Evidence map›Paper›PMID 30612267›Full record

Trial reportInternational journal of clinical oncology2019

mFOLFOX6 plus bevacizumab to treat liver-only metastases of colorectal cancer that are unsuitable for upfront resection (TRICC0808): a multicenter phase II trial comprising the final analysis for survival.

Masamichi Yasuno, Hiroyuki Uetake, Megumi Ishiguro, Nobuyuki Mizunuma, Takamichi Komori, Go Miyata, Akio Shiomi, Tatsuo Kagimura, Kenichi Sugihara

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
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

19 citing papers in PubMed.

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  17. Comprehensive review of targeted therapy for colorectal cancer.Signal transduction and targeted therapy · 2020
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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

9 authors.

Masamichi YasunoInstitute of Global Affairs, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. yassrg1@tmd.ac.jp.
Hiroyuki UetakeDepartment of Specialized Surgeries, Tokyo Medical and Dental University, Graduate School, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
Megumi IshiguroDepartment of Specialized Surgeries, Tokyo Medical and Dental University, Graduate School, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
Nobuyuki MizunumaDepartment of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto, Tokyo, 135-8550, Japan.
Takamichi KomoriDepartment of Surgery, Osaka General Medical Center, 3-1-56 Bandai-Higashi, Sumiyoshi, Osaka, 558-8558, Japan.
Go MiyataDepartment of Surgery, Iwate Prefectural Central Hospital, 1-4-1 Ueda, Morioka, Iwate, 020-0066, Japan.
Akio ShiomiColon and Rectal Surgery, Shizuoka Cancer Center, 1007 Shimonogakubo, Nagaizumi, Shunto, Shuzuoka, 411-8777, Japan.
Tatsuo KagimuraDepartment of Statistical Analysis, Translational Research Informatics Center, 1-5-4 Minatojima-minamimachi, Chou, Kobe, Hyogo, 650-0047, Japan.
Kenichi SugiharaTokyo Medical and Dental University, Graduate School, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe TRICC0808 trial is a phase II multi-institutional trial that investigated the efficacy of preoperative mFOLFOX6 + bevacizumab (BV) therapy for liver-only metastasis that is unsuitable for upfront resection. The R0 resection rate in the efficacy analysis has been reported to be 44.4%, and the final analysis for survival was conducted (data fixation on February 16, 2015).

methodsSix cycles of mFOLFOX6 + BV therapy were applied to patients with liver-only metastases, which were > 5 cm in diameter or more than four tumors (H2 and H3), and hepatectomy was performed if possible. Primary and secondary endpoints were the R0 hepatectomy rate and overall survival (OS), respectively.

resultsOf 46 patients registered, OS was analyzed for 45 patients in whom the 3-year OS rate from the starting date of chemotherapy was 44.0% with a 33.6-month median survival time (MST). The 3-year OS rate of 31 patients with hepatectomy, including resection after an additional chemotherapy, was 61.3% with a 43.1-month MST, which was significantly better than 0% of the 3-year OS rate with a 21.0-month MST of 14 patients without hepatectomy (p value < 0.0001). In 24 patients who underwent hepatectomy after six cycles of protocol chemotherapy, the 3-year relapse-free survival rate was 8.3%, with a 36.8-month MST.

conclusionsThis final analysis of the TRICC0808 trial revealed a better long-term survival in patients with hepatectomy after mFOLFOX6 + BV therapy, although most examined patients eventually developed recurrence. Thus, hepatectomy after chemotherapy might improve the survival in patients with advanced liver metastases, although cure remains difficult.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsFemaleFluorouracilHepatectomyHumansLeucovorinLiver NeoplasmsMaleMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalOrganoplatinum CompoundsBevacizumabFluorouracilLeucovorinOrganoplatinum CompoundsColorectal cancerHepatectomyInitially resectableInitially unresectableLiver metastases

Identifiers

PMID30612267
PMCPMC6469677

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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.