Grupo Español de Investigación en Sarcomas Current Lines of Research Clinical and Translational Studies Spanish Group for Research on Sarcoma (GEIS)

Spanish Group for Research on Sarcoma (GEIS) Lines of Research: 1. High-dose Ifosfamide Clinical Studies Performed Phase II of HD Ifosfamide in first-line treatment 45 pts RR 38% (JM Buesa. Ann Oncol 1998) Phase II of the combination of HD Ifosfamide and Doxorubicin 65 pts RR 40% (A López Pousa. Sarcoma 2006) Phase II of sequential dose-dense Doxorubicin and Ifosfamide 60 pts RR 38% (J Maurel. Cancer 2004) Study of Prognostic Factors in pts treated with HD Ifosfamide (J Maurel. J Surg Oncol 2004) Ongoing Study Phase II study of neoadjuvant high-dose ifosfamide and radiotherapy in high-risk localized STS Spanish Group for Research on Sarcoma (GEIS)

Lines of Research: 1. High-dose Ifosfamide

Lines of Research: 2. Studies on new drugs in STS Clinical Studies Performed TEMOZOLOMIDE: Phase II in a 6 week extended schedule in 2nd-line STS (X Garcia del Muro, Cancer 2005) TEMOZOLOMIDE: Phase II in first-line gynecological sarcoma (X Garcia del Muro, ASCO 2006) GEMCITABINE: Phase I-II of the combination of Doxorubicin and Gemcitabine in first-line ST (A López Pousa. Br J Cancer 2006) GEMCITABINE: Phase I of the combination of Gemcitabine and DTIC in STS (JM Buesa. Cancer 2004) CAELYX: Phase II study in second-line STS 27 pts RR 2 EE 12 (A Poveda. Sarcoma, 2007) Ongoing Studies LIPOSOMAL DOXORUBICIN in pts older than 65 y. (first-line) SORAFENIB: Phase I/II in combination with Ifosfamide in STS

Lines of Research: 2. Studies on new drugs in STS Randomized phase II study of DTIC plus Gemcitabine versus DTIC alone in patients with pretreated Soft Tissue Sarcoma 113 pts from 18 centers Study Design: Randomized phase II. Endpoint: PFR at 3 months ARM A: DTIC 1200 mg/m2 q 21 days ARM B: Gemcitabine 1800 mg/m2 + DTIC 500 mg/m2 q 14 day (X Garcia del Muro.ASCO 2009)

Lines of Research: 3. Studies in GIST GIST: CLINICAL AND TRANSLATIONAL STUDIES Recently Closed Clinical Trial - Phase I/II Clinical trial of Imatinib and low-dose Doxorubicin in refractory GIST (A Poveda. ASCO 2008) Intergroup Collaboration - Phase III study of adjuvant Imatinib versus observation in resected localized GIST of high-risk Translational Study Deletions affecting codons 557-558 of the c-KIT gene indicate a poor prognosis in patients with resected GIST (J Martín. J Clin Oncol 2005 / ASCO 2008)

Spanish Group for Research on Sarcoma (GEIS) GEIS Future Projects and Educational Tasks CLINICAL TRIALS OF NEW DRUGS: Phase II randomized trial of Trabectedin and Doxorubicin versus Doxorubicin alone in first-line STS Phase II randomized trial of Gemcitabine and Rapamycin versus Gemcitabine alone in pretreated STS TRANSLATIONAL TRIALS IN STS AND GIST STUDIES IN BONE SARCOMAS EDUCATIONAL TASKS: Annual GEIS Simposium Advanced Course in Sarcomas for fellows and young oncologists Guidelines in GIST and STS Spanish Group for Research on Sarcoma (GEIS)