Phase III Soft Tissue Sarcoma Trials: Success or Failure?

Author:

Lee Alexander T. J.,Pollack Seth M.,Huang Paul,Jones Robin L.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Oncology

Reference54 articles.

1. PDQ Adult Treatment Editorial Board. Levels of evidence for adult and pediatric cancer treatment studies (PDQ®): health professional version [Internet]. PDQ Cancer Information Summaries. 2002 [cited 2016 Nov 20]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26389191 .

2. Bramwell VHC, Anderson D, Charette ML. Doxorubicin-based chemotherapy for the palliative treatment of adult patients with locally advanced or metastatic soft-tissue sarcoma: a meta-analysis and clinical practice guideline. Sarcoma. 2000;4:103–12. doi: 10.1080/13577140020008066 .

3. •• Judson I, Verweij J, Gelderblom H, Hartmann JT, Schoffski P, Blay JY, et al. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014;15(4):415–23. doi: 10.1016/S1470-2045(14)70063-4 . Results of EORTC 62012 study, a large open-label phase III trial comparing single agent doxorubicin to combination doxorubicin-ifosfamide in untreated advanced STS.

4. • Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016;388(10043):488–97. doi: 10.1016/S0140-6736(16)30587-6 . Olarutumab, an anti-PDGFRa monoclonal antibody, has been granted FDA accelerated approval status on the basis of the overall survival benefit seen in this randomised phase II study in untreated advanced STS. A phase III trial of the same doxorubicin-olaratumab combination is now in follow-up.

5. Lorigan P, Verweij J, Papai Z, Rodenhuis S, Le Cesne A, Leahy MG, et al. Phase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group study. J Clin Oncol. 2007;25(21):3144–50. doi: 10.1200/JCO.2006.09.7717 .

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