The story discusses the preliminary results of lapatinib (trade name Tykerb) and chemotherapy in HER-2 positive metastatic breast cancer patients. Patients who took lapatinib and the chemotherapy drug Xeloda remained stable (i.e. cancer did not spread further) nearly twice as long as patients who only had chemotherapy (8.5 months vs. 4.5 months). However, many drugs are effective in prolonging response in metastatic disease without impacting length of life. It would be good to get survival data to back up these claims, or at least provide data on quality of life to see whether the addition of lapatinib made a difference and how much. Additionally, the results of this trial have not been scrutinized in a peer-reviewed medical journal.
The story provides a powerful, but premature suggestion of equivalence between Herceptin and lapatinib. The suggeston is not evidenced based, as the two drugs have not been compared in a controlled trial. Potential cardiac side effects are a big issue for early-stage breast cancer patients, the group of women for whom this drug is already being tested as an alternative to Herceptin, so further research comparing the two drugs is needed.
This story relies solely on sources associated with the drug manufacturer. It also appears to rely heavily on information from a press release by the study sponsor, GlaxoSmithKline. Other oncology researchers are needed for perspective on the results of lapatinib as part of treatment for HER-2 positive cancer. The story mentions that lapatinib is still being tested in clinical trials and is not yet available for sale. The story says that “GlaxoSmithKline plans to submit the drug for regulatory approval in the U.S. and Europe by the end of this year,” and later mentions Glaxo’s “high hopes for Tykerb.” It would have been better to get some other perspectives about these prospects, other than comments from the company or company-sponsored researchers.
The story does not mentioned the proposed cost of lapatinib.
The story provides early data from a trial of metastatic breast cancer patients. Cancers in these patients remained stable (i.e. it did not spread further in the body) nearly twice as long with the addition of lapatinib to chemotherapy (8.5 months vs. 4.5 months). There were fewer incidents of metastases to the brain in the women who took lapatinib and chemotherapy compared with chemotherapy alone (4 vs. 11 cases of cancer spreading to the brain). However, many drugs have been shown to effective in prolonging response in metastatic disease without impacting length of life so it would be good to get data on survival data to back up these claims or at least on quality of life to see whether it made a difference and how much.
Cardiac side effects are reported as less serious than those seen in patients who were treated with Herceptin and chemotherapy. However, this comparison with Herceptin is not a fair one. In trials of Herceptin, the incidence of cardiac problems was about 4% at 3 years, so the reduction to 2.5% with lapatinib appears to be an improvement, but there is not enough information in this story on length of time patients took lapatinib and Herceptin to get those figures (and whether those are statistically different). Although long-term cardiac problems are less of an issue for metastatic patients, this side effect is potentially a big issue for early-stage breast cancer patients – a group of women for which this drug is already being tested as an alternative to Herceptin.
The story does a good job describing the trial design and discussing the preliminary outcomes for further metastases and cardiac effects. However, the story provides a powerful but premature suggestion of equivalence between Herceptin and lapatinib and suggests that lapatinib may have superior benefits and reduced harms – despite the fact that the trial was in only 392 patients and it wasn’t a head-to head comparison with Herceptin.
There is no evidence of disease mongering. The story accurately notes that only 20-25% of women would be eligible to take lapatinib, as they have the more aggressive form of breast cancer.
The story relies solely on sources associated with GlaxoSmithKline. The lead author of the study is cited, however, the study was sponsored by this drug manufacturer. Additional oncology researchers are needed for perspective on the results of lapatinib in metastatic breast cancer patients.
The story mentions Herceptin (generic name trastuzumab) and chemotherapy (here, Xeloda) as other treatments for HER-2 positive breast cancer.
The story mentions that lapatinib is still being tested in clinical trails and is not yet available for sale. The story says that “GlaxoSmithKline plans to submit the drug for regulatory approval in the U.S. and Europe by the end of this year,” and later mentions Glaxo’s “high hopes for Tykerb.” It would have been better to get some other perspectives about these prospects, other than comments from the company or company-sponsored researchers.
Tykerb (generic name lapatinib) is a new drug for the treatment of metastatic HER-2 positive breast cancer. The story discusses the mechanism by which this drug would inhibit tumor-cell growth.
The story acknowledges that it took a quote from the principal investigator from a statement released by the drug company. The only other perspective in the story comes from a drug company staff scientist. There is no evidence of any independent reporting.
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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