Most of what I write about here highlights the evidence supporting treatments, and that’s certainly how we strive to practice oncology. But the reality is that patients and doctors often find themselves in the middle of settings where we don’t have any answers and need to rely on judgment, or we think we can potentially do better by defying conventional wisdom. Doctors lie all along the spectrum of being “data-driven” on one end and being a “cowboy” on the other end. The general perception is that many academics are more evidence-based, but I’m not sure that’s true: experts defy the guidelines all the time and say that the key is knowing when to follow and when to deviate from them.

One of the typical places in which we find ourselves at odds with a lack of evidence is in treating patients beyond about third line treatment. We have trials that show the evidence of a limited number of our treatments for NSCLC out to third line, and second line for SCLC. Most patients run out of energy and/or interest in treatment by about that time, but some patients have slow-growing and/or particularly responsive cancers and come back after multiple lines of treatment feeling well enough to come back to the clinic and ask, “what next?” Many people participating here are beyond the point where we have evidence that further treatment is beneficial. How do we manage these situations?

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Today’s NY Times included a high profile article about the difficult balance between the clinical value of some expensive cancer therapies and their financial value. I think it did a fair job of portraying both sides of the issue — that therapies like avastin, erbitux, and others are certainly priced aggressively for the modest but generally convincing benefits they provide, leaving some people wondering whether they have enough impact in a non-curative setting to justify the rather high costs. Contrasting this with inexpensive medicines (such as if an off-patent chemo were found to be modestly helpful) or expensive medicines that can be expensive but seem convincingly justified by the striking benefits (such as gleevec for chronic myelogenous leukemia, or CML), the authors offer that the costs to the patient personally can be daunting if they are paying 20% of what amounts to thousands of dollars per year, and of course also the costs to society. While countries with single-payer medical care, ranging from Canada to the UK to many/most other parts of the world, have faced questions of whether expensive cancer drugs that don’t increase the cure rate are “worth it”, the US system has not had to face much means-testing.

But with costs of cancer treatments rising rapidly, and with many competing needs, such questions are creeping into US-based discussions more and more. In the commentary about the plenary presentation of the FLEX trial that demonstrated a modest but statistically significant survival benefit in advanced NSCLC, Dr. Tom Lynch from Massachusetts General Hospital was charged with the task of providing some context about whether the 1.2 month survival benefit could justify the anticipated costs.

I think we’re going to be facing more and more of these hard questions, ones for which I don’t have any good answers. As the article notes, through the words of one of the quoted physicians (Dr. Eric Winer, a breast cancer specialist at the Dana Farber Cancer Institute in Boston), we may conclude that the cost-benefit (now financial as much or more than our usual mindset of weighing risks of side effects and quality of life issues vs. improved response rate and survival) is not favorable for society as a whole, but you have a different perspective when you have a patient looking for options in front of you.

I wonder whether the cost of things like co-payments that may run into thousands of dollars is now a factor for patients and their families. I certainly hear patients and families express a desire to explore “anything, regardless of the cost”, but is this really something that just doesn’t or shouldn’t enter into the picture? I can understand a “go for broke” (literally) approach much more in a curative setting, for which we really haven’t seen much controversy. But would people be willing to have their families go into debt for a non-curative treatment that would be expected to extend survival by 2-3 months? Is it more the hope that a person will be one of the major beneficiaries that gets many months or even years of benefit, and it’s not possible to put a price tag on hope?

These aren’t pointed questions for which I have a presumed answer. I can’t say how I’d feel if it were my father or wife or closest friend facing cancer. But I’m interested in hearing from people who face advanced cancer themselves or in someone very close to them, “is there such a thing as a cancer treatment not being worth it financially?”.

This doesn’t directly relate to lung cancer, but in a prior post I described a trial of the vitamin D analog calcitriol (Asentar) with taxotere for treating advanced NSCLC. Although it has been very unclear whether there might be any future for this agent in lung cancer, I and many others were pretty impressed by the results of a randomized phase II trial for metastatic prostate cancer, called ASCENT, with 250 patients who were randomized to taxotere and prednisone with or without calcitriol. This study actually showed an improvement in overall survival in the recipients of calcitriol with chemo, but it wasn’t a huge trial. A larger phase III randomized study with the same design (called ASCENT-2, cleverly enough) has been ongoing in prostate cancer. Presumably, if this one came out as well, it would look good for it to be approved by FDA.

While we don’t have any real results yet, we know from a press release that the trial was stopped early due to an unexpected excess of deaths on the arm that received calcitriol with chemo. This led the Data Safety Monitoring Board to close the trial. This doesn’t have any immediate implications for lung cancer, except that now I’d really doubt we’ll see the concept I described in my post followed with a larger study in lung cancer. And it’s another example of how an early small trial can look really promising, but the new treatment not only be of no significant benefit but also potentially be harmful. I haven’t been recommending high dose vitamin D for my patients, but it’s a cautionary point that there might be detrimental effects from high doses of certain vitamins (potentially from the interaction with chemo but wouldn’t occur without concurrent chemo). I don’t have any more details, but I’ll let you know if we learn more.

Medicine in general has become increasingly evidence-based, which we think is a good thing. Rather than have doctors use a wide range of approaches to the work-up and treatment of many problems, there are a growing number of guidelines that shape our “standards of care”, the defined best treatment practices. Oncology more than several other medical fields is very data-driven, looking to the actual evidence from clinical trials to help us define what is the best approach, if there is one.

Let me say that, in general, I’m a fan of evidence-based medicine and guidelines to define a standard of care. I consider it a good way to ensure that the vast majority of people receive good treatment rather than a very wide range of options in which many patients would fare far worse. But there are limitations to this approach. First, diseases that are too uncommon to be studied well, or less common subgroups of people with common medical problems, can’t be studied well enough to develop good evidence. Lung cancer is common and therefore well-studied, but tumors of the salivary gland are not. Pharmaceutical companies aren’t clamoring to develop new agents for very small patient markets (it costs a lot to develop new drugs, and it makes more sense to try to develop them for larger rather than smaller markets); the National Cancer Institute isn’t being pressured by patient advocates with salivary gland tumors to channel funds for clinical trials. Those trials never happen, and doctors and payers may say, “there’s no good evidence that treating with X helps these people.” True, but absence of proof isn’t proof of absence. Or, in the quote from the influential and somewhat sensationalized novel about the back stage of medicine, The House of God, “If you don’t take a temperature, you can’t find a fever”. Sometimes falling back on the evidence-based medicine can be a cop-out, particularly if you’re depending on good evidence and the question hasn’t been asked properly. Read the rest of this entry »

In oncology, we very frequently hear people say, “I don’t know how you do what you do”. There are plenty of times when we might start to wonder ourselves, as we fight with insurers to get a treatment, or when very bad things happen to patients we’ve developed relationships with. As I said in the introductory page here, the stakes are high with cancer. The highs are great highs, but the lows are deep lows. Although we don’t talk about it much here, because it’s not an uplifting topic and I too like to give people what they want, people die of lung cancer, and also many other cancers. But it’s not necessarily death that is the hard part; the hard part is when there’s a significant disconnect between what patients/families expect and what we can provide.

Many of my patients have died with family around them, peacefully at home or in a hospital or wherever, often with hospice care, and the patients and families were grateful that, after taking on the rigors of treatment, toward the end they didn’t suffer and that the didn’t feel alone. But it’s hard when patients and/or families want more treatment and an oncologist perceives that the treatment is worse than the disease. The hardest part is that there’s a spectrum, and everyone is at their own place on the spectrum. I recommended chemotherapy for a 78 year old man with advanced lung cancer, because I feel he’s fit enough to tolerate it, I believe I can offer a chemo regimen that won’t be too unpleasant, and there’s a real chance it will provide meaningful survival benefit and improve some cancer-related symptoms. We talked about the pros and cons at length, and he eventually said, “thanks, but I’m not interested”. Here, I was the person suggesting a more aggressive approach than the patient was inclined to pursue. But I know that every week I have a conversation with a patient in which I explain that I don’t think further treatment will be helpful, and they feel something between disappointed and betrayed. (Not every patient feels that way during these discussions, but some do.) The comedian George Carlin used to say that everyone on the road other than you was either an idiot (driving too slow) or a maniac (driving too fast). And it’s the same in medicine, perhaps especially in oncology. Some oncologists are inclined to treat as long as a patient can get in to the clinic (and then some hospitalize and give chemo to bedridden patients), while others may be more fatalistic and wonder about the point of treating if the benefit is what they’d perceive to be a small survival difference. I consider myself not the most aggressive, and definitely not the least, but everyone probably feels this way, just like everyone feels that they’re a better than average driver. We all need to be true to ourselves. Read the rest of this entry »

Member Ned raised the question of how oncologists discuss prognosis and the goals of treatment. I think this is a very important topic that touches every relationship between an oncologist and the patient (and family and/or friends directly involved). First, I’ll say that this is an area of medicine that only recently, in the last decade or two at most, was integrated as a component of medical teaching. The older medical curriculum focused on memorization of anatomy and biochemistry and other subjects, with relatively little attention on doctor-patient relationships and communication. The approach to medical education now includes much more teaching, discussion, and even role-playing about how to communicate with patients. And as you might suspect, one of the most challenging aspects is communicating about a poor, and particularly a terminal, diagnosis.

I was the beneficiary of a medical education that included as much of that training as anyplace, even including video recording of role playing interactions with critiques of how to hone communication skills. Still, much of our training is based on growing “on the job” experience. Moreover, patients and families have very different approaches and styles. Some patients want to know everything they can, the good and the bad, while others may really be uncomfortable with hearing the more daunting aspects of their cancer and treatment. Some people may be reluctant to pursue treatment, others may want to try treatment while it is likely to be beneficial and then are very ready to focus more on supportive care, and others may really want to pursue every line of treatment they can find, beyond the point where benefits are anticipated. So patients/families can be very different, and it’s no surprise that I am not the perfect fit for everyone. While I try to be as sensitive as possible, I am more forthright than some people would prefer, and less of a cheerleader if I think the situation is challenging and few good options exist. I give a lot of credit to the few oncologists I know who seem to resonate with all of their patients, who have a true gift. It’s not just about having expertise in a subject.

So we wrestle with how to communicate about a poor prognosis. As we know, far too many patients with lung cancer cannot be cured, and often that is the case at the first meeting we have with a patient. Over the past several years, I have come to speak more in generalities than in specific details about prognosis. If a patient asks about a time line, I will provide as much information as they want, at least within terms of a general population of patients with a similar stage and performance status. But I don’t want to bludgeon patients who are hearing about their lung cancer for the first time with numbers that they may not be inclined to hear. The struggle is between giving enough information for patients to make a truly informed decision about treatment and demoralizing them with too much, too fast. I believe that patients have a right to know as much as I can tell them about their cancer and prognosis, but having the right to know also includes a right to forego some knowledge.

I personally don’t feel right about giving someone chemo for advanced lung cancer without telling them that it is associated with an overall improvement in survival by several months, but can’t be reasonably foreseen to be a curative therapy. My belief is that it would be inappropriate to pass over the palliative nature of therapy (meaning potentially improving survival, but not curing — not just a pat on the back and starting a morphine drip) and potentially mislead someone into thinking that chemo for advanced lung cancer can provide a cure. We can err by omission by not saying something that needs to be said, just as we can err by commission and say something inappropriate. Some oncologists are more vague, and I think some patients and families prefer that, but we all need to be true to ourselves.

So then there’s a question of “how much time do I have, doc?”. Some people ask, and some doctors offer this information without the question. First, we aren’t that good at predicting time lines other than when it’s appearing rather immediate, in the days to weeks range. The ability to say someone has 4 or 6 or 12 months to live is more TV movie than real life. If oncologists were that good at predicting the future, we’d be working on Wall Street. The numbers are almost always based on populations, but people aren’t statistics; there are people who fall all throughout the spectrum, some doing much worse than the general numbers, and some much better. That said, if someone asks me for a direct answer because they are trying to plan their lives, I try to give some idea of a range. I think it’s too easy to just plead ignorance and offer no information, and many people need as much information as they can get. But the idea of “the doctor said I have 10 months to live” just doesn’t make sense, and I think it’s one of the downsides of talking about statistics. If we say that there is a median survival of 10 months, hopefully explaining that this is the point where half of the population will have died and half remain alive, many patients will have the impression that they have 10 months to live. I know that some family members or nurses have relayed to me that I told a patient they had “6 weeks to live”, but that wasn’t what I had said at all. But numbers and complex ideas don’t always mix well with high stress and deep emotions.

There are, however, some cases where it seems that patients are being inappropriately told a time line. One of my patients, who switched to me from another oncologist, said that their first oncologist had told them they had a year to live. She suspected the same thing I had presumed, which is that she had misunderstood that discussion. So she called her oncologist two weeks later, who apparently told her, “No, that was what I said, except now you have 11 and 1/2 months”. Wow — I think she made a good move in switching oncologists.

I would welcome people’s input on whether they want as much information as they can get — bad or good — or whether they think that stats become weapons all too often.

Last year, one of the issues I was struck by in reading the comments on a few patient-oriented websites when I really began in earnest to participate in the online sites was the tension that can occur all too often between patients and oncologists. There are certainly many potential pitfalls, but one of the common themes is that many patients need a breakthrough fast and don’t need to see the results published in the New England Journal of Medicine from multiple large trials to be convinced that a promising approach is worth trying, while oncologists are often more conservative about providing access to commercially available drugs that aren’t indicated for a certain patient’s cancer. Whether it’s celebrex or sutent or DCA, these approaches represent legitimate hope when clinical and lab investigators describe the potential value of these treatments for improving survival. Often these conclusions are based on early data, from the lab or in some small clinical studies, and the media may provide a sound bite of brief analysis in which a brief story alludes to the next great breakthrough.

In fact, some of these treatments will, in fact, become valuable treatments, and a few will become miracles, or close to that. People with an unusual called a gastrointestinal stromal tumor (GIST) used to have very minimal therapy options, but with the new targeted therapy of Gleevec, they can have remarkably dramatic and long-lasting results. Tarceva, Avastin, and some newer chemo agents and targeted therapies may provide very gratifying benefits for many lung cancer patients. But there is often a cultural difference in the willingness of patients and oncologists to pursue a non-standard treatment. Read the rest of this entry »

Yesterday, a member here made a very fair comment (here) after one of my recent posts in which I raised my concern about giving treatments without evidence to support it. The issue was whether it is really appropriate to be so protective and insular in my thinking in a setting in which patients with lung cancer may have exhausted all of the proven treatment options. Would I really defend offering no further treatment to someone in whom the only proven path is to a very disappointing and to some people an unaccaptable place? Read the rest of this entry »