Quality-of-life and symptom severity in the PALLAS randomized trial of palbociclib with adjuvant endocrine therapy in early breast cancer (AFT-05, ABCSG-42, BIG-14-03, PrE0109) Journal Article
| Authors: | Naughton, M. J.; Zahrieh, D. M.; Gnant, M.; Zdenkowski, N.; Lemieux, J.; Mao, J. J.; Bjelic-Radisic, V.; Shinn, E.; Balic, M.; Thomssen, C.; Meisel, J. L.; Ruiz, G. M.; Loibl, S.; Isaacs, C.; Cameron, D.; Henao-Carrasco, F. M.; Goetz, M. P.; Singer, C. F.; Werutsky, G.; Rugo, H. S.; Vetter, M.; Tseng, L. M.; Miller, K.; Fitzal, F.; Gil Gil, J. M.; Park, H.; Linderholm, B.; Bajetta, E.; Dayao, Z.; Prat, A.; Ehrhardt, K.; Metzger, O.; Arahmani, A.; Law, E. H.; Partridge, A. H.; Carey, L. A.; Zoroufy, A.; Dueck, A. C.; O'Brien, P.; Hlauschek, D.; DeMichele, A.; Mayer, E. L. |
| Article Title: | Quality-of-life and symptom severity in the PALLAS randomized trial of palbociclib with adjuvant endocrine therapy in early breast cancer (AFT-05, ABCSG-42, BIG-14-03, PrE0109) |
| Abstract: | Background: The PALLAS phase III, randomized trial investigated whether the addition of 2 years of palbociclib to adjuvant endocrine therapy (ET) improved invasive disease-free survival (iDFS) over adjuvant ET alone. This study reports the patient-reported outcomes (PROs) by treatment arm. Patients and methods: A total of 4688 of 5796 PALLAS patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage II-III breast cancer completed PRO measures. Patients were randomly assigned (1 : 1) to either 2 years of palbociclib (125 mg/day, 3 weeks on 1 week off) plus ongoing provider or patient-choice adjuvant ET (palbociclib + ET) versus ongoing ET alone. Eight PRO endpoints were measured serially (i.e. day 1 of each monthly cycle for the first 3 months, then every 3 months for 2 years, and once at 3 years). These endpoints were the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality-of-life (QoL) score, the Brief Fatigue Inventory (BFI) score, the modified Brief Pain Inventory (mBFI) severity and pain interference scores, the EORTC Core Quality of Life Questionaire-Breast 23 (QLQ-BR23) alopecia score, and the Breast Cancer Prevention Trial (BCPT) hot flash symptoms, vaginal problems, and musculoskeletal pain scores. Treatment with palbociclib stopped after the second interim analysis (May 2020) due to futility, and patients transitioned to follow-up. Results: After adjustment for baseline covariates, on average, no significant differences between arms were observed on any of the eight endpoints over the study period. However, there were differences by treatment regimen in the worsening of symptoms over time, and by race and ethnicity. These findings have important implications for the management of symptoms in HR-positive/HER2-negative breast cancer survivors receiving endocrine and/or other therapies long term. Conclusions: No clinically significant differences in patient-reported QoL or symptom severity were found by treatment arm. However, the results of the PRO analyses may inform patient-centered communication and adherence efforts regarding treatment toxicity in subgroups of survivors. © 2025 The Authors |
| Keywords: | adult; cancer survival; controlled study; aged; major clinical study; fatigue; cancer combination chemotherapy; treatment duration; cancer adjuvant therapy; cancer patient; disease free survival; neoadjuvant therapy; follow up; sensitivity analysis; quality of life; multiple cycle treatment; breast cancer; randomized controlled trial; aromatase inhibitor; cancer survivor; cancer hormone therapy; symptom; disease severity; severity of illness index; early cancer; adjuvant chemotherapy; scoring system; tamoxifen; phase 3 clinical trial; neoadjuvant chemotherapy; alopecia; antineoplastic hormone agonists and antagonists; symptoms; post hoc analysis; musculoskeletal pain; patient-reported outcome; brief pain inventory; anthracycline antibiotic agent; medical futility; estrogen receptor positive breast cancer; human; male; female; article; palbociclib; patient history of chemotherapy; estrogen receptor negative breast cancer; adjuvant endocrine therapy; progesterone receptor positive breast cancer; ecog performance status; progesterone receptor negative breast cancer; pain severity; european organization for research and treatment of cancer quality of life questionnaire core 30; brief fatigue inventory score; hormone receptor-positive, her2-negative breast cancer; patient centered communication; pallas; invasive disease free survival; modified brief pain inventory; pain interference score |
| Journal Title: | ESMO Open |
| Volume: | 10 |
| Issue: | 6 |
| ISSN: | 2059-7029 |
| Publisher: | European Society for Medical Oncology |
| Publication status: | Published |
| Date Published: | 2025-06-01 |
| Start Page: | 105120 |
| Language: | English |
| DOI: | 10.1016/j.esmoop.2025.105120 |
| PUBMED: | 40472660 |
| PROVIDER: | scopus |
| PMCID: | PMC12173008 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
