After protest by urologists and patient advocates, the prostate cancer panel of the National Comprehensive Cancer Network (NCCN) reversed itself on Tuesday, with restoring active surveillance (AS) as a preferred approach for "most" men with low-risk prostate cancer.
In September, the NCCN panel had published guidelines that eliminated the word "preferred" for AS in the low-risk group, putting it on par with radical prostatectomy and radiotherapy. All three approaches offer similar life expectancy, but AS eliminates quality-of-life issues experienced with the other approaches, such as incontinence and impotence.
"Writing NCCN guidelines is an iterative process," panel chair Edward Schaeffer, MD, PhD, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago, said in an interview. "I am glad to have shepherded these new guidelines through. This has been an absolutely positive experience."
The one-word change in September unleashed a twitter-storm among urologists who felt the action was unwarranted after 25 years of research establishing AS as a preferred treatment.
Matthew Cooperberg, MD, of the University of California San Francisco, who led the twitter-storm, called the September change a "step in the wrong direction," but praised the latest revision by the NCCN, the leading group for guidelines for prostate cancer.
"This is a change very much in the right direction," he said. "Active surveillance really should be the default plan for a man with low-grade prostate cancer, regardless of tumor volume, and the 'preferred' designation more or less reflects that assumption."
"There are certainly scenarios which may justify immediate treatment but none is particularly common," said Cooperberg. "As a specialty, we need to recall that overtreatment of low-risk disease was a major cause of the 'D' recommendation from the [U.S. Preventive Services Task Force] against all screening, and improved rates of surveillance were an explicit driver of the revision in favor of shared decision-making. Gleason grade group 1 tumors, regardless of volume, are very rarely lethal, with or without treatment."
Schaeffer said the new guidelines also stress the heterogeneity of low-risk prostate cancer, where three or more positive cores are diagnosed. "Many guidelines only study very low-risk patients. We have added a lot of nuance," he said.
The panel acknowledges there is "heterogeneity across the low-risk group, and that some factors may be associated with an increased probability of near-term grade reclassification, including high PSA density, a high number of positive cores (e.g., ≥3), high genomic risk (from tissue-based molecular tumor analysis), and/or a known BRCA2 germline mutation."
Both iterations of the guideline continued to support AS as the preferred option for men with very low-risk prostate cancer.
In September, Schaeffer defended the panel's actions and deflected critics who described the process of writing the guideline as not transparent. He noted that representatives of only two of 31 comprehensive centers had opposed the demotion of AS for the low-risk group.
Schaeffer, chair of the Department of Urology at Feinberg School of Medicine, took to heart the critics. But he resisted simply restoring the word preferred and instead had his panel revise the guideline for AS. NCCN is known for revising its guidelines at least once per year.
"The panel extensively revised the Principles of Active Surveillance and Observation to provide detailed guidance on important aspects of this disease state and, additionally, tabulated large active surveillance datasets as a reference," he said.
Schaeffer added that the panel strongly believes that shared decision-making, after appropriate counseling, is foundational in the development of treatment strategies for patients with localized prostate cancer.
Todd Morgan, MD, chief of Urologic Oncology at Michigan Medicine in Ann Arbor, was one of only two NCCN panelists who opposed the guideline change.
"It is important that this issue was put under the microscope a bit, through the media, patient advocacy groups, and on social media," he said. (Patient advocacy groups -- including ZERO/Us Too International, AnCan, and Active Surveillance Patients International -- had also protested the September change.)
"There are still many questions surrounding active surveillance for low-risk prostate cancer that remain unanswered, and so there is no 'perfect' guideline," said Morgan. "But the NCCN process over the past month worked very well, with a great deal of attention and engagement by panel members to create consensus recommendations based on both current evidence and expert opinion."
He added: "These guidelines will undoubtedly continue to evolve over time as we learn more about how to optimize active surveillance in men with favorable-risk prostate cancer, but the recent controversy and newly revised guideline will hopefully be another critical step towards reducing overtreatment in this patient population."
Howard Wolinsky, a Chicago-based medical writer, has written "A Patient's Journey" blog for 名媛直播 since 2016 about active surveillance for prostate cancer. He also has covered news in that field.