This HealthDay story covers a clinical trial of a new drug for breast cancer – one that may be useful in women with BRCA mutations. The opening sentence is misleading, saying that the drug, talazoparib, improves survival. The study found that talazoparib helped women go longer without progression of their cancer. It remains to be seen if they live longer. It’s an important distinction that we think should be made crystal clear for readers.
Also, there is already an FDA-approved cancer drug that works like this one. The story never explains: Why do we need another one? Is this one novel?
New treatments for breast cancer are newsworthy because the disease is one of the most common cancers in women. What’s not clear in this story is why this particular drug trial is important. Another drug on the market works similarly, so some information about why a second drug is worthy of study and worthy of news coverage would have been appreciated.
The story does not mention costs.
When a drug has not been approved, and thus is not on the market, it can be hard to estimate cost. In this case, however, there is a similar drug on the market: The PARP inhibitor olaparib (Lynparza) is $13,440 per month, without insurance, according to a 2015 report.
The story describes the drug’s benefit in terms of “progression-free survival.” Women who took talazoparib went three months longer without their cancer progressing, on average, as compared to women on standard chemotherapy. However, it did not give us precise numbers on this: What was the total, in months, before cancer progressed, in both groups?
According to OncLive, “at a median follow-up of 11.2 months, the median progression-free survival (PFS) was 8.6 months with talazoparib compared with 5.6 months” for the control group.
The HealthDay story also said women on talazoparib had a “higher response rate” than women on standard chemotherapy, but never explained what that means.
Most importantly, the story didn’t address the most important statistic: overall survival. Does the drug help women live longer? As we’ve explained, PFS is what’s known as a “surrogate marker” and is no guarantee of a longer life.
Drugs are frequently approved on the basis of uncertain markers such as “progression free survival,” which is the amount of time between treatment and worsening of symptoms. The drug Avastin won accelerated FDA approval to treat metastatic breast cancer based on its ability to delay tumor growth, but that approval was revoked when multiple randomized trials showed the drug didn’t improve survival and had significant side effects.
The story explained some of the harms, notably blood disorders, and included the rate of harms in both the treatment group and the control group, which is a useful comparison to include.
One detail that also would have been useful to include: The rate of severe adverse events was similar in both the treatment and control groups. The drop-out rate (how many women dropped out of the study due to side effects) was slightly higher in the talazoparib group.
The story gives some clues to the quality of the evidence. It mentions the size of the study (431 women), that treatment was randomized, and that funding came from the drug’s maker. However, it never discussed the limitations to the study. For example, the study was “open-label,” meaning that it wasn’t blinded–patients and researchers knew which drug was being given.
The story does not engage in disease-mongering. Some discussion of how many women grapple with this stage of breast cancer, along with treatment success rates, would have been useful to include, though.
The story mentions the study was funded by the drugmaker, Pfizer. It also clearly identifies one source, Jennifer Litton, as the lead researcher on the story.
The other quoted source, Marisa Weiss was not involved in the research. However, both Weiss and the organization she works for, Breastcancer.org, have received money from Pfizer. This was not disclosed in the story.
The story mentions another drug that has a similar mechanism of action, and is approved for BRCA-mutated breast cancer and ovarian cancer.
There is no discussion of how the drugs may differ with regard to harms or benefits–which we’ll address in novelty, below.
The story makes clear that talazoparib is not yet approved by the FDA.
The story doesn’t articulate what’s new about this finding — except the drug used. With another similar drug already on the market, what might this new drug offer? Is there an unmet need?
The story does not appear to rely on a news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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