Joleen M. Hubbard, MD, Oncology Department, Mayo Clinic speaks about the ESMO 2021 Abstract – 507TiP – PRESERVE 1: A phase III, randomized, double-blind trial of trilaciclib versus placebo in patients receiving FOLFOXIRI/bevacizumab for metastatic colorectal cancer.
Link to Abstract:
https://oncologypro.esmo.org/meeting-resources/esmo-congress-2021/preserve-1-a-phase-iii-randomized-double-blind-trial-of-trilaciclib-versus-placebo-in-patients-receiving-folfoxiri-bevacizumab-for-metastatic-co
507TiP Abstract:
Background:
Based on results from three randomized, placebo-controlled phase II studies, the FDA has authorized trilaciclib, an intravenous (IV) kinase inhibitor that preserves hematopoeitic stem and progenitor cells following chemotherapy exposure. In another randomized phase II study, giving trilaciclib before chemotherapy had modest myeloprotective effects but increased overall survival in patients with triple-negative breast cancer (OS).
Design of the experiment:
PRESERVE 1 (NCT04607668) is a randomized, double-blind, phase III trial in adult patients with previously untreated metastatic colorectal cancer to assess the myeloprotective and antitumor effects of trilaciclib given before fluorouracil (5FU), leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI)/bevacizumab. Patients must have unresectable and evaluable disease, an ECOG PS of 0/1, and sufficient organ function to be eligible. Tumors must be capable of mismatch repair and microsatellite stability, and they can have any known BRAF mutation. FOLFOXIRI/bevacizumab should not be used if the patient has symptomatic peripheral neuropathy, uncontrolled hypertension, or any other contraindications. On days 1 and 2 prior to FOLFOXIRI/bevacizumab in 14-day cycles for up to 12 cycles, approximately 296 patients will be stratified by country, previous treatment, and BRAF V600E mutant status and randomly allocated 1:1 to receive IV trilaciclib 240 mg/m2 or placebo (Induction). Prior to receiving 5FU/leucovorin/bevacizumab, patients will receive trilaciclib or a placebo after induction. Treatment will be continued until the illness progresses, intolerable toxicity occurs, the patient withdraws, or the trial ends. The duration of severe neutropenia (SN) in cycle 1 and the incidence of SN during Induction are the primary objectives. Progression-free survival, overall survival, and time to verified worsening in chemotherapy-induced tiredness during Induction are important secondary goals. Trilaciclib’s effects on red blood cell and platelet lineages will also be studied. In October 2020, recruitment began in the United States, and in early 2021, it began internationally.
Clinical trial identification:
NCT04607668 Release date: 29 October 2020.