PMID- 31394591 OWN - NLM STAT- MEDLINE DCOM- 20200622 LR - 20220114 IS - 1365-2141 (Electronic) IS - 0007-1048 (Linking) VI - 187 IP - 5 DP - 2019 Dec TI - Nilotinib efficacy, safety, adherence and impact on quality of life in newly diagnosed patients with chronic myeloid leukaemia in chronic phase: a prospective observational study in daily clinical practice. PG - 615-626 LID - 10.1111/bjh.16145 [doi] AB - This observational, prospective study assessed, in a daily clinical practice, the molecular response, safety, quality of life (QoL) and treatment adherence in 183 patients with chronic myeloid leukaemia in chronic phase (CML-CP), receiving nilotinib as first-line treatment. Premature study termination before 24 months of follow-up occurred in 61 patients (33.3%), and was essentially due to nilotinib treatment discontinuation (n = 53; 29%), motivated by treatment intolerance (n = 29; 15.8%) and inefficacy (n = 19; 10.4%). After 24 months of treatment, 112/122 patients (91.8%) had a molecular assessment, 95.5% of whom achieved a major molecular response (MMR), 32.1% achieved uMR(4) , defined as an undetectable molecular disease with 4-log molecular response sensitivity (>/=10 000 ABL1 transcripts). The Morisky Green Levine Medication Adherence Scale was completed by 94/122 patients (77.0%), and 89.4% of these patients obtained a satisfactory level of treatment adherence, defined as a score >/=3. Patients' QoL was good at baseline and stable during the follow-up period. The two most common nilotinib-related adverse events (AEs) were pruritus (14.8%) and asthenia (13.7%). Seven patients (3.8%) experienced at least one cardiovascular ischaemic AE. This French nationwide cohort study provides relevant information in daily clinical practice indicating that nilotinib is a valuable first-line treatment option for CML-CP patients. CI - (c) 2019 British Society for Haematology and John Wiley & Sons Ltd. FAU - Huguet, Francoise AU - Huguet F AD - Department of Haematology, Toulouse University Cancer Institute, Toulouse, France. FAU - Cayuela, Jean-Michel AU - Cayuela JM AD - Laboratory of Haematology, University Hospital Saint-Louis AP-HP and EA3518, University Paris Diderot, Paris, France. FAU - Cambier, Nathalie AU - Cambier N AD - Department of Oncology and Haematology, Saint Vincent de Paul Hospital, Lille, France. FAU - Carpentier, Nathalie AU - Carpentier N AD - Novartis Pharma S.A.S., Rueil-Malmaison, France. FAU - Tindel, Malka AU - Tindel M AD - Novartis Pharma S.A.S., Rueil-Malmaison, France. FAU - Violet, Isabelle AU - Violet I AD - Novartis Pharma S.A.S., Rueil-Malmaison, France. FAU - Zunic, Patricia AU - Zunic P AD - Department of Haematology, University Hospital Centre, Saint-Pierre, Reunion Island, France. FAU - Lascaux, Axelle AU - Lascaux A AD - Department of Clinical Haematology and Cell Therapy, Haut-Leveque Hospital, Bordeaux University Hospital, Pessac, France. FAU - Etienne, Gabriel AU - Etienne G AUID- ORCID: 0000-0001-7600-4954 AD - Department of Medical Oncology, Institut Bergonie, Bordeaux, France. CN - AdheRMC Investigators LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20190808 PL - England TA - Br J Haematol JT - British journal of haematology JID - 0372544 RN - 0 (Antineoplastic Agents) RN - 0 (BCR-ABL1 fusion protein, human) RN - 0 (Biomarkers, Tumor) RN - 0 (Pyrimidines) RN - EC 2.7.10.1 (Protein-Tyrosine Kinases) RN - EC 2.7.10.2 (Fusion Proteins, bcr-abl) RN - F41401512X (nilotinib) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - Asthenia/chemically induced MH - Biomarkers, Tumor/genetics MH - Drug Eruptions/etiology MH - Female MH - Follow-Up Studies MH - Fusion Proteins, bcr-abl/genetics MH - Humans MH - Leukemia, Myelogenous, Chronic, BCR-ABL Positive/*drug therapy/genetics MH - Male MH - Medication Adherence/statistics & numerical data MH - Middle Aged MH - Prospective Studies MH - Protein-Tyrosine Kinases/antagonists & inhibitors MH - Pruritus/chemically induced MH - Psychometrics MH - Pyrimidines/adverse effects/*therapeutic use MH - *Quality of Life MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - adherence OT - chronic myeloid leukaemia OT - daily clinical practice OT - nilotinib OT - tyrosine-kinase inhibitor FIR - Didier Innocent, Adiko IR - Didier Innocent A FIR - Shanti, Ame Natarajan IR - Shanti AN FIR - Carla, Araujo IR - Carla A FIR - Omar, Benbrahim IR - Omar B FIR - Martial, Boisseau IR - Martial B FIR - Dominique, Bordessoule IR - Dominique B FIR - Azzedine, Bouderbala IR - Azzedine B FIR - Nathalie, Cambier IR - Nathalie C FIR - Valerie, Coiteux IR - Valerie C FIR - Pascale, Cony Makhoul IR - Pascale CM FIR - Regis, Costello IR - Regis C FIR - Martine, Delain IR - Martine D FIR - Viviane, Dubruille IR - Viviane D FIR - Abderrazak, El Yamani IR - Abderrazak EY FIR - Gabriel, Etienne IR - Gabriel E FIR - Jose, Fernandes IR - Jose F FIR - Reda, Garidi IR - Reda G FIR - Agnes, Guerci Bresler IR - Agnes GB FIR - Denis, Guyotat IR - Denis G FIR - Maya, Hacini IR - Maya H FIR - Eric, Hermet IR - Eric H FIR - Francoise, Huguet IR - Francoise H FIR - Jean Christophe, Ianotto IR - Jean Christophe I FIR - Bertrand, Joly IR - Bertrand J FIR - Eric, Jourdan IR - Eric J FIR - Fabrice, Larosa IR - Fabrice L FIR - Axelle, Lascaux IR - Axelle L FIR - Sophie, Lefort IR - Sophie L FIR - Anne, Marfaing IR - Anne M FIR - Jean-Pierre, Marolleau IR - Jean-Pierre M FIR - Jessica, Michel IR - Jessica M FIR - Franck, Nicolini IR - Franck N FIR - Isabelle, Plantier IR - Isabelle P FIR - Philippe, Quittet IR - Philippe Q FIR - Philippe, Rodon IR - Philippe R FIR - Laurence, Sanhes IR - Laurence S FIR - Ioana, Vaida IR - Ioana V FIR - Bruno, Villemagne IR - Bruno V FIR - Sorin, Visanica IR - Sorin V FIR - Laurent, Voillat IR - Laurent V FIR - Patricia, Zunic IR - Patricia Z EDAT- 2019/08/09 06:00 MHDA- 2020/06/23 06:00 CRDT- 2019/08/09 06:00 PHST- 2019/03/19 00:00 [received] PHST- 2019/06/05 00:00 [accepted] PHST- 2019/08/09 06:00 [pubmed] PHST- 2020/06/23 06:00 [medline] PHST- 2019/08/09 06:00 [entrez] AID - 10.1111/bjh.16145 [doi] PST - ppublish SO - Br J Haematol. 2019 Dec;187(5):615-626. doi: 10.1111/bjh.16145. Epub 2019 Aug 8.