Key clinical point: Filgotinib 200 mg once daily for up to 58 weeks effectively induced and maintained clinical remission (CR) and was well tolerated compared with placebo in both biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis.

Major finding: CR was achieved by a greater proportion of patients treated with filgotinib 200 mg vs. placebo in both biologic-naïve (absolute difference [AD], 10.8%; P = .0157) and biologic-experienced (AD, 7.2%; P = .0103) patients at weeks 10 and 58 (AD, 26.0%; P less than .0001). Incidence of adverse events of interest and serious adverse events was similar across treatment arms.

Study details: Findings are from phase 2b/3 SELECTION trial involving 659 biologic-naive and 689 biologic-experienced patients with moderately to severely active ulcerative colitis randomly allocated to oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily.

Disclosures: The study was funded by Gilead Sciences. Some of the authors declared receiving grants, personal/consultancy fees, travel expense and/or non-financial support from; being an employee of; and/or holding stocks of various sources including Gilead Sciences.

Source: Feagan BG et al. Lancet. 2021 Jun 3. doi: 10.1016/S0140-6736(21)00666-8.

Key clinical point: Filgotinib 200 mg once daily for up to 58 weeks effectively induced and maintained clinical remission (CR) and was well tolerated compared with placebo in both biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis.

Major finding: CR was achieved by a greater proportion of patients treated with filgotinib 200 mg vs. placebo in both biologic-naïve (absolute difference [AD], 10.8%; P = .0157) and biologic-experienced (AD, 7.2%; P = .0103) patients at weeks 10 and 58 (AD, 26.0%; P less than .0001). Incidence of adverse events of interest and serious adverse events was similar across treatment arms.

Study details: Findings are from phase 2b/3 SELECTION trial involving 659 biologic-naive and 689 biologic-experienced patients with moderately to severely active ulcerative colitis randomly allocated to oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily.

Disclosures: The study was funded by Gilead Sciences. Some of the authors declared receiving grants, personal/consultancy fees, travel expense and/or non-financial support from; being an employee of; and/or holding stocks of various sources including Gilead Sciences.

Source: Feagan BG et al. Lancet. 2021 Jun 3. doi: 10.1016/S0140-6736(21)00666-8.

Key clinical point: Filgotinib 200 mg once daily for up to 58 weeks effectively induced and maintained clinical remission (CR) and was well tolerated compared with placebo in both biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis.

Major finding: CR was achieved by a greater proportion of patients treated with filgotinib 200 mg vs. placebo in both biologic-naïve (absolute difference [AD], 10.8%; P = .0157) and biologic-experienced (AD, 7.2%; P = .0103) patients at weeks 10 and 58 (AD, 26.0%; P less than .0001). Incidence of adverse events of interest and serious adverse events was similar across treatment arms.

Study details: Findings are from phase 2b/3 SELECTION trial involving 659 biologic-naive and 689 biologic-experienced patients with moderately to severely active ulcerative colitis randomly allocated to oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily.

Disclosures: The study was funded by Gilead Sciences. Some of the authors declared receiving grants, personal/consultancy fees, travel expense and/or non-financial support from; being an employee of; and/or holding stocks of various sources including Gilead Sciences.

Source: Feagan BG et al. Lancet. 2021 Jun 3. doi: 10.1016/S0140-6736(21)00666-8.

Janus kinase inhibitors (JAK inhibitors) have demonstrated efficacy in several immune mediated inflammatory conditions. Tofacitinib, which inhibits JAK3 and JAK1 greater than JAK2, was the first JAK inhibitor approved by the FDA for ulcerative colitis. In contrast to tofacitinib, filgotinib, preferentially inhibits JAK1. The efficacy of filgotinib during induction and maintenance therapy in ulcerative colitis was studied in a phase 2b/3 randomized control trial, the SELECTION trial. In this trial, 659 biologic-naïve and 689 biologic-experienced patients with moderate to severely active ulcerative colitis were randomized 2:2:1 to receive filgotinib 200mg daily, filgotinib 100mg daily, or placebo for 11 weeks. Responders to treatment with filgotinib at week 10 were rerandomized to their original dose or placebo in a 2:1 manner for a total treatment course of 58 weeks. The primary endpoint of the study was clinical remission which was defined as a Mayo endoscopy subscore of 0 or 1, rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency from baseline for a subscore of 0 or 1.

In biologic naïve patients, 26.1% of patients treated with filgotinib 200mg (P = .016) and 19.1% treated with filgotinib 100mg (P = 0.34) compared to 15.3% in the placebo groups achieved clinical remission at week 10. In patients previously treated with an anti-TNF agent or vedolizumab, 4.2% of patients receiving placebo compared to 11.5% taking filgotinib 200mg (P = 0.01) and 9.5% taking filgotinib 100 mg (P = .065) achieved clinical remission at week 10. Endoscopic remission was observed after induction therapy in 12.2% of patients receiving filgotinib 200 mg compared with 3.6% placebo in biologic naïve patients (P = .0047) and 3.4% of patients receiving filgotinib 200 mg compared to 2.1% of patients receiving placebo in biologic experienced patients (P = .43). Histologic remission was achieved in both biologic-naïve and biologic-experienced patients at the 200 mg dose significantly more frequently than in patients receiving placebo. At week 58, 37.2% of patients receiving filgotinib 200 mg and 11.2% of patients receiving placebo (P < .0001) were in clinical remission. In addition, 23.8% of patients receiving 100 mg were in clinical remission compared to 13.2% of patients in the placebo arm (P = .04). These results support that filgotinib may be another effective option for treating patients with moderate to severe ulcerative colitis.

Biosimilars to infliximab are increasingly used in clinical practice. Previous studies have demonstrated safety and efficacy of a single switch from originator to biosimilar infliximab. There is limited data, however, on performing multiple successive switches. In a multicenter prospective cohort, Hanzel et al evaluated 176 patients with inflammatory bowel disease (IBD). The investigators compared outcomes in three groups: group 1 (infliximab originator [INX] to CT-P13 to SB2; 2 switches), group 2 (CT-P13 to SB2; 1 switch) and group 3 (INX to CT-P13; 1 switch). After 12 months, there were no differences in the rates of clinical remission, treatment persistence, or fecal calprotectin. There were 3 infusion reactions in patients switched from CT-P13 to SB2 and none in the other 2 groups.  In conclusion, 2 switches of biosimilars in this prospective cohort were not associated with a change in effectiveness or safety.

The effectiveness of SARS-CoV2 vaccinations in an IBD population is not well known. In a retrospective cohort study with a median age of 68 years including 7376 unvaccinated and 7321 vaccinated veterans, Khan and Mahmud demonstrated the efficacy of full vaccination with the Pfizer or Moderna vaccine in preventing infection, severe infection, and death. In this cohort, less than half of patients were on a biologic or immunomodulator. Of the 6253 patients who were fully vaccinated, there were 7 infections and 3 serious infections compared to 197 infections, 47 serious infections, and 97 deaths in the 14,697 individuals monitored during an unvaccinated time period. Full vaccination (compared to unvaccinated) was 80.4% effective at preventing infection, 70.1% at preventing serious infection, and 87.3% effective and preventing all-cause mortality, whereas partial vaccination was 25.1% effective at preventing infection, 36.8% at preventing severe infection, and 27.3% at preventing all-cause mortality.

This study demonstrates the efficacy of full vaccination in patients with IBD with limited protection for patients receiving partial vaccination. It is limited by the fact that many patients considered unvaccinated may have been vaccinated outside the VA system, the relatively few numbers of events in vaccinated individuals, and lack of generalizability to other settings of patients with IBD as this study involved older men with relatively low rates of immunosuppression.

Janus kinase inhibitors (JAK inhibitors) have demonstrated efficacy in several immune mediated inflammatory conditions. Tofacitinib, which inhibits JAK3 and JAK1 greater than JAK2, was the first JAK inhibitor approved by the FDA for ulcerative colitis. In contrast to tofacitinib, filgotinib, preferentially inhibits JAK1. The efficacy of filgotinib during induction and maintenance therapy in ulcerative colitis was studied in a phase 2b/3 randomized control trial, the SELECTION trial. In this trial, 659 biologic-naïve and 689 biologic-experienced patients with moderate to severely active ulcerative colitis were randomized 2:2:1 to receive filgotinib 200mg daily, filgotinib 100mg daily, or placebo for 11 weeks. Responders to treatment with filgotinib at week 10 were rerandomized to their original dose or placebo in a 2:1 manner for a total treatment course of 58 weeks. The primary endpoint of the study was clinical remission which was defined as a Mayo endoscopy subscore of 0 or 1, rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency from baseline for a subscore of 0 or 1.

In biologic naïve patients, 26.1% of patients treated with filgotinib 200mg (P = .016) and 19.1% treated with filgotinib 100mg (P = 0.34) compared to 15.3% in the placebo groups achieved clinical remission at week 10. In patients previously treated with an anti-TNF agent or vedolizumab, 4.2% of patients receiving placebo compared to 11.5% taking filgotinib 200mg (P = 0.01) and 9.5% taking filgotinib 100 mg (P = .065) achieved clinical remission at week 10. Endoscopic remission was observed after induction therapy in 12.2% of patients receiving filgotinib 200 mg compared with 3.6% placebo in biologic naïve patients (P = .0047) and 3.4% of patients receiving filgotinib 200 mg compared to 2.1% of patients receiving placebo in biologic experienced patients (P = .43). Histologic remission was achieved in both biologic-naïve and biologic-experienced patients at the 200 mg dose significantly more frequently than in patients receiving placebo. At week 58, 37.2% of patients receiving filgotinib 200 mg and 11.2% of patients receiving placebo (P < .0001) were in clinical remission. In addition, 23.8% of patients receiving 100 mg were in clinical remission compared to 13.2% of patients in the placebo arm (P = .04). These results support that filgotinib may be another effective option for treating patients with moderate to severe ulcerative colitis.

Biosimilars to infliximab are increasingly used in clinical practice. Previous studies have demonstrated safety and efficacy of a single switch from originator to biosimilar infliximab. There is limited data, however, on performing multiple successive switches. In a multicenter prospective cohort, Hanzel et al evaluated 176 patients with inflammatory bowel disease (IBD). The investigators compared outcomes in three groups: group 1 (infliximab originator [INX] to CT-P13 to SB2; 2 switches), group 2 (CT-P13 to SB2; 1 switch) and group 3 (INX to CT-P13; 1 switch). After 12 months, there were no differences in the rates of clinical remission, treatment persistence, or fecal calprotectin. There were 3 infusion reactions in patients switched from CT-P13 to SB2 and none in the other 2 groups.  In conclusion, 2 switches of biosimilars in this prospective cohort were not associated with a change in effectiveness or safety.

The effectiveness of SARS-CoV2 vaccinations in an IBD population is not well known. In a retrospective cohort study with a median age of 68 years including 7376 unvaccinated and 7321 vaccinated veterans, Khan and Mahmud demonstrated the efficacy of full vaccination with the Pfizer or Moderna vaccine in preventing infection, severe infection, and death. In this cohort, less than half of patients were on a biologic or immunomodulator. Of the 6253 patients who were fully vaccinated, there were 7 infections and 3 serious infections compared to 197 infections, 47 serious infections, and 97 deaths in the 14,697 individuals monitored during an unvaccinated time period. Full vaccination (compared to unvaccinated) was 80.4% effective at preventing infection, 70.1% at preventing serious infection, and 87.3% effective and preventing all-cause mortality, whereas partial vaccination was 25.1% effective at preventing infection, 36.8% at preventing severe infection, and 27.3% at preventing all-cause mortality.

This study demonstrates the efficacy of full vaccination in patients with IBD with limited protection for patients receiving partial vaccination. It is limited by the fact that many patients considered unvaccinated may have been vaccinated outside the VA system, the relatively few numbers of events in vaccinated individuals, and lack of generalizability to other settings of patients with IBD as this study involved older men with relatively low rates of immunosuppression.

Janus kinase inhibitors (JAK inhibitors) have demonstrated efficacy in several immune mediated inflammatory conditions. Tofacitinib, which inhibits JAK3 and JAK1 greater than JAK2, was the first JAK inhibitor approved by the FDA for ulcerative colitis. In contrast to tofacitinib, filgotinib, preferentially inhibits JAK1. The efficacy of filgotinib during induction and maintenance therapy in ulcerative colitis was studied in a phase 2b/3 randomized control trial, the SELECTION trial. In this trial, 659 biologic-naïve and 689 biologic-experienced patients with moderate to severely active ulcerative colitis were randomized 2:2:1 to receive filgotinib 200mg daily, filgotinib 100mg daily, or placebo for 11 weeks. Responders to treatment with filgotinib at week 10 were rerandomized to their original dose or placebo in a 2:1 manner for a total treatment course of 58 weeks. The primary endpoint of the study was clinical remission which was defined as a Mayo endoscopy subscore of 0 or 1, rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency from baseline for a subscore of 0 or 1.

In biologic naïve patients, 26.1% of patients treated with filgotinib 200mg (P = .016) and 19.1% treated with filgotinib 100mg (P = 0.34) compared to 15.3% in the placebo groups achieved clinical remission at week 10. In patients previously treated with an anti-TNF agent or vedolizumab, 4.2% of patients receiving placebo compared to 11.5% taking filgotinib 200mg (P = 0.01) and 9.5% taking filgotinib 100 mg (P = .065) achieved clinical remission at week 10. Endoscopic remission was observed after induction therapy in 12.2% of patients receiving filgotinib 200 mg compared with 3.6% placebo in biologic naïve patients (P = .0047) and 3.4% of patients receiving filgotinib 200 mg compared to 2.1% of patients receiving placebo in biologic experienced patients (P = .43). Histologic remission was achieved in both biologic-naïve and biologic-experienced patients at the 200 mg dose significantly more frequently than in patients receiving placebo. At week 58, 37.2% of patients receiving filgotinib 200 mg and 11.2% of patients receiving placebo (P < .0001) were in clinical remission. In addition, 23.8% of patients receiving 100 mg were in clinical remission compared to 13.2% of patients in the placebo arm (P = .04). These results support that filgotinib may be another effective option for treating patients with moderate to severe ulcerative colitis.

Biosimilars to infliximab are increasingly used in clinical practice. Previous studies have demonstrated safety and efficacy of a single switch from originator to biosimilar infliximab. There is limited data, however, on performing multiple successive switches. In a multicenter prospective cohort, Hanzel et al evaluated 176 patients with inflammatory bowel disease (IBD). The investigators compared outcomes in three groups: group 1 (infliximab originator [INX] to CT-P13 to SB2; 2 switches), group 2 (CT-P13 to SB2; 1 switch) and group 3 (INX to CT-P13; 1 switch). After 12 months, there were no differences in the rates of clinical remission, treatment persistence, or fecal calprotectin. There were 3 infusion reactions in patients switched from CT-P13 to SB2 and none in the other 2 groups.  In conclusion, 2 switches of biosimilars in this prospective cohort were not associated with a change in effectiveness or safety.

The effectiveness of SARS-CoV2 vaccinations in an IBD population is not well known. In a retrospective cohort study with a median age of 68 years including 7376 unvaccinated and 7321 vaccinated veterans, Khan and Mahmud demonstrated the efficacy of full vaccination with the Pfizer or Moderna vaccine in preventing infection, severe infection, and death. In this cohort, less than half of patients were on a biologic or immunomodulator. Of the 6253 patients who were fully vaccinated, there were 7 infections and 3 serious infections compared to 197 infections, 47 serious infections, and 97 deaths in the 14,697 individuals monitored during an unvaccinated time period. Full vaccination (compared to unvaccinated) was 80.4% effective at preventing infection, 70.1% at preventing serious infection, and 87.3% effective and preventing all-cause mortality, whereas partial vaccination was 25.1% effective at preventing infection, 36.8% at preventing severe infection, and 27.3% at preventing all-cause mortality.

This study demonstrates the efficacy of full vaccination in patients with IBD with limited protection for patients receiving partial vaccination. It is limited by the fact that many patients considered unvaccinated may have been vaccinated outside the VA system, the relatively few numbers of events in vaccinated individuals, and lack of generalizability to other settings of patients with IBD as this study involved older men with relatively low rates of immunosuppression.

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.

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. 

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.

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.

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.

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.

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.

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.