Neglected geriatric assessment and overtreatment of older patients with pancreatic cancer - Results from a prospective phase IV clinical trial.

Autor: Betge J; Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Junior Clinical Cooperation Unit Translational Gastrointestinal Oncology and Preclinical Models (B440), German Cancer Research Center (DKFZ), Heidelberg, Germany; DKFZ-Hector Cancer Institute, Mannheim, Germany; Mannheim Cancer Center (MCC), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany., Schulte N; Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Mannheim Cancer Center (MCC), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany., Belle S; Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Mannheim Cancer Center (MCC), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany., Zhan T; Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Mannheim Cancer Center (MCC), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany., Krammer-Steiner B; Klinik für Innere Medizin III, Klinikum Südstadt Rostock, Rostock, Germany., Moulin JC; Medizinische Klinik, Sektion Hämatologie/Onkologie, Ortenau-Klinikum Lahr-Ettenheim, Lahr, Germany., Kleiß M; Klinik für Interdisziplinäre Onkologie, DRK-Kliniken Nordhessen gGmbH, Kassel, Germany., Lammert F; Health Sciences, Hannover Medical School (MHH), Hannover, Germany; Department of Medicine II, Saarland University Medical Center, Homburg, Germany., Wedding U; Department of Medicine II, University Hospital Jena, Germany., Räth S; AIO-Studien-gGmbH, Berlin, Germany., Maenz M; AIO-Studien-gGmbH, Berlin, Germany., Hegele L; Assign Data Management and Biostatistics GmbH, Innsbruck, Austria., Larcher-Senn J; Assign Data Management and Biostatistics GmbH, Innsbruck, Austria., Jesenofsky R; Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Mannheim Cancer Center (MCC), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany., Ebert MP; Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; DKFZ-Hector Cancer Institute, Mannheim, Germany; Mannheim Cancer Center (MCC), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. Electronic address: matthias.ebert@umm.de., Härtel N; Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Mannheim Cancer Center (MCC), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. Electronic address: nicolai.haertel@medma.uni-heidelberg.de.
Jazyk: angličtina
Zdroj: Journal of geriatric oncology [J Geriatr Oncol] 2022 Jun; Vol. 13 (5), pp. 662-666. Date of Electronic Publication: 2022 Jan 03.
DOI: 10.1016/j.jgo.2021.12.018
Abstrakt: Background: Older patients with metastatic pancreatic cancer may suffer increased toxicity from intensive chemotherapy. Treatment individualization by geriatric assessment (GA) might improve functional outcome.
Methods: We performed a multicenter, phase IV, open label trial in patients ≥70 years with metastatic pancreatic adenocarcinoma. Patients underwent GA and were assigned to one of three categories based on their scores: Go-Go, Slow-Go, or Frail. These categories were intended to guide physician's treatment decisions when choosing to treat patients with nab-paclitaxel/gemcitabine (arm A), gemcitabine (arm B), or best supportive care (arm C). Primary objective was a stable (loss of five points or less) Barthel's Activities of Daily Living (ADL) score during chemotherapy; secondary endpoints included GA scores during therapy, safety, quality of life, response and survival rates.
Results: Thirty-two patients were enrolled in the trial in six centers in Germany (out of 135 planned), resulting in termination due to low recruitment. Fifteen patients were allocated to nab-paclitaxel/gemcitabine, fifteen to gemcitabine, and two to best supportive care by their physicians, although according to their GA scores 29 patients (91%) were categorized as Slow-Go and three (9%) as Go-Go. Thus, fifteen of 32 (47%) patients were misclassified and given a course of treatment inconsistent with their GA scores. Median progression-free survival (PFS) were 3.3 months and 9.1 months and median time to quality-of-life deterioration 13 days and 29 days in the nab-paclitaxel/gemcitabine and gemcitabine monotherapy arms, respectively. Serious adverse events were reported in 11 (78.6%) patients in the nab-paclitaxel/gemcitabine and 8 (53.3%) patients in the gemcitabine arm.
Conclusions: Clinical evaluations by investigators differed markedly from geriatric assessments, leading to potential overtreatment. In our modest sample size study, those patients undergoing more intensive therapy had a less favorable course.
(Copyright © 2021 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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