The Standard of Care in Oncology Is Unacceptable

In medicine today, we all promise to offer the best medical care available to each of our patients, and I would argue that most of us believe we are delivering on this promise. But how do we know that we are living up to that promise? Outside of board exams and CME requirements, there is virtually no internal scoring of our performance. The legal community has been happy to judge us, and they created a legal term—standard of care—against which we are all to be compared. The original intent of this term was to define a minimum level of care, a lowest common denominator. If we at least offered the standard of care, we were delivering acceptable care. We would not be committing malpractice. This is nothing to brag about, but at least we were not dangerous.

In many fields of medicine, however, the standard of care has evolved to be considered the "appropriate" and best care. It is no longer some minimum requirement but instead a level of care that balances risk and benefit, outcomes and costs, and legal fears. There are clear standards for managing cardiovascular disease, cancer screening, diabetes, and other major illnesses. Treatment pathways have been published for many diseases, and if we follow them, they offer good outcomes. Indeed, we frequently proclaim to patients that we are suggesting a treatment that is the current standard of care, knowing that this treatment will likely have a good outcome. This new standard of care is something to be proud of. It represents our success in many diseases and helps us deliver on our promise to provide the best care.

Which standard of care are we delivering in cancer medicine—the minimum treatment that keeps us out of court or the optimized treatment pathways that result in acceptable, high-level outcomes?

We have entered into a new era, where molecular biology continues to provide us with new insights, leading to new, more effective agents. More cancer patients are cured, and more cancer patients are living longer, with a better quality of life. And as more diseases become more complicated to treat, we are forced into developing standards of care and treatment pathways for our patients. In order to stay current in all the different cancers, we need these standards, and I believe that as a general rule, they have raised the quality of care throughout the United States.

But I cannot get over the feeling that every time I offer a patient the standard of care in my oncology practice, I am raising a white flag. How can I be satisfied with treatments that are the most toxic of any in medicine and effective in only a limited subset of patients. Why do our patients accept this? Why is there not a loud, continuous outcry of dissatisfaction and outrage that we are not doing more? Why isn't every patient in the US on a clinical trial?

Take stage IV colon cancer as an example. For 20 years we had 5-FU therapy, which offered a 10% to 20% benefit. We were exposing 100 patients to chemotherapy, knowing that it would help only 10 to 20, and only briefly. Newer medicines are now available for colon cancer, but accrual to trials is embarrassingly slow. I cannot imagine how many patients with incurable stage IV colon cancer have been given "standard of care" therapy, knowing that the treatment will not cure them and will cause significant toxicity. After trying to maintain hope for our patients, we hang our heads and proclaim that we are doing our best. But are we? We have so far to go.

I believe our first priority is to optimize efficacy, and I believe we are rapidly acquiring the tools to do this. We must perform innovative clinical trials in our stage IV patients with the new agents rapidly making their way to clinic, looking for high levels of clinical activity. Large randomized trials looking for small differences between arms should be reserved for the adjuvant setting, testing the best therapies from metastatic trials.

Second, we should focus on reducing toxicity. How long have we accepted the necessity of PEB (cisplatin, etoposide, bleomycin), a very rough treatment, for testicular cancer? Yes, the outcomes are very good, a flag we wave when challenged that we have made little progress. (Just look at Lance Armstrong!) But is anyone asking whether the treatment could be gentler? We have accepted this standard of care as optimum when I would argue we still have a long way to go.

The next time you offer a standard-of-care treatment plan, I hope you stop to question that standard. Would you give it to yourself if you faced the same diagnosis? Is there a trial in which the patient can enroll? This would at least contribute to finding a better standard. We should all get a bit angry, and we should encourage our patients to push for better standards. If nothing else, I would like us all to ask whether the standard of care in oncology is acceptable. I say it is not.

—John Marshall, MD