This story reports on the FDA’s first approval of a drug to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.
The story addresses costs and laudably notes that the supporting study doesn’t address a key outcome: patient survival. However, it reports mainly from news releases, misses some important study limitations, and doesn’t include independent voices.
Certain breast cancers that affect women with inherited BRCA gene mutations are relatively small in number but difficult to treat, and they can disproportionately affect young women. As a result, drugs to treat these cancers are likely to be important news for certain patients and their families. The FDA gave its “priority review” status to olaparib, meaning it determined the drug “would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.” It’s dependent upon news stories to help put that into context that people understand–does it actually “significantly” improve patient lives?
The story says Lynparza “will cost $13,886 per month without insurance, according to AstraZeneca.” It mentions that the manufacturer is offering financial assistance to pay for it.
However, the story does not compare the cost to other treatments or address the question of whether insurance companies are expected to cover it, which are important questions now that the drug has been approved for use in breast cancer patients. Many patients with metastatic disease worry about reaching their lifetime insurance caps.
AstraZeneca also does not specify whether the financial assistance that will be provided will cover the full cost or some percentage of the cost, and how the degree of financial assistance provided will be determined.
The story says Lynparza “modestly delayed the time until cancer worsened — 7 months versus 4 months for women given one of three commonly used chemotherapies. About half the study participants responded to Lynparza compared with about a quarter of those only treated with chemotherapy. It’s unknown whether treatment increases survival.”
The story could have emphasized that last point more strongly. The outcome that was studied, known as progression-free survival, is a surrogate marker. In fact, the drug claims no benefit in terms of the most vital outcome: extending survival.
The story states: “Possible side effects are less severe than for chemotherapy, but serious problems can include blood and bone marrow cancers. Common side effects include nausea, fatigue, respiratory infections and blood count problems.”
Although this would be a rare concern, the FDA also says: “Lynparza can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception. Women taking Lynparza should not breastfeed as it could cause harm to a newborn baby.”
The story could have dug deeper into the study’s limitations. For example, it does not say how long the study lasted or what further testing is needed to determine whether responses may vary among different subsets of patients.
According to the American Society of Clinical Oncology, “Given the relatively small size of the study, it is difficult to tell which subset of patients would benefit the most from olaparib.” Further, “More research is needed to determine how well olaparib works in cancers that worsen despite platinum-based chemotherapy, a standard regimen not included in this study, and whether platinum-based chemotherapy would be useful after cancers worsen despite olaparib.”
The story does not engage in disease-mongering. However, it could have been more clear in conveying the number of breast cancer patients who might be candidates for this drug. It states:
“About 250,000 people each year are diagnosed with breast cancer and just over 40,000 die from it, according to the National Cancer Institute. About 20 percent to 25 percent of patients with hereditary [emphasis added by us] breast cancers have a BRCA mutation. BRCA-related breast cancer often strikes younger people and is harder to treat than other breast cancers.”
The story doesn’t say how many people diagnosed with breast cancer actually have a BRCA mutation. According to ASCO, “Up to 3% of all breast cancers occur in people with inherited changes in genes BRCA1 and BRCA2.”
The story does not contain any independent sources. Also, it quotes Dr. Susan M. Domchek at the University of Pennsylvania’s Abramson Cancer Center without stating her institution’s role in the clinical trial.
The story just briefly mentions the alternatives–chemotherapy.
The story says the FDA just approved the drug for patients with inherited BRCA gene mutations who have undergone chemotherapy, and that it’s been on the market since 2014 for ovarian cancer. Presumably, that means it’s widely available.
But, it then mentions that a “companion” blood test was also just approved to look for these genes. It’s not clear if this test specifically will be required before women receive the new drug, and if that test will be available right away.
The story describes this as “the first drug aimed at women with advanced breast cancer caused by an inherited flawed gene” and “the first in a new class of medicines called PARP inhibitors to be approved for breast cancer.”
While the story does not mimic a news release word-for-word, it relies heavily on two news releases, from AstraZeneca and the FDA. Both of the quotes in the story are from these news releases, for example.
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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