Key clinical point: Erenumab 70 mg was effective for the treatment of high-frequency episodic migraine (HFEM) or chronic migraine (CM) in a real-world setting.

Major finding: Erenumab was effective with a rapid progressive decrease in monthly migraine days (week 12: HEFM, 4.5 days; CM, 9.3 days). More than 50% of HEFM and 75% of CM patients responded to the treatment.

Study details: The data come from a real-life prospective cohort study of 372 patients affected by HEFM or CM with 3 or more prior preventive therapeutic failures.

Disclosures: This work was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente). C Altamura, N Brunelli, A Fallacara, CM Costa, D Santangelo, A Salerno, B Mercuri, and A Carnevale declared no conflicts of interest. The remaining authors reported ties with various institutions and/or pharmaceutical companies.

Source: Barbanti P et al. Headache. 2020 Dec 18. doi: 10.1111/head.14032.

Key clinical point: Erenumab 70 mg was effective for the treatment of high-frequency episodic migraine (HFEM) or chronic migraine (CM) in a real-world setting.

Major finding: Erenumab was effective with a rapid progressive decrease in monthly migraine days (week 12: HEFM, 4.5 days; CM, 9.3 days). More than 50% of HEFM and 75% of CM patients responded to the treatment.

Study details: The data come from a real-life prospective cohort study of 372 patients affected by HEFM or CM with 3 or more prior preventive therapeutic failures.

Disclosures: This work was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente). C Altamura, N Brunelli, A Fallacara, CM Costa, D Santangelo, A Salerno, B Mercuri, and A Carnevale declared no conflicts of interest. The remaining authors reported ties with various institutions and/or pharmaceutical companies.

Source: Barbanti P et al. Headache. 2020 Dec 18. doi: 10.1111/head.14032.

Key clinical point: Erenumab 70 mg was effective for the treatment of high-frequency episodic migraine (HFEM) or chronic migraine (CM) in a real-world setting.

Major finding: Erenumab was effective with a rapid progressive decrease in monthly migraine days (week 12: HEFM, 4.5 days; CM, 9.3 days). More than 50% of HEFM and 75% of CM patients responded to the treatment.

Study details: The data come from a real-life prospective cohort study of 372 patients affected by HEFM or CM with 3 or more prior preventive therapeutic failures.

Disclosures: This work was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente). C Altamura, N Brunelli, A Fallacara, CM Costa, D Santangelo, A Salerno, B Mercuri, and A Carnevale declared no conflicts of interest. The remaining authors reported ties with various institutions and/or pharmaceutical companies.

Source: Barbanti P et al. Headache. 2020 Dec 18. doi: 10.1111/head.14032.

Key clinical point: Chronic migraine patients who achieved early reversal to episodic migraine are likely to have persistent reversion with long-term erenumab treatment.

Major finding: At 12 weeks, 54.1% (95% confidence interval [CI], 46.6%-61.6%) of patients showed reversal to episodic migraine. Continued treatment with erenumab showed a long-term persistent reversion in 96.8% (95% CI, 91.1%-99.3%) of patients at week 64.

Study details: Data on 181 migraine patients come from a post hoc analysis of a 12-week randomized double-blind trial and a 52-week open-label extension.

Disclosures: The study was funded by Amgen Inc. The authors reported ties with various institutions and/or pharmaceutical companies. F Zhang, GA Rippon, S Cheng, and DD Mikol are employed by and own stock in Amgen.

Source: Lipton RB et al. Cephalalgia. 2020 Dec 3. doi: 10.1177/0333102420973994.

Key clinical point: Chronic migraine patients who achieved early reversal to episodic migraine are likely to have persistent reversion with long-term erenumab treatment.

Major finding: At 12 weeks, 54.1% (95% confidence interval [CI], 46.6%-61.6%) of patients showed reversal to episodic migraine. Continued treatment with erenumab showed a long-term persistent reversion in 96.8% (95% CI, 91.1%-99.3%) of patients at week 64.

Study details: Data on 181 migraine patients come from a post hoc analysis of a 12-week randomized double-blind trial and a 52-week open-label extension.

Disclosures: The study was funded by Amgen Inc. The authors reported ties with various institutions and/or pharmaceutical companies. F Zhang, GA Rippon, S Cheng, and DD Mikol are employed by and own stock in Amgen.

Source: Lipton RB et al. Cephalalgia. 2020 Dec 3. doi: 10.1177/0333102420973994.

Key clinical point: Chronic migraine patients who achieved early reversal to episodic migraine are likely to have persistent reversion with long-term erenumab treatment.

Major finding: At 12 weeks, 54.1% (95% confidence interval [CI], 46.6%-61.6%) of patients showed reversal to episodic migraine. Continued treatment with erenumab showed a long-term persistent reversion in 96.8% (95% CI, 91.1%-99.3%) of patients at week 64.

Study details: Data on 181 migraine patients come from a post hoc analysis of a 12-week randomized double-blind trial and a 52-week open-label extension.

Disclosures: The study was funded by Amgen Inc. The authors reported ties with various institutions and/or pharmaceutical companies. F Zhang, GA Rippon, S Cheng, and DD Mikol are employed by and own stock in Amgen.

Source: Lipton RB et al. Cephalalgia. 2020 Dec 3. doi: 10.1177/0333102420973994.

Key clinical point: Rates of ipsilateral breast tumor recurrence (IBTR) in patients with early breast cancer treated with lumpectomy and intraoperative radiation therapy (IORT) are higher than that reported in TARGIT-A trial and with traditional whole-breast radiation therapy or other forms of partial breast irradiation.

Major finding: At 5 years, the absolute IBTR rate was 6.6% for the entire IORT-treated cohort. IBTR rate was 8% and 1.2% for patients who received primary IORT and unintentional IORT boost treatment, respectively. No recurrences were observed in the delayed IORT or intentional-boost IORT cohorts.

Study details: Findings from an updated analysis of TARGIT-R with a 5-year follow-up assessment in 667 patients with early-stage breast cancer who underwent lumpectomy and IORT.

Disclosures: The study did not receive any funding. The lead author did not report any conflicts of interest, but some co-investigators reported relationships with various pharmaceutical companies.

Source: Valente SA et al. Ann Surg Oncol. 2021 Jan 12. doi: 10.1245/s10434-020-09432-3.

Key clinical point: Rates of ipsilateral breast tumor recurrence (IBTR) in patients with early breast cancer treated with lumpectomy and intraoperative radiation therapy (IORT) are higher than that reported in TARGIT-A trial and with traditional whole-breast radiation therapy or other forms of partial breast irradiation.

Major finding: At 5 years, the absolute IBTR rate was 6.6% for the entire IORT-treated cohort. IBTR rate was 8% and 1.2% for patients who received primary IORT and unintentional IORT boost treatment, respectively. No recurrences were observed in the delayed IORT or intentional-boost IORT cohorts.

Study details: Findings from an updated analysis of TARGIT-R with a 5-year follow-up assessment in 667 patients with early-stage breast cancer who underwent lumpectomy and IORT.

Disclosures: The study did not receive any funding. The lead author did not report any conflicts of interest, but some co-investigators reported relationships with various pharmaceutical companies.

Source: Valente SA et al. Ann Surg Oncol. 2021 Jan 12. doi: 10.1245/s10434-020-09432-3.

Key clinical point: Rates of ipsilateral breast tumor recurrence (IBTR) in patients with early breast cancer treated with lumpectomy and intraoperative radiation therapy (IORT) are higher than that reported in TARGIT-A trial and with traditional whole-breast radiation therapy or other forms of partial breast irradiation.

Major finding: At 5 years, the absolute IBTR rate was 6.6% for the entire IORT-treated cohort. IBTR rate was 8% and 1.2% for patients who received primary IORT and unintentional IORT boost treatment, respectively. No recurrences were observed in the delayed IORT or intentional-boost IORT cohorts.

Study details: Findings from an updated analysis of TARGIT-R with a 5-year follow-up assessment in 667 patients with early-stage breast cancer who underwent lumpectomy and IORT.

Disclosures: The study did not receive any funding. The lead author did not report any conflicts of interest, but some co-investigators reported relationships with various pharmaceutical companies.

Source: Valente SA et al. Ann Surg Oncol. 2021 Jan 12. doi: 10.1245/s10434-020-09432-3.

Key clinical point: Low-dose capecitabine maintenance therapy for 1 year after standard adjuvant chemotherapy resulted in significantly better disease-free survival (DFS) but not overall survival (OS) in women with early triple-negative breast cancer (TNBC).

Major finding: Capecitabine vs. observation group had significantly higher estimated 5-year DFS (82.8% vs. 73%; hazard ratio [HR], 0.64; P = .03) and distant DFS (85.8% vs. 75.8%; HR, 0.60; P = .02) but not OS (85.5% vs. 81.3%; HR, 0.75; P = .22). Hand-foot syndrome (45.2%) was the most common adverse event in the capecitabine group, with 7.7% of patients experiencing grade 3 event.

Study details: Phase 3 SYSUCC-001 trial randomly allocated 434 women with early TNBC to receive either low-dose capecitabine maintenance (n=221) or undergo observation (n=213) within 4 weeks after completion of standard adjuvant chemotherapy.

Disclosures: This study was funded by Sun Yat-sen University, the National Natural Science Foundation of China, Natural Science Foundation of Guangdong Province, and F. Hoffmann-La Roche Ltd. The study investigators did not report any conflict of interest.

Source: Wang X et al. JAMA. 2021 Jan 5. doi: 10.1001/jama.2020.23370.

Key clinical point: Low-dose capecitabine maintenance therapy for 1 year after standard adjuvant chemotherapy resulted in significantly better disease-free survival (DFS) but not overall survival (OS) in women with early triple-negative breast cancer (TNBC).

Major finding: Capecitabine vs. observation group had significantly higher estimated 5-year DFS (82.8% vs. 73%; hazard ratio [HR], 0.64; P = .03) and distant DFS (85.8% vs. 75.8%; HR, 0.60; P = .02) but not OS (85.5% vs. 81.3%; HR, 0.75; P = .22). Hand-foot syndrome (45.2%) was the most common adverse event in the capecitabine group, with 7.7% of patients experiencing grade 3 event.

Study details: Phase 3 SYSUCC-001 trial randomly allocated 434 women with early TNBC to receive either low-dose capecitabine maintenance (n=221) or undergo observation (n=213) within 4 weeks after completion of standard adjuvant chemotherapy.

Disclosures: This study was funded by Sun Yat-sen University, the National Natural Science Foundation of China, Natural Science Foundation of Guangdong Province, and F. Hoffmann-La Roche Ltd. The study investigators did not report any conflict of interest.

Source: Wang X et al. JAMA. 2021 Jan 5. doi: 10.1001/jama.2020.23370.

Key clinical point: Low-dose capecitabine maintenance therapy for 1 year after standard adjuvant chemotherapy resulted in significantly better disease-free survival (DFS) but not overall survival (OS) in women with early triple-negative breast cancer (TNBC).

Major finding: Capecitabine vs. observation group had significantly higher estimated 5-year DFS (82.8% vs. 73%; hazard ratio [HR], 0.64; P = .03) and distant DFS (85.8% vs. 75.8%; HR, 0.60; P = .02) but not OS (85.5% vs. 81.3%; HR, 0.75; P = .22). Hand-foot syndrome (45.2%) was the most common adverse event in the capecitabine group, with 7.7% of patients experiencing grade 3 event.

Study details: Phase 3 SYSUCC-001 trial randomly allocated 434 women with early TNBC to receive either low-dose capecitabine maintenance (n=221) or undergo observation (n=213) within 4 weeks after completion of standard adjuvant chemotherapy.

Disclosures: This study was funded by Sun Yat-sen University, the National Natural Science Foundation of China, Natural Science Foundation of Guangdong Province, and F. Hoffmann-La Roche Ltd. The study investigators did not report any conflict of interest.

Source: Wang X et al. JAMA. 2021 Jan 5. doi: 10.1001/jama.2020.23370.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) treated with pertuzumab, trastuzumab, and docetaxel, rash during treatment and diarrhea after docetaxel discontinuation are predictors of survival outcomes.

Major finding: Development of rash during docetaxel administration predicted progression-free survival (PFS; adjusted hazard ratio [aHR], 0.71; P = .006) and overall survival (OS; aHR, 0.66; P = .01). Development of rash after docetaxel interruption also predicted PFS (aHR, 0.55; P = .002) and OS (aHR, 0.52; P = .018). Diarrhea was prognostic only for PFS (aHR, 0.65; P = .011) after docetaxel discontinuation.

Study details: The data come from a retrospective analysis of CLEOPATRA trial involving 777 patients with de novo or recurrent advanced HER2-positive MBC treated with docetaxel plus trastuzumab with or without pertuzumab.

Disclosures: No specific funding source was identified. Some authors reported receiving travel grants, consultation fees, and honoraria from various pharmaceutical companies.

Source: Ferreira AR et al. Eur J Cancer. 2020 Dec 31. doi: 10.1016/j.ejca.2020.11.023.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) treated with pertuzumab, trastuzumab, and docetaxel, rash during treatment and diarrhea after docetaxel discontinuation are predictors of survival outcomes.

Major finding: Development of rash during docetaxel administration predicted progression-free survival (PFS; adjusted hazard ratio [aHR], 0.71; P = .006) and overall survival (OS; aHR, 0.66; P = .01). Development of rash after docetaxel interruption also predicted PFS (aHR, 0.55; P = .002) and OS (aHR, 0.52; P = .018). Diarrhea was prognostic only for PFS (aHR, 0.65; P = .011) after docetaxel discontinuation.

Study details: The data come from a retrospective analysis of CLEOPATRA trial involving 777 patients with de novo or recurrent advanced HER2-positive MBC treated with docetaxel plus trastuzumab with or without pertuzumab.

Disclosures: No specific funding source was identified. Some authors reported receiving travel grants, consultation fees, and honoraria from various pharmaceutical companies.

Source: Ferreira AR et al. Eur J Cancer. 2020 Dec 31. doi: 10.1016/j.ejca.2020.11.023.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) treated with pertuzumab, trastuzumab, and docetaxel, rash during treatment and diarrhea after docetaxel discontinuation are predictors of survival outcomes.

Major finding: Development of rash during docetaxel administration predicted progression-free survival (PFS; adjusted hazard ratio [aHR], 0.71; P = .006) and overall survival (OS; aHR, 0.66; P = .01). Development of rash after docetaxel interruption also predicted PFS (aHR, 0.55; P = .002) and OS (aHR, 0.52; P = .018). Diarrhea was prognostic only for PFS (aHR, 0.65; P = .011) after docetaxel discontinuation.

Study details: The data come from a retrospective analysis of CLEOPATRA trial involving 777 patients with de novo or recurrent advanced HER2-positive MBC treated with docetaxel plus trastuzumab with or without pertuzumab.

Disclosures: No specific funding source was identified. Some authors reported receiving travel grants, consultation fees, and honoraria from various pharmaceutical companies.

Source: Ferreira AR et al. Eur J Cancer. 2020 Dec 31. doi: 10.1016/j.ejca.2020.11.023.

Key clinical point: Hormone therapy (HT) use and benign breast disease (BBD) history are more strongly associated with a higher risk for symptom-detected breast cancer (sym-BC), whereas alcohol intake and obesity are associated with an increased screen-detected BC (scrn-BC) risk.

Major finding: Factors more strongly associated with higher sym-BC vs. scrn-BC risk were estrogen HT use (adjusted hazard ratio [aHR], 1.40; 95% confidence interval [CI], 1.15-1.71 vs. aHR, 0.95; 95% CI, 0.83-1.09), combined HT use (aHR, 2.07; 95% CI, 1.72-2.48 vs. aHR, 1.45; 95% CI, 1.27-1.65), and BBD history (aHR, 95% CI, 1.85; 1.64-2.08 vs. aHR, 1.43; 95% CI, 1.33-1.55). Factors more strongly associated with scrn-BC vs. sym-BC risk were alcohol intake (per drink aHR, 1.28; 95% CI, 1.18-1.39 vs. aHR, 1.07; 95% CI, 0.94-1.22) and body mass index ³30 kg/m² (aHR, 1.22; 95% CI, 1.01-1.48 vs. aHR, 0.76; 95% CI, 0.56-1.01).

Study details: The data come from an analysis of 77,206 women followed-up for a median of 14.8 years. BC was detected through screening or by symptoms in 2,711 and 1,281 women, respectively.

Disclosures: The study was supported by the American Cancer Society. The authors declared no conflicts of interest.

Source: Gaudet MM et al. Breast Cancer Res Treat. 2021 Jan 4. doi: 10.1007/s10549-020-06025-2.

Key clinical point: Hormone therapy (HT) use and benign breast disease (BBD) history are more strongly associated with a higher risk for symptom-detected breast cancer (sym-BC), whereas alcohol intake and obesity are associated with an increased screen-detected BC (scrn-BC) risk.

Major finding: Factors more strongly associated with higher sym-BC vs. scrn-BC risk were estrogen HT use (adjusted hazard ratio [aHR], 1.40; 95% confidence interval [CI], 1.15-1.71 vs. aHR, 0.95; 95% CI, 0.83-1.09), combined HT use (aHR, 2.07; 95% CI, 1.72-2.48 vs. aHR, 1.45; 95% CI, 1.27-1.65), and BBD history (aHR, 95% CI, 1.85; 1.64-2.08 vs. aHR, 1.43; 95% CI, 1.33-1.55). Factors more strongly associated with scrn-BC vs. sym-BC risk were alcohol intake (per drink aHR, 1.28; 95% CI, 1.18-1.39 vs. aHR, 1.07; 95% CI, 0.94-1.22) and body mass index ³30 kg/m² (aHR, 1.22; 95% CI, 1.01-1.48 vs. aHR, 0.76; 95% CI, 0.56-1.01).

Study details: The data come from an analysis of 77,206 women followed-up for a median of 14.8 years. BC was detected through screening or by symptoms in 2,711 and 1,281 women, respectively.

Disclosures: The study was supported by the American Cancer Society. The authors declared no conflicts of interest.

Source: Gaudet MM et al. Breast Cancer Res Treat. 2021 Jan 4. doi: 10.1007/s10549-020-06025-2.

Key clinical point: Hormone therapy (HT) use and benign breast disease (BBD) history are more strongly associated with a higher risk for symptom-detected breast cancer (sym-BC), whereas alcohol intake and obesity are associated with an increased screen-detected BC (scrn-BC) risk.

Major finding: Factors more strongly associated with higher sym-BC vs. scrn-BC risk were estrogen HT use (adjusted hazard ratio [aHR], 1.40; 95% confidence interval [CI], 1.15-1.71 vs. aHR, 0.95; 95% CI, 0.83-1.09), combined HT use (aHR, 2.07; 95% CI, 1.72-2.48 vs. aHR, 1.45; 95% CI, 1.27-1.65), and BBD history (aHR, 95% CI, 1.85; 1.64-2.08 vs. aHR, 1.43; 95% CI, 1.33-1.55). Factors more strongly associated with scrn-BC vs. sym-BC risk were alcohol intake (per drink aHR, 1.28; 95% CI, 1.18-1.39 vs. aHR, 1.07; 95% CI, 0.94-1.22) and body mass index ³30 kg/m² (aHR, 1.22; 95% CI, 1.01-1.48 vs. aHR, 0.76; 95% CI, 0.56-1.01).

Study details: The data come from an analysis of 77,206 women followed-up for a median of 14.8 years. BC was detected through screening or by symptoms in 2,711 and 1,281 women, respectively.

Disclosures: The study was supported by the American Cancer Society. The authors declared no conflicts of interest.

Source: Gaudet MM et al. Breast Cancer Res Treat. 2021 Jan 4. doi: 10.1007/s10549-020-06025-2.

Key clinical point: Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous (SC) injection was noninferior to intravenous (IV) dosing in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer.

Major finding: Geometric mean ratio of cycle 7 pertuzumab serum C_trough of the SC group to the IV group was 1.22 (90% confidence interval, 1.14-1.31). Total pathologic complete response was achieved by 59.5% and 59.7% of patients in IV and SC groups, respectively. Common grade 3-4 adverse events were similar.

Study details: In the phase 3 FeDeriCa trial, patients with HER2+ early breast cancer were randomly assigned to receive either fixed-dose SC (n = 248) or IV (n = 252) pertuzumab and trastuzumab along with neoadjuvant chemotherapy.

Disclosures: This study was funded by F Hoffmann-La Roche and Genentech. The lead author AR Tan reported receving financial support from F Hoffmann-La Roche, Genentech, Pfizer, Merck, Tesaro, Novartis, Immunomedics, Celgene, and AbbVie. His coauthors also reported relationships with various pharmaceutical companies including F Hoffmann-La Roche and Genentech.

Source: Tan AR et al. Lancet Oncol. 2020 Dec 21. doi: 10.1016/S1470-2045(20)30536-2.

Key clinical point: Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous (SC) injection was noninferior to intravenous (IV) dosing in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer.

Major finding: Geometric mean ratio of cycle 7 pertuzumab serum C_trough of the SC group to the IV group was 1.22 (90% confidence interval, 1.14-1.31). Total pathologic complete response was achieved by 59.5% and 59.7% of patients in IV and SC groups, respectively. Common grade 3-4 adverse events were similar.

Study details: In the phase 3 FeDeriCa trial, patients with HER2+ early breast cancer were randomly assigned to receive either fixed-dose SC (n = 248) or IV (n = 252) pertuzumab and trastuzumab along with neoadjuvant chemotherapy.

Disclosures: This study was funded by F Hoffmann-La Roche and Genentech. The lead author AR Tan reported receving financial support from F Hoffmann-La Roche, Genentech, Pfizer, Merck, Tesaro, Novartis, Immunomedics, Celgene, and AbbVie. His coauthors also reported relationships with various pharmaceutical companies including F Hoffmann-La Roche and Genentech.

Source: Tan AR et al. Lancet Oncol. 2020 Dec 21. doi: 10.1016/S1470-2045(20)30536-2.

Key clinical point: Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous (SC) injection was noninferior to intravenous (IV) dosing in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer.

Major finding: Geometric mean ratio of cycle 7 pertuzumab serum C_trough of the SC group to the IV group was 1.22 (90% confidence interval, 1.14-1.31). Total pathologic complete response was achieved by 59.5% and 59.7% of patients in IV and SC groups, respectively. Common grade 3-4 adverse events were similar.

Study details: In the phase 3 FeDeriCa trial, patients with HER2+ early breast cancer were randomly assigned to receive either fixed-dose SC (n = 248) or IV (n = 252) pertuzumab and trastuzumab along with neoadjuvant chemotherapy.

Disclosures: This study was funded by F Hoffmann-La Roche and Genentech. The lead author AR Tan reported receving financial support from F Hoffmann-La Roche, Genentech, Pfizer, Merck, Tesaro, Novartis, Immunomedics, Celgene, and AbbVie. His coauthors also reported relationships with various pharmaceutical companies including F Hoffmann-La Roche and Genentech.

Source: Tan AR et al. Lancet Oncol. 2020 Dec 21. doi: 10.1016/S1470-2045(20)30536-2.

Key clinical point: In patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (ER⁺/HER2⁻ BC), adjuvant S-1 plus standard endocrine therapy (ET) significantly reduced invasive disease-free survival (IDFS) events compared with ET alone.

Major finding: IDFS events were observed in 16% vs. 11% of patients in ET-only vs. ET+S-1 groups (hazard ratio [HR], 0.63; P = .0003), respectively. The estimated 5-year IDFS was 87% in the ET+S-1 group vs. 82% in the ET-only group. However, adverse events were higher in patients receiving ET+S-1 therapy (99%) vs. ET alone (79%) but were majorly manageable.

 Study details: Phase 3 trial included 1,930 women with ER⁺/HER⁻ BC with intermediate to high risk for recurrence who were randomly allocated to receive either ET alone (n=973) or ET+S-1 (n=957) for a median follow-up of 52.2 months.

Disclosures: This study was sponsored by the Public Health Research Foundation, Japan, and funded by Taiho Pharmaceuticals. Masakazu Toi and other study authors reported funding and ties with various pharmaceutical companies including Taiho during and outside the conduct of the study.

Source: Toi M et al. Lancet Oncol. 2021 Jan 1. doi: 10.1016/S1470-2045(20)30534-9.

Key clinical point: In patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (ER⁺/HER2⁻ BC), adjuvant S-1 plus standard endocrine therapy (ET) significantly reduced invasive disease-free survival (IDFS) events compared with ET alone.

Major finding: IDFS events were observed in 16% vs. 11% of patients in ET-only vs. ET+S-1 groups (hazard ratio [HR], 0.63; P = .0003), respectively. The estimated 5-year IDFS was 87% in the ET+S-1 group vs. 82% in the ET-only group. However, adverse events were higher in patients receiving ET+S-1 therapy (99%) vs. ET alone (79%) but were majorly manageable.

 Study details: Phase 3 trial included 1,930 women with ER⁺/HER⁻ BC with intermediate to high risk for recurrence who were randomly allocated to receive either ET alone (n=973) or ET+S-1 (n=957) for a median follow-up of 52.2 months.

Disclosures: This study was sponsored by the Public Health Research Foundation, Japan, and funded by Taiho Pharmaceuticals. Masakazu Toi and other study authors reported funding and ties with various pharmaceutical companies including Taiho during and outside the conduct of the study.

Source: Toi M et al. Lancet Oncol. 2021 Jan 1. doi: 10.1016/S1470-2045(20)30534-9.

Key clinical point: In patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (ER⁺/HER2⁻ BC), adjuvant S-1 plus standard endocrine therapy (ET) significantly reduced invasive disease-free survival (IDFS) events compared with ET alone.

Major finding: IDFS events were observed in 16% vs. 11% of patients in ET-only vs. ET+S-1 groups (hazard ratio [HR], 0.63; P = .0003), respectively. The estimated 5-year IDFS was 87% in the ET+S-1 group vs. 82% in the ET-only group. However, adverse events were higher in patients receiving ET+S-1 therapy (99%) vs. ET alone (79%) but were majorly manageable.

 Study details: Phase 3 trial included 1,930 women with ER⁺/HER⁻ BC with intermediate to high risk for recurrence who were randomly allocated to receive either ET alone (n=973) or ET+S-1 (n=957) for a median follow-up of 52.2 months.

Disclosures: This study was sponsored by the Public Health Research Foundation, Japan, and funded by Taiho Pharmaceuticals. Masakazu Toi and other study authors reported funding and ties with various pharmaceutical companies including Taiho during and outside the conduct of the study.

Source: Toi M et al. Lancet Oncol. 2021 Jan 1. doi: 10.1016/S1470-2045(20)30534-9.

Key clinical point: Metabolic syndrome (MS) is associated with poorer disease-free survival (DFS), but not with overall survival (OS) in patients with triple-negative breast cancer (TNBC). Hypertension was the only MS component associated with poor DFS and OS.

Major finding: MS was significantly associated with poor DFS (adjusted HR [aHR], 2.24; P = .030), but not OS (aHR, 1.92; P = .103). Hypertension was significantly associated with worse DFS (aHR, 3.63; P = .006) and OS (aHR, 3.45; P = .035).

Study details: Retrospective study of 177 patients with TNBC with (n=48) or without (n=129) MS who were followed-up for at least 5 years.

Disclosures: The study was supported by the Sharpe Strumia Foundation. The authors declared no conflicts of interest.

Source: Kennard K et al. Breast Cancer Res Treat. 2021 Jan 3. doi: 10.1007/s10549-020-06034-1.

Key clinical point: Metabolic syndrome (MS) is associated with poorer disease-free survival (DFS), but not with overall survival (OS) in patients with triple-negative breast cancer (TNBC). Hypertension was the only MS component associated with poor DFS and OS.

Major finding: MS was significantly associated with poor DFS (adjusted HR [aHR], 2.24; P = .030), but not OS (aHR, 1.92; P = .103). Hypertension was significantly associated with worse DFS (aHR, 3.63; P = .006) and OS (aHR, 3.45; P = .035).

Study details: Retrospective study of 177 patients with TNBC with (n=48) or without (n=129) MS who were followed-up for at least 5 years.

Disclosures: The study was supported by the Sharpe Strumia Foundation. The authors declared no conflicts of interest.

Source: Kennard K et al. Breast Cancer Res Treat. 2021 Jan 3. doi: 10.1007/s10549-020-06034-1.

Key clinical point: Metabolic syndrome (MS) is associated with poorer disease-free survival (DFS), but not with overall survival (OS) in patients with triple-negative breast cancer (TNBC). Hypertension was the only MS component associated with poor DFS and OS.

Major finding: MS was significantly associated with poor DFS (adjusted HR [aHR], 2.24; P = .030), but not OS (aHR, 1.92; P = .103). Hypertension was significantly associated with worse DFS (aHR, 3.63; P = .006) and OS (aHR, 3.45; P = .035).

Study details: Retrospective study of 177 patients with TNBC with (n=48) or without (n=129) MS who were followed-up for at least 5 years.

Disclosures: The study was supported by the Sharpe Strumia Foundation. The authors declared no conflicts of interest.

Source: Kennard K et al. Breast Cancer Res Treat. 2021 Jan 3. doi: 10.1007/s10549-020-06034-1.

The Diagnosis: Targetoid Hemosiderotic Hemangioma 

Targetoid hemosiderotic hemangioma (THH), also known as hobnail hemangioma, is a benign vascular tumor that usually occurs in young or middle-aged adults. It most commonly presents on the extremities or trunk as an isolated red-brown plaque or papule.^1,2 Histologically, THH is characterized by superficial dilated ectatic vessels with underlying proliferating vascular channels lined by plump hobnail endothelial cells.¹ Targetoid hemosiderotic hemangioma typically involves the dermis and spares the subcutis. The vascular channels may contain erythrocytes as well as pale eosinophilic lymph, as seen in our patient (quiz image). The deeper dermis contains vascular spaces that are more angulated and smaller and appear to be dissecting through the collagen bundles or collapsed.^1,3 A variable amount of hemosiderin deposition and extravasated erythrocytes are seen.^2,3 Histologic features evolve with the age of the lesion. Increasing amounts of hemosiderin deposition and erythrocyte extravasation may correspond histologically to the recent clinical color change reported by the patient.  

Verrucous hemangioma is a rare congenital vascular abnormality that is characterized by dilated vessels in the papillary dermis along with acanthosis, hyperkeratosis, and irregular papillomatosis, as seen in angiokeratoma.⁴ However, the vascular proliferation composed of variably sized, thin-walled capillaries extends into the deep dermis as well as the subcutis (Figure 1). Verrucous hemangioma most commonly is reported on the legs and generally starts as a violaceous patch that progresses into a hyperkeratotic verrucous plaque or nodule.^5,6  

Angiokeratoma is characterized by superficial vascular ectasia of the papillary dermis in association with overlying acanthosis, hyperkeratosis, and rete elongation.⁷ The dilated vascular spaces appear encircled by the epidermis (Figure 2). Intravascular thrombosis can be seen within the ectatic vessels.⁷ In contrast to verrucous hemangioma, angiokeratoma is limited to the papillary dermis. Therefore, obtaining a biopsy of sufficient depth is necessary for differentiation.⁸ There are 5 clinical presentations of angiokeratoma: sporadic, angiokeratoma of Mibelli, angiokeratoma of Fordyce, angiokeratoma circumscriptum, and angiokeratoma corporis diffusum (Fabry disease). Angiokeratomas may present on the lower extremities, tongue, trunk, and scrotum as hyperkeratotic, dark red to purple or black papules.⁷ 

There are 3 clinical stages of Kaposi sarcoma: patch, plaque, and nodular stages. The patch stage is characterized histologically by vascular channels that dissect through the dermis and extend around native vessels (the promontory sign)(Figure 3).^9,10 These features can show histologic overlap with THH. The plaque stage shows a more diffuse dermal vascular proliferation, increased cellularity of spindle cells, and possible extension into the subcutis.^9,10 Focal plasma cells, hemosiderin, and extravasated red blood cells can be seen. The nodular stage is characterized by a proliferation of spindle cells with red blood cells squeezed between slitlike vascular spaces, hyaline globules, and scattered mitotic figures, but not atypical forms.¹⁰ In this stage, plasma cells and hemosiderin are more readily identifiable. A biopsy from the nodular stage is unlikely to enter the histologic differential diagnosis with THH. Clinically, there are 4 variants of Kaposi sarcoma: the classic or sporadic form, an endemic form, iatrogenic, and AIDS associated. Overall, it is more common in males and can occur at any age.¹⁰ Human herpesvirus 8 is seen in all forms, and infected cells can be highlighted by the immunohistochemical stain for latent nuclear antigen 1.^9,10 

Angiosarcoma is a malignant endothelial tumor of soft tissue, skin, bone, and visceral organs.^11,12 Clinically, cutaneous angiosarcoma can present in a variety of ways, including single or multiple bluish red lesions that can ulcerate or bleed; violaceous nodules or plaques; and hematomalike lesions that can mimic epithelial neoplasms including squamous cell carcinoma, basal cell carcinoma, and malignant melanoma.^11,13,14 The cutaneous lesions most commonly occur on sun-exposed skin, particularly on the face and scalp.¹² Other clinical variants that are important to recognize are postradiation angiosarcoma, characterized by MYC gene amplification, and lymphedema-associated angiosarcoma (Stewart-Treves syndrome). Angiosarcoma can have a variety of morphologic features, ranging from well to poorly differentiated. Classically, angiosarcoma is characterized by infiltrating vascular spaces lined by atypical endothelial cells (Figure 4). Poorly differentiated angiosarcoma can demonstrate spindle, epithelioid, or polygonal cells with increased mitotic activity, pleomorphism, and irregular vascular spaces.¹¹ Endothelial markers such as ERG (erythroblast transformation specific-related gene)(nuclear) and CD31 (membranous) can be used to aid in the diagnosis of a poorly differentiated lesion. Epithelioid angiosarcoma also occasionally stains with cytokeratins.^13,14  

The Diagnosis: Targetoid Hemosiderotic Hemangioma 

Targetoid hemosiderotic hemangioma (THH), also known as hobnail hemangioma, is a benign vascular tumor that usually occurs in young or middle-aged adults. It most commonly presents on the extremities or trunk as an isolated red-brown plaque or papule.^1,2 Histologically, THH is characterized by superficial dilated ectatic vessels with underlying proliferating vascular channels lined by plump hobnail endothelial cells.¹ Targetoid hemosiderotic hemangioma typically involves the dermis and spares the subcutis. The vascular channels may contain erythrocytes as well as pale eosinophilic lymph, as seen in our patient (quiz image). The deeper dermis contains vascular spaces that are more angulated and smaller and appear to be dissecting through the collagen bundles or collapsed.^1,3 A variable amount of hemosiderin deposition and extravasated erythrocytes are seen.^2,3 Histologic features evolve with the age of the lesion. Increasing amounts of hemosiderin deposition and erythrocyte extravasation may correspond histologically to the recent clinical color change reported by the patient.  

Verrucous hemangioma is a rare congenital vascular abnormality that is characterized by dilated vessels in the papillary dermis along with acanthosis, hyperkeratosis, and irregular papillomatosis, as seen in angiokeratoma.⁴ However, the vascular proliferation composed of variably sized, thin-walled capillaries extends into the deep dermis as well as the subcutis (Figure 1). Verrucous hemangioma most commonly is reported on the legs and generally starts as a violaceous patch that progresses into a hyperkeratotic verrucous plaque or nodule.^5,6  

Angiokeratoma is characterized by superficial vascular ectasia of the papillary dermis in association with overlying acanthosis, hyperkeratosis, and rete elongation.⁷ The dilated vascular spaces appear encircled by the epidermis (Figure 2). Intravascular thrombosis can be seen within the ectatic vessels.⁷ In contrast to verrucous hemangioma, angiokeratoma is limited to the papillary dermis. Therefore, obtaining a biopsy of sufficient depth is necessary for differentiation.⁸ There are 5 clinical presentations of angiokeratoma: sporadic, angiokeratoma of Mibelli, angiokeratoma of Fordyce, angiokeratoma circumscriptum, and angiokeratoma corporis diffusum (Fabry disease). Angiokeratomas may present on the lower extremities, tongue, trunk, and scrotum as hyperkeratotic, dark red to purple or black papules.⁷ 

There are 3 clinical stages of Kaposi sarcoma: patch, plaque, and nodular stages. The patch stage is characterized histologically by vascular channels that dissect through the dermis and extend around native vessels (the promontory sign)(Figure 3).^9,10 These features can show histologic overlap with THH. The plaque stage shows a more diffuse dermal vascular proliferation, increased cellularity of spindle cells, and possible extension into the subcutis.^9,10 Focal plasma cells, hemosiderin, and extravasated red blood cells can be seen. The nodular stage is characterized by a proliferation of spindle cells with red blood cells squeezed between slitlike vascular spaces, hyaline globules, and scattered mitotic figures, but not atypical forms.¹⁰ In this stage, plasma cells and hemosiderin are more readily identifiable. A biopsy from the nodular stage is unlikely to enter the histologic differential diagnosis with THH. Clinically, there are 4 variants of Kaposi sarcoma: the classic or sporadic form, an endemic form, iatrogenic, and AIDS associated. Overall, it is more common in males and can occur at any age.¹⁰ Human herpesvirus 8 is seen in all forms, and infected cells can be highlighted by the immunohistochemical stain for latent nuclear antigen 1.^9,10 

Angiosarcoma is a malignant endothelial tumor of soft tissue, skin, bone, and visceral organs.^11,12 Clinically, cutaneous angiosarcoma can present in a variety of ways, including single or multiple bluish red lesions that can ulcerate or bleed; violaceous nodules or plaques; and hematomalike lesions that can mimic epithelial neoplasms including squamous cell carcinoma, basal cell carcinoma, and malignant melanoma.^11,13,14 The cutaneous lesions most commonly occur on sun-exposed skin, particularly on the face and scalp.¹² Other clinical variants that are important to recognize are postradiation angiosarcoma, characterized by MYC gene amplification, and lymphedema-associated angiosarcoma (Stewart-Treves syndrome). Angiosarcoma can have a variety of morphologic features, ranging from well to poorly differentiated. Classically, angiosarcoma is characterized by infiltrating vascular spaces lined by atypical endothelial cells (Figure 4). Poorly differentiated angiosarcoma can demonstrate spindle, epithelioid, or polygonal cells with increased mitotic activity, pleomorphism, and irregular vascular spaces.¹¹ Endothelial markers such as ERG (erythroblast transformation specific-related gene)(nuclear) and CD31 (membranous) can be used to aid in the diagnosis of a poorly differentiated lesion. Epithelioid angiosarcoma also occasionally stains with cytokeratins.^13,14  

The Diagnosis: Targetoid Hemosiderotic Hemangioma 

Targetoid hemosiderotic hemangioma (THH), also known as hobnail hemangioma, is a benign vascular tumor that usually occurs in young or middle-aged adults. It most commonly presents on the extremities or trunk as an isolated red-brown plaque or papule.^1,2 Histologically, THH is characterized by superficial dilated ectatic vessels with underlying proliferating vascular channels lined by plump hobnail endothelial cells.¹ Targetoid hemosiderotic hemangioma typically involves the dermis and spares the subcutis. The vascular channels may contain erythrocytes as well as pale eosinophilic lymph, as seen in our patient (quiz image). The deeper dermis contains vascular spaces that are more angulated and smaller and appear to be dissecting through the collagen bundles or collapsed.^1,3 A variable amount of hemosiderin deposition and extravasated erythrocytes are seen.^2,3 Histologic features evolve with the age of the lesion. Increasing amounts of hemosiderin deposition and erythrocyte extravasation may correspond histologically to the recent clinical color change reported by the patient.  

Verrucous hemangioma is a rare congenital vascular abnormality that is characterized by dilated vessels in the papillary dermis along with acanthosis, hyperkeratosis, and irregular papillomatosis, as seen in angiokeratoma.⁴ However, the vascular proliferation composed of variably sized, thin-walled capillaries extends into the deep dermis as well as the subcutis (Figure 1). Verrucous hemangioma most commonly is reported on the legs and generally starts as a violaceous patch that progresses into a hyperkeratotic verrucous plaque or nodule.^5,6  

Angiokeratoma is characterized by superficial vascular ectasia of the papillary dermis in association with overlying acanthosis, hyperkeratosis, and rete elongation.⁷ The dilated vascular spaces appear encircled by the epidermis (Figure 2). Intravascular thrombosis can be seen within the ectatic vessels.⁷ In contrast to verrucous hemangioma, angiokeratoma is limited to the papillary dermis. Therefore, obtaining a biopsy of sufficient depth is necessary for differentiation.⁸ There are 5 clinical presentations of angiokeratoma: sporadic, angiokeratoma of Mibelli, angiokeratoma of Fordyce, angiokeratoma circumscriptum, and angiokeratoma corporis diffusum (Fabry disease). Angiokeratomas may present on the lower extremities, tongue, trunk, and scrotum as hyperkeratotic, dark red to purple or black papules.⁷ 

There are 3 clinical stages of Kaposi sarcoma: patch, plaque, and nodular stages. The patch stage is characterized histologically by vascular channels that dissect through the dermis and extend around native vessels (the promontory sign)(Figure 3).^9,10 These features can show histologic overlap with THH. The plaque stage shows a more diffuse dermal vascular proliferation, increased cellularity of spindle cells, and possible extension into the subcutis.^9,10 Focal plasma cells, hemosiderin, and extravasated red blood cells can be seen. The nodular stage is characterized by a proliferation of spindle cells with red blood cells squeezed between slitlike vascular spaces, hyaline globules, and scattered mitotic figures, but not atypical forms.¹⁰ In this stage, plasma cells and hemosiderin are more readily identifiable. A biopsy from the nodular stage is unlikely to enter the histologic differential diagnosis with THH. Clinically, there are 4 variants of Kaposi sarcoma: the classic or sporadic form, an endemic form, iatrogenic, and AIDS associated. Overall, it is more common in males and can occur at any age.¹⁰ Human herpesvirus 8 is seen in all forms, and infected cells can be highlighted by the immunohistochemical stain for latent nuclear antigen 1.^9,10 

Angiosarcoma is a malignant endothelial tumor of soft tissue, skin, bone, and visceral organs.^11,12 Clinically, cutaneous angiosarcoma can present in a variety of ways, including single or multiple bluish red lesions that can ulcerate or bleed; violaceous nodules or plaques; and hematomalike lesions that can mimic epithelial neoplasms including squamous cell carcinoma, basal cell carcinoma, and malignant melanoma.^11,13,14 The cutaneous lesions most commonly occur on sun-exposed skin, particularly on the face and scalp.¹² Other clinical variants that are important to recognize are postradiation angiosarcoma, characterized by MYC gene amplification, and lymphedema-associated angiosarcoma (Stewart-Treves syndrome). Angiosarcoma can have a variety of morphologic features, ranging from well to poorly differentiated. Classically, angiosarcoma is characterized by infiltrating vascular spaces lined by atypical endothelial cells (Figure 4). Poorly differentiated angiosarcoma can demonstrate spindle, epithelioid, or polygonal cells with increased mitotic activity, pleomorphism, and irregular vascular spaces.¹¹ Endothelial markers such as ERG (erythroblast transformation specific-related gene)(nuclear) and CD31 (membranous) can be used to aid in the diagnosis of a poorly differentiated lesion. Epithelioid angiosarcoma also occasionally stains with cytokeratins.^13,14