演題詳細

ポスター / Poster

ポスター 9 (Poster 9) :CML:臨床1 (CML:Clinical Research 1)

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日程
2013年10月11日(金)
時間
16:50 - 17:50
会場
ポスター会場 / Poster (ロイトン札幌 3F ロイトンホールABCD)
座長・司会
田中 英夫 (Hideo Tanaka):1
1:広島市立安佐市民病院 血液内科
 
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Ponatinib in Philadelphia chromosome-positive (Ph+) leukemias: Results of the phase 2 PACE trial

演題番号 : PS-1-59

Jorge E Cortes:1、Dong-Wook Kim:2、Javier Pinilla-Ibarz:3、Philipp le Coutre:4、Ronald Paquette:5、Charles Chuah:6、Franck E Nicolini:7、Jane Apperley:8、H Jean Khoury:9、Moshe Talpaz:10、John DiPersio:11、Daniel DeAngelo:12、Elisabetta Abruzzese:13、Delphine Rea:14、Michele Baccarani:15、Martin C Müller:16、Carlo Gambacorti-Passerini:17、Stephanie Lustgarten:18、Victor M Rivera:18、Tim Clackson:18、Christopher D Turner:18、Frank G Haluska:18、Francois Guilhot:19、Michael W Deininger:20、Andreas Hochhaus:21、Timothy Hughes:22、John M Goldman:8、Neil Shah:23、Hagop Kantarjian:1

1:The University of Texas MD Anderson Cancer Center, Houston, TX, USA、2:Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea、3:H. Lee Moffitt Cancer Center, Tampa, FL, USA、4:Charité-Universitätsmedizin Berlin, Berlin, Germany、5:Ronald Reagan UCLA Medical Center, University of California, Los Angeles, CA, USA、6:Singapore General Hospital, Duke-NUS Graduate Medical School, Singapore、7:Centre Hospitalier Lyon Sud, Pierre Benite, France、8:Imperial College London, London, UK、9:Emory Winship Cancer Institute, Atlanta, GA, USA、10:Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA、11:Washington University School of Medicine, St Louis, MO, USA、12:Dana-Farber Cancer Institute, Boston, MA, USA、13:Ospedale S. Eugenio, Rome, Italy、14:Service des Maladies du Sang, Hopital Saint-Louis, Paris, France、15:S Orsola-Malpighi University Hospital, Bologna, Italy、16:III. Med. Klinik, Universitätsmedizin Mannheim, Mannheim, Germany、17:Unità di Ricerca Clinica - Ematologia, Azienda Ospedaliera San Gerardo/University of Milano Bicocca, Monza, Italy、18:ARIAD Pharmaceuticals, Inc., Cambridge, MA, USA、19:CIC Inserm 0802, CHU de Poitiers, France、20:Huntsman Cancer Institute University of Utah, Salt Lake City, UT USA、21:Universitätsklinikum Jena, Jena, Germany、22:Institute of Medicine and Veterinary Science, Adelaide, Australia、23:University of California San Francisco, San Francisco, CA, USA

 

Ponatinib is a potent, oral TKI with activity against native and mutant BCR-ABL. The efficacy and safety of ponatinib (45 mg once daily) in patients (pts) with Ph+ leukemia were evaluated in an international open-label clinical trial. 449 pts resistant or intolerant (R/I) to dasatinib or nilotinib or with the T315I mutation were enrolled; pts were assigned to 1 of 6 cohorts: chronic phase (CP)-CML R/I (N=203), CP CML T315I (N=64), accelerated phase (AP)-CML R/I (N=65), AP-CML T315I (N=18), blast phase (BP) CML/Ph+ ALL R/I (N=48), BP CML/Ph+ ALL T315I (N=46). The primary endpoint was major cytogenetic response (MCyR) at any time within 12 mos (CP-CML) and major hematologic response (MaHR) at any time within 6 mos (advanced Ph+ leukemia). Data as of 9 Nov 2012 are reported: median follow-up 15 (0.1 to 25) mos. Pts were heavily pretreated: 93% received ≥2 prior TKIs, 58% ≥3. Response rates were: CP-CML - 56% MCyR [95% CI 49.6-61.9%] overall (51% R/I, 70% T315I); AP-CML – 55% MaHR [95% CI 44.1-66.3%] overall (57% R/I, 50% T315I); BP-CML/Ph+ ALL – 34% MaHR [95% CI 24.6-44.5%] overall (35% R/I, 33% T315I). Responses were observed regardless of baseline mutation status. Although higher response rates were seen in CP-CML T315I pts, a multivariate analysis showed that the clinical features of these pts (eg, higher dose intensity, younger age, fewer prior TKIs, less time since diagnosis) were the strongest predictors of response, and that the presence of T315I alone is not an independent predictor of response. At the time of analysis, 49% of pts remained on therapy (63% CP-CML). Most common reasons for discontinuation: progression (19%) and AEs (12%). The most common drug related adverse events were thrombocytopenia (37%), rash (34%), and dry skin (32%). In summary, ponatinib has substantial activity and is generally well tolerated in heavily pretreated pts with Ph+ leukemia.

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