Nick Mulcahy

March 16, 2015

HOLLYWOOD, Florida ― Now in their 20th year, the National Comprehensive Cancer Network (NCCN) guidelines have greatly evolved from early efforts and continue to add new wrinkles, according to participants in a roundtable discussion at the group's annual meeting here.

But the guides are not solely evidence-based and, as a result, are subject to the biases of the authors, which can result in a variety of negative consequences, including questionable advice and excessive care, said critics at the meeting.

Among all parties, there was no dispute that the guidelines are the signature product of the NCCN.

The guidelines are the "heart and soul" of the organization, said F. Marc Stewart, MD, a medical oncologist at the Fred Hutchison Cancer Research Center, in Seattle, Washington, who moderated the roundtable.

Various clinicians described how they use the guidelines in the clinic, for issues both commonplace and rare.

In day-to-day practice, I use them as a reference. Pamela McLean

"In day-to-day practice, I use them as a reference to help guide treatment decision-making," said Pamela McLean, a nurse practitioner medical oncologist at Baystate Medical Center, Springfield, Massachusetts, who was in the audience at the roundtable and spoke with Medscape Medical News.

"We frequently carry a printout of the [guideline] page into the exam room [to share with patients]," said James Mohler, MD, a urologist at Roswell Park Cancer Center, in Buffalo, New York, during the meeting. He chairs the NCCN prostate cancer screening panel.

The guidelines are "very helpful" for management of a range of rare tumor types, said roundtable participant Jennifer Malin, MD, of the insurer Wellpoint/Anthem and a practicing oncologist in Los Angeles. They also help facilitate uniformity of treatment so that patients in any locale can be assured of quality care, she said.

But not all of the talk was praise.

The NCCN guidelines are "probably" a case of being a "mirror on the wall," whereby the recommendations reflect the practice of oncology at the group's 26 member institutions as opposed to being strictly a product of evidence that then informs community practice, said Peter Bach, MD, a pulmonologist at Memorial Sloan Kettering Cancer Center (MSKCC), in New York City, during another meeting session.

Some of the NCCN guidance is out of date or out of step, he also said.

Avastin is still listed for breast cancer in the NCCN guidelines. Dr Peter Bach

For instance, Dr Bach pointed out that "Avastin [bevacizumab, Genentech Inc] is still listed for breast cancer in the NCCN guidelines," which he described as "archaic," referring to the opinions of colleagues. This was presumably a reference to the FDA approval of bevacizumab having been rescinded after it failed to demonstrate improved survival in breast cancer.

Dr Bach also criticized the NCCN guidelines for CT screening for lung cancer, which recommend screening people who have a 20-pack-year or more history of smoking beginning at the age of 50.

"No other evidence-based guideline agrees with that, and actually no NCCN institution follows that," asserted Dr Bach.

He was referring to the fact that a host of organizations, including the American Cancer Society, support screening but for older people (starting at age 55) and for those with a longer history of smoking (at least a 30-pack-year history). These other recommendations are consistent with patient population in the landmark National Lung Screening Trial.

No other evidence-based guideline agrees with that. Dr Peter Bach

The guidelines are heavily reliant on second-tier evidence, NCCN officials admitted.

Only 8% of the guidance was "category 1" in an independent analysis of 10 NCCN guidelines conducted a few years ago, said Joan McClure, who manages guideline development for the NCCN. Randomized controlled trials and meta-analyses are most desirable but are in short supply, she also said.

High-level data are missing at many points in cancer care, said Andrew Zelenetz, MD, a hematologic oncologist at MSKCC. It is a "disservice" to patients to ignore expert opinion in the absence of evidence, he also asserted.

The NCCN guidelines are exclusively written by oncology specialists, said McClure.

That falls short of the Institute of Medicine's (IOM's) principles for creating guideines, she said.

"The IOM does not recommend the use of experts to develop clinical practice guidelines," she acknowledged. But cancer is so "specialized" that "experts are essential," added McClure.

Ideally, generalists should participate in specialty guidelines to "challenge" the inherent biases in any one field, said Dr Malin.

In the absence of such questioning, excessive care can result, she suggested.

For example, the NCCN's lymphoma guidelines have recently seen a "dramatic scaling back of how much imaging should be done," Dr Malin observed. But, for years, frequent imaging was the "standard of care not because of evidence but because that is what was always done," she said.

These are not just academic matters, suggested Dr Malin. Excessive care affects the cost of care, which in turn affects the cost of insurance premiums among the general population, she said.

Currently, the NCCN guidelines do not address the issue of treatment prices.

However, in the future, the NCCN will introduce the concept of "affordability" in the guidelines.

Different prices of different treatments will not be listed. Instead, there will be an "evidence block," a graphic in which shaded boxes (not specific numbers) indicate which treatment is relatively more affordable, as well as more effective and more tolerable, among other things. The evidence blocks will start in systemic therapy sections of guides, said McClure.

"Our goal in doing this was not to have drug companies cut their cost," she added.

"Guidelines are not designed for cost reduction but for quality care," said David Ettinger, MD, medical oncologist at Johns Hopkins University, Baltimore, Maryland, who is the long-time chair of the NCCN panel on NSCLC.

The guidance keeps getting more detailed and comprehensive, he added.

An early version of the NSCLC guide had about 30 references; the current iteration of the guide has more than 700, he said.

Forty different medical specialties now contribute to guideline panels, up from the four or five specialities in the early years, said McClure.

The NCCN has also done excellent recent work in developing survivorship guidance, said McLean. "They are really taking the lead."

Dr Ettinger has financial ties to ten pharmaceutical companies. Dr Malin is an employee of Wellpoint/Anthem. Dr Zelenetz has ties with 18 pharmaceutical and diagnostics companies. Joan McClure is an employee of NCCN. Dr Bach has ties to Genentech. Dr Mohler has financial ties with Androbiosys, Inc. Pamela McClean has disclosed no relevant financial relationships.

National Comprehensive Cancer Network (NCCN) 20th Annual Conference. Presented March 14, 2015.


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