EFFICACY AND TOXICITY OF 2-CHLORODEOXYADENOSINE (CLADRIBINE) - 2 H INFUSION FOR 5 DAYS - AS FIRST-LINE TREATMENT FOR ADVANCED LOW-GRADE NON-HODGKINS-LYMPHOMA

2-Chlorodeoxyadenosine (Cladribine) is a new purine analogue with high activity in pretreated low grade non-Hodgkin's lymphoma (NHL). To eva luate the efficacy of this drug in untreated patients with advanced NH L, we performed a prospective multicentre trial. Cladribine (0.12 mg/k g) was administered intravenously daily for 5 consecutive days in an o ut-patient setting. The treatment was repeated every 28 days for four cycles. Included were patients with a histological diagnosis of low gr ade NHL according to the Kiel classification and stage III or IV disea se. Stage II patients were included when radiotherapy had failed. 55 p atients were entered into the study. 50 patients were evaluable. The r emission rate was 44/50 (88%; 95% confidence interval 82-100%), includ ing complete remissions (CR) in 14 (28%) patients. Only 2 patients sho wed progression while on Cladribine treatment. The estimated overall s urvival, and time to treatment failure (TTF) were 85% and 51%, respect ively, after a median observation time of 92 weeks. 11 (22%) patients showed grade 3 or 4 toxicity according to the WHO grading. Haematologi cal toxicity was responsible for 86% of the overall toxicity and 100% of grade 3 and 4 toxicity. 7 patients (14%) had an infection, two of w hich were opportunistic. 12 (24%) patients did not experience any toxi city during the treatment. The results of this study clearly demonstra te the safety and considerable activity of this regimen. Cladribine is very effective even at lower doses than have been used so far. (C) 19 98 Elsevier Science Ltd. All rights reserved.