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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Veröffentlicht in:Cancer science 2016-06, Vol.107 (6), p.764-772
Hauptverfasser: Tanaka, Yoshihiro, Yoshida, Kazuhiro, Tanahashi, Toshiyuki, Okumura, Naoki, Matsuhashi, Nobuhisa, Yamaguchi, Kazuya
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container_issue 6
container_start_page 764
container_title Cancer science
container_volume 107
creator Tanaka, Yoshihiro
Yoshida, Kazuhiro
Tanahashi, Toshiyuki
Okumura, Naoki
Matsuhashi, Nobuhisa
Yamaguchi, Kazuya
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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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). 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Cancer Science published by John Wiley &amp; 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”). 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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%). 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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 &amp; dosage</topic><topic>Organoplatinum Compounds - adverse effects</topic><topic>Organoplatinum Compounds - therapeutic use</topic><topic>Original</topic><topic>Oxonic Acid - administration &amp; 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 &amp; dosage</topic><topic>Taxoids - adverse effects</topic><topic>Taxoids - therapeutic use</topic><topic>Tegafur - administration &amp; 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. 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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 &amp; 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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