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Cardiovascular risk stratification feasible in CML patients treated with TKI
Key clinical point: Cardiovascular risk stratification based on age, history of prior cardiovascular diseases, and Framingham risk score, along with additional insights from coronary artery calcium scoring (CACS), was feasible in patients with chronic myeloid leukemia (CML) treated with any tyrosine kinase inhibitors (TKI).
Major finding: During a median follow-up of 3.8 years, rates of major adverse cardiovascular events (MACE) in study-defined low-, intermediate-, and high-risk groups were 0%, 10%, and 19%, respectively. None of the patients reclassified from intermediate to low risk by CACS experienced MACE.
Study details: This retrospective study included 88 patients with CML treated with any TKI.
Disclosures: No specific source of funding was identified. Some investigators, including the lead author, reported receiving honoraria and consultancy fees or serving on advisory boards of various pharmaceutical companies.
Source: Baggio D et al. Intern Med J. 2021;51(10):1736-40 (Oct 18). Doi: 10.1111/imj.15517.
Key clinical point: Cardiovascular risk stratification based on age, history of prior cardiovascular diseases, and Framingham risk score, along with additional insights from coronary artery calcium scoring (CACS), was feasible in patients with chronic myeloid leukemia (CML) treated with any tyrosine kinase inhibitors (TKI).
Major finding: During a median follow-up of 3.8 years, rates of major adverse cardiovascular events (MACE) in study-defined low-, intermediate-, and high-risk groups were 0%, 10%, and 19%, respectively. None of the patients reclassified from intermediate to low risk by CACS experienced MACE.
Study details: This retrospective study included 88 patients with CML treated with any TKI.
Disclosures: No specific source of funding was identified. Some investigators, including the lead author, reported receiving honoraria and consultancy fees or serving on advisory boards of various pharmaceutical companies.
Source: Baggio D et al. Intern Med J. 2021;51(10):1736-40 (Oct 18). Doi: 10.1111/imj.15517.
Key clinical point: Cardiovascular risk stratification based on age, history of prior cardiovascular diseases, and Framingham risk score, along with additional insights from coronary artery calcium scoring (CACS), was feasible in patients with chronic myeloid leukemia (CML) treated with any tyrosine kinase inhibitors (TKI).
Major finding: During a median follow-up of 3.8 years, rates of major adverse cardiovascular events (MACE) in study-defined low-, intermediate-, and high-risk groups were 0%, 10%, and 19%, respectively. None of the patients reclassified from intermediate to low risk by CACS experienced MACE.
Study details: This retrospective study included 88 patients with CML treated with any TKI.
Disclosures: No specific source of funding was identified. Some investigators, including the lead author, reported receiving honoraria and consultancy fees or serving on advisory boards of various pharmaceutical companies.
Source: Baggio D et al. Intern Med J. 2021;51(10):1736-40 (Oct 18). Doi: 10.1111/imj.15517.
No margin for nonadherence in CML patients receiving imatinib
Key clinical point: Compared with 90% adherence, a 100% adherence to imatinib was associated with a 2-fold increase in achieving or maintaining treatment response in patients with chronic myeloid leukemia (CML), highlighting the urgent need to assess and promote patient adherence.
Major finding: A 90-day imatinib pill-count adherence of 100% vs. 90% increased the probabilities of achieving complete hematological response by 2.25-fold (probability of treatment response [pTR] 0.8416 vs. 0.3746), complete cytogenic response by 2.24-fold (pTR 0.8335 vs. 0.3714), major molecular response by 1.95-fold (pTR 0.7698 vs. 0.3938), and optimal response by 2.35-fold (pTR 0.8236 vs. 0.3512).
Study details: Findings are from a post hoc analysis of the ADAGIO study including 169 patients with CML.
Disclosures: This study did not receive any specific funding. Some investigators reported being equity shareholders and employees of or receiving honoraria from various sources including Novartis which funded the ADAGIO study.
Source: Obeng-Kusi M et al. Leuk Res. 2021;111:106734 (Oct 21). Doi: 10.1016/j.leukres.2021.106734.
Key clinical point: Compared with 90% adherence, a 100% adherence to imatinib was associated with a 2-fold increase in achieving or maintaining treatment response in patients with chronic myeloid leukemia (CML), highlighting the urgent need to assess and promote patient adherence.
Major finding: A 90-day imatinib pill-count adherence of 100% vs. 90% increased the probabilities of achieving complete hematological response by 2.25-fold (probability of treatment response [pTR] 0.8416 vs. 0.3746), complete cytogenic response by 2.24-fold (pTR 0.8335 vs. 0.3714), major molecular response by 1.95-fold (pTR 0.7698 vs. 0.3938), and optimal response by 2.35-fold (pTR 0.8236 vs. 0.3512).
Study details: Findings are from a post hoc analysis of the ADAGIO study including 169 patients with CML.
Disclosures: This study did not receive any specific funding. Some investigators reported being equity shareholders and employees of or receiving honoraria from various sources including Novartis which funded the ADAGIO study.
Source: Obeng-Kusi M et al. Leuk Res. 2021;111:106734 (Oct 21). Doi: 10.1016/j.leukres.2021.106734.
Key clinical point: Compared with 90% adherence, a 100% adherence to imatinib was associated with a 2-fold increase in achieving or maintaining treatment response in patients with chronic myeloid leukemia (CML), highlighting the urgent need to assess and promote patient adherence.
Major finding: A 90-day imatinib pill-count adherence of 100% vs. 90% increased the probabilities of achieving complete hematological response by 2.25-fold (probability of treatment response [pTR] 0.8416 vs. 0.3746), complete cytogenic response by 2.24-fold (pTR 0.8335 vs. 0.3714), major molecular response by 1.95-fold (pTR 0.7698 vs. 0.3938), and optimal response by 2.35-fold (pTR 0.8236 vs. 0.3512).
Study details: Findings are from a post hoc analysis of the ADAGIO study including 169 patients with CML.
Disclosures: This study did not receive any specific funding. Some investigators reported being equity shareholders and employees of or receiving honoraria from various sources including Novartis which funded the ADAGIO study.
Source: Obeng-Kusi M et al. Leuk Res. 2021;111:106734 (Oct 21). Doi: 10.1016/j.leukres.2021.106734.
Early life initiation of effective CFTR modulators increases chances of pancreatic function restoration
Key clinical point: Exocrine pancreatic insufficiency (EPI) is the major cause of nutrient malabsorption in cystic fibrosis (CF), with the likelihood of restoration of pancreatic function significantly higher if CF transmembrane conductance regulator (CFTR) modulator therapies are initiated as early in life as possible.
Main finding: In the ARRIVAL study, ivacaftor led to a mean decrease of 56% in immunoreactive trypsinogen in 12-24 month old patients with CFTR gating mutation. Similar improvements were observed in older children aged 2-5 years treated with ivacaftor in the KIWI and the open-label extension KLIMB study. However, the results are not as promising in older patients aged 5-61 years.
Study details: These are highlights from a review that summarizes the effects of highly effective CFTR modulators on growth and nutrition in patients with CF.
Disclosures: The manuscript did not receive any additional funding. The authors declared receiving grant support and serving as consultants for various sources.
Source: Bass R et al. Nutrients. 2021(Aug 24);13(9):2907. Doi: 10.3390/nu13092907.
Key clinical point: Exocrine pancreatic insufficiency (EPI) is the major cause of nutrient malabsorption in cystic fibrosis (CF), with the likelihood of restoration of pancreatic function significantly higher if CF transmembrane conductance regulator (CFTR) modulator therapies are initiated as early in life as possible.
Main finding: In the ARRIVAL study, ivacaftor led to a mean decrease of 56% in immunoreactive trypsinogen in 12-24 month old patients with CFTR gating mutation. Similar improvements were observed in older children aged 2-5 years treated with ivacaftor in the KIWI and the open-label extension KLIMB study. However, the results are not as promising in older patients aged 5-61 years.
Study details: These are highlights from a review that summarizes the effects of highly effective CFTR modulators on growth and nutrition in patients with CF.
Disclosures: The manuscript did not receive any additional funding. The authors declared receiving grant support and serving as consultants for various sources.
Source: Bass R et al. Nutrients. 2021(Aug 24);13(9):2907. Doi: 10.3390/nu13092907.
Key clinical point: Exocrine pancreatic insufficiency (EPI) is the major cause of nutrient malabsorption in cystic fibrosis (CF), with the likelihood of restoration of pancreatic function significantly higher if CF transmembrane conductance regulator (CFTR) modulator therapies are initiated as early in life as possible.
Main finding: In the ARRIVAL study, ivacaftor led to a mean decrease of 56% in immunoreactive trypsinogen in 12-24 month old patients with CFTR gating mutation. Similar improvements were observed in older children aged 2-5 years treated with ivacaftor in the KIWI and the open-label extension KLIMB study. However, the results are not as promising in older patients aged 5-61 years.
Study details: These are highlights from a review that summarizes the effects of highly effective CFTR modulators on growth and nutrition in patients with CF.
Disclosures: The manuscript did not receive any additional funding. The authors declared receiving grant support and serving as consultants for various sources.
Source: Bass R et al. Nutrients. 2021(Aug 24);13(9):2907. Doi: 10.3390/nu13092907.
PERT administration along with standard chemotherapy improves outcomes in patients with advanced PDAC
Key clinical point: Pancreatic enzyme replacement therapy (PERT) administration in patients with advanced pancreatic ductal adenocarcinoma (PDAC) undergoing standard first-line chemotherapy with gemcitabine plus nab-paclitaxel improved survival, along with weight gain and reduction in maldigestion-related symptoms.
Major finding: PERT administration was associated with longer overall survival (hazard ratio 2.85; P < .001), weight gain at 3 months (P = .02), and a significant reduction in feeling of indigestion (P = .001), bloating (P < .0001), frequent stools (P < .0001), and floating or greasy/fatty stool (P = .003).
Study details: This retrospective study included 110 patients with advanced PDAC treated with first-line chemotherapy with gemcitabine plus nab-paclitaxel with (n = 55) or without (n = 55) PERT administration.
Disclosures: No specific source of funding was identified for this study. Some investigators, including the lead author, reported receiving speaker’s fees, honoraria, travel expenses, consultant’s fees, and institutional research grants and participation in advisory boards and steering committee activities from various sources.
Source: Trestini I et al. Front Oncol. 2021(Sep 9).Doi: 10.3389/fonc.2021.688889.
Key clinical point: Pancreatic enzyme replacement therapy (PERT) administration in patients with advanced pancreatic ductal adenocarcinoma (PDAC) undergoing standard first-line chemotherapy with gemcitabine plus nab-paclitaxel improved survival, along with weight gain and reduction in maldigestion-related symptoms.
Major finding: PERT administration was associated with longer overall survival (hazard ratio 2.85; P < .001), weight gain at 3 months (P = .02), and a significant reduction in feeling of indigestion (P = .001), bloating (P < .0001), frequent stools (P < .0001), and floating or greasy/fatty stool (P = .003).
Study details: This retrospective study included 110 patients with advanced PDAC treated with first-line chemotherapy with gemcitabine plus nab-paclitaxel with (n = 55) or without (n = 55) PERT administration.
Disclosures: No specific source of funding was identified for this study. Some investigators, including the lead author, reported receiving speaker’s fees, honoraria, travel expenses, consultant’s fees, and institutional research grants and participation in advisory boards and steering committee activities from various sources.
Source: Trestini I et al. Front Oncol. 2021(Sep 9).Doi: 10.3389/fonc.2021.688889.
Key clinical point: Pancreatic enzyme replacement therapy (PERT) administration in patients with advanced pancreatic ductal adenocarcinoma (PDAC) undergoing standard first-line chemotherapy with gemcitabine plus nab-paclitaxel improved survival, along with weight gain and reduction in maldigestion-related symptoms.
Major finding: PERT administration was associated with longer overall survival (hazard ratio 2.85; P < .001), weight gain at 3 months (P = .02), and a significant reduction in feeling of indigestion (P = .001), bloating (P < .0001), frequent stools (P < .0001), and floating or greasy/fatty stool (P = .003).
Study details: This retrospective study included 110 patients with advanced PDAC treated with first-line chemotherapy with gemcitabine plus nab-paclitaxel with (n = 55) or without (n = 55) PERT administration.
Disclosures: No specific source of funding was identified for this study. Some investigators, including the lead author, reported receiving speaker’s fees, honoraria, travel expenses, consultant’s fees, and institutional research grants and participation in advisory boards and steering committee activities from various sources.
Source: Trestini I et al. Front Oncol. 2021(Sep 9).Doi: 10.3389/fonc.2021.688889.
Elevated serum amylase affects clinical outcomes in COVID-19
Key clinical point: Elevated serum amylase (ESA) was associated with adverse clinical outcomes and mortality in hospitalized patients with COVID-19.
Major finding: Hyperamylasemia (amylase > upper limit of normal [ULN] of 115 U/L) was independently associated with mortality (1-3-times ULN [1-3 ULN]: hazard ratio [HR] 1.63; P = .034; >3-fold ULN [>3 ULN]: HR 8.90; P < .001) and adverse outcomes (all P < .001), such as sepsis (1-3 ULN: odds ratio [OR] 1.15; >3 ULN: OR 1.87), disseminated intravascular coagulation (1-3 ULN: OR 1.13; >3 ULN: OR 1.65), cardiac injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.71), acute respiratory distress syndrome (1-3 ULN: OR 1.21; >3 ULN: OR 1.62), and acute kidney injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.79).
Study details: This retrospective study included 1,515 inpatients with COVID-19. Overall, 196 patients had ESA, of which 9.7% had an ESA of >3 ULN.
Disclosures: This study was supported by the National Nature Science Foundation of China and Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province. The authors declared no conflict of interests.
Source: Li G et al. Aging (Albany NY). 2021(Oct 29);13(20):23442-23458. Doi: 10.18632/aging.203653.
Key clinical point: Elevated serum amylase (ESA) was associated with adverse clinical outcomes and mortality in hospitalized patients with COVID-19.
Major finding: Hyperamylasemia (amylase > upper limit of normal [ULN] of 115 U/L) was independently associated with mortality (1-3-times ULN [1-3 ULN]: hazard ratio [HR] 1.63; P = .034; >3-fold ULN [>3 ULN]: HR 8.90; P < .001) and adverse outcomes (all P < .001), such as sepsis (1-3 ULN: odds ratio [OR] 1.15; >3 ULN: OR 1.87), disseminated intravascular coagulation (1-3 ULN: OR 1.13; >3 ULN: OR 1.65), cardiac injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.71), acute respiratory distress syndrome (1-3 ULN: OR 1.21; >3 ULN: OR 1.62), and acute kidney injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.79).
Study details: This retrospective study included 1,515 inpatients with COVID-19. Overall, 196 patients had ESA, of which 9.7% had an ESA of >3 ULN.
Disclosures: This study was supported by the National Nature Science Foundation of China and Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province. The authors declared no conflict of interests.
Source: Li G et al. Aging (Albany NY). 2021(Oct 29);13(20):23442-23458. Doi: 10.18632/aging.203653.
Key clinical point: Elevated serum amylase (ESA) was associated with adverse clinical outcomes and mortality in hospitalized patients with COVID-19.
Major finding: Hyperamylasemia (amylase > upper limit of normal [ULN] of 115 U/L) was independently associated with mortality (1-3-times ULN [1-3 ULN]: hazard ratio [HR] 1.63; P = .034; >3-fold ULN [>3 ULN]: HR 8.90; P < .001) and adverse outcomes (all P < .001), such as sepsis (1-3 ULN: odds ratio [OR] 1.15; >3 ULN: OR 1.87), disseminated intravascular coagulation (1-3 ULN: OR 1.13; >3 ULN: OR 1.65), cardiac injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.71), acute respiratory distress syndrome (1-3 ULN: OR 1.21; >3 ULN: OR 1.62), and acute kidney injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.79).
Study details: This retrospective study included 1,515 inpatients with COVID-19. Overall, 196 patients had ESA, of which 9.7% had an ESA of >3 ULN.
Disclosures: This study was supported by the National Nature Science Foundation of China and Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province. The authors declared no conflict of interests.
Source: Li G et al. Aging (Albany NY). 2021(Oct 29);13(20):23442-23458. Doi: 10.18632/aging.203653.
Intrapancreatic fat deposition after acute pancreatitis associated with pancreatic tail diameter and amylase levels
Key clinical point: An increased intrapancreatic fat deposition (IPFD) following acute pancreatitis (AP) was associated with a decrease in pancreatic tail diameter (PTD), and in turn, decreased circulating levels of pancreatic amylase.
Major finding: An increased IPFD was significantly associated with reduced PTD in patients with AP (P = .036). Pancreatic amylase was associated with PTD in AP (P = .042).
Study details: This cross-sectional study included 108 individuals with previous AP (median, 20 months post-AP) and 60 healthy controls.
Disclosures: This study was supported by the Rutherford Discovery Fellowship by the Royal Society of New Zealand to MS Petrov. The authors declared no conflict of interests.
Source: Ko J et al. Obes Facts. 2021(Nov 9). Doi: 10.1159/000519621.
Key clinical point: An increased intrapancreatic fat deposition (IPFD) following acute pancreatitis (AP) was associated with a decrease in pancreatic tail diameter (PTD), and in turn, decreased circulating levels of pancreatic amylase.
Major finding: An increased IPFD was significantly associated with reduced PTD in patients with AP (P = .036). Pancreatic amylase was associated with PTD in AP (P = .042).
Study details: This cross-sectional study included 108 individuals with previous AP (median, 20 months post-AP) and 60 healthy controls.
Disclosures: This study was supported by the Rutherford Discovery Fellowship by the Royal Society of New Zealand to MS Petrov. The authors declared no conflict of interests.
Source: Ko J et al. Obes Facts. 2021(Nov 9). Doi: 10.1159/000519621.
Key clinical point: An increased intrapancreatic fat deposition (IPFD) following acute pancreatitis (AP) was associated with a decrease in pancreatic tail diameter (PTD), and in turn, decreased circulating levels of pancreatic amylase.
Major finding: An increased IPFD was significantly associated with reduced PTD in patients with AP (P = .036). Pancreatic amylase was associated with PTD in AP (P = .042).
Study details: This cross-sectional study included 108 individuals with previous AP (median, 20 months post-AP) and 60 healthy controls.
Disclosures: This study was supported by the Rutherford Discovery Fellowship by the Royal Society of New Zealand to MS Petrov. The authors declared no conflict of interests.
Source: Ko J et al. Obes Facts. 2021(Nov 9). Doi: 10.1159/000519621.
CFTR modulator use tied to reduced acute pancreatitis hospitalizations in cystic fibrosis
Key clinical point: Cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulator use was associated with reduced incidence of acute pancreatitis (AP) hospitalizations in pancreas-sufficient (PS) and pancreas-insufficient (PI) patients with CF.
Major finding: Estimated rates of AP hospitalizations per 1000 patient-years in patients with PS-CF and PI-CF treated with CFTR modulator were 3.26 (95% CI 0.94-11.33) and 0.66 (95% CI 0.26-1.68), respectively, and those not treated with CFTR modulator were 10.20 (95% CI 6.19-16.81) and 1.76 (95% CI 0.98-3.17), respectively.
Study details: Findings are from a retrospective analysis of 10,417 patients with CF (PS n = 3,759; PI n = 6,658) with (17.2%) or without previous CFTR modulator use.
Disclosures: This study was supported by the US National Center for Advancing Translational Sciences. The authors declared no conflict of interests.
Source: Ramsey ML et al. Am J Gastroenterol. 2021(Oct 19). Doi: 10.14309/ajg.0000000000001527.
Key clinical point: Cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulator use was associated with reduced incidence of acute pancreatitis (AP) hospitalizations in pancreas-sufficient (PS) and pancreas-insufficient (PI) patients with CF.
Major finding: Estimated rates of AP hospitalizations per 1000 patient-years in patients with PS-CF and PI-CF treated with CFTR modulator were 3.26 (95% CI 0.94-11.33) and 0.66 (95% CI 0.26-1.68), respectively, and those not treated with CFTR modulator were 10.20 (95% CI 6.19-16.81) and 1.76 (95% CI 0.98-3.17), respectively.
Study details: Findings are from a retrospective analysis of 10,417 patients with CF (PS n = 3,759; PI n = 6,658) with (17.2%) or without previous CFTR modulator use.
Disclosures: This study was supported by the US National Center for Advancing Translational Sciences. The authors declared no conflict of interests.
Source: Ramsey ML et al. Am J Gastroenterol. 2021(Oct 19). Doi: 10.14309/ajg.0000000000001527.
Key clinical point: Cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulator use was associated with reduced incidence of acute pancreatitis (AP) hospitalizations in pancreas-sufficient (PS) and pancreas-insufficient (PI) patients with CF.
Major finding: Estimated rates of AP hospitalizations per 1000 patient-years in patients with PS-CF and PI-CF treated with CFTR modulator were 3.26 (95% CI 0.94-11.33) and 0.66 (95% CI 0.26-1.68), respectively, and those not treated with CFTR modulator were 10.20 (95% CI 6.19-16.81) and 1.76 (95% CI 0.98-3.17), respectively.
Study details: Findings are from a retrospective analysis of 10,417 patients with CF (PS n = 3,759; PI n = 6,658) with (17.2%) or without previous CFTR modulator use.
Disclosures: This study was supported by the US National Center for Advancing Translational Sciences. The authors declared no conflict of interests.
Source: Ramsey ML et al. Am J Gastroenterol. 2021(Oct 19). Doi: 10.14309/ajg.0000000000001527.
SARS-CoV-2 infection associated with increased risk of idiopathic acute pancreatitis but not diabetes or EPI
Key clinical point: After 12 months, SARS-CoV-2 infection increased the risk for idiopathic acute pancreatitis (AP) but not of diabetes or exocrine pancreatic insufficiency (EPI).
Major finding: Patients who were SARS-CoV-2 positive vs. negative were at a higher risk of idiopathic AP (34.7% vs. 13.9%; odds ratio [OR] 5.34; P < .001) but not of diabetes (2.3% vs. 2.5%; OR 0.61; P = .541) or EPI (OR 1.11; P = .828).
Study details: Findings are from a 12-month follow-up analysis of 1,476 patients with (n = 118) or without (n = 1,358) SARS-CoV-2 infection.
Disclosures: No source of funding was identified. The authors declared no conflict of interests.
Source: Nayar M et al. Gut. 2021(Nov 11). Doi: 10.1136/gutjnl-2021-326218.
Key clinical point: After 12 months, SARS-CoV-2 infection increased the risk for idiopathic acute pancreatitis (AP) but not of diabetes or exocrine pancreatic insufficiency (EPI).
Major finding: Patients who were SARS-CoV-2 positive vs. negative were at a higher risk of idiopathic AP (34.7% vs. 13.9%; odds ratio [OR] 5.34; P < .001) but not of diabetes (2.3% vs. 2.5%; OR 0.61; P = .541) or EPI (OR 1.11; P = .828).
Study details: Findings are from a 12-month follow-up analysis of 1,476 patients with (n = 118) or without (n = 1,358) SARS-CoV-2 infection.
Disclosures: No source of funding was identified. The authors declared no conflict of interests.
Source: Nayar M et al. Gut. 2021(Nov 11). Doi: 10.1136/gutjnl-2021-326218.
Key clinical point: After 12 months, SARS-CoV-2 infection increased the risk for idiopathic acute pancreatitis (AP) but not of diabetes or exocrine pancreatic insufficiency (EPI).
Major finding: Patients who were SARS-CoV-2 positive vs. negative were at a higher risk of idiopathic AP (34.7% vs. 13.9%; odds ratio [OR] 5.34; P < .001) but not of diabetes (2.3% vs. 2.5%; OR 0.61; P = .541) or EPI (OR 1.11; P = .828).
Study details: Findings are from a 12-month follow-up analysis of 1,476 patients with (n = 118) or without (n = 1,358) SARS-CoV-2 infection.
Disclosures: No source of funding was identified. The authors declared no conflict of interests.
Source: Nayar M et al. Gut. 2021(Nov 11). Doi: 10.1136/gutjnl-2021-326218.
Phase 3 fails to demonstrate survival benefit with tipifarnib maintenance in AML in remission
Key clinical point: Maintenance therapy with tipifarnib did not prolong survival in patients with acute myeloid leukemia (AML) in remission.
Major finding: The median disease-free survival for tipifarnib vs. observation arms was 8.9 vs. 5.3 months (hazard ratio [HR] 0.70; P = .026), which did not meet the prespecified limit to call a positive effect. The median overall survival was not significantly different between tipifarnib vs. observation arms (16.4 vs. 9.3 months; HR 0.74; P = .056).
Study details: Findings are from the phase 3 E2902 trial including 144 adult patients with non-M3 AML in remission and who were randomly assigned to tipifarnib or observation arms.
Disclosures: This study was supported by the US National Cancer Institute of the National Institutes of Health. No disclosures were reported.
Source: Luger SM et al. Leuk Res. 2021;111:106736 (Oct 28). Doi: 10.1016/j.leukres.2021.106736.
Key clinical point: Maintenance therapy with tipifarnib did not prolong survival in patients with acute myeloid leukemia (AML) in remission.
Major finding: The median disease-free survival for tipifarnib vs. observation arms was 8.9 vs. 5.3 months (hazard ratio [HR] 0.70; P = .026), which did not meet the prespecified limit to call a positive effect. The median overall survival was not significantly different between tipifarnib vs. observation arms (16.4 vs. 9.3 months; HR 0.74; P = .056).
Study details: Findings are from the phase 3 E2902 trial including 144 adult patients with non-M3 AML in remission and who were randomly assigned to tipifarnib or observation arms.
Disclosures: This study was supported by the US National Cancer Institute of the National Institutes of Health. No disclosures were reported.
Source: Luger SM et al. Leuk Res. 2021;111:106736 (Oct 28). Doi: 10.1016/j.leukres.2021.106736.
Key clinical point: Maintenance therapy with tipifarnib did not prolong survival in patients with acute myeloid leukemia (AML) in remission.
Major finding: The median disease-free survival for tipifarnib vs. observation arms was 8.9 vs. 5.3 months (hazard ratio [HR] 0.70; P = .026), which did not meet the prespecified limit to call a positive effect. The median overall survival was not significantly different between tipifarnib vs. observation arms (16.4 vs. 9.3 months; HR 0.74; P = .056).
Study details: Findings are from the phase 3 E2902 trial including 144 adult patients with non-M3 AML in remission and who were randomly assigned to tipifarnib or observation arms.
Disclosures: This study was supported by the US National Cancer Institute of the National Institutes of Health. No disclosures were reported.
Source: Luger SM et al. Leuk Res. 2021;111:106736 (Oct 28). Doi: 10.1016/j.leukres.2021.106736.
Alvocidib followed by cytarabine and mitoxantrone shows clinical activity in MCL-1-dependent R/R AML
Key clinical point: Alvocidib followed by cytarabine and mitoxantrone (ACM) was clinically active and well tolerated in patients with myeloid cell leukemia-1 (MCL-1)-dependent relapsed/refractory (R/R) acute myeloid leukemia (AML).
Major finding: The rates of composite complete remission after 1 cycle of ACM therapy were 47%, 21%, 64%, and 52% in patients with R/R AML with MCL-1 <15%, 15% to <30%, 30% to <40%, and ≥40%, respectively. The rate of 30-day mortality was 6% in the R/R AML cohort.
Study details: Findings are from the phase 2 Zella-201 study including 221 adult patients with R/R AML and an exploratory cohort of 169 patients with newly diagnosed high-risk AML, of which 39% were MCL-1 dependent (≥40%).
Disclosures: This study was supported by Tolero Pharmaceuticals, acquired by Sumitomo Dainippon Pharma (SDP). Some investigators, including the lead author, reported being employees of; receiving research funding, honoraria, grants, or drug support from; being on advisory boards or data monitoring committees for; or receiving consultancy or speaker roles from various sources, including Tolero and SDP.
Source: Zeidner JF et al. Blood Cancer J. 2021;11:175 (Oct 30). Doi: 10.1038/s41408-021-00568-3.
Key clinical point: Alvocidib followed by cytarabine and mitoxantrone (ACM) was clinically active and well tolerated in patients with myeloid cell leukemia-1 (MCL-1)-dependent relapsed/refractory (R/R) acute myeloid leukemia (AML).
Major finding: The rates of composite complete remission after 1 cycle of ACM therapy were 47%, 21%, 64%, and 52% in patients with R/R AML with MCL-1 <15%, 15% to <30%, 30% to <40%, and ≥40%, respectively. The rate of 30-day mortality was 6% in the R/R AML cohort.
Study details: Findings are from the phase 2 Zella-201 study including 221 adult patients with R/R AML and an exploratory cohort of 169 patients with newly diagnosed high-risk AML, of which 39% were MCL-1 dependent (≥40%).
Disclosures: This study was supported by Tolero Pharmaceuticals, acquired by Sumitomo Dainippon Pharma (SDP). Some investigators, including the lead author, reported being employees of; receiving research funding, honoraria, grants, or drug support from; being on advisory boards or data monitoring committees for; or receiving consultancy or speaker roles from various sources, including Tolero and SDP.
Source: Zeidner JF et al. Blood Cancer J. 2021;11:175 (Oct 30). Doi: 10.1038/s41408-021-00568-3.
Key clinical point: Alvocidib followed by cytarabine and mitoxantrone (ACM) was clinically active and well tolerated in patients with myeloid cell leukemia-1 (MCL-1)-dependent relapsed/refractory (R/R) acute myeloid leukemia (AML).
Major finding: The rates of composite complete remission after 1 cycle of ACM therapy were 47%, 21%, 64%, and 52% in patients with R/R AML with MCL-1 <15%, 15% to <30%, 30% to <40%, and ≥40%, respectively. The rate of 30-day mortality was 6% in the R/R AML cohort.
Study details: Findings are from the phase 2 Zella-201 study including 221 adult patients with R/R AML and an exploratory cohort of 169 patients with newly diagnosed high-risk AML, of which 39% were MCL-1 dependent (≥40%).
Disclosures: This study was supported by Tolero Pharmaceuticals, acquired by Sumitomo Dainippon Pharma (SDP). Some investigators, including the lead author, reported being employees of; receiving research funding, honoraria, grants, or drug support from; being on advisory boards or data monitoring committees for; or receiving consultancy or speaker roles from various sources, including Tolero and SDP.
Source: Zeidner JF et al. Blood Cancer J. 2021;11:175 (Oct 30). Doi: 10.1038/s41408-021-00568-3.