AGITG MONARCC: A Randomized Phase 2 Study of Panitumumab Monotherapy and Panitumumab Plus 5-Fluorouracil as First-Line Therapy for Older Patients With RAS and BRAF Wild Type Metastatic Colorectal Cancer. A Study by the Australasian Gastro-Intestinal Trials Group (AGITG)
File version
Author(s)
Espinoza, David
Sjoquist, Katrin Marie
Siu, Derrick Hw
Mercieca-Bebber, Rebecca
Chantrill, Lorraine A
Karapetis, Christos Stelios
Steer, Christopher B
Yip, Sonia
Cuff, Jeff
Winata, Stephanie
Tie, Jeanne
Thaker, Darshit Arunbhai
Srivastav, Ratnesh
Abdi, Ehtesham
et al.
Griffith University Author(s)
Primary Supervisor
Other Supervisors
Editor(s)
Date
Size
File type(s)
Location
License
Abstract
Background Panitumumab (pan) plus chemotherapy is a preferred first-line therapy for unresectable RAS and BRAF wild type metastatic colorectal cancer (mCRC). Older patients may not be suitable for combination regimens. We investigated 2 lower intensity pan-containing regimens.
Methods Prospective, noncomparative, randomized (1:1) phase 2 study of pan alone (Arm A) or pan plus FU (Arm B). Previously untreated mCRC were ≥70 years; RAS/BRAF wild type. Primary endpoint: 6-month progression-free survival (PFS). Secondary endpoints included: overall survival (OS), response rate (RR), feasibility of geriatric assessments and overall treatment utility (OTU)—a composite measure based on radiological response, clinical progress, toxicity and patient-reported treatment worth. Planned sample size was 40 patients per arm.
Results 36 patients (Arm A n = 19, Arm B n = 17) were randomized between June 2018 and June 2021. Median age was 79 and 80 years respectively. 6-month PFS 63% (95% CI 38%-80%) arm A 82% (95%CI 55%-94%) Arm B. Median OS 21 months Arm A (95%CI 13-31) 28 (95%CI 14-39) months Arm B. RR 47% and 65% Arms A and B respectively. Baseline comprehensive geriatric assessments were completed in >80% of patients. At week 16, OTU was categorized as good in 92% (Arm A) and 90% (Arm B). No unexpected adverse events were seen.
Conclusions Six-month PFS in both arms was consistent with that achieved with FU/bev, whilst the rate was numerically higher for Arm B. Baseline comprehensive geriatric assessments were feasible and OTU was high. Both treatment arms might be suitable in appropriately selected patients.
Journal Title
Clinical Colorectal Cancer
Conference Title
Book Title
Edition
Volume
Issue
Thesis Type
Degree Program
School
Publisher link
Patent number
Funder(s)
Grant identifier(s)
Rights Statement
Rights Statement
Item Access Status
Note
This publication has been entered in Griffith Research Online as an advance online version.
Access the data
Related item(s)
Subject
Gastroenterology and hepatology
Oncology and carcinogenesis
Persistent link to this record
Citation
Burge, ME; Espinoza, D; Sjoquist, KM; Siu, DH; Mercieca-Bebber, R; Chantrill, LA; Karapetis, CS; Steer, CB; Yip, S; Cuff, J; Winata, S; Tie, J; Thaker, DA; Srivastav, R; Abdi, E; et al., AGITG MONARCC: A Randomized Phase 2 Study of Panitumumab Monotherapy and Panitumumab Plus 5-Fluorouracil as First-Line Therapy for Older Patients With RAS and BRAF Wild Type Metastatic Colorectal Cancer. A Study by the Australasian Gastro-Intestinal Trials Group (AGITG), Clinical Colorectal Cancer, 2024