Academic Journal
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).
| Τίτλος: | 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). |
|---|---|
| Συγγραφείς: | Naughton MJ; The Ohio State University, Columbus, USA. Electronic address: Michelle.Naughton@osumc.edu., Zahrieh DM; Alliance Foundation Trials Statistics and Data Center, Mayo Clinic, Rochester, USA., Gnant M; Medical University of Vienna AT, Vienna, Austria; Austrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria., Zdenkowski N; University of Newcastle, Callagan, Australia., Lemieux J; Center Hospitalier Universitaire de Quebec, Universite Laval, Quebec City, Canada., Mao JJ; Memorial Sloan Kettering Cancer Center, New York City, USA., Bjelic-Radisic V; University Witten/Herdecke, Wuppertal, Germany., Shinn E; MD Anderson Cancer Center, Houston, USA., Balic M; Medical University Graz, Graz, Austria., Thomssen C; Universitatsfrauenklinik-Halle, Wittenberg, Germany., Meisel JL; Emory University, Atlanta, USA., Ruiz GM; European Medical Center, Moscow, Russia., Loibl S; German Breast Group, Neu-Isenburg, Germany., Isaacs C; Georgetown University, Washington, USA., Cameron D; Cancer Research UK Edinburgh Center, Edinburgh, UK., Henao-Carrasco FM; Hospital Virgen Macarena Sevilla, Seville, Spain and the GEICAM Collaborative Group., Goetz MP; Alliance Foundation Trials Statistics and Data Center, Mayo Clinic, Rochester, USA; Mayo Clinic, Rochester, MN, USA., Singer CF; Breast Centre, Sankt Veit an der Glan, Austria., Werutsky G; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil., Rugo HS; University of California, San Francisco, USA., Vetter M; University Hospital Basel, Basel, Switzerland., Tseng LM; Taipei Veterans General Hospital, Taipei, Taiwan., Miller K; Indiana University Simon Cancer Center, Indianapolis, USA., Fitzal F; Medical University of Vienna AT, Vienna, Austria; Austrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria., Gil Gil JM; Catalan Institute of Oncology, Barcelona, Spain., Park H; Washington University School of Medicine, St. Louis, USA., Linderholm B; Karolinska Institute, Solna, Sweden., Bajetta E; Institute of Oncology, Polyclinic Hospital, Monza, Italy., Dayao Z; University of New Mexico Hospital, Albuquerque, USA., Prat A; Austrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria; Hospital Clinic Barcelona, Barcelona, Spain., Ehrhardt K; Austrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria., Metzger O; Dana-Farber Cancer Institute, Boston, USA., Arahmani A; Breast International Group, Brussels, Belgium., Law EH; Pfizer, Inc., New York City, USA., Partridge AH; Dana-Farber Cancer Institute, Boston, USA., Carey LA; University of North Carolina, Chapel Hill, USA., Zoroufy A; Alliance Foundation Trials Statistics and Data Center, Mayo Clinic, Rochester, USA., Dueck AC; Alliance Foundation Trials Statistics and Data Center, Mayo Clinic, Phoenix, USA., O'Brien P; Alliance Foundation Trials Statistics and Data Center, Mayo Clinic, Phoenix, USA., Hlauschek D; Austrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria., DeMichele A; University of Pennsylvania, Philadelphia, USA., Mayer EL; Dana-Farber Cancer Institute, Boston, USA. |
| Πηγή: | ESMO open [ESMO Open] 2025 Jun; Vol. 10 (6), pp. 105120. Date of Electronic Publication: 2025 Jun 04. |
| Τύπος έκδοσης: | Journal Article; Randomized Controlled Trial; Clinical Trial, Phase III |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Country of Publication: England NLM ID: 101690685 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2059-7029 (Electronic) Linking ISSN: 20597029 NLM ISO Abbreviation: ESMO Open Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2021 : [London] : Elsevier Original Publication: London : BMJ, [2016]- |
| Ιατρικοί όροι (MeSH): | Breast Neoplasms*/drug therapy , Breast Neoplasms*/pathology , Piperazines*/therapeutic use , Piperazines*/administration & dosage , Pyridines*/therapeutic use , Pyridines*/administration & dosage , Antineoplastic Combined Chemotherapy Protocols*/therapeutic use , Antineoplastic Combined Chemotherapy Protocols*/adverse effects , Antineoplastic Agents, Hormonal*/therapeutic use , Quality of Life*, Chemotherapy, Adjuvant/methods ; Humans ; Female ; Middle Aged ; Aged ; Adult ; Patient Reported Outcome Measures |
| Περίληψη: | 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. (Copyright © 2025 The Authors. Published by Elsevier Ltd.. All rights reserved.) |
| Grant Information: | P30 CA008748 United States CA NCI NIH HHS |
| Contributed Indexing: | Keywords: PALLAS; adjuvant endocrine therapy; breast cancer; palbociclib; quality of life; symptoms |
| Substance Nomenclature: | G9ZF61LE7G (palbociclib) 0 (Piperazines) 0 (Pyridines) 0 (Antineoplastic Agents, Hormonal) |
| Entry Date(s): | Date Created: 20250605 Date Completed: 20250626 Latest Revision: 20250801 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC12173008 |
| DOI: | 10.1016/j.esmoop.2025.105120 |
| PMID: | 40472660 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 2059-7029 |
|---|---|
| DOI: | 10.1016/j.esmoop.2025.105120 |