I am writing to ask the ASCO community for help in addressing a policy decision by the Nuclear Regulatory Commission (NRC) that requires oncologists to take a 700-hour course (on the full range of nuclear medicines) to give one medicine to their patients: prepackaged radioimmunotherapy. It’s apparent that it’s just not feasible for oncologists to take the entire course to be authorized to offer this one treatment to their patients. The burdensome training requirement has contributed to the underutilization of radioimmunotherapy in the community setting—where 80% of patients receive the diagnosis of cancer and are treated.1
This is a classic “catch-22” situation: Most doctors who treat patients with lymphoma are not authorized by the NRC to give radioimmunotherapy. Those who are authorized (nuclear medicine physicians) do not see these patients. The sponsor of one remaining radioimmunotherapy drug, Zevalin [ibritumomab tiuxetan], is losing money and may discontinue it. Recently, Bexxar [tositumomab/iodine-131 tositumomab], a similar agent, was discontinued for lack of profitability.
Personal Experience
It’s evident that lives are being lost, tragically. Here I can speak from personal experience. My loved one was diagnosed with lymphoma. She suffered a relapse after rigorous combination chemotherapy in 1997, just 6 months after her initial treatment. For 8 additional years, she endured one harsh treatment after another. Each time, the lymphoma was back and progressing even before her hair grew back.
In 2004, she received radioimmunotherapy after a short course of chemotherapy. She has had no sign of lymphoma since—enjoying 12 years of normal life for which we are profoundly grateful.
A Remedy Needed
A remedy seems feasible and necessary: Have the NRC work with the sponsor of the particular drug to develop a focused course on how to safely administer a prepackaged radiolabeled antibody (as was done when it was first approved)—a protocol similar to that for the nonlabeled rituximab (Rituxan) antibody that oncologists give routinely. It’s especially important to consider the unique properties of a radioimmunotherapeutic drug and that the burdensome training requirement has negative implications for other types of cancer that may be treated with similar targeted radiotherapies.
Radioimmunotherapy is perhaps the least burdensome treatment available to patients. It takes about 1 week to give, compared with many months of chemotherapy. It’s the only non–chemotherapy-based approach with a high rate of durable remissions. It’s an important and unique choice for patients who must continue to work through or shortly after treatment; who cannot tolerate chemotherapy, because of advanced age or specific comorbidities; and who may prefer to avoid or substantially limit the on-treatment side effects of chemotherapy such as nausea, neuropathy, hair loss, as well as gastric and mucositis complications.
Durable Responses Reported
I recognize that other factors are influencing the underutilization of radioimmunotherapy and that not every patient who receives it will remain free of treatment for as long as my loved one. Yet, clearly, this is an important and easily tolerated therapy with high efficacy, particularly when given early in the disease course. It also has substantial potential for enhancement if combined with other targeted agents in clinical trials.
Larson and colleagues2 have summarized outcomes with radioimmunotherapy as follows.
Seven phase II studies and two phase III studies have tested [radioimmunotherapy] in patients newly diagnosed with [non-Hodgkin lymphoma] who received front-line therapy either alone or as consolidation following chemotherapy. These studies have all demonstrated efficacy, with [overall response rates] of 90% to 100% and [complete response rates] of 60% to 100%. Also, the [complete response rates] induced by this approach have been very durable, with median remission durations exceeding 6 years in many studies.
Ensuring Access to These Agents
We need to honor the sacrifices made by the patients who enrolled in the trials that led to the U.S. Food and Drug Administration approvals of radioimmunotherapy agents by making sure that access to these agents is not limited by where a patient happens to live. And we need to ensure that future access to these agents is not eliminated entirely.
To support the policy change described here, please contact the Senate HELP (Health, Education, Labor, and Pensions) committee and reference a patient-endorsed letter by Patients Against Lymphoma. Thank you for your attention to this urgent matter. ■
—Karl Schwartz
Riegelsville, Pennsylvania
Disclosure: Mr. Schwartz is the President and Cofounder of Patients Against Lymphoma.
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