Evidence map›Paper›PMID 35688061›Full record

Trial reportESMO open2022

Dynamic changes in RAS gene status in circulating tumour DNA: a phase II trial of first-line FOLFOXIRI plus bevacizumab for RAS-mutant metastatic colorectal cancer (JACCRO CC-11).

Y Sunakawa, H Satake, J Usher, Y Jaimes, Y Miyamoto, M Nakamura, M Kataoka, M Shiozawa, A Takagane, T Terazawa and 10 more

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.0field-weighted citation impact, top 12% 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

13 citing papers in PubMed, 20 citations in OpenAlex.

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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

20 authors at 15 institutions in 2 countries.

Y SunakawaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki. Electronic address: y.sunakawa@marianna-u.ac.jp.
H SatakeDepartment of Medical Oncology, Kochi Medical School, Kochi, Japan.
J UsherNantHealth, Morrisville, USA.
Y JaimesNantHealth, Morrisville, USA.
Y MiyamotoDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
M NakamuraAizawa Comprehensive Cancer Centre, Aizawa Hospital, Matsumoto, Japan.
M KataokaDepartment of Surgery, National Hospital Organization, Nagoya Medical Center, Nagoya, Japan.
M ShiozawaDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
A TakaganeDepartment of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan.
T TerazawaCancer Chemotherapy Center, Osaka Medical and Pharmaceutical University, Osaka, Japan.
T WatanabeDepartment of Surgery, Himeji Red Cross Hospital, Himeji, Japan.
K IshiguroDepartment of Surgery, Konan Kosei Hospital, Konan, Japan.
C TanakaDepartment of Surgery, Gifu Prefectural General Medical Center, Gigu, Japan.
M TakeuchiGraduate School of Mathematical Sciences, The University of Tokyo, Tokyo, Japan.
M FujiiDepartment of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
K DanenbergNantHealth, Morrisville, USA.
P V DanenbergDepartment of Biochemistry and Molecular Medicine, University of Southern California, Los Angeles, USA.
H-J LenzDivision of Medical Oncology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, USA.
T SekikawaDivision of Medical Oncology, Showa University Fujigaoka Hospital, Yokohama, Japan.
W IchikawaDivision of Medical Oncology, Showa University Fujigaoka Hospital, Yokohama, Japan.
Showa University Fujigaoka Hospital · JPUniversity of Southern California · USAizawa Hospital · JPGifu Prefectural General Medical Center · JPHakodate National Hospital · JPHimeji Red Cross Hospital · JPKanagawa Cancer CenterKochi Medical School Hospital · JPKonan Kosei Hospital · JPKumamoto University · JPNagoya Medical Center · JPNihon University · JPOsaka University of Pharmaceutical Sciences · JPSt. Marianna University School of Medicine · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFew prospective studies have used liquid biopsy testing in RAS-mutant metastatic colorectal cancer (mCRC), and its clinical significance remains unknown. Therefore, this study aimed to carry out a biomarker analysis by liquid biopsy using updated data of the phase II trial of FOLFOXIRI plus bevacizumab as first-line chemotherapy for RAS-mutant mCRC. MATERIALS AND

methodsA total of 64 patients who received modified FOLFOXIRI regimen (irinotecan 150 mg/m

resultsThere were 62 patients (median age: 62.5 years, 92% performance status 0, 27% right side) who were assessable for efficacy and 51 for biomarker analysis. ORR was 75.8% (95% confidence interval 65.1% to 86.5%). The median progression-free survival was 12.1 months, and the median overall survival (OS) was 30.2 months. In 78% of patients, RAS mutations disappeared in the ctDNA at 8 weeks after treatment; these patients tended to have better outcomes than those with RAS mutations. Interestingly, RAS mutations remained undetectable during progression in 62% of patients. Survival analysis indicated that the median OS from progression was significantly longer in patients with RAS mutation clearance than in those with RAS mutation in the ctDNA at disease progression (15.1 versus 7.3 months, hazard ratio: 0.21, P = 0.0046).

conclusionsOur biomarker study demonstrated no RAS mutations in ctDNA at disease progression in 62% of patients with RAS-mutant mCRC. Both OS and post-progression survival were better in patients with clearance of RAS mutations in ctDNA after triplet-based chemotherapy.

Indexed as

Circulating Tumor DNAColonic NeoplasmsColorectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinDisease ProgressionFluorouracilGenes, rasHumansLeucovorinMiddle AgedOrganoplatinum CompoundsProspective StudiesBevacizumabCamptothecinCirculating Tumor DNAFluorouracilLeucovorinOrganoplatinum Compoundscolorectal cancerFOLFOXIRI plus bevacizumabliquid biopsyRAS mutation

Identifiers

PMID35688061
PMCPMC9271512
OpenAlexW4281685547

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.