Patient-reported outcomes

No differences were observed in overall mean change from baseline with 1^st 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; PRO = 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 1^st 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; LET = letrozole; n = number of patients; NS = not significant; PLA = placebo; QoL = quality of life; PRO = patient-reported outcomes; TFI = treatment-free interval.

QoL scores, including physical, social and emotional functioning, were maintained from baseline with IBRANCE^® + fulvestrant and placebo + fulvestrant in 1^st 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.^2 †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 outcomes; PLA = placebo; QoL = quality of life.

Significant delay in time to deterioration in pain symptoms with IBRANCE^® + fulvestrant in 1^st 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.