Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer

Purpose The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 (GS) combination chemotherapy in patients with unresectable pancreatic cancer. Methods Patients were randomly assigned to receive GS (oral S-1 60 mg/m 2 daily on days 1–15 every 3 weeks and gemcitabine 1,000 mg...

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Veröffentlicht in:Cancer chemotherapy and pharmacology 2014-02, Vol.73 (2), p.389-396
Hauptverfasser: Sudo, Kentaro, Ishihara, Takeshi, Hirata, Nobuto, Ozawa, Fumiaki, Ohshima, Tadashi, Azemoto, Ryosaku, Shimura, Kenji, Nihei, Takeshi, Nishino, Takayoshi, Nakagawa, Akihiko, Nakamura, Kazuyoshi, Hara, Taro, Tada, Motohisa, Mikata, Rintaro, Tawada, Katsunobu, Yokosuka, Osamu, Nakaji, So, Yamaguchi, Taketo
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container_end_page 396
container_issue 2
container_start_page 389
container_title Cancer chemotherapy and pharmacology
container_volume 73
creator Sudo, Kentaro
Ishihara, Takeshi
Hirata, Nobuto
Ozawa, Fumiaki
Ohshima, Tadashi
Azemoto, Ryosaku
Shimura, Kenji
Nihei, Takeshi
Nishino, Takayoshi
Nakagawa, Akihiko
Nakamura, Kazuyoshi
Hara, Taro
Tada, Motohisa
Mikata, Rintaro
Tawada, Katsunobu
Yokosuka, Osamu
Nakaji, So
Yamaguchi, Taketo
description Purpose The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 (GS) combination chemotherapy in patients with unresectable pancreatic cancer. Methods Patients were randomly assigned to receive GS (oral S-1 60 mg/m 2 daily on days 1–15 every 3 weeks and gemcitabine 1,000 mg/m 2 on days 8 and 15) or gemcitabine (1,000 mg/m 2 on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS). Results One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95 % CI 0.43 – 0.98; P  = 0.039; median 5.3 vs 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P  = 0.048). Median survival was 8.6 months for GS and 8.6 months for GEM (HR 0.93; 95 % CI 0.61 – 1.41; P  = 0.714). Grade 3–4 neutropenia (44 vs 19.6 %, P  = 0.011) and thrombocytopenia (26 vs 8.7 %, P  = 0.051) were more frequent in the GS arm. Conclusions GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.
doi_str_mv 10.1007/s00280-013-2368-6
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Methods Patients were randomly assigned to receive GS (oral S-1 60 mg/m 2 daily on days 1–15 every 3 weeks and gemcitabine 1,000 mg/m 2 on days 8 and 15) or gemcitabine (1,000 mg/m 2 on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS). Results One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95 % CI 0.43 – 0.98; P  = 0.039; median 5.3 vs 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P  = 0.048). Median survival was 8.6 months for GS and 8.6 months for GEM (HR 0.93; 95 % CI 0.61 – 1.41; P  = 0.714). Grade 3–4 neutropenia (44 vs 19.6 %, P  = 0.011) and thrombocytopenia (26 vs 8.7 %, P  = 0.051) were more frequent in the GS arm. Conclusions GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.</description><identifier>ISSN: 0344-5704</identifier><identifier>EISSN: 1432-0843</identifier><identifier>DOI: 10.1007/s00280-013-2368-6</identifier><identifier>PMID: 24322377</identifier><identifier>CODEN: CCPHDZ</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject><![CDATA[Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Biological and medical sciences ; Cancer Research ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Disease-Free Survival ; Drug Administration Schedule ; Drug Combinations ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Gemcitabine ; Humans ; Liver. Biliary tract. Portal circulation. Exocrine pancreas ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Neoplasm Metastasis ; Oncology ; Original Article ; Oxonic Acid - administration & dosage ; Pancreatic cancer ; Pancreatic Neoplasms ; Pancreatic Neoplasms - drug therapy ; Pancreatic Neoplasms - pathology ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Prospective Studies ; Tegafur - administration & dosage ; Treatment Outcome ; Tumors]]></subject><ispartof>Cancer chemotherapy and pharmacology, 2014-02, Vol.73 (2), p.389-396</ispartof><rights>Springer-Verlag Berlin Heidelberg 2013</rights><rights>2015 INIST-CNRS</rights><rights>Springer-Verlag Berlin Heidelberg 2014</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c402t-2c4a254caffc14eb0626d1b63c66f084eb312d2892143dd9a58e95888b3027183</citedby><cites>FETCH-LOGICAL-c402t-2c4a254caffc14eb0626d1b63c66f084eb312d2892143dd9a58e95888b3027183</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00280-013-2368-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00280-013-2368-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51298</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=28599965$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24322377$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sudo, Kentaro</creatorcontrib><creatorcontrib>Ishihara, Takeshi</creatorcontrib><creatorcontrib>Hirata, Nobuto</creatorcontrib><creatorcontrib>Ozawa, Fumiaki</creatorcontrib><creatorcontrib>Ohshima, Tadashi</creatorcontrib><creatorcontrib>Azemoto, Ryosaku</creatorcontrib><creatorcontrib>Shimura, Kenji</creatorcontrib><creatorcontrib>Nihei, Takeshi</creatorcontrib><creatorcontrib>Nishino, Takayoshi</creatorcontrib><creatorcontrib>Nakagawa, Akihiko</creatorcontrib><creatorcontrib>Nakamura, Kazuyoshi</creatorcontrib><creatorcontrib>Hara, Taro</creatorcontrib><creatorcontrib>Tada, Motohisa</creatorcontrib><creatorcontrib>Mikata, Rintaro</creatorcontrib><creatorcontrib>Tawada, Katsunobu</creatorcontrib><creatorcontrib>Yokosuka, Osamu</creatorcontrib><creatorcontrib>Nakaji, So</creatorcontrib><creatorcontrib>Yamaguchi, Taketo</creatorcontrib><title>Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer</title><title>Cancer chemotherapy and pharmacology</title><addtitle>Cancer Chemother Pharmacol</addtitle><addtitle>Cancer Chemother Pharmacol</addtitle><description>Purpose The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 (GS) combination chemotherapy in patients with unresectable pancreatic cancer. Methods Patients were randomly assigned to receive GS (oral S-1 60 mg/m 2 daily on days 1–15 every 3 weeks and gemcitabine 1,000 mg/m 2 on days 8 and 15) or gemcitabine (1,000 mg/m 2 on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS). Results One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95 % CI 0.43 – 0.98; P  = 0.039; median 5.3 vs 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P  = 0.048). Median survival was 8.6 months for GS and 8.6 months for GEM (HR 0.93; 95 % CI 0.61 – 1.41; P  = 0.714). Grade 3–4 neutropenia (44 vs 19.6 %, P  = 0.011) and thrombocytopenia (26 vs 8.7 %, P  = 0.051) were more frequent in the GS arm. Conclusions GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.</description><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration &amp; dosage</subject><subject>Biological and medical sciences</subject><subject>Cancer Research</subject><subject>Deoxycytidine - administration &amp; dosage</subject><subject>Deoxycytidine - analogs &amp; derivatives</subject><subject>Disease-Free Survival</subject><subject>Drug Administration Schedule</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Gemcitabine</subject><subject>Humans</subject><subject>Liver. Biliary tract. Portal circulation. Exocrine pancreas</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Neoplasm Metastasis</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Oxonic Acid - administration &amp; dosage</subject><subject>Pancreatic cancer</subject><subject>Pancreatic Neoplasms</subject><subject>Pancreatic Neoplasms - drug therapy</subject><subject>Pancreatic Neoplasms - pathology</subject><subject>Pharmacology. 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Liver. Pancreas. Abdomen</topic><topic>Gemcitabine</topic><topic>Humans</topic><topic>Liver. Biliary tract. Portal circulation. Exocrine pancreas</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Neoplasm Metastasis</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Oxonic Acid - administration &amp; dosage</topic><topic>Pancreatic cancer</topic><topic>Pancreatic Neoplasms</topic><topic>Pancreatic Neoplasms - drug therapy</topic><topic>Pancreatic Neoplasms - pathology</topic><topic>Pharmacology. 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Methods Patients were randomly assigned to receive GS (oral S-1 60 mg/m 2 daily on days 1–15 every 3 weeks and gemcitabine 1,000 mg/m 2 on days 8 and 15) or gemcitabine (1,000 mg/m 2 on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS). Results One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95 % CI 0.43 – 0.98; P  = 0.039; median 5.3 vs 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P  = 0.048). Median survival was 8.6 months for GS and 8.6 months for GEM (HR 0.93; 95 % CI 0.61 – 1.41; P  = 0.714). Grade 3–4 neutropenia (44 vs 19.6 %, P  = 0.011) and thrombocytopenia (26 vs 8.7 %, P  = 0.051) were more frequent in the GS arm. Conclusions GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>24322377</pmid><doi>10.1007/s00280-013-2368-6</doi><tpages>8</tpages></addata></record>
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subjects Aged
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Biological and medical sciences
Cancer Research
Deoxycytidine - administration & dosage
Deoxycytidine - analogs & derivatives
Disease-Free Survival
Drug Administration Schedule
Drug Combinations
Female
Gastroenterology. Liver. Pancreas. Abdomen
Gemcitabine
Humans
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
Neoplasm Metastasis
Oncology
Original Article
Oxonic Acid - administration & dosage
Pancreatic cancer
Pancreatic Neoplasms
Pancreatic Neoplasms - drug therapy
Pancreatic Neoplasms - pathology
Pharmacology. Drug treatments
Pharmacology/Toxicology
Prospective Studies
Tegafur - administration & dosage
Treatment Outcome
Tumors
title Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer
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