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Is sNfL an effective biomarker for neuronal damage and drug response in MS?
Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective biomarker for identifying subclinical disease activity and monitoring drug response in multiple sclerosis (MS).
Major finding: An sNfL Z score of >1.5 indicated an increased risk for future disease activity in all patients with MS (odds ratio [OR] 3.15; P < .0001) and in patients considered stable without evidence of disease activity (OR 2.66; P = .034). The sNfL values could depict a treatment effectiveness hierarchy, with an estimated additive effect on sNfL Z score of −0.14 (P = .0018) for high efficacy monoclonal antibody therapy vs. oral therapy.
Study details: Findings are from an analysis of 1,313 patients with relapsing or secondary progressive MS from a Swiss MS cohort and 5,390 individuals without evidence of central nervous system disease.
Disclosures: The study was funded by Swiss National Science Foundation, Progressive Multiple Sclerosis Alliance, Biogen, Celgene, Novartis, and Roche. Some authors declared receiving grants, travel compensation, speaker honoraria, and advisory board/lecture and consultancy fees from various sources including the funding sources.
Source: Benkert P et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21(3):246-257 (Mar 1). Doi: 10.1016/S1474-4422(22)00009-6
Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective biomarker for identifying subclinical disease activity and monitoring drug response in multiple sclerosis (MS).
Major finding: An sNfL Z score of >1.5 indicated an increased risk for future disease activity in all patients with MS (odds ratio [OR] 3.15; P < .0001) and in patients considered stable without evidence of disease activity (OR 2.66; P = .034). The sNfL values could depict a treatment effectiveness hierarchy, with an estimated additive effect on sNfL Z score of −0.14 (P = .0018) for high efficacy monoclonal antibody therapy vs. oral therapy.
Study details: Findings are from an analysis of 1,313 patients with relapsing or secondary progressive MS from a Swiss MS cohort and 5,390 individuals without evidence of central nervous system disease.
Disclosures: The study was funded by Swiss National Science Foundation, Progressive Multiple Sclerosis Alliance, Biogen, Celgene, Novartis, and Roche. Some authors declared receiving grants, travel compensation, speaker honoraria, and advisory board/lecture and consultancy fees from various sources including the funding sources.
Source: Benkert P et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21(3):246-257 (Mar 1). Doi: 10.1016/S1474-4422(22)00009-6
Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective biomarker for identifying subclinical disease activity and monitoring drug response in multiple sclerosis (MS).
Major finding: An sNfL Z score of >1.5 indicated an increased risk for future disease activity in all patients with MS (odds ratio [OR] 3.15; P < .0001) and in patients considered stable without evidence of disease activity (OR 2.66; P = .034). The sNfL values could depict a treatment effectiveness hierarchy, with an estimated additive effect on sNfL Z score of −0.14 (P = .0018) for high efficacy monoclonal antibody therapy vs. oral therapy.
Study details: Findings are from an analysis of 1,313 patients with relapsing or secondary progressive MS from a Swiss MS cohort and 5,390 individuals without evidence of central nervous system disease.
Disclosures: The study was funded by Swiss National Science Foundation, Progressive Multiple Sclerosis Alliance, Biogen, Celgene, Novartis, and Roche. Some authors declared receiving grants, travel compensation, speaker honoraria, and advisory board/lecture and consultancy fees from various sources including the funding sources.
Source: Benkert P et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21(3):246-257 (Mar 1). Doi: 10.1016/S1474-4422(22)00009-6
Avoiding delay in AHT may improve survival in HR-positive, ERBB2-negative early BC
Key clinical point: A delay in initiation of adjuvant hormone therapy (AHT) beyond 150 days was significantly associated with poor survival in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (ERBB2)-negative breast cancer (BC) not receiving chemotherapy.
Major finding: Time to AHT (TTH) >150 days vs. ≤150 days was associated with an increased risk for death in the overall population (hazard ratio 1.31; P < .001).
Study details: Findings are from a population-based retrospective study including 144,103 patients with HR-positive/ERBB2-negative early BC who received AHT without chemotherapy, of which 6.4% of patients experienced a delay in AHT initiation (TTH >150 days) and 93.6% initiated AHT on time (TTH ≤150 days).
Disclosures: This study was supported by the Natural Science Foundation of Fujian Province and the Fujian Provincial Health Technology Project. The authors declared no conflicts of interest.
Source: Fu F et al. Association of adjuvant hormone therapy timing with overall survival among patients with hormone receptor–positive human epidermal growth factor receptor-2–negative early breast cancer without chemotherapy. JAMA Netw Open. 2022;5(2):e2145934 (Feb 15). Doi: 10.1001/jamanetworkopen.2021.45934
Key clinical point: A delay in initiation of adjuvant hormone therapy (AHT) beyond 150 days was significantly associated with poor survival in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (ERBB2)-negative breast cancer (BC) not receiving chemotherapy.
Major finding: Time to AHT (TTH) >150 days vs. ≤150 days was associated with an increased risk for death in the overall population (hazard ratio 1.31; P < .001).
Study details: Findings are from a population-based retrospective study including 144,103 patients with HR-positive/ERBB2-negative early BC who received AHT without chemotherapy, of which 6.4% of patients experienced a delay in AHT initiation (TTH >150 days) and 93.6% initiated AHT on time (TTH ≤150 days).
Disclosures: This study was supported by the Natural Science Foundation of Fujian Province and the Fujian Provincial Health Technology Project. The authors declared no conflicts of interest.
Source: Fu F et al. Association of adjuvant hormone therapy timing with overall survival among patients with hormone receptor–positive human epidermal growth factor receptor-2–negative early breast cancer without chemotherapy. JAMA Netw Open. 2022;5(2):e2145934 (Feb 15). Doi: 10.1001/jamanetworkopen.2021.45934
Key clinical point: A delay in initiation of adjuvant hormone therapy (AHT) beyond 150 days was significantly associated with poor survival in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (ERBB2)-negative breast cancer (BC) not receiving chemotherapy.
Major finding: Time to AHT (TTH) >150 days vs. ≤150 days was associated with an increased risk for death in the overall population (hazard ratio 1.31; P < .001).
Study details: Findings are from a population-based retrospective study including 144,103 patients with HR-positive/ERBB2-negative early BC who received AHT without chemotherapy, of which 6.4% of patients experienced a delay in AHT initiation (TTH >150 days) and 93.6% initiated AHT on time (TTH ≤150 days).
Disclosures: This study was supported by the Natural Science Foundation of Fujian Province and the Fujian Provincial Health Technology Project. The authors declared no conflicts of interest.
Source: Fu F et al. Association of adjuvant hormone therapy timing with overall survival among patients with hormone receptor–positive human epidermal growth factor receptor-2–negative early breast cancer without chemotherapy. JAMA Netw Open. 2022;5(2):e2145934 (Feb 15). Doi: 10.1001/jamanetworkopen.2021.45934
Pretreatment circulating reproductive hormones predict treatment response in breast cancer
Key clinical point: Pretreatment levels of testosterone and follicle-stimulating hormone (FSH) independently predicted pathological complete response (pCR) in premenopausal and postmenopausal women with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).
Major finding: The likelihood of achieving pCR was higher in premenopausal women with lower vs. higher testosterone levels (odds ratio [OR] 0.996; P = .026) and in postmenopausal women with higher vs. lower FSH levels (OR 1.045; P = .005).
Study details: This was a retrospective study of 196 premenopausal and 137 postmenopausal women with invasive BC who received NAC.
Disclosures: This study was funded by National Natural Science Foundation of China. The authors declared no conflicts of interest.
Source: Lan A et al. Pre-treatment circulating reproductive hormones levels predict pathological and survival outcomes in breast cancer submitted to neoadjuvant chemotherapy. Int J Clin Oncol. 2022 (Mar 3). Doi: 10.1007/s10147-022-02141-9
Key clinical point: Pretreatment levels of testosterone and follicle-stimulating hormone (FSH) independently predicted pathological complete response (pCR) in premenopausal and postmenopausal women with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).
Major finding: The likelihood of achieving pCR was higher in premenopausal women with lower vs. higher testosterone levels (odds ratio [OR] 0.996; P = .026) and in postmenopausal women with higher vs. lower FSH levels (OR 1.045; P = .005).
Study details: This was a retrospective study of 196 premenopausal and 137 postmenopausal women with invasive BC who received NAC.
Disclosures: This study was funded by National Natural Science Foundation of China. The authors declared no conflicts of interest.
Source: Lan A et al. Pre-treatment circulating reproductive hormones levels predict pathological and survival outcomes in breast cancer submitted to neoadjuvant chemotherapy. Int J Clin Oncol. 2022 (Mar 3). Doi: 10.1007/s10147-022-02141-9
Key clinical point: Pretreatment levels of testosterone and follicle-stimulating hormone (FSH) independently predicted pathological complete response (pCR) in premenopausal and postmenopausal women with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).
Major finding: The likelihood of achieving pCR was higher in premenopausal women with lower vs. higher testosterone levels (odds ratio [OR] 0.996; P = .026) and in postmenopausal women with higher vs. lower FSH levels (OR 1.045; P = .005).
Study details: This was a retrospective study of 196 premenopausal and 137 postmenopausal women with invasive BC who received NAC.
Disclosures: This study was funded by National Natural Science Foundation of China. The authors declared no conflicts of interest.
Source: Lan A et al. Pre-treatment circulating reproductive hormones levels predict pathological and survival outcomes in breast cancer submitted to neoadjuvant chemotherapy. Int J Clin Oncol. 2022 (Mar 3). Doi: 10.1007/s10147-022-02141-9
HER2-negative early BC: Subset of patients may benefit from anthracycline-containing chemotherapy
Key clinical point: An anthracycline-containing chemotherapy (AC-T) regimen was not associated with a survival benefit compared with 6 cycles of docetaxel/cyclophosphamide (TC6) in an overall cohort of patients with human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer (BC); however, patients with lobular tumor and ≥3 affected lymph nodes may benefit.
Major finding: Although disease-free survival (DFS) was similar between AC-T and TC6 treatment arms in the overall cohort (P = .57), the subgroup of patients with lobular tumor and ≥3 affected lymph nodes showed improved DFS with AC-T vs. TC6 (hazard ratio 3.521; P = .003). The frequency of grade 3/4 adverse events was significantly higher in AC-T vs. TC6 treatment arm (P < .001).
Study details: Findings are from the pooled analysis of two phase 3 studies, SUCCESS-C and PlanB, including 5,924 patients with high-risk HER2-negative invasive early BC who were randomly assigned to receive TC6 or AC-T.
Disclosures: The study did not receive any funding. Some authors declared receiving financial and nonfinancial support from several sources.
Source: Gregorio AD et al. The impact of anthracyclines in intermediate and high-risk HER2-negative early breast cancer—a pooled analysis of the randomised clinical trials PlanB and SUCCESS C. Br J Cancer. 2022 (Feb 22). Doi: 10.1038/s41416-021-01690-6
Key clinical point: An anthracycline-containing chemotherapy (AC-T) regimen was not associated with a survival benefit compared with 6 cycles of docetaxel/cyclophosphamide (TC6) in an overall cohort of patients with human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer (BC); however, patients with lobular tumor and ≥3 affected lymph nodes may benefit.
Major finding: Although disease-free survival (DFS) was similar between AC-T and TC6 treatment arms in the overall cohort (P = .57), the subgroup of patients with lobular tumor and ≥3 affected lymph nodes showed improved DFS with AC-T vs. TC6 (hazard ratio 3.521; P = .003). The frequency of grade 3/4 adverse events was significantly higher in AC-T vs. TC6 treatment arm (P < .001).
Study details: Findings are from the pooled analysis of two phase 3 studies, SUCCESS-C and PlanB, including 5,924 patients with high-risk HER2-negative invasive early BC who were randomly assigned to receive TC6 or AC-T.
Disclosures: The study did not receive any funding. Some authors declared receiving financial and nonfinancial support from several sources.
Source: Gregorio AD et al. The impact of anthracyclines in intermediate and high-risk HER2-negative early breast cancer—a pooled analysis of the randomised clinical trials PlanB and SUCCESS C. Br J Cancer. 2022 (Feb 22). Doi: 10.1038/s41416-021-01690-6
Key clinical point: An anthracycline-containing chemotherapy (AC-T) regimen was not associated with a survival benefit compared with 6 cycles of docetaxel/cyclophosphamide (TC6) in an overall cohort of patients with human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer (BC); however, patients with lobular tumor and ≥3 affected lymph nodes may benefit.
Major finding: Although disease-free survival (DFS) was similar between AC-T and TC6 treatment arms in the overall cohort (P = .57), the subgroup of patients with lobular tumor and ≥3 affected lymph nodes showed improved DFS with AC-T vs. TC6 (hazard ratio 3.521; P = .003). The frequency of grade 3/4 adverse events was significantly higher in AC-T vs. TC6 treatment arm (P < .001).
Study details: Findings are from the pooled analysis of two phase 3 studies, SUCCESS-C and PlanB, including 5,924 patients with high-risk HER2-negative invasive early BC who were randomly assigned to receive TC6 or AC-T.
Disclosures: The study did not receive any funding. Some authors declared receiving financial and nonfinancial support from several sources.
Source: Gregorio AD et al. The impact of anthracyclines in intermediate and high-risk HER2-negative early breast cancer—a pooled analysis of the randomised clinical trials PlanB and SUCCESS C. Br J Cancer. 2022 (Feb 22). Doi: 10.1038/s41416-021-01690-6
Real-world evidence supports use of ribociclib+letrozole in males with HR-positive/HER2-negative BC
Key clinical point: Ribociclib plus letrozole was safe and effective in male patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (BC) who did not receive prior endocrine therapy (ET).
Major finding: Male patients vs. overall population experienced fewer treatment-related adverse events (AE), especially neutropenia (all grade 53.8% vs. 74.5%; grade ≥3 41.0% vs. 57.2%). After a median follow-up of 25.4 months, median time to progression was 27.1 months for the overall cohort vs. not reached in males.
Study details: Findings are from an exploratory analysis of the phase 3b CompLEEment-1 trial including 39 males with HR-positive HER2-negative advanced BC who received ribociclib+letrozole but not prior ET for the advanced disease.
Disclosures: The study was supported by Novartis Pharmaceuticals. The authors declared serving as members of speakers’ bureau or receiving honoraria, advisory/consulting fees, expert testimony fees, research grants, or travel and accommodation expenses from several sources, including Novartis. Two authors declared being employees or shareholders of Novartis.
Source: Campone M et al. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 (Feb 25). Doi: 10.1007/s10549-022-06543-1
Key clinical point: Ribociclib plus letrozole was safe and effective in male patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (BC) who did not receive prior endocrine therapy (ET).
Major finding: Male patients vs. overall population experienced fewer treatment-related adverse events (AE), especially neutropenia (all grade 53.8% vs. 74.5%; grade ≥3 41.0% vs. 57.2%). After a median follow-up of 25.4 months, median time to progression was 27.1 months for the overall cohort vs. not reached in males.
Study details: Findings are from an exploratory analysis of the phase 3b CompLEEment-1 trial including 39 males with HR-positive HER2-negative advanced BC who received ribociclib+letrozole but not prior ET for the advanced disease.
Disclosures: The study was supported by Novartis Pharmaceuticals. The authors declared serving as members of speakers’ bureau or receiving honoraria, advisory/consulting fees, expert testimony fees, research grants, or travel and accommodation expenses from several sources, including Novartis. Two authors declared being employees or shareholders of Novartis.
Source: Campone M et al. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 (Feb 25). Doi: 10.1007/s10549-022-06543-1
Key clinical point: Ribociclib plus letrozole was safe and effective in male patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (BC) who did not receive prior endocrine therapy (ET).
Major finding: Male patients vs. overall population experienced fewer treatment-related adverse events (AE), especially neutropenia (all grade 53.8% vs. 74.5%; grade ≥3 41.0% vs. 57.2%). After a median follow-up of 25.4 months, median time to progression was 27.1 months for the overall cohort vs. not reached in males.
Study details: Findings are from an exploratory analysis of the phase 3b CompLEEment-1 trial including 39 males with HR-positive HER2-negative advanced BC who received ribociclib+letrozole but not prior ET for the advanced disease.
Disclosures: The study was supported by Novartis Pharmaceuticals. The authors declared serving as members of speakers’ bureau or receiving honoraria, advisory/consulting fees, expert testimony fees, research grants, or travel and accommodation expenses from several sources, including Novartis. Two authors declared being employees or shareholders of Novartis.
Source: Campone M et al. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 (Feb 25). Doi: 10.1007/s10549-022-06543-1
Family history of breast cancer increases likelihood of dense breast in premenopausal women
Key clinical point: A family history of breast cancer (FHBC) was positively associated with mammographic breast density in premenopausal women, highlighting the role of heredity and the need for initiating early annual screening in women with an FHBC.
Major finding: The volumetric percent density was 25% higher among premenopausal women with vs. without FHBC (odds ratio [OR] 1.25; 95% CI 1.12-1.41) in the discovery cohort, and the odds of having a dense breast was 30% higher in premenopausal women with vs. without FHBC in the validation cohort (OR 1.30; 95% CI 1.17-1.45).
Study details: This study evaluated two retrospective cohorts, a discovery set of 375 premenopausal women and a validation set of 14,040 premenopausal women without any history of cancer, including breast cancer, or breast augmentation/reduction.
Disclosures: This study was supported by US National Institutes of Health (NIH)/National Cancer Institute and the National Institute on Minority Health and Health Disparities of the NIH. The authors declared no conflicts of interest.
Source: Han Y et al. Family history of breast cancer and mammographic breast density in premenopausal women. JAMA Netw Open. 2022;5(2):e2148983 (Feb 17). Doi: 10.1001/jamanetworkopen.2021.48983
Key clinical point: A family history of breast cancer (FHBC) was positively associated with mammographic breast density in premenopausal women, highlighting the role of heredity and the need for initiating early annual screening in women with an FHBC.
Major finding: The volumetric percent density was 25% higher among premenopausal women with vs. without FHBC (odds ratio [OR] 1.25; 95% CI 1.12-1.41) in the discovery cohort, and the odds of having a dense breast was 30% higher in premenopausal women with vs. without FHBC in the validation cohort (OR 1.30; 95% CI 1.17-1.45).
Study details: This study evaluated two retrospective cohorts, a discovery set of 375 premenopausal women and a validation set of 14,040 premenopausal women without any history of cancer, including breast cancer, or breast augmentation/reduction.
Disclosures: This study was supported by US National Institutes of Health (NIH)/National Cancer Institute and the National Institute on Minority Health and Health Disparities of the NIH. The authors declared no conflicts of interest.
Source: Han Y et al. Family history of breast cancer and mammographic breast density in premenopausal women. JAMA Netw Open. 2022;5(2):e2148983 (Feb 17). Doi: 10.1001/jamanetworkopen.2021.48983
Key clinical point: A family history of breast cancer (FHBC) was positively associated with mammographic breast density in premenopausal women, highlighting the role of heredity and the need for initiating early annual screening in women with an FHBC.
Major finding: The volumetric percent density was 25% higher among premenopausal women with vs. without FHBC (odds ratio [OR] 1.25; 95% CI 1.12-1.41) in the discovery cohort, and the odds of having a dense breast was 30% higher in premenopausal women with vs. without FHBC in the validation cohort (OR 1.30; 95% CI 1.17-1.45).
Study details: This study evaluated two retrospective cohorts, a discovery set of 375 premenopausal women and a validation set of 14,040 premenopausal women without any history of cancer, including breast cancer, or breast augmentation/reduction.
Disclosures: This study was supported by US National Institutes of Health (NIH)/National Cancer Institute and the National Institute on Minority Health and Health Disparities of the NIH. The authors declared no conflicts of interest.
Source: Han Y et al. Family history of breast cancer and mammographic breast density in premenopausal women. JAMA Netw Open. 2022;5(2):e2148983 (Feb 17). Doi: 10.1001/jamanetworkopen.2021.48983
Metastatic BC: Adding pertuzumab to trastuzumab+chemotherapy prolongs survival in the real world
Key clinical point: In the real-world setting, adding pertuzumab to trastuzumab+chemotherapy improved overall survival (OS) in a large cohort of patients with metastatic breast cancer (BC).
Major finding: Median OS was higher with pertuzumab+trastuzumab+chemotherapy (40.2 months; 95% CI 35.6-47.8 months) vs. trastuzumab+chemotherapy (25.3 months; 95% CI 22.8-27.6 months), with pertuzumab associated with significantly reduced mortality (hazard ratio 0.66; 95% CI 0.57-0.79). The 1-year cumulative incidence of a direct hospital visit was lower in the pertuzumab+trastuzumab+chemotherapy vs. trastuzumab+chemotherapy group (P < .001).
Study details: Findings are from a population-based retrospective study including 1,158 patients with metastatic BC who received first-line treatment with pertuzumab+trastuzumab+chemotherapy (n = 579) or trastuzumab+chemotherapy (n = 579).
Disclosures: This study was supported by the Canadian Institutes of Health Research. Dr. Liu declared being an employee of ICES, which is funded by the Ontario Ministry of Health and Long-Term Care.
Source: Dai WF et al. Comparative effectiveness and safety of pertuzumab and trastuzumab plus chemotherapy vs trastuzumab plus chemotherapy for treatment of metastatic breast cancer. JAMA Netw Open. 2022;5(2):e2145460 (Feb 28). Doi: 10.1001/jamanetworkopen.2021.45460
Key clinical point: In the real-world setting, adding pertuzumab to trastuzumab+chemotherapy improved overall survival (OS) in a large cohort of patients with metastatic breast cancer (BC).
Major finding: Median OS was higher with pertuzumab+trastuzumab+chemotherapy (40.2 months; 95% CI 35.6-47.8 months) vs. trastuzumab+chemotherapy (25.3 months; 95% CI 22.8-27.6 months), with pertuzumab associated with significantly reduced mortality (hazard ratio 0.66; 95% CI 0.57-0.79). The 1-year cumulative incidence of a direct hospital visit was lower in the pertuzumab+trastuzumab+chemotherapy vs. trastuzumab+chemotherapy group (P < .001).
Study details: Findings are from a population-based retrospective study including 1,158 patients with metastatic BC who received first-line treatment with pertuzumab+trastuzumab+chemotherapy (n = 579) or trastuzumab+chemotherapy (n = 579).
Disclosures: This study was supported by the Canadian Institutes of Health Research. Dr. Liu declared being an employee of ICES, which is funded by the Ontario Ministry of Health and Long-Term Care.
Source: Dai WF et al. Comparative effectiveness and safety of pertuzumab and trastuzumab plus chemotherapy vs trastuzumab plus chemotherapy for treatment of metastatic breast cancer. JAMA Netw Open. 2022;5(2):e2145460 (Feb 28). Doi: 10.1001/jamanetworkopen.2021.45460
Key clinical point: In the real-world setting, adding pertuzumab to trastuzumab+chemotherapy improved overall survival (OS) in a large cohort of patients with metastatic breast cancer (BC).
Major finding: Median OS was higher with pertuzumab+trastuzumab+chemotherapy (40.2 months; 95% CI 35.6-47.8 months) vs. trastuzumab+chemotherapy (25.3 months; 95% CI 22.8-27.6 months), with pertuzumab associated with significantly reduced mortality (hazard ratio 0.66; 95% CI 0.57-0.79). The 1-year cumulative incidence of a direct hospital visit was lower in the pertuzumab+trastuzumab+chemotherapy vs. trastuzumab+chemotherapy group (P < .001).
Study details: Findings are from a population-based retrospective study including 1,158 patients with metastatic BC who received first-line treatment with pertuzumab+trastuzumab+chemotherapy (n = 579) or trastuzumab+chemotherapy (n = 579).
Disclosures: This study was supported by the Canadian Institutes of Health Research. Dr. Liu declared being an employee of ICES, which is funded by the Ontario Ministry of Health and Long-Term Care.
Source: Dai WF et al. Comparative effectiveness and safety of pertuzumab and trastuzumab plus chemotherapy vs trastuzumab plus chemotherapy for treatment of metastatic breast cancer. JAMA Netw Open. 2022;5(2):e2145460 (Feb 28). Doi: 10.1001/jamanetworkopen.2021.45460
HD201 equivalent to referent trastuzumab in ERBB2-positive early BC
Key clinical point: HD201, a trastuzumab biosimilar, and reference trastuzumab display equivalence in terms of efficacy (along with a similar safety profile) in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC) treated in the neoadjuvant setting.
Major finding: At the time of surgery, the rate of total pathological complete response with HD201 vs. referent trastuzumab was 45% vs. 48.7%, respectively, with the difference between the groups within the predefined equivalence margin (−3.8%; 95% CI −12.8% to 5.4%). Treatment-emergent adverse events of special interest for trastuzumab were reported by 88% and 84.5% of patients receiving HD201 and trastuzumab, respectively.
Study details: Findings are from the phase 3 TROIKA study including 502 women with ERBB2-positive early BC who were randomly assigned to receive HD201 or trastuzumab in a neoadjuvant setting along with chemotherapy.
Disclosures: This study was funded by Prestige BioPharma Ltd. Some of the authors declared serving as unpaid advisors or receiving personal fees and grants from several sources, including Prestige BioPharma Ltd. Three authors declared being employees of DICE Ltd.
Source: Pivot X et al. Efficacy of HD201 vs referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting: A multicenter phase 3 randomized clinical trial. JAMA Oncol. 2022 (Mar 3). Doi: 10.1001/jamaoncol.2021.8171
Key clinical point: HD201, a trastuzumab biosimilar, and reference trastuzumab display equivalence in terms of efficacy (along with a similar safety profile) in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC) treated in the neoadjuvant setting.
Major finding: At the time of surgery, the rate of total pathological complete response with HD201 vs. referent trastuzumab was 45% vs. 48.7%, respectively, with the difference between the groups within the predefined equivalence margin (−3.8%; 95% CI −12.8% to 5.4%). Treatment-emergent adverse events of special interest for trastuzumab were reported by 88% and 84.5% of patients receiving HD201 and trastuzumab, respectively.
Study details: Findings are from the phase 3 TROIKA study including 502 women with ERBB2-positive early BC who were randomly assigned to receive HD201 or trastuzumab in a neoadjuvant setting along with chemotherapy.
Disclosures: This study was funded by Prestige BioPharma Ltd. Some of the authors declared serving as unpaid advisors or receiving personal fees and grants from several sources, including Prestige BioPharma Ltd. Three authors declared being employees of DICE Ltd.
Source: Pivot X et al. Efficacy of HD201 vs referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting: A multicenter phase 3 randomized clinical trial. JAMA Oncol. 2022 (Mar 3). Doi: 10.1001/jamaoncol.2021.8171
Key clinical point: HD201, a trastuzumab biosimilar, and reference trastuzumab display equivalence in terms of efficacy (along with a similar safety profile) in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC) treated in the neoadjuvant setting.
Major finding: At the time of surgery, the rate of total pathological complete response with HD201 vs. referent trastuzumab was 45% vs. 48.7%, respectively, with the difference between the groups within the predefined equivalence margin (−3.8%; 95% CI −12.8% to 5.4%). Treatment-emergent adverse events of special interest for trastuzumab were reported by 88% and 84.5% of patients receiving HD201 and trastuzumab, respectively.
Study details: Findings are from the phase 3 TROIKA study including 502 women with ERBB2-positive early BC who were randomly assigned to receive HD201 or trastuzumab in a neoadjuvant setting along with chemotherapy.
Disclosures: This study was funded by Prestige BioPharma Ltd. Some of the authors declared serving as unpaid advisors or receiving personal fees and grants from several sources, including Prestige BioPharma Ltd. Three authors declared being employees of DICE Ltd.
Source: Pivot X et al. Efficacy of HD201 vs referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting: A multicenter phase 3 randomized clinical trial. JAMA Oncol. 2022 (Mar 3). Doi: 10.1001/jamaoncol.2021.8171
Lobular vs. ductal histology worsens outcomes in metastatic breast cancer
Key clinical point: Patients with metastatic breast cancer (BC) with a lobular subtype may have worse outcomes compared with those with a ductal subtype.
Major finding: Invasive lobular carcinoma (ILC) vs. invasive ductal carcinoma (IDC) subtype was significantly associated with worse survival (hazard ratio [HR] 1.31; P < .0001) and progression-free survival (HR 1.15; P < .0001).
Study details: Findings are from a retrospective analysis of 13,111 patients with metastatic BC with ILC (13.8%) or IDC (86.2%) subtype from the UNICANCER Epidemiological Strategy and Medico Economics (ESME)-metastatic BC cohort.
Disclosures: ESME is supported by Roche, Pfizer, and other pharmaceutical companies. The authors declared no conflicts of interest.
Source: Dalenc F et al. Impact of lobular versus ductal histology on overall survival in metastatic breast cancer: a French retrospective multicentre cohort study. Eur J Cancer. 2022;164:70-79 (Feb 14). Doi: 10.1016/j.ejca.2021.12.031
Key clinical point: Patients with metastatic breast cancer (BC) with a lobular subtype may have worse outcomes compared with those with a ductal subtype.
Major finding: Invasive lobular carcinoma (ILC) vs. invasive ductal carcinoma (IDC) subtype was significantly associated with worse survival (hazard ratio [HR] 1.31; P < .0001) and progression-free survival (HR 1.15; P < .0001).
Study details: Findings are from a retrospective analysis of 13,111 patients with metastatic BC with ILC (13.8%) or IDC (86.2%) subtype from the UNICANCER Epidemiological Strategy and Medico Economics (ESME)-metastatic BC cohort.
Disclosures: ESME is supported by Roche, Pfizer, and other pharmaceutical companies. The authors declared no conflicts of interest.
Source: Dalenc F et al. Impact of lobular versus ductal histology on overall survival in metastatic breast cancer: a French retrospective multicentre cohort study. Eur J Cancer. 2022;164:70-79 (Feb 14). Doi: 10.1016/j.ejca.2021.12.031
Key clinical point: Patients with metastatic breast cancer (BC) with a lobular subtype may have worse outcomes compared with those with a ductal subtype.
Major finding: Invasive lobular carcinoma (ILC) vs. invasive ductal carcinoma (IDC) subtype was significantly associated with worse survival (hazard ratio [HR] 1.31; P < .0001) and progression-free survival (HR 1.15; P < .0001).
Study details: Findings are from a retrospective analysis of 13,111 patients with metastatic BC with ILC (13.8%) or IDC (86.2%) subtype from the UNICANCER Epidemiological Strategy and Medico Economics (ESME)-metastatic BC cohort.
Disclosures: ESME is supported by Roche, Pfizer, and other pharmaceutical companies. The authors declared no conflicts of interest.
Source: Dalenc F et al. Impact of lobular versus ductal histology on overall survival in metastatic breast cancer: a French retrospective multicentre cohort study. Eur J Cancer. 2022;164:70-79 (Feb 14). Doi: 10.1016/j.ejca.2021.12.031
Atezolizumab fails to improve pCR in early TNBC
Key clinical point: The addition of atezolizumab to chemotherapy with nanoparticle albumin-bound nab-paclitaxel and carboplatin failed to improve pathological complete response (pCR) rates compared with chemotherapy alone in early high-risk, locally advanced, triple-negative breast cancer (TNBC).
Major finding: The rate of pCR was not significantly different between atezolizumab and non-atezolizumab treatment arms (48.6% vs. 44.4%; odds ratio 1.18; P = .48). Serious adverse events and any grade liver transaminase abnormalities were higher in the atezolizumab vs. non-atezolizumab treatment arm (P = .001).
Study details: Findings are from the NeoTRIP study including 280 women with early high-risk, locally advanced TNBC who were randomly assigned to receive neoadjuvant carboplatin and nab-paclitaxel with or without atezolizumab.
Disclosures: This study was supported by Fondazione Michelangelo. The authors declared serving on advisory boards or receiving consulting fees, honoraria, grants, support for attending meetings, and other nonfinancial support from several sources.
Source: Gianni L et al. Pathologic complete response (pCR) to neoadjuvant treatment with or without atezolizumab in triple-negative, early high-risk and locally advanced breast cancer: NeoTRIP Michelangelo randomized study. Ann Oncol. 2022 (Feb 16). Doi: 10.1016/j.annonc.2022.02.004
Key clinical point: The addition of atezolizumab to chemotherapy with nanoparticle albumin-bound nab-paclitaxel and carboplatin failed to improve pathological complete response (pCR) rates compared with chemotherapy alone in early high-risk, locally advanced, triple-negative breast cancer (TNBC).
Major finding: The rate of pCR was not significantly different between atezolizumab and non-atezolizumab treatment arms (48.6% vs. 44.4%; odds ratio 1.18; P = .48). Serious adverse events and any grade liver transaminase abnormalities were higher in the atezolizumab vs. non-atezolizumab treatment arm (P = .001).
Study details: Findings are from the NeoTRIP study including 280 women with early high-risk, locally advanced TNBC who were randomly assigned to receive neoadjuvant carboplatin and nab-paclitaxel with or without atezolizumab.
Disclosures: This study was supported by Fondazione Michelangelo. The authors declared serving on advisory boards or receiving consulting fees, honoraria, grants, support for attending meetings, and other nonfinancial support from several sources.
Source: Gianni L et al. Pathologic complete response (pCR) to neoadjuvant treatment with or without atezolizumab in triple-negative, early high-risk and locally advanced breast cancer: NeoTRIP Michelangelo randomized study. Ann Oncol. 2022 (Feb 16). Doi: 10.1016/j.annonc.2022.02.004
Key clinical point: The addition of atezolizumab to chemotherapy with nanoparticle albumin-bound nab-paclitaxel and carboplatin failed to improve pathological complete response (pCR) rates compared with chemotherapy alone in early high-risk, locally advanced, triple-negative breast cancer (TNBC).
Major finding: The rate of pCR was not significantly different between atezolizumab and non-atezolizumab treatment arms (48.6% vs. 44.4%; odds ratio 1.18; P = .48). Serious adverse events and any grade liver transaminase abnormalities were higher in the atezolizumab vs. non-atezolizumab treatment arm (P = .001).
Study details: Findings are from the NeoTRIP study including 280 women with early high-risk, locally advanced TNBC who were randomly assigned to receive neoadjuvant carboplatin and nab-paclitaxel with or without atezolizumab.
Disclosures: This study was supported by Fondazione Michelangelo. The authors declared serving on advisory boards or receiving consulting fees, honoraria, grants, support for attending meetings, and other nonfinancial support from several sources.
Source: Gianni L et al. Pathologic complete response (pCR) to neoadjuvant treatment with or without atezolizumab in triple-negative, early high-risk and locally advanced breast cancer: NeoTRIP Michelangelo randomized study. Ann Oncol. 2022 (Feb 16). Doi: 10.1016/j.annonc.2022.02.004