scholarly journals Dasatinib, even at low doses, is an effective second-line therapy for chronic myeloid leukemia patients resistant or intolerant to imatinib. Results from a real life-based Italian multicenter retrospective study on 114 patients

2010 ◽  
Vol 85 (12) ◽  
pp. 960-963 ◽  
Author(s):  
Giuseppe Visani ◽  
Massimo Breccia ◽  
Antonella Gozzini ◽  
Giorgina Specchia ◽  
Enrico Montefusco ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Real Life ◽  
Low Doses ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

Real-life comparison of nilotinib versus dasatinib as second-line therapy in chronic phase chronic myeloid leukemia patients

2021 ◽  
Vol 100 (5) ◽  
pp. 1213-1219
Author(s):  
Emilia Scalzulli ◽  
Giovanni Caocci ◽  
Fabio Efficace ◽  
Lorenzo Rizzo ◽  
Gioia Colafigli ◽  
...  
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Real Life ◽  
Chronic Phase ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

Comparasion Between Nilotinib and Dasatinib as Second-Line Therapy for Patients with Chronic Myeloid Leukemia: A Single Center Retrospective Study.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3440-3440
Author(s):  
Clarisse Lobo ◽  
Carla Boquimpani ◽  
Tania Silva Madeira ◽  
Patricia Wendling ◽  
Claudia Maximo ◽  
...  
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Second Generation ◽  
Randomized Clinical Trials ◽  
Molecular Response ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Third Line Therapy ◽  
Third Line

Abstract Abstract 3440 Nilotinib and dasatinib are second-generation tyrosine kinase inhibitors (TKI) used in patients with chronic myeloid leukemia (CML) resistant or intolerant to imatinib. There are no randomized clinical trials comparing these drugs in this context. The aim of this study was to compare, retrospectively, the hematological, cytogenetic and molecular response in patients submitted to these second-generation TKI at Hemorio, a public brazilian institution. A total of 114 patients were analyzed, 63 received nilotinib and 51 dasatinib as second-line therapy (55.3% and 44.7%, respectively). The following variables were equally distributed between these two groups (nilotinib vs. dasatinib, respectively): male sex (54% vs. 60.8%, p=0.46), median age at diagnosis (46 vs. 45 years, p=0.76), median time in months using imatinib before the switch (45.2 vs. 44.1, p=0.96), resistance to imatinib (98.4% vs. 98%, p=0.88), presence of the mutation T315I (3.2% vs. 3.9%, p=0.09), patients in chronic phase before the switch (85.7% vs. 86.3%, p=0.93). Use of another second generation TKI, as a third-line therapy, was necessary in 30 out of the 114 patients analyzed (26.1%) because of lack of response. This modification was slightly more frequent in the group initially submitted to nilotinib (31.7% vs. 19.6%, p=0.21). Patients who used a third-line therapy were excluded from response and survival analyzes. Response rates after the second-generation TKI were similar between these two groups (nilotinib vs. dasatinib): complete hematological response until three months (77.8% vs. 87.3%, p=0.24), complete cytogenetic response until six months (21.6% vs. 22.2%, p=0.95) and 12 months (32.4% vs. 33.3%, p=0.94) and major molecular response reached before 12 months (32.7% vs. 21.6%, p=0.25). Two-year overall survival (OS) and progression free-survival (PFS) were similar between these two groups (nilotinib vs. dasatinib, respectively): 92.2% vs. 87.8% (p=0.38) for OS and 87.8% vs. 83.7% (p=0.14) for PFS. Although not statistically significant, two-year OS was inferior in the group of patients who needed a third-line therapy (70.5% vs. 95.6%, p=0.70). Our results suggest that the response and survival rates are similar between nilotinib and dasatinib as second-line therapy for patients with imatinib resistant or intolerant CML. Also, they suggest an inferior prognosis for patients who need a third-line therapy. In this way, the choice between these two TKI for second-line therapy should be guided by the clinical characteristics and the mutation status of the patient. Disclosures: Lobo: NOVARTIS: Research Funding.

scholarly journals Pharmacoeconomic analysis of treatment with nilotinib as the second line therapy in patients with chronic myeloid leukemia

2018 ◽  
Vol 11 (2) ◽  
pp. 27-37
Author(s):  
N. A. Avxentyev ◽  
M. Yu. Frolov ◽  
A. S. Makarov
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Tyrosine Kinase ◽  
Medical Cost ◽  
Myeloid Leukemia ◽  
Line Treatment ◽  
Second Line ◽  
Second Line Therapy ◽  
Drug Reimbursement ◽  
Line Therapy ◽  
The Government

Ilmatinib is currently the most widely used tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia (CML) in Russia. When patients develop resistance or intolerance to imatinib, second generation tyrosine kinase inhibitors (Tkis) are used. in Russia, nilotinib, dasatinib and bosutinib are registered in second-line, however only dasatinib is included in the government drug reimbursement program.The aim of this study was to conduct a pharmacoeconomic comparison of nilotinib, dasatinib and bosutinib as second-line treatments for patients with CML from the Russian healthcare system perspective.Materials and methods. Using the clinical trial data we developed a Markov model of CML progression on nilotinib, dasatinib or bosutinib second-line therapy and calculated the medical costs per patient. Both costeffectiveness analysis and budget-impact analysis reflected the local practice and the drug reimbursement approval process.Results. The average medical cost (per year) for nilotinib (1 683 thousand rubles or US$27 075) was 8.4% lower than that for dasatinib and 35.2% lower than for bosutinib. The 4-year total medical cost of treatment with nilotinib was 4 372 thousand rubles (US$ 70 336), which was 13.9% lower compared to dasatinib and 37.3% lower compared to bosutinib. nilotinib also had a lower cost/effectiveness ratio (US$ 1 602, 1 910 and 2 537 per life month for nilotinib, dasatinib and bosutinib, respectively). The estimated number of patients in Russia who need second-line treatment for CML is 996 patients. if nilotinib were included in the Government Reimbursement Program, a saving of 771 million rubles (US$ 12,4 million) over four years would be reached.Conclusions. When compared with dasatinib or bosutinib, nilotinib is the cost-saving option for the second-line treatment of CML patients in Russia. 

scholarly journals Dasatinib in First- and Second-Line Therapy of Chronic Myeloid Leukemia: Efficacy, Safety and Quality of Life

2017 ◽  
Vol 10 (2) ◽  
pp. 206-217
Author(s):  
TI Ionova ◽  
◽  
NB Bulieva ◽  
OYu Vinogradova ◽  
TA Gritsenko ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

The Efficacy of Generic Imatinib as First- and Second-line Therapy: 3-Year Follow-up of Patients With Chronic Myeloid Leukemia

2017 ◽  
Vol 17 (4) ◽  
pp. 238-240 ◽  
Author(s):  
Erna Islamagic ◽  
Azra Hasic ◽  
Sabira Kurtovic ◽  
Emina Suljovic Hadzimesic ◽  
Lejla Mehinovic ◽  
...  
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

Efficacy Of Dasatinib Therapy In Patients With Imatinib-Resistant Or -Intolerant Chronic Myeloid Leukemia From Physician’s and Patient’s Perspective: “Real World” Data

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5185-5185
Author(s):  
Tatyana I Ionova ◽  
Tatyana P Nikitina ◽  
Taras A Gritsenko ◽  
Valentina L Ivanova ◽  
Galina B Kuchma ◽  
...  
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Real World ◽  
Myeloid Leukemia ◽  
Research Funding ◽  
Base Line ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Patient Reported ◽  
Dasatinib Treatment

Abstract There is limited published data about the efficacy and safety of the second-line therapy with dasatinib in patients in chronic phase chronic myeloid leukemia (CML-CP) in a “real world” patients setting outside clinical trials. In addition, comprehensive evaluation of benefits and risks of the treatment is worthwhile to better define treatment outcomes in this patients’ population. We aimed to study clinical and patient-reported outcomes as well as safety of dasatinib treatment in a “real world” setting within the context of its approved indication through the analysis of prospectively collected data in patients with imatinib resistance or intolerance receiving dasatinib as the second-line therapy. 75 CML-CP patients resistant or -intolerant to imatinib were enrolled in the prospective, multicenter, non-interventional study (mean age 51.3 years old, SD 15.4; range 22–83 years; male/female – 37/38). The median of disease duration was 5.0 years (0.75–17 years). 63 patients had resistance to imatinib; 12 patients were intolerant to imatinib; the median duration of imatinib treatment 40 months (3–121 months). All the patients received dasatinib as the second-line therapy (100 mg daily). Median follow-up was 12 months. For quality of life (QoL) and symptom assessment patients filled out the SF-36 and Comprehensive Symptom Profile in Chronic Myeloid Leukemia Patients (CSP Leuk-CML), respectively, at base-line, in 1, 3, 6 months after treatment start and every 6 months thereafter. Comparison of QoL and symptom scores was conducted using t-test. QoL scores were analyzed using t-test, adjusting for sociodemographic and disease status. Mean symptom severity and percentage of patients with moderate-to-severe (ratings ³ 5) symptoms was evaluated. After 12 months of treatment 83% patients achieved or maintained complete hematologic response and 35 % – complete cytogenetic response. The twenty four-month progression free survival rate was 93% (95% CI; 84–97%). Four cases of pleural effusion events were registered: they were easily managed in 3 cases; one patient died at 1 month after treatment start due to accompanied infection complication. No severe hematological adverse effects were observed except two cases of grade III-IV neutropenia. Two patients were resistant to dasatinib. Two patients died of disease progression at 6 months of follow-up. At 12 months of dasatinib treatment QoL parameters were stable for 5 out of 8 scales; vitality, social functioning and mental health significantly improved as compared with base-line (p< 0.01). At 24 months of dasatinib treatment improvement of physical functioning, vitality, social functioning and mental health as compared with base-line was registered (p< 0.01); no worsening was observed for other QoL scales. Before treatment 75% of patients experienced at least one moderate-to-severe symptom; more than 40% had more than 7 moderate-to-severe symptoms. The majority of patients (96%) experienced fatigue; half of them suffered from moderate-to-severe fatigue. While treatment the number of patients with moderate-to-severe symptoms decreased. After 12 months of therapy only 25% of patients experienced moderate-to-severe fatigue. Before treatment 36% of patients exhibited critical or severe QoL impairment. Remarkably, in the subgroup of patients (44%) with critical or severe QoL impairment at base-line dramatic QoL improvement was observed: QoL index increased 3.4 fold (p<0.01). Thus, our study on “real world” patient data confirms that dasatinib as second-line therapy in CML-CP patients is effective both in terms of clinical outcomes and patient-reported outcomes, as well as exhibits good tolerability. Comprehensive evaluation of the outcomes of the second-line treatment of CML-CP allows to assess the benefits and risks of therapy both from physician’s and patient’s perspective. Disclosures: Ionova: BMS: Research Funding. Nikitina:BMS: Research Funding. Gritsenko:BMS: Research Funding. Ivanova:BMS: Research Funding. Kuchma:BMS: Research Funding. Shnaider:BMS: Research Funding. Sannikova:BMS: Research Funding. Fedorenko:BMS: Research Funding. Kurbatova:BMS: Research Funding.

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