GRACE :: Cancer Basics

FAQ: What is Adjuvant Therapy, and How Can It Help Patients with an Early Stage Cancer?

When patients are found to have a cancer that is at an earlier stage that may be able to be cured with a “local therapy” such as surgery or radiation, we know that these cancers can recur months or years later, .This is presumably because of micrometastatic deposits traveling n the bloodstream, which cause distant recurrences, or in the region of the primary tumor, causing regional recurrences.

For many cancers, there is also a proven value in giving additional therapy to address the possibility of any invisible disease beyond what was seen on scans and by the surgeon.  This is often systemic therapy such as chemotherapy or targeted therapy, and it may also include radiation given along with or instead of systemic therapy.

When given before the potentially curative local therapy, this is called neoadjuvant (or sometimes pre-operative or induction) therapy. .When given following the local therapy, it is called adjuvant therapy, coming from the meaning of  the word adjuvant as “helper”. While there are certain advantages to a neoadjuvant approach, giving the additional treatment later has a couple of its own key advantages.

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FAQ: What is Neoadjuvant Therapy and Why Would We Want to Give it?

The cornerstone of treatment of an earlier stage cancer is a local therapy such as surgery or radiation, which is meant to remove or destroy the cancer that is limited to a specific area. We know, however, that people who have undergone complete resection or what should be complete destruction of a tumor by radiation will too often have their cancer return, sometimes near the area where it first appeared, but often in a distant location.  When we see the cancer recur in a distant site, we can presume that this was mediated by “micrometastatic” disease, circulating tumor cells that were too small to be seen on any scans or by a surgeon directly at the time of surgery, but which must have remained in the body after a good local treatment removed or destroyed all evidence of visible disease. In order to combat this risk and try to treat potential micrometastatic disease, we often give systemic therapy before and/or after the local therapy.  A particularly common approach is to follow surgery with chemotherapy, which is called adjuvant therapy, with adjuvant meaning “helper”.  Systemic therapy before surgery or possibly before radiation is typically termed neoadjuvant therapy, and there are a few reasons why we might prefer to give systemic therapy at the earliest opportunity, rather than having it follow the potentially curative local therapy.


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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

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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