Subgroup analysis of older patients treated within the randomized phase 3 doxorubicin versus doxorubicin plus evofosfamide (SARC021) trial Journal Article


Authors: Younger, E.; Ballman, K.; Lu, Y.; Pápai, Z.; Van Tine, B. A.; Attia, S.; Schöffski, P.; Reinke, D.; Tap, W. D.; Jones, R. L.
Article Title: Subgroup analysis of older patients treated within the randomized phase 3 doxorubicin versus doxorubicin plus evofosfamide (SARC021) trial
Abstract: Background: More than half of patients with soft tissue sarcoma (STS) are aged ≥65 years (older), however contemporary data on the efficacy/safety of anthracycline chemotherapy in older patients with STS are lacking. 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. © 2019 The Authors
Keywords: cancer survival; controlled study; survival rate; major clinical study; overall survival; fatigue; neutropenia; doxorubicin; cancer combination chemotherapy; diarrhea; dose response; drug dose reduction; drug efficacy; drug safety; monotherapy; chemotherapy; outcome assessment; progression free survival; multiple cycle treatment; anemia; randomized controlled trial; thrombocytopenia; survival time; adverse outcome; cardiotoxicity; soft tissue sarcoma; phase 3 clinical trial; toxicity; anthracycline; geriatric patient; hematologic disease; efficacy; older; first-line; human; male; female; priority journal; article; evofosfamide; loss of appetite; soft tissue sarcomas
Journal Title: Journal of Geriatric Oncology
Volume: 11
Issue: 3
ISSN: 1879-4068
Publisher: Elsevier Inc.  
Date Published: 2020-04-01
Start Page: 463
End Page: 469
Language: English
DOI: 10.1016/j.jgo.2019.05.008
PUBMED: 31126845
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 1 April 2020 -- Source: Scopus
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  1. William Douglas Tap
    375 Tap