HIV Transmission Risk Is Considerable at the Time of STI Diagnosis in HIV-Infected Persons

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Study Overview

Objective. To evaluate the incidence and demographic factors associated with chlamydia, gonorrhea, and syphilis among HIV-infected persons in Washington, DC.

Design. Descriptive, retrospective cohort study.

Setting and participants. HIV-infected persons enrolled at 13 DC Cohort sites from 2011 to 2015. The DC Cohort is a clinic-based, city-wide, longitudinal observational cohort launched in 2011 to better understand HIV epidemiology in DC, describe clinical outcomes among those in care, and improve the quality of care for people living with HIV in the DC metropolitan area. Eligible participants included those enrolled from 1 January 2011 to 31 March 2015. Participant follow-up time included time from enrollment to 30 June 2015 or until one of these occurred: death, withdrawal from the DC Cohort, or loss to follow-up.

Main outcomes measures. Confirmed cases of chlamydia, gonorrhea, and syphilis, as well as HIV viral loads at the time of sexually transmitted infection (STI) diagnosis as a proxy for HIV transmission risk.

Main results. Around the time of the study, there were approximately 11,235 persons with HIV infection receiving care at the 13 DC Cohort sites, of which 8732 (77.7%) were approached for enrollment. Of those approached, 7004 (80.2%) agreed to participate and provided consent, 948 (10.9%) declined to enroll, 14 (0.2%) withdrew consent, and 766 (8.8%) remained undecided. There were significant differences between those consenting and declining, including female gender (27.8% of those consenting vs 36.1% of those declining, P < 0.001), white race/ethnicity (13.1% of those consenting vs 6.6% of those declining, P < 0.001), and private insurance status (27.6% of those consenting vs 33.2% of those declining, P < 0.001).

Median age of patients was 47 years (interquartile range, 36.5–54.5 years); 71% were male, 76% were non-Hispanic black, 39% were men who have sex with men (MSM), and 29% were heterosexual. 63.8% had public insurance. 6.7% (451/6672) developed an incident STI during a median follow-up of 32.5 months (4% chlamydia, 3% gonorrhea, 2% syphilis); 30% of participants had 2 or more STI episodes. The incidence rate of any STI was 3.8 cases per 100 person-years (95% confidence interval [CI], 3.5–4.1); age 18–34 years, 10.8 (95% CI, 9.7–12.0); transgender women, 9.9 (95% CI, 6.9–14.0); Hispanics, 9.2 (95% CI, 7.2–11.8); and MSM, 7.7 (95% CI, 7.1–8.4). Multivariate regression analysis showed younger age, Hispanic ethnicity, MSM risk, and higher nadir CD4 counts to be strongly associated with STIs. Among those with an STI, 41.8% had a detectable viral load within 1 month of STI diagnosis, and 14.6% had a viral load ≥ 1500 copies/mL.

Conclusion. STIs are highly prevalent among HIV-infected persons receiving care in DC. HIV transmission risk is considerable at the time of STI diagnosis. Interventions toward risk reduction, antiretroviral therapy adherence, and HIV virologic suppression are critical at the time of STI evaluation.

Commentary

Although the number of new HIV cases in Washington, DC, has been decreasing over recent years [1], it still has one of the highest rates of HIV infection in the United States [2]. In this large-scale, single-city analysis, Lucar et al reported on the incidence and factors associated with the development of chlamydia, gonorrhea, and syphilis in a cohort of people living with HIV in care in DC. Consistent with incidence rates among the DC general population [2], chlamydia had the highest incidence, followed by gonorrhea and then syphilis, each with particularly high rates among 18- to 34-year-olds, MSM, transgender women, and Hispanics.

Studies have shown that many people with HIV do not consistently practice safer sex, placing themselves and others at risk for HIV or STI infection/co-infection [3]. While most HIV prevention programs target HIV-negative individuals, targeting sexual risk behaviors in HIV-positive people can prevent the transmission of HIV and other STIs to uninfected individuals and can also prevent co-infections with other STIs [3]. However, effective interventions to maintain long-term behavior change and prevent HIV transmission are needed. In a recent systematic review and meta-analysis by Globerman et al [3] assessing the effectiveness of HIV/STI prevention interventions for people living with HIV, group-level health education interventions were found to be effective in reducing HIV/STI incidence when compared to attention controls. Another intervention type, comprehensive risk counseling and services, was found to be effective in reducing sexual risk behaviors when compared to both active and attention controls. All other intervention types showed no statistically significant effect or had low or very low quality of evidence. Improving strategies to reduce the impact of HIV and STDs may require an understanding of how different populations are experiencing those conditions [1].

This study has several limitations. First, the observational nature of the DC Cohort precluded standardized STI screening for all participants. STIs are frequently asymptomatic, and differences in screening practices can impact the observed STI frequency [4,5]. Subsequently, reported STI incidence rates are likely underestimating the true STI incidence in people with HIV in care in DC. Furthermore, STI screening may provide diagnosis dates distant from the actual time of STI acquisition. Similarly, the study design also limited the availability of HIV viral loads during the same encounter of STI diagnosis. In addition, the population enrolled in the DC Cohort may not be fully representative of the larger HIV-infected population in DC, as enrollment requires some degree of engagement in care, and the demographics of those declining to participate differed somewhat from those who provided consent.

Strengths of the study include its city-wide reach, prospective enrollment of participants, its longitudinal study design, and the large sample size. Also, since the study linked data from clinical sites with data reported to the local health department, this improved the accuracy of STI diagnosis frequency and provided insight into care received for STIs outside of the primary HIV care site.

 

 

Applications for Clinical Practice

Risk reduction interventions are needed for people living with HIV to help control the spread of STIs and reduce HIV transmission. More high-quality research on HIV/STI prevention interventions is needed. While there have been only a few studies, the existing data indicate that integration of STI services into HIV care and treatment service can be feasible and can have positive outcomes [6].

References

1. Annual Epidemiology & Surveillance Report. District of Columbia Department of Health HIV/AIDS, Hepatitis, STD, and TB Administration (HAHSTA). Accessed at https://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/HAHSTA%20Annual%20Report%202017%20-%20Final%20%282%29.pdf.

2. Centers for Disease Control and Prevention. HIV Surveillance Report, 2016; vol. 28. Accessed at www.cdc.gov/hiv/library/reports/hiv-surveillance.html.

3. Globerman J, Mitra S, Gogolishvili D, et al. HIV/STI prevention interventions: a systematic review and meta-analysis. Open Med (Wars) 2017;12:450–67.

4. Berry SA, Ghanem KG, Mathews WC, et al; HIV Research Network. Brief report: gonorrhea and chlamydia testing increasing but still lagging in HIV clinics in the United States. J Acquir Immune Defic Syndr 2015;70:275–9.

5. Hoover KW, Butler M, Workowski K, et al; Evaluation Group for Adherence to STD and Hepatitis Screening. STD screening of HIV-infected MSM in HIV clinics. Sex Transm Dis 2010;37:771–6.

6. Kennedy CE, Haberlen SA, Narasimhan M. Integration of sexually transmitted infection (STI) services into HIV care and treatment services for women living with HIV: a systematic review. BMJ Open 2017;7:e015310.

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Study Overview

Objective. To evaluate the incidence and demographic factors associated with chlamydia, gonorrhea, and syphilis among HIV-infected persons in Washington, DC.

Design. Descriptive, retrospective cohort study.

Setting and participants. HIV-infected persons enrolled at 13 DC Cohort sites from 2011 to 2015. The DC Cohort is a clinic-based, city-wide, longitudinal observational cohort launched in 2011 to better understand HIV epidemiology in DC, describe clinical outcomes among those in care, and improve the quality of care for people living with HIV in the DC metropolitan area. Eligible participants included those enrolled from 1 January 2011 to 31 March 2015. Participant follow-up time included time from enrollment to 30 June 2015 or until one of these occurred: death, withdrawal from the DC Cohort, or loss to follow-up.

Main outcomes measures. Confirmed cases of chlamydia, gonorrhea, and syphilis, as well as HIV viral loads at the time of sexually transmitted infection (STI) diagnosis as a proxy for HIV transmission risk.

Main results. Around the time of the study, there were approximately 11,235 persons with HIV infection receiving care at the 13 DC Cohort sites, of which 8732 (77.7%) were approached for enrollment. Of those approached, 7004 (80.2%) agreed to participate and provided consent, 948 (10.9%) declined to enroll, 14 (0.2%) withdrew consent, and 766 (8.8%) remained undecided. There were significant differences between those consenting and declining, including female gender (27.8% of those consenting vs 36.1% of those declining, P < 0.001), white race/ethnicity (13.1% of those consenting vs 6.6% of those declining, P < 0.001), and private insurance status (27.6% of those consenting vs 33.2% of those declining, P < 0.001).

Median age of patients was 47 years (interquartile range, 36.5–54.5 years); 71% were male, 76% were non-Hispanic black, 39% were men who have sex with men (MSM), and 29% were heterosexual. 63.8% had public insurance. 6.7% (451/6672) developed an incident STI during a median follow-up of 32.5 months (4% chlamydia, 3% gonorrhea, 2% syphilis); 30% of participants had 2 or more STI episodes. The incidence rate of any STI was 3.8 cases per 100 person-years (95% confidence interval [CI], 3.5–4.1); age 18–34 years, 10.8 (95% CI, 9.7–12.0); transgender women, 9.9 (95% CI, 6.9–14.0); Hispanics, 9.2 (95% CI, 7.2–11.8); and MSM, 7.7 (95% CI, 7.1–8.4). Multivariate regression analysis showed younger age, Hispanic ethnicity, MSM risk, and higher nadir CD4 counts to be strongly associated with STIs. Among those with an STI, 41.8% had a detectable viral load within 1 month of STI diagnosis, and 14.6% had a viral load ≥ 1500 copies/mL.

Conclusion. STIs are highly prevalent among HIV-infected persons receiving care in DC. HIV transmission risk is considerable at the time of STI diagnosis. Interventions toward risk reduction, antiretroviral therapy adherence, and HIV virologic suppression are critical at the time of STI evaluation.

Commentary

Although the number of new HIV cases in Washington, DC, has been decreasing over recent years [1], it still has one of the highest rates of HIV infection in the United States [2]. In this large-scale, single-city analysis, Lucar et al reported on the incidence and factors associated with the development of chlamydia, gonorrhea, and syphilis in a cohort of people living with HIV in care in DC. Consistent with incidence rates among the DC general population [2], chlamydia had the highest incidence, followed by gonorrhea and then syphilis, each with particularly high rates among 18- to 34-year-olds, MSM, transgender women, and Hispanics.

Studies have shown that many people with HIV do not consistently practice safer sex, placing themselves and others at risk for HIV or STI infection/co-infection [3]. While most HIV prevention programs target HIV-negative individuals, targeting sexual risk behaviors in HIV-positive people can prevent the transmission of HIV and other STIs to uninfected individuals and can also prevent co-infections with other STIs [3]. However, effective interventions to maintain long-term behavior change and prevent HIV transmission are needed. In a recent systematic review and meta-analysis by Globerman et al [3] assessing the effectiveness of HIV/STI prevention interventions for people living with HIV, group-level health education interventions were found to be effective in reducing HIV/STI incidence when compared to attention controls. Another intervention type, comprehensive risk counseling and services, was found to be effective in reducing sexual risk behaviors when compared to both active and attention controls. All other intervention types showed no statistically significant effect or had low or very low quality of evidence. Improving strategies to reduce the impact of HIV and STDs may require an understanding of how different populations are experiencing those conditions [1].

This study has several limitations. First, the observational nature of the DC Cohort precluded standardized STI screening for all participants. STIs are frequently asymptomatic, and differences in screening practices can impact the observed STI frequency [4,5]. Subsequently, reported STI incidence rates are likely underestimating the true STI incidence in people with HIV in care in DC. Furthermore, STI screening may provide diagnosis dates distant from the actual time of STI acquisition. Similarly, the study design also limited the availability of HIV viral loads during the same encounter of STI diagnosis. In addition, the population enrolled in the DC Cohort may not be fully representative of the larger HIV-infected population in DC, as enrollment requires some degree of engagement in care, and the demographics of those declining to participate differed somewhat from those who provided consent.

Strengths of the study include its city-wide reach, prospective enrollment of participants, its longitudinal study design, and the large sample size. Also, since the study linked data from clinical sites with data reported to the local health department, this improved the accuracy of STI diagnosis frequency and provided insight into care received for STIs outside of the primary HIV care site.

 

 

Applications for Clinical Practice

Risk reduction interventions are needed for people living with HIV to help control the spread of STIs and reduce HIV transmission. More high-quality research on HIV/STI prevention interventions is needed. While there have been only a few studies, the existing data indicate that integration of STI services into HIV care and treatment service can be feasible and can have positive outcomes [6].

Study Overview

Objective. To evaluate the incidence and demographic factors associated with chlamydia, gonorrhea, and syphilis among HIV-infected persons in Washington, DC.

Design. Descriptive, retrospective cohort study.

Setting and participants. HIV-infected persons enrolled at 13 DC Cohort sites from 2011 to 2015. The DC Cohort is a clinic-based, city-wide, longitudinal observational cohort launched in 2011 to better understand HIV epidemiology in DC, describe clinical outcomes among those in care, and improve the quality of care for people living with HIV in the DC metropolitan area. Eligible participants included those enrolled from 1 January 2011 to 31 March 2015. Participant follow-up time included time from enrollment to 30 June 2015 or until one of these occurred: death, withdrawal from the DC Cohort, or loss to follow-up.

Main outcomes measures. Confirmed cases of chlamydia, gonorrhea, and syphilis, as well as HIV viral loads at the time of sexually transmitted infection (STI) diagnosis as a proxy for HIV transmission risk.

Main results. Around the time of the study, there were approximately 11,235 persons with HIV infection receiving care at the 13 DC Cohort sites, of which 8732 (77.7%) were approached for enrollment. Of those approached, 7004 (80.2%) agreed to participate and provided consent, 948 (10.9%) declined to enroll, 14 (0.2%) withdrew consent, and 766 (8.8%) remained undecided. There were significant differences between those consenting and declining, including female gender (27.8% of those consenting vs 36.1% of those declining, P < 0.001), white race/ethnicity (13.1% of those consenting vs 6.6% of those declining, P < 0.001), and private insurance status (27.6% of those consenting vs 33.2% of those declining, P < 0.001).

Median age of patients was 47 years (interquartile range, 36.5–54.5 years); 71% were male, 76% were non-Hispanic black, 39% were men who have sex with men (MSM), and 29% were heterosexual. 63.8% had public insurance. 6.7% (451/6672) developed an incident STI during a median follow-up of 32.5 months (4% chlamydia, 3% gonorrhea, 2% syphilis); 30% of participants had 2 or more STI episodes. The incidence rate of any STI was 3.8 cases per 100 person-years (95% confidence interval [CI], 3.5–4.1); age 18–34 years, 10.8 (95% CI, 9.7–12.0); transgender women, 9.9 (95% CI, 6.9–14.0); Hispanics, 9.2 (95% CI, 7.2–11.8); and MSM, 7.7 (95% CI, 7.1–8.4). Multivariate regression analysis showed younger age, Hispanic ethnicity, MSM risk, and higher nadir CD4 counts to be strongly associated with STIs. Among those with an STI, 41.8% had a detectable viral load within 1 month of STI diagnosis, and 14.6% had a viral load ≥ 1500 copies/mL.

Conclusion. STIs are highly prevalent among HIV-infected persons receiving care in DC. HIV transmission risk is considerable at the time of STI diagnosis. Interventions toward risk reduction, antiretroviral therapy adherence, and HIV virologic suppression are critical at the time of STI evaluation.

Commentary

Although the number of new HIV cases in Washington, DC, has been decreasing over recent years [1], it still has one of the highest rates of HIV infection in the United States [2]. In this large-scale, single-city analysis, Lucar et al reported on the incidence and factors associated with the development of chlamydia, gonorrhea, and syphilis in a cohort of people living with HIV in care in DC. Consistent with incidence rates among the DC general population [2], chlamydia had the highest incidence, followed by gonorrhea and then syphilis, each with particularly high rates among 18- to 34-year-olds, MSM, transgender women, and Hispanics.

Studies have shown that many people with HIV do not consistently practice safer sex, placing themselves and others at risk for HIV or STI infection/co-infection [3]. While most HIV prevention programs target HIV-negative individuals, targeting sexual risk behaviors in HIV-positive people can prevent the transmission of HIV and other STIs to uninfected individuals and can also prevent co-infections with other STIs [3]. However, effective interventions to maintain long-term behavior change and prevent HIV transmission are needed. In a recent systematic review and meta-analysis by Globerman et al [3] assessing the effectiveness of HIV/STI prevention interventions for people living with HIV, group-level health education interventions were found to be effective in reducing HIV/STI incidence when compared to attention controls. Another intervention type, comprehensive risk counseling and services, was found to be effective in reducing sexual risk behaviors when compared to both active and attention controls. All other intervention types showed no statistically significant effect or had low or very low quality of evidence. Improving strategies to reduce the impact of HIV and STDs may require an understanding of how different populations are experiencing those conditions [1].

This study has several limitations. First, the observational nature of the DC Cohort precluded standardized STI screening for all participants. STIs are frequently asymptomatic, and differences in screening practices can impact the observed STI frequency [4,5]. Subsequently, reported STI incidence rates are likely underestimating the true STI incidence in people with HIV in care in DC. Furthermore, STI screening may provide diagnosis dates distant from the actual time of STI acquisition. Similarly, the study design also limited the availability of HIV viral loads during the same encounter of STI diagnosis. In addition, the population enrolled in the DC Cohort may not be fully representative of the larger HIV-infected population in DC, as enrollment requires some degree of engagement in care, and the demographics of those declining to participate differed somewhat from those who provided consent.

Strengths of the study include its city-wide reach, prospective enrollment of participants, its longitudinal study design, and the large sample size. Also, since the study linked data from clinical sites with data reported to the local health department, this improved the accuracy of STI diagnosis frequency and provided insight into care received for STIs outside of the primary HIV care site.

 

 

Applications for Clinical Practice

Risk reduction interventions are needed for people living with HIV to help control the spread of STIs and reduce HIV transmission. More high-quality research on HIV/STI prevention interventions is needed. While there have been only a few studies, the existing data indicate that integration of STI services into HIV care and treatment service can be feasible and can have positive outcomes [6].

References

1. Annual Epidemiology & Surveillance Report. District of Columbia Department of Health HIV/AIDS, Hepatitis, STD, and TB Administration (HAHSTA). Accessed at https://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/HAHSTA%20Annual%20Report%202017%20-%20Final%20%282%29.pdf.

2. Centers for Disease Control and Prevention. HIV Surveillance Report, 2016; vol. 28. Accessed at www.cdc.gov/hiv/library/reports/hiv-surveillance.html.

3. Globerman J, Mitra S, Gogolishvili D, et al. HIV/STI prevention interventions: a systematic review and meta-analysis. Open Med (Wars) 2017;12:450–67.

4. Berry SA, Ghanem KG, Mathews WC, et al; HIV Research Network. Brief report: gonorrhea and chlamydia testing increasing but still lagging in HIV clinics in the United States. J Acquir Immune Defic Syndr 2015;70:275–9.

5. Hoover KW, Butler M, Workowski K, et al; Evaluation Group for Adherence to STD and Hepatitis Screening. STD screening of HIV-infected MSM in HIV clinics. Sex Transm Dis 2010;37:771–6.

6. Kennedy CE, Haberlen SA, Narasimhan M. Integration of sexually transmitted infection (STI) services into HIV care and treatment services for women living with HIV: a systematic review. BMJ Open 2017;7:e015310.

References

1. Annual Epidemiology & Surveillance Report. District of Columbia Department of Health HIV/AIDS, Hepatitis, STD, and TB Administration (HAHSTA). Accessed at https://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/HAHSTA%20Annual%20Report%202017%20-%20Final%20%282%29.pdf.

2. Centers for Disease Control and Prevention. HIV Surveillance Report, 2016; vol. 28. Accessed at www.cdc.gov/hiv/library/reports/hiv-surveillance.html.

3. Globerman J, Mitra S, Gogolishvili D, et al. HIV/STI prevention interventions: a systematic review and meta-analysis. Open Med (Wars) 2017;12:450–67.

4. Berry SA, Ghanem KG, Mathews WC, et al; HIV Research Network. Brief report: gonorrhea and chlamydia testing increasing but still lagging in HIV clinics in the United States. J Acquir Immune Defic Syndr 2015;70:275–9.

5. Hoover KW, Butler M, Workowski K, et al; Evaluation Group for Adherence to STD and Hepatitis Screening. STD screening of HIV-infected MSM in HIV clinics. Sex Transm Dis 2010;37:771–6.

6. Kennedy CE, Haberlen SA, Narasimhan M. Integration of sexually transmitted infection (STI) services into HIV care and treatment services for women living with HIV: a systematic review. BMJ Open 2017;7:e015310.

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KEYNOTE-054: Adjuvant pembrolizumab beat placebo in high-risk resected melanoma

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CHICAGO – Adjuvant pembrolizumab for resected high-risk melanoma slowed the rate of recurrence or death by 43% compared with placebo in a phase 3 trial of 1,519 patients.

After 15 months of follow-up, 12-month rates of recurrence-free survival (RFS) were 75% for pembrolizumab and 61% for placebo (hazard ratio, 0.57; P less than .001), Alexander M.M. Eggermont, MD, PhD, reported at the annual meeting of the American Association for Cancer Research.

By 18 months, the RFS difference between the arms had widened even more (71% versus 53%), Dr. Eggermont and his associates said at the meeting. The report was published simultaneously in the New England Journal of Medicine.

Adjuvant pembrolizumab was effective irrespective of PD-L1 tumor expression status. In a subgroup of more than 800 patients with PD-L1-positive tumors, 12-month RFS rates were 77% for pembrolizumab and 63% for placebo (HR, 0.54; 95% CI, 0.42 to 0.69; P less than .001). Among 116 patients who were PD-L1-negative, these rates were 72% and 52%, respectively (HR, 0.47; P = .01).

Treatment produced no new safety signals, said Dr. Eggermont of Gustave Roussy Cancer Campus Grand Paris and University Paris-Saclay, Villejuif, France. Grade 3 or higher toxicities affected 15% of pembrolizumab patients. Myositis caused one pembrolizumab-related death.

The findings bolster data suggesting that adjuvant therapy can stop or delay recurrence in resected high-risk melanoma. Previously, adjuvant ipilimumab was approved after significantly extending RFS and overall survival in the placebo-controlled European Organization for Research and Treatment of Cancer 18071 trial. More recently, adjuvant dabrafenib plus trametinib reduced the risk of recurrence compared with placebo in completely resected stage III melanoma with BRAF mutations (COMBI-AD), and adjuvant nivolumab significantly improved RFS and was less toxic than was ipilimumab in patients with advanced resected BRAF-mutated and BRAF-wild-type melanomas (CheckMate 238).

 

 


Like the EORTC 18071 trial, KEYNOTE-054 (EORTC 1325) enrolled adults with completely resected stage III cutaneous melanoma. Patients with stage IIIa disease were high-risk, with sentinel node tumors exceeding 1-mm diameter per Rotterdam criteria. Stage IIIB or IIIC patients had no in-transit metastases. In all, 1,015 patients received up to 18 doses of pembrolizumab (200 mg infused every 3 weeks) or placebo for approximately 1 year. Relapsers could either repeat pembrolizumab or cross over to the pembrolizumab arm.

Treatment-related adverse events occurred in 78% of pembrolizumab patients and 66% of placebo recipients. As in prior studies, the most frequent adverse effects of pembrolizumab included fatigue or asthenia (37%), skin reactions (28%), diarrhea (19%), arthralgia (12%), nausea (11%), and dyspnea (6%). Rates of immune-related adverse events of any grade were 37% versus 9%. The most common immune-related adverse event was endocrinopathy (23%), specifically hypothyroidism (14%) and hyperthyroidism (10%). Grade 3 or higher toxicities affected 15% of pembrolizumab recipients and most often consisted of colitis (2%), endocrine disorders (1.8%), or hepatobiliary disorders (1.4%). Myositis caused the only pembrolizumab-related death.

Patients and clinicians await KEYNOTE-054 readouts on distant metastasis-free survival and overall survival. In past trials of adjuvant interferon alfa or ipilimumab for high-risk melanoma, RFS and overall survival closely correlated, Dr. Eggermont noted. KEYNOTE-54 can be expected to produce similar findings unless post-relapse therapy – including crossover to the pembrolizumab arm – narrows the survival advantage of adjuvant treatment, he added.

Merck makes pembrolizumab and funded the trial. Dr. Eggermont disclosed ties to Actelion, Agenus, Bayer, BMS, Incyte, ISA Pharmaceuticals, HalioDX, Merck-Serono, MSD, Nektar, Novartis, Pfizer, and Sanofi outside the submitted work.

SOURCE: Eggermont AMM et al. AACR Annual Meeting Abstract CT001.

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CHICAGO – Adjuvant pembrolizumab for resected high-risk melanoma slowed the rate of recurrence or death by 43% compared with placebo in a phase 3 trial of 1,519 patients.

After 15 months of follow-up, 12-month rates of recurrence-free survival (RFS) were 75% for pembrolizumab and 61% for placebo (hazard ratio, 0.57; P less than .001), Alexander M.M. Eggermont, MD, PhD, reported at the annual meeting of the American Association for Cancer Research.

By 18 months, the RFS difference between the arms had widened even more (71% versus 53%), Dr. Eggermont and his associates said at the meeting. The report was published simultaneously in the New England Journal of Medicine.

Adjuvant pembrolizumab was effective irrespective of PD-L1 tumor expression status. In a subgroup of more than 800 patients with PD-L1-positive tumors, 12-month RFS rates were 77% for pembrolizumab and 63% for placebo (HR, 0.54; 95% CI, 0.42 to 0.69; P less than .001). Among 116 patients who were PD-L1-negative, these rates were 72% and 52%, respectively (HR, 0.47; P = .01).

Treatment produced no new safety signals, said Dr. Eggermont of Gustave Roussy Cancer Campus Grand Paris and University Paris-Saclay, Villejuif, France. Grade 3 or higher toxicities affected 15% of pembrolizumab patients. Myositis caused one pembrolizumab-related death.

The findings bolster data suggesting that adjuvant therapy can stop or delay recurrence in resected high-risk melanoma. Previously, adjuvant ipilimumab was approved after significantly extending RFS and overall survival in the placebo-controlled European Organization for Research and Treatment of Cancer 18071 trial. More recently, adjuvant dabrafenib plus trametinib reduced the risk of recurrence compared with placebo in completely resected stage III melanoma with BRAF mutations (COMBI-AD), and adjuvant nivolumab significantly improved RFS and was less toxic than was ipilimumab in patients with advanced resected BRAF-mutated and BRAF-wild-type melanomas (CheckMate 238).

 

 


Like the EORTC 18071 trial, KEYNOTE-054 (EORTC 1325) enrolled adults with completely resected stage III cutaneous melanoma. Patients with stage IIIa disease were high-risk, with sentinel node tumors exceeding 1-mm diameter per Rotterdam criteria. Stage IIIB or IIIC patients had no in-transit metastases. In all, 1,015 patients received up to 18 doses of pembrolizumab (200 mg infused every 3 weeks) or placebo for approximately 1 year. Relapsers could either repeat pembrolizumab or cross over to the pembrolizumab arm.

Treatment-related adverse events occurred in 78% of pembrolizumab patients and 66% of placebo recipients. As in prior studies, the most frequent adverse effects of pembrolizumab included fatigue or asthenia (37%), skin reactions (28%), diarrhea (19%), arthralgia (12%), nausea (11%), and dyspnea (6%). Rates of immune-related adverse events of any grade were 37% versus 9%. The most common immune-related adverse event was endocrinopathy (23%), specifically hypothyroidism (14%) and hyperthyroidism (10%). Grade 3 or higher toxicities affected 15% of pembrolizumab recipients and most often consisted of colitis (2%), endocrine disorders (1.8%), or hepatobiliary disorders (1.4%). Myositis caused the only pembrolizumab-related death.

Patients and clinicians await KEYNOTE-054 readouts on distant metastasis-free survival and overall survival. In past trials of adjuvant interferon alfa or ipilimumab for high-risk melanoma, RFS and overall survival closely correlated, Dr. Eggermont noted. KEYNOTE-54 can be expected to produce similar findings unless post-relapse therapy – including crossover to the pembrolizumab arm – narrows the survival advantage of adjuvant treatment, he added.

Merck makes pembrolizumab and funded the trial. Dr. Eggermont disclosed ties to Actelion, Agenus, Bayer, BMS, Incyte, ISA Pharmaceuticals, HalioDX, Merck-Serono, MSD, Nektar, Novartis, Pfizer, and Sanofi outside the submitted work.

SOURCE: Eggermont AMM et al. AACR Annual Meeting Abstract CT001.

CHICAGO – Adjuvant pembrolizumab for resected high-risk melanoma slowed the rate of recurrence or death by 43% compared with placebo in a phase 3 trial of 1,519 patients.

After 15 months of follow-up, 12-month rates of recurrence-free survival (RFS) were 75% for pembrolizumab and 61% for placebo (hazard ratio, 0.57; P less than .001), Alexander M.M. Eggermont, MD, PhD, reported at the annual meeting of the American Association for Cancer Research.

By 18 months, the RFS difference between the arms had widened even more (71% versus 53%), Dr. Eggermont and his associates said at the meeting. The report was published simultaneously in the New England Journal of Medicine.

Adjuvant pembrolizumab was effective irrespective of PD-L1 tumor expression status. In a subgroup of more than 800 patients with PD-L1-positive tumors, 12-month RFS rates were 77% for pembrolizumab and 63% for placebo (HR, 0.54; 95% CI, 0.42 to 0.69; P less than .001). Among 116 patients who were PD-L1-negative, these rates were 72% and 52%, respectively (HR, 0.47; P = .01).

Treatment produced no new safety signals, said Dr. Eggermont of Gustave Roussy Cancer Campus Grand Paris and University Paris-Saclay, Villejuif, France. Grade 3 or higher toxicities affected 15% of pembrolizumab patients. Myositis caused one pembrolizumab-related death.

The findings bolster data suggesting that adjuvant therapy can stop or delay recurrence in resected high-risk melanoma. Previously, adjuvant ipilimumab was approved after significantly extending RFS and overall survival in the placebo-controlled European Organization for Research and Treatment of Cancer 18071 trial. More recently, adjuvant dabrafenib plus trametinib reduced the risk of recurrence compared with placebo in completely resected stage III melanoma with BRAF mutations (COMBI-AD), and adjuvant nivolumab significantly improved RFS and was less toxic than was ipilimumab in patients with advanced resected BRAF-mutated and BRAF-wild-type melanomas (CheckMate 238).

 

 


Like the EORTC 18071 trial, KEYNOTE-054 (EORTC 1325) enrolled adults with completely resected stage III cutaneous melanoma. Patients with stage IIIa disease were high-risk, with sentinel node tumors exceeding 1-mm diameter per Rotterdam criteria. Stage IIIB or IIIC patients had no in-transit metastases. In all, 1,015 patients received up to 18 doses of pembrolizumab (200 mg infused every 3 weeks) or placebo for approximately 1 year. Relapsers could either repeat pembrolizumab or cross over to the pembrolizumab arm.

Treatment-related adverse events occurred in 78% of pembrolizumab patients and 66% of placebo recipients. As in prior studies, the most frequent adverse effects of pembrolizumab included fatigue or asthenia (37%), skin reactions (28%), diarrhea (19%), arthralgia (12%), nausea (11%), and dyspnea (6%). Rates of immune-related adverse events of any grade were 37% versus 9%. The most common immune-related adverse event was endocrinopathy (23%), specifically hypothyroidism (14%) and hyperthyroidism (10%). Grade 3 or higher toxicities affected 15% of pembrolizumab recipients and most often consisted of colitis (2%), endocrine disorders (1.8%), or hepatobiliary disorders (1.4%). Myositis caused the only pembrolizumab-related death.

Patients and clinicians await KEYNOTE-054 readouts on distant metastasis-free survival and overall survival. In past trials of adjuvant interferon alfa or ipilimumab for high-risk melanoma, RFS and overall survival closely correlated, Dr. Eggermont noted. KEYNOTE-54 can be expected to produce similar findings unless post-relapse therapy – including crossover to the pembrolizumab arm – narrows the survival advantage of adjuvant treatment, he added.

Merck makes pembrolizumab and funded the trial. Dr. Eggermont disclosed ties to Actelion, Agenus, Bayer, BMS, Incyte, ISA Pharmaceuticals, HalioDX, Merck-Serono, MSD, Nektar, Novartis, Pfizer, and Sanofi outside the submitted work.

SOURCE: Eggermont AMM et al. AACR Annual Meeting Abstract CT001.

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Key clinical point: Adjuvant pembrolizumab (200 mg every 3 weeks) significantly extended recurrence-free survival in adults with high-risk, completely resected stage III melanoma.

Major finding: After 15 months of median follow-up, 12-month rates of recurrence-free survival were 75% for pembrolizumab and 61% for placebo (hazard ratio, 0.57; P less than .001). There was one treatment-related death in the pembrolizumab group.

Study details: KEYNOTE-054, a randomized, double-blind, phase 3 trial of 1,019 patients.

Disclosures: Merck makes pembrolizumab and funded the trial.

Source: Eggermont AMM et al. AACR Annual Meeting. Abstract CT001.

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Nominations open for the Academy of Master Surgeon Educators

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Apply to become a member of the Academy of Master Surgeon Educators, a unique program of the American College of Surgeons. Membership will be open to master surgeon educators from across the surgical specialties. Learn more here. The deadline for nominating a colleague is April 20. The deadline for self-nomination is May 14.

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Apply to become a member of the Academy of Master Surgeon Educators, a unique program of the American College of Surgeons. Membership will be open to master surgeon educators from across the surgical specialties. Learn more here. The deadline for nominating a colleague is April 20. The deadline for self-nomination is May 14.

Apply to become a member of the Academy of Master Surgeon Educators, a unique program of the American College of Surgeons. Membership will be open to master surgeon educators from across the surgical specialties. Learn more here. The deadline for nominating a colleague is April 20. The deadline for self-nomination is May 14.

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Nivolumab shows promise in early-stage resectable NSCLC

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Neoadjuvant nivolumab did not delay surgery and produced at least 90% tumor regression in nearly half of early-stage, resectable non–small cell lung cancers (NSCLC), according to the results of a 21-patient pilot trial.

Eighty percent of patients were alive and recurrence-free a year after surgery, said Patrick M. Forde, MBBCh, and his colleagues from Johns Hopkins University, Baltimore. The only grade 3 or higher adverse event was treatment-related pneumonia, which did not prevent surgery. The findings were reported at the annual meeting of the American Association for Cancer Research and simultaneously in the New England Journal of Medicine.

©Sebastian Kaulitzki/Thinkstock
Nivolumab targets the programmed cell death 1 (PD-1) pathway and is approved in several tumor types, including advanced NSCLC that has progressed despite platinum-based or epidermal growth factor receptor or anaplastic lymphoma kinase–targeted therapy. That approval was based on the CHECKMATE-057 trial, in which nivolumab significantly outperformed docetaxel in metastatic NSCLC (median overall survival, 12.2 vs. 9.4 months; P = .002). However, programmed cell death 1 inhibition in resectable NSCLC remained unexplored, Dr. Forde and his colleagues noted.

For the study (NCT02259621), 21 patients with treatment-naive, stage I, II, or III NSCLC received two preoperative doses of nivolumab (3 mg/kg) 2 weeks apart, with surgery timed for 4 weeks after the first dose. In all, 62% of patients had adenocarcinoma, 81% had stage II or IIIa disease, and 86% were current or former smokers. Patients were followed for a median of 12 months after surgery (range, 0.8-19.7 months), and the researchers assessed safety, tumor response, programmed death ligand 1 mutational burden, and T-cell response.

Among 20 patients with evaluable resected primary tumors, nine (45%) showed a major pathologic response, defined as having 10% or fewer residual viable tumor cells. Twelve-month, recurrence-free survival was 83% (95% confidence interval, 66%-100%). The three progressors included one patient with 75% residual tumor at resection who subsequently developed a brain lesion, a patient with 5% residual tumor at resection who developed mediastinal lymph node recurrence, and a patient with 80% residual tumor at resection. The first two patients had durable responses to stereotactic radiotherapy or chemoradiotherapy, while the third patient developed fatal distal metastatic disease.

 

 

Sequencing of 11 completely resected tumors linked major pathologic response with higher tumor mutational burden (P = .01). Mutational burden did not correlate with tumor programmed death ligand 1 expression. Deep sequencing of T-cell receptor–beta chain CDR3 regions also correlated major pathologic response with increased clonality of tumor-infiltrating T-cell clones that also expanded into peripheral blood. “Many of these clones were not detected in peripheral blood before treatment,” the investigators wrote.

In all, five (23%) patients developed treatment-related adverse events, and many developed more than one side effect. Grade 1-2 anorexia, taste distortion, vomiting, and diarrhea were most common, with isolated cases of grade 1-2 fever, infusion reaction, abdominal pain, abnormal liver function, dry skin, and delirium. The case of grade 3 pneumonia developed after the first dose of nivolumab. The patient stopped treatment and underwent uncomplicated surgical resection.

Funders included Cancer Research Institute–Stand Up 2 Cancer; Johns Hopkins Bloomberg–Kimmel Institute for Cancer Immunotherapy; Bristol-Myers Squibb; International Immuno-Oncology Network, LUNGevity Foundation; International Association for the Study of Lung Cancer; Lung Cancer Foundation of America; and numerous other foundations and universities. Bristol-Myers Squibb makes nivolumab and supplied the study drug. Dr. Forde disclosed study grant support from Bristol-Myers Squibb. He reported ties to Bristol-Myers Squibb, AbbVie, and other pharmaceutical companies outside the submitted work.

SOURCE: Forde PM. AACR Annual Meeting 2018. Forde PM et al. N Engl J Med. 2018 Apr 16. doi: 10.1056/NEJMoa1716078.

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Neoadjuvant nivolumab did not delay surgery and produced at least 90% tumor regression in nearly half of early-stage, resectable non–small cell lung cancers (NSCLC), according to the results of a 21-patient pilot trial.

Eighty percent of patients were alive and recurrence-free a year after surgery, said Patrick M. Forde, MBBCh, and his colleagues from Johns Hopkins University, Baltimore. The only grade 3 or higher adverse event was treatment-related pneumonia, which did not prevent surgery. The findings were reported at the annual meeting of the American Association for Cancer Research and simultaneously in the New England Journal of Medicine.

©Sebastian Kaulitzki/Thinkstock
Nivolumab targets the programmed cell death 1 (PD-1) pathway and is approved in several tumor types, including advanced NSCLC that has progressed despite platinum-based or epidermal growth factor receptor or anaplastic lymphoma kinase–targeted therapy. That approval was based on the CHECKMATE-057 trial, in which nivolumab significantly outperformed docetaxel in metastatic NSCLC (median overall survival, 12.2 vs. 9.4 months; P = .002). However, programmed cell death 1 inhibition in resectable NSCLC remained unexplored, Dr. Forde and his colleagues noted.

For the study (NCT02259621), 21 patients with treatment-naive, stage I, II, or III NSCLC received two preoperative doses of nivolumab (3 mg/kg) 2 weeks apart, with surgery timed for 4 weeks after the first dose. In all, 62% of patients had adenocarcinoma, 81% had stage II or IIIa disease, and 86% were current or former smokers. Patients were followed for a median of 12 months after surgery (range, 0.8-19.7 months), and the researchers assessed safety, tumor response, programmed death ligand 1 mutational burden, and T-cell response.

Among 20 patients with evaluable resected primary tumors, nine (45%) showed a major pathologic response, defined as having 10% or fewer residual viable tumor cells. Twelve-month, recurrence-free survival was 83% (95% confidence interval, 66%-100%). The three progressors included one patient with 75% residual tumor at resection who subsequently developed a brain lesion, a patient with 5% residual tumor at resection who developed mediastinal lymph node recurrence, and a patient with 80% residual tumor at resection. The first two patients had durable responses to stereotactic radiotherapy or chemoradiotherapy, while the third patient developed fatal distal metastatic disease.

 

 

Sequencing of 11 completely resected tumors linked major pathologic response with higher tumor mutational burden (P = .01). Mutational burden did not correlate with tumor programmed death ligand 1 expression. Deep sequencing of T-cell receptor–beta chain CDR3 regions also correlated major pathologic response with increased clonality of tumor-infiltrating T-cell clones that also expanded into peripheral blood. “Many of these clones were not detected in peripheral blood before treatment,” the investigators wrote.

In all, five (23%) patients developed treatment-related adverse events, and many developed more than one side effect. Grade 1-2 anorexia, taste distortion, vomiting, and diarrhea were most common, with isolated cases of grade 1-2 fever, infusion reaction, abdominal pain, abnormal liver function, dry skin, and delirium. The case of grade 3 pneumonia developed after the first dose of nivolumab. The patient stopped treatment and underwent uncomplicated surgical resection.

Funders included Cancer Research Institute–Stand Up 2 Cancer; Johns Hopkins Bloomberg–Kimmel Institute for Cancer Immunotherapy; Bristol-Myers Squibb; International Immuno-Oncology Network, LUNGevity Foundation; International Association for the Study of Lung Cancer; Lung Cancer Foundation of America; and numerous other foundations and universities. Bristol-Myers Squibb makes nivolumab and supplied the study drug. Dr. Forde disclosed study grant support from Bristol-Myers Squibb. He reported ties to Bristol-Myers Squibb, AbbVie, and other pharmaceutical companies outside the submitted work.

SOURCE: Forde PM. AACR Annual Meeting 2018. Forde PM et al. N Engl J Med. 2018 Apr 16. doi: 10.1056/NEJMoa1716078.

Neoadjuvant nivolumab did not delay surgery and produced at least 90% tumor regression in nearly half of early-stage, resectable non–small cell lung cancers (NSCLC), according to the results of a 21-patient pilot trial.

Eighty percent of patients were alive and recurrence-free a year after surgery, said Patrick M. Forde, MBBCh, and his colleagues from Johns Hopkins University, Baltimore. The only grade 3 or higher adverse event was treatment-related pneumonia, which did not prevent surgery. The findings were reported at the annual meeting of the American Association for Cancer Research and simultaneously in the New England Journal of Medicine.

©Sebastian Kaulitzki/Thinkstock
Nivolumab targets the programmed cell death 1 (PD-1) pathway and is approved in several tumor types, including advanced NSCLC that has progressed despite platinum-based or epidermal growth factor receptor or anaplastic lymphoma kinase–targeted therapy. That approval was based on the CHECKMATE-057 trial, in which nivolumab significantly outperformed docetaxel in metastatic NSCLC (median overall survival, 12.2 vs. 9.4 months; P = .002). However, programmed cell death 1 inhibition in resectable NSCLC remained unexplored, Dr. Forde and his colleagues noted.

For the study (NCT02259621), 21 patients with treatment-naive, stage I, II, or III NSCLC received two preoperative doses of nivolumab (3 mg/kg) 2 weeks apart, with surgery timed for 4 weeks after the first dose. In all, 62% of patients had adenocarcinoma, 81% had stage II or IIIa disease, and 86% were current or former smokers. Patients were followed for a median of 12 months after surgery (range, 0.8-19.7 months), and the researchers assessed safety, tumor response, programmed death ligand 1 mutational burden, and T-cell response.

Among 20 patients with evaluable resected primary tumors, nine (45%) showed a major pathologic response, defined as having 10% or fewer residual viable tumor cells. Twelve-month, recurrence-free survival was 83% (95% confidence interval, 66%-100%). The three progressors included one patient with 75% residual tumor at resection who subsequently developed a brain lesion, a patient with 5% residual tumor at resection who developed mediastinal lymph node recurrence, and a patient with 80% residual tumor at resection. The first two patients had durable responses to stereotactic radiotherapy or chemoradiotherapy, while the third patient developed fatal distal metastatic disease.

 

 

Sequencing of 11 completely resected tumors linked major pathologic response with higher tumor mutational burden (P = .01). Mutational burden did not correlate with tumor programmed death ligand 1 expression. Deep sequencing of T-cell receptor–beta chain CDR3 regions also correlated major pathologic response with increased clonality of tumor-infiltrating T-cell clones that also expanded into peripheral blood. “Many of these clones were not detected in peripheral blood before treatment,” the investigators wrote.

In all, five (23%) patients developed treatment-related adverse events, and many developed more than one side effect. Grade 1-2 anorexia, taste distortion, vomiting, and diarrhea were most common, with isolated cases of grade 1-2 fever, infusion reaction, abdominal pain, abnormal liver function, dry skin, and delirium. The case of grade 3 pneumonia developed after the first dose of nivolumab. The patient stopped treatment and underwent uncomplicated surgical resection.

Funders included Cancer Research Institute–Stand Up 2 Cancer; Johns Hopkins Bloomberg–Kimmel Institute for Cancer Immunotherapy; Bristol-Myers Squibb; International Immuno-Oncology Network, LUNGevity Foundation; International Association for the Study of Lung Cancer; Lung Cancer Foundation of America; and numerous other foundations and universities. Bristol-Myers Squibb makes nivolumab and supplied the study drug. Dr. Forde disclosed study grant support from Bristol-Myers Squibb. He reported ties to Bristol-Myers Squibb, AbbVie, and other pharmaceutical companies outside the submitted work.

SOURCE: Forde PM. AACR Annual Meeting 2018. Forde PM et al. N Engl J Med. 2018 Apr 16. doi: 10.1056/NEJMoa1716078.

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REPORTING FROM AACR ANNUAL MEETING

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Key clinical point: Neoadjuvant nivolumab was tolerable and induced robust responses in resectable non–small cell lung cancers.

Major finding: In all, 45% of evaluable tumors showed a major pathological response. Eighty percent of resected patients were alive and recurrence-free a median of 12 months after surgery. One patient (5%) developed a grade 3 treatment-related adverse event.

Study details: Pilot study of 21 adults with early-stage resectable non–small cell lung cancer (NCT02259621).

Disclosures: Funders included Cancer Research Institute–Stand Up 2 Cancer; Johns Hopkins Bloomberg–Kimmel Institute for Cancer Immunotherapy; Bristol-Myers Squibb; International Immuno-Oncology Network, LUNGevity Foundation; International Association for the Study of Lung Cancer; Lung Cancer Foundation of America; and numerous other foundations and universities. Bristol-Myers Squibb makes nivolumab and supplied the study drug. Dr. Forde disclosed study grant support from Bristol-Myers Squibb. He reported ties to Bristol-Myers Squibb, AbbVie, and other pharmaceutical companies outside the submitted work.

Source: Forde PM. AACR Annual Meeting 2018. Forde PM et al. N Engl J Med. 2018 Apr 16. doi: 10.1056/NEJMoa1716078.
 

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Send Us Your Photos of Your Vascular Team

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The theme of this year’s Vascular Annual Meeting is “Home of the Vascular Team – Partners in Patient Care.” To celebrate the work of all of the members of the vascular team, we want you to send in your team pictures. Round up the staff and take a picture with your cell phone or tablet. Then send it by May 15 to communications@vascularsociety.org. We’ll use these team photos for social media and, during the meeting itself, in various slide shows. VAM will be June 20 to 23 in Boston. Exhibits are June 21-22 and scientific sessions are June 21-23.

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The theme of this year’s Vascular Annual Meeting is “Home of the Vascular Team – Partners in Patient Care.” To celebrate the work of all of the members of the vascular team, we want you to send in your team pictures. Round up the staff and take a picture with your cell phone or tablet. Then send it by May 15 to communications@vascularsociety.org. We’ll use these team photos for social media and, during the meeting itself, in various slide shows. VAM will be June 20 to 23 in Boston. Exhibits are June 21-22 and scientific sessions are June 21-23.

The theme of this year’s Vascular Annual Meeting is “Home of the Vascular Team – Partners in Patient Care.” To celebrate the work of all of the members of the vascular team, we want you to send in your team pictures. Round up the staff and take a picture with your cell phone or tablet. Then send it by May 15 to communications@vascularsociety.org. We’ll use these team photos for social media and, during the meeting itself, in various slide shows. VAM will be June 20 to 23 in Boston. Exhibits are June 21-22 and scientific sessions are June 21-23.

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Learn to Negotiate Physician Compensation Agreements

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SVS and the SVS Community Practice Committee will hold an informative webinar for SVS members on April 30 on “Negotiating Physician Employment Agreements.” The 75-minute webinar will begin at 8 p.m. Eastern, 7 p.m. Central, 6 p.m. Mountain and 5 p.m. Pacific times. Topics will include current trends, regulatory overview and key contractual provisions. Register here.

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SVS and the SVS Community Practice Committee will hold an informative webinar for SVS members on April 30 on “Negotiating Physician Employment Agreements.” The 75-minute webinar will begin at 8 p.m. Eastern, 7 p.m. Central, 6 p.m. Mountain and 5 p.m. Pacific times. Topics will include current trends, regulatory overview and key contractual provisions. Register here.

SVS and the SVS Community Practice Committee will hold an informative webinar for SVS members on April 30 on “Negotiating Physician Employment Agreements.” The 75-minute webinar will begin at 8 p.m. Eastern, 7 p.m. Central, 6 p.m. Mountain and 5 p.m. Pacific times. Topics will include current trends, regulatory overview and key contractual provisions. Register here.

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SVS 2018 Vascular Annual Meeting to Host Vascular Teams

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When: June 20-23
Where: Hynes Convention Center, Boston
Scientific Sessions: June 21-23
Exhibit Hall: June 21-22
Register: vsweb.org/VAM18
#VAM18

What’s happening this year at the Society for Vascular Surgery’s Vascular Annual Meeting?

  • Enhanced online program planner that syncs with meeting app and makes it simple to plan your schedule. Follow this link to start now
  • New opportunities for audience participation and discussion
  • Programming aimed at physicians and the vascular team in all practice settings
  • Cooperative scheduling with the Society for Vascular Nursing and physician assistants
  • Great minds, stimulating discussions and events that include the entire vascular team

The 2018 VAM, sponsored by the SVS, will be at the Hynes Convention Center in Boston, Mass., June 20-23. The scientific sessions and exhibit hall open June 21. Registration numbers are already exceeding last year’s benchmarks, organizers said.

Abstracts for all the scientific sessions will be available in the June Journal of Vascular Surgery supplement.

Some of the highlights:

Inclusive. This year’s meeting has a theme: The Vascular Team: Partners in Patient Care.  Every member of the vascular team – surgeons, nurses, nurse practitioners, PAs – will find a reason to attend.

The meeting provides programming across all practice settings with an even stronger focus on practical, take-home information for all.

View Dr. Darling’s “wicked awesome” Welcome to VAM18 video

The Society for Vascular Nursing’s annual meeting will be in the same location June 20-21. Registration for the SVN meeting includes access to VAM.

 

 

This year, the newly established membership section for vascular PAs will present PA-focused education. Within just the past few months, more than 130 PAs joined SVS and many are expected to be at VAM.

An Intuitive Planner - VAM18 meeting will see a new online program planner that allows attendees to filter by session type, areas of interest, faculty, and more. Attendees can favorite a session to build their own meeting schedule. The online planner will sync with the new meeting mobile app, so that attendees can carry their schedule with them. The mobile app will be available through the SVS store in June.

Interactive sessions - Meeting organizers have added more opportunities for small group and audience interaction during and after sessions. 

Industry’s best – This year’s Exhibit Hall will run for two days with longer hours each day than in previous years. It will feature the crowd-pleasing Vascular Live sessions each day, as well as exhibits showing off innovative devices and offering a chance to chat one-on-one with company representatives. To add to the festivities, a scavenger hunt will foster interaction.

Familiar favorites will be back – workshops, postgraduate courses, international sessions, posters, collaborative events with other societies and many, many chances to network and catch up with old friends. The essential VAM on Demand post-meeting slides, audio and video will help members revisit VAM anytime.

Learn more about the 2018 VAM here: All about VAM18

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When: June 20-23
Where: Hynes Convention Center, Boston
Scientific Sessions: June 21-23
Exhibit Hall: June 21-22
Register: vsweb.org/VAM18
#VAM18

What’s happening this year at the Society for Vascular Surgery’s Vascular Annual Meeting?

  • Enhanced online program planner that syncs with meeting app and makes it simple to plan your schedule. Follow this link to start now
  • New opportunities for audience participation and discussion
  • Programming aimed at physicians and the vascular team in all practice settings
  • Cooperative scheduling with the Society for Vascular Nursing and physician assistants
  • Great minds, stimulating discussions and events that include the entire vascular team

The 2018 VAM, sponsored by the SVS, will be at the Hynes Convention Center in Boston, Mass., June 20-23. The scientific sessions and exhibit hall open June 21. Registration numbers are already exceeding last year’s benchmarks, organizers said.

Abstracts for all the scientific sessions will be available in the June Journal of Vascular Surgery supplement.

Some of the highlights:

Inclusive. This year’s meeting has a theme: The Vascular Team: Partners in Patient Care.  Every member of the vascular team – surgeons, nurses, nurse practitioners, PAs – will find a reason to attend.

The meeting provides programming across all practice settings with an even stronger focus on practical, take-home information for all.

View Dr. Darling’s “wicked awesome” Welcome to VAM18 video

The Society for Vascular Nursing’s annual meeting will be in the same location June 20-21. Registration for the SVN meeting includes access to VAM.

 

 

This year, the newly established membership section for vascular PAs will present PA-focused education. Within just the past few months, more than 130 PAs joined SVS and many are expected to be at VAM.

An Intuitive Planner - VAM18 meeting will see a new online program planner that allows attendees to filter by session type, areas of interest, faculty, and more. Attendees can favorite a session to build their own meeting schedule. The online planner will sync with the new meeting mobile app, so that attendees can carry their schedule with them. The mobile app will be available through the SVS store in June.

Interactive sessions - Meeting organizers have added more opportunities for small group and audience interaction during and after sessions. 

Industry’s best – This year’s Exhibit Hall will run for two days with longer hours each day than in previous years. It will feature the crowd-pleasing Vascular Live sessions each day, as well as exhibits showing off innovative devices and offering a chance to chat one-on-one with company representatives. To add to the festivities, a scavenger hunt will foster interaction.

Familiar favorites will be back – workshops, postgraduate courses, international sessions, posters, collaborative events with other societies and many, many chances to network and catch up with old friends. The essential VAM on Demand post-meeting slides, audio and video will help members revisit VAM anytime.

Learn more about the 2018 VAM here: All about VAM18

When: June 20-23
Where: Hynes Convention Center, Boston
Scientific Sessions: June 21-23
Exhibit Hall: June 21-22
Register: vsweb.org/VAM18
#VAM18

What’s happening this year at the Society for Vascular Surgery’s Vascular Annual Meeting?

  • Enhanced online program planner that syncs with meeting app and makes it simple to plan your schedule. Follow this link to start now
  • New opportunities for audience participation and discussion
  • Programming aimed at physicians and the vascular team in all practice settings
  • Cooperative scheduling with the Society for Vascular Nursing and physician assistants
  • Great minds, stimulating discussions and events that include the entire vascular team

The 2018 VAM, sponsored by the SVS, will be at the Hynes Convention Center in Boston, Mass., June 20-23. The scientific sessions and exhibit hall open June 21. Registration numbers are already exceeding last year’s benchmarks, organizers said.

Abstracts for all the scientific sessions will be available in the June Journal of Vascular Surgery supplement.

Some of the highlights:

Inclusive. This year’s meeting has a theme: The Vascular Team: Partners in Patient Care.  Every member of the vascular team – surgeons, nurses, nurse practitioners, PAs – will find a reason to attend.

The meeting provides programming across all practice settings with an even stronger focus on practical, take-home information for all.

View Dr. Darling’s “wicked awesome” Welcome to VAM18 video

The Society for Vascular Nursing’s annual meeting will be in the same location June 20-21. Registration for the SVN meeting includes access to VAM.

 

 

This year, the newly established membership section for vascular PAs will present PA-focused education. Within just the past few months, more than 130 PAs joined SVS and many are expected to be at VAM.

An Intuitive Planner - VAM18 meeting will see a new online program planner that allows attendees to filter by session type, areas of interest, faculty, and more. Attendees can favorite a session to build their own meeting schedule. The online planner will sync with the new meeting mobile app, so that attendees can carry their schedule with them. The mobile app will be available through the SVS store in June.

Interactive sessions - Meeting organizers have added more opportunities for small group and audience interaction during and after sessions. 

Industry’s best – This year’s Exhibit Hall will run for two days with longer hours each day than in previous years. It will feature the crowd-pleasing Vascular Live sessions each day, as well as exhibits showing off innovative devices and offering a chance to chat one-on-one with company representatives. To add to the festivities, a scavenger hunt will foster interaction.

Familiar favorites will be back – workshops, postgraduate courses, international sessions, posters, collaborative events with other societies and many, many chances to network and catch up with old friends. The essential VAM on Demand post-meeting slides, audio and video will help members revisit VAM anytime.

Learn more about the 2018 VAM here: All about VAM18

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MDedge Daily News: Shingles boosts stroke risk

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Herpes zoster boosts short-term stroke and TIA risk. Americans don’t know about cancer drug shortages – but they want to. Complication rates rise after uterine fibroid morcellation’s boxed warning. And marijuana use may spur change in safety-sensitive industries.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

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Herpes zoster boosts short-term stroke and TIA risk. Americans don’t know about cancer drug shortages – but they want to. Complication rates rise after uterine fibroid morcellation’s boxed warning. And marijuana use may spur change in safety-sensitive industries.

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Smoking increases heart failure risk in blacks

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Cigarette smoking is an important risk factor for heart failure in blacks, according to results of an investigation of patients in the Jackson Heart Study.

Current smoking among blacks was associated with higher mean left ventricular (LV) mass and lower mean LV systolic function, even after adjustment for confounding factors, authors of the analysis reported in the journal Circulation.

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Smoking elderly man
Hospitalization for heart failure among blacks was associated not only with current smoking but also with smoking intensity, measured in cigarettes per day, and smoking burden, measured in pack-years, reported Daisuke Kamimura, MD, PhD, of the University of Mississippi Medical Center, Jackson, and associates.

While blacks are known to have a higher incidence of heart failure than do whites, Hispanics, and Asians, this is believed to be the first prospective study of a large black cohort demonstrating a dose-response relationship between smoking and incident heart failure.

“Smoking cessation may be a potential strategy to attenuate the higher rate of heart failure in blacks,” wrote Dr. Kamimura and coauthors.

The published analysis included data on 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.

That group, which was 63% female, included 503 current smokers, 742 former smokers, and 2,884 individuals who had never smoked.

 

 

At baseline, no patients had a history of heart failure or coronary heart disease, and over a median follow-up of 8.0 years, there were 147 hospitalizations for heart failure in the cohort, the investigators reported.

Current smoking, compared with never smoking, was significantly associated with incident heart failure hospitalization after adjusting for risk factors and coronary heart disease (hazard ratio, 2.82; 95% confidence interval, 1.71-4.64).

Likewise, smoking intensity of at least 20 cigarettes a day (HR, 3.48; 95% CI, 1.65-7.32) and smoking burden of at least 15 pack-years (HR, 2.06; 95% CI, 1.29-3.33) both were significantly associated with incident heart failure hospitalization .

Compared with never smoking, current smoking was significantly associated with higher mean LV mass index and lower mean LV circumferential strain, even after adjusting for confounding variables (P less than 0.05 for both comparisons).
 

 

Smoking status also was associated with higher mean levels of brain natriuretic peptide, as were smoking intensity and burden (P less than 0.05 for all three comparisons), data show.

While cigarette smoking is a well-known risk factor for cardiovascular disease, Dr. Kamimura and coauthors said the influences on cardiac structure and function may not be fully appreciated because of the strong association with coronary heart disease, a major cause of heart failure.

“These relationships were significant after adjustment for coronary heart disease, suggesting mechanisms beyond atherosclerosis probably contribute to myocardial dysfunction and increased risk of heart failure in smokers,” they wrote in a discussion of the results.

Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University, Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has also received support from the National Institute of Diabetes and Digestive and Kidney Diseases and The National Institute of General Medical Sciences.

SOURCE: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.

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Cigarette smoking is an important risk factor for heart failure in blacks, according to results of an investigation of patients in the Jackson Heart Study.

Current smoking among blacks was associated with higher mean left ventricular (LV) mass and lower mean LV systolic function, even after adjustment for confounding factors, authors of the analysis reported in the journal Circulation.

beichh4046/gettyimages
Smoking elderly man
Hospitalization for heart failure among blacks was associated not only with current smoking but also with smoking intensity, measured in cigarettes per day, and smoking burden, measured in pack-years, reported Daisuke Kamimura, MD, PhD, of the University of Mississippi Medical Center, Jackson, and associates.

While blacks are known to have a higher incidence of heart failure than do whites, Hispanics, and Asians, this is believed to be the first prospective study of a large black cohort demonstrating a dose-response relationship between smoking and incident heart failure.

“Smoking cessation may be a potential strategy to attenuate the higher rate of heart failure in blacks,” wrote Dr. Kamimura and coauthors.

The published analysis included data on 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.

That group, which was 63% female, included 503 current smokers, 742 former smokers, and 2,884 individuals who had never smoked.

 

 

At baseline, no patients had a history of heart failure or coronary heart disease, and over a median follow-up of 8.0 years, there were 147 hospitalizations for heart failure in the cohort, the investigators reported.

Current smoking, compared with never smoking, was significantly associated with incident heart failure hospitalization after adjusting for risk factors and coronary heart disease (hazard ratio, 2.82; 95% confidence interval, 1.71-4.64).

Likewise, smoking intensity of at least 20 cigarettes a day (HR, 3.48; 95% CI, 1.65-7.32) and smoking burden of at least 15 pack-years (HR, 2.06; 95% CI, 1.29-3.33) both were significantly associated with incident heart failure hospitalization .

Compared with never smoking, current smoking was significantly associated with higher mean LV mass index and lower mean LV circumferential strain, even after adjusting for confounding variables (P less than 0.05 for both comparisons).
 

 

Smoking status also was associated with higher mean levels of brain natriuretic peptide, as were smoking intensity and burden (P less than 0.05 for all three comparisons), data show.

While cigarette smoking is a well-known risk factor for cardiovascular disease, Dr. Kamimura and coauthors said the influences on cardiac structure and function may not be fully appreciated because of the strong association with coronary heart disease, a major cause of heart failure.

“These relationships were significant after adjustment for coronary heart disease, suggesting mechanisms beyond atherosclerosis probably contribute to myocardial dysfunction and increased risk of heart failure in smokers,” they wrote in a discussion of the results.

Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University, Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has also received support from the National Institute of Diabetes and Digestive and Kidney Diseases and The National Institute of General Medical Sciences.

SOURCE: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.

Cigarette smoking is an important risk factor for heart failure in blacks, according to results of an investigation of patients in the Jackson Heart Study.

Current smoking among blacks was associated with higher mean left ventricular (LV) mass and lower mean LV systolic function, even after adjustment for confounding factors, authors of the analysis reported in the journal Circulation.

beichh4046/gettyimages
Smoking elderly man
Hospitalization for heart failure among blacks was associated not only with current smoking but also with smoking intensity, measured in cigarettes per day, and smoking burden, measured in pack-years, reported Daisuke Kamimura, MD, PhD, of the University of Mississippi Medical Center, Jackson, and associates.

While blacks are known to have a higher incidence of heart failure than do whites, Hispanics, and Asians, this is believed to be the first prospective study of a large black cohort demonstrating a dose-response relationship between smoking and incident heart failure.

“Smoking cessation may be a potential strategy to attenuate the higher rate of heart failure in blacks,” wrote Dr. Kamimura and coauthors.

The published analysis included data on 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.

That group, which was 63% female, included 503 current smokers, 742 former smokers, and 2,884 individuals who had never smoked.

 

 

At baseline, no patients had a history of heart failure or coronary heart disease, and over a median follow-up of 8.0 years, there were 147 hospitalizations for heart failure in the cohort, the investigators reported.

Current smoking, compared with never smoking, was significantly associated with incident heart failure hospitalization after adjusting for risk factors and coronary heart disease (hazard ratio, 2.82; 95% confidence interval, 1.71-4.64).

Likewise, smoking intensity of at least 20 cigarettes a day (HR, 3.48; 95% CI, 1.65-7.32) and smoking burden of at least 15 pack-years (HR, 2.06; 95% CI, 1.29-3.33) both were significantly associated with incident heart failure hospitalization .

Compared with never smoking, current smoking was significantly associated with higher mean LV mass index and lower mean LV circumferential strain, even after adjusting for confounding variables (P less than 0.05 for both comparisons).
 

 

Smoking status also was associated with higher mean levels of brain natriuretic peptide, as were smoking intensity and burden (P less than 0.05 for all three comparisons), data show.

While cigarette smoking is a well-known risk factor for cardiovascular disease, Dr. Kamimura and coauthors said the influences on cardiac structure and function may not be fully appreciated because of the strong association with coronary heart disease, a major cause of heart failure.

“These relationships were significant after adjustment for coronary heart disease, suggesting mechanisms beyond atherosclerosis probably contribute to myocardial dysfunction and increased risk of heart failure in smokers,” they wrote in a discussion of the results.

Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University, Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has also received support from the National Institute of Diabetes and Digestive and Kidney Diseases and The National Institute of General Medical Sciences.

SOURCE: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.

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Key clinical point: Blacks who smoke cigarettes or who have a significant smoking history may be at increased risk of heart failure. Major finding: Current smoking, cigarettes per day, and smoking burden in pack-years were all independently associated with incident heart failure hospitalization (hazard ratio 2.82, 3.48, and 2.06, respectively) even after adjusting for risk factors and coronary heart disease.

Study details: Analysis of 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.

Disclosures: Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University; Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has received support from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of General Medical Sciences.

Source: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.

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A Cluster of Idiopathic Pulmonary Fibrosis Cases

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New data are being uncovered that shows dental personnel are at risk for idiopathic pulmonary fibrosis.

In 2016, a Virginia dentist who had been recently diagnosed with idiopathic pulmonary fibrosis (IPF) was being treated at a specialty clinic. The CDC was contacted to report concerns that IPF had been diagnosed in multiple dentists, also from Virginia, who had also sought treatment at the same specialty clinic.

CDC researchers reviewed medical records of 894 patients treated for IPF at the tertiary care center between 1996-2017. They found 8 patients were dentists and 1 was a dental technician. Seven of the patients had died.

Idiopathic pulmonary fibrosis is a chronic, progressive, fibrosing interstitial pneumonia. This is the first known described cluster of IPF among dental personnel, the CDC says. Although no clear etiology could be found, it is possible that occupational exposure contributed to the development of IPF. Viral infections, cigarette smoking, and exposure to dust, wood dust, and metal dust have been implicated. One of the surviving patients reported polishing dental appliances and preparing amalgams and impressions without respiratory protection, which could have exposed him to silica, alginate, and other compounds with known or potential respiratory toxicity.

The CDC researchers note that dental personnel are exposed to infectious agents, chemicals, airborne particulates, ionizing radiation, and other potentially hazardous materials. They cite the case of a dentist who died of respiratory failure. Postmortem analysis identified pneumoconiosis; examination of lung tissue revealed particles consistent with alginate impression powders.

Idiopathic pulmonary fibrosis has not previously been described among dental personnel, the researchers say. But when they queried the National Occupational Respiratory Mortality System for “other interstitial pulmonary diseases with fibrosis” listed as the underlying or contributing cause of death, they found 35 decedents categorized as having worked in dentists’ offices or as dentists. During 2016, dentists accounted for an estimated 0.038% of US residents, yet represented 0.893% of patients being treated for IPF at a tertiary care center—nearly a 23-fold difference. Those findings suggest, the researchers say, that a higher rate of IPF might occur among dental personnel than among the general population.

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New data are being uncovered that shows dental personnel are at risk for idiopathic pulmonary fibrosis.
New data are being uncovered that shows dental personnel are at risk for idiopathic pulmonary fibrosis.

In 2016, a Virginia dentist who had been recently diagnosed with idiopathic pulmonary fibrosis (IPF) was being treated at a specialty clinic. The CDC was contacted to report concerns that IPF had been diagnosed in multiple dentists, also from Virginia, who had also sought treatment at the same specialty clinic.

CDC researchers reviewed medical records of 894 patients treated for IPF at the tertiary care center between 1996-2017. They found 8 patients were dentists and 1 was a dental technician. Seven of the patients had died.

Idiopathic pulmonary fibrosis is a chronic, progressive, fibrosing interstitial pneumonia. This is the first known described cluster of IPF among dental personnel, the CDC says. Although no clear etiology could be found, it is possible that occupational exposure contributed to the development of IPF. Viral infections, cigarette smoking, and exposure to dust, wood dust, and metal dust have been implicated. One of the surviving patients reported polishing dental appliances and preparing amalgams and impressions without respiratory protection, which could have exposed him to silica, alginate, and other compounds with known or potential respiratory toxicity.

The CDC researchers note that dental personnel are exposed to infectious agents, chemicals, airborne particulates, ionizing radiation, and other potentially hazardous materials. They cite the case of a dentist who died of respiratory failure. Postmortem analysis identified pneumoconiosis; examination of lung tissue revealed particles consistent with alginate impression powders.

Idiopathic pulmonary fibrosis has not previously been described among dental personnel, the researchers say. But when they queried the National Occupational Respiratory Mortality System for “other interstitial pulmonary diseases with fibrosis” listed as the underlying or contributing cause of death, they found 35 decedents categorized as having worked in dentists’ offices or as dentists. During 2016, dentists accounted for an estimated 0.038% of US residents, yet represented 0.893% of patients being treated for IPF at a tertiary care center—nearly a 23-fold difference. Those findings suggest, the researchers say, that a higher rate of IPF might occur among dental personnel than among the general population.

In 2016, a Virginia dentist who had been recently diagnosed with idiopathic pulmonary fibrosis (IPF) was being treated at a specialty clinic. The CDC was contacted to report concerns that IPF had been diagnosed in multiple dentists, also from Virginia, who had also sought treatment at the same specialty clinic.

CDC researchers reviewed medical records of 894 patients treated for IPF at the tertiary care center between 1996-2017. They found 8 patients were dentists and 1 was a dental technician. Seven of the patients had died.

Idiopathic pulmonary fibrosis is a chronic, progressive, fibrosing interstitial pneumonia. This is the first known described cluster of IPF among dental personnel, the CDC says. Although no clear etiology could be found, it is possible that occupational exposure contributed to the development of IPF. Viral infections, cigarette smoking, and exposure to dust, wood dust, and metal dust have been implicated. One of the surviving patients reported polishing dental appliances and preparing amalgams and impressions without respiratory protection, which could have exposed him to silica, alginate, and other compounds with known or potential respiratory toxicity.

The CDC researchers note that dental personnel are exposed to infectious agents, chemicals, airborne particulates, ionizing radiation, and other potentially hazardous materials. They cite the case of a dentist who died of respiratory failure. Postmortem analysis identified pneumoconiosis; examination of lung tissue revealed particles consistent with alginate impression powders.

Idiopathic pulmonary fibrosis has not previously been described among dental personnel, the researchers say. But when they queried the National Occupational Respiratory Mortality System for “other interstitial pulmonary diseases with fibrosis” listed as the underlying or contributing cause of death, they found 35 decedents categorized as having worked in dentists’ offices or as dentists. During 2016, dentists accounted for an estimated 0.038% of US residents, yet represented 0.893% of patients being treated for IPF at a tertiary care center—nearly a 23-fold difference. Those findings suggest, the researchers say, that a higher rate of IPF might occur among dental personnel than among the general population.

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