Background At our centre, haematologists and department pharmacists constantly monitor outcomes and safety of treatment with lenalidomide.

Purpose To describe clinical outcomes and safety of lenalidomide in our lymphoma and myelodysplastic syndrome patients.

Materials and Methods Onco-AIFA Registry and medical records were checked as of 30/06/2012 for diagnosis, duration of treatment, incidence of adverse drug events (ADRs).

Results Data of 34 patients were reviewed, with the following diagnoses: Diffuse large B-cell lymphoma (DLBCL), 24 patients; 5q-myelodysplastic syndrome (MDS5q-), 11 patients and mantle cell lymphoma (MCL), one patient.

Of patients with DLBCL, one discontinued treatment because of serious ADRs, two because of death and 4 for disease progression after an average of 4.4 treatment cycles, corresponding to 7 months (range: 2–18).

Of patients with MDS5q-, 8 stopped treatment, two of whom because of disease progression or death and two for toxicity. The median duration of treatment was 11.8 cycles (range 1–29).

Seventeen DLBCL patients and 3 MDS5q- patients are still on therapy.

34 non-serious ADRs relating to 14 patients and 5 serious ADRs relating to 4 patients were reported, two of which were cases of development of solid neoplasia. Non-serious ADRs were mostly cases of haematological toxicity, alterations of the skin and of nervous system and infections.

Conclusions Lenalidomide seems to control the disease in patients with MDS5q- for long periods, while the Time to Progression in patients with DLBCL appears shorter.

The treatment-related toxicity appears in most cases acceptable.

Despite the limited number of data, our analysis highlights the need for close monitoring of the patients both during treatment and on follow-up, as evidenced by the two cases of onset of neoplasia.

The progressive collection of data is providing the haematologists and pharmacists the information to design a model for optimised appropriate treatment with lenalidomide.

No conflict of interest.