A journalism professor sent this story to us and we thought it was interesting enough to comment on. It follows the pattern of local TV health news stories that are usually far too brief and incomplete.
Melanoma is a nasty disease and has proven itself to be resistant to just about every treatment available if found late in its course. Because of its relative rarity (as compared to colon or lung cancer), cooperative trials involving many medical centers have been established in an effort to rapidly find new treatment options. My interest in the story was piqued by the notion that the treatment is only available at one center in Arizona.
Interleukin-2 was approved by the Food and Drug Administration in 1998 for the treatment of advanced melanoma. The FDA-approved regimen involves the intravenous injection of high doses of interleukin-2. Patients are routinely hospitalized during treatment with injections occurring every eight hours for up to 14 doses. The cycles are separated by a nine-day rest period, during which the patient can go home. The results early clinical trials on the use of interleukin-2 alone were not that impressive. In a study of 270 patients, 16% experienced tumor shrinkage with 6% of patients disease free up to three years later. The impact of interleukin-2 as a single agent on long term survival is still unresolved. It is a rigorous regimen to say the least with lots of toxicity.
A regimen that could be given on a outpatient basis would be a huge step forward, especially if it showed better results and had fewer side effects.
Based on our standard criteria, this story fails miserably. We are told very little about the regimen used, whether interleukin-2 is used in combination with other drugs and what the side effects are. Dr. Quan has been a leader in this research effort and he and his colleagues have been the sole source of published information on this regimen. Importantly, the views of other oncologists would have provided some balance to his comments. A single patient anecdote, regardless of how compelling it is, does not replace a large dataset looking at the experience of multiple patients. Dr. Quan notes a complete remission rate of 5% with his regimen. I would point out that the seminal trial involved in the drug’s approval demonstrated a 6% complete remission rate.
The story fails to point out that the regimen is in fact investigational and is listed at Clinicaltrials.gov. The study is indeed a single center study. This oversight seems rather important. According to its formal listing the trial was ongoing at Loma Linda University Medical Center in California, Dr. Quan’s previous affiliation. Immunotherapies historically have been very expensive so some information about cost and insurance coverage would have been welcomed.
Dr. Quan’s study is said to limit enrollment to 35 subjects. While it is possible to increase that number, many patients with the disease may not have the opportunity to participate. That’s why it is so important to provide additional information about available trials. There are 24 other melanoma trials listed in ClinicalTrials.gov.
Patients facing life threatening illness need information about treatment options. Unfortunately, this story came across more like an advertisement for Cancer Treatment Centers of America and/or Arizona. It remains to be seen if Dr. Quan’s investigational regimen will live up to the headline of this story.