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Nilotinib combined with multiagent chemotherapy for newly diagnosed Philadelphia-positive acute lymphoblastic leukemia.
Kim, Dae-Young; Joo, Young-Don; Lim, Sung-Nam; Kim, Sung-Doo; Lee, Jung-Hee; Lee, Je-Hwan; Kim, Dong Hwan Dennis; Kim, Kihyun; Jung, Chul Won; Kim, Inho; Yoon, Sung-Soo; Park, Seonyang; Ahn, Jae-Sook; Yang, Deok-Hwan; Lee, Je-Jung; Lee, Ho-Sup; Kim, Yang Soo; Mun, Yeung-Chul; Kim, Hawk; Park, Jae Hoo; Moon, Joon Ho; Sohn, Sang Kyun; Lee, Sang Min; Lee, Won Sik; Kim, Kyoung Ha; Won, Jong-Ho; Hyun, Myung Soo; Park, Jinny; Lee, Jae Hoon; Shin, Ho-Jin; Chung, Joo-Seop; Lee, Hyewon; Eom, Hyeon-Seok; Lee, Gyeong Won; Cho, Young-Uk; Jang, Seongsoo; Park, Chan-Jeoung; Chi, Hyun-Sook; Lee, Kyoo-Hyung.
Afiliación
  • Kim DY; Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;
  • Joo YD; Department of Internal Medicine, Haeundae Paik Hospital, College of Medicine Inje University, Busan, Korea;
  • Lim SN; Department of Internal Medicine, Haeundae Paik Hospital, College of Medicine Inje University, Busan, Korea;
  • Kim SD; Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;
  • Lee JH; Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;
  • Lee JH; Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;
  • Kim DH; Division of Hematology/Oncology, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea;
  • Kim K; Division of Hematology/Oncology, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea;
  • Jung CW; Division of Hematology/Oncology, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea;
  • Kim I; Division of Hematology-Medical Oncology, Department of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea;
  • Yoon SS; Division of Hematology-Medical Oncology, Department of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea;
  • Park S; Division of Hematology-Medical Oncology, Department of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea;
  • Ahn JS; Department of Hematology and Oncology, Chonnam National University Hwasun Hospital, Jeollanam-do, Korea;
  • Yang DH; Department of Hematology and Oncology, Chonnam National University Hwasun Hospital, Jeollanam-do, Korea;
  • Lee JJ; Department of Hematology and Oncology, Chonnam National University Hwasun Hospital, Jeollanam-do, Korea;
  • Lee HS; Division of Hematology/Oncology, Department of Internal Medicine, Kosin University College of Medicine, Kosin University Gospel Hospital, Busan, Korea;
  • Kim YS; Division of Hematology/Oncology, Department of Internal Medicine, Kosin University College of Medicine, Kosin University Gospel Hospital, Busan, Korea;
  • Mun YC; Division of Hematology-Oncology, Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea;
  • Kim H; Division of Hematology and Cellular Therapy, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea;
  • Park JH; Division of Hematology and Cellular Therapy, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea;
  • Moon JH; Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, Korea;
  • Sohn SK; Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, Korea;
  • Lee SM; Department of Hemato-Oncology, Inje University Busan Paik Hospital, Busan, Korea;
  • Lee WS; Department of Hemato-Oncology, Inje University Busan Paik Hospital, Busan, Korea;
  • Kim KH; Division of Hematology-Oncology, Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, Korea;
  • Won JH; Division of Hematology-Oncology, Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, Korea;
  • Hyun MS; Division of Hematology-Oncology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea;
  • Park J; Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea;
  • Lee JH; Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea;
  • Shin HJ; Department of Hematology-Oncology, School of Medicine, Pusan National University Hospital Medical Research Institute, Busan, Korea;
  • Chung JS; Department of Hematology-Oncology, School of Medicine, Pusan National University Hospital Medical Research Institute, Busan, Korea;
  • Lee H; Hematologic Oncology Clinic, Center for Specific Organs Center, National Cancer Center, Goyang, Korea;
  • Eom HS; Hematologic Oncology Clinic, Center for Specific Organs Center, National Cancer Center, Goyang, Korea;
  • Lee GW; Division of Hematology-Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea; and.
  • Cho YU; Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • Jang S; Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • Park CJ; Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • Chi HS; Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • Lee KH; Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;
Blood ; 126(6): 746-56, 2015 Aug 06.
Article en En | MEDLINE | ID: mdl-26065651
We investigated the effects of nilotinib plus multiagent chemotherapy, followed by consolidation/maintenance or allogeneic hematopoietic cell transplantation (allo-HCT) for adult patients with newly diagnosed Philadelphia-positive (Ph-pos) acute lymphoblastic leukemia (ALL). Study subjects received induction treatment that comprised concurrent vincristine, daunorubicin, prednisolone, and nilotinib. After achieving complete hematologic remission (HCR), subjects received either 5 courses of consolidation, followed by 2-year maintenance with nilotinib, or allo-HCT. Minimal residual disease (MRD) was assessed at HCR, and every 3 months thereafter. The molecular responses (MRs) were defined as MR3 for BCR-ABL1/G6PDH ratios ≤10(-3) and MR5 for ratios <10(-5). Ninety evaluable subjects, ages 17 to 71 years, were enrolled in 17 centers. The HCR rate was 91%; 57 subjects received allo-HCT. The cumulative MR5 rate was 94%; the 2-year hematologic relapse-free survival (HRFS) rate was 72% for 82 subjects that achieved HCR, and the 2-year overall survival rate was 72%. Subjects that failed to achieve MR3 or MR5 were 9.1 times (P = .004) or 6.3 times (P = .001) more prone to hematologic relapse, respectively, than those that achieved MR3 or MR5. MRD statuses just before allo-HCT and at 3 months after allo-HCT were predictive of 2-year HRFS. Adverse events occurred mainly during induction, and most were reversible with dose reduction or transient interruption of nilotinib. The combination of nilotinib with high-dose cytotoxic drugs was feasible, and it effectively achieved high cumulative complete molecular remission and HRFS rates. The MRD status at early postremission time was predictive of the HRFS. This trial was registered at www.clinicaltrials.gov as #NCT00844298.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirimidinas / Protocolos de Quimioterapia Combinada Antineoplásica / Trasplante de Células Madre Hematopoyéticas / Leucemia-Linfoma Linfoblástico de Células Precursoras Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Año: 2015 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirimidinas / Protocolos de Quimioterapia Combinada Antineoplásica / Trasplante de Células Madre Hematopoyéticas / Leucemia-Linfoma Linfoblástico de Células Precursoras Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Año: 2015 Tipo del documento: Article Pais de publicación: Estados Unidos