Gemcitabine in soft tissue or bone sarcoma resistant to standard chemotherapy: a phase II study

Purpose: To assess the efficacy of gemcitabine in patients with a variety o f sarcomas that have failed to respond or escaped Adriamycin- and ifosfamid e-based chemotherapy. Patients and methods. A group of 18 symptomatic heavi ly pretreated patients with sarcomas of bone or soft tissue received one in duction course of gemcitabine at a dose of 1000 mg/m(2) per week for 7 cons ecutive weeks, followed by 1 week rest. Response to the induction course wa s assessed by interview and by repeated ancillary tests. If no progression was observed, maintenance by gemcitabine 1000 mg/m(2) per week for 3 weeks every 28 days was given until failure was clinically or radiologically evid ent. Results: A total of 51 cycles of gemcitabine were given including 18 c ycles of induction. A mean of 3.6 postinductron cycles were given to nine p atients. The treatment was well tolerated by the patients. One partial resp onse (leiomyosarcoma) and one minimal response (angiosarcoma) were observed , yielding a true objective response rate of 5.5%. An additional six patien ts achieved stabilization of disease (chondrosarcoma and osteosarcoma), yie lding an overall progression-free rate of 44%. The median time to progressi on was more than 27 weeks. Clinical benefit response was observed only in t hose who also achieved a progression-free state. Conclusion: Gemcitabine wa s found to be effective in achieving stabilization and even a minimal respo nse of soft tissue or bone sarcoma refractory to standard chemotherapy.