Patient-reported outcomes in high-risk HR+ /HER2- early breast cancer patients treated with endocrine therapy with or without palbociclib within the randomized PENELOPE B study

• Published in: European journal of cancer (1990) 2024-01, Vol.196, p.113420
• Main Authors: García-Sáenz, José Angel, Marmé, Frederik, Untch, Michael, Bonnefoi, Hervé, Kim, Sung-Bae, Bear, Harry, Mc Carthy, Nicole, Gelmon, Karen, Martin, Miguel, Kelly, Catherine M, Reimer, Toralf, Toi, Masakazu, Law, Ernest, Bhattacharyya, Helen, Gnant, Michael, Makris, Andreas, Seiler, Sabine, Burchardi, Nicole, Nekljudova, Valentina, Loibl, Sibylle, Rugo, Hope S
• Format: Article
• Language: English
• ISSN: 1879-0852

The PENELOPE trial investigating efficacy and safety of additional 1-year post-neoadjuvant palbociclib to standard endocrine therapy (ET) high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer patients failed to improve invasive disease-free survival (iDFS). This analysis compared patient-reported outcomes (PROs) between treatment groups. Patients received 13 cycles of palbociclib 125 mg/day (n = 631) or placebo (n = 619) orally for 3 out of 4 weeks + ET. European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30), its breast cancer (BR23) and fatigue (FA13) modules, mood questionnaire GAD7 and European Quality of Life 5 Dimensions (EQ-5D) instruments were used for the assessment of quality of life (QoL). Repeated-measures mixed-effects models were used to evaluate differences in PRO, changes of PRO over time, and treatment-by-time interactions. 924 of 1250 patients (73.9%) completed baseline and at least one post-baseline questionnaire of all PRO instruments. General health status (GHS)/QoL based on EORTC QLQ-C30 was high in both arms (mean [SD]: palbociclib 70.1 [19.3], placebo 71.4 [18.8]) and was slightly higher in the placebo arm (LeastSquare mean difference: 0.82, p