flu vaccine is available at the CDC’s flu website, cdc.gov/flu.

Although flu vaccination is recommended for most individuals, some people should not receive the flu vaccine. According to the CDC, individuals who are allergic to eggs or who have had a history of severe reaction to an influenza vaccination should not be vaccinated, nor should anyone who has developed Guillian-Barré syndrome within 6 weeks of receiving an influenza vaccine. Those with a moderate to severe illness that includes a fever should wait until they recover before getting vaccinated. And children younger than 6 months of age should not receive any type of flu vaccine.

Click for video report.

The press conference was sponsored by the National Foundation for Infectious Diseases in partnership with the National Influenza Vaccine Summit. It was supported in part by the Centers for Disease Control and Prevention and by unrestricted educational grants to the NFID from Flu Vaccine Business Practices Initiative (c/o HIDA), Genentech, GlaxoSmithKline, MedImmune, Merck and Co., Novartis Vaccines, Pfizer, Sanofi Pasteur, and Walgreens.

WASHINGTON (EGMN) – Of 400 United States physicians surveyed online, 95% said they have received flu vaccinations for the 2010-2011 flu season or plan to do so, according to data collected by the National Foundation for Infectious Diseases.

These results are encouraging, because they show that more physicians are practicing what they preach about flu vaccination, Dr. William Schaffner, president of the NFID, said at a press conference on influenza.

“I am optimistic that we are becoming a culture of prevention,” Dr. Schaffner said.

“Plenty of flu vaccine is anticipated for this year,” along with a plentiful supply of antiviral medication, he emphasized, and vaccines are available at pharmacies as well as doctors’ offices.

“Flu vaccination is the best way to protect yourself against the flu,” said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. Every year thousands of Americans die from influenza, he said. For the 2010-2011 flu season, the CDC recommends universal vaccination for everyone aged 6 months and older. Several vaccination options are available, including a flu shot, a nasal spray, and a high-dose vaccine for older adults, Dr. Frieden said.

Dr. Daniel Jernigan, deputy director of the influenza division in the CDC’s National Center for Immunization and Respiratory Diseases, said that this year’s vaccine contains antibodies against three flu viruses: influenza B, influenza A (H3N2), and influenza A (H1N1). Approximately 119 million doses of 2010-2011 flu vaccine already have been distributed in the United States, with a total of 160 million doses anticipated, Dr. Jernigan said. There is no need for a separate H1N1 vaccine this year, he noted.

So far this year, the H3N2 virus has been the most commonly seen, said Dr. Jernigan. Although children were disproportionately affected by the 2009 H1N1 virus, “When H3N2 is dominant, we see more illness in children and older adults,” he said.

Another important reason to vaccinate children is that they are incredibly efficient at spreading the flu – to their peers, family members, and other close contacts, said Dr. Judith S. Palfrey, past president of the American Academy of Pediatrics.

“Pediatricians can play a critical role,” Dr. Palfrey emphasized. “In a recent NFID consumer survey of mothers, nearly 7 in 10 mothers said their child’s pediatrician was the first person they would turn to for information about influenza and vaccination.”

Dr. Palfrey added that children under 9 years of age who have never been vaccinated against the flu should receive two doses this year, given at about four weeks apart. One dose is sufficient for previously vaccinated children, she said. A complete algorithm for childhood vaccination is available at the American Academy of Pediatrics website.

More information about this year’s flu vaccine is available at the CDC’s flu website, cdc.gov/flu.

Although flu vaccination is recommended for most individuals, some people should not receive the flu vaccine. According to the CDC, individuals who are allergic to eggs or who have had a history of severe reaction to an influenza vaccination should not be vaccinated, nor should anyone who has developed Guillian-Barré syndrome within 6 weeks of receiving an influenza vaccine. Those with a moderate to severe illness that includes a fever should wait until they recover before getting vaccinated. And children younger than 6 months of age should not receive any type of flu vaccine.

Click for video report.

The press conference was sponsored by the National Foundation for Infectious Diseases in partnership with the National Influenza Vaccine Summit. It was supported in part by the Centers for Disease Control and Prevention and by unrestricted educational grants to the NFID from Flu Vaccine Business Practices Initiative (c/o HIDA), Genentech, GlaxoSmithKline, MedImmune, Merck and Co., Novartis Vaccines, Pfizer, Sanofi Pasteur, and Walgreens.

WASHINGTON (EGMN) – Of 400 United States physicians surveyed online, 95% said they have received flu vaccinations for the 2010-2011 flu season or plan to do so, according to data collected by the National Foundation for Infectious Diseases.

These results are encouraging, because they show that more physicians are practicing what they preach about flu vaccination, Dr. William Schaffner, president of the NFID, said at a press conference on influenza.

“I am optimistic that we are becoming a culture of prevention,” Dr. Schaffner said.

“Plenty of flu vaccine is anticipated for this year,” along with a plentiful supply of antiviral medication, he emphasized, and vaccines are available at pharmacies as well as doctors’ offices.

“Flu vaccination is the best way to protect yourself against the flu,” said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. Every year thousands of Americans die from influenza, he said. For the 2010-2011 flu season, the CDC recommends universal vaccination for everyone aged 6 months and older. Several vaccination options are available, including a flu shot, a nasal spray, and a high-dose vaccine for older adults, Dr. Frieden said.

Dr. Daniel Jernigan, deputy director of the influenza division in the CDC’s National Center for Immunization and Respiratory Diseases, said that this year’s vaccine contains antibodies against three flu viruses: influenza B, influenza A (H3N2), and influenza A (H1N1). Approximately 119 million doses of 2010-2011 flu vaccine already have been distributed in the United States, with a total of 160 million doses anticipated, Dr. Jernigan said. There is no need for a separate H1N1 vaccine this year, he noted.

So far this year, the H3N2 virus has been the most commonly seen, said Dr. Jernigan. Although children were disproportionately affected by the 2009 H1N1 virus, “When H3N2 is dominant, we see more illness in children and older adults,” he said.

Another important reason to vaccinate children is that they are incredibly efficient at spreading the flu – to their peers, family members, and other close contacts, said Dr. Judith S. Palfrey, past president of the American Academy of Pediatrics.

“Pediatricians can play a critical role,” Dr. Palfrey emphasized. “In a recent NFID consumer survey of mothers, nearly 7 in 10 mothers said their child’s pediatrician was the first person they would turn to for information about influenza and vaccination.”

Dr. Palfrey added that children under 9 years of age who have never been vaccinated against the flu should receive two doses this year, given at about four weeks apart. One dose is sufficient for previously vaccinated children, she said. A complete algorithm for childhood vaccination is available at the American Academy of Pediatrics website.

More information about this year’s flu vaccine is available at the CDC’s flu website, cdc.gov/flu.

Although flu vaccination is recommended for most individuals, some people should not receive the flu vaccine. According to the CDC, individuals who are allergic to eggs or who have had a history of severe reaction to an influenza vaccination should not be vaccinated, nor should anyone who has developed Guillian-Barré syndrome within 6 weeks of receiving an influenza vaccine. Those with a moderate to severe illness that includes a fever should wait until they recover before getting vaccinated. And children younger than 6 months of age should not receive any type of flu vaccine.

Click for video report.

The press conference was sponsored by the National Foundation for Infectious Diseases in partnership with the National Influenza Vaccine Summit. It was supported in part by the Centers for Disease Control and Prevention and by unrestricted educational grants to the NFID from Flu Vaccine Business Practices Initiative (c/o HIDA), Genentech, GlaxoSmithKline, MedImmune, Merck and Co., Novartis Vaccines, Pfizer, Sanofi Pasteur, and Walgreens.

WASHINGTON – Of 400 United States physicians surveyed online, 95% said they have received flu vaccinations for the 2010-2011 flu season or plan to do so, according to data collected by the National Foundation for Infectious Diseases.

These results are encouraging, because they show that more physicians are practicing what they preach about flu vaccination, Dr. William Schaffner, president of the NFID, said at a press conference on influenza.

“I am optimistic that we are becoming a culture of prevention,” Dr. Schaffner said.

“Plenty of flu vaccine is anticipated for this year,” along with a plentiful supply of antiviral medication, he emphasized, and vaccines are available at pharmacies as well as doctors’ offices.

“Flu vaccination is the best way to protect yourself against the flu,” said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. Every year thousands of Americans die from influenza, he said. For the 2010-2011 flu season, the CDC recommends universal vaccination for everyone aged 6 months and older. Several vaccination options are available, including a flu shot, a nasal spray, and a high-dose vaccine for older adults, Dr. Frieden said.

Dr. Daniel Jernigan, deputy director of the influenza division in the CDC’s National Center for Immunization and Respiratory Diseases, said that this year’s vaccine contains antibodies against three flu viruses: influenza B, influenza A (H3N2), and influenza A (H1N1). Approximately 119 million doses of 2010-2011 flu vaccine already have been distributed in the United States, with a total of 160 million doses anticipated, Dr. Jernigan said. There is no need for a separate H1N1 vaccine this year, he noted.

So far this year, the H3N2 virus has been the most commonly seen, said Dr. Jernigan. Although children were disproportionately affected by the 2009 H1N1 virus, “When H3N2 is dominant, we see more illness in children and older adults,” he said.

Another important reason to vaccinate children is that they are incredibly efficient at spreading the flu – to their peers, family members, and other close contacts, said Dr. Judith S. Palfrey, past president of the American Academy of Pediatrics.

“Pediatricians can play a critical role,” Dr. Palfrey emphasized. “In a recent NFID consumer survey of mothers, nearly 7 in 10 mothers said their child’s pediatrician was the first person they would turn to for information about influenza and vaccination.”

Dr. Palfrey added that children under 9 years of age who have never been vaccinated against the flu should receive two doses this year, given at about four weeks apart. One dose is sufficient for previously vaccinated children, she said. A complete algorithm for childhood vaccination is available at the American Academy of Pediatrics website.

More information about this year’s flu vaccine is available at the CDC’s flu website, cdc.gov/flu.

Although flu vaccination is recommended for most individuals, some people should not receive the flu vaccine. According to the CDC, individuals who are allergic to eggs or who have had a history of severe reaction to an influenza vaccination should not be vaccinated, nor should anyone who has developed Guillian-Barré syndrome within 6 weeks of receiving an influenza vaccine. Those with a moderate to severe illness that includes a fever should wait until they recover before getting vaccinated. And children younger than 6 months of age should not receive any type of flu vaccine.

Click for video report.

The press conference was sponsored by the National Foundation for Infectious Diseases in partnership with the National Influenza Vaccine Summit. It was supported in part by the Centers for Disease Control and Prevention and by unrestricted educational grants to the NFID from Flu Vaccine Business Practices Initiative (c/o HIDA), Genentech, GlaxoSmithKline, MedImmune, Merck and Co., Novartis Vaccines, Pfizer, Sanofi Pasteur, and Walgreens.

WASHINGTON – Of 400 United States physicians surveyed online, 95% said they have received flu vaccinations for the 2010-2011 flu season or plan to do so, according to data collected by the National Foundation for Infectious Diseases.

These results are encouraging, because they show that more physicians are practicing what they preach about flu vaccination, Dr. William Schaffner, president of the NFID, said at a press conference on influenza.

“I am optimistic that we are becoming a culture of prevention,” Dr. Schaffner said.

“Plenty of flu vaccine is anticipated for this year,” along with a plentiful supply of antiviral medication, he emphasized, and vaccines are available at pharmacies as well as doctors’ offices.

“Flu vaccination is the best way to protect yourself against the flu,” said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. Every year thousands of Americans die from influenza, he said. For the 2010-2011 flu season, the CDC recommends universal vaccination for everyone aged 6 months and older. Several vaccination options are available, including a flu shot, a nasal spray, and a high-dose vaccine for older adults, Dr. Frieden said.

Dr. Daniel Jernigan, deputy director of the influenza division in the CDC’s National Center for Immunization and Respiratory Diseases, said that this year’s vaccine contains antibodies against three flu viruses: influenza B, influenza A (H3N2), and influenza A (H1N1). Approximately 119 million doses of 2010-2011 flu vaccine already have been distributed in the United States, with a total of 160 million doses anticipated, Dr. Jernigan said. There is no need for a separate H1N1 vaccine this year, he noted.

So far this year, the H3N2 virus has been the most commonly seen, said Dr. Jernigan. Although children were disproportionately affected by the 2009 H1N1 virus, “When H3N2 is dominant, we see more illness in children and older adults,” he said.

Another important reason to vaccinate children is that they are incredibly efficient at spreading the flu – to their peers, family members, and other close contacts, said Dr. Judith S. Palfrey, past president of the American Academy of Pediatrics.

“Pediatricians can play a critical role,” Dr. Palfrey emphasized. “In a recent NFID consumer survey of mothers, nearly 7 in 10 mothers said their child’s pediatrician was the first person they would turn to for information about influenza and vaccination.”

Dr. Palfrey added that children under 9 years of age who have never been vaccinated against the flu should receive two doses this year, given at about four weeks apart. One dose is sufficient for previously vaccinated children, she said. A complete algorithm for childhood vaccination is available at the American Academy of Pediatrics website.

More information about this year’s flu vaccine is available at the CDC’s flu website, cdc.gov/flu.

Although flu vaccination is recommended for most individuals, some people should not receive the flu vaccine. According to the CDC, individuals who are allergic to eggs or who have had a history of severe reaction to an influenza vaccination should not be vaccinated, nor should anyone who has developed Guillian-Barré syndrome within 6 weeks of receiving an influenza vaccine. Those with a moderate to severe illness that includes a fever should wait until they recover before getting vaccinated. And children younger than 6 months of age should not receive any type of flu vaccine.

Click for video report.

The press conference was sponsored by the National Foundation for Infectious Diseases in partnership with the National Influenza Vaccine Summit. It was supported in part by the Centers for Disease Control and Prevention and by unrestricted educational grants to the NFID from Flu Vaccine Business Practices Initiative (c/o HIDA), Genentech, GlaxoSmithKline, MedImmune, Merck and Co., Novartis Vaccines, Pfizer, Sanofi Pasteur, and Walgreens.

WASHINGTON – Of 400 United States physicians surveyed online, 95% said they have received flu vaccinations for the 2010-2011 flu season or plan to do so, according to data collected by the National Foundation for Infectious Diseases.

These results are encouraging, because they show that more physicians are practicing what they preach about flu vaccination, Dr. William Schaffner, president of the NFID, said at a press conference on influenza.

“I am optimistic that we are becoming a culture of prevention,” Dr. Schaffner said.

“Plenty of flu vaccine is anticipated for this year,” along with a plentiful supply of antiviral medication, he emphasized, and vaccines are available at pharmacies as well as doctors’ offices.

“Flu vaccination is the best way to protect yourself against the flu,” said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. Every year thousands of Americans die from influenza, he said. For the 2010-2011 flu season, the CDC recommends universal vaccination for everyone aged 6 months and older. Several vaccination options are available, including a flu shot, a nasal spray, and a high-dose vaccine for older adults, Dr. Frieden said.

Dr. Daniel Jernigan, deputy director of the influenza division in the CDC’s National Center for Immunization and Respiratory Diseases, said that this year’s vaccine contains antibodies against three flu viruses: influenza B, influenza A (H3N2), and influenza A (H1N1). Approximately 119 million doses of 2010-2011 flu vaccine already have been distributed in the United States, with a total of 160 million doses anticipated, Dr. Jernigan said. There is no need for a separate H1N1 vaccine this year, he noted.

So far this year, the H3N2 virus has been the most commonly seen, said Dr. Jernigan. Although children were disproportionately affected by the 2009 H1N1 virus, “When H3N2 is dominant, we see more illness in children and older adults,” he said.

Another important reason to vaccinate children is that they are incredibly efficient at spreading the flu – to their peers, family members, and other close contacts, said Dr. Judith S. Palfrey, past president of the American Academy of Pediatrics.

“Pediatricians can play a critical role,” Dr. Palfrey emphasized. “In a recent NFID consumer survey of mothers, nearly 7 in 10 mothers said their child’s pediatrician was the first person they would turn to for information about influenza and vaccination.”

Dr. Palfrey added that children under 9 years of age who have never been vaccinated against the flu should receive two doses this year, given at about four weeks apart. One dose is sufficient for previously vaccinated children, she said. A complete algorithm for childhood vaccination is available at the American Academy of Pediatrics website.

More information about this year’s flu vaccine is available at the CDC’s flu website, cdc.gov/flu.

Although flu vaccination is recommended for most individuals, some people should not receive the flu vaccine. According to the CDC, individuals who are allergic to eggs or who have had a history of severe reaction to an influenza vaccination should not be vaccinated, nor should anyone who has developed Guillian-Barré syndrome within 6 weeks of receiving an influenza vaccine. Those with a moderate to severe illness that includes a fever should wait until they recover before getting vaccinated. And children younger than 6 months of age should not receive any type of flu vaccine.

Click for video report.

The press conference was sponsored by the National Foundation for Infectious Diseases in partnership with the National Influenza Vaccine Summit. It was supported in part by the Centers for Disease Control and Prevention and by unrestricted educational grants to the NFID from Flu Vaccine Business Practices Initiative (c/o HIDA), Genentech, GlaxoSmithKline, MedImmune, Merck and Co., Novartis Vaccines, Pfizer, Sanofi Pasteur, and Walgreens.

NATIONAL HARBOR, Md. – Age 50 years or older, initial clinical tumor size greater than 5 cm, and pathologic tumor response to neoadjuvant chemotherapy were significant independent predictors of locoregional failure in women who underwent neoadjuvant chemotherapy in two large breast cancer trials.

Investigators presented these results from a 10-year follow-up study of 2,961 patients in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and NSABP B-27 trials at the 2010 Breast Cancer Symposium.

Dr. Eleftherios P. Mamounas of Aultman Hospital in Canton, Ohio, and his colleagues reported the 10-year incidence of local or regional failure based on type of surgery was 12.3% in patients who had mastectomies and 10.3% in those who had lumpectomies plus chemotherapy. The incidence of local failure was 8.9% in the mastectomy group and 8.1% in the lumpectomy plus chemotherapy group. The incidence of regional failure was 3.4% and 2.2%, respectively.

In a multivariate analysis based on 318 locoregional failure events in all 2,961 patients, the overall significant predictors of locoregional failure included age 50 years or older (hazard ratio 0.79, P = .04), clinical tumor size greater than 5 cm (HR 1.52, P = .0005), and positive clinical nodal status (HR 1.64, P less than .0001). In addition, being node negative without pathologic complete response (HR 1.65, P less than .001) or node positive with pathologic complete response (HR 2.77, P less than 0.001) were significant predictors as well.

The lack of data on predictors of locoregional failure after neoadjuvant chemotherapy has raised questions about whether to use radiation therapy and when to perform sentinel node biopsies in these patients, said Dr. Mamounas.

He also presented data on locoregional failure in lumpectomy patients and mastectomy patients separately, for the purpose of developing separate treatment nomograms for each procedure. A majority of the locoregional failures in the lumpectomy patients were in-breast recurrences. In mastectomy patients, rates of chest wall recurrence were inversely correlated to pathologic nodal response, Dr. Mamounas said.

“The effect of age (in lumpectomy patients), clinical tumor size (in mastectomy patients), and clinical nodal status at locoregional failure appears to diminish with increasing pathologic response in the breast and axillary nodes,” said Dr. Mamounas.

The neoadjuvant chemotherapy regimens were one of two: doxorubicin (Adriamycin) and cyclophosphamide (AC) for four cycles, or the AC regimen for four cycles followed by four cycles of neoadjuvant/adjuvant docetaxel (Taxotere). Patients in the B-27 trial received tamoxifen in addition to their neoadjuvant chemotherapy. Lumpectomy patients were treated with radiation, but mastectomy patients were not.

The independent predictors were incorporated into two nomograms: one for mastectomy and one for lumpectomy plus breast radiation, Dr. Mamounas explained. Additional studies are planned to include treatment effects in the development and validation of the nomograms, he said.

Disclosures: Dr. Mamounas disclosed serving as a consultant for Eli Lilly & Co. and receiving honoraria from AstraZeneca and Sanofi-Aventis.

NATIONAL HARBOR, Md. – Age 50 years or older, initial clinical tumor size greater than 5 cm, and pathologic tumor response to neoadjuvant chemotherapy were significant independent predictors of locoregional failure in women who underwent neoadjuvant chemotherapy in two large breast cancer trials.

Investigators presented these results from a 10-year follow-up study of 2,961 patients in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and NSABP B-27 trials at the 2010 Breast Cancer Symposium.

Dr. Eleftherios P. Mamounas of Aultman Hospital in Canton, Ohio, and his colleagues reported the 10-year incidence of local or regional failure based on type of surgery was 12.3% in patients who had mastectomies and 10.3% in those who had lumpectomies plus chemotherapy. The incidence of local failure was 8.9% in the mastectomy group and 8.1% in the lumpectomy plus chemotherapy group. The incidence of regional failure was 3.4% and 2.2%, respectively.

In a multivariate analysis based on 318 locoregional failure events in all 2,961 patients, the overall significant predictors of locoregional failure included age 50 years or older (hazard ratio 0.79, P = .04), clinical tumor size greater than 5 cm (HR 1.52, P = .0005), and positive clinical nodal status (HR 1.64, P less than .0001). In addition, being node negative without pathologic complete response (HR 1.65, P less than .001) or node positive with pathologic complete response (HR 2.77, P less than 0.001) were significant predictors as well.

The lack of data on predictors of locoregional failure after neoadjuvant chemotherapy has raised questions about whether to use radiation therapy and when to perform sentinel node biopsies in these patients, said Dr. Mamounas.

He also presented data on locoregional failure in lumpectomy patients and mastectomy patients separately, for the purpose of developing separate treatment nomograms for each procedure. A majority of the locoregional failures in the lumpectomy patients were in-breast recurrences. In mastectomy patients, rates of chest wall recurrence were inversely correlated to pathologic nodal response, Dr. Mamounas said.

“The effect of age (in lumpectomy patients), clinical tumor size (in mastectomy patients), and clinical nodal status at locoregional failure appears to diminish with increasing pathologic response in the breast and axillary nodes,” said Dr. Mamounas.

The neoadjuvant chemotherapy regimens were one of two: doxorubicin (Adriamycin) and cyclophosphamide (AC) for four cycles, or the AC regimen for four cycles followed by four cycles of neoadjuvant/adjuvant docetaxel (Taxotere). Patients in the B-27 trial received tamoxifen in addition to their neoadjuvant chemotherapy. Lumpectomy patients were treated with radiation, but mastectomy patients were not.

The independent predictors were incorporated into two nomograms: one for mastectomy and one for lumpectomy plus breast radiation, Dr. Mamounas explained. Additional studies are planned to include treatment effects in the development and validation of the nomograms, he said.

Disclosures: Dr. Mamounas disclosed serving as a consultant for Eli Lilly & Co. and receiving honoraria from AstraZeneca and Sanofi-Aventis.

NATIONAL HARBOR, Md. – Age 50 years or older, initial clinical tumor size greater than 5 cm, and pathologic tumor response to neoadjuvant chemotherapy were significant independent predictors of locoregional failure in women who underwent neoadjuvant chemotherapy in two large breast cancer trials.

Investigators presented these results from a 10-year follow-up study of 2,961 patients in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and NSABP B-27 trials at the 2010 Breast Cancer Symposium.

Dr. Eleftherios P. Mamounas of Aultman Hospital in Canton, Ohio, and his colleagues reported the 10-year incidence of local or regional failure based on type of surgery was 12.3% in patients who had mastectomies and 10.3% in those who had lumpectomies plus chemotherapy. The incidence of local failure was 8.9% in the mastectomy group and 8.1% in the lumpectomy plus chemotherapy group. The incidence of regional failure was 3.4% and 2.2%, respectively.

In a multivariate analysis based on 318 locoregional failure events in all 2,961 patients, the overall significant predictors of locoregional failure included age 50 years or older (hazard ratio 0.79, P = .04), clinical tumor size greater than 5 cm (HR 1.52, P = .0005), and positive clinical nodal status (HR 1.64, P less than .0001). In addition, being node negative without pathologic complete response (HR 1.65, P less than .001) or node positive with pathologic complete response (HR 2.77, P less than 0.001) were significant predictors as well.

The lack of data on predictors of locoregional failure after neoadjuvant chemotherapy has raised questions about whether to use radiation therapy and when to perform sentinel node biopsies in these patients, said Dr. Mamounas.

He also presented data on locoregional failure in lumpectomy patients and mastectomy patients separately, for the purpose of developing separate treatment nomograms for each procedure. A majority of the locoregional failures in the lumpectomy patients were in-breast recurrences. In mastectomy patients, rates of chest wall recurrence were inversely correlated to pathologic nodal response, Dr. Mamounas said.

“The effect of age (in lumpectomy patients), clinical tumor size (in mastectomy patients), and clinical nodal status at locoregional failure appears to diminish with increasing pathologic response in the breast and axillary nodes,” said Dr. Mamounas.

The neoadjuvant chemotherapy regimens were one of two: doxorubicin (Adriamycin) and cyclophosphamide (AC) for four cycles, or the AC regimen for four cycles followed by four cycles of neoadjuvant/adjuvant docetaxel (Taxotere). Patients in the B-27 trial received tamoxifen in addition to their neoadjuvant chemotherapy. Lumpectomy patients were treated with radiation, but mastectomy patients were not.

The independent predictors were incorporated into two nomograms: one for mastectomy and one for lumpectomy plus breast radiation, Dr. Mamounas explained. Additional studies are planned to include treatment effects in the development and validation of the nomograms, he said.

Disclosures: Dr. Mamounas disclosed serving as a consultant for Eli Lilly & Co. and receiving honoraria from AstraZeneca and Sanofi-Aventis.

Major Finding: The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke.

Data Source: A meta-analysis of 87 studies involving 951,083 adults.

Disclosures: Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for AstraZeneca and Merck.

The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis of 87 studies in 951,083 patients.

Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues reviewed data onom 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.

The five factors in the NCEP definition are waist circumference (greater than 88 cm for women, greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women, less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.

Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.

Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease (CVD) mortality approximately doubled (relative risk, 2.40), as did the risk for CVD (RR, 2.35), stroke (RR, 2.27), and MI (1.99).

Metabolic syndrome remained significantly associated with an increased risk of CVD mortality in patients without type 2 diabetes. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113–32).

The metabolic syndrome does not require type 2 diabetes in its definition “to be closely associated with cardiovascular risk,” the researchers wrote.

The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.

Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said. Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” they said.

Major Finding: The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke.

Data Source: A meta-analysis of 87 studies involving 951,083 adults.

Disclosures: Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for AstraZeneca and Merck.

The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis of 87 studies in 951,083 patients.

Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues reviewed data onom 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.

The five factors in the NCEP definition are waist circumference (greater than 88 cm for women, greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women, less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.

Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.

Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease (CVD) mortality approximately doubled (relative risk, 2.40), as did the risk for CVD (RR, 2.35), stroke (RR, 2.27), and MI (1.99).

Metabolic syndrome remained significantly associated with an increased risk of CVD mortality in patients without type 2 diabetes. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113–32).

The metabolic syndrome does not require type 2 diabetes in its definition “to be closely associated with cardiovascular risk,” the researchers wrote.

The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.

Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said. Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” they said.

Major Finding: The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke.

Data Source: A meta-analysis of 87 studies involving 951,083 adults.

Disclosures: Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for AstraZeneca and Merck.

The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis of 87 studies in 951,083 patients.

Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues reviewed data onom 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.

The five factors in the NCEP definition are waist circumference (greater than 88 cm for women, greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women, less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.

Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.

Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease (CVD) mortality approximately doubled (relative risk, 2.40), as did the risk for CVD (RR, 2.35), stroke (RR, 2.27), and MI (1.99).

Metabolic syndrome remained significantly associated with an increased risk of CVD mortality in patients without type 2 diabetes. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113–32).

The metabolic syndrome does not require type 2 diabetes in its definition “to be closely associated with cardiovascular risk,” the researchers wrote.

The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.

Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said. Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” they said.

Ten recommendations for how best to investigate and follow patients with undifferentiated peripheral inflammatory arthritis were developed by an expert panel of nearly 700 rheumatologists from 17 countries.

Many patients who present to rheumatologists have recent-onset arthritis that doesn't meet clinical criteria, but they are concerned about their odds of developing a more serious disease, wrote Dr. Pedro Machado of the University of Coimbra (Portugal) Hospital and colleagues on behalf of the panel (Ann. Rheum. Dis. 2010 Aug. 19 [doi:10.1136/ard.2010.130625]).

To develop the recommendations, the panelists participating in the 3E (Evidence, Expertise, Exchange) Initiative created 10 clinical questions related to undifferentiated peripheral inflammatory arthritis (UPIA) and reviewed the evidence-based literature that addressed each one.

They agreed on 10 recommendations, and each participant indicated whether the recommendations would change their current clinical practices:

▸ Consider all alternatives. UPIA is a diagnosis of exclusion. All causes of arthritis — including trauma, malignancy, and metabolic problems, as well as autoimmune causes — should be ruled out. This recommendation applies only if arthritis persists, and not if it is self-limiting.

▸ Note red flags during the history and physical. Previous studies have shown that older age, female sex, and greater morning stiffness are predictors of an ultimate rheumatoid arthritis diagnosis.

▸ Perform erythrocyte sedimentation rate and C-reactive protein assessments. Do these at baseline, and repeat when clinically relevant.

▸ Test for rheumatoid factor and/or anticytoplasmic antibodies (ACPA) in patients with UPIA. But remember that negative results do not exclude eventual progression to RA.

▸ Perform baseline x-rays of affected joints. Be sure to review x-rays of affected hands, wrists, and feet when evaluating a patient for UPIA, as erosions in these areas can predict future RA. Repeat within a year of the first evaluation.

▸ MRI can be used, cautiously, to diagnose UPIA in the hands and wrists. Some evidence shows that MRI can be useful for predicting RA in UPIA patients, but the data are too limited to recommend the routine use of MRI or ultrasound imaging in these patients.

▸ Consider HLA-B27 genetic test in certain clinical settings. Although no genetic test is available that can be routinely recommended for UPIA, the HLA-B27 test might be helpful in patients with suspected spondyloarthritis.

▸ Synovial biopsy can help in the differential diagnosis in patients with monoarthritis. However, there is not enough evidence to recommend this as a routine procedure in UPIA patients.

▸ Document predictors of persistent inflammatory arthritis. Predictors include duration of 6 weeks or longer, over 30 minutes of morning stiffness, involvement of more than three joints, and evidence of radiographic erosion.

▸ Monitor disease activity as well as possible. In five studies that evaluated four different questionnaires, none stood out as fully validated for use in UPIA, but it is important to make an effort to record disease activity using a tool such as the WHO Disability Assessment Scale or the London Handicap Scale.

When the panelists were asked which recommendations were most likely to change the way they approach patients with suspected UPIA, 25% mentioned the recommendation on documenting predictors of persistent inflammatory arthritis. About 18% of the panelists said that the recommendation on MRI and ultrasound would change their practice.

The development of new criteria for RA from ACR/EULAR will likely make it harder to diagnose UPIA, because some of these patients meet the new criteria for RA, the researchers noted.

Disclosures: The study was supported by Abbott Laboratories.

View on The News

Guidelines Lack Definition

This is a very difficult area, and the authors are to be commended for the tremendous amount of work they did to try to make undifferentiated peripheral inflammatory arthritis a little clearer. They did a careful literature search and a grading system so they could be transparent about what data they had.

The question is how much the guidelines will be used. There are some problems because of the lack of data in some areas. This unavoidably led to several recommendations that were based on expert opinion rather than evidence.

Ultimately, what makes the guidelines difficult to use is that we do not end up with a definition. This document tells us how to try to define what is going on with a patient, but it doesn't say, “So this is what UPIA is.” Instead, it says a lot about what it is not. The guidelines lean strongly toward a diagnosis of RA, but it would help to have a table of tests the researchers recommend and why they recommend them.

A key point the recommendations make is to do a good history and physical, plus appropriate laboratory investigations. It is good to have that in writing.

These recommendations are a good effort, and more helpful in what not to do than what to do.

DANIEL E. FURST, M.D., is Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles. He reports having no conflicts relevant to this discussion.

Ten recommendations for how best to investigate and follow patients with undifferentiated peripheral inflammatory arthritis were developed by an expert panel of nearly 700 rheumatologists from 17 countries.

Many patients who present to rheumatologists have recent-onset arthritis that doesn't meet clinical criteria, but they are concerned about their odds of developing a more serious disease, wrote Dr. Pedro Machado of the University of Coimbra (Portugal) Hospital and colleagues on behalf of the panel (Ann. Rheum. Dis. 2010 Aug. 19 [doi:10.1136/ard.2010.130625]).

To develop the recommendations, the panelists participating in the 3E (Evidence, Expertise, Exchange) Initiative created 10 clinical questions related to undifferentiated peripheral inflammatory arthritis (UPIA) and reviewed the evidence-based literature that addressed each one.

They agreed on 10 recommendations, and each participant indicated whether the recommendations would change their current clinical practices:

▸ Consider all alternatives. UPIA is a diagnosis of exclusion. All causes of arthritis — including trauma, malignancy, and metabolic problems, as well as autoimmune causes — should be ruled out. This recommendation applies only if arthritis persists, and not if it is self-limiting.

▸ Note red flags during the history and physical. Previous studies have shown that older age, female sex, and greater morning stiffness are predictors of an ultimate rheumatoid arthritis diagnosis.

▸ Perform erythrocyte sedimentation rate and C-reactive protein assessments. Do these at baseline, and repeat when clinically relevant.

▸ Test for rheumatoid factor and/or anticytoplasmic antibodies (ACPA) in patients with UPIA. But remember that negative results do not exclude eventual progression to RA.

▸ Perform baseline x-rays of affected joints. Be sure to review x-rays of affected hands, wrists, and feet when evaluating a patient for UPIA, as erosions in these areas can predict future RA. Repeat within a year of the first evaluation.

▸ MRI can be used, cautiously, to diagnose UPIA in the hands and wrists. Some evidence shows that MRI can be useful for predicting RA in UPIA patients, but the data are too limited to recommend the routine use of MRI or ultrasound imaging in these patients.

▸ Consider HLA-B27 genetic test in certain clinical settings. Although no genetic test is available that can be routinely recommended for UPIA, the HLA-B27 test might be helpful in patients with suspected spondyloarthritis.

▸ Synovial biopsy can help in the differential diagnosis in patients with monoarthritis. However, there is not enough evidence to recommend this as a routine procedure in UPIA patients.

▸ Document predictors of persistent inflammatory arthritis. Predictors include duration of 6 weeks or longer, over 30 minutes of morning stiffness, involvement of more than three joints, and evidence of radiographic erosion.

▸ Monitor disease activity as well as possible. In five studies that evaluated four different questionnaires, none stood out as fully validated for use in UPIA, but it is important to make an effort to record disease activity using a tool such as the WHO Disability Assessment Scale or the London Handicap Scale.

When the panelists were asked which recommendations were most likely to change the way they approach patients with suspected UPIA, 25% mentioned the recommendation on documenting predictors of persistent inflammatory arthritis. About 18% of the panelists said that the recommendation on MRI and ultrasound would change their practice.

The development of new criteria for RA from ACR/EULAR will likely make it harder to diagnose UPIA, because some of these patients meet the new criteria for RA, the researchers noted.

Disclosures: The study was supported by Abbott Laboratories.

View on The News

Guidelines Lack Definition

This is a very difficult area, and the authors are to be commended for the tremendous amount of work they did to try to make undifferentiated peripheral inflammatory arthritis a little clearer. They did a careful literature search and a grading system so they could be transparent about what data they had.

The question is how much the guidelines will be used. There are some problems because of the lack of data in some areas. This unavoidably led to several recommendations that were based on expert opinion rather than evidence.

Ultimately, what makes the guidelines difficult to use is that we do not end up with a definition. This document tells us how to try to define what is going on with a patient, but it doesn't say, “So this is what UPIA is.” Instead, it says a lot about what it is not. The guidelines lean strongly toward a diagnosis of RA, but it would help to have a table of tests the researchers recommend and why they recommend them.

A key point the recommendations make is to do a good history and physical, plus appropriate laboratory investigations. It is good to have that in writing.

These recommendations are a good effort, and more helpful in what not to do than what to do.

DANIEL E. FURST, M.D., is Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles. He reports having no conflicts relevant to this discussion.

Ten recommendations for how best to investigate and follow patients with undifferentiated peripheral inflammatory arthritis were developed by an expert panel of nearly 700 rheumatologists from 17 countries.

Many patients who present to rheumatologists have recent-onset arthritis that doesn't meet clinical criteria, but they are concerned about their odds of developing a more serious disease, wrote Dr. Pedro Machado of the University of Coimbra (Portugal) Hospital and colleagues on behalf of the panel (Ann. Rheum. Dis. 2010 Aug. 19 [doi:10.1136/ard.2010.130625]).

To develop the recommendations, the panelists participating in the 3E (Evidence, Expertise, Exchange) Initiative created 10 clinical questions related to undifferentiated peripheral inflammatory arthritis (UPIA) and reviewed the evidence-based literature that addressed each one.

They agreed on 10 recommendations, and each participant indicated whether the recommendations would change their current clinical practices:

▸ Consider all alternatives. UPIA is a diagnosis of exclusion. All causes of arthritis — including trauma, malignancy, and metabolic problems, as well as autoimmune causes — should be ruled out. This recommendation applies only if arthritis persists, and not if it is self-limiting.

▸ Note red flags during the history and physical. Previous studies have shown that older age, female sex, and greater morning stiffness are predictors of an ultimate rheumatoid arthritis diagnosis.

▸ Perform erythrocyte sedimentation rate and C-reactive protein assessments. Do these at baseline, and repeat when clinically relevant.

▸ Test for rheumatoid factor and/or anticytoplasmic antibodies (ACPA) in patients with UPIA. But remember that negative results do not exclude eventual progression to RA.

▸ Perform baseline x-rays of affected joints. Be sure to review x-rays of affected hands, wrists, and feet when evaluating a patient for UPIA, as erosions in these areas can predict future RA. Repeat within a year of the first evaluation.

▸ MRI can be used, cautiously, to diagnose UPIA in the hands and wrists. Some evidence shows that MRI can be useful for predicting RA in UPIA patients, but the data are too limited to recommend the routine use of MRI or ultrasound imaging in these patients.

▸ Consider HLA-B27 genetic test in certain clinical settings. Although no genetic test is available that can be routinely recommended for UPIA, the HLA-B27 test might be helpful in patients with suspected spondyloarthritis.

▸ Synovial biopsy can help in the differential diagnosis in patients with monoarthritis. However, there is not enough evidence to recommend this as a routine procedure in UPIA patients.

▸ Document predictors of persistent inflammatory arthritis. Predictors include duration of 6 weeks or longer, over 30 minutes of morning stiffness, involvement of more than three joints, and evidence of radiographic erosion.

▸ Monitor disease activity as well as possible. In five studies that evaluated four different questionnaires, none stood out as fully validated for use in UPIA, but it is important to make an effort to record disease activity using a tool such as the WHO Disability Assessment Scale or the London Handicap Scale.

When the panelists were asked which recommendations were most likely to change the way they approach patients with suspected UPIA, 25% mentioned the recommendation on documenting predictors of persistent inflammatory arthritis. About 18% of the panelists said that the recommendation on MRI and ultrasound would change their practice.

The development of new criteria for RA from ACR/EULAR will likely make it harder to diagnose UPIA, because some of these patients meet the new criteria for RA, the researchers noted.

Disclosures: The study was supported by Abbott Laboratories.

View on The News

Guidelines Lack Definition

This is a very difficult area, and the authors are to be commended for the tremendous amount of work they did to try to make undifferentiated peripheral inflammatory arthritis a little clearer. They did a careful literature search and a grading system so they could be transparent about what data they had.

The question is how much the guidelines will be used. There are some problems because of the lack of data in some areas. This unavoidably led to several recommendations that were based on expert opinion rather than evidence.

Ultimately, what makes the guidelines difficult to use is that we do not end up with a definition. This document tells us how to try to define what is going on with a patient, but it doesn't say, “So this is what UPIA is.” Instead, it says a lot about what it is not. The guidelines lean strongly toward a diagnosis of RA, but it would help to have a table of tests the researchers recommend and why they recommend them.

A key point the recommendations make is to do a good history and physical, plus appropriate laboratory investigations. It is good to have that in writing.

These recommendations are a good effort, and more helpful in what not to do than what to do.

DANIEL E. FURST, M.D., is Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles. He reports having no conflicts relevant to this discussion.

CRYSTAL CITY, VA. — The combination of smoking and an active lifestyle was associated with significantly worse lung function than was the combination of nonsmoking and a sedentary lifestyle in blacks, on the basis of data from more than 3,000 participants in the Jackson Heart Study.

Previous studies have shown that the poor lung function associated with a sedentary lifestyle can significantly predict cardiovascular problems, said Brenda Campbell Jenkins, Ph.D., and her colleagues at Jackson (Miss.) State University. Additional research suggests that blacks might be especially vulnerable to lung damage from smoking, they noted.

But no study has examined the combined effects of smoking and sedentary lifestyle and their effects on lung function, Dr. Campbell Jenkins said in an interview.

“We know that among African Americans there is a low prevalence of smoking and a high prevalence of sedentary lifestyle,” she said.

In this study, the researchers examined the joint effect of smoking and sedentary lifestyle on heart health in blacks, using data from the Jackson Heart Study, a population-based observational study including black adults aged 21–94 years living in the area of Jackson, Miss.

The researchers measured pulmonary function using forced vital capacity (FVC) and forced expiratory volume per second (FEV₁). The study findings were presented in a poster at the meeting.

The participants were divided into four groups: nonsmoking nonsedentary, nonsmoking sedentary, smoking nonsedentary, and smoking sedentary. Sedentary lifestyle was defined as the lowest quartile of physical activity.

The mean percentages of predicted FEV₁ values in women in the nonsmoking nonsedentary, nonsmoking sedentary, smoking nonsedentary, and smoking sedentary groups were 95%, 94%, 89%, and 85%. The differences between women in the nonsmoking sedentary and in the smoking nonsedentary groups were significant after controlling for multiple variables.

The mean percentages of predicted FVC values in women in the nonsmoking nonsedentary, nonsmoking sedentary, smoking nonsedentary, and smoking sedentary groups was 94%, 92%, 89%, and 88%, respectively.

The differences between women in the nonsmoking sedentary and in the smoking nonsedentary groups were significant after adjustment for multiple variables.

For men, the mean percentages of predicted FEV₁ values in the four groups were 93%, 89%, 88%, 76%, respectively, but these differences were not significant. In addition, the mean percentages of predicted FVC values in each group were 91%, 88%, 91%, and 80%, respectively, and these differences were not significant.

However, after controlling for multiple variables, the mean FEV₁ to FVC ratio was significantly higher among men in the nonsmoking sedentary group, compared with the smoking nonsedentary group (78.8 vs. 77.5).

Based on these findings, smoking and sedentary lifestyle were both negatively associated with lung function, but smoking tended to have more harmful effects, which was consistent with the literature, noted Dr. Sarpong, director, co—principal investigator, and senior biostatistician of the Jackson Heart Study.

However, more research is needed to determine the clinical implications of the findings.

Study participants were enrolled during 2000–2004. The current study included 1,191 men and 2,065 women aged 21–93 years (average, 54 years). Participants with prevalent cardiovascular disease, asthma, and incomplete measures of smoking or lung function were excluded.

The researchers had no financial conflicts to disclose. The study was supported by grants from the National Heart, Lung, and Blood Institute and the National Center for Minority Health and Health Disparities.

CRYSTAL CITY, VA. — The combination of smoking and an active lifestyle was associated with significantly worse lung function than was the combination of nonsmoking and a sedentary lifestyle in blacks, on the basis of data from more than 3,000 participants in the Jackson Heart Study.

Previous studies have shown that the poor lung function associated with a sedentary lifestyle can significantly predict cardiovascular problems, said Brenda Campbell Jenkins, Ph.D., and her colleagues at Jackson (Miss.) State University. Additional research suggests that blacks might be especially vulnerable to lung damage from smoking, they noted.

But no study has examined the combined effects of smoking and sedentary lifestyle and their effects on lung function, Dr. Campbell Jenkins said in an interview.

“We know that among African Americans there is a low prevalence of smoking and a high prevalence of sedentary lifestyle,” she said.

In this study, the researchers examined the joint effect of smoking and sedentary lifestyle on heart health in blacks, using data from the Jackson Heart Study, a population-based observational study including black adults aged 21–94 years living in the area of Jackson, Miss.

The researchers measured pulmonary function using forced vital capacity (FVC) and forced expiratory volume per second (FEV₁). The study findings were presented in a poster at the meeting.

The participants were divided into four groups: nonsmoking nonsedentary, nonsmoking sedentary, smoking nonsedentary, and smoking sedentary. Sedentary lifestyle was defined as the lowest quartile of physical activity.

The mean percentages of predicted FEV₁ values in women in the nonsmoking nonsedentary, nonsmoking sedentary, smoking nonsedentary, and smoking sedentary groups were 95%, 94%, 89%, and 85%. The differences between women in the nonsmoking sedentary and in the smoking nonsedentary groups were significant after controlling for multiple variables.

The mean percentages of predicted FVC values in women in the nonsmoking nonsedentary, nonsmoking sedentary, smoking nonsedentary, and smoking sedentary groups was 94%, 92%, 89%, and 88%, respectively.

The differences between women in the nonsmoking sedentary and in the smoking nonsedentary groups were significant after adjustment for multiple variables.

For men, the mean percentages of predicted FEV₁ values in the four groups were 93%, 89%, 88%, 76%, respectively, but these differences were not significant. In addition, the mean percentages of predicted FVC values in each group were 91%, 88%, 91%, and 80%, respectively, and these differences were not significant.

However, after controlling for multiple variables, the mean FEV₁ to FVC ratio was significantly higher among men in the nonsmoking sedentary group, compared with the smoking nonsedentary group (78.8 vs. 77.5).

Based on these findings, smoking and sedentary lifestyle were both negatively associated with lung function, but smoking tended to have more harmful effects, which was consistent with the literature, noted Dr. Sarpong, director, co—principal investigator, and senior biostatistician of the Jackson Heart Study.

However, more research is needed to determine the clinical implications of the findings.

Study participants were enrolled during 2000–2004. The current study included 1,191 men and 2,065 women aged 21–93 years (average, 54 years). Participants with prevalent cardiovascular disease, asthma, and incomplete measures of smoking or lung function were excluded.

The researchers had no financial conflicts to disclose. The study was supported by grants from the National Heart, Lung, and Blood Institute and the National Center for Minority Health and Health Disparities.

CRYSTAL CITY, VA. — The combination of smoking and an active lifestyle was associated with significantly worse lung function than was the combination of nonsmoking and a sedentary lifestyle in blacks, on the basis of data from more than 3,000 participants in the Jackson Heart Study.

Previous studies have shown that the poor lung function associated with a sedentary lifestyle can significantly predict cardiovascular problems, said Brenda Campbell Jenkins, Ph.D., and her colleagues at Jackson (Miss.) State University. Additional research suggests that blacks might be especially vulnerable to lung damage from smoking, they noted.

But no study has examined the combined effects of smoking and sedentary lifestyle and their effects on lung function, Dr. Campbell Jenkins said in an interview.

“We know that among African Americans there is a low prevalence of smoking and a high prevalence of sedentary lifestyle,” she said.

In this study, the researchers examined the joint effect of smoking and sedentary lifestyle on heart health in blacks, using data from the Jackson Heart Study, a population-based observational study including black adults aged 21–94 years living in the area of Jackson, Miss.

The researchers measured pulmonary function using forced vital capacity (FVC) and forced expiratory volume per second (FEV₁). The study findings were presented in a poster at the meeting.

The participants were divided into four groups: nonsmoking nonsedentary, nonsmoking sedentary, smoking nonsedentary, and smoking sedentary. Sedentary lifestyle was defined as the lowest quartile of physical activity.

The mean percentages of predicted FEV₁ values in women in the nonsmoking nonsedentary, nonsmoking sedentary, smoking nonsedentary, and smoking sedentary groups were 95%, 94%, 89%, and 85%. The differences between women in the nonsmoking sedentary and in the smoking nonsedentary groups were significant after controlling for multiple variables.

The mean percentages of predicted FVC values in women in the nonsmoking nonsedentary, nonsmoking sedentary, smoking nonsedentary, and smoking sedentary groups was 94%, 92%, 89%, and 88%, respectively.

The differences between women in the nonsmoking sedentary and in the smoking nonsedentary groups were significant after adjustment for multiple variables.

For men, the mean percentages of predicted FEV₁ values in the four groups were 93%, 89%, 88%, 76%, respectively, but these differences were not significant. In addition, the mean percentages of predicted FVC values in each group were 91%, 88%, 91%, and 80%, respectively, and these differences were not significant.

However, after controlling for multiple variables, the mean FEV₁ to FVC ratio was significantly higher among men in the nonsmoking sedentary group, compared with the smoking nonsedentary group (78.8 vs. 77.5).

Based on these findings, smoking and sedentary lifestyle were both negatively associated with lung function, but smoking tended to have more harmful effects, which was consistent with the literature, noted Dr. Sarpong, director, co—principal investigator, and senior biostatistician of the Jackson Heart Study.

However, more research is needed to determine the clinical implications of the findings.

Study participants were enrolled during 2000–2004. The current study included 1,191 men and 2,065 women aged 21–93 years (average, 54 years). Participants with prevalent cardiovascular disease, asthma, and incomplete measures of smoking or lung function were excluded.

The researchers had no financial conflicts to disclose. The study was supported by grants from the National Heart, Lung, and Blood Institute and the National Center for Minority Health and Health Disparities.

Memantine might improve behavioral symptoms and reduce brain deterioration in patients with mild to moderate Lewy body dementia, but not Parkinson's disease dementia, data from a randomized, placebo-controlled trial show.

The higher amount of Alzheimer's disease–like amyloid pathology that is normally observed in patients with dementia with Lewy bodies (DLB) might explain why the drug appears to provide symptomatic relief to that group but not to patients with Parkinson's disease dementia (PDD), in whom amyloid pathology is encountered less often, Dr. Murat Emre of Istanbul (Turkey) University and his colleagues reported online.

Dr. Emre and his coauthors conducted the study of memantine, which is approved in the United States for treating moderate to severe Alzheimer's disease, because previous studies had suggested that the drug might yield similar benefits in patients with Lewy body–related dementias such as PDD or DLB, which have some overlap in pathology.

The researchers randomized 78 patients with DLB and 121 patients with PDD to a 20-mg dose of memantine once daily or a placebo. Concomitant use of cholinesterase inhibitors was not allowed (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70194-0]).

Patients were assessed when they were screened, at baseline, and at weeks 4, 12, 16, and 24. The study included patients from 30 sites in Austria, France, Germany, Greece, Italy, Spain, Turkey, and the United Kingdom.

In DLB patients, memantine significantly improved scores on the ADCS-CGIC (Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change) scale from baseline to 24 weeks, compared with placebo (mean change from baseline, 3.3 vs. 3.9, respectively). In addition, NPI (Neuropsychiatry Inventory) scores improved significantly more from baseline to 24 weeks in memantine-treated patients than in placebo-treated patients.

Among PDD patients, memantine did not significantly change scores with either measurement, compared with placebo. “Memantine might exert stronger beneficial effects in patients with more prominent Alzheimer's disease–type pathology,” the investigators wrote. The differences in effects between DLB and PDD patients also could be accounted for by the range in symptoms and in concomitant drug use between these two patient populations, they added.

Disclosures: The study was funded by Lundbeck, a maker and distributor of memantine. Dr. Emre and some of his coauthors disclosed financial relationships with Lundbeck and other pharmaceutical companies. One author is an employee of Lundbeck.

View on the News

Hopeful Results

The study by Dr. Emre raises the possibility that memantine could improve global function by improving mood symptoms.

More research is needed, but memantine could be part of a plan to manage DLB and PDD symptoms until definitive cognitive therapies are developed.

LAURA MARSH, M.D., is from Baylor College of Medicine in Houston. Her comments are paraphrased from an editorial (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70208-8]). Dr. Marsh has received funding from Forest Research Institute to study the effects of memantine on the treatment of dementia in Parkinson's ddisease.

Vitals

Memantine might improve behavioral symptoms and reduce brain deterioration in patients with mild to moderate Lewy body dementia, but not Parkinson's disease dementia, data from a randomized, placebo-controlled trial show.

The higher amount of Alzheimer's disease–like amyloid pathology that is normally observed in patients with dementia with Lewy bodies (DLB) might explain why the drug appears to provide symptomatic relief to that group but not to patients with Parkinson's disease dementia (PDD), in whom amyloid pathology is encountered less often, Dr. Murat Emre of Istanbul (Turkey) University and his colleagues reported online.

Dr. Emre and his coauthors conducted the study of memantine, which is approved in the United States for treating moderate to severe Alzheimer's disease, because previous studies had suggested that the drug might yield similar benefits in patients with Lewy body–related dementias such as PDD or DLB, which have some overlap in pathology.

The researchers randomized 78 patients with DLB and 121 patients with PDD to a 20-mg dose of memantine once daily or a placebo. Concomitant use of cholinesterase inhibitors was not allowed (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70194-0]).

Patients were assessed when they were screened, at baseline, and at weeks 4, 12, 16, and 24. The study included patients from 30 sites in Austria, France, Germany, Greece, Italy, Spain, Turkey, and the United Kingdom.

In DLB patients, memantine significantly improved scores on the ADCS-CGIC (Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change) scale from baseline to 24 weeks, compared with placebo (mean change from baseline, 3.3 vs. 3.9, respectively). In addition, NPI (Neuropsychiatry Inventory) scores improved significantly more from baseline to 24 weeks in memantine-treated patients than in placebo-treated patients.

Among PDD patients, memantine did not significantly change scores with either measurement, compared with placebo. “Memantine might exert stronger beneficial effects in patients with more prominent Alzheimer's disease–type pathology,” the investigators wrote. The differences in effects between DLB and PDD patients also could be accounted for by the range in symptoms and in concomitant drug use between these two patient populations, they added.

Disclosures: The study was funded by Lundbeck, a maker and distributor of memantine. Dr. Emre and some of his coauthors disclosed financial relationships with Lundbeck and other pharmaceutical companies. One author is an employee of Lundbeck.

View on the News

Hopeful Results

The study by Dr. Emre raises the possibility that memantine could improve global function by improving mood symptoms.

More research is needed, but memantine could be part of a plan to manage DLB and PDD symptoms until definitive cognitive therapies are developed.

LAURA MARSH, M.D., is from Baylor College of Medicine in Houston. Her comments are paraphrased from an editorial (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70208-8]). Dr. Marsh has received funding from Forest Research Institute to study the effects of memantine on the treatment of dementia in Parkinson's ddisease.

Vitals

Memantine might improve behavioral symptoms and reduce brain deterioration in patients with mild to moderate Lewy body dementia, but not Parkinson's disease dementia, data from a randomized, placebo-controlled trial show.

The higher amount of Alzheimer's disease–like amyloid pathology that is normally observed in patients with dementia with Lewy bodies (DLB) might explain why the drug appears to provide symptomatic relief to that group but not to patients with Parkinson's disease dementia (PDD), in whom amyloid pathology is encountered less often, Dr. Murat Emre of Istanbul (Turkey) University and his colleagues reported online.

Dr. Emre and his coauthors conducted the study of memantine, which is approved in the United States for treating moderate to severe Alzheimer's disease, because previous studies had suggested that the drug might yield similar benefits in patients with Lewy body–related dementias such as PDD or DLB, which have some overlap in pathology.

The researchers randomized 78 patients with DLB and 121 patients with PDD to a 20-mg dose of memantine once daily or a placebo. Concomitant use of cholinesterase inhibitors was not allowed (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70194-0]).

Patients were assessed when they were screened, at baseline, and at weeks 4, 12, 16, and 24. The study included patients from 30 sites in Austria, France, Germany, Greece, Italy, Spain, Turkey, and the United Kingdom.

In DLB patients, memantine significantly improved scores on the ADCS-CGIC (Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change) scale from baseline to 24 weeks, compared with placebo (mean change from baseline, 3.3 vs. 3.9, respectively). In addition, NPI (Neuropsychiatry Inventory) scores improved significantly more from baseline to 24 weeks in memantine-treated patients than in placebo-treated patients.

Among PDD patients, memantine did not significantly change scores with either measurement, compared with placebo. “Memantine might exert stronger beneficial effects in patients with more prominent Alzheimer's disease–type pathology,” the investigators wrote. The differences in effects between DLB and PDD patients also could be accounted for by the range in symptoms and in concomitant drug use between these two patient populations, they added.

Disclosures: The study was funded by Lundbeck, a maker and distributor of memantine. Dr. Emre and some of his coauthors disclosed financial relationships with Lundbeck and other pharmaceutical companies. One author is an employee of Lundbeck.

View on the News

Hopeful Results

The study by Dr. Emre raises the possibility that memantine could improve global function by improving mood symptoms.

More research is needed, but memantine could be part of a plan to manage DLB and PDD symptoms until definitive cognitive therapies are developed.

LAURA MARSH, M.D., is from Baylor College of Medicine in Houston. Her comments are paraphrased from an editorial (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70208-8]). Dr. Marsh has received funding from Forest Research Institute to study the effects of memantine on the treatment of dementia in Parkinson's ddisease.

Vitals

Only one in four women diagnosed with breast cancer in the 1940s was alive 10 years later, compared with three of four women diagnosed in recent years, based on data gathered over a 6-decade period at a single institution.

Overall, the 10-year survival rate for all types of breast cancer improved significantly over 60 years, from 25% between 1944 and 1954, to 77% between 1995 and 2004. This improvement is because of earlier disease detection and a multimodal approach to managing and treating patients with different stages of breast cancer, Dr. Aman Buzdar, the study’s lead author, reported Sept. 29.

The goal of the study was to quantify the steady improvements in breast cancer survival rates over the past 6 decades in patients seen at the MD Anderson Cancer Center in Houston. Dr. Buzdar said he believes that the survival rates seen at MD Anderson are generalizable to survival rates at smaller regional hospitals and community cancer centers, given the rapid adoption of the multimodal treatment model and new therapies.

“If patients are appropriately managed, they have a much better chance of surviving breast cancer today than they would have had 30 or 20 or even 10 years ago, because the therapies are constantly evolving and improving,” Dr. Buzdar, professor of medicine and breast medical oncology at the center, said in a written statement. Therefore, if the approaches used at MD Anderson are applied in the community, similar outcomes can be achieved, he said during a press briefing sponsored by the American Society of Clinical Oncology.

Dr. Buzdar and his colleagues reviewed the center’s detailed database on breast cancer patients dating back to the 1940s. The database included approximately 57,000 breast cancer patients seen between 1944 and 2004. The review included 12,809 patients who had their diagnoses established and treatments initiated at MD Anderson.

Ten-year survival rates improved significantly from the 1944-1954 period to the 1995-2004 period: For local breast cancer, the rates rose from 55% to 86% and for regional breast cancer they increased from 16% to 76%. The survival rate for metastatic disease improved from 3% to 22%.

Disclosures: Dr. Buzdar said he had no financial conflicts to disclose.

Only one in four women diagnosed with breast cancer in the 1940s was alive 10 years later, compared with three of four women diagnosed in recent years, based on data gathered over a 6-decade period at a single institution.

Overall, the 10-year survival rate for all types of breast cancer improved significantly over 60 years, from 25% between 1944 and 1954, to 77% between 1995 and 2004. This improvement is because of earlier disease detection and a multimodal approach to managing and treating patients with different stages of breast cancer, Dr. Aman Buzdar, the study’s lead author, reported Sept. 29.

The goal of the study was to quantify the steady improvements in breast cancer survival rates over the past 6 decades in patients seen at the MD Anderson Cancer Center in Houston. Dr. Buzdar said he believes that the survival rates seen at MD Anderson are generalizable to survival rates at smaller regional hospitals and community cancer centers, given the rapid adoption of the multimodal treatment model and new therapies.

“If patients are appropriately managed, they have a much better chance of surviving breast cancer today than they would have had 30 or 20 or even 10 years ago, because the therapies are constantly evolving and improving,” Dr. Buzdar, professor of medicine and breast medical oncology at the center, said in a written statement. Therefore, if the approaches used at MD Anderson are applied in the community, similar outcomes can be achieved, he said during a press briefing sponsored by the American Society of Clinical Oncology.

Dr. Buzdar and his colleagues reviewed the center’s detailed database on breast cancer patients dating back to the 1940s. The database included approximately 57,000 breast cancer patients seen between 1944 and 2004. The review included 12,809 patients who had their diagnoses established and treatments initiated at MD Anderson.

Ten-year survival rates improved significantly from the 1944-1954 period to the 1995-2004 period: For local breast cancer, the rates rose from 55% to 86% and for regional breast cancer they increased from 16% to 76%. The survival rate for metastatic disease improved from 3% to 22%.

Disclosures: Dr. Buzdar said he had no financial conflicts to disclose.

Only one in four women diagnosed with breast cancer in the 1940s was alive 10 years later, compared with three of four women diagnosed in recent years, based on data gathered over a 6-decade period at a single institution.

Overall, the 10-year survival rate for all types of breast cancer improved significantly over 60 years, from 25% between 1944 and 1954, to 77% between 1995 and 2004. This improvement is because of earlier disease detection and a multimodal approach to managing and treating patients with different stages of breast cancer, Dr. Aman Buzdar, the study’s lead author, reported Sept. 29.

The goal of the study was to quantify the steady improvements in breast cancer survival rates over the past 6 decades in patients seen at the MD Anderson Cancer Center in Houston. Dr. Buzdar said he believes that the survival rates seen at MD Anderson are generalizable to survival rates at smaller regional hospitals and community cancer centers, given the rapid adoption of the multimodal treatment model and new therapies.

“If patients are appropriately managed, they have a much better chance of surviving breast cancer today than they would have had 30 or 20 or even 10 years ago, because the therapies are constantly evolving and improving,” Dr. Buzdar, professor of medicine and breast medical oncology at the center, said in a written statement. Therefore, if the approaches used at MD Anderson are applied in the community, similar outcomes can be achieved, he said during a press briefing sponsored by the American Society of Clinical Oncology.

Dr. Buzdar and his colleagues reviewed the center’s detailed database on breast cancer patients dating back to the 1940s. The database included approximately 57,000 breast cancer patients seen between 1944 and 2004. The review included 12,809 patients who had their diagnoses established and treatments initiated at MD Anderson.

Ten-year survival rates improved significantly from the 1944-1954 period to the 1995-2004 period: For local breast cancer, the rates rose from 55% to 86% and for regional breast cancer they increased from 16% to 76%. The survival rate for metastatic disease improved from 3% to 22%.

Disclosures: Dr. Buzdar said he had no financial conflicts to disclose.

A uterus-sparing therapy that combines delivery of progesterone via an intrauterine device with injections of gonadotropin-releasing hormone appears to have preserved fertility in a majority of women treated for early endometrial cancer in a small prospective study.

Data on 34 patients younger than 43 years were published online Sept. 28 in the Annals of Oncology.

Previous studies had examined oral progestins as fertility-preserving therapies for younger women with atypical endometrial hyperplasia (AEH) and endometrial cancer, but neither the dose nor the schedule were standardized, said Dr. Lucas Minig of Hospital Universitario Madrid Norte Sanchinarro in Madrid, Spain, and coauthors.

In this study, Dr. Minig and colleagues tested the combination of a levonorgestrel-release intrauterine device (Mirena) and a gonadotropin-releasing hormone (GnRH) analog as a fertility-preserving treatment for AEH and well-differentiated endometrial cancer (EC-G1). “The progesterone-releasing intrauterine device (IUD) is a newly available delivery system for treatment of estrogen-dependent endometrial cancer,” the researchers said.

A total of 43 patients were selected between January 1996 and June 2009. Three patients dropped out, and five remain under treatment, leaving 20 women with AEH and 14 with EC-G1 in the current analysis. They received 20 mcg of levonorgestrel released daily by the IUD for up to 5 years and monthly depot injections of 3.75 mg of the GnRH for 6 months. The IUDs were removed after 1 year.

After 1 year of treatment, the complete response rate was 95% in the AEH patients and 57% in the EC-G1 patients, with 19 of 20 patients and 8 of 14 patients, respectively, responding in each group. Disease progression was noted in one AEH patient (5%) and four EC-G1 patients (28%).

Recurrence of disease occurred in 4 AEH patients and 2 EC-GI patients after an average of 36 months. They were staged surgically and received adjuvant chemotherapy and/or radiation. With the exception of one patient lost to follow-up, all were alive and disease free at last follow-up.

The researchers noted no major side effects or complications caused by the IUD-delivered hormonal treatment.

Of the 27 patients who had a complete response, 9 achieved 11 spontaneous pregnancies after their IUDs were removed. Seven of these had reached full term at the time of the report, and two ended in miscarriages.

The average age of the women was 34 years, and the median follow-up time was 29 months. Prior to the study, five women (14%) were diagnosed with concomitant early-stage ovarian cancer, but none of these patients underwent adjuvant chemotherapy, and two of them had full-term pregnancies (Ann. Onc. 2010 Sept. 28 [doi:10.1093/annonc/mdq463]).

The study was limited by its small size, but the trial is the first known to test the combination of IUD and GnRH in women with endometrial cancer who want to preserve fertility, the researchers noted. Longer follow-up data are needed to reinforce the findings, but the results suggest that the treatment can be effective in some patients. However, “given the risks of disease progression or relapse, only those patients with significant expected benefit from uterine retention should be considered and then only following an adequate pretreatment evaluation,” the researchers said.

Disclosures: The researchers said they had no financial conflicts to disclose.

A uterus-sparing therapy that combines delivery of progesterone via an intrauterine device with injections of gonadotropin-releasing hormone appears to have preserved fertility in a majority of women treated for early endometrial cancer in a small prospective study.

Data on 34 patients younger than 43 years were published online Sept. 28 in the Annals of Oncology.

Previous studies had examined oral progestins as fertility-preserving therapies for younger women with atypical endometrial hyperplasia (AEH) and endometrial cancer, but neither the dose nor the schedule were standardized, said Dr. Lucas Minig of Hospital Universitario Madrid Norte Sanchinarro in Madrid, Spain, and coauthors.

In this study, Dr. Minig and colleagues tested the combination of a levonorgestrel-release intrauterine device (Mirena) and a gonadotropin-releasing hormone (GnRH) analog as a fertility-preserving treatment for AEH and well-differentiated endometrial cancer (EC-G1). “The progesterone-releasing intrauterine device (IUD) is a newly available delivery system for treatment of estrogen-dependent endometrial cancer,” the researchers said.

A total of 43 patients were selected between January 1996 and June 2009. Three patients dropped out, and five remain under treatment, leaving 20 women with AEH and 14 with EC-G1 in the current analysis. They received 20 mcg of levonorgestrel released daily by the IUD for up to 5 years and monthly depot injections of 3.75 mg of the GnRH for 6 months. The IUDs were removed after 1 year.

After 1 year of treatment, the complete response rate was 95% in the AEH patients and 57% in the EC-G1 patients, with 19 of 20 patients and 8 of 14 patients, respectively, responding in each group. Disease progression was noted in one AEH patient (5%) and four EC-G1 patients (28%).

Recurrence of disease occurred in 4 AEH patients and 2 EC-GI patients after an average of 36 months. They were staged surgically and received adjuvant chemotherapy and/or radiation. With the exception of one patient lost to follow-up, all were alive and disease free at last follow-up.

The researchers noted no major side effects or complications caused by the IUD-delivered hormonal treatment.

Of the 27 patients who had a complete response, 9 achieved 11 spontaneous pregnancies after their IUDs were removed. Seven of these had reached full term at the time of the report, and two ended in miscarriages.

The average age of the women was 34 years, and the median follow-up time was 29 months. Prior to the study, five women (14%) were diagnosed with concomitant early-stage ovarian cancer, but none of these patients underwent adjuvant chemotherapy, and two of them had full-term pregnancies (Ann. Onc. 2010 Sept. 28 [doi:10.1093/annonc/mdq463]).

The study was limited by its small size, but the trial is the first known to test the combination of IUD and GnRH in women with endometrial cancer who want to preserve fertility, the researchers noted. Longer follow-up data are needed to reinforce the findings, but the results suggest that the treatment can be effective in some patients. However, “given the risks of disease progression or relapse, only those patients with significant expected benefit from uterine retention should be considered and then only following an adequate pretreatment evaluation,” the researchers said.

Disclosures: The researchers said they had no financial conflicts to disclose.

A uterus-sparing therapy that combines delivery of progesterone via an intrauterine device with injections of gonadotropin-releasing hormone appears to have preserved fertility in a majority of women treated for early endometrial cancer in a small prospective study.

Data on 34 patients younger than 43 years were published online Sept. 28 in the Annals of Oncology.

Previous studies had examined oral progestins as fertility-preserving therapies for younger women with atypical endometrial hyperplasia (AEH) and endometrial cancer, but neither the dose nor the schedule were standardized, said Dr. Lucas Minig of Hospital Universitario Madrid Norte Sanchinarro in Madrid, Spain, and coauthors.

In this study, Dr. Minig and colleagues tested the combination of a levonorgestrel-release intrauterine device (Mirena) and a gonadotropin-releasing hormone (GnRH) analog as a fertility-preserving treatment for AEH and well-differentiated endometrial cancer (EC-G1). “The progesterone-releasing intrauterine device (IUD) is a newly available delivery system for treatment of estrogen-dependent endometrial cancer,” the researchers said.

A total of 43 patients were selected between January 1996 and June 2009. Three patients dropped out, and five remain under treatment, leaving 20 women with AEH and 14 with EC-G1 in the current analysis. They received 20 mcg of levonorgestrel released daily by the IUD for up to 5 years and monthly depot injections of 3.75 mg of the GnRH for 6 months. The IUDs were removed after 1 year.

After 1 year of treatment, the complete response rate was 95% in the AEH patients and 57% in the EC-G1 patients, with 19 of 20 patients and 8 of 14 patients, respectively, responding in each group. Disease progression was noted in one AEH patient (5%) and four EC-G1 patients (28%).

Recurrence of disease occurred in 4 AEH patients and 2 EC-GI patients after an average of 36 months. They were staged surgically and received adjuvant chemotherapy and/or radiation. With the exception of one patient lost to follow-up, all were alive and disease free at last follow-up.

The researchers noted no major side effects or complications caused by the IUD-delivered hormonal treatment.

Of the 27 patients who had a complete response, 9 achieved 11 spontaneous pregnancies after their IUDs were removed. Seven of these had reached full term at the time of the report, and two ended in miscarriages.

The average age of the women was 34 years, and the median follow-up time was 29 months. Prior to the study, five women (14%) were diagnosed with concomitant early-stage ovarian cancer, but none of these patients underwent adjuvant chemotherapy, and two of them had full-term pregnancies (Ann. Onc. 2010 Sept. 28 [doi:10.1093/annonc/mdq463]).

The study was limited by its small size, but the trial is the first known to test the combination of IUD and GnRH in women with endometrial cancer who want to preserve fertility, the researchers noted. Longer follow-up data are needed to reinforce the findings, but the results suggest that the treatment can be effective in some patients. However, “given the risks of disease progression or relapse, only those patients with significant expected benefit from uterine retention should be considered and then only following an adequate pretreatment evaluation,” the researchers said.

Disclosures: The researchers said they had no financial conflicts to disclose.

Patients with systemic sclerosis have about a 55% chance of dying from their disease. Specifically, more than half of systemic sclerosis deaths are caused by pulmonary fibrosis, pulmonary arterial hypertension, and heart-related problems that are attributable to the disease, according to an analysis of data from an international registry.

The findings were published in the October issue of the Annals of the Rheumatic Diseases.

The overall mortality from systemic sclerosis (SSc) remains high, wrote Dr. Anthony J. Tyndall of the department of rheumatology at the University of Basel (Switzerland) and colleagues. To identify the causes and predictors of death in SSc patients, the researchers reviewed data from 5,860 adults who were enrolled in the EULAR Scleroderma Trial and Research Database (EUSTAR) database between 2004 and 2008. In all, 284 deaths were reported during the study period. Complete data were available for 234 deaths via questionnaires completed by the medical centers that reported a death in an SSc patient (Ann. Rheum. Dis. 2010;69:1809-15).

More than half (55%) of the deaths were directly attributable to SSc. Another 41% of deaths were not related to SSc, and the cause of death was not known in the remaining 4%.

Pulmonary fibrosis was the most common cause of death in SSc deaths (19%), followed by pulmonary arterial hypertension (14%) and myocardial causes (14%). Most myocardial causes were attributed to arrhythmia. Another 4% of SSc deaths were caused by renal crises.

These findings contrast with data from other autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis, in which clinically overt myocardial infarctions are more common causes of death, the researchers noted.

The main causes of death that were not related to SSc were infections (33%), malignancies (31%), and cardiovascular causes (29%). However, 25% of the patients who died of non-SSc causes had SSc-related comorbidities that likely contributed to their deaths, the researchers noted. These comorbidities included pneumonia, sepsis, and gastrointestinal hemorrhage. If these cases were added to the deaths directly caused by SSc, “the disease-related death toll would be as high as 65%,” the researchers said.

The average age of patients entering the study was 57 years, and 80% were women.

After control for multiple variables, the independent predictors of death in SSc patients included proteinuria, pulmonary arterial hypertension (PAH), forced vital capacity (FVC) less than 80% of normal, shortness of breath on exertion, reduced diffusing capacity of the lung for carbon monoxide (DLCO), and older age at onset of SSc (defined by the first signs of Raynaud’s phenomenon and modified Rodnan skin scores).

Sex was not an independent predictor of death in this study, but the researchers said that the effect of sex can be accounted for by the other variables.

The study was limited by possible biases in the coding of death certificates, but the findings support data from previous studies showing PAH and pulmonary restriction as independent risk factors for mortality in SSc patients, the researchers noted.

“The EUSTAR figures presented here are useful in estimating the number of patients that need to be included in clinical trials that investigate survival as an end point,” they said.

The researchers had no financial conflicts to disclose. EUSTAR exists under the auspices of the EULAR Standing Committee for Clinical Affairs and is funded by a research grant from EULAR.

Patients with systemic sclerosis have about a 55% chance of dying from their disease. Specifically, more than half of systemic sclerosis deaths are caused by pulmonary fibrosis, pulmonary arterial hypertension, and heart-related problems that are attributable to the disease, according to an analysis of data from an international registry.

The findings were published in the October issue of the Annals of the Rheumatic Diseases.

The overall mortality from systemic sclerosis (SSc) remains high, wrote Dr. Anthony J. Tyndall of the department of rheumatology at the University of Basel (Switzerland) and colleagues. To identify the causes and predictors of death in SSc patients, the researchers reviewed data from 5,860 adults who were enrolled in the EULAR Scleroderma Trial and Research Database (EUSTAR) database between 2004 and 2008. In all, 284 deaths were reported during the study period. Complete data were available for 234 deaths via questionnaires completed by the medical centers that reported a death in an SSc patient (Ann. Rheum. Dis. 2010;69:1809-15).

More than half (55%) of the deaths were directly attributable to SSc. Another 41% of deaths were not related to SSc, and the cause of death was not known in the remaining 4%.

Pulmonary fibrosis was the most common cause of death in SSc deaths (19%), followed by pulmonary arterial hypertension (14%) and myocardial causes (14%). Most myocardial causes were attributed to arrhythmia. Another 4% of SSc deaths were caused by renal crises.

These findings contrast with data from other autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis, in which clinically overt myocardial infarctions are more common causes of death, the researchers noted.

The main causes of death that were not related to SSc were infections (33%), malignancies (31%), and cardiovascular causes (29%). However, 25% of the patients who died of non-SSc causes had SSc-related comorbidities that likely contributed to their deaths, the researchers noted. These comorbidities included pneumonia, sepsis, and gastrointestinal hemorrhage. If these cases were added to the deaths directly caused by SSc, “the disease-related death toll would be as high as 65%,” the researchers said.

The average age of patients entering the study was 57 years, and 80% were women.

After control for multiple variables, the independent predictors of death in SSc patients included proteinuria, pulmonary arterial hypertension (PAH), forced vital capacity (FVC) less than 80% of normal, shortness of breath on exertion, reduced diffusing capacity of the lung for carbon monoxide (DLCO), and older age at onset of SSc (defined by the first signs of Raynaud’s phenomenon and modified Rodnan skin scores).

Sex was not an independent predictor of death in this study, but the researchers said that the effect of sex can be accounted for by the other variables.

The study was limited by possible biases in the coding of death certificates, but the findings support data from previous studies showing PAH and pulmonary restriction as independent risk factors for mortality in SSc patients, the researchers noted.

“The EUSTAR figures presented here are useful in estimating the number of patients that need to be included in clinical trials that investigate survival as an end point,” they said.

The researchers had no financial conflicts to disclose. EUSTAR exists under the auspices of the EULAR Standing Committee for Clinical Affairs and is funded by a research grant from EULAR.

Patients with systemic sclerosis have about a 55% chance of dying from their disease. Specifically, more than half of systemic sclerosis deaths are caused by pulmonary fibrosis, pulmonary arterial hypertension, and heart-related problems that are attributable to the disease, according to an analysis of data from an international registry.

The findings were published in the October issue of the Annals of the Rheumatic Diseases.

The overall mortality from systemic sclerosis (SSc) remains high, wrote Dr. Anthony J. Tyndall of the department of rheumatology at the University of Basel (Switzerland) and colleagues. To identify the causes and predictors of death in SSc patients, the researchers reviewed data from 5,860 adults who were enrolled in the EULAR Scleroderma Trial and Research Database (EUSTAR) database between 2004 and 2008. In all, 284 deaths were reported during the study period. Complete data were available for 234 deaths via questionnaires completed by the medical centers that reported a death in an SSc patient (Ann. Rheum. Dis. 2010;69:1809-15).

More than half (55%) of the deaths were directly attributable to SSc. Another 41% of deaths were not related to SSc, and the cause of death was not known in the remaining 4%.

Pulmonary fibrosis was the most common cause of death in SSc deaths (19%), followed by pulmonary arterial hypertension (14%) and myocardial causes (14%). Most myocardial causes were attributed to arrhythmia. Another 4% of SSc deaths were caused by renal crises.

These findings contrast with data from other autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis, in which clinically overt myocardial infarctions are more common causes of death, the researchers noted.

The main causes of death that were not related to SSc were infections (33%), malignancies (31%), and cardiovascular causes (29%). However, 25% of the patients who died of non-SSc causes had SSc-related comorbidities that likely contributed to their deaths, the researchers noted. These comorbidities included pneumonia, sepsis, and gastrointestinal hemorrhage. If these cases were added to the deaths directly caused by SSc, “the disease-related death toll would be as high as 65%,” the researchers said.

The average age of patients entering the study was 57 years, and 80% were women.

After control for multiple variables, the independent predictors of death in SSc patients included proteinuria, pulmonary arterial hypertension (PAH), forced vital capacity (FVC) less than 80% of normal, shortness of breath on exertion, reduced diffusing capacity of the lung for carbon monoxide (DLCO), and older age at onset of SSc (defined by the first signs of Raynaud’s phenomenon and modified Rodnan skin scores).

Sex was not an independent predictor of death in this study, but the researchers said that the effect of sex can be accounted for by the other variables.

The study was limited by possible biases in the coding of death certificates, but the findings support data from previous studies showing PAH and pulmonary restriction as independent risk factors for mortality in SSc patients, the researchers noted.

“The EUSTAR figures presented here are useful in estimating the number of patients that need to be included in clinical trials that investigate survival as an end point,” they said.

The researchers had no financial conflicts to disclose. EUSTAR exists under the auspices of the EULAR Standing Committee for Clinical Affairs and is funded by a research grant from EULAR.