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

Eugenie Younger, Karla Ballman, Yao Lu, Zsuzsanna Pápai, Brian A. Van Tine, Steven Attia, Patrick Schöffski, Denise Reinke, William D. Tap, Robin L. Jones

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalJournal of Geriatric Oncology
DOIs
StatePublished - Jan 1 2019

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Doxorubicin
Anthracyclines
Sarcoma
TH 302
Drug Therapy
Safety
Benchmarking
Research Ethics Committees
Disease-Free Survival

Keywords

  • Anthracycline
  • Chemotherapy
  • Efficacy
  • First-line
  • Older
  • Soft tissue sarcomas
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Geriatrics and Gerontology

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Subgroup analysis of older patients treated within the randomized phase 3 doxorubicin versus doxorubicin plus evofosfamide (SARC021) trial. / Younger, Eugenie; Ballman, Karla; Lu, Yao; Pápai, Zsuzsanna; Van Tine, Brian A.; Attia, Steven; Schöffski, Patrick; Reinke, Denise; Tap, William D.; Jones, Robin L.

In: Journal of Geriatric Oncology, 01.01.2019.

Research output: Contribution to journalArticle

Younger, Eugenie ; Ballman, Karla ; Lu, Yao ; Pápai, Zsuzsanna ; Van Tine, Brian A. ; Attia, Steven ; Schöffski, Patrick ; Reinke, Denise ; Tap, William D. ; Jones, Robin L. / Subgroup analysis of older patients treated within the randomized phase 3 doxorubicin versus doxorubicin plus evofosfamide (SARC021) trial. In: Journal of Geriatric Oncology. 2019.
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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.",
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T1 - Subgroup analysis of older patients treated within the randomized phase 3 doxorubicin versus doxorubicin plus evofosfamide (SARC021) trial

AU - Younger, Eugenie

AU - Ballman, Karla

AU - Lu, Yao

AU - Pápai, Zsuzsanna

AU - Van Tine, Brian A.

AU - Attia, Steven

AU - Schöffski, Patrick

AU - Reinke, Denise

AU - Tap, William D.

AU - Jones, Robin L.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - Anthracycline

KW - Chemotherapy

KW - Efficacy

KW - First-line

KW - Older

KW - Soft tissue sarcomas

KW - Toxicity

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