Phase II trial of neoadjuvant chemotherapy with docetaxel, nedaplatin, and S1 for advanced esophageal squamous cell carcinoma
Although standard chemotherapy for esophageal cancer patients is fluorouracil and cisplatin, the prognosis is still unsatisfactory. A new therapeutic regimen combining docetaxel, cisplatin, and 5‐fluorouracil was recently developed to improve both local and distant tumor control. We developed a new...
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description | Although standard chemotherapy for esophageal cancer patients is fluorouracil and cisplatin, the prognosis is still unsatisfactory. A new therapeutic regimen combining docetaxel, cisplatin, and 5‐fluorouracil was recently developed to improve both local and distant tumor control. We developed a new regimen of docetaxel, nedaplatin, and S1 (DGS) and previously reported the recommended dose in a phase I dose‐escalation study. We then undertook a phase II study of DGS for advanced esophageal squamous cell carcinoma. Patients with clinical stage IB/II/III disease were eligible. Patients received two courses of chemotherapy: docetaxel 35 mg/m2 with nedaplatin 40 mg/m2 on day 8, 80 mg/m2 S1 on days 1–14, and 2 weeks off. After completion of chemotherapy, patients underwent esophagectomy. The primary endpoint was the completion rate of protocol treatment (completion of two courses of preoperative chemotherapy and R0 surgery [no residual tumor]). We enrolled 32 patients. The completion rate of protocol treatment was 96.9%. During chemotherapy, the most common grade 3 or 4 toxicity was neutropenia (25.0%). No treatment‐related deaths were observed, and the incidence of operative morbidity was tolerable. The overall response rate after chemotherapy was 83.3%. This DGS regimen was well tolerated and highly active. This trial is registered with the University Hospital Medical Information Network (UMIN ID: 000014626).
This DGS regimen was well tolerated and highly active. |
doi_str_mv | 10.1111/cas.12943 |
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This DGS regimen was well tolerated and highly active.</description><identifier>ISSN: 1347-9032</identifier><identifier>EISSN: 1349-7006</identifier><identifier>DOI: 10.1111/cas.12943</identifier><identifier>PMID: 27061001</identifier><language>eng</language><publisher>England: John Wiley & Sons, Inc</publisher><subject>5-Fluorouracil ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Cancer therapies ; Carcinoma, Squamous Cell - drug therapy ; Carcinoma, Squamous Cell - pathology ; Carcinoma, Squamous Cell - surgery ; Chemotherapy ; Cisplatin ; Docetaxel ; Drug Combinations ; Drug dosages ; Esophageal cancer ; Esophageal Neoplasms - drug therapy ; Esophageal Neoplasms - pathology ; Esophageal Neoplasms - surgery ; Esophageal Squamous Cell Carcinoma ; Esophagectomy ; Esophagus ; Female ; Humans ; Hydration ; Kaplan-Meier Estimate ; Lymphatic system ; Male ; Medical prognosis ; Metastasis ; Middle Aged ; Morbidity ; Mortality ; nedaplatin ; Neoadjuvant Therapy ; Neoplasm Staging ; Neutropenia ; Neutropenia - chemically induced ; Organoplatinum Compounds - administration & dosage ; Organoplatinum Compounds - adverse effects ; Organoplatinum Compounds - therapeutic use ; Original ; Oxonic Acid - administration & dosage ; Oxonic Acid - adverse effects ; Oxonic Acid - therapeutic use ; Patients ; Pharmaceuticals ; phase II ; Quality of life ; Squamous cell carcinoma ; Surgery ; Taxoids - administration & dosage ; Taxoids - adverse effects ; Taxoids - therapeutic use ; Tegafur - administration & dosage ; Tegafur - adverse effects ; Tegafur - therapeutic use ; Toxicity ; Treatment Outcome ; Tumors</subject><ispartof>Cancer science, 2016-06, Vol.107 (6), p.764-772</ispartof><rights>2016 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.</rights><rights>2016. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5373-f36210a656caa3754d9570ece6acbac89716bfc719cd848c80a83c6216fcd0fd3</citedby><cites>FETCH-LOGICAL-c5373-f36210a656caa3754d9570ece6acbac89716bfc719cd848c80a83c6216fcd0fd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968606/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968606/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,1417,11562,27924,27925,45574,45575,46052,46476,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27061001$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tanaka, Yoshihiro</creatorcontrib><creatorcontrib>Yoshida, Kazuhiro</creatorcontrib><creatorcontrib>Tanahashi, Toshiyuki</creatorcontrib><creatorcontrib>Okumura, Naoki</creatorcontrib><creatorcontrib>Matsuhashi, Nobuhisa</creatorcontrib><creatorcontrib>Yamaguchi, Kazuya</creatorcontrib><title>Phase II trial of neoadjuvant chemotherapy with docetaxel, nedaplatin, and S1 for advanced esophageal squamous cell carcinoma</title><title>Cancer science</title><addtitle>Cancer Sci</addtitle><description>Although standard chemotherapy for esophageal cancer patients is fluorouracil and cisplatin, the prognosis is still unsatisfactory. A new therapeutic regimen combining docetaxel, cisplatin, and 5‐fluorouracil was recently developed to improve both local and distant tumor control. We developed a new regimen of docetaxel, nedaplatin, and S1 (DGS) and previously reported the recommended dose in a phase I dose‐escalation study. We then undertook a phase II study of DGS for advanced esophageal squamous cell carcinoma. Patients with clinical stage IB/II/III disease were eligible. Patients received two courses of chemotherapy: docetaxel 35 mg/m2 with nedaplatin 40 mg/m2 on day 8, 80 mg/m2 S1 on days 1–14, and 2 weeks off. After completion of chemotherapy, patients underwent esophagectomy. The primary endpoint was the completion rate of protocol treatment (completion of two courses of preoperative chemotherapy and R0 surgery [no residual tumor]). We enrolled 32 patients. The completion rate of protocol treatment was 96.9%. During chemotherapy, the most common grade 3 or 4 toxicity was neutropenia (25.0%). No treatment‐related deaths were observed, and the incidence of operative morbidity was tolerable. The overall response rate after chemotherapy was 83.3%. This DGS regimen was well tolerated and highly active. This trial is registered with the University Hospital Medical Information Network (UMIN ID: 000014626).
This DGS regimen was well tolerated and highly active.</description><subject>5-Fluorouracil</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Cancer therapies</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Carcinoma, Squamous Cell - pathology</subject><subject>Carcinoma, Squamous Cell - surgery</subject><subject>Chemotherapy</subject><subject>Cisplatin</subject><subject>Docetaxel</subject><subject>Drug Combinations</subject><subject>Drug dosages</subject><subject>Esophageal cancer</subject><subject>Esophageal Neoplasms - drug therapy</subject><subject>Esophageal Neoplasms - pathology</subject><subject>Esophageal Neoplasms - surgery</subject><subject>Esophageal Squamous Cell Carcinoma</subject><subject>Esophagectomy</subject><subject>Esophagus</subject><subject>Female</subject><subject>Humans</subject><subject>Hydration</subject><subject>Kaplan-Meier Estimate</subject><subject>Lymphatic system</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Morbidity</subject><subject>Mortality</subject><subject>nedaplatin</subject><subject>Neoadjuvant Therapy</subject><subject>Neoplasm Staging</subject><subject>Neutropenia</subject><subject>Neutropenia - chemically induced</subject><subject>Organoplatinum Compounds - administration & dosage</subject><subject>Organoplatinum Compounds - adverse effects</subject><subject>Organoplatinum Compounds - therapeutic use</subject><subject>Original</subject><subject>Oxonic Acid - administration & dosage</subject><subject>Oxonic Acid - adverse effects</subject><subject>Oxonic Acid - therapeutic use</subject><subject>Patients</subject><subject>Pharmaceuticals</subject><subject>phase II</subject><subject>Quality of life</subject><subject>Squamous cell carcinoma</subject><subject>Surgery</subject><subject>Taxoids - administration & dosage</subject><subject>Taxoids - adverse effects</subject><subject>Taxoids - therapeutic use</subject><subject>Tegafur - administration & dosage</subject><subject>Tegafur - adverse effects</subject><subject>Tegafur - therapeutic use</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>1347-9032</issn><issn>1349-7006</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp1kcFq3DAQhkVpadJtD32BIuipECeS5ZWtSyEsbbIQaCDpWcyOxrEX23IkO-ke-u5Vs0lID9VlBPrm0zA_Yx-lOJbpnCDEY5mbQr1ih1IVJiuF0K8f7mVmhMoP2LsYt0IoXZjiLTvIS6GlEPKQ_b5sIBJfr_kUWui4r_lAHtx2voNh4thQ76eGAow7ft9ODXceaYJf1B0l0MHYwdQORxwGx68kr33g4FIrkuMU_djADSVtvJ2h93PkSF3HEQK2g-_hPXtTQxfpw2NdsJ_fv12vzrOLH2fr1elFhktVqqxWOpcC9FIjgCqXhTPLUhCSBtwAVqaUelNjKQ26qqiwElApTD26Ridqpxbs6947zpueHNIwBejsGNoews56aO2_L0Pb2Bt_ZwujKy10Enx-FAR_O1Oc7NbPYUgz2zw3Itc6T9tdsC97CoOPMVD9_IMU9m9SNiVlH5JK7KeXIz2TT9Ek4GQP3Lcd7f5vsqvTq73yD-67n8g</recordid><startdate>201606</startdate><enddate>201606</enddate><creator>Tanaka, Yoshihiro</creator><creator>Yoshida, Kazuhiro</creator><creator>Tanahashi, Toshiyuki</creator><creator>Okumura, Naoki</creator><creator>Matsuhashi, Nobuhisa</creator><creator>Yamaguchi, Kazuya</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>8FE</scope><scope>8FH</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>LK8</scope><scope>M7P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>201606</creationdate><title>Phase II trial of neoadjuvant chemotherapy with docetaxel, nedaplatin, and S1 for advanced esophageal squamous cell carcinoma</title><author>Tanaka, Yoshihiro ; Yoshida, Kazuhiro ; Tanahashi, Toshiyuki ; Okumura, Naoki ; Matsuhashi, Nobuhisa ; Yamaguchi, Kazuya</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5373-f36210a656caa3754d9570ece6acbac89716bfc719cd848c80a83c6216fcd0fd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>5-Fluorouracil</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Cancer therapies</topic><topic>Carcinoma, Squamous Cell - drug therapy</topic><topic>Carcinoma, Squamous Cell - pathology</topic><topic>Carcinoma, Squamous Cell - surgery</topic><topic>Chemotherapy</topic><topic>Cisplatin</topic><topic>Docetaxel</topic><topic>Drug Combinations</topic><topic>Drug dosages</topic><topic>Esophageal cancer</topic><topic>Esophageal Neoplasms - drug therapy</topic><topic>Esophageal Neoplasms - pathology</topic><topic>Esophageal Neoplasms - surgery</topic><topic>Esophageal Squamous Cell Carcinoma</topic><topic>Esophagectomy</topic><topic>Esophagus</topic><topic>Female</topic><topic>Humans</topic><topic>Hydration</topic><topic>Kaplan-Meier Estimate</topic><topic>Lymphatic system</topic><topic>Male</topic><topic>Medical prognosis</topic><topic>Metastasis</topic><topic>Middle Aged</topic><topic>Morbidity</topic><topic>Mortality</topic><topic>nedaplatin</topic><topic>Neoadjuvant Therapy</topic><topic>Neoplasm Staging</topic><topic>Neutropenia</topic><topic>Neutropenia - chemically induced</topic><topic>Organoplatinum Compounds - administration & dosage</topic><topic>Organoplatinum Compounds - adverse effects</topic><topic>Organoplatinum Compounds - therapeutic use</topic><topic>Original</topic><topic>Oxonic Acid - administration & dosage</topic><topic>Oxonic Acid - adverse effects</topic><topic>Oxonic Acid - therapeutic use</topic><topic>Patients</topic><topic>Pharmaceuticals</topic><topic>phase II</topic><topic>Quality of life</topic><topic>Squamous cell carcinoma</topic><topic>Surgery</topic><topic>Taxoids - administration & dosage</topic><topic>Taxoids - adverse effects</topic><topic>Taxoids - therapeutic use</topic><topic>Tegafur - administration & dosage</topic><topic>Tegafur - adverse effects</topic><topic>Tegafur - therapeutic use</topic><topic>Toxicity</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tanaka, Yoshihiro</creatorcontrib><creatorcontrib>Yoshida, Kazuhiro</creatorcontrib><creatorcontrib>Tanahashi, Toshiyuki</creatorcontrib><creatorcontrib>Okumura, Naoki</creatorcontrib><creatorcontrib>Matsuhashi, Nobuhisa</creatorcontrib><creatorcontrib>Yamaguchi, Kazuya</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Biological Science Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancer science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tanaka, Yoshihiro</au><au>Yoshida, Kazuhiro</au><au>Tanahashi, Toshiyuki</au><au>Okumura, Naoki</au><au>Matsuhashi, Nobuhisa</au><au>Yamaguchi, Kazuya</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II trial of neoadjuvant chemotherapy with docetaxel, nedaplatin, and S1 for advanced esophageal squamous cell carcinoma</atitle><jtitle>Cancer science</jtitle><addtitle>Cancer Sci</addtitle><date>2016-06</date><risdate>2016</risdate><volume>107</volume><issue>6</issue><spage>764</spage><epage>772</epage><pages>764-772</pages><issn>1347-9032</issn><eissn>1349-7006</eissn><abstract>Although standard chemotherapy for esophageal cancer patients is fluorouracil and cisplatin, the prognosis is still unsatisfactory. A new therapeutic regimen combining docetaxel, cisplatin, and 5‐fluorouracil was recently developed to improve both local and distant tumor control. We developed a new regimen of docetaxel, nedaplatin, and S1 (DGS) and previously reported the recommended dose in a phase I dose‐escalation study. We then undertook a phase II study of DGS for advanced esophageal squamous cell carcinoma. Patients with clinical stage IB/II/III disease were eligible. Patients received two courses of chemotherapy: docetaxel 35 mg/m2 with nedaplatin 40 mg/m2 on day 8, 80 mg/m2 S1 on days 1–14, and 2 weeks off. After completion of chemotherapy, patients underwent esophagectomy. The primary endpoint was the completion rate of protocol treatment (completion of two courses of preoperative chemotherapy and R0 surgery [no residual tumor]). We enrolled 32 patients. The completion rate of protocol treatment was 96.9%. During chemotherapy, the most common grade 3 or 4 toxicity was neutropenia (25.0%). No treatment‐related deaths were observed, and the incidence of operative morbidity was tolerable. The overall response rate after chemotherapy was 83.3%. This DGS regimen was well tolerated and highly active. This trial is registered with the University Hospital Medical Information Network (UMIN ID: 000014626).
This DGS regimen was well tolerated and highly active.</abstract><cop>England</cop><pub>John Wiley & Sons, Inc</pub><pmid>27061001</pmid><doi>10.1111/cas.12943</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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subjects | 5-Fluorouracil Adult Aged Aged, 80 and over Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Cancer therapies Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - pathology Carcinoma, Squamous Cell - surgery Chemotherapy Cisplatin Docetaxel Drug Combinations Drug dosages Esophageal cancer Esophageal Neoplasms - drug therapy Esophageal Neoplasms - pathology Esophageal Neoplasms - surgery Esophageal Squamous Cell Carcinoma Esophagectomy Esophagus Female Humans Hydration Kaplan-Meier Estimate Lymphatic system Male Medical prognosis Metastasis Middle Aged Morbidity Mortality nedaplatin Neoadjuvant Therapy Neoplasm Staging Neutropenia Neutropenia - chemically induced Organoplatinum Compounds - administration & dosage Organoplatinum Compounds - adverse effects Organoplatinum Compounds - therapeutic use Original Oxonic Acid - administration & dosage Oxonic Acid - adverse effects Oxonic Acid - therapeutic use Patients Pharmaceuticals phase II Quality of life Squamous cell carcinoma Surgery Taxoids - administration & dosage Taxoids - adverse effects Taxoids - therapeutic use Tegafur - administration & dosage Tegafur - adverse effects Tegafur - therapeutic use Toxicity Treatment Outcome Tumors |
title | Phase II trial of neoadjuvant chemotherapy with docetaxel, nedaplatin, and S1 for advanced esophageal squamous cell carcinoma |
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