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Breast Cancer Drug Looks More Promising

Rating

3 Star

Breast Cancer Drug Looks More Promising

Our Review Summary

This story discusses the drug Herceptin as a “promising” drug for both early and late-stage breast cancer. Currently, Herceptin is only approved for late-stage breast cancer, though some women in the early stages of breast cancer have been included in clinical trials. Two of these clinical trials reported in this story are randomized studies that tested different combinations of drugs. The article notes that Herceptin is only useful in about one-quarter of breast cancers, but there is no mention that women must first be screened (via a test on the biopsy or tumor, which may be presented in a pathology report) to determine if they are among this group. There is little long-term data on the survival benefit of Herceptin, and only recurrence rates (after two and three years) are available in this news story. The story is balanced in that it presents Herceptin as an adjunct to existing adjuvant breast cancer treatment regimens, but some of the serious side effects of heart failure seem to be downplayed, and there is no perspective on frequency or severity of heart disease. That data on heart disease would be important information for women with early stage breast cancer who are expected to live longer. To claim that “Herceptin is very safe”, may be an overstatement at this time in the drug’s history.

Criteria

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

Satisfactory

The story provided

absolute numbers. One angle the journalist could have developed further: comparing the two studies at three years, the

Finnish groups are doing a lot better than the U.S. groups. What’s going on? Is it the patient population?

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

Not Satisfactory

There is no perspective on

frequency or severity of heart disease. Need to put magnitude of problem in perspective — the BCIRG study showed the cardiac

toxicity was significant and still persisted for more than 18 months at the date of the last follow up. Of the 3,222 patients

in the study, 353 experienced a greater than 10 percent loss of heart function. Of those, 91 patients (9 percent) were

enrolled in the ACT study arm; 82 patients (8 percent) were in the TCH arm; and 180 patients (17.3 percent) were in the ACTH

arm, which paired Adriamycin with Herceptin. Can argue whether this amount of loss of function is significant (only 3 on ACT

and 4 in other arms combined developed severe problems – left ventricular dysfunction) but for women who have high chance of

living many years with things other than breast cancer likely to cause their death it could be. Finally, the story only

discusses one potential harm of treatment, that of heart failure. And there’s no mention that heart failure may remain even

after the drug is discontinued.

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

Not Satisfactory

Both are

randomized trials that tested different combinations of drugs. The story briefly mentions randomization but doesn’t mention

anything else about the study design. It is important to mention the stage of breast cancer of women in the trials and if

they were those with the appropriate tumor profile and positive for HER2/neu overexpression.

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

Satisfactory

Potential conflicts of interest noted for pharmaceutical-funded studies and for

Dr. Slamon. Physicians not affiliated with drug company research also cited for balance.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Except for chemotherapyt, no other adjuvant therapies are compared with Herceptin in terms of risk of recurrence.

This drug is still very new and not as much data is available about adverse outcomes for women with early breast cancer.

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

Not Satisfactory

Does not explicitly state that

Herceptin is not currently approved for early stage breast cancer. Only being used in clinical trails for women with early

stage cancer.

Total Score: 6 of 10 Satisfactory

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