How to Treat Chronic Lymphocytic Leukemia? Data From a Clinical Registry by Office-Based Hematologists in Germany (TLN Registry)

The treatment of patients with Chronic Lymphocytic Leukemia (CLL) has changed significantly over the last years. To select an appropriate treatment, multiple factors have to be considered. In particular, the stage of disease, patient’s age, comorbidities and personal preferences, respectively, influence decision making. The clinical tumor registry on lymphoid neoplasms (TLN Registry) conducted by the iOMEDICO AG in collaboration with the Arbeitskreis Klinische Studien (AKS) and the Kompetenznetz Maligne Lymphome (KML) was established to collect data on the daily practice treatment of 3000 non-selected patients with lymphoid neoplasms. Here, we present data regarding treatment and sequences of regimes in patients (pts) with CLL treated by office-based hematologists in Germany.

While targeting 500 CLL pts, the registry prospectively collects data on pts characteristics, tumor history, treatment, response rates and sequences of regimes. In addition data on adverse drug reactions and concomitant diseases are documented. CLL pts older than 18 years receiving a first- or second line therapy which has started no longer than 4 weeks before patient enrolment can be recruited into the registry if informed written consent is present. All pts are followed for 5 years. Currently, 116 sites across Germany are participating.

The TLN Registry started in May 2009. Currently, 492 pts with CLL have been recruited. The mean age at the start of first line therapy is 69 years. The majority of pts (63%) are male. About 20% of the pts in first line therapy are treated within clinical trials. Median time between diagnosis and start of first line therapy is 22 months (range 0 – 285 months). Most of the pts receive Bendamustine/Rituximab (BR, 34%) or Fludarabin/Cyclophosphamide/Rituximab (FCR, 21%) in first line therapy. Overall, 97% of the first line therapies were successful (91% CR/PR, 6% SD). In particular, 99% of BR (98% CR/PR, 1% SD) and 100% of FCR (98% CR/PR, 2% SD) therapies were successful. Over time, a change in treatment selection becomes apparent. 50% of the pts started first line therapy before October 2009. They mainly received BR (19%), Bendamustine (16%), FCR (16%) or Chlorambucil (15%), respectively. Pts starting first line therapy after October 2009 mainly received BR (43%) or FCR (24%). Bendamustine-containing regimens are more often used as first line therapy in pts older than 75 years as compared to younger ones (62% vs. 42%). Fludarabine-containing regimens are more often used in pts younger than 75 years (37% vs. 6%). Similar to the first line therapy, BR is the most often used second line therapy (52%). About 41% of the pts have completed first line therapy and have not yet started second line therapy. The median treatment-free interval since the end of the first line therapy is 10 months. Data on second line therapy are available in 24% of the pts. The majority of these pts (73%) were recruited at the start of second line therapy. Most of them receive BR as second line therapy after first line therapy either with Chlorambucil (17%) or Bendamustine (13%). The median treatment-free interval between the end of first line therapy and the start of second line therapy is 16 months (range 1 – 49 months).

The registry provides an overview on particularities and changes in routine treatment of pts with CLL treated by office-based hematologists in Germany. Implementation of new standards affecting treatment preferences are currently under evaluation. BR and FCR are widely accepted and very effective as first line therapies. Our data indicate that age is an important factor for selecting the appropriate treatment. Further analyses will investigate additional variables influencing the choice of treatment. With more data becoming available the sequences of regimes and their effectiveness can be analyzed.

No relevant conflicts of interest to declare.