Evidence map›Paper›PMID 29464396›Full record

ArticleInternational journal of clinical oncology2018

Phase I study of primary treatment with 5-FU, oxaliplatin, irinotecan, levofolinate, and panitumumab combination chemotherapy in patients with advanced/recurrent colorectal cancer involving the wild-type RAS gene: the JACCRO CC-14 study.

Hironaga Satake, Akihito Tsuji, Masato Nakamura, Masaaki Ogawa, Takeshi Kotake, Yukimasa Hatachi, Hisateru Yasui, Akinori Takagane, Yoshihiro Okita, Kumi Nakamura and 3 more

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

Article in International journal of clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 27% 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

7 citing papers in PubMed, 13 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

13 authors at 8 institutions in 2 countries.

Hironaga SatakeDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.ORCID http://orcid.org/0000-0001-7629-6803
Akihito TsujiDepartment of Clinical Oncology, Kagawa University Faculty of Medicine-Kagawa University Hospital, 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, Japan. atsuji@med.kagawa-u.ac.jp.
Masato NakamuraAizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.
Masaaki OgawaDepartment of Surgery, Kazuno Kosei Hospital, Kazuno, Japan.
Takeshi KotakeDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Yukimasa HatachiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Hisateru YasuiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Akinori TakaganeDepartment of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan.
Yoshihiro OkitaDepartment of Clinical Oncology, Kagawa University Faculty of Medicine-Kagawa University Hospital, 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, Japan.
Kumi NakamuraAizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.
Toshihide OnikuboAizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.
Masahiro TakeuchiDepartment of Clinical Medicine (Biostatistics), Kitasato University School of Pharmacy, Tokyo, Japan.
Masashi FujiiJapan Clinical Cancer Research Organization, Tokyo, Japan.
Kobe City Medical Center General Hospital · JPAizawa Hospital · JPHakodate National Hospital · JPJapan Clinical Cancer Research Organization · JPKagawa University · JPKagawa University Hospital · JPKazMunayGas (Kazakhstan) · KZKitasato University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFOLFOXIRI is now regarded as the chemotherapy regimen that offers the best platform for the treatment of colorectal cancer. However, the safety and efficacy of FOLFOXIRI + panitumumab has not been demonstrated. We conducted a phase I study to determine the recommended dose of FOLFOXIRI + panitumumab as first-line treatment for RAS wild-type metastatic colorectal cancer (mCRC).

methodsPatients received combination therapy consisting of panitumumab (6 mg/kg on day 1) + FOLFOXIRI [irinotecan (CPT-11), oxaliplatin (L-OHP) 85 mg/m

resultsSeven patients were enrolled, and six were assessed for safety and efficacy. Maximum tolerated dose was not reached at level 1; all patients were treated at these levels. The common Grade 3 or 4 relevant toxicities were diarrhea (50%), hypokalemia (33%) and stomatitis (33%). No treatment-related deaths occurred. Of the six patients assessed four had partial response and the two others had stable disease; hence, the response rate was 66.7% (95% confidence interval 28.9-100%) and the disease control rate was 100%. Time to protocol treatment failure was 7.2 (1.4-7.3) months.

conclusionThe FOLFOXIRI + panitumumab chemotherapy regimen was well tolerated by our patients with mCRC and showed promising anti-tumor activity. The recommended phase II dose was determined to be the same as the standard doses of this regimen used worldwide.

Indexed as

AdultAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCamptothecinColorectal NeoplasmsFemaleFluorouracilHumansIrinotecanLeucovorinMaleMaximum Tolerated DoseMiddle AgedOrganoplatinum CompoundsOxaliplatinAntibodies, MonoclonalCamptothecinFluorouracilIrinotecanLeucovorinOrganoplatinum CompoundsOxaliplatinPanitumumabras ProteinsFOLFOXIRIMetastatic colorectal cancerPanitumumabRASTriplet chemotherapy

Identifiers

PMID29464396
PMCPMC5951897
OpenAlexW2790593368

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.