Evidence map›Paper›PMID 34407800›Full record

ArticleBMC cancer2021

MONARCC: 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).

Ho Wai Derrick Siu, Niall Tebbutt, Lorraine Chantrill, Chris Karapetis, Christopher Steer, Kate Wilson, David Espinoza, Lisa Bailey, Sonia Yip, Jeff Cuff and 14 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 18 institutions in 1 country.

Ho Wai Derrick SiuNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia. monarcc@ctc.usyd.edu.au.ORCID http://orcid.org/0000-0002-2219-2459
Niall TebbuttAustin Hospital, Melbourne, Australia.
Lorraine ChantrillShoalhaven Cancer Care Centre, Nowra, Australia.
Chris KarapetisFlinders Medical Centre, Adelaide, Australia.
Christopher SteerBorder Medical Oncology Research Unit, Albury-Wodonga, Australia.
Kate WilsonNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
David EspinozaNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Lisa BaileyNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Sonia YipNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Jeff CuffAustralasian Gastrointestinal Group (AGITG), Sydney, Australia.
Nick PavlakisNorthern Cancer Institute, Sydney, Australia.
Subotheni ThavaneswaranSt Vincent's Public Hospital, Sydney, Australia.
Karen BriscoeCoffs Harbour Health Campus, Coffs Harbour, Australia.
Ratnesh SrivastavThe Tweed Hospital, Tweed Heads, Australia.
Jennifer ShannonNepean Hospital, Sydney, Australia.
Eva SegelovMonash Medical Centre, Melbourne, Australia.
Jeannie TieSunshine Hospital, Melbourne, Australia.
Susan CairdGold Coast University Hospital, Gold Coast, Australia.
Alessandra FrancesconiSunshine Coast University Hospital, Sunshine Coast, Australia.
Timothy PriceThe Queen Elizabeth Hospital, Adelaide, Australia.
Melanie WuttkeRoyal Hobart Hospital, Hobart, Australia.
Rahul LadwaPrincess Alexandra Hospital, Brisbane, Australia.
Katrin SjoquistNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Matthew BurgeRoyal Brisbane and Women's Hospital, Brisbane, Australia.
The University of Sydney · AUAlbury Wodonga Health · AUAustin Hospital · AUCoffs Harbour City Council · AUFlinders Medical Centre · AUGold Coast Hospital · AUMonash Medical Centre · AUNepean Hospital · AUNorthern Cancer Institute · AUPrincess Alexandra Hospital · AUQueen Elizabeth Hospital · AURoyal Brisbane and Women's Hospital · AURoyal Hobart Hospital · AUShoalhaven District Memorial Hospital · AUSt Vincent's Hospital Melbourne · AUSunshine Coast University Hospital · AUSunshine Hospital · AUTweed Shire Council · AU

Funding

Amgen 20149129
6 · The paper itself

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. 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 registrationAustralia New Zealand Clinical Trials Registry: ACTRN12618000233224 , prospectively registered 14 February 2018.

Indexed as

MutationAgedAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase II as TopicColorectal NeoplasmsFemaleFluorouracilFollow-Up StudiesHumansMaleMulticenter Studies as TopicNeoplasm MetastasisPanitumumabPrognosisProspective StudiesProto-Oncogene Proteins B-rafBRAF protein, humanFluorouracilPanitumumabProto-Oncogene Proteins B-rafras ProteinsBRAFCetuximabClinical trialElderlyMetastatic colorectal cancerOlder adultsPanitumumabRAS

Identifiers

PMID34407800
PMCPMC8371602
OpenAlexW3194391374

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.