Results of a phase 3 study in metastatic soft tissue sarcoma patients: towards personalized medicine and shared decision making.
Soft tissue sarcomas are rare mesenchymal tumors which tend to metastasize in half of the cases. The prognosis of patients with metastatic STS is poor, the 5 years survival is less than 5%. There is a long (transatlantic) debate about the value of combination chemotherapy with doxorubicin and ifosfamide versus doxorubicin alone in the metastatic or locally advanced setting.
In this phase 3 study performed by the Soft Tissue and Bone Sarcoma Group of the European Organisation of Research and Treatment in Cancer (EORTC) 455 patients with metastatic STS were entered by investigators from 38 hospitals in Europe and Canada. Half of the patients received combination chemotherapy, the other half received single agent therapy. Results of the study show no benefit of the combination therapy with regard to the primary end-point overall survival, but a doubling in response percentage and a significant improvement in progression-free survival, albeit at the price of considerable more toxicity. The outcome of the study supports that combination therapy should be restricted to a certain subgroup of patients with symptomatic disease demanding a rapid and meaningful volume response. With these results oncologists can better decide together with the patient which the optimal treatment is in a certain situation.
Chairman of the EORTC Sarcoma Group and senior author of the paper, Winette van der Graaf, Professor of Medical Oncology at Radboudumc: Our research shows that we can only make progress in rare malignancies such as sarcomas if we work closely together in international collaborations, such as the EORTC STBSG, which has a unique setting and structure in performing studies like this one.
The next meeting of the EORTC STBSG will be held in Nijmegen, March 27-28.
Ian Judson, Jaap Verweij, Hans Gelderblom, Jörg Hartmann, Patrick Schöffski, Jean-Yves Blay, Martijn Kerst, Josef Sufliarsky, Jeremy Whelan, Peter Hohenberger, Anders Krarup-Hansen, Thierry Alcindor, Sandrine Marreaud, Sasksia Litière, Catherine Hermans, Cyril Fisher, Pancras Hogendoorn, A Paolo dei Tos, Winette van der Graaf, "Single agent doxorubicin versus intensified doxorubicin plus ifosfamide in the first line treatment of advanced or metastatic soft tissue sarcoma: A randomised phase III trial by the European Organisation and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group (STBSG)", Lancet Oncology, 2014
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