title: Impact of palbociclib plus letrozole on pain severity and pain interference with daily activities in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer as first-line treatment.
abstract: Background Palbociclib is a recently approved drug for use in combination with letrozole as initial endocrine-based therapy for the treatment of postmenopausal women with advanced estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. This report assesses the impact of palbociclib in combination with letrozole versus letrozole alone on patient-reported outcomes of pain. Methods Palbociclib was evaluated in an open-label, randomized, phase II study (PALOMA-1/TRIO-18) among postmenopausal women with advanced ER+/HER2- breast cancer who had not received prior systemic treatment for their advanced disease. Patients received continuous oral letrozole 2.5 mg daily alone or the same letrozole dose and schedule plus oral palbociclib 125 mg, given once daily for 3 weeks followed by 1 week off over repeated 28-day cycles. The primary study endpoint was investigator-assessed progression-free survival in the intent-to-treat population, and these results have recently been published (Finn et al., Lancet Oncol 2015;16:25-35). One of the key secondary endpoints was the evaluation of pain, as measured using the Brief Pain Inventory (BPI) patient-reported outcome tool. The BPI was administered at baseline and on day 1 of every cycle thereafter until disease progression and/or treatment discontinuation. Clinical trial registration This study is registered with ClinicalTrials.gov (NCT00721409). Results There were no statistically significant differences in Pain Severity or Pain Interference scores of the BPI between the two treatment groups for the overall population or among those with any bone disease at baseline. A limitation of the study is that results were not adjusted for the concomitant use of opioids or other medications used to control pain. Conclusions The addition of palbociclib to letrozole was associated with increased efficacy without negatively impacting pain severity or pain interference with daily activities.
authors.affiliation: a Pfizer Inc. , New York , NY , USA ;
authors.forename: T
authors.initials: T
authors.lastname: Bell
authors.affiliation: b St. Vincent's University Hospital , Dublin , Ireland ;
authors.forename: J P
authors.initials: JP
authors.lastname: Crown
authors.affiliation: c Orszagos Onkologiai Intezet, Kemoterapia B , Budapest , Hungary ;
authors.forename: I
authors.initials: I
authors.lastname: Lang
authors.affiliation: a Pfizer Inc. , New York , NY , USA ;
authors.forename: H
authors.initials: H
authors.lastname: Bhattacharyya
authors.affiliation: a Pfizer Inc. , New York , NY , USA ;
authors.forename: G
authors.initials: G
authors.lastname: Zanotti
authors.affiliation: d Pfizer Inc. , San Diego , CA , USA ;
authors.forename: S
authors.initials: S
authors.lastname: Randolph
authors.affiliation: d Pfizer Inc. , San Diego , CA , USA ;
authors.forename: S
authors.initials: S
authors.lastname: Kim
authors.affiliation: d Pfizer Inc. , San Diego , CA , USA ;
authors.forename: X
authors.initials: X
authors.lastname: Huang
authors.affiliation: a Pfizer Inc. , New York , NY , USA ;
authors.forename: C
authors.initials: C
authors.lastname: Huang Bartlett
authors.affiliation: e David Geffen School of Medicine at UCLA , Los Angeles , CA , USA.
authors.forename: R S
authors.initials: RS
authors.lastname: Finn
authors.affiliation: e David Geffen School of Medicine at UCLA , Los Angeles , CA , USA.
authors.forename: D
authors.initials: D
authors.lastname: Slamon
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy*; D000072716:Cancer Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000077289:Letrozole; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use*; D010147:Pain Measurement; D010879:Piperazines / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D014230:Triazoles / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D000077289:Letrozole; D009570:Nitriles; D010879:Piperazines; D011725:Pyridines; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D014230:Triazoles; C508053:ERBB2 protein, human; C500026:palbociclib
keywords: Breast cancer; CDK 4/6; Cyclin-dependent kinases 4/6; ER+; Estrogen receptor-positive; Palbociclib; Patient-reported outcomes