(ChemotherapyAdvisor) – Patients with adenocarcinoma of the stomach or GE junction treated with tesetaxel, a novel, orally absorbed taxane, had median overall survival (OS) rates of 7.6 and 7.5 months, according to a phase 2b trial reported at the ASCO 2012 Gastrointestinal Cancers Symposium.
The study enrolled 41 patients who had progressed on at least one prior chemotherapy regimen that included a platinum compound—cisplatin, oxaliplatin, or carboplatin—and a fluoropyrimidine compound, either 5-fluorouracil or capecitabine. Cohort 1 received flat doses starting at 40–45 mg and cohort 2, 50–60 mg. However, Jaffer A. Ajani, MD, of the University of Texas M. D. Anderson Cancer Center, Houston, TX, and colleagues found that “extreme body weight differences resulted in marked underdosing and precluded flat dosing.”
Therefore, cohort 3, which remains open to accrual, received tesetaxel at the maximally tolerated dose of 27 mg/m2 (with escalation to 35 mg/m2 pending tolerability) every three weeks; median OS for this group has not yet been reached. Overall response rate, the primary end point, is 20% (2 partial responses). Previous studies have shown second-line docetaxel to result in median OS rates of 3.5 to 8.4 months.
The most common ≥ grade 3 event was uncomplicated neutropenia (13%). Tesetaxel is not associated with hypersensitivity, eliminating the need for premedication and extended medical and nursing observation, the investigators noted. A Phase 3 study of tesetaxel as second-line therapy in patients with advanced gastric cancer in which OS is the primary end point is planned.