Evidence map›Paper›PMID 33400355›Full record

Trial reportThe oncologist2021

Modified FOLFOXIRI With or Without Cetuximab as Conversion Therapy in Patients with RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer: The FOCULM Multicenter Phase II Trial.

Huabin Hu, Kun Wang, Meijin Huang, Liang Kang, Wei Wang, Hui Wang, Meng Qiu, Rongbo Lin, Haibo Zhang, Ping Lan and 18 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 6 pooled it
3.7field-weighted citation impact, top 5% 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

28 citing papers in PubMed, 6 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
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  14. CSCO guidelines for colorectal cancer version 2024: Updates and discussions.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2024
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  19. BRAFAmerican journal of cancer research · 2023
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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

28 authors at 8 institutions in 1 country.

Huabin Hu *Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Kun Wang *Hepatopancreatobiliary Surgery Department I, Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education, Peking University School of Oncology, Beijing Cancer Hospital and Institute, Beijing, People's Republic of China.
Meijin Huang *Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Liang Kang *Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Wei WangDepartment of Gastrointestinal Oncology, The First People's Hospital of Foshan, Foshan, People's Republic of China.
Hui WangDepartment of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Meng QiuDepartment of Medical Oncology, Cancer Center, The State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Rongbo LinDepartment of Gastrointestinal Oncology, Fujian Cancer Hospital, Fuzhou, People's Republic of China.
Haibo ZhangDepartment of Oncology, Guangdong Provincial Academy of Chinese Medical Sciences, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, People's Republic of China.
Ping LanDepartment of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Xiaojian WuDepartment of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Guangjian LiuDepartment of Medical Ultrasonics, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Yunle WanDepartment of Hepatobiliary Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Ming LiuHepatopancreatobiliary Surgery Department I, Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education, Peking University School of Oncology, Beijing Cancer Hospital and Institute, Beijing, People's Republic of China.
Zhiyang ZhouDepartment of Radiology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Yan HuangDepartment of Pathology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Fangqian LiDepartment of Radiology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Jianwei ZhangDepartment of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Yue CaiDepartment of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Tenghui MaDepartment of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Jiaming ZhouDepartment of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Huaiming WangDepartment of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Jiayu LingDepartment of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Yonghua CaiDepartment of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Zehua WuDepartment of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Shuangling LuoDepartment of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Li LingSun Yat-sen Center for Migrant Health Policy, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.
Yanhong DengDepartment of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Sixth Affiliated Hospital of Sun Yat-sen University · CNSun Yat-sen University · CNFirst People's Hospital of Foshan · CNFujian Medical University · CNGuangzhou University of Chinese Medicine · CNPeking University · CNPeking University Cancer Hospital · CNState Key Laboratory of Biotherapy

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis trial evaluated the addition of cetuximab to a modified FOLFOXIRI (mFOLFOXIRI: 5-fluorouracil/folinic acid, oxaliplatin, irinotecan) as conversion therapy in a two-group, nonrandomized, multicenter, phase II trial in patients with initially technically unresectable colorectal liver-limited metastases (CLM) and BRAF/RAS wild-type. PATIENTS AND

methodsPatients were enrolled to receive cetuximab (500 mg/m

resultsBetween February 2014 and July 2019, 117 patients were registered for screening at six centers in China, and 101 of these were enrolled (67 cetuximab group, 34 control group). The rate of NED achieved was 70.1% in the cetuximab group and 41.2% in the control group (difference 29.0%; 95% confidence interval [CI], 9.1%-48.8%; p = .005). Patients in the cetuximab group had improved ORR (95.5% vs. 76.5%; difference 19.1%; 95% CI, 17.4%-36.4%; p = .010) compared with those in control group. Progression-free survival and overall survival showed the trend to favor the cetuximab group. The incidence of grade 3 and 4 adverse events was similar in the two groups.

conclusionAddition of cetuximab to mFOLFOXIRI improved the rate of NED achieved. This combination could be an option of conversion regimen for molecularly selected patients with initially technically unresectable CLM. IMPLICATIONS FOR PRACTICE: This trial evaluated the addition of cetuximab to a modified FOLFOXIRI as conversion therapy in a phase II trial in patients with initially technically unresectable colorectal liver-limited metastases and BRAF/RAS wild-type. The rate of no evidence of disease achieved was 70.1% in the cetuximab plus modified FOLFOXIRI group and 41.2% in the modified FOLFOXIRI group. Objective response rates, overall survival, and progression-free survival were improved in the cetuximab group when compared with the modified FOLFOXIRI group. Addition of cetuximab to modified FOLFOXIRI increased the rate of no evidence of disease achieved, and this combination could be an option of conversion regimen for molecularly selected patients with initially technically unresectable colorectal liver-limited metastasis.

Indexed as

Colorectal NeoplasmsLiver NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCetuximabChinaFluorouracilHumansLeucovorinOrganoplatinum CompoundsProto-Oncogene Proteins B-rafBRAF protein, humanCamptothecinCetuximabFluorouracilLeucovorinOrganoplatinum CompoundsProto-Oncogene Proteins B-rafCetuximabColorectal cancerConversion therapyLiver metastasisModified FOLFOXIRI

Identifiers

PMID33400355
PMCPMC7794191
OpenAlexW3094966287

What OpenQuestion holds

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Registered trials

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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.