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Grupo Español de Investigación en Sarcomas GEIS Spanish Sarcoma Research Group Boca Raton, Fl. November 2005. About GEIS.
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Grupo Español de Investigación en Sarcomas GEIS Spanish Sarcoma Research Group Boca Raton, Fl. November 2005
About GEIS • Early in 1994 a group of oncologists expressed their concern for the need to work on a cooperative basis on the medical treatment of soft tissue sarcomas. • Initially, phase II trials in advanced STS looking for activity with new schemes and old drugs. • GEIS Registry for STS was started in 1995. Tool for compliance of defined guidelines: 2006-2007. http//:www.registrogeis.com • Since December 1997 GEIS has had legal status in the form of a scientific association.
Mission and Vision... • Promote clinical and translational research into sarcomas. • Lay down guidelines of action in the diagnosis and treatment that may be of service to all the spanish’s oncologists. • Act as a reference pointfor the treatment of soft tissue sarcomas in our country and work together with other similar groups internationally. • Create a GEIS Group Register of Sarcomas in order to have epidemiological data available that will permit us to know Spain’s actual situation in this field. • Have a Data Centre of our own with a common data base for different studies.
and... • Recently, some Portuguese centers have been incorporated, and there is also interest of other countries.
International collaborative task PHASE III LOCALIZED, HIGH-RISK SOFT TISSUE SARCOMAS OF LIMBS AND SUPERFICIAL TRUNK IN ADULTS: AN INTEGRATED APPROACH INCLUDING CHEMOTHERAPY FOR THREE OR FIVE COURSES . Phase III Intergroup Study (EORTC 62024; ISG; FSG; GEIS-10) Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: A controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery
Lines of Research • STUDIES ON HIGH-DOSE (HD) IFOSFAMIDE IN STS: • Clinical Studies Performed • Phase II of HD Ifosfamide in first-line treatment 45 pts RR 38% (Ann Oncol 1998; 9:871) • Phase II of the combination of HD Ifosfamide and Doxorubicin 65 pts RR 40% (ASCO 2000) • Phase II of sequential dose-dense Doxorubicin and Ifosfamide 60 pts RR 38% (Cancer 2004; 100:1498) • Study of Prognostic Factors in pts treated with HD Ifosfamide 156 pts (J Surg Oncol 2004; 88:44)
STUDIES ON HIGH-DOSE (HD) IFOSFAMIDE IN STS: • OngoingClinical Study • - Phase III Randomized Study of Doxorubicin versus HD Doxorubicin in combination with Ifosfamide in first-line STS • AccrualStart : 2004 Expected Accrual 132 pts • 1.b AFTER HD IFOSFAMIDE • Activity of doxorubicin after high-dose ifosfamide in adult patients with advanced soft tissue sarcoma: A study of the Spanish Group for Research on Sarcomas (GEIS). (Ann Oncol 1998; 9: 783-785).
Lines of Research • STUDIES ON NEW DRUGS IN STS: • Clinical Studies Performed • CAELYX: Phase II study in second-line STS 27 pts RR 2 EE 12 (Sarcoma, in press) • TEMOZOLOMIDE: Phase II in a 6 week extended schedule in second-line STS 45 pts RR 15% (uterine sarcoma)(Cancer 2005; 104:1706) • GEMCITABINE: Phase I-II of the combination of Doxorubicin and Gemcitabine in first-line STS 47 pts RR 19.5% (ASCO 2003)
STUDIES ON NEW DRUGS IN STS: • Ongoing Clinical Studies • LIPOSOMAL DOXORUBICIN in pts older than 65 y. (first-line) • TEMOZOLOMIDE: Phase II in first-line gynecological sarcoma • GEMCITABINE: Phase II randomized of the combination of Gemcitabine and DTIC in second-line STS
Lines of Research • GIST: CLINICAL AND TRANSLATIONAL STUDIES • Ongoing Clinical Study • - Phase I-II Clinical Study of Imatinib in combination with Doxorubicin in refractory GIST • Translational Study • Study of the Prognostic Value of the KIT mutations in GIST completely resected 162 pts Deletions of codons 557-558 have Independent poor prognostic value for DFS (J Clin Oncol 2005;23:6190)
Lines of Research 4. STUDIES IN LOCALIZED DISEASE: STS PHASE III LOCALIZED, HIGH-RISK SOFT TISSUE SARCOMAS OF LIMBS AND SUPERFICIAL TRUNK IN ADULTS: AN INTEGRATED APPROACH INCLUDING CHEMOTHERAPY FOR THREE OR FIVE COURSES . GIST Phase III Intergroup Study (EORTC 62024; ISG; FSG; GEIS-10) Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: A controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery
New Trends • Potentiate traslational research • Promote adequate referral practice of STS patients • Participate with other groups in new strategies for new studies (i.e. Hystologic Subtype Specific Treatment) • Start studies in bone sarcoma patients • ...