Final Results of MARIANNE Trial of T-DM1 in HER2-Positive Advanced Breast Cancer
Posted: Wednesday, October 9, 2019
Based on the final results of the randomized, phase III MARIANNE trial, trastuzumab emtansine (T-DM1) may be an effective first-line treatment option for patients with HER2-positive metastatic breast cancer who are considered to be unsuitable for taxane-based therapy. However, the median overall survival with T-DM1 as well as with T-DM1 plus pertuzumab was found to be noninferior—but not superior—to that with trastuzumab plus a taxane. In addition, patients experienced fewer treatment-related side effects with T-DM1 and a longer time to patient-experienced neurotoxicity symptoms. Edith A. Perez, MD, of the Mayo Clinic Cancer Center, Jacksonville, Florida, and colleagues published the results of their study in Cancer.
The study included a total of 1,095 patients and was designed to evaluate the safety and efficacy of T-DM1 with a placebo and T-DM1 with pertuzumab. In the control arm (n = 365), 257 patients received trastuzumab plus docetaxel and 96 patients received trastuzumab plus paclitaxel. Overall, 367 and 363 patients were randomly assigned to T-DM1 and T-DM1 plus pertuzumab, respectively.
At the final analysis, the median overall survival was 50.9 months in the control group, 53.7 months in the T-DM1 group, and 51.8 months in the T-DM1 plus pertuzumab group. None of the analyzed subgroups showed a benefit with one treatment compared with another. As a whole, patients treated with trastuzumab emtansine had a favorable tolerability profile in comparison to trastuzumab plus a taxane.
Disclosure: The study authors’ disclosures can be found at onlinelibrary.wiley.com.