During a session at the 2019 Genitourinary Cancers Symposium (GUCS) held recently in San Francisco, researchers presented findings from phase 3 studies showing that immunotherapy-based combination regimens are superior to sunitinib alone at improving progression-free survival among patients with previously untreated advanced kidney cancer.
One study demonstrated improved overall survival. The study presenters concluded that their findings support the combination regimens as a new standard of care.
Perhaps, but when does a new treatment actually become a standard of care? Is this a matter of how widely accepted and routinely used it is? The precise point at which a new medicine becomes a standard of care is difficult, if not impossible, to identify, unless the date on which a medical society announces its endorsement of the therapy, or releases guidelines recommending it, indicates an “official” acceptance of the therapy as a standard of care. In medical malpractice suits, standard of care is established on a case-by-case basis according to how a physician defendant’s peers in a particular community manage medical cases similar to the one being litigated.
Whatever milestone marks the ascendancy of a treatment to standard-of-care status, years may pass before it is reached even after pivotal clinical trials show the superiority of a new therapeutic approach. Physicians must be convinced that it really is better than the treatments they have been using. They may wait until trial data are published in a peer-reviewed journal so they can read more detailed information than typically is provided in a brief presentation at a medical conference. Even after a new treatment wins FDA approval, physicians may have lingering concerns about adverse effects, contraindications, patient comorbidities and therapeutic adherence, and whether patients’ insurance will cover it.
Regardless of how a new treatment evolves into a new standard of care, the process must start somewhere. Investigators presenting research findings before their peers, as in the aforementioned GUCS session, is an important beginning. Many of these peers are opinion leaders at the institutions with which they are affiliated, and, in some cases, in the international medical community as well. It is not inconceivable that some of those opinion leaders sitting in the session returned home believing in the promise of the new approach to managing untreated advanced kidney cancer. They may share their thoughts and enthusiasm with colleagues over coffee in the cafeteria, in casual chats in a hallway, during in-house meetings and lectures, or at a gathering of their local medical society. And a new treatment could well be on its way to becoming a new standard of care.