[A late phase-II trial comparing KW-2307 with vindesine in non-small cell lung cancer (1). Lung cancer section in KW-2307 Study Group].

A multicenter cooperative study was performed to compare KW-2307 (KW), a novel vinca alkaloid (VA) derivative, and vindesine (VDS), with respect to tumor response and toxicity in patients (pts) with non-small cell lung cancer. In the former part of the trial, pts received monotherapy with KW 25 mg/m2 or VDS 3 mg/m2. Pts refractory to treatment with KW or VDS were crossed over to treatment with VDS (3 mg/m2/W x 3) or KW (20 mg/m2/W x 3), respectively, in combination with cisplatin (CDDP) 80 mg/m2. Both drugs were administered in 4 courses or more once weekly by intravenous bolus injection in monotherapy. In the subsequent combination therapy, non-responders were treated with CDDP on day 1 and KW or VDS on day 1, 8 and 15 with a course of 28 days, and treatment was given in 2 courses or more in principle. According to the method of O'Brien/Fleming, comparison of tumor response between the 2 treatment groups in the 2nd stage was performed in 154 cases. The response rate of KW group (29.4%, 22/75) was significantly better than that of VDS group (9.3%, 7/75). The main adverse effect in both groups was leukopenia (neutropenia), and no significant difference was observed between the incidence in each group. Among other adverse effects, increased GOT, fever and phlebitis were slightly more often found in KW group, and alopecia and paresthesia a little more in the VDS group. In the later part of combination therapy with CD DP, the KW group achieved PR in 10 of 34 pts (29.4%), and no response was observed in the VDS group (28 pts).