Drug may prevent lung cancer, study finds

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No price tags. A New York Times article from 2005 discussed the expense of drugs like Tarceva. According to drugstore.com, the regimen used in the study costs $4700 a month. Iloprost isn’t cheap, either.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

No data are presented for the iloprost study. As this was the lead item in the article, we have to give an Unsatisfactory rating. Even though preliminary data from a conference presentation has to be taken with a skeptical eyebrow, the public learns even less from a vague, flat, non-quantified summary of the benefits. 

Some data are presented for the erlotinib study.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

No harms of iloprost or erlotinib are mentioned. In the iloprost study, 11% of subjects receiving the drug reported serious adverse events. That’s a pretty big omission.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

Both halves of the story were good to point out the number of subjects and placebo control groups in each study. The venues for presentation and trial phases are critical pieces of information, but terms like Phase II aren’t meaningful to most people. They should have been explained.

Regarding the iloprost study, the marquee topic, the story fails to point out that Phase II data reported at conferences are preliminary. Although the article acknowledges that further study is needed, it simply quotes the abstract and provides no context. It should’ve been clearer that conference abstracts haven’t gone through full peer review process. It also doesn’t explain, related to the key finding, what it means to have significant improvement in "endobronchial dysplasia." The study looked at changes in lung tissue. From the abstract, it doesn’t seem that study made any clinical assessments or diagnoses. In other words, the study didn’t tell us which subjects did and did not ultimately develop lung cancer. While the drug may prove effective towards that end, this study doesn’t tell us.

Also missing from the details on the iloprost study was the fact that the study didn’t enroll just smokers and ex-smokers: it enrolled those at increased risk of lung cancer because they had abnormal cells in their sputum. According to one study, most but not all smokers have this risk factor.

The second half of the story begins by citing vague, unnamed research about myo-inositol in the prevention of lung cancer. No evaluation of the quality of this evidence was provided, nor was there a way for readers to find out more.

Then we move to a published study of erlotinib maintenance therapy for patients with advanced lung cancer. We’re unsure how it’s connected to the previous half of the article, as the heading is simply "Italian research." The reporting of this study is slightly better than the iloprost coverage, including some actual data. But without caveats for the studies discussed previously, we’re led to think the three studies are of equal high quality. Most readers will not be able to decode terms like "Phase 2," "Phase 3," "presented to a meeting," and "reported in Lancet Oncology." If the author had decided to cover a smorgasborg of disparate lung cancer news, which there’s nothing wrong with, it should not have implied that the first study was on equal footing to the second. 

It would have also been good to note whether the "little" differences in the erlotinib study were statistically significant. (They were.) An independent source could’ve spoken to the clinical significance of these results. (For example, the accompanying Lancet Oncology editorial suggests that they were only compelling enough to change therapy for the subgroup who had EGFR mutations.)

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

Independent sources were entirely absent. An independent voice might have added the missing caveats to the preliminary nature of the iloprost data, the fact that the results had already been presented last year, etc.

For the coverage of the erlotinib study, independent appraisal might have added some objective context beyond taking the investigators’ claim that their study shows that more clinicians should follow their strategy. The independent source could have been the Lancet Oncology editorial that accompanied the erlotinib study, which discussed some potential limitations in this approach in clinical practice, e.g., regarding EGFR mutations and a history of chemotherapy treatment. Finally, an unaffiliated voice may have pointed out the history and context: in April, the FDA used the results of the erlotinib study to approve Tarceva for the use in maintenance therapy, and not without some controversy. It was against the recommendation of the FDA’s advisory panel, who voted 12-1 vote against approval. (See this article for more details.) The story makes the publication of this study in the journal sound like a bombshell in a vacuum.

No conflicts of interest were identified. The erlotinib study was funded by a drug company.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

As the first study did not show that the drug can prevent cancer, no alternative needs to be mentioned. The story did mention a natural supplement that was recently studied for prevention; we think this nod was so fast and vague, it was more confusing than helpful. It almost felt like a non sequitur.

The story mentions that less than half of patients with successfully treated lung cancer currently receive maintenance therapy thereafter. Besides no treatment, none of the alternatives are mentioned.

Does the story establish the true novelty of the approach?

Not Satisfactory

A mixed bag here. The story establishes that iloprost is currently not approved for the prevention of lung cancer. It’s unclear about the novelty of the oral formulation in any indication. Also, it seems that the study was already reported at a different conference in August 2009, which had some press coverage. There may have been further analysis, but the conclusion seems to have been the same. It speaks to newsworthiness of the 2010 presentation.

Regarding erlotinib, the story tells us that less than half of patients with successfully treated lung cancer currently receive maintenance therapy thereafter. What’s missing is that Tarcvea is already approved for this use, due to earlier access to the results of the Italian study. It’s a pretty important piece of information, and it would’ve put the news in much more context.