TY - JOUR
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.
N1 - Funding Information:
Eugenie Younger, Yao Lu, Zsuzsanna Pápai, and Patrick Schöffski have no conflict of interest disclosures. Brian A. Van Tine reports personal fees from Threshold and EMD Serono. Steven Attia reports grants from Threshold Pharmaceuticals, during the conduct of the study; grants from Bayer, AB Science, CytRx, Novartis, Diaachi Sankyo, Lilly, Karyopharm Pharmaceuticals, Epizyme, Blueprint Medicines, Genmab, CBA Pharmaceuticals, Desmoid Tumor Research Foundation, Merck, Deciphera, Takeda Oncology, Philogen, Gradilis, Incyte, Morphotek, grants and non-financial support from TRACON Pharmaceuticals and from Immune Design, outside the submitted work. William D. Tap reports personal fees from Eli Lilly, EMD Serono, Novartis, Eisai, Janssen, Immune Design, Adaptimmune, Daiichi Sankyo, Blueprint, Loxo, GlaxoSmithKline, outside the submitted work. In addition, Dr. Tap has a patent Companion Diagnostic for CDK4 inhibitors - 14/854,329 pending to MSKCC/SKI. Denise Reinke reports grants from Threshold Pharmaceuticals, during the conduct of the study. Karla Ballman reports grants from SARC Foundation, during the conduct of the study. Robin L. Jones reports consultant work for Threshold, Adaptimmune, Blueprint, Clinigen, Eisai, Epizyme, Daiichi Sankyo, Deciphera, Immunedesign, Eli Lilly, Merck and PharmaMar.
Funding Information:
SARC021 was sponsored and funded by Threshold Pharmaceuticals . We would like to thank the patients, their family and caregivers, the investigators and study teams, SARC and the international sarcoma community who participated in the original study.
Funding Information:
SARC021 was sponsored and funded by Threshold Pharmaceuticals. We would like to thank the patients, their family and caregivers, the investigators and study teams, SARC and the international sarcoma community who participated in the original study. This study was supported in part by the SPORE in Soft Tissue Sarcaoma (P50 CA217694).
Publisher Copyright:
© 2019 The Authors
PY - 2020/4
Y1 - 2020/4
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
UR - http://www.scopus.com/inward/record.url?scp=85065833633&partnerID=8YFLogxK
U2 - 10.1016/j.jgo.2019.05.008
DO - 10.1016/j.jgo.2019.05.008
M3 - Article
C2 - 31126845
AN - SCOPUS:85065833633
SN - 1879-4068
VL - 11
SP - 463
EP - 469
JO - Journal of Geriatric Oncology
JF - Journal of Geriatric Oncology
IS - 3
ER -