NEW YORK (Reuters Health) - Young adult cancer survivors will continue to have high hospitalization rates over time, a Canadian study shows.

In five-year cancer survivors diagnosed between ages 20 and 44, hospitalization rates were elevated for at least 20 years, compared to rates in age- and sex-matched controls, according to Dr. Nancy N. Baxter at St. Michael's Hospital in Toronto and colleagues.

For all malignancies except melanoma and testicular cancer, the adjusted relative rate (ARR) of hospitalizations was significantly higher among survivors than controls.

"Late effects and complications of cancer treatments are experienced by many survivors for the rest of their lives," Dr. Baxter told Reuters Health in an e-mail.

The patients in this population-based study were treated from 1992-1999.

"Therapies have changed, she said. "In some cases there may be fewer late effects, but in others, they may be worse."

The study cohort included 20,275 survivors of young adult cancers who were recurrence-free for at least five years, and 101,344 controls. The authors observed survivors for a median of 9.93 years (range 0-16 years), according to their report online July 13 in the Journal of Clinical Oncology.

During this period, 34.3% had at least one hospitalization, vs. 27.3% for controls. The rate per 100 person-years was similar between male and female survivors.

Overall, the ARR of hospitalization in survivors compared with controls was 1.51.

At all time periods, survivors were more likely to be hospitalized than controls. The rate of hospitalization (per 100-person years) among survivors was 0.22 during years 5 to 8, 9 to11, and 12 to14. It decreased significantly during years 15 to 17 and 18 to 20, falling to 0.17 and 0.15, respectively (p

Among controls, the hospitalization rate was relatively constant during all time periods, ranging from 0.13 at 5 to 8 years to 0.12 at years 18 to 20.

The ARR of hospitalizations in survivors compared with controls was also relatively constant during for the first three3 time periods: 1.67, 1.55, and 1.57 at years 5 to 8, 9 to 11, and 12 to 14, respectively. It decreased to 1.36 at 15 to 17 years and 1.22 at years 18 to 20.

Those who survived gastrointestinal, urologic, colorectal, or brain cancers, or leukemia or lymphoma, had an ARR of hospitalization at least twice that of controls.

"We only looked at hospital admissions, not visits to the family doctor or medical conditions and disabilities that didn't require inpatient care," Dr. Baxter said, explaining that this likely underestimated the long-term impact of intense treatments that include surgery, chemotherapy, radiation, and hormonal therapy.

Lillie D. Shockney, Director of Cancer Survivorship Programs at the Sidney Kimmel Cancer Center at Johns Hopkins in Baltimore, said in an e-mail to Reuters Health that physical symptoms can be "guilty by association."

"If a patient had cancer, more tests, including inpatient procedures, might be done to rule out recurrence or the presence of a new malignancy," she said.

Studies such as this one could pave the way for more detailed research on the risk of treatment-related conditions that lead to more medical care, she said.

Shockney also said the report raises awareness of the need to pay special attention to cancer survivors; to consider survivorship as we would a chronic illness.

"Understanding the late effects of cancer treatment will help us design better treatments, counsel patients, and improve symptom management," said Dr. Baxter.

NEW YORK (Reuters Health) - Young adult cancer survivors will continue to have high hospitalization rates over time, a Canadian study shows.

In five-year cancer survivors diagnosed between ages 20 and 44, hospitalization rates were elevated for at least 20 years, compared to rates in age- and sex-matched controls, according to Dr. Nancy N. Baxter at St. Michael's Hospital in Toronto and colleagues.

For all malignancies except melanoma and testicular cancer, the adjusted relative rate (ARR) of hospitalizations was significantly higher among survivors than controls.

"Late effects and complications of cancer treatments are experienced by many survivors for the rest of their lives," Dr. Baxter told Reuters Health in an e-mail.

The patients in this population-based study were treated from 1992-1999.

"Therapies have changed, she said. "In some cases there may be fewer late effects, but in others, they may be worse."

The study cohort included 20,275 survivors of young adult cancers who were recurrence-free for at least five years, and 101,344 controls. The authors observed survivors for a median of 9.93 years (range 0-16 years), according to their report online July 13 in the Journal of Clinical Oncology.

During this period, 34.3% had at least one hospitalization, vs. 27.3% for controls. The rate per 100 person-years was similar between male and female survivors.

Overall, the ARR of hospitalization in survivors compared with controls was 1.51.

At all time periods, survivors were more likely to be hospitalized than controls. The rate of hospitalization (per 100-person years) among survivors was 0.22 during years 5 to 8, 9 to11, and 12 to14. It decreased significantly during years 15 to 17 and 18 to 20, falling to 0.17 and 0.15, respectively (p

Among controls, the hospitalization rate was relatively constant during all time periods, ranging from 0.13 at 5 to 8 years to 0.12 at years 18 to 20.

The ARR of hospitalizations in survivors compared with controls was also relatively constant during for the first three3 time periods: 1.67, 1.55, and 1.57 at years 5 to 8, 9 to 11, and 12 to 14, respectively. It decreased to 1.36 at 15 to 17 years and 1.22 at years 18 to 20.

Those who survived gastrointestinal, urologic, colorectal, or brain cancers, or leukemia or lymphoma, had an ARR of hospitalization at least twice that of controls.

"We only looked at hospital admissions, not visits to the family doctor or medical conditions and disabilities that didn't require inpatient care," Dr. Baxter said, explaining that this likely underestimated the long-term impact of intense treatments that include surgery, chemotherapy, radiation, and hormonal therapy.

Lillie D. Shockney, Director of Cancer Survivorship Programs at the Sidney Kimmel Cancer Center at Johns Hopkins in Baltimore, said in an e-mail to Reuters Health that physical symptoms can be "guilty by association."

"If a patient had cancer, more tests, including inpatient procedures, might be done to rule out recurrence or the presence of a new malignancy," she said.

Studies such as this one could pave the way for more detailed research on the risk of treatment-related conditions that lead to more medical care, she said.

Shockney also said the report raises awareness of the need to pay special attention to cancer survivors; to consider survivorship as we would a chronic illness.

"Understanding the late effects of cancer treatment will help us design better treatments, counsel patients, and improve symptom management," said Dr. Baxter.

NEW YORK (Reuters Health) - Young adult cancer survivors will continue to have high hospitalization rates over time, a Canadian study shows.

In five-year cancer survivors diagnosed between ages 20 and 44, hospitalization rates were elevated for at least 20 years, compared to rates in age- and sex-matched controls, according to Dr. Nancy N. Baxter at St. Michael's Hospital in Toronto and colleagues.

For all malignancies except melanoma and testicular cancer, the adjusted relative rate (ARR) of hospitalizations was significantly higher among survivors than controls.

"Late effects and complications of cancer treatments are experienced by many survivors for the rest of their lives," Dr. Baxter told Reuters Health in an e-mail.

The patients in this population-based study were treated from 1992-1999.

"Therapies have changed, she said. "In some cases there may be fewer late effects, but in others, they may be worse."

The study cohort included 20,275 survivors of young adult cancers who were recurrence-free for at least five years, and 101,344 controls. The authors observed survivors for a median of 9.93 years (range 0-16 years), according to their report online July 13 in the Journal of Clinical Oncology.

During this period, 34.3% had at least one hospitalization, vs. 27.3% for controls. The rate per 100 person-years was similar between male and female survivors.

Overall, the ARR of hospitalization in survivors compared with controls was 1.51.

At all time periods, survivors were more likely to be hospitalized than controls. The rate of hospitalization (per 100-person years) among survivors was 0.22 during years 5 to 8, 9 to11, and 12 to14. It decreased significantly during years 15 to 17 and 18 to 20, falling to 0.17 and 0.15, respectively (p

Among controls, the hospitalization rate was relatively constant during all time periods, ranging from 0.13 at 5 to 8 years to 0.12 at years 18 to 20.

The ARR of hospitalizations in survivors compared with controls was also relatively constant during for the first three3 time periods: 1.67, 1.55, and 1.57 at years 5 to 8, 9 to 11, and 12 to 14, respectively. It decreased to 1.36 at 15 to 17 years and 1.22 at years 18 to 20.

Those who survived gastrointestinal, urologic, colorectal, or brain cancers, or leukemia or lymphoma, had an ARR of hospitalization at least twice that of controls.

"We only looked at hospital admissions, not visits to the family doctor or medical conditions and disabilities that didn't require inpatient care," Dr. Baxter said, explaining that this likely underestimated the long-term impact of intense treatments that include surgery, chemotherapy, radiation, and hormonal therapy.

Lillie D. Shockney, Director of Cancer Survivorship Programs at the Sidney Kimmel Cancer Center at Johns Hopkins in Baltimore, said in an e-mail to Reuters Health that physical symptoms can be "guilty by association."

"If a patient had cancer, more tests, including inpatient procedures, might be done to rule out recurrence or the presence of a new malignancy," she said.

Studies such as this one could pave the way for more detailed research on the risk of treatment-related conditions that lead to more medical care, she said.

Shockney also said the report raises awareness of the need to pay special attention to cancer survivors; to consider survivorship as we would a chronic illness.

"Understanding the late effects of cancer treatment will help us design better treatments, counsel patients, and improve symptom management," said Dr. Baxter.

Blood sample collection

Photo by Juan D. Alfonso

Researchers from the International Myeloma Working Group (IMWG) have proposed revising the International Staging System (ISS) used to stratify patients with newly diagnosed multiple myeloma (MM).

The group’s revised ISS (R-ISS) combines the current ISS with tests for chromosomal abnormalities (CAs) and serum lactate dehydrogenase (LDH) in an attempt to refine the system’s prognostic value.

IMWG researchers assessed the R-ISS in more than 3000 newly diagnosed MM patients and found that patients with R-ISS stage I disease had better overall survival (OS) and progression-free survival (PFS) than patients with stage I disease according to the ISS.

And patients with R-ISS stage III disease had worse survival rates than patients with stage III disease according to the ISS. But PFS and OS numbers for stage II disease were the same with both systems.

The researchers reported these results in the Journal of Clinical Oncology.

They noted that the existing ISS relies on tests for serum β₂-microglobulin and serum albumin to divide patients into 3 risk-factor stages. But the R-ISS adds interphase fluorescence in situ hybridization to check for CAs, along with separate tests for heightened LDH.

The researchers define the 3 R-ISS groups as follows:

• R-ISS I includes patients with ISS stage I disease (serum β₂-microglobulin level < 3.5 mg/L and serum albumin level ≥ 3.5 g/dL), no high-risk CAs (del[17p] and/or t[4;14] and/or t[14;16]), and normal LDH levels (less than the upper limit of normal range).
• R-ISS III includes patients with ISS stage III disease (serum β₂-microglobulin level > 5.5 mg/L) and high-risk CAs or high LDH levels.
• R-ISS II includes patients with all other possible combinations.

To evaluate the prognostic value of the R-ISS, the researchers analyzed data from 4445 newly diagnosed MM patients who were enrolled in 11 completed trials. ISS, CA, and LDH data were available for 3060 patients.

At a median follow-up of 46 months, the 5-year OS rate was 82% in the R-ISS I group (n=871), 62% in the R-ISS II group (n=1894), and 40% in the R-ISS III group (n=295). The 5-year PFS rates were 55%, 36%, and 24%, respectively.

In comparison, the 5-year OS rate was 77% for patients with ISS stage I disease (n=1615), 62% for ISS stage II (n=1630), and 47% for ISS stage III (n=987). The 5-year PFS rates were 49%, 36%, and 30%, respectively.

Based on this work, the researchers said the R-ISS is a simple but powerful prognostic staging system, and they recommend its use in future studies to stratify newly diagnosed MM patients effectively.

“The revised staging system can be used by doctors to discuss prognostic results very carefully with individual patients,” added Brian G.M. Durie, MD, chairman of the IMWG.

“It’s helpful to know the expectations and consider how treatments can be modified based on the new ISS system.”

Blood sample collection

Photo by Juan D. Alfonso

Researchers from the International Myeloma Working Group (IMWG) have proposed revising the International Staging System (ISS) used to stratify patients with newly diagnosed multiple myeloma (MM).

The group’s revised ISS (R-ISS) combines the current ISS with tests for chromosomal abnormalities (CAs) and serum lactate dehydrogenase (LDH) in an attempt to refine the system’s prognostic value.

IMWG researchers assessed the R-ISS in more than 3000 newly diagnosed MM patients and found that patients with R-ISS stage I disease had better overall survival (OS) and progression-free survival (PFS) than patients with stage I disease according to the ISS.

And patients with R-ISS stage III disease had worse survival rates than patients with stage III disease according to the ISS. But PFS and OS numbers for stage II disease were the same with both systems.

The researchers reported these results in the Journal of Clinical Oncology.

They noted that the existing ISS relies on tests for serum β₂-microglobulin and serum albumin to divide patients into 3 risk-factor stages. But the R-ISS adds interphase fluorescence in situ hybridization to check for CAs, along with separate tests for heightened LDH.

The researchers define the 3 R-ISS groups as follows:

• R-ISS I includes patients with ISS stage I disease (serum β₂-microglobulin level < 3.5 mg/L and serum albumin level ≥ 3.5 g/dL), no high-risk CAs (del[17p] and/or t[4;14] and/or t[14;16]), and normal LDH levels (less than the upper limit of normal range).
• R-ISS III includes patients with ISS stage III disease (serum β₂-microglobulin level > 5.5 mg/L) and high-risk CAs or high LDH levels.
• R-ISS II includes patients with all other possible combinations.

To evaluate the prognostic value of the R-ISS, the researchers analyzed data from 4445 newly diagnosed MM patients who were enrolled in 11 completed trials. ISS, CA, and LDH data were available for 3060 patients.

At a median follow-up of 46 months, the 5-year OS rate was 82% in the R-ISS I group (n=871), 62% in the R-ISS II group (n=1894), and 40% in the R-ISS III group (n=295). The 5-year PFS rates were 55%, 36%, and 24%, respectively.

In comparison, the 5-year OS rate was 77% for patients with ISS stage I disease (n=1615), 62% for ISS stage II (n=1630), and 47% for ISS stage III (n=987). The 5-year PFS rates were 49%, 36%, and 30%, respectively.

Based on this work, the researchers said the R-ISS is a simple but powerful prognostic staging system, and they recommend its use in future studies to stratify newly diagnosed MM patients effectively.

“The revised staging system can be used by doctors to discuss prognostic results very carefully with individual patients,” added Brian G.M. Durie, MD, chairman of the IMWG.

“It’s helpful to know the expectations and consider how treatments can be modified based on the new ISS system.”

Blood sample collection

Photo by Juan D. Alfonso

Researchers from the International Myeloma Working Group (IMWG) have proposed revising the International Staging System (ISS) used to stratify patients with newly diagnosed multiple myeloma (MM).

The group’s revised ISS (R-ISS) combines the current ISS with tests for chromosomal abnormalities (CAs) and serum lactate dehydrogenase (LDH) in an attempt to refine the system’s prognostic value.

IMWG researchers assessed the R-ISS in more than 3000 newly diagnosed MM patients and found that patients with R-ISS stage I disease had better overall survival (OS) and progression-free survival (PFS) than patients with stage I disease according to the ISS.

And patients with R-ISS stage III disease had worse survival rates than patients with stage III disease according to the ISS. But PFS and OS numbers for stage II disease were the same with both systems.

The researchers reported these results in the Journal of Clinical Oncology.

They noted that the existing ISS relies on tests for serum β₂-microglobulin and serum albumin to divide patients into 3 risk-factor stages. But the R-ISS adds interphase fluorescence in situ hybridization to check for CAs, along with separate tests for heightened LDH.

The researchers define the 3 R-ISS groups as follows:

• R-ISS I includes patients with ISS stage I disease (serum β₂-microglobulin level < 3.5 mg/L and serum albumin level ≥ 3.5 g/dL), no high-risk CAs (del[17p] and/or t[4;14] and/or t[14;16]), and normal LDH levels (less than the upper limit of normal range).
• R-ISS III includes patients with ISS stage III disease (serum β₂-microglobulin level > 5.5 mg/L) and high-risk CAs or high LDH levels.
• R-ISS II includes patients with all other possible combinations.

To evaluate the prognostic value of the R-ISS, the researchers analyzed data from 4445 newly diagnosed MM patients who were enrolled in 11 completed trials. ISS, CA, and LDH data were available for 3060 patients.

At a median follow-up of 46 months, the 5-year OS rate was 82% in the R-ISS I group (n=871), 62% in the R-ISS II group (n=1894), and 40% in the R-ISS III group (n=295). The 5-year PFS rates were 55%, 36%, and 24%, respectively.

In comparison, the 5-year OS rate was 77% for patients with ISS stage I disease (n=1615), 62% for ISS stage II (n=1630), and 47% for ISS stage III (n=987). The 5-year PFS rates were 49%, 36%, and 30%, respectively.

Based on this work, the researchers said the R-ISS is a simple but powerful prognostic staging system, and they recommend its use in future studies to stratify newly diagnosed MM patients effectively.

“The revised staging system can be used by doctors to discuss prognostic results very carefully with individual patients,” added Brian G.M. Durie, MD, chairman of the IMWG.

“It’s helpful to know the expectations and consider how treatments can be modified based on the new ISS system.”

Growing monoclonal antibodies

Photo by Linda Bartlett

The US Food and Drug Administration (FDA) has granted orphan designation to veltuzumab for the treatment of immune thrombocytopenia (ITP).

Veltuzumab is a 2nd-generation, humanized monoclonal antibody targeting CD20. The drug is being developed by Immunomedics as a treatment for ITP, other autoimmune diseases, and non-Hodgkin lymphoma.

Veltuzumab was considered active and well-tolerated in a phase 1 study of adults with ITP. The drug produced responses in about half of patients, with some responses lasting more than 4 years.

The study included 50 patients with primary ITP who had failed 1 or more types of standard therapy, had platelet levels of 30,000/μL or less, and did not have major bleeding. The patients’ median age was 54, and most were female (n=31). Eight patients had undergone splenectomy.

Patients were a median of 2 years from diagnosis. Fourteen had been diagnosed with ITP for a year or less and had received corticosteroids and/or immunoglobulins.

Thirty-six patients had chronic ITP and had received azathioprine or danazol (n=15), thrombopoietin-receptor agonists (n=10), rituximab (n=7), platelets (n=5), and/or chemotherapy (n=4).

The 34 patients assigned to cohort 1 received 2 doses of subcutaneous veltuzumab at 80 mg, 160 mg, or 320 mg, 2 weeks apart (total doses of 160 mg, 320 mg, and 640 mg, respectively). The 18 patients in cohort 2 (which included 2 rollovers) received once-weekly doses at 320 mg for 4 weeks (total dose of 1280 mg).

The researchers said veltuzumab was well tolerated. The only adverse events were grade 1-2, transient injection reactions.

Forty-seven patients were evaluable for response. Forty-seven percent (n=22) had objective responses (ORs), and 28% (n=13) had complete responses (CRs).

Responses did not differ much according to disease duration. Patients with chronic ITP had an OR rate of 42% and a CR rate of 27%. Patients who had ITP for a year or less had an OR rate of 51% and a CR rate of 29%.

The median time to relapse (TTR) did not differ much between patients with CRs and those with partial responses, but there was a sizable difference between patients with chronic ITP and those with newly diagnosed ITP.

The median TTR was 7.9 months for patients with a CR and 7.6 months for patients with a partial response. The median TTR was 6.9 months for patients with chronic ITP and 14.4 months for patients who had ITP for a year or less.

The phase 2 expansion trial of veltuzumab in ITP has completed accrual, and patients are being followed for up to 5 years.

About orphan designation

The FDA grants orphan designation to drugs that are intended to treat diseases or conditions affecting fewer than 200,000 patients in the US. Orphan designation provides the sponsor of a drug with various development incentives.

The orphan designation for veltuzumab provides Immunomedics with opportunities to apply for research-related tax credits and grant funding, assistance in designing clinical trials, 7 years of US marketing exclusivity if the drug is approved, and other benefits.

Growing monoclonal antibodies

Photo by Linda Bartlett

The US Food and Drug Administration (FDA) has granted orphan designation to veltuzumab for the treatment of immune thrombocytopenia (ITP).

Veltuzumab is a 2nd-generation, humanized monoclonal antibody targeting CD20. The drug is being developed by Immunomedics as a treatment for ITP, other autoimmune diseases, and non-Hodgkin lymphoma.

Veltuzumab was considered active and well-tolerated in a phase 1 study of adults with ITP. The drug produced responses in about half of patients, with some responses lasting more than 4 years.

The study included 50 patients with primary ITP who had failed 1 or more types of standard therapy, had platelet levels of 30,000/μL or less, and did not have major bleeding. The patients’ median age was 54, and most were female (n=31). Eight patients had undergone splenectomy.

Patients were a median of 2 years from diagnosis. Fourteen had been diagnosed with ITP for a year or less and had received corticosteroids and/or immunoglobulins.

Thirty-six patients had chronic ITP and had received azathioprine or danazol (n=15), thrombopoietin-receptor agonists (n=10), rituximab (n=7), platelets (n=5), and/or chemotherapy (n=4).

The 34 patients assigned to cohort 1 received 2 doses of subcutaneous veltuzumab at 80 mg, 160 mg, or 320 mg, 2 weeks apart (total doses of 160 mg, 320 mg, and 640 mg, respectively). The 18 patients in cohort 2 (which included 2 rollovers) received once-weekly doses at 320 mg for 4 weeks (total dose of 1280 mg).

The researchers said veltuzumab was well tolerated. The only adverse events were grade 1-2, transient injection reactions.

Forty-seven patients were evaluable for response. Forty-seven percent (n=22) had objective responses (ORs), and 28% (n=13) had complete responses (CRs).

Responses did not differ much according to disease duration. Patients with chronic ITP had an OR rate of 42% and a CR rate of 27%. Patients who had ITP for a year or less had an OR rate of 51% and a CR rate of 29%.

The median time to relapse (TTR) did not differ much between patients with CRs and those with partial responses, but there was a sizable difference between patients with chronic ITP and those with newly diagnosed ITP.

The median TTR was 7.9 months for patients with a CR and 7.6 months for patients with a partial response. The median TTR was 6.9 months for patients with chronic ITP and 14.4 months for patients who had ITP for a year or less.

The phase 2 expansion trial of veltuzumab in ITP has completed accrual, and patients are being followed for up to 5 years.

About orphan designation

The FDA grants orphan designation to drugs that are intended to treat diseases or conditions affecting fewer than 200,000 patients in the US. Orphan designation provides the sponsor of a drug with various development incentives.

The orphan designation for veltuzumab provides Immunomedics with opportunities to apply for research-related tax credits and grant funding, assistance in designing clinical trials, 7 years of US marketing exclusivity if the drug is approved, and other benefits.

Growing monoclonal antibodies

Photo by Linda Bartlett

The US Food and Drug Administration (FDA) has granted orphan designation to veltuzumab for the treatment of immune thrombocytopenia (ITP).

Veltuzumab is a 2nd-generation, humanized monoclonal antibody targeting CD20. The drug is being developed by Immunomedics as a treatment for ITP, other autoimmune diseases, and non-Hodgkin lymphoma.

Veltuzumab was considered active and well-tolerated in a phase 1 study of adults with ITP. The drug produced responses in about half of patients, with some responses lasting more than 4 years.

The study included 50 patients with primary ITP who had failed 1 or more types of standard therapy, had platelet levels of 30,000/μL or less, and did not have major bleeding. The patients’ median age was 54, and most were female (n=31). Eight patients had undergone splenectomy.

Patients were a median of 2 years from diagnosis. Fourteen had been diagnosed with ITP for a year or less and had received corticosteroids and/or immunoglobulins.

Thirty-six patients had chronic ITP and had received azathioprine or danazol (n=15), thrombopoietin-receptor agonists (n=10), rituximab (n=7), platelets (n=5), and/or chemotherapy (n=4).

The 34 patients assigned to cohort 1 received 2 doses of subcutaneous veltuzumab at 80 mg, 160 mg, or 320 mg, 2 weeks apart (total doses of 160 mg, 320 mg, and 640 mg, respectively). The 18 patients in cohort 2 (which included 2 rollovers) received once-weekly doses at 320 mg for 4 weeks (total dose of 1280 mg).

The researchers said veltuzumab was well tolerated. The only adverse events were grade 1-2, transient injection reactions.

Forty-seven patients were evaluable for response. Forty-seven percent (n=22) had objective responses (ORs), and 28% (n=13) had complete responses (CRs).

Responses did not differ much according to disease duration. Patients with chronic ITP had an OR rate of 42% and a CR rate of 27%. Patients who had ITP for a year or less had an OR rate of 51% and a CR rate of 29%.

The median time to relapse (TTR) did not differ much between patients with CRs and those with partial responses, but there was a sizable difference between patients with chronic ITP and those with newly diagnosed ITP.

The median TTR was 7.9 months for patients with a CR and 7.6 months for patients with a partial response. The median TTR was 6.9 months for patients with chronic ITP and 14.4 months for patients who had ITP for a year or less.

The phase 2 expansion trial of veltuzumab in ITP has completed accrual, and patients are being followed for up to 5 years.

About orphan designation

The FDA grants orphan designation to drugs that are intended to treat diseases or conditions affecting fewer than 200,000 patients in the US. Orphan designation provides the sponsor of a drug with various development incentives.

The orphan designation for veltuzumab provides Immunomedics with opportunities to apply for research-related tax credits and grant funding, assistance in designing clinical trials, 7 years of US marketing exclusivity if the drug is approved, and other benefits.

Preparing pills for a clinical trial

Photo by Esther Dyson

The reporting requirements developed to increase transparency in US medical research may lead to fewer positive trial outcomes, according to a study published in PLOS ONE.

Researchers analyzed data from large-budget trials funded by the National Heart, Lung and Blood Institute (NHLBI).

And they found evidence suggesting the reporting requirements may have contributed to a significant reduction in studies with positive findings.

The reporting standards were phased in around 2000. They require researchers conducting drug or dietary supplement trials using human subjects to identify

projected outcomes and register their trials on ClinicalTrials.gov before they begin to collect data.

When entering their trial into the database, researchers are required to state the specific outcome on which they will focus. In the past, a researcher might have published an aspect of a study that was successful, even if the study overall did not produce the expected results.

But the new requirements mean researchers are less likely to change their analysis plan to consider another outcome that may have shown a positive result, said Veronica L. Irvin, PhD, of Oregon State University in Corvallis.

Dr Irvin began working on this project with the study’s lead author, Robert M. Kaplan, PhD, of the Agency for Healthcare Research and Quality in Rockville,

Maryland, while the two worked together in the National Institutes of Health’s Office of Behavior and Social Science Research.

The pair reviewed all large-budget clinical trials evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease that had received funding from the NHLBI between 1970 and 2012.

They chose large-budget, NHLBI-funded trials in part because outcomes from the trials were more likely to be published, even if they did not produce the expected result.

Fifty-five studies were included in the research. Thirty were published prior to the reporting changes in 2000 (1970 to 1999), and 25 were published after the changes (2000 to 2012).

Of the studies published after 2000, only 2 (8%) showed positive outcomes, while 17 (57%) of the studies published before 2000 showed positive results.

Drs Kaplan and Irvin acknowledged that factors other than the reporting requirements may be contributing to the decline in positive outcomes, but they were unable to identify other compelling explanations.

For example, one suggestion was that older trials were more likely to compare new treatments to placebos, while newer trials were more likely to compare new

treatments to established treatments.

But when Drs Kaplan and Irvin examined the data, they found that 60% of trials published before 2000 used placebo comparators and nearly the same amount, 64%, of trials published after 2000 used placebos.

The researchers noted that although this work focused on clinical trials related to cardiovascular health, it would be reasonable to see similar changes in results

across other disease types.

“We don’t know if this decrease in positive outcomes also affects drug trials for prevention and treatment of cancer, diabetes, or other diseases,” Dr Irvin said. “But it would not be surprising because they have the same reporting requirements.”

Preparing pills for a clinical trial

Photo by Esther Dyson

The reporting requirements developed to increase transparency in US medical research may lead to fewer positive trial outcomes, according to a study published in PLOS ONE.

Researchers analyzed data from large-budget trials funded by the National Heart, Lung and Blood Institute (NHLBI).

And they found evidence suggesting the reporting requirements may have contributed to a significant reduction in studies with positive findings.

The reporting standards were phased in around 2000. They require researchers conducting drug or dietary supplement trials using human subjects to identify

projected outcomes and register their trials on ClinicalTrials.gov before they begin to collect data.

When entering their trial into the database, researchers are required to state the specific outcome on which they will focus. In the past, a researcher might have published an aspect of a study that was successful, even if the study overall did not produce the expected results.

But the new requirements mean researchers are less likely to change their analysis plan to consider another outcome that may have shown a positive result, said Veronica L. Irvin, PhD, of Oregon State University in Corvallis.

Dr Irvin began working on this project with the study’s lead author, Robert M. Kaplan, PhD, of the Agency for Healthcare Research and Quality in Rockville,

Maryland, while the two worked together in the National Institutes of Health’s Office of Behavior and Social Science Research.

The pair reviewed all large-budget clinical trials evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease that had received funding from the NHLBI between 1970 and 2012.

They chose large-budget, NHLBI-funded trials in part because outcomes from the trials were more likely to be published, even if they did not produce the expected result.

Fifty-five studies were included in the research. Thirty were published prior to the reporting changes in 2000 (1970 to 1999), and 25 were published after the changes (2000 to 2012).

Of the studies published after 2000, only 2 (8%) showed positive outcomes, while 17 (57%) of the studies published before 2000 showed positive results.

Drs Kaplan and Irvin acknowledged that factors other than the reporting requirements may be contributing to the decline in positive outcomes, but they were unable to identify other compelling explanations.

For example, one suggestion was that older trials were more likely to compare new treatments to placebos, while newer trials were more likely to compare new

treatments to established treatments.

But when Drs Kaplan and Irvin examined the data, they found that 60% of trials published before 2000 used placebo comparators and nearly the same amount, 64%, of trials published after 2000 used placebos.

The researchers noted that although this work focused on clinical trials related to cardiovascular health, it would be reasonable to see similar changes in results

across other disease types.

“We don’t know if this decrease in positive outcomes also affects drug trials for prevention and treatment of cancer, diabetes, or other diseases,” Dr Irvin said. “But it would not be surprising because they have the same reporting requirements.”

Preparing pills for a clinical trial

Photo by Esther Dyson

The reporting requirements developed to increase transparency in US medical research may lead to fewer positive trial outcomes, according to a study published in PLOS ONE.

Researchers analyzed data from large-budget trials funded by the National Heart, Lung and Blood Institute (NHLBI).

And they found evidence suggesting the reporting requirements may have contributed to a significant reduction in studies with positive findings.

The reporting standards were phased in around 2000. They require researchers conducting drug or dietary supplement trials using human subjects to identify

projected outcomes and register their trials on ClinicalTrials.gov before they begin to collect data.

When entering their trial into the database, researchers are required to state the specific outcome on which they will focus. In the past, a researcher might have published an aspect of a study that was successful, even if the study overall did not produce the expected results.

But the new requirements mean researchers are less likely to change their analysis plan to consider another outcome that may have shown a positive result, said Veronica L. Irvin, PhD, of Oregon State University in Corvallis.

Dr Irvin began working on this project with the study’s lead author, Robert M. Kaplan, PhD, of the Agency for Healthcare Research and Quality in Rockville,

Maryland, while the two worked together in the National Institutes of Health’s Office of Behavior and Social Science Research.

The pair reviewed all large-budget clinical trials evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease that had received funding from the NHLBI between 1970 and 2012.

They chose large-budget, NHLBI-funded trials in part because outcomes from the trials were more likely to be published, even if they did not produce the expected result.

Fifty-five studies were included in the research. Thirty were published prior to the reporting changes in 2000 (1970 to 1999), and 25 were published after the changes (2000 to 2012).

Of the studies published after 2000, only 2 (8%) showed positive outcomes, while 17 (57%) of the studies published before 2000 showed positive results.

Drs Kaplan and Irvin acknowledged that factors other than the reporting requirements may be contributing to the decline in positive outcomes, but they were unable to identify other compelling explanations.

For example, one suggestion was that older trials were more likely to compare new treatments to placebos, while newer trials were more likely to compare new

treatments to established treatments.

But when Drs Kaplan and Irvin examined the data, they found that 60% of trials published before 2000 used placebo comparators and nearly the same amount, 64%, of trials published after 2000 used placebos.

The researchers noted that although this work focused on clinical trials related to cardiovascular health, it would be reasonable to see similar changes in results

across other disease types.

“We don’t know if this decrease in positive outcomes also affects drug trials for prevention and treatment of cancer, diabetes, or other diseases,” Dr Irvin said. “But it would not be surprising because they have the same reporting requirements.”

Blood smear showing MDS

Treatment with lenalidomide can have a significant effect on pulmonary sarcoidosis in myelodysplastic syndrome (MDS), according to a case study.

The case was a 71-year-old woman with newly diagnosed 5q-MDS and a long-standing history of refractory pulmonary sarcoidosis.

After 2 cycles of treatment with lenalidomide, the patient had substantial improvements in lung function, fatigue, daily activity, and quality of life.

This case is the first of its kind to show the potential effects of lenalidomide as a therapeutic option in patients with pulmonary sarcoidosis.

Ali Bazargan, MD, of St. Vincent’s Hospital in Melbourne, Victoria, Australia, and his colleagues described this case in CHEST.

The patient had a 12-year history of stage IV pulmonary sarcoidosis with no extrapulmonary organ involvement. She had never smoked but had a history of hypertension that was managed with perindopril.

The patient presented with refractory and worsening dyspnea, despite receiving long-term therapy with methotrexate and inhaled and systemic corticosteroids. Before she began receiving lenalidomide, the patient was taking 15 mg of prednisolone and 400 mg of inhaled budesonide daily.

Blood tests revealed the patient had macrocytic anemia (hemoglobin level, 81 g/L; mean corpuscular volume, 114 fL).

A subsequent bone marrow biopsy revealed hypocellular marrow with trilineage dysplasia consistent with 5q-MDS but no evidence of noncaseating granulomas. So the patient began receiving lenalidomide at 10 mg daily.

While the researchers were trying to establish her diagnosis of 5q-MDS, the patient became transfusion-dependent and experienced severe dyspnea, fatigue, and a considerable decline in quality of life.

A chest CT scan revealed irregular masses in her lung, with bibasal alveolar infiltrates that had developed within a 12-month period.

However, after 2 cycles of lenalidomide, the patient had significant improvements in dyspnea, fatigue, daily activity, and quality of life. Lung function testing showed an increase in vital capacity from 1.73 L to 1.93 L.

And a chest CT scan performed 4 months after the patient began taking lenalidomide showed that the bibasal alveolar infiltrates had completely cleared.

During this period, the patient’s dose of prednisolone was reduced from 15 mg daily to 5 mg on alternate days, but she continues to receive the same dose of lenalidomide.

Blood smear showing MDS

Treatment with lenalidomide can have a significant effect on pulmonary sarcoidosis in myelodysplastic syndrome (MDS), according to a case study.

The case was a 71-year-old woman with newly diagnosed 5q-MDS and a long-standing history of refractory pulmonary sarcoidosis.

After 2 cycles of treatment with lenalidomide, the patient had substantial improvements in lung function, fatigue, daily activity, and quality of life.

This case is the first of its kind to show the potential effects of lenalidomide as a therapeutic option in patients with pulmonary sarcoidosis.

Ali Bazargan, MD, of St. Vincent’s Hospital in Melbourne, Victoria, Australia, and his colleagues described this case in CHEST.

The patient had a 12-year history of stage IV pulmonary sarcoidosis with no extrapulmonary organ involvement. She had never smoked but had a history of hypertension that was managed with perindopril.

The patient presented with refractory and worsening dyspnea, despite receiving long-term therapy with methotrexate and inhaled and systemic corticosteroids. Before she began receiving lenalidomide, the patient was taking 15 mg of prednisolone and 400 mg of inhaled budesonide daily.

Blood tests revealed the patient had macrocytic anemia (hemoglobin level, 81 g/L; mean corpuscular volume, 114 fL).

A subsequent bone marrow biopsy revealed hypocellular marrow with trilineage dysplasia consistent with 5q-MDS but no evidence of noncaseating granulomas. So the patient began receiving lenalidomide at 10 mg daily.

While the researchers were trying to establish her diagnosis of 5q-MDS, the patient became transfusion-dependent and experienced severe dyspnea, fatigue, and a considerable decline in quality of life.

A chest CT scan revealed irregular masses in her lung, with bibasal alveolar infiltrates that had developed within a 12-month period.

However, after 2 cycles of lenalidomide, the patient had significant improvements in dyspnea, fatigue, daily activity, and quality of life. Lung function testing showed an increase in vital capacity from 1.73 L to 1.93 L.

And a chest CT scan performed 4 months after the patient began taking lenalidomide showed that the bibasal alveolar infiltrates had completely cleared.

During this period, the patient’s dose of prednisolone was reduced from 15 mg daily to 5 mg on alternate days, but she continues to receive the same dose of lenalidomide.

Blood smear showing MDS

Treatment with lenalidomide can have a significant effect on pulmonary sarcoidosis in myelodysplastic syndrome (MDS), according to a case study.

The case was a 71-year-old woman with newly diagnosed 5q-MDS and a long-standing history of refractory pulmonary sarcoidosis.

After 2 cycles of treatment with lenalidomide, the patient had substantial improvements in lung function, fatigue, daily activity, and quality of life.

This case is the first of its kind to show the potential effects of lenalidomide as a therapeutic option in patients with pulmonary sarcoidosis.

Ali Bazargan, MD, of St. Vincent’s Hospital in Melbourne, Victoria, Australia, and his colleagues described this case in CHEST.

The patient had a 12-year history of stage IV pulmonary sarcoidosis with no extrapulmonary organ involvement. She had never smoked but had a history of hypertension that was managed with perindopril.

The patient presented with refractory and worsening dyspnea, despite receiving long-term therapy with methotrexate and inhaled and systemic corticosteroids. Before she began receiving lenalidomide, the patient was taking 15 mg of prednisolone and 400 mg of inhaled budesonide daily.

Blood tests revealed the patient had macrocytic anemia (hemoglobin level, 81 g/L; mean corpuscular volume, 114 fL).

A subsequent bone marrow biopsy revealed hypocellular marrow with trilineage dysplasia consistent with 5q-MDS but no evidence of noncaseating granulomas. So the patient began receiving lenalidomide at 10 mg daily.

While the researchers were trying to establish her diagnosis of 5q-MDS, the patient became transfusion-dependent and experienced severe dyspnea, fatigue, and a considerable decline in quality of life.

A chest CT scan revealed irregular masses in her lung, with bibasal alveolar infiltrates that had developed within a 12-month period.

However, after 2 cycles of lenalidomide, the patient had significant improvements in dyspnea, fatigue, daily activity, and quality of life. Lung function testing showed an increase in vital capacity from 1.73 L to 1.93 L.

And a chest CT scan performed 4 months after the patient began taking lenalidomide showed that the bibasal alveolar infiltrates had completely cleared.

During this period, the patient’s dose of prednisolone was reduced from 15 mg daily to 5 mg on alternate days, but she continues to receive the same dose of lenalidomide.

Only a minority of patients with atrial fibrillation or venous thromboembolism achieved good anticoagulation control while on warfarin, according to a population-based data analysis by Ana Filipa Macedo and her colleagues at Boehringer Ingelheim in the United Kingdom. In fact, only 44% of 140,078 AF patients and 36% of 70,371 VTE patients assessed had an optimal International Normalized Ratio (INR) time in therapeutic range (TTR) more than 70% of the time while on warfarin.

Patient characteristics associated with a significant increase in time spent above or below the recommended INR range of 2.0-3.0 were current smoking, the use of NSAIDs, age less than 45 years, and a body mass index less than 18.5 kg/m² in both AF and VTE patients, whereas patients with VTE alone had predictors of poor control that included chronic obstructive pulmonary disease or asthma, heart failure, and active cancer.

“The study provides evidence that in the first 12 months of warfarin use, there is a high amount of unpredictable variability in an individual’s TTR,” the researchers summarized. “These findings confirm the difficulty of achieving high-quality anticoagulation with warfarin in real-world clinical practice and can be used to identify patients who require closer monitoring or innovative management strategies,” the authors added.

More of the study can be read here (Thromb Res. 2015 Aug; 136(2):250-260.).

The study received funding from Boehringer Ingelheim, and the authors disclosed that they were all employees of the company, which makes a variety of cardiovascular therapies, including anticoagulants.

[email protected]

Only a minority of patients with atrial fibrillation or venous thromboembolism achieved good anticoagulation control while on warfarin, according to a population-based data analysis by Ana Filipa Macedo and her colleagues at Boehringer Ingelheim in the United Kingdom. In fact, only 44% of 140,078 AF patients and 36% of 70,371 VTE patients assessed had an optimal International Normalized Ratio (INR) time in therapeutic range (TTR) more than 70% of the time while on warfarin.

Patient characteristics associated with a significant increase in time spent above or below the recommended INR range of 2.0-3.0 were current smoking, the use of NSAIDs, age less than 45 years, and a body mass index less than 18.5 kg/m² in both AF and VTE patients, whereas patients with VTE alone had predictors of poor control that included chronic obstructive pulmonary disease or asthma, heart failure, and active cancer.

“The study provides evidence that in the first 12 months of warfarin use, there is a high amount of unpredictable variability in an individual’s TTR,” the researchers summarized. “These findings confirm the difficulty of achieving high-quality anticoagulation with warfarin in real-world clinical practice and can be used to identify patients who require closer monitoring or innovative management strategies,” the authors added.

More of the study can be read here (Thromb Res. 2015 Aug; 136(2):250-260.).

The study received funding from Boehringer Ingelheim, and the authors disclosed that they were all employees of the company, which makes a variety of cardiovascular therapies, including anticoagulants.

[email protected]

Only a minority of patients with atrial fibrillation or venous thromboembolism achieved good anticoagulation control while on warfarin, according to a population-based data analysis by Ana Filipa Macedo and her colleagues at Boehringer Ingelheim in the United Kingdom. In fact, only 44% of 140,078 AF patients and 36% of 70,371 VTE patients assessed had an optimal International Normalized Ratio (INR) time in therapeutic range (TTR) more than 70% of the time while on warfarin.

Patient characteristics associated with a significant increase in time spent above or below the recommended INR range of 2.0-3.0 were current smoking, the use of NSAIDs, age less than 45 years, and a body mass index less than 18.5 kg/m² in both AF and VTE patients, whereas patients with VTE alone had predictors of poor control that included chronic obstructive pulmonary disease or asthma, heart failure, and active cancer.

“The study provides evidence that in the first 12 months of warfarin use, there is a high amount of unpredictable variability in an individual’s TTR,” the researchers summarized. “These findings confirm the difficulty of achieving high-quality anticoagulation with warfarin in real-world clinical practice and can be used to identify patients who require closer monitoring or innovative management strategies,” the authors added.

More of the study can be read here (Thromb Res. 2015 Aug; 136(2):250-260.).

The study received funding from Boehringer Ingelheim, and the authors disclosed that they were all employees of the company, which makes a variety of cardiovascular therapies, including anticoagulants.

[email protected]

Involved-field radiotherapy alone should be the treatment of choice for stage 1A nodular lymphocyte-predominant Hodgkin lymphoma because it yields similar survival outcomes but fewer toxic effects than other therapies, investigators reported online Aug. 3 in Journal of Clinical Oncology.

Few studies have examined the long-term outcomes of patients who have this generally indolent malignancy, even though late treatment-associated effects are their major cause of death, said Dr. Dennis A. Eichenauer and his associates at University Hospital Cologne and University Hospital Münster, both in Germany.

To assess long-term outcomes in nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL), the investigators analyzed data for 256 patients who participated in seven prospective randomized clinical trials comparing various treatments during a 21-year period, who were followed for a median of 91 months. The study participants’ median age at diagnosis was 39 years (range, 16-75 years), and all achieved remission with therapy. They were categorized by treatment type: 108 received involved-field radiotherapy (IF-RT) alone; 49 received extended-field radiotherapy (EF-RT) alone; 72 received combined modality treatment involving various combinations of doxorubicin, bleomycin, vinblastine, dacarbazine, IF-RT, EF-RT, and/or rituximab; and 27 received rituximab alone.

At 8 years, progression-free survival was 91.9% with IF-RT, 84.3% with EF-RT, and 88.5% with combined modalities, which are nonsignificant differences. Overall survival was 99.0%, 95.7%, and 98.6%, respectively, which also are nonsignificant differences. Rituximab alone was markedly less effective than the other treatments, with a 4-year progression-free survival of only 81.0%. “Compared with patients who received IF-RT, patients treated with rituximab had a hazard ratio of 4.99 for relapse,” Dr. Eichenauer and his associates wrote (J Clin Oncol. 2015 Aug 3 [doi: 10.1200/JCO. 2014.60.4363]).

Only 3.7% of patients treated with IF-RT developed a second malignancy during follow-up, compared with 11.1% of those treated with combined modalities, 6.1% of those treated with EF-RT, and 7.4% of those treated with rituximab. The rate of relapse was markedly higher with rituximab than with the other treatments.

The main study findings are twofold. First, IF-RT was at least as effective as other treatments in controlling NLPHL, was less toxic acutely, and carried similar or reduced risks of late adverse effects such as relapse and second malignancies. It should be considered the first-line treatment of choice. Second, rituximab alone should not be used routinely in these patients because it yields poorer survival outcomes and a higher relapse rate. “However, it might represent an option for individual patients, such as young women with abdominal disease, to avoid gonadotoxic effects of radiotherapy,” the investigators said.

Involved-field radiotherapy alone should be the treatment of choice for stage 1A nodular lymphocyte-predominant Hodgkin lymphoma because it yields similar survival outcomes but fewer toxic effects than other therapies, investigators reported online Aug. 3 in Journal of Clinical Oncology.

Few studies have examined the long-term outcomes of patients who have this generally indolent malignancy, even though late treatment-associated effects are their major cause of death, said Dr. Dennis A. Eichenauer and his associates at University Hospital Cologne and University Hospital Münster, both in Germany.

To assess long-term outcomes in nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL), the investigators analyzed data for 256 patients who participated in seven prospective randomized clinical trials comparing various treatments during a 21-year period, who were followed for a median of 91 months. The study participants’ median age at diagnosis was 39 years (range, 16-75 years), and all achieved remission with therapy. They were categorized by treatment type: 108 received involved-field radiotherapy (IF-RT) alone; 49 received extended-field radiotherapy (EF-RT) alone; 72 received combined modality treatment involving various combinations of doxorubicin, bleomycin, vinblastine, dacarbazine, IF-RT, EF-RT, and/or rituximab; and 27 received rituximab alone.

At 8 years, progression-free survival was 91.9% with IF-RT, 84.3% with EF-RT, and 88.5% with combined modalities, which are nonsignificant differences. Overall survival was 99.0%, 95.7%, and 98.6%, respectively, which also are nonsignificant differences. Rituximab alone was markedly less effective than the other treatments, with a 4-year progression-free survival of only 81.0%. “Compared with patients who received IF-RT, patients treated with rituximab had a hazard ratio of 4.99 for relapse,” Dr. Eichenauer and his associates wrote (J Clin Oncol. 2015 Aug 3 [doi: 10.1200/JCO. 2014.60.4363]).

Only 3.7% of patients treated with IF-RT developed a second malignancy during follow-up, compared with 11.1% of those treated with combined modalities, 6.1% of those treated with EF-RT, and 7.4% of those treated with rituximab. The rate of relapse was markedly higher with rituximab than with the other treatments.

The main study findings are twofold. First, IF-RT was at least as effective as other treatments in controlling NLPHL, was less toxic acutely, and carried similar or reduced risks of late adverse effects such as relapse and second malignancies. It should be considered the first-line treatment of choice. Second, rituximab alone should not be used routinely in these patients because it yields poorer survival outcomes and a higher relapse rate. “However, it might represent an option for individual patients, such as young women with abdominal disease, to avoid gonadotoxic effects of radiotherapy,” the investigators said.

Involved-field radiotherapy alone should be the treatment of choice for stage 1A nodular lymphocyte-predominant Hodgkin lymphoma because it yields similar survival outcomes but fewer toxic effects than other therapies, investigators reported online Aug. 3 in Journal of Clinical Oncology.

Few studies have examined the long-term outcomes of patients who have this generally indolent malignancy, even though late treatment-associated effects are their major cause of death, said Dr. Dennis A. Eichenauer and his associates at University Hospital Cologne and University Hospital Münster, both in Germany.

To assess long-term outcomes in nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL), the investigators analyzed data for 256 patients who participated in seven prospective randomized clinical trials comparing various treatments during a 21-year period, who were followed for a median of 91 months. The study participants’ median age at diagnosis was 39 years (range, 16-75 years), and all achieved remission with therapy. They were categorized by treatment type: 108 received involved-field radiotherapy (IF-RT) alone; 49 received extended-field radiotherapy (EF-RT) alone; 72 received combined modality treatment involving various combinations of doxorubicin, bleomycin, vinblastine, dacarbazine, IF-RT, EF-RT, and/or rituximab; and 27 received rituximab alone.

At 8 years, progression-free survival was 91.9% with IF-RT, 84.3% with EF-RT, and 88.5% with combined modalities, which are nonsignificant differences. Overall survival was 99.0%, 95.7%, and 98.6%, respectively, which also are nonsignificant differences. Rituximab alone was markedly less effective than the other treatments, with a 4-year progression-free survival of only 81.0%. “Compared with patients who received IF-RT, patients treated with rituximab had a hazard ratio of 4.99 for relapse,” Dr. Eichenauer and his associates wrote (J Clin Oncol. 2015 Aug 3 [doi: 10.1200/JCO. 2014.60.4363]).

Only 3.7% of patients treated with IF-RT developed a second malignancy during follow-up, compared with 11.1% of those treated with combined modalities, 6.1% of those treated with EF-RT, and 7.4% of those treated with rituximab. The rate of relapse was markedly higher with rituximab than with the other treatments.

The main study findings are twofold. First, IF-RT was at least as effective as other treatments in controlling NLPHL, was less toxic acutely, and carried similar or reduced risks of late adverse effects such as relapse and second malignancies. It should be considered the first-line treatment of choice. Second, rituximab alone should not be used routinely in these patients because it yields poorer survival outcomes and a higher relapse rate. “However, it might represent an option for individual patients, such as young women with abdominal disease, to avoid gonadotoxic effects of radiotherapy,” the investigators said.

The Food and Drug Administration is investigating the risk of brain deposits after recurring use of gadolinium-based contrast agents for MRI, the agency announced in a statement.

Studies suggest that gadolinium-based contrast agent (GBCA) deposits may stay in the brains of patients who have four or more contrast MRI scans, though it is unknown whether these deposits cause adverse effects, the FDA said.

GBCAs are usually expelled through the kidneys, but may remain in the brain after repeated exposure. FDA’s National Center for Toxicological

Research will further investigate safety risks in consultation with researchers and industry, the statement said.

The FDA is not requiring manufacturers to change the labels of GBCA products until more information is known. The agency is, however, recommending that clinicians limit GBCA use to situations in which it would be necessary for patient care.

“Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols,” the FDA said.

Patients may report side effects and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

[email protected]

The Food and Drug Administration is investigating the risk of brain deposits after recurring use of gadolinium-based contrast agents for MRI, the agency announced in a statement.

Studies suggest that gadolinium-based contrast agent (GBCA) deposits may stay in the brains of patients who have four or more contrast MRI scans, though it is unknown whether these deposits cause adverse effects, the FDA said.

GBCAs are usually expelled through the kidneys, but may remain in the brain after repeated exposure. FDA’s National Center for Toxicological

Research will further investigate safety risks in consultation with researchers and industry, the statement said.

The FDA is not requiring manufacturers to change the labels of GBCA products until more information is known. The agency is, however, recommending that clinicians limit GBCA use to situations in which it would be necessary for patient care.

“Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols,” the FDA said.

Patients may report side effects and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

[email protected]

The Food and Drug Administration is investigating the risk of brain deposits after recurring use of gadolinium-based contrast agents for MRI, the agency announced in a statement.

Studies suggest that gadolinium-based contrast agent (GBCA) deposits may stay in the brains of patients who have four or more contrast MRI scans, though it is unknown whether these deposits cause adverse effects, the FDA said.

GBCAs are usually expelled through the kidneys, but may remain in the brain after repeated exposure. FDA’s National Center for Toxicological

Research will further investigate safety risks in consultation with researchers and industry, the statement said.

The FDA is not requiring manufacturers to change the labels of GBCA products until more information is known. The agency is, however, recommending that clinicians limit GBCA use to situations in which it would be necessary for patient care.

“Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols,” the FDA said.

Patients may report side effects and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

[email protected]

To improve patient care and outcomes, leading dermatologists offered their recommendations on top products for sensitive skin. Consideration must be given to:

• Aveeno Eczema Therapy Moisturizing Cream

• Cetaphil Restoraderm

• PRESCRIBEDsolutions Don’t Be So Sensitive Post-Procedure Cleanser

• Rosaliac AR Intense

• Vanicream

Cutis invites readers to send us their recommendations. Skin care products for babies, men’s shaving products, eye creams, and OTC dandruff treatments will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on top products for sensitive skin. Consideration must be given to:

• Aveeno Eczema Therapy Moisturizing Cream

• Cetaphil Restoraderm

• PRESCRIBEDsolutions Don’t Be So Sensitive Post-Procedure Cleanser

• Rosaliac AR Intense

• Vanicream

Cutis invites readers to send us their recommendations. Skin care products for babies, men’s shaving products, eye creams, and OTC dandruff treatments will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on top products for sensitive skin. Consideration must be given to:

• Aveeno Eczema Therapy Moisturizing Cream

• Cetaphil Restoraderm

• PRESCRIBEDsolutions Don’t Be So Sensitive Post-Procedure Cleanser

• Rosaliac AR Intense

• Vanicream

Cutis invites readers to send us their recommendations. Skin care products for babies, men’s shaving products, eye creams, and OTC dandruff treatments will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.