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
QoL scores, including physical, social and emotional functioning, were maintained from baseline with IBRANCE + fulvestrant and placebo + fulvestrant in 1st line or later in PALOMA-3 (PROs; secondary endpoint)2
​​​​​​​
  • Statistically significant difference in global QoL and emotional functioning from baseline vs placebo + fulvestrant*2
Mean overall change from baseline on EORTC QLQ-C30 *2 ​​​​​​​
Adapted from Harbeck N, et al. 2016.2
Data cut-off December 5, 2014 used for interim analysis; median follow-up 5.6 months.


• In a post-hoc analysis, IBRANCE + fulvestrant demonstrated a greater delay in QoL deterioration vs placebo + fulvestrant (HR=0.641; p=0.0065)†2

*Mean overall change from baseline on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Module (QLQ-C30). Higher scores (range 0–100) indicated better functioning/QoL or higher symptom severity. The changes from baseline that were statistically significantly different between treatment groups were for Global QoL and emotional functioning.Time to deterioration was defined as a decrease of ≥10 points from baseline, with no subsequent increase above this threshold.2

​​​​​​​
FUL = fulvestrant; HR = hazard ratio; n = number of patients; NS = not significant; PRO = patient-reported outcome; PLA = placebo;
QoL = quality of life.

Significant delay in time to deterioration in pain symptoms with IBRANCE + fulvestrant in 1st line or later vs placebo + fulvestrant in PALOMA-3 (PROs; secondary endpoint)2
Median time to deterioration (mTTD) in pain symptoms*2
Adapted from Harbeck N, et al. 2016.2
Data cut-off date: March 16, 2015.3

  • In a post-hoc analysis, IBRANCE + fulvestrant demonstrated a greater decrease in pain symptom scores vs placebo + fulvestrant (-3.3 vs 2.0; p=0.0011)2
  • In a post-hoc analysis, decreases in pain symptom scores in patients with visceral disease were consistent with those observed in the primary PRO analysis‡2


*TTD defined as time to ≥10-point increase from baseline. 131 (39.1%) patients in the IBRANCE + fulvestrant group had an event vs 83 (50%) in the placebo + fulvestrant group.2 †Mean overall change from baseline on the EORTC QLQ-C30. Higher scores (range 0–100) indicated better functioning/QoL or higher symptom severity.2 Visceral metastasis was defined as lung, liver, brain, pleural, or peritoneal involvement. 59% of patients in PALOMA-3 who received IBRANCE + fulvestrant presented with visceral metastasis (n=206).3 Consistent results shown in a sub-group of 199 patients.2

CI = confidence interval; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30;
FUL = fulvestrant;  HR = hazard ratio; n = number of patients; NE = non-estimable; PLA = placebo; PRO = patient-reported outcome;
QoL = quality of life; TTD = time to deterioration.

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Harbeck N, et al. Ann Oncol. 2016;27(6):1047-1054.
  3. Cristofanilli M, et al. 2016;17(4):425-439.

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

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