KAMILLA Trial: T-DM1 Safety in HER2-Positive Breast Cancer
Posted: Monday, April 1, 2019
The KAMILLA phase IIIb safety trial of trastuzumab emtansine (T-DM1) confirms previous research that the agent is “safe, tolerable, and efficacious” in the treatment of patients with HER2-positive breast cancer. Filippo Montemurro, MD, of the Condiolo Cancer Institute in Torino Italy, and colleagues published the results of their single-arm, open-label, international study, reportedly the largest cohort of patients treated with T-DM1 to date, in the European Journal of Cancer.
This trial followed 2,002 patients who had HER2-positive breast cancer with recurrent, metastatic, or unresectable locally advanced disease. Approximately 66% of patients had received 2 or more prior metastatic treatments, and 19.9% of patients had baseline central nervous system metastases. Patients were treated with 3.6 mg/kg of T-DM1 every 3 weeks until unacceptable toxicity, withdrawal, or disease progression.
Adverse effects were seen in 93% of patients, and serious adverse events occurred in 21.3% of patients. Grade 3 or higher events were seen in 37.5% of patients, with anemia, thrombocytopenia, and fatigue being the most common.
Progression-free survival was 6.9 months, and the median overall survival was 27.2 months. Patients who had tried multiple previous therapies (4+) had decreased overall and progression-free survival compared with those who had tried fewer previous therapies (0–1). Progression-free survival decreased from 8.3 to 5.6 months, whereas overall survival decreased from 31.3 to 22.5 months.
“We believe the size of the KAMILLA study and breadth of the patient population may make our findings more comparable with the experience of oncologists prescribing T-DM1 in the clinical setting, compared with the more strictly defined setting of previous registration studies,” the investigators concluded.
Disclosure: The study authors’ disclosure information can be found at ejcancer.com.