In Reply: Dr. Geller makes some excellent points about sleep and opioid use.

Opioids pose risks,¹ just like any other type of medication. In particular, opioids have been linked to sleep-disordered breathing, which affects 70% to 85% of patients taking opioids.^2–4

Other options can be used in some older adults, but they are not always successful. Ideally, nonpharmacologic strategies and nonopioid medications such as acetaminophen, nonsteroidal anti-inflammatory agents, antidepressants, and anticonvulsants should be used, although these medications have their own side effects. Optimum pain control may offer the potential for significant improvement in function, and opioids are but one tool in the clinician’s kit.

Ongoing discussions of the risks and benefits are necessary, along with continuous re-evaluation of the need for and effect of opioids.

In Reply: Dr. Geller makes some excellent points about sleep and opioid use.

Opioids pose risks,¹ just like any other type of medication. In particular, opioids have been linked to sleep-disordered breathing, which affects 70% to 85% of patients taking opioids.^2–4

Other options can be used in some older adults, but they are not always successful. Ideally, nonpharmacologic strategies and nonopioid medications such as acetaminophen, nonsteroidal anti-inflammatory agents, antidepressants, and anticonvulsants should be used, although these medications have their own side effects. Optimum pain control may offer the potential for significant improvement in function, and opioids are but one tool in the clinician’s kit.

Ongoing discussions of the risks and benefits are necessary, along with continuous re-evaluation of the need for and effect of opioids.

In Reply: Dr. Geller makes some excellent points about sleep and opioid use.

Opioids pose risks,¹ just like any other type of medication. In particular, opioids have been linked to sleep-disordered breathing, which affects 70% to 85% of patients taking opioids.^2–4

Other options can be used in some older adults, but they are not always successful. Ideally, nonpharmacologic strategies and nonopioid medications such as acetaminophen, nonsteroidal anti-inflammatory agents, antidepressants, and anticonvulsants should be used, although these medications have their own side effects. Optimum pain control may offer the potential for significant improvement in function, and opioids are but one tool in the clinician’s kit.

Ongoing discussions of the risks and benefits are necessary, along with continuous re-evaluation of the need for and effect of opioids.

To the Editor: I read with interest the review on submassive pulmonary embolism by Ataya et al¹ in the December 2016 issue. I had 3 questions or observations for the authors

First, systemic thrombolytic therapy for massive or hemodynamically unstable pulmonary embolism is given a grade 2C recommendation, similar to the level for select patients with submassive pulmonary embolism with low bleeding risk but at high risk of developing hypotension. The reference for this is the 2012 American College of Chest Physicians guidelines.² I would like to point out that these guidelines were updated and published in February 2016,³ and systemic thrombolytic therapy for massive pulmonary embolism now carries a grade 2B recommendation. Thrombolytic therapy still has a grade 2C recommendation for select patients with submassive pulmonary embolism.

Second, the Moderate Pulmonary Embolism Treated With Thrombolysis (MOPETT) trial is described as a randomized trial in patients with moderate pulmonary hypertension and right ventricular dysfunction. I would like to point out that right ventricular dysfunction was not a criterion for enrollment in the trial.⁴

Finally, catheter-directed thrombolytic therapy is mentioned as an option for select patients with submassive and massive pulmonary embolism. The advantage is believed to be due to local action of the drug with fewer systemic effects. Since the protocol involves alteplase for 12 or 24 hours with a maximum dose of 24 mg, and since in most cases pulmonary embolism originates in the lower extremity, are we not exposing these patients to further clot propagation for 12 or 24 hours without the benefit of concomitant systemic anticoagulation or an inferior vena cava filter?

To the Editor: I read with interest the review on submassive pulmonary embolism by Ataya et al¹ in the December 2016 issue. I had 3 questions or observations for the authors

First, systemic thrombolytic therapy for massive or hemodynamically unstable pulmonary embolism is given a grade 2C recommendation, similar to the level for select patients with submassive pulmonary embolism with low bleeding risk but at high risk of developing hypotension. The reference for this is the 2012 American College of Chest Physicians guidelines.² I would like to point out that these guidelines were updated and published in February 2016,³ and systemic thrombolytic therapy for massive pulmonary embolism now carries a grade 2B recommendation. Thrombolytic therapy still has a grade 2C recommendation for select patients with submassive pulmonary embolism.

Second, the Moderate Pulmonary Embolism Treated With Thrombolysis (MOPETT) trial is described as a randomized trial in patients with moderate pulmonary hypertension and right ventricular dysfunction. I would like to point out that right ventricular dysfunction was not a criterion for enrollment in the trial.⁴

Finally, catheter-directed thrombolytic therapy is mentioned as an option for select patients with submassive and massive pulmonary embolism. The advantage is believed to be due to local action of the drug with fewer systemic effects. Since the protocol involves alteplase for 12 or 24 hours with a maximum dose of 24 mg, and since in most cases pulmonary embolism originates in the lower extremity, are we not exposing these patients to further clot propagation for 12 or 24 hours without the benefit of concomitant systemic anticoagulation or an inferior vena cava filter?

To the Editor: I read with interest the review on submassive pulmonary embolism by Ataya et al¹ in the December 2016 issue. I had 3 questions or observations for the authors

First, systemic thrombolytic therapy for massive or hemodynamically unstable pulmonary embolism is given a grade 2C recommendation, similar to the level for select patients with submassive pulmonary embolism with low bleeding risk but at high risk of developing hypotension. The reference for this is the 2012 American College of Chest Physicians guidelines.² I would like to point out that these guidelines were updated and published in February 2016,³ and systemic thrombolytic therapy for massive pulmonary embolism now carries a grade 2B recommendation. Thrombolytic therapy still has a grade 2C recommendation for select patients with submassive pulmonary embolism.

Second, the Moderate Pulmonary Embolism Treated With Thrombolysis (MOPETT) trial is described as a randomized trial in patients with moderate pulmonary hypertension and right ventricular dysfunction. I would like to point out that right ventricular dysfunction was not a criterion for enrollment in the trial.⁴

Finally, catheter-directed thrombolytic therapy is mentioned as an option for select patients with submassive and massive pulmonary embolism. The advantage is believed to be due to local action of the drug with fewer systemic effects. Since the protocol involves alteplase for 12 or 24 hours with a maximum dose of 24 mg, and since in most cases pulmonary embolism originates in the lower extremity, are we not exposing these patients to further clot propagation for 12 or 24 hours without the benefit of concomitant systemic anticoagulation or an inferior vena cava filter?

In Reply: We thank Dr. Katyal for his thoughtful comments.

Dr. Katyal points out that the grade of recommendation for thrombolysis in patients with massive pulmonary embolism was upgraded from 2C to 2B in the 2016 American College of Chest Physicians (ACCP) guidelines¹ compared with the 2012 guidelines² that we cited. The upgrade in this recommendation was owing to 2 small trials and 1 large randomized controlled trial that included patients with submassive pulmonary embolism.^3–5 Interestingly, these 3 studies led to an upgrade in the level of recommendation for thrombolysis in the treatment of massive pulmonary embolism, perhaps more from a safety aspect (in view of the incidence of major bleeding vs mortality). Regardless, Dr. Katyal is correct in highlighting that the new 2016 ACCP guidelines now give a grade of 2B for thrombolytic therapy in the treatment of massive pulmonary embolism. These guidelines had not been published at the time of submission of our manuscript.

Dr. Katyal is also correct that patients were not required to have right ventricular dysfunction to be enrolled in the MOPETT trial.³ As we pointed out, “Only 20% of the participants were enrolled on the basis of right ventricular dysfunction on echocardiography, whereas almost 60% had elevated cardiac biomarkers.”⁶

Regarding catheter-directed therapy, patients who received low-dose catheter-directed alteplase were also concurrently anticoagulated with systemic unfractionated heparin in the Ultrasound-Assisted, Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism (ULTIMA) trial.⁷ The ULTIMA trial authors commented that unfractionated heparin was started with an 80-U/kg bolus followed by an 18-U/kg/hour infusion to target an anti-factor Xa level of 0.3 to 0.7 μg/mL, which is considered therapeutic anticoagulation. The investigators in the SEATTLE II trial⁸ continued systemic unfractionated heparin but targeted a lower “intermediate” anticoagulation target (an augmented partial thromboplastin time of 40–60 seconds), so these patients weren’t completely without systemic anticoagulation either. At our institution, the current practice is to target an anti-Xa level of 0.3 to 0.7 μg/mL in patients receiving catheter-directed therapy for large-volume pulmonary embolism.

In Reply: We thank Dr. Katyal for his thoughtful comments.

Dr. Katyal points out that the grade of recommendation for thrombolysis in patients with massive pulmonary embolism was upgraded from 2C to 2B in the 2016 American College of Chest Physicians (ACCP) guidelines¹ compared with the 2012 guidelines² that we cited. The upgrade in this recommendation was owing to 2 small trials and 1 large randomized controlled trial that included patients with submassive pulmonary embolism.^3–5 Interestingly, these 3 studies led to an upgrade in the level of recommendation for thrombolysis in the treatment of massive pulmonary embolism, perhaps more from a safety aspect (in view of the incidence of major bleeding vs mortality). Regardless, Dr. Katyal is correct in highlighting that the new 2016 ACCP guidelines now give a grade of 2B for thrombolytic therapy in the treatment of massive pulmonary embolism. These guidelines had not been published at the time of submission of our manuscript.

Dr. Katyal is also correct that patients were not required to have right ventricular dysfunction to be enrolled in the MOPETT trial.³ As we pointed out, “Only 20% of the participants were enrolled on the basis of right ventricular dysfunction on echocardiography, whereas almost 60% had elevated cardiac biomarkers.”⁶

Regarding catheter-directed therapy, patients who received low-dose catheter-directed alteplase were also concurrently anticoagulated with systemic unfractionated heparin in the Ultrasound-Assisted, Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism (ULTIMA) trial.⁷ The ULTIMA trial authors commented that unfractionated heparin was started with an 80-U/kg bolus followed by an 18-U/kg/hour infusion to target an anti-factor Xa level of 0.3 to 0.7 μg/mL, which is considered therapeutic anticoagulation. The investigators in the SEATTLE II trial⁸ continued systemic unfractionated heparin but targeted a lower “intermediate” anticoagulation target (an augmented partial thromboplastin time of 40–60 seconds), so these patients weren’t completely without systemic anticoagulation either. At our institution, the current practice is to target an anti-Xa level of 0.3 to 0.7 μg/mL in patients receiving catheter-directed therapy for large-volume pulmonary embolism.

In Reply: We thank Dr. Katyal for his thoughtful comments.

Dr. Katyal points out that the grade of recommendation for thrombolysis in patients with massive pulmonary embolism was upgraded from 2C to 2B in the 2016 American College of Chest Physicians (ACCP) guidelines¹ compared with the 2012 guidelines² that we cited. The upgrade in this recommendation was owing to 2 small trials and 1 large randomized controlled trial that included patients with submassive pulmonary embolism.^3–5 Interestingly, these 3 studies led to an upgrade in the level of recommendation for thrombolysis in the treatment of massive pulmonary embolism, perhaps more from a safety aspect (in view of the incidence of major bleeding vs mortality). Regardless, Dr. Katyal is correct in highlighting that the new 2016 ACCP guidelines now give a grade of 2B for thrombolytic therapy in the treatment of massive pulmonary embolism. These guidelines had not been published at the time of submission of our manuscript.

Dr. Katyal is also correct that patients were not required to have right ventricular dysfunction to be enrolled in the MOPETT trial.³ As we pointed out, “Only 20% of the participants were enrolled on the basis of right ventricular dysfunction on echocardiography, whereas almost 60% had elevated cardiac biomarkers.”⁶

Regarding catheter-directed therapy, patients who received low-dose catheter-directed alteplase were also concurrently anticoagulated with systemic unfractionated heparin in the Ultrasound-Assisted, Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism (ULTIMA) trial.⁷ The ULTIMA trial authors commented that unfractionated heparin was started with an 80-U/kg bolus followed by an 18-U/kg/hour infusion to target an anti-factor Xa level of 0.3 to 0.7 μg/mL, which is considered therapeutic anticoagulation. The investigators in the SEATTLE II trial⁸ continued systemic unfractionated heparin but targeted a lower “intermediate” anticoagulation target (an augmented partial thromboplastin time of 40–60 seconds), so these patients weren’t completely without systemic anticoagulation either. At our institution, the current practice is to target an anti-Xa level of 0.3 to 0.7 μg/mL in patients receiving catheter-directed therapy for large-volume pulmonary embolism.

Few fireworks are expected as confirmation hearings begin for David J. Shulkin, MD, for secretary of the Department of Veterans Affairs. Dr. Shulkin, who served as under secretary of health during the Obama administration, has widespread support from veteran service organizations, Democrats, and Republicans.  

Related: Shulkin: VA "Not a Political Issue”

“We ask for the speedy confirmation of Dr. David Shulkin,” Randy Reeves, president of the National Association of State Directors of Veterans Affairs wrote in a letter to committee members. “As we all know, Dr. Shulkin is an accomplished physician and leader in healthcare. Most importantly, I think, he has been an important leader in the team that has effected the largest (positive) transformation in VA’s history. We can all agree there is still work ahead and we are confident that David Shulkin will be a great leader for VA, serve our veterans well and continue the MyVA Transformation.”

One of the likely topics in the hearing will be in the impact of the federal hiring freeze implemented by the Trump administration. The Acting Secretary of Veterans Affairs Robert Snyder recently released a memo that insisted that the freeze will not affect many categories of VA employees. The VA will exempt frontline personnel at VA medical centers, outpatient clinics, community-based outpatient clinics, and health centers who “it deems necessary for public health and safety,” Snyder said in a statement. As VA Secretary Nominee, Dr. Shulkin recently told Federal Practitioner, there are currently 45,000 openings at the VA for frontline medical positions.

Related: Shulkin Addresses APRN Rule, Health Care Vacancies, and Access

Recognizing the important role the VA plays in “training the nations health care providers,” the memo also exempted personnel involved in training and residency programs.

Those positions have proven to be difficult to fill. According to an investigation by National Public Radio (NPR) and local member stations, even an infusion of $2.5 billion from the Veterans Choice and Accountability Act of 2014, which was meant to help VA medical centers with the most urgent wait time problems, has not helped. “New hires weren’t sent to VA hospitals with the longest wait times,” NPR reported, “and the VA medical centers that got new hires were not more likely to see improved wait times.”

According to the NPR report, about 13% of the candidates for VA positions withdraw before they are hired due to the “months-long lag time after they are hired.”

Related: Get to Know the Trump Administration VA Secretary Nominee

Few fireworks are expected as confirmation hearings begin for David J. Shulkin, MD, for secretary of the Department of Veterans Affairs. Dr. Shulkin, who served as under secretary of health during the Obama administration, has widespread support from veteran service organizations, Democrats, and Republicans.  

Related: Shulkin: VA "Not a Political Issue”

“We ask for the speedy confirmation of Dr. David Shulkin,” Randy Reeves, president of the National Association of State Directors of Veterans Affairs wrote in a letter to committee members. “As we all know, Dr. Shulkin is an accomplished physician and leader in healthcare. Most importantly, I think, he has been an important leader in the team that has effected the largest (positive) transformation in VA’s history. We can all agree there is still work ahead and we are confident that David Shulkin will be a great leader for VA, serve our veterans well and continue the MyVA Transformation.”

One of the likely topics in the hearing will be in the impact of the federal hiring freeze implemented by the Trump administration. The Acting Secretary of Veterans Affairs Robert Snyder recently released a memo that insisted that the freeze will not affect many categories of VA employees. The VA will exempt frontline personnel at VA medical centers, outpatient clinics, community-based outpatient clinics, and health centers who “it deems necessary for public health and safety,” Snyder said in a statement. As VA Secretary Nominee, Dr. Shulkin recently told Federal Practitioner, there are currently 45,000 openings at the VA for frontline medical positions.

Related: Shulkin Addresses APRN Rule, Health Care Vacancies, and Access

Recognizing the important role the VA plays in “training the nations health care providers,” the memo also exempted personnel involved in training and residency programs.

Those positions have proven to be difficult to fill. According to an investigation by National Public Radio (NPR) and local member stations, even an infusion of $2.5 billion from the Veterans Choice and Accountability Act of 2014, which was meant to help VA medical centers with the most urgent wait time problems, has not helped. “New hires weren’t sent to VA hospitals with the longest wait times,” NPR reported, “and the VA medical centers that got new hires were not more likely to see improved wait times.”

According to the NPR report, about 13% of the candidates for VA positions withdraw before they are hired due to the “months-long lag time after they are hired.”

Related: Get to Know the Trump Administration VA Secretary Nominee

Few fireworks are expected as confirmation hearings begin for David J. Shulkin, MD, for secretary of the Department of Veterans Affairs. Dr. Shulkin, who served as under secretary of health during the Obama administration, has widespread support from veteran service organizations, Democrats, and Republicans.  

Related: Shulkin: VA "Not a Political Issue”

“We ask for the speedy confirmation of Dr. David Shulkin,” Randy Reeves, president of the National Association of State Directors of Veterans Affairs wrote in a letter to committee members. “As we all know, Dr. Shulkin is an accomplished physician and leader in healthcare. Most importantly, I think, he has been an important leader in the team that has effected the largest (positive) transformation in VA’s history. We can all agree there is still work ahead and we are confident that David Shulkin will be a great leader for VA, serve our veterans well and continue the MyVA Transformation.”

One of the likely topics in the hearing will be in the impact of the federal hiring freeze implemented by the Trump administration. The Acting Secretary of Veterans Affairs Robert Snyder recently released a memo that insisted that the freeze will not affect many categories of VA employees. The VA will exempt frontline personnel at VA medical centers, outpatient clinics, community-based outpatient clinics, and health centers who “it deems necessary for public health and safety,” Snyder said in a statement. As VA Secretary Nominee, Dr. Shulkin recently told Federal Practitioner, there are currently 45,000 openings at the VA for frontline medical positions.

Related: Shulkin Addresses APRN Rule, Health Care Vacancies, and Access

Recognizing the important role the VA plays in “training the nations health care providers,” the memo also exempted personnel involved in training and residency programs.

Those positions have proven to be difficult to fill. According to an investigation by National Public Radio (NPR) and local member stations, even an infusion of $2.5 billion from the Veterans Choice and Accountability Act of 2014, which was meant to help VA medical centers with the most urgent wait time problems, has not helped. “New hires weren’t sent to VA hospitals with the longest wait times,” NPR reported, “and the VA medical centers that got new hires were not more likely to see improved wait times.”

According to the NPR report, about 13% of the candidates for VA positions withdraw before they are hired due to the “months-long lag time after they are hired.”

Related: Get to Know the Trump Administration VA Secretary Nominee

Click here to access the Best Practices in Hematology and Oncology 2017 Digital Edition.

Table of Contents

• Timeliness of Lung Cancer Diagnosis and Treatment
• Treatment and Management of Multiple Myeloma
• Ketogenic Diets and Cancer: Emerging Evidence
• Distress Screening and Management in an Outpatient VA Cancer Clinic: A Pilot Project Involving Ambulatory Patients Across the Disease Trajectory
• A Road Map for Creating a CPRS Template for a Cancer Survivorship Treatment Summary and Care Plan

Click here to access the Best Practices in Hematology and Oncology 2017 Digital Edition.

Table of Contents

• Timeliness of Lung Cancer Diagnosis and Treatment
• Treatment and Management of Multiple Myeloma
• Ketogenic Diets and Cancer: Emerging Evidence
• Distress Screening and Management in an Outpatient VA Cancer Clinic: A Pilot Project Involving Ambulatory Patients Across the Disease Trajectory
• A Road Map for Creating a CPRS Template for a Cancer Survivorship Treatment Summary and Care Plan

Click here to access the Best Practices in Hematology and Oncology 2017 Digital Edition.

Table of Contents

• Timeliness of Lung Cancer Diagnosis and Treatment
• Treatment and Management of Multiple Myeloma
• Ketogenic Diets and Cancer: Emerging Evidence
• Distress Screening and Management in an Outpatient VA Cancer Clinic: A Pilot Project Involving Ambulatory Patients Across the Disease Trajectory
• A Road Map for Creating a CPRS Template for a Cancer Survivorship Treatment Summary and Care Plan

Click here to access the February 2017 Digital Edition.

Table of Contents

• The VA Is Not Just a Hospital, It Is a Community
• Minimizing Postdisaster Fatalities
• A Primary Hospital Antimicrobial Stewardship Intervention on Pneumonia Treatment Duration
• Review of the Long-Term Effects of Proton Pump Inhibitors
• Malnutrition as a Fall Risk Factor
• Sleep-Disordered Breathing in the Active-Duty Military Population and Its Civilian Care Cost
• Anticoagulation Management Outcomes in Veterans: Office vs Telephone Visits
• Allergic Reaction to Phenylephrine
• FDA Updates
• COVER to COVER: Connecting Older Veterans (Especially Rural) to Community or Veteran-Eligible Resources

Click here to access the February 2017 Digital Edition.

Table of Contents

• The VA Is Not Just a Hospital, It Is a Community
• Minimizing Postdisaster Fatalities
• A Primary Hospital Antimicrobial Stewardship Intervention on Pneumonia Treatment Duration
• Review of the Long-Term Effects of Proton Pump Inhibitors
• Malnutrition as a Fall Risk Factor
• Sleep-Disordered Breathing in the Active-Duty Military Population and Its Civilian Care Cost
• Anticoagulation Management Outcomes in Veterans: Office vs Telephone Visits
• Allergic Reaction to Phenylephrine
• FDA Updates
• COVER to COVER: Connecting Older Veterans (Especially Rural) to Community or Veteran-Eligible Resources

Click here to access the February 2017 Digital Edition.

Table of Contents

• The VA Is Not Just a Hospital, It Is a Community
• Minimizing Postdisaster Fatalities
• A Primary Hospital Antimicrobial Stewardship Intervention on Pneumonia Treatment Duration
• Review of the Long-Term Effects of Proton Pump Inhibitors
• Malnutrition as a Fall Risk Factor
• Sleep-Disordered Breathing in the Active-Duty Military Population and Its Civilian Care Cost
• Anticoagulation Management Outcomes in Veterans: Office vs Telephone Visits
• Allergic Reaction to Phenylephrine
• FDA Updates
• COVER to COVER: Connecting Older Veterans (Especially Rural) to Community or Veteran-Eligible Resources

Session at the 9th Annual

T-cell Lymphoma Forum

Photo by Larry Young

SAN FRANCISCO—Researchers have used data from the T-Cell Project (TCP) to create a prognostic model for peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

Analyses have suggested the TCP model is more accurate for PTCL-NOS than 4 other prognostic models—the International Prognostic Index (IPI), the Prognostic Index for T-cell Lymphoma (PIT), the International Peripheral T-cell Lymphoma Project score (IPTCLP), and the modified PIT (mPIT).

Massimo Federico, MD, of the University of Modena and Reggio Emilia in Italy, described the TCP model at the 9th Annual T-cell Lymphoma Forum.

Creating the model

TCP is a prospective registry that includes data from T-cell lymphoma patients in 15 countries located in 5 different regions of the world. As of December 31, 2016, 1523 cases of T-cell lymphoma have been registered with TCP.

Dr Federico and his colleagues used these data to create their prognostic model. There were 311 patients with PTCL-NOS who had adequate data for analysis. The 5-year overall survival (OS) for these patients was 36%.

The researchers chose 13 variables from the literature that have been reported to have a prognostic impact on survival in PTCL-NOS:

• Age > 60
• Lactate dehydrogenase > upper limit of normal
• Albumin < 3.5 g/dL
• Hemoglobin < 12 g/dL
• Platelets < 150/mm³
• Lymphocyte to monocyte ratio ≤ 2.1
• Neutrophil to lymphocyte ratio > 6.5
• Absolute neutrophil count (ANC) > 6.5/mm³
• ECOG performance status > 1
• Stage III-IV disease
• B symptoms
• Extra nodal sites > 1
• Male gender.

In univariate analysis, nearly all of these factors were significantly associated with OS in the cohort of TCP patients. (The 2 exceptions were age older than 60 and having more than 1 extranodal site.)

However, Dr Federico and his colleagues said the factors with the greatest prognostic impact were:

• ECOG performance status > 1, with a hazard ratio (HR) of 2.12 (P<0.001)
• Albumin < 3.5 g/dL, with an HR of 2.03 (P<0.001)
• ANC > 6.5/mm³, with an HR of 1.85 (P<0.001)
• Stage III-IV disease, with an HR of 1.74 (P=0.010).

So the researchers used these factors in their model, which has 3 risk categories.

Risk categories

Patients were considered low-risk if they had 0 of the 4 risk factors. These patients had a 3-year OS of 76% and a 5-year OS of 69%.

Patients were considered intermediate-risk if they had 1 to 2 risk factors. These patients had a 3-year OS of 43% and a 5-year OS of 31%. Compared to low-risk patients, the HR was 3.08 (P<0.001).

Patients were considered high-risk if they had 3 to 4 risk factors. The 3-year OS was 11% for these patients, and the 5-year OS was 8%.

The HR was 8.88 (P<0.001) for high-risk compared to low-risk patients and 2.88 (P<0.001) for high-risk compared to intermediate-risk patients.

Validation

The researchers tested the TCP model in a validation cohort of 98 patients from the COMPLETE registry. As with the training cohort of TCP patients, the model revealed 3 different risk groups (in terms of OS) in the validation cohort.

Dr Federico noted that there were no significant differences between the training and validation cohorts, except when it came to follow-up. The median follow-up was 46 months in the TCP group and 18 months in the COMPLETE group.

The researchers also found the TCP could classify patients into 3 different risk groups according to progression-free survival.

Comparison

Finally, Dr Federico and his colleagues compared the TCP model to the IPI, PIT, IPTCLP, and mPIT models using 208 patients.

“The discriminant power of the proposed model is superior to the others in terms of all of the statistical tests we adopted,” Dr Federico said.

In closing, Dr Federico said the TCP model clearly defines risk groups in PTCL-NOS and identifies patients with relatively good prognosis.

However, there is a need for emerging biologic variables to be tested for prognostic value and included in prognostic tools to allow for better risk stratification.

*c-Harrel: Harrell’s concordance index, 95% CI: confidence interval, D-Royston: Royston/Sauerbrei’s D statistic (Stat Med 2004 Mar 15, 23[5]:723-48), SE: standard error, R²: explained randomness, AIC: Akaike information criterion, AUC: area under the curve (according to Heagerty et al, Biometrics, 2000 Jun, 56[2]:337-44).

Session at the 9th Annual

T-cell Lymphoma Forum

Photo by Larry Young

SAN FRANCISCO—Researchers have used data from the T-Cell Project (TCP) to create a prognostic model for peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

Analyses have suggested the TCP model is more accurate for PTCL-NOS than 4 other prognostic models—the International Prognostic Index (IPI), the Prognostic Index for T-cell Lymphoma (PIT), the International Peripheral T-cell Lymphoma Project score (IPTCLP), and the modified PIT (mPIT).

Massimo Federico, MD, of the University of Modena and Reggio Emilia in Italy, described the TCP model at the 9th Annual T-cell Lymphoma Forum.

Creating the model

TCP is a prospective registry that includes data from T-cell lymphoma patients in 15 countries located in 5 different regions of the world. As of December 31, 2016, 1523 cases of T-cell lymphoma have been registered with TCP.

Dr Federico and his colleagues used these data to create their prognostic model. There were 311 patients with PTCL-NOS who had adequate data for analysis. The 5-year overall survival (OS) for these patients was 36%.

The researchers chose 13 variables from the literature that have been reported to have a prognostic impact on survival in PTCL-NOS:

• Age > 60
• Lactate dehydrogenase > upper limit of normal
• Albumin < 3.5 g/dL
• Hemoglobin < 12 g/dL
• Platelets < 150/mm³
• Lymphocyte to monocyte ratio ≤ 2.1
• Neutrophil to lymphocyte ratio > 6.5
• Absolute neutrophil count (ANC) > 6.5/mm³
• ECOG performance status > 1
• Stage III-IV disease
• B symptoms
• Extra nodal sites > 1
• Male gender.

In univariate analysis, nearly all of these factors were significantly associated with OS in the cohort of TCP patients. (The 2 exceptions were age older than 60 and having more than 1 extranodal site.)

However, Dr Federico and his colleagues said the factors with the greatest prognostic impact were:

• ECOG performance status > 1, with a hazard ratio (HR) of 2.12 (P<0.001)
• Albumin < 3.5 g/dL, with an HR of 2.03 (P<0.001)
• ANC > 6.5/mm³, with an HR of 1.85 (P<0.001)
• Stage III-IV disease, with an HR of 1.74 (P=0.010).

So the researchers used these factors in their model, which has 3 risk categories.

Risk categories

Patients were considered low-risk if they had 0 of the 4 risk factors. These patients had a 3-year OS of 76% and a 5-year OS of 69%.

Patients were considered intermediate-risk if they had 1 to 2 risk factors. These patients had a 3-year OS of 43% and a 5-year OS of 31%. Compared to low-risk patients, the HR was 3.08 (P<0.001).

Patients were considered high-risk if they had 3 to 4 risk factors. The 3-year OS was 11% for these patients, and the 5-year OS was 8%.

The HR was 8.88 (P<0.001) for high-risk compared to low-risk patients and 2.88 (P<0.001) for high-risk compared to intermediate-risk patients.

Validation

The researchers tested the TCP model in a validation cohort of 98 patients from the COMPLETE registry. As with the training cohort of TCP patients, the model revealed 3 different risk groups (in terms of OS) in the validation cohort.

Dr Federico noted that there were no significant differences between the training and validation cohorts, except when it came to follow-up. The median follow-up was 46 months in the TCP group and 18 months in the COMPLETE group.

The researchers also found the TCP could classify patients into 3 different risk groups according to progression-free survival.

Comparison

Finally, Dr Federico and his colleagues compared the TCP model to the IPI, PIT, IPTCLP, and mPIT models using 208 patients.

“The discriminant power of the proposed model is superior to the others in terms of all of the statistical tests we adopted,” Dr Federico said.

In closing, Dr Federico said the TCP model clearly defines risk groups in PTCL-NOS and identifies patients with relatively good prognosis.

However, there is a need for emerging biologic variables to be tested for prognostic value and included in prognostic tools to allow for better risk stratification.

*c-Harrel: Harrell’s concordance index, 95% CI: confidence interval, D-Royston: Royston/Sauerbrei’s D statistic (Stat Med 2004 Mar 15, 23[5]:723-48), SE: standard error, R²: explained randomness, AIC: Akaike information criterion, AUC: area under the curve (according to Heagerty et al, Biometrics, 2000 Jun, 56[2]:337-44).

Session at the 9th Annual

T-cell Lymphoma Forum

Photo by Larry Young

SAN FRANCISCO—Researchers have used data from the T-Cell Project (TCP) to create a prognostic model for peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

Analyses have suggested the TCP model is more accurate for PTCL-NOS than 4 other prognostic models—the International Prognostic Index (IPI), the Prognostic Index for T-cell Lymphoma (PIT), the International Peripheral T-cell Lymphoma Project score (IPTCLP), and the modified PIT (mPIT).

Massimo Federico, MD, of the University of Modena and Reggio Emilia in Italy, described the TCP model at the 9th Annual T-cell Lymphoma Forum.

Creating the model

TCP is a prospective registry that includes data from T-cell lymphoma patients in 15 countries located in 5 different regions of the world. As of December 31, 2016, 1523 cases of T-cell lymphoma have been registered with TCP.

Dr Federico and his colleagues used these data to create their prognostic model. There were 311 patients with PTCL-NOS who had adequate data for analysis. The 5-year overall survival (OS) for these patients was 36%.

The researchers chose 13 variables from the literature that have been reported to have a prognostic impact on survival in PTCL-NOS:

• Age > 60
• Lactate dehydrogenase > upper limit of normal
• Albumin < 3.5 g/dL
• Hemoglobin < 12 g/dL
• Platelets < 150/mm³
• Lymphocyte to monocyte ratio ≤ 2.1
• Neutrophil to lymphocyte ratio > 6.5
• Absolute neutrophil count (ANC) > 6.5/mm³
• ECOG performance status > 1
• Stage III-IV disease
• B symptoms
• Extra nodal sites > 1
• Male gender.

In univariate analysis, nearly all of these factors were significantly associated with OS in the cohort of TCP patients. (The 2 exceptions were age older than 60 and having more than 1 extranodal site.)

However, Dr Federico and his colleagues said the factors with the greatest prognostic impact were:

• ECOG performance status > 1, with a hazard ratio (HR) of 2.12 (P<0.001)
• Albumin < 3.5 g/dL, with an HR of 2.03 (P<0.001)
• ANC > 6.5/mm³, with an HR of 1.85 (P<0.001)
• Stage III-IV disease, with an HR of 1.74 (P=0.010).

So the researchers used these factors in their model, which has 3 risk categories.

Risk categories

Patients were considered low-risk if they had 0 of the 4 risk factors. These patients had a 3-year OS of 76% and a 5-year OS of 69%.

Patients were considered intermediate-risk if they had 1 to 2 risk factors. These patients had a 3-year OS of 43% and a 5-year OS of 31%. Compared to low-risk patients, the HR was 3.08 (P<0.001).

Patients were considered high-risk if they had 3 to 4 risk factors. The 3-year OS was 11% for these patients, and the 5-year OS was 8%.

The HR was 8.88 (P<0.001) for high-risk compared to low-risk patients and 2.88 (P<0.001) for high-risk compared to intermediate-risk patients.

Validation

The researchers tested the TCP model in a validation cohort of 98 patients from the COMPLETE registry. As with the training cohort of TCP patients, the model revealed 3 different risk groups (in terms of OS) in the validation cohort.

Dr Federico noted that there were no significant differences between the training and validation cohorts, except when it came to follow-up. The median follow-up was 46 months in the TCP group and 18 months in the COMPLETE group.

The researchers also found the TCP could classify patients into 3 different risk groups according to progression-free survival.

Comparison

Finally, Dr Federico and his colleagues compared the TCP model to the IPI, PIT, IPTCLP, and mPIT models using 208 patients.

“The discriminant power of the proposed model is superior to the others in terms of all of the statistical tests we adopted,” Dr Federico said.

In closing, Dr Federico said the TCP model clearly defines risk groups in PTCL-NOS and identifies patients with relatively good prognosis.

However, there is a need for emerging biologic variables to be tested for prognostic value and included in prognostic tools to allow for better risk stratification.

*c-Harrel: Harrell’s concordance index, 95% CI: confidence interval, D-Royston: Royston/Sauerbrei’s D statistic (Stat Med 2004 Mar 15, 23[5]:723-48), SE: standard error, R²: explained randomness, AIC: Akaike information criterion, AUC: area under the curve (according to Heagerty et al, Biometrics, 2000 Jun, 56[2]:337-44).

Massimo Federico, MD
Photo by Larry Young

SAN FRANCISCO—The T-Cell Project has provided information that can enhance our understanding of T-cell lymphomas, according to a presentation at the 9th Annual T-cell Lymphoma Forum.

The project is a prospective registry that includes data from T-cell lymphoma patients in 15 countries located in 5 different regions of the world. 

The data showed that peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) is the most common subtype of T-cell lymphoma in all 5 regions, although the distribution of other subtypes varies.

A majority of patients in the registry received chemotherapy as induction, and anthracycline-containing regimens were the most popular treatment choice.

Although 60% of patients in the registry had low-risk or low/intermediate-risk disease, progression-free survival (PFS) and overall survival (OS) rates were low. The 5-year PFS was 32%, and the 5-year OS was 42%.

Massimo Federico, MD, of the University of Modena and Reggio Emilia in Italy, presented these data at the meeting.

About the project

Dr Federico said the goals of the T-Cell Project are to determine if prospective data collection provides more accurate information to better define prognosis of the most frequent subtypes of T-cell lymphoma and to improve our knowledge of clinical and biological characteristics, as well as outcomes, of the more uncommon subtypes.

“Why did we choose to propose a prospective registry for the collection of information in T-cell lymphoma?” Dr Federico asked. “Because it is, by far, less expensive than a clinical trial, but also because it can offer excellent data for generating new research programs and is a great opportunity for academic cooperation.”

As of December 31, 2016, the registry included 1523 patients. There were 75 sites (with at least 1 patient) active in the registry.

Fifteen countries in 5 geographic regions were represented. Europe was the greatest contributor (44%), followed by North America (US only, 25%), South America (20%), the Far East (9%), the Middle East (2%), and Oceania (<1%).

Subtypes

Overall, the distribution of the different T-cell lymphoma subtypes is as follows:

PTCL-NOS—36%
Angioimmunoblastic T-cell lymphoma (AITL)—17%
ALK- anaplastic large-cell lymphoma (ALCL)—16%
NK/T-cell lymphoma (NKTCL)—11%
ALK+ ALCL—8%
Enteropathy-associated T-cell lymphoma—4%
Unclassifiable T-cell lymphoma—3%
Hepatosplenic T-cell lymphoma—2%
Subcutaneous panniculitis-like T-cell lymphoma—2%
Peripheral gamma delta T-cell lymphoma—1%

Geographic distribution

The most common T-cell lymphoma subtypes in Europe were PTCL-NOS (37%), AITL (21%), and ALK- ALCL (14%). Likewise, the most common subtypes in the US were PTCL-NOS (35%), AITL (21%), and ALK- ALCL (13%).

In the Middle East, the most common subtypes were PTCL-NOS (40%), AITL (16%), and ALK+ ALCL (13%). In South America, they were PTCL-NOS (41%), ALK- ALCL (26%), and NKTCL (10%). And in Asia, they were PTCL-NOS (29%), NKTCL (29%), and AITL (17%).

Patient characteristics

Dr Federico presented data on patient characteristics for 1391 individuals, validated as of April 30, 2016.

The patients’ median age was 56 (range, 18-89). Forty-four percent were 60 or older, and 60% were male. Twenty-six percent had ECOG performance status > 1, 50% had B symptoms, and 72% had disease-related discomfort.

Sixty percent had low-risk or low/intermediate-risk disease according to the International Prognostic Index (IPI) and the Prognostic Index for T-cell Lymphoma (PIT).

Treatment

Treatment details are available for 1022 patients. Ninety-two percent received therapy with curative intent.

For induction, 76% of patients received chemotherapy alone, 14% received chemotherapy and radiotherapy, 8% received best supportive care, and 2% received radiotherapy alone.

Seventy-one percent of patients who received chemotherapy had an anthracycline-containing regimen, 13% received etoposide-containing chemotherapy, 9% received chemotherapy containing an anthracycline and etoposide, and 7% of patients received other therapy.

Thirteen percent of patients received a transplant as salvage treatment, and 7% received a transplant as consolidation.

Outcomes

Data on patient responses to initial treatment were available for 888 individuals. The 84 patients who received best supportive care were not included, and 50 patients were not evaluable for response.

The complete response/unconfirmed complete response rate was 53%, and the partial response rate was 19%. Twenty-eight percent of patients had no response or progressed.

The median PFS was 16 months. The 5-year PFS rate was 32% overall, 23% for PTCL-NOS, 28% for AITL, 39% for ALK- ALCL, and 57% for ALK+ ALCL.

The median OS was 36 months. The 5-year OS was 42% overall, 34% for PTCL-NOS, 42% for AITL, 46% for ALK- ALCL, and 76% for ALK+ ALCL.

Dr Federico and his colleagues have used these data to develop a prognostic model for PTCL-NOS that, they say, is more accurate than current models.

Massimo Federico, MD
Photo by Larry Young

SAN FRANCISCO—The T-Cell Project has provided information that can enhance our understanding of T-cell lymphomas, according to a presentation at the 9th Annual T-cell Lymphoma Forum.

The project is a prospective registry that includes data from T-cell lymphoma patients in 15 countries located in 5 different regions of the world. 

The data showed that peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) is the most common subtype of T-cell lymphoma in all 5 regions, although the distribution of other subtypes varies.

A majority of patients in the registry received chemotherapy as induction, and anthracycline-containing regimens were the most popular treatment choice.

Although 60% of patients in the registry had low-risk or low/intermediate-risk disease, progression-free survival (PFS) and overall survival (OS) rates were low. The 5-year PFS was 32%, and the 5-year OS was 42%.

Massimo Federico, MD, of the University of Modena and Reggio Emilia in Italy, presented these data at the meeting.

About the project

Dr Federico said the goals of the T-Cell Project are to determine if prospective data collection provides more accurate information to better define prognosis of the most frequent subtypes of T-cell lymphoma and to improve our knowledge of clinical and biological characteristics, as well as outcomes, of the more uncommon subtypes.

“Why did we choose to propose a prospective registry for the collection of information in T-cell lymphoma?” Dr Federico asked. “Because it is, by far, less expensive than a clinical trial, but also because it can offer excellent data for generating new research programs and is a great opportunity for academic cooperation.”

As of December 31, 2016, the registry included 1523 patients. There were 75 sites (with at least 1 patient) active in the registry.

Fifteen countries in 5 geographic regions were represented. Europe was the greatest contributor (44%), followed by North America (US only, 25%), South America (20%), the Far East (9%), the Middle East (2%), and Oceania (<1%).

Subtypes

Overall, the distribution of the different T-cell lymphoma subtypes is as follows:

PTCL-NOS—36%
Angioimmunoblastic T-cell lymphoma (AITL)—17%
ALK- anaplastic large-cell lymphoma (ALCL)—16%
NK/T-cell lymphoma (NKTCL)—11%
ALK+ ALCL—8%
Enteropathy-associated T-cell lymphoma—4%
Unclassifiable T-cell lymphoma—3%
Hepatosplenic T-cell lymphoma—2%
Subcutaneous panniculitis-like T-cell lymphoma—2%
Peripheral gamma delta T-cell lymphoma—1%

Geographic distribution

The most common T-cell lymphoma subtypes in Europe were PTCL-NOS (37%), AITL (21%), and ALK- ALCL (14%). Likewise, the most common subtypes in the US were PTCL-NOS (35%), AITL (21%), and ALK- ALCL (13%).

In the Middle East, the most common subtypes were PTCL-NOS (40%), AITL (16%), and ALK+ ALCL (13%). In South America, they were PTCL-NOS (41%), ALK- ALCL (26%), and NKTCL (10%). And in Asia, they were PTCL-NOS (29%), NKTCL (29%), and AITL (17%).

Patient characteristics

Dr Federico presented data on patient characteristics for 1391 individuals, validated as of April 30, 2016.

The patients’ median age was 56 (range, 18-89). Forty-four percent were 60 or older, and 60% were male. Twenty-six percent had ECOG performance status > 1, 50% had B symptoms, and 72% had disease-related discomfort.

Sixty percent had low-risk or low/intermediate-risk disease according to the International Prognostic Index (IPI) and the Prognostic Index for T-cell Lymphoma (PIT).

Treatment

Treatment details are available for 1022 patients. Ninety-two percent received therapy with curative intent.

For induction, 76% of patients received chemotherapy alone, 14% received chemotherapy and radiotherapy, 8% received best supportive care, and 2% received radiotherapy alone.

Seventy-one percent of patients who received chemotherapy had an anthracycline-containing regimen, 13% received etoposide-containing chemotherapy, 9% received chemotherapy containing an anthracycline and etoposide, and 7% of patients received other therapy.

Thirteen percent of patients received a transplant as salvage treatment, and 7% received a transplant as consolidation.

Outcomes

Data on patient responses to initial treatment were available for 888 individuals. The 84 patients who received best supportive care were not included, and 50 patients were not evaluable for response.

The complete response/unconfirmed complete response rate was 53%, and the partial response rate was 19%. Twenty-eight percent of patients had no response or progressed.

The median PFS was 16 months. The 5-year PFS rate was 32% overall, 23% for PTCL-NOS, 28% for AITL, 39% for ALK- ALCL, and 57% for ALK+ ALCL.

The median OS was 36 months. The 5-year OS was 42% overall, 34% for PTCL-NOS, 42% for AITL, 46% for ALK- ALCL, and 76% for ALK+ ALCL.

Dr Federico and his colleagues have used these data to develop a prognostic model for PTCL-NOS that, they say, is more accurate than current models.

Massimo Federico, MD
Photo by Larry Young

SAN FRANCISCO—The T-Cell Project has provided information that can enhance our understanding of T-cell lymphomas, according to a presentation at the 9th Annual T-cell Lymphoma Forum.

The project is a prospective registry that includes data from T-cell lymphoma patients in 15 countries located in 5 different regions of the world. 

The data showed that peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) is the most common subtype of T-cell lymphoma in all 5 regions, although the distribution of other subtypes varies.

A majority of patients in the registry received chemotherapy as induction, and anthracycline-containing regimens were the most popular treatment choice.

Although 60% of patients in the registry had low-risk or low/intermediate-risk disease, progression-free survival (PFS) and overall survival (OS) rates were low. The 5-year PFS was 32%, and the 5-year OS was 42%.

Massimo Federico, MD, of the University of Modena and Reggio Emilia in Italy, presented these data at the meeting.

About the project

Dr Federico said the goals of the T-Cell Project are to determine if prospective data collection provides more accurate information to better define prognosis of the most frequent subtypes of T-cell lymphoma and to improve our knowledge of clinical and biological characteristics, as well as outcomes, of the more uncommon subtypes.

“Why did we choose to propose a prospective registry for the collection of information in T-cell lymphoma?” Dr Federico asked. “Because it is, by far, less expensive than a clinical trial, but also because it can offer excellent data for generating new research programs and is a great opportunity for academic cooperation.”

As of December 31, 2016, the registry included 1523 patients. There were 75 sites (with at least 1 patient) active in the registry.

Fifteen countries in 5 geographic regions were represented. Europe was the greatest contributor (44%), followed by North America (US only, 25%), South America (20%), the Far East (9%), the Middle East (2%), and Oceania (<1%).

Subtypes

Overall, the distribution of the different T-cell lymphoma subtypes is as follows:

PTCL-NOS—36%
Angioimmunoblastic T-cell lymphoma (AITL)—17%
ALK- anaplastic large-cell lymphoma (ALCL)—16%
NK/T-cell lymphoma (NKTCL)—11%
ALK+ ALCL—8%
Enteropathy-associated T-cell lymphoma—4%
Unclassifiable T-cell lymphoma—3%
Hepatosplenic T-cell lymphoma—2%
Subcutaneous panniculitis-like T-cell lymphoma—2%
Peripheral gamma delta T-cell lymphoma—1%

Geographic distribution

The most common T-cell lymphoma subtypes in Europe were PTCL-NOS (37%), AITL (21%), and ALK- ALCL (14%). Likewise, the most common subtypes in the US were PTCL-NOS (35%), AITL (21%), and ALK- ALCL (13%).

In the Middle East, the most common subtypes were PTCL-NOS (40%), AITL (16%), and ALK+ ALCL (13%). In South America, they were PTCL-NOS (41%), ALK- ALCL (26%), and NKTCL (10%). And in Asia, they were PTCL-NOS (29%), NKTCL (29%), and AITL (17%).

Patient characteristics

Dr Federico presented data on patient characteristics for 1391 individuals, validated as of April 30, 2016.

The patients’ median age was 56 (range, 18-89). Forty-four percent were 60 or older, and 60% were male. Twenty-six percent had ECOG performance status > 1, 50% had B symptoms, and 72% had disease-related discomfort.

Sixty percent had low-risk or low/intermediate-risk disease according to the International Prognostic Index (IPI) and the Prognostic Index for T-cell Lymphoma (PIT).

Treatment

Treatment details are available for 1022 patients. Ninety-two percent received therapy with curative intent.

For induction, 76% of patients received chemotherapy alone, 14% received chemotherapy and radiotherapy, 8% received best supportive care, and 2% received radiotherapy alone.

Seventy-one percent of patients who received chemotherapy had an anthracycline-containing regimen, 13% received etoposide-containing chemotherapy, 9% received chemotherapy containing an anthracycline and etoposide, and 7% of patients received other therapy.

Thirteen percent of patients received a transplant as salvage treatment, and 7% received a transplant as consolidation.

Outcomes

Data on patient responses to initial treatment were available for 888 individuals. The 84 patients who received best supportive care were not included, and 50 patients were not evaluable for response.

The complete response/unconfirmed complete response rate was 53%, and the partial response rate was 19%. Twenty-eight percent of patients had no response or progressed.

The median PFS was 16 months. The 5-year PFS rate was 32% overall, 23% for PTCL-NOS, 28% for AITL, 39% for ALK- ALCL, and 57% for ALK+ ALCL.

The median OS was 36 months. The 5-year OS was 42% overall, 34% for PTCL-NOS, 42% for AITL, 46% for ALK- ALCL, and 76% for ALK+ ALCL.

Dr Federico and his colleagues have used these data to develop a prognostic model for PTCL-NOS that, they say, is more accurate than current models.

Prescription drugs
Photo by Steven Harbour

AMSTERDAM—The UK has seen substantial price increases for some generic cancer drugs over the last few years, according to a study presented at ECCO 2017: European Cancer Congress (abstract 966).

Of the 89 drugs analyzed in this study, 21 of them—including 17 generics—had price increases from 2011 to 2016.

Fourteen of the generic cancer drugs had price increases over 100%, and 2 of the drugs had increases exceeding 1000%.

“We were surprised to find several companies consistently raising the prices of cancer treatment,” said study investigator Andrew Hill, PhD, of the University of Liverpool in the UK.

“Twenty treatments have shown rises of over 100% in the last 5 years, and in 2—busulfan (used to treat leukemia) and tamoxifen (breast cancer)—prices have increased by over 1000%. We have found that some companies take over the supply of some generic cancer medicines and then raise the price progressively.”

Dr Hill and his co-investigator Melissa Barber, of the London School of Hygiene and Tropical Medicine in the UK, analyzed prices for 190 formulations of 89 cancer drugs.

Twenty-eight formulations of 21 drugs had price increases from 2011 to 2016. Seventeen of these 21 drugs were generic in 2016.

Twenty formulations of 14 generic cancer drugs had price increases exceeding 100%.

For example, the cost per tablet or injection increased for:

• Ifosfamide (2 g vial)—from £89 to £180, or 103%.
• Melphalan (50 mg vial)—from £33 to £137, or 315%.
• Chlorambucil (2 mg)—from £0.33 to £1.62, or 390%.
• Cyclophosphamide (50 mg)—from £0.20 to £1.39, or 695%.
• Busulfan (2 mg)—from £0.21 to £2.61, or 1227%.

Dr Hill said the UK’s Department of Health is aware of this issue and has introduced the Health Services Medical Supplies (Costs) Bill to enable price regulation in the future.

Companies found to be raising prices with no clear justification will be referred to the Competition and Markets Authority, and they could face fines.

However, Dr Hill and Barber said they found large price increases for generic cancer drugs in other European countries as well.

In Spain and Italy, failure to accept the high prices demanded for some generic drugs has led to warnings from companies that they could stop the supply of these drugs.

For instance, Italy fined the generic company Aspen €5 million after a 1500% increase in the price of cancer drugs, including melphalan and chlorambucil. Aspen then threatened Italy with drug shortages unless higher prices were accepted. 

In Spain, Aspen demanded a 4000% increase in melphalan prices.

“We hope that, by explaining what we have found in the UK, other European countries will take note and protect themselves against these kinds of price rises,” Dr Hill said. “At a time when cancer patients are living longer and better lives due to effective treatments, this situation is particularly worrying.”

Prescription drugs
Photo by Steven Harbour

AMSTERDAM—The UK has seen substantial price increases for some generic cancer drugs over the last few years, according to a study presented at ECCO 2017: European Cancer Congress (abstract 966).

Of the 89 drugs analyzed in this study, 21 of them—including 17 generics—had price increases from 2011 to 2016.

Fourteen of the generic cancer drugs had price increases over 100%, and 2 of the drugs had increases exceeding 1000%.

“We were surprised to find several companies consistently raising the prices of cancer treatment,” said study investigator Andrew Hill, PhD, of the University of Liverpool in the UK.

“Twenty treatments have shown rises of over 100% in the last 5 years, and in 2—busulfan (used to treat leukemia) and tamoxifen (breast cancer)—prices have increased by over 1000%. We have found that some companies take over the supply of some generic cancer medicines and then raise the price progressively.”

Dr Hill and his co-investigator Melissa Barber, of the London School of Hygiene and Tropical Medicine in the UK, analyzed prices for 190 formulations of 89 cancer drugs.

Twenty-eight formulations of 21 drugs had price increases from 2011 to 2016. Seventeen of these 21 drugs were generic in 2016.

Twenty formulations of 14 generic cancer drugs had price increases exceeding 100%.

For example, the cost per tablet or injection increased for:

• Ifosfamide (2 g vial)—from £89 to £180, or 103%.
• Melphalan (50 mg vial)—from £33 to £137, or 315%.
• Chlorambucil (2 mg)—from £0.33 to £1.62, or 390%.
• Cyclophosphamide (50 mg)—from £0.20 to £1.39, or 695%.
• Busulfan (2 mg)—from £0.21 to £2.61, or 1227%.

Dr Hill said the UK’s Department of Health is aware of this issue and has introduced the Health Services Medical Supplies (Costs) Bill to enable price regulation in the future.

Companies found to be raising prices with no clear justification will be referred to the Competition and Markets Authority, and they could face fines.

However, Dr Hill and Barber said they found large price increases for generic cancer drugs in other European countries as well.

In Spain and Italy, failure to accept the high prices demanded for some generic drugs has led to warnings from companies that they could stop the supply of these drugs.

For instance, Italy fined the generic company Aspen €5 million after a 1500% increase in the price of cancer drugs, including melphalan and chlorambucil. Aspen then threatened Italy with drug shortages unless higher prices were accepted. 

In Spain, Aspen demanded a 4000% increase in melphalan prices.

“We hope that, by explaining what we have found in the UK, other European countries will take note and protect themselves against these kinds of price rises,” Dr Hill said. “At a time when cancer patients are living longer and better lives due to effective treatments, this situation is particularly worrying.”

Prescription drugs
Photo by Steven Harbour

AMSTERDAM—The UK has seen substantial price increases for some generic cancer drugs over the last few years, according to a study presented at ECCO 2017: European Cancer Congress (abstract 966).

Of the 89 drugs analyzed in this study, 21 of them—including 17 generics—had price increases from 2011 to 2016.

Fourteen of the generic cancer drugs had price increases over 100%, and 2 of the drugs had increases exceeding 1000%.

“We were surprised to find several companies consistently raising the prices of cancer treatment,” said study investigator Andrew Hill, PhD, of the University of Liverpool in the UK.

“Twenty treatments have shown rises of over 100% in the last 5 years, and in 2—busulfan (used to treat leukemia) and tamoxifen (breast cancer)—prices have increased by over 1000%. We have found that some companies take over the supply of some generic cancer medicines and then raise the price progressively.”

Dr Hill and his co-investigator Melissa Barber, of the London School of Hygiene and Tropical Medicine in the UK, analyzed prices for 190 formulations of 89 cancer drugs.

Twenty-eight formulations of 21 drugs had price increases from 2011 to 2016. Seventeen of these 21 drugs were generic in 2016.

Twenty formulations of 14 generic cancer drugs had price increases exceeding 100%.

For example, the cost per tablet or injection increased for:

• Ifosfamide (2 g vial)—from £89 to £180, or 103%.
• Melphalan (50 mg vial)—from £33 to £137, or 315%.
• Chlorambucil (2 mg)—from £0.33 to £1.62, or 390%.
• Cyclophosphamide (50 mg)—from £0.20 to £1.39, or 695%.
• Busulfan (2 mg)—from £0.21 to £2.61, or 1227%.

Dr Hill said the UK’s Department of Health is aware of this issue and has introduced the Health Services Medical Supplies (Costs) Bill to enable price regulation in the future.

Companies found to be raising prices with no clear justification will be referred to the Competition and Markets Authority, and they could face fines.

However, Dr Hill and Barber said they found large price increases for generic cancer drugs in other European countries as well.

In Spain and Italy, failure to accept the high prices demanded for some generic drugs has led to warnings from companies that they could stop the supply of these drugs.

For instance, Italy fined the generic company Aspen €5 million after a 1500% increase in the price of cancer drugs, including melphalan and chlorambucil. Aspen then threatened Italy with drug shortages unless higher prices were accepted. 

In Spain, Aspen demanded a 4000% increase in melphalan prices.

“We hope that, by explaining what we have found in the UK, other European countries will take note and protect themselves against these kinds of price rises,” Dr Hill said. “At a time when cancer patients are living longer and better lives due to effective treatments, this situation is particularly worrying.”

Blood donation

The Swiss Agency for Therapeutic Products (Swissmedic) has agreed to lift the ban on blood donations from men who have sex with men (MSM).

Instead, MSMs will be allowed to donate blood if it has been at least 12 months since their last sexual contact with another man.

Swiss Transfusion SRC Inc. expects to implement the modified donation criteria for MSMs in regional blood transfusion services starting in mid-2017.

However, Swissmedic’s decision is subject to certain conditions.

Specifically, blood transfusion services will have to record additional data on the effects of the modified donation criteria and donors’ compliance with them, as well as closely monitor the risk trend.

Swissmedic said that, since January 2016, the tests for specific pathogens in donated blood in Switzerland have been further refined, resulting in a higher level of sensitivity.

The diagnostic window—the period in which any infections carried by blood donors cannot yet be discovered—for the relevant pathogens has been further narrowed. Depending on the virus, the diagnostic window is 3 days to 15 days after infection.

Therefore, Swissmedic believes that a 12-month deferral period for MSM blood donors would not expose recipients of blood transfusions to an increased risk of contracting a blood-borne infection.

Swissmedic noted that approximately half of all new HIV infections in Switzerland are attributable to MSMs. This is one of the reasons MSMs have been permanently excluded from giving blood since 1977.

The new 12-month deferral period for MSMs is in line with the precautionary measures applicable to various other behaviors that have been shown to increase the risk of HIV transmission, such as changing sexual partners, staying in countries with a high AIDS rate, and sexual contact with partners who have stayed in countries with a high AIDS rate for a lengthy period.

The change to a 1-year deferral period for MSM blood donors brings Switzerland into line with other nations that have adopted similar policies, such as Ireland, Canada, the US, and the UK.

Blood donation

The Swiss Agency for Therapeutic Products (Swissmedic) has agreed to lift the ban on blood donations from men who have sex with men (MSM).

Instead, MSMs will be allowed to donate blood if it has been at least 12 months since their last sexual contact with another man.

Swiss Transfusion SRC Inc. expects to implement the modified donation criteria for MSMs in regional blood transfusion services starting in mid-2017.

However, Swissmedic’s decision is subject to certain conditions.

Specifically, blood transfusion services will have to record additional data on the effects of the modified donation criteria and donors’ compliance with them, as well as closely monitor the risk trend.

Swissmedic said that, since January 2016, the tests for specific pathogens in donated blood in Switzerland have been further refined, resulting in a higher level of sensitivity.

The diagnostic window—the period in which any infections carried by blood donors cannot yet be discovered—for the relevant pathogens has been further narrowed. Depending on the virus, the diagnostic window is 3 days to 15 days after infection.

Therefore, Swissmedic believes that a 12-month deferral period for MSM blood donors would not expose recipients of blood transfusions to an increased risk of contracting a blood-borne infection.

Swissmedic noted that approximately half of all new HIV infections in Switzerland are attributable to MSMs. This is one of the reasons MSMs have been permanently excluded from giving blood since 1977.

The new 12-month deferral period for MSMs is in line with the precautionary measures applicable to various other behaviors that have been shown to increase the risk of HIV transmission, such as changing sexual partners, staying in countries with a high AIDS rate, and sexual contact with partners who have stayed in countries with a high AIDS rate for a lengthy period.

The change to a 1-year deferral period for MSM blood donors brings Switzerland into line with other nations that have adopted similar policies, such as Ireland, Canada, the US, and the UK.

Blood donation

The Swiss Agency for Therapeutic Products (Swissmedic) has agreed to lift the ban on blood donations from men who have sex with men (MSM).

Instead, MSMs will be allowed to donate blood if it has been at least 12 months since their last sexual contact with another man.

Swiss Transfusion SRC Inc. expects to implement the modified donation criteria for MSMs in regional blood transfusion services starting in mid-2017.

However, Swissmedic’s decision is subject to certain conditions.

Specifically, blood transfusion services will have to record additional data on the effects of the modified donation criteria and donors’ compliance with them, as well as closely monitor the risk trend.

Swissmedic said that, since January 2016, the tests for specific pathogens in donated blood in Switzerland have been further refined, resulting in a higher level of sensitivity.

The diagnostic window—the period in which any infections carried by blood donors cannot yet be discovered—for the relevant pathogens has been further narrowed. Depending on the virus, the diagnostic window is 3 days to 15 days after infection.

Therefore, Swissmedic believes that a 12-month deferral period for MSM blood donors would not expose recipients of blood transfusions to an increased risk of contracting a blood-borne infection.

Swissmedic noted that approximately half of all new HIV infections in Switzerland are attributable to MSMs. This is one of the reasons MSMs have been permanently excluded from giving blood since 1977.

The new 12-month deferral period for MSMs is in line with the precautionary measures applicable to various other behaviors that have been shown to increase the risk of HIV transmission, such as changing sexual partners, staying in countries with a high AIDS rate, and sexual contact with partners who have stayed in countries with a high AIDS rate for a lengthy period.

The change to a 1-year deferral period for MSM blood donors brings Switzerland into line with other nations that have adopted similar policies, such as Ireland, Canada, the US, and the UK.