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Quality of life predicts chemo tolerance in early breast cancer

Article Type
Changed
Fri, 02/03/2023 - 12:37

Fatigue and poor physical functioning before starting treatment for early breast cancer were independently associated with chemotherapy dose reductions and postchemotherapy toxicities, a new analysis found.

Baseline quality-of-life measures, most often fatigue and physical functioning, have “been associated with survival in various cancers,” the authors explain. These latest findings signal that assessing fatigue and physical functioning prior to treatment “could help to identify patients who are at risk for poor chemotherapy tolerability.”

The findings were published online in the journal Cancer.

Although quality of life is recognized as a predictor of survival in patients with advanced cancer, the evidence is less clear in early-stage breast cancer.

To understand the role quality-of-life measures play in early breast cancer, the investigators performed an ancillary analysis of the French Cancer and Toxicities (CANTO) study, which enrolled women with newly diagnosed stage I-III invasive breast cancer at 26 centers in France.

The ancillary CANTO‐PRED study was designed to explore the association between baseline quality of life measures and chemotherapy dose reductions and postchemotherapy toxicities among 3,079 patients with early breast cancer. This included 718 patients who received chemotherapy in the neoadjuvant setting and 2,361 who received chemotherapy as adjuvant treatment.

Most patients received taxanes (94.2%) and/or anthracyclines (90.5%). Other major adjuvant treatments were breast radiation therapy (92.6%), trastuzumab (21%), and endocrine therapy (74%), and all women underwent either breast-conserving surgery (74%) and/or lymph node dissection (60%). Fatigue and physical functioning were measured using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.

Among the 3,079 patients, 15.5% experienced chemotherapy dose reductions and 31% developed postchemotherapy toxicities.

After multivariable adjustment for clinical and patient factors, those with baseline fatigue scores greater than 39 (vs. 39 or less) had higher odds of chemotherapy dose reductions (odds ratio, 1.43) and postchemotherapy toxicities (OR, 1.32). Those with baseline physical functioning scores less than 83 (vs. 83 or higher) also had higher odds of chemotherapy dose reductions (OR, 1.54) and postchemotherapy toxicities (OR, 1.50), the authors found.

In addition, cognitive functioning, pain, sleep disturbances, and appetite loss dimensions were associated with both chemotherapy dose reductions and postchemotherapy toxicities, whereas nausea, vomiting, and dyspnea were associated with postchemotherapy toxicities.

The researchers also found that performance status was not associated with chemotherapy dose reductions or postchemotherapy toxicities, suggesting patient-reported quality of life may be a better predictor of outcomes, the authors said.

“The ability to predict important toxicities with baseline information could lead to improvements in the prevention and management of adverse treatment effects by targeting a group of patients who may need [dose reductions] or may have residual toxicities,” the authors concluded.

This study was funded by the French National Research Agency. The authors reported various relevant financial relationships.
 

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

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Fatigue and poor physical functioning before starting treatment for early breast cancer were independently associated with chemotherapy dose reductions and postchemotherapy toxicities, a new analysis found.

Baseline quality-of-life measures, most often fatigue and physical functioning, have “been associated with survival in various cancers,” the authors explain. These latest findings signal that assessing fatigue and physical functioning prior to treatment “could help to identify patients who are at risk for poor chemotherapy tolerability.”

The findings were published online in the journal Cancer.

Although quality of life is recognized as a predictor of survival in patients with advanced cancer, the evidence is less clear in early-stage breast cancer.

To understand the role quality-of-life measures play in early breast cancer, the investigators performed an ancillary analysis of the French Cancer and Toxicities (CANTO) study, which enrolled women with newly diagnosed stage I-III invasive breast cancer at 26 centers in France.

The ancillary CANTO‐PRED study was designed to explore the association between baseline quality of life measures and chemotherapy dose reductions and postchemotherapy toxicities among 3,079 patients with early breast cancer. This included 718 patients who received chemotherapy in the neoadjuvant setting and 2,361 who received chemotherapy as adjuvant treatment.

Most patients received taxanes (94.2%) and/or anthracyclines (90.5%). Other major adjuvant treatments were breast radiation therapy (92.6%), trastuzumab (21%), and endocrine therapy (74%), and all women underwent either breast-conserving surgery (74%) and/or lymph node dissection (60%). Fatigue and physical functioning were measured using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.

Among the 3,079 patients, 15.5% experienced chemotherapy dose reductions and 31% developed postchemotherapy toxicities.

After multivariable adjustment for clinical and patient factors, those with baseline fatigue scores greater than 39 (vs. 39 or less) had higher odds of chemotherapy dose reductions (odds ratio, 1.43) and postchemotherapy toxicities (OR, 1.32). Those with baseline physical functioning scores less than 83 (vs. 83 or higher) also had higher odds of chemotherapy dose reductions (OR, 1.54) and postchemotherapy toxicities (OR, 1.50), the authors found.

In addition, cognitive functioning, pain, sleep disturbances, and appetite loss dimensions were associated with both chemotherapy dose reductions and postchemotherapy toxicities, whereas nausea, vomiting, and dyspnea were associated with postchemotherapy toxicities.

The researchers also found that performance status was not associated with chemotherapy dose reductions or postchemotherapy toxicities, suggesting patient-reported quality of life may be a better predictor of outcomes, the authors said.

“The ability to predict important toxicities with baseline information could lead to improvements in the prevention and management of adverse treatment effects by targeting a group of patients who may need [dose reductions] or may have residual toxicities,” the authors concluded.

This study was funded by the French National Research Agency. The authors reported various relevant financial relationships.
 

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

Fatigue and poor physical functioning before starting treatment for early breast cancer were independently associated with chemotherapy dose reductions and postchemotherapy toxicities, a new analysis found.

Baseline quality-of-life measures, most often fatigue and physical functioning, have “been associated with survival in various cancers,” the authors explain. These latest findings signal that assessing fatigue and physical functioning prior to treatment “could help to identify patients who are at risk for poor chemotherapy tolerability.”

The findings were published online in the journal Cancer.

Although quality of life is recognized as a predictor of survival in patients with advanced cancer, the evidence is less clear in early-stage breast cancer.

To understand the role quality-of-life measures play in early breast cancer, the investigators performed an ancillary analysis of the French Cancer and Toxicities (CANTO) study, which enrolled women with newly diagnosed stage I-III invasive breast cancer at 26 centers in France.

The ancillary CANTO‐PRED study was designed to explore the association between baseline quality of life measures and chemotherapy dose reductions and postchemotherapy toxicities among 3,079 patients with early breast cancer. This included 718 patients who received chemotherapy in the neoadjuvant setting and 2,361 who received chemotherapy as adjuvant treatment.

Most patients received taxanes (94.2%) and/or anthracyclines (90.5%). Other major adjuvant treatments were breast radiation therapy (92.6%), trastuzumab (21%), and endocrine therapy (74%), and all women underwent either breast-conserving surgery (74%) and/or lymph node dissection (60%). Fatigue and physical functioning were measured using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.

Among the 3,079 patients, 15.5% experienced chemotherapy dose reductions and 31% developed postchemotherapy toxicities.

After multivariable adjustment for clinical and patient factors, those with baseline fatigue scores greater than 39 (vs. 39 or less) had higher odds of chemotherapy dose reductions (odds ratio, 1.43) and postchemotherapy toxicities (OR, 1.32). Those with baseline physical functioning scores less than 83 (vs. 83 or higher) also had higher odds of chemotherapy dose reductions (OR, 1.54) and postchemotherapy toxicities (OR, 1.50), the authors found.

In addition, cognitive functioning, pain, sleep disturbances, and appetite loss dimensions were associated with both chemotherapy dose reductions and postchemotherapy toxicities, whereas nausea, vomiting, and dyspnea were associated with postchemotherapy toxicities.

The researchers also found that performance status was not associated with chemotherapy dose reductions or postchemotherapy toxicities, suggesting patient-reported quality of life may be a better predictor of outcomes, the authors said.

“The ability to predict important toxicities with baseline information could lead to improvements in the prevention and management of adverse treatment effects by targeting a group of patients who may need [dose reductions] or may have residual toxicities,” the authors concluded.

This study was funded by the French National Research Agency. The authors reported various relevant financial relationships.
 

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

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FDA OKs elacestrant for ESR1+ advanced, metastatic breast cancer

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Changed
Thu, 02/02/2023 - 15:47

The Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that progressed on at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic to identify breast cancer patients who meet the treatment requirements, according to the agency’s press release announcing the approval.

The novel oral selective estrogen receptor degrader was approved based on the phase 3 EMERALD trial, which included 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer, about half of whom had ESR1 mutations. Patients had progressed on one or two prior lines of endocrine therapy, including one containing a CDK4/6 inhibitor. Participants could also have had one prior line of chemotherapy in the advanced or metastatic setting.

Participants were randomized 1:1 to either elacestrant 345 mg orally once daily or investigator’s choice of endocrine therapy, which included fulvestrant or an aromatase inhibitor.

In the 228 patients (48%) with ESR1 mutations, median progression-free survival (PFS) was 3.8 months with elacestrant versus 1.9 months in the fulvestrant or aromatase inhibitor arm (hazard ratio, 0.55; P = .0005). Investigators observed no statistically significant PFS difference between the treatment arms in patients who didn’t have the mutation.
 

Fair comparison?

In June, experts raised concerns about the adequacy of the “standard of care” control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.

“The expression ‘standard of care’ is applied generously, as the control arm is restricted” to single agents and no combinations, which “may have led to a substandard” comparison group, Timothée Olivier, MD, Geneva University Hospital, and Vinay Prasad, MD, MPH, University of California, San Francisco, said in an editorial quoted in the piece.

EMERALD investigators acknowledged that there were issues with the control group, noting that in the “United States and Europe, combination therapy with fulvestrant” – instead of single agents – “is increasingly being used as the second-line [standard of care] treatment.”

However, the goal of the study “was to compare a novel endocrine therapy vs. currently available endocrine therapies,” not combination regimens, the investigators said.

Also, “the benefit of elacestrant over fulvestrant and AIs [aromatase inhibitors] in our monotherapy trial ... suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.”
 

Lipid monitoring necessary

The most common adverse events with elacestrant, occurring in 10% or more of patients, are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia, according to labeling.

Labeling warns that elacestrant “may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.”

The recommended elacestrant dose is the trial dose, 345 mg orally with food once daily until disease progression or unacceptable toxicity.

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

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The Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that progressed on at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic to identify breast cancer patients who meet the treatment requirements, according to the agency’s press release announcing the approval.

The novel oral selective estrogen receptor degrader was approved based on the phase 3 EMERALD trial, which included 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer, about half of whom had ESR1 mutations. Patients had progressed on one or two prior lines of endocrine therapy, including one containing a CDK4/6 inhibitor. Participants could also have had one prior line of chemotherapy in the advanced or metastatic setting.

Participants were randomized 1:1 to either elacestrant 345 mg orally once daily or investigator’s choice of endocrine therapy, which included fulvestrant or an aromatase inhibitor.

In the 228 patients (48%) with ESR1 mutations, median progression-free survival (PFS) was 3.8 months with elacestrant versus 1.9 months in the fulvestrant or aromatase inhibitor arm (hazard ratio, 0.55; P = .0005). Investigators observed no statistically significant PFS difference between the treatment arms in patients who didn’t have the mutation.
 

Fair comparison?

In June, experts raised concerns about the adequacy of the “standard of care” control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.

“The expression ‘standard of care’ is applied generously, as the control arm is restricted” to single agents and no combinations, which “may have led to a substandard” comparison group, Timothée Olivier, MD, Geneva University Hospital, and Vinay Prasad, MD, MPH, University of California, San Francisco, said in an editorial quoted in the piece.

EMERALD investigators acknowledged that there were issues with the control group, noting that in the “United States and Europe, combination therapy with fulvestrant” – instead of single agents – “is increasingly being used as the second-line [standard of care] treatment.”

However, the goal of the study “was to compare a novel endocrine therapy vs. currently available endocrine therapies,” not combination regimens, the investigators said.

Also, “the benefit of elacestrant over fulvestrant and AIs [aromatase inhibitors] in our monotherapy trial ... suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.”
 

Lipid monitoring necessary

The most common adverse events with elacestrant, occurring in 10% or more of patients, are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia, according to labeling.

Labeling warns that elacestrant “may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.”

The recommended elacestrant dose is the trial dose, 345 mg orally with food once daily until disease progression or unacceptable toxicity.

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

The Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that progressed on at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic to identify breast cancer patients who meet the treatment requirements, according to the agency’s press release announcing the approval.

The novel oral selective estrogen receptor degrader was approved based on the phase 3 EMERALD trial, which included 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer, about half of whom had ESR1 mutations. Patients had progressed on one or two prior lines of endocrine therapy, including one containing a CDK4/6 inhibitor. Participants could also have had one prior line of chemotherapy in the advanced or metastatic setting.

Participants were randomized 1:1 to either elacestrant 345 mg orally once daily or investigator’s choice of endocrine therapy, which included fulvestrant or an aromatase inhibitor.

In the 228 patients (48%) with ESR1 mutations, median progression-free survival (PFS) was 3.8 months with elacestrant versus 1.9 months in the fulvestrant or aromatase inhibitor arm (hazard ratio, 0.55; P = .0005). Investigators observed no statistically significant PFS difference between the treatment arms in patients who didn’t have the mutation.
 

Fair comparison?

In June, experts raised concerns about the adequacy of the “standard of care” control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.

“The expression ‘standard of care’ is applied generously, as the control arm is restricted” to single agents and no combinations, which “may have led to a substandard” comparison group, Timothée Olivier, MD, Geneva University Hospital, and Vinay Prasad, MD, MPH, University of California, San Francisco, said in an editorial quoted in the piece.

EMERALD investigators acknowledged that there were issues with the control group, noting that in the “United States and Europe, combination therapy with fulvestrant” – instead of single agents – “is increasingly being used as the second-line [standard of care] treatment.”

However, the goal of the study “was to compare a novel endocrine therapy vs. currently available endocrine therapies,” not combination regimens, the investigators said.

Also, “the benefit of elacestrant over fulvestrant and AIs [aromatase inhibitors] in our monotherapy trial ... suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.”
 

Lipid monitoring necessary

The most common adverse events with elacestrant, occurring in 10% or more of patients, are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia, according to labeling.

Labeling warns that elacestrant “may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.”

The recommended elacestrant dose is the trial dose, 345 mg orally with food once daily until disease progression or unacceptable toxicity.

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

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Commentary: Genetic variants, ovarian suppression, and metabolic syndrome in BC, February 2023

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Changed
Wed, 02/22/2023 - 20:23

Yara Abdou, MD
A recently published study by Yadav and colleagues looked at the risk for contralateral breast cancer (BC) among women with germline pathogenic variants (PV) in ATMBRCA1BRCA2CHEK2, and PALB2. The analysis included 15,104 prospectively followed women within the CARRIERS study treated with ipsilateral surgery for invasive BC. Findings showed that women with invasive BC who have germline PV in BRCA1, BRCA2, CHEK2, or PALB2 have a significantly higher risk for contralateral BC than do those without these PV. However, ATM PV carriers did not have significantly increased risks for contralateral BC. The overall risk for contralateral BC was significantly elevated in all women with germline PV in BRCA1 (hazard ratio [HR] 2.7; P < .001), BRCA2 (HR 3.0; P < .001), and CHEK2 (HR 1.9; P = .03). Only the subset of PALB2 PV carriers with estrogen receptor (ER)–negative BC had increased risk for contralateral BC (HR 2.9; P = .006). The study also examined associations by race or ethnicity and age, showing that Black PV carriers had similarly elevated risks for contralateral BC compared with non-Hispanic White PV carriers. In addition, premenopausal women had higher 10-year cumulative incidence of contralateral BC compared with postmenopausal PV carriers (33% vs 12% for BRCA1, 27% vs 9% for BRCA2, 13% vs 4% for CHEK2 PV carriers). In conclusion, there is a substantially increased risk for contralateral BC among women with germline PV, and therefore, these patients would benefit from risk reduction approaches and enhanced surveillance strategies.

Poly-(ADP-ribose) polymerase (PARP) inhibitors have emerged as essential therapeutic agents in patients with germline BRCA1/2-mutated BC. A BRCA-like phenotype is displayed by a large subset of patients with germline BRCA1/2-wildtype BC who present with homologous recombination deficiency (HRD). The randomized phase 2 S1416 trial (Rodler et al) evaluated the efficacy of cisplatin combined with the PARP inhibitor veliparib in three cohorts of metastatic BC: mutated germline BRCA1/2, BRCA-like, and non-BRCA–like. A total of 335 patients with metastatic or recurrent triple-negative BC (TNBC) or germline BRCA1/2-mutated metastatic BC were randomly assigned (1:1) to receive cisplatin plus either veliparib or a matching placebo. The findings showed that the addition of veliparib to cisplatin significantly improved progression-free survival (PFS) in patients with BRCA-like metastatic TNBC compared with placebo (5.9 vs 4.2 months; HR 0.57; log-rank P = .01), but not in mutated germline BRCA1/2 (6.2 vs 6.4 months; P = .54) and non-BRCA–like (4.0 vs 3.0 months; P = .57) groups. No new toxicity signals were observed. These findings suggest BRCA-like TNBC might show sensitivity to PARP inhibitors and therefore these agents should be explored further in this cohort.

A recent update from the combined analysis of the SOFT and TEXT studies comparing outcomes in 4690 premenopausal women with estrogen/progesterone receptor–positive early BC (Pagani et al) showed that exemestane plus ovarian function suppression (OFS) led to a greater reduction in recurrence risk compared with tamoxifen plus OFS in premenopausal women. After a median follow-up of 13 years, results showed a 4.6% absolute improvement in 12-year disease-free survival (HR 0.79; P < .001) and a 1.8% absolute improvement in disease recurrence-free interval (HR 0.83; P = .03) with exemestane plus OFS compared with tamoxifen plus OFS. These treatment effects on recurrence began to attenuate over time, being strongest in the first 5 years with no further improvement after 10 or more years. No improvement in overall survival (OS) was noted with exemestane vs tamoxifen, although both arms had excellent survival outcomes (90.1% vs 89.1%; HR 0.93; 95% CI 0.78-1.11). It is important to note that there was a 3.3% absolute improvement in 12-year OS with exemestane plus OFS among patients with HER2-negative tumors who received chemotherapy. This OS benefit was also noted amongst patients with high-risk clinicopathologic characteristics (<35 years and those with > 2 cm or grade 3 tumors), ranging from 4.0% to 5.5% absolute improvement. In conclusion, sustained recurrence risk reductions were noted with adjuvant exemestane plus OFS compared with tamoxifen plus OFS, with the most clinically meaningful survival benefit noted for patients with higher risk tumors. Proper selection of patients who are most likely to benefit from exemestane over tamoxifen is vital to maximize the survival benefit while minimizing the burden of treatment intensification.

Findings from a retrospective study including 221 women with BC who received preoperative neoadjuvant chemotherapy (NAC) showed that the presence of metabolic syndrome (MetS) worsened survival outcomes and increased disease recurrence risk (Zhou et al). Patients were divided into MetS and non-MetS groups according to National Cholesterol Education Program Adult Treatment Panel III criteria to investigate the association between MetS and clinicopathologic characteristics, pathologic complete response (pCR), and long-term survival. The MetS group had a significantly lower likelihood of achieving pCR after NAC compared with the non-MetS group (odds ratio [OR] 0.316; P = .028), with the risk for death (OR 2.587; P = .004) and disease recurrence (OR 2.228; P = .007) being significantly higher in patients with vs without MetS. In a multivariate analysis, MetS (P = 0.028) and hormone receptors status were independent predictors of pCR after NAC in BC. These findings emphasize the importance of timely intervention of metabolic syndrome to improve outcomes in patients with BC.

Author and Disclosure Information

Yara Abdou, MD
Breast Medical Oncologist
Assistant Professor, Division of Oncology
University of North Carolina at Chapel Hill
Lineberger Comprehensive Cancer Center

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Yara Abdou, MD
Breast Medical Oncologist
Assistant Professor, Division of Oncology
University of North Carolina at Chapel Hill
Lineberger Comprehensive Cancer Center

Author and Disclosure Information

Yara Abdou, MD
Breast Medical Oncologist
Assistant Professor, Division of Oncology
University of North Carolina at Chapel Hill
Lineberger Comprehensive Cancer Center

Yara Abdou, MD
A recently published study by Yadav and colleagues looked at the risk for contralateral breast cancer (BC) among women with germline pathogenic variants (PV) in ATMBRCA1BRCA2CHEK2, and PALB2. The analysis included 15,104 prospectively followed women within the CARRIERS study treated with ipsilateral surgery for invasive BC. Findings showed that women with invasive BC who have germline PV in BRCA1, BRCA2, CHEK2, or PALB2 have a significantly higher risk for contralateral BC than do those without these PV. However, ATM PV carriers did not have significantly increased risks for contralateral BC. The overall risk for contralateral BC was significantly elevated in all women with germline PV in BRCA1 (hazard ratio [HR] 2.7; P < .001), BRCA2 (HR 3.0; P < .001), and CHEK2 (HR 1.9; P = .03). Only the subset of PALB2 PV carriers with estrogen receptor (ER)–negative BC had increased risk for contralateral BC (HR 2.9; P = .006). The study also examined associations by race or ethnicity and age, showing that Black PV carriers had similarly elevated risks for contralateral BC compared with non-Hispanic White PV carriers. In addition, premenopausal women had higher 10-year cumulative incidence of contralateral BC compared with postmenopausal PV carriers (33% vs 12% for BRCA1, 27% vs 9% for BRCA2, 13% vs 4% for CHEK2 PV carriers). In conclusion, there is a substantially increased risk for contralateral BC among women with germline PV, and therefore, these patients would benefit from risk reduction approaches and enhanced surveillance strategies.

Poly-(ADP-ribose) polymerase (PARP) inhibitors have emerged as essential therapeutic agents in patients with germline BRCA1/2-mutated BC. A BRCA-like phenotype is displayed by a large subset of patients with germline BRCA1/2-wildtype BC who present with homologous recombination deficiency (HRD). The randomized phase 2 S1416 trial (Rodler et al) evaluated the efficacy of cisplatin combined with the PARP inhibitor veliparib in three cohorts of metastatic BC: mutated germline BRCA1/2, BRCA-like, and non-BRCA–like. A total of 335 patients with metastatic or recurrent triple-negative BC (TNBC) or germline BRCA1/2-mutated metastatic BC were randomly assigned (1:1) to receive cisplatin plus either veliparib or a matching placebo. The findings showed that the addition of veliparib to cisplatin significantly improved progression-free survival (PFS) in patients with BRCA-like metastatic TNBC compared with placebo (5.9 vs 4.2 months; HR 0.57; log-rank P = .01), but not in mutated germline BRCA1/2 (6.2 vs 6.4 months; P = .54) and non-BRCA–like (4.0 vs 3.0 months; P = .57) groups. No new toxicity signals were observed. These findings suggest BRCA-like TNBC might show sensitivity to PARP inhibitors and therefore these agents should be explored further in this cohort.

A recent update from the combined analysis of the SOFT and TEXT studies comparing outcomes in 4690 premenopausal women with estrogen/progesterone receptor–positive early BC (Pagani et al) showed that exemestane plus ovarian function suppression (OFS) led to a greater reduction in recurrence risk compared with tamoxifen plus OFS in premenopausal women. After a median follow-up of 13 years, results showed a 4.6% absolute improvement in 12-year disease-free survival (HR 0.79; P < .001) and a 1.8% absolute improvement in disease recurrence-free interval (HR 0.83; P = .03) with exemestane plus OFS compared with tamoxifen plus OFS. These treatment effects on recurrence began to attenuate over time, being strongest in the first 5 years with no further improvement after 10 or more years. No improvement in overall survival (OS) was noted with exemestane vs tamoxifen, although both arms had excellent survival outcomes (90.1% vs 89.1%; HR 0.93; 95% CI 0.78-1.11). It is important to note that there was a 3.3% absolute improvement in 12-year OS with exemestane plus OFS among patients with HER2-negative tumors who received chemotherapy. This OS benefit was also noted amongst patients with high-risk clinicopathologic characteristics (<35 years and those with > 2 cm or grade 3 tumors), ranging from 4.0% to 5.5% absolute improvement. In conclusion, sustained recurrence risk reductions were noted with adjuvant exemestane plus OFS compared with tamoxifen plus OFS, with the most clinically meaningful survival benefit noted for patients with higher risk tumors. Proper selection of patients who are most likely to benefit from exemestane over tamoxifen is vital to maximize the survival benefit while minimizing the burden of treatment intensification.

Findings from a retrospective study including 221 women with BC who received preoperative neoadjuvant chemotherapy (NAC) showed that the presence of metabolic syndrome (MetS) worsened survival outcomes and increased disease recurrence risk (Zhou et al). Patients were divided into MetS and non-MetS groups according to National Cholesterol Education Program Adult Treatment Panel III criteria to investigate the association between MetS and clinicopathologic characteristics, pathologic complete response (pCR), and long-term survival. The MetS group had a significantly lower likelihood of achieving pCR after NAC compared with the non-MetS group (odds ratio [OR] 0.316; P = .028), with the risk for death (OR 2.587; P = .004) and disease recurrence (OR 2.228; P = .007) being significantly higher in patients with vs without MetS. In a multivariate analysis, MetS (P = 0.028) and hormone receptors status were independent predictors of pCR after NAC in BC. These findings emphasize the importance of timely intervention of metabolic syndrome to improve outcomes in patients with BC.

Yara Abdou, MD
A recently published study by Yadav and colleagues looked at the risk for contralateral breast cancer (BC) among women with germline pathogenic variants (PV) in ATMBRCA1BRCA2CHEK2, and PALB2. The analysis included 15,104 prospectively followed women within the CARRIERS study treated with ipsilateral surgery for invasive BC. Findings showed that women with invasive BC who have germline PV in BRCA1, BRCA2, CHEK2, or PALB2 have a significantly higher risk for contralateral BC than do those without these PV. However, ATM PV carriers did not have significantly increased risks for contralateral BC. The overall risk for contralateral BC was significantly elevated in all women with germline PV in BRCA1 (hazard ratio [HR] 2.7; P < .001), BRCA2 (HR 3.0; P < .001), and CHEK2 (HR 1.9; P = .03). Only the subset of PALB2 PV carriers with estrogen receptor (ER)–negative BC had increased risk for contralateral BC (HR 2.9; P = .006). The study also examined associations by race or ethnicity and age, showing that Black PV carriers had similarly elevated risks for contralateral BC compared with non-Hispanic White PV carriers. In addition, premenopausal women had higher 10-year cumulative incidence of contralateral BC compared with postmenopausal PV carriers (33% vs 12% for BRCA1, 27% vs 9% for BRCA2, 13% vs 4% for CHEK2 PV carriers). In conclusion, there is a substantially increased risk for contralateral BC among women with germline PV, and therefore, these patients would benefit from risk reduction approaches and enhanced surveillance strategies.

Poly-(ADP-ribose) polymerase (PARP) inhibitors have emerged as essential therapeutic agents in patients with germline BRCA1/2-mutated BC. A BRCA-like phenotype is displayed by a large subset of patients with germline BRCA1/2-wildtype BC who present with homologous recombination deficiency (HRD). The randomized phase 2 S1416 trial (Rodler et al) evaluated the efficacy of cisplatin combined with the PARP inhibitor veliparib in three cohorts of metastatic BC: mutated germline BRCA1/2, BRCA-like, and non-BRCA–like. A total of 335 patients with metastatic or recurrent triple-negative BC (TNBC) or germline BRCA1/2-mutated metastatic BC were randomly assigned (1:1) to receive cisplatin plus either veliparib or a matching placebo. The findings showed that the addition of veliparib to cisplatin significantly improved progression-free survival (PFS) in patients with BRCA-like metastatic TNBC compared with placebo (5.9 vs 4.2 months; HR 0.57; log-rank P = .01), but not in mutated germline BRCA1/2 (6.2 vs 6.4 months; P = .54) and non-BRCA–like (4.0 vs 3.0 months; P = .57) groups. No new toxicity signals were observed. These findings suggest BRCA-like TNBC might show sensitivity to PARP inhibitors and therefore these agents should be explored further in this cohort.

A recent update from the combined analysis of the SOFT and TEXT studies comparing outcomes in 4690 premenopausal women with estrogen/progesterone receptor–positive early BC (Pagani et al) showed that exemestane plus ovarian function suppression (OFS) led to a greater reduction in recurrence risk compared with tamoxifen plus OFS in premenopausal women. After a median follow-up of 13 years, results showed a 4.6% absolute improvement in 12-year disease-free survival (HR 0.79; P < .001) and a 1.8% absolute improvement in disease recurrence-free interval (HR 0.83; P = .03) with exemestane plus OFS compared with tamoxifen plus OFS. These treatment effects on recurrence began to attenuate over time, being strongest in the first 5 years with no further improvement after 10 or more years. No improvement in overall survival (OS) was noted with exemestane vs tamoxifen, although both arms had excellent survival outcomes (90.1% vs 89.1%; HR 0.93; 95% CI 0.78-1.11). It is important to note that there was a 3.3% absolute improvement in 12-year OS with exemestane plus OFS among patients with HER2-negative tumors who received chemotherapy. This OS benefit was also noted amongst patients with high-risk clinicopathologic characteristics (<35 years and those with > 2 cm or grade 3 tumors), ranging from 4.0% to 5.5% absolute improvement. In conclusion, sustained recurrence risk reductions were noted with adjuvant exemestane plus OFS compared with tamoxifen plus OFS, with the most clinically meaningful survival benefit noted for patients with higher risk tumors. Proper selection of patients who are most likely to benefit from exemestane over tamoxifen is vital to maximize the survival benefit while minimizing the burden of treatment intensification.

Findings from a retrospective study including 221 women with BC who received preoperative neoadjuvant chemotherapy (NAC) showed that the presence of metabolic syndrome (MetS) worsened survival outcomes and increased disease recurrence risk (Zhou et al). Patients were divided into MetS and non-MetS groups according to National Cholesterol Education Program Adult Treatment Panel III criteria to investigate the association between MetS and clinicopathologic characteristics, pathologic complete response (pCR), and long-term survival. The MetS group had a significantly lower likelihood of achieving pCR after NAC compared with the non-MetS group (odds ratio [OR] 0.316; P = .028), with the risk for death (OR 2.587; P = .004) and disease recurrence (OR 2.228; P = .007) being significantly higher in patients with vs without MetS. In a multivariate analysis, MetS (P = 0.028) and hormone receptors status were independent predictors of pCR after NAC in BC. These findings emphasize the importance of timely intervention of metabolic syndrome to improve outcomes in patients with BC.

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Disparities in breast cancer deaths, MRI screening persist

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Despite improvements in access to health coverage under the Affordable Care Act (ACA), racial disparities in breast cancer mortality rates persist and the underuse of advanced breast imaging may be one culprit, experts say.
 

In a recent position statement, researchers highlighted the disproportionally high breast cancer mortality rates among Black women in Louisiana – a state that has one of the highest breast cancer mortality rates in the nation. In 2019, the breast cancer mortality rate among Black women in Louisiana was 29.3 per 100,000 women compared with the national rate of 19.4 per 100,000.

Although Louisiana has made strides in improving access to breast cancer screening in recent years, the use of advanced imaging – specifically breast MRI – remains underused in this high-risk population. A major barrier to wider use of breast MRI has been cost, and ACA expansion led to higher, not lower, out-of-pocket costs for this screening modality.

“Breast MRI is a powerful imaging tool for early detection and for screening women at high risk for breast cancer,” wrote the researchers, led by Brooke L. Morrell, MD, of Louisiana State University Health and Sciences Center, New Orleans.

However, greater access to health care has not necessarily translated to increased breast MRI screening or improved survival among Black women. Even years after the adoption of the ACA, “Black women in Louisiana continue to die of breast cancer at rates significantly greater than the national average,” the authors wrote.

The position statement was published in Cancer.

Breast MRI is known to provide the highest rate of breast cancer detection among commonly used imaging options, with a sensitivity ranging from 81% to 100%. That’s about twice as high as the sensitivity range for mammography after factoring in breast density.

“This is of particular importance when we consider the risk‐based screening of younger populations, in which dense breasts are more prevalent,” the authors explained.

For Black women in particular, studies show nearly a quarter (23%) who develop breast cancer are diagnosed under the age of 50, compared with 16% of White women. Black women are also more likely to develop more aggressive, premenopausal breast cancers, including triple-negative breast cancer, that are more easily detected on MRI.

“Adding supplemental screening breast MRI to annual mammography in higher risk women has been shown to detect up to 18 additional cancers out of 1,000 patients,” Dr. Morrell said. And “many of these cancers are detected much earlier than with mammography alone.”

Still, with ACA expansion, out-of-pocket costs for breast MRI actually increased. This increase likely occurred, in part, because the financial protections outlined in the ACA’s Women’s Preventive Services Guidelines covered mammograms but not breast MRI.

More specifically, under the ACA, Medicaid and most private health insurance plans are required to provide coverage for mammograms at no cost to the patient. The percentage of health plans providing zero cost sharing for mammograms increased under the ACA from 81.9% to 96.8%, but the corresponding rates of zero cost sharing for breast MRI screening went in the opposite direction – from 43.1% in 2009 to only 26.2% in 2017, a 2022 study found.

This study also highlighted geographic variations in zero cost sharing and out-of-pocket costs for screening breast MRI, with a higher financial burden observed for women living in the South. In addition, studies have demonstrated that race and socioeconomic factors, including education and income, play a role in the underuse of screening, including breast MRI.

These factors all likely contribute to screening breast MRI remaining inaccessible to many women, Dr. Morrell and colleagues said.

The authors also outlined three key action items that could help address barriers to MRI breast screening, which include reducing the high cost of breast MRI, lobbying to include breast MRI in ACA protections, and addressing knowledge gaps among patients and clinicians to better identify women who might benefit from breast MRI.

On the financial front, the team explained that a central driver for high costs is the scan time for breast MRI, which could be substantially reduced from 30 to 5 minutes, using an abbreviated protocol.

“Widespread use of low‐cost breast abbreviated MRI screening could remove the cost barrier of adding breast MRI screening to ACA coverage,” without compromising diagnostic accuracy, the authors noted.

Further efforts should focus on overcoming cultural barriers, including fear and mistrust of the health care system among Black women. Outreach efforts could include public campaigns or town hall and church gatherings that enlist patient navigators, advocates, or community members.

“Our visibility in the community builds trust and affords us the opportunity to share knowledge that may empower women to be their own health advocates,” the authors wrote.

In terms of the feasibility of revising ACA policies to improve breast MRI access and affordability, Dr. Morrell pointed to improvements made in colon cancer screening.

“Studies have demonstrated that after ACA policy changes lowering out-of-pocket cost for colonoscopies, screening colonoscopy rates significantly increased among men, predominantly in socioeconomically disadvantaged population,” she noted. “Similarly, we should investigate how to this can be applied to screening breast MRI.”

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

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Despite improvements in access to health coverage under the Affordable Care Act (ACA), racial disparities in breast cancer mortality rates persist and the underuse of advanced breast imaging may be one culprit, experts say.
 

In a recent position statement, researchers highlighted the disproportionally high breast cancer mortality rates among Black women in Louisiana – a state that has one of the highest breast cancer mortality rates in the nation. In 2019, the breast cancer mortality rate among Black women in Louisiana was 29.3 per 100,000 women compared with the national rate of 19.4 per 100,000.

Although Louisiana has made strides in improving access to breast cancer screening in recent years, the use of advanced imaging – specifically breast MRI – remains underused in this high-risk population. A major barrier to wider use of breast MRI has been cost, and ACA expansion led to higher, not lower, out-of-pocket costs for this screening modality.

“Breast MRI is a powerful imaging tool for early detection and for screening women at high risk for breast cancer,” wrote the researchers, led by Brooke L. Morrell, MD, of Louisiana State University Health and Sciences Center, New Orleans.

However, greater access to health care has not necessarily translated to increased breast MRI screening or improved survival among Black women. Even years after the adoption of the ACA, “Black women in Louisiana continue to die of breast cancer at rates significantly greater than the national average,” the authors wrote.

The position statement was published in Cancer.

Breast MRI is known to provide the highest rate of breast cancer detection among commonly used imaging options, with a sensitivity ranging from 81% to 100%. That’s about twice as high as the sensitivity range for mammography after factoring in breast density.

“This is of particular importance when we consider the risk‐based screening of younger populations, in which dense breasts are more prevalent,” the authors explained.

For Black women in particular, studies show nearly a quarter (23%) who develop breast cancer are diagnosed under the age of 50, compared with 16% of White women. Black women are also more likely to develop more aggressive, premenopausal breast cancers, including triple-negative breast cancer, that are more easily detected on MRI.

“Adding supplemental screening breast MRI to annual mammography in higher risk women has been shown to detect up to 18 additional cancers out of 1,000 patients,” Dr. Morrell said. And “many of these cancers are detected much earlier than with mammography alone.”

Still, with ACA expansion, out-of-pocket costs for breast MRI actually increased. This increase likely occurred, in part, because the financial protections outlined in the ACA’s Women’s Preventive Services Guidelines covered mammograms but not breast MRI.

More specifically, under the ACA, Medicaid and most private health insurance plans are required to provide coverage for mammograms at no cost to the patient. The percentage of health plans providing zero cost sharing for mammograms increased under the ACA from 81.9% to 96.8%, but the corresponding rates of zero cost sharing for breast MRI screening went in the opposite direction – from 43.1% in 2009 to only 26.2% in 2017, a 2022 study found.

This study also highlighted geographic variations in zero cost sharing and out-of-pocket costs for screening breast MRI, with a higher financial burden observed for women living in the South. In addition, studies have demonstrated that race and socioeconomic factors, including education and income, play a role in the underuse of screening, including breast MRI.

These factors all likely contribute to screening breast MRI remaining inaccessible to many women, Dr. Morrell and colleagues said.

The authors also outlined three key action items that could help address barriers to MRI breast screening, which include reducing the high cost of breast MRI, lobbying to include breast MRI in ACA protections, and addressing knowledge gaps among patients and clinicians to better identify women who might benefit from breast MRI.

On the financial front, the team explained that a central driver for high costs is the scan time for breast MRI, which could be substantially reduced from 30 to 5 minutes, using an abbreviated protocol.

“Widespread use of low‐cost breast abbreviated MRI screening could remove the cost barrier of adding breast MRI screening to ACA coverage,” without compromising diagnostic accuracy, the authors noted.

Further efforts should focus on overcoming cultural barriers, including fear and mistrust of the health care system among Black women. Outreach efforts could include public campaigns or town hall and church gatherings that enlist patient navigators, advocates, or community members.

“Our visibility in the community builds trust and affords us the opportunity to share knowledge that may empower women to be their own health advocates,” the authors wrote.

In terms of the feasibility of revising ACA policies to improve breast MRI access and affordability, Dr. Morrell pointed to improvements made in colon cancer screening.

“Studies have demonstrated that after ACA policy changes lowering out-of-pocket cost for colonoscopies, screening colonoscopy rates significantly increased among men, predominantly in socioeconomically disadvantaged population,” she noted. “Similarly, we should investigate how to this can be applied to screening breast MRI.”

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

Despite improvements in access to health coverage under the Affordable Care Act (ACA), racial disparities in breast cancer mortality rates persist and the underuse of advanced breast imaging may be one culprit, experts say.
 

In a recent position statement, researchers highlighted the disproportionally high breast cancer mortality rates among Black women in Louisiana – a state that has one of the highest breast cancer mortality rates in the nation. In 2019, the breast cancer mortality rate among Black women in Louisiana was 29.3 per 100,000 women compared with the national rate of 19.4 per 100,000.

Although Louisiana has made strides in improving access to breast cancer screening in recent years, the use of advanced imaging – specifically breast MRI – remains underused in this high-risk population. A major barrier to wider use of breast MRI has been cost, and ACA expansion led to higher, not lower, out-of-pocket costs for this screening modality.

“Breast MRI is a powerful imaging tool for early detection and for screening women at high risk for breast cancer,” wrote the researchers, led by Brooke L. Morrell, MD, of Louisiana State University Health and Sciences Center, New Orleans.

However, greater access to health care has not necessarily translated to increased breast MRI screening or improved survival among Black women. Even years after the adoption of the ACA, “Black women in Louisiana continue to die of breast cancer at rates significantly greater than the national average,” the authors wrote.

The position statement was published in Cancer.

Breast MRI is known to provide the highest rate of breast cancer detection among commonly used imaging options, with a sensitivity ranging from 81% to 100%. That’s about twice as high as the sensitivity range for mammography after factoring in breast density.

“This is of particular importance when we consider the risk‐based screening of younger populations, in which dense breasts are more prevalent,” the authors explained.

For Black women in particular, studies show nearly a quarter (23%) who develop breast cancer are diagnosed under the age of 50, compared with 16% of White women. Black women are also more likely to develop more aggressive, premenopausal breast cancers, including triple-negative breast cancer, that are more easily detected on MRI.

“Adding supplemental screening breast MRI to annual mammography in higher risk women has been shown to detect up to 18 additional cancers out of 1,000 patients,” Dr. Morrell said. And “many of these cancers are detected much earlier than with mammography alone.”

Still, with ACA expansion, out-of-pocket costs for breast MRI actually increased. This increase likely occurred, in part, because the financial protections outlined in the ACA’s Women’s Preventive Services Guidelines covered mammograms but not breast MRI.

More specifically, under the ACA, Medicaid and most private health insurance plans are required to provide coverage for mammograms at no cost to the patient. The percentage of health plans providing zero cost sharing for mammograms increased under the ACA from 81.9% to 96.8%, but the corresponding rates of zero cost sharing for breast MRI screening went in the opposite direction – from 43.1% in 2009 to only 26.2% in 2017, a 2022 study found.

This study also highlighted geographic variations in zero cost sharing and out-of-pocket costs for screening breast MRI, with a higher financial burden observed for women living in the South. In addition, studies have demonstrated that race and socioeconomic factors, including education and income, play a role in the underuse of screening, including breast MRI.

These factors all likely contribute to screening breast MRI remaining inaccessible to many women, Dr. Morrell and colleagues said.

The authors also outlined three key action items that could help address barriers to MRI breast screening, which include reducing the high cost of breast MRI, lobbying to include breast MRI in ACA protections, and addressing knowledge gaps among patients and clinicians to better identify women who might benefit from breast MRI.

On the financial front, the team explained that a central driver for high costs is the scan time for breast MRI, which could be substantially reduced from 30 to 5 minutes, using an abbreviated protocol.

“Widespread use of low‐cost breast abbreviated MRI screening could remove the cost barrier of adding breast MRI screening to ACA coverage,” without compromising diagnostic accuracy, the authors noted.

Further efforts should focus on overcoming cultural barriers, including fear and mistrust of the health care system among Black women. Outreach efforts could include public campaigns or town hall and church gatherings that enlist patient navigators, advocates, or community members.

“Our visibility in the community builds trust and affords us the opportunity to share knowledge that may empower women to be their own health advocates,” the authors wrote.

In terms of the feasibility of revising ACA policies to improve breast MRI access and affordability, Dr. Morrell pointed to improvements made in colon cancer screening.

“Studies have demonstrated that after ACA policy changes lowering out-of-pocket cost for colonoscopies, screening colonoscopy rates significantly increased among men, predominantly in socioeconomically disadvantaged population,” she noted. “Similarly, we should investigate how to this can be applied to screening breast MRI.”

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

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Metabolic syndromes worsen outcomes in BC patients treated with neoadjuvant chemotherapy

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Key clinical point: The presence of metabolic syndromes (MetS) worsened survival outcomes and increased disease recurrence risk in patients with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).

Major finding: The MetS group had a significantly lower likelihood of achieving pathological complete response than the non-MetS group (odds ratio [OR] 0.316; P  =  .028), with the risk for death (OR 2.587; P  =  .004) and disease recurrence (OR 2.228; P  =  .007) being significantly higher in patients with vs without MetS.

Study details: Findings are from a retrospective study including 221 women with BC who received preoperative NAC, of which 22.2% of patients were included in the MetS group.

Disclosures: This study was supported by the Beijing Medical Award Foundation. The authors declared no conflicts of interest.

Source: Zhou Z et al. Metabolic syndrome is a risk factor for breast cancer patients receiving neoadjuvant chemotherapy: A case-control study. Front Oncol. 2023;12:1080054 (Jan 4). Doi: 10.3389/fonc.2022.1080054

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Key clinical point: The presence of metabolic syndromes (MetS) worsened survival outcomes and increased disease recurrence risk in patients with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).

Major finding: The MetS group had a significantly lower likelihood of achieving pathological complete response than the non-MetS group (odds ratio [OR] 0.316; P  =  .028), with the risk for death (OR 2.587; P  =  .004) and disease recurrence (OR 2.228; P  =  .007) being significantly higher in patients with vs without MetS.

Study details: Findings are from a retrospective study including 221 women with BC who received preoperative NAC, of which 22.2% of patients were included in the MetS group.

Disclosures: This study was supported by the Beijing Medical Award Foundation. The authors declared no conflicts of interest.

Source: Zhou Z et al. Metabolic syndrome is a risk factor for breast cancer patients receiving neoadjuvant chemotherapy: A case-control study. Front Oncol. 2023;12:1080054 (Jan 4). Doi: 10.3389/fonc.2022.1080054

Key clinical point: The presence of metabolic syndromes (MetS) worsened survival outcomes and increased disease recurrence risk in patients with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).

Major finding: The MetS group had a significantly lower likelihood of achieving pathological complete response than the non-MetS group (odds ratio [OR] 0.316; P  =  .028), with the risk for death (OR 2.587; P  =  .004) and disease recurrence (OR 2.228; P  =  .007) being significantly higher in patients with vs without MetS.

Study details: Findings are from a retrospective study including 221 women with BC who received preoperative NAC, of which 22.2% of patients were included in the MetS group.

Disclosures: This study was supported by the Beijing Medical Award Foundation. The authors declared no conflicts of interest.

Source: Zhou Z et al. Metabolic syndrome is a risk factor for breast cancer patients receiving neoadjuvant chemotherapy: A case-control study. Front Oncol. 2023;12:1080054 (Jan 4). Doi: 10.3389/fonc.2022.1080054

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Metastatic BC: Not worth changing the 4-weekly schedule of pegylated liposomal doxorubicin

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Key clinical point: Recent phase 2 trials have recommended a 2-weekly schedule of pegylated liposomal doxorubicin (PLD) in patients with heavily treated metastatic breast cancer (BC); however, it failed to demonstrate any advantage in terms of efficacy or safety over the registered 4-weekly regimen of PLD.

Major finding: The median progression-free survival was 3.0 and 3.4 months in the 2-weekly and 4-weekly PLD schedule groups, respectively, with a weighted hazard ratio of 1.12 (P  =  .54). The rate of adverse events also appeared comparable between both the groups.

Study details: Findings are from a retrospective study including 191 heavily pretreated patients with metastatic BC who received a 2-weekly (n = 95) or the registered 4-weekly (n = 96) schedule of PLD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Bischoff H et al. A propensity score-weighted study comparing a two- versus four-weekly pegylated liposomal doxorubicin regimen in metastatic breast cancer. Breast Cancer Res Treat. 2022 (Dec 23). Doi: 10.1007/s10549-022-06844-5

 

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Key clinical point: Recent phase 2 trials have recommended a 2-weekly schedule of pegylated liposomal doxorubicin (PLD) in patients with heavily treated metastatic breast cancer (BC); however, it failed to demonstrate any advantage in terms of efficacy or safety over the registered 4-weekly regimen of PLD.

Major finding: The median progression-free survival was 3.0 and 3.4 months in the 2-weekly and 4-weekly PLD schedule groups, respectively, with a weighted hazard ratio of 1.12 (P  =  .54). The rate of adverse events also appeared comparable between both the groups.

Study details: Findings are from a retrospective study including 191 heavily pretreated patients with metastatic BC who received a 2-weekly (n = 95) or the registered 4-weekly (n = 96) schedule of PLD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Bischoff H et al. A propensity score-weighted study comparing a two- versus four-weekly pegylated liposomal doxorubicin regimen in metastatic breast cancer. Breast Cancer Res Treat. 2022 (Dec 23). Doi: 10.1007/s10549-022-06844-5

 

Key clinical point: Recent phase 2 trials have recommended a 2-weekly schedule of pegylated liposomal doxorubicin (PLD) in patients with heavily treated metastatic breast cancer (BC); however, it failed to demonstrate any advantage in terms of efficacy or safety over the registered 4-weekly regimen of PLD.

Major finding: The median progression-free survival was 3.0 and 3.4 months in the 2-weekly and 4-weekly PLD schedule groups, respectively, with a weighted hazard ratio of 1.12 (P  =  .54). The rate of adverse events also appeared comparable between both the groups.

Study details: Findings are from a retrospective study including 191 heavily pretreated patients with metastatic BC who received a 2-weekly (n = 95) or the registered 4-weekly (n = 96) schedule of PLD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Bischoff H et al. A propensity score-weighted study comparing a two- versus four-weekly pegylated liposomal doxorubicin regimen in metastatic breast cancer. Breast Cancer Res Treat. 2022 (Dec 23). Doi: 10.1007/s10549-022-06844-5

 

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Early autologous fat grafting associated with increased BC recurrence risk

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Key clinical point: Autologous fat grafting (AFG) in the second stage of a 2-stage prosthetic breast reconstruction was linked to a higher risk for breast cancer (BC) recurrence when performed within a year after mastectomy.

Major finding: Patients who did vs did not undergo AFG within 1 year after the primary operation had a significantly increased risk for disease recurrence (hazard ratio 5.701; 95% CI 1.164-27.927). However, delaying the fat grafting beyond 12 months after mastectomy did not affect survival outcomes.

Study details: Findings are from a retrospective cohort study including 267 patients with unilateral invasive BC who underwent total mastectomy and immediate tissue-expander-based reconstruction, of which 203 patients underwent the second-stage operation within 12 months of mastectomy and 64 patients underwent the operation after 12 months of mastectomy.

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

Source: Lee KT et al. Association of fat graft with breast cancer recurrence in implant-based reconstruction: Does the timing matter? Ann Surg Oncol. 2022;30(2):1087-1097 (Dec 10). Doi: 10.1245/s10434-022-12389-0

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Key clinical point: Autologous fat grafting (AFG) in the second stage of a 2-stage prosthetic breast reconstruction was linked to a higher risk for breast cancer (BC) recurrence when performed within a year after mastectomy.

Major finding: Patients who did vs did not undergo AFG within 1 year after the primary operation had a significantly increased risk for disease recurrence (hazard ratio 5.701; 95% CI 1.164-27.927). However, delaying the fat grafting beyond 12 months after mastectomy did not affect survival outcomes.

Study details: Findings are from a retrospective cohort study including 267 patients with unilateral invasive BC who underwent total mastectomy and immediate tissue-expander-based reconstruction, of which 203 patients underwent the second-stage operation within 12 months of mastectomy and 64 patients underwent the operation after 12 months of mastectomy.

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

Source: Lee KT et al. Association of fat graft with breast cancer recurrence in implant-based reconstruction: Does the timing matter? Ann Surg Oncol. 2022;30(2):1087-1097 (Dec 10). Doi: 10.1245/s10434-022-12389-0

Key clinical point: Autologous fat grafting (AFG) in the second stage of a 2-stage prosthetic breast reconstruction was linked to a higher risk for breast cancer (BC) recurrence when performed within a year after mastectomy.

Major finding: Patients who did vs did not undergo AFG within 1 year after the primary operation had a significantly increased risk for disease recurrence (hazard ratio 5.701; 95% CI 1.164-27.927). However, delaying the fat grafting beyond 12 months after mastectomy did not affect survival outcomes.

Study details: Findings are from a retrospective cohort study including 267 patients with unilateral invasive BC who underwent total mastectomy and immediate tissue-expander-based reconstruction, of which 203 patients underwent the second-stage operation within 12 months of mastectomy and 64 patients underwent the operation after 12 months of mastectomy.

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

Source: Lee KT et al. Association of fat graft with breast cancer recurrence in implant-based reconstruction: Does the timing matter? Ann Surg Oncol. 2022;30(2):1087-1097 (Dec 10). Doi: 10.1245/s10434-022-12389-0

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Meta-analysis compares adjuvant chemotherapy regimens for resected early-stage TNBC

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Key clinical point: In patients with early-stage triple-negative breast cancer (TNBC), adding capecitabine to classic anthracycline/taxane-based adjuvant chemotherapy improved overall survival (OS) and carboplatin/paclitaxel was the most effective regimen for improving disease-free survival (DFS).

Major finding: Adjuvant chemotherapy with anthracyclines/taxanes plus capecitabine vs anthracyclines significantly improved OS outcomes (hazard ratio [HR] 0.56; 95% CI 0.36-0.87; probability for ranking the first 29%), whereas carboplatin/paclitaxel vs anthracyclines was the best regimen for improving DFS outcomes (HR 0.51; 95% CI 0.30-0.86; probability for ranking the first 41%).

Study details: Findings are from a network meta-analysis of 27 randomized phase 3 trials that compared adjuvant chemotherapy regimens in patients with resected, stage I-III TNBC.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Petrelli F et al. Adjuvant chemotherapy for resected triple negative breast cancer patients: A network meta-analysis. Breast. 2022;67:8-13 (Dec 15). Doi: 10.1016/j.breast.2022.12.004

 

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Key clinical point: In patients with early-stage triple-negative breast cancer (TNBC), adding capecitabine to classic anthracycline/taxane-based adjuvant chemotherapy improved overall survival (OS) and carboplatin/paclitaxel was the most effective regimen for improving disease-free survival (DFS).

Major finding: Adjuvant chemotherapy with anthracyclines/taxanes plus capecitabine vs anthracyclines significantly improved OS outcomes (hazard ratio [HR] 0.56; 95% CI 0.36-0.87; probability for ranking the first 29%), whereas carboplatin/paclitaxel vs anthracyclines was the best regimen for improving DFS outcomes (HR 0.51; 95% CI 0.30-0.86; probability for ranking the first 41%).

Study details: Findings are from a network meta-analysis of 27 randomized phase 3 trials that compared adjuvant chemotherapy regimens in patients with resected, stage I-III TNBC.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Petrelli F et al. Adjuvant chemotherapy for resected triple negative breast cancer patients: A network meta-analysis. Breast. 2022;67:8-13 (Dec 15). Doi: 10.1016/j.breast.2022.12.004

 

Key clinical point: In patients with early-stage triple-negative breast cancer (TNBC), adding capecitabine to classic anthracycline/taxane-based adjuvant chemotherapy improved overall survival (OS) and carboplatin/paclitaxel was the most effective regimen for improving disease-free survival (DFS).

Major finding: Adjuvant chemotherapy with anthracyclines/taxanes plus capecitabine vs anthracyclines significantly improved OS outcomes (hazard ratio [HR] 0.56; 95% CI 0.36-0.87; probability for ranking the first 29%), whereas carboplatin/paclitaxel vs anthracyclines was the best regimen for improving DFS outcomes (HR 0.51; 95% CI 0.30-0.86; probability for ranking the first 41%).

Study details: Findings are from a network meta-analysis of 27 randomized phase 3 trials that compared adjuvant chemotherapy regimens in patients with resected, stage I-III TNBC.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Petrelli F et al. Adjuvant chemotherapy for resected triple negative breast cancer patients: A network meta-analysis. Breast. 2022;67:8-13 (Dec 15). Doi: 10.1016/j.breast.2022.12.004

 

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Overall survival improved with chemotherapy in ER-negative/HER2-negative, T1abN0 BC

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Key clinical point: Treatment with adjuvant chemotherapy significantly improved overall survival (OS) outcomes in patients with estrogen receptor-negative (ER−)/human epidermal growth factor receptor 2-negative (HER2−), T1abN0 breast cancer (BC).

Major finding: After a median follow-up of 7.7 years, a significant improvement was observed in OS with vs without chemotherapy in the overall cohort of patients with T1abN0 BC (hazard ratio 0.35; P  =  .02), along with both subgroups of patients with T1a (log-rank P  =  .001) and T1b (P  =  .001) BC.

Study details: Findings are from a nationwide, retrospective cohort study including 296 patients with ER− /HER2−, T1abN0 BC, of which 79.4% of patients received adjuvant chemotherapy.

Disclosures: This study was supported by the Danish Cancer Society, Denmark, and other sources. Some authors declared receiving personal fees, speaker honorarium, or research grants from various sources.

Source: Hassing CMS et al. Adjuvant chemotherapy in patients with ER-negative/HER2-negative, T1abN0 breast cancer: A nationwide study. Breast Cancer Res Treat. 2022 (Dec 28). Doi: 10.1007/s10549-022-06839-2

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Key clinical point: Treatment with adjuvant chemotherapy significantly improved overall survival (OS) outcomes in patients with estrogen receptor-negative (ER−)/human epidermal growth factor receptor 2-negative (HER2−), T1abN0 breast cancer (BC).

Major finding: After a median follow-up of 7.7 years, a significant improvement was observed in OS with vs without chemotherapy in the overall cohort of patients with T1abN0 BC (hazard ratio 0.35; P  =  .02), along with both subgroups of patients with T1a (log-rank P  =  .001) and T1b (P  =  .001) BC.

Study details: Findings are from a nationwide, retrospective cohort study including 296 patients with ER− /HER2−, T1abN0 BC, of which 79.4% of patients received adjuvant chemotherapy.

Disclosures: This study was supported by the Danish Cancer Society, Denmark, and other sources. Some authors declared receiving personal fees, speaker honorarium, or research grants from various sources.

Source: Hassing CMS et al. Adjuvant chemotherapy in patients with ER-negative/HER2-negative, T1abN0 breast cancer: A nationwide study. Breast Cancer Res Treat. 2022 (Dec 28). Doi: 10.1007/s10549-022-06839-2

Key clinical point: Treatment with adjuvant chemotherapy significantly improved overall survival (OS) outcomes in patients with estrogen receptor-negative (ER−)/human epidermal growth factor receptor 2-negative (HER2−), T1abN0 breast cancer (BC).

Major finding: After a median follow-up of 7.7 years, a significant improvement was observed in OS with vs without chemotherapy in the overall cohort of patients with T1abN0 BC (hazard ratio 0.35; P  =  .02), along with both subgroups of patients with T1a (log-rank P  =  .001) and T1b (P  =  .001) BC.

Study details: Findings are from a nationwide, retrospective cohort study including 296 patients with ER− /HER2−, T1abN0 BC, of which 79.4% of patients received adjuvant chemotherapy.

Disclosures: This study was supported by the Danish Cancer Society, Denmark, and other sources. Some authors declared receiving personal fees, speaker honorarium, or research grants from various sources.

Source: Hassing CMS et al. Adjuvant chemotherapy in patients with ER-negative/HER2-negative, T1abN0 breast cancer: A nationwide study. Breast Cancer Res Treat. 2022 (Dec 28). Doi: 10.1007/s10549-022-06839-2

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ERBB2 mRNA expression predicts prognosis in trastuzumab emtansine-treated advanced HER2+ BC patients

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ERBB2 mRNA expression predicts prognosis in trastuzumab emtansine-treated advanced HER2+ BC patients

Key clinical point: In patients with advanced human epidermal growth factor receptor 2-positive (HER2+ or ERBB2+) breast cancer (BC) treated with trastuzumab emtansine, the pre-established levels of ERBB2 mRNA expression according to the HER2DX standardized assay served as an important prognostic biomarker in predicting survival outcomes.

Major finding: High, medium, and low levels of ERBB2 mRNA expression were associated with overall response rates of 56%, 29%, and 0%, respectively, with high ERBB2 mRNA expression being associated with both better progression-free survival (P < .001) and overall survival (P  =  .007) outcomes.

Study details: Findings are from a study including 87 patients with HER2+ advanced BC who received treatment with trastuzumab emtansine.

Disclosures: This study was funded by Hospital Clinic, Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, University of Padova, Italy, and other sources. The authors declared serving as consultants; receiving advisory, lecture, or consulting fees; or having other ties with several sources.

Source: Brasó-Maristany F et al. HER2DX ERBB2 mRNA expression in advanced HER2-positive breast cancer treated with T-DM1. J Natl Cancer Inst. 2022 (Dec 28). Doi: 10.1093/jnci/djac227

 

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Key clinical point: In patients with advanced human epidermal growth factor receptor 2-positive (HER2+ or ERBB2+) breast cancer (BC) treated with trastuzumab emtansine, the pre-established levels of ERBB2 mRNA expression according to the HER2DX standardized assay served as an important prognostic biomarker in predicting survival outcomes.

Major finding: High, medium, and low levels of ERBB2 mRNA expression were associated with overall response rates of 56%, 29%, and 0%, respectively, with high ERBB2 mRNA expression being associated with both better progression-free survival (P < .001) and overall survival (P  =  .007) outcomes.

Study details: Findings are from a study including 87 patients with HER2+ advanced BC who received treatment with trastuzumab emtansine.

Disclosures: This study was funded by Hospital Clinic, Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, University of Padova, Italy, and other sources. The authors declared serving as consultants; receiving advisory, lecture, or consulting fees; or having other ties with several sources.

Source: Brasó-Maristany F et al. HER2DX ERBB2 mRNA expression in advanced HER2-positive breast cancer treated with T-DM1. J Natl Cancer Inst. 2022 (Dec 28). Doi: 10.1093/jnci/djac227

 

Key clinical point: In patients with advanced human epidermal growth factor receptor 2-positive (HER2+ or ERBB2+) breast cancer (BC) treated with trastuzumab emtansine, the pre-established levels of ERBB2 mRNA expression according to the HER2DX standardized assay served as an important prognostic biomarker in predicting survival outcomes.

Major finding: High, medium, and low levels of ERBB2 mRNA expression were associated with overall response rates of 56%, 29%, and 0%, respectively, with high ERBB2 mRNA expression being associated with both better progression-free survival (P < .001) and overall survival (P  =  .007) outcomes.

Study details: Findings are from a study including 87 patients with HER2+ advanced BC who received treatment with trastuzumab emtansine.

Disclosures: This study was funded by Hospital Clinic, Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, University of Padova, Italy, and other sources. The authors declared serving as consultants; receiving advisory, lecture, or consulting fees; or having other ties with several sources.

Source: Brasó-Maristany F et al. HER2DX ERBB2 mRNA expression in advanced HER2-positive breast cancer treated with T-DM1. J Natl Cancer Inst. 2022 (Dec 28). Doi: 10.1093/jnci/djac227

 

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