کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2754747 1149792 2015 4 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Ofatumumab in Refractory Chronic Lymphocytic Leukemia: Experience Through the French Early Access Program
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی بیهوشی و پزشکی درد
پیش نمایش صفحه اول مقاله
Ofatumumab in Refractory Chronic Lymphocytic Leukemia: Experience Through the French Early Access Program
چکیده انگلیسی

BackgroundThe Autorisation Temporaire d’Utilisation (ATU) is an early access program available in France for drugs aimed at treating severe diseases not yet covered by a marketing authorization, for patients without any other therapeutic option and who cannot be included in a clinical trial.Patients and MethodsThis report presents the use of single-agent ofatumumab in 30 patients with advanced chronic lymphocytic leukemia (CLL) in the French ATU program.ResultsThese very-high-risk patients had received multiple previous treatments (median = 6), and most had disease that was fludarabine-refractory or alemtuzumab-refractory (or both) or was unsuitable for alemtuzumab treatment. In the intent-to-treat analysis, the overall response rate was 47% (4 of 30, complete response; 10 of 30, partial response). Of 13 patients with 17p deletion, 6 displayed response to ofatumumab, including 2 complete responses. Treatment was well tolerated, with 17 grade 3 or 4 adverse events; 4 cases of grade 3 or 4 infusion reactions were reported, with favorable immediate outcome. Among nonhematologic complications, infections were the most frequent.ConclusionThe results confirm the efficacy and acceptable tolerability profile of ofatumumab as a single agent in severely ill patients with CLL. Attention should be paid to possible early infusion reactions to ofatumumab, as well as to the risk of infection.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Clinical Lymphoma Myeloma and Leukemia - Volume 15, Issue 2, February 2015, Pages e43–e46
نویسندگان
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