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Short stint of Herceptin holds promise for breast cancer
March 05, 2006
"Administering a short course of the drug Herceptin prior to chemotherapy improves survival among certain women with early-stage breast cancer, a new study suggests. Still, experts say it's unclear how long the drug should be used to get the optimum benefit. Usually it's administered for a longer period after chemotherapy. ""What's intriguing is that their rates of breast cancer survival were similar to a study that gave Herceptin for a year,"" said James A. Stewart, an oncologist and professor of medicine at the University of Wisconsin's Comprehensive Cancer Center in Madison who was not involved in this study. ""It's a teaser,"" he said. ""It really makes you wonder how long you need to treat with Herceptin. Do you need a year, two years or less? We really don't know."" "
Our Review Summary
This story discusses the results of a recent study involving women with high-risk early breast cancer (node positive or >2cm, age younger than 66 - there were 25 year olds on the trial). One aspect of this trial focused on the short-term use of Herceptin with chemotherapy. Women with overexpression of the HER2/neu gene, as measured by the CISH immunohistochemistry, were randomly assigned 9 weeks of Herceptin or no Herceptin immediately following breast cancer surgery and in conjunction with certain types of chemotherapy. This regimen of treatment differed from other trials in which Herceptin was given for 12 months following chemotherapy. In this study, the drug was given in conjunction with certain types of chemotherapy, but before radiation and chemotherapy regimens known to damage the heart. The journalist states the Herceptin was given "prior to chemotherapy," which is not completely accurate. Herceptin is only FDA approved to treat advanced breast cancer, but it is used in clinical trials in early-stage breast cancer. However, this is not mentioned in the story. There is adequate discussion of the study design and reporting of disease-free survival at 3 years follow-up. There was little discussion in the piece of the side effects of chemotherapy as reported in the trial, but the addition of Herceptin was the main focus of the story. While the journalist provides quantitative benefit of 9 weeks of Herceptin vs. no Herceptin, and notes no cardiac failure in the Herceptin group, the follow-up period of 3 years may not be long-enough to determine the effects of chemotherapy and Herceptin on the heart. Overall, the journalist did a good job describing the randomization, as well as putting the results into context of other trials, and into context of how this may or may not change providers' practice. The story could have better stated the limitations of analysis for such a small subgroup (116 in each arm). The small sample randomized to Herceptin certainly warrants more study, and although the relative benefits were large, these women still had fairly good recurrence free survival -- 80% w/o and 90% with -- so although it looks like that will translate to overall survival. The question for women with overexpression of the HER/neu gene is: How much do you want to do to avoid recurrence? Sources in addition to the study investigators are cited, which provides some balance to the piece, however, there is no mention that the trial was funded in part by pharmaceutical companies. Some study investigators also receive research funding from drug companies.
Click on Criteria for definitions.
Herceptin is only FDA approved to treat advanced breast cancer, but is used in clinical trials in early-stage breast cancer. This is not mentioned in the story.
Mentions cost for one year of Herceptin as $40,000-$50,000.
Appropriately discusses the percentage of women who are eligible for Herceptin due to overexpression of HER2/neu. The story would have been helped by some context for the risk these women face. As Herceptin is used earlier and earlier these women have less to gain because they have less risk to begin with. Relative risk reductions may be very high but the absolute is not as big.
One aspect of this trial focused on randomization of women with Her2/neu overexpression to 9 weeks of Herceptin or no Herceptin immediately following breast cancer surgery. The drug was given in conjunction with certain types of chemotherapy, but before radiation and chemotherapy regimens known to damage the heart. The journalist states the Herceptin was given "prior to chemotherapy", which is not completely accurate. There is an adequate mention of the study design and discussion of disease-free survival at 3 years follow-up. Good job putting the results into context of other trials, and into context of how this may or may not change providers' practice. The story could have better stated the limitations of analysis for such a small subgroup - 116 in each arm.
Mentions potential harms of Herceptin on the heart, especially when given after certain chemotherapy. The story does not mention that there were side effects with certain chemotherapy drugs and doses needed to be decreased during the course of the trial.
Novel use of Herceptin for short-term treatment prior to anthracycline chemotherapy.
Mentions quantitative benefit of 9 weeks of Herceptin vs. no Herceptin with certain chemotherapy. Also, while no women in the Herceptin group had cardiac failure at 3 years, the follow-up period may not be long-enough to determine the effects of chemotherapy and Herceptin on the heart.
No evidence that this story relies on a press release.
Sources in addition to study authors are cited. No mention that this trial was funded in part by pharmaceutical companies. Some study investigators also receive research funding drug companies. Other doctors cited express caution about the early results of Herceptin studies, so there is some balance to the piece.
The women in this trial had undergone breast cancer surgery and those with ER+ tumors were taking Tamoxifen. This is not explicitly mentioned, only that treatment took place following surgery. Still OK.
Total Score: 9 of 10 Satisfactory
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