SINGLE-AGENT ACTIVITY OF RHIZOXIN IN NON-SMALL-CELL LUNG-CANCER - A PHASE-II TRIAL OF THE EORTC EARLY CLINICAL-TRIALS GROUP

In a multicentre trial of the EORTC-Early Clinical Trials Group (ECTG) we treated 31 chemotherapy-naive patients with advanced non-small-cel l lung cancer (NSCLC) with rhizoxin, a novel tubulin-binding agent. Th e drug was given as an i.v. bolus injection at 2 mg m(-2) once every 3 weeks in an outpatient setting. Prophylactic antiemetics were not rou tinely given. Of the 29 eligible patients, nine had been treated surgi cally and three had received radiotherapy. The main toxic effects obse rved were stomatitis (34% of cycles) and neutropenia (41% of cycles). Neutropenic fever was rare (3% of cycles). Twenty-seven patients were evaluable for response. There were four partial responses (15%), while 13 patients (48%) showed stabilisation of their disease. The median d uration of response was 7 months (range 6.0-10.7 months) and median su rvival from the start of rhizoxin treatment was 6 months (range 2-14.7 months). Rhizoxin as single agent shows activity in patients with adv anced NSCLC.