NF10 Project: An International, Prospective, Observational Study Of Patients With Indolent Non-Follicular Lymphoma. Analysis Of First 215 Patients

Indolent non follicular B-Cell Lymphomas (INFL) are a heterogeneous group of lymphomas and include small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphomas (LPL), and marginal zone lymphomas (MZL). In 2010 the NF10 study was proposed by the Fondazione Italiana Linfomi as a prospective registry specifically devised for investigating the prognosis of this group of lymphomas with particular emphasis on splenic MZL.

The purpose of the study is to verify whether a prospective collection would provide more accurate data to better define prognosis of INFL. The registration of consecutive patients with newly diagnosed INFL satisfying entry criteria is ongoing at a dedicated website via secure HTTP protocols. Each patient should be followed for up to 5 years. So far the study has been activated in several centers in Europe, South America and Asia. Patients who have a locally established diagnosis of SLL, LPL, or MZL and have never received anti-lymphoma therapy are eligible for inclusion in the study. All ages and disease stages were allowed.

Between September 1st 2011 and August 1st 2013, 215 cases from 28 European and South American Institutions have been registered. At time of current analysis, data on 186 cases were available. Based on local pathology report 12% of cases were registered as SLL, 19% as LPL and 57% as MZL, including splenic (20%), nodal (15%), and extranodal (22%) subtypes; 12% of cases were classified has CD5-negative B-cell chronic lymphoproliferative disorders. Median age was 66 years (rage 28-90), 54% of patients were males; Ann Arbor stage was I-II in 23% and III-IV in 77%; 13% had B symptoms, 10% had ECOG performance status > 1, LDH and Beta2-microglobulin were elevated in 19%, and 49% of cases, respectively. Six percent of cases were HCV positive. Regarding HBV infection, 20% of patients were HBcAb-positive and only 3% of patients were HbsAg-positive. Among baseline characteristics, also details on initial treatment plan were collected; an immediate systemic therapy was planned in 48% of cases and included the use of anti-CD20 monoclonal antibody in 94% of cases, the use of alkylating agents-based regimens in 57%, CHOP/like in 15% and bendamustine in 15%. Patient enrollment and data collection on actual therapy, response and follow-up and histological revision are currently ongoing.

The NF10 confirms that a web based world-wide cooperation allows the collection of a relevant and quite complete set of data in a limited period of time, providing a platform for future prognostic and therapeutic studies.

Federico: MedImmune: Research Funding.