Key clinical point: In addition to switching endocrine therapy (ET), continuing the cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with ribociclib therapy vs placebo demonstrated progression-free survival (PFS) benefits in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) who had progressed on previous ET and CDK4/6i.

Major finding: At a median follow-up of 18.2 months, a significant improvement in PFS was observed in the ET+ribociclib+CDK4/6i vs ET+placebo group (hazard ratio 0.57; P = .006). ET+ribociclib+CDK4/6i demonstrated a manageable safety profile.

Study details: Findings are from the phase 2 MAINTAIN trial including 119 patients with HR+/HER2− metastatic BC who progressed on ET and CDK4/6i and were randomly assigned to receive a different ET with ribociclib plus CDK4/6i or placebo.

Disclosures: This study was supported by Novartis Pharmaceuticals and other sources. The authors declared no conflicts of interest.

Source: Kalinsky K et al. Randomized phase II trial of endocrine therapy with or without ribociclib after progression on cyclin-dependent kinase 4/6 inhibition in hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: MAINTAIN trial. J Clin Oncol. 2023 (May 19). doi: 10.1200/JCO.22.02392

Key clinical point: In addition to switching endocrine therapy (ET), continuing the cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with ribociclib therapy vs placebo demonstrated progression-free survival (PFS) benefits in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) who had progressed on previous ET and CDK4/6i.

Major finding: At a median follow-up of 18.2 months, a significant improvement in PFS was observed in the ET+ribociclib+CDK4/6i vs ET+placebo group (hazard ratio 0.57; P = .006). ET+ribociclib+CDK4/6i demonstrated a manageable safety profile.

Study details: Findings are from the phase 2 MAINTAIN trial including 119 patients with HR+/HER2− metastatic BC who progressed on ET and CDK4/6i and were randomly assigned to receive a different ET with ribociclib plus CDK4/6i or placebo.

Disclosures: This study was supported by Novartis Pharmaceuticals and other sources. The authors declared no conflicts of interest.

Source: Kalinsky K et al. Randomized phase II trial of endocrine therapy with or without ribociclib after progression on cyclin-dependent kinase 4/6 inhibition in hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: MAINTAIN trial. J Clin Oncol. 2023 (May 19). doi: 10.1200/JCO.22.02392

Key clinical point: In addition to switching endocrine therapy (ET), continuing the cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with ribociclib therapy vs placebo demonstrated progression-free survival (PFS) benefits in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) who had progressed on previous ET and CDK4/6i.

Major finding: At a median follow-up of 18.2 months, a significant improvement in PFS was observed in the ET+ribociclib+CDK4/6i vs ET+placebo group (hazard ratio 0.57; P = .006). ET+ribociclib+CDK4/6i demonstrated a manageable safety profile.

Study details: Findings are from the phase 2 MAINTAIN trial including 119 patients with HR+/HER2− metastatic BC who progressed on ET and CDK4/6i and were randomly assigned to receive a different ET with ribociclib plus CDK4/6i or placebo.

Disclosures: This study was supported by Novartis Pharmaceuticals and other sources. The authors declared no conflicts of interest.

Source: Kalinsky K et al. Randomized phase II trial of endocrine therapy with or without ribociclib after progression on cyclin-dependent kinase 4/6 inhibition in hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: MAINTAIN trial. J Clin Oncol. 2023 (May 19). doi: 10.1200/JCO.22.02392

Key clinical point: Dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor, plus letrozole or anastrozole demonstrated progression-free survival (PFS) benefits and a manageable safety profile in untreated patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A 12.4-month improvement in PFS was observed with dalpiciclib vs placebo, with both letrozole and anastrozole (stratified hazard ratio 0.51; P < .0001). Dalpiciclib plus letrozole or anastrozole demonstrated a manageable safety profile, with similar proportions of patients in the dalpiciclib and placebo groups (4% and 2%, respectively) discontinuing the treatment.

Study details: Findings are from the phase 3 DAWNA-2 study including 456 patients with HR+/HER2− advanced BC who were randomly assigned to receive either letrozole or anastrozole with dalpiciclib or placebo.

Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals and partly by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences. Three authors declared being employees of Hengrui, and Binghe Xu declared receiving research grants and fees from some sources.

Source: Zhang P et al. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023;24:646-657 (May 11). doi: 10.1016/S1470-2045(23)00172-9

Key clinical point: Dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor, plus letrozole or anastrozole demonstrated progression-free survival (PFS) benefits and a manageable safety profile in untreated patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A 12.4-month improvement in PFS was observed with dalpiciclib vs placebo, with both letrozole and anastrozole (stratified hazard ratio 0.51; P < .0001). Dalpiciclib plus letrozole or anastrozole demonstrated a manageable safety profile, with similar proportions of patients in the dalpiciclib and placebo groups (4% and 2%, respectively) discontinuing the treatment.

Study details: Findings are from the phase 3 DAWNA-2 study including 456 patients with HR+/HER2− advanced BC who were randomly assigned to receive either letrozole or anastrozole with dalpiciclib or placebo.

Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals and partly by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences. Three authors declared being employees of Hengrui, and Binghe Xu declared receiving research grants and fees from some sources.

Source: Zhang P et al. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023;24:646-657 (May 11). doi: 10.1016/S1470-2045(23)00172-9

Key clinical point: Dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor, plus letrozole or anastrozole demonstrated progression-free survival (PFS) benefits and a manageable safety profile in untreated patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A 12.4-month improvement in PFS was observed with dalpiciclib vs placebo, with both letrozole and anastrozole (stratified hazard ratio 0.51; P < .0001). Dalpiciclib plus letrozole or anastrozole demonstrated a manageable safety profile, with similar proportions of patients in the dalpiciclib and placebo groups (4% and 2%, respectively) discontinuing the treatment.

Study details: Findings are from the phase 3 DAWNA-2 study including 456 patients with HR+/HER2− advanced BC who were randomly assigned to receive either letrozole or anastrozole with dalpiciclib or placebo.

Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals and partly by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences. Three authors declared being employees of Hengrui, and Binghe Xu declared receiving research grants and fees from some sources.

Source: Zhang P et al. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023;24:646-657 (May 11). doi: 10.1016/S1470-2045(23)00172-9

Key clinical point: The combination of apatinib and etoposide proved to be a feasible treatment option for patients with triple-negative breast cancer (TNBC) who had failed ≥1 line of chemotherapy in the advanced setting.

Major finding: The median progression-free survival and overall survival were 6.0 and 24.5 months, respectively, with an objective response rate of 10.0% and a disease control rate of 62.5%. Overall, 95.0% of patients experienced adverse events (AE) of any grade, mostly grade 1 and 2. Hypertension (65.0%), nausea (47.5%), vomiting (42.5%), and hand-foot syndrome (32.5%) were the most common AE.

Study details: Findings are from a single-arm phase 2 study including 40 patients with advanced TNBC who had failed ≥1 line of chemotherapy and received oral apatinib plus oral etoposide.

Disclosures: This study was funded by National Cancer Fund Climbing Fund. The authors declared no conflicts of interest.

Source: Cao M et al. Apatinib plus etoposide in pretreated patients with advanced triple-negative breast cancer: A phase II trial. BMC Cancer. 2023;23:463 (May 19). doi: 10.1186/s12885-023-10768-8

Key clinical point: The combination of apatinib and etoposide proved to be a feasible treatment option for patients with triple-negative breast cancer (TNBC) who had failed ≥1 line of chemotherapy in the advanced setting.

Major finding: The median progression-free survival and overall survival were 6.0 and 24.5 months, respectively, with an objective response rate of 10.0% and a disease control rate of 62.5%. Overall, 95.0% of patients experienced adverse events (AE) of any grade, mostly grade 1 and 2. Hypertension (65.0%), nausea (47.5%), vomiting (42.5%), and hand-foot syndrome (32.5%) were the most common AE.

Study details: Findings are from a single-arm phase 2 study including 40 patients with advanced TNBC who had failed ≥1 line of chemotherapy and received oral apatinib plus oral etoposide.

Disclosures: This study was funded by National Cancer Fund Climbing Fund. The authors declared no conflicts of interest.

Source: Cao M et al. Apatinib plus etoposide in pretreated patients with advanced triple-negative breast cancer: A phase II trial. BMC Cancer. 2023;23:463 (May 19). doi: 10.1186/s12885-023-10768-8

Key clinical point: The combination of apatinib and etoposide proved to be a feasible treatment option for patients with triple-negative breast cancer (TNBC) who had failed ≥1 line of chemotherapy in the advanced setting.

Major finding: The median progression-free survival and overall survival were 6.0 and 24.5 months, respectively, with an objective response rate of 10.0% and a disease control rate of 62.5%. Overall, 95.0% of patients experienced adverse events (AE) of any grade, mostly grade 1 and 2. Hypertension (65.0%), nausea (47.5%), vomiting (42.5%), and hand-foot syndrome (32.5%) were the most common AE.

Study details: Findings are from a single-arm phase 2 study including 40 patients with advanced TNBC who had failed ≥1 line of chemotherapy and received oral apatinib plus oral etoposide.

Disclosures: This study was funded by National Cancer Fund Climbing Fund. The authors declared no conflicts of interest.

Source: Cao M et al. Apatinib plus etoposide in pretreated patients with advanced triple-negative breast cancer: A phase II trial. BMC Cancer. 2023;23:463 (May 19). doi: 10.1186/s12885-023-10768-8

A panel of advisers to the Food and Drug Administration unanimously has agreed that the next COVID-19 vaccines should target the XBB variants of the SARS-CoV-2 virus now in circulation in the United States, but questioned whether the population as a whole needs booster shots and how often they should be given.

The Vaccines and Related Biological Products Advisory Committee of the FDA voted 21-0 in favor of the recommendation about the strain to be used in the next crop of vaccines.

In the briefing document for the meeting, FDA staff said the available evidence suggests that a monovalent (single-strain) XBB-lineage vaccine “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus and two strains from the Omicron variant.

FDA staff also noted how such a shift would be in line with the World Health Organization toward targeting the XBB family of subvariants. European regulators have done this as well. 

The FDA is not obligated to act on the panel’s recommendations. But the agency often does and is highly likely to do so in this case. Vaccine companies will need the recommendation from the FDA to begin making vaccines for the fall.
 

New shot every year?

The FDA asked its expert panel to vote only on the question about the makeup of future vaccines in terms of which strain to include. 

But panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual flu shots. 

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, argued for greater focus on the response of T cells after vaccination, even in light of the already recognized waning of antibody protection. 

In a recent Substack article, Dr. Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived,” and their “protection against severe disease often lasts for years and sometimes decades.”

Dr. Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the one now in place for influenza vaccines.

The Centers for Disease Control and Prevention recommends flu shots for everyone 6 months and older, with rare exceptions. 

“We need to continue to define who those high-risk groups are and not make this a recommendation for everybody every season,” he said.

Dr. Offit offered his own experience as an example. While he had been vaccinated against the virus’s early Wuhan strain, he still was infected, most likely with a variant that emerged later. 

“That was a drifted virus. That’s why I had a mild infection but I didn’t have a severe infection, because presumably I had T cells which prevented that severe infection, which may last for years,” Dr. Offit said.

Pfizer and Moderna, the two companies that make mRNA-based COVID vaccines, are working on experimental products meant to protect against both flu and SARS-COv-2 in one shot. Novavax, maker of a more traditional protein-based COVID shot, is doing the same. 

The idea of these combination products is to make it more convenient for people to protect against both viruses, while also offering companies some marketing advantages.

But without referring to these drugmakers’ plans for future combo flu-COVID shots, members of the FDA panel raised objections to an assumption of routine annual vaccines against variants of SARS-CoV-2. 

Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices. 

Bernstein questioned the approach of dubbing these the “2023-2024 formulas,” as this approach conveyed a sense of an expectation for a need for annual vaccines, as happens with flu. 

“It’s not clear to me that this is a seasonal virus yet,” said Dr. Bernstein, who is also a professor of pediatrics at Hofstra University, Hempstead, N.Y..

In response to Dr. Bernstein’s point, Arnold Monto, MD, the acting chair of the FDA panel, suggested such a pattern could emerge, while also agreeing that it’s too soon to say for sure.

A professor emeritus at the University of Michigan, Ann Arbor, Dr. Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.

“I think it’s premature to say that this virus will not become seasonal,” Dr. Monto said about SARS-CoV-2. “I agree. We’re not there yet, but we may be.”

At the end of the meeting, Dr. Monto recapped the meeting’s key points, noting that there was a general consensus that the XBB.1.5 subvariant would be the best to use in future COVID shots. 

He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, already have honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.

“The fact that most of the manufacturers are ready to work on an XBB 1.5 [vaccine] is an added reason to select this strain or this variant, given the immunologic data,” Dr. Monto said. 

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the demands involved in manufacturing vaccines tilts toward annual changes.

“Practically, we’re going to have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.

Dr. Marks questioned the panelists’ concerns about likening flu and COVID vaccination practices. The FDA staff’s intent was to try to help the public understand the need for follow-on vaccination.

“I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza. People understand a yearly influenza vaccine,” Dr. Marks said. 

And it’s not certain when another major change in the COVID virus will follow the XBB subvariant, but it’s likely one will – and soon, Dr. Marks said. 

“It looks like, probably by next fall, there’ll be further drift from this,” he said.
 

Informing the public 

Dr. Marks also stressed the need to better convey the benefits of vaccination to people in the United States. 

CDC data estimate that 70% of the U.S. population completed an initial series of the original monovalent vaccines, with only 17% then getting bivalent shots. There’s even a decline among people ages 65 and older. CDC estimates 94% of this group completed their primary series, but only 43% got the bivalent booster dose.

“We have to do better because we have not done a good job today communicating to the American public what’s going on here,” Marks said.

Researchers also are still trying to determine the best timing for people to get additional COVID shots. Finding the “sweet spot” where people can maximize additional protection is tricky, with people most protected if they happen to get shot near the beginning of an uptick in viral spread, the CDC’s Ruth Link-Gelles, PhD, MPH, told the panel during a presentation. 

“You’re going to get the best incremental benefit if it’s been longer since your last vaccine,” she said. “But of course, if you wait too long since your last vaccine, you’re left with very little protection, and so you’re at higher risk of severe illness.”

Like Dr. Marks, Dr. Link-Gelles stressed the need for persuading more people to get follow-on vaccines. 

“Most Americans, at this point, haven’t even received the bivalent and so are a year or more out from their monovalent dose and so have relatively little protection left,” she said.

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

A panel of advisers to the Food and Drug Administration unanimously has agreed that the next COVID-19 vaccines should target the XBB variants of the SARS-CoV-2 virus now in circulation in the United States, but questioned whether the population as a whole needs booster shots and how often they should be given.

The Vaccines and Related Biological Products Advisory Committee of the FDA voted 21-0 in favor of the recommendation about the strain to be used in the next crop of vaccines.

In the briefing document for the meeting, FDA staff said the available evidence suggests that a monovalent (single-strain) XBB-lineage vaccine “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus and two strains from the Omicron variant.

FDA staff also noted how such a shift would be in line with the World Health Organization toward targeting the XBB family of subvariants. European regulators have done this as well. 

The FDA is not obligated to act on the panel’s recommendations. But the agency often does and is highly likely to do so in this case. Vaccine companies will need the recommendation from the FDA to begin making vaccines for the fall.
 

New shot every year?

The FDA asked its expert panel to vote only on the question about the makeup of future vaccines in terms of which strain to include. 

But panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual flu shots. 

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, argued for greater focus on the response of T cells after vaccination, even in light of the already recognized waning of antibody protection. 

In a recent Substack article, Dr. Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived,” and their “protection against severe disease often lasts for years and sometimes decades.”

Dr. Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the one now in place for influenza vaccines.

The Centers for Disease Control and Prevention recommends flu shots for everyone 6 months and older, with rare exceptions. 

“We need to continue to define who those high-risk groups are and not make this a recommendation for everybody every season,” he said.

Dr. Offit offered his own experience as an example. While he had been vaccinated against the virus’s early Wuhan strain, he still was infected, most likely with a variant that emerged later. 

“That was a drifted virus. That’s why I had a mild infection but I didn’t have a severe infection, because presumably I had T cells which prevented that severe infection, which may last for years,” Dr. Offit said.

Pfizer and Moderna, the two companies that make mRNA-based COVID vaccines, are working on experimental products meant to protect against both flu and SARS-COv-2 in one shot. Novavax, maker of a more traditional protein-based COVID shot, is doing the same. 

The idea of these combination products is to make it more convenient for people to protect against both viruses, while also offering companies some marketing advantages.

But without referring to these drugmakers’ plans for future combo flu-COVID shots, members of the FDA panel raised objections to an assumption of routine annual vaccines against variants of SARS-CoV-2. 

Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices. 

Bernstein questioned the approach of dubbing these the “2023-2024 formulas,” as this approach conveyed a sense of an expectation for a need for annual vaccines, as happens with flu. 

“It’s not clear to me that this is a seasonal virus yet,” said Dr. Bernstein, who is also a professor of pediatrics at Hofstra University, Hempstead, N.Y..

In response to Dr. Bernstein’s point, Arnold Monto, MD, the acting chair of the FDA panel, suggested such a pattern could emerge, while also agreeing that it’s too soon to say for sure.

A professor emeritus at the University of Michigan, Ann Arbor, Dr. Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.

“I think it’s premature to say that this virus will not become seasonal,” Dr. Monto said about SARS-CoV-2. “I agree. We’re not there yet, but we may be.”

At the end of the meeting, Dr. Monto recapped the meeting’s key points, noting that there was a general consensus that the XBB.1.5 subvariant would be the best to use in future COVID shots. 

He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, already have honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.

“The fact that most of the manufacturers are ready to work on an XBB 1.5 [vaccine] is an added reason to select this strain or this variant, given the immunologic data,” Dr. Monto said. 

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the demands involved in manufacturing vaccines tilts toward annual changes.

“Practically, we’re going to have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.

Dr. Marks questioned the panelists’ concerns about likening flu and COVID vaccination practices. The FDA staff’s intent was to try to help the public understand the need for follow-on vaccination.

“I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza. People understand a yearly influenza vaccine,” Dr. Marks said. 

And it’s not certain when another major change in the COVID virus will follow the XBB subvariant, but it’s likely one will – and soon, Dr. Marks said. 

“It looks like, probably by next fall, there’ll be further drift from this,” he said.
 

Informing the public 

Dr. Marks also stressed the need to better convey the benefits of vaccination to people in the United States. 

CDC data estimate that 70% of the U.S. population completed an initial series of the original monovalent vaccines, with only 17% then getting bivalent shots. There’s even a decline among people ages 65 and older. CDC estimates 94% of this group completed their primary series, but only 43% got the bivalent booster dose.

“We have to do better because we have not done a good job today communicating to the American public what’s going on here,” Marks said.

Researchers also are still trying to determine the best timing for people to get additional COVID shots. Finding the “sweet spot” where people can maximize additional protection is tricky, with people most protected if they happen to get shot near the beginning of an uptick in viral spread, the CDC’s Ruth Link-Gelles, PhD, MPH, told the panel during a presentation. 

“You’re going to get the best incremental benefit if it’s been longer since your last vaccine,” she said. “But of course, if you wait too long since your last vaccine, you’re left with very little protection, and so you’re at higher risk of severe illness.”

Like Dr. Marks, Dr. Link-Gelles stressed the need for persuading more people to get follow-on vaccines. 

“Most Americans, at this point, haven’t even received the bivalent and so are a year or more out from their monovalent dose and so have relatively little protection left,” she said.

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

A panel of advisers to the Food and Drug Administration unanimously has agreed that the next COVID-19 vaccines should target the XBB variants of the SARS-CoV-2 virus now in circulation in the United States, but questioned whether the population as a whole needs booster shots and how often they should be given.

The Vaccines and Related Biological Products Advisory Committee of the FDA voted 21-0 in favor of the recommendation about the strain to be used in the next crop of vaccines.

In the briefing document for the meeting, FDA staff said the available evidence suggests that a monovalent (single-strain) XBB-lineage vaccine “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus and two strains from the Omicron variant.

FDA staff also noted how such a shift would be in line with the World Health Organization toward targeting the XBB family of subvariants. European regulators have done this as well. 

The FDA is not obligated to act on the panel’s recommendations. But the agency often does and is highly likely to do so in this case. Vaccine companies will need the recommendation from the FDA to begin making vaccines for the fall.
 

New shot every year?

The FDA asked its expert panel to vote only on the question about the makeup of future vaccines in terms of which strain to include. 

But panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual flu shots. 

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, argued for greater focus on the response of T cells after vaccination, even in light of the already recognized waning of antibody protection. 

In a recent Substack article, Dr. Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived,” and their “protection against severe disease often lasts for years and sometimes decades.”

Dr. Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the one now in place for influenza vaccines.

The Centers for Disease Control and Prevention recommends flu shots for everyone 6 months and older, with rare exceptions. 

“We need to continue to define who those high-risk groups are and not make this a recommendation for everybody every season,” he said.

Dr. Offit offered his own experience as an example. While he had been vaccinated against the virus’s early Wuhan strain, he still was infected, most likely with a variant that emerged later. 

“That was a drifted virus. That’s why I had a mild infection but I didn’t have a severe infection, because presumably I had T cells which prevented that severe infection, which may last for years,” Dr. Offit said.

Pfizer and Moderna, the two companies that make mRNA-based COVID vaccines, are working on experimental products meant to protect against both flu and SARS-COv-2 in one shot. Novavax, maker of a more traditional protein-based COVID shot, is doing the same. 

The idea of these combination products is to make it more convenient for people to protect against both viruses, while also offering companies some marketing advantages.

But without referring to these drugmakers’ plans for future combo flu-COVID shots, members of the FDA panel raised objections to an assumption of routine annual vaccines against variants of SARS-CoV-2. 

Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices. 

Bernstein questioned the approach of dubbing these the “2023-2024 formulas,” as this approach conveyed a sense of an expectation for a need for annual vaccines, as happens with flu. 

“It’s not clear to me that this is a seasonal virus yet,” said Dr. Bernstein, who is also a professor of pediatrics at Hofstra University, Hempstead, N.Y..

In response to Dr. Bernstein’s point, Arnold Monto, MD, the acting chair of the FDA panel, suggested such a pattern could emerge, while also agreeing that it’s too soon to say for sure.

A professor emeritus at the University of Michigan, Ann Arbor, Dr. Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.

“I think it’s premature to say that this virus will not become seasonal,” Dr. Monto said about SARS-CoV-2. “I agree. We’re not there yet, but we may be.”

At the end of the meeting, Dr. Monto recapped the meeting’s key points, noting that there was a general consensus that the XBB.1.5 subvariant would be the best to use in future COVID shots. 

He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, already have honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.

“The fact that most of the manufacturers are ready to work on an XBB 1.5 [vaccine] is an added reason to select this strain or this variant, given the immunologic data,” Dr. Monto said. 

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the demands involved in manufacturing vaccines tilts toward annual changes.

“Practically, we’re going to have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.

Dr. Marks questioned the panelists’ concerns about likening flu and COVID vaccination practices. The FDA staff’s intent was to try to help the public understand the need for follow-on vaccination.

“I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza. People understand a yearly influenza vaccine,” Dr. Marks said. 

And it’s not certain when another major change in the COVID virus will follow the XBB subvariant, but it’s likely one will – and soon, Dr. Marks said. 

“It looks like, probably by next fall, there’ll be further drift from this,” he said.
 

Informing the public 

Dr. Marks also stressed the need to better convey the benefits of vaccination to people in the United States. 

CDC data estimate that 70% of the U.S. population completed an initial series of the original monovalent vaccines, with only 17% then getting bivalent shots. There’s even a decline among people ages 65 and older. CDC estimates 94% of this group completed their primary series, but only 43% got the bivalent booster dose.

“We have to do better because we have not done a good job today communicating to the American public what’s going on here,” Marks said.

Researchers also are still trying to determine the best timing for people to get additional COVID shots. Finding the “sweet spot” where people can maximize additional protection is tricky, with people most protected if they happen to get shot near the beginning of an uptick in viral spread, the CDC’s Ruth Link-Gelles, PhD, MPH, told the panel during a presentation. 

“You’re going to get the best incremental benefit if it’s been longer since your last vaccine,” she said. “But of course, if you wait too long since your last vaccine, you’re left with very little protection, and so you’re at higher risk of severe illness.”

Like Dr. Marks, Dr. Link-Gelles stressed the need for persuading more people to get follow-on vaccines. 

“Most Americans, at this point, haven’t even received the bivalent and so are a year or more out from their monovalent dose and so have relatively little protection left,” she said.

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

Key clinical point: Atypical hyperplasia (AH) at the surgical margins of breast-conserving surgery (BCS) did not increase the risk for ipsilateral breast cancer (BC) recurrence, distant metastasis, or mortality in patients with BC who had received neoadjuvant chemotherapy (NAC).

Major finding: The 5-year ipsilateral breast tumor recurrence (IBTR) rate was 4.6% (95% CI 3.2%-6.0%) in patients with AH and 6.2% (95% CI 4.6%-7.8%) in patients without AH, with no significant differences observed between both groups in terms of IBTR (P = .448), distant metastasis-free survival (P = .506), and overall survival (P = .432).

Study details: Findings are from a retrospective analysis including 598 patients with BC who received NAC and BCS, of which 301 patients had AH at the margins of BCS and 297 patients did not have AH at the margins of BCS.

Disclosures: This study was supported by grants from the Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Su A et al. Impact of atypical hyperplasia at surgical margins on breast cancer outcomes in patients treated with neoadjuvant chemotherapy. Front Oncol. 2023;13:1202689 (May 19). Doi: 10.3389/fonc.2023.1202689

Key clinical point: Atypical hyperplasia (AH) at the surgical margins of breast-conserving surgery (BCS) did not increase the risk for ipsilateral breast cancer (BC) recurrence, distant metastasis, or mortality in patients with BC who had received neoadjuvant chemotherapy (NAC).

Major finding: The 5-year ipsilateral breast tumor recurrence (IBTR) rate was 4.6% (95% CI 3.2%-6.0%) in patients with AH and 6.2% (95% CI 4.6%-7.8%) in patients without AH, with no significant differences observed between both groups in terms of IBTR (P = .448), distant metastasis-free survival (P = .506), and overall survival (P = .432).

Study details: Findings are from a retrospective analysis including 598 patients with BC who received NAC and BCS, of which 301 patients had AH at the margins of BCS and 297 patients did not have AH at the margins of BCS.

Disclosures: This study was supported by grants from the Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Su A et al. Impact of atypical hyperplasia at surgical margins on breast cancer outcomes in patients treated with neoadjuvant chemotherapy. Front Oncol. 2023;13:1202689 (May 19). Doi: 10.3389/fonc.2023.1202689

Key clinical point: Atypical hyperplasia (AH) at the surgical margins of breast-conserving surgery (BCS) did not increase the risk for ipsilateral breast cancer (BC) recurrence, distant metastasis, or mortality in patients with BC who had received neoadjuvant chemotherapy (NAC).

Major finding: The 5-year ipsilateral breast tumor recurrence (IBTR) rate was 4.6% (95% CI 3.2%-6.0%) in patients with AH and 6.2% (95% CI 4.6%-7.8%) in patients without AH, with no significant differences observed between both groups in terms of IBTR (P = .448), distant metastasis-free survival (P = .506), and overall survival (P = .432).

Study details: Findings are from a retrospective analysis including 598 patients with BC who received NAC and BCS, of which 301 patients had AH at the margins of BCS and 297 patients did not have AH at the margins of BCS.

Disclosures: This study was supported by grants from the Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Su A et al. Impact of atypical hyperplasia at surgical margins on breast cancer outcomes in patients treated with neoadjuvant chemotherapy. Front Oncol. 2023;13:1202689 (May 19). Doi: 10.3389/fonc.2023.1202689

Key clinical point: Aspirin intake may be associated with a reduced risk for incident breast cancer (BC) in adults.

Major finding: Aspirin users vs nonusers had a significantly reduced risk for BC (hazard ratio [HR] 0.91; P =  .002), especially estrogen receptor-positive BC (HR 0.90; P = .0004).

Study details: Findings are from a meta-analysis of 28 cohort studies including adults who received aspirin.

Disclosures: This study did not report the funding source. The authors declared no conflicts of interest.

Source: Bakierzynska M et al. Prophylactic aspirin intake and breast cancer risk: A systematic review and meta-analysis of observational cohort studies. Eur J Surg Oncol. 2023 (Jun 6). doi: 10.1016/j.ejso.2023.05.015

Key clinical point: Aspirin intake may be associated with a reduced risk for incident breast cancer (BC) in adults.

Major finding: Aspirin users vs nonusers had a significantly reduced risk for BC (hazard ratio [HR] 0.91; P =  .002), especially estrogen receptor-positive BC (HR 0.90; P = .0004).

Study details: Findings are from a meta-analysis of 28 cohort studies including adults who received aspirin.

Disclosures: This study did not report the funding source. The authors declared no conflicts of interest.

Source: Bakierzynska M et al. Prophylactic aspirin intake and breast cancer risk: A systematic review and meta-analysis of observational cohort studies. Eur J Surg Oncol. 2023 (Jun 6). doi: 10.1016/j.ejso.2023.05.015

Key clinical point: Aspirin intake may be associated with a reduced risk for incident breast cancer (BC) in adults.

Major finding: Aspirin users vs nonusers had a significantly reduced risk for BC (hazard ratio [HR] 0.91; P =  .002), especially estrogen receptor-positive BC (HR 0.90; P = .0004).

Study details: Findings are from a meta-analysis of 28 cohort studies including adults who received aspirin.

Disclosures: This study did not report the funding source. The authors declared no conflicts of interest.

Source: Bakierzynska M et al. Prophylactic aspirin intake and breast cancer risk: A systematic review and meta-analysis of observational cohort studies. Eur J Surg Oncol. 2023 (Jun 6). doi: 10.1016/j.ejso.2023.05.015

Key clinical point: Adjuvant capecitabine was extremely well tolerated in a real-world population of patients with early triple-negative breast cancer (TNBC) who had invasive residual disease at surgery after receiving neoadjuvant chemotherapy.

Major finding: The rate of treatment discontinuation due to adjuvant capecitabine-related toxicity was very low (10.4%). After a median follow-up of 15 months, the 2-year disease-free survival rate was 62.0%, and the 2- and 3-year overall survival rates were 84.0% and 76.2%, respectively.

Study details: Findings are from an observational, retrospective study including 270 patients with TNBC who had residual disease even after receiving neoadjuvant chemotherapy and were treated with adjuvant capecitabine.

Disclosures: This research was supported by Funds Ricerca Corrente 2023 from the Italian Ministry of Health. Some authors declared receiving research grants, personal fees, speaker fees, honoraria, or travel grants or having other ties with several sources.

Source: Di Lisa FS et al. Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: Real-world evidence from CaRe, a multicentric, observational study. Front Oncol. 2023;13:1152123 (May 16). doi: 10.3389/fonc.2023.1152123

Key clinical point: Adjuvant capecitabine was extremely well tolerated in a real-world population of patients with early triple-negative breast cancer (TNBC) who had invasive residual disease at surgery after receiving neoadjuvant chemotherapy.

Major finding: The rate of treatment discontinuation due to adjuvant capecitabine-related toxicity was very low (10.4%). After a median follow-up of 15 months, the 2-year disease-free survival rate was 62.0%, and the 2- and 3-year overall survival rates were 84.0% and 76.2%, respectively.

Study details: Findings are from an observational, retrospective study including 270 patients with TNBC who had residual disease even after receiving neoadjuvant chemotherapy and were treated with adjuvant capecitabine.

Disclosures: This research was supported by Funds Ricerca Corrente 2023 from the Italian Ministry of Health. Some authors declared receiving research grants, personal fees, speaker fees, honoraria, or travel grants or having other ties with several sources.

Source: Di Lisa FS et al. Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: Real-world evidence from CaRe, a multicentric, observational study. Front Oncol. 2023;13:1152123 (May 16). doi: 10.3389/fonc.2023.1152123

Key clinical point: Adjuvant capecitabine was extremely well tolerated in a real-world population of patients with early triple-negative breast cancer (TNBC) who had invasive residual disease at surgery after receiving neoadjuvant chemotherapy.

Major finding: The rate of treatment discontinuation due to adjuvant capecitabine-related toxicity was very low (10.4%). After a median follow-up of 15 months, the 2-year disease-free survival rate was 62.0%, and the 2- and 3-year overall survival rates were 84.0% and 76.2%, respectively.

Study details: Findings are from an observational, retrospective study including 270 patients with TNBC who had residual disease even after receiving neoadjuvant chemotherapy and were treated with adjuvant capecitabine.

Disclosures: This research was supported by Funds Ricerca Corrente 2023 from the Italian Ministry of Health. Some authors declared receiving research grants, personal fees, speaker fees, honoraria, or travel grants or having other ties with several sources.

Source: Di Lisa FS et al. Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: Real-world evidence from CaRe, a multicentric, observational study. Front Oncol. 2023;13:1152123 (May 16). doi: 10.3389/fonc.2023.1152123

Key clinical point: Surgery improved locoregional progression or recurrence rate in patients with de novo human epidermal growth factor receptor 2-positive (HER2+) metastatic inflammatory breast cancer (BC) who received first-line systemic therapy.

Major finding: Patients who underwent mastectomy had a median overall survival of 5.2 years from the date of surgery. Only one incidence of a locoregional progression or recurrence was reported 7.8 years after surgery, and pathological complete response was achieved by 10 patients, all of whom were alive at last follow-up.

Study details: Findings are from a retrospective study including 78 patients with de novo HER2+ metastatic inflammatory BC who received first-line systemic therapy, of which 41 patients underwent mastectomy with (n = 33) or without (n = 8) subsequent radiation therapy.

Disclosures: This study was funded by the Dana-Farber Cancer Institute IBC Research Fund and Reardon Family Fund. The authors declared serving as consultants or advisors or receiving speaker honorarium or travel support from, or holding stocks in several sources.

Source: Garrido-Castro AC et al. Clinical outcomes of de novo metastatic HER2-positive inflammatory breast cancer. NPJ Breast Cancer. 2023;9:50 (Jun 2). doi: 10.1038/s41523-023-00555-w

Key clinical point: Surgery improved locoregional progression or recurrence rate in patients with de novo human epidermal growth factor receptor 2-positive (HER2+) metastatic inflammatory breast cancer (BC) who received first-line systemic therapy.

Major finding: Patients who underwent mastectomy had a median overall survival of 5.2 years from the date of surgery. Only one incidence of a locoregional progression or recurrence was reported 7.8 years after surgery, and pathological complete response was achieved by 10 patients, all of whom were alive at last follow-up.

Study details: Findings are from a retrospective study including 78 patients with de novo HER2+ metastatic inflammatory BC who received first-line systemic therapy, of which 41 patients underwent mastectomy with (n = 33) or without (n = 8) subsequent radiation therapy.

Disclosures: This study was funded by the Dana-Farber Cancer Institute IBC Research Fund and Reardon Family Fund. The authors declared serving as consultants or advisors or receiving speaker honorarium or travel support from, or holding stocks in several sources.

Source: Garrido-Castro AC et al. Clinical outcomes of de novo metastatic HER2-positive inflammatory breast cancer. NPJ Breast Cancer. 2023;9:50 (Jun 2). doi: 10.1038/s41523-023-00555-w

Key clinical point: Surgery improved locoregional progression or recurrence rate in patients with de novo human epidermal growth factor receptor 2-positive (HER2+) metastatic inflammatory breast cancer (BC) who received first-line systemic therapy.

Major finding: Patients who underwent mastectomy had a median overall survival of 5.2 years from the date of surgery. Only one incidence of a locoregional progression or recurrence was reported 7.8 years after surgery, and pathological complete response was achieved by 10 patients, all of whom were alive at last follow-up.

Study details: Findings are from a retrospective study including 78 patients with de novo HER2+ metastatic inflammatory BC who received first-line systemic therapy, of which 41 patients underwent mastectomy with (n = 33) or without (n = 8) subsequent radiation therapy.

Disclosures: This study was funded by the Dana-Farber Cancer Institute IBC Research Fund and Reardon Family Fund. The authors declared serving as consultants or advisors or receiving speaker honorarium or travel support from, or holding stocks in several sources.

Source: Garrido-Castro AC et al. Clinical outcomes of de novo metastatic HER2-positive inflammatory breast cancer. NPJ Breast Cancer. 2023;9:50 (Jun 2). doi: 10.1038/s41523-023-00555-w

Key clinical point: A family history of estrogen receptor (ER)-positive (+) and negative (−) breast cancer (BC) as well as other cancers among first-degree relatives is associated with an increased risk for ER-subtypes of BC.

Major finding: Women with familial ER+ and ER− BC had ~2 times increased risk for ER+ (hazard ratio [HR] 1.96; 95% CI 1.84-2.09) and ER− (HR 2.67; 95% CI 2.10-3.40) BC, respectively. A family history of liver (odds ratio [OR] 1.33; 95% CI 1.05-1.67), ovarian (OR 1.28; 95% CI 1.01-1.61), and testicular (OR 1.78; 95% CI 1.01-3.14) cancers was associated with a higher risk for ER− vs ER+ BC.

Study details: Findings are from a population-based cohort study including 464,707 female participants, of which 25,273 were diagnosed with BC (including 16,286 and 3613 patients with ER+ and ER− BC, respectively).

Disclosures: This study was supported by the Swedish Research Council and other sources. The authors declared no conflicts of interest.

Source: Wang Q et al. Risk of ER-specific breast cancer by family history of ER subtypes and other cancers. J Natl Cancer Inst. 2023 (May 27). doi: 10.1093/jnci/djad104

Key clinical point: A family history of estrogen receptor (ER)-positive (+) and negative (−) breast cancer (BC) as well as other cancers among first-degree relatives is associated with an increased risk for ER-subtypes of BC.

Major finding: Women with familial ER+ and ER− BC had ~2 times increased risk for ER+ (hazard ratio [HR] 1.96; 95% CI 1.84-2.09) and ER− (HR 2.67; 95% CI 2.10-3.40) BC, respectively. A family history of liver (odds ratio [OR] 1.33; 95% CI 1.05-1.67), ovarian (OR 1.28; 95% CI 1.01-1.61), and testicular (OR 1.78; 95% CI 1.01-3.14) cancers was associated with a higher risk for ER− vs ER+ BC.

Study details: Findings are from a population-based cohort study including 464,707 female participants, of which 25,273 were diagnosed with BC (including 16,286 and 3613 patients with ER+ and ER− BC, respectively).

Disclosures: This study was supported by the Swedish Research Council and other sources. The authors declared no conflicts of interest.

Source: Wang Q et al. Risk of ER-specific breast cancer by family history of ER subtypes and other cancers. J Natl Cancer Inst. 2023 (May 27). doi: 10.1093/jnci/djad104

Key clinical point: A family history of estrogen receptor (ER)-positive (+) and negative (−) breast cancer (BC) as well as other cancers among first-degree relatives is associated with an increased risk for ER-subtypes of BC.

Major finding: Women with familial ER+ and ER− BC had ~2 times increased risk for ER+ (hazard ratio [HR] 1.96; 95% CI 1.84-2.09) and ER− (HR 2.67; 95% CI 2.10-3.40) BC, respectively. A family history of liver (odds ratio [OR] 1.33; 95% CI 1.05-1.67), ovarian (OR 1.28; 95% CI 1.01-1.61), and testicular (OR 1.78; 95% CI 1.01-3.14) cancers was associated with a higher risk for ER− vs ER+ BC.

Study details: Findings are from a population-based cohort study including 464,707 female participants, of which 25,273 were diagnosed with BC (including 16,286 and 3613 patients with ER+ and ER− BC, respectively).

Disclosures: This study was supported by the Swedish Research Council and other sources. The authors declared no conflicts of interest.

Source: Wang Q et al. Risk of ER-specific breast cancer by family history of ER subtypes and other cancers. J Natl Cancer Inst. 2023 (May 27). doi: 10.1093/jnci/djad104

Key clinical point: In patients with locally advanced breast cancer (BC), staging with ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) was more effective than conventional staging for detecting asymptomatic distant metastases.

Major finding: More than twice the number of patients undergoing PET-CT vs conventional staging were upstaged to stage IV BC (relative risk 2.4; P = .002), with combined modality treatment being received by fewer patients in the PET-CT vs conventional staging group (81% vs 89%; P = .03).

Study details: Findings are from the PET ABC study including 369 patients with invasive ductal carcinoma of the breast and TNM stage III or IIb BC who were randomly assigned to undergo ¹⁸F-labeled fluorodeoxyglucose PET-CT (whole body) or conventional staging (bone scan and CT of the chest/abdomen and pelvis).

Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria from or serving as employees, consultants, or advisors for different sources.

Source: Dayes IS et al. Impact of ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography versus conventional staging in patients with locally advanced breast cancer. J Clin Oncol. 2023 (May 26). doi: 10.1200/JCO.23.00249

Key clinical point: In patients with locally advanced breast cancer (BC), staging with ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) was more effective than conventional staging for detecting asymptomatic distant metastases.

Major finding: More than twice the number of patients undergoing PET-CT vs conventional staging were upstaged to stage IV BC (relative risk 2.4; P = .002), with combined modality treatment being received by fewer patients in the PET-CT vs conventional staging group (81% vs 89%; P = .03).

Study details: Findings are from the PET ABC study including 369 patients with invasive ductal carcinoma of the breast and TNM stage III or IIb BC who were randomly assigned to undergo ¹⁸F-labeled fluorodeoxyglucose PET-CT (whole body) or conventional staging (bone scan and CT of the chest/abdomen and pelvis).

Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria from or serving as employees, consultants, or advisors for different sources.

Source: Dayes IS et al. Impact of ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography versus conventional staging in patients with locally advanced breast cancer. J Clin Oncol. 2023 (May 26). doi: 10.1200/JCO.23.00249

Key clinical point: In patients with locally advanced breast cancer (BC), staging with ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) was more effective than conventional staging for detecting asymptomatic distant metastases.

Major finding: More than twice the number of patients undergoing PET-CT vs conventional staging were upstaged to stage IV BC (relative risk 2.4; P = .002), with combined modality treatment being received by fewer patients in the PET-CT vs conventional staging group (81% vs 89%; P = .03).

Study details: Findings are from the PET ABC study including 369 patients with invasive ductal carcinoma of the breast and TNM stage III or IIb BC who were randomly assigned to undergo ¹⁸F-labeled fluorodeoxyglucose PET-CT (whole body) or conventional staging (bone scan and CT of the chest/abdomen and pelvis).

Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria from or serving as employees, consultants, or advisors for different sources.

Source: Dayes IS et al. Impact of ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography versus conventional staging in patients with locally advanced breast cancer. J Clin Oncol. 2023 (May 26). doi: 10.1200/JCO.23.00249