Exploratory Final Analysis of T-DM1 in Metastatic Breast Cancer: KAMILLA Trial
Posted: Tuesday, August 25, 2020
Trastuzumab emtansine (T-DM1) was found to be an effective and tolerable treatment of patients with HER2-positive locally advanced or metastatic breast cancer who had brain metastases and received prior HER2-targeted therapy and chemotherapy, according to the single-arm phase IIIb KAMILLA trial by Paul Ellis, MD, of Guy’s Hospital and Sarah Cannon Research Institute, London, and colleagues. Based on their findings, which were published in Annals of Oncology, the authors suggested further studies of T-DM1 in this setting are warranted.
“KAMILLA included the largest population to date of patients with HER2-positive advanced breast cancer and brain metastases treated with T-DM1 in a prospective clinical trial (n = 398),” the authors concluded. “Although KAMILLA was not specifically designed to address T-DM1 activity in this particular patient population, our post hoc analysis provides some interesting insights.”
In this ongoing, phase IIIb study, a total of 2,002 patients received T-DM1 at 3.6 mg/kg every 3 weeks until intolerable toxicity, withdrawal of consent, or disease progression. The authors used best overall response rate and clinical benefit rate as measures for the outcomes using Response Evaluation Criteria in Solid Tumors, version 1.1, progression-free survival, overall survival, and safety. A total of 398 patients had baseline brain metastases.
The best overall response rate for the 126 patients with measurable brain metastases was 21.4%, and the clinical benefit rate was 42.9%. The median progression-free survival and overall survival were 5.5 months and 18.9 months for the 398 patients with baseline brain metastases, respectively.
Adverse events were comparable for both groups. Adverse events effecting the central nervous system were more common in patients with baseline brain metastases.
Disclosure: The study authors’ disclosure information can be found at annalsofoncology.org.
