Herceptin Advantage Continues Strong
This, from MedScape, is the report of a study presented at ASCO earlier this month. The good news about the efficacy of herceptin continues.
Here is the summary and then a link to read more:
Trastuzumab Adjuvant Survival Benefit: Going Strong at 4 Years Lidia Schapira, MD
Treatment With Trastuzumab for 1 Year After Adjuvant Chemotherapy in Patients With HER2-Positive Early Breast Cancer: A 4 Year Follow-up of a Randomised Controlled Trial
Gianni L, Dafni U, Gelber RD, et al Lancet Oncol. 2011;12:236-244
The HERA (Herceptin® Adjuvant) trial, an international, multicenter, randomized, open-label, phase 3 trial, compares treatment with trastuzumab for 1 and 2 years with observation after standard neoadjuvant or adjuvant chemotherapy in patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival (DFS). After a positive first-interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation, event-free patients in the observation group were allowed to cross over to receive trastuzumab.
Gianni and coworkers reported the outcomes for the trastuzumab and observation groups at a median follow-up of 48.4 months and assessed the effect of the extensive crossover from the observation group to trastuzumab treatment. The HERA trial involved 1698 patients randomly assigned to an observation group and 1703 patients to the 1-year treatment with trastuzumab group. Of the1698 patients in the observation group, 885 (65%) crossed over to trastuzumab, corresponding to 52%. These patients tended to be younger; to have received anthracyclines and taxanes; and, to a lesser extent, to be premenopausal with hormone-positive breast cancer that was node positive. Intention-to-treat analysis of DFS showed a significant benefit in favor of patients in the 1-year trastuzumab group compared with the observation group. Intention-to-treat analysis of overall survival showed no difference. Patients from the observation group who crossed over to receive trastuzumab began treatment at a median of 22.8 months from randomization. Patients in the selective crossover cohort had fewer DFS events than patients in the observation group. Higher incidences of grade 3-4 and fatal adverse events were noted in the 1-year trastuzumab group compared with the observation group. The most common adverse events (each < 1%) were congestive heart failure, hypertension, arthralgia, back pain, infection, vasomotor symptoms, headache, and diarrhea. As reported previously, 1 cardiac death occurred in the observation group. More patients on 1-year trastuzumab had congestive heart failure with a confirmed drop in left ventricular ejection fraction.
The investigators concluded that treatment with adjuvant trastuzumab for 1 year after chemotherapy is associated with significant clinical benefit at 4-year median follow-up. The substantial selective crossover from the observation group to trastuzumab treatment was associated with improved outcomes for this cohort.