The National Comprehensive Cancer Network (NCCN) is under fire for removing active surveillance's (AS) "preferred" status in its low-risk prostate cancer .
AS has been listed as preferred since 2019, and the change puts it on par with radical prostatectomy and radiation therapy in this patient population.
Edward "Ted" Schaeffer, MD, PhD, chairman of the NCCN prostate cancer guidelines panel, defended the change as a "minor adjustment" that will serve patients by encouraging more discussion of options for low-risk patients.
"My personal feeling is that there is more nuance as the risk groups increase," said Schaeffer, of Northwestern University's Feinberg School of Medicine in Chicago. "Each individual case should be more strongly reviewed and discussed with patients, and patients should be involved in the shared decision-making process. I don't feel there is any change in the guidelines. Active surveillance is still listed first, and it's still listed as an option."
He stressed that the guidelines, dated September 10, still hold that AS is "preferred" for very-low risk prostate cancer.
Matthew Cooperberg, MD, a urology professor at the University of California San Francisco (UCSF), sees the change as "a step backward" in the quarter century campaign to reduce overdiagnosis and overtreatment of low-risk prostate cancer.
"I believe we should be carefully expanding the pool for active surveillance, not narrowing it," said Stacy Loeb, MD, a professor of urology at New York University and the Manhattan Veterans Affairs Medical Center.
"Uptake of active surveillance is lagging and heterogeneous in the United States," she said. "It is well-established that active surveillance is safe for men with low-risk prostate cancer, and offers important benefits in reducing overtreatment and preserving quality of life."
While the NCCN guideline "doesn't carry the weight of law," said Cooperberg, "it is very easy for a clinician to point at this and say: 'Look, NCCN says it is no less appropriate to do surgery or radiation than it is to do active surveillance for low-risk disease.'"
Patient groups were divided about the potential impact on their constituents.
AS patient Mark Lichty, chair of patient group Active Surveillance Patients International, said the reduced status for AS could discourage some men from going on AS. "We have seen great progress in countering the overtreatment of low-risk [prostate cancer], and we hope this guideline change will not slow that trend," he said.
Advanced prostate cancer patient Tom Farrington, a consumer member of the NCCN panel and founder of the Prostate Health Education Network, said the change is especially important for Black men, who have not fared as well as white men on AS. He said the change will result in more discussion of options for low-risk patients.
Cooperberg, however, countered that "the question of AS outcomes being different for African American men is definitely not settled -- many believe there's actually no difference once you adjust for clinical factors."
According to the NCCN guidelines, which are highly influential in decisions by practitioners, health insurers, and Medicare:
A patient meets criteria for low-risk disease if all of the following are met: a clinical T stage no higher than cT2a (involves half of one side or less), tumor Grade Group 1 (Gleason ≤6), and a prostate-specific antigen (PSA) level below 10 ng/mL.
Very-low-risk criteria are more stringent. While grade group and PSA are the same, the tumor must be cT1c (tumor identified by needle biopsy found in one or both sides, but not palpable). In addition, fewer than three prostate biopsy fragments or cores can be positive, with ≤50% cancer in each fragment/core, and PSA density must be below 0.15 ng/mL/g.
Brian Helfand, MD, PhD, chief of the Division of Urology at NorthShore University HealthSystem outside Chicago, said in practical terms the distinction between low-risk and very-low-risk disease is not significant.
"I am surprised that the guidelines would distinguish between preferred management strategies," said Helfand. "I believe based upon the low risk of disease progression, that regardless of prostate cancer core involvement, that all Grade Group 1 tumors (regardless of classification of very-low or low) should be offered active surveillance as the primary management strategy."
The panel held no formal vote. Schaeffer took the temperature on a phone call for consensus in favor of the change with only two panelists objecting. (Formal votes at NCCN are only required for legal reasons when recommending medications.)
While the change was published on September 10, it went unnoticed until September 28.
That's when eagle-eyed Daniel Lin, MD, chief of Urologic Oncology at the University of Washington in Seattle, spotted the change, and Cooperberg for fellow urology leaders on Twitter.
The reaction was intense and immediate, with the charge led by Cooperberg at UCSF, one of the centers that 25 years ago helped develop AS -- a strategy of closely monitoring low-risk disease that is now accepted by 55% of U.S. patients who qualify for the approach.
Several urologists charged the NCCN with making decisions behind closed doors.
"It's a democratic process. There is no secret agenda," Schaeffer said. He added that panelists take proposed changes back to their centers and elicit comment. Only two panelists objected to the change in preferred status.
One was Todd Morgan, MD, chief of Urologic Oncology at Michigan Medicine in Ann Arbor. "NCCN could absolutely be more transparent -- no reason not to be," he said. "I would say that the vast, vast majority of this guideline is outstanding and evidence-based. This one mistake takes away from what really is a state-of-the-art guideline."
Cooperberg ran an online survey of 341 of his Twitter followers, asking if NCCN should restore "preferred" for men with low-risk disease: 86.2% said yes, 4.4% said no, and 9.4% said the topic needs more debate.
Laurence Klotz, MD, the "father of AS" at University of Toronto, said, "You have to recognize the strengths and limitations of NCCN. NCCN is basically a consensus of expert opinion. People call it 'eminence-based opinion.' The gray-haired eminences. It's not the final word on the topic. It may reflect the opinion of some experts who aren't sold on the idea of surveilling, wrongly."
Schaeffer was blindsided by the backlash. He had hoped the group of experts from major cancer centers might get kudos for the first U.S. guidelines for PET-based imaging and for inclusion of the first oral testosterone-blocking agent, relugolix (Orgovyx), for advanced disease.
The guidelines are not a rule book and are fluid over time, he said, "the pendulum swings."
Howard Wolinsky is a Chicago-based medical freelancer who has written this blog about his cancer journey for 乌鸦传媒 since 2016. He is the author of the just-released book,