Phase III Soft Tissue Sarcoma Trials: Success or Failure?
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Oncology
Link
http://link.springer.com/content/pdf/10.1007/s11864-017-0457-1.pdf
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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