New England Journal of Medicine· 2014Q1
Daha Önce Tedavi Görmüş Kronik Lenfoid Lösemide İbrutinib ve Ofatumumab Karşılaştırması
Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia
- 1.629atıf
- Q1SCImago
- 2014yıl
Kısa özet
İbrutinib, daha önce tedavi görmüş kronik lenfoid lösemi (KLL) hastalarında ofatumumaba kıyasla ilerlemesiz sağkalımı (medyan ulaşılamadı vs. 8.1 ay), genel sağkalımı (%90 vs. %81, 12 ayda) ve yanıt oranını (%42.6 vs. %4.1) anlamlı şekilde iyileştirmiştir.
Yapay zekâ ile başlık ve abstract'tan üretildi; tam metin okunmaz.
Ana noktalar
- İbrutinib, daha önce tedavi görmüş KLL hastalarında ilerlemesiz sağkalımı anlamlı şekilde iyileştirmiştir (medyan ulaşılamadı vs. 8.1 ay).
- 12 aylık genel sağkalım, ofatumumaba kıyasla ibrutinib grubunda daha yüksekti (%90'a karşılık %81).
- Genel yanıt oranı ibrutinib için anlamlı derecede daha yüksekti (%42.6'ya karşılık %4.1).
- İbrutinib'in faydaları, 17p13.1 delesyonu veya pürin analoglarına direnç varlığından bağımsız olarak gözlemlenmiştir.
Yapay zekâ ile başlık ve abstract'tan üretildi; tam metin okunmaz.
Özet (abstract)
BACKGROUND: In patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL), a short duration of response to therapy or adverse cytogenetic abnormalities are associated with a poor outcome. We evaluated the efficacy of ibrutinib, a covalent inhibitor of Bruton's tyrosine kinase, in patients at risk for a poor outcome. METHODS: In this multicenter, open-label, phase 3 study, we randomly assigned 391 patients with relapsed or refractory CLL or SLL to receive daily ibrutinib or the anti-CD20 antibody ofatumumab. The primary end point was the duration of progression-free survival, with the duration of overall survival and the overall response rate as secondary end points. RESULTS: At a median follow-up of 9.4 months, ibrutinib significantly improved progression-free survival; the median duration was not reached in the ibrutinib group (with a rate of progression-free survival of 88% at 6 months), as compared with a median of 8.1 months in the ofatumumab group (hazard ratio for progression or death in the ibrutinib group, 0.22; P<0.001). Ibrutinib also significantly improved overall survival (hazard ratio for death, 0.43; P=0.005). At 12 months, the overall survival rate was 90% in the ibrutinib group and 81% in the ofatumumab group. The overall response rate was significantly higher in the ibrutinib group than in the ofatumumab group (42.6% vs. 4.1%, P<0.001). An additional 20% of ibrutinib-treated patients had a partial response with lymphocytosis. Similar effects were observed regardless of whether patients had a chromosome 17p13.1 deletion or resistance to purine analogues. The most frequent nonhematologic adverse events were diarrhea, fatigue, pyrexia, and nausea in the ibrutinib group and fatigue, infusion-related reactions, and cough in the ofatumumab group. CONCLUSIONS: Ibrutinib, as compared with ofatumumab, significantly improved progression-free survival, overall survival, and response rate among patients with previously treated CLL or SLL. (Funded by Pharmacyclics and Janssen; RESONATE ClinicalTrials.gov number, NCT01578707.).
Yazarların özeti; kaynağından alınmıştır. New England Journal of Medicine, 2014 · DOI ↗
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