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Immune checkpoint inhibitors and regorafenib combo shows promising efficacy in MSS CRC
Key clinical point: The combination of immune checkpoint inhibitors (ICIs) with regorafenib showed promising efficacy in chemotherapy-refractory microsatellite stable (MSS) colorectal cancer (CRC).
Major finding: Overall, 5% and 45% of patients achieved partial response and stable disease as the best response, respectively. The median overall survival and progression-free survival (PFS) were 17.3 months (95% CI, 11.3-not reached) and 3.1 months (95% CI, 2.3-4.2), respectively, with 13% of patients achieving PFS of ≥6 months. Grade 3 or higher treatment-related adverse events were reported by 19% of patients.
Study details: Findings are from a retrospective analysis of 84 patients with chemotherapy-refractory advanced or metastatic MSS CRC who received at least 1 dose of ICIs combined with regorafenib.
Disclosures: This work was supported by grants from the National Natural Science Foundation of China and CAMS Innovation Fund for Medical Sciences. The authors declare no conflict of interests.
Source: Yang K et al. Cancer Immunol Immunother. 2021 Oct 24. doi: 10.1007/s00262-021-03083-3.
Key clinical point: The combination of immune checkpoint inhibitors (ICIs) with regorafenib showed promising efficacy in chemotherapy-refractory microsatellite stable (MSS) colorectal cancer (CRC).
Major finding: Overall, 5% and 45% of patients achieved partial response and stable disease as the best response, respectively. The median overall survival and progression-free survival (PFS) were 17.3 months (95% CI, 11.3-not reached) and 3.1 months (95% CI, 2.3-4.2), respectively, with 13% of patients achieving PFS of ≥6 months. Grade 3 or higher treatment-related adverse events were reported by 19% of patients.
Study details: Findings are from a retrospective analysis of 84 patients with chemotherapy-refractory advanced or metastatic MSS CRC who received at least 1 dose of ICIs combined with regorafenib.
Disclosures: This work was supported by grants from the National Natural Science Foundation of China and CAMS Innovation Fund for Medical Sciences. The authors declare no conflict of interests.
Source: Yang K et al. Cancer Immunol Immunother. 2021 Oct 24. doi: 10.1007/s00262-021-03083-3.
Key clinical point: The combination of immune checkpoint inhibitors (ICIs) with regorafenib showed promising efficacy in chemotherapy-refractory microsatellite stable (MSS) colorectal cancer (CRC).
Major finding: Overall, 5% and 45% of patients achieved partial response and stable disease as the best response, respectively. The median overall survival and progression-free survival (PFS) were 17.3 months (95% CI, 11.3-not reached) and 3.1 months (95% CI, 2.3-4.2), respectively, with 13% of patients achieving PFS of ≥6 months. Grade 3 or higher treatment-related adverse events were reported by 19% of patients.
Study details: Findings are from a retrospective analysis of 84 patients with chemotherapy-refractory advanced or metastatic MSS CRC who received at least 1 dose of ICIs combined with regorafenib.
Disclosures: This work was supported by grants from the National Natural Science Foundation of China and CAMS Innovation Fund for Medical Sciences. The authors declare no conflict of interests.
Source: Yang K et al. Cancer Immunol Immunother. 2021 Oct 24. doi: 10.1007/s00262-021-03083-3.
Complications and outcomes of different management pathways of CRC and synchronous liver metastases
Key clinical point: Management of colorectal cancer (CRC) and synchronous liver metastases with staged liver-first or bowel-first routes or synchronous combined liver and bowel surgery, all with contemporary systemic chemotherapy, led to similar perioperative complications and oncological outcomes.
Major finding: Postoperative complications (P = .66), total critical care occupancy (P = .92) and mean total inpatient stay (P = .91) were similar between synchronous and staged management pathways. Overall, 35% of patients were disease-free at 12 months, with no difference between groups (P = .448).
Study details: Findings are from CoSMIC, a prospective inception cohort study including 125 patients with CRC and synchronous liver metastases.
Disclosures: AKC Chan was supported by a grant from the Dickinson Trust.
Source: Chan AKC et al. Ann Surg Oncol. 2021 Oct 30. doi: 10.1245/s10434-021-11017-7.
Key clinical point: Management of colorectal cancer (CRC) and synchronous liver metastases with staged liver-first or bowel-first routes or synchronous combined liver and bowel surgery, all with contemporary systemic chemotherapy, led to similar perioperative complications and oncological outcomes.
Major finding: Postoperative complications (P = .66), total critical care occupancy (P = .92) and mean total inpatient stay (P = .91) were similar between synchronous and staged management pathways. Overall, 35% of patients were disease-free at 12 months, with no difference between groups (P = .448).
Study details: Findings are from CoSMIC, a prospective inception cohort study including 125 patients with CRC and synchronous liver metastases.
Disclosures: AKC Chan was supported by a grant from the Dickinson Trust.
Source: Chan AKC et al. Ann Surg Oncol. 2021 Oct 30. doi: 10.1245/s10434-021-11017-7.
Key clinical point: Management of colorectal cancer (CRC) and synchronous liver metastases with staged liver-first or bowel-first routes or synchronous combined liver and bowel surgery, all with contemporary systemic chemotherapy, led to similar perioperative complications and oncological outcomes.
Major finding: Postoperative complications (P = .66), total critical care occupancy (P = .92) and mean total inpatient stay (P = .91) were similar between synchronous and staged management pathways. Overall, 35% of patients were disease-free at 12 months, with no difference between groups (P = .448).
Study details: Findings are from CoSMIC, a prospective inception cohort study including 125 patients with CRC and synchronous liver metastases.
Disclosures: AKC Chan was supported by a grant from the Dickinson Trust.
Source: Chan AKC et al. Ann Surg Oncol. 2021 Oct 30. doi: 10.1245/s10434-021-11017-7.
Preoperative SCRT with subsequent CAPOX and camrelizumab shows promise in locally advanced rectal cancer
Key clinical point: Short-course radiotherapy (SCRT) combined with subsequent capecitabine plus oxaliplatin (CAPOX) and camrelizumab followed by delayed surgery showed remarkable pathological complete response (pCR) with manageable toxicity in patients with locally advanced rectal cancer (LARC).
Major finding: Overall, 48.1% of patients, including 46.2% patients with proficient mismatch repair tumors and 100% of patients with deficient mismatch repair tumors, achieved pCR. All immune-related adverse events were of grade 1-2, with the most common being reactive cutaneous capillary endothelial proliferation (81.5%).
Study details: Findings are from a single-arm, phase 2 trial including 30 patients with LARC, of which 27 received preoperative SCRT combined with subsequent CAPOX and camrelizumab followed by radical surgery after 1 week.
Disclosures: This work was supported by the Ministry of Science and Technology of China, 2018 National Natural Science Foundation of China, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. T Zhang declared receiving research funding from and Z Hou and C Ma declared being employees of Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Source: Lin Z et al. J Immunother Cancer. 2021 Nov 1. doi: 10.1136/jitc-2021-003554.
Key clinical point: Short-course radiotherapy (SCRT) combined with subsequent capecitabine plus oxaliplatin (CAPOX) and camrelizumab followed by delayed surgery showed remarkable pathological complete response (pCR) with manageable toxicity in patients with locally advanced rectal cancer (LARC).
Major finding: Overall, 48.1% of patients, including 46.2% patients with proficient mismatch repair tumors and 100% of patients with deficient mismatch repair tumors, achieved pCR. All immune-related adverse events were of grade 1-2, with the most common being reactive cutaneous capillary endothelial proliferation (81.5%).
Study details: Findings are from a single-arm, phase 2 trial including 30 patients with LARC, of which 27 received preoperative SCRT combined with subsequent CAPOX and camrelizumab followed by radical surgery after 1 week.
Disclosures: This work was supported by the Ministry of Science and Technology of China, 2018 National Natural Science Foundation of China, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. T Zhang declared receiving research funding from and Z Hou and C Ma declared being employees of Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Source: Lin Z et al. J Immunother Cancer. 2021 Nov 1. doi: 10.1136/jitc-2021-003554.
Key clinical point: Short-course radiotherapy (SCRT) combined with subsequent capecitabine plus oxaliplatin (CAPOX) and camrelizumab followed by delayed surgery showed remarkable pathological complete response (pCR) with manageable toxicity in patients with locally advanced rectal cancer (LARC).
Major finding: Overall, 48.1% of patients, including 46.2% patients with proficient mismatch repair tumors and 100% of patients with deficient mismatch repair tumors, achieved pCR. All immune-related adverse events were of grade 1-2, with the most common being reactive cutaneous capillary endothelial proliferation (81.5%).
Study details: Findings are from a single-arm, phase 2 trial including 30 patients with LARC, of which 27 received preoperative SCRT combined with subsequent CAPOX and camrelizumab followed by radical surgery after 1 week.
Disclosures: This work was supported by the Ministry of Science and Technology of China, 2018 National Natural Science Foundation of China, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. T Zhang declared receiving research funding from and Z Hou and C Ma declared being employees of Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Source: Lin Z et al. J Immunother Cancer. 2021 Nov 1. doi: 10.1136/jitc-2021-003554.
Higher intake of preserved vegetables and colorectal polyps: What is the link?
Key clinical point: Higher consumption of preserved vegetables was associated with an increased prevalence of colorectal polyps as a precursor lesion of colorectal cancer (CRC), particularly small polyps in a population at high risk for CRC.
Major finding: Consumption of preserved vegetables was associated with an 18% higher prevalence of colorectal polyps (adjusted odds ratio highest vs lowest quartile [aORQ4 vs Q1], 1.18; P trend = .02) and 17% higher prevalence of small polyps (aORQ4 vs Q1, 1.17; P trend = .03).
Study details: Findings are from a survey analysis of 6,783 respondents from Lanxi Pre-colorectal Cancer Cohort who were at high risk for CRC.
Disclosures: This study was supported by Lanxi Municipal Government funds. The authors declared no conflict of interests.
Source: Wu F et al. Eur J Nutr. 2021 Nov 8. doi: 10.1007/s00394-021-02719-5.
Key clinical point: Higher consumption of preserved vegetables was associated with an increased prevalence of colorectal polyps as a precursor lesion of colorectal cancer (CRC), particularly small polyps in a population at high risk for CRC.
Major finding: Consumption of preserved vegetables was associated with an 18% higher prevalence of colorectal polyps (adjusted odds ratio highest vs lowest quartile [aORQ4 vs Q1], 1.18; P trend = .02) and 17% higher prevalence of small polyps (aORQ4 vs Q1, 1.17; P trend = .03).
Study details: Findings are from a survey analysis of 6,783 respondents from Lanxi Pre-colorectal Cancer Cohort who were at high risk for CRC.
Disclosures: This study was supported by Lanxi Municipal Government funds. The authors declared no conflict of interests.
Source: Wu F et al. Eur J Nutr. 2021 Nov 8. doi: 10.1007/s00394-021-02719-5.
Key clinical point: Higher consumption of preserved vegetables was associated with an increased prevalence of colorectal polyps as a precursor lesion of colorectal cancer (CRC), particularly small polyps in a population at high risk for CRC.
Major finding: Consumption of preserved vegetables was associated with an 18% higher prevalence of colorectal polyps (adjusted odds ratio highest vs lowest quartile [aORQ4 vs Q1], 1.18; P trend = .02) and 17% higher prevalence of small polyps (aORQ4 vs Q1, 1.17; P trend = .03).
Study details: Findings are from a survey analysis of 6,783 respondents from Lanxi Pre-colorectal Cancer Cohort who were at high risk for CRC.
Disclosures: This study was supported by Lanxi Municipal Government funds. The authors declared no conflict of interests.
Source: Wu F et al. Eur J Nutr. 2021 Nov 8. doi: 10.1007/s00394-021-02719-5.
Young age tied with higher risk for relapse in high-risk stage III CRC
Key clinical point: Patients with stage III early-onset colorectal cancer (EO-CRC) experienced more frequent disease recurrence and cancer-specific mortality than patients with late-onset CRC (LO-CRC), suggesting more aggressive disease biology.
Major finding: Despite a higher likelihood of receiving more aggressive treatment and completing planned 6-month therapy duration (P < .001), patients with stage III EO-CRC vs LO-CRC had a significantly lower 3-year relapse-free rate (hazard ratio [HR], 1.21; P = .003) and higher 5-year cancer-specific mortality rate (HR, 1.20; P = .03).
Study details: This was a pooled analysis of 16,349 patients with CRC from 6 clinical trials of adjuvant chemotherapy including 1,564 patients with EO-CRC and 14,785 with LO-CRC.
Disclosures: This study was supported by European Organisation for Research and Treatment of Cancer, Japanese Foundation for Multidisciplinary Treatment of Cancer, and others. The authors declared receiving honoraria, research funding, consulting or advisory role, travel, accommodation expenses, stock, and other ownership interests from various sources.
Source: Fontana E et al. J Clin Oncol. 2021 Nov 9. doi: 10.1200/JCO.21.02008.
Key clinical point: Patients with stage III early-onset colorectal cancer (EO-CRC) experienced more frequent disease recurrence and cancer-specific mortality than patients with late-onset CRC (LO-CRC), suggesting more aggressive disease biology.
Major finding: Despite a higher likelihood of receiving more aggressive treatment and completing planned 6-month therapy duration (P < .001), patients with stage III EO-CRC vs LO-CRC had a significantly lower 3-year relapse-free rate (hazard ratio [HR], 1.21; P = .003) and higher 5-year cancer-specific mortality rate (HR, 1.20; P = .03).
Study details: This was a pooled analysis of 16,349 patients with CRC from 6 clinical trials of adjuvant chemotherapy including 1,564 patients with EO-CRC and 14,785 with LO-CRC.
Disclosures: This study was supported by European Organisation for Research and Treatment of Cancer, Japanese Foundation for Multidisciplinary Treatment of Cancer, and others. The authors declared receiving honoraria, research funding, consulting or advisory role, travel, accommodation expenses, stock, and other ownership interests from various sources.
Source: Fontana E et al. J Clin Oncol. 2021 Nov 9. doi: 10.1200/JCO.21.02008.
Key clinical point: Patients with stage III early-onset colorectal cancer (EO-CRC) experienced more frequent disease recurrence and cancer-specific mortality than patients with late-onset CRC (LO-CRC), suggesting more aggressive disease biology.
Major finding: Despite a higher likelihood of receiving more aggressive treatment and completing planned 6-month therapy duration (P < .001), patients with stage III EO-CRC vs LO-CRC had a significantly lower 3-year relapse-free rate (hazard ratio [HR], 1.21; P = .003) and higher 5-year cancer-specific mortality rate (HR, 1.20; P = .03).
Study details: This was a pooled analysis of 16,349 patients with CRC from 6 clinical trials of adjuvant chemotherapy including 1,564 patients with EO-CRC and 14,785 with LO-CRC.
Disclosures: This study was supported by European Organisation for Research and Treatment of Cancer, Japanese Foundation for Multidisciplinary Treatment of Cancer, and others. The authors declared receiving honoraria, research funding, consulting or advisory role, travel, accommodation expenses, stock, and other ownership interests from various sources.
Source: Fontana E et al. J Clin Oncol. 2021 Nov 9. doi: 10.1200/JCO.21.02008.
Simultaneous colectomy and HAIP placement safe in liver metastases of colon carcinoma
Key clinical point: Simultaneous resection of primary colonic tumor and hepatic arterial infusion pump (HAIP) implantation are safe in patients with colon cancer and synchronous liver metastases.
Major finding: Grade 3-4 complications were similar between patients who underwent simultaneous colectomy and HAIP placement vs prior colectomy (P = .872), whereas grade 1-2 complications (36.8% vs 19.0%; P < .001) and the rate for surgical site infection (25.6% vs14.7%; P = .022) were significantly higher with simultaneous colectomy and HAIP placement. The median time from pump placement to the start of HAIP chemotherapy was not different between the groups (P = .924).
Study details: Findings are from a retrospective analysis of 398 patients with colon cancer and synchronous liver metastases who underwent resection of the primary colon tumor either simultaneous with HAIP placement (n=258) or prior to HAIP placement (n=116).
Disclosures: This study was partly supported by National Cancer Institute. J Garcia-Aguilar declared receiving honoraria from Johnson & Johnson, Medtronic, and Intuitive Inc.
Source: Verheij FS et al. Ann Surg Oncol. 2021 Nov 9. doi: 10.1245/s10434-021-11029-3.
Key clinical point: Simultaneous resection of primary colonic tumor and hepatic arterial infusion pump (HAIP) implantation are safe in patients with colon cancer and synchronous liver metastases.
Major finding: Grade 3-4 complications were similar between patients who underwent simultaneous colectomy and HAIP placement vs prior colectomy (P = .872), whereas grade 1-2 complications (36.8% vs 19.0%; P < .001) and the rate for surgical site infection (25.6% vs14.7%; P = .022) were significantly higher with simultaneous colectomy and HAIP placement. The median time from pump placement to the start of HAIP chemotherapy was not different between the groups (P = .924).
Study details: Findings are from a retrospective analysis of 398 patients with colon cancer and synchronous liver metastases who underwent resection of the primary colon tumor either simultaneous with HAIP placement (n=258) or prior to HAIP placement (n=116).
Disclosures: This study was partly supported by National Cancer Institute. J Garcia-Aguilar declared receiving honoraria from Johnson & Johnson, Medtronic, and Intuitive Inc.
Source: Verheij FS et al. Ann Surg Oncol. 2021 Nov 9. doi: 10.1245/s10434-021-11029-3.
Key clinical point: Simultaneous resection of primary colonic tumor and hepatic arterial infusion pump (HAIP) implantation are safe in patients with colon cancer and synchronous liver metastases.
Major finding: Grade 3-4 complications were similar between patients who underwent simultaneous colectomy and HAIP placement vs prior colectomy (P = .872), whereas grade 1-2 complications (36.8% vs 19.0%; P < .001) and the rate for surgical site infection (25.6% vs14.7%; P = .022) were significantly higher with simultaneous colectomy and HAIP placement. The median time from pump placement to the start of HAIP chemotherapy was not different between the groups (P = .924).
Study details: Findings are from a retrospective analysis of 398 patients with colon cancer and synchronous liver metastases who underwent resection of the primary colon tumor either simultaneous with HAIP placement (n=258) or prior to HAIP placement (n=116).
Disclosures: This study was partly supported by National Cancer Institute. J Garcia-Aguilar declared receiving honoraria from Johnson & Johnson, Medtronic, and Intuitive Inc.
Source: Verheij FS et al. Ann Surg Oncol. 2021 Nov 9. doi: 10.1245/s10434-021-11029-3.
A single flexible sigmoidoscopy shows strong protective effect for CRC incidence and mortality
Key clinical point: A single flexible sigmoidoscopy (FS) at the age of 55-64 years substantially reduced the risk for colorectal cancer (CRC) incidence and CRC-related mortality, which was maintained up to 15 and 19 years, respectively.
Major finding: CRC incidence and CRC mortality reduced by 19% (rate ratio [RR], 0.81; 95% CI, 0.71-0.93) and 22% (RR, 0.78; 95% CI, 0.61-0.98), respectively, in the group that underwent FS vs usual care, with the reduction mainly driven by a reduced incidence of distal CRC (RR, 0.70; 95% CI, 0.59-0.84) and distal CRC mortality (RR, 0.69; 95% CI, 0.50-0.95).
Study details: Findings are from SCORE randomized control trial including 34,272 participants who expressed interest in having FS and were randomly assigned to FS (n=17,136) or usual care (n=17,136) groups.
Disclosures: The trial was supported by Italian Association for Cancer Research, Italian National Research Council, and others. C Semore declared receiving research funding, travel support, and paid/unpaid leadership or fiduciary role for various sources.
Source: Senore C et al. Ann Intern Med. 2021 Nov 9. doi: 10.7326/M21-0977.
Key clinical point: A single flexible sigmoidoscopy (FS) at the age of 55-64 years substantially reduced the risk for colorectal cancer (CRC) incidence and CRC-related mortality, which was maintained up to 15 and 19 years, respectively.
Major finding: CRC incidence and CRC mortality reduced by 19% (rate ratio [RR], 0.81; 95% CI, 0.71-0.93) and 22% (RR, 0.78; 95% CI, 0.61-0.98), respectively, in the group that underwent FS vs usual care, with the reduction mainly driven by a reduced incidence of distal CRC (RR, 0.70; 95% CI, 0.59-0.84) and distal CRC mortality (RR, 0.69; 95% CI, 0.50-0.95).
Study details: Findings are from SCORE randomized control trial including 34,272 participants who expressed interest in having FS and were randomly assigned to FS (n=17,136) or usual care (n=17,136) groups.
Disclosures: The trial was supported by Italian Association for Cancer Research, Italian National Research Council, and others. C Semore declared receiving research funding, travel support, and paid/unpaid leadership or fiduciary role for various sources.
Source: Senore C et al. Ann Intern Med. 2021 Nov 9. doi: 10.7326/M21-0977.
Key clinical point: A single flexible sigmoidoscopy (FS) at the age of 55-64 years substantially reduced the risk for colorectal cancer (CRC) incidence and CRC-related mortality, which was maintained up to 15 and 19 years, respectively.
Major finding: CRC incidence and CRC mortality reduced by 19% (rate ratio [RR], 0.81; 95% CI, 0.71-0.93) and 22% (RR, 0.78; 95% CI, 0.61-0.98), respectively, in the group that underwent FS vs usual care, with the reduction mainly driven by a reduced incidence of distal CRC (RR, 0.70; 95% CI, 0.59-0.84) and distal CRC mortality (RR, 0.69; 95% CI, 0.50-0.95).
Study details: Findings are from SCORE randomized control trial including 34,272 participants who expressed interest in having FS and were randomly assigned to FS (n=17,136) or usual care (n=17,136) groups.
Disclosures: The trial was supported by Italian Association for Cancer Research, Italian National Research Council, and others. C Semore declared receiving research funding, travel support, and paid/unpaid leadership or fiduciary role for various sources.
Source: Senore C et al. Ann Intern Med. 2021 Nov 9. doi: 10.7326/M21-0977.
Sleep-related hypoxia and COVID-19 outcomes
Key clinical point: Sleep-related hypoxia is associated with worse outcomes in patients with COVID-19.
Major finding: Sleep-related hypoxia was associated with an increased risk for COVID-19-related hospitalization and mortality (adjusted hazard ratio, 1.31; 95% CI, 1.08-1.57; P = .005).
Study details: The data come from a case-control study involving 5,402 individuals who had previously participated in a sleep study, of whom 1,935 tested positive for SARS-CoV-2.
Disclosures: The study was supported by the Neuroscience Transformative Research Resource Development Award (R Mehra). A Milinovich reported ties with various pharmaceutical companies and research organizations. L Aboussouan, L Jehi, R Mehra, and C Pena Orbea reported ties with research organizations and/or publishing companies. The remaining authors declared no competing interests.
Source: Pena Orbea C et al. JAMA Netw Open. 2021 Nov 10. doi: 10.1001/jamanetworkopen.2021.34241.
Key clinical point: Sleep-related hypoxia is associated with worse outcomes in patients with COVID-19.
Major finding: Sleep-related hypoxia was associated with an increased risk for COVID-19-related hospitalization and mortality (adjusted hazard ratio, 1.31; 95% CI, 1.08-1.57; P = .005).
Study details: The data come from a case-control study involving 5,402 individuals who had previously participated in a sleep study, of whom 1,935 tested positive for SARS-CoV-2.
Disclosures: The study was supported by the Neuroscience Transformative Research Resource Development Award (R Mehra). A Milinovich reported ties with various pharmaceutical companies and research organizations. L Aboussouan, L Jehi, R Mehra, and C Pena Orbea reported ties with research organizations and/or publishing companies. The remaining authors declared no competing interests.
Source: Pena Orbea C et al. JAMA Netw Open. 2021 Nov 10. doi: 10.1001/jamanetworkopen.2021.34241.
Key clinical point: Sleep-related hypoxia is associated with worse outcomes in patients with COVID-19.
Major finding: Sleep-related hypoxia was associated with an increased risk for COVID-19-related hospitalization and mortality (adjusted hazard ratio, 1.31; 95% CI, 1.08-1.57; P = .005).
Study details: The data come from a case-control study involving 5,402 individuals who had previously participated in a sleep study, of whom 1,935 tested positive for SARS-CoV-2.
Disclosures: The study was supported by the Neuroscience Transformative Research Resource Development Award (R Mehra). A Milinovich reported ties with various pharmaceutical companies and research organizations. L Aboussouan, L Jehi, R Mehra, and C Pena Orbea reported ties with research organizations and/or publishing companies. The remaining authors declared no competing interests.
Source: Pena Orbea C et al. JAMA Netw Open. 2021 Nov 10. doi: 10.1001/jamanetworkopen.2021.34241.
Real-world effectiveness of J&J's COVID-19 vaccine
Key clinical point: Johnson & Johnson's (J&J) adenoviral vector COVID-19 vaccine (Ad26.COV) was effective in preventing COVID-19 and severe outcomes in a real-world setting.
Major finding: The incidence rate ratio of COVID-19 in the Ad26.COV-vaccinated vs unvaccinated cohort was 0.26 (95% CI, 0.20-0.34), corresponding to an effectiveness of 73.6% (95% CI, 65.9%-79.9%). Ad26.COV recipients also had a lower risk for hospitalization (odds ratio [OR], 0.32; P = .00028) and ICU admissions (OR, 0.00; P = .001) compared with unvaccinated individuals.
Study details: The data come from an analysis of 8,889 individuals vaccinated with Ad26.COV and 88,898 unvaccinated matched controls.
Disclosures: No information on funding was available. J Corchado-Garcia, D Zemmour, T Hughes, P Lenehan, C Pawlowski, JC O’Horo, AD Badley, MD Swift, T Wagner, and V Soundararajan reported relationships with various pharmaceutical companies. The remaining authors declared no conflict of interests.
Source: Corchado-Garcia J et al. JAMA Netw Open. 2021 Nov 2. doi: 10.1001/jamanetworkopen.2021.32540.
Key clinical point: Johnson & Johnson's (J&J) adenoviral vector COVID-19 vaccine (Ad26.COV) was effective in preventing COVID-19 and severe outcomes in a real-world setting.
Major finding: The incidence rate ratio of COVID-19 in the Ad26.COV-vaccinated vs unvaccinated cohort was 0.26 (95% CI, 0.20-0.34), corresponding to an effectiveness of 73.6% (95% CI, 65.9%-79.9%). Ad26.COV recipients also had a lower risk for hospitalization (odds ratio [OR], 0.32; P = .00028) and ICU admissions (OR, 0.00; P = .001) compared with unvaccinated individuals.
Study details: The data come from an analysis of 8,889 individuals vaccinated with Ad26.COV and 88,898 unvaccinated matched controls.
Disclosures: No information on funding was available. J Corchado-Garcia, D Zemmour, T Hughes, P Lenehan, C Pawlowski, JC O’Horo, AD Badley, MD Swift, T Wagner, and V Soundararajan reported relationships with various pharmaceutical companies. The remaining authors declared no conflict of interests.
Source: Corchado-Garcia J et al. JAMA Netw Open. 2021 Nov 2. doi: 10.1001/jamanetworkopen.2021.32540.
Key clinical point: Johnson & Johnson's (J&J) adenoviral vector COVID-19 vaccine (Ad26.COV) was effective in preventing COVID-19 and severe outcomes in a real-world setting.
Major finding: The incidence rate ratio of COVID-19 in the Ad26.COV-vaccinated vs unvaccinated cohort was 0.26 (95% CI, 0.20-0.34), corresponding to an effectiveness of 73.6% (95% CI, 65.9%-79.9%). Ad26.COV recipients also had a lower risk for hospitalization (odds ratio [OR], 0.32; P = .00028) and ICU admissions (OR, 0.00; P = .001) compared with unvaccinated individuals.
Study details: The data come from an analysis of 8,889 individuals vaccinated with Ad26.COV and 88,898 unvaccinated matched controls.
Disclosures: No information on funding was available. J Corchado-Garcia, D Zemmour, T Hughes, P Lenehan, C Pawlowski, JC O’Horo, AD Badley, MD Swift, T Wagner, and V Soundararajan reported relationships with various pharmaceutical companies. The remaining authors declared no conflict of interests.
Source: Corchado-Garcia J et al. JAMA Netw Open. 2021 Nov 2. doi: 10.1001/jamanetworkopen.2021.32540.
Single-dose levilimab safe and effective in severe COVID-19
Key clinical point: A single subcutaneous dose of levilimab (LVL) was safe and effective in severely ill patients with COVID-19 not requiring mechanical ventilation.
Major finding: 63.1% of patients in the LVL group vs 42.7% in the placebo group achieved sustained clinical improvement on day 14 (P = .0017). Adverse event frequency was comparable between the groups.
Study details: In the phase 3 CORONA trial, 206 patients were randomly assigned (1:1) to receive either LVL+standard of care (SOC) vs placebo+SOC.
Disclosures: This study was funded by JSC BIOCAD. MY Gilyarov reported ties with various pharmaceutical companies. AI Seleznev, YN Linkova, EA Dokukina, PS Pukhtinskaia, AV Eremeeva, MA Morozova, AV Zinkina-Orikhan, and AA Lutckii are employees of JSC BIOCAD.
Source: Lomakin NV et al. Inflamm Res. 2021 Sep 29. doi: 10.1007/s00011-021-01507-5.
Key clinical point: A single subcutaneous dose of levilimab (LVL) was safe and effective in severely ill patients with COVID-19 not requiring mechanical ventilation.
Major finding: 63.1% of patients in the LVL group vs 42.7% in the placebo group achieved sustained clinical improvement on day 14 (P = .0017). Adverse event frequency was comparable between the groups.
Study details: In the phase 3 CORONA trial, 206 patients were randomly assigned (1:1) to receive either LVL+standard of care (SOC) vs placebo+SOC.
Disclosures: This study was funded by JSC BIOCAD. MY Gilyarov reported ties with various pharmaceutical companies. AI Seleznev, YN Linkova, EA Dokukina, PS Pukhtinskaia, AV Eremeeva, MA Morozova, AV Zinkina-Orikhan, and AA Lutckii are employees of JSC BIOCAD.
Source: Lomakin NV et al. Inflamm Res. 2021 Sep 29. doi: 10.1007/s00011-021-01507-5.
Key clinical point: A single subcutaneous dose of levilimab (LVL) was safe and effective in severely ill patients with COVID-19 not requiring mechanical ventilation.
Major finding: 63.1% of patients in the LVL group vs 42.7% in the placebo group achieved sustained clinical improvement on day 14 (P = .0017). Adverse event frequency was comparable between the groups.
Study details: In the phase 3 CORONA trial, 206 patients were randomly assigned (1:1) to receive either LVL+standard of care (SOC) vs placebo+SOC.
Disclosures: This study was funded by JSC BIOCAD. MY Gilyarov reported ties with various pharmaceutical companies. AI Seleznev, YN Linkova, EA Dokukina, PS Pukhtinskaia, AV Eremeeva, MA Morozova, AV Zinkina-Orikhan, and AA Lutckii are employees of JSC BIOCAD.
Source: Lomakin NV et al. Inflamm Res. 2021 Sep 29. doi: 10.1007/s00011-021-01507-5.