A phase II trial of teniposide (VM 26) in advanced non-Hodgkin's lymphoma, with emphasis on the treatment of elderly patients.

Fifty-four patients entered a phase II trial of teniposide (VM 26) in Stage III (35 patients) and stage IV (19 patients) non-Hodgkin's lymphoma (NHL) classified according to modified Rappaport system. The median age was 71 years (range, 19-85). Thirty-two patients were previously treated at least with combination chemotherapy and radiotherapy, whereas 22 were elderly (range, 70-85 years) untreated patients with a median Karnofsky score of 70. VM 26 was given by IV infusion at 100 mg/m2 weekly for at least 3 doses in "unfavorable" histologic subtypes, and for at least 6 to 9 doses in "favorable" subtypes, prior to the evaluation of response. The overall objective response rate was 43% in the 51 evaluable patients. The median duration of the 12 complete responses (CRs) was 7+ months (26+ to 2). According to the histology, VM 26 was very effective in the six patients with diffuse "histiocytic" (DH) subtype (four CRs, one partial response [PR]), and in the 8 patients with mycosis fungoides (MF) (two CRs, two PRs). Diffuse lymphocytic poorly differentiated and lymphoblastic NHL were less sensitive subtypes to VM 26. Among the 20 evaluable elderly patients a 50% objective response rate was obtained with five CRs. Four CRs and one PR were obtained in the five patients with DH subtype; no response was obtained in the only patient with MF. Toxicity, usually hematologic, was mild, even in elderly patients; neurotoxicity occurred in four instances. VM 26 seemed to be an effective and well-tolerated drug in advanced NHL; this drug should be further evaluated as first line chemotherapy in elderly (greater than or equal to 70 years) previously untreated patients with poor general conditions and DH histology.