Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, CT-P6, a trastuzumab biosimilar shows 3-year survival comparable with trastuzumab.

Major finding: Median disease-free survival (DFS), overall survival (OS), and progression-free survival (PFS) were not reached in either group. In the CT-P6 vs trastuzumab group, the 3-year DFS, PFS, and OS rates were 83% vs 83%, 81% vs 87%, and 93% vs 94%, respectively.

Study details: A randomized, double-blind, active-controlled, phase 3 equivalence trial of 549 patients with HER2‑positive early breast cancer who received neoadjuvant treatment with CT-P6 or trastuzumab with chemotherapy, followed by surgery. Patients were followed up for 3 years (n=528) after receiving adjuvant CT-P6 or trastuzumab.

Disclosures: The study was funded by Celltrion, Inc. The authors received grants and consulting/advisory fees from various sources. Dr. SJ Lee and Dr. S Kim were employees of and/or stockholders in Celltrion.

Source: Stebbing J et al. Breast Cancer Res Treat. 2021 Jun 20. doi: 10.1007/s10549-021-06240-5.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, CT-P6, a trastuzumab biosimilar shows 3-year survival comparable with trastuzumab.

Major finding: Median disease-free survival (DFS), overall survival (OS), and progression-free survival (PFS) were not reached in either group. In the CT-P6 vs trastuzumab group, the 3-year DFS, PFS, and OS rates were 83% vs 83%, 81% vs 87%, and 93% vs 94%, respectively.

Study details: A randomized, double-blind, active-controlled, phase 3 equivalence trial of 549 patients with HER2‑positive early breast cancer who received neoadjuvant treatment with CT-P6 or trastuzumab with chemotherapy, followed by surgery. Patients were followed up for 3 years (n=528) after receiving adjuvant CT-P6 or trastuzumab.

Disclosures: The study was funded by Celltrion, Inc. The authors received grants and consulting/advisory fees from various sources. Dr. SJ Lee and Dr. S Kim were employees of and/or stockholders in Celltrion.

Source: Stebbing J et al. Breast Cancer Res Treat. 2021 Jun 20. doi: 10.1007/s10549-021-06240-5.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, CT-P6, a trastuzumab biosimilar shows 3-year survival comparable with trastuzumab.

Major finding: Median disease-free survival (DFS), overall survival (OS), and progression-free survival (PFS) were not reached in either group. In the CT-P6 vs trastuzumab group, the 3-year DFS, PFS, and OS rates were 83% vs 83%, 81% vs 87%, and 93% vs 94%, respectively.

Study details: A randomized, double-blind, active-controlled, phase 3 equivalence trial of 549 patients with HER2‑positive early breast cancer who received neoadjuvant treatment with CT-P6 or trastuzumab with chemotherapy, followed by surgery. Patients were followed up for 3 years (n=528) after receiving adjuvant CT-P6 or trastuzumab.

Disclosures: The study was funded by Celltrion, Inc. The authors received grants and consulting/advisory fees from various sources. Dr. SJ Lee and Dr. S Kim were employees of and/or stockholders in Celltrion.

Source: Stebbing J et al. Breast Cancer Res Treat. 2021 Jun 20. doi: 10.1007/s10549-021-06240-5.

Key clinical point: Bisphosphonate therapy for 5 vs 2 years in patients with high-risk early breast cancer yields no added survival benefit and leads to increased risk for adverse events.

Major finding: There were no significant differences in disease-free survival (hazard ratio [HR], 0.97; P = .81), overall survival (HR, 0.98; P = .90), and distant disease-free survival (HR, 0.87; P = .38) between 5- and 2-year bisphosphonate treatment groups. The rate of adverse events was 46.2% with 5-year therapy and 27.2% with 2-year treatment.

Study details: A randomized phase 3, open-label SUCCESS A trial of 2,987 patients with high-risk early breast cancer randomly assigned to receive bisphosphonate zoledronate for either 5 or 2 years.

Disclosures: The study was supported by AstraZeneca, Chugai, Menarini Silicon Biosystems (formerly Veridex), Lilly, Novartis, and Sanofi-Aventis. The authors received honoraria, personal fees, research support, consulting fees, and travel grants from various sources.

Source: Friedl TWP et al. JAMA Oncol. 2021 Jun 24. doi: 10.1001/jamaoncol.2021.1854.

Key clinical point: Bisphosphonate therapy for 5 vs 2 years in patients with high-risk early breast cancer yields no added survival benefit and leads to increased risk for adverse events.

Major finding: There were no significant differences in disease-free survival (hazard ratio [HR], 0.97; P = .81), overall survival (HR, 0.98; P = .90), and distant disease-free survival (HR, 0.87; P = .38) between 5- and 2-year bisphosphonate treatment groups. The rate of adverse events was 46.2% with 5-year therapy and 27.2% with 2-year treatment.

Study details: A randomized phase 3, open-label SUCCESS A trial of 2,987 patients with high-risk early breast cancer randomly assigned to receive bisphosphonate zoledronate for either 5 or 2 years.

Disclosures: The study was supported by AstraZeneca, Chugai, Menarini Silicon Biosystems (formerly Veridex), Lilly, Novartis, and Sanofi-Aventis. The authors received honoraria, personal fees, research support, consulting fees, and travel grants from various sources.

Source: Friedl TWP et al. JAMA Oncol. 2021 Jun 24. doi: 10.1001/jamaoncol.2021.1854.

Key clinical point: Bisphosphonate therapy for 5 vs 2 years in patients with high-risk early breast cancer yields no added survival benefit and leads to increased risk for adverse events.

Major finding: There were no significant differences in disease-free survival (hazard ratio [HR], 0.97; P = .81), overall survival (HR, 0.98; P = .90), and distant disease-free survival (HR, 0.87; P = .38) between 5- and 2-year bisphosphonate treatment groups. The rate of adverse events was 46.2% with 5-year therapy and 27.2% with 2-year treatment.

Study details: A randomized phase 3, open-label SUCCESS A trial of 2,987 patients with high-risk early breast cancer randomly assigned to receive bisphosphonate zoledronate for either 5 or 2 years.

Disclosures: The study was supported by AstraZeneca, Chugai, Menarini Silicon Biosystems (formerly Veridex), Lilly, Novartis, and Sanofi-Aventis. The authors received honoraria, personal fees, research support, consulting fees, and travel grants from various sources.

Source: Friedl TWP et al. JAMA Oncol. 2021 Jun 24. doi: 10.1001/jamaoncol.2021.1854.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive locally recurrent or metastatic breast cancer, paclitaxel can be an alternative to docetaxel with first-line pertuzumab plus trastuzumab.

Major finding: The median follow-up was 68.7 months. The median progression-free survival was 19.4 (95% confidence interval [CI], 16.9-22.1) months in the docetaxel, 23.2 (95% CI,19.6-25.6) months in the paclitaxel, and 19.2 (95% CI, 11.7-37.1) months in the nab-paclitaxel group. Docetaxel was associated with higher rates of grade ≥3 neutropenia and febrile neutropenia.

Study details: A multicenter, open-label, single-arm phase 3b PERUSE study of 1,436 eligible patients with inoperable HER2-positive locally recurrent or metastatic breast cancer who received pertuzumab and trastuzumab with a taxane (docetaxel, paclitaxel, or nab-paclitaxel).

Disclosures: The study was supported by F. Hoffmann-La Roche Ltd, Basel, Switzerland. The authors reported receiving research funding, personal fees, grants, honoraria, advisory/speaker/consulting fees, and travel/accommodation/expenses from various sources. Some authors were employed by and/or owned stocks in pharmaceutical companies.

Source: Miles D et al. Ann Oncol. 2021 Jul 1. doi: 10.1016/j.annonc.2021.06.024.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive locally recurrent or metastatic breast cancer, paclitaxel can be an alternative to docetaxel with first-line pertuzumab plus trastuzumab.

Major finding: The median follow-up was 68.7 months. The median progression-free survival was 19.4 (95% confidence interval [CI], 16.9-22.1) months in the docetaxel, 23.2 (95% CI,19.6-25.6) months in the paclitaxel, and 19.2 (95% CI, 11.7-37.1) months in the nab-paclitaxel group. Docetaxel was associated with higher rates of grade ≥3 neutropenia and febrile neutropenia.

Study details: A multicenter, open-label, single-arm phase 3b PERUSE study of 1,436 eligible patients with inoperable HER2-positive locally recurrent or metastatic breast cancer who received pertuzumab and trastuzumab with a taxane (docetaxel, paclitaxel, or nab-paclitaxel).

Disclosures: The study was supported by F. Hoffmann-La Roche Ltd, Basel, Switzerland. The authors reported receiving research funding, personal fees, grants, honoraria, advisory/speaker/consulting fees, and travel/accommodation/expenses from various sources. Some authors were employed by and/or owned stocks in pharmaceutical companies.

Source: Miles D et al. Ann Oncol. 2021 Jul 1. doi: 10.1016/j.annonc.2021.06.024.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive locally recurrent or metastatic breast cancer, paclitaxel can be an alternative to docetaxel with first-line pertuzumab plus trastuzumab.

Major finding: The median follow-up was 68.7 months. The median progression-free survival was 19.4 (95% confidence interval [CI], 16.9-22.1) months in the docetaxel, 23.2 (95% CI,19.6-25.6) months in the paclitaxel, and 19.2 (95% CI, 11.7-37.1) months in the nab-paclitaxel group. Docetaxel was associated with higher rates of grade ≥3 neutropenia and febrile neutropenia.

Study details: A multicenter, open-label, single-arm phase 3b PERUSE study of 1,436 eligible patients with inoperable HER2-positive locally recurrent or metastatic breast cancer who received pertuzumab and trastuzumab with a taxane (docetaxel, paclitaxel, or nab-paclitaxel).

Disclosures: The study was supported by F. Hoffmann-La Roche Ltd, Basel, Switzerland. The authors reported receiving research funding, personal fees, grants, honoraria, advisory/speaker/consulting fees, and travel/accommodation/expenses from various sources. Some authors were employed by and/or owned stocks in pharmaceutical companies.

Source: Miles D et al. Ann Oncol. 2021 Jul 1. doi: 10.1016/j.annonc.2021.06.024.

Key clinical point: Atezolizumab plus nab-paclitaxel shows no overall survival (OS) advantage in patients with advanced/metastatic triple-negative breast cancer (TNBC) overall, but improves OS in in a patient subgroup positive for programmed death-ligand 1 (PD-L1) expression in tumor-infiltrating immune cells.

Major finding: There was no difference in OS in the intent-to-treat population (P = .077). An exploratory analysis in the PD-L1 immune cell-positive population showed OS improvement with atezolizumab plus nab-paclitaxel (stratified hazard ratio, 0.67; 95% confidence interval, 0.53-0.86).

Study details: A randomized, double-blind, placebo-controlled phase 3 IMpassion130 trial of 902 patients with advanced/metastatic TNBC who received atezolizumab plus nab-paclitaxel (n=451) or placebo plus nab-paclitaxel (n=451).

Disclosures: This study was sponsored by F. Hoffmann-La Roche Ltd./Genentech, Inc. The authors received honoraria, travel support, research funding, consulting/advisory/steering committee fees, and grants from various sources. Some of the authors were employed by and/or owned stocks in Genentech/Roche.

Source: Emens LA et al. Ann Oncol. 2021 Jul 1. doi: 10.1016/j.annonc.2021.05.355.

Key clinical point: Atezolizumab plus nab-paclitaxel shows no overall survival (OS) advantage in patients with advanced/metastatic triple-negative breast cancer (TNBC) overall, but improves OS in in a patient subgroup positive for programmed death-ligand 1 (PD-L1) expression in tumor-infiltrating immune cells.

Major finding: There was no difference in OS in the intent-to-treat population (P = .077). An exploratory analysis in the PD-L1 immune cell-positive population showed OS improvement with atezolizumab plus nab-paclitaxel (stratified hazard ratio, 0.67; 95% confidence interval, 0.53-0.86).

Study details: A randomized, double-blind, placebo-controlled phase 3 IMpassion130 trial of 902 patients with advanced/metastatic TNBC who received atezolizumab plus nab-paclitaxel (n=451) or placebo plus nab-paclitaxel (n=451).

Disclosures: This study was sponsored by F. Hoffmann-La Roche Ltd./Genentech, Inc. The authors received honoraria, travel support, research funding, consulting/advisory/steering committee fees, and grants from various sources. Some of the authors were employed by and/or owned stocks in Genentech/Roche.

Source: Emens LA et al. Ann Oncol. 2021 Jul 1. doi: 10.1016/j.annonc.2021.05.355.

Key clinical point: Atezolizumab plus nab-paclitaxel shows no overall survival (OS) advantage in patients with advanced/metastatic triple-negative breast cancer (TNBC) overall, but improves OS in in a patient subgroup positive for programmed death-ligand 1 (PD-L1) expression in tumor-infiltrating immune cells.

Major finding: There was no difference in OS in the intent-to-treat population (P = .077). An exploratory analysis in the PD-L1 immune cell-positive population showed OS improvement with atezolizumab plus nab-paclitaxel (stratified hazard ratio, 0.67; 95% confidence interval, 0.53-0.86).

Study details: A randomized, double-blind, placebo-controlled phase 3 IMpassion130 trial of 902 patients with advanced/metastatic TNBC who received atezolizumab plus nab-paclitaxel (n=451) or placebo plus nab-paclitaxel (n=451).

Disclosures: This study was sponsored by F. Hoffmann-La Roche Ltd./Genentech, Inc. The authors received honoraria, travel support, research funding, consulting/advisory/steering committee fees, and grants from various sources. Some of the authors were employed by and/or owned stocks in Genentech/Roche.

Source: Emens LA et al. Ann Oncol. 2021 Jul 1. doi: 10.1016/j.annonc.2021.05.355.

Key clinical point: Atezolizumab in combination with paclitaxel does not improve survival in patients with unresectable locally advanced/metastatic triple-negative breast cancer (TNBC) vs paclitaxel plus placebo.

Major finding: The median follow-up was 14.2 months in the atezolizumab group and 14.5 months in the placebo group. Atezolizumab plus paclitaxel did not improve median overall survival vs paclitaxel plus placebo (hazard ratio, 1.11; 95% confidence interval, 0.76-1.64). Compared with placebo plus paclitaxel, atezolizumab plus paclitaxel was associated with a higher incidence of serious (25% vs 18%) and grade 3/4 adverse events (53% vs 46%).

Study details: A global randomized, double-blind, placebo-controlled phase 3 IMpassion131 trial of 651 patients with advanced/metastatic TNBC who were randomly assigned to atezolizumab plus paclitaxel or placebo plus paclitaxel.

Disclosures: The study was supported by F. Hoffmann-La Roche Ltd. The authors received honoraria, research grants, speaker/advisory/consulting fees, personal fees, and travel/accommodation/expenses from various sources. Some authors were employed by and/or owned stocks in pharmaceutical companies.

Source: Miles D et al. Ann Oncol. 2021 Jul 1. doi: 10.1016/j.annonc.2021.05.801.

Key clinical point: Atezolizumab in combination with paclitaxel does not improve survival in patients with unresectable locally advanced/metastatic triple-negative breast cancer (TNBC) vs paclitaxel plus placebo.

Major finding: The median follow-up was 14.2 months in the atezolizumab group and 14.5 months in the placebo group. Atezolizumab plus paclitaxel did not improve median overall survival vs paclitaxel plus placebo (hazard ratio, 1.11; 95% confidence interval, 0.76-1.64). Compared with placebo plus paclitaxel, atezolizumab plus paclitaxel was associated with a higher incidence of serious (25% vs 18%) and grade 3/4 adverse events (53% vs 46%).

Study details: A global randomized, double-blind, placebo-controlled phase 3 IMpassion131 trial of 651 patients with advanced/metastatic TNBC who were randomly assigned to atezolizumab plus paclitaxel or placebo plus paclitaxel.

Disclosures: The study was supported by F. Hoffmann-La Roche Ltd. The authors received honoraria, research grants, speaker/advisory/consulting fees, personal fees, and travel/accommodation/expenses from various sources. Some authors were employed by and/or owned stocks in pharmaceutical companies.

Source: Miles D et al. Ann Oncol. 2021 Jul 1. doi: 10.1016/j.annonc.2021.05.801.

Key clinical point: Atezolizumab in combination with paclitaxel does not improve survival in patients with unresectable locally advanced/metastatic triple-negative breast cancer (TNBC) vs paclitaxel plus placebo.

Major finding: The median follow-up was 14.2 months in the atezolizumab group and 14.5 months in the placebo group. Atezolizumab plus paclitaxel did not improve median overall survival vs paclitaxel plus placebo (hazard ratio, 1.11; 95% confidence interval, 0.76-1.64). Compared with placebo plus paclitaxel, atezolizumab plus paclitaxel was associated with a higher incidence of serious (25% vs 18%) and grade 3/4 adverse events (53% vs 46%).

Study details: A global randomized, double-blind, placebo-controlled phase 3 IMpassion131 trial of 651 patients with advanced/metastatic TNBC who were randomly assigned to atezolizumab plus paclitaxel or placebo plus paclitaxel.

Disclosures: The study was supported by F. Hoffmann-La Roche Ltd. The authors received honoraria, research grants, speaker/advisory/consulting fees, personal fees, and travel/accommodation/expenses from various sources. Some authors were employed by and/or owned stocks in pharmaceutical companies.

Source: Miles D et al. Ann Oncol. 2021 Jul 1. doi: 10.1016/j.annonc.2021.05.801.

Key clinical point: Among human leukocyte antigen (HLA)-matched donor-recipient pairs (DRPs) who underwent unrelated donor hematopoietic cell transplantation (HCT) for acute myeloid leukemia (AML), higher inhibitory and missing killer immunoglobulin-like receptors (KIRs) were associated with a reduced risk for relapse, but without any survival advantage.

Major finding: Higher inhibitory KIR (subhazard ratio [SHR], 0.86; P = .01) and missing KIR (SHR, 0.84; P = .02) scores were associated with a reduced risk for relapse. Patients with inhibitory ‘maxima’ (IM)-KIR of 5 had a lower risk for relapse (SHR, 0.80; P = .004) vs those with IM of less than 5. However, increased transplant-related mortality (SHR, 1.32; P less than .05) was observed in 8/8 HLA-matched DRPs with IM 5 vs less than 5.

Study details: Findings are from a retrospective analysis of 2,365 DRPs who underwent unrelated donor HCT with HLA match grade of 8/8 (85%) or 7/8 for early- or intermediate-risk AML.

Disclosures: No specific source of funding was identified for this work. The authors declared no conflicts of interest.

Source: Krieger E et al. Bone Marrow Transplant. 2021 Jul 7. doi: 10.1038/s41409-021-01393-9.

Key clinical point: Among human leukocyte antigen (HLA)-matched donor-recipient pairs (DRPs) who underwent unrelated donor hematopoietic cell transplantation (HCT) for acute myeloid leukemia (AML), higher inhibitory and missing killer immunoglobulin-like receptors (KIRs) were associated with a reduced risk for relapse, but without any survival advantage.

Major finding: Higher inhibitory KIR (subhazard ratio [SHR], 0.86; P = .01) and missing KIR (SHR, 0.84; P = .02) scores were associated with a reduced risk for relapse. Patients with inhibitory ‘maxima’ (IM)-KIR of 5 had a lower risk for relapse (SHR, 0.80; P = .004) vs those with IM of less than 5. However, increased transplant-related mortality (SHR, 1.32; P less than .05) was observed in 8/8 HLA-matched DRPs with IM 5 vs less than 5.

Study details: Findings are from a retrospective analysis of 2,365 DRPs who underwent unrelated donor HCT with HLA match grade of 8/8 (85%) or 7/8 for early- or intermediate-risk AML.

Disclosures: No specific source of funding was identified for this work. The authors declared no conflicts of interest.

Source: Krieger E et al. Bone Marrow Transplant. 2021 Jul 7. doi: 10.1038/s41409-021-01393-9.

Key clinical point: Among human leukocyte antigen (HLA)-matched donor-recipient pairs (DRPs) who underwent unrelated donor hematopoietic cell transplantation (HCT) for acute myeloid leukemia (AML), higher inhibitory and missing killer immunoglobulin-like receptors (KIRs) were associated with a reduced risk for relapse, but without any survival advantage.

Major finding: Higher inhibitory KIR (subhazard ratio [SHR], 0.86; P = .01) and missing KIR (SHR, 0.84; P = .02) scores were associated with a reduced risk for relapse. Patients with inhibitory ‘maxima’ (IM)-KIR of 5 had a lower risk for relapse (SHR, 0.80; P = .004) vs those with IM of less than 5. However, increased transplant-related mortality (SHR, 1.32; P less than .05) was observed in 8/8 HLA-matched DRPs with IM 5 vs less than 5.

Study details: Findings are from a retrospective analysis of 2,365 DRPs who underwent unrelated donor HCT with HLA match grade of 8/8 (85%) or 7/8 for early- or intermediate-risk AML.

Disclosures: No specific source of funding was identified for this work. The authors declared no conflicts of interest.

Source: Krieger E et al. Bone Marrow Transplant. 2021 Jul 7. doi: 10.1038/s41409-021-01393-9.

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.

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.

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.

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.