Sorafenib and dacarbazine in soft tissue sarcoma: a single institution experience.

Bruno Vincenzi, Marianna Silletta, Gaia Schiavon, Anna Maria Frezza, Raimondo Del Vescovo, Bruno Beomonte Zobel, Daniele Santini, Angelo Paolo Dei Tos, Giuseppe Tonini

University Campus Bio Medico, Rome, Italy. b.vincenzi@unicampus.it

Expert opinion on investigational drugs 2013 Jan

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To report on the anti-tumour activity and toxicity of sorafenib combined with dacarbazine in patients with pre-treated advanced soft tissue sarcoma (STSs). From November 2009 to December 2010, 17 patients affected by STSs who had failed two or more regimen of chemotherapy, with a performance status ≤ 2 and measurable disease were consecutively enrolled in the present case series. Sorafenib was administered at 400 mg b.i.d. continuous dosing in combination with dacarbazine, 300 mg/m(2) for three consecutive days every 21 days until disease progression or intolerable toxicity. Fourteen patients were evaluable for response. Three patients stopped treatment early and were not evaluable for response. One of them died for not disease-dependent reason, the other two went off-study due to rapid clinical worsening, without performing radiologic evaluation. No complete responses were registered. As by RECIST, partial responses (PR) were observed in three patients (21%), stable disease (SD) in six patients (43%) and progressive disease (PD) in five patients (36%), with a clinical benefit rate (RECIST PR+SD > 6 months) of 64%. The median time of progression was 20 weeks (range: 9 - 34 weeks) and the median overall survival was 43 weeks (range: 17 - 65 weeks). The main toxicities were neutropenia (36%), thrombocytopenia (36%), hypertension (36%), fatigue (50%) and skin reactions (57%). Five patients required dose reductions (both dacarbazine and sorafenib) for toxicity and three patients required only sorafenib reduction for dermatologic reactions. One patient was taken off-study because of severe sorafenib-related dermatologic toxicity. Sorafenib and dacarbazine combination seems to be an active and safety regimen in pre-treated STSs. A Phase II trial is ongoing in patient affected by selected sarcoma subtypes.

Citation

Bruno Vincenzi, Marianna Silletta, Gaia Schiavon, Anna Maria Frezza, Raimondo Del Vescovo, Bruno Beomonte Zobel, Daniele Santini, Angelo Paolo Dei Tos, Giuseppe Tonini. Sorafenib and dacarbazine in soft tissue sarcoma: a single institution experience. Expert opinion on investigational drugs. 2013 Jan;22(1):1-7