PMID- 36657323 OWN - NLM STAT- MEDLINE DCOM- 20230223 LR - 20230325 IS - 1879-0852 (Electronic) IS - 0959-8049 (Linking) VI - 181 DP - 2023 Mar TI - A post hoc analysis of the EPAZ trial: The role of geriatric variables in elderly soft tissue sarcoma patients on toxicity and outcome. PG - 145-154 LID - S0959-8049(22)01814-7 [pii] LID - 10.1016/j.ejca.2022.12.012 [doi] AB - OBJECTIVE: The EPAZ study (NCT01861951) showed recently that pazopanib was non-inferior to doxorubicin in patients >/=60 years treated in first line for advanced soft tissue sarcoma . The current post-hoc analysis aimed to assess the prognostic impact of frailty. METHODS: Geriatric assessments were evaluated at baseline. Age >75 years, liposarcoma, ECOG = 2, G8 /=1 and Charlson Comorbidity Index >/=2 were tested for their impact on progression-free survival (PFS), overall survival (OS), CTCAE grade 3/4 adverse events (AEs) or serious AEs (SAEs), using univariate and multivariate analysis models. RESULTS: univariate analysis showed an increased risk of grade 3/4 AEs and SAEs for ECOG = 2, G8 score /=1, independent of treatment. The multivariate analysis exhibited for pazopanib a significantly reduced risk for grade 3/4 AEs (HR 0.53; p = 0.033), and in patients with G8 /=1 for OS (HR 2.02; p = 0.007). ECOG = 2 was the strongest negative predictor for PFS (HR 4.39; p = 0.001) and OS (HR 3.74; p = 0.004). Neither age nor Charlson Comorbidity Index showed any impact on PFS, OS, incidence of grade 3/4 AEs or SAEs. CONCLUSIONS: This post hoc analysis demonstrated that age is not a denominator for outcome or toxicity in elderly patients with soft tissue sarcoma . Instead, geriatric and functional assessments should be used to counsel patients and tailor therapy to individual needs. Moreover, pazopanib has a reduced risk for grade 3/4 AEs compared to doxorubicin. CI - Copyright (c) 2022 Elsevier Ltd. All rights reserved. FAU - Hamacher, Rainer AU - Hamacher R AD - Department of Medical Oncology, Sarcoma Center, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany; German Cancer Consortium (DKTK), Partner Site University Hospital Essen, Essen, Germany. FAU - Liu, Xiaofei AU - Liu X AD - Institute for Biostatistics, Hannover Medical School, Hannover, Germany. FAU - Schuler, Markus K AU - Schuler MK AD - Division of Hematology, Oncology and Stem Cell Transplantation, Medical Clinic I, Department of Medicine I, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany. FAU - Hentschel, Leopold AU - Hentschel L AD - National Center for Tumor Diseases (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany. FAU - Schoffski, Patrick AU - Schoffski P AD - Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, KU Leuven, Leuven, Belgium. FAU - Kopp, Hans-Georg AU - Kopp HG AD - Robert Bosch Centrum fur Tumorerkrankungen Stuttgart, Stuttgart, Germany. FAU - Bauer, Sebastian AU - Bauer S AD - Department of Medical Oncology, Sarcoma Center, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany; German Cancer Consortium (DKTK), Partner Site University Hospital Essen, Essen, Germany. FAU - Kasper, Bernd AU - Kasper B AD - Sarcoma Unit, Mannheim University Medical Center, Mannheim, Germany. FAU - Lindner, Lars AU - Lindner L AD - Department of Medicine III, University Hospital, Ludwig Maximilian University Munich, Munich, Germany. FAU - Chemnitz, Jens-Markus AU - Chemnitz JM AD - Community Hospital Middle Rine, Middle Rine, Germany; Department of Hematology, Oncology, Clinical Infectious Diseases, Clinical Immunology, Hemostaseology and Medical Intensive Care, University Hospital Cologne, Cologne, Germany. FAU - Crysandt, Martina AU - Crysandt M AD - Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, RWTH Aachen University, Center for Integrated Oncology Aachen Bonn Cologne Dusseldorf (CIO ABCD), Aachen, Germany. FAU - Stein, Alexander AU - Stein A AD - University Hospital Hamburg-Eppendorf, Hamburg-Eppendorf, Germany. FAU - Steffen, Bjorn AU - Steffen B AD - University Hospital Frankfurt, Frankfurt, Germany. FAU - Richter, Stephan AU - Richter S AD - National Center for Tumor Diseases (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany. FAU - Egerer, Gerlinde AU - Egerer G AD - University Hospital Heidelberg, Heidelberg, Germany. FAU - Ivanyi, Philipp AU - Ivanyi P AD - Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Medical School Hannover, Hannover, Germany. FAU - Kunitz, Annegret AU - Kunitz A AD - Vivantes Clinic Berlin-Spandau, Berlin-Spandau, Germany; Department of Hematology, Oncology and Tumor Immunology, University Hospital Charite, Berlin, Germany. FAU - Grunwald, Viktor AU - Grunwald V AD - German Cancer Consortium (DKTK), Partner Site University Hospital Essen, Essen, Germany; Interdisciplinary Genitourinary Oncology at the West-German Cancer Center, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, University Hospital Essen, Essen, Germany. Electronic address: viktor.gruenwald@uk-essen.de. LA - eng SI - ClinicalTrials.gov/NCT01861951 PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20221227 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 80168379AG (Doxorubicin) RN - 0 (Indazoles) RN - 7RN5DR86CK (pazopanib) SB - IM MH - Aged MH - Humans MH - Activities of Daily Living MH - Doxorubicin/adverse effects MH - Indazoles/adverse effects MH - *Sarcoma/drug therapy MH - *Soft Tissue Neoplasms OTO - NOTNLM OT - Doxorubicin OT - EPAZ OT - Elderly OT - Frailty OT - Geriatric OT - Pazopanib OT - Post-hoc OT - Prognosis OT - Soft tissue sarcoma OT - Toxicity EDAT- 2023/01/20 06:00 MHDA- 2023/02/15 06:00 CRDT- 2023/01/19 18:15 PHST- 2022/09/19 00:00 [received] PHST- 2022/12/02 00:00 [revised] PHST- 2022/12/15 00:00 [accepted] PHST- 2023/01/20 06:00 [pubmed] PHST- 2023/02/15 06:00 [medline] PHST- 2023/01/19 18:15 [entrez] AID - S0959-8049(22)01814-7 [pii] AID - 10.1016/j.ejca.2022.12.012 [doi] PST - ppublish SO - Eur J Cancer. 2023 Mar;181:145-154. doi: 10.1016/j.ejca.2022.12.012. Epub 2022 Dec 27.