A combination of chemotherapy and Herceptin significantly increases survival in women with early-stage aggressive breast cancer, according to a study by UCLA’s Jonsson Comprehensive Cancer Center published in the October 6, 2011, edition of the New England Journal of Medicine.
Also, anthracyclines aren’t required to treat early-stage breast cancer successfully, and the associated toxicities can and should be avoided, said study lead author Dennis Slamon, MD, PhD, whose basic laboratory and clinical research led to the development of Herceptin.
“We’re encouraged that the survival advantages found in this study have been maintained and continue to be significant,” said Slamon, director of clinical/translational research at UCLA’s Jonsson Comprehensive Cancer Center. According to Slamon, this is the first time that overall survival has been measured to this extent (a little more than 5 years out) in this population of breast cancerpatients.
Between April 2001 and March 2004, the study enrolled 3222 women with early-stage breast cancer. Patients were randomized to 1 of the 3 arms:
1. Adriamycin and carboplatin followed by Taxotere (ACT)
2. ACT plus 1 year of Herceptin (ACTH)
3. Taxotere and carboplatin with 1 year of Herceptin (TCH)
The study determined a survival advantage for patients in the Herceptin-containing arms, with the following results after 5 years:
- The survival rate for patients on ACTH and TCH was 92% and 91%, respectively
- The survival rate for patients on the ACT arm was 87%
- The estimated disease-free survival for patients receiving ACTH and TCH was 84% and 81%, respectively
- The estimated disease-free survival for patients on the ACT arm was 75%
To determine whether oncologists could provide a therapy as effective as ACTH without the resulting toxicities, the study specifically tested Herceptin with and without anthracylines. The study’s primary end point was disease-free survival, but it also measured overall survival, safety (cardiac toxicities), pathologic and molecular markers, and quality of life. The study, Slamon said, showed that the patients who were not treated with Adriamycin had much less heart toxicity, yet they still had outcomes similar to those who were treated with Adriamycin.
“Given the data in this study, it makes one really question what role Adriamycin should play in the treatment of HER-2 positive early breast cancer, or in the treatment of early breast cancer at all,” Slamon said. “This trial should impact the way these breast cancers are treated, with a non-anthracycline regimen being our preferred option. I think this is a change that is going to be slow in coming, unfortunately, as many of our adjuvant treatments for breast cancer are built on the backbone of anthracyclines. While they’re effective, whatever gain patients may receive is more than made up for in the serious and chronic long-term side effects.”
Source: UCLA Jonsson CCC.