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High expression of PRR34-AS1 worsens prognosis in AML
Key clinical point: High PRR34 antisense RNA 1 (PRR34-AS1) expression was associated with poor chemotherapeutic response and prognosis in patients with acute myeloid leukemia (AML).
Major finding: Patients with high (n=42) vs low (n=41) expression of PRR34-AS1 had a significantly lower rate of complete remission (CR; 37.1% vs 72.7%; P = .004) and shorter overall survival (P = .002). PRR34-AS1 was an independent factor affecting CR in patients with whole AML (odds ratio [OR], 0.282; P = .032), non-acute promyelocytic leukemia-AML (OR, 0.253; P = .039), and cytogenetically normal AML (OR, 0.210; P = .033).
Study details: This study assessed PRR34-AS1 expression in 84 adult patients with newly diagnosed AML and 29 healthy controls.
Disclosures: This study was supported by the National Natural Science Foundation of China, Medical Innovation Team of Jiangsu Province, Zhenjiang Clinical Research Center of Hematology, Social Development Foundation of Zhenjiang, and Scientific Research Project of the Fifth 169 Project of Zhenjiang. The authors declared no conflicts of interest.
Source: Nan FY et al. Cancer Med. 2021 Jul 5. doi: 10.1002/cam4.4085.
Key clinical point: High PRR34 antisense RNA 1 (PRR34-AS1) expression was associated with poor chemotherapeutic response and prognosis in patients with acute myeloid leukemia (AML).
Major finding: Patients with high (n=42) vs low (n=41) expression of PRR34-AS1 had a significantly lower rate of complete remission (CR; 37.1% vs 72.7%; P = .004) and shorter overall survival (P = .002). PRR34-AS1 was an independent factor affecting CR in patients with whole AML (odds ratio [OR], 0.282; P = .032), non-acute promyelocytic leukemia-AML (OR, 0.253; P = .039), and cytogenetically normal AML (OR, 0.210; P = .033).
Study details: This study assessed PRR34-AS1 expression in 84 adult patients with newly diagnosed AML and 29 healthy controls.
Disclosures: This study was supported by the National Natural Science Foundation of China, Medical Innovation Team of Jiangsu Province, Zhenjiang Clinical Research Center of Hematology, Social Development Foundation of Zhenjiang, and Scientific Research Project of the Fifth 169 Project of Zhenjiang. The authors declared no conflicts of interest.
Source: Nan FY et al. Cancer Med. 2021 Jul 5. doi: 10.1002/cam4.4085.
Key clinical point: High PRR34 antisense RNA 1 (PRR34-AS1) expression was associated with poor chemotherapeutic response and prognosis in patients with acute myeloid leukemia (AML).
Major finding: Patients with high (n=42) vs low (n=41) expression of PRR34-AS1 had a significantly lower rate of complete remission (CR; 37.1% vs 72.7%; P = .004) and shorter overall survival (P = .002). PRR34-AS1 was an independent factor affecting CR in patients with whole AML (odds ratio [OR], 0.282; P = .032), non-acute promyelocytic leukemia-AML (OR, 0.253; P = .039), and cytogenetically normal AML (OR, 0.210; P = .033).
Study details: This study assessed PRR34-AS1 expression in 84 adult patients with newly diagnosed AML and 29 healthy controls.
Disclosures: This study was supported by the National Natural Science Foundation of China, Medical Innovation Team of Jiangsu Province, Zhenjiang Clinical Research Center of Hematology, Social Development Foundation of Zhenjiang, and Scientific Research Project of the Fifth 169 Project of Zhenjiang. The authors declared no conflicts of interest.
Source: Nan FY et al. Cancer Med. 2021 Jul 5. doi: 10.1002/cam4.4085.
TP53-mutated AML: No survival benefit with addition of venetoclax to standard therapies
Key clinical point: The addition of venetoclax to standard treatment regimens (VEN-based) did not improve clinical outcomes in patients with TP53-mutated acute myeloid leukemia (AML), highlighting the need for novel therapies in this patient population.
Major finding: Overall, no significant differences were observed in the rates of composite complete remission (P = .18), overall survival (median, 5.7 months vs 6.6 months; P = .4), relapse-free survival (median, 3.5 months vs 4.7 months; P = .43), 4-week mortality (7% vs 10%; P = .5), and 8-week mortality (22% vs 17%; P = .4) in patients receiving VEN-based vs non-VEN-based therapies.
Study details: Findings are from a retrospective analysis of 238 patients with newly diagnosed TP53-mutated AML treated with either VEN-based (n=58) or non-VEN-based (n=180) therapies.
Disclosures: This study was supported partly by the University of Texas MD Anderson Cancer Center Support Grant from the National Cancer Institute. Some investigators reported ties with various pharmaceutical companies.
Source: Venugopal S et al. Cancer. 2021 Jun 28. doi: 10.1002/cncr.33675.
Key clinical point: The addition of venetoclax to standard treatment regimens (VEN-based) did not improve clinical outcomes in patients with TP53-mutated acute myeloid leukemia (AML), highlighting the need for novel therapies in this patient population.
Major finding: Overall, no significant differences were observed in the rates of composite complete remission (P = .18), overall survival (median, 5.7 months vs 6.6 months; P = .4), relapse-free survival (median, 3.5 months vs 4.7 months; P = .43), 4-week mortality (7% vs 10%; P = .5), and 8-week mortality (22% vs 17%; P = .4) in patients receiving VEN-based vs non-VEN-based therapies.
Study details: Findings are from a retrospective analysis of 238 patients with newly diagnosed TP53-mutated AML treated with either VEN-based (n=58) or non-VEN-based (n=180) therapies.
Disclosures: This study was supported partly by the University of Texas MD Anderson Cancer Center Support Grant from the National Cancer Institute. Some investigators reported ties with various pharmaceutical companies.
Source: Venugopal S et al. Cancer. 2021 Jun 28. doi: 10.1002/cncr.33675.
Key clinical point: The addition of venetoclax to standard treatment regimens (VEN-based) did not improve clinical outcomes in patients with TP53-mutated acute myeloid leukemia (AML), highlighting the need for novel therapies in this patient population.
Major finding: Overall, no significant differences were observed in the rates of composite complete remission (P = .18), overall survival (median, 5.7 months vs 6.6 months; P = .4), relapse-free survival (median, 3.5 months vs 4.7 months; P = .43), 4-week mortality (7% vs 10%; P = .5), and 8-week mortality (22% vs 17%; P = .4) in patients receiving VEN-based vs non-VEN-based therapies.
Study details: Findings are from a retrospective analysis of 238 patients with newly diagnosed TP53-mutated AML treated with either VEN-based (n=58) or non-VEN-based (n=180) therapies.
Disclosures: This study was supported partly by the University of Texas MD Anderson Cancer Center Support Grant from the National Cancer Institute. Some investigators reported ties with various pharmaceutical companies.
Source: Venugopal S et al. Cancer. 2021 Jun 28. doi: 10.1002/cncr.33675.
GM-EIA and BDG assays ineffective for IFD diagnosis in AML patients receiving antifungal prophylaxis
Key clinical point: Twice-weekly surveillance with galactomannan enzyme immunoassay (GM-EIA) and b-D-glucan (BDG) assay was ineffective at detecting invasive fungal diseases (IFDs) in children, adolescents, and young adults with acute myeloid leukemia (AML) receiving antifungal prophylaxis.
Major finding: The negative predictive value was greater than 99% for an individual or combination of GM-EIA and BDG assays. However, true positive results were not observed in any sample collected within 7 days of an invasive aspergillosis/candidiasis diagnosis, resulting in sensitivity and positive predictive value for each test of 0%.
Study details: This observational study imbedded within a phase 3 Children’s Oncology Group trial (ACCL0933) included 471 patients with AML (age, 3 months-30 years) receiving fluconazole (n=235) or caspofungin (n=236).
Disclosures: This study was supported by the National Cancer Institute’s (NCI) Biomarker, Imaging and Quality of Life Studies Funding Program, and the NCI support of the Children’s Oncology Group. Some investigators including the lead author reported ties with various pharmaceutical companies.
Source: Fisher BT et al. J Pediatric Infect Dis Soc. 2021 Jun 26. doi: 10.1093/jpids/piab036.
Key clinical point: Twice-weekly surveillance with galactomannan enzyme immunoassay (GM-EIA) and b-D-glucan (BDG) assay was ineffective at detecting invasive fungal diseases (IFDs) in children, adolescents, and young adults with acute myeloid leukemia (AML) receiving antifungal prophylaxis.
Major finding: The negative predictive value was greater than 99% for an individual or combination of GM-EIA and BDG assays. However, true positive results were not observed in any sample collected within 7 days of an invasive aspergillosis/candidiasis diagnosis, resulting in sensitivity and positive predictive value for each test of 0%.
Study details: This observational study imbedded within a phase 3 Children’s Oncology Group trial (ACCL0933) included 471 patients with AML (age, 3 months-30 years) receiving fluconazole (n=235) or caspofungin (n=236).
Disclosures: This study was supported by the National Cancer Institute’s (NCI) Biomarker, Imaging and Quality of Life Studies Funding Program, and the NCI support of the Children’s Oncology Group. Some investigators including the lead author reported ties with various pharmaceutical companies.
Source: Fisher BT et al. J Pediatric Infect Dis Soc. 2021 Jun 26. doi: 10.1093/jpids/piab036.
Key clinical point: Twice-weekly surveillance with galactomannan enzyme immunoassay (GM-EIA) and b-D-glucan (BDG) assay was ineffective at detecting invasive fungal diseases (IFDs) in children, adolescents, and young adults with acute myeloid leukemia (AML) receiving antifungal prophylaxis.
Major finding: The negative predictive value was greater than 99% for an individual or combination of GM-EIA and BDG assays. However, true positive results were not observed in any sample collected within 7 days of an invasive aspergillosis/candidiasis diagnosis, resulting in sensitivity and positive predictive value for each test of 0%.
Study details: This observational study imbedded within a phase 3 Children’s Oncology Group trial (ACCL0933) included 471 patients with AML (age, 3 months-30 years) receiving fluconazole (n=235) or caspofungin (n=236).
Disclosures: This study was supported by the National Cancer Institute’s (NCI) Biomarker, Imaging and Quality of Life Studies Funding Program, and the NCI support of the Children’s Oncology Group. Some investigators including the lead author reported ties with various pharmaceutical companies.
Source: Fisher BT et al. J Pediatric Infect Dis Soc. 2021 Jun 26. doi: 10.1093/jpids/piab036.
AML with CBFB-MYH11: D816V KIT mutation and peri-transplant CBFB-MYH11 MRD positivity predict post-HSCT outcomes
Key clinical point: Among patients with acute myeloid leukemia (AML) with CBFB-MYH11 who underwent allogeneic or autologous hematopoietic stem cell transplantation (HSCT) in remission, D816V KIT mutation, and peri-transplant CBFB-MYH11 measurable residual disease (MRD) monitoring were associated with posttransplant relapse and survival.
Major finding: Patients with D816V KIT mutation had an increased cumulative incidence of relapse (CIR; P less than .001) and worse disease-free survival (P = .002) vs patients with other or no KIT mutations. The presence of MRD defined by 2.0 log reduction before and 3 months post-HSCT were associated with increased CIR and poorer overall survival (all P less than .001).
Study details: Findings are from a retrospective analysis of 88 patients with AML with CBFB-MYH11 who underwent HSCT in the first (n=81) or second (n=7) complete remission.
Disclosures: This study was supported by the National Research Foundation of Korea, funded by the Ministry of Education and the National R&D Program for Cancer Control, Ministry for Health and Welfare, Republic of Korea. The authors declared no conflicts of interest.
Source: Cho BS et al. Bone Marrow Transplant. 2021 Jun 28. doi: 10.1038/s41409-021-01384-w.
Key clinical point: Among patients with acute myeloid leukemia (AML) with CBFB-MYH11 who underwent allogeneic or autologous hematopoietic stem cell transplantation (HSCT) in remission, D816V KIT mutation, and peri-transplant CBFB-MYH11 measurable residual disease (MRD) monitoring were associated with posttransplant relapse and survival.
Major finding: Patients with D816V KIT mutation had an increased cumulative incidence of relapse (CIR; P less than .001) and worse disease-free survival (P = .002) vs patients with other or no KIT mutations. The presence of MRD defined by 2.0 log reduction before and 3 months post-HSCT were associated with increased CIR and poorer overall survival (all P less than .001).
Study details: Findings are from a retrospective analysis of 88 patients with AML with CBFB-MYH11 who underwent HSCT in the first (n=81) or second (n=7) complete remission.
Disclosures: This study was supported by the National Research Foundation of Korea, funded by the Ministry of Education and the National R&D Program for Cancer Control, Ministry for Health and Welfare, Republic of Korea. The authors declared no conflicts of interest.
Source: Cho BS et al. Bone Marrow Transplant. 2021 Jun 28. doi: 10.1038/s41409-021-01384-w.
Key clinical point: Among patients with acute myeloid leukemia (AML) with CBFB-MYH11 who underwent allogeneic or autologous hematopoietic stem cell transplantation (HSCT) in remission, D816V KIT mutation, and peri-transplant CBFB-MYH11 measurable residual disease (MRD) monitoring were associated with posttransplant relapse and survival.
Major finding: Patients with D816V KIT mutation had an increased cumulative incidence of relapse (CIR; P less than .001) and worse disease-free survival (P = .002) vs patients with other or no KIT mutations. The presence of MRD defined by 2.0 log reduction before and 3 months post-HSCT were associated with increased CIR and poorer overall survival (all P less than .001).
Study details: Findings are from a retrospective analysis of 88 patients with AML with CBFB-MYH11 who underwent HSCT in the first (n=81) or second (n=7) complete remission.
Disclosures: This study was supported by the National Research Foundation of Korea, funded by the Ministry of Education and the National R&D Program for Cancer Control, Ministry for Health and Welfare, Republic of Korea. The authors declared no conflicts of interest.
Source: Cho BS et al. Bone Marrow Transplant. 2021 Jun 28. doi: 10.1038/s41409-021-01384-w.
Females have a survival advantage over males in nonacute promyelocytic leukemia AML
Key clinical point: Female vs male gender confers a survival advantage in patients with nonacute promyelocytic leukemia (APL) acute myeloid leukemia (AML). However, reasons for this sex-specific advantage remain to be explored.
Major finding: Among patients with non-APL AML, females vs males had a significantly longer overall survival (hazard ratio, 0.85; P = .0001), but not disease-free survival (P = .14). This survival advantage was irrespective of patient age, white blood cell count, or initial blood and marrow blast counts.
Study details: Findings are from a retrospective analysis of 3,546 newly diagnosed patients with AML, including 548 with APL enrolled in 10 studies of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group between March 1984 and November 2008.
Disclosures: This study was supported by the National Cancer Institute of the National Institutes of Health. The authors declared no conflicts of interest.
Source: Wiernik PH et al. Br J Haematol. 2021 Jun 17. doi: 10.1111/bjh.17523.
Key clinical point: Female vs male gender confers a survival advantage in patients with nonacute promyelocytic leukemia (APL) acute myeloid leukemia (AML). However, reasons for this sex-specific advantage remain to be explored.
Major finding: Among patients with non-APL AML, females vs males had a significantly longer overall survival (hazard ratio, 0.85; P = .0001), but not disease-free survival (P = .14). This survival advantage was irrespective of patient age, white blood cell count, or initial blood and marrow blast counts.
Study details: Findings are from a retrospective analysis of 3,546 newly diagnosed patients with AML, including 548 with APL enrolled in 10 studies of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group between March 1984 and November 2008.
Disclosures: This study was supported by the National Cancer Institute of the National Institutes of Health. The authors declared no conflicts of interest.
Source: Wiernik PH et al. Br J Haematol. 2021 Jun 17. doi: 10.1111/bjh.17523.
Key clinical point: Female vs male gender confers a survival advantage in patients with nonacute promyelocytic leukemia (APL) acute myeloid leukemia (AML). However, reasons for this sex-specific advantage remain to be explored.
Major finding: Among patients with non-APL AML, females vs males had a significantly longer overall survival (hazard ratio, 0.85; P = .0001), but not disease-free survival (P = .14). This survival advantage was irrespective of patient age, white blood cell count, or initial blood and marrow blast counts.
Study details: Findings are from a retrospective analysis of 3,546 newly diagnosed patients with AML, including 548 with APL enrolled in 10 studies of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group between March 1984 and November 2008.
Disclosures: This study was supported by the National Cancer Institute of the National Institutes of Health. The authors declared no conflicts of interest.
Source: Wiernik PH et al. Br J Haematol. 2021 Jun 17. doi: 10.1111/bjh.17523.
Conditioning regimen with Flu/Bu4/Mel vs conventional myeloablative conditioning improves survival in R/R AML patients in non-remission
Key clinical point: A myeloablative conditioning regimen consisting of fludarabine, a myeloablative dose of intravenous busulfan, and melphalan (Flu/Bu4/Mel) vs conventional myeloablative conditioning regimen (cMAC) before allogeneic hematopoietic stem cell transplantation resulted in improved prognosis in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) in non-remission.
Major finding: Flu/Bu4/Mel vs cMAC resulted in significantly improved 5-year overall survival (adjusted hazard ratio [aHR], 0.57; P = .015), relapse (aHR, 0.64; P = .031), and relapse-associated mortality (aHR, 0.64; P = .043).
Study details: This study assessed the prognostic impact of Flu/Bu4/Mel (n=94) vs cMAC (n=94) in 188 adult patients with R/R AML in non-remission.
Disclosures: No specific source of funding was identified. The authors declared no conflicts of interest.
Source: Shimomura Y et al. Bone Marrow Transplant. 2021 Jun 21. doi: 10.1038/s41409-021-01380-0.
Key clinical point: A myeloablative conditioning regimen consisting of fludarabine, a myeloablative dose of intravenous busulfan, and melphalan (Flu/Bu4/Mel) vs conventional myeloablative conditioning regimen (cMAC) before allogeneic hematopoietic stem cell transplantation resulted in improved prognosis in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) in non-remission.
Major finding: Flu/Bu4/Mel vs cMAC resulted in significantly improved 5-year overall survival (adjusted hazard ratio [aHR], 0.57; P = .015), relapse (aHR, 0.64; P = .031), and relapse-associated mortality (aHR, 0.64; P = .043).
Study details: This study assessed the prognostic impact of Flu/Bu4/Mel (n=94) vs cMAC (n=94) in 188 adult patients with R/R AML in non-remission.
Disclosures: No specific source of funding was identified. The authors declared no conflicts of interest.
Source: Shimomura Y et al. Bone Marrow Transplant. 2021 Jun 21. doi: 10.1038/s41409-021-01380-0.
Key clinical point: A myeloablative conditioning regimen consisting of fludarabine, a myeloablative dose of intravenous busulfan, and melphalan (Flu/Bu4/Mel) vs conventional myeloablative conditioning regimen (cMAC) before allogeneic hematopoietic stem cell transplantation resulted in improved prognosis in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) in non-remission.
Major finding: Flu/Bu4/Mel vs cMAC resulted in significantly improved 5-year overall survival (adjusted hazard ratio [aHR], 0.57; P = .015), relapse (aHR, 0.64; P = .031), and relapse-associated mortality (aHR, 0.64; P = .043).
Study details: This study assessed the prognostic impact of Flu/Bu4/Mel (n=94) vs cMAC (n=94) in 188 adult patients with R/R AML in non-remission.
Disclosures: No specific source of funding was identified. The authors declared no conflicts of interest.
Source: Shimomura Y et al. Bone Marrow Transplant. 2021 Jun 21. doi: 10.1038/s41409-021-01380-0.
Improved infection control with romyelocel-L in AML patients receiving induction chemotherapy
Key clinical point: Romyelocel-L plus granulocyte colony-stimulating factor (G-CSF) vs G-CSF monotherapy led to a significant reduction in the incidence of infections and length of hospitalization in patients with acute myeloid leukemia (AML) receiving induction chemotherapy.
Major finding: From days 15 to 28, romyelocel-L plus G-CSF vs G-CSF monotherapy significantly reduced the mean duration of febrile episodes (2.36 days vs 3.90 days; P = .02) and incidence of infections (6.8% vs 27.9%; P = .0013). Length of hospitalization was significantly shorter in the romyelocel-L plus G-CSF vs G-CSF monotherapy group (25.5 days vs 28.7 days; P = .002).
Study details: This phase 2 study included 163 patients with de novo AML receiving induction chemotherapy. Evaluable patients (n=120) were randomly assigned to receive either romyelocel-L plus G-CSF (n=59) or G-CSF monotherapy (n=61).
Disclosures: This study was supported by the Biomedical Advanced Research and Development Authority. Some investigators including the lead author reported ties with various pharmaceutical companies.
Source: Desai PM et al. J Clin Oncol. 2021 Jun 22. doi: 10.1200/JCO.20.01739.
Key clinical point: Romyelocel-L plus granulocyte colony-stimulating factor (G-CSF) vs G-CSF monotherapy led to a significant reduction in the incidence of infections and length of hospitalization in patients with acute myeloid leukemia (AML) receiving induction chemotherapy.
Major finding: From days 15 to 28, romyelocel-L plus G-CSF vs G-CSF monotherapy significantly reduced the mean duration of febrile episodes (2.36 days vs 3.90 days; P = .02) and incidence of infections (6.8% vs 27.9%; P = .0013). Length of hospitalization was significantly shorter in the romyelocel-L plus G-CSF vs G-CSF monotherapy group (25.5 days vs 28.7 days; P = .002).
Study details: This phase 2 study included 163 patients with de novo AML receiving induction chemotherapy. Evaluable patients (n=120) were randomly assigned to receive either romyelocel-L plus G-CSF (n=59) or G-CSF monotherapy (n=61).
Disclosures: This study was supported by the Biomedical Advanced Research and Development Authority. Some investigators including the lead author reported ties with various pharmaceutical companies.
Source: Desai PM et al. J Clin Oncol. 2021 Jun 22. doi: 10.1200/JCO.20.01739.
Key clinical point: Romyelocel-L plus granulocyte colony-stimulating factor (G-CSF) vs G-CSF monotherapy led to a significant reduction in the incidence of infections and length of hospitalization in patients with acute myeloid leukemia (AML) receiving induction chemotherapy.
Major finding: From days 15 to 28, romyelocel-L plus G-CSF vs G-CSF monotherapy significantly reduced the mean duration of febrile episodes (2.36 days vs 3.90 days; P = .02) and incidence of infections (6.8% vs 27.9%; P = .0013). Length of hospitalization was significantly shorter in the romyelocel-L plus G-CSF vs G-CSF monotherapy group (25.5 days vs 28.7 days; P = .002).
Study details: This phase 2 study included 163 patients with de novo AML receiving induction chemotherapy. Evaluable patients (n=120) were randomly assigned to receive either romyelocel-L plus G-CSF (n=59) or G-CSF monotherapy (n=61).
Disclosures: This study was supported by the Biomedical Advanced Research and Development Authority. Some investigators including the lead author reported ties with various pharmaceutical companies.
Source: Desai PM et al. J Clin Oncol. 2021 Jun 22. doi: 10.1200/JCO.20.01739.
MRD status guides post-remission treatment in patients with intermediate-risk AML
Key clinical point: Clinical therapeutic decisions based on dynamic measurable residual disease (MRD) may improve therapy stratification and optimize post-remission treatment with either chemotherapy, autologous stem cell transplant (auto-SCT), or allogeneic SCT (allo-SCT) in patients with intermediate-risk acute myeloid leukemia (AML).
Major finding: In patients with persistent MRD-negative after 1, 2, or 3 chemotherapy cycles, chemotherapy (P = .03) and auto-SCT (P = .01) vs allo-SCT improved graft-vs-host-disease-free, relapse-free survival. Allo-SCT led to favorable outcomes among patients with persistent MRD-positive or MRD-negative after 3 chemotherapy courses and those with recurrent MRD-positive after MRD-negative. Patients who were MRD-negative after 2 chemotherapy cycles had better leukemia-free survival, overall survival, and relapse with auto-SCT vs allo-SCT and chemotherapy (all P less than .05).
Study details: Findings are from 549 patients with intermediate-risk AML treated with either chemotherapy, auto-SCT or allo-SCT after the first complete remission.
Disclosures: This study was funded by grants from the National Key Research and Development Projects, National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.
Source: Yu S et al. JAMA Netw Open. 2021 Jul 7. doi: 10.1001/jamanetworkopen.2021.15991.
Key clinical point: Clinical therapeutic decisions based on dynamic measurable residual disease (MRD) may improve therapy stratification and optimize post-remission treatment with either chemotherapy, autologous stem cell transplant (auto-SCT), or allogeneic SCT (allo-SCT) in patients with intermediate-risk acute myeloid leukemia (AML).
Major finding: In patients with persistent MRD-negative after 1, 2, or 3 chemotherapy cycles, chemotherapy (P = .03) and auto-SCT (P = .01) vs allo-SCT improved graft-vs-host-disease-free, relapse-free survival. Allo-SCT led to favorable outcomes among patients with persistent MRD-positive or MRD-negative after 3 chemotherapy courses and those with recurrent MRD-positive after MRD-negative. Patients who were MRD-negative after 2 chemotherapy cycles had better leukemia-free survival, overall survival, and relapse with auto-SCT vs allo-SCT and chemotherapy (all P less than .05).
Study details: Findings are from 549 patients with intermediate-risk AML treated with either chemotherapy, auto-SCT or allo-SCT after the first complete remission.
Disclosures: This study was funded by grants from the National Key Research and Development Projects, National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.
Source: Yu S et al. JAMA Netw Open. 2021 Jul 7. doi: 10.1001/jamanetworkopen.2021.15991.
Key clinical point: Clinical therapeutic decisions based on dynamic measurable residual disease (MRD) may improve therapy stratification and optimize post-remission treatment with either chemotherapy, autologous stem cell transplant (auto-SCT), or allogeneic SCT (allo-SCT) in patients with intermediate-risk acute myeloid leukemia (AML).
Major finding: In patients with persistent MRD-negative after 1, 2, or 3 chemotherapy cycles, chemotherapy (P = .03) and auto-SCT (P = .01) vs allo-SCT improved graft-vs-host-disease-free, relapse-free survival. Allo-SCT led to favorable outcomes among patients with persistent MRD-positive or MRD-negative after 3 chemotherapy courses and those with recurrent MRD-positive after MRD-negative. Patients who were MRD-negative after 2 chemotherapy cycles had better leukemia-free survival, overall survival, and relapse with auto-SCT vs allo-SCT and chemotherapy (all P less than .05).
Study details: Findings are from 549 patients with intermediate-risk AML treated with either chemotherapy, auto-SCT or allo-SCT after the first complete remission.
Disclosures: This study was funded by grants from the National Key Research and Development Projects, National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.
Source: Yu S et al. JAMA Netw Open. 2021 Jul 7. doi: 10.1001/jamanetworkopen.2021.15991.
CPX-351 vs standard chemotherapy continues to show improved OS in high-risk or secondary AML
Key clinical point: At 5 years of follow-up, a fixed combination of daunorubicin and cytarabine (CPX-351) vs standard chemotherapy with cytarabine for 7 days and daunorubicin for 3 days (7+3) improved overall survival (OS) in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML).
Major finding: Favorable difference in median OS in favor of CPX-351 vs 7+3 group was maintained (hazard ratio, 0.70; 95% confidence interval [CI], 0.55-0.91). At 5 years, survival estimates were higher for CPX-351 vs 7+3 (18% [95% CI, 12%-25%] vs 8% [95% CI, 4%-13%]). Overall, 5% of deaths in both groups were considered related to the study treatment.
Study details: Findings are the final 5-year follow-up results of a phase 3 trial including 309 patients aged 60-75 years with newly diagnosed high-risk or secondary AML. Patients were randomly assigned to either CPX-351 (n=153) or 7+3 chemotherapy (n=156).
Disclosures: This study was supported by Jazz Pharmaceuticals. The lead author reported consulting for various sources. Other authors reported ties with various pharmaceutical companies including Jazz Pharmaceuticals.
Source: Lancet JE et al. Lancet Haematol. 2021 Jul. doi: 10.1016/S2352-3026(21)00134-4.
Key clinical point: At 5 years of follow-up, a fixed combination of daunorubicin and cytarabine (CPX-351) vs standard chemotherapy with cytarabine for 7 days and daunorubicin for 3 days (7+3) improved overall survival (OS) in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML).
Major finding: Favorable difference in median OS in favor of CPX-351 vs 7+3 group was maintained (hazard ratio, 0.70; 95% confidence interval [CI], 0.55-0.91). At 5 years, survival estimates were higher for CPX-351 vs 7+3 (18% [95% CI, 12%-25%] vs 8% [95% CI, 4%-13%]). Overall, 5% of deaths in both groups were considered related to the study treatment.
Study details: Findings are the final 5-year follow-up results of a phase 3 trial including 309 patients aged 60-75 years with newly diagnosed high-risk or secondary AML. Patients were randomly assigned to either CPX-351 (n=153) or 7+3 chemotherapy (n=156).
Disclosures: This study was supported by Jazz Pharmaceuticals. The lead author reported consulting for various sources. Other authors reported ties with various pharmaceutical companies including Jazz Pharmaceuticals.
Source: Lancet JE et al. Lancet Haematol. 2021 Jul. doi: 10.1016/S2352-3026(21)00134-4.
Key clinical point: At 5 years of follow-up, a fixed combination of daunorubicin and cytarabine (CPX-351) vs standard chemotherapy with cytarabine for 7 days and daunorubicin for 3 days (7+3) improved overall survival (OS) in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML).
Major finding: Favorable difference in median OS in favor of CPX-351 vs 7+3 group was maintained (hazard ratio, 0.70; 95% confidence interval [CI], 0.55-0.91). At 5 years, survival estimates were higher for CPX-351 vs 7+3 (18% [95% CI, 12%-25%] vs 8% [95% CI, 4%-13%]). Overall, 5% of deaths in both groups were considered related to the study treatment.
Study details: Findings are the final 5-year follow-up results of a phase 3 trial including 309 patients aged 60-75 years with newly diagnosed high-risk or secondary AML. Patients were randomly assigned to either CPX-351 (n=153) or 7+3 chemotherapy (n=156).
Disclosures: This study was supported by Jazz Pharmaceuticals. The lead author reported consulting for various sources. Other authors reported ties with various pharmaceutical companies including Jazz Pharmaceuticals.
Source: Lancet JE et al. Lancet Haematol. 2021 Jul. doi: 10.1016/S2352-3026(21)00134-4.
NPM1-mutated AML: CD33 SNP rs12459419 predicts relapse in gemtuzumab ozogamicin-treated patients
Key clinical point: Cluster of differentiation 33 (CD33) single-nucleotide polymorphism (SNP) rs12459419 predicts the rate of relapse in patients with nucleophosmin1 (NPM1)-mutated acute myeloid leukemia (AML) treated with gemtuzumab ozogamicin (GO).
Major finding: Complete remission, event-free survival, and cumulative incidence of death were not significantly different between genotypes in the treatment arms. However, patients with c.41 C/C genotype for rs12459419 in the GO vs. standard arm showed significant improvement in relapse-free survival (P = .03) and cumulative incidence of relapse (P = .023).
Study details: Findings are from the phase 3 AMLSG 09-09 trial including 588 adult patients with NPM1-mutated AML who were eligible for intensive therapy. Patients were randomly allocated to receive 2 cycles of induction chemotherapy with (n=273) or without (n=272) GO.
Disclosures: This work was supported by grants from the Deutsche José Carreras Leukämie-Stiftung e.V., German Federal Ministry of Education and Research, and Deutsche Forschungsgemeinschaft. The authors declared no conflicts of interest.
Source: Teich K et al. Haematologica. 2021 May 27. doi: 10.3324/haematol.2021.278894.
Key clinical point: Cluster of differentiation 33 (CD33) single-nucleotide polymorphism (SNP) rs12459419 predicts the rate of relapse in patients with nucleophosmin1 (NPM1)-mutated acute myeloid leukemia (AML) treated with gemtuzumab ozogamicin (GO).
Major finding: Complete remission, event-free survival, and cumulative incidence of death were not significantly different between genotypes in the treatment arms. However, patients with c.41 C/C genotype for rs12459419 in the GO vs. standard arm showed significant improvement in relapse-free survival (P = .03) and cumulative incidence of relapse (P = .023).
Study details: Findings are from the phase 3 AMLSG 09-09 trial including 588 adult patients with NPM1-mutated AML who were eligible for intensive therapy. Patients were randomly allocated to receive 2 cycles of induction chemotherapy with (n=273) or without (n=272) GO.
Disclosures: This work was supported by grants from the Deutsche José Carreras Leukämie-Stiftung e.V., German Federal Ministry of Education and Research, and Deutsche Forschungsgemeinschaft. The authors declared no conflicts of interest.
Source: Teich K et al. Haematologica. 2021 May 27. doi: 10.3324/haematol.2021.278894.
Key clinical point: Cluster of differentiation 33 (CD33) single-nucleotide polymorphism (SNP) rs12459419 predicts the rate of relapse in patients with nucleophosmin1 (NPM1)-mutated acute myeloid leukemia (AML) treated with gemtuzumab ozogamicin (GO).
Major finding: Complete remission, event-free survival, and cumulative incidence of death were not significantly different between genotypes in the treatment arms. However, patients with c.41 C/C genotype for rs12459419 in the GO vs. standard arm showed significant improvement in relapse-free survival (P = .03) and cumulative incidence of relapse (P = .023).
Study details: Findings are from the phase 3 AMLSG 09-09 trial including 588 adult patients with NPM1-mutated AML who were eligible for intensive therapy. Patients were randomly allocated to receive 2 cycles of induction chemotherapy with (n=273) or without (n=272) GO.
Disclosures: This work was supported by grants from the Deutsche José Carreras Leukämie-Stiftung e.V., German Federal Ministry of Education and Research, and Deutsche Forschungsgemeinschaft. The authors declared no conflicts of interest.
Source: Teich K et al. Haematologica. 2021 May 27. doi: 10.3324/haematol.2021.278894.