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July 24, 2020
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Screwing up cancer care

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These are times when, under assault from the COVID-19 pandemic and many parts of government, those of us who are relatively powerless can seek to regain control by influencing what we can influence.

It is so frustrating to see national health care decisions made by men who oppose science and data. However, we certainly can still impact the quality of medical care itself, so I have decided to focus on that today.

Before continuing, I want to thank the governor of North Carolina, Roy Cooper, who has taken some real hits from the less-enlightened domains but has worked to keep our population as safe as possible during this pandemic, standing shoulder to shoulder with courageous regional leaders on issues of masking and social distancing.

Regional treatment centers

Returning to medical quality, I rarely like the new vogue of retrospective “big, real-world” data analyses, because they often ignore huge case selection biases and pose questions that simply cannot be answered accurately by the data sets employed.

Derek Raghavan, MD, PhD, FACP, FRACP, FASCO
Derek Raghavan

That said, there are two important studies that recently used big data sets effectively and contextualized them appropriately.

I was struck by “Severe de Vere’s” paper in Journal of Clinical Oncology on how the treatment of invasive bladder cancer is screwed up and how to fix the problem. I can use that nickname as we have been pals for decades, and it is what Crusty — or E. David — Crawford and I have always called him, dating to the SWOG Genitourinary Committee days.

Emeritus professor Ralph de Vere White, MD, and colleagues addressed the lack of progress in outcomes of treatment for muscle-invasive bladder cancer, despite the improvements in proffered treatments, such as neoadjuvant chemotherapy and radical cystectomy (see related article).

In an article endorsed by the Society of Urologic Oncology, the authors postulated that the key problem is that optimal treatment is not made available by the gatekeepers who control the cases. They noted that a substantial proportion of patients with muscle-invasive bladder cancer are followed by some variant of surveillance rather than receiving treatment with curative intent, based on two studies comprising more than 30,000 patients.

In fact, in my own academic work, I have complained about the number of urologists who fail to offer neoadjuvant chemotherapy — which is well-supported by level-one data — citing insufficient robustness of the patient, while feeling comfortable to complete a radical cystectomy.

De Vere White and colleagues proposed a solution that includes improved education of clinicians about the benefits of aggressive and optimal treatment of bladder cancer, combined with the creation of regional Centers of Excellence. These centers would eliminate the need for long-distance travel and all the associated problems of chemotherapy and surgery at distant sites while providing optimal protocolized care for this complex issue.

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I like his thinking and believe this strategy works — that has been the basis of our creation of Levine Cancer Institute, with more than 25 sites in North Carolina and South Carolina that offer clinical early-phase and randomized cancer trials, participation in translational research and all the resources of a comprehensive cancer center. We have already begun to see improved outcomes less than 10 years after the creation of this entity.

This strategy works well for delivery of chemotherapy and radiotherapy, via the use of standardized protocols, electronically accessible pathways and virtual tumor boards, but is not a simple solution for surgery. In the most complex tumor types — and invasive bladder cancer is an exemplar of those — experience and annual case volume are directly correlated with outcome, and the concept of multiple regional centers of surgical excellence is inconsistent with the evolution of that expertise among individual surgeons.

A reasonable compromise is to ensure that, for complex cancer surgery, surgical oncologists at Centers of Excellence that accrue high volumes are functionally linked to cancer treatment outposts within the local geography, allowing easy referral but with local connections and follow-up.

Although our model provides care to all-comers, irrespective of fiscal status — which may explain part of our improvement in cancer outcomes — de Vere White and colleagues’ analysis did not really address that key aspect of the problem — that is, there are extensive data to show that minority populations and those who are fiscally challenged routinely get less aggressive cancer care than those with good health insurance and financial support, particularly in the domain of cancer surgery.

This is a pattern seen at both major academic Centers of Excellence and community hospitals and will need to be overcome if we truly wish to improve outcomes.

Current federal leadership in health care policy is committed to the end of the Affordable Care Act, thus not helping the problem. But, it also is fair to say that the ACA has not been a universal solution to the plight of the impoverished and geographically isolated patients with cancer.

Treatment delays

Hang on a moment. There’s more to this story.

The aforementioned Crusty (aka Professor E. David Crawford, MD) has published on another aspect of this important topic under the careful tutelage of Professor Maha Hussain, MD, FACP, FASCO. In a recent edition of Journal of Urology, Crawford and colleagues described another critically important impediment to high-quality care — the denizens within parts of the health insurance industry.

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A detailed analysis of 22,860 patients treated with luteinizing hormone-releasing hormone (LHRH) agonists showed that a substantial number were late for treatment. These agents, which provide a time-release depot of drug, must be used on time; they are structured to give a short window to allow patients to be covered therapeutically for a couple of days beyond a 28-day cycle (some preparations extend for a 3- or 6-month delivery).

However, as reported by Crawford and colleagues, many health insurance companies have set standard operating procedures that do not allow reordering of the medications in a timely fashion, thus interfering with on-time delivery.

Of real concern, they found that measurements of circulating testosterone below the level of 20 ng/mL were not reached in a quarter to one-third of patients, depending on the time of measurement vs. due-date of treatment. This happened much less frequently with on-time treatment.

In other words, delays of treatment delivery are allowing the key stimulus to prostate cancer growth to recur more often than for on-time treatment, and other studies have shown that unsuppressed testosterone is associated with relapse and death.

The problem is much more widespread, and all of us involved in treatment of cancer are only too familiar with the delays created by payers — excessive documentation requirements, small-print rules that delay pre-approvals and approvals, requirements to secure approvals from family practitioners who have become the insurance gatekeepers, and obstructions to complaints and/or litigation.

Here, the solution is for the federal government to stop pandering to lobbyists and to act on behalf of the population who purportedly elect them based on promises of protection, support and good governance.

Whatever the problem, this is a time when physicians need to stand up for principle, leverage their strong community reputations, and do the right thing.

References:

Crawford ED, et al. J Urol. 2020;doi:10.1097/JU.0000000000000577.

De Vere White R, et al. J Clin Oncol. 2020;doi:10.1200/JCO.19.01731.

Join the conversation:

Share your thoughts on this editorial at healio.com/authors/draghavan.

For more information:

Derek Raghavan, MD, PhD, FACP, FRACP, FASCO, is HemOnc Today’s Chief Medical Editor for Oncology. He also is president of Levine Cancer Institute at Atrium Health. He can be reached at derek.raghavan@atriumhealth.org.