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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2020.1
- 수록면
- 139 - 145 (7page)
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BackgroundGeneric formulations of imatinib mesylate have been introduced in Western Europe since 2017 to treat patients with chronic myeloid leukemia (CML). However, results on the safety and efficacy of generic formulations are contrasting. The aim of this study was to investigate the safety and efficacy of generic imatinib in CML patients treated in 12 Italian institutes.MethodsThis is an observational, retro-prospective analysis of patients with CML for whom the treatment was switched from brand to generic imatinib. We analyzed and compared the variation in quantitative PCR values before and after the switch, and the proportion of patients who maintained molecular response after changing from brand to generic imatinib. Adverse events (AEs) were also evaluated. ResultsTwo hundred patients were enrolled. The median PCR value after the switch was reduced by 0.25 compared to the values before the switch. A significant difference was found be-tween median PCR values before and after the switch in favor of generic imatinib (P= 0.003). Molecular responses remained stable in 69.0%, improved in 25.5%, and wors-ened in 5.5% of patients. AEs were similar in the pre- and post-switch periods; however, a significant difference was found in favor of generic imatinib for muscular cramps (P＜0.0001), periorbital edema (P=0.0028), edema of the limbs (P＜0.0001), fatigue (P=0.0482), and diarrhea (P=0.0027).ConclusionOur data indicate that generic imatinib does not have deleterious effects on CML control and present an acceptable safety profile, similar or better than brand imatinib.
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등록된 정보가 없습니다.
참고문헌 (25)
참고문헌 신청
Yang YT / 2016 / Generic oncology drugs: are they all safe? / Lancet Oncol 17:e493~501
Vargas M / 2017 / Bioequivalence study of imatinib formulations that contain 400 mg in healthy colombians / J Bioequivalence Bioavailab 9:483~488
Rachna Arora / 2016 / A Multi-centric Bioequivalence Trial in Ph+ Chronic Myeloid Leukemia Patients to Assess Bioequivalence and Safety Evaluation of Generic Imatinib Mesylate 400 mg Tablets / Cancer Research and Treatment 48(3):1120~1129
Ostojic A / 2016 / Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia : unicentric study / Clin Lymphoma Myeloma Leuk 16:472~476
Goubran HA / 2009 / Failure of a non-authorized copy product to maintain response achieved with imatinib in a patient with chronic phase chronic myeloid leukemia : a case report / J Med Case Rep 3:7112
Vargas M / 2017 / Bioequivalence study of imatinib formulations that contain 400 mg in healthy colombians / J Bioequivalence Bioavailab 9:483~488
Rachna Arora / 2016 / A Multi-centric Bioequivalence Trial in Ph+ Chronic Myeloid Leukemia Patients to Assess Bioequivalence and Safety Evaluation of Generic Imatinib Mesylate 400 mg Tablets / Cancer Research and Treatment 48(3):1120~1129
Ostojic A / 2016 / Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia : unicentric study / Clin Lymphoma Myeloma Leuk 16:472~476
Goubran HA / 2009 / Failure of a non-authorized copy product to maintain response achieved with imatinib in a patient with chronic phase chronic myeloid leukemia : a case report / J Med Case Rep 3:7112
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