TY - JOUR
T1 - MONARCC
T2 - A randomised phase II study of panitumumab monotherapy and panitumumab plus 5-fluorouracil as first-line therapy for RAS and BRAF wildtype metastatic colorectal cancer: a study by the Australasian Gastrointestinal Trials Group (AGITG)
AU - Siu, Ho Wai Derrick
AU - Tebbutt, Niall
AU - Chantrill, Lorraine
AU - Karapetis, Chris
AU - Steer, Christopher
AU - Wilson, Kate
AU - Espinoza, David
AU - Bailey, Lisa
AU - Yip, Sonia
AU - Cuff, Jeff
AU - Pavlakis, Nick
AU - Thavaneswaran, Subotheni
AU - Briscoe, Karen
AU - Srivastav, Ratnesh
AU - Shannon, Jennifer
AU - Segelov, Eva
AU - Tie, Jeannie
AU - Caird, Susan
AU - Francesconi, Alessandra
AU - Price, Timothy
AU - Wuttke, Melanie
AU - Ladwa, Rahul
AU - Sjoquist, Katrin
AU - Burge, Matthew
PY - 2021/12
Y1 - 2021/12
N2 - Background: Doublet chemotherapy in combination with a biologic agent has been a standard of care in patients with metastatic colorectal cancer for over a decade. The evidence for a “lighter” treatment approach is limited to mono-chemotherapy plus bevacizumab in the RAS unselected population. Anti-EGFR antibodies have activity as monotherapy or in combination with chemotherapy in RAS wildtype metastatic colorectal cancer; however their role in first-line treatment in combination with 5-fluorouracil monotherapy or when given alone has not been well studied. MONARCC aims to investigate this approach in an elderly population. Methods/design: MONARCC is a prospective, open-label, multicentre, non-comparative randomised phase II trial. Eligible patients aged ≥70 with unresectable metastatic, untreated, RAS/BRAF wildtype metastatic colorectal cancer will be randomised 1:1 to receive panitumumab alone or panitumumab plus infusional 5-fluorouracil. RAS and BRAF analyses will be performed in local laboratories. Comprehensive Health Assessment and Limited Health Assessments will be performed at baseline and at 16 weeks, respectively, to assess frailty. The Patient Symptom Questionnaire and Overall Treatment Utility are to be undertaken at different timepoints to assess the impact of treatment-related toxicities and quality of life. Treatment will be delivered every 2 weeks until disease progression, unacceptable toxicity (as determined by treating clinician or patient), delay of treatment of more than 6 weeks, or withdrawal of consent. The primary end point is 6-month progression-free survival in both arms. Secondary end points include overall survival, time to treatment failure, objective tumour response rate as defined by RECIST v1.1 and safety (adverse events). Tertiary and correlative endpoints include the feasibility and utility of a comprehensive geriatric assessment, quality of life and biological substudies. Discussion: MONARCC investigates the activity and tolerability of first-line panitumumab-based treatments with a view to expand on current treatment options while maximising progression-free and overall survival and quality of life in molecularly selected elderly patients with metastatic colorectal cancer. Trial registration: Australia New Zealand Clinical Trials Registry: ACTRN12618000233224, prospectively registered 14 February 2018.
AB - Background: Doublet chemotherapy in combination with a biologic agent has been a standard of care in patients with metastatic colorectal cancer for over a decade. The evidence for a “lighter” treatment approach is limited to mono-chemotherapy plus bevacizumab in the RAS unselected population. Anti-EGFR antibodies have activity as monotherapy or in combination with chemotherapy in RAS wildtype metastatic colorectal cancer; however their role in first-line treatment in combination with 5-fluorouracil monotherapy or when given alone has not been well studied. MONARCC aims to investigate this approach in an elderly population. Methods/design: MONARCC is a prospective, open-label, multicentre, non-comparative randomised phase II trial. Eligible patients aged ≥70 with unresectable metastatic, untreated, RAS/BRAF wildtype metastatic colorectal cancer will be randomised 1:1 to receive panitumumab alone or panitumumab plus infusional 5-fluorouracil. RAS and BRAF analyses will be performed in local laboratories. Comprehensive Health Assessment and Limited Health Assessments will be performed at baseline and at 16 weeks, respectively, to assess frailty. The Patient Symptom Questionnaire and Overall Treatment Utility are to be undertaken at different timepoints to assess the impact of treatment-related toxicities and quality of life. Treatment will be delivered every 2 weeks until disease progression, unacceptable toxicity (as determined by treating clinician or patient), delay of treatment of more than 6 weeks, or withdrawal of consent. The primary end point is 6-month progression-free survival in both arms. Secondary end points include overall survival, time to treatment failure, objective tumour response rate as defined by RECIST v1.1 and safety (adverse events). Tertiary and correlative endpoints include the feasibility and utility of a comprehensive geriatric assessment, quality of life and biological substudies. Discussion: MONARCC investigates the activity and tolerability of first-line panitumumab-based treatments with a view to expand on current treatment options while maximising progression-free and overall survival and quality of life in molecularly selected elderly patients with metastatic colorectal cancer. Trial registration: Australia New Zealand Clinical Trials Registry: ACTRN12618000233224, prospectively registered 14 February 2018.
KW - BRAF
KW - Cetuximab
KW - Clinical trial
KW - Elderly
KW - Metastatic colorectal cancer
KW - Older adults
KW - Panitumumab
KW - RAS
UR - http://www.scopus.com/inward/record.url?scp=85112747529&partnerID=8YFLogxK
U2 - 10.1186/s12885-021-08644-4
DO - 10.1186/s12885-021-08644-4
M3 - Article
C2 - 34407800
AN - SCOPUS:85112747529
SN - 1471-2407
VL - 21
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 932
ER -
