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Cancer drug shortage implicated in relapses among young Hodgkin lymphoma patients

A shortage of a cancer drug used to treat Hodgkin lymphoma has been linked to increased cancer relapses among children with this type of lymphoma, or cancer of the lymph glands, according to a report released today in the New England Journal of Medicine.

Chemotherapy drug shortages have been in the news a lot this year, with heart-wrenching reports focusing on families who were told their children's chemo might become unavailable. So far, most chemotherapy shortages have been resolved in time to give patients the treatment they needed, but the drug shortages continue to threaten the treatment of many pediatric and adult patients.

The finding implies that some pediatric cancer patients [experienced] more acute and long-term side effects than they would have had the mechlorethamide shortage not occurred

The mechlorethamine shortage, which began in 2009 and ended recently, was different. The drug, one of a group of chemotherapy medications typically used to treat Hodgkin lymphoma, was completely unavailable for more than two years. In its absence, doctors had no choice but to substitute a different drug, cyclophosphamide, into the chemo regimens of their patients with Hodgkin lymphoma. This substitution seemed very reasonable because the two drugs are close relatives and work by similar mechanisms.  In fact, cyclophosphamide has been used to treat patients with Hodgkin lymphoma for many years.

Three pediatric cancer researchers, including scientists at St. Jude Children's Research Hospital, the Dana-Farber Cancer Institute, and Stanford's Michael Link, MD, analyzed the consequences of the substitution. Initially, they thought the two drugs would work equally well, but they found something quite different.

Using a chemotherapy regimen that included mechlorethamide, 88 percent of patients were cancer-free two years after completing therapy; among patients who received the same regimen but with cyclophosphamide instead of mechlorethamide, only 75 percent were cancer-free two years after therapy ended. The patients who developed relapse required additional, intensive therapies, including bone marrow transplants to treat recurrence. Although doctors gave the best treatments they had available and all patients are still living, the finding implies that some pediatric cancer patients received additional therapy associated with more acute and long-term side effects than they would have had the mechlorethamide shortage not occurred.

From our press release about the findings:

“This is a devastating example of how drug shortages affect patients and why these shortages must be prevented,” said Monika Metzger, MD, an associate member of the St. Jude Department of Oncology and the study’s principal investigator. “Our results demonstrate that, for many chemotherapy drugs, there are no adequate substitute drugs available.”

“This puts a face on the problem of drug shortages and shows that the problem is real, not theoretical. This is about a curative therapy that we were unable to administer because the drug we needed was not available,” Link said. “Despite heroic efforts by the drug shortage office of the Food and Drug Administration to solve the shortages of a number of medically necessary drugs, it is clear that patients are still suffering from the unavailability of life-saving drugs. A more systematic solution to the problem is needed.”

Previously: A Q&A on cancer-drug supply shortage; An in-depth look at the even-deeper problem of drug supply and Childhood leukemia patient on methotrexate shortage

From Dec. 24 to Jan. 7, Scope will be on a limited holiday publishing schedule. During that time, it may also take longer than usual for comments to be approved.

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