Olaratumab combined with doxorubicin does not prolong the lives of patients with advanced or metastatic soft tissue sarcoma compared with doxorubicin alone, the phase III ANNOUNCE trial has found. While full study results are awaited, the US Food and Drugs Administration (FDA) recommends that:
Olaratumab should not be initiated in new patients outside of an investigational study
Patients who are currently receiving olaratumab should consult with their healthcare provider about whether to remain on the treatment.
Based on the available information, there are no safety concerns with the medicine.
In October 2016, the Food and Drug Administration granted olaratumab (in combination with doxorubicin) accelerated approval for the treatment of specific adult patients with soft tissue sarcoma not amenable to curative treatment. However, at the time of approval, data on the effects of the treatment were limited due to the small number of patients included in the main study supporting the application. The accelerated approval of olaratumab was, therefore, on the proviso that additional data from the phase III ANNOUNCE trial confirmed the efficacy and safety of the medicine. The study did not meet its primary efficacy objective of prolonging survival (HR: 1.05; median 20.4 vs. 19.7 months for olaratumab plus doxorubicin versus doxorubicin, respectively).
In April 2019, the European Medicines Agency (EMA) recommended that the marketing authorisation for olaratumab should be withdrawn.See Management: approach
Sarcoma is a group of rare solid tumors of connective tissue. More than 50 different histologic subtypes are known.
Most commonly it presents as a soft-tissue swelling, which may or may not be painful. Differential diagnoses that should be considered are lymphoma, metastatic carcinoma, and benign lesions such as lipoma and neuroma.
Some sarcomas are associated with specific gene mutations, in particular chromosomal translocations.
Diagnosis is made by biopsy, which should have a sufficient amount of tissue for accurate pathologic diagnosis.
Pathology should be reviewed by an expert pathologist who has experience in sarcoma histology. Diagnostic laboratory methods may include immunohistochemistry, cytogenetics, and molecular genetic testing.
Treatment is based on stage and histological subtype, with only some subtypes being chemotherapy-sensitive.
Sarcoma is a group of rare solid tumors originating in mesenchymal (connective tissue) cells and accounting for 1% of all adult malignancies. They can be divided into 2 broad categories: sarcoma of soft tissues (including fat, muscle, nerve and nerve sheath, blood vessels, and other connective tissue) and sarcoma of bone.         More than 50 different histologic subtypes of sarcoma of soft tissues are known.  
Assistant Professor of Clinical Medicine
USC Norris Comprehensive Cancer Center
JSH declares that he has no competing interests.
USC Norris Comprehensive Cancer Center
SS declares that she has no competing interests.
Sarcoma Oncology Center
SPC declares that he has no competing interests.
Dr Swati Sikaria, Dr James S. Hu, and Dr Sant P. Chawla would like to gratefully acknowledge Dr Jonathan C. Trent, Dr Saira Hassan, and Dr David Thomas, previous contributors to this monograph. JCT and SH each declare that they have no competing interests. DT has received research support from Pfizer, Amgen, and Novartis.
Department of Surgical Sciences
Professor and Chairman
University of Udine
AF declares that he has no competing interests.
Professor of Musculoskeletal Pathology
Institute of Orthopaedics and Musculoskeletal Science
University College London
AF declares that she has no competing interests.
Memorial Sloan-Kettering Cancer Center
RM declares that he has no competing interests.
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