The cetuximab saga.

Top Line(s): The decade-long obsession with cetuximab by head and neck (H&N) cancer clinical trialists is puzzling. While the treatment of lung cancer has undergone a molecular renaissance during the same time, H&N cancer trials have essentially tried every possible iteration of cetuximab, chemotherapy, and altered fractionation to no real avail. In 2010, the negative results of RTOG 0129 were a footnote to the realization that patients with HPV-mediated oropharyngeal cancer had remarkably better survival than their HPV-negative counterparts. Granted (at least by some), this superior survival was in the setting of intensive cisplatin-based chemoradiation. A rationale for de-intensifying treatment for these cancers soon came onto the scene, apparently borne from the fact that they respond exceedingly well...to intensified treatment. So, with that reasoning in mind, let’s see how things panned out with De-ESCALaTE and RTOG 1016.
Bottom Line(s): We won't mince words. These are lackluster outcomes following the glimmer of hope offered by initial cetuximab results. But let’s not forget the persistent truth that patients with HPV-driven oropharyngeal cancers do extremely well with our tried and true radiation with concurrent cisplatin. More globally, this should serve as yet another cautionary tale of de-escalating treatment without the due diligence of appropriate phase 3 trials. To end on a positive note, we salute the patients who volunteered for these studies and the investigators who dedicated years to their design, enrollment, and analyses. | Mehanna & Gillison, Lancet 2018

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