2001 CTOS Annual Meeting Posters— Medical Oncology

TEMOZOLOMIDE AS A 6-WEEK CONTINUOUS ORAL SCHEDULE IN ADVANCED SOFT TISSUE SARCOMA: A PHASE II TRIAL OF THE SPANISH GROUP FOR RESEARCH ON SARCOMAS (GEIS)
X Garcia del Muro,  A Lopez Pousa,  J M Buesa,  J Martin,  A Poveda,  I Bover,  P Escudero,  J Martinez Trufero,  A Casado
Institut Catala d'Oncologia

METHODS: A multicenter phase II study was performed to assess the activity and toxicity of Temozolomide administered at a dose of 75 mg/m2/day, as a 6-week oral continuous schedule every 9 weeks, in adult patients (pts) with previously treated STS. From November 1999 to date, 30 pts with advanced STS and non-irradiated measurable lesions were included into the study.

RESULTS: At present, 27 pts were evaluable: 2 were inelegible and 1 refused treatment. Median age was 51 (29-76) years; 11 male and 16 female; PS: 0:9, 1:14, 2:4 pts. Histologic types were: GIST:4, MFH:5, fibrosarcoma:3, leiomyosarcoma:4, liposarcoma:2, angiosarcoma:2, mixed mullerian tumor:2, and others:5. Grade: III:15, II:9, I:3 pts. Prior regimens included doxorubicin and Ifosfamide in 26 and 25 pts, respectively. A total of 42 cycles were administered. Six pts did not receive a complete cycle of treatment due to: 3 rapid progression, 2 early death from disease, 1 pulmonary thromboembolism, and they were considered as treatment failures. There were 4 PR and 3 SD (Overall response rate: 15%, 95% CI: 4-34). Partial responses were seen in 2 pts with uterine leiomyosarcoma, 1 mixed mullerian tumor and 1 GIST, and they lasted 14,10+, 7 and 4 months. Hematological toxicity was: Neutropenia G-IV:1, G-III:1, G-II:2 pts, Thrombocytopenia GIII:2, GII:3 pts, Anemia G-III:4, G-II:3 pts). Non-hematological toxicity was: Nausea G-II:3 pts, Vomiting G-II:4 pts, Asthenia G II:4 pts.

CONCLUSION: Temozolomide at this extended continuous schedule has activity against STS, appears to be well tolerated, and deserves further evaluation, specially against uterine sarcomas.