This release reports the findings of a large clinical trial testing whether alternative dosing regimens of standard chemotherapeutic drugs can improve the treatment of B-acute lymphoblastic leukemia. The study showed that using high doses of the drug methotrexate, rather than the standard regimen of gradually increasing doses, improved the outcomes for patients with the disease. The study also showed that using the steroid dexamethasone increased a debilitating bone condition in patients 10 and older but not in patients nine or younger.
While the study results are promising, they are by no means clear-cut in the release. The release needed some qualifiers in order to give a clear picture of the benefits. The release also neglected to discuss costs and potential conflicts of interest among the investigators.
This form of cancer — B-acute lymphoblastic leukemia — is the most common cancer in children and a major cause of cancer death in patients under 40 years old. And while the majority of patients survive with appropriate treatment, anywhere from one-fifth to one-quarter of patients do not. This study showed that refining the dosing of standard cancer drugs may improve the outcome for some high-risk patients.
This release makes no mention of the costs of the drugs compared in this study, even though the drugs have been in use for years and are widely available. Since the study is a comparison of various treatments for this form of cancer, it seems relevant to offer a cost comparison as well as a comparison of efficacy. It appears that the high dose methotrexate is given over a 24-hour period, presumably in the hospital, while the standard methotrexate is given as a single dose. Also, the high dose methotrexate is followed by leucovorin administration while the standard dose is not.
According to the site GoodRx, the cost for methotrexate in low-dose (2.5 mg) pill form averages out to about $50 for a month’s supply. Newer, injectable variations of the drug cost upwards of $500 a month for the 25 mg dose.
The release states that patients receiving high doses of the drug methotrexate “had a significantly better outcome, by 5 to 6 percent” than did patients receiving the current standard of care, which is gradually escalating doses of the drug. The release also explains that patients nine years old or younger who were also treated with a steroid called decadron (dexamethasone) for half as long as normal (14 versus 28 days) benefited from the treatment while patients 10 and older did not.
We’re not sure of the meaning behind these results as portrayed in the release. Which outcome was better by 5 or 6 percent? The study has several. Does that mean the relapse rate was reduced or is it the event free survival that was better? It would be more meaningful to readers if the release had included the actual relapse and event free survival rates for each group analyzed in terms most people can understand. For example: “relapse rates were 5 percent lower in Group X compared to Group Y.”
We’ll give this category a satisfactory rating largely due to the release including information that patients 10 and older receiving dexamethasone “were at much higher risk for a debilitating bone condition called osteonecrosis,” although we would have been happier if that greater risk would have been quantified. However, the published study explains that there were toxicity problems beyond that of dexamethasone and the release would have been stronger including that information as well.
The release stated the study was randomized and controlled, and provides a broad overview of the study design, for which we give the release a borderline satisfactory under this criteria.
However, these are the superficial results. On deeper delving into the study methodology, the statistical significances of the results were very close to not statistically significant. This is due to their planned interim stopping of the treatment and the fact that they were looking at multiple outcomes in multiple groups.
This release doesn’t demonstrate disease-mongering.
While the release does say that this clinical trial was run by the Children’s Oncology Group, which is funded by the National Cancer Institute and the National Institutes of Health, it makes no mention of possible conflicts of interest. Compounding that is the fact that the published study says, “Disclosures provided by the authors are available with this article at www.jco.org,” but that information is behind the journal’s paywall for most readers, so it’s unknown if there is, or is not, a conflict. It appears as though five of the authors (out of a total of about 20) have some conflicts of interest, mostly from several types of drug company payments.
The release is comparing the efficacy of treatment regimens using different drugs so alternative treatments for B-acute lymphoblastic leukemia are noted.
The release makes clear at the end that the treatment of this disease is improving thanks to refinement of the use of existing drug treatments, meaning that they are readily available for patient use.
The release suggests the study findings could change the way childhood leukemia is treated. Modifying existing treatments to enhance a patient’s survival is certainly novel enough to warrant a release.
There is no use of unjustifiable language in this release. However, the tone may be a bit overly optimistic given the study findings.