Clinical effectiveness and cost-effectiveness results from the randomised, Phase IIB trial in previously untreated patients with chronic lymphocytic leukaemia to compare fludarabine, cyclophosphamide and rituximab with fludarabine, cyclophosphamide, mitoxantrone and low-dose rituximab: the Attenuated dose Rituximab with ChemoTherapy In Chronic lymphocytic leukaemia (ARCTIC) trial.

The trial demonstrated that oral fludarabine, cyclophosphamide and rituximab (FCR) yields extremely high response rates in patients with chronic lymphocytic leukaemia (CLL) compared with historical series with intravenous chemotherapy. The study found that fludarabine, cyclophosphamide, mitoxantrone and low-dose rituximab(FCM-miniR) is less well tolerated, with poorer efficacy than FCR, partly owing to the additional toxicity associated with mitoxantrone. FCR had better response rates and a higher proportion of participants achieving eradication of minimal residual disease. The cost-effectiveness analysis indicates that, although FCM-miniR is expected to be cost-effective in the short term, it is unlikely to be cost-effective when taking into account long-term costs and health benefits. In view of these results, FCM-miniR will not be taken forward into a larger definitive Phase III trial. Oral FCR remains the gold-standard therapy for CLL in patients considered fit for fludarabine-based therapy.

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