PFS has been controversial for decades in Oncology trials. But, it was the only way to keep trials from gong on for years and have an alternative marker for survival. As everything in science there was intellectual controversy over PFS. There is no control arm in our trial, that ship has sailed. And pseudoprogression is the issue only with DCVax, not in SOC, trust me on this. Radiologists who read for clinical trials are experienced in what pseudoprogression looks like from radiotherapy. They were not for a DC vaccine. It was unexpected. This changed everything and was a side effect of being a translational technology; every other ongoing vaccine trial just gave up, because they were being run by traditional biotech CEOs who had no interest in working their asses off for something that might actually be real. They were hired guns who’d abandon something the moment the risk/benefit for them personally didn’t fit what an MBA told them they should do.
The blended/blinded data told the story. Clinicians familiar with DCVax know what’s up; there are thousands of us. You don’t need to look anywhere beyond everything that’s public to see this, but it makes a difference that those of us in the business of medicine discuss this amongst ourselves and reaffirm our perspectives based on this evidence.
This is why I believe the Journal will not be the NEJM; I believe it’s Annals of Oncololgy. It makes the most sense because it’s influential and trending in that arena because it’s not only the Journal of the Society of European Oncologist and the Japanese Society of Oncologists but also a Journal that is openly “translational” in it’s editorial perspective. They’ve increased their impact factor in the past year because of their focus on Immune therapies in Oncology. Here’s their “scope” from their website:
Annals of Oncology, the journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, provides rapid and efficient peer-review publications on innovative cancer treatments or translational work related to oncology and precision medicine. Main focuses of interest include: systemic anticancer therapy (with specific interest on molecular targeted agents and new immune therapies), randomized trials (including negatives ones), top-level guidelines, and new fields currently emerging as key components of personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Radiotherapy, surgery and pediatrics manuscripts can be considered if they display a clear interaction with one of the fields above or are paradigm-shifting.
