The FDA approval of adjuvant Keytruda is a significant advancement in the treatment of renal cell carcinoma. Immune based adjuvant therapy provides an exciting new option for a patient population in desperate need of improved outcomes.
Over the past four years, KCCure has strived to be a voice for patients diagnosed with localized disease. Our surveys uncovered profoundly high levels of fear of cancer recurrence (FCR) in this patient population. Additional data revealed that high anxiety levels were independent of stage (and risk). We presented data at multiple medical conferences showing that patients want adjuvant therapy and that they are willing to use it regardless of overall survival benefit or toxicity levels.
We can celebrate the achievement that this approval represents – while still acknowledging a most profound gap in research and care. The disproportionate focus on adjuvant drug development combined with a woefully insufficient and underfunded focus on identifying which patients need adjuvant therapy, leaves us unable to determine who will derive benefit from adjuvant therapy – and conversely who will be subjected to needless over-treatment.
This is a patient population that struggles significantly from uncertainty and the threat of recurrent cancer. As a result, they are likely to overestimate benefit and underestimate risk of treatment. To them, any option represents hope. This latest approval will no doubt be met with enthusiasm in patient communities. And our organization will be inundated with requests from patients asking how they can get access to therapy (despite being years post-surgical removal).
But let’s all be clear – despite this approval – we are still no closer to answering the question that these patients have been asking all along: Will I recur?
And that is an answer that they deserve.