IFOSFAMIDE AND CONTINUOUS-INFUSION ETOPOSIDE IN ADVANCED ADULT SOFT-TISSUE SARCOMA - A SCANDINAVIAN SARCOMA GROUP PHASE-II STUDY

The purpose of this study was to evaluate tumour response and toxicity to ifosfamide and continuous infusion etoposide in metastatic or loca lly advanced soft tissue sarcoma, with dose escalations under G-CSF (g ranulocyte colony-stimulating factor) support. Of 92 eligible patients (median age 51 years), 85% had tumours of high-grade malignancy and 8 2% had metastatic disease. Chemotherapy, the baseline dose, consisted of etoposide 600 mg/m(2) as a 72 h infusion and ifosfamide 1500 mg/m(2 )/day for 3 days, followed by G-CSF support (VIG regimen). Stepwise 10 % dose escalations were performed depending on haematological toxicity . For patients considered operable after induction chemotherapy, surgi cal resection of all identifiable residual tumour was attempted. Compl ete and partial response rates were 11% and 31%, for an overall respon se rate of 42% (95% CI 31-52%). Forty-eight per cent of courses were d ose escalated by a median of 20%. Complete responders had significantl y higher, and patients with progressive disease had significantly lowe r, dose levels than other patients. None of 20 patients with Liver met astases responded despite high dose levels. Compared to a preceding pi lot study, the addition of G-CSF led to significantly higher dose leve ls, improved schedule adherence and less haematological toxicity, but no apparent increase in response rate. In view of the modest dose of i fosfamide applied in this study, it is possible that the prolonged inf usion of etoposide made a significant contribution to the regimen's an titumour activity, although this can only be determined definitively i n a randomised study. (C) 1997 Elsevier Science Ltd.