Real World Efficacy Evaluation of Branded and Copy Imatinib in Chronic Myeloid Leukemia: A Retrospective Multicentric Study from Argentina (original) (raw)
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Revista Brasileira de Hematologia e Hemoterapia, 2013
This retrospective study was based on information obtained from patients' records in the Hematology Service of Hospital Universitário Walter Cantídio of Universidade Federal do Ceará (HUWC / UFC), in northeast Brazil. The study was approved by that institution's Ethics Research Committee. Population and Sample All patients diagnosed with CML that took IM for a minimum of 12 months in the period from January 2001 to January 2011 were included in the study. From a population of 160 patients, 100 were eligible for analysis. In the assessment of factors related to treatment response, two patients were excluded because they were referred for bone marrow transplantation (BMT) before response evaluation. A special form was used to collect sociodemographic characteristics and data related to diagnosis and therapeutic response based on the LeukemiaNet criteria (7) (hematologic, cytogenetic and molecular), as well as time to response and adherence to treatment. Background: In the last decade, there has been a revolution in chronic myeloid leukemia treatment with the introduction of tyrosine kinase inhibitors with imatinib mesylate becoming the frontline therapy. Objective: To evaluate the therapeutic efficacy of imatinib mesylate in treating chronic myeloid leukemia patients and to identify factors related to therapeutic efficacy.
Introduction and Aim: Generic imatinib formulations are increasingly being used as more affordable alternatives worldwide and a few studies have evaluated the safety and efficacy of these. We have retrospectively analyzed our chronic-phase chronic myeloid leukemia (CP- CML) cohort in terms of first-line treatment with Glivec versus generic imatinib. This study aims to evaluate the safety and efficacy of generic imatinib products in CP- CML as the first-line treatment. Material and Method: We retrospectively analyzed our CP- CML cohort from January 2000 to December 2020 treated with either Glivec or one of the generic imatinib formulations. All our patients were followed in accordance with European Leukemia Net (ELN) 2020 recommendations and national hematology association CML guidelines and response definitions were applied according to ELN 2020 criteria. Event-free survival (EFS) was defined as the time between treatment initiation and either loss of hematological response, progres...
Generic Imatinib in the Treatment of Chronic Myeloid Leukemia: Two Years’ Experience in Latvia
Experimental Oncology, 2019
Background: Imatinib is tyrosine kinase inhibitor (TKI) and as a targeted anti-cancer agent has significantly changed chronic myeloid leukemia (CML) prognosis and patient survival. Currently TKI is the main therapy in CML Philadelphia chromosome-positive (Ph-positive) cases. When generics of imatinib appeared in the pharmaceuticals market, reimbursement policies in many countries switched to using generics or encouraged use of generic imatinib to lower the expenses. Cost savings were substantial; however, for doctors and CML patients the efficacy, safety and quality of generic imatinib were an issue of concern. Objective: Since the global number of CML patients, who in the future will have to switch from original imatinib to generic imatinib, is high, the aim of study was to monitor, whether during 24 months of generic imatinib usage patients maintain the achieved major molecular response (MMR) or whether the treatment results are inferior. Methods: We conducted a retrospective stud...
Vojnosanitetski pregled
Background / Aim. The treatment of chronic myeloid leukemia (CML) has changed dramatically with the advent of targeted therapies. The study aimed to assess the efficacy of generic imatinib in CML patients treated in our center. Methods The study was retrospective. It included 101 patients with the diagnosis of CMLchronic phase (CP). There were two study groups. Group 1 included 55 patients initially treated with branded imatinib and then switched to generic imatinib. Group 2 consisted of 46 newly diagnosed patients who received only generic imatinib from the start of therapy. Results. The patients were treated with branded imatinib for the mean of 42 months (range 6-132 months) before switching to generic imatinib. Treatment with generic imatinib lasted for 25 months in average (range 3-66 months). A quarter of the patients from Group 1 lost their cytogenetic response after being switched to generic imatinib but without signs of transformation to acute leukemia. Patients treated with branded imatinib had a significantly longer event-free survival (EFS) and failure-free survival (FFS) (log-rank p=0.01 and p=0.03). These results could have been influenced by frequent changes of the brand and dosage formulation of generic imatinib. Conclusions. Our study showed a significantly longer EFS nad FFS on treatment with initially branded imatinib due to cross over study design, but provide some informative data of these two group of patients Key words: branded imatinib mesylate; generic imatinib mesylate; chronic myeloid leukemia. Apstrakt Uvod / Cilj. Ciljna terapija je značajno izmenila uspeh lečenje bolesnika sa hroničnom mijeloidnom leukemijom. Cilj rada je bio da se proceni efikasnost lečenja obolelih od hronične mijeloidne leukemije generičkim imatinibom u našem centru. Metode: Istraživanje je bilo retrospektivno. Obuhvatilo je 101 obolelog od hronične mijeloidne leukemije u hroničnj fazi. Bolesnici su bili podeljeni u dve grupe. Prvu grupu je činilo 55 bolesnika koji su inicijalno lečenji originalnim imatinibom i koji su kasnije tokom lečenja prevedeni na terapiju gneričkim imatinibom. Drugu grupu je činilo 46 novodijagnostikovanih bolesnika koji su od početka lečeni generičkim imatinibom. Rezultati. Bolesnici su originalnim imatinibom lečeni u proseku 42 meseca (od 6 do 132 4 meseca) nakon čega su prevedeni na generički imatinib. Lečenje generičkim imatinibom je u proseku trajalo 25 meseci (od 3 do 66 meseci). Četvrtina bolesnika prve grupe je izgubila citogenetski odgovor nakon prevoĎenja na generički imatinib. Nije bilo znakova za transformaciju u akutnu leukemiju. Bolesnici lečeni originalnim imatinibom su imali statistički značajno duže preživljavanje bez dogaĎaja koje podrazumeva smrtni ishod i preživljavanje bez neuspeha terapije (log-rank p=0.01 and p=0.03). Na ovakve rezultate je mogla imati uticaj učestala promena dozne formulacije i poizvoĎača generičkog imatiniba. Zaključak. Naše istraživanje je ukazalo na značajno duže preživljavanje bez dogaĎaja koje podrazumeva smrtni ishod i preživljavanje bez neuspeha terapije kod bolesnika koji su lečenje započeli originalnim imatinibom u odnosu na drugu grupu pacijenata koji su lečeni sve vreme generičkim imatinibom. Navedeni rezultati pružaju korisnu informaciju, ali se moraju tumačiti u kontekstu studije po tipu "cross over dizajna". Ključne reči: brendirani imatinib mesilat; generički imatinib mesilat; hronična mijeloidna leukemija.
Imatinib for Chronic Myeloid Leukemia Patients: A Single Institution Experience
Blood
4429 Background Imatinib mesylate (IM) is considered the mainstay of chronic myeloid leukemia (CML) treatment for almost a decade. The primary goal of the study is to share data of a substantial number of CML patients followed at one center. Methods We analyzed data from 177 CML patients who were treated in our institution and received IM for at least 24 months. They were stratified into low, intermediate and high risk groups based on Sokal score. Early chronic phase (ECP) (within one year from diagnosis to IM start), late chronic phase (LCP) (≥ 12 months from diagnosis), and accelerated phase (AP) CML patients were included in the study. Patients were evaluated for hematologic, cytogenetic and molecular responses, event-free survival (EFS) and overall survival (OS), frequency of adverse events. Results The median age was 51.2 years (range, 22–86 years), with 77 females and 100 males. Patients were followed for a median of 60 months (range, 24–116 months). IM was started at a dose o...
Background and Objectives First-line treatment of chronic phase (CP) chronic myeloid leukemia (CML) is based on the first-generation tyrosine kinase inhibitor (TKI) imatinib or the second-generation TKIs dasatinib or nilotinib. Thanks to the efficacy of TKIs, CML has switched from a fatal to a 'chronic' pathology, and data from clinical trials have become insufficient to drive physicians' prescription choices and address long-term treatment outcomes. On the brink of commercialization of generic imatinib, this study aims to evaluate the therapeutic pattern of CP-CML and the occurrence of adverse events (AEs) over a decade of local real clinical practice. Methods A retrospective cohort study was performed on CP-CML patients followed up in the Local Health Unit of Treviso (Veneto Region, Italy) during the period 2005-2015. Data were captured from both administrative databases and physicians' patient diaries. Results Of 81 CP-CML patients, 73 were treated with first-line imatinib; among the second-generation TKIs, only nilotinib was used (n = 8). Overall, 38% of imatinib-treated subjects needed to switch, mainly due to intolerance, whereas no switches occurred in the nilotinib cohort. Osteoarticular pain was the most common AE and was significantly more frequent in the imatinib cohort (68.49 vs. 25.00%, p = 0.022). Other common AEs were dermatologic manifestations, asthenia, and diarrhea. Conclusion Although based on a small population, this study represents an unbiased reference on the long-term management of CML in an Italian clinical setting. Our results indicate a better profile of first-line nilotinib, both in terms of persistency and tolerability. AEs remain a major concern, highlighting the importance of close monitoring.
Generic imatinib in the treatment of chronic myeloid leukemia: Cerrahpa a experience
Journal of Oncology Pharmacy Practice, 2015
As the first tyrosine kinase inhibitor (TKI), imatinib (Gleevec or Glivec, Novartis Pharmaceuticals) was introduced, the treatment of chronic myeloid leukemia (CML) has changed radically, and the TKIs are now the mainstay of CML treatment. The substantially high treatment cost has unfortunately been a major issue, which puts a strain on healthcare budgets even in developed countries. So reimbursement policies encourage generic drug (i.e. generic imatinib) use to lower the expenses, and it is true that generics would lead to considerable cost savings, but they also give rise to questions associated with their efficacy, safety and quality. In this commentary, we discuss the current evidence on generic imatinib based mainly on our ''Cerrahpaşa'' experience along with other data available in the literature together with the data discussed by de Lemos and colleagues.