A Trial Comparing Two Medications as First Treatment in Elderly Patients With Metastatic or Advanced Soft Tissue Sarcoma

Summary

Patients with a locally advanced or metastatic (i.e., there are already metastases of the diagnosed tumor in the body outside the primary lesion) soft tissue sarcoma will be recruited for this study. The minimum age to enter the study is 60 years. Therapy with doxorubicin is the mainstay of palliative chemotherapy for these patients, which is associated with hematological toxicity and an increase of the infection rate. Pazopanib is known to rarely induce hematological toxicity or to trigger infection. We therefore assume that pazopanib exerts similar activity while decreasing neutropenia and neutropenic fever. Pazopanib is already approved in the U.S. and Europe for the treatment of advanced soft tissue sarcoma. Doxorubicin and pazopanib will be randomly allocated to either receive doxorubicin or pazopanib in a phase II clinical trial. The aim of this study is to measure the treatment effect (reduction in tumor size or tumor stabilization) for both drugs, as well as the survival rate, and the duration of tumor control by the different therapies. A further objective is to measure the quality of life by standardized questionnaires throughout the course of treatment.

Timeline

Start

2012-10

Primary completion

2017-07-11

Completion

2017-07-11

Outcome

Met primary endpoint

paper PFS was noninferior (HR, 1.00; 95% CI, 0.65 to 1.53) PMID 32840417 ↗

Publications

• Hamacher R, Liu X, Schuler MK, Hentschel L, Schoffski P, Kopp HG, Bauer S, Kasper B, Lindner L, Chemnitz JM, Crysandt M, Stein A, Steffen B, Richter S, Egerer G, Ivanyi P, Kunitz A, Grunwald V. A post hoc analysis of the EPAZ trial: The role of geriatric variables in elderly soft tissue sarcoma patients on toxicity and outcome. Eur J Cancer. 2023 Mar;181:145-154. doi: 10.1016/j.ejca.2022.12.012. Epub 2022 Dec 27.
• Grunwald V, Karch A, Schuler M, Schoffski P, Kopp HG, Bauer S, Kasper B, Lindner LH, Chemnitz JM, Crysandt M, Stein A, Steffen B, Richter S, Egerer G, Ivanyi P, Zimmermann S, Liu X, Kunitz A. Randomized Comparison of Pazopanib and Doxorubicin as First-Line Treatment in Patients With Metastatic Soft Tissue Sarcoma Age 60 Years or Older: Results of a German Intergroup Study. J Clin Oncol. 2020 Oct 20;38(30):3555-3564. doi: 10.1200/JCO.20.00714. Epub 2020 Aug 24.
• Crombie JL, Armand P. Diffuse Large B-Cell Lymphoma's New Genomics: The Bridge and the Chasm. J Clin Oncol. 2020 Oct 20;38(30):3565-3574. doi: 10.1200/JCO.20.01501. Epub 2020 Aug 19. No abstract available.
• Karch A, Koch A, Grunwald V. A phase II trial comparing pazopanib with doxorubicin as first-line treatment in elderly patients with metastatic or advanced soft tissue sarcoma (EPAZ): study protocol for a randomized controlled trial. Trials. 2016 Jul 7;17(1):312. doi: 10.1186/s13063-016-1434-x.

Drugs

Indications