Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial

Abstract

BackgroundPatient-reported outcomes are integral in benefit–risk assessments of new treatment regimens. The PALOMA-2 study provides the largest body of evidence for patient-reported health-related quality of life (QOL) for patients with metastatic breast cancer (MBC) receiving first-line endocrine-based therapy (palbociclib plus letrozole and letrozole alone).Patients and methodsTreatment-naïve postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) MBC were randomized 2 : 1 to palbociclib plus letrozole (n = 444) or placebo plus letrozole (n = 222). Patient-reported outcomes were assessed at baseline, day 1 of cycles 2 and 3, and day 1 of every other cycle from cycle 5 using the Functional Assessment of Cancer Therapy (FACT)-Breast and EuroQOL 5 dimensions (EQ-5D) questionnaires.ResultsAs of 26 February 2016, the median duration of follow-up was 23 months. Baseline scores were comparable between the two treatment arms. No significant between-arm differences were observed in change from baseline in FACT-Breast Total, FACT-General Total, or EQ-5D scores. Significantly greater improvement in pain scores was observed in the palbociclib plus letrozole arm (−0.256 versus −0.098; P = 0.0183). In both arms, deterioration of FACT-Breast Total score was significantly delayed in patients without progression versus those with progression and patients with partial or complete response versus those without. No significant difference was observed in FACT-Breast and EQ-5D index scores in patients with and without neutropenia.ConclusionsOverall, women with MBC receiving first-line endocrine therapy have a good QOL. The addition of palbociclib to letrozole maintains health-related QOL and improves pain scores in treatment-naïve postmenopausal patients with ER+/HER2− MBC compared with letrozole alone. Significantly greater delay in deterioration of health-related QOL was observed in patients without progression versus those who progressed and in patients with an objective response versus non-responders.ClinicalTrials.gov: NCT01740427 (https://clinicaltrials.gov/ct2/show/NCT01740427)

Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2− Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA-2 Trial

“…Patient responses demonstrated that adding palbociclib to letrozole therapy maintained health‐related quality of life and was associated with improved pain scores in treatment‐naive postmenopausal women with ER+/HER2− ABC compared with those treated with letrozole alone. In particular, no statistically significant difference was observed for either index score in patients with or without neutropenia .…”

“…However, the observed increased incidence of AEs could potentially have a negative impact on patient health and quality of life. Consequently, a recent analysis of PALOMA‐2 was performed using the Functional Assessment of Cancer Therapy–Breast and EuroQoL–5 Dimension questionnaires to assess patient‐reported health‐related quality of life . Patient responses demonstrated that adding palbociclib to letrozole therapy maintained health‐related quality of life and was associated with improved pain scores in treatment‐naive postmenopausal women with ER+/HER2− ABC compared with those treated with letrozole alone.…”

Association of Disease Progression With Health-Related Quality of Life Among Adults With Breast, Lung, Pancreatic, and Colorectal Cancer

“…Moderate-to-large clinically meaningful changes were seen in 17 of 45 Few studies [12][13][14][15] have published analyses on the association of progression with HRQoL for one of these cancers by examining HRQoL before and after progression. Some other studies [33][34][35] have used data from clinical trials to investigate whether longer PFS resulted in better HRQoL or whether HRQoL differed between patients with or without progression. Using these methodological approaches, it must be kept in mind that there is no control for the kind of treatment; thus, the toxic effects of treatment may nullify the positive association of a longer PFS.…”

Understanding the benefits and challenges of first‐line cyclin‐dependent kinases 4 and 6 inhibitors in advanced breast cancer among postmenopausal women

“…In premenopausal patients, the MONALEESA‐7 study has shown a significant improvement in pain scores and time to deterioration of HRQoL in patients treated by ribociclib, compared to placebo . This adds further reassurance to patients when oncologists discuss the use of CDK4/6 inhibitors as a first‐line therapy.…”