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GRACE :: Cancer Basics

Cancer Ouija Boards, Umbrellas, and Baskets: The Evolution of Genomic Oncology

Cancer treatment is in the midst of a transformation in real time.  Genomic testing of a tumor– looking for a wide range of dozens to potentially hundreds of markers at a time — is moving quickly from bleeding edge to mass adoption, at least in the US. This change is partly driven by ever-changing data and ever-changing clinical experience, partly driven by the general promise felt by patients and clinicians alike that new information will lead to vast improvements in our understanding and therapeutic options, and (lest we be naïve) partly driven by marketing from institutions and diagnostics companies who stand to gain by promoting this work.

That there are potential gains is undeniable – regardless of what the future may bring, even today it is a tangible gain to avoid missing the immediately actionable findings such as an EGFR mutation (for someone with  non-small cell lung cancer (NSCLC), for instance), but it can find many less common but clearly “actionable” mutations ranging from HER-2/neu to BRAF or a few others that are now mentioned in the guidelines developed by the National Comprehensive Cancer Network (NCCN) that typically lead to insurer coverage of the treatments recognized as effective for these rare mutations, which range from <1% to 3-4% of the lung cancer population.

But these tests are not going to offer only unmitigated positive opportunities. Aside from the cost of several thousand dollars per tumor profile performed, the results of these profiling tests most often reveal not a clearly actionable mutation, but one or more rare mutations that are accompanied by a synopsis of lab-based suggestions for unapproved and clinically untested options in that particular tumor type from the testing company. While a patient and their oncologist may say that they will ignore treatment options that are poorly studied and essentially just wildly speculative (there is a rather weak correlation between cancer treatments that work in the lab and those that are safe and clearly active in human cancer patients), that’s easier said than done. Instead, the molecular results often lead oncologists to be tempted to practice the black art of using the profile as a “medical Ouija board” to cobble together a treatment plan with no good clinical evidence to support it, all too often bypassing the treatments that are well established as helping improve treatment options in thousands of cancer patients with that tumor type. 

Ouija Board

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How much evidence is needed to change practice in cancer care? 8 key factors help set the bar.

The concept of statistical significance, a line drawn at the level of less than 5% probability that the effects of a new approach could be due to chance alone and not the intervention itself, implies that there’s a point of demarcation where we considera result positive. In truth, however, science and medicine are far messier than that, and we see adoption of new tests and new treatments adopted in a pattern more reminiscent of deciding to upgrade your mobile phone and television, in which there are bleeding edge people who are eager to pursue the latest approach with the first hint of potential value (called “innovators” and “early adopters” in technology, and in medicine they may be considered as “cowboys”), a much larger pool of people who need more evidence and comfort in something becoming a new standard of care, and a minority of “laggards” (the people for whom a phone upgrade today is focusing on whether to replace their rotary phone yet). 

technology-adoption-curve-Rogers(From the website www.joycehostyn.com)

In truth, there are several variables that affect how eagerly or reluctantly members of the health care community adopt a new test or treatment. Here are the top 5 factors as I see them:

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Frogs in boiling water: On breaking the $10,000 barrier

Note: Novartis has provided funding to GRACE for our recent ALK-positive patient forum.

Last week, the FDA approved Zykadia (ceritinib), the second generation ALK inhibitor.  As I wrote in my post about this new agent its rapid approval as the first effective treatment for acquired resistance to a targeted therapy in advanced lung cancer, there should be little question that it provides a helpful new option.  A couple of days later, I learned the cost: $13,500/month.

I felt some sticker shock over this. After initially being shocked at the price of EGFR inhibitors at around $5000/month, then having then escalate every few years, we saw the approval of XALKORI (crizotinib), setting a new pace in lung cancer, at $9800/month. Though that represents a heady range, we cou;d also potentially justify the cost by saying this was a very limited population and that criotinib provided a profound benefit. 

I was shocked about the cost of Zykadia, at $13,500, which made the $9800/month cost of XALKORI seem quaint, like a relative bargain. I expressed my concerns to the folks at Novartis, saying that I thought the price was aggressive and approaching extortionate, especially after the FDA approved the drug just a couple of years after it began phase II testing, based on just 140 patients, not the typical requirement of large, expensive phase III trials over many years that provided the justification for the high cost of these drugs in the past.

To their credit, they were very responsive and got back to me about my concerns.  They made several points that made me feel as though the question of cost and value for cancer agents is a fair concern, but also that their pricing was a thoutful process, what they estimated as fair market value relative to other agents and not just a simple opportunity to demand the absolute most that could be obtained.

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The Spectrum of Cancer Progression (50 Shades of Progression)

Here’s a general summary of a thoughtful approach to how we might assess progression of disease, recognizing that it isn’t just a simple matter of a “yes/no” question of progression or not.  

And for those who want the pdf to print, here it is: 50 Shades of Cancer Progression

Feel free to leave questions. comments, objections, etc. here.I hope it’s helpful.

 

 


How a Cancer Adapts: Key Clinical Implications from the Evolution of an Advanced Cancer

Key Clinical Implications of how a Cancer Evolves from H. Jack West

The associated, printable pdf is here.


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