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Avoiding intensive chemotherapy due to older age alone is not advisable in mCRC
Key clinical point: Prognosis was similar among patients with metastatic colorectal cancer (mCRC) receiving intensive chemotherapy aged 80 years or older vs. those younger than 80 years. These findings do not recommend avoiding intensive chemotherapy for patients with mCRC only because of older age.
Major finding: Among patients who received intensive chemotherapy, the 5-year overall survival (OS) was comparable among those aged 80 years vs. those younger (13.6% vs. 21.4%; P = .58). Moreover, age of 80 years and older was not an independent risk factor for OS (adjusted hazard ratio, 1.29; 95% confidence interval, 0.84-2.00).
Study details: Findings are from a population-based cohort study of 1,260 patients with mCRC. Patients were classified into those aged 80 years or older (n=234) or those younger than 80 years (n=1,026) during diagnosis.
Disclosures: There was no financial support for this research. The authors declared no conflicts of interest.
Source: Nakayama Y et al. Int J Clin Oncol. 2021 Jun 5. doi: 10.1007/s10147-021-01909-9.
Key clinical point: Prognosis was similar among patients with metastatic colorectal cancer (mCRC) receiving intensive chemotherapy aged 80 years or older vs. those younger than 80 years. These findings do not recommend avoiding intensive chemotherapy for patients with mCRC only because of older age.
Major finding: Among patients who received intensive chemotherapy, the 5-year overall survival (OS) was comparable among those aged 80 years vs. those younger (13.6% vs. 21.4%; P = .58). Moreover, age of 80 years and older was not an independent risk factor for OS (adjusted hazard ratio, 1.29; 95% confidence interval, 0.84-2.00).
Study details: Findings are from a population-based cohort study of 1,260 patients with mCRC. Patients were classified into those aged 80 years or older (n=234) or those younger than 80 years (n=1,026) during diagnosis.
Disclosures: There was no financial support for this research. The authors declared no conflicts of interest.
Source: Nakayama Y et al. Int J Clin Oncol. 2021 Jun 5. doi: 10.1007/s10147-021-01909-9.
Key clinical point: Prognosis was similar among patients with metastatic colorectal cancer (mCRC) receiving intensive chemotherapy aged 80 years or older vs. those younger than 80 years. These findings do not recommend avoiding intensive chemotherapy for patients with mCRC only because of older age.
Major finding: Among patients who received intensive chemotherapy, the 5-year overall survival (OS) was comparable among those aged 80 years vs. those younger (13.6% vs. 21.4%; P = .58). Moreover, age of 80 years and older was not an independent risk factor for OS (adjusted hazard ratio, 1.29; 95% confidence interval, 0.84-2.00).
Study details: Findings are from a population-based cohort study of 1,260 patients with mCRC. Patients were classified into those aged 80 years or older (n=234) or those younger than 80 years (n=1,026) during diagnosis.
Disclosures: There was no financial support for this research. The authors declared no conflicts of interest.
Source: Nakayama Y et al. Int J Clin Oncol. 2021 Jun 5. doi: 10.1007/s10147-021-01909-9.
Diagnostic efficacy of fecal immunochemical tests for assessment of suspected symptomatic CRC in primary care
Key clinical point: Implementation of fecal immunochemical tests (FIT) as a triage test during assessment of suspected symptomatic colorectal cancer (CRC) in primary care may improve the efficiency of referrals without missing cases of CRC.
Major finding: At a cutoff value of fecal hemoglobin (f-Hb) 150 μg Hb/g or higher, FIT identified more than half of CRC cases using few resources (sensitivity, 64.1%; specificity, 95.0%), whereas an f-Hb threshold of 20 μg Hb/g feces ruled out more than 85% of CRC (specificity, 86.6%; sensitivity 84.1%) at an expected prevalence of 1%-3%.
Study details: Findings are from a systematic review and meta-analysis of 22 studies including 69,536 symptomatic patients who consulted for abdominal symptoms in primary care.
Disclosures: This study was financed by Spain’s Carlos III Health Care Institute. The authors declared no conflicts of interest.
Source: Pin-Vieito N et al. Gut. 2021 Jun 9. doi: 10.1136/gutjnl-2021-324856.
Key clinical point: Implementation of fecal immunochemical tests (FIT) as a triage test during assessment of suspected symptomatic colorectal cancer (CRC) in primary care may improve the efficiency of referrals without missing cases of CRC.
Major finding: At a cutoff value of fecal hemoglobin (f-Hb) 150 μg Hb/g or higher, FIT identified more than half of CRC cases using few resources (sensitivity, 64.1%; specificity, 95.0%), whereas an f-Hb threshold of 20 μg Hb/g feces ruled out more than 85% of CRC (specificity, 86.6%; sensitivity 84.1%) at an expected prevalence of 1%-3%.
Study details: Findings are from a systematic review and meta-analysis of 22 studies including 69,536 symptomatic patients who consulted for abdominal symptoms in primary care.
Disclosures: This study was financed by Spain’s Carlos III Health Care Institute. The authors declared no conflicts of interest.
Source: Pin-Vieito N et al. Gut. 2021 Jun 9. doi: 10.1136/gutjnl-2021-324856.
Key clinical point: Implementation of fecal immunochemical tests (FIT) as a triage test during assessment of suspected symptomatic colorectal cancer (CRC) in primary care may improve the efficiency of referrals without missing cases of CRC.
Major finding: At a cutoff value of fecal hemoglobin (f-Hb) 150 μg Hb/g or higher, FIT identified more than half of CRC cases using few resources (sensitivity, 64.1%; specificity, 95.0%), whereas an f-Hb threshold of 20 μg Hb/g feces ruled out more than 85% of CRC (specificity, 86.6%; sensitivity 84.1%) at an expected prevalence of 1%-3%.
Study details: Findings are from a systematic review and meta-analysis of 22 studies including 69,536 symptomatic patients who consulted for abdominal symptoms in primary care.
Disclosures: This study was financed by Spain’s Carlos III Health Care Institute. The authors declared no conflicts of interest.
Source: Pin-Vieito N et al. Gut. 2021 Jun 9. doi: 10.1136/gutjnl-2021-324856.
FTD/TPI effective and well tolerated in elderly patients with advanced colorectal cancer
Key clinical point: Trifluridine/tipiracil (FTD/TPI) was effective and well tolerated in elderly patients with advanced colorectal cancer.
Major finding: Mean progression-free survival (PFS) was 2.3 (95% confidence interval [CI], 1.9-4.3) months, with the study meeting its predefined primary endpoint of PFS with the lower limit of 95% CI being more than 1.0 month. The median overall survival was 5.7 (95% CI, 3.7-8.9) months. Grade 3 or 4 adverse events were observed in 80% of patients, the most common being neutropenia, anemia, and anorexia.
Study details: Findings are from a single-arm phase 2 trial of 30 elderly patients aged 65 years or older who had fluoropyrimidine-refractory advanced colorectal cancer and received FTD/TPI.
Disclosures: This study was supported by the Tohoku Clinical Oncology Research and Education Society. M Takahashi and C Ishioka reported receiving lecture fees and/or funding from various sources. The remaining authors declared no conflicts of interest.
Source: Takahashi M et al. Cancer Chemother Pharmacol. 2021 May 24. doi: 10.1007/s00280-021-04277-3.
Key clinical point: Trifluridine/tipiracil (FTD/TPI) was effective and well tolerated in elderly patients with advanced colorectal cancer.
Major finding: Mean progression-free survival (PFS) was 2.3 (95% confidence interval [CI], 1.9-4.3) months, with the study meeting its predefined primary endpoint of PFS with the lower limit of 95% CI being more than 1.0 month. The median overall survival was 5.7 (95% CI, 3.7-8.9) months. Grade 3 or 4 adverse events were observed in 80% of patients, the most common being neutropenia, anemia, and anorexia.
Study details: Findings are from a single-arm phase 2 trial of 30 elderly patients aged 65 years or older who had fluoropyrimidine-refractory advanced colorectal cancer and received FTD/TPI.
Disclosures: This study was supported by the Tohoku Clinical Oncology Research and Education Society. M Takahashi and C Ishioka reported receiving lecture fees and/or funding from various sources. The remaining authors declared no conflicts of interest.
Source: Takahashi M et al. Cancer Chemother Pharmacol. 2021 May 24. doi: 10.1007/s00280-021-04277-3.
Key clinical point: Trifluridine/tipiracil (FTD/TPI) was effective and well tolerated in elderly patients with advanced colorectal cancer.
Major finding: Mean progression-free survival (PFS) was 2.3 (95% confidence interval [CI], 1.9-4.3) months, with the study meeting its predefined primary endpoint of PFS with the lower limit of 95% CI being more than 1.0 month. The median overall survival was 5.7 (95% CI, 3.7-8.9) months. Grade 3 or 4 adverse events were observed in 80% of patients, the most common being neutropenia, anemia, and anorexia.
Study details: Findings are from a single-arm phase 2 trial of 30 elderly patients aged 65 years or older who had fluoropyrimidine-refractory advanced colorectal cancer and received FTD/TPI.
Disclosures: This study was supported by the Tohoku Clinical Oncology Research and Education Society. M Takahashi and C Ishioka reported receiving lecture fees and/or funding from various sources. The remaining authors declared no conflicts of interest.
Source: Takahashi M et al. Cancer Chemother Pharmacol. 2021 May 24. doi: 10.1007/s00280-021-04277-3.
Dietary vitamin D intake tied to lower risk for colorectal cancer in patients at high CV risk
Key clinical point: A higher dietary vitamin D intake was associated with reduced risk for colorectal cancer (CRC) and colon cancer in older individuals at high cardiovascular (CV) risk.
Major finding: After excluding individuals consuming vitamin D and/or calcium medication or prescribed supplements at baseline, those in highest vs. lowest quartile of vitamin D intake had 48% (hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.28-0.96) and 56% (HR, 0.41; 95% CI, 0.12-0.85) lower risk of developing CRC and colon cancer alone, respectively.
Study details: Findings are from an analysis of 7,216 men and women aged between 55 and 80 years and at high CV risk from the PREvención con DIeta MEDiterránea study.
Disclosures: Spanish Instituto de Salud Carlos III (ISCIII) is funded by FEDER and supported by the official funding agency for biomedical research of the Spanish government, ISCIII, and others. J Salas‐Salvadó declared being a member of and receiving grants/research support, honoraria, and personal fees from various sources. The other authors declared no conflicts of interest.
Source: Hernández-Alonso P et al. Eur J Nutr. 2021 May 28. doi: 10.1007/s00394-021-02585-1.
Key clinical point: A higher dietary vitamin D intake was associated with reduced risk for colorectal cancer (CRC) and colon cancer in older individuals at high cardiovascular (CV) risk.
Major finding: After excluding individuals consuming vitamin D and/or calcium medication or prescribed supplements at baseline, those in highest vs. lowest quartile of vitamin D intake had 48% (hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.28-0.96) and 56% (HR, 0.41; 95% CI, 0.12-0.85) lower risk of developing CRC and colon cancer alone, respectively.
Study details: Findings are from an analysis of 7,216 men and women aged between 55 and 80 years and at high CV risk from the PREvención con DIeta MEDiterránea study.
Disclosures: Spanish Instituto de Salud Carlos III (ISCIII) is funded by FEDER and supported by the official funding agency for biomedical research of the Spanish government, ISCIII, and others. J Salas‐Salvadó declared being a member of and receiving grants/research support, honoraria, and personal fees from various sources. The other authors declared no conflicts of interest.
Source: Hernández-Alonso P et al. Eur J Nutr. 2021 May 28. doi: 10.1007/s00394-021-02585-1.
Key clinical point: A higher dietary vitamin D intake was associated with reduced risk for colorectal cancer (CRC) and colon cancer in older individuals at high cardiovascular (CV) risk.
Major finding: After excluding individuals consuming vitamin D and/or calcium medication or prescribed supplements at baseline, those in highest vs. lowest quartile of vitamin D intake had 48% (hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.28-0.96) and 56% (HR, 0.41; 95% CI, 0.12-0.85) lower risk of developing CRC and colon cancer alone, respectively.
Study details: Findings are from an analysis of 7,216 men and women aged between 55 and 80 years and at high CV risk from the PREvención con DIeta MEDiterránea study.
Disclosures: Spanish Instituto de Salud Carlos III (ISCIII) is funded by FEDER and supported by the official funding agency for biomedical research of the Spanish government, ISCIII, and others. J Salas‐Salvadó declared being a member of and receiving grants/research support, honoraria, and personal fees from various sources. The other authors declared no conflicts of interest.
Source: Hernández-Alonso P et al. Eur J Nutr. 2021 May 28. doi: 10.1007/s00394-021-02585-1.
Obesity tied to increased risk for colorectal cancer in patients with Lynch syndrome
Key clinical point: Obesity is a significant risk factor for colorectal cancer (CRC) in men with Lynch syndrome (LS). Moreover, obesity significantly increased CRC risk in patients with a mutation in mismatch repair gene MLH1.
Major finding: Obesity was associated with a significant 2-fold higher risk for CRC in men (summary relative risk [SRR], 2.09; 95% confidence interval [CI], 1.23-3.55) but not in women. Also, the mutation in MLH1 significantly increased the risk for CRC by 49% for every increase of 5 kg/m2 (SRR, 1.49; 95% CI, 1.11-1.99).
Study details: Findings are from a meta-analysis of 4 observational studies that reported obesity and risk for CRC in patients with LS. The number of patients varied from 265 to 3,595.
Disclosures: This research received no external funding. The authors declared no conflicts of interest.
Source: Lazzeroni M et al. Nutrients. 2021 May 20. doi: 10.3390/nu13051736.
Key clinical point: Obesity is a significant risk factor for colorectal cancer (CRC) in men with Lynch syndrome (LS). Moreover, obesity significantly increased CRC risk in patients with a mutation in mismatch repair gene MLH1.
Major finding: Obesity was associated with a significant 2-fold higher risk for CRC in men (summary relative risk [SRR], 2.09; 95% confidence interval [CI], 1.23-3.55) but not in women. Also, the mutation in MLH1 significantly increased the risk for CRC by 49% for every increase of 5 kg/m2 (SRR, 1.49; 95% CI, 1.11-1.99).
Study details: Findings are from a meta-analysis of 4 observational studies that reported obesity and risk for CRC in patients with LS. The number of patients varied from 265 to 3,595.
Disclosures: This research received no external funding. The authors declared no conflicts of interest.
Source: Lazzeroni M et al. Nutrients. 2021 May 20. doi: 10.3390/nu13051736.
Key clinical point: Obesity is a significant risk factor for colorectal cancer (CRC) in men with Lynch syndrome (LS). Moreover, obesity significantly increased CRC risk in patients with a mutation in mismatch repair gene MLH1.
Major finding: Obesity was associated with a significant 2-fold higher risk for CRC in men (summary relative risk [SRR], 2.09; 95% confidence interval [CI], 1.23-3.55) but not in women. Also, the mutation in MLH1 significantly increased the risk for CRC by 49% for every increase of 5 kg/m2 (SRR, 1.49; 95% CI, 1.11-1.99).
Study details: Findings are from a meta-analysis of 4 observational studies that reported obesity and risk for CRC in patients with LS. The number of patients varied from 265 to 3,595.
Disclosures: This research received no external funding. The authors declared no conflicts of interest.
Source: Lazzeroni M et al. Nutrients. 2021 May 20. doi: 10.3390/nu13051736.
Anlotinib substantially prolongs PFS in metastatic CRC
Key clinical point: Anlotinib was effective and tolerated in patients with refractory metastatic colorectal cancer (mCRC). Although overall survival (OS) did not reach statistical significance, anlotinib could still be clinically beneficial by substantially prolonged progression-free survival (PFS).
Major finding: Patients treated with anlotinib vs. placebo showed a significant 66% reduced risk for PFS (hazard ratio [HR], 0.34; P less than .0001); however, median OS was similar (HR, 1.02; P = .871). Hypertension (20.9%), increased γ-GT (7.1%), and hand-foot skin reaction (6.4%) were the most common anlotinib-related grade 3 or higher adverse events.
Study details: Findings are from the phase 3 ALTER0703 trial including 419 patients with mCRC who were randomly allocated to receive oral anlotinib (12 mg/day; n=282) or placebo (n=137) plus best supportive care.
Disclosures: The study was sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Source: Chi Y et al. Oncologist. 2021 Jun 8. doi: 10.1002/onco.13857.
Key clinical point: Anlotinib was effective and tolerated in patients with refractory metastatic colorectal cancer (mCRC). Although overall survival (OS) did not reach statistical significance, anlotinib could still be clinically beneficial by substantially prolonged progression-free survival (PFS).
Major finding: Patients treated with anlotinib vs. placebo showed a significant 66% reduced risk for PFS (hazard ratio [HR], 0.34; P less than .0001); however, median OS was similar (HR, 1.02; P = .871). Hypertension (20.9%), increased γ-GT (7.1%), and hand-foot skin reaction (6.4%) were the most common anlotinib-related grade 3 or higher adverse events.
Study details: Findings are from the phase 3 ALTER0703 trial including 419 patients with mCRC who were randomly allocated to receive oral anlotinib (12 mg/day; n=282) or placebo (n=137) plus best supportive care.
Disclosures: The study was sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Source: Chi Y et al. Oncologist. 2021 Jun 8. doi: 10.1002/onco.13857.
Key clinical point: Anlotinib was effective and tolerated in patients with refractory metastatic colorectal cancer (mCRC). Although overall survival (OS) did not reach statistical significance, anlotinib could still be clinically beneficial by substantially prolonged progression-free survival (PFS).
Major finding: Patients treated with anlotinib vs. placebo showed a significant 66% reduced risk for PFS (hazard ratio [HR], 0.34; P less than .0001); however, median OS was similar (HR, 1.02; P = .871). Hypertension (20.9%), increased γ-GT (7.1%), and hand-foot skin reaction (6.4%) were the most common anlotinib-related grade 3 or higher adverse events.
Study details: Findings are from the phase 3 ALTER0703 trial including 419 patients with mCRC who were randomly allocated to receive oral anlotinib (12 mg/day; n=282) or placebo (n=137) plus best supportive care.
Disclosures: The study was sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Source: Chi Y et al. Oncologist. 2021 Jun 8. doi: 10.1002/onco.13857.
Cumulative social risk linked to reduced receipt of chemotherapy in patients with advanced CRC
Key clinical point: Assessment of cumulative social risk can help identify patients with advanced colorectal cancer (CRC) at higher risk of omitting chemotherapy for nonclinical reasons. Systematic assessment of patients for social risk and a more holistic support program may encourage such patients to undergo their recommended chemotherapy regimen.
Major finding: Compared with participants with 0 social risk factors, those with 3 (odds ratio [OR], 0.48; P = .02) or more (6 or more; OR, 0.22; P = .001) risk factors were significantly less likely to receive planned chemotherapy. Those who reported 2 (OR, 3.05; P = .007) or more (6 or more sources; OR, 5.95; P less than .001) sources of social support were more likely to receive chemotherapy than participants with no social support.
Study details: Findings are from a cross-sectional, population-based survey of 1,087 adults diagnosed with stage III CRC.
Disclosures: The study was supported by a research scholar grant from the American Cancer Society. Dr. Abrahamse, Dr. Kato, and Dr. Ward reported receiving grants from various sources.
Source: Davis RE et al. JAMA Netw Open. 2021 Jun 1. doi: 10.1001/jamanetworkopen.2021.13533.
Key clinical point: Assessment of cumulative social risk can help identify patients with advanced colorectal cancer (CRC) at higher risk of omitting chemotherapy for nonclinical reasons. Systematic assessment of patients for social risk and a more holistic support program may encourage such patients to undergo their recommended chemotherapy regimen.
Major finding: Compared with participants with 0 social risk factors, those with 3 (odds ratio [OR], 0.48; P = .02) or more (6 or more; OR, 0.22; P = .001) risk factors were significantly less likely to receive planned chemotherapy. Those who reported 2 (OR, 3.05; P = .007) or more (6 or more sources; OR, 5.95; P less than .001) sources of social support were more likely to receive chemotherapy than participants with no social support.
Study details: Findings are from a cross-sectional, population-based survey of 1,087 adults diagnosed with stage III CRC.
Disclosures: The study was supported by a research scholar grant from the American Cancer Society. Dr. Abrahamse, Dr. Kato, and Dr. Ward reported receiving grants from various sources.
Source: Davis RE et al. JAMA Netw Open. 2021 Jun 1. doi: 10.1001/jamanetworkopen.2021.13533.
Key clinical point: Assessment of cumulative social risk can help identify patients with advanced colorectal cancer (CRC) at higher risk of omitting chemotherapy for nonclinical reasons. Systematic assessment of patients for social risk and a more holistic support program may encourage such patients to undergo their recommended chemotherapy regimen.
Major finding: Compared with participants with 0 social risk factors, those with 3 (odds ratio [OR], 0.48; P = .02) or more (6 or more; OR, 0.22; P = .001) risk factors were significantly less likely to receive planned chemotherapy. Those who reported 2 (OR, 3.05; P = .007) or more (6 or more sources; OR, 5.95; P less than .001) sources of social support were more likely to receive chemotherapy than participants with no social support.
Study details: Findings are from a cross-sectional, population-based survey of 1,087 adults diagnosed with stage III CRC.
Disclosures: The study was supported by a research scholar grant from the American Cancer Society. Dr. Abrahamse, Dr. Kato, and Dr. Ward reported receiving grants from various sources.
Source: Davis RE et al. JAMA Netw Open. 2021 Jun 1. doi: 10.1001/jamanetworkopen.2021.13533.
HLX04, an alternative biosimilar to bevacizumab for refractory/metastatic colorectal cancer
Key clinical point: HLX04, a potential bevacizumab biosimilar, demonstrated efficacy equivalence with reference bevacizumab with comparable safety and immunogenicity in patients with recurrent/metastatic colorectal cancer (CRC).
Major finding: The progression-free survival rate at week 36 in HLX04 vs. bevacizumab group was 46.4% vs. 50.7% leading to rate difference (4.2%; 90% confidence interval [CI], −10.6 to 2.1) and rate ratio (0.92; 90% CI, 0.80 to −1.05) within the prespecified equivalence margins. Grade 3 or higher treatment-emergent adverse events were reported by 65.5% vs. 70.6% of patients in the HLX04 vs. bevacizumab group. Detection of antidrug and neutralizing antibodies was comparable.
Study details: Findings are from a phase 3 equivalence study including 677 patients with recurrent/metastatic CRC randomly allocated to either HLX04 or reference bevacizumab in combination with modified FOLFOX6 or XELOX.
Disclosures: The study was sponsored by the Shanghai Henlius Biotech, Inc. W Kang declared being an employee of Shanghai Henlius Biotech, Inc. The other authors declared having no directly relevant conflicts of interest.
Source: Qin S et al. BioDrugs. 2021 May 20. doi: 10.1007/s40259-021-00484-9.
Key clinical point: HLX04, a potential bevacizumab biosimilar, demonstrated efficacy equivalence with reference bevacizumab with comparable safety and immunogenicity in patients with recurrent/metastatic colorectal cancer (CRC).
Major finding: The progression-free survival rate at week 36 in HLX04 vs. bevacizumab group was 46.4% vs. 50.7% leading to rate difference (4.2%; 90% confidence interval [CI], −10.6 to 2.1) and rate ratio (0.92; 90% CI, 0.80 to −1.05) within the prespecified equivalence margins. Grade 3 or higher treatment-emergent adverse events were reported by 65.5% vs. 70.6% of patients in the HLX04 vs. bevacizumab group. Detection of antidrug and neutralizing antibodies was comparable.
Study details: Findings are from a phase 3 equivalence study including 677 patients with recurrent/metastatic CRC randomly allocated to either HLX04 or reference bevacizumab in combination with modified FOLFOX6 or XELOX.
Disclosures: The study was sponsored by the Shanghai Henlius Biotech, Inc. W Kang declared being an employee of Shanghai Henlius Biotech, Inc. The other authors declared having no directly relevant conflicts of interest.
Source: Qin S et al. BioDrugs. 2021 May 20. doi: 10.1007/s40259-021-00484-9.
Key clinical point: HLX04, a potential bevacizumab biosimilar, demonstrated efficacy equivalence with reference bevacizumab with comparable safety and immunogenicity in patients with recurrent/metastatic colorectal cancer (CRC).
Major finding: The progression-free survival rate at week 36 in HLX04 vs. bevacizumab group was 46.4% vs. 50.7% leading to rate difference (4.2%; 90% confidence interval [CI], −10.6 to 2.1) and rate ratio (0.92; 90% CI, 0.80 to −1.05) within the prespecified equivalence margins. Grade 3 or higher treatment-emergent adverse events were reported by 65.5% vs. 70.6% of patients in the HLX04 vs. bevacizumab group. Detection of antidrug and neutralizing antibodies was comparable.
Study details: Findings are from a phase 3 equivalence study including 677 patients with recurrent/metastatic CRC randomly allocated to either HLX04 or reference bevacizumab in combination with modified FOLFOX6 or XELOX.
Disclosures: The study was sponsored by the Shanghai Henlius Biotech, Inc. W Kang declared being an employee of Shanghai Henlius Biotech, Inc. The other authors declared having no directly relevant conflicts of interest.
Source: Qin S et al. BioDrugs. 2021 May 20. doi: 10.1007/s40259-021-00484-9.
Perioperative systemic therapy feasible and safe in patients with resectable colorectal peritoneal metastases
Key clinical point: Findings from this phase 2 trial support feasibility and safety of perioperative systemic therapy in patients with resectable colorectal peritoneal metastases (CPM).
Major finding: The proportion of patients undergoing macroscopic complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC; risk ratio, 1.04; P = .74) and with Clavien-Dindo grade 3 or higher postoperative morbidity (risk ratio, 0.65; P = .25) was not significantly different between the perioperative systemic therapy and CRS-HIPEC alone arms.
Study details: Findings are from CAIRO6, a phase 2-superiority trial that included 79 patients with resectable CPM who were randomly allocated to either perioperative systemic therapy or CRS-HIPEC alone.
Disclosures: The study was funded by the Dutch Cancer Society and F. Hoffmann-La Roche. Dr. Koopman, Dr. Punt, Dr. Tanis, and Dr. de Hingh reported serving as a paid advisor and/or receiving grants from various sources. No other disclosures were reported.
Source: KP Rovers et al. JAMA Surg. 2021 May 19. doi: 10.1001/jamasurg.2021.1642.
Key clinical point: Findings from this phase 2 trial support feasibility and safety of perioperative systemic therapy in patients with resectable colorectal peritoneal metastases (CPM).
Major finding: The proportion of patients undergoing macroscopic complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC; risk ratio, 1.04; P = .74) and with Clavien-Dindo grade 3 or higher postoperative morbidity (risk ratio, 0.65; P = .25) was not significantly different between the perioperative systemic therapy and CRS-HIPEC alone arms.
Study details: Findings are from CAIRO6, a phase 2-superiority trial that included 79 patients with resectable CPM who were randomly allocated to either perioperative systemic therapy or CRS-HIPEC alone.
Disclosures: The study was funded by the Dutch Cancer Society and F. Hoffmann-La Roche. Dr. Koopman, Dr. Punt, Dr. Tanis, and Dr. de Hingh reported serving as a paid advisor and/or receiving grants from various sources. No other disclosures were reported.
Source: KP Rovers et al. JAMA Surg. 2021 May 19. doi: 10.1001/jamasurg.2021.1642.
Key clinical point: Findings from this phase 2 trial support feasibility and safety of perioperative systemic therapy in patients with resectable colorectal peritoneal metastases (CPM).
Major finding: The proportion of patients undergoing macroscopic complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC; risk ratio, 1.04; P = .74) and with Clavien-Dindo grade 3 or higher postoperative morbidity (risk ratio, 0.65; P = .25) was not significantly different between the perioperative systemic therapy and CRS-HIPEC alone arms.
Study details: Findings are from CAIRO6, a phase 2-superiority trial that included 79 patients with resectable CPM who were randomly allocated to either perioperative systemic therapy or CRS-HIPEC alone.
Disclosures: The study was funded by the Dutch Cancer Society and F. Hoffmann-La Roche. Dr. Koopman, Dr. Punt, Dr. Tanis, and Dr. de Hingh reported serving as a paid advisor and/or receiving grants from various sources. No other disclosures were reported.
Source: KP Rovers et al. JAMA Surg. 2021 May 19. doi: 10.1001/jamasurg.2021.1642.
Continuation of screening endoscopy beyond age 75 prevents CRC incidence and death
Key clinical point: Screening lower gastrointestinal tract endoscopy in adults older than 75 years with no substantial comorbidities was associated with a lower risk for colorectal cancer (CRC) incidence and survival gain, regardless of screening history.
Major finding: Irrespective of prior screening history, endoscopic screening after 75 years of age was associated with a significantly lower incidence of CRC (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.51-0.74) and CRC-related mortality (HR, 0.60; 95% CI, 0.46-0.78), particularly in individuals without cardiovascular diseases or substantial comorbidities.
Study details: Findings are from an analysis of 2 prospective cohorts of 56,374 U.S. adults who reached 75 years of age during follow-up.
Disclosures: The study was supported by grants from the National Institutes of Health, a Stuart and Suzanne Steele Massachusetts General Hospital (MGH) Research Scholar award (Dr. Chan), and an MGH Executive Committee on Research Tosteson and Fund for Medical Discovery Postdoctoral Fellowship award (Dr. Ma). Dr. Nishihara and Dr. Chan reported holding stocks and/or consulting for various sources.
Source: Ma W et al. JAMA Oncol. 2021 May 20. doi: 10.1001/jamaoncol.2021.1364.
Key clinical point: Screening lower gastrointestinal tract endoscopy in adults older than 75 years with no substantial comorbidities was associated with a lower risk for colorectal cancer (CRC) incidence and survival gain, regardless of screening history.
Major finding: Irrespective of prior screening history, endoscopic screening after 75 years of age was associated with a significantly lower incidence of CRC (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.51-0.74) and CRC-related mortality (HR, 0.60; 95% CI, 0.46-0.78), particularly in individuals without cardiovascular diseases or substantial comorbidities.
Study details: Findings are from an analysis of 2 prospective cohorts of 56,374 U.S. adults who reached 75 years of age during follow-up.
Disclosures: The study was supported by grants from the National Institutes of Health, a Stuart and Suzanne Steele Massachusetts General Hospital (MGH) Research Scholar award (Dr. Chan), and an MGH Executive Committee on Research Tosteson and Fund for Medical Discovery Postdoctoral Fellowship award (Dr. Ma). Dr. Nishihara and Dr. Chan reported holding stocks and/or consulting for various sources.
Source: Ma W et al. JAMA Oncol. 2021 May 20. doi: 10.1001/jamaoncol.2021.1364.
Key clinical point: Screening lower gastrointestinal tract endoscopy in adults older than 75 years with no substantial comorbidities was associated with a lower risk for colorectal cancer (CRC) incidence and survival gain, regardless of screening history.
Major finding: Irrespective of prior screening history, endoscopic screening after 75 years of age was associated with a significantly lower incidence of CRC (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.51-0.74) and CRC-related mortality (HR, 0.60; 95% CI, 0.46-0.78), particularly in individuals without cardiovascular diseases or substantial comorbidities.
Study details: Findings are from an analysis of 2 prospective cohorts of 56,374 U.S. adults who reached 75 years of age during follow-up.
Disclosures: The study was supported by grants from the National Institutes of Health, a Stuart and Suzanne Steele Massachusetts General Hospital (MGH) Research Scholar award (Dr. Chan), and an MGH Executive Committee on Research Tosteson and Fund for Medical Discovery Postdoctoral Fellowship award (Dr. Ma). Dr. Nishihara and Dr. Chan reported holding stocks and/or consulting for various sources.
Source: Ma W et al. JAMA Oncol. 2021 May 20. doi: 10.1001/jamaoncol.2021.1364.