Adjuvant HER2-Targeted TherapyAdjuvant HER2 targeted therapyThe panel recommends HER2-targeted therapy in patients with HER2- positive tumor
Adjuvant HER2-Targeted Therapy
Adjuvant HER2 targeted therapy
The panel recommends HER2-targeted therapy in patients with HER2- positive tumors (see Principles of HER2 Testing Trastuzumab is a). Humanized monoclonal antibody with specificity for the extracellular domain of HER2. Results of several randomized trials testing trastuzumab as adjuvant therapy have been reported.
HER2 targeted therapy in the HER2 positive tumor group (see HER2 test principle). Trastuzumab is a specific humanized monoclonal antibody of HER2 extracellular domain. Has been reported in studies of trastuzumab as adjuvant therapy for a number of random test results.
NSABP B-31 patients with HER2-positive, node-positive breast cancer were randomly assigned to 4 cycles of AC every followed by paclitaxel 3 weeks for 4 cycles every 3 weeks or the same regimen with of trastuzumab commencing with 52 weeks paclitaxel. In the NCCTG N9831 trial, patients with HER2-positive breast cancer that was node-positive, or node-negative, with primary tumors greater than 1 cm in size if ER- and PR-negative or greater than in size if ER- 2 cm or PR-positive, were similarly randomized except that paclitaxel was given by a low-dose weekly schedule for and a third arm 12 weeks delayed trastuzumab until the completion of paclitaxel.
From the beginning of paclitaxel positive breast cancer patients were randomly assigned to each of the 3 week 1 AC4 every 3 weeks for 1 cycle sequential paclitaxel 4 cycle or the same regimen combined with 52 weeks of trastuzumab, positive lymph node NSABP B-31 HER2. In the NCCTG N9831 test, positive lymph node or lymph node negative ER and PR negative primary tumors larger than 1cm or ER or PR positive primary tumors larger than 2cm HER2 positive breast cancer patients, except paclitaxel in the same way randomly given low doses per week for 12 weeks and third for trastuzumab delay to paclitaxel after.
The B-31 and NCCTG N9831 trials have been jointly analyzed with the merged control arms for both trials compared with the merged arms using trastuzumab begun concurrently with paclitaxel. There were patients included in the joint analysis 4045 performed at 3.9 years median follow-up. A reduction in the risk of recurrence 48% (HR, 0.52; 95% CI, 0.45-0.60; P <.001; and a) 39% reduction in the risk of death (HR, 0.61; 95% CI, 0.50-0.75; log-rank P =.001 were Similar significant effects) documented. on DFS were observed when results of the NSABP B-31 and NCCTG N9831 trials were analyzed separately. Cardiac toxicity was increased in patients treated with trastuzumab. In the adjuvant trastuzumab trials. The rates of grade III/IV congestive H Eart failure (CHF) or cardiac-related death in patients receiving treatment regimens containing trastuzumab ranged from 0% (FinHer trial) 4.1% to (NSABP B-31 trial) The of cardiac dysfunction. Frequency appears to be related to both age and baseline left ventricular ejection fraction. An analysis of data from N9831 showed the 3-year cumulative incidence of CHF or cardiac death to be, 0.3%, 2.8%, 3.3% and in the arms of the trial without trastuzumab with trastuzumab, following chemotherapy, and with trastuzumab initially combined with paclitaxel, respectively. The acceptable rate of significant cardiac toxicity observed in the trastuzumab adjuvant trials in part reflects rigorous monitoring for cardiac dysfunction. Furthermore, concerns have Been raised regarding long-term risks associated trastuzumab based on results of evaluations of cardiac function follow-up in patients enrolled in some with of these cardiac trials. therapy the
B-31 and NCCTG N9831 trials have been conducted to study the combination of two trials with the control group and the combination of paclitaxel with the start of the trastuzumab group. In a median follow-up of 3.9 years, the joint analysis included a total of 4045 patients. The risk of recurrence was reduced by 48% (HR, 0.52; CI, 0.45-0.60; P