Irinotecan plus S-1 versus S-1 in patients with previously treated recurrent or metastatic esophageal cancer (ESWN 01): a prospective randomized, ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-12

AUTHORS

Jing Huang, Binghe Xu, Ying Liu, Junxing Huang, Ping Lu, Yi Ba, Lin Wu, Yuxian Bai, Shu Zhang, Jifeng Feng, Ying Cheng, Jie Li, Lu Wen, Xianglin Yuan, Changwu Ma, Chunhong Hu, Qingxia Fan, Xi Wang

ABSTRACT

BACKGROUND: The benefit of systemic treatments in esophageal squamous cell carcinoma (ESCC) which has progressed after chemotherapy is still uncertain and optimal regimens based on randomized trials have not yet been established. We aimed to compare the efficacy of irinotecan plus S-1 with S-1 monotherapy in recurrent or metastatic ESCC patients who had resistance to platinum- or taxane-based chemotherapy. METHODS: We conducted a prospective randomized, multicenter, open-label, phase 3 trial in 15 centers across China. Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC, and were randomly assigned (ratio, 1:1) to receive either irinotecan plus S-1 (intravenous infusion of irinotecan [160 mg/m2] on day 1 and oral S-1 [80-120 mg] on days 1-10, repeated every 14 days) or oral S-1 monotherapy (80-120 mg/day on days 1-14, repeated every 21 days) using a central computerized minimization procedure. The primary endpoint was progression-free survival (PFS). RESULTS: Between December 23, 2014 and July 25, 2016, we screened 148 patients and randomly assigned 123 patients to receive either irinotecan plus S-1 regimen (n = 61) or S-1 monotherapy (n = 62). After a median follow-up of 29.2 months (95% confidence interval [CI] 17.5-40.9 months), the median PFS was significantly longer in the irinotecan plus S-1 group than in the S-1 monotherapy group (3.8 months [95% CI 2.9-4.3 months] vs. 1.7 months [95% CI 1.4-2.7 months], hazard ratio = 0.58, 95% CI 0.38-0.86, P = 0.006). The objective response rates were 24.6% in the irinotecan plus S-1 group and 9.7% in the S-1 monotherapy group (P = 0.002). The patients in the irinotecan plus S-1 group presented with increased rates of grade 3-4 leukopenia (16.4% vs. 0%), neutropenia (14.8% vs. 1.6%), and nausea (4.9% vs. 0%). No significant difference in grade 3-4 diarrhea and no treatment-related deaths were observed in both groups. CONCLUSIONS: The combination of irinotecan with S-1 was similarly tolerable but significantly prolonged PFS compared to S-1 monotherapy as a second- or third-line treatment in patients with recurrent or metastatic ESCC. Clinical Trial Registration NCT02319187. Registered on December 9, 2014. More... »

PAGES

16

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s40880-019-0359-7

DOI

http://dx.doi.org/10.1186/s40880-019-0359-7

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1113179528

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30940189


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1112", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Oncology and Carcinogenesis", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Peking Union Medical College Hospital", 
          "id": "https://www.grid.ac/institutes/grid.413106.1", 
          "name": [
            "Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No 17 Panjiayuan Nanli, Chaoyang District, 100021, Beijing, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Huang", 
        "givenName": "Jing", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Peking Union Medical College Hospital", 
          "id": "https://www.grid.ac/institutes/grid.413106.1", 
          "name": [
            "Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No 17 Panjiayuan Nanli, Chaoyang District, 100021, Beijing, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Xu", 
        "givenName": "Binghe", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Henan Cancer Hospital", 
          "id": "https://www.grid.ac/institutes/grid.414008.9", 
          "name": [
            "Department of Medical Oncology, Henan Cancer Hospital, 450008, Zhengzhou, Henan, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Liu", 
        "givenName": "Ying", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Taizhou People's Hospital", 
          "id": "https://www.grid.ac/institutes/grid.479690.5", 
          "name": [
            "Department of Medical Oncology, Taizhou People\u2019s Hospital, 225300, Taizhou, Jiangsu, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Huang", 
        "givenName": "Junxing", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "First Affiliated Hospital of Xinxiang Medical University", 
          "id": "https://www.grid.ac/institutes/grid.493088.e", 
          "name": [
            "Department of Medical Oncology, First Affiliated Hospital of Xinxiang Medical University, 453100, Xinxiang, Henan, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Lu", 
        "givenName": "Ping", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Tianjin Medical University Cancer Institute and Hospital", 
          "id": "https://www.grid.ac/institutes/grid.411918.4", 
          "name": [
            "Department of Medical Oncology, Tianjin Cancer Hospital, 300060, Tianjin, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Ba", 
        "givenName": "Yi", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Hunan Cancer Hospital", 
          "id": "https://www.grid.ac/institutes/grid.410622.3", 
          "name": [
            "Department of Medical Oncology, Hunan Cancer Hospital, 410006, Changsha, Hunan, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Wu", 
        "givenName": "Lin", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Third Affiliated Hospital of Harbin Medical University", 
          "id": "https://www.grid.ac/institutes/grid.412651.5", 
          "name": [
            "Department of Medical Oncology, Harbin Medical University Cancer Hospital, 150040, Harbin, Heilongjiang, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Bai", 
        "givenName": "Yuxian", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Shandong Tumor Hospital", 
          "id": "https://www.grid.ac/institutes/grid.440144.1", 
          "name": [
            "Department of Medical Oncology, Shandong Cancer Hospital, 250117, Jinan, Shandong, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Zhang", 
        "givenName": "Shu", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Jiangsu Cancer Hospital", 
          "id": "https://www.grid.ac/institutes/grid.452509.f", 
          "name": [
            "Department of Medical Oncology, Jiangsu Cancer Hospital, 210009, Nanjing, Jiangsu, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Feng", 
        "givenName": "Jifeng", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Jilin Province Tumor Hospital", 
          "id": "https://www.grid.ac/institutes/grid.440230.1", 
          "name": [
            "Department of Medical Oncology, Jilin Cancer Hospital, 130012, Changchun, Jilin, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Cheng", 
        "givenName": "Ying", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Department of Radiotherapy, Shanxi Cancer Hospital, 030013, Taiyuan, Shanxi, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Li", 
        "givenName": "Jie", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Department of Medical Oncology, Shanxi Cancer Hospital, 030013, Taiyuan, Shanxi, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Wen", 
        "givenName": "Lu", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Tongji Hospital", 
          "id": "https://www.grid.ac/institutes/grid.412793.a", 
          "name": [
            "Department of Medical Oncology, Tongji Hospital, 430030, Wuhan, Hubei, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Yuan", 
        "givenName": "Xianglin", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Department of Medical Oncology, Chifeng Municipal Hospital, 024000, Chifeng, Inner Mongolia, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Ma", 
        "givenName": "Changwu", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Second Xiangya Hospital of Central South University", 
          "id": "https://www.grid.ac/institutes/grid.452708.c", 
          "name": [
            "Department of Oncology, The Second Xiangya Hospital of Central South University, 410011, Changsha, Hunan, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hu", 
        "givenName": "Chunhong", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "First Affiliated Hospital of Zhengzhou University", 
          "id": "https://www.grid.ac/institutes/grid.412633.1", 
          "name": [
            "Department of Oncology, The First Affiliated Hospital of Zhengzhou University, 450052, Zhengzhou, Henan, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Fan", 
        "givenName": "Qingxia", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Peking Union Medical College Hospital", 
          "id": "https://www.grid.ac/institutes/grid.413106.1", 
          "name": [
            "Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No 17 Panjiayuan Nanli, Chaoyang District, 100021, Beijing, P. R. China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Wang", 
        "givenName": "Xi", 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "https://doi.org/10.1001/jamaoncol.2016.5688", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1000195011"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1001/jamaoncol.2016.5688", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1000195011"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jtho.2016.02.020", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1013281432"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10147-006-0610-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1013357947", 
          "https://doi.org/10.1007/s10147-006-0610-5"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10147-006-0610-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1013357947", 
          "https://doi.org/10.1007/s10147-006-0610-5"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s1470-2045(14)70024-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1030836859"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00280-008-0893-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1031153823", 
          "https://doi.org/10.1007/s00280-008-0893-5"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00280-008-0893-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1031153823", 
          "https://doi.org/10.1007/s00280-008-0893-5"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s12032-012-0343-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1038826231", 
          "https://doi.org/10.1007/s12032-012-0343-4"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s12032-012-0343-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1038826231", 
          "https://doi.org/10.1007/s12032-012-0343-4"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1200/jco.2011.36.7599", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1039094870"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/coc.0b013e3181bead92", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041003471"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/coc.0b013e3181bead92", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041003471"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/coc.0b013e3181bead92", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041003471"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/1759-7714.12323", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044035480"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/annonc/mdh007", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044779901"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1159/000348294", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1045869512"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1159/000348294", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1045869512"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.ejca.2011.06.002", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1051799274"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1077827111", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1077858124", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s1470-2045(17)30181-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1084052519"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s1470-2045(17)30181-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1084052519"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1200/jco.2017.74.9846", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1092595046"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1158/1078-0432.ccr-17-2439", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1100562940"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1158/1078-0432.ccr-17-2439", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1100562940"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2019-12", 
    "datePublishedReg": "2019-12-01", 
    "description": "BACKGROUND: The benefit of systemic treatments in esophageal squamous cell carcinoma (ESCC) which has progressed after chemotherapy is still uncertain and optimal regimens based on randomized trials have not yet been established. We aimed to compare the efficacy of irinotecan plus S-1 with S-1 monotherapy in recurrent or metastatic ESCC patients who had resistance to platinum- or taxane-based chemotherapy.\nMETHODS: We conducted a prospective randomized, multicenter, open-label, phase 3 trial in 15 centers across China. Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC, and were randomly assigned (ratio, 1:1) to receive either irinotecan plus S-1 (intravenous infusion of irinotecan [160\u00a0mg/m2] on day 1 and oral S-1 [80-120\u00a0mg] on days 1-10, repeated every 14\u00a0days) or oral S-1 monotherapy (80-120\u00a0mg/day on days 1-14, repeated every 21\u00a0days) using a central computerized minimization procedure. The primary endpoint was progression-free survival (PFS).\nRESULTS: Between December 23, 2014 and July 25, 2016, we screened 148 patients and randomly assigned 123 patients to receive either irinotecan plus S-1 regimen (n\u2009=\u200961) or S-1 monotherapy (n\u2009=\u200962). After a median follow-up of 29.2\u00a0months (95% confidence interval [CI] 17.5-40.9\u00a0months), the median PFS was significantly longer in the irinotecan plus S-1 group than in the S-1 monotherapy group (3.8\u00a0months [95% CI 2.9-4.3\u00a0months] vs. 1.7\u00a0months [95% CI 1.4-2.7\u00a0months], hazard ratio\u2009=\u20090.58, 95% CI 0.38-0.86, P\u2009=\u20090.006). The objective response rates were 24.6% in the irinotecan plus S-1 group and 9.7% in the S-1 monotherapy group (P\u2009=\u20090.002). The patients in the irinotecan plus S-1 group presented with increased rates of grade 3-4 leukopenia (16.4% vs. 0%), neutropenia (14.8% vs. 1.6%), and nausea (4.9% vs. 0%). No significant difference in grade 3-4 diarrhea and no treatment-related deaths were observed in both groups.\nCONCLUSIONS: The combination of irinotecan with S-1 was similarly tolerable but significantly prolonged PFS compared to S-1 monotherapy as a second- or third-line treatment in patients with recurrent or metastatic ESCC. Clinical Trial Registration NCT02319187. Registered on December 9, 2014.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1186/s40880-019-0359-7", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": true, 
    "isPartOf": [
      {
        "id": "sg:journal.1041144", 
        "issn": [
          "1000-467X", 
          "2523-3548"
        ], 
        "name": "Cancer Communications", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "39"
      }
    ], 
    "name": "Irinotecan plus S-1 versus S-1 in patients with previously treated recurrent or metastatic esophageal cancer (ESWN 01): a prospective randomized, multicenter, open-labeled phase 3 trial", 
    "pagination": "16", 
    "productId": [
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/s40880-019-0359-7"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1113179528"
        ]
      }, 
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "4a93646dac4cc441f1d3e1a63bd2173f5ee5a779407da3b45aff32d99f1f1def"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "101723675"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "30940189"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/s40880-019-0359-7", 
      "https://app.dimensions.ai/details/publication/pub.1113179528"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-16T06:23", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000377_0000000377/records_106822_00000002.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://link.springer.com/10.1186%2Fs40880-019-0359-7"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/s40880-019-0359-7'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/s40880-019-0359-7'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/s40880-019-0359-7'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/s40880-019-0359-7'


 

This table displays all metadata directly associated to this object as RDF triples.

264 TRIPLES      21 PREDICATES      46 URIs      21 LITERALS      9 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/s40880-019-0359-7 schema:about anzsrc-for:11
2 anzsrc-for:1112
3 schema:author N7c973ff274d647359931532b1b21a708
4 schema:citation sg:pub.10.1007/s00280-008-0893-5
5 sg:pub.10.1007/s10147-006-0610-5
6 sg:pub.10.1007/s12032-012-0343-4
7 https://app.dimensions.ai/details/publication/pub.1077827111
8 https://app.dimensions.ai/details/publication/pub.1077858124
9 https://doi.org/10.1001/jamaoncol.2016.5688
10 https://doi.org/10.1016/j.ejca.2011.06.002
11 https://doi.org/10.1016/j.jtho.2016.02.020
12 https://doi.org/10.1016/s1470-2045(14)70024-5
13 https://doi.org/10.1016/s1470-2045(17)30181-x
14 https://doi.org/10.1093/annonc/mdh007
15 https://doi.org/10.1097/coc.0b013e3181bead92
16 https://doi.org/10.1111/1759-7714.12323
17 https://doi.org/10.1158/1078-0432.ccr-17-2439
18 https://doi.org/10.1159/000348294
19 https://doi.org/10.1200/jco.2011.36.7599
20 https://doi.org/10.1200/jco.2017.74.9846
21 schema:datePublished 2019-12
22 schema:datePublishedReg 2019-12-01
23 schema:description BACKGROUND: The benefit of systemic treatments in esophageal squamous cell carcinoma (ESCC) which has progressed after chemotherapy is still uncertain and optimal regimens based on randomized trials have not yet been established. We aimed to compare the efficacy of irinotecan plus S-1 with S-1 monotherapy in recurrent or metastatic ESCC patients who had resistance to platinum- or taxane-based chemotherapy. METHODS: We conducted a prospective randomized, multicenter, open-label, phase 3 trial in 15 centers across China. Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC, and were randomly assigned (ratio, 1:1) to receive either irinotecan plus S-1 (intravenous infusion of irinotecan [160 mg/m2] on day 1 and oral S-1 [80-120 mg] on days 1-10, repeated every 14 days) or oral S-1 monotherapy (80-120 mg/day on days 1-14, repeated every 21 days) using a central computerized minimization procedure. The primary endpoint was progression-free survival (PFS). RESULTS: Between December 23, 2014 and July 25, 2016, we screened 148 patients and randomly assigned 123 patients to receive either irinotecan plus S-1 regimen (n = 61) or S-1 monotherapy (n = 62). After a median follow-up of 29.2 months (95% confidence interval [CI] 17.5-40.9 months), the median PFS was significantly longer in the irinotecan plus S-1 group than in the S-1 monotherapy group (3.8 months [95% CI 2.9-4.3 months] vs. 1.7 months [95% CI 1.4-2.7 months], hazard ratio = 0.58, 95% CI 0.38-0.86, P = 0.006). The objective response rates were 24.6% in the irinotecan plus S-1 group and 9.7% in the S-1 monotherapy group (P = 0.002). The patients in the irinotecan plus S-1 group presented with increased rates of grade 3-4 leukopenia (16.4% vs. 0%), neutropenia (14.8% vs. 1.6%), and nausea (4.9% vs. 0%). No significant difference in grade 3-4 diarrhea and no treatment-related deaths were observed in both groups. CONCLUSIONS: The combination of irinotecan with S-1 was similarly tolerable but significantly prolonged PFS compared to S-1 monotherapy as a second- or third-line treatment in patients with recurrent or metastatic ESCC. Clinical Trial Registration NCT02319187. Registered on December 9, 2014.
24 schema:genre research_article
25 schema:inLanguage en
26 schema:isAccessibleForFree true
27 schema:isPartOf N95459ccc402041ba9a680726004c26e3
28 Ne077540849734e8ab85d48a042817219
29 sg:journal.1041144
30 schema:name Irinotecan plus S-1 versus S-1 in patients with previously treated recurrent or metastatic esophageal cancer (ESWN 01): a prospective randomized, multicenter, open-labeled phase 3 trial
31 schema:pagination 16
32 schema:productId N316c1bc6d88941569aa5341a200d420e
33 N3db11bebf5f84d8692e781a776d6f6ab
34 N8d39fa516d74464782d59c4fdb21d724
35 Ndbd530c9a4264e708015ef7614ba032a
36 Ne1ca251bcf5d43ca8cd98191468c6b5d
37 schema:sameAs https://app.dimensions.ai/details/publication/pub.1113179528
38 https://doi.org/10.1186/s40880-019-0359-7
39 schema:sdDatePublished 2019-04-16T06:23
40 schema:sdLicense https://scigraph.springernature.com/explorer/license/
41 schema:sdPublisher Nd2210c40a55240ffa9785c6c50fe1bfa
42 schema:url https://link.springer.com/10.1186%2Fs40880-019-0359-7
43 sgo:license sg:explorer/license/
44 sgo:sdDataset articles
45 rdf:type schema:ScholarlyArticle
46 N0469e9fd3bd043afa768c798e1685c00 rdf:first N8f631cd77c2c4a23bec4aee44efa9bc9
47 rdf:rest N1d4b8e6563e84278b3c10c346efa0a6d
48 N084c1cff202646b7a0206d57bc41d181 rdf:first Nf4f4c8fabe9a4a7fb8df05053326cc40
49 rdf:rest Ncfdcec776e064238b8b5160f43962787
50 N0b58f3c787824deeb3d942cacfcb29b3 schema:affiliation https://www.grid.ac/institutes/grid.452708.c
51 schema:familyName Hu
52 schema:givenName Chunhong
53 rdf:type schema:Person
54 N10ca74e8032446f78a0ad95786d3be3f rdf:first Neb4ac860ed164f83adbc504420d58d15
55 rdf:rest Ne803768bcaaf4773a6dcab3d52f818f9
56 N19558f77dd8e43159933330ae1ae99e8 rdf:first N4f788e202d9f486785500a58466acc94
57 rdf:rest N59ff25c594cd4b4491fa4f14c3b7ce2c
58 N19fab399b7844036aff270c384e6cccf schema:affiliation N55170d6f423f4070aeda894cd4b02ca0
59 schema:familyName Ma
60 schema:givenName Changwu
61 rdf:type schema:Person
62 N1d4b8e6563e84278b3c10c346efa0a6d rdf:first N19fab399b7844036aff270c384e6cccf
63 rdf:rest N91c2563095e044cba67db6aae5c73b7b
64 N2212482aafa1464ea4b88a99413f9836 schema:affiliation https://www.grid.ac/institutes/grid.413106.1
65 schema:familyName Wang
66 schema:givenName Xi
67 rdf:type schema:Person
68 N23191ba06d424f5c80edd3fc95f684ca rdf:first Nccdcd2eadf234dc3847b8a4ff6789d4e
69 rdf:rest N0469e9fd3bd043afa768c798e1685c00
70 N2a8e2212ada847388289d3cee094acc3 schema:affiliation https://www.grid.ac/institutes/grid.411918.4
71 schema:familyName Ba
72 schema:givenName Yi
73 rdf:type schema:Person
74 N2e09456602a649b5b169088851bf1834 schema:affiliation https://www.grid.ac/institutes/grid.413106.1
75 schema:familyName Huang
76 schema:givenName Jing
77 rdf:type schema:Person
78 N316c1bc6d88941569aa5341a200d420e schema:name nlm_unique_id
79 schema:value 101723675
80 rdf:type schema:PropertyValue
81 N3266b760232f458e8face9edca7607d5 schema:affiliation https://www.grid.ac/institutes/grid.440144.1
82 schema:familyName Zhang
83 schema:givenName Shu
84 rdf:type schema:Person
85 N39e87c16afa74fc7b2026e761f6515a4 schema:affiliation https://www.grid.ac/institutes/grid.440230.1
86 schema:familyName Cheng
87 schema:givenName Ying
88 rdf:type schema:Person
89 N3db11bebf5f84d8692e781a776d6f6ab schema:name dimensions_id
90 schema:value pub.1113179528
91 rdf:type schema:PropertyValue
92 N3fd98a80b7e24cc9a820802538cb5e4a schema:affiliation https://www.grid.ac/institutes/grid.414008.9
93 schema:familyName Liu
94 schema:givenName Ying
95 rdf:type schema:Person
96 N4f788e202d9f486785500a58466acc94 schema:affiliation https://www.grid.ac/institutes/grid.412633.1
97 schema:familyName Fan
98 schema:givenName Qingxia
99 rdf:type schema:Person
100 N55170d6f423f4070aeda894cd4b02ca0 schema:name Department of Medical Oncology, Chifeng Municipal Hospital, 024000, Chifeng, Inner Mongolia, P. R. China
101 rdf:type schema:Organization
102 N59f54d15e0fd45c789444fd28e0fca9c schema:affiliation https://www.grid.ac/institutes/grid.413106.1
103 schema:familyName Xu
104 schema:givenName Binghe
105 rdf:type schema:Person
106 N59ff25c594cd4b4491fa4f14c3b7ce2c rdf:first N2212482aafa1464ea4b88a99413f9836
107 rdf:rest rdf:nil
108 N641e96278af04ac7b95b98c18e0474dd schema:affiliation https://www.grid.ac/institutes/grid.479690.5
109 schema:familyName Huang
110 schema:givenName Junxing
111 rdf:type schema:Person
112 N68f67fc972de4206a306f67a80554a2c schema:affiliation N7bc53ca734224ff6b3d062e25d89b866
113 schema:familyName Li
114 schema:givenName Jie
115 rdf:type schema:Person
116 N795a60e7026d42c3b1e3aa52bfe40a9d rdf:first N39e87c16afa74fc7b2026e761f6515a4
117 rdf:rest N9b021ea588b34e94b38902472c50ceef
118 N7986e0d21a464e5495aca77b76a21e78 schema:name Department of Medical Oncology, Shanxi Cancer Hospital, 030013, Taiyuan, Shanxi, P. R. China
119 rdf:type schema:Organization
120 N7bc53ca734224ff6b3d062e25d89b866 schema:name Department of Radiotherapy, Shanxi Cancer Hospital, 030013, Taiyuan, Shanxi, P. R. China
121 rdf:type schema:Organization
122 N7c973ff274d647359931532b1b21a708 rdf:first N2e09456602a649b5b169088851bf1834
123 rdf:rest Nf47d5d22279c4738a5c92c9c7413ff55
124 N87a3c37f680840edbd9cfd5654ac0690 rdf:first N641e96278af04ac7b95b98c18e0474dd
125 rdf:rest N10ca74e8032446f78a0ad95786d3be3f
126 N8c90d926ac8f46e19d551505749167b2 rdf:first N3266b760232f458e8face9edca7607d5
127 rdf:rest N91c1855e96554b5d8e6773e4be4d772f
128 N8d39fa516d74464782d59c4fdb21d724 schema:name readcube_id
129 schema:value 4a93646dac4cc441f1d3e1a63bd2173f5ee5a779407da3b45aff32d99f1f1def
130 rdf:type schema:PropertyValue
131 N8f631cd77c2c4a23bec4aee44efa9bc9 schema:affiliation https://www.grid.ac/institutes/grid.412793.a
132 schema:familyName Yuan
133 schema:givenName Xianglin
134 rdf:type schema:Person
135 N91c1855e96554b5d8e6773e4be4d772f rdf:first Nf862823de4814f3388aa2bd4f474f33e
136 rdf:rest N795a60e7026d42c3b1e3aa52bfe40a9d
137 N91c2563095e044cba67db6aae5c73b7b rdf:first N0b58f3c787824deeb3d942cacfcb29b3
138 rdf:rest N19558f77dd8e43159933330ae1ae99e8
139 N95459ccc402041ba9a680726004c26e3 schema:issueNumber 1
140 rdf:type schema:PublicationIssue
141 N9b021ea588b34e94b38902472c50ceef rdf:first N68f67fc972de4206a306f67a80554a2c
142 rdf:rest N23191ba06d424f5c80edd3fc95f684ca
143 Nccdcd2eadf234dc3847b8a4ff6789d4e schema:affiliation N7986e0d21a464e5495aca77b76a21e78
144 schema:familyName Wen
145 schema:givenName Lu
146 rdf:type schema:Person
147 Ncfdcec776e064238b8b5160f43962787 rdf:first Ne83d2452f11d4637baf2cacccfb84e17
148 rdf:rest N8c90d926ac8f46e19d551505749167b2
149 Nd2210c40a55240ffa9785c6c50fe1bfa schema:name Springer Nature - SN SciGraph project
150 rdf:type schema:Organization
151 Ndbd530c9a4264e708015ef7614ba032a schema:name doi
152 schema:value 10.1186/s40880-019-0359-7
153 rdf:type schema:PropertyValue
154 Ne077540849734e8ab85d48a042817219 schema:volumeNumber 39
155 rdf:type schema:PublicationVolume
156 Ne1ca251bcf5d43ca8cd98191468c6b5d schema:name pubmed_id
157 schema:value 30940189
158 rdf:type schema:PropertyValue
159 Ne803768bcaaf4773a6dcab3d52f818f9 rdf:first N2a8e2212ada847388289d3cee094acc3
160 rdf:rest N084c1cff202646b7a0206d57bc41d181
161 Ne83d2452f11d4637baf2cacccfb84e17 schema:affiliation https://www.grid.ac/institutes/grid.412651.5
162 schema:familyName Bai
163 schema:givenName Yuxian
164 rdf:type schema:Person
165 Neb4ac860ed164f83adbc504420d58d15 schema:affiliation https://www.grid.ac/institutes/grid.493088.e
166 schema:familyName Lu
167 schema:givenName Ping
168 rdf:type schema:Person
169 Nf47d5d22279c4738a5c92c9c7413ff55 rdf:first N59f54d15e0fd45c789444fd28e0fca9c
170 rdf:rest Nf498c61ac54047ebbaa3037a1b2046c6
171 Nf498c61ac54047ebbaa3037a1b2046c6 rdf:first N3fd98a80b7e24cc9a820802538cb5e4a
172 rdf:rest N87a3c37f680840edbd9cfd5654ac0690
173 Nf4f4c8fabe9a4a7fb8df05053326cc40 schema:affiliation https://www.grid.ac/institutes/grid.410622.3
174 schema:familyName Wu
175 schema:givenName Lin
176 rdf:type schema:Person
177 Nf862823de4814f3388aa2bd4f474f33e schema:affiliation https://www.grid.ac/institutes/grid.452509.f
178 schema:familyName Feng
179 schema:givenName Jifeng
180 rdf:type schema:Person
181 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
182 schema:name Medical and Health Sciences
183 rdf:type schema:DefinedTerm
184 anzsrc-for:1112 schema:inDefinedTermSet anzsrc-for:
185 schema:name Oncology and Carcinogenesis
186 rdf:type schema:DefinedTerm
187 sg:journal.1041144 schema:issn 1000-467X
188 2523-3548
189 schema:name Cancer Communications
190 rdf:type schema:Periodical
191 sg:pub.10.1007/s00280-008-0893-5 schema:sameAs https://app.dimensions.ai/details/publication/pub.1031153823
192 https://doi.org/10.1007/s00280-008-0893-5
193 rdf:type schema:CreativeWork
194 sg:pub.10.1007/s10147-006-0610-5 schema:sameAs https://app.dimensions.ai/details/publication/pub.1013357947
195 https://doi.org/10.1007/s10147-006-0610-5
196 rdf:type schema:CreativeWork
197 sg:pub.10.1007/s12032-012-0343-4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1038826231
198 https://doi.org/10.1007/s12032-012-0343-4
199 rdf:type schema:CreativeWork
200 https://app.dimensions.ai/details/publication/pub.1077827111 schema:CreativeWork
201 https://app.dimensions.ai/details/publication/pub.1077858124 schema:CreativeWork
202 https://doi.org/10.1001/jamaoncol.2016.5688 schema:sameAs https://app.dimensions.ai/details/publication/pub.1000195011
203 rdf:type schema:CreativeWork
204 https://doi.org/10.1016/j.ejca.2011.06.002 schema:sameAs https://app.dimensions.ai/details/publication/pub.1051799274
205 rdf:type schema:CreativeWork
206 https://doi.org/10.1016/j.jtho.2016.02.020 schema:sameAs https://app.dimensions.ai/details/publication/pub.1013281432
207 rdf:type schema:CreativeWork
208 https://doi.org/10.1016/s1470-2045(14)70024-5 schema:sameAs https://app.dimensions.ai/details/publication/pub.1030836859
209 rdf:type schema:CreativeWork
210 https://doi.org/10.1016/s1470-2045(17)30181-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1084052519
211 rdf:type schema:CreativeWork
212 https://doi.org/10.1093/annonc/mdh007 schema:sameAs https://app.dimensions.ai/details/publication/pub.1044779901
213 rdf:type schema:CreativeWork
214 https://doi.org/10.1097/coc.0b013e3181bead92 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041003471
215 rdf:type schema:CreativeWork
216 https://doi.org/10.1111/1759-7714.12323 schema:sameAs https://app.dimensions.ai/details/publication/pub.1044035480
217 rdf:type schema:CreativeWork
218 https://doi.org/10.1158/1078-0432.ccr-17-2439 schema:sameAs https://app.dimensions.ai/details/publication/pub.1100562940
219 rdf:type schema:CreativeWork
220 https://doi.org/10.1159/000348294 schema:sameAs https://app.dimensions.ai/details/publication/pub.1045869512
221 rdf:type schema:CreativeWork
222 https://doi.org/10.1200/jco.2011.36.7599 schema:sameAs https://app.dimensions.ai/details/publication/pub.1039094870
223 rdf:type schema:CreativeWork
224 https://doi.org/10.1200/jco.2017.74.9846 schema:sameAs https://app.dimensions.ai/details/publication/pub.1092595046
225 rdf:type schema:CreativeWork
226 https://www.grid.ac/institutes/grid.410622.3 schema:alternateName Hunan Cancer Hospital
227 schema:name Department of Medical Oncology, Hunan Cancer Hospital, 410006, Changsha, Hunan, P. R. China
228 rdf:type schema:Organization
229 https://www.grid.ac/institutes/grid.411918.4 schema:alternateName Tianjin Medical University Cancer Institute and Hospital
230 schema:name Department of Medical Oncology, Tianjin Cancer Hospital, 300060, Tianjin, P. R. China
231 rdf:type schema:Organization
232 https://www.grid.ac/institutes/grid.412633.1 schema:alternateName First Affiliated Hospital of Zhengzhou University
233 schema:name Department of Oncology, The First Affiliated Hospital of Zhengzhou University, 450052, Zhengzhou, Henan, P. R. China
234 rdf:type schema:Organization
235 https://www.grid.ac/institutes/grid.412651.5 schema:alternateName Third Affiliated Hospital of Harbin Medical University
236 schema:name Department of Medical Oncology, Harbin Medical University Cancer Hospital, 150040, Harbin, Heilongjiang, P. R. China
237 rdf:type schema:Organization
238 https://www.grid.ac/institutes/grid.412793.a schema:alternateName Tongji Hospital
239 schema:name Department of Medical Oncology, Tongji Hospital, 430030, Wuhan, Hubei, P. R. China
240 rdf:type schema:Organization
241 https://www.grid.ac/institutes/grid.413106.1 schema:alternateName Peking Union Medical College Hospital
242 schema:name Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No 17 Panjiayuan Nanli, Chaoyang District, 100021, Beijing, P. R. China
243 rdf:type schema:Organization
244 https://www.grid.ac/institutes/grid.414008.9 schema:alternateName Henan Cancer Hospital
245 schema:name Department of Medical Oncology, Henan Cancer Hospital, 450008, Zhengzhou, Henan, P. R. China
246 rdf:type schema:Organization
247 https://www.grid.ac/institutes/grid.440144.1 schema:alternateName Shandong Tumor Hospital
248 schema:name Department of Medical Oncology, Shandong Cancer Hospital, 250117, Jinan, Shandong, P. R. China
249 rdf:type schema:Organization
250 https://www.grid.ac/institutes/grid.440230.1 schema:alternateName Jilin Province Tumor Hospital
251 schema:name Department of Medical Oncology, Jilin Cancer Hospital, 130012, Changchun, Jilin, P. R. China
252 rdf:type schema:Organization
253 https://www.grid.ac/institutes/grid.452509.f schema:alternateName Jiangsu Cancer Hospital
254 schema:name Department of Medical Oncology, Jiangsu Cancer Hospital, 210009, Nanjing, Jiangsu, P. R. China
255 rdf:type schema:Organization
256 https://www.grid.ac/institutes/grid.452708.c schema:alternateName Second Xiangya Hospital of Central South University
257 schema:name Department of Oncology, The Second Xiangya Hospital of Central South University, 410011, Changsha, Hunan, P. R. China
258 rdf:type schema:Organization
259 https://www.grid.ac/institutes/grid.479690.5 schema:alternateName Taizhou People's Hospital
260 schema:name Department of Medical Oncology, Taizhou People’s Hospital, 225300, Taizhou, Jiangsu, P. R. China
261 rdf:type schema:Organization
262 https://www.grid.ac/institutes/grid.493088.e schema:alternateName First Affiliated Hospital of Xinxiang Medical University
263 schema:name Department of Medical Oncology, First Affiliated Hospital of Xinxiang Medical University, 453100, Xinxiang, Henan, P. R. China
264 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...