scholarly journals PS1181 DOSING PATTERNS OF DASATINIB AND NILOTINIB USE IN SIMPLICITY, AN OBSERVATIONAL STUDY IN CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) PATIENTS (PTS) IN ROUTINE CLINICAL PRACTICE

HemaSphere ◽  
2019 ◽  
Vol 3 (S1) ◽  
pp. 537-538
Author(s):  
J. Cortes ◽  
C. Gambacorti-Passerini ◽  
S. Goldberg ◽  
M. Mauro ◽  
C. Chen ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Chronic Myeloid Leukemia ◽  
Observational Study ◽  
Myeloid Leukemia ◽  
Chronic Phase ◽  
Routine Clinical Practice ◽  
Dosing Patterns

scholarly journals Russian Registry of Chronic Myeloid Leukemia Management in Routine Clinical Practice-Local Therapy and Monitoring

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5156-5156
Author(s):  
Anna Turkina ◽  
Anatoly Golenkov ◽  
Lyudmila Napso ◽  
Irina Krylova ◽  
Tatiana Klitochenko ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Chronic Myeloid Leukemia ◽  
Observational Study ◽  
Myeloid Leukemia ◽  
Chronic Phase ◽  
Local Therapy ◽  
Routine Clinical Practice ◽  
Treatment Results ◽  
Number Of Patients ◽  
Leukemic Clone

Abstract Introduction: in the last 10 years the number of tyrosine kinase inhibitors (TKI) used to treat patients with chronic myeloid leukemia (CML) significantly increased. The basic principle of therapy was also changed, now it is aimed at early induction of deep response (ELN, NCCN). The treatment results in clinical practice may vary widely and depend on the effectiveness of the entire complex TKI, based on timely evaluation of residual leukemic clone. Objective: To characterize the TKI treatment results and monitoring of residual leukemic clone in clinical practice in CML patients in the Russian Federation (RF). Methods: The observational study "Russian registry of chronic myeloid leukemia management in routine clinical practice" (CSTI571ARU06 LLC) was launched in November 2011 by Novartis. Patients with Ph'+ CML were enrolled into study after signing the informed consent. Thus the study has a retrospective part (4626 patients) and prospective group of 1828 CML patients. By February 2015, the Registry contained information about 6466 patients from 110 centers of 80 regions of the RF. The annual increase of newly registered CML cases ranged from 493 to 694 people per year or 10-13% of the total number of patients included in the Registry on the treatment of CML in 2012- 2014. Characteristics of patients in the Registry: median duration of the disease was 71 months (from 0.2 to 343 months); median age at registration time and CML diagnosis was 49.5 years (range 2 - 94 years); male 43%. The biggest number of cases was diagnosing with patients aged 50-69 years old, which is 50% out of all the registered patients. It is important to note that the number of female patients aged 50 years old and older (39.1% in total, out of the overall number of CML cases) prevails the same male patients age group (25.6% of the cases). Chronic phase was in 93.6% of patients, accelerated phase and blast crisis- 5.6% and 0.6% cases, accordantly. Sokal risk group's ratio was 50%/31%/19% for low, intermediate and high risk, respectively. Results: The data for the analysis were available for 5632 patients (93% of CML patients in the Registry). The 1st line TKI therapy was Imatinib (IM)- in 4908 of the 5632 patients (87%), including the advanced phases of CML; in 71 and 14 patients the 1st line treatment was nilotinib and dasatinib respectively(totally 1%). The percentage of patients receiving TKI-2 ranged from 10 to 35% in different regions of RF. In 2006, the diagnosis CML was confirmed by the data of karyological analysis only with 42% of the patients, but it should be pointed out that currently cytogenetic and/or molecular-based analysis has been conducted at least once with 99% of the patients. Thus, the data presented in Registry of CML treatment provides grounds to state that almost all the patients have had their diagnosis verified within routine clinical practice. The presented data demonstrate the amount of work done to obtain such results during the previous ten-year period. We evaluated cytogenetic monitoring (CyM)/molecular monitoring (MM) frequency during years 2013-2014. Two or more studies per year of cytogenetic CyM/MM were done only 20% of 40 patients per year (2320 persons); with 50% (2960 in 2013, 1203 in 2014) of patients CyM/MM was performed once; no studies have been done in 489 patients in 2013 and 3580 patients in 2014. There was a trend of increasing of molecular studies to evaluate minimal residual disease:1829 MM vs 491 CyM in 2013 and 1028 MM vs 179 CyM in 2014. The absence of optimal response (ELN2013) was observed in 887 patients on different TKIs: (759patients on IM: in 732 patients with the duration of IM therapy over 12months and in 27 patients-less than 12months. Change of treatment to 2nd line was performed in 639 (12%) patients. The death occurred in 373 (6.2%) patients, no data of the living status was in 50 (0.8%) cases. According to the Registry data, death due to the CML progression was in 99 cases (26%). Conclusions: The observational study "Russian registry of chronic myeloid leukemia management in routine clinical practice" is the largest registry of hematological diseases in Russia, providing information about CML patients receiving TKI therapy more than 10 years. The introduction of information technologies to analyze a large amount of data is an essential component to improve the quality of medical care. The evaluation of therapy results can give objective information of the TKI 1st and 2nd generations requirement. Disclosures Turkina: Pfizer: Consultancy; Bristol Myers Squibb: Consultancy; Novartis Pharma: Consultancy. Golenkov:Novartis: Consultancy.

scholarly journals First-line treatment selection and early monitoring patterns in chronic phase-chronic myeloid leukemia in routine clinical practice: SIMPLICITY

2017 ◽  
Vol 92 (11) ◽  
pp. 1214-1223 ◽  
Author(s):  
Stuart L. Goldberg ◽  
Jorge E. Cortes ◽  
Carlo Gambacorti-Passerini ◽  
Rüdiger Hehlmann ◽  
H. Jean Khoury ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Chronic Phase ◽  
Routine Clinical Practice ◽  
Treatment Selection ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

CLO19-029: Dosing Patterns of Nilotinib Use in SIMPLICITY, an Observational Study in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients (Pts) in Routine Clinical Practice

2019 ◽  
Vol 17 (3.5) ◽  
pp. CLO19-029
Author(s):  
Jorge Cortes ◽  
Clara Chen ◽  
Michael Mauro ◽  
Neela Kumar ◽  
Catherine Davis ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Dose Reduction ◽  
Chronic Phase ◽  
Routine Clinical Practice ◽  
Myelogenous Leukemia ◽  
Categorical Variables ◽  
Imatinib Resistance ◽  
Dose Reductions ◽  
Dosing Patterns

Introduction: Dosing patterns of nilotinib (NIL) in chronic phase chronic myelogenous leukemia (CP-CML) patients (Pts) have not been well documented outside of clinical trials. SIMPLICITY (NCT01244750) is an ongoing observational study exploring tyrosine kinase inhibitor (TKI) use in routine clinical practice among CP-CML pts receiving TKIs in the US and Europe since 2010. This analysis reports NIL dosing patterns and explores predictors of dose reductions. A subset analysis focusing on the first-line (1L) approved dose of 300 mg twice daily (BID) will also be presented. Methods: Only SIMPLICITY pts receiving 1L NIL BID (n=349/408) were included. Baseline demographics and dosing patterns (starting dose, dose changes, time to dose reduction, and duration of therapy [DoT]) were analyzed descriptively. Statistical comparisons were made using t-tests, the Mann-Whitney U test for continuous variables, and chi-square for categorical variables. Logistic regression models were used to identify factors associated with dose reductions. Results: Of the 349 pts treated with 1L NIL, 281 (80.5%) started at the standard dose of 300 mg (BID) or the 400 mg (BID) dose for imatinib-resistance/intolerance, and 37 (10.6%) and 31 pts (8.9%) started on 150‒200 mg BID and 450‒800 mg BID. European pts were more likely to start on a dose >400 mg BID than US pts (P<.0001). Pts at academic centers were more likely to start on >400 mg BID than those treated at community practices (P<.0029). Among the pts starting NIL at 300 or 400 mg (BID) in 1L, 70.9% remained on these doses; 26.6% received a dose reduction (median time to dose reduction: 80.5 days); and 2.5% received a dose increase. Median DoT with NIL was 30.4 vs 43.9 months for pts with vs without a dose reduction (P=NS). The main reason for dose reduction was intolerance (n=51; 68.9%); in 51% of pts, a specific side effect was cited. Dose reductions were more likely in patients at academic centers (odds ratio=1.996; P=.021), but not in pts experiencing baseline fatigue (OR=1.799; P=0.072). Conclusions: Most pts treated with 1L NIL were started on 300 or 400 mg (BID); however, 1 in 4 pts required a dose reduction, most often due to intolerance. Physicians at academic centers were more likely to reduce the NIL dose than those in community practices. DoT with NIL for pts who received a dose reduction was shorter than that for those who did not. These findings will aid clinical decisions on dose optimization and maintaining response, whilst improving the patient quality of life.

scholarly journals Safety and efficacy of nilotinib in routine clinical practice in patients with chronic myeloid leukemia in chronic or accelerated phase with resistance or intolerance to imatinib: results from the NOVEL study

2018 ◽  
Vol 9 (3) ◽  
pp. 65-78 ◽  
Author(s):  
Ching-Yuan Kuo ◽  
Po-Nan Wang ◽  
Wen-Li Hwang ◽  
Cheng-Hwai Tzeng ◽  
Li-Yaun Bai ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Kinase Inhibitor ◽  
Safety Data ◽  
Chronic Phase ◽  
Routine Clinical Practice ◽  
Molecular Response ◽  
Open Label ◽  
Safety And Efficacy

Background: Nilotinib, a second-generation tyrosine kinase inhibitor (TKI), is approved for the treatment of patients with chronic myeloid leukemia (CML) in many countries, including Taiwan. Though a number of controlled clinical trials have demonstrated the safety and efficacy of nilotinib, studies assessing the safety and efficacy of nilotinib in routine clinical practice are limited. Methods: The current study was an open-label, single-arm study conducted across 12 centers in Taiwan in adult patients with CML in chronic or accelerated phase with confirmed Ph+ chromosome (or BCR-ABL) and resistant or intolerant to one or more previous TKIs. The primary objective was to collect the long-term safety data in patients treated with nilotinib 400 mg, twice daily for up to 2 years. Results: The study enrolled 85 patients with CML, including 76 in the chronic phase (CML-CP) and 9 in the accelerated phase (CML-AP). Overall, 1166 adverse events (AEs) were reported in 80 patients (94.1%), of which 70 AEs (6%) in 28 patients (32.9%) were serious and 336 AEs (28.8%) reported in 60 patients (70.6%) were drug-related. Common drug-related AEs were thrombocytopenia (21.2%), increased alanine aminotransferase (21.2%) and pruritus (17.7%). Of the 85 patients, 19 switched from imatinib due to intolerance – AEs were resolved in 16 of these 19 patients (84.2%). By 24 months, the cumulative rates of complete cytogenetic response (CCyR), major molecular response (MMR), MR4.0 ( BCR-ABL1IS ⩽0.01%) and MR4.5 ( BCR-ABL1IS ⩽0.0032%) were 75.3, 56.8, 16.2 and 7.4%, respectively. Patients with CML-CP at baseline had higher overall survival (OS) and progression-free survival (PFS) than those with CML-AP. Conclusion: This is the first study that demonstrated that nilotinib is effective and well-tolerated in patients resistant or intolerant to imatinib in the real-world setting in Taiwan, reflecting effective management of CML by physicians under routine clinical practice in Taiwan.

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