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Cancer drug may elude many women who need it

Rating

3 Star

Cancer drug may elude many women who need it

Our Review Summary

This is a story about two presentations at the The American Society of Clinical Oncology (ASCO) meeting about evidence questioning the accuracy of tumor testing to determine which women qualify for treatment with trastuzumab (trade name Herceptin). 

Tumor profiling has been hailed as a new era in individualized cancer treatment, but reports from ASCO demonstrate the imperfect nature of the current science, either in the ability to consistently provide accurate results, or in the validity of the assumptions made in the tightness of the linkage between diagnostics, drugs and effectiveness tests.

The story lists some of the problems of inconsistent cutoff values for testing, but only provides limited quantitative evidence.

The story mentions trastuzumab as a promising drug in the arsenal of breast cancer treatments; however, the story does not mention that trastuzumab is given along with chemotherapy.  We are also not told that women take trastuzumab by infusion (IV) for up to a year.  This may be play into the cost/benefit decision making process of whether to retest formerly Her2/neu negative women, or whether it makes sense for them to now take the drug, regardless of their status.

The story only says that Herceptin is "expensive" but it doesn’t give cost estimates for the drug (about $20,000 per year) nor for the HER2 receptor testing. 

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story only says that Herceptin is "expensive" but it doesn’t give cost estimates for the drug (about $20,000 per year) nor for the HER2 receptor testing. 


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

Not Satisfactory

The story mentions that Herceptin could reduce the risk of recurrence by half. The story does not mention the benefit of re-testing women previously thought to be Her2/neu negative. And if these women are now considered positive, how will they receive Herceptin if they have already had chemotherapy? The story lists some of the problems of inconsistent cutoff values for testing, but only provides limited quantitative evidence.

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

Satisfactory

The story mentions the potential harms of treatment (i.e. slight increased risk of heart failure in some women).  The story also mentions that even women diagnosed as positive are not guaranteed benefit from the drug.

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

Not Satisfactory

The story mentions the known benefit of Herceptin for women classified as Her2/neu positive–that is a reduced risk of recurrence of about 50%.  The story mentions that double the number of women may benefit from Herceptin, but provides no further evidence of long-term benefit or any data comparing Her2/neu negative women with those diagnosed as Her2/neu positive.

The story also did not warn readers about reaching conclusions from unpublished data presented at a scientific meeting.  See our primer on this topic. 

Does the story commit disease-mongering?

Satisfactory

No overt disease-mongering, although there are elements of drug-mongering.  See "Benefits" below.

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

Satisfactory

The story is balanced in term of sources cited. The story identifies researchers who conducted reviews, oncologists in practice, the physician who designed guidelines for Her2/neu testing, and a representative from Genentech. Clinicians express frustration and confusion about a lack of standardization for determining who should receive Herceptin and similar treatments.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story mentions Herceptin as a promising drug in the arsenal of breast cancer treatments; however, the story does not mention that Herceptin is given along with chemotherapy.  We are also not told that women take Herceptin by infusion (IV), sometimes for up to a year.  This may be play into the cost/benefit decision-making process of whether to retest formerly Her2/neu negative women, or whether it makes sense for Her2/neu women to now take the drug.

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

Satisfactory

The story correctly points out that Herceptin treatment has been approved and available for about ten years, and discusses testing for the presence of the HER2 receptor. 

Does the story establish the true novelty of the approach?

Satisfactory

The focus of the story is new (unpublished) data from The American Society of Clinical Oncology meeting suggesting inconsistencies in the determination of Her2/neu status. Tumor profiling has been hailed as a new era in individualized breast cancer treatment, but recent reports from ASCO demonstrate the imperfect nature of the current science, either in the ability to consistently provide accurate results, or in the validity of the assumptions made in the tightness of the linkage between diagnostics, drugs and effectiveness.

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

Satisfactory

The story does not appear to rely on a press release as several sources are cited.

Total Score: 6 of 10 Satisfactory

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