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Read Original Story

FDA approves new drug to treat aggressive breast cancer

Rating

3 Star

FDA approves new drug to treat aggressive breast cancer

Our Review Summary

 This story reports oon FDA approval of a new targeted cancer drug for treatment-resistance metastatic breast cancer. The story mentions that lapatinib (trade name Tykerb) is a tailored treatment for women with the HER2/neu gene and advanced (metastatic) breast cancer.  The story does mention Herceptin, chemotherapy and other drugs as treatments typically used prior to lapatinib.   The story does not mention the side effects reported by patients in clinical trials. These included:  gastrointestinal problems, and hand-foot syndrome which may include numbness, tingling, redness, swelling and shortness of breath. More serious, but rare reports of heart failure (in most cases reversible) were also reported in clinical trials. The story should have included the cost of this new drug, which is $2,900/month and the fact that it is approved for use with another drug – capecitabine(Xeloda). The failure to include comments about the side effect profile of Xeloda is significant. Xeloda costs about $1,500/month. Additionally, the story does not mention the cost of this newer drug treatment or if it is covered by Medicare or private health insurance.  

Unfortunately, a wonderful opportunity was missed in the reporting of this story.  Far from "a godsend", lapatinib is a useful addition to existing treatments for advanced breast cancer.  The ease of use and relatively low side effect profile make the drug a valuable addition when combined with Xeloda.  The story fails to note any quantitative evidence from clinical trials on tumor response to lapatinib. Women with advanced  breast cancer need this information so they can weigh the pros and cons of taking yet another round of treatment.

The story instead provided only one woman's anecdotal response, which gave the viewer a greatly exaggerated impression of the value of this new drug.  The reality is that advanced breast cancer is a terrible problem for which there are still no good answers.  While the treatments are better, none are curative.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention the cost of this newer drug treatment or if it is likely to be covered by Medicare or private health insurance. This should have been included since the drug costs $2,900/month and is approved for use with capecitabine(Xeloda).  Xeloda costs about $1,500/month.

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

Not Satisfactory

 The story provides no quantitative evidence on the benefits of lapatinib over other targeted therapies for aggressive breast cancer. The story also does not list the incidence of side effects common among women who took lapatinib with capectabine (Xeloda), another cancer drug.  The response rate is only 1 in 4 in combination with Xeloda with a median time to tumor progression of 6 months. 

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

Not Satisfactory

The story does not mention the side effects reported by patients in clinical trials. These included:  gastrointestinal problems, and hand-foot syndrome which may include numbness, tingling, redness, swelling and shortness of breath. More serious, but rare reports of heart failure (in most cases reversible) were also reported in clinical trials. The story mentions there are "fewer side effects" with targeted therapies, but this is not necessarily the case, especially since these drugs are taken in combination with chemotherapy or other cancer drugs. The story mentions that this treatment in pill form is "easier to take" than Herceptin, but that might not be the case for all women. We are not told how long a woman needs to take lapatinib vs. Herceptin.  In addition, the failure to include comments about the side effect profile of Xeloda is significant.

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

Not Satisfactory

There is no quantitative evidence from clinical trials presented in this story. Instead the story relies on one woman's testimony that the "drugs were a godsend", and a reporter's comment that she is now cancer-free.  This anecdotal evidence is misleading and would suggest that these drugs cure metastatic cancer, when they may only shrink existing tumors and prevent others from recurring.  The story should provide data in order that women with this form of cancer can weigh the pros and cons of taking yet another round of treatment to treat their breast cancer. Additionally, lapatinib is a new drug and there is not yet data on whether this drug helps women with metastatic breast cancer live longer than with other therapies.

Does the story commit disease-mongering?

Satisfactory

The story does not engage in disease mongering because it hints at the fact that this drug is only for the 20-25% of women with the HER2/neu gene who have taken other medicines to treat advanced cancer, but for whom these drugs have stopped working.

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

Not Satisfactory

The story does cite two breast cancer specialists who discuss targeted therapies for breast cancer, but the story doesn't explain if they were involved in the trials or if they have any potential conflict of interest.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story does mention Herceptin, chemotherapy and other drugs as treatments typically used prior to lapatinib in women with metastatic cancer.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

It's clear from the story that lapatinib (trade name Tykerb) has just been approved by the FDA.  

Does the story establish the true novelty of the approach?

Satisfactory

The story mentions that lapatinib (trade name Tykerb) is a tailored, second line treatment for advanced breast cancer. This drug is for the treatment of metastatic HER-2 positive breast cancer. However the failure to note the necessity of a second drug is a major flaw in the reporting.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The information presented in this story is not taken directly from the FDA press release. Two independent sources are cited to provide some background on newer targeted drugs used to treat aggressive forms of breast cancer.

Total Score: 5 of 10 Satisfactory

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