Evidence map›Paper›PMID 34327766›Full record

Trial reportCancer science2021

Impact of UGT1A1 genotype on the efficacy and safety of irinotecan-based chemotherapy in metastatic colorectal cancer.

Satoru Iwasa, Kei Muro, Satoshi Morita, Young Suk Park, Masato Nakamura, Masahito Kotaka, Tomohiro Nishina, Hiroshi Matsuoka, Joong Bae Ahn, Keun-Wook Lee and 11 more

Open access · goldAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 31% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Guideline
  2. Frontiers in oncology · 2022
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Characteristics and Clinical Implication of UGT1A1 Heterozygous Mutation in Tumor.Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2022
    Article
  8. Implementing Pre-TherapeuticJournal of personalized medicine · 2022
    Article
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 3 countries.

Satoru IwasaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0003-3863-9582
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Young Suk ParkDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Masato NakamuraDepartment of Chemotherapy, Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.
Masahito KotakaDepartment of Digestive Surgery, Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.
Tomohiro NishinaDepartment of Gastroenterology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Hiroshi MatsuokaDepartment of General Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Japan.
Joong Bae AhnDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Yong Sang HongDepartment of Oncology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.
Sae Won HanDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Sang-Hee ChoDepartment of Hematology-Oncology, Chonnam National University Hospital, Medical School, Gwangju, Korea.ORCID https://orcid.org/0000-0002-7995-7862
Dong-Sheng ZhangDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Wei-Jia FangDepartment of Medical Oncology, First Affiliated Hospital, Zhejiang University, Hangzhou, China.ORCID https://orcid.org/0000-0001-9849-347X
Li BaiDepartment of Medical Oncology, Chinese PLA General Hospital, Beijing, China.
Xiang-Lin YuanDepartment of Gastrointestinal Oncology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China.
Ying YuanDepartment of Medical Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Yasuhide YamadaComprehensive Cancer Center, National Center for Global Health and Medicine, Shizuoka, Japan.
Junichi SakamotoTokai Central Hospital, Kakamigahara, Japan.
Tae Won KimDepartment of Oncology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.
Ulsan College · KRAichi Cancer Center · JPAizawa Hospital · JPChinese PLA General Hospital · CNChonnam National University Hospital · KRFirst Affiliated Hospital Zhejiang University · CNFujita Health University Hospital · JPHamamatsu University School of Medicine · JPKyoto University · JPNational Cancer Center Hospital East · JPSamsung Medical Center · KRSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRShikoku Cancer Center · JPSun Yat-sen University · CNTokai Central Hospital · JPTongji Hospital · CNYonsei University · KRZhejiang University · CN

Funding

Chugai PharmaceuticalF Hoffmann-La Roche
6 · The paper itself

Abstract

The phase III AXEPT study showed the noninferiority of modified capecitabine plus irinotecan (mXELIRI) with or without bevacizumab relative to fluorouracil, leucovorin, and irinotecan (FOLFIRI) with or without bevacizumab as a second-line treatment for metastatic colorectal cancer. We evaluated the associations between the UGT1A1 genotype linked to adverse events-caused by irinotecan-and the efficacy and safety of mXELIRI and FOLFIRI. The UGT1A1 genotype was prospectively determined and patients were categorized into three groups according to WT (*1/*1), single heterozygous (SH; *28/*1 or *6/*1), and double heterozygous or homozygous (DHH; *28/*28, *6/*6, or *28/*6). Overall survival (OS), progression-free survival, response rate, and safety were assessed. The UGT1A1 genotype was available in all 650 randomized patients (WT, 309 [47.5%]; SH, 291 [44.8%]; DHH, 50 [7.7%]). The median OS was 15.9, 17.7, and 10.6 months in the WT, SH, and DHH groups, respectively, with an adjusted hazard ratio (HR) of 1.53 (95% confidence interval [CI], 1.12-2.09; P = .008) for DHH vs WT or SH. The median OS in the mXELIRI and FOLFIRI arms was 18.1 vs 14.3 months (HR 0.80; 95% CI, 0.62-1.03) in the WT group, 16.3 vs 18.3 months (HR 1.04; 95% CI, 0.79-1.36) in the SH group, and 13.0 vs 9.1 months (HR 0.71; 95% CI, 0.39-1.31) in the DHH group, respectively. Modified capecitabine plus irinotecan with or without bevacizumab could be a standard second-line chemotherapy in terms of efficacy and safety regardless of the UGT1A1 genotype.

Indexed as

GenotypeAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinColorectal NeoplasmsConfidence IntervalsDeoxycytidineFemaleFluorouracilGlucuronosyltransferaseHumansLeucovorinMaleBevacizumabCamptothecinDeoxycytidineFluorouracilGlucuronosyltransferaseLeucovorinTopoisomerase I InhibitorsUGT1A1 Enzymecapecitabinecolorectal canceririnotecanUGT1A1XELIRI

Identifiers

PMID34327766
PMCPMC8586680
OpenAlexW3184751650

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.