Tesetaxel Plus Reduced-Dose Capecitabine in Metastatic Breast Cancer
Posted: Thursday, January 14, 2021
Editor's Note: On March 22, 2021, Odonate Therapeutics announced it was discontinuing the development of tesetaxel and will wind down the company's operations.
Joyce O’Shaughnessy, MD, of Baylor University Medical Center, Dallas, and colleagues presented data from the phase III CONTESSA trial, which evaluated the safety and efficacy of an all-oral regimen of a reduced dose of capecitabine plus tesetaxel versus capecitabine alone in patients with HER2-negative, hormone receptor–positive metastatic breast cancer. They reported an improvement in progression-free survival with the combination therapy during a presentation at the 2020 San Antonio Breast Cancer Symposium (SABCS; Abstract GS4-01).
This multinational, multicenter study enrolled a total of 685 patients. Participants were randomized 1:1 into groups receiving either 1,650 mg/m2/day of capecitabine for 14 days plus an initial dose of 27 mg/m2 of tesetaxel or 2,500 mg/m2 of capecitabine alone for 14 days. All patients received one chemotherapy at most and also received a taxane in the neoadjuvant setting.
The median progression-free survival with the combination therapy was 9.8 months, compared with capecitabine alone at 6.9 months. Objective response rates were 57% and 41%, respectively.
Grade 3 or greater treatment-emergent adverse effects with the combination therapy versus capecitabine alone were diarrhea (13.4% vs. 8.9%), febrile neutropenia (12.8% vs. 1.2%), neutropenia (71.2% vs. 8.3%), fatigue (8.6% vs. 4.5%), leukopenia (10.1% vs. 0.9%), anemia (8.0% vs. 2.1%), hypokalemia (8.6% vs. 2.7%), and hand‑foot syndrome (6.8% vs. 12.2%). Neuropathy of at least grade 3 occurred in 5.9% and 0.9% of patients, respectively. Alopecia of grade 2 was observed in 8.0% and 0.3% of patients, respectively. The rate of patients who discontinued treatment of tesetaxel plus reduced capecitabine versus capecitabine alone was 23.1% and 11.9%, respectively.
Disclosure: For full disclosures of study authors, visit sabcs.org.