title: Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial.
abstract: In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in hormone receptor-positive, HER2- endocrine-resistant metastatic breast cancer (MBC). This analysis compared patient-reported outcomes (PROs) between the two treatment groups.
  
  
  
  Patients were randomized 2 : 1 to receive palbociclib 125 mg/day orally for 3 weeks followed by 1 week off (n = 347) plus fulvestrant (500 mg i.m. per standard of care) or placebo plus fulvestrant (n = 174). PROs were assessed on day 1 of cycles 1-4 and of every other subsequent cycle starting with cycle 6 using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. High scores (range 0-100) could indicate better functioning/quality of life (QoL) or worse symptom severity. Repeated-measures mixed-effect analyses were carried out to compare on-treatment overall scores and changes from baseline between treatment groups while controlling for baseline. Between-group comparisons of time to deterioration in global QoL and pain were made using an unstratified log-rank test and Cox proportional hazards model.
  
  
  
  Questionnaire completion rates were high at baseline and during treatment (from baseline to cycle 14, ≥95.8% in each group completed ≥1 question on the EORTC QLQ-C30). On treatment, estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group [66.1, 95% confidence interval (CI) 64.5-67.7 versus 63.0, 95% CI 60.6-65.3; P = 0.0313]. Significantly greater improvement from baseline in pain was also observed in this group (-3.3, 95% CI -5.1 to -1.5 versus 2.0, 95% CI -0.6 to 4.6; P = 0.0011). No significant differences were observed for other QLQ-BR23 functioning domains, breast or arm symptoms. Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone.
  
  
  
  Palbociclib plus fulvestrant allowed patients to maintain good QoL in the endocrine resistance setting while experiencing substantially delayed disease progression.
  
  
  
  NCT01942135.
authors.affiliation: Department of Obstetrics and Gynecology, Brustzentrum der Universität München, München (LMU), Germany. Electronic address: nadia.harbeck@med.uni-muenchen.de.
authors.forename: N
authors.initials: N
authors.lastname: Harbeck
authors.affiliation: Pfizer Inc, New York, USA.
authors.forename: S
authors.initials: S
authors.lastname: Iyer
authors.affiliation: Department of Molecular Oncology, Royal Marsden Hospital and Institute of Cancer Research, London, UK.
authors.forename: N
authors.initials: N
authors.lastname: Turner
authors.affiliation: Department of Medical Oncology, Thomas Jefferson University, Philadelphia, USA.
authors.forename: M
authors.initials: M
authors.lastname: Cristofanilli
authors.affiliation: Department of Medicine, National Cancer Center, Goyang-si, Korea.
authors.forename: J
authors.initials: J
authors.lastname: Ro
authors.affiliation: Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France.
authors.forename: F
authors.initials: F
authors.lastname: André
authors.affiliation: Department of Oncology, Peter MacCallum Cancer Centre, East Melbourne, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Loi
authors.affiliation: Department of Medicine, Sunnybrook Odette Cancer Centre, Toronto, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Verma
authors.affiliation: Department of Transfusion, Aichi Cancer Center Hospital, Nagoya, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Iwata
authors.affiliation: Pfizer Inc, New York, USA.
authors.forename: H
authors.initials: H
authors.lastname: Bhattacharyya
authors.affiliation: Pfizer Inc, Cambridge, USA.
authors.forename: K
authors.initials: K
authors.lastname: Puyana Theall
authors.affiliation: Pfizer Inc, New York, USA.
authors.forename: C H
authors.initials: CH
authors.lastname: Bartlett
authors.affiliation: Department of Oncology, German Breast Group Forschungs GmbH, Neu-Isenburg, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Loibl
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D000077267:Fulvestrant; D006801:Humans; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D011960:Receptors, Estrogen / Q000235:genetics
chemical_list: D004958:Estradiol; D000077267:Fulvestrant; D010879:Piperazines; D011725:Pyridines; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; C500026:palbociclib
keywords: breast cancer; endocrine resistance; palbociclib; patient-reported outcomes; quality of life