To its credit, this story does inject some caution into its coverage of a new treatment for advanced melanoma. Nevertheless, we think it is important to emphasize that the research being discussed was a phase 1 study that had only 32 patients in the arm that was reported on. The primary objective of this study was to ascertain the most effective dose that was tolerable to patients–it wasn’t designed to test whether this treatment is clinically effective for melanoma treatment. So while we can understand the excitement about the apparent benefits that were observed, we think it is critical to balance the discussion with extensive caveats about limitations and potential harms. This story didn’t come quite as close as we’d like to meeting that standard.
Advanced melanoma is a disease which often kills patients within a year of diagnosis. We need better options to treat it.
No discussion of costs. This is perhaps understandable considering the early stage of the research.. But we think the story needed to include some comment about the likely price tag, as discussed by USA Today. Expensive new cancer drugs are among the fastest-rising areas of healthcare spending.
The lead sentence of the story states that the new drug shrank tumors "in 81 percent of patients" with advanced melanoma. The story did not immediately specify that the benefit was limited to patients whose tumors had a specific genetic mutation. It isn’t until the 12th paragraph that we learn that this mutation is present in only about 50% of melanoma tumors, and that the other half of melanoma patients aren’t candidates for the therapy. So the number of patients who might benefit from this therapy, while still significantly, is quite a bit smaller than 81% suggested at the outset of this story.
Considering that this was a phase 1 study, the purpose of which is primarily to establish a new drug’s safety, we think there wasn’t enough discussion of the potential harms of this treatment. We thought the brief catalog of side effects provided at the end of the story — "rash, fatigue, joint pain and a high risk of a different type of skin cancer known as cutaneous squamous-cell carcinoma" — tends to minimize the impact of these harms. The rashes observed in this study were grade 2 or 3, which are moderate to severe (grade 4 is life-threatening). And even though the story quantified the number of patients who developed squamous-cell carcinomas, its only comment about the impact of these tumors is that they are "easier to treat" than melanoma. The story should have explained that these cancers have to be biopsied and may need to be surgically removed. And we certainly do not know whether or not these new squamous cell carcinomas will remain "easier to treat," as they may be changed in behavior by the treatment itself, and could be more difficult to treat.
The story adequately described what happened in the study and reported on the primary outcomes. It also inserted some caveats about the durability of the benefits reported (these are described as "temporary" and "fleeting"). On the other hand, there wasn’t any discussion about the small size of the study, the lack of a control group, or how these limitations affect our interpretation of the research. As the competing HealthDay coverage noted, the results in this small group of very ill patients studied may not be representative of the drug’s effects in a larger, more heterogeneous population. And we don’t yet know if this drug actually prolongs survival or improves quality of life compared with standard treatment.
Lastly, there is sentence in this story which says "The hope is that the drug can be combined with other treatments to produce a long-lasting effect…" But hope is not evidence.
A close call here, but we feel the failure to discuss these key limitations may give readers an unbalanced view of how far along this research is.
No disease-mongering here.
There was no discussion of the fact that the study was funded by the drug’s developer, Roche. Nor was there any discussion of the ties between the study authors and the company.
The story notes that conventional chemotherapy is typically effective only in 10 percent to 20 percent of advanced melanoma cases.
The story notes that the drug is "experimental" and in "early phase" testing, suggesting that it is not widely available.
This story didn’t adequately characterize what’s new about this drug compared with existing treatments. The new drug affects only melanoma cells with a specific genetic mutation; this makes it much more targeted than other approaches such chemotherapy, which destroy all fast-dividing cells including healthy ones.
The story includes an interview with one of the study investigators, so we can be sure it isn’t based on a news release.