The Diagnosis: Microvenular Hemangioma  

Microvenular hemangioma is an acquired benign vascular neoplasm that was described by Hunt et al¹ in 1991, though Bantel et al² reported a similar entity termed micropapillary angioma in 1989. Microvenular hemangioma typically presents as a solitary, slowly enlarging, red to violaceous, asymptomatic papule, plaque, or nodule measuring 5 to 20 mm in diameter. It usually is located on the trunk, arms, or legs of young adults without any gender predilection. Microvenular hemangioma is rare.³ The etiology has not been elucidated, though a relationship with hormonal factors such as pregnancy or hormonal contraceptives has been described.²  

Histopathologically, microvenular hemangioma has a characteristic morphology. It is comprised of a well-circumscribed collection of thin-walled blood vessels with narrow lumens (quiz image).⁴ The blood vessels tend to infiltrate the superficial and deep dermis and are surrounded by a collagenous or desmoplastic stroma. The endothelial cells are normal in size without atypia, mitotic figures, or pleomorphism. A mild lymphoplasmacytic inflammatory infiltrate sometimes is present. Microvenular hemangioma expresses many vascular markers confirming its endothelial origin, including CD34, CD31, WT1, factor VIII-related antigen, and von Willebrand factor.³ Moreover, WT1 staining suggests the lesion is a vascular proliferative growth, as it usually is negative in vascular malformations due to errors of endothelial development.⁵ In addition, it lacks expression of podoplanin (D2-40), which also supports a vascular as opposed to a lymphatic origin.⁴  

Cutaneous angiosarcoma is a rare and highly aggressive malignant neoplasm of the vascular endothelium with a predilection for the skin and superficial soft tissue. Clinical presentation is variable, as it can arise sporadically, commonly on the scalp and face of elderly patients, in areas of chronic radiation therapy, or in association with chronic lymphedema (Stewart-Treves syndrome).⁶ Sporadic neoplasms appear clinically as purpuric macules, plaques, or nodules and are more common in elderly men than women. They are aggressive tumors that tend to recur and metastasize despite aggressive therapy and therefore carry a poor prognosis.⁷ Histopathologically, well-differentiated tumors are characterized by irregular dissecting vessels lined with crowded inconspicuous endothelial cells (Figure 1). Cutaneous angiosarcoma is poorly circumscribed with marked cytologic atypia, and the vessels can take on a sinusoidal growth pattern.⁸ 

Kaposi sarcoma (KS) is a virally induced lymphoangioproliferative disease, with human herpesvirus 8 as the implicated agent. There are 4 principal clinical variants of KS: epidemic or AIDS-associated KS, endemic or African KS, KS due to iatrogenic immunosuppression, and Mediterranean or classic KS.⁹ Cutaneous lesions vary from pink patches to dark purple plaques or nodules that commonly occur on the lower legs¹⁰; however, the clinical appearance of KS varies depending on the clinical variant and stage. Histopathologically, early lesions of KS exhibit a superficial dermal proliferation of small angulated and jagged vessels that tend to separate into collagen bundles and are surrounded by a lymphoplasmacytic perivascular infiltrate. These native vascular structures often are surrounded by more ectatic neoplastic channels with plump endothelial cells, known as the promontory sign (Figure 2).¹¹ With more advanced lesions, the proliferation of slitlike vessels becomes more cellular and extends deeper into the dermis and subcutis. Although the histopathologic features vary with the stage of the lesion, they do not notably vary between clinical subtypes. 

Targetoid hemosiderotic hemangioma, also known as hobnail hemangioma, is a small, benign, vascular tumor that usually affects the trunk, arms, and legs in young to middle-aged adults without a gender predilection. Clinically, it appears as a small, solitary, red to purple papule or macule that typically is surrounded by a pale thin area and a peripheral ecchymotic ring, creating a targetoid appearance, thus the term targetoid hemosiderotic hemangioma.¹² Histopathologically, there is a prominent dermal vascular proliferation. In the papillary dermis, there are dilated superficial vessels lined with a single layer of endothelial cells characterized by a plump, hobnail-like appearance that protrude into the lumen (Figure 3). In the deeper dermis, the vascular spaces are angulated and slitlike and appear to dissect through collagen bundles. Hemosiderin, thrombi, extravasated erythrocytes, and a lymphocytic infiltrate also are often seen.¹³  

Tufted angioma is a rare benign vascular lesion that usually presents as an acquired lesion in children and young adults, though it may be congenital. It is commonly localized to the skin and subcutaneous tissues. Clinically, the lesions appear as red to purple patches and plaques that typically are located on the neck or trunk. More than 50% of cases present during the first year of life and slowly spread to involve large areas before stabilizing in size.¹⁴ Partial spontaneous regression may occur, but complete regression is rare.¹⁵ Lesions usually are asymptomatic but may be painful during periods of platelet trapping (Kasabach-Merritt phenomenon), which may develop in congenital cases. Tufted angioma is named for its characteristic histopathologic appearance, which consists of multiple discrete lobules or tufts of tightly packed capillaries in a cannonball-like appearance throughout the dermis and subcutis (Figure 4).^14,15  

The Diagnosis: Microvenular Hemangioma  

Microvenular hemangioma is an acquired benign vascular neoplasm that was described by Hunt et al¹ in 1991, though Bantel et al² reported a similar entity termed micropapillary angioma in 1989. Microvenular hemangioma typically presents as a solitary, slowly enlarging, red to violaceous, asymptomatic papule, plaque, or nodule measuring 5 to 20 mm in diameter. It usually is located on the trunk, arms, or legs of young adults without any gender predilection. Microvenular hemangioma is rare.³ The etiology has not been elucidated, though a relationship with hormonal factors such as pregnancy or hormonal contraceptives has been described.²  

Histopathologically, microvenular hemangioma has a characteristic morphology. It is comprised of a well-circumscribed collection of thin-walled blood vessels with narrow lumens (quiz image).⁴ The blood vessels tend to infiltrate the superficial and deep dermis and are surrounded by a collagenous or desmoplastic stroma. The endothelial cells are normal in size without atypia, mitotic figures, or pleomorphism. A mild lymphoplasmacytic inflammatory infiltrate sometimes is present. Microvenular hemangioma expresses many vascular markers confirming its endothelial origin, including CD34, CD31, WT1, factor VIII-related antigen, and von Willebrand factor.³ Moreover, WT1 staining suggests the lesion is a vascular proliferative growth, as it usually is negative in vascular malformations due to errors of endothelial development.⁵ In addition, it lacks expression of podoplanin (D2-40), which also supports a vascular as opposed to a lymphatic origin.⁴  

Cutaneous angiosarcoma is a rare and highly aggressive malignant neoplasm of the vascular endothelium with a predilection for the skin and superficial soft tissue. Clinical presentation is variable, as it can arise sporadically, commonly on the scalp and face of elderly patients, in areas of chronic radiation therapy, or in association with chronic lymphedema (Stewart-Treves syndrome).⁶ Sporadic neoplasms appear clinically as purpuric macules, plaques, or nodules and are more common in elderly men than women. They are aggressive tumors that tend to recur and metastasize despite aggressive therapy and therefore carry a poor prognosis.⁷ Histopathologically, well-differentiated tumors are characterized by irregular dissecting vessels lined with crowded inconspicuous endothelial cells (Figure 1). Cutaneous angiosarcoma is poorly circumscribed with marked cytologic atypia, and the vessels can take on a sinusoidal growth pattern.⁸ 

Kaposi sarcoma (KS) is a virally induced lymphoangioproliferative disease, with human herpesvirus 8 as the implicated agent. There are 4 principal clinical variants of KS: epidemic or AIDS-associated KS, endemic or African KS, KS due to iatrogenic immunosuppression, and Mediterranean or classic KS.⁹ Cutaneous lesions vary from pink patches to dark purple plaques or nodules that commonly occur on the lower legs¹⁰; however, the clinical appearance of KS varies depending on the clinical variant and stage. Histopathologically, early lesions of KS exhibit a superficial dermal proliferation of small angulated and jagged vessels that tend to separate into collagen bundles and are surrounded by a lymphoplasmacytic perivascular infiltrate. These native vascular structures often are surrounded by more ectatic neoplastic channels with plump endothelial cells, known as the promontory sign (Figure 2).¹¹ With more advanced lesions, the proliferation of slitlike vessels becomes more cellular and extends deeper into the dermis and subcutis. Although the histopathologic features vary with the stage of the lesion, they do not notably vary between clinical subtypes. 

Targetoid hemosiderotic hemangioma, also known as hobnail hemangioma, is a small, benign, vascular tumor that usually affects the trunk, arms, and legs in young to middle-aged adults without a gender predilection. Clinically, it appears as a small, solitary, red to purple papule or macule that typically is surrounded by a pale thin area and a peripheral ecchymotic ring, creating a targetoid appearance, thus the term targetoid hemosiderotic hemangioma.¹² Histopathologically, there is a prominent dermal vascular proliferation. In the papillary dermis, there are dilated superficial vessels lined with a single layer of endothelial cells characterized by a plump, hobnail-like appearance that protrude into the lumen (Figure 3). In the deeper dermis, the vascular spaces are angulated and slitlike and appear to dissect through collagen bundles. Hemosiderin, thrombi, extravasated erythrocytes, and a lymphocytic infiltrate also are often seen.¹³  

Tufted angioma is a rare benign vascular lesion that usually presents as an acquired lesion in children and young adults, though it may be congenital. It is commonly localized to the skin and subcutaneous tissues. Clinically, the lesions appear as red to purple patches and plaques that typically are located on the neck or trunk. More than 50% of cases present during the first year of life and slowly spread to involve large areas before stabilizing in size.¹⁴ Partial spontaneous regression may occur, but complete regression is rare.¹⁵ Lesions usually are asymptomatic but may be painful during periods of platelet trapping (Kasabach-Merritt phenomenon), which may develop in congenital cases. Tufted angioma is named for its characteristic histopathologic appearance, which consists of multiple discrete lobules or tufts of tightly packed capillaries in a cannonball-like appearance throughout the dermis and subcutis (Figure 4).^14,15  

The Diagnosis: Microvenular Hemangioma  

Microvenular hemangioma is an acquired benign vascular neoplasm that was described by Hunt et al¹ in 1991, though Bantel et al² reported a similar entity termed micropapillary angioma in 1989. Microvenular hemangioma typically presents as a solitary, slowly enlarging, red to violaceous, asymptomatic papule, plaque, or nodule measuring 5 to 20 mm in diameter. It usually is located on the trunk, arms, or legs of young adults without any gender predilection. Microvenular hemangioma is rare.³ The etiology has not been elucidated, though a relationship with hormonal factors such as pregnancy or hormonal contraceptives has been described.²  

Histopathologically, microvenular hemangioma has a characteristic morphology. It is comprised of a well-circumscribed collection of thin-walled blood vessels with narrow lumens (quiz image).⁴ The blood vessels tend to infiltrate the superficial and deep dermis and are surrounded by a collagenous or desmoplastic stroma. The endothelial cells are normal in size without atypia, mitotic figures, or pleomorphism. A mild lymphoplasmacytic inflammatory infiltrate sometimes is present. Microvenular hemangioma expresses many vascular markers confirming its endothelial origin, including CD34, CD31, WT1, factor VIII-related antigen, and von Willebrand factor.³ Moreover, WT1 staining suggests the lesion is a vascular proliferative growth, as it usually is negative in vascular malformations due to errors of endothelial development.⁵ In addition, it lacks expression of podoplanin (D2-40), which also supports a vascular as opposed to a lymphatic origin.⁴  

Cutaneous angiosarcoma is a rare and highly aggressive malignant neoplasm of the vascular endothelium with a predilection for the skin and superficial soft tissue. Clinical presentation is variable, as it can arise sporadically, commonly on the scalp and face of elderly patients, in areas of chronic radiation therapy, or in association with chronic lymphedema (Stewart-Treves syndrome).⁶ Sporadic neoplasms appear clinically as purpuric macules, plaques, or nodules and are more common in elderly men than women. They are aggressive tumors that tend to recur and metastasize despite aggressive therapy and therefore carry a poor prognosis.⁷ Histopathologically, well-differentiated tumors are characterized by irregular dissecting vessels lined with crowded inconspicuous endothelial cells (Figure 1). Cutaneous angiosarcoma is poorly circumscribed with marked cytologic atypia, and the vessels can take on a sinusoidal growth pattern.⁸ 

Kaposi sarcoma (KS) is a virally induced lymphoangioproliferative disease, with human herpesvirus 8 as the implicated agent. There are 4 principal clinical variants of KS: epidemic or AIDS-associated KS, endemic or African KS, KS due to iatrogenic immunosuppression, and Mediterranean or classic KS.⁹ Cutaneous lesions vary from pink patches to dark purple plaques or nodules that commonly occur on the lower legs¹⁰; however, the clinical appearance of KS varies depending on the clinical variant and stage. Histopathologically, early lesions of KS exhibit a superficial dermal proliferation of small angulated and jagged vessels that tend to separate into collagen bundles and are surrounded by a lymphoplasmacytic perivascular infiltrate. These native vascular structures often are surrounded by more ectatic neoplastic channels with plump endothelial cells, known as the promontory sign (Figure 2).¹¹ With more advanced lesions, the proliferation of slitlike vessels becomes more cellular and extends deeper into the dermis and subcutis. Although the histopathologic features vary with the stage of the lesion, they do not notably vary between clinical subtypes. 

Targetoid hemosiderotic hemangioma, also known as hobnail hemangioma, is a small, benign, vascular tumor that usually affects the trunk, arms, and legs in young to middle-aged adults without a gender predilection. Clinically, it appears as a small, solitary, red to purple papule or macule that typically is surrounded by a pale thin area and a peripheral ecchymotic ring, creating a targetoid appearance, thus the term targetoid hemosiderotic hemangioma.¹² Histopathologically, there is a prominent dermal vascular proliferation. In the papillary dermis, there are dilated superficial vessels lined with a single layer of endothelial cells characterized by a plump, hobnail-like appearance that protrude into the lumen (Figure 3). In the deeper dermis, the vascular spaces are angulated and slitlike and appear to dissect through collagen bundles. Hemosiderin, thrombi, extravasated erythrocytes, and a lymphocytic infiltrate also are often seen.¹³  

Tufted angioma is a rare benign vascular lesion that usually presents as an acquired lesion in children and young adults, though it may be congenital. It is commonly localized to the skin and subcutaneous tissues. Clinically, the lesions appear as red to purple patches and plaques that typically are located on the neck or trunk. More than 50% of cases present during the first year of life and slowly spread to involve large areas before stabilizing in size.¹⁴ Partial spontaneous regression may occur, but complete regression is rare.¹⁵ Lesions usually are asymptomatic but may be painful during periods of platelet trapping (Kasabach-Merritt phenomenon), which may develop in congenital cases. Tufted angioma is named for its characteristic histopathologic appearance, which consists of multiple discrete lobules or tufts of tightly packed capillaries in a cannonball-like appearance throughout the dermis and subcutis (Figure 4).^14,15  

CHICAGO – Subcutaneous (SC) daratumumab is noninferior to intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma (MM), according findings from a phase 3 trial.

In the COLUMBA trial, SC daratumumab proved noninferior to IV daratumumab with regard to overall response rate and maximum trough concentration (Ctrough).

The safety profiles of the two formulations were similar, although patients who received SC daratumumab had a lower rate of infusion-related reactions. SC daratumumab also had a lower treatment burden.

“The COLUMBA study shows that [SC daratumumab] can be used in every myeloma patient [as a] single agent or, maybe in the future, in combination with the different backbones,” said Maria-Victoria Mateos, MD, PhD, of University Hospital of Salamanca (Spain).

Dr. Mateos presented results from the COLUMBA trial at the annual meeting of the American Society of Clinical Oncology.

Dr. Mateos cited a previous phase 1b study that had suggested that SC daratumumab might produce similar results as IV daratumumab (Blood. 2017;130:838) while providing a more convenient delivery method. She pointed out that infusions of IV daratumumab can last hours, while the SC formulation can be delivered in minutes.

The aim of the phase 3 COLUMBA study was to compare the IV and SC formulations head-to-head. The trial enrolled 522 patients with relapsed/refractory multiple myeloma. They were randomized to receive daratumumab SC (n = 263) or IV (n = 259).

The median patient age was 68 years (range, 33-92 years) in the IV arm and 65 years (range, 42-84 years) in the SC arm. Patients had received a median of four prior lines of therapy (range, 1-15 in the IV arm and 2-12 in the SC arm). Most patients were refractory to their last line of therapy – 85% in the IV arm and 80% in the SC arm – and most patients had standard-risk cytogenetics – 83% and 74%, respectively.

Treatment

Patients received SC daratumumab at 1,800 mg and IV daratumumab at 16 mg/kg. Both were given weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter until disease progression.

The median duration of the first infusion was 421 minutes in the IV arm and 5 minutes in the SC arm. The median duration of the second infusion was 255 minutes and 5 minutes, respectively, and the median duration of subsequent infusions was 205 minutes and 5 minutes, respectively.

At a median follow-up of 7.46 months, 57% of patients in each arm had discontinued the study treatment. The most common reasons for discontinuation were progression – 44% of the IV arm and 43% of the SC arm – and adverse events (AEs) – 8% and 7%, respectively.

Safety

Dr. Mateos said the safety profiles of IV and SC daratumumab were comparable. However, infusion-related reactions were significantly less likely in the SC arm, occurring in 12.7% of those patients and 34.5% of patients in the IV arm (P less than .0001).

Grade 3 or higher treatment-emergent AEs occurred in 49% of patients in the IV arm and 46% of those in the SC arm. Rates of grade 5 AEs were 7% and 5%, respectively. The most common grade 3/4 AEs (in the IV and SC arms, respectively) were anemia (14% and 13%), thrombocytopenia (14% for both), neutropenia (8% and 13%), lymphopenia (6% and 5%), and hypertension (6% and 3%).

Efficacy

One of the study’s primary endpoints was overall response rate, which was 37.1% in the IV arm and 41.1% in the SC arm (relative risk, 1.11; 95% CI, 0.89-1.37; P less than .0001). This met the criteria for noninferiority, and overall response rates were comparable across all patient subgroups, Dr. Mateos noted.

The rates of complete response or stringent complete response were also comparable at 2.7% in the IV arm and 1.9% in the SC arm. Rates of very good partial response were 17.0% and 19.0%, respectively.

The study’s other primary endpoint was maximum Ctrough predose on day 1 of cycle 3. The ratio of maximum Ctrough for daratumumab SC over IV was 107.93% (90% CI, 95.74%-121.67%), which met the noninferiority criterion.

Survival outcomes were also similar between the IV and SC arms. The median progression-free survival was 6.1 months and 5.6 months, respectively (P = .9258). The rate of overall survival at 6 months was 83.0% and 87.5%, respectively (P = .6032).

Considering these results together, Dr. Mateos and colleagues concluded that SC daratumumab is noninferior to IV daratumumab.

“[SC daratumumab] has a reduced treatment burden due to a considerably shorter administration duration, and patients treated with [SC daratumumab] reported higher satisfaction with therapy,” Dr. Mateos said.

The results support the use of flat-dose 1,800-mg SC daratumumab, which is comparable with the IV formulation, she said.

The COLUMBA trial was sponsored by Janssen Research & Development. Dr. Mateos reported relationships with Amgen, Celgene, Janssen-Cilag, and Takeda.

[email protected]

SOURCE: Mateos MV et al. ASCO 2019, Abstract 8005.

CHICAGO – Subcutaneous (SC) daratumumab is noninferior to intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma (MM), according findings from a phase 3 trial.

In the COLUMBA trial, SC daratumumab proved noninferior to IV daratumumab with regard to overall response rate and maximum trough concentration (Ctrough).

The safety profiles of the two formulations were similar, although patients who received SC daratumumab had a lower rate of infusion-related reactions. SC daratumumab also had a lower treatment burden.

“The COLUMBA study shows that [SC daratumumab] can be used in every myeloma patient [as a] single agent or, maybe in the future, in combination with the different backbones,” said Maria-Victoria Mateos, MD, PhD, of University Hospital of Salamanca (Spain).

Dr. Mateos presented results from the COLUMBA trial at the annual meeting of the American Society of Clinical Oncology.

Dr. Mateos cited a previous phase 1b study that had suggested that SC daratumumab might produce similar results as IV daratumumab (Blood. 2017;130:838) while providing a more convenient delivery method. She pointed out that infusions of IV daratumumab can last hours, while the SC formulation can be delivered in minutes.

The aim of the phase 3 COLUMBA study was to compare the IV and SC formulations head-to-head. The trial enrolled 522 patients with relapsed/refractory multiple myeloma. They were randomized to receive daratumumab SC (n = 263) or IV (n = 259).

The median patient age was 68 years (range, 33-92 years) in the IV arm and 65 years (range, 42-84 years) in the SC arm. Patients had received a median of four prior lines of therapy (range, 1-15 in the IV arm and 2-12 in the SC arm). Most patients were refractory to their last line of therapy – 85% in the IV arm and 80% in the SC arm – and most patients had standard-risk cytogenetics – 83% and 74%, respectively.

Treatment

Patients received SC daratumumab at 1,800 mg and IV daratumumab at 16 mg/kg. Both were given weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter until disease progression.

The median duration of the first infusion was 421 minutes in the IV arm and 5 minutes in the SC arm. The median duration of the second infusion was 255 minutes and 5 minutes, respectively, and the median duration of subsequent infusions was 205 minutes and 5 minutes, respectively.

At a median follow-up of 7.46 months, 57% of patients in each arm had discontinued the study treatment. The most common reasons for discontinuation were progression – 44% of the IV arm and 43% of the SC arm – and adverse events (AEs) – 8% and 7%, respectively.

Safety

Dr. Mateos said the safety profiles of IV and SC daratumumab were comparable. However, infusion-related reactions were significantly less likely in the SC arm, occurring in 12.7% of those patients and 34.5% of patients in the IV arm (P less than .0001).

Grade 3 or higher treatment-emergent AEs occurred in 49% of patients in the IV arm and 46% of those in the SC arm. Rates of grade 5 AEs were 7% and 5%, respectively. The most common grade 3/4 AEs (in the IV and SC arms, respectively) were anemia (14% and 13%), thrombocytopenia (14% for both), neutropenia (8% and 13%), lymphopenia (6% and 5%), and hypertension (6% and 3%).

Efficacy

One of the study’s primary endpoints was overall response rate, which was 37.1% in the IV arm and 41.1% in the SC arm (relative risk, 1.11; 95% CI, 0.89-1.37; P less than .0001). This met the criteria for noninferiority, and overall response rates were comparable across all patient subgroups, Dr. Mateos noted.

The rates of complete response or stringent complete response were also comparable at 2.7% in the IV arm and 1.9% in the SC arm. Rates of very good partial response were 17.0% and 19.0%, respectively.

The study’s other primary endpoint was maximum Ctrough predose on day 1 of cycle 3. The ratio of maximum Ctrough for daratumumab SC over IV was 107.93% (90% CI, 95.74%-121.67%), which met the noninferiority criterion.

Survival outcomes were also similar between the IV and SC arms. The median progression-free survival was 6.1 months and 5.6 months, respectively (P = .9258). The rate of overall survival at 6 months was 83.0% and 87.5%, respectively (P = .6032).

Considering these results together, Dr. Mateos and colleagues concluded that SC daratumumab is noninferior to IV daratumumab.

“[SC daratumumab] has a reduced treatment burden due to a considerably shorter administration duration, and patients treated with [SC daratumumab] reported higher satisfaction with therapy,” Dr. Mateos said.

The results support the use of flat-dose 1,800-mg SC daratumumab, which is comparable with the IV formulation, she said.

The COLUMBA trial was sponsored by Janssen Research & Development. Dr. Mateos reported relationships with Amgen, Celgene, Janssen-Cilag, and Takeda.

[email protected]

SOURCE: Mateos MV et al. ASCO 2019, Abstract 8005.

CHICAGO – Subcutaneous (SC) daratumumab is noninferior to intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma (MM), according findings from a phase 3 trial.

In the COLUMBA trial, SC daratumumab proved noninferior to IV daratumumab with regard to overall response rate and maximum trough concentration (Ctrough).

The safety profiles of the two formulations were similar, although patients who received SC daratumumab had a lower rate of infusion-related reactions. SC daratumumab also had a lower treatment burden.

“The COLUMBA study shows that [SC daratumumab] can be used in every myeloma patient [as a] single agent or, maybe in the future, in combination with the different backbones,” said Maria-Victoria Mateos, MD, PhD, of University Hospital of Salamanca (Spain).

Dr. Mateos presented results from the COLUMBA trial at the annual meeting of the American Society of Clinical Oncology.

Dr. Mateos cited a previous phase 1b study that had suggested that SC daratumumab might produce similar results as IV daratumumab (Blood. 2017;130:838) while providing a more convenient delivery method. She pointed out that infusions of IV daratumumab can last hours, while the SC formulation can be delivered in minutes.

The aim of the phase 3 COLUMBA study was to compare the IV and SC formulations head-to-head. The trial enrolled 522 patients with relapsed/refractory multiple myeloma. They were randomized to receive daratumumab SC (n = 263) or IV (n = 259).

The median patient age was 68 years (range, 33-92 years) in the IV arm and 65 years (range, 42-84 years) in the SC arm. Patients had received a median of four prior lines of therapy (range, 1-15 in the IV arm and 2-12 in the SC arm). Most patients were refractory to their last line of therapy – 85% in the IV arm and 80% in the SC arm – and most patients had standard-risk cytogenetics – 83% and 74%, respectively.

Treatment

Patients received SC daratumumab at 1,800 mg and IV daratumumab at 16 mg/kg. Both were given weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter until disease progression.

The median duration of the first infusion was 421 minutes in the IV arm and 5 minutes in the SC arm. The median duration of the second infusion was 255 minutes and 5 minutes, respectively, and the median duration of subsequent infusions was 205 minutes and 5 minutes, respectively.

At a median follow-up of 7.46 months, 57% of patients in each arm had discontinued the study treatment. The most common reasons for discontinuation were progression – 44% of the IV arm and 43% of the SC arm – and adverse events (AEs) – 8% and 7%, respectively.

Safety

Dr. Mateos said the safety profiles of IV and SC daratumumab were comparable. However, infusion-related reactions were significantly less likely in the SC arm, occurring in 12.7% of those patients and 34.5% of patients in the IV arm (P less than .0001).

Grade 3 or higher treatment-emergent AEs occurred in 49% of patients in the IV arm and 46% of those in the SC arm. Rates of grade 5 AEs were 7% and 5%, respectively. The most common grade 3/4 AEs (in the IV and SC arms, respectively) were anemia (14% and 13%), thrombocytopenia (14% for both), neutropenia (8% and 13%), lymphopenia (6% and 5%), and hypertension (6% and 3%).

Efficacy

One of the study’s primary endpoints was overall response rate, which was 37.1% in the IV arm and 41.1% in the SC arm (relative risk, 1.11; 95% CI, 0.89-1.37; P less than .0001). This met the criteria for noninferiority, and overall response rates were comparable across all patient subgroups, Dr. Mateos noted.

The rates of complete response or stringent complete response were also comparable at 2.7% in the IV arm and 1.9% in the SC arm. Rates of very good partial response were 17.0% and 19.0%, respectively.

The study’s other primary endpoint was maximum Ctrough predose on day 1 of cycle 3. The ratio of maximum Ctrough for daratumumab SC over IV was 107.93% (90% CI, 95.74%-121.67%), which met the noninferiority criterion.

Survival outcomes were also similar between the IV and SC arms. The median progression-free survival was 6.1 months and 5.6 months, respectively (P = .9258). The rate of overall survival at 6 months was 83.0% and 87.5%, respectively (P = .6032).

Considering these results together, Dr. Mateos and colleagues concluded that SC daratumumab is noninferior to IV daratumumab.

“[SC daratumumab] has a reduced treatment burden due to a considerably shorter administration duration, and patients treated with [SC daratumumab] reported higher satisfaction with therapy,” Dr. Mateos said.

The results support the use of flat-dose 1,800-mg SC daratumumab, which is comparable with the IV formulation, she said.

The COLUMBA trial was sponsored by Janssen Research & Development. Dr. Mateos reported relationships with Amgen, Celgene, Janssen-Cilag, and Takeda.

[email protected]

SOURCE: Mateos MV et al. ASCO 2019, Abstract 8005.

Mary Alissa Willis, MD, is the Medical Director for the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. We spoke with Dr. Willis about mental health issues in persons with MS and what health care facilities can do to better care for these patients.

What is the prevalence of depression in patients with MS?
Depression and anxiety are common in persons with multiple sclerosis (PwMS). In a systematic review, Ruth Ann Marrie, MD, PhD, and colleagues estimated the prevalence of depression in PwMS to be 23.7%. Approximately half of all PwMS experience depression at some point after their diagnosis.^1-3 This makes depression nearly twice as common in MS as in the general population.

What are some reasons patients with MS might begin to experience depression? What are some warning signs to look out for?

Many people assume that PwMS experience depression because of psychosocial stressors, unpredictability of disease progression, or poor coping strategies. Although these factors do contribute to depression, there is increasing evidence that immune dysregulation and structural changes in the brain caused by MS disease activity make some PwMS uniquely vulnerable to depression. Functional MRI studies have shown abnormalities in the prefrontal-subcortical network connectivity, which is involved in mood regulation. In addition, persistent somatic symptoms such as severe pain and fatigue limit daily activities and social participation—generally considered to be protective factors in depression.⁴ Warning signs for depression include loss of interest in activities, weight loss or weight gain, changes in sleep—too much or too little, an increase in fatigue, expressions of hopelessness or guilt, or increasing drug or alcohol use. 

What are some special considerations for patients with MS battling suicidal ideation?

Anthony Feinstein, MBBCh, MPhil, PhD, and colleagues reported that more than 28% of PwMS had suicidal ideation at some point.⁵ This is a huge number of people struggling with thoughts of suicide. Depression is a risk factor for suicide but other risks specific to PwMS include perceived loss of control, loss of job/income/social roles, loss of driving privileges, and marked physical or cognitive difficulties. While we are doing a better job screening for depression with quick screening tools such as the PHQ9, we could do better in suicide risk assessment.

What can health care providers do better to address depression and risk for suicide? What safety/preventative measures can they take?

 The first step in better addressing depression and risk for suicide is to directly ask patients. Pay attention to changes in appearance, behavior, requests for prescription refills, frequency of appointments, and who accompanies patients to appointments. Explore the reasons for these changes. It is important to respond proactively when comments or behavior suggest a patient at risk. Ask specific questions about plan, access to means, previous suicide attempts, and support network. Refer promptly for emergency or mental health services when appropriate. Familiarity with mental health colleagues, local crisis centers, and helplines can be helpful in engaging a team of people to provide assistance to a patient in need.

References

1. Marrie RA, Fisk JD, Tremlett H, et al. Differences in the burden of psychiatric comorbidity in MS vs the general population. Neurology. 2015;85(22):1972-1979.

2. Minden SL, Schiffer RB. Affective disorders in multiple sclerosis. Review and recommendations for clinical research. Arch Neurol. 1990;47(1):98-104.

3. Marrie RA, Walld R, Bolton JM, et al; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Estimating annual prevalence of depression and anxiety disorder in multiple sclerosis using administrative data. BMC Res Notes. 2017;10(1):619.

4. Passamonti L. Cerasa A, Liguori M, et al. Neurobiological mechanisms underlying emotional processing in relapsing-remitting multiple sclerosis. Brain. 2009;132(pt 12):3380-3391.

5. Feinstein A. An examination of suicidal intent in patients with multiple sclerosis. Neurology. 2002;59(5):674-678.

Mary Alissa Willis, MD, is the Medical Director for the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. We spoke with Dr. Willis about mental health issues in persons with MS and what health care facilities can do to better care for these patients.

What is the prevalence of depression in patients with MS?
Depression and anxiety are common in persons with multiple sclerosis (PwMS). In a systematic review, Ruth Ann Marrie, MD, PhD, and colleagues estimated the prevalence of depression in PwMS to be 23.7%. Approximately half of all PwMS experience depression at some point after their diagnosis.^1-3 This makes depression nearly twice as common in MS as in the general population.

What are some reasons patients with MS might begin to experience depression? What are some warning signs to look out for?

Many people assume that PwMS experience depression because of psychosocial stressors, unpredictability of disease progression, or poor coping strategies. Although these factors do contribute to depression, there is increasing evidence that immune dysregulation and structural changes in the brain caused by MS disease activity make some PwMS uniquely vulnerable to depression. Functional MRI studies have shown abnormalities in the prefrontal-subcortical network connectivity, which is involved in mood regulation. In addition, persistent somatic symptoms such as severe pain and fatigue limit daily activities and social participation—generally considered to be protective factors in depression.⁴ Warning signs for depression include loss of interest in activities, weight loss or weight gain, changes in sleep—too much or too little, an increase in fatigue, expressions of hopelessness or guilt, or increasing drug or alcohol use. 

What are some special considerations for patients with MS battling suicidal ideation?

Anthony Feinstein, MBBCh, MPhil, PhD, and colleagues reported that more than 28% of PwMS had suicidal ideation at some point.⁵ This is a huge number of people struggling with thoughts of suicide. Depression is a risk factor for suicide but other risks specific to PwMS include perceived loss of control, loss of job/income/social roles, loss of driving privileges, and marked physical or cognitive difficulties. While we are doing a better job screening for depression with quick screening tools such as the PHQ9, we could do better in suicide risk assessment.

What can health care providers do better to address depression and risk for suicide? What safety/preventative measures can they take?

 The first step in better addressing depression and risk for suicide is to directly ask patients. Pay attention to changes in appearance, behavior, requests for prescription refills, frequency of appointments, and who accompanies patients to appointments. Explore the reasons for these changes. It is important to respond proactively when comments or behavior suggest a patient at risk. Ask specific questions about plan, access to means, previous suicide attempts, and support network. Refer promptly for emergency or mental health services when appropriate. Familiarity with mental health colleagues, local crisis centers, and helplines can be helpful in engaging a team of people to provide assistance to a patient in need.

References

1. Marrie RA, Fisk JD, Tremlett H, et al. Differences in the burden of psychiatric comorbidity in MS vs the general population. Neurology. 2015;85(22):1972-1979.

2. Minden SL, Schiffer RB. Affective disorders in multiple sclerosis. Review and recommendations for clinical research. Arch Neurol. 1990;47(1):98-104.

3. Marrie RA, Walld R, Bolton JM, et al; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Estimating annual prevalence of depression and anxiety disorder in multiple sclerosis using administrative data. BMC Res Notes. 2017;10(1):619.

4. Passamonti L. Cerasa A, Liguori M, et al. Neurobiological mechanisms underlying emotional processing in relapsing-remitting multiple sclerosis. Brain. 2009;132(pt 12):3380-3391.

5. Feinstein A. An examination of suicidal intent in patients with multiple sclerosis. Neurology. 2002;59(5):674-678.

Mary Alissa Willis, MD, is the Medical Director for the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. We spoke with Dr. Willis about mental health issues in persons with MS and what health care facilities can do to better care for these patients.

What is the prevalence of depression in patients with MS?
Depression and anxiety are common in persons with multiple sclerosis (PwMS). In a systematic review, Ruth Ann Marrie, MD, PhD, and colleagues estimated the prevalence of depression in PwMS to be 23.7%. Approximately half of all PwMS experience depression at some point after their diagnosis.^1-3 This makes depression nearly twice as common in MS as in the general population.

What are some reasons patients with MS might begin to experience depression? What are some warning signs to look out for?

Many people assume that PwMS experience depression because of psychosocial stressors, unpredictability of disease progression, or poor coping strategies. Although these factors do contribute to depression, there is increasing evidence that immune dysregulation and structural changes in the brain caused by MS disease activity make some PwMS uniquely vulnerable to depression. Functional MRI studies have shown abnormalities in the prefrontal-subcortical network connectivity, which is involved in mood regulation. In addition, persistent somatic symptoms such as severe pain and fatigue limit daily activities and social participation—generally considered to be protective factors in depression.⁴ Warning signs for depression include loss of interest in activities, weight loss or weight gain, changes in sleep—too much or too little, an increase in fatigue, expressions of hopelessness or guilt, or increasing drug or alcohol use. 

What are some special considerations for patients with MS battling suicidal ideation?

Anthony Feinstein, MBBCh, MPhil, PhD, and colleagues reported that more than 28% of PwMS had suicidal ideation at some point.⁵ This is a huge number of people struggling with thoughts of suicide. Depression is a risk factor for suicide but other risks specific to PwMS include perceived loss of control, loss of job/income/social roles, loss of driving privileges, and marked physical or cognitive difficulties. While we are doing a better job screening for depression with quick screening tools such as the PHQ9, we could do better in suicide risk assessment.

What can health care providers do better to address depression and risk for suicide? What safety/preventative measures can they take?

 The first step in better addressing depression and risk for suicide is to directly ask patients. Pay attention to changes in appearance, behavior, requests for prescription refills, frequency of appointments, and who accompanies patients to appointments. Explore the reasons for these changes. It is important to respond proactively when comments or behavior suggest a patient at risk. Ask specific questions about plan, access to means, previous suicide attempts, and support network. Refer promptly for emergency or mental health services when appropriate. Familiarity with mental health colleagues, local crisis centers, and helplines can be helpful in engaging a team of people to provide assistance to a patient in need.

References

1. Marrie RA, Fisk JD, Tremlett H, et al. Differences in the burden of psychiatric comorbidity in MS vs the general population. Neurology. 2015;85(22):1972-1979.

2. Minden SL, Schiffer RB. Affective disorders in multiple sclerosis. Review and recommendations for clinical research. Arch Neurol. 1990;47(1):98-104.

3. Marrie RA, Walld R, Bolton JM, et al; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Estimating annual prevalence of depression and anxiety disorder in multiple sclerosis using administrative data. BMC Res Notes. 2017;10(1):619.

4. Passamonti L. Cerasa A, Liguori M, et al. Neurobiological mechanisms underlying emotional processing in relapsing-remitting multiple sclerosis. Brain. 2009;132(pt 12):3380-3391.

5. Feinstein A. An examination of suicidal intent in patients with multiple sclerosis. Neurology. 2002;59(5):674-678.

Among pregnant women with inherited bleeding disorders, having a contraindication to regional anesthesia appears not to impact labor outcomes, according to a retrospective analysis.

oceandigital/Thinkstock

“The purpose of this study was to determine the anesthetic use in labour in a cohort of women with inherited bleeding disorders,” wrote Sean C. Boyd, of Coombe Women & Infants University Hospital in Dublin, Ireland, and colleagues. The findings were reported in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The study comprised 97 pregnant women with an inherited bleeding disorder and outcomes related to 130 delivered newborns.

The researchers reviewed medical records of patients with a variety of inherited bleeding disorders: type 1 von Willebrand disease (VWD), deficiencies of factors VII, VIII, IX, X, and XI, combined deficiencies, and others.

Various clinical data, including both obstetric and anesthetic outcomes, were collected from January 2011 to December 2016.

When researchers compared pregnancies where regional anesthesia was contraindicated to those in which it was considered safe, women with a contraindication were more likely to receive general anesthesia for cesarean section (20% vs. 1%), more likely to use a remifentanil infusion (31% vs. 0), and more likely to require prophylactic hemostatic support for delivery (61% vs. 1%).

Vaginal (71% vs. 65%; P = .4) and caesarean section (29% vs. 32%; P = .28) delivery rates were similar between the two groups.

Rates of postpartum hemorrhage were greater in pregnancies where regional anesthesia was contraindicated (24% vs. 12%), but not significantly different (P = .07). No cases of vertebral canal hematoma or neonatal hemorrhage were reported among participants.

“Women are anxious about analgesia and anesthesia in labour and understandably, more so, when they are aware that they are unable to have an epidural or spinal,” the researchers wrote. “This study shows what alternative analgesia is used in labour and, reassuringly, that labour outcome is the same.”

Two key limitations of the study were the small sample size and the wide range of included bleeding disorders.

No funding sources were reported. The authors did not report conflicts of interest.

SOURCE: Boyd SC et al. Eur J Obstet Gynecol Reprod Biol. 2019 Jun 3. doi: 10.1016/j.ejogrb.2019.05.043.

Among pregnant women with inherited bleeding disorders, having a contraindication to regional anesthesia appears not to impact labor outcomes, according to a retrospective analysis.

oceandigital/Thinkstock

“The purpose of this study was to determine the anesthetic use in labour in a cohort of women with inherited bleeding disorders,” wrote Sean C. Boyd, of Coombe Women & Infants University Hospital in Dublin, Ireland, and colleagues. The findings were reported in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The study comprised 97 pregnant women with an inherited bleeding disorder and outcomes related to 130 delivered newborns.

The researchers reviewed medical records of patients with a variety of inherited bleeding disorders: type 1 von Willebrand disease (VWD), deficiencies of factors VII, VIII, IX, X, and XI, combined deficiencies, and others.

Various clinical data, including both obstetric and anesthetic outcomes, were collected from January 2011 to December 2016.

When researchers compared pregnancies where regional anesthesia was contraindicated to those in which it was considered safe, women with a contraindication were more likely to receive general anesthesia for cesarean section (20% vs. 1%), more likely to use a remifentanil infusion (31% vs. 0), and more likely to require prophylactic hemostatic support for delivery (61% vs. 1%).

Vaginal (71% vs. 65%; P = .4) and caesarean section (29% vs. 32%; P = .28) delivery rates were similar between the two groups.

Rates of postpartum hemorrhage were greater in pregnancies where regional anesthesia was contraindicated (24% vs. 12%), but not significantly different (P = .07). No cases of vertebral canal hematoma or neonatal hemorrhage were reported among participants.

“Women are anxious about analgesia and anesthesia in labour and understandably, more so, when they are aware that they are unable to have an epidural or spinal,” the researchers wrote. “This study shows what alternative analgesia is used in labour and, reassuringly, that labour outcome is the same.”

Two key limitations of the study were the small sample size and the wide range of included bleeding disorders.

No funding sources were reported. The authors did not report conflicts of interest.

SOURCE: Boyd SC et al. Eur J Obstet Gynecol Reprod Biol. 2019 Jun 3. doi: 10.1016/j.ejogrb.2019.05.043.

Among pregnant women with inherited bleeding disorders, having a contraindication to regional anesthesia appears not to impact labor outcomes, according to a retrospective analysis.

oceandigital/Thinkstock

“The purpose of this study was to determine the anesthetic use in labour in a cohort of women with inherited bleeding disorders,” wrote Sean C. Boyd, of Coombe Women & Infants University Hospital in Dublin, Ireland, and colleagues. The findings were reported in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The study comprised 97 pregnant women with an inherited bleeding disorder and outcomes related to 130 delivered newborns.

The researchers reviewed medical records of patients with a variety of inherited bleeding disorders: type 1 von Willebrand disease (VWD), deficiencies of factors VII, VIII, IX, X, and XI, combined deficiencies, and others.

Various clinical data, including both obstetric and anesthetic outcomes, were collected from January 2011 to December 2016.

When researchers compared pregnancies where regional anesthesia was contraindicated to those in which it was considered safe, women with a contraindication were more likely to receive general anesthesia for cesarean section (20% vs. 1%), more likely to use a remifentanil infusion (31% vs. 0), and more likely to require prophylactic hemostatic support for delivery (61% vs. 1%).

Vaginal (71% vs. 65%; P = .4) and caesarean section (29% vs. 32%; P = .28) delivery rates were similar between the two groups.

Rates of postpartum hemorrhage were greater in pregnancies where regional anesthesia was contraindicated (24% vs. 12%), but not significantly different (P = .07). No cases of vertebral canal hematoma or neonatal hemorrhage were reported among participants.

“Women are anxious about analgesia and anesthesia in labour and understandably, more so, when they are aware that they are unable to have an epidural or spinal,” the researchers wrote. “This study shows what alternative analgesia is used in labour and, reassuringly, that labour outcome is the same.”

Two key limitations of the study were the small sample size and the wide range of included bleeding disorders.

No funding sources were reported. The authors did not report conflicts of interest.

SOURCE: Boyd SC et al. Eur J Obstet Gynecol Reprod Biol. 2019 Jun 3. doi: 10.1016/j.ejogrb.2019.05.043.

Primary cutaneous melanomas more than 2 mm thick can be excised with 2-cm margins with outcomes similar to excision with 4-cm margins, based on data from a randomized, multicenter trial of 936 patients.

“Over time, and in light of the findings of several randomized studies, less extensive surgery for primary melanoma with tumor thickness greater than 2 mm has become more established,” and most recent guidelines recommend a 2-cm margin for these tumors, wrote Deborah Utjés, MD, of the Karolinska Institute in Stockholm and colleagues.

To reinforce the safety and effectiveness of the 2-cm margin, the researchers conducted an open-label, randomized trial of clinically staged melanoma patients aged 75 years and younger with localized cutaneous melanomas thicker than 2 mm, from January 1992 to May 2004. Patients were treated in Denmark, Estonia, Norway, and Sweden. The findings were published in the Lancet.

Patients were randomized to treatment with a 2-cm (471) or 4-cm excision margin (465). The melanomas were located on the trunk, upper extremities, or lower extremities.

The primary outcome of overall survival was similar between the groups. Over a median 20-year follow-up period, the death rate was approximately 50% in each group (49% in the 2-cm group and 51% in the 4-cm group). Disease-specific survival rates were similar as well. Of the 621 reported deaths, 397 were attributed to melanoma: 192 (48%) in the 2-cm group and 205 (52%) in the 4-cm group.

The study findings were limited by several factors, including a lower-than-expected number of patients, lack of nodal staging during the study period, and a focus only on the surgical margin without recording data on pathological excision margins.

However, the extended follow-up supports the safe use of the 2-cm margin for the treatment of melanomas thicker than 2 mm, the investigators wrote. In addition, results from an ongoing trial comparing 1-cm and 2-cm margins for melanomas at least 1 mm thick may yield more evidence to support still narrower surgical margins for some cutaneous melanomas.

The study notes that guidelines from organizations that include the American National Comprehensive Cancer Network and the American Academy of Dermatology recommend the 2-cm margin for tumors that are thicker than 2 mm.

The study was supported by the Swedish Cancer Society, Stockholm Cancer Society, Swedish Society for Medical Research, and the Stockholm County Council, and by funds from Radiumhemmet Research and Wallström. The authors reported no disclosures.

SOURCE: Utjés D et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31132-8.

Primary cutaneous melanomas more than 2 mm thick can be excised with 2-cm margins with outcomes similar to excision with 4-cm margins, based on data from a randomized, multicenter trial of 936 patients.

“Over time, and in light of the findings of several randomized studies, less extensive surgery for primary melanoma with tumor thickness greater than 2 mm has become more established,” and most recent guidelines recommend a 2-cm margin for these tumors, wrote Deborah Utjés, MD, of the Karolinska Institute in Stockholm and colleagues.

To reinforce the safety and effectiveness of the 2-cm margin, the researchers conducted an open-label, randomized trial of clinically staged melanoma patients aged 75 years and younger with localized cutaneous melanomas thicker than 2 mm, from January 1992 to May 2004. Patients were treated in Denmark, Estonia, Norway, and Sweden. The findings were published in the Lancet.

Patients were randomized to treatment with a 2-cm (471) or 4-cm excision margin (465). The melanomas were located on the trunk, upper extremities, or lower extremities.

The primary outcome of overall survival was similar between the groups. Over a median 20-year follow-up period, the death rate was approximately 50% in each group (49% in the 2-cm group and 51% in the 4-cm group). Disease-specific survival rates were similar as well. Of the 621 reported deaths, 397 were attributed to melanoma: 192 (48%) in the 2-cm group and 205 (52%) in the 4-cm group.

The study findings were limited by several factors, including a lower-than-expected number of patients, lack of nodal staging during the study period, and a focus only on the surgical margin without recording data on pathological excision margins.

However, the extended follow-up supports the safe use of the 2-cm margin for the treatment of melanomas thicker than 2 mm, the investigators wrote. In addition, results from an ongoing trial comparing 1-cm and 2-cm margins for melanomas at least 1 mm thick may yield more evidence to support still narrower surgical margins for some cutaneous melanomas.

The study notes that guidelines from organizations that include the American National Comprehensive Cancer Network and the American Academy of Dermatology recommend the 2-cm margin for tumors that are thicker than 2 mm.

The study was supported by the Swedish Cancer Society, Stockholm Cancer Society, Swedish Society for Medical Research, and the Stockholm County Council, and by funds from Radiumhemmet Research and Wallström. The authors reported no disclosures.

SOURCE: Utjés D et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31132-8.

Primary cutaneous melanomas more than 2 mm thick can be excised with 2-cm margins with outcomes similar to excision with 4-cm margins, based on data from a randomized, multicenter trial of 936 patients.

“Over time, and in light of the findings of several randomized studies, less extensive surgery for primary melanoma with tumor thickness greater than 2 mm has become more established,” and most recent guidelines recommend a 2-cm margin for these tumors, wrote Deborah Utjés, MD, of the Karolinska Institute in Stockholm and colleagues.

To reinforce the safety and effectiveness of the 2-cm margin, the researchers conducted an open-label, randomized trial of clinically staged melanoma patients aged 75 years and younger with localized cutaneous melanomas thicker than 2 mm, from January 1992 to May 2004. Patients were treated in Denmark, Estonia, Norway, and Sweden. The findings were published in the Lancet.

Patients were randomized to treatment with a 2-cm (471) or 4-cm excision margin (465). The melanomas were located on the trunk, upper extremities, or lower extremities.

The primary outcome of overall survival was similar between the groups. Over a median 20-year follow-up period, the death rate was approximately 50% in each group (49% in the 2-cm group and 51% in the 4-cm group). Disease-specific survival rates were similar as well. Of the 621 reported deaths, 397 were attributed to melanoma: 192 (48%) in the 2-cm group and 205 (52%) in the 4-cm group.

The study findings were limited by several factors, including a lower-than-expected number of patients, lack of nodal staging during the study period, and a focus only on the surgical margin without recording data on pathological excision margins.

However, the extended follow-up supports the safe use of the 2-cm margin for the treatment of melanomas thicker than 2 mm, the investigators wrote. In addition, results from an ongoing trial comparing 1-cm and 2-cm margins for melanomas at least 1 mm thick may yield more evidence to support still narrower surgical margins for some cutaneous melanomas.

The study notes that guidelines from organizations that include the American National Comprehensive Cancer Network and the American Academy of Dermatology recommend the 2-cm margin for tumors that are thicker than 2 mm.

The study was supported by the Swedish Cancer Society, Stockholm Cancer Society, Swedish Society for Medical Research, and the Stockholm County Council, and by funds from Radiumhemmet Research and Wallström. The authors reported no disclosures.

SOURCE: Utjés D et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31132-8.

Cockatoo cha-cha-cha

GlobalP/iStock/Getty Images Plus

Humans love to dance. Whether it’s just a little bobbing back and forth or a full-on tango, spontaneous dancing is a universal expression of feeling and joy. However, feeling the rhythm is nearly unique to the human species. Not even our closest relatives in the animal kingdom, primates, have been observed busting a move to music.

So who are our ballroom brethren? Parrots, strangely enough. Parrots are nature’s great imitators, so how can we be sure they aren’t just mimicking (or mocking) their human owners’ movements?

Several studies have been conducted on a particularly funky cockatoo named Snowball. He’s a viral Internet sensation, and researchers have been watching him for the past decade as he stomps his feet and bangs his head to all kinds of music – he jams to everything from classic rock to modern pop. Snowball’s owner also assured scientists that her bird does not get his dance moves from her; Snowball is a unique choreographer.

A follow-up study about Snowball was recently published, in which the authors suggested the reason for spontaneous parrot dancing could be the strong auditory-motor connections that exist in parrot brains. They’re similar to humans, but not primates. They also detailed Snowball’s 14 distinct dance moves. Someone get that parrot on America’s Got Talent, ASAP.
 

It’s a bird, it’s a plane – oh no, it’s a spider

Torsdatter/iStock/Getty Images Plus

Arachnophobes, just skip this one. If you’re not unsettled by spiders yet, you’re about to be!

In case you didn’t know, spiders can fly. Or rather, they float (spiders with wings would just be straight-up horrifying).

Scientists (and fans of Charlotte’s Web) have known for centuries that spiders can turn into their own personal airships, but it wasn’t always clear how they do it. It was commonly believed that spider-flying, aka “ballooning,” was caused by the spider using its silk as a kind of kite, with the wind catching on the silk and bringing the spider along with it. That explanation, however, doesn’t account for the fact that spiders only balloon during light winds, which are rarely strong enough to carry a spider.

Two intrepid spider fans from the University of Bristol (England) think they have solved the mystery of the flying arachnids.

It turns out that spiders are able to sense the earth’s electric field and use that to soar around. They let loose some silk, which picks up a negative charge. This charge repels the negative charge of whatever they are standing on and can create enough force to launch them into the air. Spiders, those smart little buggers, can increase these charges by climbing onto twigs or grass. Plants rooted in the earth have a strong negative charge but stick up into the positively charged air.

All this fancy science-babble to say: Spiders can fly, and we know how! Stay indoors, folks.
 

Hospital lures fishermen to ED

juliedeshaies/iStock/Getty Images Plus

There are some things you expect to see when you walk into a hospital: an admitting desk, waiting areas full of people, security guards, bad art work, maybe a friendly greeter at the door (sorry, that’s the Walmart).

The main lobby at Adirondack Medical Center in Saranac Lake, N.Y., however, has something you might not expect: a display of fishing lures.

Each of the more than 100 lures on display originally showed up at the hospital’s emergency department attached to an arm, leg, nose, or lip – pretty much every body part possible, Gary Nye, a physician assistant in the ED, told newyorkupstate.com. He’s even removed lures from several patients’ penises and scrotums. “Usually alcohol has something to do with it,” he noted.

One individual came in with hooks from a lure stuck on both thumbs. He got one set of hooks stuck on one thumb, and as he tried to get it out, he ended up getting the lure’s other set of hooks caught on his other thumb. A nurse who has worked in the ED for 20 years said that alcohol may been involved.

Dr. Michael Pond, the hospital’s former medical director and the one who started the display in 1990, explained why the lures are now kept in a locked case. A number of years ago, when the display was less secure, “someone cut out and stole four to five antique lures out of the case. I mean, these were absolutely gorgeous and expensive lures – Pikie Minnows and [other] things. [They] were made out of wood and painted.”

As with so many fish stories, you should have seen the one that got away.
 

Inspiration really can come from anywhere

Jillian Cooper/iStock/Getty Images Plus

On the surface, a study detailing a new, potentially practice-changing method of converting type A blood to type O doesn’t seem disgusting, silly, or odd enough to make it into Livin’ on the MDedge. But when you dig a little deeper, you’ll see that the method involves a bacteria in the human microbiome.

Now you might be getting a bit suspicious. This is going to be another story about poop, you might be thinking.

And you’d be right!

But the real star of the show isn’t human poop. No, in this case, we owe this groundbreaking discovery to the humble beaver.

In an earlier study published in the ISME Journal, the same group of researchers from the University of British Columbia in Vancouver (of course they’re Canadian) analyzed the microbiomes of beavers to see just how they broke down the complex carbohydrates and glycoproteins found in wood. That was the catalyst that got the researchers thinking about the human microbiome and the problem of stripping red blood cells of their antigens.

Basically, just as the beaver breaks down wood with bacteria in their microbiome, the modified bacteria the researchers conjured up can be used to break down the A and B antigens of red blood cells, leaving a simple type O cell that can be transfused into any patient.

Rumors that all future blood transfusions are required by law to be accompanied by a playing of O Canada remain unsubstantiated.

Cockatoo cha-cha-cha

GlobalP/iStock/Getty Images Plus

Humans love to dance. Whether it’s just a little bobbing back and forth or a full-on tango, spontaneous dancing is a universal expression of feeling and joy. However, feeling the rhythm is nearly unique to the human species. Not even our closest relatives in the animal kingdom, primates, have been observed busting a move to music.

So who are our ballroom brethren? Parrots, strangely enough. Parrots are nature’s great imitators, so how can we be sure they aren’t just mimicking (or mocking) their human owners’ movements?

Several studies have been conducted on a particularly funky cockatoo named Snowball. He’s a viral Internet sensation, and researchers have been watching him for the past decade as he stomps his feet and bangs his head to all kinds of music – he jams to everything from classic rock to modern pop. Snowball’s owner also assured scientists that her bird does not get his dance moves from her; Snowball is a unique choreographer.

A follow-up study about Snowball was recently published, in which the authors suggested the reason for spontaneous parrot dancing could be the strong auditory-motor connections that exist in parrot brains. They’re similar to humans, but not primates. They also detailed Snowball’s 14 distinct dance moves. Someone get that parrot on America’s Got Talent, ASAP.
 

It’s a bird, it’s a plane – oh no, it’s a spider

Torsdatter/iStock/Getty Images Plus

Arachnophobes, just skip this one. If you’re not unsettled by spiders yet, you’re about to be!

In case you didn’t know, spiders can fly. Or rather, they float (spiders with wings would just be straight-up horrifying).

Scientists (and fans of Charlotte’s Web) have known for centuries that spiders can turn into their own personal airships, but it wasn’t always clear how they do it. It was commonly believed that spider-flying, aka “ballooning,” was caused by the spider using its silk as a kind of kite, with the wind catching on the silk and bringing the spider along with it. That explanation, however, doesn’t account for the fact that spiders only balloon during light winds, which are rarely strong enough to carry a spider.

Two intrepid spider fans from the University of Bristol (England) think they have solved the mystery of the flying arachnids.

It turns out that spiders are able to sense the earth’s electric field and use that to soar around. They let loose some silk, which picks up a negative charge. This charge repels the negative charge of whatever they are standing on and can create enough force to launch them into the air. Spiders, those smart little buggers, can increase these charges by climbing onto twigs or grass. Plants rooted in the earth have a strong negative charge but stick up into the positively charged air.

All this fancy science-babble to say: Spiders can fly, and we know how! Stay indoors, folks.
 

Hospital lures fishermen to ED

juliedeshaies/iStock/Getty Images Plus

There are some things you expect to see when you walk into a hospital: an admitting desk, waiting areas full of people, security guards, bad art work, maybe a friendly greeter at the door (sorry, that’s the Walmart).

The main lobby at Adirondack Medical Center in Saranac Lake, N.Y., however, has something you might not expect: a display of fishing lures.

Each of the more than 100 lures on display originally showed up at the hospital’s emergency department attached to an arm, leg, nose, or lip – pretty much every body part possible, Gary Nye, a physician assistant in the ED, told newyorkupstate.com. He’s even removed lures from several patients’ penises and scrotums. “Usually alcohol has something to do with it,” he noted.

One individual came in with hooks from a lure stuck on both thumbs. He got one set of hooks stuck on one thumb, and as he tried to get it out, he ended up getting the lure’s other set of hooks caught on his other thumb. A nurse who has worked in the ED for 20 years said that alcohol may been involved.

Dr. Michael Pond, the hospital’s former medical director and the one who started the display in 1990, explained why the lures are now kept in a locked case. A number of years ago, when the display was less secure, “someone cut out and stole four to five antique lures out of the case. I mean, these were absolutely gorgeous and expensive lures – Pikie Minnows and [other] things. [They] were made out of wood and painted.”

As with so many fish stories, you should have seen the one that got away.
 

Inspiration really can come from anywhere

Jillian Cooper/iStock/Getty Images Plus

On the surface, a study detailing a new, potentially practice-changing method of converting type A blood to type O doesn’t seem disgusting, silly, or odd enough to make it into Livin’ on the MDedge. But when you dig a little deeper, you’ll see that the method involves a bacteria in the human microbiome.

Now you might be getting a bit suspicious. This is going to be another story about poop, you might be thinking.

And you’d be right!

But the real star of the show isn’t human poop. No, in this case, we owe this groundbreaking discovery to the humble beaver.

In an earlier study published in the ISME Journal, the same group of researchers from the University of British Columbia in Vancouver (of course they’re Canadian) analyzed the microbiomes of beavers to see just how they broke down the complex carbohydrates and glycoproteins found in wood. That was the catalyst that got the researchers thinking about the human microbiome and the problem of stripping red blood cells of their antigens.

Basically, just as the beaver breaks down wood with bacteria in their microbiome, the modified bacteria the researchers conjured up can be used to break down the A and B antigens of red blood cells, leaving a simple type O cell that can be transfused into any patient.

Rumors that all future blood transfusions are required by law to be accompanied by a playing of O Canada remain unsubstantiated.

Cockatoo cha-cha-cha

GlobalP/iStock/Getty Images Plus

Humans love to dance. Whether it’s just a little bobbing back and forth or a full-on tango, spontaneous dancing is a universal expression of feeling and joy. However, feeling the rhythm is nearly unique to the human species. Not even our closest relatives in the animal kingdom, primates, have been observed busting a move to music.

So who are our ballroom brethren? Parrots, strangely enough. Parrots are nature’s great imitators, so how can we be sure they aren’t just mimicking (or mocking) their human owners’ movements?

Several studies have been conducted on a particularly funky cockatoo named Snowball. He’s a viral Internet sensation, and researchers have been watching him for the past decade as he stomps his feet and bangs his head to all kinds of music – he jams to everything from classic rock to modern pop. Snowball’s owner also assured scientists that her bird does not get his dance moves from her; Snowball is a unique choreographer.

A follow-up study about Snowball was recently published, in which the authors suggested the reason for spontaneous parrot dancing could be the strong auditory-motor connections that exist in parrot brains. They’re similar to humans, but not primates. They also detailed Snowball’s 14 distinct dance moves. Someone get that parrot on America’s Got Talent, ASAP.
 

It’s a bird, it’s a plane – oh no, it’s a spider

Torsdatter/iStock/Getty Images Plus

Arachnophobes, just skip this one. If you’re not unsettled by spiders yet, you’re about to be!

In case you didn’t know, spiders can fly. Or rather, they float (spiders with wings would just be straight-up horrifying).

Scientists (and fans of Charlotte’s Web) have known for centuries that spiders can turn into their own personal airships, but it wasn’t always clear how they do it. It was commonly believed that spider-flying, aka “ballooning,” was caused by the spider using its silk as a kind of kite, with the wind catching on the silk and bringing the spider along with it. That explanation, however, doesn’t account for the fact that spiders only balloon during light winds, which are rarely strong enough to carry a spider.

Two intrepid spider fans from the University of Bristol (England) think they have solved the mystery of the flying arachnids.

It turns out that spiders are able to sense the earth’s electric field and use that to soar around. They let loose some silk, which picks up a negative charge. This charge repels the negative charge of whatever they are standing on and can create enough force to launch them into the air. Spiders, those smart little buggers, can increase these charges by climbing onto twigs or grass. Plants rooted in the earth have a strong negative charge but stick up into the positively charged air.

All this fancy science-babble to say: Spiders can fly, and we know how! Stay indoors, folks.
 

Hospital lures fishermen to ED

juliedeshaies/iStock/Getty Images Plus

There are some things you expect to see when you walk into a hospital: an admitting desk, waiting areas full of people, security guards, bad art work, maybe a friendly greeter at the door (sorry, that’s the Walmart).

The main lobby at Adirondack Medical Center in Saranac Lake, N.Y., however, has something you might not expect: a display of fishing lures.

Each of the more than 100 lures on display originally showed up at the hospital’s emergency department attached to an arm, leg, nose, or lip – pretty much every body part possible, Gary Nye, a physician assistant in the ED, told newyorkupstate.com. He’s even removed lures from several patients’ penises and scrotums. “Usually alcohol has something to do with it,” he noted.

One individual came in with hooks from a lure stuck on both thumbs. He got one set of hooks stuck on one thumb, and as he tried to get it out, he ended up getting the lure’s other set of hooks caught on his other thumb. A nurse who has worked in the ED for 20 years said that alcohol may been involved.

Dr. Michael Pond, the hospital’s former medical director and the one who started the display in 1990, explained why the lures are now kept in a locked case. A number of years ago, when the display was less secure, “someone cut out and stole four to five antique lures out of the case. I mean, these were absolutely gorgeous and expensive lures – Pikie Minnows and [other] things. [They] were made out of wood and painted.”

As with so many fish stories, you should have seen the one that got away.
 

Inspiration really can come from anywhere

Jillian Cooper/iStock/Getty Images Plus

On the surface, a study detailing a new, potentially practice-changing method of converting type A blood to type O doesn’t seem disgusting, silly, or odd enough to make it into Livin’ on the MDedge. But when you dig a little deeper, you’ll see that the method involves a bacteria in the human microbiome.

Now you might be getting a bit suspicious. This is going to be another story about poop, you might be thinking.

And you’d be right!

But the real star of the show isn’t human poop. No, in this case, we owe this groundbreaking discovery to the humble beaver.

In an earlier study published in the ISME Journal, the same group of researchers from the University of British Columbia in Vancouver (of course they’re Canadian) analyzed the microbiomes of beavers to see just how they broke down the complex carbohydrates and glycoproteins found in wood. That was the catalyst that got the researchers thinking about the human microbiome and the problem of stripping red blood cells of their antigens.

Basically, just as the beaver breaks down wood with bacteria in their microbiome, the modified bacteria the researchers conjured up can be used to break down the A and B antigens of red blood cells, leaving a simple type O cell that can be transfused into any patient.

Rumors that all future blood transfusions are required by law to be accompanied by a playing of O Canada remain unsubstantiated.

AbbVie to Acquire Allergan

AbbVie Inc and Allergan announce that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care, and virology. Furthermore, Allergan’s product portfolio will be enhanced by AbbVie’s commercial strength, expertise, and international infrastructure. For more information, visit www.abbvie.com and www.allergan.com.

Avène Launches Mineral Sunscreen Fluids

Pierre Fabre Dermo-Cosmetique introduces Avène Mineral Sunscreen Fluids SPF 50+ in both tinted and nontinted varieties. With active ingredients titanium dioxide (11.4%) and zinc oxide (14.6%), both products provide broad-spectrum UVA and UVB protection and are free from octinoxate and oxybenzone (reef friendly). These lightweight lotions are ideal for use on the face; they absorb quickly and can be layered invisibly under makeup. Additionally, the tinted fluid offers protection against blue light. For more information, visit www.aveneusa.com.

CoolTone Device Clearance Expanded

Allergan announces US Food and Drug Administration clearance of the nonsurgical CoolTone device for the improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone also is indicated for the strengthening, toning, and firming of buttocks and thighs. Using magnetic muscle stimulation, CoolTone technology penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibers, resulting in a more defined and toned appearance. For more information, visit www.cooltonebycoolsculpting.com.

Duobrii Lotion for Plaque Psoriasis Now Available

Ortho Dermatologics announces the US launch of Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045%. Duobrii was approved by the US Food and Drug Administration in April 2019 for the treatment of plaque psoriasis in adult patients, offering psoriasis patients a treatment with strong efficacy and an extended duration of use in a once-daily lotion that can be dosed to clearance. When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited to 2 to 4 weeks, and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in a patented once-daily moisturizing lotion, the Duobrii formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface. Unlike other topical products that either contain steroids or are steroids on their own, Duobrii is not restricted to 8 weeks or less of use. The approved labeling for Duobrii does not include a duration limitation; it can be dosed to clearance as long as local skin reactions do not occur, and treatment should be discontinued once clearance is achieved. For more information, visit www.duobrii.com.

Zika Virus Diagnostic Test Receives Marketing Authorization

The US Food and Drug Administration authorizes marketing of the ZIKV Detect 2.0 IgM Capture ELISA (enzymelinked immunosorbent assay)(InBios International, Inc) for the qualitative detection of Zika virus IgM antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body’s immune system when it tests for Zika virus infection in the blood; IgM antibodies indicate an early immune response. The test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection and/or those who meet the Centers for Disease Control and Prevention’s Zika virus epidemiologic criteria, such as history of residence in or travel to a geographic region with active Zika transmission at the time of travel. For more information, visit www.inbios.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

AbbVie to Acquire Allergan

AbbVie Inc and Allergan announce that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care, and virology. Furthermore, Allergan’s product portfolio will be enhanced by AbbVie’s commercial strength, expertise, and international infrastructure. For more information, visit www.abbvie.com and www.allergan.com.

Avène Launches Mineral Sunscreen Fluids

Pierre Fabre Dermo-Cosmetique introduces Avène Mineral Sunscreen Fluids SPF 50+ in both tinted and nontinted varieties. With active ingredients titanium dioxide (11.4%) and zinc oxide (14.6%), both products provide broad-spectrum UVA and UVB protection and are free from octinoxate and oxybenzone (reef friendly). These lightweight lotions are ideal for use on the face; they absorb quickly and can be layered invisibly under makeup. Additionally, the tinted fluid offers protection against blue light. For more information, visit www.aveneusa.com.

CoolTone Device Clearance Expanded

Allergan announces US Food and Drug Administration clearance of the nonsurgical CoolTone device for the improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone also is indicated for the strengthening, toning, and firming of buttocks and thighs. Using magnetic muscle stimulation, CoolTone technology penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibers, resulting in a more defined and toned appearance. For more information, visit www.cooltonebycoolsculpting.com.

Duobrii Lotion for Plaque Psoriasis Now Available

Ortho Dermatologics announces the US launch of Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045%. Duobrii was approved by the US Food and Drug Administration in April 2019 for the treatment of plaque psoriasis in adult patients, offering psoriasis patients a treatment with strong efficacy and an extended duration of use in a once-daily lotion that can be dosed to clearance. When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited to 2 to 4 weeks, and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in a patented once-daily moisturizing lotion, the Duobrii formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface. Unlike other topical products that either contain steroids or are steroids on their own, Duobrii is not restricted to 8 weeks or less of use. The approved labeling for Duobrii does not include a duration limitation; it can be dosed to clearance as long as local skin reactions do not occur, and treatment should be discontinued once clearance is achieved. For more information, visit www.duobrii.com.

Zika Virus Diagnostic Test Receives Marketing Authorization

The US Food and Drug Administration authorizes marketing of the ZIKV Detect 2.0 IgM Capture ELISA (enzymelinked immunosorbent assay)(InBios International, Inc) for the qualitative detection of Zika virus IgM antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body’s immune system when it tests for Zika virus infection in the blood; IgM antibodies indicate an early immune response. The test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection and/or those who meet the Centers for Disease Control and Prevention’s Zika virus epidemiologic criteria, such as history of residence in or travel to a geographic region with active Zika transmission at the time of travel. For more information, visit www.inbios.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

AbbVie to Acquire Allergan

AbbVie Inc and Allergan announce that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care, and virology. Furthermore, Allergan’s product portfolio will be enhanced by AbbVie’s commercial strength, expertise, and international infrastructure. For more information, visit www.abbvie.com and www.allergan.com.

Avène Launches Mineral Sunscreen Fluids

Pierre Fabre Dermo-Cosmetique introduces Avène Mineral Sunscreen Fluids SPF 50+ in both tinted and nontinted varieties. With active ingredients titanium dioxide (11.4%) and zinc oxide (14.6%), both products provide broad-spectrum UVA and UVB protection and are free from octinoxate and oxybenzone (reef friendly). These lightweight lotions are ideal for use on the face; they absorb quickly and can be layered invisibly under makeup. Additionally, the tinted fluid offers protection against blue light. For more information, visit www.aveneusa.com.

CoolTone Device Clearance Expanded

Allergan announces US Food and Drug Administration clearance of the nonsurgical CoolTone device for the improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone also is indicated for the strengthening, toning, and firming of buttocks and thighs. Using magnetic muscle stimulation, CoolTone technology penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibers, resulting in a more defined and toned appearance. For more information, visit www.cooltonebycoolsculpting.com.

Duobrii Lotion for Plaque Psoriasis Now Available

Ortho Dermatologics announces the US launch of Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045%. Duobrii was approved by the US Food and Drug Administration in April 2019 for the treatment of plaque psoriasis in adult patients, offering psoriasis patients a treatment with strong efficacy and an extended duration of use in a once-daily lotion that can be dosed to clearance. When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited to 2 to 4 weeks, and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in a patented once-daily moisturizing lotion, the Duobrii formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface. Unlike other topical products that either contain steroids or are steroids on their own, Duobrii is not restricted to 8 weeks or less of use. The approved labeling for Duobrii does not include a duration limitation; it can be dosed to clearance as long as local skin reactions do not occur, and treatment should be discontinued once clearance is achieved. For more information, visit www.duobrii.com.

Zika Virus Diagnostic Test Receives Marketing Authorization

The US Food and Drug Administration authorizes marketing of the ZIKV Detect 2.0 IgM Capture ELISA (enzymelinked immunosorbent assay)(InBios International, Inc) for the qualitative detection of Zika virus IgM antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body’s immune system when it tests for Zika virus infection in the blood; IgM antibodies indicate an early immune response. The test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection and/or those who meet the Centers for Disease Control and Prevention’s Zika virus epidemiologic criteria, such as history of residence in or travel to a geographic region with active Zika transmission at the time of travel. For more information, visit www.inbios.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

For clinicians seeking to provide a pathway to treatment or diagnosis that is individualized to the patient, a recent study found that the issues go beyond awareness or a patient’s degree of comfort – there remains the question of something as simple as: what should we call it?

Clinicians remain uncertain whether to name the new field precision or personalized medicine according the new CHEST Clinical Perspectives^TM white paper, “Precision Medicine: Adoption of Emerging Methods of Evaluation and Therapy.” A survey of leading community clinicians from among CHEST membership found that only 35 % called tailoring medical treatment to the individual characteristics of each patient “precision medicine,” with 24% preferring “personalized” medicine. Thirty-six percent of respondents used the terms interchangeably.

Beyond the communication issues, the study found that most clinicians surveyed did not know enough about precision medicine to adopt it into their practice. Those surveyed reported that they wanted to see more published studies on the effectiveness of the newly available tools before discussing these options with their patients.

The majority of the respondents were general pulmonologists with intensivists and interventional pulmonologists also responding. The study was led by Nichole T. Tanner, MD, MSCR, FCCP, of the Medical University of South Carolina. Dr Tanner will be hosting a webinar to review the conclusions of this paper at 10:00 AM CT on Tuesday, July 30.

More information about CHEST Clinical Perspectives^TM, part of the CHEST Analytics program, can be found at insights.chestnet.org. To suggest a topic to be covered in a future issue, contact Linda Tomczynski, [email protected] or +1 (224) 521-9593. Register today at https://hubs.ly/H0jqCGb0.

For clinicians seeking to provide a pathway to treatment or diagnosis that is individualized to the patient, a recent study found that the issues go beyond awareness or a patient’s degree of comfort – there remains the question of something as simple as: what should we call it?

Clinicians remain uncertain whether to name the new field precision or personalized medicine according the new CHEST Clinical Perspectives^TM white paper, “Precision Medicine: Adoption of Emerging Methods of Evaluation and Therapy.” A survey of leading community clinicians from among CHEST membership found that only 35 % called tailoring medical treatment to the individual characteristics of each patient “precision medicine,” with 24% preferring “personalized” medicine. Thirty-six percent of respondents used the terms interchangeably.

Beyond the communication issues, the study found that most clinicians surveyed did not know enough about precision medicine to adopt it into their practice. Those surveyed reported that they wanted to see more published studies on the effectiveness of the newly available tools before discussing these options with their patients.

The majority of the respondents were general pulmonologists with intensivists and interventional pulmonologists also responding. The study was led by Nichole T. Tanner, MD, MSCR, FCCP, of the Medical University of South Carolina. Dr Tanner will be hosting a webinar to review the conclusions of this paper at 10:00 AM CT on Tuesday, July 30.

More information about CHEST Clinical Perspectives^TM, part of the CHEST Analytics program, can be found at insights.chestnet.org. To suggest a topic to be covered in a future issue, contact Linda Tomczynski, [email protected] or +1 (224) 521-9593. Register today at https://hubs.ly/H0jqCGb0.

For clinicians seeking to provide a pathway to treatment or diagnosis that is individualized to the patient, a recent study found that the issues go beyond awareness or a patient’s degree of comfort – there remains the question of something as simple as: what should we call it?

Clinicians remain uncertain whether to name the new field precision or personalized medicine according the new CHEST Clinical Perspectives^TM white paper, “Precision Medicine: Adoption of Emerging Methods of Evaluation and Therapy.” A survey of leading community clinicians from among CHEST membership found that only 35 % called tailoring medical treatment to the individual characteristics of each patient “precision medicine,” with 24% preferring “personalized” medicine. Thirty-six percent of respondents used the terms interchangeably.

Beyond the communication issues, the study found that most clinicians surveyed did not know enough about precision medicine to adopt it into their practice. Those surveyed reported that they wanted to see more published studies on the effectiveness of the newly available tools before discussing these options with their patients.

The majority of the respondents were general pulmonologists with intensivists and interventional pulmonologists also responding. The study was led by Nichole T. Tanner, MD, MSCR, FCCP, of the Medical University of South Carolina. Dr Tanner will be hosting a webinar to review the conclusions of this paper at 10:00 AM CT on Tuesday, July 30.

More information about CHEST Clinical Perspectives^TM, part of the CHEST Analytics program, can be found at insights.chestnet.org. To suggest a topic to be covered in a future issue, contact Linda Tomczynski, [email protected] or +1 (224) 521-9593. Register today at https://hubs.ly/H0jqCGb0.

CHEST Inspiration is a collection of programmatic initiatives developed by the American College of Chest Physicians leadership and aimed at stimulating and encouraging innovation within the association. One of the components of CHEST Inspiration is the Environmental Scan, a series of articles focusing on the internal and external environmental factors that bear on success currently and in the future. See “Envisioning the Future: the CHEST Environmental Scan,” CHEST Physician, June 2019, p. 44, for an introduction to the series.

Chest physicians are witnessing a revolution within the environment in which they practice. Information technology, changing consumer behavior, and the social imperative to contain costs are coming together to transform health care.

Innovation in the prevention, diagnosis, and treatment of health-related issues is being fueled by the emergence of accessible and affordable technology-based solutions and changes in patient approaches to health care. Consumers and employers are increasingly motivated to look for cost-effective options for health in care delivery and for economical access to innovations.¹ Organizations will need to respond with a strategy that aligns with the changing environment and position physicians to lead these trends in the direction of improved patient care.²

Enabling technologies like electronic health records, blockchain, and artificial intelligence will increase connectivity among all the stakeholders in the health-care system. The exponential increase in connectivity means growing engagement of health systems, health plans, patients, and families in all aspects of health care. For health-care providers, these technologies will mean an acceleration of the requirement to generate data in clinical settings and utilize data for clinical decision making. Easily available data on outcomes and, most importantly, cost of treatment will be expected at point of service.³

Access to information will continue to empower consumers to take an active role in their own health care. More patients will be comfortable with delivery of some health care via digital devices, apps, and virtual access to treatment. The market will respond with technology that helps consumers navigate health-care systems, explore options, and communicate directly with providers. The use of apps and virtual encounters is expected to transform the role of primary care providers: patients will increasingly utilize nonphysician resources in outpatient settings, bypassing primary care physicians and reaching out to specialty care as needed.⁴

David A. Schulman, MD, FCCP, Professor of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University School of Medicine, Atlanta, and Editor in Chief of CHEST Physician, has seen the transformation of patient behavior and attitudes in his own practice.

“In general, they have done far more research about their health problems before seeking my counsel than patients did previously. Many use the internet not just to read about their symptoms and diseases, but also to connect with others having similar issues, sharing experiences, treatments, outcomes, and emotions; in some ways, this is the new ‘crowdsourcing’ of medicine.”

Patients who do their own “research” can present a challenge for physicians. Dr. Schulman noted, “I am often surprised about the misconceptions about disease that derive from information gleaned from a web-based source. One need not look any farther than the groundswell of misinformation being spread about vaccinations to see the potential downside of the pervasive availability of medical ‘facts’ online. Since we are unlikely to convince our patients to avoid the online milieu entirely, our role as health-care providers is to help our patients process and appropriately weigh the information that they receive, potentially partnering with our national societies to help curate such information.”

• Delivery of procedures and services will trend from physicians to other members of the health-care team and to lower cost, outpatient settings.⁹

• Health-care systems will ramp up investment in products and services that improve outcomes and cost effectiveness.¹⁰

• Increased regulatory requirements and new payment models mean an ever-growing utilization of information technology by providers to fulfill data imperatives.¹¹

• Physicians will have an increased need for tools that prioritize costs and outcomes data at the point of care.¹²
• Integration of data from new technologies will touch every aspect of health-care delivery with the objective of improving outcomes and, in turn, reducing costs.¹³
• Changing consumer attitudes toward delivery of care will be based on a growing familiarity of patients with a digital or virtual interface with providers, facility with health-care apps, and preference for a menu of options for health-care delivery.¹⁴

Dr. Schulman concluded, “We can no more expect our patients to ignore the full panoply of medical information on the internet and digital tools on their mobile devices than we can tell the tide not to come in. The die is cast; this is the world within which we must ply our trade. By identifying best practices and sharing our successes, we can come through this revolution better for the experience.”

MDedge News

References

1. https://www.modernhealthcare.com/article/20181220/NEWS/181229992/number-of-outpatient-facilities-surges-as-industry-values-more

2. https://www.accenture.com/us-en/insights/health/digital-health-tech-vision-2018

3.  https://www.accenture.com/us-en/insights/health/digital-health-primary-care

4. PcW Health Research Institute: Top health industry issues of 2019

5. https://www.accenture.com/us-en/insights/health/digital-health-primary-care

6. https://www.census.gov/newsroom/press-releases/2017/cb17-100.html

7. https://www.cdc.gov/chronicdisease/index.htm

8. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/health-care-current-december4-2018.html

9. PcW Health Research Institute Top health industry issues of 2019: The New Health Economy comes of age

10. https://www.accenture.com/us-en/insights/health/digital-health-tech-vision-2018

11. https://www2.deloitte.com/insights/us/en/industry/life-sciences/medtech-research-and-development-innovation.html

12. https://www2.deloitte.com/insights/us/en/industry/health-care/volume-to-value-based-care.html

13. https://www2.deloitte.com/insights/us/en/industry/health-care/volume-to-value-based-care.html

14. https://www.accenture.com/us-en/insights/health/digital-health-primary-care


 

CHEST Inspiration is a collection of programmatic initiatives developed by the American College of Chest Physicians leadership and aimed at stimulating and encouraging innovation within the association. One of the components of CHEST Inspiration is the Environmental Scan, a series of articles focusing on the internal and external environmental factors that bear on success currently and in the future. See “Envisioning the Future: the CHEST Environmental Scan,” CHEST Physician, June 2019, p. 44, for an introduction to the series.

Chest physicians are witnessing a revolution within the environment in which they practice. Information technology, changing consumer behavior, and the social imperative to contain costs are coming together to transform health care.

Innovation in the prevention, diagnosis, and treatment of health-related issues is being fueled by the emergence of accessible and affordable technology-based solutions and changes in patient approaches to health care. Consumers and employers are increasingly motivated to look for cost-effective options for health in care delivery and for economical access to innovations.¹ Organizations will need to respond with a strategy that aligns with the changing environment and position physicians to lead these trends in the direction of improved patient care.²

Enabling technologies like electronic health records, blockchain, and artificial intelligence will increase connectivity among all the stakeholders in the health-care system. The exponential increase in connectivity means growing engagement of health systems, health plans, patients, and families in all aspects of health care. For health-care providers, these technologies will mean an acceleration of the requirement to generate data in clinical settings and utilize data for clinical decision making. Easily available data on outcomes and, most importantly, cost of treatment will be expected at point of service.³

Access to information will continue to empower consumers to take an active role in their own health care. More patients will be comfortable with delivery of some health care via digital devices, apps, and virtual access to treatment. The market will respond with technology that helps consumers navigate health-care systems, explore options, and communicate directly with providers. The use of apps and virtual encounters is expected to transform the role of primary care providers: patients will increasingly utilize nonphysician resources in outpatient settings, bypassing primary care physicians and reaching out to specialty care as needed.⁴

David A. Schulman, MD, FCCP, Professor of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University School of Medicine, Atlanta, and Editor in Chief of CHEST Physician, has seen the transformation of patient behavior and attitudes in his own practice.

“In general, they have done far more research about their health problems before seeking my counsel than patients did previously. Many use the internet not just to read about their symptoms and diseases, but also to connect with others having similar issues, sharing experiences, treatments, outcomes, and emotions; in some ways, this is the new ‘crowdsourcing’ of medicine.”

Patients who do their own “research” can present a challenge for physicians. Dr. Schulman noted, “I am often surprised about the misconceptions about disease that derive from information gleaned from a web-based source. One need not look any farther than the groundswell of misinformation being spread about vaccinations to see the potential downside of the pervasive availability of medical ‘facts’ online. Since we are unlikely to convince our patients to avoid the online milieu entirely, our role as health-care providers is to help our patients process and appropriately weigh the information that they receive, potentially partnering with our national societies to help curate such information.”

• Delivery of procedures and services will trend from physicians to other members of the health-care team and to lower cost, outpatient settings.⁹

• Health-care systems will ramp up investment in products and services that improve outcomes and cost effectiveness.¹⁰

• Increased regulatory requirements and new payment models mean an ever-growing utilization of information technology by providers to fulfill data imperatives.¹¹

• Physicians will have an increased need for tools that prioritize costs and outcomes data at the point of care.¹²
• Integration of data from new technologies will touch every aspect of health-care delivery with the objective of improving outcomes and, in turn, reducing costs.¹³
• Changing consumer attitudes toward delivery of care will be based on a growing familiarity of patients with a digital or virtual interface with providers, facility with health-care apps, and preference for a menu of options for health-care delivery.¹⁴

Dr. Schulman concluded, “We can no more expect our patients to ignore the full panoply of medical information on the internet and digital tools on their mobile devices than we can tell the tide not to come in. The die is cast; this is the world within which we must ply our trade. By identifying best practices and sharing our successes, we can come through this revolution better for the experience.”

MDedge News

References

1. https://www.modernhealthcare.com/article/20181220/NEWS/181229992/number-of-outpatient-facilities-surges-as-industry-values-more

2. https://www.accenture.com/us-en/insights/health/digital-health-tech-vision-2018

3.  https://www.accenture.com/us-en/insights/health/digital-health-primary-care

4. PcW Health Research Institute: Top health industry issues of 2019

5. https://www.accenture.com/us-en/insights/health/digital-health-primary-care

6. https://www.census.gov/newsroom/press-releases/2017/cb17-100.html

7. https://www.cdc.gov/chronicdisease/index.htm

8. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/health-care-current-december4-2018.html

9. PcW Health Research Institute Top health industry issues of 2019: The New Health Economy comes of age

10. https://www.accenture.com/us-en/insights/health/digital-health-tech-vision-2018

11. https://www2.deloitte.com/insights/us/en/industry/life-sciences/medtech-research-and-development-innovation.html

12. https://www2.deloitte.com/insights/us/en/industry/health-care/volume-to-value-based-care.html

13. https://www2.deloitte.com/insights/us/en/industry/health-care/volume-to-value-based-care.html

14. https://www.accenture.com/us-en/insights/health/digital-health-primary-care


 

CHEST Inspiration is a collection of programmatic initiatives developed by the American College of Chest Physicians leadership and aimed at stimulating and encouraging innovation within the association. One of the components of CHEST Inspiration is the Environmental Scan, a series of articles focusing on the internal and external environmental factors that bear on success currently and in the future. See “Envisioning the Future: the CHEST Environmental Scan,” CHEST Physician, June 2019, p. 44, for an introduction to the series.

Chest physicians are witnessing a revolution within the environment in which they practice. Information technology, changing consumer behavior, and the social imperative to contain costs are coming together to transform health care.

Innovation in the prevention, diagnosis, and treatment of health-related issues is being fueled by the emergence of accessible and affordable technology-based solutions and changes in patient approaches to health care. Consumers and employers are increasingly motivated to look for cost-effective options for health in care delivery and for economical access to innovations.¹ Organizations will need to respond with a strategy that aligns with the changing environment and position physicians to lead these trends in the direction of improved patient care.²

Enabling technologies like electronic health records, blockchain, and artificial intelligence will increase connectivity among all the stakeholders in the health-care system. The exponential increase in connectivity means growing engagement of health systems, health plans, patients, and families in all aspects of health care. For health-care providers, these technologies will mean an acceleration of the requirement to generate data in clinical settings and utilize data for clinical decision making. Easily available data on outcomes and, most importantly, cost of treatment will be expected at point of service.³

Access to information will continue to empower consumers to take an active role in their own health care. More patients will be comfortable with delivery of some health care via digital devices, apps, and virtual access to treatment. The market will respond with technology that helps consumers navigate health-care systems, explore options, and communicate directly with providers. The use of apps and virtual encounters is expected to transform the role of primary care providers: patients will increasingly utilize nonphysician resources in outpatient settings, bypassing primary care physicians and reaching out to specialty care as needed.⁴

David A. Schulman, MD, FCCP, Professor of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University School of Medicine, Atlanta, and Editor in Chief of CHEST Physician, has seen the transformation of patient behavior and attitudes in his own practice.

“In general, they have done far more research about their health problems before seeking my counsel than patients did previously. Many use the internet not just to read about their symptoms and diseases, but also to connect with others having similar issues, sharing experiences, treatments, outcomes, and emotions; in some ways, this is the new ‘crowdsourcing’ of medicine.”

Patients who do their own “research” can present a challenge for physicians. Dr. Schulman noted, “I am often surprised about the misconceptions about disease that derive from information gleaned from a web-based source. One need not look any farther than the groundswell of misinformation being spread about vaccinations to see the potential downside of the pervasive availability of medical ‘facts’ online. Since we are unlikely to convince our patients to avoid the online milieu entirely, our role as health-care providers is to help our patients process and appropriately weigh the information that they receive, potentially partnering with our national societies to help curate such information.”

• Delivery of procedures and services will trend from physicians to other members of the health-care team and to lower cost, outpatient settings.⁹

• Health-care systems will ramp up investment in products and services that improve outcomes and cost effectiveness.¹⁰

• Increased regulatory requirements and new payment models mean an ever-growing utilization of information technology by providers to fulfill data imperatives.¹¹

• Physicians will have an increased need for tools that prioritize costs and outcomes data at the point of care.¹²
• Integration of data from new technologies will touch every aspect of health-care delivery with the objective of improving outcomes and, in turn, reducing costs.¹³
• Changing consumer attitudes toward delivery of care will be based on a growing familiarity of patients with a digital or virtual interface with providers, facility with health-care apps, and preference for a menu of options for health-care delivery.¹⁴

Dr. Schulman concluded, “We can no more expect our patients to ignore the full panoply of medical information on the internet and digital tools on their mobile devices than we can tell the tide not to come in. The die is cast; this is the world within which we must ply our trade. By identifying best practices and sharing our successes, we can come through this revolution better for the experience.”

MDedge News

References

1. https://www.modernhealthcare.com/article/20181220/NEWS/181229992/number-of-outpatient-facilities-surges-as-industry-values-more

2. https://www.accenture.com/us-en/insights/health/digital-health-tech-vision-2018

3.  https://www.accenture.com/us-en/insights/health/digital-health-primary-care

4. PcW Health Research Institute: Top health industry issues of 2019

5. https://www.accenture.com/us-en/insights/health/digital-health-primary-care

6. https://www.census.gov/newsroom/press-releases/2017/cb17-100.html

7. https://www.cdc.gov/chronicdisease/index.htm

8. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/health-care-current-december4-2018.html

9. PcW Health Research Institute Top health industry issues of 2019: The New Health Economy comes of age

10. https://www.accenture.com/us-en/insights/health/digital-health-tech-vision-2018

11. https://www2.deloitte.com/insights/us/en/industry/life-sciences/medtech-research-and-development-innovation.html

12. https://www2.deloitte.com/insights/us/en/industry/health-care/volume-to-value-based-care.html

13. https://www2.deloitte.com/insights/us/en/industry/health-care/volume-to-value-based-care.html

14. https://www.accenture.com/us-en/insights/health/digital-health-primary-care


 

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

[email protected]

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

[email protected]

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

[email protected]