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 |
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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 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_1493099999</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3198299601</sourcerecordid><originalsourceid>FETCH-LOGICAL-c402t-2c4a254caffc14eb0626d1b63c66f084eb312d2892143dd9a58e95888b3027183</originalsourceid><addsrcrecordid>eNp1kE1v1DAQhi0EotvCD-CCLCGOhvFHHOeIqvIhVUJqy9lynEmbKokXO6m0HPnlndUu0Au-eDR-3nc8L2NvJHyQAPXHAqAcCJBaKG2dsM_YRhqtBDijn7MNaGNEVYM5Yael3AOAkVq_ZCeKIKXresN-X4W5S9PwCzse07zkNI5UlmXtdjz1_BanOCyhHWbk23Et_FpIAidqhGVIM493OKXlDnPY7vgD5kLMU1GfMl_njAUjdUZyCXPMSOLII5WYX7EXfRgLvj7eZ-zH54ub86_i8vuXb-efLkU0oBahogmqMjH0fZQGW7DKdrK1Olrb08LYaqk65RpFEXRdEyqHTeWcazWoWjp9xt4dfLc5_VyxLP4-rXmmkV6aRkOzP0TJAxVzKiVj77d5mELeeQl-n7o_pO4pdb9P3VvSvD06r-2E3V_Fn5gJeH8EQolh7DMtPpR_nKtotK2IUweu0NN8i_nJF_87_REzbpuv</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1493099999</pqid></control><display><type>article</type><title>Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><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</creator><creatorcontrib>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</creatorcontrib><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><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&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 & dosage</subject><subject>Biological and medical sciences</subject><subject>Cancer Research</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & 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 & 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 & dosage</subject><subject>Pancreatic cancer</subject><subject>Pancreatic Neoplasms</subject><subject>Pancreatic Neoplasms - drug therapy</subject><subject>Pancreatic Neoplasms - pathology</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Prospective Studies</subject><subject>Tegafur - administration & dosage</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>0344-5704</issn><issn>1432-0843</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kE1v1DAQhi0EotvCD-CCLCGOhvFHHOeIqvIhVUJqy9lynEmbKokXO6m0HPnlndUu0Au-eDR-3nc8L2NvJHyQAPXHAqAcCJBaKG2dsM_YRhqtBDijn7MNaGNEVYM5Yael3AOAkVq_ZCeKIKXresN-X4W5S9PwCzse07zkNI5UlmXtdjz1_BanOCyhHWbk23Et_FpIAidqhGVIM493OKXlDnPY7vgD5kLMU1GfMl_njAUjdUZyCXPMSOLII5WYX7EXfRgLvj7eZ-zH54ub86_i8vuXb-efLkU0oBahogmqMjH0fZQGW7DKdrK1Olrb08LYaqk65RpFEXRdEyqHTeWcazWoWjp9xt4dfLc5_VyxLP4-rXmmkV6aRkOzP0TJAxVzKiVj77d5mELeeQl-n7o_pO4pdb9P3VvSvD06r-2E3V_Fn5gJeH8EQolh7DMtPpR_nKtotK2IUweu0NN8i_nJF_87_REzbpuv</recordid><startdate>20140201</startdate><enddate>20140201</enddate><creator>Sudo, Kentaro</creator><creator>Ishihara, Takeshi</creator><creator>Hirata, Nobuto</creator><creator>Ozawa, Fumiaki</creator><creator>Ohshima, Tadashi</creator><creator>Azemoto, Ryosaku</creator><creator>Shimura, Kenji</creator><creator>Nihei, Takeshi</creator><creator>Nishino, Takayoshi</creator><creator>Nakagawa, Akihiko</creator><creator>Nakamura, Kazuyoshi</creator><creator>Hara, Taro</creator><creator>Tada, Motohisa</creator><creator>Mikata, Rintaro</creator><creator>Tawada, Katsunobu</creator><creator>Yokosuka, Osamu</creator><creator>Nakaji, So</creator><creator>Yamaguchi, Taketo</creator><general>Springer Berlin Heidelberg</general><general>Springer</general><general>Springer Nature B.V</general><scope>IQODW</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>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope></search><sort><creationdate>20140201</creationdate><title>Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c402t-2c4a254caffc14eb0626d1b63c66f084eb312d2892143dd9a58e95888b3027183</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Biological and medical sciences</topic><topic>Cancer Research</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Disease-Free Survival</topic><topic>Drug Administration Schedule</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Gastroenterology. 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 & 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 & dosage</topic><topic>Pancreatic cancer</topic><topic>Pancreatic Neoplasms</topic><topic>Pancreatic Neoplasms - drug therapy</topic><topic>Pancreatic Neoplasms - pathology</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Prospective Studies</topic><topic>Tegafur - administration & dosage</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><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><collection>Pascal-Francis</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 Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><jtitle>Cancer chemotherapy and pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sudo, Kentaro</au><au>Ishihara, Takeshi</au><au>Hirata, Nobuto</au><au>Ozawa, Fumiaki</au><au>Ohshima, Tadashi</au><au>Azemoto, Ryosaku</au><au>Shimura, Kenji</au><au>Nihei, Takeshi</au><au>Nishino, Takayoshi</au><au>Nakagawa, Akihiko</au><au>Nakamura, Kazuyoshi</au><au>Hara, Taro</au><au>Tada, Motohisa</au><au>Mikata, Rintaro</au><au>Tawada, Katsunobu</au><au>Yokosuka, Osamu</au><au>Nakaji, So</au><au>Yamaguchi, Taketo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer</atitle><jtitle>Cancer chemotherapy and pharmacology</jtitle><stitle>Cancer Chemother Pharmacol</stitle><addtitle>Cancer Chemother Pharmacol</addtitle><date>2014-02-01</date><risdate>2014</risdate><volume>73</volume><issue>2</issue><spage>389</spage><epage>396</epage><pages>389-396</pages><issn>0344-5704</issn><eissn>1432-0843</eissn><coden>CCPHDZ</coden><abstract>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.</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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language | eng |
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source | MEDLINE; Springer Nature - Complete Springer Journals |
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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