Generic Imatinib Therapy Among Jordanians: An Observational Assessment of Efficacy and Safety in Routine Clinical Practice (original) (raw)
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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...
Advanced Biomedical Research, 2013
Background: Currently, imatinib is the drug of choice for initiation of medical treatment of chronic myeloid leukemia (CML) in the chronic phase. The current study was carried out to compare effectiveness and safety of Iranian vs. Indian imatinib. Materials and Methods: The clinical study was performed on newly diagnosed CML patients in Seyyed-oShohada Hospital (Isfahan) and Khansari Hospital (Arak) from January to June 2011. The control group consisted of CML patients who received Indian imatinib previously. The drug was initiated with the dose of 400 mg daily. The patients were followed for six months, and the treatment outcomes (WBC <10 4) and molecular response. Finally, the two groups were compared in these respects. Result: We evaluated 43 patients in each group. The hematological and molecular responses for the Iranian Imatinib were respectively 86.0% and 46.5%, while the rates were respectively 86.0 and 44.2% for the Indian imatinib. The two groups were similar with regard to the treatment outcome. The two groups were not significantly different with regard to the drug adverse effects. Conclusion: According to the findings, the Iranian imatinib is not different from the Indian drug in the hematological and molecular responses in treatment of the chronic phase of CML patients. Furthermore, the adverse effects of the two kinds were not significantly different. Compared with the results of other studies, the effectiveness of Iranian imatinib is equivalent to the Indian drug can be employed for treatment of CML patients in the chronic phase.
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.
Clinical Lymphoma Myeloma and Leukemia, 2019
Context: Outcomes in patients with CML-BP are historically dismal. The median survival in patients with blastic phase CML is less than 12 months. Pathobiology of CML-BP involves various pathways with genetic and epigenetic abnormalities involved in transformation but isn't fully understood. These statements are applicable for CML with primary blast crisis (De-Novo CML BP). But some clinical data suggests that De-Novo CML-BP may have different pathobiology and prognosis for these patients may be better. Meanwhile, the distinction between De-Novo CML BP and De-Novo BCR-ABL (+) AML is challenging in many cases. Objective: The aim of this study is to describe the characteristics of patients with De-Novo CML-BP in Armenia. Design and Patients: Descriptive study of retrospective case series. This study involves patients who were diagnosed with CML in Hematology Center between 2014 and 2018. Distinction between Ph(+) AML and De-Novo CML-BP was based on splenomegaly, basophilia, Ph(+) metaphase proportion, left shift in myelogram. Results: Total 6 patients were identified, who were diagnosed with De-Novo CML-BP in the mentioned period of time. 4/6 of patients were males, 2/6 females. Median age at diagnosis was 48.5 years. Proportion of De-Novo CML-BP in total CML patients was 5.6%. Proportion in total CML-BP was 26%. 4/6 patients are still alive, median OS was not reached. 1 year OS was 66% (significantly better than in secondary CML-BP patients). 1 patient with concomitant 11q23 rearrangement received two cycles of standard 7+3 chemotherapy and imatinib 600 mg QID, he achieved MMR at 1 mo. Other 3 patients are in chronic phase now. 1 patient was treated with imatinib 600 mg alone and is in CP now. 2 other patients received imatinib 400 mg QID. The first patient who passed away initially was treated with imatinib 600 mg, after lack of effect he received Nilotinib 400 mg BID and passed away while he was in this treatment. The second patient passed away on imatinib 400 mg. No one of patients underwent Allo-HSCT because this procedure still isn't available in Armenia. Conclusions: Prognosis of CML with Primary Blast crisis with first and second generation TKIs not as effective as for CML-CP patients. Despite this, experience from Armenia reinforces the hypothesis that CML with primary blast crisis has different features and better prognosis from secondary CML-BP.
Leukemia Research, 2018
The use of generic drugs after patent expiration of their originators is a relative novelty in the treatment of chronic cancer patients in Western countries. In this observational study we analyzed a cohort of 294 Italian chronic phase chronic myeloid leukemia patients treated frontline with branded imatinib (Glivec®) for at least 6 months and then uniformly switched to generic imatinib upon requirement of health authorities in early 2017. Median age at diagnosis was 57 years (range 19-87). Sokal risk was low/intermediate/high in 55%, 32% and 8% of cases, respectively. Median duration of branded imatinib treatment was 7.4 years (range 0.5-16.7). At a median follow-up of 7.5 months after switch to generic imatinib, 17% of patients reported new or worsening side effects, but grade 3-4 non-hematological adverse events were rare. Six patients switched back to branded imatinib, with improvement in the side effect profile, and 4 pts moved to bosutinib or nilotinib for resistance/ intolerance. The majority of patients were in major (26%) or deep molecular response (66%) at the time of switch. Molecular responses remained stable, improved or worsened in 61%, 25% and 14% of patients, respectively. We conclude that switch to generic imatinib for patients who have been receiving branded imatinib appears to be effective and safe. Molecular responses may continue to improve over time. Some patients experienced new or worsened side effects but less than 5% of the whole cohort needed to switch back to branded imatinib or move to other treatments. Savings were around 3 million Euros.
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: 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.
The Turkish Journal of Hematology, 2013
Objective: Imatinib mesylate, a tyrosine kinase inhibitor, is presently the drug of choice for chronic myeloid leukemia (CML). During therapy, a few patients may develop hematological and non-hematological adverse effects. Materials and Methods: The aim of this study was to evaluate the safety of imatinib therapy in patients with CML. Between December 2007 and October 2009 two hundred patients with CML in chronic phase were included in the study. Written informed consent was obtained from all patients prior to the start of the study. Imatinib was started at 400 mg orally daily. Patients were monitored carefully for any adverse effects. Complete blood count, liver, and renal function tests were done once in 2 weeks during the first month and on a monthly basis during follow-up. Toxicities that encountered were graded as per the National Cancer Institute common toxicity criteria version 2. Both hematologic and non-hematologic toxicities were managed with short interruptions of treatment and supportive measures, but the daily dose of imatinib was not reduced below 300 mg/day. Results: Two hundred CML patients in chronic phase were included in this study; the male:female ratio was 0.7:1 with mean age 39.06±13.21 years (ranged from 15-81 years). The study showed that the commonest hematological side effects were grade 2 anemia (12.5%) followed by leukopenia (8%) and thrombocytopenia (4%), while the most common non-hematological adverse effects were superficial edema and weight gain (51.5%), followed by musculoskeletal pain (35.5%), then gastro-intestinal symptoms (vomiting, diarrhea) (19%). Fluid retention was the commonest side effect, which responded to low-dose diuretics. The drug was safe and well tolerated. There were no deaths due to toxicity. Conclusion: Imatinib mesylate a well-tolerated drug, and all undesirable effects could be ameliorated easily. The most common hematological and non-hematological side effects were anemia and fluid retention, respectively.
European Journal of Cancer, 2002
Imatinib (Glivec , formerly STI571, Novartis Pharma AG, Basel, Switzerland) potently inhibits several protein tyrosine kinases, including Bcr-Abl, Kit, and the platelet-derived growth factor receptor. Phase I and II studies demonstrated that orally administered imatinib is highly effective and well tolerated in all phases of chronic myeloid leukemia (CML) at doses ranging from 400 to 600 mg. Importantly, preliminary evidence suggests that patients with advanced CML achieving hematologic or major cytogenetic responses to imatinib may have longer survival than those without such responses, whereas chronic phase patients who respond to treatment may have longer times to disease progression. Ongoing and planned studies are focused on optimizing CML treatment with imatinib, evaluating imatinib-based combination therapy, defining additional therapeutic targets and exploring the use of imatinib in children. In particular, results from several combination phase I studies are expected shortly, including an evaluation of combination imatinib-interferon-α therapy and imatinib-cytarabine in chronic phase CML, and a phase I study of single-agent imatinib in children with Philadelphia chromosome-positive leukemia is ongoing. A large phase III trial comparing imatinib with standard inferferon alfa plus cytarabine in first-line CML treatment is also ongoing.