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kdl0721

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引用回帖:

10樓: Originally posted by xiaoerduomao at 2014-04-09 09:50:28
這個3期臨床還沒結(jié)束呢，按照你給的是ongoing，并不是completed
http://scimore.asia:1080/pharmallPluswebsite/database/tpharma/cortallis/ibrutinib001755.htm

謝謝，這個三期臨床試驗(yàn)由于結(jié)果呈顯著陽性已經(jīng)被FDA審查機(jī)構(gòu)統(tǒng)一結(jié)束了，數(shù)據(jù)還沒有公布，可能要到2014年ASCO年會上。你這個是湯森路透的數(shù)據(jù)？

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11樓2014-04-09 11:13:19

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xiaoerduomao

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11樓: Originally posted by kdl0721 at 2014-04-09 11:13:19
謝謝，這個三期臨床試驗(yàn)由于結(jié)果呈顯著陽性已經(jīng)被FDA審查機(jī)構(gòu)統(tǒng)一結(jié)束了，數(shù)據(jù)還沒有公布，可能要到2014年ASCO年會上。你這個是湯森路透的數(shù)據(jù)？...

是的

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12樓2014-04-09 11:36:52

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dengchun14

13樓2014-04-09 11:43:16

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kdl0721

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看來都沒有知道該臨床試驗(yàn)具體數(shù)據(jù)的，只能等2014ASCO年會了。

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14樓2014-04-09 13:36:44

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kdl0721

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12樓: Originally posted by xiaoerduomao at 2014-04-09 11:36:52
是的...

能給我發(fā)一份最新完整版的湯森路透報(bào)告嗎？謝謝，金幣都給你。

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15樓2014-04-09 13:39:23

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kdl0721

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版主，請關(guān)閉該求助帖子，我已得到結(jié)果，謝謝！

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16樓2014-06-06 10:38:12

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tsenghw

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【答案】應(yīng)助回帖

N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.
Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia.
Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators.
Collaborators (67)

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.).

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17樓2015-11-11 22:17:53

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