Abstract
BackgroundDoublet 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/designMONARCC 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.DiscussionMONARCC 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 registrationAustralia New Zealand Clinical Trials Registry: ACTRN12618000233224, prospectively registered 14 February 2018.
Highlights
Doublet chemotherapy in combination with a biologic agent has been a standard of care in patients with metastatic colorectal cancer for over a decade
In patients with KRAS exon 2 wildtype metastatic colorectal cancer (mCRC), the use of anti-Epidermal growth factor receptor (EGFR) antibodies with doublet chemotherapy in the first-line setting has demonstrated superior overall survival (OS) compared with bevacizumab with doublet chemotherapy or doublet chemotherapy alone [1,2,3]
The results demonstrated that while elderly patients derived similar survival benefit from anti-EGFR antibodies plus doublet chemotherapy compared to the younger population, this may be associated with higher rates of toxicity
Summary
MONARCC addresses a clinically important question in a prevalent, but under-investigated population that will help inform future practice in elderly patients with RAS/ BRAF wildtype mCRC. Similar to the PANDA trial, MONARCC incorporates geriatric assessment by prospectively collecting Comprehensive Health and Limited Health Assessment questionnaires, together with physical activity levels measured by activity tracking devices. These aspects of cancer treatment remain underresearched and will add value to the study
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