The Olympiad Trial: Who Won The Gold?
OlympiAD was a phase 3 randomized controlled trial of a PARP inhibitor olaparib for metastatic HER2 negative breast cancer patients harboring a BRCA mutation. Although the OlympiAD trial met its primary endpoint, there are concerns regarding whether olaparib truly improves meaningful outcomes for these patients. In this editorial, I examine these issues in detail.
An exploration of these issues will provide important educational insights for oncologists and cancer policy makers. I conclude that although olaparib seems to have won the Gold with OlympiAD, the patients probably have not. We need to stop celebrating a gold-plated bronze as a true gold so that one day our patients can finally get the gold they deserve.
[D]espite all these caveats, olaparib failed to improve survival.
For a 2.8 months benefit in PFS without benefit in OS observed in an unblind trial against a weak comparator, are we ready as a society to pay $100,000 per patient? Indeed, it is difficult to define value for cancer drugs; but if $100,000 can be charged without improving survival, would there be any incentives to work harder to improve real significant outcomes for our patients?
Finally, the Trial Oversight section of the article reads “Astrazeneca was responsible for overseeing the collection, analysis, and interpretation of the data….The manuscript was written with medical-writing support, which was funded by Astrazeneca, with critical review and input from authors”.
There is no debate as to the importance of collaboration between the industry and clinicians to conduct trials but shouldn’t we draw a line somewhere in this relationship so as to allow the public to trust the data presented?
In my opinion, at the very least, the “interpretation” and “writing of manuscript” part of any trial should be exclusively the responsibility of clinicians involved in the trials, and not the sponsor.
Gyawali B. The OlympiAD trial: who won the gold? ecancer. Editorials
OlympiAD was a phase 3 randomized controlled trial of a PARP inhibitor olaparib for metastatic HER2 negative breast cancer patients harboring a BRCA mutation. Although the OlympiAD trial met its primary endpoint, there are concerns regarding whether olaparib truly improves meaningful outcomes for these patients. In this editorial, I examine these issues in detail.
An exploration of these issues will provide important educational insights for oncologists and cancer policy makers. I conclude that although olaparib seems to have won the Gold with OlympiAD, the patients probably have not. We need to stop celebrating a gold-plated bronze as a true gold so that one day our patients can finally get the gold they deserve.
[D]espite all these caveats, olaparib failed to improve survival.
For a 2.8 months benefit in PFS without benefit in OS observed in an unblind trial against a weak comparator, are we ready as a society to pay $100,000 per patient? Indeed, it is difficult to define value for cancer drugs; but if $100,000 can be charged without improving survival, would there be any incentives to work harder to improve real significant outcomes for our patients?
Finally, the Trial Oversight section of the article reads “Astrazeneca was responsible for overseeing the collection, analysis, and interpretation of the data….The manuscript was written with medical-writing support, which was funded by Astrazeneca, with critical review and input from authors”.
There is no debate as to the importance of collaboration between the industry and clinicians to conduct trials but shouldn’t we draw a line somewhere in this relationship so as to allow the public to trust the data presented?
In my opinion, at the very least, the “interpretation” and “writing of manuscript” part of any trial should be exclusively the responsibility of clinicians involved in the trials, and not the sponsor.
Gyawali B. The OlympiAD trial: who won the gold? ecancer. Editorials
