MODIFIED WEEKLY REGIMEN WITH VINORELBINE AS A SINGLE-AGENT IN UNRESECTABLE NONSMALL CELL LUNG-CANCER

After a 26% response rate was reported with a 20/mg/m(2)/week vinorelb ine (VRL) dose, a multicenter phase II trial of a modified weekly VRL treatment protocol (30 mg/m(2) days 1 and 8 every 21 days) for unresec table non-small cell lung cancer (NSCLC) was designed to determine its clinical activity, toxicity, and survival of treated patients. As mye lotoxicity frequently precludes the administration of VRL, by suppress ing the dose that would correspond to day 15 of a weekly protocol, we allowed bone marrow recovery to take place and avoided the administrat ion of the drug at the nadir of the cycle. The trial included 71 conse cutive, previously untreated patients with unresectable and measurable disease. A total of 297 three-week treatment courses were administere d with an average of 4 courses per patient (range 1-11). Results showe d that in spite of attaining a median dose intensity of 19 mg/m(2)/wee k, this modified weekly VRL treatment regimen has a low level of activ ity (7.5% response rate) in NSCLC. Although a more tolerable level of toxicity is achieved, in order to maintain its antitumor activity, the recommended dose of VRL when given alone for NSCLC treatment (30 mg/m (2)/weekly) should not be decreased. (C) 1997 Elsevier Science Ireland Ltd.