First line therapy with Bendamustine in
advanced indolent Non-Hodgkin Lymphoma
in treatment routine
Non-interventional study
Becker, M.1, Tschechne, B.2, Reeb, M.3, Schwinger, U.4, Bruch, H.-R.5, Straßl, L.6
1 Onkologische Praxis Minden-Porta, Porta Westfalica 2 Praxis für Hämatologie und internistische Onkologie, Neustadt 3 Onkologische
Schwerpunktpraxis, Kaiserslautern 4 Schwerpunktpraxis und Tagesklinik, Stuttgart 5 Schwerpunktpraxis Bonn, Bonn 6 iOMEDICO AG, Freiburg
BACKGROUND/OBJECTIVES
METHODS
Bendamustine has become a standard for treatment of indolent nonHodgkin lymphoma (NHL). Trial results of NHL1-2003 showed better
efficacy and lower toxicity of BR compared with CHOP-R1. The noninterventional study Be-1st reveals treatment and outcome in daily
practice with Bendamustine in 1st line NHL in Germany in 2010 and
2011.
From 04/2010 until 10/2011 324 patients (pts) were enrolled at 57 study centres in Germany.
Data sets include demographic information, treatment regime, efficacy and side effects.
Treatment modalities were electronically recorded for 6 months until 12/2011. Major inclusion
criteria are advanced indolent NHL according to WHO-classification. In addition patients are
requiring 1st line treatment, and did have no previous chemotherapy and no pre-treatment with
Interferone or Rituximab.
RESULTS
Analysis Sets
Different outcome sets were
necessary to assess treatment
duration and response rates
respectively, as the observation
period for some patients was
not completed at study end on
31. Dec. 2011.
Patients
Age at therapy onset
Patient characteristics
Gender
Median age (range 27‐92)
At least one comorbidity
Median time to treatment after primary diagnosis
Spalte1
balanced
70.5 yrs
62.5%
8.6 weeks
Safety Set: 323 pts
Therapy
Treatment regimes
The combination of Bendamustine and Rituximab (BR)
was most common, applied to a
total of 94,1% of pts (n=289). In
11% (n=33) of these pts BR
was supplemented by Dexamethasone (D) or Prednisone (P).
Bendamustine
monotherapy
was chosen in 4,6 % (n=14) of
the pts. Four patients (1,3%)
received other combinations.
Dosing
Treatment was mostly administered on day 1 and 2 at 4week intervals with a median
dose of Bendamustine of 88,4
mg/m2 (177 mg/m2 per cycle).
Treatment duration
The median treatment duration
was 6 cycles.
Follicular lymphoma
50%
Marginal‐
zone lymphoma
17%
General Analysis Set: 307 pts
Outcome Set Treatment Duration:
277 pts
Mantle‐cell lymphoma
12%
Immuno‐
cytoma
15%
Enrolled:
324 pts
Outcome Set Response Rates: 281 pts
Others
6%
Ann Arbor tumor stage
Tumor entities
Efficacy
The overall response rate (ORR) of patients
with completed treatment documentation
(n=281) was 85,1%. Median and mean time
to best response was 4,5 months (n=240).
Most frequent comorbidities at therapy onset
Safety
Side effects of Bendamustine
In 161 (49,8 %) of 323 patients (safety population) a total of 429 Bendamustinerelated side effects of all CTCAE grades were documented.
Bendamustine related side effects (> 2% of pts)
Best response
Assessment of therapy by the treating
physician
Efficacy of treatment with Bendamustine was
assessed as very good or good in 88% of pts
by the treating physician. Tolerability was
judged as very good or good in 89% of pts.
Two grade 5 toxicities were documented. One death was associated with
thrombocytopenia. The reason of death in the other case was unknown.
Serious adverse drug reactions (SADR)
10 SADR were documented for 9 pts according to the following CTCAE
categories: constitutional symptoms (3), blood/bone marrow (2), infection (2),
cardiac arrhythmia (1), gastrointestinal (1), and death (not categorized, 1).
CONCLUSIONS
References
Be-1st reflects the first-line treatment routine of Bendamustine for indolent NHL in Germany in 2010/2011. In addition to
experiences from interventional trials, Bendamustine demonstrates a favorable efficacy and toxicity profile in clinical
routine as well.
1 Rummel
• The response rates were in line with expectations based on existing trial experience1. The achieved CR-rate meets
reported values by Rummel et al. for BR in first-line treatment (42,7% vs. 39,6%)1. ORR is slightly lower than
reported (85,1% vs. 92,7%), which may be attributed to the different patient population treated in clinical routine.
• Safety results reflect the well-known safety profile of Bendamustine. Most frequent side effect is hematotoxicity
occurring in about 35% of pts (all grades) and in 13% of pts (grades 3/4) respectively.
• Bendamustine is mostly given in combination with Rituximab (94% of pts) with a median dose of 88,4 mg/m2 on days
1+2 according to current consensus guidelines2.
The study was sponsored by
Mundipharma GmbH, Limburg/Lahn,
Germany.
2 Cheson
et al., Lancet 381; 2013
et al., CLML10; 2010
Data analysis and medical writing:
iOMEDICO AG, Freiburg supported by
Mundipharma GmbH.