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Prostate cancer screening guidelines: To PSA or not to PSA
In the United States this year, approximately 288,300 men will be newly diagnosed with prostate cancer and about 34,700 men will die from this disease. It is the second leading cause of cancer in men, and one out of every eight men will be diagnosed with this cancer at some point in their lives.
As primary care physicians, a large part of our role is to prevent or detect cancers early. Patients look to us for this guidance. However, prostate cancer screening has long been a controversial issue. Earlier this year, the American Urological Association along with the Society of Urologic Oncology published updated guidelines.
Clear recommendations that come from this set of guidelines that are relevant to primary care physicians include:
- using PSA as the screening test of choice.
- repeating PSA in patients with newly elevated results before moving on to other test.
- offering PSA screening every 2-4 years in patients aged 50-69 years.
- offering baseline screening in those between 45-50 years of age.
In high-risk patients, screening can be initiated at 40-45 years of age. All of these recommendations come with the caveat that we give the patient all the pros and cons and leave it up to their “values and preferences.”
The guidelines make recommendations regarding PSA screening and biopsy standards. These guidelines are very specific in their recommendations; however, the question about whether to do PSA screening in the first place is left open to debate. While shared decision-making is important with any testing, it is more difficult with prostate cancer screening. Patients need to understand that there are possible adverse events that can result because of an elevated PSA, such as unneeded biopsies that may come with complications.
The authors of this set of guidelines suggest that physicians talk to patients more often about the benefits of the screening than they do about the negative consequences. This assumes that a negative biopsy result is an unnecessary test, which is not a fair assessment. Negative test results can provide useful clinical information. While a PSA result may lead to a biopsy that could have possibly been avoided, we don’t have any better screening tests available. Missing a prostate cancer that could have been detected by PSA screening is also very harmful. Deciding whether to do PSA screening for any given patient then becomes a difficult question.
More research into biomarkers to detect prostate cancer is needed, as suggested by the guideline authors. As primary care doctors, we’re the first ones to order these tests and make decisions regarding the results. While we may not be the ones to do the biopsies, we do need to know when to refer the patients to specialists or when we can just repeat the test.
Population health is often the benchmark used when looking at screening guidelines. But in the primary care setting, we are responsible for individual patients. Applying guidelines that take whole populations into consideration often doesn’t translate well to single patients. We do need to make them responsible for their own health care decisions but, at the same time, we need to offer them some guidance. If the guidelines are clear, this is easy. When they suggest giving patients all the pros and cons and letting them make their own decision, this is hard. Some of them want us to tell them what to do.
Additionally, patients in the primary care setting develop close relationships with their physicians. They are not an elevated PSA test or a negative biopsy result. They have concerns and fears. When they are high risk, the advice is easy. Keeping in mind that prostate cancer is the second leading cause of cancer in men in the United States, we should have clear screening guidelines, such as we do with mammograms in women. Yes, shared decision-making is important, but we also need to know the answer when our patients ask us whether or not they should have a PSA test done.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.
In the United States this year, approximately 288,300 men will be newly diagnosed with prostate cancer and about 34,700 men will die from this disease. It is the second leading cause of cancer in men, and one out of every eight men will be diagnosed with this cancer at some point in their lives.
As primary care physicians, a large part of our role is to prevent or detect cancers early. Patients look to us for this guidance. However, prostate cancer screening has long been a controversial issue. Earlier this year, the American Urological Association along with the Society of Urologic Oncology published updated guidelines.
Clear recommendations that come from this set of guidelines that are relevant to primary care physicians include:
- using PSA as the screening test of choice.
- repeating PSA in patients with newly elevated results before moving on to other test.
- offering PSA screening every 2-4 years in patients aged 50-69 years.
- offering baseline screening in those between 45-50 years of age.
In high-risk patients, screening can be initiated at 40-45 years of age. All of these recommendations come with the caveat that we give the patient all the pros and cons and leave it up to their “values and preferences.”
The guidelines make recommendations regarding PSA screening and biopsy standards. These guidelines are very specific in their recommendations; however, the question about whether to do PSA screening in the first place is left open to debate. While shared decision-making is important with any testing, it is more difficult with prostate cancer screening. Patients need to understand that there are possible adverse events that can result because of an elevated PSA, such as unneeded biopsies that may come with complications.
The authors of this set of guidelines suggest that physicians talk to patients more often about the benefits of the screening than they do about the negative consequences. This assumes that a negative biopsy result is an unnecessary test, which is not a fair assessment. Negative test results can provide useful clinical information. While a PSA result may lead to a biopsy that could have possibly been avoided, we don’t have any better screening tests available. Missing a prostate cancer that could have been detected by PSA screening is also very harmful. Deciding whether to do PSA screening for any given patient then becomes a difficult question.
More research into biomarkers to detect prostate cancer is needed, as suggested by the guideline authors. As primary care doctors, we’re the first ones to order these tests and make decisions regarding the results. While we may not be the ones to do the biopsies, we do need to know when to refer the patients to specialists or when we can just repeat the test.
Population health is often the benchmark used when looking at screening guidelines. But in the primary care setting, we are responsible for individual patients. Applying guidelines that take whole populations into consideration often doesn’t translate well to single patients. We do need to make them responsible for their own health care decisions but, at the same time, we need to offer them some guidance. If the guidelines are clear, this is easy. When they suggest giving patients all the pros and cons and letting them make their own decision, this is hard. Some of them want us to tell them what to do.
Additionally, patients in the primary care setting develop close relationships with their physicians. They are not an elevated PSA test or a negative biopsy result. They have concerns and fears. When they are high risk, the advice is easy. Keeping in mind that prostate cancer is the second leading cause of cancer in men in the United States, we should have clear screening guidelines, such as we do with mammograms in women. Yes, shared decision-making is important, but we also need to know the answer when our patients ask us whether or not they should have a PSA test done.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.
In the United States this year, approximately 288,300 men will be newly diagnosed with prostate cancer and about 34,700 men will die from this disease. It is the second leading cause of cancer in men, and one out of every eight men will be diagnosed with this cancer at some point in their lives.
As primary care physicians, a large part of our role is to prevent or detect cancers early. Patients look to us for this guidance. However, prostate cancer screening has long been a controversial issue. Earlier this year, the American Urological Association along with the Society of Urologic Oncology published updated guidelines.
Clear recommendations that come from this set of guidelines that are relevant to primary care physicians include:
- using PSA as the screening test of choice.
- repeating PSA in patients with newly elevated results before moving on to other test.
- offering PSA screening every 2-4 years in patients aged 50-69 years.
- offering baseline screening in those between 45-50 years of age.
In high-risk patients, screening can be initiated at 40-45 years of age. All of these recommendations come with the caveat that we give the patient all the pros and cons and leave it up to their “values and preferences.”
The guidelines make recommendations regarding PSA screening and biopsy standards. These guidelines are very specific in their recommendations; however, the question about whether to do PSA screening in the first place is left open to debate. While shared decision-making is important with any testing, it is more difficult with prostate cancer screening. Patients need to understand that there are possible adverse events that can result because of an elevated PSA, such as unneeded biopsies that may come with complications.
The authors of this set of guidelines suggest that physicians talk to patients more often about the benefits of the screening than they do about the negative consequences. This assumes that a negative biopsy result is an unnecessary test, which is not a fair assessment. Negative test results can provide useful clinical information. While a PSA result may lead to a biopsy that could have possibly been avoided, we don’t have any better screening tests available. Missing a prostate cancer that could have been detected by PSA screening is also very harmful. Deciding whether to do PSA screening for any given patient then becomes a difficult question.
More research into biomarkers to detect prostate cancer is needed, as suggested by the guideline authors. As primary care doctors, we’re the first ones to order these tests and make decisions regarding the results. While we may not be the ones to do the biopsies, we do need to know when to refer the patients to specialists or when we can just repeat the test.
Population health is often the benchmark used when looking at screening guidelines. But in the primary care setting, we are responsible for individual patients. Applying guidelines that take whole populations into consideration often doesn’t translate well to single patients. We do need to make them responsible for their own health care decisions but, at the same time, we need to offer them some guidance. If the guidelines are clear, this is easy. When they suggest giving patients all the pros and cons and letting them make their own decision, this is hard. Some of them want us to tell them what to do.
Additionally, patients in the primary care setting develop close relationships with their physicians. They are not an elevated PSA test or a negative biopsy result. They have concerns and fears. When they are high risk, the advice is easy. Keeping in mind that prostate cancer is the second leading cause of cancer in men in the United States, we should have clear screening guidelines, such as we do with mammograms in women. Yes, shared decision-making is important, but we also need to know the answer when our patients ask us whether or not they should have a PSA test done.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.
Blood transfusions linked to intracerebral hemorrhage risk
In an exploratory analysis, patients receiving red blood cell transfusions from donors who later developed multiple spontaneous ICHs, and were assumed to have CAA, were at a significantly increased risk of developing spontaneous ICH themselves.
“This may suggest a transfusion-transmissible agent associated with some types of spontaneous ICH, although the findings may be susceptible to selection bias and residual confounding, and further research is needed to investigate if transfusion transmission of CAA might explain this association,” the investigators noted.
“We do not think that the findings motivate a change in practice, and we should not let these results discourage otherwise indicated blood transfusion,” said lead author Jingcheng Zhao, MD, PhD, with Karolinska University Hospital Solna, Stockholm.
The study was published online in the Journal of the American Medical Association.
Novel finding
Recent evidence suggests that CAA exhibits “prion-like” transmissivity, with reports of transmission through cadaveric pituitary hormone contaminated with amyloid-beta and tau protein, dura mater grafts, and possibly neurosurgical instruments.
CAA, which is characterized by the deposition of amyloid protein in the brain, is the second most common cause of spontaneous ICH.
The researchers hypothesized that transfusion transmission of CAA may manifest through an increased risk for spontaneous ICH among transfusion recipients given blood from a donor with spontaneous ICH. To explore this hypothesis, they analyzed national registry data from Sweden and Denmark for ICH in recipients of red blood cell transfusion from donors who themselves had ICH over the years after their blood donations, with the assumption that donors with two or more ICHs would likely have CAA.
The cohort included nearly 760,000 individuals in Sweden (median age, 65 years; 59% women) and 330,000 in Denmark (median age, 64 years; 58% women), with a median follow-up of 5.8 and 6.1 years, respectively.
Receiving red blood cell transfusions from donors who later developed multiple spontaneous ICHs was associated with a greater than twofold increased risk of developing spontaneous ICH, compared with receiving a transfusion from donors without subsequent ICH (hazard ratio, 2.73; P < .001 in the Swedish cohort and HR, 2.32; P = .04 in the Danish cohort).
“The observed increased risk of spontaneous ICH associated with receiving a red blood cell transfusion from a donor who later developed multiple spontaneous ICHs, corresponding to a 30-year cumulative incidence difference of 2.3%, is a novel finding,” the researchers wrote.
There was no increase in post-transfusion ICH risk among recipients whose donors had a single post–blood-donation ICH.
The findings were robust to several of the sensitivity analyses.
A “negative” control analysis of post-transfusion ischemic stroke (instead of ICH) found no increased risk among recipients of blood from donors who had single or multiple ICHs.
This study provides “exploratory evidence of possible transfusion-transmission of a factor that causes ICHs, but more research is needed to confirm and to understand the mechanism,” said Dr. Zhao.
The researchers noted that they did not directly assess CAA but expect it would be more common among donors who develop multiple spontaneous ICHs, “as CAA-related ICH has been reported to have a 7-fold increase for recurrent ICHs, compared with non–CAA-related ICH.”
Worrisome finding or false alarm?
In an accompanying editorial, Steven Greenberg, MD, PhD, with the department of neurology, Harvard Medical School, Boston, said there are “good reasons to treat the possibility of CAA transmission via blood transfusion seriously – and good reasons to remain skeptical, at least for the present.”
“Powerful” arguments in support of the findings include the robust study methodology and the “striking” similarity in results from the two registries, which argues against a chance finding. Another is the negative control with ischemic stroke as the outcome, which argues against unsuspected confounding-causing associations with all types of stroke, Dr. Greenberg noted.
Arguments for remaining “unconvinced” of the association center on the weakness of evidence for a plausible biological mechanism for the finding, he points out. Another is the short-time course of ICHs after blood transfusion, which is “quite challenging to explain,” Dr. Greenberg said. Nearly half of the ICHs among blood recipients occurred within 5 years of transfusion, which is “dramatically” faster than the 30- to 40-year interval reported between neurosurgical exposure to cadaveric tissue and first ICH, he added.
Another related “mechanistic reservation” is the plausibility that a transmissible species of amyloid-beta could travel from blood to brain in sufficient quantities to trigger advanced CAA or Alzheimer disease pathology, he wrote.
He added the current study leaves him “squarely at the corner of anxiety and skepticism.”
With more than 10 million units of blood transfused in the United States each year, even a modest increase in risk for future brain hemorrhages or dementia conferred by “an uncommon – but as of now undetectable – donor trait would represent a substantial public health concern,” Dr. Greenberg wrote.
“From the standpoint of scientific plausibility, however, even this well-conducted analysis is at risk of representing a false alarm,” he cautioned.
Looking ahead, Dr. Greenberg said one clear direction is independent replication, ideally with datasets in which donor and recipient dementia can be reliably ascertained to assess the possibility of Alzheimer’s disease as well as CAA transmissibility.
“The other challenge is for experimental biologists to consider the alternative possibility of transfusion-related acceleration of downstream steps in the CAA-ICH pathway, such as the vessel remodeling by which amyloid beta–laden vessels proceed to rupture and bleed.”
“The current study is not yet a reason for alarm, certainly not a reason to avoid otherwise indicated blood transfusion, but it is a strong call for more scientific digging,” Dr. Greenberg concluded.
The study was funded by grants from the Karolinska Institute, the Swedish Research Council, and Region Stockholm. Dr. Zhao and Dr. Greenberg report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In an exploratory analysis, patients receiving red blood cell transfusions from donors who later developed multiple spontaneous ICHs, and were assumed to have CAA, were at a significantly increased risk of developing spontaneous ICH themselves.
“This may suggest a transfusion-transmissible agent associated with some types of spontaneous ICH, although the findings may be susceptible to selection bias and residual confounding, and further research is needed to investigate if transfusion transmission of CAA might explain this association,” the investigators noted.
“We do not think that the findings motivate a change in practice, and we should not let these results discourage otherwise indicated blood transfusion,” said lead author Jingcheng Zhao, MD, PhD, with Karolinska University Hospital Solna, Stockholm.
The study was published online in the Journal of the American Medical Association.
Novel finding
Recent evidence suggests that CAA exhibits “prion-like” transmissivity, with reports of transmission through cadaveric pituitary hormone contaminated with amyloid-beta and tau protein, dura mater grafts, and possibly neurosurgical instruments.
CAA, which is characterized by the deposition of amyloid protein in the brain, is the second most common cause of spontaneous ICH.
The researchers hypothesized that transfusion transmission of CAA may manifest through an increased risk for spontaneous ICH among transfusion recipients given blood from a donor with spontaneous ICH. To explore this hypothesis, they analyzed national registry data from Sweden and Denmark for ICH in recipients of red blood cell transfusion from donors who themselves had ICH over the years after their blood donations, with the assumption that donors with two or more ICHs would likely have CAA.
The cohort included nearly 760,000 individuals in Sweden (median age, 65 years; 59% women) and 330,000 in Denmark (median age, 64 years; 58% women), with a median follow-up of 5.8 and 6.1 years, respectively.
Receiving red blood cell transfusions from donors who later developed multiple spontaneous ICHs was associated with a greater than twofold increased risk of developing spontaneous ICH, compared with receiving a transfusion from donors without subsequent ICH (hazard ratio, 2.73; P < .001 in the Swedish cohort and HR, 2.32; P = .04 in the Danish cohort).
“The observed increased risk of spontaneous ICH associated with receiving a red blood cell transfusion from a donor who later developed multiple spontaneous ICHs, corresponding to a 30-year cumulative incidence difference of 2.3%, is a novel finding,” the researchers wrote.
There was no increase in post-transfusion ICH risk among recipients whose donors had a single post–blood-donation ICH.
The findings were robust to several of the sensitivity analyses.
A “negative” control analysis of post-transfusion ischemic stroke (instead of ICH) found no increased risk among recipients of blood from donors who had single or multiple ICHs.
This study provides “exploratory evidence of possible transfusion-transmission of a factor that causes ICHs, but more research is needed to confirm and to understand the mechanism,” said Dr. Zhao.
The researchers noted that they did not directly assess CAA but expect it would be more common among donors who develop multiple spontaneous ICHs, “as CAA-related ICH has been reported to have a 7-fold increase for recurrent ICHs, compared with non–CAA-related ICH.”
Worrisome finding or false alarm?
In an accompanying editorial, Steven Greenberg, MD, PhD, with the department of neurology, Harvard Medical School, Boston, said there are “good reasons to treat the possibility of CAA transmission via blood transfusion seriously – and good reasons to remain skeptical, at least for the present.”
“Powerful” arguments in support of the findings include the robust study methodology and the “striking” similarity in results from the two registries, which argues against a chance finding. Another is the negative control with ischemic stroke as the outcome, which argues against unsuspected confounding-causing associations with all types of stroke, Dr. Greenberg noted.
Arguments for remaining “unconvinced” of the association center on the weakness of evidence for a plausible biological mechanism for the finding, he points out. Another is the short-time course of ICHs after blood transfusion, which is “quite challenging to explain,” Dr. Greenberg said. Nearly half of the ICHs among blood recipients occurred within 5 years of transfusion, which is “dramatically” faster than the 30- to 40-year interval reported between neurosurgical exposure to cadaveric tissue and first ICH, he added.
Another related “mechanistic reservation” is the plausibility that a transmissible species of amyloid-beta could travel from blood to brain in sufficient quantities to trigger advanced CAA or Alzheimer disease pathology, he wrote.
He added the current study leaves him “squarely at the corner of anxiety and skepticism.”
With more than 10 million units of blood transfused in the United States each year, even a modest increase in risk for future brain hemorrhages or dementia conferred by “an uncommon – but as of now undetectable – donor trait would represent a substantial public health concern,” Dr. Greenberg wrote.
“From the standpoint of scientific plausibility, however, even this well-conducted analysis is at risk of representing a false alarm,” he cautioned.
Looking ahead, Dr. Greenberg said one clear direction is independent replication, ideally with datasets in which donor and recipient dementia can be reliably ascertained to assess the possibility of Alzheimer’s disease as well as CAA transmissibility.
“The other challenge is for experimental biologists to consider the alternative possibility of transfusion-related acceleration of downstream steps in the CAA-ICH pathway, such as the vessel remodeling by which amyloid beta–laden vessels proceed to rupture and bleed.”
“The current study is not yet a reason for alarm, certainly not a reason to avoid otherwise indicated blood transfusion, but it is a strong call for more scientific digging,” Dr. Greenberg concluded.
The study was funded by grants from the Karolinska Institute, the Swedish Research Council, and Region Stockholm. Dr. Zhao and Dr. Greenberg report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In an exploratory analysis, patients receiving red blood cell transfusions from donors who later developed multiple spontaneous ICHs, and were assumed to have CAA, were at a significantly increased risk of developing spontaneous ICH themselves.
“This may suggest a transfusion-transmissible agent associated with some types of spontaneous ICH, although the findings may be susceptible to selection bias and residual confounding, and further research is needed to investigate if transfusion transmission of CAA might explain this association,” the investigators noted.
“We do not think that the findings motivate a change in practice, and we should not let these results discourage otherwise indicated blood transfusion,” said lead author Jingcheng Zhao, MD, PhD, with Karolinska University Hospital Solna, Stockholm.
The study was published online in the Journal of the American Medical Association.
Novel finding
Recent evidence suggests that CAA exhibits “prion-like” transmissivity, with reports of transmission through cadaveric pituitary hormone contaminated with amyloid-beta and tau protein, dura mater grafts, and possibly neurosurgical instruments.
CAA, which is characterized by the deposition of amyloid protein in the brain, is the second most common cause of spontaneous ICH.
The researchers hypothesized that transfusion transmission of CAA may manifest through an increased risk for spontaneous ICH among transfusion recipients given blood from a donor with spontaneous ICH. To explore this hypothesis, they analyzed national registry data from Sweden and Denmark for ICH in recipients of red blood cell transfusion from donors who themselves had ICH over the years after their blood donations, with the assumption that donors with two or more ICHs would likely have CAA.
The cohort included nearly 760,000 individuals in Sweden (median age, 65 years; 59% women) and 330,000 in Denmark (median age, 64 years; 58% women), with a median follow-up of 5.8 and 6.1 years, respectively.
Receiving red blood cell transfusions from donors who later developed multiple spontaneous ICHs was associated with a greater than twofold increased risk of developing spontaneous ICH, compared with receiving a transfusion from donors without subsequent ICH (hazard ratio, 2.73; P < .001 in the Swedish cohort and HR, 2.32; P = .04 in the Danish cohort).
“The observed increased risk of spontaneous ICH associated with receiving a red blood cell transfusion from a donor who later developed multiple spontaneous ICHs, corresponding to a 30-year cumulative incidence difference of 2.3%, is a novel finding,” the researchers wrote.
There was no increase in post-transfusion ICH risk among recipients whose donors had a single post–blood-donation ICH.
The findings were robust to several of the sensitivity analyses.
A “negative” control analysis of post-transfusion ischemic stroke (instead of ICH) found no increased risk among recipients of blood from donors who had single or multiple ICHs.
This study provides “exploratory evidence of possible transfusion-transmission of a factor that causes ICHs, but more research is needed to confirm and to understand the mechanism,” said Dr. Zhao.
The researchers noted that they did not directly assess CAA but expect it would be more common among donors who develop multiple spontaneous ICHs, “as CAA-related ICH has been reported to have a 7-fold increase for recurrent ICHs, compared with non–CAA-related ICH.”
Worrisome finding or false alarm?
In an accompanying editorial, Steven Greenberg, MD, PhD, with the department of neurology, Harvard Medical School, Boston, said there are “good reasons to treat the possibility of CAA transmission via blood transfusion seriously – and good reasons to remain skeptical, at least for the present.”
“Powerful” arguments in support of the findings include the robust study methodology and the “striking” similarity in results from the two registries, which argues against a chance finding. Another is the negative control with ischemic stroke as the outcome, which argues against unsuspected confounding-causing associations with all types of stroke, Dr. Greenberg noted.
Arguments for remaining “unconvinced” of the association center on the weakness of evidence for a plausible biological mechanism for the finding, he points out. Another is the short-time course of ICHs after blood transfusion, which is “quite challenging to explain,” Dr. Greenberg said. Nearly half of the ICHs among blood recipients occurred within 5 years of transfusion, which is “dramatically” faster than the 30- to 40-year interval reported between neurosurgical exposure to cadaveric tissue and first ICH, he added.
Another related “mechanistic reservation” is the plausibility that a transmissible species of amyloid-beta could travel from blood to brain in sufficient quantities to trigger advanced CAA or Alzheimer disease pathology, he wrote.
He added the current study leaves him “squarely at the corner of anxiety and skepticism.”
With more than 10 million units of blood transfused in the United States each year, even a modest increase in risk for future brain hemorrhages or dementia conferred by “an uncommon – but as of now undetectable – donor trait would represent a substantial public health concern,” Dr. Greenberg wrote.
“From the standpoint of scientific plausibility, however, even this well-conducted analysis is at risk of representing a false alarm,” he cautioned.
Looking ahead, Dr. Greenberg said one clear direction is independent replication, ideally with datasets in which donor and recipient dementia can be reliably ascertained to assess the possibility of Alzheimer’s disease as well as CAA transmissibility.
“The other challenge is for experimental biologists to consider the alternative possibility of transfusion-related acceleration of downstream steps in the CAA-ICH pathway, such as the vessel remodeling by which amyloid beta–laden vessels proceed to rupture and bleed.”
“The current study is not yet a reason for alarm, certainly not a reason to avoid otherwise indicated blood transfusion, but it is a strong call for more scientific digging,” Dr. Greenberg concluded.
The study was funded by grants from the Karolinska Institute, the Swedish Research Council, and Region Stockholm. Dr. Zhao and Dr. Greenberg report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
From JAMA
CDK4/6i can replace chemotherapy in ER+/HER2− advanced BC with impending or established visceral crisis
Key clinical point: Compared with paclitaxel chemotherapy, treatment with first-line cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) demonstrated better survival outcomes and a similar speed of improvement in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC) who had a visceral crisis (VC) or impending VC (IVC).
Major finding: CDK4/6i vs paclitaxel improved time-to-treatment failure (hazard ratio [HR] 0.33; P = .0002), progression-free survival (HR 0.38; P = .002), and overall survival (HR 0.37; P = .002) outcomes. The median time to first improvement in IVC/VC was comparable between the treatment groups (P = .773).
Study details: Findings are from a retrospective study including 59 patients with ER+/HER2− advanced BC who had either VC or IVC, of whom 27 patients received first-line treatment with CDK4/6i + endocrine therapy and 32 patients who were treated with weekly paclitaxel.
Disclosures: This study did not receive any funding. Two authors declared having joint working agreements with or receiving honoraria, conference fees, travel expenses, or research funding from various sources.
Source: Behrouzi R et al. CDK4/6 inhibitors versus weekly paclitaxel for treatment of ER+/HER2− advanced breast cancer with impending or established visceral crisis. Breast Cancer Res Treat. 2023 (Aug 16). doi: 10.1007/s10549-023-07035-6
Key clinical point: Compared with paclitaxel chemotherapy, treatment with first-line cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) demonstrated better survival outcomes and a similar speed of improvement in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC) who had a visceral crisis (VC) or impending VC (IVC).
Major finding: CDK4/6i vs paclitaxel improved time-to-treatment failure (hazard ratio [HR] 0.33; P = .0002), progression-free survival (HR 0.38; P = .002), and overall survival (HR 0.37; P = .002) outcomes. The median time to first improvement in IVC/VC was comparable between the treatment groups (P = .773).
Study details: Findings are from a retrospective study including 59 patients with ER+/HER2− advanced BC who had either VC or IVC, of whom 27 patients received first-line treatment with CDK4/6i + endocrine therapy and 32 patients who were treated with weekly paclitaxel.
Disclosures: This study did not receive any funding. Two authors declared having joint working agreements with or receiving honoraria, conference fees, travel expenses, or research funding from various sources.
Source: Behrouzi R et al. CDK4/6 inhibitors versus weekly paclitaxel for treatment of ER+/HER2− advanced breast cancer with impending or established visceral crisis. Breast Cancer Res Treat. 2023 (Aug 16). doi: 10.1007/s10549-023-07035-6
Key clinical point: Compared with paclitaxel chemotherapy, treatment with first-line cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) demonstrated better survival outcomes and a similar speed of improvement in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC) who had a visceral crisis (VC) or impending VC (IVC).
Major finding: CDK4/6i vs paclitaxel improved time-to-treatment failure (hazard ratio [HR] 0.33; P = .0002), progression-free survival (HR 0.38; P = .002), and overall survival (HR 0.37; P = .002) outcomes. The median time to first improvement in IVC/VC was comparable between the treatment groups (P = .773).
Study details: Findings are from a retrospective study including 59 patients with ER+/HER2− advanced BC who had either VC or IVC, of whom 27 patients received first-line treatment with CDK4/6i + endocrine therapy and 32 patients who were treated with weekly paclitaxel.
Disclosures: This study did not receive any funding. Two authors declared having joint working agreements with or receiving honoraria, conference fees, travel expenses, or research funding from various sources.
Source: Behrouzi R et al. CDK4/6 inhibitors versus weekly paclitaxel for treatment of ER+/HER2− advanced breast cancer with impending or established visceral crisis. Breast Cancer Res Treat. 2023 (Aug 16). doi: 10.1007/s10549-023-07035-6
Meta-analysis indicates an elevated risk for type 2 diabetes in breast cancer survivors
Key clinical point: Patients who survive breast cancer (BC) may have an elevated risk of developing type 2 diabetes mellitus (T2D), especially after receiving tamoxifen therapy.
Major finding: The risk for incident T2D was elevated in patients with BC (effect estimate [EE] 1.23; 95% CI 1.13-1.33), particularly those who received endocrine therapy (EE 1.23; 95% CI 1.16-1.32), compared with individuals without BC. Moreover, the risk of developing T2D was higher among patients with BC who did vs did not receive tamoxifen (EE 1.28; 95% CI 1.18-1.38).
Study details: Findings are from a meta-analysis of 15 observational studies.
Disclosures: This study was funded by the Novo Nordisk Foundation and other sources. The authors declared no conflicts of interest.
Source: Jordt N et al. Breast cancer and incidence of type 2 diabetes mellitus: A systematic review and meta-analysis. Breast Cancer Res Treat. 2023 (Sep 1). doi: 10.1007/s10549-023-07043-6
Key clinical point: Patients who survive breast cancer (BC) may have an elevated risk of developing type 2 diabetes mellitus (T2D), especially after receiving tamoxifen therapy.
Major finding: The risk for incident T2D was elevated in patients with BC (effect estimate [EE] 1.23; 95% CI 1.13-1.33), particularly those who received endocrine therapy (EE 1.23; 95% CI 1.16-1.32), compared with individuals without BC. Moreover, the risk of developing T2D was higher among patients with BC who did vs did not receive tamoxifen (EE 1.28; 95% CI 1.18-1.38).
Study details: Findings are from a meta-analysis of 15 observational studies.
Disclosures: This study was funded by the Novo Nordisk Foundation and other sources. The authors declared no conflicts of interest.
Source: Jordt N et al. Breast cancer and incidence of type 2 diabetes mellitus: A systematic review and meta-analysis. Breast Cancer Res Treat. 2023 (Sep 1). doi: 10.1007/s10549-023-07043-6
Key clinical point: Patients who survive breast cancer (BC) may have an elevated risk of developing type 2 diabetes mellitus (T2D), especially after receiving tamoxifen therapy.
Major finding: The risk for incident T2D was elevated in patients with BC (effect estimate [EE] 1.23; 95% CI 1.13-1.33), particularly those who received endocrine therapy (EE 1.23; 95% CI 1.16-1.32), compared with individuals without BC. Moreover, the risk of developing T2D was higher among patients with BC who did vs did not receive tamoxifen (EE 1.28; 95% CI 1.18-1.38).
Study details: Findings are from a meta-analysis of 15 observational studies.
Disclosures: This study was funded by the Novo Nordisk Foundation and other sources. The authors declared no conflicts of interest.
Source: Jordt N et al. Breast cancer and incidence of type 2 diabetes mellitus: A systematic review and meta-analysis. Breast Cancer Res Treat. 2023 (Sep 1). doi: 10.1007/s10549-023-07043-6
Predictors of 4 or more axillary lymph node metastases in clinically node-negative BC patients
Key clinical point: Certain preoperative clinicopathological factors can predict the presence of ≥4 pathologically positive lymph nodes in postmenopausal women with clinically node-negative (cN0) breast cancer (BC) who underwent sentinel lymph node biopsy (SLNB) with or without completion axillary lymph node dissection (cALND).
Major finding: Only 2.5% of the evaluated patients reported having ≥4 positive lymph nodes, with the factors serving as independent predictors of ≥4 positive nodes being larger tumor size (odds ratio [OR] 1.42; P < .0001), invasive lobular carcinoma (ILC) or mixed invasive ductal carcinoma/ILC histology (OR 3.03 or 1.99, respectively; P = .008), multifocality (OR 3.58; P < .0001), and the presence of lymphovascular invasion (OR 4.77; P < .0001).
Study details: This retrospective review included 2532 postmenopausal women with cN0 BC who underwent SLNB, of whom 24.3% underwent cALND.
Disclosures: This study was supported by an US National Institutes of Health/National Cancer Institute Cancer Center Support Grant. Some authors declared serving on medical or scientific advisory boards of, receiving research funding or support for clinical trials from, or having other ties with various sources.
Source: Farley C et al. To dissect or not to dissect: Can we predict the presence of four or more axillary lymph node metastases in postmenopausal women with clinically node-negative breast cancer? Ann Surg Oncol. 2023 (Sep 5). doi: 10.1245/s10434-023-14245-1
Key clinical point: Certain preoperative clinicopathological factors can predict the presence of ≥4 pathologically positive lymph nodes in postmenopausal women with clinically node-negative (cN0) breast cancer (BC) who underwent sentinel lymph node biopsy (SLNB) with or without completion axillary lymph node dissection (cALND).
Major finding: Only 2.5% of the evaluated patients reported having ≥4 positive lymph nodes, with the factors serving as independent predictors of ≥4 positive nodes being larger tumor size (odds ratio [OR] 1.42; P < .0001), invasive lobular carcinoma (ILC) or mixed invasive ductal carcinoma/ILC histology (OR 3.03 or 1.99, respectively; P = .008), multifocality (OR 3.58; P < .0001), and the presence of lymphovascular invasion (OR 4.77; P < .0001).
Study details: This retrospective review included 2532 postmenopausal women with cN0 BC who underwent SLNB, of whom 24.3% underwent cALND.
Disclosures: This study was supported by an US National Institutes of Health/National Cancer Institute Cancer Center Support Grant. Some authors declared serving on medical or scientific advisory boards of, receiving research funding or support for clinical trials from, or having other ties with various sources.
Source: Farley C et al. To dissect or not to dissect: Can we predict the presence of four or more axillary lymph node metastases in postmenopausal women with clinically node-negative breast cancer? Ann Surg Oncol. 2023 (Sep 5). doi: 10.1245/s10434-023-14245-1
Key clinical point: Certain preoperative clinicopathological factors can predict the presence of ≥4 pathologically positive lymph nodes in postmenopausal women with clinically node-negative (cN0) breast cancer (BC) who underwent sentinel lymph node biopsy (SLNB) with or without completion axillary lymph node dissection (cALND).
Major finding: Only 2.5% of the evaluated patients reported having ≥4 positive lymph nodes, with the factors serving as independent predictors of ≥4 positive nodes being larger tumor size (odds ratio [OR] 1.42; P < .0001), invasive lobular carcinoma (ILC) or mixed invasive ductal carcinoma/ILC histology (OR 3.03 or 1.99, respectively; P = .008), multifocality (OR 3.58; P < .0001), and the presence of lymphovascular invasion (OR 4.77; P < .0001).
Study details: This retrospective review included 2532 postmenopausal women with cN0 BC who underwent SLNB, of whom 24.3% underwent cALND.
Disclosures: This study was supported by an US National Institutes of Health/National Cancer Institute Cancer Center Support Grant. Some authors declared serving on medical or scientific advisory boards of, receiving research funding or support for clinical trials from, or having other ties with various sources.
Source: Farley C et al. To dissect or not to dissect: Can we predict the presence of four or more axillary lymph node metastases in postmenopausal women with clinically node-negative breast cancer? Ann Surg Oncol. 2023 (Sep 5). doi: 10.1245/s10434-023-14245-1
Surgical complications likely in obese patients undergoing mastectomy with immediate reconstruction
Key clinical point: Patients with obesity and stages I-III breast cancer (BC) who undergo mastectomy with immediate reconstruction have a higher likelihood of experiencing surgical complications than patients without obesity.
Major finding: Compared with patients who underwent lumpectomy, the risk for surgical complications was significantly higher in those who underwent mastectomy with (odds ratio [OR] 7.45; P < .0001) or without (OR 3.15; P = .002) immediate reconstruction. Moreover, obesity vs non-obesity was associated with worse surgical complications among patients undergoing mastectomy with reconstruction (OR 2.25; P = .02).
Study details: Findings are from a retrospective study including 692 patients with stages I-III BC who underwent surgery and received body composition measurements using bioelectrical impedance spectrometry.
Disclosures: This study did not disclose the funding source. SA Valente and HCF Moore declared serving as consultants for, receiving fees or grants from, or having contracts with various sources.
Source: Aleixo GFP et al. Association of body composition and surgical outcomes in patients with early-stage breast cancer. Breast Cancer Res Treat. 2023 (Aug 28). doi: 10.1007/s10549-023-07060-5
Key clinical point: Patients with obesity and stages I-III breast cancer (BC) who undergo mastectomy with immediate reconstruction have a higher likelihood of experiencing surgical complications than patients without obesity.
Major finding: Compared with patients who underwent lumpectomy, the risk for surgical complications was significantly higher in those who underwent mastectomy with (odds ratio [OR] 7.45; P < .0001) or without (OR 3.15; P = .002) immediate reconstruction. Moreover, obesity vs non-obesity was associated with worse surgical complications among patients undergoing mastectomy with reconstruction (OR 2.25; P = .02).
Study details: Findings are from a retrospective study including 692 patients with stages I-III BC who underwent surgery and received body composition measurements using bioelectrical impedance spectrometry.
Disclosures: This study did not disclose the funding source. SA Valente and HCF Moore declared serving as consultants for, receiving fees or grants from, or having contracts with various sources.
Source: Aleixo GFP et al. Association of body composition and surgical outcomes in patients with early-stage breast cancer. Breast Cancer Res Treat. 2023 (Aug 28). doi: 10.1007/s10549-023-07060-5
Key clinical point: Patients with obesity and stages I-III breast cancer (BC) who undergo mastectomy with immediate reconstruction have a higher likelihood of experiencing surgical complications than patients without obesity.
Major finding: Compared with patients who underwent lumpectomy, the risk for surgical complications was significantly higher in those who underwent mastectomy with (odds ratio [OR] 7.45; P < .0001) or without (OR 3.15; P = .002) immediate reconstruction. Moreover, obesity vs non-obesity was associated with worse surgical complications among patients undergoing mastectomy with reconstruction (OR 2.25; P = .02).
Study details: Findings are from a retrospective study including 692 patients with stages I-III BC who underwent surgery and received body composition measurements using bioelectrical impedance spectrometry.
Disclosures: This study did not disclose the funding source. SA Valente and HCF Moore declared serving as consultants for, receiving fees or grants from, or having contracts with various sources.
Source: Aleixo GFP et al. Association of body composition and surgical outcomes in patients with early-stage breast cancer. Breast Cancer Res Treat. 2023 (Aug 28). doi: 10.1007/s10549-023-07060-5
Home-based exercise and nutritional intervention may benefit patients with newly diagnosed BC
Key clinical point: Home-based exercise and nutritional intervention vs usual care (UC) routine improved the physical activity levels, diet quality, and pathological complete response (pCR) rates in patients who initiated chemotherapy after a breast cancer (BC) diagnosis.
Major finding: Women in the intervention vs UC group reported greater improvements in physical activity (143.4 vs 47.7 minutes/week; P < .001) and a higher intake of fruits, vegetables, and dietary fiber (P ≤ .01) along with increased pCR rates (53% vs 28%; P = .037).
Study details: Findings are from the Lifestyle, Exercise, and Nutrition Early After Breast Cancer study including 173 women with newly diagnosed stages I-III breast cancer who initiated chemotherapy and were randomly assigned to undergo either a UC routine or a home-based exercise and nutritional intervention.
Disclosures: This study was financially supported by the corresponding author ML Irwin. Some authors declared serving in the speakers’ bureau of or in consulting, advisory, or leadership roles in or receiving honoraria from various sources.
Source: Sanft T et al. Randomized trial of exercise and nutrition on chemotherapy completion and pathologic complete response in women with breast cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis study. J Clin Oncol. 2023 (Sep 1). doi: 10.1200/JCO.23.00871
Key clinical point: Home-based exercise and nutritional intervention vs usual care (UC) routine improved the physical activity levels, diet quality, and pathological complete response (pCR) rates in patients who initiated chemotherapy after a breast cancer (BC) diagnosis.
Major finding: Women in the intervention vs UC group reported greater improvements in physical activity (143.4 vs 47.7 minutes/week; P < .001) and a higher intake of fruits, vegetables, and dietary fiber (P ≤ .01) along with increased pCR rates (53% vs 28%; P = .037).
Study details: Findings are from the Lifestyle, Exercise, and Nutrition Early After Breast Cancer study including 173 women with newly diagnosed stages I-III breast cancer who initiated chemotherapy and were randomly assigned to undergo either a UC routine or a home-based exercise and nutritional intervention.
Disclosures: This study was financially supported by the corresponding author ML Irwin. Some authors declared serving in the speakers’ bureau of or in consulting, advisory, or leadership roles in or receiving honoraria from various sources.
Source: Sanft T et al. Randomized trial of exercise and nutrition on chemotherapy completion and pathologic complete response in women with breast cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis study. J Clin Oncol. 2023 (Sep 1). doi: 10.1200/JCO.23.00871
Key clinical point: Home-based exercise and nutritional intervention vs usual care (UC) routine improved the physical activity levels, diet quality, and pathological complete response (pCR) rates in patients who initiated chemotherapy after a breast cancer (BC) diagnosis.
Major finding: Women in the intervention vs UC group reported greater improvements in physical activity (143.4 vs 47.7 minutes/week; P < .001) and a higher intake of fruits, vegetables, and dietary fiber (P ≤ .01) along with increased pCR rates (53% vs 28%; P = .037).
Study details: Findings are from the Lifestyle, Exercise, and Nutrition Early After Breast Cancer study including 173 women with newly diagnosed stages I-III breast cancer who initiated chemotherapy and were randomly assigned to undergo either a UC routine or a home-based exercise and nutritional intervention.
Disclosures: This study was financially supported by the corresponding author ML Irwin. Some authors declared serving in the speakers’ bureau of or in consulting, advisory, or leadership roles in or receiving honoraria from various sources.
Source: Sanft T et al. Randomized trial of exercise and nutrition on chemotherapy completion and pathologic complete response in women with breast cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis study. J Clin Oncol. 2023 (Sep 1). doi: 10.1200/JCO.23.00871
HER2+ metastatic BC with brain metastasis: Pyrotinib shows long-term meaningful outcomes in real world
Key clinical point: Pyrotinib led to promising long-term outcomes and was well-tolerated in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) and brain metastases (BM).
Major finding: In patients with BM, the overall median progression-free survival (PFS), considering both intracranial and extracranial lesions, was 7.50 months (95% CI 5.84-9.16) and median overall survival was 21.27 months (95% CI 20.10-22.44), with the median PFS not improving in patients who received vs did not receive radiotherapy (P = .319). Diarrhea (any grade) was the most common adverse event.
Study details: This real-world study included 239 patients with HER2+ metastatic BC who received pyrotinib-based therapy, of whom 61 patients had BM.
Disclosures: This study was supported by the keyAtlas precision medicine and clinical research project of Shanghai Science & Technology Development Foundation, China. The authors declared no conflicts of interest.
Source: Liang X et al. Long-term outcome analysis of pyrotinib in patients with HER2-Positive metastatic breast cancer and brain metastasis: A real-world study. Oncologist. 2023 (Aug 17). doi: 10.1093/oncolo/oyad228
Key clinical point: Pyrotinib led to promising long-term outcomes and was well-tolerated in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) and brain metastases (BM).
Major finding: In patients with BM, the overall median progression-free survival (PFS), considering both intracranial and extracranial lesions, was 7.50 months (95% CI 5.84-9.16) and median overall survival was 21.27 months (95% CI 20.10-22.44), with the median PFS not improving in patients who received vs did not receive radiotherapy (P = .319). Diarrhea (any grade) was the most common adverse event.
Study details: This real-world study included 239 patients with HER2+ metastatic BC who received pyrotinib-based therapy, of whom 61 patients had BM.
Disclosures: This study was supported by the keyAtlas precision medicine and clinical research project of Shanghai Science & Technology Development Foundation, China. The authors declared no conflicts of interest.
Source: Liang X et al. Long-term outcome analysis of pyrotinib in patients with HER2-Positive metastatic breast cancer and brain metastasis: A real-world study. Oncologist. 2023 (Aug 17). doi: 10.1093/oncolo/oyad228
Key clinical point: Pyrotinib led to promising long-term outcomes and was well-tolerated in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) and brain metastases (BM).
Major finding: In patients with BM, the overall median progression-free survival (PFS), considering both intracranial and extracranial lesions, was 7.50 months (95% CI 5.84-9.16) and median overall survival was 21.27 months (95% CI 20.10-22.44), with the median PFS not improving in patients who received vs did not receive radiotherapy (P = .319). Diarrhea (any grade) was the most common adverse event.
Study details: This real-world study included 239 patients with HER2+ metastatic BC who received pyrotinib-based therapy, of whom 61 patients had BM.
Disclosures: This study was supported by the keyAtlas precision medicine and clinical research project of Shanghai Science & Technology Development Foundation, China. The authors declared no conflicts of interest.
Source: Liang X et al. Long-term outcome analysis of pyrotinib in patients with HER2-Positive metastatic breast cancer and brain metastasis: A real-world study. Oncologist. 2023 (Aug 17). doi: 10.1093/oncolo/oyad228
Adjuvant capecitabine plus ibandronate combination fails in phase 3 study
Key clinical point: Adjuvant capecitabine plus ibandronate failed to show improved survival outcomes compared with ibandronate alone in older patients with node-positive/high-risk node-negative breast cancer (BC).
Major finding: At a median follow-up of 61 months, the 5-year invasive disease-free survival rates were comparable between the adjuvant ibandronate + capecitabine and ibandronate arms (hazard ratio 0.96; 95% CI 0.78-1.19). The incidences of high-grade gastrointestinal disorders (6.7% vs 1.0%; P < .001) and skin toxicity (14.6% vs 0.6%; P < .01) were significantly higher in the ibandronate + capecitabine vs ibandronate arm.
Study details: Findings are from a phase 3 study including 1358 patients age ≥ 65 years with early BC who were randomly assigned to receive ibandronate with or without capecitabine.
Disclosures: This study was sponsored by the German Breast Group. Some authors declared receiving personal fees, grants, contracts, consulting fees, payment, honoraria, support for attending meetings, or travel support from or having other ties with various sources.
Source: Schmidt M et al. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE Randomized Clinical Trial. Eur J Cancer. 2023;113324 (Sep 6). doi: 10.1016/j.ejca.2023.113324
Key clinical point: Adjuvant capecitabine plus ibandronate failed to show improved survival outcomes compared with ibandronate alone in older patients with node-positive/high-risk node-negative breast cancer (BC).
Major finding: At a median follow-up of 61 months, the 5-year invasive disease-free survival rates were comparable between the adjuvant ibandronate + capecitabine and ibandronate arms (hazard ratio 0.96; 95% CI 0.78-1.19). The incidences of high-grade gastrointestinal disorders (6.7% vs 1.0%; P < .001) and skin toxicity (14.6% vs 0.6%; P < .01) were significantly higher in the ibandronate + capecitabine vs ibandronate arm.
Study details: Findings are from a phase 3 study including 1358 patients age ≥ 65 years with early BC who were randomly assigned to receive ibandronate with or without capecitabine.
Disclosures: This study was sponsored by the German Breast Group. Some authors declared receiving personal fees, grants, contracts, consulting fees, payment, honoraria, support for attending meetings, or travel support from or having other ties with various sources.
Source: Schmidt M et al. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE Randomized Clinical Trial. Eur J Cancer. 2023;113324 (Sep 6). doi: 10.1016/j.ejca.2023.113324
Key clinical point: Adjuvant capecitabine plus ibandronate failed to show improved survival outcomes compared with ibandronate alone in older patients with node-positive/high-risk node-negative breast cancer (BC).
Major finding: At a median follow-up of 61 months, the 5-year invasive disease-free survival rates were comparable between the adjuvant ibandronate + capecitabine and ibandronate arms (hazard ratio 0.96; 95% CI 0.78-1.19). The incidences of high-grade gastrointestinal disorders (6.7% vs 1.0%; P < .001) and skin toxicity (14.6% vs 0.6%; P < .01) were significantly higher in the ibandronate + capecitabine vs ibandronate arm.
Study details: Findings are from a phase 3 study including 1358 patients age ≥ 65 years with early BC who were randomly assigned to receive ibandronate with or without capecitabine.
Disclosures: This study was sponsored by the German Breast Group. Some authors declared receiving personal fees, grants, contracts, consulting fees, payment, honoraria, support for attending meetings, or travel support from or having other ties with various sources.
Source: Schmidt M et al. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE Randomized Clinical Trial. Eur J Cancer. 2023;113324 (Sep 6). doi: 10.1016/j.ejca.2023.113324
Adding ovarian suppression to adjuvant tamoxifen is beneficial for women with existing ovarian function and ER+ BC
Key clinical point: Adding ovarian function suppression (OFS) to adjuvant tamoxifen for 2 years demonstrated consistent improvement in disease-free survival (DFS) outcomes and high overall survival (OS) rates in women with estrogen receptor-positive (ER+) breast cancer (BC) who remained premenopausal or regained ovarian function after chemotherapy.
Major finding: The 8-year DFS rates improved consistently in women who received tamoxifen + OFS vs tamoxifen only (85.4% vs 80.2%; hazard ratio 0.67; P = .003). Although the 8-year OS rates were comparable between both treatment groups (P = .305), they were considerably high (>95%).
Study details: Findings are from an 8-year follow-up of the phase 3 ASTRRA trial including 1282 premenopausal women with ER+ BC, who remained premenopausal or regained ovarian function after chemotherapy and were randomly assigned to receive tamoxifen with or without OFS.
Disclosures: This study was supported by the Korea Health Industry Development Institute, Republic of Korea. Some authors declared receiving honoraria or research funding from or serving in consulting or advisory roles with various sources.
Source: Baek SY et al. Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: An 8-year follow-up of the ASTRRA trial. J Clin Oncol. 2023 (Aug 22). doi: 10.1200/JCO.23.00557
Key clinical point: Adding ovarian function suppression (OFS) to adjuvant tamoxifen for 2 years demonstrated consistent improvement in disease-free survival (DFS) outcomes and high overall survival (OS) rates in women with estrogen receptor-positive (ER+) breast cancer (BC) who remained premenopausal or regained ovarian function after chemotherapy.
Major finding: The 8-year DFS rates improved consistently in women who received tamoxifen + OFS vs tamoxifen only (85.4% vs 80.2%; hazard ratio 0.67; P = .003). Although the 8-year OS rates were comparable between both treatment groups (P = .305), they were considerably high (>95%).
Study details: Findings are from an 8-year follow-up of the phase 3 ASTRRA trial including 1282 premenopausal women with ER+ BC, who remained premenopausal or regained ovarian function after chemotherapy and were randomly assigned to receive tamoxifen with or without OFS.
Disclosures: This study was supported by the Korea Health Industry Development Institute, Republic of Korea. Some authors declared receiving honoraria or research funding from or serving in consulting or advisory roles with various sources.
Source: Baek SY et al. Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: An 8-year follow-up of the ASTRRA trial. J Clin Oncol. 2023 (Aug 22). doi: 10.1200/JCO.23.00557
Key clinical point: Adding ovarian function suppression (OFS) to adjuvant tamoxifen for 2 years demonstrated consistent improvement in disease-free survival (DFS) outcomes and high overall survival (OS) rates in women with estrogen receptor-positive (ER+) breast cancer (BC) who remained premenopausal or regained ovarian function after chemotherapy.
Major finding: The 8-year DFS rates improved consistently in women who received tamoxifen + OFS vs tamoxifen only (85.4% vs 80.2%; hazard ratio 0.67; P = .003). Although the 8-year OS rates were comparable between both treatment groups (P = .305), they were considerably high (>95%).
Study details: Findings are from an 8-year follow-up of the phase 3 ASTRRA trial including 1282 premenopausal women with ER+ BC, who remained premenopausal or regained ovarian function after chemotherapy and were randomly assigned to receive tamoxifen with or without OFS.
Disclosures: This study was supported by the Korea Health Industry Development Institute, Republic of Korea. Some authors declared receiving honoraria or research funding from or serving in consulting or advisory roles with various sources.
Source: Baek SY et al. Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: An 8-year follow-up of the ASTRRA trial. J Clin Oncol. 2023 (Aug 22). doi: 10.1200/JCO.23.00557