title: Health-related quality of life outcomes of lenalidomide in transfusion-dependent patients with Low- or Intermediate-1-risk myelodysplastic syndromes with a chromosome 5q deletion: results from a randomized clinical trial.
abstract: We report health-related quality of life (HRQL) outcomes assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) among 167 RBC transfusion-dependent patients with IPSS Low-/Intermediate-1-risk del5q31 MDS treated with lenalidomide versus placebo in a randomized phase 3 clinical trial, MDS-004. Mean baseline to 12 week changes in FACT-An Total scores improved following treatment with lenalidomide 5 and 10mg (+5.7 and +5.7, respectively) versus placebo (-2.8) (both p<0.05). Clinically important changes in HRQL from baseline were observed at weeks 12, 24, 36, and 48 among RBC-TI≥26 week responders in both treatment groups. Lenalidomide treatment may be effective in improving HRQL outcomes.
authors.affiliation: United BioSource Corporation, Bethesda, MD, USA. Dennis.Revicki@unitedbiosource.com
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Brandenburg
authors.forename: Petra
authors.initials: P
authors.lastname: Muus
authors.forename: Ren
authors.initials: R
authors.lastname: Yu
authors.forename: Robert
authors.initials: R
authors.lastname: Knight
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000748:Anemia, Macrocytic / Q000150:complications* / Q000628:therapy; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001803:Blood Transfusion; D002872:Chromosome Deletion; D002895:Chromosomes, Human, Pair 5; D003131:Combined Modality Therapy; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000150:complications* / Q000188:drug therapy / Q000235:genetics / Q000628:therapy*; D010919:Placebos; D011788:Quality of Life; D012306:Risk; D012720:Severity of Illness Index; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010919:Placebos; D013792:Thalidomide; D000077269:Lenalidomide