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Meta-analysis shows link between pretreatment prognostic nutritional index and survival in breast cancer

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Key clinical point: Improved pretreatment values of the prognostic nutritional index (PNI), an indicator of nutritional immune status, was linked to better long-term survival outcomes in patients with breast cancer (BC).

Major finding: Although low pretreatment PNI did not have any effect on 1-year overall survival (OS) outcomes (odds ratio [OR] 1.55; P = .353), it was significantly associated with worse 3-year (OR 2.34; P < .001), 5-year (OR 3.18; P < .001), 8-year (OR 2.74; P = .001), and 10-year (OR 2.58; P = .021) OS.

Study details: Findings are from a meta-analysis of eight studies including 2322 patients with BC.

Disclosures: This study was funded by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Hu G et al. Low pretreatment prognostic nutritional index predicts poor survival in breast cancer patients: A meta-analysis. PLoS One. 2023;18(1):e0280669 (Jan 20). Doi: 10.1371/journal.pone.0280669

 

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Key clinical point: Improved pretreatment values of the prognostic nutritional index (PNI), an indicator of nutritional immune status, was linked to better long-term survival outcomes in patients with breast cancer (BC).

Major finding: Although low pretreatment PNI did not have any effect on 1-year overall survival (OS) outcomes (odds ratio [OR] 1.55; P = .353), it was significantly associated with worse 3-year (OR 2.34; P < .001), 5-year (OR 3.18; P < .001), 8-year (OR 2.74; P = .001), and 10-year (OR 2.58; P = .021) OS.

Study details: Findings are from a meta-analysis of eight studies including 2322 patients with BC.

Disclosures: This study was funded by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Hu G et al. Low pretreatment prognostic nutritional index predicts poor survival in breast cancer patients: A meta-analysis. PLoS One. 2023;18(1):e0280669 (Jan 20). Doi: 10.1371/journal.pone.0280669

 

Key clinical point: Improved pretreatment values of the prognostic nutritional index (PNI), an indicator of nutritional immune status, was linked to better long-term survival outcomes in patients with breast cancer (BC).

Major finding: Although low pretreatment PNI did not have any effect on 1-year overall survival (OS) outcomes (odds ratio [OR] 1.55; P = .353), it was significantly associated with worse 3-year (OR 2.34; P < .001), 5-year (OR 3.18; P < .001), 8-year (OR 2.74; P = .001), and 10-year (OR 2.58; P = .021) OS.

Study details: Findings are from a meta-analysis of eight studies including 2322 patients with BC.

Disclosures: This study was funded by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Hu G et al. Low pretreatment prognostic nutritional index predicts poor survival in breast cancer patients: A meta-analysis. PLoS One. 2023;18(1):e0280669 (Jan 20). Doi: 10.1371/journal.pone.0280669

 

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Interval BC have more unfavorable characteristics than screen-detected BC

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Key clinical point: Interval breast cancers (BC) detected between annual mammograms have significantly worse prognostic characteristics than BC detected during mammographic screening.

Major finding: Breast density is significantly associated with the development of an interval cancer (adjusted odds ratio 2.17; P = .003). Interval vs screen-detected BC were more often primary tumor stage II or higher (43% vs 12%; P < .001), regional lymph node stage I or higher (22% vs 12%; P = .003), triple negative (21% vs 6%; P < .001) with high Ki67 proliferation indices (62% vs 38%; P = .002), and significantly more invasive (P = .007).

Study details: Findings are from a retrospective cohort study including 1232 women diagnosed with BC within 1 year of screening, of which 1136 had screen-detected BC and 96 had interval BC.

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

Source: Ambinder EB et al. Interval breast cancers versus screen detected breast cancers: A retrospective cohort study. Acad Radiol. 2023 (Feb 3). Doi: 10.1016/j.acra.2023.01.007

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Key clinical point: Interval breast cancers (BC) detected between annual mammograms have significantly worse prognostic characteristics than BC detected during mammographic screening.

Major finding: Breast density is significantly associated with the development of an interval cancer (adjusted odds ratio 2.17; P = .003). Interval vs screen-detected BC were more often primary tumor stage II or higher (43% vs 12%; P < .001), regional lymph node stage I or higher (22% vs 12%; P = .003), triple negative (21% vs 6%; P < .001) with high Ki67 proliferation indices (62% vs 38%; P = .002), and significantly more invasive (P = .007).

Study details: Findings are from a retrospective cohort study including 1232 women diagnosed with BC within 1 year of screening, of which 1136 had screen-detected BC and 96 had interval BC.

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

Source: Ambinder EB et al. Interval breast cancers versus screen detected breast cancers: A retrospective cohort study. Acad Radiol. 2023 (Feb 3). Doi: 10.1016/j.acra.2023.01.007

Key clinical point: Interval breast cancers (BC) detected between annual mammograms have significantly worse prognostic characteristics than BC detected during mammographic screening.

Major finding: Breast density is significantly associated with the development of an interval cancer (adjusted odds ratio 2.17; P = .003). Interval vs screen-detected BC were more often primary tumor stage II or higher (43% vs 12%; P < .001), regional lymph node stage I or higher (22% vs 12%; P = .003), triple negative (21% vs 6%; P < .001) with high Ki67 proliferation indices (62% vs 38%; P = .002), and significantly more invasive (P = .007).

Study details: Findings are from a retrospective cohort study including 1232 women diagnosed with BC within 1 year of screening, of which 1136 had screen-detected BC and 96 had interval BC.

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

Source: Ambinder EB et al. Interval breast cancers versus screen detected breast cancers: A retrospective cohort study. Acad Radiol. 2023 (Feb 3). Doi: 10.1016/j.acra.2023.01.007

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Risk for local recurrence higher in microinvasive vs T1a-2 BC

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Key clinical point: Patients with microinvasive breast cancer (BC) had a significantly higher risk for local recurrence and comparable rates of distant recurrence and death compared with patients with T1a-2 BC.

Major finding: Although the 10-year local recurrence rate was significantly higher in patients with microinvasive vs T1a-2 BC (hazard ratio 3.73; P < .001), the 10-year distant recurrence risk (P = .36) and overall survival rates (P = .14) were similar between both patient populations.

Study details: Findings are from the Canadian Hypofractionation trial including 1234 patients with T1-2 N0 invasive BC who were randomly assigned to receive hypofractionated or conventional fractionated whole breast irradiation, of which 3% of patients had microinvasive BC.

Disclosures: Dr Whelan declared receiving support from the Canada Research Chair in Breast Cancer Research and research funding unrelated to this study.

Source: Goldberg M et al. Long-term outcomes and effects of hypofractionated radiotherapy in microinvasive breast cancer: Analysis from a randomized trial. Breast. 2023;68:189-193 (Feb 9). Doi: 10.1016/j.breast.2023.02.005

 

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Key clinical point: Patients with microinvasive breast cancer (BC) had a significantly higher risk for local recurrence and comparable rates of distant recurrence and death compared with patients with T1a-2 BC.

Major finding: Although the 10-year local recurrence rate was significantly higher in patients with microinvasive vs T1a-2 BC (hazard ratio 3.73; P < .001), the 10-year distant recurrence risk (P = .36) and overall survival rates (P = .14) were similar between both patient populations.

Study details: Findings are from the Canadian Hypofractionation trial including 1234 patients with T1-2 N0 invasive BC who were randomly assigned to receive hypofractionated or conventional fractionated whole breast irradiation, of which 3% of patients had microinvasive BC.

Disclosures: Dr Whelan declared receiving support from the Canada Research Chair in Breast Cancer Research and research funding unrelated to this study.

Source: Goldberg M et al. Long-term outcomes and effects of hypofractionated radiotherapy in microinvasive breast cancer: Analysis from a randomized trial. Breast. 2023;68:189-193 (Feb 9). Doi: 10.1016/j.breast.2023.02.005

 

Key clinical point: Patients with microinvasive breast cancer (BC) had a significantly higher risk for local recurrence and comparable rates of distant recurrence and death compared with patients with T1a-2 BC.

Major finding: Although the 10-year local recurrence rate was significantly higher in patients with microinvasive vs T1a-2 BC (hazard ratio 3.73; P < .001), the 10-year distant recurrence risk (P = .36) and overall survival rates (P = .14) were similar between both patient populations.

Study details: Findings are from the Canadian Hypofractionation trial including 1234 patients with T1-2 N0 invasive BC who were randomly assigned to receive hypofractionated or conventional fractionated whole breast irradiation, of which 3% of patients had microinvasive BC.

Disclosures: Dr Whelan declared receiving support from the Canada Research Chair in Breast Cancer Research and research funding unrelated to this study.

Source: Goldberg M et al. Long-term outcomes and effects of hypofractionated radiotherapy in microinvasive breast cancer: Analysis from a randomized trial. Breast. 2023;68:189-193 (Feb 9). Doi: 10.1016/j.breast.2023.02.005

 

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High PD-L2 levels may predict worse clinical outcomes in ER+ BC

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Key clinical point: Programmed cell death-1 ligand-2 (PD-L2) protein levels were high in approximately one-third of estrogen receptor-positive (ER+) breast cancer (BC) tumors and were associated with greater odds of disease recurrence.

Major finding: High levels of PD-L2 protein were present in 33% of ER+ tumors and were associated with shorter progression-free survival in the entire cohort of patients with ER+ BC (hazard ratio [HR] 2.0; P < .001) and in the subgroup of patients treated with adjuvant chemotherapy (HR 3.4; P < .001).

Study details: Findings are from a retrospective study including patients with ER+ BC who were categorized into the main study cohort (n = 684) and the external validation cohort (n = 273).

Disclosures: This study was supported by grants from Susan G. Komen, US National Institutes of Health, and other sources. The authors declared serving in leadership, employment, or consulting or advisory roles or receiving funding, honoraria, or travel and accommodation expenses from several sources.

Source: Chervoneva I et al. High PD-L2 predicts early recurrence of ER-positive breast cancer. JCO Precis Oncol. 2023;7:e2100498 (Jan 18). Doi: 10.1200/PO.21.00498

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Key clinical point: Programmed cell death-1 ligand-2 (PD-L2) protein levels were high in approximately one-third of estrogen receptor-positive (ER+) breast cancer (BC) tumors and were associated with greater odds of disease recurrence.

Major finding: High levels of PD-L2 protein were present in 33% of ER+ tumors and were associated with shorter progression-free survival in the entire cohort of patients with ER+ BC (hazard ratio [HR] 2.0; P < .001) and in the subgroup of patients treated with adjuvant chemotherapy (HR 3.4; P < .001).

Study details: Findings are from a retrospective study including patients with ER+ BC who were categorized into the main study cohort (n = 684) and the external validation cohort (n = 273).

Disclosures: This study was supported by grants from Susan G. Komen, US National Institutes of Health, and other sources. The authors declared serving in leadership, employment, or consulting or advisory roles or receiving funding, honoraria, or travel and accommodation expenses from several sources.

Source: Chervoneva I et al. High PD-L2 predicts early recurrence of ER-positive breast cancer. JCO Precis Oncol. 2023;7:e2100498 (Jan 18). Doi: 10.1200/PO.21.00498

Key clinical point: Programmed cell death-1 ligand-2 (PD-L2) protein levels were high in approximately one-third of estrogen receptor-positive (ER+) breast cancer (BC) tumors and were associated with greater odds of disease recurrence.

Major finding: High levels of PD-L2 protein were present in 33% of ER+ tumors and were associated with shorter progression-free survival in the entire cohort of patients with ER+ BC (hazard ratio [HR] 2.0; P < .001) and in the subgroup of patients treated with adjuvant chemotherapy (HR 3.4; P < .001).

Study details: Findings are from a retrospective study including patients with ER+ BC who were categorized into the main study cohort (n = 684) and the external validation cohort (n = 273).

Disclosures: This study was supported by grants from Susan G. Komen, US National Institutes of Health, and other sources. The authors declared serving in leadership, employment, or consulting or advisory roles or receiving funding, honoraria, or travel and accommodation expenses from several sources.

Source: Chervoneva I et al. High PD-L2 predicts early recurrence of ER-positive breast cancer. JCO Precis Oncol. 2023;7:e2100498 (Jan 18). Doi: 10.1200/PO.21.00498

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Adjuvant abemaciclib+ET shows treatment benefit regardless of menopausal status in HR+/HER2− early BC

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Key clinical point: The addition of abemaciclib to endocrine therapy (ET) demonstrated robust treatment benefits regardless of menopausal status in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−), high-risk early breast cancer (BC).

Major finding: Abemaciclib+ET significantly improved invasive disease-free survival (iDFS; hazard ratio 0.785; nominal P = .0268) in postmenopausal women with HR+/HER2− BC and led to even greater iDFS improvement (hazard ratio 0.578; P < .0001) in premenopausal women. No new safety events were reported.

Study details: Findings are from an exploratory analysis of the monarchE trial including 5637 patients with HR+/HER2−, node-positive, high-risk early BC who were randomly assigned to receive standard of care ET with/without adjuvant abemaciclib, of which 43.5% and 56.4% of patients were premenopausal and postmenopausal, respectively.

Disclosures: This study was funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly. The other authors reported ties with several sources, including Eli Lilly.

Source: Paluch-Shimon S et al, on behalf of the monarchE investigators. Efficacy and safety results by menopausal status in monarchE: adjuvant abemaciclib combined with endocrine therapy in patients with HR+, HER2−, node-positive, high-risk early breast cancer. Ther Adv Med Oncol. 2023 (Feb 3). Doi: 10.1177/17588359231151840

 

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Key clinical point: The addition of abemaciclib to endocrine therapy (ET) demonstrated robust treatment benefits regardless of menopausal status in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−), high-risk early breast cancer (BC).

Major finding: Abemaciclib+ET significantly improved invasive disease-free survival (iDFS; hazard ratio 0.785; nominal P = .0268) in postmenopausal women with HR+/HER2− BC and led to even greater iDFS improvement (hazard ratio 0.578; P < .0001) in premenopausal women. No new safety events were reported.

Study details: Findings are from an exploratory analysis of the monarchE trial including 5637 patients with HR+/HER2−, node-positive, high-risk early BC who were randomly assigned to receive standard of care ET with/without adjuvant abemaciclib, of which 43.5% and 56.4% of patients were premenopausal and postmenopausal, respectively.

Disclosures: This study was funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly. The other authors reported ties with several sources, including Eli Lilly.

Source: Paluch-Shimon S et al, on behalf of the monarchE investigators. Efficacy and safety results by menopausal status in monarchE: adjuvant abemaciclib combined with endocrine therapy in patients with HR+, HER2−, node-positive, high-risk early breast cancer. Ther Adv Med Oncol. 2023 (Feb 3). Doi: 10.1177/17588359231151840

 

Key clinical point: The addition of abemaciclib to endocrine therapy (ET) demonstrated robust treatment benefits regardless of menopausal status in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−), high-risk early breast cancer (BC).

Major finding: Abemaciclib+ET significantly improved invasive disease-free survival (iDFS; hazard ratio 0.785; nominal P = .0268) in postmenopausal women with HR+/HER2− BC and led to even greater iDFS improvement (hazard ratio 0.578; P < .0001) in premenopausal women. No new safety events were reported.

Study details: Findings are from an exploratory analysis of the monarchE trial including 5637 patients with HR+/HER2−, node-positive, high-risk early BC who were randomly assigned to receive standard of care ET with/without adjuvant abemaciclib, of which 43.5% and 56.4% of patients were premenopausal and postmenopausal, respectively.

Disclosures: This study was funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly. The other authors reported ties with several sources, including Eli Lilly.

Source: Paluch-Shimon S et al, on behalf of the monarchE investigators. Efficacy and safety results by menopausal status in monarchE: adjuvant abemaciclib combined with endocrine therapy in patients with HR+, HER2−, node-positive, high-risk early breast cancer. Ther Adv Med Oncol. 2023 (Feb 3). Doi: 10.1177/17588359231151840

 

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Adding ET to dual anti-HER2 targeted therapy beneficial in HER2+/HR+ metastatic BC

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Key clinical point: In patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC), adding endocrine therapy (ET) to dual anti-HER2 targeted therapy after chemotherapy improved progression-free survival (PFS) without increasing the rate of adverse events.

Major finding: There was a significant improvement in 5-year PFS with vs without the addition of ET (hazard ratio 0.59; P = .031). Nausea and vomiting were more common in patients who did not vs did receive ET (21% vs 7%; P = .010).

Study details: This study analyzed the real-world data of 147 patients with HER2+/HR+ metastatic BC from a prospective registry who received first-line chemotherapy plus trastuzumab and pertuzumab with (n = 91) or without (n = 56) concurrent ET.

Disclosures: This study did not receive any funding. Some authors declared serving on the advisory board for or receiving research funding, speaker honoraria, or travel grants from several sources.

Source: Loft M et al. Addition of endocrine therapy to dual anti-HER2 targeted therapy in initial treatment of HER2 + /HR + metastatic breast cancer. Breast Cancer Res Treat. 2023;198:67-74 (Jan 9). Doi: 10.1007/s10549-022-06856-1

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Key clinical point: In patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC), adding endocrine therapy (ET) to dual anti-HER2 targeted therapy after chemotherapy improved progression-free survival (PFS) without increasing the rate of adverse events.

Major finding: There was a significant improvement in 5-year PFS with vs without the addition of ET (hazard ratio 0.59; P = .031). Nausea and vomiting were more common in patients who did not vs did receive ET (21% vs 7%; P = .010).

Study details: This study analyzed the real-world data of 147 patients with HER2+/HR+ metastatic BC from a prospective registry who received first-line chemotherapy plus trastuzumab and pertuzumab with (n = 91) or without (n = 56) concurrent ET.

Disclosures: This study did not receive any funding. Some authors declared serving on the advisory board for or receiving research funding, speaker honoraria, or travel grants from several sources.

Source: Loft M et al. Addition of endocrine therapy to dual anti-HER2 targeted therapy in initial treatment of HER2 + /HR + metastatic breast cancer. Breast Cancer Res Treat. 2023;198:67-74 (Jan 9). Doi: 10.1007/s10549-022-06856-1

Key clinical point: In patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC), adding endocrine therapy (ET) to dual anti-HER2 targeted therapy after chemotherapy improved progression-free survival (PFS) without increasing the rate of adverse events.

Major finding: There was a significant improvement in 5-year PFS with vs without the addition of ET (hazard ratio 0.59; P = .031). Nausea and vomiting were more common in patients who did not vs did receive ET (21% vs 7%; P = .010).

Study details: This study analyzed the real-world data of 147 patients with HER2+/HR+ metastatic BC from a prospective registry who received first-line chemotherapy plus trastuzumab and pertuzumab with (n = 91) or without (n = 56) concurrent ET.

Disclosures: This study did not receive any funding. Some authors declared serving on the advisory board for or receiving research funding, speaker honoraria, or travel grants from several sources.

Source: Loft M et al. Addition of endocrine therapy to dual anti-HER2 targeted therapy in initial treatment of HER2 + /HR + metastatic breast cancer. Breast Cancer Res Treat. 2023;198:67-74 (Jan 9). Doi: 10.1007/s10549-022-06856-1

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SPIO can help avoid upfront sentinel lymph node dissection in ductal carcinoma in situ of the breast

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Key clinical point: Marking sentinel lymph nodes (SLN) with superparamagnetic iron oxide (SPIO) nanoparticles led to a substantial proportion of patients with ductal carcinoma in situ (DCIS) of the breast avoiding an upfront SLN dissection (SLND).

Major finding: Upfront SLND could be avoided in 78.3% of patients after marking SLN with SPIO nanoparticles. Among patients receiving delayed SLND, the detection rate was significantly better with SPIO vs radioisotope (99Tc), both with (98.2% vs 63.6%) and without the concomitant use of blue dye (92.7% vs 50.9%; both P < .001).

Study details: Findings are from a prospective, multicenter cohort study including 254 patients with DCIS.

Disclosures: This study was funded by the Uppsala University. One author declared serving on an advisory board and receiving institutional grants and speaker honoraria from several sources.

Source: Karakatsanis A et al. Delayed sentinel lymph node dissection in patients with a preoperative diagnosis of ductal cancer in situ by preoperative injection with superparamagnetic iron oxide (SPIO) nanoparticles: The SentiNot study. Ann Surg Oncol. 2023 (Jan 31). Doi: 10.1245/s10434-022-13064-0

 

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Key clinical point: Marking sentinel lymph nodes (SLN) with superparamagnetic iron oxide (SPIO) nanoparticles led to a substantial proportion of patients with ductal carcinoma in situ (DCIS) of the breast avoiding an upfront SLN dissection (SLND).

Major finding: Upfront SLND could be avoided in 78.3% of patients after marking SLN with SPIO nanoparticles. Among patients receiving delayed SLND, the detection rate was significantly better with SPIO vs radioisotope (99Tc), both with (98.2% vs 63.6%) and without the concomitant use of blue dye (92.7% vs 50.9%; both P < .001).

Study details: Findings are from a prospective, multicenter cohort study including 254 patients with DCIS.

Disclosures: This study was funded by the Uppsala University. One author declared serving on an advisory board and receiving institutional grants and speaker honoraria from several sources.

Source: Karakatsanis A et al. Delayed sentinel lymph node dissection in patients with a preoperative diagnosis of ductal cancer in situ by preoperative injection with superparamagnetic iron oxide (SPIO) nanoparticles: The SentiNot study. Ann Surg Oncol. 2023 (Jan 31). Doi: 10.1245/s10434-022-13064-0

 

Key clinical point: Marking sentinel lymph nodes (SLN) with superparamagnetic iron oxide (SPIO) nanoparticles led to a substantial proportion of patients with ductal carcinoma in situ (DCIS) of the breast avoiding an upfront SLN dissection (SLND).

Major finding: Upfront SLND could be avoided in 78.3% of patients after marking SLN with SPIO nanoparticles. Among patients receiving delayed SLND, the detection rate was significantly better with SPIO vs radioisotope (99Tc), both with (98.2% vs 63.6%) and without the concomitant use of blue dye (92.7% vs 50.9%; both P < .001).

Study details: Findings are from a prospective, multicenter cohort study including 254 patients with DCIS.

Disclosures: This study was funded by the Uppsala University. One author declared serving on an advisory board and receiving institutional grants and speaker honoraria from several sources.

Source: Karakatsanis A et al. Delayed sentinel lymph node dissection in patients with a preoperative diagnosis of ductal cancer in situ by preoperative injection with superparamagnetic iron oxide (SPIO) nanoparticles: The SentiNot study. Ann Surg Oncol. 2023 (Jan 31). Doi: 10.1245/s10434-022-13064-0

 

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Contralateral prophylactic mastectomy offers no survival advantage in TNBC

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Key clinical point: Contralateral prophylactic mastectomy (CPM) did not offer any survival benefit to patients with triple-negative breast cancer (TNBC) irrespective of the presence of BRCA mutations.

Major finding: The 5-year overall survival did not significantly improve with vs without CPM in the entire population of patients with TNBC (P = .05) and in the subgroups of patients with (P = .35) and without (P = .12) BRCA mutations.

Study details: Findings are from a multi-institutional database study including 796 patients with TNBC, of which 15.5% of patients underwent CPM.

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

Source: Fasano GA et al. Survival outcomes in women with unilateral, triple-negative, breast cancer correlated with contralateral prophylactic mastectomy. Ann Surg Oncol. 2023 (Jan 21). Doi: 10.1245/s10434-022-13056-0

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Key clinical point: Contralateral prophylactic mastectomy (CPM) did not offer any survival benefit to patients with triple-negative breast cancer (TNBC) irrespective of the presence of BRCA mutations.

Major finding: The 5-year overall survival did not significantly improve with vs without CPM in the entire population of patients with TNBC (P = .05) and in the subgroups of patients with (P = .35) and without (P = .12) BRCA mutations.

Study details: Findings are from a multi-institutional database study including 796 patients with TNBC, of which 15.5% of patients underwent CPM.

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

Source: Fasano GA et al. Survival outcomes in women with unilateral, triple-negative, breast cancer correlated with contralateral prophylactic mastectomy. Ann Surg Oncol. 2023 (Jan 21). Doi: 10.1245/s10434-022-13056-0

Key clinical point: Contralateral prophylactic mastectomy (CPM) did not offer any survival benefit to patients with triple-negative breast cancer (TNBC) irrespective of the presence of BRCA mutations.

Major finding: The 5-year overall survival did not significantly improve with vs without CPM in the entire population of patients with TNBC (P = .05) and in the subgroups of patients with (P = .35) and without (P = .12) BRCA mutations.

Study details: Findings are from a multi-institutional database study including 796 patients with TNBC, of which 15.5% of patients underwent CPM.

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

Source: Fasano GA et al. Survival outcomes in women with unilateral, triple-negative, breast cancer correlated with contralateral prophylactic mastectomy. Ann Surg Oncol. 2023 (Jan 21). Doi: 10.1245/s10434-022-13056-0

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Adjuvant AI yields better survival outcomes than tamoxifen or tamoxifen+AI in HR+/HER2+ BC

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Key clinical point: Adjuvant endocrine therapy (ET) with an aromatase inhibitor (AI) was associated with better disease-free survival (DFS) than tamoxifen-only or tamoxifen+AI in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor2-positive (HER2+) breast cancer (BC).

Major finding: Adjuvant ET with tamoxifen or tamoxifen+AI was associated with significantly worse DFS rates than AI in the entire population of women with HR+/HER2+ BC (hazard ratio 1.64; P = .025), with gonadotropin-releasing hormone being associated with improved DFS rates in premenopausal patients aged ≤45 years (hazard ratio 0.41; P = .023).

Study details: Findings are from a post hoc analysis of the ShortHER trial including 784 patients with HR+/HER2+ early BC who received adjuvant anthracycline/taxane-based chemotherapy plus trastuzumab.

Disclosures: This study was supported by Agenzia Italiana del Farmaco and other sources. Some authors declared receiving personal fees from several sources.

Source: Dieci MV et al. Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive/HER2-positive BC: Analysis from the phase III randomized ShortHER trial. NPJ Breast Cancer. 2023;9(1):6 (Feb 4). Doi: 10.1038/s41523-023-00509-2

 

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Key clinical point: Adjuvant endocrine therapy (ET) with an aromatase inhibitor (AI) was associated with better disease-free survival (DFS) than tamoxifen-only or tamoxifen+AI in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor2-positive (HER2+) breast cancer (BC).

Major finding: Adjuvant ET with tamoxifen or tamoxifen+AI was associated with significantly worse DFS rates than AI in the entire population of women with HR+/HER2+ BC (hazard ratio 1.64; P = .025), with gonadotropin-releasing hormone being associated with improved DFS rates in premenopausal patients aged ≤45 years (hazard ratio 0.41; P = .023).

Study details: Findings are from a post hoc analysis of the ShortHER trial including 784 patients with HR+/HER2+ early BC who received adjuvant anthracycline/taxane-based chemotherapy plus trastuzumab.

Disclosures: This study was supported by Agenzia Italiana del Farmaco and other sources. Some authors declared receiving personal fees from several sources.

Source: Dieci MV et al. Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive/HER2-positive BC: Analysis from the phase III randomized ShortHER trial. NPJ Breast Cancer. 2023;9(1):6 (Feb 4). Doi: 10.1038/s41523-023-00509-2

 

Key clinical point: Adjuvant endocrine therapy (ET) with an aromatase inhibitor (AI) was associated with better disease-free survival (DFS) than tamoxifen-only or tamoxifen+AI in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor2-positive (HER2+) breast cancer (BC).

Major finding: Adjuvant ET with tamoxifen or tamoxifen+AI was associated with significantly worse DFS rates than AI in the entire population of women with HR+/HER2+ BC (hazard ratio 1.64; P = .025), with gonadotropin-releasing hormone being associated with improved DFS rates in premenopausal patients aged ≤45 years (hazard ratio 0.41; P = .023).

Study details: Findings are from a post hoc analysis of the ShortHER trial including 784 patients with HR+/HER2+ early BC who received adjuvant anthracycline/taxane-based chemotherapy plus trastuzumab.

Disclosures: This study was supported by Agenzia Italiana del Farmaco and other sources. Some authors declared receiving personal fees from several sources.

Source: Dieci MV et al. Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive/HER2-positive BC: Analysis from the phase III randomized ShortHER trial. NPJ Breast Cancer. 2023;9(1):6 (Feb 4). Doi: 10.1038/s41523-023-00509-2

 

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Real-world survival benefit with CDK4/6 inhibitors in MBC

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Fri, 02/24/2023 - 10:34

A real-world analysis shows “meaningful” overall survival benefits when a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor is added to endocrine therapy for older women with hormone receptor (HR)–positive/HER2-negative metastatic breast cancer (MBC).

Three years after starting first-line treatment, overall survival rates were 49% with endocrine therapy alone versus 73% with endocrine therapy plus a CDK4/6 inhibitor – findings largely consistent with clinical trial data.

Treatment with endocrine therapy alone “should have a limited role in early lines of therapy for patients with HR-positive/HER2-negative MBC,” the researchers concluded.

The study was published online in the journal Cancer.

The Food and Drug Administration has approved the CDK4/6 inhibitors palbociclib, abemaciclib, and ribociclib for HR-positive/HER2-negative MBC in first and advanced therapy lines. The approval was based on phase 3, randomized, controlled trial data.

Yet gaps in evidence remain regarding survival outcomes in real-world settings for patients starting treatment with a CDK4/6 inhibitor, particularly for patients aged 65 and older, who typically aren’t included in randomized clinical trials.

To address these gaps, Ravi Goyal, PhD, with the University of Houston, and colleagues conducted a retrospective cohort study using the Survey Epidemiology and End Results Medicare database.

Dr. Goyal and coauthors identified 630 Medicare patients with HR-positive/HER2-negative MBC for whom first-line treatment was initiated within 12 months of diagnosis. Patients received either endocrine therapy alone (461 patients) or endocrine therapy plus a CDK4/6 inhibitor (169 patients), most commonly palbociclib.

The median duration of follow-up from the start of treatment was 24 months in the endocrine therapy–alone group and 30 months in the combination therapy group.

In a Kaplan-Meier analysis, the overall survival rate at 3 years after starting first-line treatment was 73% for the combination therapy group versus49% for the endocrine therapy group (P < .0001). Median overall survival from first-line therapy was not estimable in the endocrine therapy plus CDK4/6 inhibitor group; it was 34.8 months in the endocrine therapy–only group.

In multivariable Cox regression models, first-line dual therapy was independently associated with 41% lower rate of death in comparison with endocrine therapy alone (adjusted hazard ratio, 0.59).

Dr. Goyal and colleagues also performed a separate analysis of 206 patients for whom treatment was initiated in the second line; 88 received endocrine therapy alone, and 118 received endocrine therapy plus CDK4/6 inhibitor therapy.

In this setting, a similar benefit of dual therapy was observed. The 3-year overall survival rate was 68% for the combination group versus 50% for endocrine therapy alone (P = .0051). Median overall survival with second-line therapy was not estimable for the combination group; it was 30.9 months for the endocrine therapy group.

In the second line, multivariable Cox regression analysis showed that combination therapy was associated with a nearly 58% lower rate of death in comparison with endocrine therapy alone (aHR, 0.42).

The coauthors of an editorial in Cancer explain that the combination of a CDK4/6 inhibitor and endocrine therapy has become the “preferred first-line approach” in the management of HR-positive/HER2-negative MBC.

Dario Trapani, MD, and Erica Mayer, MD, with Dana-Farber Cancer Institute, Boston, noted that an overall survival benefit of similar magnitude from endocrine therapy plus a CDK4/6 inhibitor has also been reported in a recent real-world study of palbociclib and letrozole.

The work of Dr. Goyal and colleagues provides “confirmatory real-world evidence observed in clinical trials for endocrine sensitive, de novo, metastatic [breast cancer] in an older population,” Dr. Trapani and Dr. Mayer wrote.

The study had no specific funding. The authors and Dr. Trapani disclosed no relevant financial relaitonships. Dr. Mayer has consulted for Lilly, Novartis, Gilead, AstraZeneca, and Diaccurate.

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

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A real-world analysis shows “meaningful” overall survival benefits when a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor is added to endocrine therapy for older women with hormone receptor (HR)–positive/HER2-negative metastatic breast cancer (MBC).

Three years after starting first-line treatment, overall survival rates were 49% with endocrine therapy alone versus 73% with endocrine therapy plus a CDK4/6 inhibitor – findings largely consistent with clinical trial data.

Treatment with endocrine therapy alone “should have a limited role in early lines of therapy for patients with HR-positive/HER2-negative MBC,” the researchers concluded.

The study was published online in the journal Cancer.

The Food and Drug Administration has approved the CDK4/6 inhibitors palbociclib, abemaciclib, and ribociclib for HR-positive/HER2-negative MBC in first and advanced therapy lines. The approval was based on phase 3, randomized, controlled trial data.

Yet gaps in evidence remain regarding survival outcomes in real-world settings for patients starting treatment with a CDK4/6 inhibitor, particularly for patients aged 65 and older, who typically aren’t included in randomized clinical trials.

To address these gaps, Ravi Goyal, PhD, with the University of Houston, and colleagues conducted a retrospective cohort study using the Survey Epidemiology and End Results Medicare database.

Dr. Goyal and coauthors identified 630 Medicare patients with HR-positive/HER2-negative MBC for whom first-line treatment was initiated within 12 months of diagnosis. Patients received either endocrine therapy alone (461 patients) or endocrine therapy plus a CDK4/6 inhibitor (169 patients), most commonly palbociclib.

The median duration of follow-up from the start of treatment was 24 months in the endocrine therapy–alone group and 30 months in the combination therapy group.

In a Kaplan-Meier analysis, the overall survival rate at 3 years after starting first-line treatment was 73% for the combination therapy group versus49% for the endocrine therapy group (P < .0001). Median overall survival from first-line therapy was not estimable in the endocrine therapy plus CDK4/6 inhibitor group; it was 34.8 months in the endocrine therapy–only group.

In multivariable Cox regression models, first-line dual therapy was independently associated with 41% lower rate of death in comparison with endocrine therapy alone (adjusted hazard ratio, 0.59).

Dr. Goyal and colleagues also performed a separate analysis of 206 patients for whom treatment was initiated in the second line; 88 received endocrine therapy alone, and 118 received endocrine therapy plus CDK4/6 inhibitor therapy.

In this setting, a similar benefit of dual therapy was observed. The 3-year overall survival rate was 68% for the combination group versus 50% for endocrine therapy alone (P = .0051). Median overall survival with second-line therapy was not estimable for the combination group; it was 30.9 months for the endocrine therapy group.

In the second line, multivariable Cox regression analysis showed that combination therapy was associated with a nearly 58% lower rate of death in comparison with endocrine therapy alone (aHR, 0.42).

The coauthors of an editorial in Cancer explain that the combination of a CDK4/6 inhibitor and endocrine therapy has become the “preferred first-line approach” in the management of HR-positive/HER2-negative MBC.

Dario Trapani, MD, and Erica Mayer, MD, with Dana-Farber Cancer Institute, Boston, noted that an overall survival benefit of similar magnitude from endocrine therapy plus a CDK4/6 inhibitor has also been reported in a recent real-world study of palbociclib and letrozole.

The work of Dr. Goyal and colleagues provides “confirmatory real-world evidence observed in clinical trials for endocrine sensitive, de novo, metastatic [breast cancer] in an older population,” Dr. Trapani and Dr. Mayer wrote.

The study had no specific funding. The authors and Dr. Trapani disclosed no relevant financial relaitonships. Dr. Mayer has consulted for Lilly, Novartis, Gilead, AstraZeneca, and Diaccurate.

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

A real-world analysis shows “meaningful” overall survival benefits when a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor is added to endocrine therapy for older women with hormone receptor (HR)–positive/HER2-negative metastatic breast cancer (MBC).

Three years after starting first-line treatment, overall survival rates were 49% with endocrine therapy alone versus 73% with endocrine therapy plus a CDK4/6 inhibitor – findings largely consistent with clinical trial data.

Treatment with endocrine therapy alone “should have a limited role in early lines of therapy for patients with HR-positive/HER2-negative MBC,” the researchers concluded.

The study was published online in the journal Cancer.

The Food and Drug Administration has approved the CDK4/6 inhibitors palbociclib, abemaciclib, and ribociclib for HR-positive/HER2-negative MBC in first and advanced therapy lines. The approval was based on phase 3, randomized, controlled trial data.

Yet gaps in evidence remain regarding survival outcomes in real-world settings for patients starting treatment with a CDK4/6 inhibitor, particularly for patients aged 65 and older, who typically aren’t included in randomized clinical trials.

To address these gaps, Ravi Goyal, PhD, with the University of Houston, and colleagues conducted a retrospective cohort study using the Survey Epidemiology and End Results Medicare database.

Dr. Goyal and coauthors identified 630 Medicare patients with HR-positive/HER2-negative MBC for whom first-line treatment was initiated within 12 months of diagnosis. Patients received either endocrine therapy alone (461 patients) or endocrine therapy plus a CDK4/6 inhibitor (169 patients), most commonly palbociclib.

The median duration of follow-up from the start of treatment was 24 months in the endocrine therapy–alone group and 30 months in the combination therapy group.

In a Kaplan-Meier analysis, the overall survival rate at 3 years after starting first-line treatment was 73% for the combination therapy group versus49% for the endocrine therapy group (P < .0001). Median overall survival from first-line therapy was not estimable in the endocrine therapy plus CDK4/6 inhibitor group; it was 34.8 months in the endocrine therapy–only group.

In multivariable Cox regression models, first-line dual therapy was independently associated with 41% lower rate of death in comparison with endocrine therapy alone (adjusted hazard ratio, 0.59).

Dr. Goyal and colleagues also performed a separate analysis of 206 patients for whom treatment was initiated in the second line; 88 received endocrine therapy alone, and 118 received endocrine therapy plus CDK4/6 inhibitor therapy.

In this setting, a similar benefit of dual therapy was observed. The 3-year overall survival rate was 68% for the combination group versus 50% for endocrine therapy alone (P = .0051). Median overall survival with second-line therapy was not estimable for the combination group; it was 30.9 months for the endocrine therapy group.

In the second line, multivariable Cox regression analysis showed that combination therapy was associated with a nearly 58% lower rate of death in comparison with endocrine therapy alone (aHR, 0.42).

The coauthors of an editorial in Cancer explain that the combination of a CDK4/6 inhibitor and endocrine therapy has become the “preferred first-line approach” in the management of HR-positive/HER2-negative MBC.

Dario Trapani, MD, and Erica Mayer, MD, with Dana-Farber Cancer Institute, Boston, noted that an overall survival benefit of similar magnitude from endocrine therapy plus a CDK4/6 inhibitor has also been reported in a recent real-world study of palbociclib and letrozole.

The work of Dr. Goyal and colleagues provides “confirmatory real-world evidence observed in clinical trials for endocrine sensitive, de novo, metastatic [breast cancer] in an older population,” Dr. Trapani and Dr. Mayer wrote.

The study had no specific funding. The authors and Dr. Trapani disclosed no relevant financial relaitonships. Dr. Mayer has consulted for Lilly, Novartis, Gilead, AstraZeneca, and Diaccurate.

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

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