Radiation treatment errors with Intensity-Modulated Radiation Therapy (IMRT)

In a recent series of articles in the New York Times, Walt Bogdanich uncovered an alarming series of radiation treatment errors associated with implementation of new computerized treatment technologies such as Intensity-Modulated Radiation Therapy (IMRT).

Based on this article, reporting hundreds of cases, some of them fatal, it appears that a variety of causes are associated with errors, including inadequate training of physicists and radiation therapists, difficulty physically validating computer-generated treatment plans, over-reliance on reliability of computer technology and inadequacy of traditional radiation oncology quality assurance approaches in the era of new technologies.

Most disturbing is the fact that errors reportedly occurred at some major institutions with programs that have routinely developed and delivered cutting-edge technologies that have benefited cancer patients for decades.  Radiation oncology, radiation therapy and radiation physics professional organizations along with the manufacturers of new radiation equipment are addressing the issues and will find a solution.

The more disturbing question is whether medical oncology patients are or will be at similar risk as new technologies become regularly used to treat cancer.  Increasingly, new medications, some in categories never previously used in people, become available to treat cancer.  Like IMRT, they offer the promise of better outcomes with reduced toxicity.  Several of them are already in the oncology clinic.  When new drugs emerge that treat large numbers of patients (such as non-small cell lung cancer, Her2+ breast cancer and kras wild-type colon cancer), they get broad attention from oncologists and their support staff.  They learn the best way to use the drugs, methods for avoiding and treating toxicities, and ways to identify patients at risk for side effects and drug interactions.  The cooperation of professional associations, major cancer centers, the FDA and the pharmaceutical industry has served cancer patients well and allowed safe introduction of new technologies.

What will happen when the current new agent pipeline comes to the clinic, the number of new agents skyrockets and personalized medicine becomes the predominant practice pattern in medical oncology?  Each patient’s tumor will be analyzed to identify the most appropriate therapy, perhaps a drug that will be used only for a small number of tumors with a specific genetic or molecular profile. Who will have the time to spend learning the intricacies of a new drug class when only 3,000 patients per year need the treatment?  How will oncology nurses, mid-level providers, and pharmacists learn and remember all of the very specific information they need to know when they only use the drug twice per year?  How will they gain access to the most recent ways to optimize the outcome and safety when changes to the package insert may take years to catch up to best practice?  How will they identify and access disease experts with extensive experience with the new agents?

Community oncologists, academic experts, pharmaceutical manufacturers, medical education providers and the FDA need to identify new, more efficient ways to share new information if patients are to get the most benefit out of the rapid progress in oncology without exposing them to unnecessary risk.

Richard Leff is Chief Medical Officer of Conisus.

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