Key clinical point: Improvements in patient-reported functional outcomes in patients with chronic-phase chronic myeloid leukemia (CML-CP) in treatment-free remission (TFR) deteriorated after restarting tyrosine kinase inhibitor (TKI).

Major finding: Among patients in TFR at 12 months, 92.0% had at least a 3-point improvement in social function, 71.4% in social isolation, 9.8% in sexual satisfaction, and 3.6% in physical function. No patients had at least a 3-point improvement in cognitive function or interest in sexual activity. All functional changes worsened after restarting TKI.

Study details: Findings are from the prospective LAST study including 172 adult patients with CML-CP attempting TFR after at least 3 years of treatment with a first- or second-generation TKI and at least 2 years in molecular response 4.

Disclosures: This study was supported by the National Cancer Institute at the National Institute of Health. The lead author reported research support from the American Society of Hematology. Some investigators reported ties with various pharmaceutical companies.

Source: Schoenbeck KL et al. J Natl Cancer Inst. 2021 Sep 7. doi: 10.1093/jnci/djab184.

Key clinical point: Improvements in patient-reported functional outcomes in patients with chronic-phase chronic myeloid leukemia (CML-CP) in treatment-free remission (TFR) deteriorated after restarting tyrosine kinase inhibitor (TKI).

Major finding: Among patients in TFR at 12 months, 92.0% had at least a 3-point improvement in social function, 71.4% in social isolation, 9.8% in sexual satisfaction, and 3.6% in physical function. No patients had at least a 3-point improvement in cognitive function or interest in sexual activity. All functional changes worsened after restarting TKI.

Study details: Findings are from the prospective LAST study including 172 adult patients with CML-CP attempting TFR after at least 3 years of treatment with a first- or second-generation TKI and at least 2 years in molecular response 4.

Disclosures: This study was supported by the National Cancer Institute at the National Institute of Health. The lead author reported research support from the American Society of Hematology. Some investigators reported ties with various pharmaceutical companies.

Source: Schoenbeck KL et al. J Natl Cancer Inst. 2021 Sep 7. doi: 10.1093/jnci/djab184.

Key clinical point: Improvements in patient-reported functional outcomes in patients with chronic-phase chronic myeloid leukemia (CML-CP) in treatment-free remission (TFR) deteriorated after restarting tyrosine kinase inhibitor (TKI).

Major finding: Among patients in TFR at 12 months, 92.0% had at least a 3-point improvement in social function, 71.4% in social isolation, 9.8% in sexual satisfaction, and 3.6% in physical function. No patients had at least a 3-point improvement in cognitive function or interest in sexual activity. All functional changes worsened after restarting TKI.

Study details: Findings are from the prospective LAST study including 172 adult patients with CML-CP attempting TFR after at least 3 years of treatment with a first- or second-generation TKI and at least 2 years in molecular response 4.

Disclosures: This study was supported by the National Cancer Institute at the National Institute of Health. The lead author reported research support from the American Society of Hematology. Some investigators reported ties with various pharmaceutical companies.

Source: Schoenbeck KL et al. J Natl Cancer Inst. 2021 Sep 7. doi: 10.1093/jnci/djab184.

Key clinical point: BCR-ABL1 transcript doubling time (DT) at 2 months was strongly associated with treatment-free remission (TFR) failure after imatinib discontinuation in patients with chronic-phase chronic myeloid leukemia (CML-CP).

Major finding: The molecular recurrence-free survival at 12 months was 5.0% in patients in the high-risk (DT at 2 months, <12.75 days) vs. 47.2% in the intermediate-risk (DT at 2 months, ≥12.75 days) and 90.1% in the low-risk (DT at 2 months, 0 or less) groups (P < .001). DT at 2 months determined high-risk (hazard ratio [HR] 8.062; P = .0006) and low-risk (HR 0.196; P = .0110) groups for TFR failure.

Study details: This study assessed 131 patients with CML-CP in the imatinib discontinuation phase enrolled in the TRAD study.

Disclosures: This study was supported by BMS Canada and partly by the Princess Margaret Cancer Foundation. The lead author reported a research grant from the BMS and Novartis.

Source: Kim DDH et al. Br J Haematol. 2021 Sep 8. doi: 10.1111/bjh.17807

Key clinical point: BCR-ABL1 transcript doubling time (DT) at 2 months was strongly associated with treatment-free remission (TFR) failure after imatinib discontinuation in patients with chronic-phase chronic myeloid leukemia (CML-CP).

Major finding: The molecular recurrence-free survival at 12 months was 5.0% in patients in the high-risk (DT at 2 months, <12.75 days) vs. 47.2% in the intermediate-risk (DT at 2 months, ≥12.75 days) and 90.1% in the low-risk (DT at 2 months, 0 or less) groups (P < .001). DT at 2 months determined high-risk (hazard ratio [HR] 8.062; P = .0006) and low-risk (HR 0.196; P = .0110) groups for TFR failure.

Study details: This study assessed 131 patients with CML-CP in the imatinib discontinuation phase enrolled in the TRAD study.

Disclosures: This study was supported by BMS Canada and partly by the Princess Margaret Cancer Foundation. The lead author reported a research grant from the BMS and Novartis.

Source: Kim DDH et al. Br J Haematol. 2021 Sep 8. doi: 10.1111/bjh.17807

Key clinical point: BCR-ABL1 transcript doubling time (DT) at 2 months was strongly associated with treatment-free remission (TFR) failure after imatinib discontinuation in patients with chronic-phase chronic myeloid leukemia (CML-CP).

Major finding: The molecular recurrence-free survival at 12 months was 5.0% in patients in the high-risk (DT at 2 months, <12.75 days) vs. 47.2% in the intermediate-risk (DT at 2 months, ≥12.75 days) and 90.1% in the low-risk (DT at 2 months, 0 or less) groups (P < .001). DT at 2 months determined high-risk (hazard ratio [HR] 8.062; P = .0006) and low-risk (HR 0.196; P = .0110) groups for TFR failure.

Study details: This study assessed 131 patients with CML-CP in the imatinib discontinuation phase enrolled in the TRAD study.

Disclosures: This study was supported by BMS Canada and partly by the Princess Margaret Cancer Foundation. The lead author reported a research grant from the BMS and Novartis.

Source: Kim DDH et al. Br J Haematol. 2021 Sep 8. doi: 10.1111/bjh.17807

Key clinical point: Asciminib showed superior efficacy and a favorable safety profile compared with bosutinib in patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant or intolerant to at least 2 prior tyrosine kinase inhibitor (TKI) therapies.

Major finding: The rates of major molecular response (MMR) at week 24 in patients receiving asciminib and bosutinib were 25.5% and 13.2%, respectively (difference 12.2%; P = .029). Bosutinib vs. asciminib arms had a more frequent occurrence of grade 3 or higher adverse events (AEs; 60.5% vs. 50.6%) and AEs leading to treatment discontinuation (21.1% vs. 5.8%).

Study details: Findings are from the phase 3 ASCEMBL trial including 233 adult patients with CML-CP previously treated with at least 2 TKIs randomly assigned to receive either 40 mg asciminib twice daily or 500 mg bosutinib once daily.

Disclosures: This study was sponsored and funded by Novartis Pharmaceuticals Corporation. Some investigators including, the lead author, reported ties with various pharmaceutical companies, including Novartis.

Source: Rea D et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2020009984.

Key clinical point: Asciminib showed superior efficacy and a favorable safety profile compared with bosutinib in patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant or intolerant to at least 2 prior tyrosine kinase inhibitor (TKI) therapies.

Major finding: The rates of major molecular response (MMR) at week 24 in patients receiving asciminib and bosutinib were 25.5% and 13.2%, respectively (difference 12.2%; P = .029). Bosutinib vs. asciminib arms had a more frequent occurrence of grade 3 or higher adverse events (AEs; 60.5% vs. 50.6%) and AEs leading to treatment discontinuation (21.1% vs. 5.8%).

Study details: Findings are from the phase 3 ASCEMBL trial including 233 adult patients with CML-CP previously treated with at least 2 TKIs randomly assigned to receive either 40 mg asciminib twice daily or 500 mg bosutinib once daily.

Disclosures: This study was sponsored and funded by Novartis Pharmaceuticals Corporation. Some investigators including, the lead author, reported ties with various pharmaceutical companies, including Novartis.

Source: Rea D et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2020009984.

Key clinical point: Asciminib showed superior efficacy and a favorable safety profile compared with bosutinib in patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant or intolerant to at least 2 prior tyrosine kinase inhibitor (TKI) therapies.

Major finding: The rates of major molecular response (MMR) at week 24 in patients receiving asciminib and bosutinib were 25.5% and 13.2%, respectively (difference 12.2%; P = .029). Bosutinib vs. asciminib arms had a more frequent occurrence of grade 3 or higher adverse events (AEs; 60.5% vs. 50.6%) and AEs leading to treatment discontinuation (21.1% vs. 5.8%).

Study details: Findings are from the phase 3 ASCEMBL trial including 233 adult patients with CML-CP previously treated with at least 2 TKIs randomly assigned to receive either 40 mg asciminib twice daily or 500 mg bosutinib once daily.

Disclosures: This study was sponsored and funded by Novartis Pharmaceuticals Corporation. Some investigators including, the lead author, reported ties with various pharmaceutical companies, including Novartis.

Source: Rea D et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2020009984.

Key clinical point: In patients with chronic-phase chronic myeloid leukemia (CML-CP) undergoing tyrosine kinase inhibitor (TKI) treatment, the European Treatment and Outcome Study for CML long-term survival (ELTS) offered better overall prediction accuracy than the Sokal score, especially in those receiving the second-generation TKI (2G-TKIs).

Major finding: Overall, ELTS was a better predictor of molecular response (MR)4 (high vs. low; hazard ratio [HR], 0.6; P = .013), MR4.5 (high vs. low; HR, 0.6; P = .030), and CML-related survival (high vs. low; HR, 4.3; P < .001) than the Sokal score. In patients receiving 2G-TKIs, only the ELTS score predicted complete cytogenic response, major MR, MR4, and failure- and progression-free survival (all P < .05).

Study details: Findings are from a retrospective analysis of 1,661 adult patients with newly

diagnosed CML-CP receiving either imatinib, dasatinib, or nilotinib.

Disclosures: This study was partly funded by the National Nature Science Foundation of China. RP

Gale reported ties with various pharmaceutical companies. Other authors had no disclosures.

Source: Zhang XS et al. Leukemia. 2021 Aug 19. doi: 10.1038/s41375-021-01387-y.

Key clinical point: In patients with chronic-phase chronic myeloid leukemia (CML-CP) undergoing tyrosine kinase inhibitor (TKI) treatment, the European Treatment and Outcome Study for CML long-term survival (ELTS) offered better overall prediction accuracy than the Sokal score, especially in those receiving the second-generation TKI (2G-TKIs).

Major finding: Overall, ELTS was a better predictor of molecular response (MR)4 (high vs. low; hazard ratio [HR], 0.6; P = .013), MR4.5 (high vs. low; HR, 0.6; P = .030), and CML-related survival (high vs. low; HR, 4.3; P < .001) than the Sokal score. In patients receiving 2G-TKIs, only the ELTS score predicted complete cytogenic response, major MR, MR4, and failure- and progression-free survival (all P < .05).

Study details: Findings are from a retrospective analysis of 1,661 adult patients with newly

diagnosed CML-CP receiving either imatinib, dasatinib, or nilotinib.

Disclosures: This study was partly funded by the National Nature Science Foundation of China. RP

Gale reported ties with various pharmaceutical companies. Other authors had no disclosures.

Source: Zhang XS et al. Leukemia. 2021 Aug 19. doi: 10.1038/s41375-021-01387-y.

Key clinical point: In patients with chronic-phase chronic myeloid leukemia (CML-CP) undergoing tyrosine kinase inhibitor (TKI) treatment, the European Treatment and Outcome Study for CML long-term survival (ELTS) offered better overall prediction accuracy than the Sokal score, especially in those receiving the second-generation TKI (2G-TKIs).

Major finding: Overall, ELTS was a better predictor of molecular response (MR)4 (high vs. low; hazard ratio [HR], 0.6; P = .013), MR4.5 (high vs. low; HR, 0.6; P = .030), and CML-related survival (high vs. low; HR, 4.3; P < .001) than the Sokal score. In patients receiving 2G-TKIs, only the ELTS score predicted complete cytogenic response, major MR, MR4, and failure- and progression-free survival (all P < .05).

Study details: Findings are from a retrospective analysis of 1,661 adult patients with newly

diagnosed CML-CP receiving either imatinib, dasatinib, or nilotinib.

Disclosures: This study was partly funded by the National Nature Science Foundation of China. RP

Gale reported ties with various pharmaceutical companies. Other authors had no disclosures.

Source: Zhang XS et al. Leukemia. 2021 Aug 19. doi: 10.1038/s41375-021-01387-y.

Key clinical point: Pulmonary hypertension (PH) is common in patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKI), warranting careful screening for PH in this patient population.

Major finding: Overall, 10.7% of patients undergoing transthoracic echocardiography (TTE) during TKI treatment were diagnosed with PH. Dasatinib treatment (odds ratio [OR] 8.2; P = .03), age above 60 years (OR 12.3; P = .04), and presence of cardiopulmonary symptoms/signs (OR 36.1; P = .001) were significant risk factors for PH.

Study details: Findings are from a retrospective analysis of 112 patients with CML who underwent TTE during TKI treatment.

Disclosures: This study was funded by the Research Fund of Chungnam National University Hospital and the Bio and Medical Technology Development Program of the National Research Foundation of Korea. The authors declared no conflict of interests.

Source: Song IC et al. Medicine. 2021 Aug 20. doi: 10.1097/MD.0000000000026975.

Key clinical point: Pulmonary hypertension (PH) is common in patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKI), warranting careful screening for PH in this patient population.

Major finding: Overall, 10.7% of patients undergoing transthoracic echocardiography (TTE) during TKI treatment were diagnosed with PH. Dasatinib treatment (odds ratio [OR] 8.2; P = .03), age above 60 years (OR 12.3; P = .04), and presence of cardiopulmonary symptoms/signs (OR 36.1; P = .001) were significant risk factors for PH.

Study details: Findings are from a retrospective analysis of 112 patients with CML who underwent TTE during TKI treatment.

Disclosures: This study was funded by the Research Fund of Chungnam National University Hospital and the Bio and Medical Technology Development Program of the National Research Foundation of Korea. The authors declared no conflict of interests.

Source: Song IC et al. Medicine. 2021 Aug 20. doi: 10.1097/MD.0000000000026975.

Key clinical point: Pulmonary hypertension (PH) is common in patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKI), warranting careful screening for PH in this patient population.

Major finding: Overall, 10.7% of patients undergoing transthoracic echocardiography (TTE) during TKI treatment were diagnosed with PH. Dasatinib treatment (odds ratio [OR] 8.2; P = .03), age above 60 years (OR 12.3; P = .04), and presence of cardiopulmonary symptoms/signs (OR 36.1; P = .001) were significant risk factors for PH.

Study details: Findings are from a retrospective analysis of 112 patients with CML who underwent TTE during TKI treatment.

Disclosures: This study was funded by the Research Fund of Chungnam National University Hospital and the Bio and Medical Technology Development Program of the National Research Foundation of Korea. The authors declared no conflict of interests.

Source: Song IC et al. Medicine. 2021 Aug 20. doi: 10.1097/MD.0000000000026975.

Key clinical point: The addition of low-dose pegylated interferon-a2b (PegIFN-a2b) to dasatinib 3 months after initiation of tyrosine kinase inhibitor was effective and well tolerated without an increased risk for late toxicity in patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).

Major finding: At 5 years, rates of major molecular response (MR), MR4, and MR4.5 were 84.6%, 64.1%, and 51.3%, respectively. No disease progression or CML-related deaths were observed. Grade 2 or higher hematological adverse events were not observed after 12 months. After 24 months, pleural effusion was reported in 10% of patients.

Study details: Findings are from a 5-year follow-up of phase 2 NordCML007 trial including 40 adult patients with newly diagnosed CML-CP who were given upfront dasatinib. Low-dose PegIFN-a2b was added from months 4 to 15 after dasatinib initiation.

Disclosures: This study was sponsored by the Norwegian University of Science and Technology. No disclosures were reported.

Source: Flygt H et al. Eur J Haematol. 2021 Aug 21. doi: 10.1111/ejh.13699.

Key clinical point: The addition of low-dose pegylated interferon-a2b (PegIFN-a2b) to dasatinib 3 months after initiation of tyrosine kinase inhibitor was effective and well tolerated without an increased risk for late toxicity in patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).

Major finding: At 5 years, rates of major molecular response (MR), MR4, and MR4.5 were 84.6%, 64.1%, and 51.3%, respectively. No disease progression or CML-related deaths were observed. Grade 2 or higher hematological adverse events were not observed after 12 months. After 24 months, pleural effusion was reported in 10% of patients.

Study details: Findings are from a 5-year follow-up of phase 2 NordCML007 trial including 40 adult patients with newly diagnosed CML-CP who were given upfront dasatinib. Low-dose PegIFN-a2b was added from months 4 to 15 after dasatinib initiation.

Disclosures: This study was sponsored by the Norwegian University of Science and Technology. No disclosures were reported.

Source: Flygt H et al. Eur J Haematol. 2021 Aug 21. doi: 10.1111/ejh.13699.

Key clinical point: The addition of low-dose pegylated interferon-a2b (PegIFN-a2b) to dasatinib 3 months after initiation of tyrosine kinase inhibitor was effective and well tolerated without an increased risk for late toxicity in patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).

Major finding: At 5 years, rates of major molecular response (MR), MR4, and MR4.5 were 84.6%, 64.1%, and 51.3%, respectively. No disease progression or CML-related deaths were observed. Grade 2 or higher hematological adverse events were not observed after 12 months. After 24 months, pleural effusion was reported in 10% of patients.

Study details: Findings are from a 5-year follow-up of phase 2 NordCML007 trial including 40 adult patients with newly diagnosed CML-CP who were given upfront dasatinib. Low-dose PegIFN-a2b was added from months 4 to 15 after dasatinib initiation.

Disclosures: This study was sponsored by the Norwegian University of Science and Technology. No disclosures were reported.

Source: Flygt H et al. Eur J Haematol. 2021 Aug 21. doi: 10.1111/ejh.13699.

Key clinical point: Although all starting ponatinib doses showed clinical benefit among patients with resistant chronic-phase chronic myeloid leukemia (CML-CP), the optimal benefit-risk ratio was observed with 45 mg ponatinib reduced to 15 mg on achievement of a response.

Major finding: The response rates at 12 months in patients receiving 45 mg, 30 mg, or 15 mg ponatinib were 44.1% (98.3% CI 31.7%-57.0%), 29.0% (98.3% CI 18.4%-41.6%), and 23.1% (98.3% CI 13.4%-35.3%), respectively. Grade 3-5 treatment-emergent arterial occlusive events were observed in 5, 5, and 3 patients in the 45, 30, and 15 mg ponatinib cohorts, respectively.

Study details: The phase 2 OPTIC trial included 283 adult patients with CML-CP resistant/intolerant to at least 2 prior tyrosine kinase inhibitors or with T315l mutation, randomly assigned to receive a once-daily starting dose of 45 mg, 30 mg, or 15 mg ponatinib. Patients receiving 45 mg or 30 mg doses were reduced to 15 mg upon achievement of a response.

Disclosures: No source of funding was identified other than Millennium Pharmaceuticals, Inc. for medical writing assistance. Some investigators, including the lead author, reported ties with various pharmaceutical companies.

Source: Cortes J et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2021012082.

Key clinical point: Although all starting ponatinib doses showed clinical benefit among patients with resistant chronic-phase chronic myeloid leukemia (CML-CP), the optimal benefit-risk ratio was observed with 45 mg ponatinib reduced to 15 mg on achievement of a response.

Major finding: The response rates at 12 months in patients receiving 45 mg, 30 mg, or 15 mg ponatinib were 44.1% (98.3% CI 31.7%-57.0%), 29.0% (98.3% CI 18.4%-41.6%), and 23.1% (98.3% CI 13.4%-35.3%), respectively. Grade 3-5 treatment-emergent arterial occlusive events were observed in 5, 5, and 3 patients in the 45, 30, and 15 mg ponatinib cohorts, respectively.

Study details: The phase 2 OPTIC trial included 283 adult patients with CML-CP resistant/intolerant to at least 2 prior tyrosine kinase inhibitors or with T315l mutation, randomly assigned to receive a once-daily starting dose of 45 mg, 30 mg, or 15 mg ponatinib. Patients receiving 45 mg or 30 mg doses were reduced to 15 mg upon achievement of a response.

Disclosures: No source of funding was identified other than Millennium Pharmaceuticals, Inc. for medical writing assistance. Some investigators, including the lead author, reported ties with various pharmaceutical companies.

Source: Cortes J et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2021012082.

Key clinical point: Although all starting ponatinib doses showed clinical benefit among patients with resistant chronic-phase chronic myeloid leukemia (CML-CP), the optimal benefit-risk ratio was observed with 45 mg ponatinib reduced to 15 mg on achievement of a response.

Major finding: The response rates at 12 months in patients receiving 45 mg, 30 mg, or 15 mg ponatinib were 44.1% (98.3% CI 31.7%-57.0%), 29.0% (98.3% CI 18.4%-41.6%), and 23.1% (98.3% CI 13.4%-35.3%), respectively. Grade 3-5 treatment-emergent arterial occlusive events were observed in 5, 5, and 3 patients in the 45, 30, and 15 mg ponatinib cohorts, respectively.

Study details: The phase 2 OPTIC trial included 283 adult patients with CML-CP resistant/intolerant to at least 2 prior tyrosine kinase inhibitors or with T315l mutation, randomly assigned to receive a once-daily starting dose of 45 mg, 30 mg, or 15 mg ponatinib. Patients receiving 45 mg or 30 mg doses were reduced to 15 mg upon achievement of a response.

Disclosures: No source of funding was identified other than Millennium Pharmaceuticals, Inc. for medical writing assistance. Some investigators, including the lead author, reported ties with various pharmaceutical companies.

Source: Cortes J et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2021012082.

Key clinical point: Patients with chronic myeloid leukemia (CML) treated with first-line nilotinib vs. imatinib may have a higher risk for vascular adverse events (VAE), suggesting that older patients and those with a history of cerebrovascular diseases using nilotinib should be closely monitored.

Major finding: The risk for VAEs was significantly higher in patients treated with nilotinib vs. imatinib (hazard ratio 3.13; P < .05). Nilotinib use (odds ratio [OR] 3.43; P = .03), older age (OR, 1.04; P < .01), and history of cerebrovascular diseases (OR, 3.49; P = .02) were significant risk factors for VAEs.

Study details: Findings are from a retrospective analysis of 1,111 adult patients with CML treated with either frontline imatinib (n=565), nilotinib (n=306), or dasatinib (n=240).

Disclosures: No funding source or disclosures were reported.

Source: Chen MT et al. Oncologist. 2021 Aug 21. doi: 10.1002/onco.13944.

Key clinical point: Patients with chronic myeloid leukemia (CML) treated with first-line nilotinib vs. imatinib may have a higher risk for vascular adverse events (VAE), suggesting that older patients and those with a history of cerebrovascular diseases using nilotinib should be closely monitored.

Major finding: The risk for VAEs was significantly higher in patients treated with nilotinib vs. imatinib (hazard ratio 3.13; P < .05). Nilotinib use (odds ratio [OR] 3.43; P = .03), older age (OR, 1.04; P < .01), and history of cerebrovascular diseases (OR, 3.49; P = .02) were significant risk factors for VAEs.

Study details: Findings are from a retrospective analysis of 1,111 adult patients with CML treated with either frontline imatinib (n=565), nilotinib (n=306), or dasatinib (n=240).

Disclosures: No funding source or disclosures were reported.

Source: Chen MT et al. Oncologist. 2021 Aug 21. doi: 10.1002/onco.13944.

Key clinical point: Patients with chronic myeloid leukemia (CML) treated with first-line nilotinib vs. imatinib may have a higher risk for vascular adverse events (VAE), suggesting that older patients and those with a history of cerebrovascular diseases using nilotinib should be closely monitored.

Major finding: The risk for VAEs was significantly higher in patients treated with nilotinib vs. imatinib (hazard ratio 3.13; P < .05). Nilotinib use (odds ratio [OR] 3.43; P = .03), older age (OR, 1.04; P < .01), and history of cerebrovascular diseases (OR, 3.49; P = .02) were significant risk factors for VAEs.

Study details: Findings are from a retrospective analysis of 1,111 adult patients with CML treated with either frontline imatinib (n=565), nilotinib (n=306), or dasatinib (n=240).

Disclosures: No funding source or disclosures were reported.

Source: Chen MT et al. Oncologist. 2021 Aug 21. doi: 10.1002/onco.13944.

Key clinical point: Among patients with acute myeloid leukemia (AML) who underwent first allogeneic hematopoietic stem cell transplantation (allo-HSCT), children showed superior clinical outcomes compared to adolescents and postadolescents (APA) and young adults.

Major finding: At 2 years, the cumulative incidence of chronic graft-versus-host disease (P < .0001), relapse (P = .0254), and nonrelapse mortality (P < .0001) were significantly lower, and overall survival (P = .0009) and event-free survival (P = .0186) were higher in children compared to APA and young adult patients with AML.

Study details: Findings are from a retrospective analysis of children (age 0-14 years; n = 564), APA patients (age 15-25 years; n = 647), and young adults (age 26-40 years; n = 1,434) with AML who received a first allo-HSCT in the first or further remission or in refractory state.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Pochon C et al. J Cancer Res Clin Oncol. 2021 Sep 4. doi: 10.1007/s00432-021-03761-w.

Key clinical point: Among patients with acute myeloid leukemia (AML) who underwent first allogeneic hematopoietic stem cell transplantation (allo-HSCT), children showed superior clinical outcomes compared to adolescents and postadolescents (APA) and young adults.

Major finding: At 2 years, the cumulative incidence of chronic graft-versus-host disease (P < .0001), relapse (P = .0254), and nonrelapse mortality (P < .0001) were significantly lower, and overall survival (P = .0009) and event-free survival (P = .0186) were higher in children compared to APA and young adult patients with AML.

Study details: Findings are from a retrospective analysis of children (age 0-14 years; n = 564), APA patients (age 15-25 years; n = 647), and young adults (age 26-40 years; n = 1,434) with AML who received a first allo-HSCT in the first or further remission or in refractory state.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Pochon C et al. J Cancer Res Clin Oncol. 2021 Sep 4. doi: 10.1007/s00432-021-03761-w.

Key clinical point: Among patients with acute myeloid leukemia (AML) who underwent first allogeneic hematopoietic stem cell transplantation (allo-HSCT), children showed superior clinical outcomes compared to adolescents and postadolescents (APA) and young adults.

Major finding: At 2 years, the cumulative incidence of chronic graft-versus-host disease (P < .0001), relapse (P = .0254), and nonrelapse mortality (P < .0001) were significantly lower, and overall survival (P = .0009) and event-free survival (P = .0186) were higher in children compared to APA and young adult patients with AML.

Study details: Findings are from a retrospective analysis of children (age 0-14 years; n = 564), APA patients (age 15-25 years; n = 647), and young adults (age 26-40 years; n = 1,434) with AML who received a first allo-HSCT in the first or further remission or in refractory state.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Pochon C et al. J Cancer Res Clin Oncol. 2021 Sep 4. doi: 10.1007/s00432-021-03761-w.

Key clinical point: The maximum tolerated dose (MTD) of combined romidepsin and azacitidine (ROM/AZA) therapy was well tolerated and clinically active in patients with newly diagnosed, relapsed or refractory (R/R) acute myeloid leukemia (AML) and unfit for intensive chemotherapy.

Major finding: Overall, 23.7% of patients treated with the MTD had a complete remission (CR)/incomplete CR or partial response by cycle 6. The combination therapy was well tolerated with 5 grade 3 or higher nonhematologic treatment-related adverse events affecting at least 10% of patients. Only 4 patients discontinued treatment because of toxicity.

Study details: Findings are from the phase 1/2 ROMAZA trial including 48 patients with newly diagnosed, R/R AML ineligible for intensive chemotherapy. The MTD of ROM/AZA therapy was established as 12 mg/m² romidepcin on days 8 and 15 with 75 mg/m² azacitidine on days 1-9.

Disclosures: This study was funded by Bloodwise and Celgene. The lead author reported ties with Novartis, Daichi-Sankyo, Pfizer, Janssen, and Amgen. Some investigators reported ties with various pharmaceutical companies, including Celgene.

Source: Loke J et al. Br J Haematol. 2021 Sep 6. doi: 10.1111/bjh.17823.

Key clinical point: The maximum tolerated dose (MTD) of combined romidepsin and azacitidine (ROM/AZA) therapy was well tolerated and clinically active in patients with newly diagnosed, relapsed or refractory (R/R) acute myeloid leukemia (AML) and unfit for intensive chemotherapy.

Major finding: Overall, 23.7% of patients treated with the MTD had a complete remission (CR)/incomplete CR or partial response by cycle 6. The combination therapy was well tolerated with 5 grade 3 or higher nonhematologic treatment-related adverse events affecting at least 10% of patients. Only 4 patients discontinued treatment because of toxicity.

Study details: Findings are from the phase 1/2 ROMAZA trial including 48 patients with newly diagnosed, R/R AML ineligible for intensive chemotherapy. The MTD of ROM/AZA therapy was established as 12 mg/m² romidepcin on days 8 and 15 with 75 mg/m² azacitidine on days 1-9.

Disclosures: This study was funded by Bloodwise and Celgene. The lead author reported ties with Novartis, Daichi-Sankyo, Pfizer, Janssen, and Amgen. Some investigators reported ties with various pharmaceutical companies, including Celgene.

Source: Loke J et al. Br J Haematol. 2021 Sep 6. doi: 10.1111/bjh.17823.

Key clinical point: The maximum tolerated dose (MTD) of combined romidepsin and azacitidine (ROM/AZA) therapy was well tolerated and clinically active in patients with newly diagnosed, relapsed or refractory (R/R) acute myeloid leukemia (AML) and unfit for intensive chemotherapy.

Major finding: Overall, 23.7% of patients treated with the MTD had a complete remission (CR)/incomplete CR or partial response by cycle 6. The combination therapy was well tolerated with 5 grade 3 or higher nonhematologic treatment-related adverse events affecting at least 10% of patients. Only 4 patients discontinued treatment because of toxicity.

Study details: Findings are from the phase 1/2 ROMAZA trial including 48 patients with newly diagnosed, R/R AML ineligible for intensive chemotherapy. The MTD of ROM/AZA therapy was established as 12 mg/m² romidepcin on days 8 and 15 with 75 mg/m² azacitidine on days 1-9.

Disclosures: This study was funded by Bloodwise and Celgene. The lead author reported ties with Novartis, Daichi-Sankyo, Pfizer, Janssen, and Amgen. Some investigators reported ties with various pharmaceutical companies, including Celgene.

Source: Loke J et al. Br J Haematol. 2021 Sep 6. doi: 10.1111/bjh.17823.