Breast Cancer

Key clinical point: Atypical hyperplasia (AH) at the surgical margins of breast-conserving surgery (BCS) did not increase the risk for ipsilateral breast cancer (BC) recurrence, distant metastasis, or mortality in patients with BC who had received neoadjuvant chemotherapy (NAC).

Major finding: The 5-year ipsilateral breast tumor recurrence (IBTR) rate was 4.6% (95% CI 3.2%-6.0%) in patients with AH and 6.2% (95% CI 4.6%-7.8%) in patients without AH, with no significant differences observed between both groups in terms of IBTR (P = .448), distant metastasis-free survival (P = .506), and overall survival (P = .432).

Study details: Findings are from a retrospective analysis including 598 patients with BC who received NAC and BCS, of which 301 patients had AH at the margins of BCS and 297 patients did not have AH at the margins of BCS.

Disclosures: This study was supported by grants from the Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Su A et al. Impact of atypical hyperplasia at surgical margins on breast cancer outcomes in patients treated with neoadjuvant chemotherapy. Front Oncol. 2023;13:1202689 (May 19). Doi: 10.3389/fonc.2023.1202689

Key clinical point: Atypical hyperplasia (AH) at the surgical margins of breast-conserving surgery (BCS) did not increase the risk for ipsilateral breast cancer (BC) recurrence, distant metastasis, or mortality in patients with BC who had received neoadjuvant chemotherapy (NAC).

Major finding: The 5-year ipsilateral breast tumor recurrence (IBTR) rate was 4.6% (95% CI 3.2%-6.0%) in patients with AH and 6.2% (95% CI 4.6%-7.8%) in patients without AH, with no significant differences observed between both groups in terms of IBTR (P = .448), distant metastasis-free survival (P = .506), and overall survival (P = .432).

Study details: Findings are from a retrospective analysis including 598 patients with BC who received NAC and BCS, of which 301 patients had AH at the margins of BCS and 297 patients did not have AH at the margins of BCS.

Disclosures: This study was supported by grants from the Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Su A et al. Impact of atypical hyperplasia at surgical margins on breast cancer outcomes in patients treated with neoadjuvant chemotherapy. Front Oncol. 2023;13:1202689 (May 19). Doi: 10.3389/fonc.2023.1202689

Key clinical point: Atypical hyperplasia (AH) at the surgical margins of breast-conserving surgery (BCS) did not increase the risk for ipsilateral breast cancer (BC) recurrence, distant metastasis, or mortality in patients with BC who had received neoadjuvant chemotherapy (NAC).

Major finding: The 5-year ipsilateral breast tumor recurrence (IBTR) rate was 4.6% (95% CI 3.2%-6.0%) in patients with AH and 6.2% (95% CI 4.6%-7.8%) in patients without AH, with no significant differences observed between both groups in terms of IBTR (P = .448), distant metastasis-free survival (P = .506), and overall survival (P = .432).

Study details: Findings are from a retrospective analysis including 598 patients with BC who received NAC and BCS, of which 301 patients had AH at the margins of BCS and 297 patients did not have AH at the margins of BCS.

Disclosures: This study was supported by grants from the Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Su A et al. Impact of atypical hyperplasia at surgical margins on breast cancer outcomes in patients treated with neoadjuvant chemotherapy. Front Oncol. 2023;13:1202689 (May 19). Doi: 10.3389/fonc.2023.1202689

Key clinical point: Aspirin intake may be associated with a reduced risk for incident breast cancer (BC) in adults.

Major finding: Aspirin users vs nonusers had a significantly reduced risk for BC (hazard ratio [HR] 0.91; P =  .002), especially estrogen receptor-positive BC (HR 0.90; P = .0004).

Study details: Findings are from a meta-analysis of 28 cohort studies including adults who received aspirin.

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

Source: Bakierzynska M et al. Prophylactic aspirin intake and breast cancer risk: A systematic review and meta-analysis of observational cohort studies. Eur J Surg Oncol. 2023 (Jun 6). doi: 10.1016/j.ejso.2023.05.015

Key clinical point: Aspirin intake may be associated with a reduced risk for incident breast cancer (BC) in adults.

Major finding: Aspirin users vs nonusers had a significantly reduced risk for BC (hazard ratio [HR] 0.91; P =  .002), especially estrogen receptor-positive BC (HR 0.90; P = .0004).

Study details: Findings are from a meta-analysis of 28 cohort studies including adults who received aspirin.

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

Source: Bakierzynska M et al. Prophylactic aspirin intake and breast cancer risk: A systematic review and meta-analysis of observational cohort studies. Eur J Surg Oncol. 2023 (Jun 6). doi: 10.1016/j.ejso.2023.05.015

Key clinical point: Aspirin intake may be associated with a reduced risk for incident breast cancer (BC) in adults.

Major finding: Aspirin users vs nonusers had a significantly reduced risk for BC (hazard ratio [HR] 0.91; P =  .002), especially estrogen receptor-positive BC (HR 0.90; P = .0004).

Study details: Findings are from a meta-analysis of 28 cohort studies including adults who received aspirin.

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

Source: Bakierzynska M et al. Prophylactic aspirin intake and breast cancer risk: A systematic review and meta-analysis of observational cohort studies. Eur J Surg Oncol. 2023 (Jun 6). doi: 10.1016/j.ejso.2023.05.015

Key clinical point: Adjuvant capecitabine was extremely well tolerated in a real-world population of patients with early triple-negative breast cancer (TNBC) who had invasive residual disease at surgery after receiving neoadjuvant chemotherapy.

Major finding: The rate of treatment discontinuation due to adjuvant capecitabine-related toxicity was very low (10.4%). After a median follow-up of 15 months, the 2-year disease-free survival rate was 62.0%, and the 2- and 3-year overall survival rates were 84.0% and 76.2%, respectively.

Study details: Findings are from an observational, retrospective study including 270 patients with TNBC who had residual disease even after receiving neoadjuvant chemotherapy and were treated with adjuvant capecitabine.

Disclosures: This research was supported by Funds Ricerca Corrente 2023 from the Italian Ministry of Health. Some authors declared receiving research grants, personal fees, speaker fees, honoraria, or travel grants or having other ties with several sources.

Source: Di Lisa FS et al. Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: Real-world evidence from CaRe, a multicentric, observational study. Front Oncol. 2023;13:1152123 (May 16). doi: 10.3389/fonc.2023.1152123

Key clinical point: Adjuvant capecitabine was extremely well tolerated in a real-world population of patients with early triple-negative breast cancer (TNBC) who had invasive residual disease at surgery after receiving neoadjuvant chemotherapy.

Major finding: The rate of treatment discontinuation due to adjuvant capecitabine-related toxicity was very low (10.4%). After a median follow-up of 15 months, the 2-year disease-free survival rate was 62.0%, and the 2- and 3-year overall survival rates were 84.0% and 76.2%, respectively.

Study details: Findings are from an observational, retrospective study including 270 patients with TNBC who had residual disease even after receiving neoadjuvant chemotherapy and were treated with adjuvant capecitabine.

Disclosures: This research was supported by Funds Ricerca Corrente 2023 from the Italian Ministry of Health. Some authors declared receiving research grants, personal fees, speaker fees, honoraria, or travel grants or having other ties with several sources.

Source: Di Lisa FS et al. Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: Real-world evidence from CaRe, a multicentric, observational study. Front Oncol. 2023;13:1152123 (May 16). doi: 10.3389/fonc.2023.1152123

Key clinical point: Adjuvant capecitabine was extremely well tolerated in a real-world population of patients with early triple-negative breast cancer (TNBC) who had invasive residual disease at surgery after receiving neoadjuvant chemotherapy.

Major finding: The rate of treatment discontinuation due to adjuvant capecitabine-related toxicity was very low (10.4%). After a median follow-up of 15 months, the 2-year disease-free survival rate was 62.0%, and the 2- and 3-year overall survival rates were 84.0% and 76.2%, respectively.

Study details: Findings are from an observational, retrospective study including 270 patients with TNBC who had residual disease even after receiving neoadjuvant chemotherapy and were treated with adjuvant capecitabine.

Disclosures: This research was supported by Funds Ricerca Corrente 2023 from the Italian Ministry of Health. Some authors declared receiving research grants, personal fees, speaker fees, honoraria, or travel grants or having other ties with several sources.

Source: Di Lisa FS et al. Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: Real-world evidence from CaRe, a multicentric, observational study. Front Oncol. 2023;13:1152123 (May 16). doi: 10.3389/fonc.2023.1152123

Key clinical point: Surgery improved locoregional progression or recurrence rate in patients with de novo human epidermal growth factor receptor 2-positive (HER2+) metastatic inflammatory breast cancer (BC) who received first-line systemic therapy.

Major finding: Patients who underwent mastectomy had a median overall survival of 5.2 years from the date of surgery. Only one incidence of a locoregional progression or recurrence was reported 7.8 years after surgery, and pathological complete response was achieved by 10 patients, all of whom were alive at last follow-up.

Study details: Findings are from a retrospective study including 78 patients with de novo HER2+ metastatic inflammatory BC who received first-line systemic therapy, of which 41 patients underwent mastectomy with (n = 33) or without (n = 8) subsequent radiation therapy.

Disclosures: This study was funded by the Dana-Farber Cancer Institute IBC Research Fund and Reardon Family Fund. The authors declared serving as consultants or advisors or receiving speaker honorarium or travel support from, or holding stocks in several sources.

Source: Garrido-Castro AC et al. Clinical outcomes of de novo metastatic HER2-positive inflammatory breast cancer. NPJ Breast Cancer. 2023;9:50 (Jun 2). doi: 10.1038/s41523-023-00555-w

Key clinical point: Surgery improved locoregional progression or recurrence rate in patients with de novo human epidermal growth factor receptor 2-positive (HER2+) metastatic inflammatory breast cancer (BC) who received first-line systemic therapy.

Major finding: Patients who underwent mastectomy had a median overall survival of 5.2 years from the date of surgery. Only one incidence of a locoregional progression or recurrence was reported 7.8 years after surgery, and pathological complete response was achieved by 10 patients, all of whom were alive at last follow-up.

Study details: Findings are from a retrospective study including 78 patients with de novo HER2+ metastatic inflammatory BC who received first-line systemic therapy, of which 41 patients underwent mastectomy with (n = 33) or without (n = 8) subsequent radiation therapy.

Disclosures: This study was funded by the Dana-Farber Cancer Institute IBC Research Fund and Reardon Family Fund. The authors declared serving as consultants or advisors or receiving speaker honorarium or travel support from, or holding stocks in several sources.

Source: Garrido-Castro AC et al. Clinical outcomes of de novo metastatic HER2-positive inflammatory breast cancer. NPJ Breast Cancer. 2023;9:50 (Jun 2). doi: 10.1038/s41523-023-00555-w

Key clinical point: Surgery improved locoregional progression or recurrence rate in patients with de novo human epidermal growth factor receptor 2-positive (HER2+) metastatic inflammatory breast cancer (BC) who received first-line systemic therapy.

Major finding: Patients who underwent mastectomy had a median overall survival of 5.2 years from the date of surgery. Only one incidence of a locoregional progression or recurrence was reported 7.8 years after surgery, and pathological complete response was achieved by 10 patients, all of whom were alive at last follow-up.

Study details: Findings are from a retrospective study including 78 patients with de novo HER2+ metastatic inflammatory BC who received first-line systemic therapy, of which 41 patients underwent mastectomy with (n = 33) or without (n = 8) subsequent radiation therapy.

Disclosures: This study was funded by the Dana-Farber Cancer Institute IBC Research Fund and Reardon Family Fund. The authors declared serving as consultants or advisors or receiving speaker honorarium or travel support from, or holding stocks in several sources.

Source: Garrido-Castro AC et al. Clinical outcomes of de novo metastatic HER2-positive inflammatory breast cancer. NPJ Breast Cancer. 2023;9:50 (Jun 2). doi: 10.1038/s41523-023-00555-w

Key clinical point: A family history of estrogen receptor (ER)-positive (+) and negative (−) breast cancer (BC) as well as other cancers among first-degree relatives is associated with an increased risk for ER-subtypes of BC.

Major finding: Women with familial ER+ and ER− BC had ~2 times increased risk for ER+ (hazard ratio [HR] 1.96; 95% CI 1.84-2.09) and ER− (HR 2.67; 95% CI 2.10-3.40) BC, respectively. A family history of liver (odds ratio [OR] 1.33; 95% CI 1.05-1.67), ovarian (OR 1.28; 95% CI 1.01-1.61), and testicular (OR 1.78; 95% CI 1.01-3.14) cancers was associated with a higher risk for ER− vs ER+ BC.

Study details: Findings are from a population-based cohort study including 464,707 female participants, of which 25,273 were diagnosed with BC (including 16,286 and 3613 patients with ER+ and ER− BC, respectively).

Disclosures: This study was supported by the Swedish Research Council and other sources. The authors declared no conflicts of interest.

Source: Wang Q et al. Risk of ER-specific breast cancer by family history of ER subtypes and other cancers. J Natl Cancer Inst. 2023 (May 27). doi: 10.1093/jnci/djad104

Key clinical point: A family history of estrogen receptor (ER)-positive (+) and negative (−) breast cancer (BC) as well as other cancers among first-degree relatives is associated with an increased risk for ER-subtypes of BC.

Major finding: Women with familial ER+ and ER− BC had ~2 times increased risk for ER+ (hazard ratio [HR] 1.96; 95% CI 1.84-2.09) and ER− (HR 2.67; 95% CI 2.10-3.40) BC, respectively. A family history of liver (odds ratio [OR] 1.33; 95% CI 1.05-1.67), ovarian (OR 1.28; 95% CI 1.01-1.61), and testicular (OR 1.78; 95% CI 1.01-3.14) cancers was associated with a higher risk for ER− vs ER+ BC.

Study details: Findings are from a population-based cohort study including 464,707 female participants, of which 25,273 were diagnosed with BC (including 16,286 and 3613 patients with ER+ and ER− BC, respectively).

Disclosures: This study was supported by the Swedish Research Council and other sources. The authors declared no conflicts of interest.

Source: Wang Q et al. Risk of ER-specific breast cancer by family history of ER subtypes and other cancers. J Natl Cancer Inst. 2023 (May 27). doi: 10.1093/jnci/djad104

Key clinical point: A family history of estrogen receptor (ER)-positive (+) and negative (−) breast cancer (BC) as well as other cancers among first-degree relatives is associated with an increased risk for ER-subtypes of BC.

Major finding: Women with familial ER+ and ER− BC had ~2 times increased risk for ER+ (hazard ratio [HR] 1.96; 95% CI 1.84-2.09) and ER− (HR 2.67; 95% CI 2.10-3.40) BC, respectively. A family history of liver (odds ratio [OR] 1.33; 95% CI 1.05-1.67), ovarian (OR 1.28; 95% CI 1.01-1.61), and testicular (OR 1.78; 95% CI 1.01-3.14) cancers was associated with a higher risk for ER− vs ER+ BC.

Study details: Findings are from a population-based cohort study including 464,707 female participants, of which 25,273 were diagnosed with BC (including 16,286 and 3613 patients with ER+ and ER− BC, respectively).

Disclosures: This study was supported by the Swedish Research Council and other sources. The authors declared no conflicts of interest.

Source: Wang Q et al. Risk of ER-specific breast cancer by family history of ER subtypes and other cancers. J Natl Cancer Inst. 2023 (May 27). doi: 10.1093/jnci/djad104

Key clinical point: In patients with locally advanced breast cancer (BC), staging with ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) was more effective than conventional staging for detecting asymptomatic distant metastases.

Major finding: More than twice the number of patients undergoing PET-CT vs conventional staging were upstaged to stage IV BC (relative risk 2.4; P = .002), with combined modality treatment being received by fewer patients in the PET-CT vs conventional staging group (81% vs 89%; P = .03).

Study details: Findings are from the PET ABC study including 369 patients with invasive ductal carcinoma of the breast and TNM stage III or IIb BC who were randomly assigned to undergo ¹⁸F-labeled fluorodeoxyglucose PET-CT (whole body) or conventional staging (bone scan and CT of the chest/abdomen and pelvis).

Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria from or serving as employees, consultants, or advisors for different sources.

Source: Dayes IS et al. Impact of ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography versus conventional staging in patients with locally advanced breast cancer. J Clin Oncol. 2023 (May 26). doi: 10.1200/JCO.23.00249

Key clinical point: In patients with locally advanced breast cancer (BC), staging with ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) was more effective than conventional staging for detecting asymptomatic distant metastases.

Major finding: More than twice the number of patients undergoing PET-CT vs conventional staging were upstaged to stage IV BC (relative risk 2.4; P = .002), with combined modality treatment being received by fewer patients in the PET-CT vs conventional staging group (81% vs 89%; P = .03).

Study details: Findings are from the PET ABC study including 369 patients with invasive ductal carcinoma of the breast and TNM stage III or IIb BC who were randomly assigned to undergo ¹⁸F-labeled fluorodeoxyglucose PET-CT (whole body) or conventional staging (bone scan and CT of the chest/abdomen and pelvis).

Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria from or serving as employees, consultants, or advisors for different sources.

Source: Dayes IS et al. Impact of ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography versus conventional staging in patients with locally advanced breast cancer. J Clin Oncol. 2023 (May 26). doi: 10.1200/JCO.23.00249

Key clinical point: In patients with locally advanced breast cancer (BC), staging with ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) was more effective than conventional staging for detecting asymptomatic distant metastases.

Major finding: More than twice the number of patients undergoing PET-CT vs conventional staging were upstaged to stage IV BC (relative risk 2.4; P = .002), with combined modality treatment being received by fewer patients in the PET-CT vs conventional staging group (81% vs 89%; P = .03).

Study details: Findings are from the PET ABC study including 369 patients with invasive ductal carcinoma of the breast and TNM stage III or IIb BC who were randomly assigned to undergo ¹⁸F-labeled fluorodeoxyglucose PET-CT (whole body) or conventional staging (bone scan and CT of the chest/abdomen and pelvis).

Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria from or serving as employees, consultants, or advisors for different sources.

Source: Dayes IS et al. Impact of ¹⁸F-labeled fluorodeoxyglucose positron emission tomography-computed tomography versus conventional staging in patients with locally advanced breast cancer. J Clin Oncol. 2023 (May 26). doi: 10.1200/JCO.23.00249

Key clinical point: Simultaneous integrated boost (SIB) radiotherapy was safe and demonstrated noninferior clinical outcomes compared with sequential photon tumor-bed boost in patients with early breast cancer (BC) who underwent breast-conserving surgery (BCS).

Major finding: SIB with 48 Gy in 15 fractions to the tumor-bed volume vs sequential photon tumor-bed boost resulted in comparable rates of ipsilateral breast tumor relapse (hazard ratio [HR] 1.04; P = .91), whereas dose-escalated SIB (53 Gy) proved disadvantageous (HR 1.76; P = .041). There was no increase in toxicity outcomes with 48 Gy SIB vs sequential photon tumor-bed boost.

Study details: Findings are from the phase 3 IMPORT HIGH study including 2617 patients with early BC who underwent BCS and were randomly assigned to receive sequential photon tumor-bed boost or SIB with 48 or 53 Gy in 15 fractions to the tumor-bed volume.

Disclosures: This study was supported by Cancer Research U.K. Some authors declared receiving grants or funding from various sources, including Cancer Research U.K.

Source: Coles CE et al. Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): A multicentre, phase 3, non-inferiority, open-label, randomised controlled trial. Lancet. 2023 (Jun 8). doi: 10.1016/S0140-6736(23)00619-0

Key clinical point: Simultaneous integrated boost (SIB) radiotherapy was safe and demonstrated noninferior clinical outcomes compared with sequential photon tumor-bed boost in patients with early breast cancer (BC) who underwent breast-conserving surgery (BCS).

Major finding: SIB with 48 Gy in 15 fractions to the tumor-bed volume vs sequential photon tumor-bed boost resulted in comparable rates of ipsilateral breast tumor relapse (hazard ratio [HR] 1.04; P = .91), whereas dose-escalated SIB (53 Gy) proved disadvantageous (HR 1.76; P = .041). There was no increase in toxicity outcomes with 48 Gy SIB vs sequential photon tumor-bed boost.

Study details: Findings are from the phase 3 IMPORT HIGH study including 2617 patients with early BC who underwent BCS and were randomly assigned to receive sequential photon tumor-bed boost or SIB with 48 or 53 Gy in 15 fractions to the tumor-bed volume.

Disclosures: This study was supported by Cancer Research U.K. Some authors declared receiving grants or funding from various sources, including Cancer Research U.K.

Source: Coles CE et al. Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): A multicentre, phase 3, non-inferiority, open-label, randomised controlled trial. Lancet. 2023 (Jun 8). doi: 10.1016/S0140-6736(23)00619-0

Key clinical point: Simultaneous integrated boost (SIB) radiotherapy was safe and demonstrated noninferior clinical outcomes compared with sequential photon tumor-bed boost in patients with early breast cancer (BC) who underwent breast-conserving surgery (BCS).

Major finding: SIB with 48 Gy in 15 fractions to the tumor-bed volume vs sequential photon tumor-bed boost resulted in comparable rates of ipsilateral breast tumor relapse (hazard ratio [HR] 1.04; P = .91), whereas dose-escalated SIB (53 Gy) proved disadvantageous (HR 1.76; P = .041). There was no increase in toxicity outcomes with 48 Gy SIB vs sequential photon tumor-bed boost.

Study details: Findings are from the phase 3 IMPORT HIGH study including 2617 patients with early BC who underwent BCS and were randomly assigned to receive sequential photon tumor-bed boost or SIB with 48 or 53 Gy in 15 fractions to the tumor-bed volume.

Disclosures: This study was supported by Cancer Research U.K. Some authors declared receiving grants or funding from various sources, including Cancer Research U.K.

Source: Coles CE et al. Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): A multicentre, phase 3, non-inferiority, open-label, randomised controlled trial. Lancet. 2023 (Jun 8). doi: 10.1016/S0140-6736(23)00619-0

Key clinical point: In patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2-positive (ERBB2+, aka HER2+) breast cancer (BC), de-escalated neoadjuvant chemotherapy with paclitaxel plus trastuzumab and pertuzumab resulted in excellent pathological complete response (pCR) rates, which were superior to those achieved with endocrine therapy plus pertuzumab and trastuzumab.

Major finding: At 12 weeks, endocrine therapy+trastuzumab+pertuzumab led to a significantly inferior pCR rate compared with paclitaxel+trastuzumab+pertuzumab (23.7% vs 56.4%; odds ratio 0.24; P < .001). Both the types of treatment were well tolerated.

Study details: Findings are from the prospective, phase 2 WSG-TP-II trial including 207 patients with HR+/ERBB2+ early BC who were randomly assigned to receive trastuzumab+pertuzumab with paclitaxel or standard endocrine therapy for 12 weeks in the neoadjuvant setting.

Disclosures: This study was supported by Roche Pharma AG. The authors declared receiving personal fees, consulting fees, payments, grants, or travel support or having other ties with Roche and other sources.

Source: Gluz O et al. Efficacy of endocrine therapy plus trastuzumab and pertuzumab vs de-escalated chemotherapy in patients with hormone receptor-positive/ERBB2-positive early breast cancer: The neoadjuvant WSG-TP-II randomized clinical trial. JAMA Oncol. 2023 (May 11). doi: 10.1001/jamaoncol.2023.0646

Key clinical point: In patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2-positive (ERBB2+, aka HER2+) breast cancer (BC), de-escalated neoadjuvant chemotherapy with paclitaxel plus trastuzumab and pertuzumab resulted in excellent pathological complete response (pCR) rates, which were superior to those achieved with endocrine therapy plus pertuzumab and trastuzumab.

Major finding: At 12 weeks, endocrine therapy+trastuzumab+pertuzumab led to a significantly inferior pCR rate compared with paclitaxel+trastuzumab+pertuzumab (23.7% vs 56.4%; odds ratio 0.24; P < .001). Both the types of treatment were well tolerated.

Study details: Findings are from the prospective, phase 2 WSG-TP-II trial including 207 patients with HR+/ERBB2+ early BC who were randomly assigned to receive trastuzumab+pertuzumab with paclitaxel or standard endocrine therapy for 12 weeks in the neoadjuvant setting.

Disclosures: This study was supported by Roche Pharma AG. The authors declared receiving personal fees, consulting fees, payments, grants, or travel support or having other ties with Roche and other sources.

Source: Gluz O et al. Efficacy of endocrine therapy plus trastuzumab and pertuzumab vs de-escalated chemotherapy in patients with hormone receptor-positive/ERBB2-positive early breast cancer: The neoadjuvant WSG-TP-II randomized clinical trial. JAMA Oncol. 2023 (May 11). doi: 10.1001/jamaoncol.2023.0646

Key clinical point: In patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2-positive (ERBB2+, aka HER2+) breast cancer (BC), de-escalated neoadjuvant chemotherapy with paclitaxel plus trastuzumab and pertuzumab resulted in excellent pathological complete response (pCR) rates, which were superior to those achieved with endocrine therapy plus pertuzumab and trastuzumab.

Major finding: At 12 weeks, endocrine therapy+trastuzumab+pertuzumab led to a significantly inferior pCR rate compared with paclitaxel+trastuzumab+pertuzumab (23.7% vs 56.4%; odds ratio 0.24; P < .001). Both the types of treatment were well tolerated.

Study details: Findings are from the prospective, phase 2 WSG-TP-II trial including 207 patients with HR+/ERBB2+ early BC who were randomly assigned to receive trastuzumab+pertuzumab with paclitaxel or standard endocrine therapy for 12 weeks in the neoadjuvant setting.

Disclosures: This study was supported by Roche Pharma AG. The authors declared receiving personal fees, consulting fees, payments, grants, or travel support or having other ties with Roche and other sources.

Source: Gluz O et al. Efficacy of endocrine therapy plus trastuzumab and pertuzumab vs de-escalated chemotherapy in patients with hormone receptor-positive/ERBB2-positive early breast cancer: The neoadjuvant WSG-TP-II randomized clinical trial. JAMA Oncol. 2023 (May 11). doi: 10.1001/jamaoncol.2023.0646

Key clinical point: Capivasertib-fulvestrant therapy demonstrated significant progression-free survival (PFS) benefit and a manageable safety profile in patients with endocrine therapy-resistant hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: Significant PFS benefits were observed with capivasertib+fulvestrant vs placebo+fulvestrant in the overall population (hazard ratio for progression or death 0.60; P < .001) and in patients with AKT pathway-altered (PIK3CA, AKT1, or PTEN) tumors (hazard ratio 0.50; P < .001). Diarrhea and rash were the most common adverse events in the capivasertib+fulvestrant group.

Study details: Findings are from a primary analysis of the phase 3 CAPItello-291 study including 708 patients with HR+/HER2− advanced BC who had progressed on an aromatase inhibitor with or without cyclin-dependent kinase 4 and 6 inhibitor and were randomly assigned to receive fulvestrant with capivasertib or placebo.

Disclosures: This study was supported by AstraZeneca and other sources. Four authors declared being employees and stockholders in AstraZeneca. Some authors declared having ties with several sources.

Source: Turner NC et al for the CAPItello-291 Study Group. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med. 2023;388(22):2058-2070 (Jun 1). doi: 10.1056/NEJMoa2214131

Key clinical point: Capivasertib-fulvestrant therapy demonstrated significant progression-free survival (PFS) benefit and a manageable safety profile in patients with endocrine therapy-resistant hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: Significant PFS benefits were observed with capivasertib+fulvestrant vs placebo+fulvestrant in the overall population (hazard ratio for progression or death 0.60; P < .001) and in patients with AKT pathway-altered (PIK3CA, AKT1, or PTEN) tumors (hazard ratio 0.50; P < .001). Diarrhea and rash were the most common adverse events in the capivasertib+fulvestrant group.

Study details: Findings are from a primary analysis of the phase 3 CAPItello-291 study including 708 patients with HR+/HER2− advanced BC who had progressed on an aromatase inhibitor with or without cyclin-dependent kinase 4 and 6 inhibitor and were randomly assigned to receive fulvestrant with capivasertib or placebo.

Disclosures: This study was supported by AstraZeneca and other sources. Four authors declared being employees and stockholders in AstraZeneca. Some authors declared having ties with several sources.

Source: Turner NC et al for the CAPItello-291 Study Group. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med. 2023;388(22):2058-2070 (Jun 1). doi: 10.1056/NEJMoa2214131

Key clinical point: Capivasertib-fulvestrant therapy demonstrated significant progression-free survival (PFS) benefit and a manageable safety profile in patients with endocrine therapy-resistant hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: Significant PFS benefits were observed with capivasertib+fulvestrant vs placebo+fulvestrant in the overall population (hazard ratio for progression or death 0.60; P < .001) and in patients with AKT pathway-altered (PIK3CA, AKT1, or PTEN) tumors (hazard ratio 0.50; P < .001). Diarrhea and rash were the most common adverse events in the capivasertib+fulvestrant group.

Study details: Findings are from a primary analysis of the phase 3 CAPItello-291 study including 708 patients with HR+/HER2− advanced BC who had progressed on an aromatase inhibitor with or without cyclin-dependent kinase 4 and 6 inhibitor and were randomly assigned to receive fulvestrant with capivasertib or placebo.

Disclosures: This study was supported by AstraZeneca and other sources. Four authors declared being employees and stockholders in AstraZeneca. Some authors declared having ties with several sources.

Source: Turner NC et al for the CAPItello-291 Study Group. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med. 2023;388(22):2058-2070 (Jun 1). doi: 10.1056/NEJMoa2214131

NEWS FROM THE FDA/CDC

New USPSTF draft suggests mammography start at 40, not 50

Kerry Dooley Young

The US Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
 

FDA approves OTC naloxone, but will cost be a barrier?

Alicia Ault

The US Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on US shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022—to $373.7 million—blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

CONFERENCE COVERAGE

Should you prescribe bioidentical hormones for menopause?

Karen Blum

The off-label prescribing of compounded, bioidentical hormone therapy—in pills, creams, or pellets—for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the Food and Drug Administration.

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center in Amarillo.

Following the 2002 Women’s Health Initiative report showing a link between hormone therapy (HT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Dr. Kauffman said. The association was later determined to be spurious: HT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HT still is largely ignored by younger physicians, Dr. Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.
 

Once-daily nifedipine sufficient for hypertension in pregnancy

Tara Haelle

A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose—the most common adjustment—and 20.7% needed both an increase in nifedipine and an additional medication. ●

NEWS FROM THE FDA/CDC

New USPSTF draft suggests mammography start at 40, not 50

Kerry Dooley Young

The US Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
 

FDA approves OTC naloxone, but will cost be a barrier?

Alicia Ault

The US Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on US shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022—to $373.7 million—blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

CONFERENCE COVERAGE

Should you prescribe bioidentical hormones for menopause?

Karen Blum

The off-label prescribing of compounded, bioidentical hormone therapy—in pills, creams, or pellets—for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the Food and Drug Administration.

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center in Amarillo.

Following the 2002 Women’s Health Initiative report showing a link between hormone therapy (HT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Dr. Kauffman said. The association was later determined to be spurious: HT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HT still is largely ignored by younger physicians, Dr. Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.
 

Once-daily nifedipine sufficient for hypertension in pregnancy

Tara Haelle

A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose—the most common adjustment—and 20.7% needed both an increase in nifedipine and an additional medication. ●

NEWS FROM THE FDA/CDC

New USPSTF draft suggests mammography start at 40, not 50

Kerry Dooley Young

The US Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
 

FDA approves OTC naloxone, but will cost be a barrier?

Alicia Ault

The US Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on US shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022—to $373.7 million—blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

CONFERENCE COVERAGE

Should you prescribe bioidentical hormones for menopause?

Karen Blum

The off-label prescribing of compounded, bioidentical hormone therapy—in pills, creams, or pellets—for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the Food and Drug Administration.

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center in Amarillo.

Following the 2002 Women’s Health Initiative report showing a link between hormone therapy (HT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Dr. Kauffman said. The association was later determined to be spurious: HT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HT still is largely ignored by younger physicians, Dr. Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.
 

Once-daily nifedipine sufficient for hypertension in pregnancy

Tara Haelle

A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose—the most common adjustment—and 20.7% needed both an increase in nifedipine and an additional medication. ●