Clinical Edge Journal Scan

Key clinical point: Use of progestin-releasing long-acting reversible contraceptives (LARC) was linked to weight gain in nulliparous adolescents aged 14-19 years; 25% of the study population was obese, and significant interaction effect (P = .017) showed a greater increase in BMI in this subset of participants who used an LARC compared to a copper intrauterine device (IUD).

Major finding:  The mean change in body mass index among teen girls who used LARC was an increase of 0.73 kg/m²; BMI increases averaged 0.92 kg/m² for those who used an etornogestrel subdermal implant plus levonorgestrel intrauterine device (LNG-IUD) and 0.37 kg/m² in those who used a copper IUD.

Study details: The data come from a retrospective cohort study of 196 adolescents aged 14-19 years who underwent placement of long-acting reversible contraceptive devices.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Scott N et al. J Pediatr Adolesc Gynecol. 2021 Aug 10. doi: 10.1016/j.jpag.2021.08.004.

Key clinical point: Use of progestin-releasing long-acting reversible contraceptives (LARC) was linked to weight gain in nulliparous adolescents aged 14-19 years; 25% of the study population was obese, and significant interaction effect (P = .017) showed a greater increase in BMI in this subset of participants who used an LARC compared to a copper intrauterine device (IUD).

Major finding:  The mean change in body mass index among teen girls who used LARC was an increase of 0.73 kg/m²; BMI increases averaged 0.92 kg/m² for those who used an etornogestrel subdermal implant plus levonorgestrel intrauterine device (LNG-IUD) and 0.37 kg/m² in those who used a copper IUD.

Study details: The data come from a retrospective cohort study of 196 adolescents aged 14-19 years who underwent placement of long-acting reversible contraceptive devices.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Scott N et al. J Pediatr Adolesc Gynecol. 2021 Aug 10. doi: 10.1016/j.jpag.2021.08.004.

Key clinical point: Use of progestin-releasing long-acting reversible contraceptives (LARC) was linked to weight gain in nulliparous adolescents aged 14-19 years; 25% of the study population was obese, and significant interaction effect (P = .017) showed a greater increase in BMI in this subset of participants who used an LARC compared to a copper intrauterine device (IUD).

Major finding:  The mean change in body mass index among teen girls who used LARC was an increase of 0.73 kg/m²; BMI increases averaged 0.92 kg/m² for those who used an etornogestrel subdermal implant plus levonorgestrel intrauterine device (LNG-IUD) and 0.37 kg/m² in those who used a copper IUD.

Study details: The data come from a retrospective cohort study of 196 adolescents aged 14-19 years who underwent placement of long-acting reversible contraceptive devices.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Scott N et al. J Pediatr Adolesc Gynecol. 2021 Aug 10. doi: 10.1016/j.jpag.2021.08.004.

Key clinical point: A review of 58 YouTube videos on removal of long-acting reversible contraception showed more than 4 million views overall; reasons for removal included negative side effects, fear of side effects, and desire for pregnancy.

Major finding:  Most of the women who created the 58 videos were white (53%), 31% were Black, and 14% were Latina. Of these, 56 of 58 successfully removed their device and described the experience as positive in terms of ease of removal.

Study details: The data come from a review of 58 videos on self-removal of long-acting reversible contraception based on YouTube keyword searches. The videos included 48 individuals removing an intrauterine device and 10 removing an implant.

Disclosures: The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and by the National Science Foundation Graduate Research Fellowship Program. The researchers had no financial conflicts to disclose.

Source: Broussard K and Becker A. Contraception. 2021 Aug 13. doi: 10.1016/j.contraception.2021.08.002.

Key clinical point: A review of 58 YouTube videos on removal of long-acting reversible contraception showed more than 4 million views overall; reasons for removal included negative side effects, fear of side effects, and desire for pregnancy.

Major finding:  Most of the women who created the 58 videos were white (53%), 31% were Black, and 14% were Latina. Of these, 56 of 58 successfully removed their device and described the experience as positive in terms of ease of removal.

Study details: The data come from a review of 58 videos on self-removal of long-acting reversible contraception based on YouTube keyword searches. The videos included 48 individuals removing an intrauterine device and 10 removing an implant.

Disclosures: The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and by the National Science Foundation Graduate Research Fellowship Program. The researchers had no financial conflicts to disclose.

Source: Broussard K and Becker A. Contraception. 2021 Aug 13. doi: 10.1016/j.contraception.2021.08.002.

Key clinical point: A review of 58 YouTube videos on removal of long-acting reversible contraception showed more than 4 million views overall; reasons for removal included negative side effects, fear of side effects, and desire for pregnancy.

Major finding:  Most of the women who created the 58 videos were white (53%), 31% were Black, and 14% were Latina. Of these, 56 of 58 successfully removed their device and described the experience as positive in terms of ease of removal.

Study details: The data come from a review of 58 videos on self-removal of long-acting reversible contraception based on YouTube keyword searches. The videos included 48 individuals removing an intrauterine device and 10 removing an implant.

Disclosures: The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and by the National Science Foundation Graduate Research Fellowship Program. The researchers had no financial conflicts to disclose.

Source: Broussard K and Becker A. Contraception. 2021 Aug 13. doi: 10.1016/j.contraception.2021.08.002.

Key clinical point: Among young women, the average Pregnancy Risk Index (PRI) was 4.75; individuals using teratogenic medication had the lowest PRI (0.32); 88% of these individuals used reversible contraception and 31% used long-acting reversible contraception.

Major finding:  Approximately 73% of sexually active young women received contraceptive counseling, which was associated with a significantly increased use of reversible and dual contraception, but not long-acting reversible contraception. At last reported vaginal sex, 65% reported using condoms, 49% reported using reversible contraception, and 12% reported using long-acting reversible contraception.

Study details: The data come from a cross-sectional survey of 177 hospitalized females aged 14 to 21 years at two academic medical centers; the surveys assessed sexual health behaviors, contraceptive use, contraceptive counseling, and pregnancy complications. Researchers calculated the Pregnancy Risk Index (the number per 100 individuals who will become pregnant in the next year).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Hunt JA et al. Hosp Pediatr. 2021 Sep 13. doi: 10.1542/hpeds.2021-005810.

Key clinical point: Among young women, the average Pregnancy Risk Index (PRI) was 4.75; individuals using teratogenic medication had the lowest PRI (0.32); 88% of these individuals used reversible contraception and 31% used long-acting reversible contraception.

Major finding:  Approximately 73% of sexually active young women received contraceptive counseling, which was associated with a significantly increased use of reversible and dual contraception, but not long-acting reversible contraception. At last reported vaginal sex, 65% reported using condoms, 49% reported using reversible contraception, and 12% reported using long-acting reversible contraception.

Study details: The data come from a cross-sectional survey of 177 hospitalized females aged 14 to 21 years at two academic medical centers; the surveys assessed sexual health behaviors, contraceptive use, contraceptive counseling, and pregnancy complications. Researchers calculated the Pregnancy Risk Index (the number per 100 individuals who will become pregnant in the next year).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Hunt JA et al. Hosp Pediatr. 2021 Sep 13. doi: 10.1542/hpeds.2021-005810.

Key clinical point: Among young women, the average Pregnancy Risk Index (PRI) was 4.75; individuals using teratogenic medication had the lowest PRI (0.32); 88% of these individuals used reversible contraception and 31% used long-acting reversible contraception.

Major finding:  Approximately 73% of sexually active young women received contraceptive counseling, which was associated with a significantly increased use of reversible and dual contraception, but not long-acting reversible contraception. At last reported vaginal sex, 65% reported using condoms, 49% reported using reversible contraception, and 12% reported using long-acting reversible contraception.

Study details: The data come from a cross-sectional survey of 177 hospitalized females aged 14 to 21 years at two academic medical centers; the surveys assessed sexual health behaviors, contraceptive use, contraceptive counseling, and pregnancy complications. Researchers calculated the Pregnancy Risk Index (the number per 100 individuals who will become pregnant in the next year).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Hunt JA et al. Hosp Pediatr. 2021 Sep 13. doi: 10.1542/hpeds.2021-005810.

Key clinical point: Women with potential contraindications to estrogen were significantly more likely than those without contraindication to use permanent contraception or no contraception

Major finding:  A total of 15% of women with potential contraindications to estrogen reported using the pill, patch, or ring, compared to 20% of women with no potential contraindications to estrogen. Women with contraindications to estrogen also were significantly more likely than those without contraindications to use permanent contraception (odds ratio vs. patch, pill, or ring 1.48) or no contraception (OR vs. patch, pill, or ring 1.37). 

Study details: The data come from surveys of 32,098 women aged 18-44 years who participated in the 2017 Behavioral Risk Factor Surveillance System, 16% of whom had at least one potential contraindication to estrogen.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Erly SJ et al. J Womens Health. 2021 Sep 1. doi: 10.1089/jwh.2020.8905. 

Key clinical point: Women with potential contraindications to estrogen were significantly more likely than those without contraindication to use permanent contraception or no contraception

Major finding:  A total of 15% of women with potential contraindications to estrogen reported using the pill, patch, or ring, compared to 20% of women with no potential contraindications to estrogen. Women with contraindications to estrogen also were significantly more likely than those without contraindications to use permanent contraception (odds ratio vs. patch, pill, or ring 1.48) or no contraception (OR vs. patch, pill, or ring 1.37). 

Study details: The data come from surveys of 32,098 women aged 18-44 years who participated in the 2017 Behavioral Risk Factor Surveillance System, 16% of whom had at least one potential contraindication to estrogen.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Erly SJ et al. J Womens Health. 2021 Sep 1. doi: 10.1089/jwh.2020.8905. 

Key clinical point: Women with potential contraindications to estrogen were significantly more likely than those without contraindication to use permanent contraception or no contraception

Major finding:  A total of 15% of women with potential contraindications to estrogen reported using the pill, patch, or ring, compared to 20% of women with no potential contraindications to estrogen. Women with contraindications to estrogen also were significantly more likely than those without contraindications to use permanent contraception (odds ratio vs. patch, pill, or ring 1.48) or no contraception (OR vs. patch, pill, or ring 1.37). 

Study details: The data come from surveys of 32,098 women aged 18-44 years who participated in the 2017 Behavioral Risk Factor Surveillance System, 16% of whom had at least one potential contraindication to estrogen.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Erly SJ et al. J Womens Health. 2021 Sep 1. doi: 10.1089/jwh.2020.8905. 

Key clinical point: Expulsion rates were similar for women using a 52 mg levonorgestrel intrauterine system for heavy menstrual bleeding and those who used it for contraception; a history of cesarean delivery increased the risk of expulsion in both groups.

Major finding:  Expulsion of the device occurred in 548 of the women with heavy menstrual bleeding (5.6%) and 315 of the women using the device for contraception (5.6%). The odds ratio for expulsion for women with a history of cesarean delivery in either group was 1.93.

Study details: The data come from an audit of 548 women who used a 52 mg levonorgestrel intrauterine system to manage heavy menstrual bleeding and 5,655 who used it for contraception.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Furlan RM et al. Contraception. 2021 Sep 5. doi: 10.1016/j.contraception.2021.09.001.

Key clinical point: Expulsion rates were similar for women using a 52 mg levonorgestrel intrauterine system for heavy menstrual bleeding and those who used it for contraception; a history of cesarean delivery increased the risk of expulsion in both groups.

Major finding:  Expulsion of the device occurred in 548 of the women with heavy menstrual bleeding (5.6%) and 315 of the women using the device for contraception (5.6%). The odds ratio for expulsion for women with a history of cesarean delivery in either group was 1.93.

Study details: The data come from an audit of 548 women who used a 52 mg levonorgestrel intrauterine system to manage heavy menstrual bleeding and 5,655 who used it for contraception.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Furlan RM et al. Contraception. 2021 Sep 5. doi: 10.1016/j.contraception.2021.09.001.

Key clinical point: Expulsion rates were similar for women using a 52 mg levonorgestrel intrauterine system for heavy menstrual bleeding and those who used it for contraception; a history of cesarean delivery increased the risk of expulsion in both groups.

Major finding:  Expulsion of the device occurred in 548 of the women with heavy menstrual bleeding (5.6%) and 315 of the women using the device for contraception (5.6%). The odds ratio for expulsion for women with a history of cesarean delivery in either group was 1.93.

Study details: The data come from an audit of 548 women who used a 52 mg levonorgestrel intrauterine system to manage heavy menstrual bleeding and 5,655 who used it for contraception.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Furlan RM et al. Contraception. 2021 Sep 5. doi: 10.1016/j.contraception.2021.09.001.

Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women

Major finding:  Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.

Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.  

Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.

Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.

Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women

Major finding:  Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.

Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.  

Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.

Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.

Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women

Major finding:  Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.

Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.  

Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.

Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.

Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.

Major finding:  Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.

Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring. 

Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.

Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.

Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.

Major finding:  Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.

Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring. 

Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.

Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.

Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.

Major finding:  Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.

Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring. 

Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.

Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.

Latin American countries have a high rate of SARS-CoV-2 infection and some of the highest COVID-19 deaths worldwide. Brazil, Colombia, Argentina, and Mexico have reported the highest number of confirmed cases. More recently has been reported that in series form US and Europe the mortality of COVID-19 has not been as high as reported in other hematological conditions and the response to vaccination also has bene described as high. In a recent report, Pagnano et al. (Leuk Lymphoma. 2021) has recently reported the clinical evolution and outcome of COVID-19 in patients with chronic myeloid leukemia in Latin America. In an observational multicenter study with a total of 92 patients with COVID-19 between March and December 2020 with 26% of whom were severe or critical. Eighty-one patients recovered (88%), and 11 (11.9%) died from COVID-19. Almost half of them had at least one comorbidity. Patients with a major molecular response presented superior overall survival compared to patients with no major molecular response (91 vs. 61%, respectively; P = 0.004). Patients in treatment-free remission and receiving tyrosine kinase inhibitors showed higher survival rates (100 and 89%) than patients who underwent hematopoietic stem cell transplantation and those who did not receive tyrosine kinase inhibitors (50 and 33%).

Currently the most common reason for TKI discontinuation is intolerance. Ma et al (Leuk Res. 2021) reports the long-term outcomes associated with switch to an alternative TKI after first-line therapy with a 2GTKI. Of 232 patients who initiated a 2GTKI during the study period, 76 (33 %) switched to an alternative TKI. Reasons for switching included intolerance (79 %) and resistance (21 %). Among the 60 patients who switched due to intolerance, 53 (88 %) were able to achieve or maintain a major molecular response (MMR) with 5-year progression-free survival (PFS) 90.5 % (95 % CI 90.4–90.6 %). However, amongst the 16 patients who switched due to resistance, 8 patients (50 %) were able to achieve MMR with 5-year PFS 80.4 % (95 % CI 80.2–80.6 %). Most patients who switched due to intolerance remained on their second-line TKI. Patients who switch for intolerance continue to enjoy excellent long term clinical outcomes.

Latin American countries have a high rate of SARS-CoV-2 infection and some of the highest COVID-19 deaths worldwide. Brazil, Colombia, Argentina, and Mexico have reported the highest number of confirmed cases. More recently has been reported that in series form US and Europe the mortality of COVID-19 has not been as high as reported in other hematological conditions and the response to vaccination also has bene described as high. In a recent report, Pagnano et al. (Leuk Lymphoma. 2021) has recently reported the clinical evolution and outcome of COVID-19 in patients with chronic myeloid leukemia in Latin America. In an observational multicenter study with a total of 92 patients with COVID-19 between March and December 2020 with 26% of whom were severe or critical. Eighty-one patients recovered (88%), and 11 (11.9%) died from COVID-19. Almost half of them had at least one comorbidity. Patients with a major molecular response presented superior overall survival compared to patients with no major molecular response (91 vs. 61%, respectively; P = 0.004). Patients in treatment-free remission and receiving tyrosine kinase inhibitors showed higher survival rates (100 and 89%) than patients who underwent hematopoietic stem cell transplantation and those who did not receive tyrosine kinase inhibitors (50 and 33%).

Currently the most common reason for TKI discontinuation is intolerance. Ma et al (Leuk Res. 2021) reports the long-term outcomes associated with switch to an alternative TKI after first-line therapy with a 2GTKI. Of 232 patients who initiated a 2GTKI during the study period, 76 (33 %) switched to an alternative TKI. Reasons for switching included intolerance (79 %) and resistance (21 %). Among the 60 patients who switched due to intolerance, 53 (88 %) were able to achieve or maintain a major molecular response (MMR) with 5-year progression-free survival (PFS) 90.5 % (95 % CI 90.4–90.6 %). However, amongst the 16 patients who switched due to resistance, 8 patients (50 %) were able to achieve MMR with 5-year PFS 80.4 % (95 % CI 80.2–80.6 %). Most patients who switched due to intolerance remained on their second-line TKI. Patients who switch for intolerance continue to enjoy excellent long term clinical outcomes.

Latin American countries have a high rate of SARS-CoV-2 infection and some of the highest COVID-19 deaths worldwide. Brazil, Colombia, Argentina, and Mexico have reported the highest number of confirmed cases. More recently has been reported that in series form US and Europe the mortality of COVID-19 has not been as high as reported in other hematological conditions and the response to vaccination also has bene described as high. In a recent report, Pagnano et al. (Leuk Lymphoma. 2021) has recently reported the clinical evolution and outcome of COVID-19 in patients with chronic myeloid leukemia in Latin America. In an observational multicenter study with a total of 92 patients with COVID-19 between March and December 2020 with 26% of whom were severe or critical. Eighty-one patients recovered (88%), and 11 (11.9%) died from COVID-19. Almost half of them had at least one comorbidity. Patients with a major molecular response presented superior overall survival compared to patients with no major molecular response (91 vs. 61%, respectively; P = 0.004). Patients in treatment-free remission and receiving tyrosine kinase inhibitors showed higher survival rates (100 and 89%) than patients who underwent hematopoietic stem cell transplantation and those who did not receive tyrosine kinase inhibitors (50 and 33%).

Currently the most common reason for TKI discontinuation is intolerance. Ma et al (Leuk Res. 2021) reports the long-term outcomes associated with switch to an alternative TKI after first-line therapy with a 2GTKI. Of 232 patients who initiated a 2GTKI during the study period, 76 (33 %) switched to an alternative TKI. Reasons for switching included intolerance (79 %) and resistance (21 %). Among the 60 patients who switched due to intolerance, 53 (88 %) were able to achieve or maintain a major molecular response (MMR) with 5-year progression-free survival (PFS) 90.5 % (95 % CI 90.4–90.6 %). However, amongst the 16 patients who switched due to resistance, 8 patients (50 %) were able to achieve MMR with 5-year PFS 80.4 % (95 % CI 80.2–80.6 %). Most patients who switched due to intolerance remained on their second-line TKI. Patients who switch for intolerance continue to enjoy excellent long term clinical outcomes.

Of the 50 patients enrolled, 90%, 8% and 2% had newly diagnosed AML, myelodysplastic syndrome and mixed phenotype acute leukemia respectively. Overall, 94% (95% confidence interval [CI], 83%-98%) had a composite complete response and 82% (95% CI, 68%-92%) achieved measurable residual disease negativity. At 12 months, the rates of duration of response, overall survival, and event-free survival were 74% (95% CI, 60%-92%), 85% (95% CI, 75%-97%), and 68% (95% CI, 54%-85%), respectively. The most common grade 3 or worse adverse events were febrile neutropenia (84%), infection (12%), and alanine aminotransferase elevations (12%). Only one patient had a p53 mutation and that patient did not respond.  Another study by Alwash et al, demonstrated that 15% of patients acquire a TP53 mutation during AML therapy.

The poor prognosis of patients with a p53 ,mutation was also seen in a retrospective study of patients with newly diagnosed or relapsed/refractory AML treated with 10-day decitabine + venetoclax (DEC10-VEN). Of the 118 patients, 35 had a TP53 mutation. Complete remission/complete remission with incomplete count recovery (57% vs 775), and overall response was better for patients without vs with a TP53 mutation. In addition, overall survival was dismal (5.2 months) for patients with TP53 mutation vs those without (19.4 months).

This study reiterates the need for newer therapies for this group of  patients with a TP53 mutation (Kim K et al). The overall outcome of patients treated with DEC10-VEN was  better compared to intensive chemotherapy (IC) in patients with relapsed refractory AML. This was evaluated in a retrospective study assessing the outcomes of adult patients with R/R AML treated with DEC10-VEN (n=65) a vs IC-based regimen (n=130) using propensity score-matched analysis. Patients receiving DEC10-VEN vs IC had superior overall response rate (odds ratio [OR], 3.28; P < .001), minimal residual disease negativity (OR, 2.48; P = .017), event-free survival (hazard ratio [HR], 0.46; P < .001), and overall survival (HR, 0.56; P = .008). Rates of refractory disease (OR, 0.46; P = .011) and 60-day mortality (OR, 0.40; P = .029) were significantly lower in patients receiving DEC10-VEN vs IC.

Of the 50 patients enrolled, 90%, 8% and 2% had newly diagnosed AML, myelodysplastic syndrome and mixed phenotype acute leukemia respectively. Overall, 94% (95% confidence interval [CI], 83%-98%) had a composite complete response and 82% (95% CI, 68%-92%) achieved measurable residual disease negativity. At 12 months, the rates of duration of response, overall survival, and event-free survival were 74% (95% CI, 60%-92%), 85% (95% CI, 75%-97%), and 68% (95% CI, 54%-85%), respectively. The most common grade 3 or worse adverse events were febrile neutropenia (84%), infection (12%), and alanine aminotransferase elevations (12%). Only one patient had a p53 mutation and that patient did not respond.  Another study by Alwash et al, demonstrated that 15% of patients acquire a TP53 mutation during AML therapy.

The poor prognosis of patients with a p53 ,mutation was also seen in a retrospective study of patients with newly diagnosed or relapsed/refractory AML treated with 10-day decitabine + venetoclax (DEC10-VEN). Of the 118 patients, 35 had a TP53 mutation. Complete remission/complete remission with incomplete count recovery (57% vs 775), and overall response was better for patients without vs with a TP53 mutation. In addition, overall survival was dismal (5.2 months) for patients with TP53 mutation vs those without (19.4 months).

This study reiterates the need for newer therapies for this group of  patients with a TP53 mutation (Kim K et al). The overall outcome of patients treated with DEC10-VEN was  better compared to intensive chemotherapy (IC) in patients with relapsed refractory AML. This was evaluated in a retrospective study assessing the outcomes of adult patients with R/R AML treated with DEC10-VEN (n=65) a vs IC-based regimen (n=130) using propensity score-matched analysis. Patients receiving DEC10-VEN vs IC had superior overall response rate (odds ratio [OR], 3.28; P < .001), minimal residual disease negativity (OR, 2.48; P = .017), event-free survival (hazard ratio [HR], 0.46; P < .001), and overall survival (HR, 0.56; P = .008). Rates of refractory disease (OR, 0.46; P = .011) and 60-day mortality (OR, 0.40; P = .029) were significantly lower in patients receiving DEC10-VEN vs IC.

Of the 50 patients enrolled, 90%, 8% and 2% had newly diagnosed AML, myelodysplastic syndrome and mixed phenotype acute leukemia respectively. Overall, 94% (95% confidence interval [CI], 83%-98%) had a composite complete response and 82% (95% CI, 68%-92%) achieved measurable residual disease negativity. At 12 months, the rates of duration of response, overall survival, and event-free survival were 74% (95% CI, 60%-92%), 85% (95% CI, 75%-97%), and 68% (95% CI, 54%-85%), respectively. The most common grade 3 or worse adverse events were febrile neutropenia (84%), infection (12%), and alanine aminotransferase elevations (12%). Only one patient had a p53 mutation and that patient did not respond.  Another study by Alwash et al, demonstrated that 15% of patients acquire a TP53 mutation during AML therapy.

The poor prognosis of patients with a p53 ,mutation was also seen in a retrospective study of patients with newly diagnosed or relapsed/refractory AML treated with 10-day decitabine + venetoclax (DEC10-VEN). Of the 118 patients, 35 had a TP53 mutation. Complete remission/complete remission with incomplete count recovery (57% vs 775), and overall response was better for patients without vs with a TP53 mutation. In addition, overall survival was dismal (5.2 months) for patients with TP53 mutation vs those without (19.4 months).

This study reiterates the need for newer therapies for this group of  patients with a TP53 mutation (Kim K et al). The overall outcome of patients treated with DEC10-VEN was  better compared to intensive chemotherapy (IC) in patients with relapsed refractory AML. This was evaluated in a retrospective study assessing the outcomes of adult patients with R/R AML treated with DEC10-VEN (n=65) a vs IC-based regimen (n=130) using propensity score-matched analysis. Patients receiving DEC10-VEN vs IC had superior overall response rate (odds ratio [OR], 3.28; P < .001), minimal residual disease negativity (OR, 2.48; P = .017), event-free survival (hazard ratio [HR], 0.46; P < .001), and overall survival (HR, 0.56; P = .008). Rates of refractory disease (OR, 0.46; P = .011) and 60-day mortality (OR, 0.40; P = .029) were significantly lower in patients receiving DEC10-VEN vs IC.

Our first study comes out of Sheffield, UK, and Halle, Germany, and looks at the correlation between sarcopenia and EPI (Jalal et al). Notably sarcopenia, or reduction in muscle mass, is a known complication of malnutrition and conditions like EPI. It has traditionally been difficult to diagnose because traditional methods have suffered from low accuracy (i.e., mid-arm circumference). In recent years, commercially available software has been developed to digitally assess skeletal muscle mass on axial CT imaging. Digital imaging allows for granular assessments of metrics such as myosteatosis and sacropenic obesity, both of which remained relatively elusive metrics in prior ways of assessing sarcopenia.

In this study, researchers postulate that, since CT scans are recently performed in the evaluation of those patients with suspected pancreatic pathology, it would be natural to assess for sarcopenia on said CT imaging. Identifying sarcopenia might allow clinicians to identify those patients with or at risk for EPI.

Patients referred to EUS for suspected pancreatic pathology were included in the study (except those found to have pancreatic cancer). This prospective study included 102 patients with suspected or proven benign pancreatic pathology, chronic pancreatitis, or recurrent pancreatic type pain. Fecal elastase testing was used to determine those with EPI, and digital CT analysis was used to recognize patients with sarcopenia.

Overall, EPI was present in 45.1% of patients. The prevalence of sarcopenia (67.4% vs. 37.55%; P < .003), myosteatosis (52.2% vs. 10.7%; P = .046), and sarcopenic obesity (66.7% vs. 24.3%; P = .002) was significantly higher in patients with vs without EPI. Sarcopenia (odds ratio [OR], 4.8; P = .02) was strongly associated with EPI. The authors conclude that digital skeletal mass analysis can be performed on patients already undergoing CT scans for suspected pancreatic pathology for possible further diagnosis, risk assessment and to better inform clinical management.

Another notable study came out of Baylor College of Medicine that looked at the clinical significance of fatty pancreas (FP) (Krill et al). Diffuse echogenicity of the pancreas is a common finding on endoscopic ultrasound (EUS), but of unknown clinical significance. Krill’s group aimed to determine if diffuse fatty infiltration of the pancreas had any clinical implication on pancreatic function. They conducted a retrospective case-control study comparing adult patients with diffuse echogenicity of the pancreas to those without known pancreatic disease with chronic diarrhea. Notably, the incidence of EPI (47% vs. 6%) and chronic pancreatitis (18% vs. 0%) was significantly higher (both P < .001) in the fatty pancreas group vs. the control group. 

The authors conclude “Our findings suggest that FP may not merely be a benign sonographic finding, but rather imply underlying parenchymal dysfunction, such as that seen when fat deposition occurs in the liver (i.e., nonalcoholic fatty liver disease).” Additionally the paper states that recent literature has found an association between fatty pancreas and increasing body mass index (BMI), hyperlipidemia, insulin resistance, and metabolic syndrome. Perhaps we will further appreciate the likely prominent and under-appreciated role of metabolic syndrome in the development of acute and chronic pancreatitis.

References:

Jalal M, Rosendahl J, Campbell JA, Vinayagam R, Al-Mukhtar A, Hopper AD. Identification of “digital sarcopenia” can aid the detection of pancreatic exocrine insufficiency and malnutrition assessment in patients with suspected pancreatic pathology. Dig Dis 2021 (Jun 8), (in press).

Krill JT, Szafron D, Elhanafi S, et al. Endoscopic ultrasound finding of diffuse echogenicity in the pancreas, is it relevant? Dig Dis Sci 2021 (Aug 4), (in press).

Our first study comes out of Sheffield, UK, and Halle, Germany, and looks at the correlation between sarcopenia and EPI (Jalal et al). Notably sarcopenia, or reduction in muscle mass, is a known complication of malnutrition and conditions like EPI. It has traditionally been difficult to diagnose because traditional methods have suffered from low accuracy (i.e., mid-arm circumference). In recent years, commercially available software has been developed to digitally assess skeletal muscle mass on axial CT imaging. Digital imaging allows for granular assessments of metrics such as myosteatosis and sacropenic obesity, both of which remained relatively elusive metrics in prior ways of assessing sarcopenia.

In this study, researchers postulate that, since CT scans are recently performed in the evaluation of those patients with suspected pancreatic pathology, it would be natural to assess for sarcopenia on said CT imaging. Identifying sarcopenia might allow clinicians to identify those patients with or at risk for EPI.

Patients referred to EUS for suspected pancreatic pathology were included in the study (except those found to have pancreatic cancer). This prospective study included 102 patients with suspected or proven benign pancreatic pathology, chronic pancreatitis, or recurrent pancreatic type pain. Fecal elastase testing was used to determine those with EPI, and digital CT analysis was used to recognize patients with sarcopenia.

Overall, EPI was present in 45.1% of patients. The prevalence of sarcopenia (67.4% vs. 37.55%; P < .003), myosteatosis (52.2% vs. 10.7%; P = .046), and sarcopenic obesity (66.7% vs. 24.3%; P = .002) was significantly higher in patients with vs without EPI. Sarcopenia (odds ratio [OR], 4.8; P = .02) was strongly associated with EPI. The authors conclude that digital skeletal mass analysis can be performed on patients already undergoing CT scans for suspected pancreatic pathology for possible further diagnosis, risk assessment and to better inform clinical management.

Another notable study came out of Baylor College of Medicine that looked at the clinical significance of fatty pancreas (FP) (Krill et al). Diffuse echogenicity of the pancreas is a common finding on endoscopic ultrasound (EUS), but of unknown clinical significance. Krill’s group aimed to determine if diffuse fatty infiltration of the pancreas had any clinical implication on pancreatic function. They conducted a retrospective case-control study comparing adult patients with diffuse echogenicity of the pancreas to those without known pancreatic disease with chronic diarrhea. Notably, the incidence of EPI (47% vs. 6%) and chronic pancreatitis (18% vs. 0%) was significantly higher (both P < .001) in the fatty pancreas group vs. the control group. 

The authors conclude “Our findings suggest that FP may not merely be a benign sonographic finding, but rather imply underlying parenchymal dysfunction, such as that seen when fat deposition occurs in the liver (i.e., nonalcoholic fatty liver disease).” Additionally the paper states that recent literature has found an association between fatty pancreas and increasing body mass index (BMI), hyperlipidemia, insulin resistance, and metabolic syndrome. Perhaps we will further appreciate the likely prominent and under-appreciated role of metabolic syndrome in the development of acute and chronic pancreatitis.

References:

Jalal M, Rosendahl J, Campbell JA, Vinayagam R, Al-Mukhtar A, Hopper AD. Identification of “digital sarcopenia” can aid the detection of pancreatic exocrine insufficiency and malnutrition assessment in patients with suspected pancreatic pathology. Dig Dis 2021 (Jun 8), (in press).

Krill JT, Szafron D, Elhanafi S, et al. Endoscopic ultrasound finding of diffuse echogenicity in the pancreas, is it relevant? Dig Dis Sci 2021 (Aug 4), (in press).

Our first study comes out of Sheffield, UK, and Halle, Germany, and looks at the correlation between sarcopenia and EPI (Jalal et al). Notably sarcopenia, or reduction in muscle mass, is a known complication of malnutrition and conditions like EPI. It has traditionally been difficult to diagnose because traditional methods have suffered from low accuracy (i.e., mid-arm circumference). In recent years, commercially available software has been developed to digitally assess skeletal muscle mass on axial CT imaging. Digital imaging allows for granular assessments of metrics such as myosteatosis and sacropenic obesity, both of which remained relatively elusive metrics in prior ways of assessing sarcopenia.

In this study, researchers postulate that, since CT scans are recently performed in the evaluation of those patients with suspected pancreatic pathology, it would be natural to assess for sarcopenia on said CT imaging. Identifying sarcopenia might allow clinicians to identify those patients with or at risk for EPI.

Patients referred to EUS for suspected pancreatic pathology were included in the study (except those found to have pancreatic cancer). This prospective study included 102 patients with suspected or proven benign pancreatic pathology, chronic pancreatitis, or recurrent pancreatic type pain. Fecal elastase testing was used to determine those with EPI, and digital CT analysis was used to recognize patients with sarcopenia.

Overall, EPI was present in 45.1% of patients. The prevalence of sarcopenia (67.4% vs. 37.55%; P < .003), myosteatosis (52.2% vs. 10.7%; P = .046), and sarcopenic obesity (66.7% vs. 24.3%; P = .002) was significantly higher in patients with vs without EPI. Sarcopenia (odds ratio [OR], 4.8; P = .02) was strongly associated with EPI. The authors conclude that digital skeletal mass analysis can be performed on patients already undergoing CT scans for suspected pancreatic pathology for possible further diagnosis, risk assessment and to better inform clinical management.

Another notable study came out of Baylor College of Medicine that looked at the clinical significance of fatty pancreas (FP) (Krill et al). Diffuse echogenicity of the pancreas is a common finding on endoscopic ultrasound (EUS), but of unknown clinical significance. Krill’s group aimed to determine if diffuse fatty infiltration of the pancreas had any clinical implication on pancreatic function. They conducted a retrospective case-control study comparing adult patients with diffuse echogenicity of the pancreas to those without known pancreatic disease with chronic diarrhea. Notably, the incidence of EPI (47% vs. 6%) and chronic pancreatitis (18% vs. 0%) was significantly higher (both P < .001) in the fatty pancreas group vs. the control group. 

The authors conclude “Our findings suggest that FP may not merely be a benign sonographic finding, but rather imply underlying parenchymal dysfunction, such as that seen when fat deposition occurs in the liver (i.e., nonalcoholic fatty liver disease).” Additionally the paper states that recent literature has found an association between fatty pancreas and increasing body mass index (BMI), hyperlipidemia, insulin resistance, and metabolic syndrome. Perhaps we will further appreciate the likely prominent and under-appreciated role of metabolic syndrome in the development of acute and chronic pancreatitis.

References:

Jalal M, Rosendahl J, Campbell JA, Vinayagam R, Al-Mukhtar A, Hopper AD. Identification of “digital sarcopenia” can aid the detection of pancreatic exocrine insufficiency and malnutrition assessment in patients with suspected pancreatic pathology. Dig Dis 2021 (Jun 8), (in press).

Krill JT, Szafron D, Elhanafi S, et al. Endoscopic ultrasound finding of diffuse echogenicity in the pancreas, is it relevant? Dig Dis Sci 2021 (Aug 4), (in press).