Key clinical point: In patients with advanced pancreatic cancer, pancreatic enzyme replacement therapy (PERT) for exocrine pancreatic insufficiency (EPI) does not affect survival.

Major finding: There was no significant difference in the overall survival in patients who received PERT vs. those who did not (weighted estimate, 9.5 months vs. 8.1 months; P = .464). No PERT-related adverse events were reported.

Study details: A meta-analysis of 4 randomized controlled trials including 194 patients with pancreatic cancer. The patients with EPI received PERT.

Disclosures: No specific sponsor was identified. One reviewer received personal fees from Abbott Pharmaceuticals and Mylan.

Citation: Ammar K. Expert Rev Gastroenterol Hepatol. 2021 Feb 15. doi: 10.1080/17474124.2021.1884544.

Key clinical point: In patients with advanced pancreatic cancer, pancreatic enzyme replacement therapy (PERT) for exocrine pancreatic insufficiency (EPI) does not affect survival.

Major finding: There was no significant difference in the overall survival in patients who received PERT vs. those who did not (weighted estimate, 9.5 months vs. 8.1 months; P = .464). No PERT-related adverse events were reported.

Study details: A meta-analysis of 4 randomized controlled trials including 194 patients with pancreatic cancer. The patients with EPI received PERT.

Disclosures: No specific sponsor was identified. One reviewer received personal fees from Abbott Pharmaceuticals and Mylan.

Citation: Ammar K. Expert Rev Gastroenterol Hepatol. 2021 Feb 15. doi: 10.1080/17474124.2021.1884544.

Key clinical point: In patients with advanced pancreatic cancer, pancreatic enzyme replacement therapy (PERT) for exocrine pancreatic insufficiency (EPI) does not affect survival.

Major finding: There was no significant difference in the overall survival in patients who received PERT vs. those who did not (weighted estimate, 9.5 months vs. 8.1 months; P = .464). No PERT-related adverse events were reported.

Study details: A meta-analysis of 4 randomized controlled trials including 194 patients with pancreatic cancer. The patients with EPI received PERT.

Disclosures: No specific sponsor was identified. One reviewer received personal fees from Abbott Pharmaceuticals and Mylan.

Citation: Ammar K. Expert Rev Gastroenterol Hepatol. 2021 Feb 15. doi: 10.1080/17474124.2021.1884544.

Key clinical point: Presence of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis is associated with lower levels of phytosterol and cholesterol. Pancreatic enzyme supplement improves cholesterol levels in these patients.

Major finding: Total fat and cholesterol intake were higher in patients with cystic fibrosis. Total cholesterol, low-density lipoprotein cholesterol, campesterol, and β-sitosterol levels were significantly lower in cystic fibrosis patients with EPI vs. those without (all P less than .05). The rate of hypocholesterolemia was lower in patients with EPI receiving a supplementation dose of greater than 2500 U of lipase/g of fat (P = .0026).

Study details: The study included 55 patients with cystic fibrosis and 45 healthy adults. Forty-eight patients with cystic fibrosis had EPI (fecal elastase-1 concentrations less than 100 µg/g) and received pancreatic enzymes.

Disclosures: The study was supported by the Polish National Science Centre. The authors declared no conflicts of interest.

Citation: Drzymała-Czyż S et al. Biomolecules. 2021 Feb 19. doi: 10.3390/biom11020313.

Key clinical point: Presence of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis is associated with lower levels of phytosterol and cholesterol. Pancreatic enzyme supplement improves cholesterol levels in these patients.

Major finding: Total fat and cholesterol intake were higher in patients with cystic fibrosis. Total cholesterol, low-density lipoprotein cholesterol, campesterol, and β-sitosterol levels were significantly lower in cystic fibrosis patients with EPI vs. those without (all P less than .05). The rate of hypocholesterolemia was lower in patients with EPI receiving a supplementation dose of greater than 2500 U of lipase/g of fat (P = .0026).

Study details: The study included 55 patients with cystic fibrosis and 45 healthy adults. Forty-eight patients with cystic fibrosis had EPI (fecal elastase-1 concentrations less than 100 µg/g) and received pancreatic enzymes.

Disclosures: The study was supported by the Polish National Science Centre. The authors declared no conflicts of interest.

Citation: Drzymała-Czyż S et al. Biomolecules. 2021 Feb 19. doi: 10.3390/biom11020313.

Key clinical point: Presence of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis is associated with lower levels of phytosterol and cholesterol. Pancreatic enzyme supplement improves cholesterol levels in these patients.

Major finding: Total fat and cholesterol intake were higher in patients with cystic fibrosis. Total cholesterol, low-density lipoprotein cholesterol, campesterol, and β-sitosterol levels were significantly lower in cystic fibrosis patients with EPI vs. those without (all P less than .05). The rate of hypocholesterolemia was lower in patients with EPI receiving a supplementation dose of greater than 2500 U of lipase/g of fat (P = .0026).

Study details: The study included 55 patients with cystic fibrosis and 45 healthy adults. Forty-eight patients with cystic fibrosis had EPI (fecal elastase-1 concentrations less than 100 µg/g) and received pancreatic enzymes.

Disclosures: The study was supported by the Polish National Science Centre. The authors declared no conflicts of interest.

Citation: Drzymała-Czyż S et al. Biomolecules. 2021 Feb 19. doi: 10.3390/biom11020313.

Key clinical point: Impaired exocrine pancreatic function is reported in a subgroup of patients undergoing esophagectomy, and pancreatic enzyme replacement therapy can improve symptoms and body weight in these patients.

Major finding: Fecal elastase-1 levels of less than 200 µg/g were reported in 16%-18% of patients at 4-6 months following esophagectomy. Pancreatic enzyme replacement therapy (25,000-50,000 units lipase per meal) improved gastrointestinal symptoms, body weight, and normalized stool in patients with steatorrhea.

Study details: Systematic review of 3 prospective cohort studies reporting exocrine pancreatic insufficiency (EPI) in 107 patients undergoing esophagectomy.

Disclosures: No sponsor was identified for this review.

Citation: Blonk L et al. Dis Esophagus. 2021 Feb 9. doi: 10.1093/dote/doab003.

Key clinical point: Impaired exocrine pancreatic function is reported in a subgroup of patients undergoing esophagectomy, and pancreatic enzyme replacement therapy can improve symptoms and body weight in these patients.

Major finding: Fecal elastase-1 levels of less than 200 µg/g were reported in 16%-18% of patients at 4-6 months following esophagectomy. Pancreatic enzyme replacement therapy (25,000-50,000 units lipase per meal) improved gastrointestinal symptoms, body weight, and normalized stool in patients with steatorrhea.

Study details: Systematic review of 3 prospective cohort studies reporting exocrine pancreatic insufficiency (EPI) in 107 patients undergoing esophagectomy.

Disclosures: No sponsor was identified for this review.

Citation: Blonk L et al. Dis Esophagus. 2021 Feb 9. doi: 10.1093/dote/doab003.

Key clinical point: Impaired exocrine pancreatic function is reported in a subgroup of patients undergoing esophagectomy, and pancreatic enzyme replacement therapy can improve symptoms and body weight in these patients.

Major finding: Fecal elastase-1 levels of less than 200 µg/g were reported in 16%-18% of patients at 4-6 months following esophagectomy. Pancreatic enzyme replacement therapy (25,000-50,000 units lipase per meal) improved gastrointestinal symptoms, body weight, and normalized stool in patients with steatorrhea.

Study details: Systematic review of 3 prospective cohort studies reporting exocrine pancreatic insufficiency (EPI) in 107 patients undergoing esophagectomy.

Disclosures: No sponsor was identified for this review.

Citation: Blonk L et al. Dis Esophagus. 2021 Feb 9. doi: 10.1093/dote/doab003.

Key clinical point: Asymptomatic patients with pancreatic trauma may have exocrine insufficiency when evaluated with specific investigations.

Major finding: Patients who underwent pancreatic resection had a lower fecal elastase value vs. those who did not, but the difference was not statistically significant (113 vs. 162.5 μg/g; P = .7). One patient in the resection group reported steatorrhea. Three patients in the pancreatic resection and 1 in the nonresection group had severe pancreatic exocrine insufficiency (P = .7). No patient required pancreatic enzyme supplements.

Study details: A study of 20 patients (mean age, 25 years) with pancreatic trauma between June 2016 and December 2017. Partial pancreatic resection was performed in 12 patients. Exocrine functions were evaluated with the fecal elastase test at 6 months.

Disclosures: No study sponsor was identified.

Citation: Colney L et al. Eur J Trauma Emerg Surg. 2021 Mar 14. doi: 10.1007/s00068-021-01638-8.

Key clinical point: Asymptomatic patients with pancreatic trauma may have exocrine insufficiency when evaluated with specific investigations.

Major finding: Patients who underwent pancreatic resection had a lower fecal elastase value vs. those who did not, but the difference was not statistically significant (113 vs. 162.5 μg/g; P = .7). One patient in the resection group reported steatorrhea. Three patients in the pancreatic resection and 1 in the nonresection group had severe pancreatic exocrine insufficiency (P = .7). No patient required pancreatic enzyme supplements.

Study details: A study of 20 patients (mean age, 25 years) with pancreatic trauma between June 2016 and December 2017. Partial pancreatic resection was performed in 12 patients. Exocrine functions were evaluated with the fecal elastase test at 6 months.

Disclosures: No study sponsor was identified.

Citation: Colney L et al. Eur J Trauma Emerg Surg. 2021 Mar 14. doi: 10.1007/s00068-021-01638-8.

Key clinical point: Asymptomatic patients with pancreatic trauma may have exocrine insufficiency when evaluated with specific investigations.

Major finding: Patients who underwent pancreatic resection had a lower fecal elastase value vs. those who did not, but the difference was not statistically significant (113 vs. 162.5 μg/g; P = .7). One patient in the resection group reported steatorrhea. Three patients in the pancreatic resection and 1 in the nonresection group had severe pancreatic exocrine insufficiency (P = .7). No patient required pancreatic enzyme supplements.

Study details: A study of 20 patients (mean age, 25 years) with pancreatic trauma between June 2016 and December 2017. Partial pancreatic resection was performed in 12 patients. Exocrine functions were evaluated with the fecal elastase test at 6 months.

Disclosures: No study sponsor was identified.

Citation: Colney L et al. Eur J Trauma Emerg Surg. 2021 Mar 14. doi: 10.1007/s00068-021-01638-8.

Key clinical point: Patients who experience malabsorption with sorafenib treatment may develop exocrine pancreatic insufficiency (EPI); supplementation with pancreatic enzymes may benefit these patients.

Major finding: Two patients had moderate and 6 patients had severe pancreatic insufficiency. Six patients who developed EPI received pancreatic enzymes and recovered from the malabsorption symptoms within 1 month. The fecal elastase values recovered in 5 of 6 patients who received pancreatic enzymes.

Study details: A prospective study of 21 patients with hepatocellular carcinoma treated with sorafenib who developed malabsorption.

Disclosures: No study sponsor was identified. The authors received speaker fees and grants outside the study work.

Citation: Díaz-González A et al. J Clin Gastroenterol. 2021 Mar 1. doi: 10.1097/MCG.0000000000001366.

Key clinical point: Patients who experience malabsorption with sorafenib treatment may develop exocrine pancreatic insufficiency (EPI); supplementation with pancreatic enzymes may benefit these patients.

Major finding: Two patients had moderate and 6 patients had severe pancreatic insufficiency. Six patients who developed EPI received pancreatic enzymes and recovered from the malabsorption symptoms within 1 month. The fecal elastase values recovered in 5 of 6 patients who received pancreatic enzymes.

Study details: A prospective study of 21 patients with hepatocellular carcinoma treated with sorafenib who developed malabsorption.

Disclosures: No study sponsor was identified. The authors received speaker fees and grants outside the study work.

Citation: Díaz-González A et al. J Clin Gastroenterol. 2021 Mar 1. doi: 10.1097/MCG.0000000000001366.

Key clinical point: Patients who experience malabsorption with sorafenib treatment may develop exocrine pancreatic insufficiency (EPI); supplementation with pancreatic enzymes may benefit these patients.

Major finding: Two patients had moderate and 6 patients had severe pancreatic insufficiency. Six patients who developed EPI received pancreatic enzymes and recovered from the malabsorption symptoms within 1 month. The fecal elastase values recovered in 5 of 6 patients who received pancreatic enzymes.

Study details: A prospective study of 21 patients with hepatocellular carcinoma treated with sorafenib who developed malabsorption.

Disclosures: No study sponsor was identified. The authors received speaker fees and grants outside the study work.

Citation: Díaz-González A et al. J Clin Gastroenterol. 2021 Mar 1. doi: 10.1097/MCG.0000000000001366.

Key clinical point: Exocrine pancreatic insufficiency is a feature of type 1 diabetes (T1D). Lower levels of fecal elastase-1 and amylase are reported in patients with T1D vs. healthy individuals.

Major finding: Compared with healthy individuals, fecal elastase-1 levels were significantly lower in participants with new-onset and long-standing T1D (P = .0070 and .0010, respectively). Pancreatic amylase levels were significantly lower in patients with long-standing T1D vs. healthy individuals (P = .0001). The markers of impaired exocrine function tests (fecal elastase-1, serum pancreatic amylase, and lipase) correlated with the reduction of fasting and urinary C-peptide (all P less than .001).

Study details: A single-center, cross-sectional study of pancreatic exocrine function in adult patients with new-onset T1D (n = 12) or long-standing T1D (n = 19) and healthy individuals (n = 25).

Disclosures: This study was supported by a grant received by Battaglia M from the Italian Diabetes Society (SID) Research Foundation SID.

Citation: Dozio N et al. BMJ Open Diab Res Care. 2021 Feb. doi: 10.1136/bmjdrc-2019-001158.

Key clinical point: Exocrine pancreatic insufficiency is a feature of type 1 diabetes (T1D). Lower levels of fecal elastase-1 and amylase are reported in patients with T1D vs. healthy individuals.

Major finding: Compared with healthy individuals, fecal elastase-1 levels were significantly lower in participants with new-onset and long-standing T1D (P = .0070 and .0010, respectively). Pancreatic amylase levels were significantly lower in patients with long-standing T1D vs. healthy individuals (P = .0001). The markers of impaired exocrine function tests (fecal elastase-1, serum pancreatic amylase, and lipase) correlated with the reduction of fasting and urinary C-peptide (all P less than .001).

Study details: A single-center, cross-sectional study of pancreatic exocrine function in adult patients with new-onset T1D (n = 12) or long-standing T1D (n = 19) and healthy individuals (n = 25).

Disclosures: This study was supported by a grant received by Battaglia M from the Italian Diabetes Society (SID) Research Foundation SID.

Citation: Dozio N et al. BMJ Open Diab Res Care. 2021 Feb. doi: 10.1136/bmjdrc-2019-001158.

Key clinical point: Exocrine pancreatic insufficiency is a feature of type 1 diabetes (T1D). Lower levels of fecal elastase-1 and amylase are reported in patients with T1D vs. healthy individuals.

Major finding: Compared with healthy individuals, fecal elastase-1 levels were significantly lower in participants with new-onset and long-standing T1D (P = .0070 and .0010, respectively). Pancreatic amylase levels were significantly lower in patients with long-standing T1D vs. healthy individuals (P = .0001). The markers of impaired exocrine function tests (fecal elastase-1, serum pancreatic amylase, and lipase) correlated with the reduction of fasting and urinary C-peptide (all P less than .001).

Study details: A single-center, cross-sectional study of pancreatic exocrine function in adult patients with new-onset T1D (n = 12) or long-standing T1D (n = 19) and healthy individuals (n = 25).

Disclosures: This study was supported by a grant received by Battaglia M from the Italian Diabetes Society (SID) Research Foundation SID.

Citation: Dozio N et al. BMJ Open Diab Res Care. 2021 Feb. doi: 10.1136/bmjdrc-2019-001158.

Key clinical point: Exocrine pancreatic insufficiency (EPI) is common in patients with gastroenteropancreatic neuroendocrine neoplasia (NEN) receiving somatostatin analogs. Pancreatic enzyme replacement therapy (PERT) is justified in patients experiencing EPI symptoms.

Major findings: Studies have reported an EPI prevalence of 20% to 38% in patients with NEN receiving somatostatin analogs. Its symptoms overlap with clinical features of tumor and common side effects of somatostatin analogs. EPI can be diagnosed with noninvasive fecal elastase-1 test and is easy to treat using PERT. However, there is a general lack of awareness about EPI and PERT. A multidisciplinary team of gastroenterologists and nutritionists can increase the odds of providing the best care.

Study details: An editorial on EPI in patients with NEN receiving somatostatin analogs.

Disclosures: No specific funding was identified for this editorial. Panzuto F received speaker honoraria from Mylan Italia.

Source: Panzuto F et al. Expert Opin Drug Saf. 2021 Feb 2. doi: 10.1080/14740338.2021.1881478.

Key clinical point: Exocrine pancreatic insufficiency (EPI) is common in patients with gastroenteropancreatic neuroendocrine neoplasia (NEN) receiving somatostatin analogs. Pancreatic enzyme replacement therapy (PERT) is justified in patients experiencing EPI symptoms.

Major findings: Studies have reported an EPI prevalence of 20% to 38% in patients with NEN receiving somatostatin analogs. Its symptoms overlap with clinical features of tumor and common side effects of somatostatin analogs. EPI can be diagnosed with noninvasive fecal elastase-1 test and is easy to treat using PERT. However, there is a general lack of awareness about EPI and PERT. A multidisciplinary team of gastroenterologists and nutritionists can increase the odds of providing the best care.

Study details: An editorial on EPI in patients with NEN receiving somatostatin analogs.

Disclosures: No specific funding was identified for this editorial. Panzuto F received speaker honoraria from Mylan Italia.

Source: Panzuto F et al. Expert Opin Drug Saf. 2021 Feb 2. doi: 10.1080/14740338.2021.1881478.

Key clinical point: Exocrine pancreatic insufficiency (EPI) is common in patients with gastroenteropancreatic neuroendocrine neoplasia (NEN) receiving somatostatin analogs. Pancreatic enzyme replacement therapy (PERT) is justified in patients experiencing EPI symptoms.

Major findings: Studies have reported an EPI prevalence of 20% to 38% in patients with NEN receiving somatostatin analogs. Its symptoms overlap with clinical features of tumor and common side effects of somatostatin analogs. EPI can be diagnosed with noninvasive fecal elastase-1 test and is easy to treat using PERT. However, there is a general lack of awareness about EPI and PERT. A multidisciplinary team of gastroenterologists and nutritionists can increase the odds of providing the best care.

Study details: An editorial on EPI in patients with NEN receiving somatostatin analogs.

Disclosures: No specific funding was identified for this editorial. Panzuto F received speaker honoraria from Mylan Italia.

Source: Panzuto F et al. Expert Opin Drug Saf. 2021 Feb 2. doi: 10.1080/14740338.2021.1881478.

Two-thirds of epidemiologists from leading academic institutions say the world will need new or modified vaccines for COVID-19 within a year, new research shows.

South_agency/Getty Images

In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted that the world has a year or less before variants make current vaccines ineffective. The People’s Vaccine Alliance is a coalition of more than 50 organizations, including the African Alliance, Oxfam, Public Citizen, and UNAIDS (the Joint United Nations Programme on HIV/AIDS).

Almost a third (32.5%) of those surveyed said ineffectiveness would happen in 9 months or less; 18.2% said 6 months or less.

Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview that, while it’s hard to say whether vaccines could become ineffective in that time frame, “It’s perfectly reasonable to think it could happen.”

The good news, said Dr. Offit, who was not involved with the survey, is that SARS-CoV-2 mutates slowly, compared with other viruses such as influenza.

“To date,” he said, “the mutations that have occurred are not far enough away from the immunity induced by your natural infection or immunization such that one isn’t protected at least against severe and critical disease.”

That’s the goal of vaccines, he noted: “to keep people from suffering mightily.”
 

A line may be crossed

“And so far that’s happening, even with the variants,” Dr. Offit said. “That line has not been crossed. But I think we should assume that it might be.”

Dr. Offit said it will be critical to monitor anyone who gets hospitalized who is known to have been infected or fully vaccinated. Then countries need to get really good at sequencing those viruses.

The great majority of those surveyed (88%) said that persistently low vaccine coverage in many countries would make it more likely that vaccine-resistant mutations will appear.

Coverage comparisons between countries are stark.
 

Many countries haven’t given a single vaccine dose

While rich countries are giving COVID-19 vaccinations at the rate of a person a second, many of the poorest countries have given hardly any vaccines, the People’s Vaccine Alliance says.

Additionally, according to researchers at the Global Health Innovation Center at Duke University, Durham, N.C., high- and upper-middle–income countries, which represent one-fifth of the world’s population, have bought about 6 billion doses. But low- and lower-middle–income countries, which make up four-fifths of the population, have bought only about 2.6 billion, an article in Nature reports.

“You’re only as strong as your weakest country,” Dr. Offit said. “If we haven’t learned that what happens in other countries can [affect the global population], we haven’t been paying attention.”

Gregg Gonsalves, PhD, associate professor of epidemiology at Yale University, New Haven, Conn., one of the academic centers surveyed, didn’t specify a timeline for when vaccines would become ineffective, but said in a press release that the urgency for widespread global vaccination is real.

“Unless we vaccinate the world,” he said, “we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them.”
 

“Dire, but not surprising”

Panagis Galiatsatos, MD, MHS, a pulmonologist at John Hopkins University, Baltimore, whose research focuses on health care disparities, said the survey findings were “dire, but not surprising.”

Johns Hopkins was another of the centers surveyed, but Dr. Galiatsatos wasn’t personally involved with the survey.

COVID-19, Dr. Galiatsatos pointed out, has laid bare disparities, both in who gets the vaccine and who’s involved in trials to develop the vaccines.

“It’s morally concerning and an ethical reckoning,” he said in an interview.

Recognition of the borderless swath of destruction the virus is exacting is critical, he said.

The United States “has to realize this can’t be a U.S.-centric issue,” he said. “We’re going to be back to the beginning if we don’t make sure that every country is doing well. We haven’t seen that level of uniform approach.”

He noted that scientists have always known that viruses mutate, but now the race is on to find the parts of SARS-CoV-2 that don’t mutate as much.

“My suspicion is we’ll probably need boosters instead of a whole different vaccine,” Dr. Galiatsatos said.

Among the strategies sought by the People’s Vaccine Alliance is for all pharmaceutical companies working on COVID-19 vaccines to openly share technology and intellectual property through the World Health Organization COVID-19 Technology Access Pool, to speed production and rollout of vaccines to all countries.

In the survey, 74% said that open sharing of technology and intellectual property could boost global vaccine coverage; 23% said maybe and 3% said it wouldn’t help.

The survey was carried out between Feb. 17 and March 25, 2021. Respondents included epidemiologists, virologists, and infection disease specialists from the following countries: Algeria, Argentina, Australia, Belgium, Bolivia, Canada, Denmark, Ethiopia, France, Guatemala, India, Italy, Kenya, Lebanon, Norway, Philippines, Senegal, Somalia, South Africa, South Sudan, Spain, United Arab Emirates, Uganda, United Kingdom, United States, Vietnam, Zambia, and Zimbabwe.

Dr. Offit and Dr. Galiatsatos reported no relevant financial relationships.

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

Two-thirds of epidemiologists from leading academic institutions say the world will need new or modified vaccines for COVID-19 within a year, new research shows.

South_agency/Getty Images

In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted that the world has a year or less before variants make current vaccines ineffective. The People’s Vaccine Alliance is a coalition of more than 50 organizations, including the African Alliance, Oxfam, Public Citizen, and UNAIDS (the Joint United Nations Programme on HIV/AIDS).

Almost a third (32.5%) of those surveyed said ineffectiveness would happen in 9 months or less; 18.2% said 6 months or less.

Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview that, while it’s hard to say whether vaccines could become ineffective in that time frame, “It’s perfectly reasonable to think it could happen.”

The good news, said Dr. Offit, who was not involved with the survey, is that SARS-CoV-2 mutates slowly, compared with other viruses such as influenza.

“To date,” he said, “the mutations that have occurred are not far enough away from the immunity induced by your natural infection or immunization such that one isn’t protected at least against severe and critical disease.”

That’s the goal of vaccines, he noted: “to keep people from suffering mightily.”
 

A line may be crossed

“And so far that’s happening, even with the variants,” Dr. Offit said. “That line has not been crossed. But I think we should assume that it might be.”

Dr. Offit said it will be critical to monitor anyone who gets hospitalized who is known to have been infected or fully vaccinated. Then countries need to get really good at sequencing those viruses.

The great majority of those surveyed (88%) said that persistently low vaccine coverage in many countries would make it more likely that vaccine-resistant mutations will appear.

Coverage comparisons between countries are stark.
 

Many countries haven’t given a single vaccine dose

While rich countries are giving COVID-19 vaccinations at the rate of a person a second, many of the poorest countries have given hardly any vaccines, the People’s Vaccine Alliance says.

Additionally, according to researchers at the Global Health Innovation Center at Duke University, Durham, N.C., high- and upper-middle–income countries, which represent one-fifth of the world’s population, have bought about 6 billion doses. But low- and lower-middle–income countries, which make up four-fifths of the population, have bought only about 2.6 billion, an article in Nature reports.

“You’re only as strong as your weakest country,” Dr. Offit said. “If we haven’t learned that what happens in other countries can [affect the global population], we haven’t been paying attention.”

Gregg Gonsalves, PhD, associate professor of epidemiology at Yale University, New Haven, Conn., one of the academic centers surveyed, didn’t specify a timeline for when vaccines would become ineffective, but said in a press release that the urgency for widespread global vaccination is real.

“Unless we vaccinate the world,” he said, “we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them.”
 

“Dire, but not surprising”

Panagis Galiatsatos, MD, MHS, a pulmonologist at John Hopkins University, Baltimore, whose research focuses on health care disparities, said the survey findings were “dire, but not surprising.”

Johns Hopkins was another of the centers surveyed, but Dr. Galiatsatos wasn’t personally involved with the survey.

COVID-19, Dr. Galiatsatos pointed out, has laid bare disparities, both in who gets the vaccine and who’s involved in trials to develop the vaccines.

“It’s morally concerning and an ethical reckoning,” he said in an interview.

Recognition of the borderless swath of destruction the virus is exacting is critical, he said.

The United States “has to realize this can’t be a U.S.-centric issue,” he said. “We’re going to be back to the beginning if we don’t make sure that every country is doing well. We haven’t seen that level of uniform approach.”

He noted that scientists have always known that viruses mutate, but now the race is on to find the parts of SARS-CoV-2 that don’t mutate as much.

“My suspicion is we’ll probably need boosters instead of a whole different vaccine,” Dr. Galiatsatos said.

Among the strategies sought by the People’s Vaccine Alliance is for all pharmaceutical companies working on COVID-19 vaccines to openly share technology and intellectual property through the World Health Organization COVID-19 Technology Access Pool, to speed production and rollout of vaccines to all countries.

In the survey, 74% said that open sharing of technology and intellectual property could boost global vaccine coverage; 23% said maybe and 3% said it wouldn’t help.

The survey was carried out between Feb. 17 and March 25, 2021. Respondents included epidemiologists, virologists, and infection disease specialists from the following countries: Algeria, Argentina, Australia, Belgium, Bolivia, Canada, Denmark, Ethiopia, France, Guatemala, India, Italy, Kenya, Lebanon, Norway, Philippines, Senegal, Somalia, South Africa, South Sudan, Spain, United Arab Emirates, Uganda, United Kingdom, United States, Vietnam, Zambia, and Zimbabwe.

Dr. Offit and Dr. Galiatsatos reported no relevant financial relationships.

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

Two-thirds of epidemiologists from leading academic institutions say the world will need new or modified vaccines for COVID-19 within a year, new research shows.

South_agency/Getty Images

In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted that the world has a year or less before variants make current vaccines ineffective. The People’s Vaccine Alliance is a coalition of more than 50 organizations, including the African Alliance, Oxfam, Public Citizen, and UNAIDS (the Joint United Nations Programme on HIV/AIDS).

Almost a third (32.5%) of those surveyed said ineffectiveness would happen in 9 months or less; 18.2% said 6 months or less.

Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview that, while it’s hard to say whether vaccines could become ineffective in that time frame, “It’s perfectly reasonable to think it could happen.”

The good news, said Dr. Offit, who was not involved with the survey, is that SARS-CoV-2 mutates slowly, compared with other viruses such as influenza.

“To date,” he said, “the mutations that have occurred are not far enough away from the immunity induced by your natural infection or immunization such that one isn’t protected at least against severe and critical disease.”

That’s the goal of vaccines, he noted: “to keep people from suffering mightily.”
 

A line may be crossed

“And so far that’s happening, even with the variants,” Dr. Offit said. “That line has not been crossed. But I think we should assume that it might be.”

Dr. Offit said it will be critical to monitor anyone who gets hospitalized who is known to have been infected or fully vaccinated. Then countries need to get really good at sequencing those viruses.

The great majority of those surveyed (88%) said that persistently low vaccine coverage in many countries would make it more likely that vaccine-resistant mutations will appear.

Coverage comparisons between countries are stark.
 

Many countries haven’t given a single vaccine dose

While rich countries are giving COVID-19 vaccinations at the rate of a person a second, many of the poorest countries have given hardly any vaccines, the People’s Vaccine Alliance says.

Additionally, according to researchers at the Global Health Innovation Center at Duke University, Durham, N.C., high- and upper-middle–income countries, which represent one-fifth of the world’s population, have bought about 6 billion doses. But low- and lower-middle–income countries, which make up four-fifths of the population, have bought only about 2.6 billion, an article in Nature reports.

“You’re only as strong as your weakest country,” Dr. Offit said. “If we haven’t learned that what happens in other countries can [affect the global population], we haven’t been paying attention.”

Gregg Gonsalves, PhD, associate professor of epidemiology at Yale University, New Haven, Conn., one of the academic centers surveyed, didn’t specify a timeline for when vaccines would become ineffective, but said in a press release that the urgency for widespread global vaccination is real.

“Unless we vaccinate the world,” he said, “we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them.”
 

“Dire, but not surprising”

Panagis Galiatsatos, MD, MHS, a pulmonologist at John Hopkins University, Baltimore, whose research focuses on health care disparities, said the survey findings were “dire, but not surprising.”

Johns Hopkins was another of the centers surveyed, but Dr. Galiatsatos wasn’t personally involved with the survey.

COVID-19, Dr. Galiatsatos pointed out, has laid bare disparities, both in who gets the vaccine and who’s involved in trials to develop the vaccines.

“It’s morally concerning and an ethical reckoning,” he said in an interview.

Recognition of the borderless swath of destruction the virus is exacting is critical, he said.

The United States “has to realize this can’t be a U.S.-centric issue,” he said. “We’re going to be back to the beginning if we don’t make sure that every country is doing well. We haven’t seen that level of uniform approach.”

He noted that scientists have always known that viruses mutate, but now the race is on to find the parts of SARS-CoV-2 that don’t mutate as much.

“My suspicion is we’ll probably need boosters instead of a whole different vaccine,” Dr. Galiatsatos said.

Among the strategies sought by the People’s Vaccine Alliance is for all pharmaceutical companies working on COVID-19 vaccines to openly share technology and intellectual property through the World Health Organization COVID-19 Technology Access Pool, to speed production and rollout of vaccines to all countries.

In the survey, 74% said that open sharing of technology and intellectual property could boost global vaccine coverage; 23% said maybe and 3% said it wouldn’t help.

The survey was carried out between Feb. 17 and March 25, 2021. Respondents included epidemiologists, virologists, and infection disease specialists from the following countries: Algeria, Argentina, Australia, Belgium, Bolivia, Canada, Denmark, Ethiopia, France, Guatemala, India, Italy, Kenya, Lebanon, Norway, Philippines, Senegal, Somalia, South Africa, South Sudan, Spain, United Arab Emirates, Uganda, United Kingdom, United States, Vietnam, Zambia, and Zimbabwe.

Dr. Offit and Dr. Galiatsatos reported no relevant financial relationships.

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

Key clinical point: Pancrelipase improves stool consistency and frequency and coefficient of fat absorption (CFA) in patients with chronic pancreatitis with moderate to severe exocrine pancreatic insufficiency (EPI).

Major finding: Higher number of patients reported decreased stool frequency at week 1 with pancrelipase vs. placebo (72% vs. 38%; P less than .001). Mean change in CFA from baseline was significantly greater with pancrelipase vs. placebo (24.7% vs. 6.4%; P less than .001). Improvements in stool consistency (P = .03) and frequency (P less than .001) correlated with CFA improvement. Symptom improvements persisted over 52 weeks of treatment.

Study details: A pooled study of 2 randomized double-blind trials including patients with chronic pancreatitis and EPI, who received either pancrelipase (n = 59) or placebo (n = 57). Thirty-four patients received open-label pancrelipase treatment for 51 weeks in another trial.

Disclosures: The editorial support for this study was funded by AbbVie. The authors reported no conflicts of interest.

Source: Barkin JA et al. Pancreas. 2021 Feb 1. doi: 10.1097/MPA.0000000000001733.

Key clinical point: Pancrelipase improves stool consistency and frequency and coefficient of fat absorption (CFA) in patients with chronic pancreatitis with moderate to severe exocrine pancreatic insufficiency (EPI).

Major finding: Higher number of patients reported decreased stool frequency at week 1 with pancrelipase vs. placebo (72% vs. 38%; P less than .001). Mean change in CFA from baseline was significantly greater with pancrelipase vs. placebo (24.7% vs. 6.4%; P less than .001). Improvements in stool consistency (P = .03) and frequency (P less than .001) correlated with CFA improvement. Symptom improvements persisted over 52 weeks of treatment.

Study details: A pooled study of 2 randomized double-blind trials including patients with chronic pancreatitis and EPI, who received either pancrelipase (n = 59) or placebo (n = 57). Thirty-four patients received open-label pancrelipase treatment for 51 weeks in another trial.

Disclosures: The editorial support for this study was funded by AbbVie. The authors reported no conflicts of interest.

Source: Barkin JA et al. Pancreas. 2021 Feb 1. doi: 10.1097/MPA.0000000000001733.

Key clinical point: Pancrelipase improves stool consistency and frequency and coefficient of fat absorption (CFA) in patients with chronic pancreatitis with moderate to severe exocrine pancreatic insufficiency (EPI).

Major finding: Higher number of patients reported decreased stool frequency at week 1 with pancrelipase vs. placebo (72% vs. 38%; P less than .001). Mean change in CFA from baseline was significantly greater with pancrelipase vs. placebo (24.7% vs. 6.4%; P less than .001). Improvements in stool consistency (P = .03) and frequency (P less than .001) correlated with CFA improvement. Symptom improvements persisted over 52 weeks of treatment.

Study details: A pooled study of 2 randomized double-blind trials including patients with chronic pancreatitis and EPI, who received either pancrelipase (n = 59) or placebo (n = 57). Thirty-four patients received open-label pancrelipase treatment for 51 weeks in another trial.

Disclosures: The editorial support for this study was funded by AbbVie. The authors reported no conflicts of interest.

Source: Barkin JA et al. Pancreas. 2021 Feb 1. doi: 10.1097/MPA.0000000000001733.

Lowering the starting dose of lenvatinib for recurrent, advanced endometrial cancer reduces adverse events without compromising efficacy, according to a retrospective study.

The study included 70 patients who received lenvatinib in combination with pembrolizumab. Patients who were started on 14 mg of lenvatinib per day had fewer dose reductions and a longer time to the first dose reduction, compared with patients who were started on the recommended 20-mg dose. There were no significant differences in response, progression-free survival, or overall survival between the two dose groups.

“Published studies and these results may support using lenvatinib at a starting dose of 14 mg daily in clinical practice,” said Jeffrey How, MD, a gynecologic oncology fellow at MD Anderson Cancer Center in Houston.

Dr. How presented the results at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 10775).

This is not the first time a recommended starting dose has been deemed too high to use in practice, according to Carol Aghajanian, MD, chief of gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in New York and a panelist for the session where Dr. How presented his research.

Dr. Aghajanian noted that pegylated liposomal doxorubicin and topotecan are “rarely, if ever” started at the labeling doses for recurrent ovarian cancer. Those doses proved to be too high for general practice and “not tolerable with multicycle treatment,” she said.

“We may again be experiencing the effect of single-cycle, dose-limiting toxicity information not guiding us well in how to treat patients over time,” she added.
 

Study rationale

Based on a 38% overall response rate in the phase 2 KEYNOTE-146 trial, lenvatinib plus pembrolizumab was approved in September 2019 to treat patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair deficient who have progressed on systemic therapy and are not candidates for curative surgery or radiation.

However, the rate of grade 3/4 adverse events with the combination was 66.9% in the trial, leading to dose interruptions or reductions and a discontinuation rate of 17.7%.

MD Anderson oncologists noticed similar toxicity rates at the approved lenvatinib dose of 20 mg per day when they started using the combination in October 2019. It raised a question about the feasibility of implementing the regimen in general practice as well as concerns about compliance, Dr. How said.

“As a consequence, our team started patients on a reduced dose of lenvatinib to improve safety and tolerability,” he added.

The mean dose intensity in the phase 2 trial was 14.4 mg/day, so the team began to start patients on 14 mg daily.
 

Results and implications

Of the 70 patients studied, 16 were started at 20 mg, and 54 were started at 14 mg. There were no significant differences between the two groups at baseline.

In the entire cohort, the median age was 65.5 years, and patients had received a median of two prior lines of therapy (range, one to nine). Most patients (90%) had a performance status of 0 or 1, 92.9% had microsatellite stable tumors, and 27.1% each had endometrioid or serous histology.

There was no significant difference between the dose groups with regard to any hospitalization (P = .46), hospitalization due to treatment-related adverse events (P = .55), dose interruption (P = .18), or treatment discontinuation due to treatment-related adverse events (P = .54).

However, the average number of dose reductions per patient was higher in the 20-mg group than in the 14-mg group – 1.1 and 0.4, respectively (P = .003).

The increased dose reductions with the higher starting dose were due mostly to gastrointestinal and hematologic adverse events as well as fatigue and anorexia, all of which were far more common in patients started at 20 mg.

Patients in the 14-mg group had a longer time to the first dose reduction or discontinuation due to toxicity – 107 days vs. 42 days in the 20-mg group (P = .001).

There was no significant difference in response rates between the 14-mg and 20-mg groups – 38.2% and 28.6%, respectively (P = .51) – and no significant difference in clinical benefit rates – 72.3% and 57.1%, respectively.

The median progression-free survival was 3.2 months in the 20-mg group and 5.5 months in the 14-mg group (P = .25). The median overall survival was 8.6 months and 10.3 months, respectively (P = .95).

Dr. How noted that this study was limited by its retrospective nature, and the small number of women started at 20 mg may have limited the ability to detect differences with a lower starting dose. Still, these results seem to support a starting dose of 14 mg, he concluded.

In a discussion after Dr. How’s presentation, panelist Judith Smith, PharmD, of UT Health in Houston, noted that her practice is starting women on lenvatinib at 12 mg per day.

“You can use the 14-mg convenience pack, but, from a cost perspective ... we have to be cognizant of the financial toxicity,” she said. “[Combining the] 10-mg and 4-mg tablets is going to be more expensive, so we’ve been using the 4-mg tablets [three per day] and starting at 12 mg.”

This study was funded by MD Anderson and the National Institutes of Health. Dr. How reported having no conflicts of interest. Dr. Aghajanian and Dr. Smith did not provide disclosures.

aotto@mdedge.com

Lowering the starting dose of lenvatinib for recurrent, advanced endometrial cancer reduces adverse events without compromising efficacy, according to a retrospective study.

The study included 70 patients who received lenvatinib in combination with pembrolizumab. Patients who were started on 14 mg of lenvatinib per day had fewer dose reductions and a longer time to the first dose reduction, compared with patients who were started on the recommended 20-mg dose. There were no significant differences in response, progression-free survival, or overall survival between the two dose groups.

“Published studies and these results may support using lenvatinib at a starting dose of 14 mg daily in clinical practice,” said Jeffrey How, MD, a gynecologic oncology fellow at MD Anderson Cancer Center in Houston.

Dr. How presented the results at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 10775).

This is not the first time a recommended starting dose has been deemed too high to use in practice, according to Carol Aghajanian, MD, chief of gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in New York and a panelist for the session where Dr. How presented his research.

Dr. Aghajanian noted that pegylated liposomal doxorubicin and topotecan are “rarely, if ever” started at the labeling doses for recurrent ovarian cancer. Those doses proved to be too high for general practice and “not tolerable with multicycle treatment,” she said.

“We may again be experiencing the effect of single-cycle, dose-limiting toxicity information not guiding us well in how to treat patients over time,” she added.
 

Study rationale

Based on a 38% overall response rate in the phase 2 KEYNOTE-146 trial, lenvatinib plus pembrolizumab was approved in September 2019 to treat patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair deficient who have progressed on systemic therapy and are not candidates for curative surgery or radiation.

However, the rate of grade 3/4 adverse events with the combination was 66.9% in the trial, leading to dose interruptions or reductions and a discontinuation rate of 17.7%.

MD Anderson oncologists noticed similar toxicity rates at the approved lenvatinib dose of 20 mg per day when they started using the combination in October 2019. It raised a question about the feasibility of implementing the regimen in general practice as well as concerns about compliance, Dr. How said.

“As a consequence, our team started patients on a reduced dose of lenvatinib to improve safety and tolerability,” he added.

The mean dose intensity in the phase 2 trial was 14.4 mg/day, so the team began to start patients on 14 mg daily.
 

Results and implications

Of the 70 patients studied, 16 were started at 20 mg, and 54 were started at 14 mg. There were no significant differences between the two groups at baseline.

In the entire cohort, the median age was 65.5 years, and patients had received a median of two prior lines of therapy (range, one to nine). Most patients (90%) had a performance status of 0 or 1, 92.9% had microsatellite stable tumors, and 27.1% each had endometrioid or serous histology.

There was no significant difference between the dose groups with regard to any hospitalization (P = .46), hospitalization due to treatment-related adverse events (P = .55), dose interruption (P = .18), or treatment discontinuation due to treatment-related adverse events (P = .54).

However, the average number of dose reductions per patient was higher in the 20-mg group than in the 14-mg group – 1.1 and 0.4, respectively (P = .003).

The increased dose reductions with the higher starting dose were due mostly to gastrointestinal and hematologic adverse events as well as fatigue and anorexia, all of which were far more common in patients started at 20 mg.

Patients in the 14-mg group had a longer time to the first dose reduction or discontinuation due to toxicity – 107 days vs. 42 days in the 20-mg group (P = .001).

There was no significant difference in response rates between the 14-mg and 20-mg groups – 38.2% and 28.6%, respectively (P = .51) – and no significant difference in clinical benefit rates – 72.3% and 57.1%, respectively.

The median progression-free survival was 3.2 months in the 20-mg group and 5.5 months in the 14-mg group (P = .25). The median overall survival was 8.6 months and 10.3 months, respectively (P = .95).

Dr. How noted that this study was limited by its retrospective nature, and the small number of women started at 20 mg may have limited the ability to detect differences with a lower starting dose. Still, these results seem to support a starting dose of 14 mg, he concluded.

In a discussion after Dr. How’s presentation, panelist Judith Smith, PharmD, of UT Health in Houston, noted that her practice is starting women on lenvatinib at 12 mg per day.

“You can use the 14-mg convenience pack, but, from a cost perspective ... we have to be cognizant of the financial toxicity,” she said. “[Combining the] 10-mg and 4-mg tablets is going to be more expensive, so we’ve been using the 4-mg tablets [three per day] and starting at 12 mg.”

This study was funded by MD Anderson and the National Institutes of Health. Dr. How reported having no conflicts of interest. Dr. Aghajanian and Dr. Smith did not provide disclosures.

aotto@mdedge.com

Lowering the starting dose of lenvatinib for recurrent, advanced endometrial cancer reduces adverse events without compromising efficacy, according to a retrospective study.

The study included 70 patients who received lenvatinib in combination with pembrolizumab. Patients who were started on 14 mg of lenvatinib per day had fewer dose reductions and a longer time to the first dose reduction, compared with patients who were started on the recommended 20-mg dose. There were no significant differences in response, progression-free survival, or overall survival between the two dose groups.

“Published studies and these results may support using lenvatinib at a starting dose of 14 mg daily in clinical practice,” said Jeffrey How, MD, a gynecologic oncology fellow at MD Anderson Cancer Center in Houston.

Dr. How presented the results at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 10775).

This is not the first time a recommended starting dose has been deemed too high to use in practice, according to Carol Aghajanian, MD, chief of gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in New York and a panelist for the session where Dr. How presented his research.

Dr. Aghajanian noted that pegylated liposomal doxorubicin and topotecan are “rarely, if ever” started at the labeling doses for recurrent ovarian cancer. Those doses proved to be too high for general practice and “not tolerable with multicycle treatment,” she said.

“We may again be experiencing the effect of single-cycle, dose-limiting toxicity information not guiding us well in how to treat patients over time,” she added.
 

Study rationale

Based on a 38% overall response rate in the phase 2 KEYNOTE-146 trial, lenvatinib plus pembrolizumab was approved in September 2019 to treat patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair deficient who have progressed on systemic therapy and are not candidates for curative surgery or radiation.

However, the rate of grade 3/4 adverse events with the combination was 66.9% in the trial, leading to dose interruptions or reductions and a discontinuation rate of 17.7%.

MD Anderson oncologists noticed similar toxicity rates at the approved lenvatinib dose of 20 mg per day when they started using the combination in October 2019. It raised a question about the feasibility of implementing the regimen in general practice as well as concerns about compliance, Dr. How said.

“As a consequence, our team started patients on a reduced dose of lenvatinib to improve safety and tolerability,” he added.

The mean dose intensity in the phase 2 trial was 14.4 mg/day, so the team began to start patients on 14 mg daily.
 

Results and implications

Of the 70 patients studied, 16 were started at 20 mg, and 54 were started at 14 mg. There were no significant differences between the two groups at baseline.

In the entire cohort, the median age was 65.5 years, and patients had received a median of two prior lines of therapy (range, one to nine). Most patients (90%) had a performance status of 0 or 1, 92.9% had microsatellite stable tumors, and 27.1% each had endometrioid or serous histology.

There was no significant difference between the dose groups with regard to any hospitalization (P = .46), hospitalization due to treatment-related adverse events (P = .55), dose interruption (P = .18), or treatment discontinuation due to treatment-related adverse events (P = .54).

However, the average number of dose reductions per patient was higher in the 20-mg group than in the 14-mg group – 1.1 and 0.4, respectively (P = .003).

The increased dose reductions with the higher starting dose were due mostly to gastrointestinal and hematologic adverse events as well as fatigue and anorexia, all of which were far more common in patients started at 20 mg.

Patients in the 14-mg group had a longer time to the first dose reduction or discontinuation due to toxicity – 107 days vs. 42 days in the 20-mg group (P = .001).

There was no significant difference in response rates between the 14-mg and 20-mg groups – 38.2% and 28.6%, respectively (P = .51) – and no significant difference in clinical benefit rates – 72.3% and 57.1%, respectively.

The median progression-free survival was 3.2 months in the 20-mg group and 5.5 months in the 14-mg group (P = .25). The median overall survival was 8.6 months and 10.3 months, respectively (P = .95).

Dr. How noted that this study was limited by its retrospective nature, and the small number of women started at 20 mg may have limited the ability to detect differences with a lower starting dose. Still, these results seem to support a starting dose of 14 mg, he concluded.

In a discussion after Dr. How’s presentation, panelist Judith Smith, PharmD, of UT Health in Houston, noted that her practice is starting women on lenvatinib at 12 mg per day.

“You can use the 14-mg convenience pack, but, from a cost perspective ... we have to be cognizant of the financial toxicity,” she said. “[Combining the] 10-mg and 4-mg tablets is going to be more expensive, so we’ve been using the 4-mg tablets [three per day] and starting at 12 mg.”

This study was funded by MD Anderson and the National Institutes of Health. Dr. How reported having no conflicts of interest. Dr. Aghajanian and Dr. Smith did not provide disclosures.

aotto@mdedge.com