Article

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

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

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

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

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

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

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

Key clinical point: Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab postsurgery significantly prolonged event-free survival (EFS) compared with neoadjuvant chemotherapy alone in patients with early triple-negative breast cancer (TNBC).

Major finding: At 36 months, estimated EFS significantly improved in the pembrolizumab-chemotherapy vs. placebo-chemotherapy group (84.5% vs. 76.8%; hazard ratio for event or death, 0.63; P < .001). No new adverse events were reported.

Study details: Findings are from an interim analysis of the phase 3 KEYNOTE-522 study including 1,174 patients with early, previously untreated stage II/III TNBC who were randomly assigned to receive neoadjuvant therapy with pembrolizumab or placebo. In the adjuvant phase, patients received pembrolizumab or placebo after definitive surgery and radiotherapy, if indicated.

Disclosures: This study was supported by Merck Sharp and Dohme. The authors declared serving as consultants, advisory board members, or receiving research grants, contracts, and honoraria from several sources, including Merck/Merck Sharp and Dohme. Four authors declared being employees and stock/stock option owners of Merck/Merck Sharp and Dohme.

Source: Schmid P et al. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567 (Feb 10). Doi: 10.1056/NEJMoa2112651

Key clinical point: Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab postsurgery significantly prolonged event-free survival (EFS) compared with neoadjuvant chemotherapy alone in patients with early triple-negative breast cancer (TNBC).

Major finding: At 36 months, estimated EFS significantly improved in the pembrolizumab-chemotherapy vs. placebo-chemotherapy group (84.5% vs. 76.8%; hazard ratio for event or death, 0.63; P < .001). No new adverse events were reported.

Study details: Findings are from an interim analysis of the phase 3 KEYNOTE-522 study including 1,174 patients with early, previously untreated stage II/III TNBC who were randomly assigned to receive neoadjuvant therapy with pembrolizumab or placebo. In the adjuvant phase, patients received pembrolizumab or placebo after definitive surgery and radiotherapy, if indicated.

Disclosures: This study was supported by Merck Sharp and Dohme. The authors declared serving as consultants, advisory board members, or receiving research grants, contracts, and honoraria from several sources, including Merck/Merck Sharp and Dohme. Four authors declared being employees and stock/stock option owners of Merck/Merck Sharp and Dohme.

Source: Schmid P et al. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567 (Feb 10). Doi: 10.1056/NEJMoa2112651

Key clinical point: Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab postsurgery significantly prolonged event-free survival (EFS) compared with neoadjuvant chemotherapy alone in patients with early triple-negative breast cancer (TNBC).

Major finding: At 36 months, estimated EFS significantly improved in the pembrolizumab-chemotherapy vs. placebo-chemotherapy group (84.5% vs. 76.8%; hazard ratio for event or death, 0.63; P < .001). No new adverse events were reported.

Study details: Findings are from an interim analysis of the phase 3 KEYNOTE-522 study including 1,174 patients with early, previously untreated stage II/III TNBC who were randomly assigned to receive neoadjuvant therapy with pembrolizumab or placebo. In the adjuvant phase, patients received pembrolizumab or placebo after definitive surgery and radiotherapy, if indicated.

Disclosures: This study was supported by Merck Sharp and Dohme. The authors declared serving as consultants, advisory board members, or receiving research grants, contracts, and honoraria from several sources, including Merck/Merck Sharp and Dohme. Four authors declared being employees and stock/stock option owners of Merck/Merck Sharp and Dohme.

Source: Schmid P et al. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567 (Feb 10). Doi: 10.1056/NEJMoa2112651

Key clinical point: Patients with atopic dermatitis (AD) vs. healthy controls had significantly lower levels of serum 25-hydroxyvitamin D (25[OH]D), with the levels even lower in patients with severe vs. mild/moderate AD. Supplementation with vitamin D helped improve AD symptoms.

Major finding: The mean serum 25(OH)D level was significantly lower by 7.42 ng/mL in patients with AD vs. healthy controls and by an average of 7.99 ng/mL and 2.95 ng/mL in patients with severe vs. mild and moderate AD, respectively (all P < .001). Over a weighted mean of 2.88 months, patients receiving vitamin D supplementation at a weighted mean dose of 1,721 IU/day reported improvement in AD symptoms (P < .001).

Study details: Findings are from a meta-analysis of 20 studies with 1,882 cases of AD.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Ng JC and Yew YW. Effect of vitamin D serum levels and supplementation on atopic dermatitis: A systematic review and meta-analysis. Am J Clin Dermatol. 2022 (Mar 5). Doi: 10.1007/s40257-022-00677-0

Key clinical point: Patients with atopic dermatitis (AD) vs. healthy controls had significantly lower levels of serum 25-hydroxyvitamin D (25[OH]D), with the levels even lower in patients with severe vs. mild/moderate AD. Supplementation with vitamin D helped improve AD symptoms.

Major finding: The mean serum 25(OH)D level was significantly lower by 7.42 ng/mL in patients with AD vs. healthy controls and by an average of 7.99 ng/mL and 2.95 ng/mL in patients with severe vs. mild and moderate AD, respectively (all P < .001). Over a weighted mean of 2.88 months, patients receiving vitamin D supplementation at a weighted mean dose of 1,721 IU/day reported improvement in AD symptoms (P < .001).

Study details: Findings are from a meta-analysis of 20 studies with 1,882 cases of AD.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Ng JC and Yew YW. Effect of vitamin D serum levels and supplementation on atopic dermatitis: A systematic review and meta-analysis. Am J Clin Dermatol. 2022 (Mar 5). Doi: 10.1007/s40257-022-00677-0

Key clinical point: Patients with atopic dermatitis (AD) vs. healthy controls had significantly lower levels of serum 25-hydroxyvitamin D (25[OH]D), with the levels even lower in patients with severe vs. mild/moderate AD. Supplementation with vitamin D helped improve AD symptoms.

Major finding: The mean serum 25(OH)D level was significantly lower by 7.42 ng/mL in patients with AD vs. healthy controls and by an average of 7.99 ng/mL and 2.95 ng/mL in patients with severe vs. mild and moderate AD, respectively (all P < .001). Over a weighted mean of 2.88 months, patients receiving vitamin D supplementation at a weighted mean dose of 1,721 IU/day reported improvement in AD symptoms (P < .001).

Study details: Findings are from a meta-analysis of 20 studies with 1,882 cases of AD.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Ng JC and Yew YW. Effect of vitamin D serum levels and supplementation on atopic dermatitis: A systematic review and meta-analysis. Am J Clin Dermatol. 2022 (Mar 5). Doi: 10.1007/s40257-022-00677-0

Key clinical point: Cimetidine at a dose of 25-40 mg/kg along with standard treatment reduced severity of acute extrinsic atopic dermatitis (AD) without any serious adverse events.

Major finding: The SCORing Atopic Dermatitis (SCORAD) and objective SCORAD scores improved significantly in the cimetidine vs. placebo group at week 2 (both P = .004) and continued to improve further at weeks 4 (both P = .001), 6 (both P < .001), and 8 (both P < .001) after treatment. At week 2, gastric discomfort was reported by 1 patient receiving cimetidine, which improved after treatment discontinuation.

Study details: Findings are from a phase 3 study including 26 patients aged 12-60 years with AD who had acute lesions and were randomly assigned to receive 25-40 mg/kg cimetidine daily or placebo, both in conjunction with standard AD treatment.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Novianto E et al. Effectiveness of cimetidine as adjuvant therapy in the treatment of acute-extrinsic atopic dermatitis: A double-blind randomized controlled trial. Dermatol Ther (Heidelb). 2022 (Feb 17). Doi: 10.1007/s13555-022-00688-z

Key clinical point: Cimetidine at a dose of 25-40 mg/kg along with standard treatment reduced severity of acute extrinsic atopic dermatitis (AD) without any serious adverse events.

Major finding: The SCORing Atopic Dermatitis (SCORAD) and objective SCORAD scores improved significantly in the cimetidine vs. placebo group at week 2 (both P = .004) and continued to improve further at weeks 4 (both P = .001), 6 (both P < .001), and 8 (both P < .001) after treatment. At week 2, gastric discomfort was reported by 1 patient receiving cimetidine, which improved after treatment discontinuation.

Study details: Findings are from a phase 3 study including 26 patients aged 12-60 years with AD who had acute lesions and were randomly assigned to receive 25-40 mg/kg cimetidine daily or placebo, both in conjunction with standard AD treatment.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Novianto E et al. Effectiveness of cimetidine as adjuvant therapy in the treatment of acute-extrinsic atopic dermatitis: A double-blind randomized controlled trial. Dermatol Ther (Heidelb). 2022 (Feb 17). Doi: 10.1007/s13555-022-00688-z

Key clinical point: Cimetidine at a dose of 25-40 mg/kg along with standard treatment reduced severity of acute extrinsic atopic dermatitis (AD) without any serious adverse events.

Major finding: The SCORing Atopic Dermatitis (SCORAD) and objective SCORAD scores improved significantly in the cimetidine vs. placebo group at week 2 (both P = .004) and continued to improve further at weeks 4 (both P = .001), 6 (both P < .001), and 8 (both P < .001) after treatment. At week 2, gastric discomfort was reported by 1 patient receiving cimetidine, which improved after treatment discontinuation.

Study details: Findings are from a phase 3 study including 26 patients aged 12-60 years with AD who had acute lesions and were randomly assigned to receive 25-40 mg/kg cimetidine daily or placebo, both in conjunction with standard AD treatment.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Novianto E et al. Effectiveness of cimetidine as adjuvant therapy in the treatment of acute-extrinsic atopic dermatitis: A double-blind randomized controlled trial. Dermatol Ther (Heidelb). 2022 (Feb 17). Doi: 10.1007/s13555-022-00688-z