Key clinical point: In patients with early-stage triple-negative breast cancer (TNBC), capecitabine improved survival and demonstrated a tolerable safety profile, with lower dosage, higher frequency, and adjuvant setting being related with better survival outcomes.

Major finding: Capecitabine vs chemotherapy without capecitabine improved disease-free survival (DFS; hazard ratio [HR] 0.77; P < .001) and overall survival (HR 0.73; P < .0001). A lower dose (<1000 mg; HR 0.69; P  =  .002), a higher dosage frequency (≥6 cycles; HR 0.72; P < .0001) and an adjuvant setting (HR 0.74; P < .0001) were associated with a higher DFS. Capecitabine was associated with higher risk for diarrhea (P < .0001), hand-foot syndrome (P < .0001), and leukopenia (P < .01).

Study details: Findings are from a meta-analysis of 11 phase 3 randomized controlled trials including 5175 female patients with early-stage TNBC who received neoadjuvant or adjuvant chemotherapy with or without capecitabine.

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

Source: Xun X et al. Efficacy and safety of capecitabine for triple-negative breast cancer: A meta-analysis. Front Oncol. 2022;12:899423 (Jul 7). Doi: 10.3389/fonc.2022.899423

Key clinical point: In patients with early-stage triple-negative breast cancer (TNBC), capecitabine improved survival and demonstrated a tolerable safety profile, with lower dosage, higher frequency, and adjuvant setting being related with better survival outcomes.

Major finding: Capecitabine vs chemotherapy without capecitabine improved disease-free survival (DFS; hazard ratio [HR] 0.77; P < .001) and overall survival (HR 0.73; P < .0001). A lower dose (<1000 mg; HR 0.69; P  =  .002), a higher dosage frequency (≥6 cycles; HR 0.72; P < .0001) and an adjuvant setting (HR 0.74; P < .0001) were associated with a higher DFS. Capecitabine was associated with higher risk for diarrhea (P < .0001), hand-foot syndrome (P < .0001), and leukopenia (P < .01).

Study details: Findings are from a meta-analysis of 11 phase 3 randomized controlled trials including 5175 female patients with early-stage TNBC who received neoadjuvant or adjuvant chemotherapy with or without capecitabine.

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

Source: Xun X et al. Efficacy and safety of capecitabine for triple-negative breast cancer: A meta-analysis. Front Oncol. 2022;12:899423 (Jul 7). Doi: 10.3389/fonc.2022.899423

Key clinical point: In patients with early-stage triple-negative breast cancer (TNBC), capecitabine improved survival and demonstrated a tolerable safety profile, with lower dosage, higher frequency, and adjuvant setting being related with better survival outcomes.

Major finding: Capecitabine vs chemotherapy without capecitabine improved disease-free survival (DFS; hazard ratio [HR] 0.77; P < .001) and overall survival (HR 0.73; P < .0001). A lower dose (<1000 mg; HR 0.69; P  =  .002), a higher dosage frequency (≥6 cycles; HR 0.72; P < .0001) and an adjuvant setting (HR 0.74; P < .0001) were associated with a higher DFS. Capecitabine was associated with higher risk for diarrhea (P < .0001), hand-foot syndrome (P < .0001), and leukopenia (P < .01).

Study details: Findings are from a meta-analysis of 11 phase 3 randomized controlled trials including 5175 female patients with early-stage TNBC who received neoadjuvant or adjuvant chemotherapy with or without capecitabine.

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

Source: Xun X et al. Efficacy and safety of capecitabine for triple-negative breast cancer: A meta-analysis. Front Oncol. 2022;12:899423 (Jul 7). Doi: 10.3389/fonc.2022.899423

Key clinical point: Postmastectomy radiotherapy (PMRT) did not influence locoregional recurrence (LRR) in patients with pT1-2 and 1-3 node-positive breast cancer (BC).

Major finding: Rate of LRR at 5 years was similar in patients receiving PMRT and no PMRT (P  =  .61), and PMRT was not significantly associated with LRR in the overall population (P  =  .305).

Study details: Findings are from a retrospective, cohort study including 8914 patients with pT1-2 BC tumors and 1-3 lymph node metastases who received PMRT (n = 492) or no PMRT (n = 8422) after undergoing mastectomy and axillary lymph node dissection.

Disclosures: This study was supported by the Japanese Breast Cancer Society. Some authors declared receiving speaker’s fees, consulting fees, research funds, or honoraria from several sources.

Source: Yamada A et al. Prognostic impact of postoperative radiotherapy in patients with breast cancer and with pT1-2 and 1–3 lymph node metastases: A retrospective cohort study based on the Japanese Breast Cancer Registry. Eur J Cancer. 2022;172:32-40 (Jun 22). Doi: 10.1016/j.ejca.2022.05.017

Key clinical point: Postmastectomy radiotherapy (PMRT) did not influence locoregional recurrence (LRR) in patients with pT1-2 and 1-3 node-positive breast cancer (BC).

Major finding: Rate of LRR at 5 years was similar in patients receiving PMRT and no PMRT (P  =  .61), and PMRT was not significantly associated with LRR in the overall population (P  =  .305).

Study details: Findings are from a retrospective, cohort study including 8914 patients with pT1-2 BC tumors and 1-3 lymph node metastases who received PMRT (n = 492) or no PMRT (n = 8422) after undergoing mastectomy and axillary lymph node dissection.

Disclosures: This study was supported by the Japanese Breast Cancer Society. Some authors declared receiving speaker’s fees, consulting fees, research funds, or honoraria from several sources.

Source: Yamada A et al. Prognostic impact of postoperative radiotherapy in patients with breast cancer and with pT1-2 and 1–3 lymph node metastases: A retrospective cohort study based on the Japanese Breast Cancer Registry. Eur J Cancer. 2022;172:32-40 (Jun 22). Doi: 10.1016/j.ejca.2022.05.017

Key clinical point: Postmastectomy radiotherapy (PMRT) did not influence locoregional recurrence (LRR) in patients with pT1-2 and 1-3 node-positive breast cancer (BC).

Major finding: Rate of LRR at 5 years was similar in patients receiving PMRT and no PMRT (P  =  .61), and PMRT was not significantly associated with LRR in the overall population (P  =  .305).

Study details: Findings are from a retrospective, cohort study including 8914 patients with pT1-2 BC tumors and 1-3 lymph node metastases who received PMRT (n = 492) or no PMRT (n = 8422) after undergoing mastectomy and axillary lymph node dissection.

Disclosures: This study was supported by the Japanese Breast Cancer Society. Some authors declared receiving speaker’s fees, consulting fees, research funds, or honoraria from several sources.

Source: Yamada A et al. Prognostic impact of postoperative radiotherapy in patients with breast cancer and with pT1-2 and 1–3 lymph node metastases: A retrospective cohort study based on the Japanese Breast Cancer Registry. Eur J Cancer. 2022;172:32-40 (Jun 22). Doi: 10.1016/j.ejca.2022.05.017

Key clinical point: Addition of atezolizumab vs placebo to pertuzumab-trastuzumab (PH)+chemotherapy did not improve pathological complete response (pCR) rates in patients with high-risk, human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC).

Major finding: The rate of pCR was similar with atezolizumab and placebo in the intention-to-treat (62.4% and 62.7%, respectively; P  =  .9551) and programmed cell death-ligand 1-positive (64.2% and 72.5%, respectively; P  =  .1846) populations. The atezolizumab vs placebo group reported 5 vs 0 grade 5 adverse events, respectively.

Study details: Findings are from the phase 3 IMpassion050 study including 454 patients with high-risk, HER2+ early BC who were randomly assigned to receive atezolizumab or placebo with PH+chemotherapy in the neoadjuvant setting and continued atezolizumab or placebo with PH in the adjuvant phase.

Disclosures: This study was sponsored by F. Hoffmann-La Roche Ltd. Six authors declared being employees or stockowners at Roche, and the other authors reported ties with various sources, including Roche.

Source: Huober J et al. Atezolizumab With Neoadjuvant anti–human epidermal growth factor receptor 2 therapy and chemotherapy in human epidermal growth factor receptor 2–positive early breast cancer: Primary results of the randomized phase III IMpassion050 trial. J Clin Oncol. 2022 (Jun 28). Doi:  10.1200/JCO.21.02772

Key clinical point: Addition of atezolizumab vs placebo to pertuzumab-trastuzumab (PH)+chemotherapy did not improve pathological complete response (pCR) rates in patients with high-risk, human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC).

Major finding: The rate of pCR was similar with atezolizumab and placebo in the intention-to-treat (62.4% and 62.7%, respectively; P  =  .9551) and programmed cell death-ligand 1-positive (64.2% and 72.5%, respectively; P  =  .1846) populations. The atezolizumab vs placebo group reported 5 vs 0 grade 5 adverse events, respectively.

Study details: Findings are from the phase 3 IMpassion050 study including 454 patients with high-risk, HER2+ early BC who were randomly assigned to receive atezolizumab or placebo with PH+chemotherapy in the neoadjuvant setting and continued atezolizumab or placebo with PH in the adjuvant phase.

Disclosures: This study was sponsored by F. Hoffmann-La Roche Ltd. Six authors declared being employees or stockowners at Roche, and the other authors reported ties with various sources, including Roche.

Source: Huober J et al. Atezolizumab With Neoadjuvant anti–human epidermal growth factor receptor 2 therapy and chemotherapy in human epidermal growth factor receptor 2–positive early breast cancer: Primary results of the randomized phase III IMpassion050 trial. J Clin Oncol. 2022 (Jun 28). Doi:  10.1200/JCO.21.02772

Key clinical point: Addition of atezolizumab vs placebo to pertuzumab-trastuzumab (PH)+chemotherapy did not improve pathological complete response (pCR) rates in patients with high-risk, human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC).

Major finding: The rate of pCR was similar with atezolizumab and placebo in the intention-to-treat (62.4% and 62.7%, respectively; P  =  .9551) and programmed cell death-ligand 1-positive (64.2% and 72.5%, respectively; P  =  .1846) populations. The atezolizumab vs placebo group reported 5 vs 0 grade 5 adverse events, respectively.

Study details: Findings are from the phase 3 IMpassion050 study including 454 patients with high-risk, HER2+ early BC who were randomly assigned to receive atezolizumab or placebo with PH+chemotherapy in the neoadjuvant setting and continued atezolizumab or placebo with PH in the adjuvant phase.

Disclosures: This study was sponsored by F. Hoffmann-La Roche Ltd. Six authors declared being employees or stockowners at Roche, and the other authors reported ties with various sources, including Roche.

Source: Huober J et al. Atezolizumab With Neoadjuvant anti–human epidermal growth factor receptor 2 therapy and chemotherapy in human epidermal growth factor receptor 2–positive early breast cancer: Primary results of the randomized phase III IMpassion050 trial. J Clin Oncol. 2022 (Jun 28). Doi:  10.1200/JCO.21.02772

Key clinical point: The prophylactic use of etoricoxib reduced the incidence and severity of taxane-associated acute pain syndrome (T-APS) and potentially attenuated docetaxel-induced peripheral neuropathy in patients receiving docetaxel-based chemotherapy for breast cancer (BC).

Major finding: Incidence rates of all T-APS (57.1% vs 91.5%) and severe T-APS (11.4% vs 54.9%; both P < .001) were significantly lower in the etoricoxib vs no treatment group. At 3 months follow-up after 4 cycles of docetaxel chemotherapy, the etoricoxib vs no treatment group showed a significantly higher mean Functional Assessment of Cancer Treatment Neurotoxicity subscale score (38.46 vs 34.59; P < .001).

Study details: Findings are from a phase 2 study including 144 adult women with stage I-III BC who received 4 cycles of docetaxel-based chemotherapy and were randomly assigned to receive prophylactic etoricoxib or no treatment.

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

Source: Zhang J et al. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022;171:150-160 (Jun 17). Doi: 10.1016/j.ejca.2022.05.019

Key clinical point: The prophylactic use of etoricoxib reduced the incidence and severity of taxane-associated acute pain syndrome (T-APS) and potentially attenuated docetaxel-induced peripheral neuropathy in patients receiving docetaxel-based chemotherapy for breast cancer (BC).

Major finding: Incidence rates of all T-APS (57.1% vs 91.5%) and severe T-APS (11.4% vs 54.9%; both P < .001) were significantly lower in the etoricoxib vs no treatment group. At 3 months follow-up after 4 cycles of docetaxel chemotherapy, the etoricoxib vs no treatment group showed a significantly higher mean Functional Assessment of Cancer Treatment Neurotoxicity subscale score (38.46 vs 34.59; P < .001).

Study details: Findings are from a phase 2 study including 144 adult women with stage I-III BC who received 4 cycles of docetaxel-based chemotherapy and were randomly assigned to receive prophylactic etoricoxib or no treatment.

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

Source: Zhang J et al. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022;171:150-160 (Jun 17). Doi: 10.1016/j.ejca.2022.05.019

Key clinical point: The prophylactic use of etoricoxib reduced the incidence and severity of taxane-associated acute pain syndrome (T-APS) and potentially attenuated docetaxel-induced peripheral neuropathy in patients receiving docetaxel-based chemotherapy for breast cancer (BC).

Major finding: Incidence rates of all T-APS (57.1% vs 91.5%) and severe T-APS (11.4% vs 54.9%; both P < .001) were significantly lower in the etoricoxib vs no treatment group. At 3 months follow-up after 4 cycles of docetaxel chemotherapy, the etoricoxib vs no treatment group showed a significantly higher mean Functional Assessment of Cancer Treatment Neurotoxicity subscale score (38.46 vs 34.59; P < .001).

Study details: Findings are from a phase 2 study including 144 adult women with stage I-III BC who received 4 cycles of docetaxel-based chemotherapy and were randomly assigned to receive prophylactic etoricoxib or no treatment.

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

Source: Zhang J et al. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022;171:150-160 (Jun 17). Doi: 10.1016/j.ejca.2022.05.019

Key clinical point: First-line treatment with nivolumab, bevacizumab, and paclitaxel showed promising efficacy with a tolerable safety profile in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (BC).

Major finding: The objective response rate was 70% (95% CI 55.9%-81.2%) in the overall cohort of patients with HER2-negative metastatic BC, 74% in patients with hormone receptor-positive BC, and 59% in patients with triple-negative BC. Grade 3/4 adverse drug reactions were reported by 58% of patients.

Study details: Findings are primary results from the phase 2 NEWBEAT study including 57 women with invasive, metastatic, or inoperable HER2-negative BC who received the first-line triple therapy with nivolumab, bevacizumab, and paclitaxel.

Disclosures: This study was supported by Ono Pharmaceutical Company. The authors declared receiving research funds, grants, personal fees, lecture fees, honoraria, or consulting fees from several sources, including Ono Pharmaceuticals.

Source: Ozaki Y et al. Safety and efficacy of nivolumab plus bevacizumab, paclitaxel for HER2-negative metastatic breast cancer: Primary results and biomarker data from a phase 2 trial (WJOG9917B). Eur J Cancer. 2022;171:193-202 (Jun 18). Doi: 10.1016/j.ejca.2022.05.014

Key clinical point: First-line treatment with nivolumab, bevacizumab, and paclitaxel showed promising efficacy with a tolerable safety profile in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (BC).

Major finding: The objective response rate was 70% (95% CI 55.9%-81.2%) in the overall cohort of patients with HER2-negative metastatic BC, 74% in patients with hormone receptor-positive BC, and 59% in patients with triple-negative BC. Grade 3/4 adverse drug reactions were reported by 58% of patients.

Study details: Findings are primary results from the phase 2 NEWBEAT study including 57 women with invasive, metastatic, or inoperable HER2-negative BC who received the first-line triple therapy with nivolumab, bevacizumab, and paclitaxel.

Disclosures: This study was supported by Ono Pharmaceutical Company. The authors declared receiving research funds, grants, personal fees, lecture fees, honoraria, or consulting fees from several sources, including Ono Pharmaceuticals.

Source: Ozaki Y et al. Safety and efficacy of nivolumab plus bevacizumab, paclitaxel for HER2-negative metastatic breast cancer: Primary results and biomarker data from a phase 2 trial (WJOG9917B). Eur J Cancer. 2022;171:193-202 (Jun 18). Doi: 10.1016/j.ejca.2022.05.014

Key clinical point: First-line treatment with nivolumab, bevacizumab, and paclitaxel showed promising efficacy with a tolerable safety profile in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (BC).

Major finding: The objective response rate was 70% (95% CI 55.9%-81.2%) in the overall cohort of patients with HER2-negative metastatic BC, 74% in patients with hormone receptor-positive BC, and 59% in patients with triple-negative BC. Grade 3/4 adverse drug reactions were reported by 58% of patients.

Study details: Findings are primary results from the phase 2 NEWBEAT study including 57 women with invasive, metastatic, or inoperable HER2-negative BC who received the first-line triple therapy with nivolumab, bevacizumab, and paclitaxel.

Disclosures: This study was supported by Ono Pharmaceutical Company. The authors declared receiving research funds, grants, personal fees, lecture fees, honoraria, or consulting fees from several sources, including Ono Pharmaceuticals.

Source: Ozaki Y et al. Safety and efficacy of nivolumab plus bevacizumab, paclitaxel for HER2-negative metastatic breast cancer: Primary results and biomarker data from a phase 2 trial (WJOG9917B). Eur J Cancer. 2022;171:193-202 (Jun 18). Doi: 10.1016/j.ejca.2022.05.014

Key clinical point: The risk for hemorrhage was not significantly different in patients with breast cancer (BC) aged ≥ 66 years who received direct oral anticoagulants (DOAC) concurrently with tamoxifen vs aromatase inhibitors (AI).

Major finding: During a median follow-up of 166 days, the risk for major hemorrhage requiring an emergency department visit or hospitalization (2.5% vs 3.3%; weighted hazard ratio [HR] 0.68; 95% CI 0.44-1.06) or any hemorrhage (4.9% vs 4.6%; weighted HR 1.04; 95% CI 0.75-1.43) was not higher with tamoxifen+DOAC compared with AI+DOAC.

Study details: Findings are from a population-based, retrospective cohort study including 4753 patients aged ≥ 66 years with BC who were prescribed tamoxifen or AI concurrently with a DOAC.

Disclosures: This study was supported by Canadian Institutes of Health Research and ICES. Some authors declared serving on advisory boards of or receiving grants, personal fees, or travel expenses from several sources.

Source: Wang T-F et al. Hemorrhage risk among patients with breast cancer receiving concurrent direct oral anticoagulants with tamoxifen vs aromatase inhibitors. JAMA Netw Open. 2022;5(6):e2219128 (Jun 28). Doi: 10.1001/jamanetworkopen.2022.19128

Key clinical point: The risk for hemorrhage was not significantly different in patients with breast cancer (BC) aged ≥ 66 years who received direct oral anticoagulants (DOAC) concurrently with tamoxifen vs aromatase inhibitors (AI).

Major finding: During a median follow-up of 166 days, the risk for major hemorrhage requiring an emergency department visit or hospitalization (2.5% vs 3.3%; weighted hazard ratio [HR] 0.68; 95% CI 0.44-1.06) or any hemorrhage (4.9% vs 4.6%; weighted HR 1.04; 95% CI 0.75-1.43) was not higher with tamoxifen+DOAC compared with AI+DOAC.

Study details: Findings are from a population-based, retrospective cohort study including 4753 patients aged ≥ 66 years with BC who were prescribed tamoxifen or AI concurrently with a DOAC.

Disclosures: This study was supported by Canadian Institutes of Health Research and ICES. Some authors declared serving on advisory boards of or receiving grants, personal fees, or travel expenses from several sources.

Source: Wang T-F et al. Hemorrhage risk among patients with breast cancer receiving concurrent direct oral anticoagulants with tamoxifen vs aromatase inhibitors. JAMA Netw Open. 2022;5(6):e2219128 (Jun 28). Doi: 10.1001/jamanetworkopen.2022.19128

Key clinical point: The risk for hemorrhage was not significantly different in patients with breast cancer (BC) aged ≥ 66 years who received direct oral anticoagulants (DOAC) concurrently with tamoxifen vs aromatase inhibitors (AI).

Major finding: During a median follow-up of 166 days, the risk for major hemorrhage requiring an emergency department visit or hospitalization (2.5% vs 3.3%; weighted hazard ratio [HR] 0.68; 95% CI 0.44-1.06) or any hemorrhage (4.9% vs 4.6%; weighted HR 1.04; 95% CI 0.75-1.43) was not higher with tamoxifen+DOAC compared with AI+DOAC.

Study details: Findings are from a population-based, retrospective cohort study including 4753 patients aged ≥ 66 years with BC who were prescribed tamoxifen or AI concurrently with a DOAC.

Disclosures: This study was supported by Canadian Institutes of Health Research and ICES. Some authors declared serving on advisory boards of or receiving grants, personal fees, or travel expenses from several sources.

Source: Wang T-F et al. Hemorrhage risk among patients with breast cancer receiving concurrent direct oral anticoagulants with tamoxifen vs aromatase inhibitors. JAMA Netw Open. 2022;5(6):e2219128 (Jun 28). Doi: 10.1001/jamanetworkopen.2022.19128

Key clinical point: Digital breast tomosynthesis (DBT) reduced the likelihood of advanced breast cancer (BC) diagnosis compared with digital mammography in women with extremely dense breasts and a high risk for BC.

Major finding: Overall screening outcomes per 1000 examinations were similar with DBT vs digital mammography for interval invasive cancer (difference −0.04; 95% CI −0.14 to 0.06); however, the advanced cancer detection rate was lower in women with extremely dense breasts and a high BC risk (difference −0.53; 95% CI −0.97 to −0.10).

Study details: Findings are from a cohort study including 504,427 women with no history of BC or mastectomy who underwent 1,003,900 digital mammography screening examinations or 374,002 DBT screening examinations.

Disclosures: This study was funded by Patient-Centered Outcomes Research Institute, National Cancer Institute, and other sources. Some authors declared receiving grants, consulting fees, or royalties from or serving as consultants or on the editorial board for several sources.

Source: Kerlikowske K et al. Association of screening with digital breast tomosynthesis vs digital mammography with risk of interval invasive and advanced breast cancer. JAMA. 2022;327(22):2220–2230 (Jun 14). Doi: 10.1001/jama.2022.7672

Key clinical point: Digital breast tomosynthesis (DBT) reduced the likelihood of advanced breast cancer (BC) diagnosis compared with digital mammography in women with extremely dense breasts and a high risk for BC.

Major finding: Overall screening outcomes per 1000 examinations were similar with DBT vs digital mammography for interval invasive cancer (difference −0.04; 95% CI −0.14 to 0.06); however, the advanced cancer detection rate was lower in women with extremely dense breasts and a high BC risk (difference −0.53; 95% CI −0.97 to −0.10).

Study details: Findings are from a cohort study including 504,427 women with no history of BC or mastectomy who underwent 1,003,900 digital mammography screening examinations or 374,002 DBT screening examinations.

Disclosures: This study was funded by Patient-Centered Outcomes Research Institute, National Cancer Institute, and other sources. Some authors declared receiving grants, consulting fees, or royalties from or serving as consultants or on the editorial board for several sources.

Source: Kerlikowske K et al. Association of screening with digital breast tomosynthesis vs digital mammography with risk of interval invasive and advanced breast cancer. JAMA. 2022;327(22):2220–2230 (Jun 14). Doi: 10.1001/jama.2022.7672

Key clinical point: Digital breast tomosynthesis (DBT) reduced the likelihood of advanced breast cancer (BC) diagnosis compared with digital mammography in women with extremely dense breasts and a high risk for BC.

Major finding: Overall screening outcomes per 1000 examinations were similar with DBT vs digital mammography for interval invasive cancer (difference −0.04; 95% CI −0.14 to 0.06); however, the advanced cancer detection rate was lower in women with extremely dense breasts and a high BC risk (difference −0.53; 95% CI −0.97 to −0.10).

Study details: Findings are from a cohort study including 504,427 women with no history of BC or mastectomy who underwent 1,003,900 digital mammography screening examinations or 374,002 DBT screening examinations.

Disclosures: This study was funded by Patient-Centered Outcomes Research Institute, National Cancer Institute, and other sources. Some authors declared receiving grants, consulting fees, or royalties from or serving as consultants or on the editorial board for several sources.

Source: Kerlikowske K et al. Association of screening with digital breast tomosynthesis vs digital mammography with risk of interval invasive and advanced breast cancer. JAMA. 2022;327(22):2220–2230 (Jun 14). Doi: 10.1001/jama.2022.7672

Key clinical point: Trastuzumab deruxtecan vs physician’s choice of chemotherapy reduced the risk for disease progression or death by ~50% in previously treated patients with human epidermal growth factor receptor-2 (HER2)-low metastatic breast cancer (BC).

Major finding: Trastuzumab deruxtecan vs chemotherapy significantly improved the median progression-free survival in the overall cohort of patients (hazard ratio for disease progression/death [HR] 0.50; P < .001), irrespective of the hormone-receptor status (positive: HR 0.51; P < .001, or negative: HR 0.46; 95% CI 0.24-0.89). The incidence of grade ≥3 adverse events was 52.6% with trastuzumab deruxtecan and 67.4% with chemotherapy.

Study details: Findings are from the phase 3 DESTINY-Breast04 study including 557 patients with HER2-low metastatic BC who were previously treated with 1 or 2 lines of chemotherapy and were randomly assigned to receive trastuzumab deruxtecan or physician’s choice of chemotherapy.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daiichi Sankyo, and the other authors reported ties with various sources, including AstraZeneca and Daiichi Sankyo.

Source: Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-20 (Jun 5). Doi: 10.1056/NEJMoa2203690

Key clinical point: Trastuzumab deruxtecan vs physician’s choice of chemotherapy reduced the risk for disease progression or death by ~50% in previously treated patients with human epidermal growth factor receptor-2 (HER2)-low metastatic breast cancer (BC).

Major finding: Trastuzumab deruxtecan vs chemotherapy significantly improved the median progression-free survival in the overall cohort of patients (hazard ratio for disease progression/death [HR] 0.50; P < .001), irrespective of the hormone-receptor status (positive: HR 0.51; P < .001, or negative: HR 0.46; 95% CI 0.24-0.89). The incidence of grade ≥3 adverse events was 52.6% with trastuzumab deruxtecan and 67.4% with chemotherapy.

Study details: Findings are from the phase 3 DESTINY-Breast04 study including 557 patients with HER2-low metastatic BC who were previously treated with 1 or 2 lines of chemotherapy and were randomly assigned to receive trastuzumab deruxtecan or physician’s choice of chemotherapy.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daiichi Sankyo, and the other authors reported ties with various sources, including AstraZeneca and Daiichi Sankyo.

Source: Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-20 (Jun 5). Doi: 10.1056/NEJMoa2203690

Key clinical point: Trastuzumab deruxtecan vs physician’s choice of chemotherapy reduced the risk for disease progression or death by ~50% in previously treated patients with human epidermal growth factor receptor-2 (HER2)-low metastatic breast cancer (BC).

Major finding: Trastuzumab deruxtecan vs chemotherapy significantly improved the median progression-free survival in the overall cohort of patients (hazard ratio for disease progression/death [HR] 0.50; P < .001), irrespective of the hormone-receptor status (positive: HR 0.51; P < .001, or negative: HR 0.46; 95% CI 0.24-0.89). The incidence of grade ≥3 adverse events was 52.6% with trastuzumab deruxtecan and 67.4% with chemotherapy.

Study details: Findings are from the phase 3 DESTINY-Breast04 study including 557 patients with HER2-low metastatic BC who were previously treated with 1 or 2 lines of chemotherapy and were randomly assigned to receive trastuzumab deruxtecan or physician’s choice of chemotherapy.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daiichi Sankyo, and the other authors reported ties with various sources, including AstraZeneca and Daiichi Sankyo.

Source: Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-20 (Jun 5). Doi: 10.1056/NEJMoa2203690

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

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

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

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

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

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

Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.

IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.

Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.

“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.

“Our findings, if proven causal, suggest reduced consumption of sugar-sweetened beverages as a strategy for prevention of IBD, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.

The study was published online in Alimentary Pharmacology and Therapeutics.
 

Link significant for Crohn’s disease but not ulcerative colitis

The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.

Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.

While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.

During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).

Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.

The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.

They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.

Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.

A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.

Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
 

Study adds to previous evidence

Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.

“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.

His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.

Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.

However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.

Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.

The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.

The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.

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

Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.

IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.

Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.

“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.

“Our findings, if proven causal, suggest reduced consumption of sugar-sweetened beverages as a strategy for prevention of IBD, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.

The study was published online in Alimentary Pharmacology and Therapeutics.
 

Link significant for Crohn’s disease but not ulcerative colitis

The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.

Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.

While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.

During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).

Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.

The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.

They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.

Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.

A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.

Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
 

Study adds to previous evidence

Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.

“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.

His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.

Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.

However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.

Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.

The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.

The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.

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

Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.

IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.

Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.

“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.

“Our findings, if proven causal, suggest reduced consumption of sugar-sweetened beverages as a strategy for prevention of IBD, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.

The study was published online in Alimentary Pharmacology and Therapeutics.
 

Link significant for Crohn’s disease but not ulcerative colitis

The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.

Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.

While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.

During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).

Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.

The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.

They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.

Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.

A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.

Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
 

Study adds to previous evidence

Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.

“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.

His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.

Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.

However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.

Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.

The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.

The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.

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