Abstract | BACKGROUND: METHODS: SARC021 randomized patients to receive first-line doxorubicin or doxorubicin plus evofosfamide. The main aim of this study was to compare the outcome and safety of first-line anthracycline-based therapy in older patients compared with those <65 years. IRB approval was obtained at all participating sites and this research meets requirements for protection of human subjects. RESULTS: Of 640 patients, 209 (33%) were older, with a median age 70 (range 65-89) years. The median overall survival (OS) was 16.7 months (95%CI: 13.2-20.0) in older patients compared to 20.1 months (95%CI: 16.9-23.2) in those aged <65 years (n = 431), HR 1.21 (95%CI: 0.99-1.48), p = .057. The median progression-free survival (PFS) in older patients was 6.3 months (95%CI: 5.8-7.2) compared to 6.0 (95%CI: 5.1-6.4) in those <65 years, HR 0.86 (95%CI: 0.70-1.05), p = .14. Older patients had significantly more hematological (141 [67%] versus 208 [48%], p < .0001), non-hematological (131 [63%] versus 215 [50%], p = .0097) and ≥ Grade 3 adverse events (178 [85%] versus 299 [69%], p = .0002), compared to younger patients. More older patients (30, 14%) stopped treatment due to adverse events compared to younger patients (22, 5%), p = .0001. CONCLUSIONS: The efficacy of first-line anthracycline-based chemotherapy did not differ significantly between older and younger advanced sarcoma patients. Significantly more older patients stopped chemotherapy due to adverse events. These results provide a benchmark for daily clinical practice and future trials in older patients.
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Authors | Eugenie Younger, Karla Ballman, Yao Lu, Zsuzsanna Pápai, Brian A Van Tine, Steven Attia, Patrick Schöffski, Denise Reinke, William D Tap, Robin L Jones |
Journal | Journal of geriatric oncology
(J Geriatr Oncol)
Vol. 11
Issue 3
Pg. 463-469
(04 2020)
ISSN: 1879-4076 [Electronic] Netherlands |
PMID | 31126845
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved. |
Chemical References |
- Antibiotics, Antineoplastic
- Nitroimidazoles
- Phosphoramide Mustards
- TH 302
- Doxorubicin
|
Topics |
- Aged
- Aged, 80 and over
- Antibiotics, Antineoplastic
(therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Doxorubicin
(therapeutic use)
- Humans
- Nitroimidazoles
(pharmacology)
- Phosphoramide Mustards
(pharmacology)
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