We performed a retrospective analysis of the use in real life of subcutaneous bortezomib. This was something particularly let’s say simple, but to my opinion interesting because we know that all the results coming from prospective randomized clinical trials of bortezomib in newly diagnosed transplant-eligible patients were coming from the intravenous use of bortezomib, because this was the initial label of this drug...
We performed a retrospective analysis of the use in real life of subcutaneous bortezomib. This was something particularly let’s say simple, but to my opinion interesting because we know that all the results coming from prospective randomized clinical trials of bortezomib in newly diagnosed transplant-eligible patients were coming from the intravenous use of bortezomib, because this was the initial label of this drug. But then with the publication of the use of subcu bortezomib in the relapse/refractory setting, all the people, all the physicians, are currently exclusively using subcutaneous bortezomib because of course it’s less time-consuming, it’s more feasible, it’s more practical for the patients and for the physician as well.
So, we didn’t have really an real life analysis of the outcome of those patients, so this is what we simply did, and what it came out would be somehow expected. So, the results in terms of efficacy are exactly the one that we can expect with the use of IV bortezomib. So, in the study, we compared of course not in a randomized fashion, but just comparing the results in terms of efficacy that came out to be reproducible of what the randomized clinical trials told us, with of course a lower cost in terms of toxicity, and I’m referring in particular of the neurotoxicity that was significantly lower, in particular for the grade 3 and 4.
So, as I said at the beginning, the use of bortezomib nowadays is exclusively subcutaneous. I think that these data are important because of course we do have many other newer drugs, second/third generation proteasome inhibitors, novel classes of agents. However, bortezomib still stay as a good partner for many newer drugs. So, we still have many ongoing prospective Phase III trials in the upfront setting, but also in the relapse/refractory setting, where the combination are based on bortezomib, and one of the standard of care is still bortezomib-len-dex upfront, as well as many monoclonal antibodies are combined with bortezomib.
So, to know that in real life the results are what I told you just a few minutes ago is good, because it means that you can routinely use this drug in the subcutaneous way, having the guarantee of the same efficacy results.