The Cancer Letter
Raja Flores says oncology is loose with staging jargon, and now “it’s confusing my patients.”
In last week’s issue of The Cancer Letter , Raja Flores wrote a guest editorial explaining how he, with his expertise in thoracic surgery, took issue with a nuance in a recent Keytruda commercial. In this week’s episode of In the Headlines, Flores spoke with Paul Goldberg, editor and publisher of The Cancer Letter , to explain how his deep dive into the issue led him to discover a broader issue in oncology: How loose terminology among oncologists, however innocuous or inconsequential it might seem, could lead to patient harm. “When you look at early stage lung cancer, and for this particular commercial, as a surgeon, I'm concerned that if all patients, not 3As or stage 2s, but if stage 1s get neoadjuvant therapy, they may miss their shot at being cured.” The commercial advertises the utility of preoperative Keytruda for people with “early stage” lung cancer. The commercial is supported by data from a clinical trial and an FDA approval, but the oncology community’s loose terminology when it comes to staging (at least in lung cancer), seems to have led to the commercial targeting all “early stage” patients, when the data supports preoperative Keytruda for patients with stage 2 and 3 disease, not stage 1. “That's the important point is that the commercial doesn't talk about what was in the supplemental forms of that paper that was published in The New England Journal of Medicine,” Flores said. “About one out of every five patients who underwent preoperative therapy, preoperative Keytruda, did not make it to surgery.” Flores researched the commercial’s history to understand how it got through the endless regulations that govern medical advertising. “I started doing my homework about this label of ‘early stage.’ And I tried to find out the first time it was used in the KEYNOTE-671 trial, the trial that the commercial is based on,” Flores said. “So, I went to clinicaltrials.org and I went to the first online publication of the trial and it said preoperative therapy for stage 2, stage 3A, and stage 3B. I said, ‘Okay, that doesn't say early stage.’ Then several months later, in an ASCO abstract, the same authors had down the same title, 2, 3A, 3B. But then, within the abstract, it mentioned for the first time, early stage lung cancer. “Then I said, ‘Huh, interesting.’ Then when you go to the publication in The New England Journal of Medicine , in the title, it doesn't say 2, 3A, 3B. It says early stage lung cancer. “Then I said, ‘How did this get passed by the FDA?’ Then I went to the FDA records and I looked in the FDA records and I could see that when this trial or when these drugs went up for their label, it didn't have a committee meeting. They felt that the data was compelling enough, and so it passed the FDA. “So, when you look at all the safeguards that we have in place: FDA, peer-reviewed process, The New England Journal of Medicine, clinical trials office, it completely missed this thing about early stage lung cancer.” This Keytruda commercial is only one iteration of a broader concern, Flores said. “I'm in the middle of continuing to investigate this,” Flores said. “And in the end, I'm kind of concerned that we've gotten so loose with our oncologic terminology because if you're speaking to another doctor and you say early stage, they're going to say, ‘Well, what specific stage are you talking about?’ “It's actually something that has penetrated the oncologic culture for the past several decades. And I think it's time to shine a light on it and shift how we talk about it because it's confusing, at least confusing my patients,” Flores said. This episode is sponsored by the American Society of Clinical Oncology. Learn more at asco.org/ascoaction . Stories mentioned in this podcast include: Marketing hope before surgery: Does the new Keytruda commercial tell patients the whole story? A transcript of this podcast is available: https://cancerletter.com/podcastc/20260819-flores/
