We gave this story the benefit of the doubt on several jump-ball scoring decisions.
Benefits were vaguely described.
Harms were vaguely described but not quantified so readers had no sense of the scope of potential problems.
The saving grace was the input from Dr. Len Lichtenfeld of the American Cancer Society, offering important independent analytical perspectives.
Women with HER2-positive breast cancers hang on any news about potential progress. They deserve a more clear breakdown of harms and benefits than what was provided in this story.
HER-2 positive breast cancer is an aggressive form of the disease. Earlier studies have suggested that women with the marker have a higher likelihood of recurrence than those without the HER-2 protein. This study is an early proof of concept study that was designed to determine if early and prolonged treatment with a standard chemotherapy drug and two drugs that block the HER-2 protein would result in better tissue response as measured by pathology. Importantly, the study was not designed to see if the combination would prolong the disease free interval or result in better 5 year survival. While the results are encouraging, additional studies are needed to see if the combination is successful.
Cost of Tykerb was estimated – about $4,000/month wholesale. No mention of Herceptin’s cost. Strange to include one but not the other since this was a story about a “drug duo.”
Cost is always an important consideration in this type of story. This is especially true when the drug costs are so high. The drug costs for the combination regimen approaches $100,000 a year. Since the combination treatment is not standard, insurance coverage will be spotty at best.
The first 1/3 of the story repeatedly referred to “response…massive improvement in response” but never really defined what that meant for lay readers. The story then said that the researchers could “see how the approaches affected survival” but later quoted Dr. Len Lichtenfeld of the American Cancer Society saying the question of overall survival has not been answered. This is terribly incomplete and confusing.
There was a high level description of possible side effects from these drugs. But no sense of the scope of these problems was provided.
More diarrhea? More frequent liver-enzyme alterations? Deaths have been reported?
How much more? How many deaths?
If you can quantify ill-described “response,” you can quantify the harms.
The quote from Lichtenfeld of the American Cancer Society is the only saving grace on this criterion:
The important question, however, has not been answered yet, Lichtenfeld said. That’s the effect on overall survival in using the two-drug approach. The researchers are continuing to evaluate that.
No disease-mongering at play here. It may have been useful to note that 20-25% of all breast cancers are HER-2 positive.
One independent source quoted. Drug company funding of the study was noted.
There was no comparison given with past research about pre-operative chemotherapy attempts to alter the course of breast cancer outcomes.
Readers have to connect the dots to figure out the availability of these drugs. We’re told that Tykerb was approved in 2007 and we’re told its retail price – so you can infer that it’s available. There was no overt description of the availability of Herceptin.
We’ll call this satisfactory by a weak nod.
We’ll give the story the benefit of the doubt for at least offering this perspective:
“Lapatinib (Tykerb) was approved for advanced breast cancer in 2007,” Baselga said. “The question we had was, what is the efficacy if we give it in early-stage breast cancer prior to surgery?”
It does not appear that the story relied on a news release.