ROXANNE NELSON, RN, BSN

Experts at the National Comprehensive Cancer Network have now issued an updated recommendation for COVID-19 vaccination in people with cancer. The panel calls for these patients to be among the highest-priority group to be vaccinated against COVID-19 and to receive the newly approved third dose of vaccine.

The NCCN has recommended in February that all patients receiving active cancer treatment should receive a COVID-19 vaccine and should be prioritized for vaccination. In August, the FDA authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems. Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems

The new NCCN recommendations state that the following groups should be considered eligible for a third dose of the mRNA COVID-19 vaccine immediately, based on the latest decisions from the Food and Drug Administration and the Centers for Disease Control and Prevention:

• Patients with solid tumors (either new or recurring) receiving treatment within 1 year of their initial vaccine dose, regardless of their type of cancer therapy.
• Patients with active hematologic malignancies regardless of whether they are currently receiving cancer therapy.
• Anyone who received a stem cell transplant (SCT) or engineered cellular therapy (for example, chimeric antigen receptor T cells), especially within the past 2 years.
• Any recipients of allogeneic SCT on immunosuppressive therapy or with a history of graft-versus-host disease regardless of the time of transplant.
• Anyone with an additional immunosuppressive condition (for example, HIV) or being treated with immunosuppressive agents unrelated to their cancer therapy.

Cancer patients at high risk of complications

As previously reported by this news organization, infection with COVID-19 in people with cancer can severely impact survival. One study published in 2020 found that patients with both COVID-19 infection and progressing cancer had a fivefold increase in the risk of 30-day mortality, compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer.

Another study found that cancer type, stage, and recent treatment could affect outcomes of COVID-19 in patients with cancer. Patients with hematologic malignancies and metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying. Conversely, those with nonmetastatic disease had outcomes that were comparable with persons without cancer and a COVID-19 infection. This study also found that having undergone recent surgery or receiving immunotherapy also put patients at a higher risk of poor outcomes, although patients with cancer who were treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.

“COVID-19 can be very dangerous, especially for people living with cancer, which is why we’re so grateful for safe and effective vaccines that are saving lives,” Robert W. Carlson, MD, CEO of NCCN, said in a statement.
 

Right timing and location

The current NCCN update also recommends that individuals wait at least 4 weeks between the second and third doses, and those who are infected with COVID-19 after being vaccinated should wait until they have documented clearance of the virus before receiving a third dose.

It also recommends that people who live in the same household with immunocompromised individuals should also get a third dose once it becomes available, and that it is best to have a third dose of the same type of vaccine as the first two doses. However, a different mRNA vaccine is also acceptable.

Immunocompromised individuals should try to receive their third dose in a health care delivery setting, as opposed to a pharmacy or public vaccination clinic if possible, as it would limit their risk of exposure to the general population.

Steve Pergam, MD, MPH, associate professor, vaccine and infectious disease division, Fred Hutchinson Cancer Research Center, Seattle, commented that it is still necessary to take precautions, even after getting the booster dose.

“That means, even after a third dose of vaccine, we still recommend immunocompromised people, such as those undergoing cancer treatment, continue to be cautious, wear masks, and avoid large group gatherings, particularly around those who are unvaccinated,” said Dr. Pergam, who is also coleader of the NCCN COVID-19 Vaccination Advisory Committee. “All of us should do our part to reduce the spread of COVID-19 and get vaccinated to protect those around us from preventable suffering.”

A version of this article first appeared on Medscape.com.

Experts at the National Comprehensive Cancer Network have now issued an updated recommendation for COVID-19 vaccination in people with cancer. The panel calls for these patients to be among the highest-priority group to be vaccinated against COVID-19 and to receive the newly approved third dose of vaccine.

The NCCN has recommended in February that all patients receiving active cancer treatment should receive a COVID-19 vaccine and should be prioritized for vaccination. In August, the FDA authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems. Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems

The new NCCN recommendations state that the following groups should be considered eligible for a third dose of the mRNA COVID-19 vaccine immediately, based on the latest decisions from the Food and Drug Administration and the Centers for Disease Control and Prevention:

• Patients with solid tumors (either new or recurring) receiving treatment within 1 year of their initial vaccine dose, regardless of their type of cancer therapy.
• Patients with active hematologic malignancies regardless of whether they are currently receiving cancer therapy.
• Anyone who received a stem cell transplant (SCT) or engineered cellular therapy (for example, chimeric antigen receptor T cells), especially within the past 2 years.
• Any recipients of allogeneic SCT on immunosuppressive therapy or with a history of graft-versus-host disease regardless of the time of transplant.
• Anyone with an additional immunosuppressive condition (for example, HIV) or being treated with immunosuppressive agents unrelated to their cancer therapy.

Cancer patients at high risk of complications

As previously reported by this news organization, infection with COVID-19 in people with cancer can severely impact survival. One study published in 2020 found that patients with both COVID-19 infection and progressing cancer had a fivefold increase in the risk of 30-day mortality, compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer.

Another study found that cancer type, stage, and recent treatment could affect outcomes of COVID-19 in patients with cancer. Patients with hematologic malignancies and metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying. Conversely, those with nonmetastatic disease had outcomes that were comparable with persons without cancer and a COVID-19 infection. This study also found that having undergone recent surgery or receiving immunotherapy also put patients at a higher risk of poor outcomes, although patients with cancer who were treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.

“COVID-19 can be very dangerous, especially for people living with cancer, which is why we’re so grateful for safe and effective vaccines that are saving lives,” Robert W. Carlson, MD, CEO of NCCN, said in a statement.
 

Right timing and location

The current NCCN update also recommends that individuals wait at least 4 weeks between the second and third doses, and those who are infected with COVID-19 after being vaccinated should wait until they have documented clearance of the virus before receiving a third dose.

It also recommends that people who live in the same household with immunocompromised individuals should also get a third dose once it becomes available, and that it is best to have a third dose of the same type of vaccine as the first two doses. However, a different mRNA vaccine is also acceptable.

Immunocompromised individuals should try to receive their third dose in a health care delivery setting, as opposed to a pharmacy or public vaccination clinic if possible, as it would limit their risk of exposure to the general population.

Steve Pergam, MD, MPH, associate professor, vaccine and infectious disease division, Fred Hutchinson Cancer Research Center, Seattle, commented that it is still necessary to take precautions, even after getting the booster dose.

“That means, even after a third dose of vaccine, we still recommend immunocompromised people, such as those undergoing cancer treatment, continue to be cautious, wear masks, and avoid large group gatherings, particularly around those who are unvaccinated,” said Dr. Pergam, who is also coleader of the NCCN COVID-19 Vaccination Advisory Committee. “All of us should do our part to reduce the spread of COVID-19 and get vaccinated to protect those around us from preventable suffering.”

A version of this article first appeared on Medscape.com.

Experts at the National Comprehensive Cancer Network have now issued an updated recommendation for COVID-19 vaccination in people with cancer. The panel calls for these patients to be among the highest-priority group to be vaccinated against COVID-19 and to receive the newly approved third dose of vaccine.

The NCCN has recommended in February that all patients receiving active cancer treatment should receive a COVID-19 vaccine and should be prioritized for vaccination. In August, the FDA authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems. Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems

The new NCCN recommendations state that the following groups should be considered eligible for a third dose of the mRNA COVID-19 vaccine immediately, based on the latest decisions from the Food and Drug Administration and the Centers for Disease Control and Prevention:

• Patients with solid tumors (either new or recurring) receiving treatment within 1 year of their initial vaccine dose, regardless of their type of cancer therapy.
• Patients with active hematologic malignancies regardless of whether they are currently receiving cancer therapy.
• Anyone who received a stem cell transplant (SCT) or engineered cellular therapy (for example, chimeric antigen receptor T cells), especially within the past 2 years.
• Any recipients of allogeneic SCT on immunosuppressive therapy or with a history of graft-versus-host disease regardless of the time of transplant.
• Anyone with an additional immunosuppressive condition (for example, HIV) or being treated with immunosuppressive agents unrelated to their cancer therapy.

Cancer patients at high risk of complications

As previously reported by this news organization, infection with COVID-19 in people with cancer can severely impact survival. One study published in 2020 found that patients with both COVID-19 infection and progressing cancer had a fivefold increase in the risk of 30-day mortality, compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer.

Another study found that cancer type, stage, and recent treatment could affect outcomes of COVID-19 in patients with cancer. Patients with hematologic malignancies and metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying. Conversely, those with nonmetastatic disease had outcomes that were comparable with persons without cancer and a COVID-19 infection. This study also found that having undergone recent surgery or receiving immunotherapy also put patients at a higher risk of poor outcomes, although patients with cancer who were treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.

“COVID-19 can be very dangerous, especially for people living with cancer, which is why we’re so grateful for safe and effective vaccines that are saving lives,” Robert W. Carlson, MD, CEO of NCCN, said in a statement.
 

Right timing and location

The current NCCN update also recommends that individuals wait at least 4 weeks between the second and third doses, and those who are infected with COVID-19 after being vaccinated should wait until they have documented clearance of the virus before receiving a third dose.

It also recommends that people who live in the same household with immunocompromised individuals should also get a third dose once it becomes available, and that it is best to have a third dose of the same type of vaccine as the first two doses. However, a different mRNA vaccine is also acceptable.

Immunocompromised individuals should try to receive their third dose in a health care delivery setting, as opposed to a pharmacy or public vaccination clinic if possible, as it would limit their risk of exposure to the general population.

Steve Pergam, MD, MPH, associate professor, vaccine and infectious disease division, Fred Hutchinson Cancer Research Center, Seattle, commented that it is still necessary to take precautions, even after getting the booster dose.

“That means, even after a third dose of vaccine, we still recommend immunocompromised people, such as those undergoing cancer treatment, continue to be cautious, wear masks, and avoid large group gatherings, particularly around those who are unvaccinated,” said Dr. Pergam, who is also coleader of the NCCN COVID-19 Vaccination Advisory Committee. “All of us should do our part to reduce the spread of COVID-19 and get vaccinated to protect those around us from preventable suffering.”

A version of this article first appeared on Medscape.com.

When chronic graft-versus-host disease (cGVHD) develops as a complication of allogeneic hematopoietic stem cell transplant (alloHSCT), treatment options are limited. New findings show that ruxolitinib (Jakafi) was superior to standard therapy in reducing symptoms of cGVHD in the second-line setting, and the results are potentially practice changing.  

The new data, from the REACH3 trial, were presented at the annual meeting of the American Society of Hematology, held virtually this year.

This trial is “almost certainly a practice changer,” Robert Brodsky, MD, ASH secretary, said during a press preview webinar.  

Chronic GVHD occurs in approximately 30%-70% of patients who undergo alloSCT, and “has been really hard to treat,” said Dr. Brodsky, of Johns Hopkins University, Baltimore. “Steroids are the first-line treatment, but after that, nothing else has shown any improvement and even steroids don’t work that well.”

Of the patients assessed, 50% of those who received ruxolitinib responded to therapy compared with only 25% who received standard therapies.

“This is the first multicenter randomized controlled trial for chronic GVHD that is positive,” said senior study author Robert Zeiser, PhD, of University Medical Center, Freiburg, Germany. “It shows a significant advantage for ruxolitinib. It is likely that this trial will lead to approval for this indication and change the guidelines for the treatment of this disease.”

Ruxolitinib, a JAK inhibitor first marketed for use in myelofibrosis, is already  approved for acute GVHD. The Food and Drug Administration approved that indication last year on the basis of data from two previous trials, REACH 1 and REACH 2. The trials found that ruxolitinib was superior to best available therapy for treating patients with acute GVHD.
 

Superior to best available therapy

In the current REACH 3 study, Dr. Zeiser and colleagues compared ruxolitinib with best available therapy in 329 patients with moderate-to-severe cGVHD (both steroid dependent and steroid resistant).

All patients had undergone alloSCT and were randomly assigned to ruxolitinib (10 mg twice daily) for six 28-day cycles or investigator-selected best available therapy (BAT), of which there were 10 options. Patients continued receiving their regimen of corticosteroids, and viral prophylaxis and antibiotics were allowed as needed for infection prevention and treatment.

The study permitted crossover: Patients on BAT were allowed to start on ruxolitinib on or after cycle 7 day 1 for those who did not achieve or maintain a response, developed toxicity to BAT, or had a cGVHD flare.

The study met its primary endpoint of overall response rate (ORR), with a clear and substantial improvement among patients taking ruxolitinib (50% vs 26%; odds ratio, 2.99; P < .0001a), Dr. Zeiser noted. The complete response rate was also higher (7% vs. 3%).

Both key secondary endpoints also showed that ruxolitinib was superior to BAT. Failure-free survival was significantly longer in the ruxolitinib group (median not reached vs 5.7 months; hazard ratio, 0.370; P < .0001). There was also an improvement in symptoms based on changes in the modified Lee symptom score (mLSS; 0 [no symptoms] to 100 [worst symptoms]) at cycle 7 day 1; the results show that the mLSS responder rate was higher in patients on ruxolitinib (24% vs. 11%; odds ratio, 2.62; P = .0011).

A total of 31 patients in the ruxolitinib group died (19%) along with 27 in the BAT group (16%), with the cGVHD as the main cause of death.

Adverse events were comparable in both groups (ruxolitinib 98% [grade ≥ 3, 57%]; BAT, 92% [grade ≥ 3, 58%], with the most common being anemia (29% vs. 13%), hypertension (16% vs. 13%), pyrexia (16% vs. 9%), and ALT increase (15% vs 4%).
 

More options for patients

“The addition of ruxolitinib is definitely practice changing for this very difficult to treat population,” said James Essell, MD,  medical director of the Blood Cancer Center at Mercy Health, Cincinnati, who was not involved in the study.

However, he added, “more options are still required, as evidenced by the continued deaths of patients despite this new option.”

Dr. Essell pointed out that ibrutinib (Imbruvica) is already approved for the treatment of cGVHD. “Ruxolitinib offers another option for treating this group of patients,” he said, and predicted that “it will be used frequently and has a different toxicity profile, ultimately improving the care for patients with cGVHD.”

It is likely that ruxolitinib will be considered earlier in the treatment of cGVHD to avoid the toxicity of chronic steroid use, he added, but price is a consideration. “The cost of ruxolitinib is over 200 times more than prednisone, limiting the adoption front line without a clinical trial.”

Another expert approached for comment was enthusiastic. “The abstract gave good evidence and efficacy with chronic GVHD,” said Ryotaro Nakamura, MD, associate professor of hematology & hematopoietic cell transplantation at City of Hope, Duarte, Calif. He noted that there have been two previous REACH trials which showed a benefit for ruxolitinib in acute GVHD.

What this means is that there is now global evidence that ruxolitinib is better than anything else so far, he said, and this latest trial is just part of the “practice-changing data,” from the three studies. “It is practice changing in that it is providing options now for these patients,” he said.

Dr. Zeiser has disclosed relationships with Incyte, Novartis and Mallinckrodt; other authors disclosed relationships with industry as noted in the abstract. Dr. Essell and Dr. Nakamura have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

When chronic graft-versus-host disease (cGVHD) develops as a complication of allogeneic hematopoietic stem cell transplant (alloHSCT), treatment options are limited. New findings show that ruxolitinib (Jakafi) was superior to standard therapy in reducing symptoms of cGVHD in the second-line setting, and the results are potentially practice changing.  

The new data, from the REACH3 trial, were presented at the annual meeting of the American Society of Hematology, held virtually this year.

This trial is “almost certainly a practice changer,” Robert Brodsky, MD, ASH secretary, said during a press preview webinar.  

Chronic GVHD occurs in approximately 30%-70% of patients who undergo alloSCT, and “has been really hard to treat,” said Dr. Brodsky, of Johns Hopkins University, Baltimore. “Steroids are the first-line treatment, but after that, nothing else has shown any improvement and even steroids don’t work that well.”

Of the patients assessed, 50% of those who received ruxolitinib responded to therapy compared with only 25% who received standard therapies.

“This is the first multicenter randomized controlled trial for chronic GVHD that is positive,” said senior study author Robert Zeiser, PhD, of University Medical Center, Freiburg, Germany. “It shows a significant advantage for ruxolitinib. It is likely that this trial will lead to approval for this indication and change the guidelines for the treatment of this disease.”

Ruxolitinib, a JAK inhibitor first marketed for use in myelofibrosis, is already  approved for acute GVHD. The Food and Drug Administration approved that indication last year on the basis of data from two previous trials, REACH 1 and REACH 2. The trials found that ruxolitinib was superior to best available therapy for treating patients with acute GVHD.
 

Superior to best available therapy

In the current REACH 3 study, Dr. Zeiser and colleagues compared ruxolitinib with best available therapy in 329 patients with moderate-to-severe cGVHD (both steroid dependent and steroid resistant).

All patients had undergone alloSCT and were randomly assigned to ruxolitinib (10 mg twice daily) for six 28-day cycles or investigator-selected best available therapy (BAT), of which there were 10 options. Patients continued receiving their regimen of corticosteroids, and viral prophylaxis and antibiotics were allowed as needed for infection prevention and treatment.

The study permitted crossover: Patients on BAT were allowed to start on ruxolitinib on or after cycle 7 day 1 for those who did not achieve or maintain a response, developed toxicity to BAT, or had a cGVHD flare.

The study met its primary endpoint of overall response rate (ORR), with a clear and substantial improvement among patients taking ruxolitinib (50% vs 26%; odds ratio, 2.99; P < .0001a), Dr. Zeiser noted. The complete response rate was also higher (7% vs. 3%).

Both key secondary endpoints also showed that ruxolitinib was superior to BAT. Failure-free survival was significantly longer in the ruxolitinib group (median not reached vs 5.7 months; hazard ratio, 0.370; P < .0001). There was also an improvement in symptoms based on changes in the modified Lee symptom score (mLSS; 0 [no symptoms] to 100 [worst symptoms]) at cycle 7 day 1; the results show that the mLSS responder rate was higher in patients on ruxolitinib (24% vs. 11%; odds ratio, 2.62; P = .0011).

A total of 31 patients in the ruxolitinib group died (19%) along with 27 in the BAT group (16%), with the cGVHD as the main cause of death.

Adverse events were comparable in both groups (ruxolitinib 98% [grade ≥ 3, 57%]; BAT, 92% [grade ≥ 3, 58%], with the most common being anemia (29% vs. 13%), hypertension (16% vs. 13%), pyrexia (16% vs. 9%), and ALT increase (15% vs 4%).
 

More options for patients

“The addition of ruxolitinib is definitely practice changing for this very difficult to treat population,” said James Essell, MD,  medical director of the Blood Cancer Center at Mercy Health, Cincinnati, who was not involved in the study.

However, he added, “more options are still required, as evidenced by the continued deaths of patients despite this new option.”

Dr. Essell pointed out that ibrutinib (Imbruvica) is already approved for the treatment of cGVHD. “Ruxolitinib offers another option for treating this group of patients,” he said, and predicted that “it will be used frequently and has a different toxicity profile, ultimately improving the care for patients with cGVHD.”

It is likely that ruxolitinib will be considered earlier in the treatment of cGVHD to avoid the toxicity of chronic steroid use, he added, but price is a consideration. “The cost of ruxolitinib is over 200 times more than prednisone, limiting the adoption front line without a clinical trial.”

Another expert approached for comment was enthusiastic. “The abstract gave good evidence and efficacy with chronic GVHD,” said Ryotaro Nakamura, MD, associate professor of hematology & hematopoietic cell transplantation at City of Hope, Duarte, Calif. He noted that there have been two previous REACH trials which showed a benefit for ruxolitinib in acute GVHD.

What this means is that there is now global evidence that ruxolitinib is better than anything else so far, he said, and this latest trial is just part of the “practice-changing data,” from the three studies. “It is practice changing in that it is providing options now for these patients,” he said.

Dr. Zeiser has disclosed relationships with Incyte, Novartis and Mallinckrodt; other authors disclosed relationships with industry as noted in the abstract. Dr. Essell and Dr. Nakamura have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

When chronic graft-versus-host disease (cGVHD) develops as a complication of allogeneic hematopoietic stem cell transplant (alloHSCT), treatment options are limited. New findings show that ruxolitinib (Jakafi) was superior to standard therapy in reducing symptoms of cGVHD in the second-line setting, and the results are potentially practice changing.  

The new data, from the REACH3 trial, were presented at the annual meeting of the American Society of Hematology, held virtually this year.

This trial is “almost certainly a practice changer,” Robert Brodsky, MD, ASH secretary, said during a press preview webinar.  

Chronic GVHD occurs in approximately 30%-70% of patients who undergo alloSCT, and “has been really hard to treat,” said Dr. Brodsky, of Johns Hopkins University, Baltimore. “Steroids are the first-line treatment, but after that, nothing else has shown any improvement and even steroids don’t work that well.”

Of the patients assessed, 50% of those who received ruxolitinib responded to therapy compared with only 25% who received standard therapies.

“This is the first multicenter randomized controlled trial for chronic GVHD that is positive,” said senior study author Robert Zeiser, PhD, of University Medical Center, Freiburg, Germany. “It shows a significant advantage for ruxolitinib. It is likely that this trial will lead to approval for this indication and change the guidelines for the treatment of this disease.”

Ruxolitinib, a JAK inhibitor first marketed for use in myelofibrosis, is already  approved for acute GVHD. The Food and Drug Administration approved that indication last year on the basis of data from two previous trials, REACH 1 and REACH 2. The trials found that ruxolitinib was superior to best available therapy for treating patients with acute GVHD.
 

Superior to best available therapy

In the current REACH 3 study, Dr. Zeiser and colleagues compared ruxolitinib with best available therapy in 329 patients with moderate-to-severe cGVHD (both steroid dependent and steroid resistant).

All patients had undergone alloSCT and were randomly assigned to ruxolitinib (10 mg twice daily) for six 28-day cycles or investigator-selected best available therapy (BAT), of which there were 10 options. Patients continued receiving their regimen of corticosteroids, and viral prophylaxis and antibiotics were allowed as needed for infection prevention and treatment.

The study permitted crossover: Patients on BAT were allowed to start on ruxolitinib on or after cycle 7 day 1 for those who did not achieve or maintain a response, developed toxicity to BAT, or had a cGVHD flare.

The study met its primary endpoint of overall response rate (ORR), with a clear and substantial improvement among patients taking ruxolitinib (50% vs 26%; odds ratio, 2.99; P < .0001a), Dr. Zeiser noted. The complete response rate was also higher (7% vs. 3%).

Both key secondary endpoints also showed that ruxolitinib was superior to BAT. Failure-free survival was significantly longer in the ruxolitinib group (median not reached vs 5.7 months; hazard ratio, 0.370; P < .0001). There was also an improvement in symptoms based on changes in the modified Lee symptom score (mLSS; 0 [no symptoms] to 100 [worst symptoms]) at cycle 7 day 1; the results show that the mLSS responder rate was higher in patients on ruxolitinib (24% vs. 11%; odds ratio, 2.62; P = .0011).

A total of 31 patients in the ruxolitinib group died (19%) along with 27 in the BAT group (16%), with the cGVHD as the main cause of death.

Adverse events were comparable in both groups (ruxolitinib 98% [grade ≥ 3, 57%]; BAT, 92% [grade ≥ 3, 58%], with the most common being anemia (29% vs. 13%), hypertension (16% vs. 13%), pyrexia (16% vs. 9%), and ALT increase (15% vs 4%).
 

More options for patients

“The addition of ruxolitinib is definitely practice changing for this very difficult to treat population,” said James Essell, MD,  medical director of the Blood Cancer Center at Mercy Health, Cincinnati, who was not involved in the study.

However, he added, “more options are still required, as evidenced by the continued deaths of patients despite this new option.”

Dr. Essell pointed out that ibrutinib (Imbruvica) is already approved for the treatment of cGVHD. “Ruxolitinib offers another option for treating this group of patients,” he said, and predicted that “it will be used frequently and has a different toxicity profile, ultimately improving the care for patients with cGVHD.”

It is likely that ruxolitinib will be considered earlier in the treatment of cGVHD to avoid the toxicity of chronic steroid use, he added, but price is a consideration. “The cost of ruxolitinib is over 200 times more than prednisone, limiting the adoption front line without a clinical trial.”

Another expert approached for comment was enthusiastic. “The abstract gave good evidence and efficacy with chronic GVHD,” said Ryotaro Nakamura, MD, associate professor of hematology & hematopoietic cell transplantation at City of Hope, Duarte, Calif. He noted that there have been two previous REACH trials which showed a benefit for ruxolitinib in acute GVHD.

What this means is that there is now global evidence that ruxolitinib is better than anything else so far, he said, and this latest trial is just part of the “practice-changing data,” from the three studies. “It is practice changing in that it is providing options now for these patients,” he said.

Dr. Zeiser has disclosed relationships with Incyte, Novartis and Mallinckrodt; other authors disclosed relationships with industry as noted in the abstract. Dr. Essell and Dr. Nakamura have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.