Treatment Patterns in Newly Treated and Relapse/Refractory Patients with Follicular Lymphoma in Routine Clinical Care — a United States Electronic Medical Record Database Study

Background: Follicular lymphoma (FL) represents 70% of all indolent non-Hodgkin lymphomas and it is widely recognized that FL is a heterogeneous disease, with patients presenting with differing amounts of tumor burden and prognostic indicators. The NCCN guideline recommends using rituximab (R) as a single-agent or in combination with other chemotherapies as first-line therapy (1LT) or second-line therapy (2LT). No recommendations are provided beyond 2LT. The aim of our study was to evaluate first-, second-, and third-line treatment patterns and associated response in patients with newly diagnosed FL in routine care in the United States (US).

Methods: Newly diagnosed FL patients aged ³18 years were selected from Humedica, a large, national US electronic medical record database between 01/01/08 and 07/31/15 if they had ≥1 inpatient record or ≥2 outpatient records with FL diagnosis codes. The date of the first FL record was the index date. Patients were followed from index date until end of continuous activity, progression to diffuse large B-cell lymphoma, death, or end of study period (09/30/15), and were evalauted for FL treatment patterns and treatment response. Possible remission was defined as no additional chemotherapy and no supportive care use or receipt of supportive care <30 days after end of line of therapy (LOT) for <30 days. Lack of remission was defined as receipt of supportive <30 days after end of LOT for >30 days. Progression was defined as initiation of another LOT, transition to DLBCL, or evidence of supportive care >30 days after end of LOT.

Results: Of the3,756 patients selected into the study, 1,346 (35.8%) initiated 1LT and median (interquartile range [IQR]) time to therapy was 1.3 (0.5-5.9) months. Overall, treatment regimens were mainly R-based. In 1LT, more patients initiated combination chemotherapy (61.4%) vs single-agent chemotherapy (38.6%). Bendamustine+R (43.8%), R-CHOP (25.5%), R-CVP (12.8%) were the most common combination regimens and R (85.8%) was the most common single-agent. Median (IQR) duration of 1LT was 4.3 (1.7-10.4) months. At the end of the 1LT, 54.7% (n=736) had evidence of remission, 25.5% (n=344) progressed, and 1.6% (n=22) had no evidence of remission. 201 initiated 2LT; 34.3% received a single-agent and 65.7% received combination chemotherapy. 2LT regimens were similar to the 1LT, with R (55.1%) remaining the top single-agent, while bendamustine+R (39.4%), R-CHOP (9.8%), and R-CVP (12.8%) remained the top combinations. Median (IQR) duration of 2LT was 3.6 (1.4-6.1) months. Of patients receiving 2LT, 41.3% (n=83) had evidence of remission, 35.4% (n=71) progressed, and 1.5% (n=3) had no evidence of remission. 45 patients received third-line therapy (3LT); 35.6% received a single-agent, while 64.4% received combination chemotherapy. In 3LT, R (31.2%) was the most common single-agent; bendamustine+R (31.1%) was the most common combinations. Median (IQR) duration of 3LT was 2.8 (1.4-4.7) months. Following the 3LT, 26.7% (n=12) had evidence of remission, 39.9% (n=18) progressed, and 4.4% (n=2) had no evidence of remission.

CONCLUSIONS: FL treatment in routine clinical care aligns with treatment guidelines in 1LT and 2LT, with most patients receiving R-based combination chemotherapy. Similar regimens were used in the 3LT setting. As expected, the rates of remission decreased with subsequent LOTs. With similar treatments being used in newly diagnosed and relapse/refractory patients, newer treatment options are needed to provide alternative options for patients who do not benefit from currently available treatments.