The efficacy of bendamustine and rituximab in the treatment of indolent lymphoma diseases

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Published: 25 Jun 2010
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Dr Mathias Rummel - University Hospital, Giessen, Germany
Although it is known that rituximab (trade name Rituxan) should be used in combination with chemotherapy to treat patients with indolent lymphoma diseases, there has been no research to demonstrate which chemotherapy regimen was the most effective. Dr Rummel outlines the results of a randomised phase III trial comparing the use of bendamustine plus rituximab with CHOP plus rituximab. This study established that bendamustine plus rituximab had a lower toxicity profile and a clear superiority in efficacy. Despite these positive results and the fact that this combination is already common use in Germany, it has not yet been approved for use in the United States.

This interview has been supported by a restricted grant from Mundipharma GmbH . Bendamustine is licensed as Ribomustin (R) in Germany and Switzerland. The licence will vary in other countries.

Click here to see an in interview with Dr Rummel from ASH 2009

ASCO 2010 Annual Meeting, 4—8 June 2010, Chicago

Interview with Dr Mathias Rummel (University Hospital, Giessen, Germany )

The efficacy of Bendamustine and Rituximab in the treatment of indolent lymphoma diseases

What did you present at ASCO 2010?

We are asked a question which would be the best first line treatment approach for patients with indolent lymphoma diseases and most often CHOP plus Rituximab (R) is given and we’re missing some comparison to older chemotherapy regimens.  It’s very clear that Rituxan added to chemotherapy is better than chemotherapy alone but which chemotherapy regimen is best to be combined with Rituxan, this question has not yet been addressed and therefore we initiated this study in Germany because we have a lot of experience with Bendamustine which was developed 50 years ago in Germany as a routine lymphoma treatment.  Therefore we randomised Bendamustine in combination with Rituxan, the so called BR schema against CHOP R.

What were the findings of this trial?

We found out surprisingly that was Bendamustine plus Rituxan better tolerated by the patients.   In particular it has less haemotoxicity, as a consequence of this, fewer infectious complications will be observed and also the very well-known organ toxicity from CHOP R, like cardiotoxicity and neurotoxicity is not seen with Bendamustine R.  In terms of efficacy we wanted to address the non-inferiority of Bendamustin R.  Everybody was surprised because it showed clear superiority over CHOP R.  Bendamustine R was better in respect to progression free survival.  So, we have a treatment approach which is better tolerated and at the same time has a higher activity and therefore we recommend in Germany that Bendamustine R is the standard first line treatment approach.

What is the situation regarding the registration of this combination?

Registration is of course a topic to which I don’t pay attention so much, yes, because in Germany it’s approved. It’s approved with a very wide range of diseases and disease stages.  It doesn’t matter about first line or second line so in Germany there’s no question about this and therefore it’s not in my focus.  I know of course what you want to say: it’s not approved for this disease situation in America; however, I just present the data because I’m a scientist and I recommend the use of Bendamustine Rituxan.

Is there a need for additional research to improve this regimen?

Yes, we know that all patients eventually will relapse with this disease.  You cannot cure this disease, therefore even when you have found an improvement with a new regimen you need to further improve it. So how to further improve Bendamustine plus Rituxan? I would say it’s not a good idea to increase the dose of Bendamustine.  I would say that to have a better efficacy maybe it is meaningful to add another new compound.  Of course, a new compound which does not have an overlapping toxicity for instance lenolidimide or Bortezomib.

Is the combination of Rituximab plus Bendamustine currently being used by practitioners?

In Germany it’s the most often used regimen,  in these patients with indolent lymphoma, follicular lymphoma and so on, They are most often treated in the private practice setting, not in hospitals.  You can give the treatment very easily in an outpatient setting.  I cannot give you this answer to the United States.   I know that it’s only approved here for Rituxan refractory patients, however I would say that also patients far beyond this treatment approach, I mean in first line or second line, are also already being treated with Bendamustine R.

What is the key message for patients to take from the outcome of this trial?

I have got a lot of positive feedback from my patients. Of course as you can imagine because patients are not losing their hair and even if you are not very vain, yes, you love to keep your hair, even if you are a man, yes.  Everybody, if he has a choice, would choose not to lose his hair so this is very, very important side effect for the patient, making the quality of life really very bad if the patient has total alopecia and this is not so important in our view as a clinician; we want to cure the patient, we want to treat him but if you have a treatment which is in the end at least better then of course it’s also a good thing if this treatment is associated with a better toxicity profile. This is the most important message in the patient groups in Germany which are communicating on the internet and they all say they prefer to go for Bendamustine R because it is not giving you a high risk for organ toxicity, no damage to the heart potentially, no neuropathy and in the end you have your hair, you can to go to your job, you don’t lose your job, you can go on vacation and so on also because Bendamustine R is less toxic to bone marrow so also the risk for infections during the treatment period is a little bit lower than compared to