Italian real life experience with brentuximab vedotin : results of a large observational study on 40 relapsed/refractory systemic anaplastic large cell lymphoma

From November 2012 to July 2014, brentuximab vedotin was available in Italy for patients with relapsed systemic anaplastic large cell lymphoma outside a clinical trial context according to the national law 648/96. A large Italian observational retrospective study was conducted on the use of brentuximab vedotin in the everyday clinical practice to check if clinical trial results are confirmed even in a real life context. Primary endpoint was the best response; secondary endpoints were the overall response rate at the end of the treatment, duration of response, survival and the safety profile. A total of 40 heavily pretreated patients were enrolled. Best response was observed after a median of 4 cycles in 77.5%: globally, 47.5% patients obtained a complete response, 64.2% in the elderly subset. Overall response rate was 62.5%. At the latest follow up 15/18 patients are still in complete response (3 with consolidative procedure). Progression free survival was 39.1% at 24 months and disease free survival 54% at 24 months (median not reached). Particularly, all the long term responders were aged <30 years at first infusion. The treatment was well tolerated even in this real life context and no death has been linked to drug toxicity. Brentuximab vedotin induces clinical responses quite rapidly, i.e. within the first 4 cycles in most responder patients, thus permitting the timely application of the transplantation phase. For patients ineligible for transplant or for who transplant failed, brentuximab vedotin may represent a feasible effective therapeutic option in everyday clinical practice.