Temozolomide in uterine leiomyosarcomas.

OBJECTIVE: Temozolomide has been studied in soft-tissue sarcomas with varying dosing schedules. We review the Memorial Sloan-Kettering Cancer Center (MSKCC) experience in women with metastatic or unresectable leiomyosarcoma treated with continuous daily dose (CDD) or bolus-dose (BD) temozolomide. We include a literature review of temozolomide activity in leiomyosarcoma patients.
METHODS: After obtaining Institutional Review Board approval, we identified women with recurrent leiomyosarcoma treated with temozolomide at MSKCC from 9/2001 to 9/2004. Patients were treated daily with dosages ranging from 50 to 75 mg/m(2) for 6 out of 8 weeks or for 5 days every 4 weeks with 150-300 mg/m(2) daily. All patients were evaluated at least every month for toxicity and response. We reviewed patients' charts for age at diagnosis, stage, performance status, prior treatments, temozolomide dose and schedule, best response to treatment, and treatment delays or dose reductions due to toxicity.
RESULTS: Twelve patients were treated with CDD temozolomide (median age, 54 years; range, 35-72 years). All patients had previously received doxorubicin; 11 had received >/=2 previous chemotherapy regimens. One patient achieved a prolonged partial response for 4 cycles; 4 demonstrated stabilization of disease for 2-5+ cycles. Seven patients were treated with BD temozolomide (median age, 50 years; range, 43-63 years). All patients received previous doxorubicin and received >/=2 previous chemotherapy regimens. Four patients achieved stabilization of disease for 3, 5, 6, and 16 cycles, respectively. One patient achieved a near complete response for 13 cycles and continues to be followed off therapy for 10+ months.
CONCLUSIONS: Temozolomide has promising therapeutic benefit and is well tolerated in patients with metastatic unresectable leiomyosarcoma. Further investigation of temozolomide in leiomyosarcoma patients is warranted.