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Prostate cancer: Oral relugolix has efficacy and safety comparable with parenteral degarelix
Key clinical point: A network meta-analysis suggests that relugolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, had similar efficacy and safety to parenteral degarelix.
Major finding: Compared with GnRH agonists, there was no significant difference in castration rate at 12 months with relugolix (risk ratio [RR], 1.09; 95% credible interval [CrI], 0.95-1.23) and degarelix (RR, 0.98; 95% CrI, 0.91-1.06). Efficacy ranking analyses showed that relugolix was the most effective medical castration drug to induce sustained castration at 12 months. Compared with GnRH agonists, adverse events rates were similar with relugolix (RR, 0.99; 95% CrI, 0.6-1.6) and degarelix (RR, 1.1; 95% CrI, 0.75-1.35).
Study design: A network meta-analysis of 4 studies compared relugolix and degarelix with GnRH antagonists in 2,059 patients with advanced prostate cancer.
Disclosures: The study did not receive any funding. The authors declared no competing interest.
Source: Motlagh RS et al. Eur Urol Oncol. 2021 Jul 20. doi: 10.1016/j.euo.2021.07.002.
Key clinical point: A network meta-analysis suggests that relugolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, had similar efficacy and safety to parenteral degarelix.
Major finding: Compared with GnRH agonists, there was no significant difference in castration rate at 12 months with relugolix (risk ratio [RR], 1.09; 95% credible interval [CrI], 0.95-1.23) and degarelix (RR, 0.98; 95% CrI, 0.91-1.06). Efficacy ranking analyses showed that relugolix was the most effective medical castration drug to induce sustained castration at 12 months. Compared with GnRH agonists, adverse events rates were similar with relugolix (RR, 0.99; 95% CrI, 0.6-1.6) and degarelix (RR, 1.1; 95% CrI, 0.75-1.35).
Study design: A network meta-analysis of 4 studies compared relugolix and degarelix with GnRH antagonists in 2,059 patients with advanced prostate cancer.
Disclosures: The study did not receive any funding. The authors declared no competing interest.
Source: Motlagh RS et al. Eur Urol Oncol. 2021 Jul 20. doi: 10.1016/j.euo.2021.07.002.
Key clinical point: A network meta-analysis suggests that relugolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, had similar efficacy and safety to parenteral degarelix.
Major finding: Compared with GnRH agonists, there was no significant difference in castration rate at 12 months with relugolix (risk ratio [RR], 1.09; 95% credible interval [CrI], 0.95-1.23) and degarelix (RR, 0.98; 95% CrI, 0.91-1.06). Efficacy ranking analyses showed that relugolix was the most effective medical castration drug to induce sustained castration at 12 months. Compared with GnRH agonists, adverse events rates were similar with relugolix (RR, 0.99; 95% CrI, 0.6-1.6) and degarelix (RR, 1.1; 95% CrI, 0.75-1.35).
Study design: A network meta-analysis of 4 studies compared relugolix and degarelix with GnRH antagonists in 2,059 patients with advanced prostate cancer.
Disclosures: The study did not receive any funding. The authors declared no competing interest.
Source: Motlagh RS et al. Eur Urol Oncol. 2021 Jul 20. doi: 10.1016/j.euo.2021.07.002.
CRPC: Survival benefits of androgen receptor inhibitors are not age-dependent
Key clinical point: Androgen receptor inhibitors (ARIs) improve survival in patients with nonmetastatic castration-resistant prostate cancer (CRPC) regardless of age. Older patients (age, 80 years and above) experience higher rates of high-grade and serious adverse events.
Major finding: ARIs vs placebo improved overall survival in older (adjusted hazard ratio [aHR], 0.79; 95% confidence interval [CI], 0.64-0.98) and younger patients (aHR, 0.69; 95% CI, 0.60-0.80). ARIs also improved metastasis-free survival in older (aHR, 0.37; 95% CI, 0.28-0.47) and younger patients (aHR, 0.31; 95% CI, 0.27-0.35). Patients who received ARIs vs placebo experienced higher rates of adverse events.
Study details: A pooled analysis of 3 randomized trials including patients with nonmetastatic CRPC randomly assigned to receive ARI (apalutamide, enzalutamide, or darolutamide; n=2,694) or placebo (n=1,423).
Disclosures: The study did not receive any funding. The authors declared no competing interests.
Source: Fallah J et al. Lancet Oncol. 2021 Jul 23. doi: 10.1016/S1470-2045(21)00334-X.
Key clinical point: Androgen receptor inhibitors (ARIs) improve survival in patients with nonmetastatic castration-resistant prostate cancer (CRPC) regardless of age. Older patients (age, 80 years and above) experience higher rates of high-grade and serious adverse events.
Major finding: ARIs vs placebo improved overall survival in older (adjusted hazard ratio [aHR], 0.79; 95% confidence interval [CI], 0.64-0.98) and younger patients (aHR, 0.69; 95% CI, 0.60-0.80). ARIs also improved metastasis-free survival in older (aHR, 0.37; 95% CI, 0.28-0.47) and younger patients (aHR, 0.31; 95% CI, 0.27-0.35). Patients who received ARIs vs placebo experienced higher rates of adverse events.
Study details: A pooled analysis of 3 randomized trials including patients with nonmetastatic CRPC randomly assigned to receive ARI (apalutamide, enzalutamide, or darolutamide; n=2,694) or placebo (n=1,423).
Disclosures: The study did not receive any funding. The authors declared no competing interests.
Source: Fallah J et al. Lancet Oncol. 2021 Jul 23. doi: 10.1016/S1470-2045(21)00334-X.
Key clinical point: Androgen receptor inhibitors (ARIs) improve survival in patients with nonmetastatic castration-resistant prostate cancer (CRPC) regardless of age. Older patients (age, 80 years and above) experience higher rates of high-grade and serious adverse events.
Major finding: ARIs vs placebo improved overall survival in older (adjusted hazard ratio [aHR], 0.79; 95% confidence interval [CI], 0.64-0.98) and younger patients (aHR, 0.69; 95% CI, 0.60-0.80). ARIs also improved metastasis-free survival in older (aHR, 0.37; 95% CI, 0.28-0.47) and younger patients (aHR, 0.31; 95% CI, 0.27-0.35). Patients who received ARIs vs placebo experienced higher rates of adverse events.
Study details: A pooled analysis of 3 randomized trials including patients with nonmetastatic CRPC randomly assigned to receive ARI (apalutamide, enzalutamide, or darolutamide; n=2,694) or placebo (n=1,423).
Disclosures: The study did not receive any funding. The authors declared no competing interests.
Source: Fallah J et al. Lancet Oncol. 2021 Jul 23. doi: 10.1016/S1470-2045(21)00334-X.
CRPC: Darolutamide maintains QoL
Key clinical point: In asymptomatic patients with nonmetastatic castration-resistant prostate cancer (CRPC), darolutamide vs placebo maintains health-related quality of life (QoL).
Major finding: Darolutamide vs placebo significantly delayed time to deterioration of Functional Assessment of Cancer Therapy-Prostate cancer subscale (hazard ratio [HR], 0.80; P = .0005), urinary symptoms (HR, 0.64; P < .0001), and bowel symptoms (HR, 0.78; P = .0027).
Study details: A study of patient-reported health-related QoL from randomized, double-blind, placebo-controlled, phase 3 ARAMIS trial, which evaluated 1,509 patients with nonmetastatic CRPC and prostate-specific antigen doubling time of 10 months or less who were randomly assigned 2:1 to receive darolutamide or placebo while continuing androgen deprivation therapy.
Disclosures: This study was funded by Bayer AG and Orion Pharma. The authors received grants, personal fees, and/or nonfinancial support from various sources. Some authors were employees of pharmaceutical companies.
Source: Smith MR. Eur J Cancer. 2021 Jul 14. doi: 10.1016/j.ejca.2021.06.010.
Key clinical point: In asymptomatic patients with nonmetastatic castration-resistant prostate cancer (CRPC), darolutamide vs placebo maintains health-related quality of life (QoL).
Major finding: Darolutamide vs placebo significantly delayed time to deterioration of Functional Assessment of Cancer Therapy-Prostate cancer subscale (hazard ratio [HR], 0.80; P = .0005), urinary symptoms (HR, 0.64; P < .0001), and bowel symptoms (HR, 0.78; P = .0027).
Study details: A study of patient-reported health-related QoL from randomized, double-blind, placebo-controlled, phase 3 ARAMIS trial, which evaluated 1,509 patients with nonmetastatic CRPC and prostate-specific antigen doubling time of 10 months or less who were randomly assigned 2:1 to receive darolutamide or placebo while continuing androgen deprivation therapy.
Disclosures: This study was funded by Bayer AG and Orion Pharma. The authors received grants, personal fees, and/or nonfinancial support from various sources. Some authors were employees of pharmaceutical companies.
Source: Smith MR. Eur J Cancer. 2021 Jul 14. doi: 10.1016/j.ejca.2021.06.010.
Key clinical point: In asymptomatic patients with nonmetastatic castration-resistant prostate cancer (CRPC), darolutamide vs placebo maintains health-related quality of life (QoL).
Major finding: Darolutamide vs placebo significantly delayed time to deterioration of Functional Assessment of Cancer Therapy-Prostate cancer subscale (hazard ratio [HR], 0.80; P = .0005), urinary symptoms (HR, 0.64; P < .0001), and bowel symptoms (HR, 0.78; P = .0027).
Study details: A study of patient-reported health-related QoL from randomized, double-blind, placebo-controlled, phase 3 ARAMIS trial, which evaluated 1,509 patients with nonmetastatic CRPC and prostate-specific antigen doubling time of 10 months or less who were randomly assigned 2:1 to receive darolutamide or placebo while continuing androgen deprivation therapy.
Disclosures: This study was funded by Bayer AG and Orion Pharma. The authors received grants, personal fees, and/or nonfinancial support from various sources. Some authors were employees of pharmaceutical companies.
Source: Smith MR. Eur J Cancer. 2021 Jul 14. doi: 10.1016/j.ejca.2021.06.010.
CRPC: Cabazitaxel extends radiographic PFS, regardless of age
Key clinical point: Cabazitaxel improves radiographic progression-free survival (rPFS) in older (age, 70 years and above) and younger (age, less than 70 years) patients with metastatic castration-resistant prostate cancer (CRPC) vs abiraterone or enzalutamide.
Major finding: The median rPFS significantly improved with cabazitaxel vs abiraterone/enzalutamide in older (hazard ratio [HR], 0.58; P = .012) and younger patients (HR, 0.47; P < .001). There was no significant improvement in overall survival with cabazitaxel in older (P = .084) and younger patients (P = .093).
Study details: An open-label, randomized CARD study of 255 patients with metastatic CRPC randomly assigned to either cabazitaxel plus prednisone and granulocyte colony-stimulating factor or enzalutamide/abiraterone+prednisone.
Disclosures: The study was funded by Sanofi. The authors reported grants or funding, honoraria, consulting/advisory fees, royalties, patents, employment/affiliation, and/or stock ownership/options.
Source: Sternberg CN et al. Eur Urol. 2021 Jul 14. doi: 10.1016/j.eururo.2021.06.021.
Key clinical point: Cabazitaxel improves radiographic progression-free survival (rPFS) in older (age, 70 years and above) and younger (age, less than 70 years) patients with metastatic castration-resistant prostate cancer (CRPC) vs abiraterone or enzalutamide.
Major finding: The median rPFS significantly improved with cabazitaxel vs abiraterone/enzalutamide in older (hazard ratio [HR], 0.58; P = .012) and younger patients (HR, 0.47; P < .001). There was no significant improvement in overall survival with cabazitaxel in older (P = .084) and younger patients (P = .093).
Study details: An open-label, randomized CARD study of 255 patients with metastatic CRPC randomly assigned to either cabazitaxel plus prednisone and granulocyte colony-stimulating factor or enzalutamide/abiraterone+prednisone.
Disclosures: The study was funded by Sanofi. The authors reported grants or funding, honoraria, consulting/advisory fees, royalties, patents, employment/affiliation, and/or stock ownership/options.
Source: Sternberg CN et al. Eur Urol. 2021 Jul 14. doi: 10.1016/j.eururo.2021.06.021.
Key clinical point: Cabazitaxel improves radiographic progression-free survival (rPFS) in older (age, 70 years and above) and younger (age, less than 70 years) patients with metastatic castration-resistant prostate cancer (CRPC) vs abiraterone or enzalutamide.
Major finding: The median rPFS significantly improved with cabazitaxel vs abiraterone/enzalutamide in older (hazard ratio [HR], 0.58; P = .012) and younger patients (HR, 0.47; P < .001). There was no significant improvement in overall survival with cabazitaxel in older (P = .084) and younger patients (P = .093).
Study details: An open-label, randomized CARD study of 255 patients with metastatic CRPC randomly assigned to either cabazitaxel plus prednisone and granulocyte colony-stimulating factor or enzalutamide/abiraterone+prednisone.
Disclosures: The study was funded by Sanofi. The authors reported grants or funding, honoraria, consulting/advisory fees, royalties, patents, employment/affiliation, and/or stock ownership/options.
Source: Sternberg CN et al. Eur Urol. 2021 Jul 14. doi: 10.1016/j.eururo.2021.06.021.
CML-CP: NK cell subsets associated with relapse outcomes after TKI discontinuation
Key clinical point: Natural killer (NK) cell subsets, particularly CD56bright NK cells, were associated with relapse outcomes after tyrosine kinase inhibitor (TKI) discontinuation in patients with chronic-phase chronic myeloid leukemia (CML-CP). Moreover, interferon-a therapy gradually increased levels of CD56bright NK cells.
Major finding: Among patients who did not receive interferon-a therapy, the nonrelapsed vs relapsed patients had a significantly higher proportion of CD3-CD56+ NK cells (P = .016), particularly CD3-CD56dimCD16+ NK cells (P = .017), at 1 month after TKI discontinuation. Patients who received interferon-a therapy showed an increase in CD56bright NK cells at 3- and 6- months post-therapy vs pre-therapy (P < .05).
Study details: Findings are from a retrospective analysis of 34 patients with CML-CP who discontinued TKI therapy after 3 or more years and at least 2 years of MR4.5. Twelve patients received interferon-a therapy post-TKI discontinuation.
Disclosures: This study was supported by the Capital Characteristic Clinic Project Foundation. The authors declared no conflict of interests.
Source: Kong J et al. Ann Hematol. 2021 Jul 19. doi: 10.1007/s00277-021-04606-9.
Key clinical point: Natural killer (NK) cell subsets, particularly CD56bright NK cells, were associated with relapse outcomes after tyrosine kinase inhibitor (TKI) discontinuation in patients with chronic-phase chronic myeloid leukemia (CML-CP). Moreover, interferon-a therapy gradually increased levels of CD56bright NK cells.
Major finding: Among patients who did not receive interferon-a therapy, the nonrelapsed vs relapsed patients had a significantly higher proportion of CD3-CD56+ NK cells (P = .016), particularly CD3-CD56dimCD16+ NK cells (P = .017), at 1 month after TKI discontinuation. Patients who received interferon-a therapy showed an increase in CD56bright NK cells at 3- and 6- months post-therapy vs pre-therapy (P < .05).
Study details: Findings are from a retrospective analysis of 34 patients with CML-CP who discontinued TKI therapy after 3 or more years and at least 2 years of MR4.5. Twelve patients received interferon-a therapy post-TKI discontinuation.
Disclosures: This study was supported by the Capital Characteristic Clinic Project Foundation. The authors declared no conflict of interests.
Source: Kong J et al. Ann Hematol. 2021 Jul 19. doi: 10.1007/s00277-021-04606-9.
Key clinical point: Natural killer (NK) cell subsets, particularly CD56bright NK cells, were associated with relapse outcomes after tyrosine kinase inhibitor (TKI) discontinuation in patients with chronic-phase chronic myeloid leukemia (CML-CP). Moreover, interferon-a therapy gradually increased levels of CD56bright NK cells.
Major finding: Among patients who did not receive interferon-a therapy, the nonrelapsed vs relapsed patients had a significantly higher proportion of CD3-CD56+ NK cells (P = .016), particularly CD3-CD56dimCD16+ NK cells (P = .017), at 1 month after TKI discontinuation. Patients who received interferon-a therapy showed an increase in CD56bright NK cells at 3- and 6- months post-therapy vs pre-therapy (P < .05).
Study details: Findings are from a retrospective analysis of 34 patients with CML-CP who discontinued TKI therapy after 3 or more years and at least 2 years of MR4.5. Twelve patients received interferon-a therapy post-TKI discontinuation.
Disclosures: This study was supported by the Capital Characteristic Clinic Project Foundation. The authors declared no conflict of interests.
Source: Kong J et al. Ann Hematol. 2021 Jul 19. doi: 10.1007/s00277-021-04606-9.
Advanced phase CML: Factors influencing long-term survival after hematopoietic stem cell transplantation
Key clinical point: Among patients with advanced phase chronic myeloid leukemia (CML), long-term survival after hematopoietic stem cell transplantation (HSCT) was influenced by donor age, CD34+ cell dose in the graft, and blast crisis (BC) at HSCT.
Major finding: At 15 years, overall survival (OS) and progression-free survival were 34% (95% confidence interval [CI], 22%-46%) and 26% (95% CI, 16%-36%), respectively. Donor age above 36 years (hazard ratio [HR], 1.74; P = .02), BC at HSCT (HR, 1.85; P = .01), and lower CD34+ cell dose in the graft (HR using continuous variables, 1.12; HR using categorical variables, 2.14; both P < .01) were associated with inferior OS.
Study details: Findings are from a retrospective analysis of 147 patients with advanced CML (BC, n=37; accelerated phase, n=40; second or higher chronic phase, n=70) who underwent HSCT between 1990 and 2018.
Disclosures: Open Access funding was enabled and organized by Projekt DEAL. The authors declared no conflict of interests.
Source: Niederwieser C et al. Bone Marrow Transplant. 2021 Jul 30. doi: 10.1038/s41409-021-01410-x.
Key clinical point: Among patients with advanced phase chronic myeloid leukemia (CML), long-term survival after hematopoietic stem cell transplantation (HSCT) was influenced by donor age, CD34+ cell dose in the graft, and blast crisis (BC) at HSCT.
Major finding: At 15 years, overall survival (OS) and progression-free survival were 34% (95% confidence interval [CI], 22%-46%) and 26% (95% CI, 16%-36%), respectively. Donor age above 36 years (hazard ratio [HR], 1.74; P = .02), BC at HSCT (HR, 1.85; P = .01), and lower CD34+ cell dose in the graft (HR using continuous variables, 1.12; HR using categorical variables, 2.14; both P < .01) were associated with inferior OS.
Study details: Findings are from a retrospective analysis of 147 patients with advanced CML (BC, n=37; accelerated phase, n=40; second or higher chronic phase, n=70) who underwent HSCT between 1990 and 2018.
Disclosures: Open Access funding was enabled and organized by Projekt DEAL. The authors declared no conflict of interests.
Source: Niederwieser C et al. Bone Marrow Transplant. 2021 Jul 30. doi: 10.1038/s41409-021-01410-x.
Key clinical point: Among patients with advanced phase chronic myeloid leukemia (CML), long-term survival after hematopoietic stem cell transplantation (HSCT) was influenced by donor age, CD34+ cell dose in the graft, and blast crisis (BC) at HSCT.
Major finding: At 15 years, overall survival (OS) and progression-free survival were 34% (95% confidence interval [CI], 22%-46%) and 26% (95% CI, 16%-36%), respectively. Donor age above 36 years (hazard ratio [HR], 1.74; P = .02), BC at HSCT (HR, 1.85; P = .01), and lower CD34+ cell dose in the graft (HR using continuous variables, 1.12; HR using categorical variables, 2.14; both P < .01) were associated with inferior OS.
Study details: Findings are from a retrospective analysis of 147 patients with advanced CML (BC, n=37; accelerated phase, n=40; second or higher chronic phase, n=70) who underwent HSCT between 1990 and 2018.
Disclosures: Open Access funding was enabled and organized by Projekt DEAL. The authors declared no conflict of interests.
Source: Niederwieser C et al. Bone Marrow Transplant. 2021 Jul 30. doi: 10.1038/s41409-021-01410-x.
Thyroid abnormalities associated with better treatment response in CML-CP patients on TKI therapy
Key clinical point: Thyroid abnormalities were more frequently observed in patients with chronic-phase chronic myeloid leukemia (CML-CP) on second-generation tyrosine kinase inhibitor (TKI) therapy vs imatinib and were associated with better treatment response.
Major finding: Hashimoto’s thyroiditis (HT; 30.4%) was more prevalent with nilotinib or dasatinib vs imatinib treatment (43.75% vs 18.9%; P = .03). The incidence of deep molecular response (DMR) was higher (73.1% vs 26.9%) and that of major molecular response (MMR) was lower (11.6% vs 88.4%) in patients with vs without thyroid alterations (P = .0001). HT was more prevalent in patients with DMR vs MMR (69.2% vs 7%; P = .0001).
Study details: Findings are from an analysis of 69 adult patients with Philadelphia chromosome-positive CML-CP treated with imatinib (n=37), nilotinib (n=21), or dasatinib (n=11) as first- or second-line therapy.
Disclosures: No funding was received for this study. Open access funding was provided by Universita degli Studi di Cagliari. The authors declared no conflict of interests.
Source: Rodia R et al. J Endocrinol Invest. 2021 Jul 20. doi: 10.1007/s40618-021-01613-5.
Key clinical point: Thyroid abnormalities were more frequently observed in patients with chronic-phase chronic myeloid leukemia (CML-CP) on second-generation tyrosine kinase inhibitor (TKI) therapy vs imatinib and were associated with better treatment response.
Major finding: Hashimoto’s thyroiditis (HT; 30.4%) was more prevalent with nilotinib or dasatinib vs imatinib treatment (43.75% vs 18.9%; P = .03). The incidence of deep molecular response (DMR) was higher (73.1% vs 26.9%) and that of major molecular response (MMR) was lower (11.6% vs 88.4%) in patients with vs without thyroid alterations (P = .0001). HT was more prevalent in patients with DMR vs MMR (69.2% vs 7%; P = .0001).
Study details: Findings are from an analysis of 69 adult patients with Philadelphia chromosome-positive CML-CP treated with imatinib (n=37), nilotinib (n=21), or dasatinib (n=11) as first- or second-line therapy.
Disclosures: No funding was received for this study. Open access funding was provided by Universita degli Studi di Cagliari. The authors declared no conflict of interests.
Source: Rodia R et al. J Endocrinol Invest. 2021 Jul 20. doi: 10.1007/s40618-021-01613-5.
Key clinical point: Thyroid abnormalities were more frequently observed in patients with chronic-phase chronic myeloid leukemia (CML-CP) on second-generation tyrosine kinase inhibitor (TKI) therapy vs imatinib and were associated with better treatment response.
Major finding: Hashimoto’s thyroiditis (HT; 30.4%) was more prevalent with nilotinib or dasatinib vs imatinib treatment (43.75% vs 18.9%; P = .03). The incidence of deep molecular response (DMR) was higher (73.1% vs 26.9%) and that of major molecular response (MMR) was lower (11.6% vs 88.4%) in patients with vs without thyroid alterations (P = .0001). HT was more prevalent in patients with DMR vs MMR (69.2% vs 7%; P = .0001).
Study details: Findings are from an analysis of 69 adult patients with Philadelphia chromosome-positive CML-CP treated with imatinib (n=37), nilotinib (n=21), or dasatinib (n=11) as first- or second-line therapy.
Disclosures: No funding was received for this study. Open access funding was provided by Universita degli Studi di Cagliari. The authors declared no conflict of interests.
Source: Rodia R et al. J Endocrinol Invest. 2021 Jul 20. doi: 10.1007/s40618-021-01613-5.
Early response predictive of future stable MR4.5 in imatinib-treated patients with CML
Key clinical point: Achievement of BCR-ABL1 less than or equal to 0.16%IS at 6 months was predictive of future stable molecular response 4.5 (MR4.5) among patients with chronic myeloid leukemia (CML) receiving first-line imatinib therapy.
Major finding: Achievement of a molecular response of BCR-ABL1 less than or equal to 0.16%IS predicted future stable MR4.5 (odds ratio, 3.1; P less than .001). At 8 years, patients with BCR-ABL1 less than or equal to 0.16%IS vs more than 0.16%IS at 6 months of imatinib treatment were more likely to achieve stable MR4.5 (65.8% vs 17.2%; P < .0001).
Study details: Findings are from a retrospective analysis of 593 patients with CML treated with frontline imatinib between 2000 and 2016.
Disclosures: No source of funding was identified. The authors declared no conflict of interests.
Source: Nee A et al. Leuk Lymphoma. 2021 Aug 11. doi: 10.1080/10428194.2021.1961234.
Key clinical point: Achievement of BCR-ABL1 less than or equal to 0.16%IS at 6 months was predictive of future stable molecular response 4.5 (MR4.5) among patients with chronic myeloid leukemia (CML) receiving first-line imatinib therapy.
Major finding: Achievement of a molecular response of BCR-ABL1 less than or equal to 0.16%IS predicted future stable MR4.5 (odds ratio, 3.1; P less than .001). At 8 years, patients with BCR-ABL1 less than or equal to 0.16%IS vs more than 0.16%IS at 6 months of imatinib treatment were more likely to achieve stable MR4.5 (65.8% vs 17.2%; P < .0001).
Study details: Findings are from a retrospective analysis of 593 patients with CML treated with frontline imatinib between 2000 and 2016.
Disclosures: No source of funding was identified. The authors declared no conflict of interests.
Source: Nee A et al. Leuk Lymphoma. 2021 Aug 11. doi: 10.1080/10428194.2021.1961234.
Key clinical point: Achievement of BCR-ABL1 less than or equal to 0.16%IS at 6 months was predictive of future stable molecular response 4.5 (MR4.5) among patients with chronic myeloid leukemia (CML) receiving first-line imatinib therapy.
Major finding: Achievement of a molecular response of BCR-ABL1 less than or equal to 0.16%IS predicted future stable MR4.5 (odds ratio, 3.1; P less than .001). At 8 years, patients with BCR-ABL1 less than or equal to 0.16%IS vs more than 0.16%IS at 6 months of imatinib treatment were more likely to achieve stable MR4.5 (65.8% vs 17.2%; P < .0001).
Study details: Findings are from a retrospective analysis of 593 patients with CML treated with frontline imatinib between 2000 and 2016.
Disclosures: No source of funding was identified. The authors declared no conflict of interests.
Source: Nee A et al. Leuk Lymphoma. 2021 Aug 11. doi: 10.1080/10428194.2021.1961234.
CML-CP: Favorable outcomes post-TKI switch in patients intolerant/resistant to frontline 2G-TKI
Key clinical point: Majority of patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) who switched from frontline second-generation (2G) tyrosine kinase inhibitor (TKI) to alternative TKIs because of intolerance or resistance were able to achieve or maintain favorable clinical outcomes.
Major finding: Among patients who switched because of intolerance, 88% achieved or maintained a major molecular response (MMR) with 5-year progression-free survival (PFS) and overall survival (OS) of 90.5% (95% confidence interval [CI], 90.4%-90.6%) and 95.2% (95% CI, 95.1%-95.3%), respectively. Among patients who switched because of resistance, 50% achieved or maintained an MMR with 5-year PFS and OS of 80.4% (95% CI, 80.2%-80.6%) and 80.0% (95% CI, 79.8%-80.2%).
Study details: Findings are from a retrospective analysis of 232 patients with newly diagnosed CML-CP treated with frontline 2G-TKI (dasatinib, n=187; nilotinib, n=45) who subsequently switched to alternative TKI.
Disclosures: This study was supported by Pharmacy Services, Alberta Health Services. K Jamani and L Savoie received honoraria from Novartis, Pfizer, Bristol Myers Squibb, and Paladin.
Source: Ma CE et al. Leuk Res. 2021 Jul 24. doi: 10.1016/j.leukres.2021.106674.
Key clinical point: Majority of patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) who switched from frontline second-generation (2G) tyrosine kinase inhibitor (TKI) to alternative TKIs because of intolerance or resistance were able to achieve or maintain favorable clinical outcomes.
Major finding: Among patients who switched because of intolerance, 88% achieved or maintained a major molecular response (MMR) with 5-year progression-free survival (PFS) and overall survival (OS) of 90.5% (95% confidence interval [CI], 90.4%-90.6%) and 95.2% (95% CI, 95.1%-95.3%), respectively. Among patients who switched because of resistance, 50% achieved or maintained an MMR with 5-year PFS and OS of 80.4% (95% CI, 80.2%-80.6%) and 80.0% (95% CI, 79.8%-80.2%).
Study details: Findings are from a retrospective analysis of 232 patients with newly diagnosed CML-CP treated with frontline 2G-TKI (dasatinib, n=187; nilotinib, n=45) who subsequently switched to alternative TKI.
Disclosures: This study was supported by Pharmacy Services, Alberta Health Services. K Jamani and L Savoie received honoraria from Novartis, Pfizer, Bristol Myers Squibb, and Paladin.
Source: Ma CE et al. Leuk Res. 2021 Jul 24. doi: 10.1016/j.leukres.2021.106674.
Key clinical point: Majority of patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) who switched from frontline second-generation (2G) tyrosine kinase inhibitor (TKI) to alternative TKIs because of intolerance or resistance were able to achieve or maintain favorable clinical outcomes.
Major finding: Among patients who switched because of intolerance, 88% achieved or maintained a major molecular response (MMR) with 5-year progression-free survival (PFS) and overall survival (OS) of 90.5% (95% confidence interval [CI], 90.4%-90.6%) and 95.2% (95% CI, 95.1%-95.3%), respectively. Among patients who switched because of resistance, 50% achieved or maintained an MMR with 5-year PFS and OS of 80.4% (95% CI, 80.2%-80.6%) and 80.0% (95% CI, 79.8%-80.2%).
Study details: Findings are from a retrospective analysis of 232 patients with newly diagnosed CML-CP treated with frontline 2G-TKI (dasatinib, n=187; nilotinib, n=45) who subsequently switched to alternative TKI.
Disclosures: This study was supported by Pharmacy Services, Alberta Health Services. K Jamani and L Savoie received honoraria from Novartis, Pfizer, Bristol Myers Squibb, and Paladin.
Source: Ma CE et al. Leuk Res. 2021 Jul 24. doi: 10.1016/j.leukres.2021.106674.
CML-CP: Late responses may be possible in patients initially refractory to TKIs
Key clinical point: Patients with chronic-phase chronic myeloid leukemia (CML-CP) who achieved an early (within 24 months) complete cytogenetic response (CCyR) to tyrosine kinase inhibitor (TKI) therapy (responders) had more favorable outcomes. However, continued TKI therapy led to late responses in a proportion of patients initially refractory to TKIs (nonresponders).
Major finding: During a median follow-up of 8.1 years, responders vs non-responders had significantly higher overall survival (93% vs 85%) and progression-free survival (93% vs 75%; both P less than .001) and lower progression to blast phase (1.9% vs 10.4%; P = .004). However, 34% of early nonresponders achieved CCyR with continued TKI therapy.
Study details: Findings are from a retrospective analysis of 305 adult patients with CML-CP treated with TKIs between 2001 and 2014.
Disclosures: This work was supported by the Thomas H. Brown Research Fund for Blood Cancers. M Talpaz reported ties with Novartis US and Takeda. Other authors declared no conflict of interests.
Source: Shaya J et al. Clin Lymphoma Myeloma Leuk. 2021 Jul 18. doi: 10.1016/j.clml.2021.07.001.
Key clinical point: Patients with chronic-phase chronic myeloid leukemia (CML-CP) who achieved an early (within 24 months) complete cytogenetic response (CCyR) to tyrosine kinase inhibitor (TKI) therapy (responders) had more favorable outcomes. However, continued TKI therapy led to late responses in a proportion of patients initially refractory to TKIs (nonresponders).
Major finding: During a median follow-up of 8.1 years, responders vs non-responders had significantly higher overall survival (93% vs 85%) and progression-free survival (93% vs 75%; both P less than .001) and lower progression to blast phase (1.9% vs 10.4%; P = .004). However, 34% of early nonresponders achieved CCyR with continued TKI therapy.
Study details: Findings are from a retrospective analysis of 305 adult patients with CML-CP treated with TKIs between 2001 and 2014.
Disclosures: This work was supported by the Thomas H. Brown Research Fund for Blood Cancers. M Talpaz reported ties with Novartis US and Takeda. Other authors declared no conflict of interests.
Source: Shaya J et al. Clin Lymphoma Myeloma Leuk. 2021 Jul 18. doi: 10.1016/j.clml.2021.07.001.
Key clinical point: Patients with chronic-phase chronic myeloid leukemia (CML-CP) who achieved an early (within 24 months) complete cytogenetic response (CCyR) to tyrosine kinase inhibitor (TKI) therapy (responders) had more favorable outcomes. However, continued TKI therapy led to late responses in a proportion of patients initially refractory to TKIs (nonresponders).
Major finding: During a median follow-up of 8.1 years, responders vs non-responders had significantly higher overall survival (93% vs 85%) and progression-free survival (93% vs 75%; both P less than .001) and lower progression to blast phase (1.9% vs 10.4%; P = .004). However, 34% of early nonresponders achieved CCyR with continued TKI therapy.
Study details: Findings are from a retrospective analysis of 305 adult patients with CML-CP treated with TKIs between 2001 and 2014.
Disclosures: This work was supported by the Thomas H. Brown Research Fund for Blood Cancers. M Talpaz reported ties with Novartis US and Takeda. Other authors declared no conflict of interests.
Source: Shaya J et al. Clin Lymphoma Myeloma Leuk. 2021 Jul 18. doi: 10.1016/j.clml.2021.07.001.