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Can a Mediterranean diet reduce breast cancer recurrence?
TOPLINE:
However, women at high risk for recurrence who made the greatest improvements in their diet quality demonstrated a 41% lower risk for recurrence, compared with peers who made the fewest improvements.
METHODOLOGY:
- A growing body of evidence suggests that a better dietary quality may improve survival among patients with breast cancer, but whether diet impacts breast cancer–specific mortality remains controversial.
- To better understand the relationship between diet and breast cancer outcomes, investigators recruited 1,542 women with breast cancer who had undergone surgical resection in the past 5 years and were considered high risk for recurrence.
- All women received general recommendations for cancer prevention, while the intervention group received active support to adhere to a macro–Mediterranean-style diet, which encourages mainly consuming whole grains, legumes, and high-fiber vegetables and discourages eating foods high in saturated and trans fats, processed meats, and foods and beverages high in sugar.
- Diet was assessed at baseline, 1 year, and every few months in subsequent years via food frequency diaries. Compliance with dietary recommendations for the whole cohort was assessed using a dietary index developed for the trial.
- In addition to diet, women in the diet intervention group were encouraged to maintain moderate to intense physical activity – 30 minutes, on average, each day – and received pedometers to track steps, aiming for 10,000 per day.
TAKEAWAY:
- Over 5 years of follow-up, the rate of breast cancer recurrence did not differ between women in the diet intervention group and those in the control group. Overall, 95 of 769 women in the intervention group and 98 of 773 in the control group had a breast cancer recurrence (hazard ratio, 0.99).
- When evaluating outcomes in the entire cohort, looking at everyone’s level of compliance with dietary recommendations, women who adhered the most to the dietary guidelines had a 41% lower recurrence risk compared with women who adhered the least (HR, 0.59).
- The greatest protective effect among women who demonstrated high compliance occurred in those with ER-positive cancers (HR, 0.42) and those with ER-positive cancers who received tamoxifen (HR, 0.30).
IN PRACTICE:
This intervention trial “did not confirm the hypothesis that a comprehensive dietary modification reduces breast cancer recurrence and metastases,” but when looking at compliance to the Mediterranean diet overall, the analysis did find “a significantly better prognosis” for women with the best adherence.
SOURCE:
The study, with first author Franco Berrino, MD, PhD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, was published online in Clinical Cancer Research.
LIMITATIONS:
The study relied on self-reported dietary data. No dietary instrument was used to estimate nutrient intake and the dietary index developed for the trial remains unvalidated.
DISCLOSURES:
The study was supported by the Italian Department of Health, the Associazione Italiana per la Ricerca sul Cancro, and the Vita e Salute Foundation. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
However, women at high risk for recurrence who made the greatest improvements in their diet quality demonstrated a 41% lower risk for recurrence, compared with peers who made the fewest improvements.
METHODOLOGY:
- A growing body of evidence suggests that a better dietary quality may improve survival among patients with breast cancer, but whether diet impacts breast cancer–specific mortality remains controversial.
- To better understand the relationship between diet and breast cancer outcomes, investigators recruited 1,542 women with breast cancer who had undergone surgical resection in the past 5 years and were considered high risk for recurrence.
- All women received general recommendations for cancer prevention, while the intervention group received active support to adhere to a macro–Mediterranean-style diet, which encourages mainly consuming whole grains, legumes, and high-fiber vegetables and discourages eating foods high in saturated and trans fats, processed meats, and foods and beverages high in sugar.
- Diet was assessed at baseline, 1 year, and every few months in subsequent years via food frequency diaries. Compliance with dietary recommendations for the whole cohort was assessed using a dietary index developed for the trial.
- In addition to diet, women in the diet intervention group were encouraged to maintain moderate to intense physical activity – 30 minutes, on average, each day – and received pedometers to track steps, aiming for 10,000 per day.
TAKEAWAY:
- Over 5 years of follow-up, the rate of breast cancer recurrence did not differ between women in the diet intervention group and those in the control group. Overall, 95 of 769 women in the intervention group and 98 of 773 in the control group had a breast cancer recurrence (hazard ratio, 0.99).
- When evaluating outcomes in the entire cohort, looking at everyone’s level of compliance with dietary recommendations, women who adhered the most to the dietary guidelines had a 41% lower recurrence risk compared with women who adhered the least (HR, 0.59).
- The greatest protective effect among women who demonstrated high compliance occurred in those with ER-positive cancers (HR, 0.42) and those with ER-positive cancers who received tamoxifen (HR, 0.30).
IN PRACTICE:
This intervention trial “did not confirm the hypothesis that a comprehensive dietary modification reduces breast cancer recurrence and metastases,” but when looking at compliance to the Mediterranean diet overall, the analysis did find “a significantly better prognosis” for women with the best adherence.
SOURCE:
The study, with first author Franco Berrino, MD, PhD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, was published online in Clinical Cancer Research.
LIMITATIONS:
The study relied on self-reported dietary data. No dietary instrument was used to estimate nutrient intake and the dietary index developed for the trial remains unvalidated.
DISCLOSURES:
The study was supported by the Italian Department of Health, the Associazione Italiana per la Ricerca sul Cancro, and the Vita e Salute Foundation. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
However, women at high risk for recurrence who made the greatest improvements in their diet quality demonstrated a 41% lower risk for recurrence, compared with peers who made the fewest improvements.
METHODOLOGY:
- A growing body of evidence suggests that a better dietary quality may improve survival among patients with breast cancer, but whether diet impacts breast cancer–specific mortality remains controversial.
- To better understand the relationship between diet and breast cancer outcomes, investigators recruited 1,542 women with breast cancer who had undergone surgical resection in the past 5 years and were considered high risk for recurrence.
- All women received general recommendations for cancer prevention, while the intervention group received active support to adhere to a macro–Mediterranean-style diet, which encourages mainly consuming whole grains, legumes, and high-fiber vegetables and discourages eating foods high in saturated and trans fats, processed meats, and foods and beverages high in sugar.
- Diet was assessed at baseline, 1 year, and every few months in subsequent years via food frequency diaries. Compliance with dietary recommendations for the whole cohort was assessed using a dietary index developed for the trial.
- In addition to diet, women in the diet intervention group were encouraged to maintain moderate to intense physical activity – 30 minutes, on average, each day – and received pedometers to track steps, aiming for 10,000 per day.
TAKEAWAY:
- Over 5 years of follow-up, the rate of breast cancer recurrence did not differ between women in the diet intervention group and those in the control group. Overall, 95 of 769 women in the intervention group and 98 of 773 in the control group had a breast cancer recurrence (hazard ratio, 0.99).
- When evaluating outcomes in the entire cohort, looking at everyone’s level of compliance with dietary recommendations, women who adhered the most to the dietary guidelines had a 41% lower recurrence risk compared with women who adhered the least (HR, 0.59).
- The greatest protective effect among women who demonstrated high compliance occurred in those with ER-positive cancers (HR, 0.42) and those with ER-positive cancers who received tamoxifen (HR, 0.30).
IN PRACTICE:
This intervention trial “did not confirm the hypothesis that a comprehensive dietary modification reduces breast cancer recurrence and metastases,” but when looking at compliance to the Mediterranean diet overall, the analysis did find “a significantly better prognosis” for women with the best adherence.
SOURCE:
The study, with first author Franco Berrino, MD, PhD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, was published online in Clinical Cancer Research.
LIMITATIONS:
The study relied on self-reported dietary data. No dietary instrument was used to estimate nutrient intake and the dietary index developed for the trial remains unvalidated.
DISCLOSURES:
The study was supported by the Italian Department of Health, the Associazione Italiana per la Ricerca sul Cancro, and the Vita e Salute Foundation. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA OKs capivasertib for certain advanced breast cancers
Specifically, the first-in-class AKT kinase inhibitor approval is for patients with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, whose metastatic disease progressed on at least one endocrine-based regimen or who experienced recurrence on or within 12 months of completing adjuvant therapy, according to the FDA approval announcement.
The FDA also approved a companion diagnostic device, the FoundationOne CDx assay, to identify patients who are eligible for treatment with capivasertib.
Approval of capivasertib was based on findings from the randomized, placebo-controlled, phase 3 CAPItello-291 trial, which involved 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, including 289 whose tumors had PIK3CA/AKT1/PTEN alterations. All had progressed on aromatase inhibitor–based treatment and may have received up to two prior lines of endocrine therapy and up to one line of chemotherapy.
Patients were randomized to either 400 mg of oral capivasertib or placebo twice daily for 4 days, followed by 3 days off treatment each week over a 28-day treatment cycle. Patients in both arms received 500 mg intramuscular fulvestrant on cycle 1 days 1 and 15, and then every 28 days thereafter. Treatment continued until disease progression or unacceptable toxicity.
In the 289 patients with PIK3CA/AKT1/PTEN–altered tumors, median progression-free survival (PFS) in the capivasertib arm was 7.3 months versus 3.1 months in the placebo group (hazard ratio, 0.50).
An exploratory analysis of PFS in the 313 (44%) patients whose tumors did not have a PIK3CA/AKT1/PTEN alteration demonstrated a less notable benefit to the combination (HR, 0.79; 95% confidence interval, 0.61-1.02), indicating that “the difference in the overall population was primarily attributed to the results seen in the population of patients whose tumors have PIK3CA/AKT1/PTEN alteration,” the FDA explained.
Adverse reactions occurring in at least 20% of patients included decreased lymphocytes, leukocytes, hemoglobin, and neutrophils; increased fasting glucose, creatinine, and triglycerides; and diarrhea, nausea, fatigue, vomiting, and stomatitis.
The recommended capivasertib dose is 400 mg orally twice daily, given about 12 hours apart with or without food, for 4 days followed by 3 off days until disease progression or unacceptable toxicity, according to the prescribing information.
A version of this article first appeared on Medscape.com.
Specifically, the first-in-class AKT kinase inhibitor approval is for patients with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, whose metastatic disease progressed on at least one endocrine-based regimen or who experienced recurrence on or within 12 months of completing adjuvant therapy, according to the FDA approval announcement.
The FDA also approved a companion diagnostic device, the FoundationOne CDx assay, to identify patients who are eligible for treatment with capivasertib.
Approval of capivasertib was based on findings from the randomized, placebo-controlled, phase 3 CAPItello-291 trial, which involved 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, including 289 whose tumors had PIK3CA/AKT1/PTEN alterations. All had progressed on aromatase inhibitor–based treatment and may have received up to two prior lines of endocrine therapy and up to one line of chemotherapy.
Patients were randomized to either 400 mg of oral capivasertib or placebo twice daily for 4 days, followed by 3 days off treatment each week over a 28-day treatment cycle. Patients in both arms received 500 mg intramuscular fulvestrant on cycle 1 days 1 and 15, and then every 28 days thereafter. Treatment continued until disease progression or unacceptable toxicity.
In the 289 patients with PIK3CA/AKT1/PTEN–altered tumors, median progression-free survival (PFS) in the capivasertib arm was 7.3 months versus 3.1 months in the placebo group (hazard ratio, 0.50).
An exploratory analysis of PFS in the 313 (44%) patients whose tumors did not have a PIK3CA/AKT1/PTEN alteration demonstrated a less notable benefit to the combination (HR, 0.79; 95% confidence interval, 0.61-1.02), indicating that “the difference in the overall population was primarily attributed to the results seen in the population of patients whose tumors have PIK3CA/AKT1/PTEN alteration,” the FDA explained.
Adverse reactions occurring in at least 20% of patients included decreased lymphocytes, leukocytes, hemoglobin, and neutrophils; increased fasting glucose, creatinine, and triglycerides; and diarrhea, nausea, fatigue, vomiting, and stomatitis.
The recommended capivasertib dose is 400 mg orally twice daily, given about 12 hours apart with or without food, for 4 days followed by 3 off days until disease progression or unacceptable toxicity, according to the prescribing information.
A version of this article first appeared on Medscape.com.
Specifically, the first-in-class AKT kinase inhibitor approval is for patients with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, whose metastatic disease progressed on at least one endocrine-based regimen or who experienced recurrence on or within 12 months of completing adjuvant therapy, according to the FDA approval announcement.
The FDA also approved a companion diagnostic device, the FoundationOne CDx assay, to identify patients who are eligible for treatment with capivasertib.
Approval of capivasertib was based on findings from the randomized, placebo-controlled, phase 3 CAPItello-291 trial, which involved 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, including 289 whose tumors had PIK3CA/AKT1/PTEN alterations. All had progressed on aromatase inhibitor–based treatment and may have received up to two prior lines of endocrine therapy and up to one line of chemotherapy.
Patients were randomized to either 400 mg of oral capivasertib or placebo twice daily for 4 days, followed by 3 days off treatment each week over a 28-day treatment cycle. Patients in both arms received 500 mg intramuscular fulvestrant on cycle 1 days 1 and 15, and then every 28 days thereafter. Treatment continued until disease progression or unacceptable toxicity.
In the 289 patients with PIK3CA/AKT1/PTEN–altered tumors, median progression-free survival (PFS) in the capivasertib arm was 7.3 months versus 3.1 months in the placebo group (hazard ratio, 0.50).
An exploratory analysis of PFS in the 313 (44%) patients whose tumors did not have a PIK3CA/AKT1/PTEN alteration demonstrated a less notable benefit to the combination (HR, 0.79; 95% confidence interval, 0.61-1.02), indicating that “the difference in the overall population was primarily attributed to the results seen in the population of patients whose tumors have PIK3CA/AKT1/PTEN alteration,” the FDA explained.
Adverse reactions occurring in at least 20% of patients included decreased lymphocytes, leukocytes, hemoglobin, and neutrophils; increased fasting glucose, creatinine, and triglycerides; and diarrhea, nausea, fatigue, vomiting, and stomatitis.
The recommended capivasertib dose is 400 mg orally twice daily, given about 12 hours apart with or without food, for 4 days followed by 3 off days until disease progression or unacceptable toxicity, according to the prescribing information.
A version of this article first appeared on Medscape.com.
Meta-analysis shows benefits of capecitabine-based chemo in early TNBC
Key clinical point: Capecitabine-based chemotherapy improved prognostic outcomes in patients with early-stage triple-negative breast cancer (TNBC).
Major finding: Capecitabine-based chemotherapy vs capecitabine-free regimens improved disease-free survival (DFS; hazard ratio [HR] 0.81; P < .001) and overall survival (HR 0.75; P < .001) outcomes. DFS benefits were particularly observed in the adjuvant setting (HR 0.79; P < .001) and in the subgroup of patients with lymph node-negative TNBC (HR 0.68; P = .006) and in those who received capecitabine for ≥ 6 cycles (HR 0.71; P < .001).
Study details: Findings are from a meta-analysis of 12 randomized controlled trials including 5390 patients with TNBC who were treated with capecitabine-based chemotherapy or capecitabine-free regimens.
Disclosures: This study was supported by the National Natural Science Foundation of China and the Natural Science Foundation of Chongqing. The authors declared no conflicts of interest.
Source: Bai J et al. Capecitabine-based chemotherapy in early-stage triple-negative breast cancer: A meta-analysis. Front Oncol. 2023;13:1245650 (Oct 25). doi: 10.3389/fonc.2023.1245650
Key clinical point: Capecitabine-based chemotherapy improved prognostic outcomes in patients with early-stage triple-negative breast cancer (TNBC).
Major finding: Capecitabine-based chemotherapy vs capecitabine-free regimens improved disease-free survival (DFS; hazard ratio [HR] 0.81; P < .001) and overall survival (HR 0.75; P < .001) outcomes. DFS benefits were particularly observed in the adjuvant setting (HR 0.79; P < .001) and in the subgroup of patients with lymph node-negative TNBC (HR 0.68; P = .006) and in those who received capecitabine for ≥ 6 cycles (HR 0.71; P < .001).
Study details: Findings are from a meta-analysis of 12 randomized controlled trials including 5390 patients with TNBC who were treated with capecitabine-based chemotherapy or capecitabine-free regimens.
Disclosures: This study was supported by the National Natural Science Foundation of China and the Natural Science Foundation of Chongqing. The authors declared no conflicts of interest.
Source: Bai J et al. Capecitabine-based chemotherapy in early-stage triple-negative breast cancer: A meta-analysis. Front Oncol. 2023;13:1245650 (Oct 25). doi: 10.3389/fonc.2023.1245650
Key clinical point: Capecitabine-based chemotherapy improved prognostic outcomes in patients with early-stage triple-negative breast cancer (TNBC).
Major finding: Capecitabine-based chemotherapy vs capecitabine-free regimens improved disease-free survival (DFS; hazard ratio [HR] 0.81; P < .001) and overall survival (HR 0.75; P < .001) outcomes. DFS benefits were particularly observed in the adjuvant setting (HR 0.79; P < .001) and in the subgroup of patients with lymph node-negative TNBC (HR 0.68; P = .006) and in those who received capecitabine for ≥ 6 cycles (HR 0.71; P < .001).
Study details: Findings are from a meta-analysis of 12 randomized controlled trials including 5390 patients with TNBC who were treated with capecitabine-based chemotherapy or capecitabine-free regimens.
Disclosures: This study was supported by the National Natural Science Foundation of China and the Natural Science Foundation of Chongqing. The authors declared no conflicts of interest.
Source: Bai J et al. Capecitabine-based chemotherapy in early-stage triple-negative breast cancer: A meta-analysis. Front Oncol. 2023;13:1245650 (Oct 25). doi: 10.3389/fonc.2023.1245650
Regional nodal irradiation may not be needed after preoperative systemic therapy in HER2+ BC
Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received docetaxel/carboplatin/trastuzumab/pertuzumab (TCHP)-based preoperative systemic therapy experienced no extra clinical benefits with postoperative regional nodal irradiation (RNI).
Major finding: Patients who did vs did not receive RNI had comparable locoregional recurrence frequency (2.6% vs 1.0%; P = .651) and disease-free survival outcomes (hazard ratio 0.72; P = .638); however, pathological complete response was achieved by a significantly higher proportion of patients in the no-RNI vs RNI group (72.5% vs 44.4%; P < .001).
Study details: This retrospective study included 255 patients with HER2+ BC who received six cycles of TCHP, of which 60% of patients received RNI.
Disclosures: This study did not declare the source of funding or conflicts of interest.
Source: Kim N, Kim J-Y, et al. Benefit of postoperative regional nodal irradiation in patients receiving preoperative systemic therapy with docetaxel/carboplatin/trastuzumab/pertuzumab for HER2-positive breast cancer. Breast. 2023;72:103594 (Oct 30). doi: 10.1016/j.breast.2023.103594
Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received docetaxel/carboplatin/trastuzumab/pertuzumab (TCHP)-based preoperative systemic therapy experienced no extra clinical benefits with postoperative regional nodal irradiation (RNI).
Major finding: Patients who did vs did not receive RNI had comparable locoregional recurrence frequency (2.6% vs 1.0%; P = .651) and disease-free survival outcomes (hazard ratio 0.72; P = .638); however, pathological complete response was achieved by a significantly higher proportion of patients in the no-RNI vs RNI group (72.5% vs 44.4%; P < .001).
Study details: This retrospective study included 255 patients with HER2+ BC who received six cycles of TCHP, of which 60% of patients received RNI.
Disclosures: This study did not declare the source of funding or conflicts of interest.
Source: Kim N, Kim J-Y, et al. Benefit of postoperative regional nodal irradiation in patients receiving preoperative systemic therapy with docetaxel/carboplatin/trastuzumab/pertuzumab for HER2-positive breast cancer. Breast. 2023;72:103594 (Oct 30). doi: 10.1016/j.breast.2023.103594
Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received docetaxel/carboplatin/trastuzumab/pertuzumab (TCHP)-based preoperative systemic therapy experienced no extra clinical benefits with postoperative regional nodal irradiation (RNI).
Major finding: Patients who did vs did not receive RNI had comparable locoregional recurrence frequency (2.6% vs 1.0%; P = .651) and disease-free survival outcomes (hazard ratio 0.72; P = .638); however, pathological complete response was achieved by a significantly higher proportion of patients in the no-RNI vs RNI group (72.5% vs 44.4%; P < .001).
Study details: This retrospective study included 255 patients with HER2+ BC who received six cycles of TCHP, of which 60% of patients received RNI.
Disclosures: This study did not declare the source of funding or conflicts of interest.
Source: Kim N, Kim J-Y, et al. Benefit of postoperative regional nodal irradiation in patients receiving preoperative systemic therapy with docetaxel/carboplatin/trastuzumab/pertuzumab for HER2-positive breast cancer. Breast. 2023;72:103594 (Oct 30). doi: 10.1016/j.breast.2023.103594
Taxanes followed by PLD show promise in metastatic BC under real-world settings
Key clinical point: First-line treatment with taxanes followed by pegylated liposomal doxorubicin (PLD) was associated with improved prognostic outcomes in patients with human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) than with PLD followed by taxanes.
Major finding: First-line taxane followed by PLD vs first-line PLD followed by taxane significantly improved time to next chemotherapy (9.9 vs 4.9 months; P = .006) and progression-free survival outcomes (9.0 vs 4.4 months; P = .005).
Study details: Findings are from a retrospective study including 42 patients with HER2− metastatic BC who received first-line PLD and later taxane (n = 23) or first-line taxane and later PLD (n = 19).
Disclosures: This study did not receive any specific grants. The authors declared no conflicts of interest.
Source: Wallrabenstein T et al. Upfront taxane could be superior to pegylated liposomal doxorubicin (PLD): A retrospective real-world analysis of treatment sequence taxane-PLD versus PLD-taxane in patients with metastatic breast cancer. Cancers (Basel). 2023;15(20):4953 (Oct 12). doi: 10.3390/cancers15204953
Key clinical point: First-line treatment with taxanes followed by pegylated liposomal doxorubicin (PLD) was associated with improved prognostic outcomes in patients with human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) than with PLD followed by taxanes.
Major finding: First-line taxane followed by PLD vs first-line PLD followed by taxane significantly improved time to next chemotherapy (9.9 vs 4.9 months; P = .006) and progression-free survival outcomes (9.0 vs 4.4 months; P = .005).
Study details: Findings are from a retrospective study including 42 patients with HER2− metastatic BC who received first-line PLD and later taxane (n = 23) or first-line taxane and later PLD (n = 19).
Disclosures: This study did not receive any specific grants. The authors declared no conflicts of interest.
Source: Wallrabenstein T et al. Upfront taxane could be superior to pegylated liposomal doxorubicin (PLD): A retrospective real-world analysis of treatment sequence taxane-PLD versus PLD-taxane in patients with metastatic breast cancer. Cancers (Basel). 2023;15(20):4953 (Oct 12). doi: 10.3390/cancers15204953
Key clinical point: First-line treatment with taxanes followed by pegylated liposomal doxorubicin (PLD) was associated with improved prognostic outcomes in patients with human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) than with PLD followed by taxanes.
Major finding: First-line taxane followed by PLD vs first-line PLD followed by taxane significantly improved time to next chemotherapy (9.9 vs 4.9 months; P = .006) and progression-free survival outcomes (9.0 vs 4.4 months; P = .005).
Study details: Findings are from a retrospective study including 42 patients with HER2− metastatic BC who received first-line PLD and later taxane (n = 23) or first-line taxane and later PLD (n = 19).
Disclosures: This study did not receive any specific grants. The authors declared no conflicts of interest.
Source: Wallrabenstein T et al. Upfront taxane could be superior to pegylated liposomal doxorubicin (PLD): A retrospective real-world analysis of treatment sequence taxane-PLD versus PLD-taxane in patients with metastatic breast cancer. Cancers (Basel). 2023;15(20):4953 (Oct 12). doi: 10.3390/cancers15204953
Better efficacy-safety with 3-week vs 4-week nab-paclitaxel in HER2− metastatic BC
Key clinical point: A 3-week vs 4-week nab-paclitaxel schedule showed more effective anti-tumor activity and a more manageable safety profile in patients with human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC).
Major finding: Compared with a 4-week paclitaxel regimen, a 3-week regimen led to a 56% improvement in progression-free survival outcomes (hazard ratio 0.44; P = .029) and was associated with a lower rate of grade ≥ 3 adverse events (14.9% vs 42.6%).
Study details: Findings are from a phase 2 study including 94 patients with HER2− metastatic BC who were randomly assigned to receive nab-paclitaxel for either a 3-week or 4-week schedule.
Disclosures: This study was sponsored by CSPC Ouyi Pharmaceutical Co., Ltd, China. The authors declared no conflicts of interest.
Source: Liu Y et al. Three-week versus 4-week schedule of nab-paclitaxel in patients with metastatic breast cancer: A randomized phase II study. Oncologist. 2023 (Oct 26). doi: 10.1093/oncolo/oyad288
Key clinical point: A 3-week vs 4-week nab-paclitaxel schedule showed more effective anti-tumor activity and a more manageable safety profile in patients with human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC).
Major finding: Compared with a 4-week paclitaxel regimen, a 3-week regimen led to a 56% improvement in progression-free survival outcomes (hazard ratio 0.44; P = .029) and was associated with a lower rate of grade ≥ 3 adverse events (14.9% vs 42.6%).
Study details: Findings are from a phase 2 study including 94 patients with HER2− metastatic BC who were randomly assigned to receive nab-paclitaxel for either a 3-week or 4-week schedule.
Disclosures: This study was sponsored by CSPC Ouyi Pharmaceutical Co., Ltd, China. The authors declared no conflicts of interest.
Source: Liu Y et al. Three-week versus 4-week schedule of nab-paclitaxel in patients with metastatic breast cancer: A randomized phase II study. Oncologist. 2023 (Oct 26). doi: 10.1093/oncolo/oyad288
Key clinical point: A 3-week vs 4-week nab-paclitaxel schedule showed more effective anti-tumor activity and a more manageable safety profile in patients with human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC).
Major finding: Compared with a 4-week paclitaxel regimen, a 3-week regimen led to a 56% improvement in progression-free survival outcomes (hazard ratio 0.44; P = .029) and was associated with a lower rate of grade ≥ 3 adverse events (14.9% vs 42.6%).
Study details: Findings are from a phase 2 study including 94 patients with HER2− metastatic BC who were randomly assigned to receive nab-paclitaxel for either a 3-week or 4-week schedule.
Disclosures: This study was sponsored by CSPC Ouyi Pharmaceutical Co., Ltd, China. The authors declared no conflicts of interest.
Source: Liu Y et al. Three-week versus 4-week schedule of nab-paclitaxel in patients with metastatic breast cancer: A randomized phase II study. Oncologist. 2023 (Oct 26). doi: 10.1093/oncolo/oyad288
MRI as effective as MRI+mammography for BC screening in women with dense breasts
Key clinical point: In women with dense breasts, who are generally at an intermediate risk for breast cancer (BC), screening with magnetic resonance imaging (MRI) alone or with mammography increased the rates of screen-detected early-stage cancer and false-positive recalls compared with mammography alone.
Major finding: The rate of screen-detected early-stage cancer in women with dense breasts was higher with MRI alone vs MRI + mammography (difference 11.7/1000 examinations; 95% CI 4.6-18.8/1000 examinations) and MR + mammography vs mammography alone (difference 4.0/1000 examinations; 95% CI 1.4-6.7/1000 examinations); however, false-positive recall rates were higher with MRI + mammography vs mammography alone (difference 149.8/1000 examinations; 95% CI 135.7-163.9/1000 examinations) and comparable with both MRI and MRI + mammography.
Study details: This cohort study analyzed the data of women aged 40-79 years who had undergone screening with MRI (2611 screenings), MRI + mammography (6518 screenings), or mammography (65,180 screenings) from the Breast Cancer Surveillance Consortium registry.
Disclosures: This study was funded by the US Patient-Centered Outcomes Research Institute award and other sources. The authors declared no conflicts of interest.
Source: Kerlikowske K et al. Supplemental magnetic resonance imaging plus mammography compared with magnetic resonance imaging or mammography by extent of breast density. J Natl Cancer Inst. 2023 (Oct 27). doi: 10.1093/jnci/djad201
Key clinical point: In women with dense breasts, who are generally at an intermediate risk for breast cancer (BC), screening with magnetic resonance imaging (MRI) alone or with mammography increased the rates of screen-detected early-stage cancer and false-positive recalls compared with mammography alone.
Major finding: The rate of screen-detected early-stage cancer in women with dense breasts was higher with MRI alone vs MRI + mammography (difference 11.7/1000 examinations; 95% CI 4.6-18.8/1000 examinations) and MR + mammography vs mammography alone (difference 4.0/1000 examinations; 95% CI 1.4-6.7/1000 examinations); however, false-positive recall rates were higher with MRI + mammography vs mammography alone (difference 149.8/1000 examinations; 95% CI 135.7-163.9/1000 examinations) and comparable with both MRI and MRI + mammography.
Study details: This cohort study analyzed the data of women aged 40-79 years who had undergone screening with MRI (2611 screenings), MRI + mammography (6518 screenings), or mammography (65,180 screenings) from the Breast Cancer Surveillance Consortium registry.
Disclosures: This study was funded by the US Patient-Centered Outcomes Research Institute award and other sources. The authors declared no conflicts of interest.
Source: Kerlikowske K et al. Supplemental magnetic resonance imaging plus mammography compared with magnetic resonance imaging or mammography by extent of breast density. J Natl Cancer Inst. 2023 (Oct 27). doi: 10.1093/jnci/djad201
Key clinical point: In women with dense breasts, who are generally at an intermediate risk for breast cancer (BC), screening with magnetic resonance imaging (MRI) alone or with mammography increased the rates of screen-detected early-stage cancer and false-positive recalls compared with mammography alone.
Major finding: The rate of screen-detected early-stage cancer in women with dense breasts was higher with MRI alone vs MRI + mammography (difference 11.7/1000 examinations; 95% CI 4.6-18.8/1000 examinations) and MR + mammography vs mammography alone (difference 4.0/1000 examinations; 95% CI 1.4-6.7/1000 examinations); however, false-positive recall rates were higher with MRI + mammography vs mammography alone (difference 149.8/1000 examinations; 95% CI 135.7-163.9/1000 examinations) and comparable with both MRI and MRI + mammography.
Study details: This cohort study analyzed the data of women aged 40-79 years who had undergone screening with MRI (2611 screenings), MRI + mammography (6518 screenings), or mammography (65,180 screenings) from the Breast Cancer Surveillance Consortium registry.
Disclosures: This study was funded by the US Patient-Centered Outcomes Research Institute award and other sources. The authors declared no conflicts of interest.
Source: Kerlikowske K et al. Supplemental magnetic resonance imaging plus mammography compared with magnetic resonance imaging or mammography by extent of breast density. J Natl Cancer Inst. 2023 (Oct 27). doi: 10.1093/jnci/djad201
Prognosis remains poor in inflammatory BC despite neoadjuvant chemotherapy
Key clinical point: Despite treatment with neoadjuvant chemotherapy (NAC), patients with locally advanced inflammatory breast cancer (BC) showed poorer survival outcomes than those with noninflammatory BC.
Major finding: Patients with inflammatory vs noninflammatory locally advanced BC who received NAC had significantly lower rates of 5-year overall survival (58.9% vs 86.7%; P = .00005), relapse-free survival (53.0% vs 80.3%; P = .0001), and distant relapse-free survival (53.3% vs 80.9%; P = .0001).
Study details: This retrospective analysis included 84 patients with stage III inflammatory BC and 81 matched-control individuals with stage III noninflammatory BC, all of whom received neoadjuvant chemotherapy.
Disclosures: This study did not receive any specific funding. KU Park declared being a consultant with Bayer LLC. The other authors declared no conflicts of interest.
Source: Johnson KCC et al. Survival outcomes seen with neoadjuvant chemotherapy in the management of locally advanced inflammatory breast cancer (IBC) versus matched controls. Breast. 2023;72:103591 (Oct 13). doi: 10.1016/j.breast.2023.103591
Key clinical point: Despite treatment with neoadjuvant chemotherapy (NAC), patients with locally advanced inflammatory breast cancer (BC) showed poorer survival outcomes than those with noninflammatory BC.
Major finding: Patients with inflammatory vs noninflammatory locally advanced BC who received NAC had significantly lower rates of 5-year overall survival (58.9% vs 86.7%; P = .00005), relapse-free survival (53.0% vs 80.3%; P = .0001), and distant relapse-free survival (53.3% vs 80.9%; P = .0001).
Study details: This retrospective analysis included 84 patients with stage III inflammatory BC and 81 matched-control individuals with stage III noninflammatory BC, all of whom received neoadjuvant chemotherapy.
Disclosures: This study did not receive any specific funding. KU Park declared being a consultant with Bayer LLC. The other authors declared no conflicts of interest.
Source: Johnson KCC et al. Survival outcomes seen with neoadjuvant chemotherapy in the management of locally advanced inflammatory breast cancer (IBC) versus matched controls. Breast. 2023;72:103591 (Oct 13). doi: 10.1016/j.breast.2023.103591
Key clinical point: Despite treatment with neoadjuvant chemotherapy (NAC), patients with locally advanced inflammatory breast cancer (BC) showed poorer survival outcomes than those with noninflammatory BC.
Major finding: Patients with inflammatory vs noninflammatory locally advanced BC who received NAC had significantly lower rates of 5-year overall survival (58.9% vs 86.7%; P = .00005), relapse-free survival (53.0% vs 80.3%; P = .0001), and distant relapse-free survival (53.3% vs 80.9%; P = .0001).
Study details: This retrospective analysis included 84 patients with stage III inflammatory BC and 81 matched-control individuals with stage III noninflammatory BC, all of whom received neoadjuvant chemotherapy.
Disclosures: This study did not receive any specific funding. KU Park declared being a consultant with Bayer LLC. The other authors declared no conflicts of interest.
Source: Johnson KCC et al. Survival outcomes seen with neoadjuvant chemotherapy in the management of locally advanced inflammatory breast cancer (IBC) versus matched controls. Breast. 2023;72:103591 (Oct 13). doi: 10.1016/j.breast.2023.103591
Oral SERD improve PFS in ER+/HER2− metastatic BC, shows meta-analysis
Key clinical point: Oral selective estrogen receptor degraders (SERD) improved the progression-free survival (PFS) outcomes in patients with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC), particularly in those with ESR1 mutations.
Major finding: Compared with endocrine therapies (ET) of the physician’s choice, oral SERD led to a greater improvement in PFS outcomes in the overall population (hazard ratio [HR] 0.783; P < .001) and in the subgroup of patients with ESR1 mutations (HR 0.557; P < .001); however, no PFS benefit was observed in the ESR1 wild-type subgroup (P = .543).
Study details: Findings are from a meta-analysis of individual patient data from four randomized clinical trials including 1290 patients with ER+/HER2− metastatic BC who received oral SERD or ET of physician’s choice.
Disclosures: This study did not receive any specific funding. Some authors declared receiving honoraria, research funding, or travel grants from or serving in advisory or consulting roles for various sources.
Source: Wong NZH et al. Efficacy of oral SERDs in the treatment of ER+, HER2 - metastatic breast cancer, a stratified analysis of the ESR1 wild type and mutant subgroups. Ann Oncol. 2023 (Oct 21). doi: 10.1016/j.annonc.2023.10.122
Key clinical point: Oral selective estrogen receptor degraders (SERD) improved the progression-free survival (PFS) outcomes in patients with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC), particularly in those with ESR1 mutations.
Major finding: Compared with endocrine therapies (ET) of the physician’s choice, oral SERD led to a greater improvement in PFS outcomes in the overall population (hazard ratio [HR] 0.783; P < .001) and in the subgroup of patients with ESR1 mutations (HR 0.557; P < .001); however, no PFS benefit was observed in the ESR1 wild-type subgroup (P = .543).
Study details: Findings are from a meta-analysis of individual patient data from four randomized clinical trials including 1290 patients with ER+/HER2− metastatic BC who received oral SERD or ET of physician’s choice.
Disclosures: This study did not receive any specific funding. Some authors declared receiving honoraria, research funding, or travel grants from or serving in advisory or consulting roles for various sources.
Source: Wong NZH et al. Efficacy of oral SERDs in the treatment of ER+, HER2 - metastatic breast cancer, a stratified analysis of the ESR1 wild type and mutant subgroups. Ann Oncol. 2023 (Oct 21). doi: 10.1016/j.annonc.2023.10.122
Key clinical point: Oral selective estrogen receptor degraders (SERD) improved the progression-free survival (PFS) outcomes in patients with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC), particularly in those with ESR1 mutations.
Major finding: Compared with endocrine therapies (ET) of the physician’s choice, oral SERD led to a greater improvement in PFS outcomes in the overall population (hazard ratio [HR] 0.783; P < .001) and in the subgroup of patients with ESR1 mutations (HR 0.557; P < .001); however, no PFS benefit was observed in the ESR1 wild-type subgroup (P = .543).
Study details: Findings are from a meta-analysis of individual patient data from four randomized clinical trials including 1290 patients with ER+/HER2− metastatic BC who received oral SERD or ET of physician’s choice.
Disclosures: This study did not receive any specific funding. Some authors declared receiving honoraria, research funding, or travel grants from or serving in advisory or consulting roles for various sources.
Source: Wong NZH et al. Efficacy of oral SERDs in the treatment of ER+, HER2 - metastatic breast cancer, a stratified analysis of the ESR1 wild type and mutant subgroups. Ann Oncol. 2023 (Oct 21). doi: 10.1016/j.annonc.2023.10.122
Neoadjuvant camrelizumab plus chemo shows promising efficacy and safety in early TNBC
Key clinical point: Neoadjuvant immunotherapy with camrelizumab plus chemotherapy with nab-paclitaxel and epirubicin showed promising anti-tumor activity and a manageable safety profile in patients with early triple-negative breast cancer (TNBC).
Major finding: The majority of patients achieved a pathological complete response rate (64.1%; 95% CI 47.2%-78.8%) and an objective response rate (89.7%; 95% CI 74.8%-96.7%). Decreased white blood cell (56.4%), neutropenia (41.0%), and anemia (20.5%) were the most common grade 3 or 4 adverse events, and no treatment-related deaths were reported.
Study details: This phase 2 trial included 39 treatment-naive patients with early TNBC who received neoadjuvant camrelizumab, nab-paclitaxel, and epirubicin every 3 weeks for 6 cycles.
Disclosures: This study was supported by Jiangsu Hengrui Pharmaceuticals Co., Ltd, China. The authors declared no conflicts of interest.
Source: Wang C et al. Neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin in early triple-negative breast cancer: A single-arm phase II trial. Nat Commun. 2023;14:6654 (Oct 20). doi: 10.1038/s41467-023-42479-w
Key clinical point: Neoadjuvant immunotherapy with camrelizumab plus chemotherapy with nab-paclitaxel and epirubicin showed promising anti-tumor activity and a manageable safety profile in patients with early triple-negative breast cancer (TNBC).
Major finding: The majority of patients achieved a pathological complete response rate (64.1%; 95% CI 47.2%-78.8%) and an objective response rate (89.7%; 95% CI 74.8%-96.7%). Decreased white blood cell (56.4%), neutropenia (41.0%), and anemia (20.5%) were the most common grade 3 or 4 adverse events, and no treatment-related deaths were reported.
Study details: This phase 2 trial included 39 treatment-naive patients with early TNBC who received neoadjuvant camrelizumab, nab-paclitaxel, and epirubicin every 3 weeks for 6 cycles.
Disclosures: This study was supported by Jiangsu Hengrui Pharmaceuticals Co., Ltd, China. The authors declared no conflicts of interest.
Source: Wang C et al. Neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin in early triple-negative breast cancer: A single-arm phase II trial. Nat Commun. 2023;14:6654 (Oct 20). doi: 10.1038/s41467-023-42479-w
Key clinical point: Neoadjuvant immunotherapy with camrelizumab plus chemotherapy with nab-paclitaxel and epirubicin showed promising anti-tumor activity and a manageable safety profile in patients with early triple-negative breast cancer (TNBC).
Major finding: The majority of patients achieved a pathological complete response rate (64.1%; 95% CI 47.2%-78.8%) and an objective response rate (89.7%; 95% CI 74.8%-96.7%). Decreased white blood cell (56.4%), neutropenia (41.0%), and anemia (20.5%) were the most common grade 3 or 4 adverse events, and no treatment-related deaths were reported.
Study details: This phase 2 trial included 39 treatment-naive patients with early TNBC who received neoadjuvant camrelizumab, nab-paclitaxel, and epirubicin every 3 weeks for 6 cycles.
Disclosures: This study was supported by Jiangsu Hengrui Pharmaceuticals Co., Ltd, China. The authors declared no conflicts of interest.
Source: Wang C et al. Neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin in early triple-negative breast cancer: A single-arm phase II trial. Nat Commun. 2023;14:6654 (Oct 20). doi: 10.1038/s41467-023-42479-w