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Guidelines vs. Rules:


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Guidelines vs. Rules: Deviating from the Standard of Care When Strong Principles Lead You There

January 21st, 2014 - by Dr. Jack West

This week I found myself recommending surgery for a patient who had already undergone chemo and chest radiation, then more chemotherapy and more radiation, for limited stage small cell lung cancer (SCLC). To be clear, there is no standard role for surgery in this setting, no data to support it, and I can’t recall a situation in which I’ve felt surgery was an appropriate approach for previously treated SCLC. Nevertheless, his case was unique enough that not only did I feel surgery is clearly a compelling idea, but our multidisciplinary tumor board reviewed his situation and emerged with a clear consensus favoring surgery, at least if some additional components of his work up supports it.

Though I and other experts here try to make decisions based on the best evidence and the national guidelines derived from them, we also recognize that there are special cases for which there is no good evidence to inform our decisions. In such cases, it’s important to recognize that guidelines are not the same as rules, and that it can be perfectly acceptable, even ideal, to go beyond the guidelines when the right principles lead us to a more “creative” approach.

The patient in question is a 72 year old longtime smoking man who was diagnosed with limited stage SCLC in his right upper lobe in June of 2012. After receiving standard chemo and radiation to his chest tumor, he continued to have a persistent primary tumor visible on imaging. He was actually treated at another facility and went on to receive additional chemo for several months in a way that I don’t think I would have done, since it wasn’t clear whether this residual primary tumor represented viable cancer or dead/dying cancer after extensive treatment. Regardless, he continued to have repeated scans (PET/CT scans on every occasion, as is often done but often leads to very ambiguous findings and, I believe, a temptation to make unconventional decisions) that tempted his oncologist to keep advocating chemo, which the patient had a lot of difficulty tolerating, eventually developing neuropathy and weakness so severe he couldn’t walk without falling down and needed to use a walker to get around.

After getting PCI and his scans continuing to show a residual PET avid primary cancer in the right upper lobe, he was referred to a thoracic surgeon I work with, who carefully considered the potential value of surgery but declined to do it because he felt that this man was too debilitated to safety tolerate the rigors of it.

He was then referred to a radiation oncologist for additional radiation and received stereotactic body radiation therapy (SBRT)/Cyber Knife to the residual mass, based on a presumption that it represents ongoing viable cancer. The treatment was completed in late July of 2013.

Since then, he has continued to be followed by another oncologist, who has continued to do regular PET/CT scans for surveillance. These have been essentially stable, but with residual metabolic activity and a visible mass, his oncologist now favors surgery to remove it. Over the past nearly 6 months with no treatment, this gentleman has recovered from many of the difficult side effects and has returned to a much more active life, no longer needing a walker, though still far weaker than he started.

I saw the patient as a second opinion, reviewed all of these findings and discussed them with the surgeon, and we agreed that if a biopsy proves there to be residual viable cancer and a repeat brain MRI shows no new brain metastases, surgery in this very unusual case makes sense. Part of our confidence about the potential utility of surgery comes from the fact that it has been over 18 months since his diagnosis and about 9 months since his last chemotherapy, and his cancer still hasn’t demonstrated progression elsewhere. This makes us realistically hopeful that we won’t see new spread in the weeks or months just after surgery.

You might ask why we’d be sticklers about a repeat biopsy. If interpreting a PET/CT after standard chemo and radiation is difficult, we’re learning that interpreting a PET/CT after SBRT approaches impossible. Specifically, we’re seeing that treated lesions look for all the world like residual viable cancer on a PET/CT even many months after they’ve been treated but may well just be treated, dead cancer. How do we know? Because we reviewed results from a surgery in a very similar case just a week ago who underwent surgery for a presumed residually PET-avid cancer after SBRT to an NSCLC lesion, with pathology subsequently showing no viable cancer at all.

A key principle I always try to follow is to treat the situation you’re seeing, rather than being absolutely limited by the tissue diagnosis. Because cancer mutates over time, it doesn’t feel a need to conform to rigid rules, so neither should we. If an extremely unusual SCLC leads us to a situation in which surgery makes sense, we shouldn’t rule out the possibility just because there’s no place for it in the guidelines, which are for more usual cases. We just need to be diligent about not going far outside of the guidelines if it actually doesn’t make sense, such as if we don’t actually know that there’s viable cancer or there’s any evidence of disease outside of the primary tumor.

This case discussion isn’t meant to imply that we should be doing surgery after chemo and radiation for SCLC. I do mean to convey, however, that the general approaches we recommend as clear standards of care aren’t meant to be inviolable. In individual cases, a personalized approach can be very appropriate, even if it transgresses the prevailing standards of care.

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