Evidence map›Paper›PMID 32863385›Full record

Trial reportBritish journal of cancer2020

Phase 2 study of irinotecan plus cetuximab rechallenge as third-line treatment in KRAS wild-type metastatic colorectal cancer: JACCRO CC-08.

Toshiki Masuishi, Akihito Tsuji, Masahito Kotaka, Masato Nakamura, Mitsugu Kochi, Akinori Takagane, Ken Shimada, Tadamichi Denda, Yoshihiko Segawa, Hiroaki Tanioka and 11 more

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

Trial report in British journal of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% 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

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  19. Therapeutic landscape and future direction of metastatic colorectal cancer.Nature reviews. Gastroenterology & hepatology · 2023
    Review
  20. A Review of Gut Microbiota-Derived Metabolites in Tumor Progression and Cancer Therapy.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023
    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

21 authors at 19 institutions in 1 country.

Toshiki MasuishiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan. tmasuishi@aichi-cc.jp.ORCID http://orcid.org/0000-0002-7521-1596
Akihito TsujiDepartment of Medical Oncology, Kagawa University Hospital, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, Japan.
Masahito KotakaGastrointestinal Cancer Center, Sano Hospital, 2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Hyogo, 655-0031, Japan.
Masato NakamuraAizawa Comprehensive Cancer Center, Aizawa Hospital, 2-5-1 Honjyou, Matsumoto, Nagano, 390-8510, Japan.
Mitsugu KochiDepartment of Digestive Surgery, Nihon University School of Medicine, 30-1 Oyaguchikamimachi, Itabashi-ku, Tokyo, 173-8610, Japan.
Akinori TakaganeDepartment of Surgery, Hakodate Goryoukaku Hospital, 38-3 Goryoukaku-cho, Hakodate, Hokkaido, 040-8611, Japan.
Ken ShimadaDepartment of Internal Medicine, Showa University Koto Toyosu Hospital, 5-1-38 Toyosu, Koto-ku, Tokyo, 135-8577, Japan.
Tadamichi DendaDepartment of Gastroenterology, Chiba Cancer Center, 666-2 Nitona-cho, Chuo-ku, Chiba, 350-1298, Japan.
Yoshihiko SegawaDepartment of Medical Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Hiroaki TaniokaClinical Oncology, Kawasaki Medical School Hospital, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center, 780 Komuro, ina, Kita-adachi-gun, Saitama, 362-0806, Japan.
Tamotsu SagawaDepartment of Gastroenterology, Hokkaido Cancer Center, 2-3-54 Kikusuishijyo, Shiroishi-ku, Sapporo, Hokkaido, 003-0804, Japan.
Takanori WatanabeDepartment of Surgery, Japanese Red Cross Society Himeji Hospital, 1-12-1 Shimoteno, Himeji, Hyogo, 670-8540, Japan.
Takao TakahashiDepartment of Surgical Oncology, Gifu University, Graduate School of Medicine, 1-1 Yanagido, Gifu, 501-1194, Japan.
Yuji NegoroDepartment of Gastroenterology, Kochi Health Sciences Center, 2125-1 Ike, Kochi, 781-8555, Japan.
Dai ManakaDepartment of Surgery, Kyoto Katsura Hospital, 17 Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan.
Hideto FujitaDepartment of Digestive Surgery, Kanazawa Medical University Hospital, 1-1 Daigaku, Uchinadamachi, Kahoku-gun, Ishikawa, 920-0293, Japan.
Takeshi SutoDepartment of Gastroenterological Surgery, Yamagata Prefectural Central Hospital, 1800 Ooazaaoyagi, Yamagata, 990-2292, Japan.
Masahiro TakeuchiDepartment of Clinical Medicine (Biostatistics), Kitasato University School of Pharmacy, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.
Wataru IchikawaDivision of Medical Oncology, Showa University Fujigaoka Hospital, 1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa, 227-8501, Japan.
Masashi FujiiDepartment of Digestive Surgery, Nihon University School of Medicine, 30-1 Oyaguchikamimachi, Itabashi-ku, Tokyo, 173-8610, Japan.
Nihon University · JPAizawa Hospital · JPChiba Cancer Center · JPGifu University · JPHakodate National Hospital · JPHimeji Red Cross Hospital · JPHokkaido University Hospital · JPKagawa University Hospital · JPKanazawa Medical University Hospital · JPKawasaki Medical School · JPKitasato University · JPKyoto Katsura Hospital · JPSaitama Cancer Center · JPSaitama Medical University · JPShimizu (Japan) · JPShowa University · JPShowa University Fujigaoka Hospital · JPTsuchiura Kyodo General Hospital · JPYamagata Prefectural Central Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRegorafenib or trifluridine/tipiracil as third-line treatment have limited efficacy in metastatic colorectal cancer (mCRC).

methodsThis Phase 2 trial evaluated the efficacy and safety of irinotecan plus cetuximab rechallenge as third-line treatment in KRAS wild-type mCRC patients who achieved clinical benefit with first-line cetuximab-containing therapy. The primary endpoint was 3-month progression-free survival (PFS) rate. A sample size was calculated; 30 patients with a 3-month PFS rate of 45% deemed promising and 15% unacceptable. Patients with greater and less than the cut-off value of cetuximab-free intervals (CFIs) were classified into the long and short CFI groups, respectively, in subgroup analyses.

resultsAmong 34 eligible patients who received treatment at least once, 3-month PFS rate was 44.1% (95% confidence interval, 27.4-60.8%). The median PFS and overall survival (OS) were 2.4 and 8.2 months, respectively. The response and disease control rates were 2.9 and 55.9%, respectively. PFS and OS were significantly longer in the long- than in the short CFI group.

conclusionsIrinotecan plus cetuximab rechallenge as third-line treatment for KRAS wild-type mCRC was safe and had promising activity, especially in those with a long CFI, warranting further investigation in a Phase 3 randomised trial. CLINICAL

trial registrationUMIN000010638.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCetuximabChemotherapy, AdjuvantColorectal NeoplasmsFemaleHumansIrinotecanMaleMiddle AgedNeoplasm MetastasisProto-Oncogene Proteins p21(ras)Salvage TherapyCetuximabIrinotecanKRAS protein, humanProto-Oncogene Proteins p21(ras)

Identifiers

PMID32863385
PMCPMC7652864
OpenAlexW3082640385

What OpenQuestion holds

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LicenceCC BY
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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.