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Associated Press

SAN ANTONIO - The drug Herceptin, already viewed as promising for women with both early and late-stage breast cancer, got another boost Thursday with new research showing the heart damage it sometimes causes might be avoidable.

It also might still be effective when given for a shorter time, a finding that could drastically lower the cost of the pricey treatment.

At a meeting of more than 7,000 breast cancer experts on Thursday, Finnish doctors said nine weeks of Herceptin instead of the usual year prevented recurrences and didn't raise the risk of heart failure....

The original article can be found at: http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20051209/breast_cancer_drug_051209/20051209/

The original article can found in the Media Doctor archives.

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This coverage is part of the emerging story of the effects of Herceptin in women who have been treated for HER-2 positive breast cancer and its potential link to cardiac failure. This study compared three different regimes in 3,222 women: Adriamycin (an anthracycline) and carboplatin with Taxotere (ACT); standard treatment plus a year of Herceptin (ACTH); or a combination of Taxotere and carboplatin plus Herceptin but no anthracycline (TCH).

The key fault with this story is in clearly, and definitively describing in absolute terms, the nature of the harm versus the benefit of the drug. As well, the study combined endpoints such as noting that after two years "147 of the women on standard treatment had died or relapsed compared with only 77 and 98 women in the two groups, respectively, that got Herceptin." While this makes it sound like Herceptin is wonderful, one cannot draw that conclusion without knowing how many of those women fell into the 'relapse' group and how many into the 'death' group.

There was information in the press release that didn't make it in the story. One press release, issued by PR Newswire noted the benefits in relative terms and the cardiac side effects in absolute terms: "The relative reduction in the risk of relapse was 51% [95% CI: 35%-63%] and 39% [95% CI: 21%-53%] for the AC-TH and TCH arms, respectively, compared to the AC-T control arm." The cardiac events are reported as follows: " 1.2%, 2.3% and 1.2% for the AC-T, AC-TH, and TCH arms respectively ."

From the other press release, issued by UCLA Jonsson Comprehensive Cancer Centre
"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. In other words, the risk of experiencing a greater than 10% loss of heart function in the latter group was nearly twice what it was in the former two groups."

A final point on terminology: In this case "disease-free survival time" is the language used in the press releases, and yet not replicated in the article. Being 'disease-free' means not having a recurrent tumour, but this is distinct from "survival" meaning not dying. It can be potentially misleading to suggest, as some stories on cancer therapies have done, that 'disease free survival' is the same as 'survival'. They are two distinct things.

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