Nicholas Fidelman, MD (he/him/his)
University Of California San Francisco
Disclosure(s): Boston Scientific: Research Grant or Support (); Merck: Research Grant or Support (); Sirtex Medical: Research Grant or Support ()
Adult patients with bilobar liver-dominant chemo-refractory mCRC were treated with sequential lobar TARE (body surface area dosimetry) using 90Y resin microspheres in combination with TAS-102 (20mg/m2, 27mg/m2, and 35mg/m2) in 28-day cycles according to 3+3 dose escalation design with a 12-patient dose expansion cohort. Primary objectives were to determine maximum tolerated dose (MTD) of TAS-102 and to establish safety of TAS-102 in combination with TARE.
Results: A total of 21 patients (14 women, 7 men) with median age of 60 years were enrolled. No dose limiting toxicities were observed. Treatment related severe adverse events included cytopenias (10 patients, 48%) and radioembolization-induced liver disease (2 patients, 10%). Disease control rate in the liver lobes treated with TARE was 100%. Best observed radiographic responses were partial response for 4 patients (19%) and stable disease for 12 patients (57%).
Conclusion: The combination of TAS-102 and TARE for patients with liver-dominant mCRC is safe and consistently achieved disease control within the liver.