Ibrance is indicated for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant in patients with disease progression following endocrine therapy.1

Patient-reported outcomes

​​​​​​​
​​​​​​​
Patient-reported outcomes with
​​​​​​​IBRANCE + letrozole in 1st line
Patient-reported outcomes with
​​​​​​​IBRANCE + fulvestrant in 1st line or later
No differences were observed in overall mean change from baseline with 1st line IBRANCE + letrozole vs placebo + letrozole in FACT-B total and FACT-G total scores in PALOMA-2​​​​​​​ (PROs; secondary endpoint)*2
Between-treatment comparison of overall change from baseline in FACT-B scores (FACT-B, FACT-G, and TOI)*2

P=NS for all scales and domains.
​​​​​​​Adapted from Rugo HS, et al. 2018.
2

  • In a post-hoc analysis, IBRANCE + letrozole demonstrated a greater improvement in pain scores vs placebo + letrozole: 0.256 vs -0.098; p=0.0183*2
​​​​​​​

*FACT-B is a 37-item self-reporting instrument containing the 27-question FACT-G survey and a 10-question breast cancer additional concerns scale. A higher score in any FACT-B assessment indicates better QoL. A higher raw score on the pain item indicates higher pain severity. Between-treatment comparisons were non-statistically significantly different for all scales and domains.2

​​​​​​​CI = confidence interval; FACT-B = Functional Assessment of Cancer Therapy – Breast; FACT-G = Functional Assessment of Cancer Therapy – General; LET = letrozole;  NS = not significant; PLA = placebo; PROs = patient-reported outcomes; QoL = quality of life; TOI = Trial Outcome Index.
​​​​​​​

In an updated non-prespecified subgroup analysis, no differences were observed in overall mean change from baseline with 1st line IBRANCE + letrozole vs placebo + letrozole in FACT-B total score across all subgroups studied in PALOMA-2 (PROs; secondary endpoint)*3
Between-treatment comparison of overall change from baseline in FACT-B total score by subgroups*3
Adapted from Rugo HS, et al. 2019.3

*
FACT-B is a 37-item self-reporting instrument containing the 27-question FACT-G survey and a 10-question breast cancer additional concerns scale. A higher score in any FACT-B assessment indicates better QoL. A higher raw score on the pain item indicates higher pain severity. Between treatment comparisons were non-statistically significantly different for all scales and domains.2

CI = confidence interval; ECOG PS = Eastern Cooperative Oncology Group performance status; FACT-B = Functional Assessment of Cancer Therapy – Breast;  FACT-G = Functional Assessment of Cancer Therapy – General; n = number of patients; LET = letrozole; NS = not significant; PLA = placebo; QoL = quality of life; PRO = patient-reported outcome; TFI = treatment-free interval.

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Rugo HS, et al. Ann Oncol. 2018;29(4):888-894.
  3. Rugo H, et al. Breast Cancer Res Treat. 2019;174(3):719-729.

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All rights reserved. Date of preparation: June 2020 PP-IBR-GLB-0254

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