Evidence map›Paper›PMID 31217818›Full record

ArticleTherapeutic advances in gastroenterology2019

An expansion study of genotype-driven weekly irinotecan and capecitabine in combination with neoadjuvant radiotherapy for locally advanced rectal cancer with UGT1A1 *1*1 genotype.

Yun Guan, Yunzhu Shen, Ye Xu, Chao Li, Jingwen Wang, Weilie Gu, Peng Lian, Dan Huang, Sanjun Cai, Zhen Zhang and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02605265 (A Randomized Phase III Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

NCT02605265 phase3completednot on this map

A Randomized Phase III Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer

TypeinterventionalSponsorFudan UniversityRan2015 to 2023Enrolled356ConditionsLocally Advanced Rectal CancerArmsRadiation, Capecitabine, Irinotecan, Oxaliplatin
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Multicenter, Randomized, Phase III Trial of Neoadjuvant Chemoradiation With Capecitabine and Irinotecan Guided byJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  3. Review
  4. Article
  5. 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

11 authors at 3 institutions in 1 country.

Yun GuanDepartment of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China.
Yunzhu ShenDepartment of Oncology, Nanjing Medical University, Nanjing, China.
Ye XuDepartment of Colorectal Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.
Chao LiDepartment of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China.
Jingwen WangDepartment of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China.
Weilie GuDepartment of Colorectal Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.
Peng LianDepartment of Colorectal Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.
Dan HuangDepartment of Pathology, Fudan University Shanghai Cancer Centre, Shanghai, China.
Sanjun CaiDepartment of Colorectal Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.
Zhen ZhangDepartment of Radiation Oncology, Fudan University Shanghai Cancer Centre, No. 270, Dong'An Road, Shanghai 200032, China.
Ji ZhuDepartment of Radiation Oncology, Fudan University Shanghai Cancer Centre, No. 270, Dong'An Road, Shanghai 200032, China.ORCID https://orcid.org/0000-0001-7134-9419
Fudan University · CNShanghai Medical College of Fudan University · CNNanjing Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn our previous dose-escalation study, we uncovered the maximum tolerated dose (MTD) of weekly irinotecan was escalated to 80 mg/m

methodsPatients with clinical stage T3-4, N0-2 rectal cancer eligible for preoperative chemoradiotherapy were screened for the UGT1A1*28 genotype. A total of 52 patients with the *1*1 genotype were enrolled. Whole-pelvic intensity-modulated radiation therapy was given in 50 Gy/25 fractions. Concurrently, irinotecan of 80 mg/m

resultsAll patients completed capecitabine-based radiotherapy as scheduled, and 42 (81%) patients completed more than three cycles of weekly irinotecan. Overall, grade 3/4 toxicities were observed in 20 cases, including 11 leucopenia, 10 neutropenia and 12 diarrhoea. Forty-three patients (83%) underwent a radical surgery, and 12 were evaluated as pCR. Another four patients accepted a watch-and-wait strategy because of clinical complete response (CCR).

conclusionsOur data demonstrated manageable toxicities and an encouraging CCR rate for UGT1A1 *1*1 genotype in an enhanced neoadjuvant therapy. A phase III trial is ongoing to evaluate the value of irinotecan in neoadjuvant therapy (CinClare) [ClinicalTrials.gov identifier: NCT02605265].

Indexed as

intensity-modulated radiation therapyirinotecanneoadjuvant chemoradiotherapyrectal cancerUGT1A1*28

Identifiers

PMID31217818
PMCPMC6557009
OpenAlexW2977261409

What OpenQuestion holds

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Registered trials

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.