35th ESMO Congress, 8–12 October 2010, Milan

Professor Fausto Roila (Terni Hospital, Italy)

A new treatment for fractured vertebrae and the antiemetic efficacy of palonosetron

Can you tell us a bit about what you are presenting here at ESMO? I know you are moderating two sessions so maybe you can tell us a bit about these sessions?

Yes. Yesterday I was the chair of a poster session and I discussed two abstracts presented at this meeting, one concerning the treatment of painful vertebral fractures with the introduction of a new procedure, a minimally invasive procedure, named balloon kyphoplasty. That means to reduce the pain, to reduce the disability of the patients and improve the quality of life a small orthopaedic balloon is inserted in a vertebra, the fractured vertebra, then is inflated so that it can restore the shape and strength of the vertebra. Then the balloon is removed and bone cement is injected in the vertebra, this permits stabilisation of the vertebra and therefore reduces the symptoms of this terrible phenomenon. This study compared balloon kyphoplasty with a non-invasive procedure, for example treating these symptoms with drugs, and the study demonstrated that balloon kyphoplasty is superior with respect to non-surgical procedures. Unfortunately, one year ago two studies have been published showing that vertebral plasty is similar to kyphoplasty except they do not insert the balloon in the vertebra, but in any case inject cement in the vertebra, did not demonstrate any advantage with respect to a sham procedure. A sham procedure means that neither the investigators except those involved in the procedure nor the patients and the outcome assessor were aware of the assigned treatment. In these two studies there was no difference of results. Permit us to think it possible that the placebo effect can be considered in this procedure, in evaluating the results. The conclusion is that more studies, especially double blind studies, are necessary to identify the real role of balloon kyphoplasty in clinical practice.

Thank you. And what concerns and studies are interesting in antiemetic therapies? Can you tell us a bit more about that too?

Yes. Yesterday a study on antiemetic use of palonosetron with respect to granisetron , two different 5-HT3 receptor antagonists, one with a longer half-life, about 40 hours, the other with a shorter half-life. Both were combined with dexamethasone and were tested against emesis induced by cisplatin or cancer combination such as AC/EC used in breast cancer patients. In this study the principal objective was to evaluate the impact of the two antiemetic treatments in the control of nausea.

The study showed that while in the first 24 hours after cancer drug administration the complete protection from nausea was similar in the two groups of patients, in the delayed emesis, from day 2 to day 5, the complete protection from nausea was superior with palonosetron. Interestingly it seems that the better efficacy of palonosetron was superior in particular subgroups of patients – patients receiving cisplatin, patients that were younger and female patients. Those are the most favourable prognostic factors for the phenomenon of nausea and vomiting.

Of course more studies are necessary to identify better treatment for the control of nausea because all antiemetics have less efficacy against nausea with respect to vomiting. There are not clear neurotransmitter receptors identified for nausea and for vomiting . And therefore I have some suggestions that some drugs, for example cannabinoids, for example ginger, can have an efficacy against nausea but they should require more studies.

Thank you. Can I ask you a last question regarding your suggestions that you just mentioned about the cannabinoids as the kind of drugs that can help the vomiting and nausea? What is the state of the use of cannabinoids in Italy?

In Italy cannabinoids are not permitted by law. In other countries they can be used for the control of cancer pain and the control of nausea vomiting. But if you look at the data related to cannabinoids, you can see that in the prevention of chemotherapy induced emesis we have a lot of drugs more effective than cannabinoids, therefore their role is minimal. And in the control of cancer pain, there is efficacy less than morphine, less than an opioid, a strong opioid. Therefore, the role of cannabinoids is a small role in the therapeutic armament for cancer pain and chemotherapy induced nausea.

Thank you again for joining us today.