[A randomized phase II study of (2''R)-4'-0-tetrahydropyranyladriamycin and adriamycin in combination with vincristine and ACNU in small cell lung cancer--THP-ADM, VCR, ACNU vs ADM, VCR, ACNU].

Between April 1984 and March 1988, a comparative randomized phase II study was performed to compare the effects of (2''R)-4'-0-Tetrahydropyranyl-adriamycin (THP) and adriamycin in combination with vincristine (VCR) and ACNU in 60 previously untreated and evaluable patients with small cell lung cancer (SCLC). Arm AVA was constituted by adriamycin, VCR and ACNU, and arm TAVA by THP, VCR, ACNU. Of the 30 patients treated with AVA, there were 20 partial responses, 7 with no change and 3 with progressive disease, for an overall response rate of 66.7%. On the other hand, of the 30 patients on TAVA, one complete response and 22 partial responses were observed, for an overall response rate of 76.7% Median survival time of AVA was 10.0 M, that, of TAVA was 9.3 M. But significant differences between the two arms was not found. During induction therapy, leukopenia was the main side effect. Over WHO Grade 3 leukopenia was seen in 53.3% of patients on AVA and 70.0% of those on TAVA. Moderate hair loss (Grade 2) was significantly less frequent with TAVA than AVA. In conclusion, the results indicated that THP is active in SCLC with the same level of adriamycin, and has less toxicity. THP is a suitable drug as a first line combination chemotherapy for SCLC.