The release focuses on a small, phase 2 study which evaluated the use of the drug trastuzumab in conjunction with conventional chemotherapy to treat women who have been diagnosed with a form of cancer called uterine serous carcinoma (USC). The release does a good job of describing the study and articulating the limited nature of the benefits — it appears to limit cancer growth for some months, but is not a cure.
The release’s headline is misleading when it claims the new combo “improves survival” and neglects to clarify that progression-free survival may not translate to improved overall survival.
In addition, the release does not address cost or delve into specific harms. Although it mentions the disease is rare, the release could have stressed even more that few patients have the characteristics necessary to make this treatment a viable option.
As the release notes, USC is somewhat rare, but it is aggressive. Patients and their loved ones will likely be eager to hear about a new treatment option that has the potential to add months to a patient’s life. But as we’ve seen all too often, early hype surrounding early stage trials is often not confirmed in larger studies. That makes it particularly important to highlight that only a subset of patients may be eligible for the treatment — if and when it becomes available for use in treating USC. That said, the release as a whole does a good job of striking a cautious note in describing the research.
Cost is not discussed, which is unusual given that trastuzumab is already on the market (under various trade names) for use in breast cancer treatment. And the cost associated with those treatments is significant. For example, the cost of a trastuzumab treatment called Herceptin can cost $4,500 per month.
The release does a good job articulating what the benefits were (as expressed in months of survival during which the cancer did not spread) and how those benefits differed depending on whether patients had an advanced stage of USC or a recurrent case.
But the release didn’t explain the limitations of progression-free survival as a surrogate for overall survival and that’s a big omission.
Potential harms were not addressed. This trial was relatively small, with only 58 patients, and the relevant journal article notes that the trastuzumab “was well tolerated” by study participants. However, because trastuzumab is already in clinical use for treating other cancers, we know that it is associated with some risks. And those risks are not insignificant. For example, Herceptin’s manufacturers note that the drug “can result in sub-clinical and clinical cardiac failure” — and that is in addition to more common, but less severe, adverse reactions.
Although practices vary, patients need to be monitored with an echocardiogram while on trastuzumab.
Sometimes patients with existing heart problems may be precluded from getting this drug. The abstract, but not the release, addressed risks but only in part, when it states: “Toxicity was not different between treatment arms, and no unexpected safety signals emerged. Conclusion: Addition of trastuzumab to carboplatin-paclitaxel was well tolerated and increased progression-free survival.”
The release provides a good overview of the study but didn’t list any of the limitations found in the published report.
The study noted several study factors that could have introduced bias or overestimation of the results:
The release clearly notes that the study was funded by a company that produces one brand of trastuzumab, which is good. The release also notes that one of the researchers had reported a consulting or advisory role for a pharmaceutical company. Since it mentioned that researcher’s potential conflict of interest, it would be easy to assume that the other researchers (who were not mentioned) did not have potential conflicts of interest. That assumption would be incorrect. The journal article itself makes clear that several other researchers had conflicts of interest, including one researcher with ties to another pharmaceutical company (Genentech) that makes a different brand of trastuzumab.
In this case, the alternative to taking trastuzumab with conventional chemotherapy is to not take trastuzumab with conventional chemotherapy — i.e., the control group in the study. The release covers this.
According to Cancer.Net, “Uterine cancer is treated by 1 or a combination of treatments, including surgery, radiation therapy, chemotherapy, and hormone therapy.”
The release notes that researchers have submitted their findings to the National Comprehensive Cancer Network, “which guides the design of standard treatment plans around the country.” However, it’s not clear when or whether USC patients may have access to trastuzumab — either through FDA approval or via off-label prescriptions by health care providers. More importantly, though, the release could be a bit more clear on the percentage of patients with uterine cancers who may benefit from trastuzumab. There are bits and pieces of information scattered throughout the release, but it would be good to pull them together and add up what it all means. Here’s what we’re talking about (bear with us): according to the American Cancer Society, there are expected to be about 63,230 new cases of uterine cancer diagnosed in the U.S. in 2018; about 92 percent of those uterine cancers are likely to be endometrial, bringing the number to around 58,171; approximately 10 percent of those endometrial cancers will be USC, bringing the number to 5,817; and about 30 percent of those patients with USC test positive for HER2/neu receptor proteins that trastuzumab blocks. In other words, of the 5,817 women who may be diagnosed with USC in 2018, only 1,745 of them may be able to benefit from trastuzumab. That’s an important idea to get across clearly.
The release makes clear what is novel about the research.
The release’s headline is misleading when it claims the new combo “improves survival.” The study found some patients had four to eight months of progression-free survival. That’s not the same things as overall survival and that needed clarification.
We give the release credit for taking a more cautious tone in other parts of the release.
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