Made to measure: Choosing the optimal regimen in transplant-eligible NDMM
Dr Andreas du Bois talks to ecancer at ASCO 2013 about the phase III clinical trial in women with advanced ovarian cancer that found treatment with the oral targeted drug pazopanib following initial successful chemotherapy extended disease-free survival by an average of 5.6 months, compared to placebo.
Pazopanib is an oral drug that blocks several targets involved in the growth of tumors and their blood vessels (angiogenesis). In the study, 940 patients with stage III/IV ovarian, fallopian tube, and primary peritoneal cancer were randomly assigned to receive pazopanib or placebo daily for 24 months.
All patients had prior surgery and five or more rounds of chemotherapy that successfully prevented the disease from worsening. Patients were followed for 24 months, on average. The median time to disease worsening (progression-free survival) in the pazopanib and placebo group was 17.9 and 12.3 months, respectively.
ecancer's filming at ASCO has been kindly supported by Amgen through the ECMS Foundation. ecancer is editorially independent and there is no influence over content.
ASCO 2013
Delayed relapse of advanced ovarian cancer when treating with pazopanib
Dr Andreas du Bois - Kliniken Essen Mitte, Essen, Germany
What led up to this data?
Ovarian cancer is still that cancer with the highest mortality rate among gynaecological cancers. Here in the US about 14,000 women die each year of that disease so there is an unmet need to help, to better treat these patients. In the past decades we have succeeded to improve first line treatment with surgery and chemotherapy and nowadays about 80% of patients are free of tumour after their primary therapy. That sounds good but, again, 70-80% of these patients recur so relapse is the major problem. So we have to invent therapies that maintain this success so that was the reason for doing a maintenance trial to evaluate therapies which could maintain this success.
What have been the results?
Yes, the results of our trial was that pazopanib gained an almost six months benefit of progression free survival so it delays recurrence, it delays need of secondary chemotherapies and it prolongs the time where the patient gets control over disease instead of disease getting control over the patient.
What are the survival rates?
We have no meaningful analysis of overall survival currently. We have an observation period of two years and fortunately only 20% of patients have died. So at the moment there is no direction in either way for this drug. But we hope that we can translate that.
What can we anticipate?
Currently at 24 months where we have reliable data there is no coming together of the curves. So we hope that there will be translation into overall survival but we cannot say that at the moment.
What about toxicity?
The toxicity we observed in this trial is class specific. It’s a typical toxicity we know from this drug which is already registered in renal cancer and in sarcoma. So it’s hypertension mainly, some diarrhoea, some neutropenia.
What are your overall conclusions?
Our overall conclusion is that we have another trial which supports that anti-VEGF treatment directed against angiogenesis is very effective in ovarian cancer. We have now a drug available which can be used orally during maintenance and which offers a significant benefit for the patients and it works even in patients where there is no residual tumour. So just prolonging recurrence, this is a significant and valuable gain for the patients.
Can this impact practice now?
Yes, I would say so. This study helps to register the drugs and hopefully the registrational agencies will register and label that drug and then I’m sure it will be used in daily practice.
What advice do you have for doctors?
They should closely follow up the process so the filing is done currently. So maybe in six months we’ll have more information whether this drug is registered for ovarian cancer and then this should be discussed with the patients.
Made to measure: Choosing the optimal regimen in transplant-eligible NDMM
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