Phase I-II trial of twice-weekly gemcitabine and concomitant irradiation in patients undergoing pancreaticoduodenectomy with extended lymphadenectomy for locally advanced pancreatic cancer
Define the maximum tolerated dose (MTD), tolerability, and efficacy of gemcitabine given concomitantly with radiotherapy in patients with locally advanced pancreatic cancer. Patients were required to have locally advanced T1–T3 resectable pancreatic cancer. Gemcitabine, given twice weekly before irr...
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| Veröffentlicht in: | International journal of radiation oncology, biology, physics biology, physics, 2004-10, Vol.60 (2), p.444-452 |
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| container_title | International journal of radiation oncology, biology, physics |
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| creator | Joensuu, Timo K. Kiviluoto, Tuula Kärkkäinen, Päivi Vento, Pälvi Kivisaari, Leena Tenhunen, Mikko Westberg, Ronny Elomaa, Inkeri |
| description | Define the maximum tolerated dose (MTD), tolerability, and efficacy of gemcitabine given concomitantly with radiotherapy in patients with locally advanced pancreatic cancer.
Patients were required to have locally advanced T1–T3 resectable pancreatic cancer. Gemcitabine, given twice weekly before irradiation as a 30-min infusion, was tested at 3 dose levels: 20, 50, and 100 mg/m
2. The radiation dose was 50.4 Gy (ICRU) in 28 fractions. The targeted irradiation volume included the tumor, edema, and a 1-cm margin.
Twenty-eight of 34 patients was eligible for analysis of the treatment. The median age was 67 years (range 38–82). Six patients had T1, 9 had T2, and 19 had T3 diseases (AJCC). Dose-limiting toxicities were Grade 4, fatigue and nausea; Grade 3, thrombocytopenia, diarrhea, and infection. The MTD established was at the 50-mg/m
2 gemcitabine dose. A total of 21 of 28 patients underwent surgery: 18 had pancreaticoduodenectomy, 2 had total pancreatectomy, and 1 for palliative surgery. At the time of analysis, 13 of 28 (46%) were disease-free. The estimated median survival was 25 months and overall survival rate at 2 years (Kaplan-Meier) was 55%.
Gemcitabine 50 mg/m
2 given twice weekly with concomitant irradiation induces acceptable and manageable toxicity and might prolong survival. |
| doi_str_mv | 10.1016/j.ijrobp.2004.03.026 |
| format | Article |
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Patients were required to have locally advanced T1–T3 resectable pancreatic cancer. Gemcitabine, given twice weekly before irradiation as a 30-min infusion, was tested at 3 dose levels: 20, 50, and 100 mg/m
2. The radiation dose was 50.4 Gy (ICRU) in 28 fractions. The targeted irradiation volume included the tumor, edema, and a 1-cm margin.
Twenty-eight of 34 patients was eligible for analysis of the treatment. The median age was 67 years (range 38–82). Six patients had T1, 9 had T2, and 19 had T3 diseases (AJCC). Dose-limiting toxicities were Grade 4, fatigue and nausea; Grade 3, thrombocytopenia, diarrhea, and infection. The MTD established was at the 50-mg/m
2 gemcitabine dose. A total of 21 of 28 patients underwent surgery: 18 had pancreaticoduodenectomy, 2 had total pancreatectomy, and 1 for palliative surgery. At the time of analysis, 13 of 28 (46%) were disease-free. The estimated median survival was 25 months and overall survival rate at 2 years (Kaplan-Meier) was 55%.
Gemcitabine 50 mg/m
2 given twice weekly with concomitant irradiation induces acceptable and manageable toxicity and might prolong survival.</description><identifier>ISSN: 0360-3016</identifier><identifier>EISSN: 1879-355X</identifier><identifier>DOI: 10.1016/j.ijrobp.2004.03.026</identifier><identifier>PMID: 15380578</identifier><identifier>CODEN: IOBPD3</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antimetabolites, Antineoplastic - administration & dosage ; Antimetabolites, Antineoplastic - adverse effects ; Biological and medical sciences ; Carcinoma, Pancreatic Ductal - drug therapy ; Carcinoma, Pancreatic Ductal - pathology ; Carcinoma, Pancreatic Ductal - radiotherapy ; Carcinoma, Pancreatic Ductal - surgery ; Combined Modality Therapy ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Female ; Gemcitabine ; Humans ; Lymph Node Excision ; Male ; Maximum Tolerated Dose ; Medical sciences ; Middle Aged ; Neoadjuvant chemoradiotherapy ; Neoadjuvant Therapy ; Pancreatectomy ; Pancreatic cancer ; Pancreatic Neoplasms - drug therapy ; Pancreatic Neoplasms - pathology ; Pancreatic Neoplasms - radiotherapy ; Pancreatic Neoplasms - surgery ; Pancreaticoduodenectomy ; Radiation-Sensitizing Agents - administration & dosage ; Radiation-Sensitizing Agents - adverse effects ; Radical surgery ; Radiotherapy Dosage ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Technology. Biomaterials. Equipments. Material. Instrumentation</subject><ispartof>International journal of radiation oncology, biology, physics, 2004-10, Vol.60 (2), p.444-452</ispartof><rights>2004 Elsevier Inc.</rights><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c419t-bb56a3389c61c5ffe51827ca39913feee437f70098ef3475432a2c90867107453</citedby><cites>FETCH-LOGICAL-c419t-bb56a3389c61c5ffe51827ca39913feee437f70098ef3475432a2c90867107453</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ijrobp.2004.03.026$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16127261$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15380578$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Joensuu, Timo K.</creatorcontrib><creatorcontrib>Kiviluoto, Tuula</creatorcontrib><creatorcontrib>Kärkkäinen, Päivi</creatorcontrib><creatorcontrib>Vento, Pälvi</creatorcontrib><creatorcontrib>Kivisaari, Leena</creatorcontrib><creatorcontrib>Tenhunen, Mikko</creatorcontrib><creatorcontrib>Westberg, Ronny</creatorcontrib><creatorcontrib>Elomaa, Inkeri</creatorcontrib><title>Phase I-II trial of twice-weekly gemcitabine and concomitant irradiation in patients undergoing pancreaticoduodenectomy with extended lymphadenectomy for locally advanced pancreatic cancer</title><title>International journal of radiation oncology, biology, physics</title><addtitle>Int J Radiat Oncol Biol Phys</addtitle><description>Define the maximum tolerated dose (MTD), tolerability, and efficacy of gemcitabine given concomitantly with radiotherapy in patients with locally advanced pancreatic cancer.
Patients were required to have locally advanced T1–T3 resectable pancreatic cancer. Gemcitabine, given twice weekly before irradiation as a 30-min infusion, was tested at 3 dose levels: 20, 50, and 100 mg/m
2. The radiation dose was 50.4 Gy (ICRU) in 28 fractions. The targeted irradiation volume included the tumor, edema, and a 1-cm margin.
Twenty-eight of 34 patients was eligible for analysis of the treatment. The median age was 67 years (range 38–82). Six patients had T1, 9 had T2, and 19 had T3 diseases (AJCC). Dose-limiting toxicities were Grade 4, fatigue and nausea; Grade 3, thrombocytopenia, diarrhea, and infection. The MTD established was at the 50-mg/m
2 gemcitabine dose. A total of 21 of 28 patients underwent surgery: 18 had pancreaticoduodenectomy, 2 had total pancreatectomy, and 1 for palliative surgery. At the time of analysis, 13 of 28 (46%) were disease-free. The estimated median survival was 25 months and overall survival rate at 2 years (Kaplan-Meier) was 55%.
Gemcitabine 50 mg/m
2 given twice weekly with concomitant irradiation induces acceptable and manageable toxicity and might prolong survival.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antimetabolites, Antineoplastic - administration & dosage</subject><subject>Antimetabolites, Antineoplastic - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Carcinoma, Pancreatic Ductal - drug therapy</subject><subject>Carcinoma, Pancreatic Ductal - pathology</subject><subject>Carcinoma, Pancreatic Ductal - radiotherapy</subject><subject>Carcinoma, Pancreatic Ductal - surgery</subject><subject>Combined Modality Therapy</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Female</subject><subject>Gemcitabine</subject><subject>Humans</subject><subject>Lymph Node Excision</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoadjuvant chemoradiotherapy</subject><subject>Neoadjuvant Therapy</subject><subject>Pancreatectomy</subject><subject>Pancreatic cancer</subject><subject>Pancreatic Neoplasms - drug therapy</subject><subject>Pancreatic Neoplasms - pathology</subject><subject>Pancreatic Neoplasms - radiotherapy</subject><subject>Pancreatic Neoplasms - surgery</subject><subject>Pancreaticoduodenectomy</subject><subject>Radiation-Sensitizing Agents - administration & dosage</subject><subject>Radiation-Sensitizing Agents - adverse effects</subject><subject>Radical surgery</subject><subject>Radiotherapy Dosage</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Technology. Biomaterials. Equipments. Material. Instrumentation</subject><issn>0360-3016</issn><issn>1879-355X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kcGO0zAQhi0EYsvCGyDkC9wS7DiJkwsSWi1LpZXgABI3y7HHrUtiB9vZ0nfj4dbdVuqNk62Zb37N_D9CbykpKaHtx11pd8EPc1kRUpeElaRqn6EV7XhfsKb59RytCGtJwTJ8hV7FuCOEUMrrl-iKNqwjDe9W6N_3rYyA18V6jVOwcsTe4LS3Coo9wO_xgDcwKZvkYB1g6TRW3ik_5YpL2IYgtZXJeoetw3P-gUsRL05D2HjrNrnmVIDcUF4vXoMDlfx0wHubthj-JsioxuNhmrfy0jU-4NErOeYFpH7IGhm6SGF1rITX6IWRY4Q35_ca_fxy--Pma3H_7W598_m-UDXtUzEMTSsZ63rVUtUYAw3tKq4k63vKDADUjBtOSN-BYTVvalbJSvWkazklvG7YNfpw0p2D_7NATGKyUcE4Sgd-ieKYQEuewPoEquBjDGDEHOwkw0FQIo6piZ04pfY0IwgTObU89u6svwwT6MvQOaYMvD8DMmZTTMjn23jhWlrxqqWZ-3TiILvxYCGIqHIi2TwbsrNCe_v_TR4BTXa8tg</recordid><startdate>20041001</startdate><enddate>20041001</enddate><creator>Joensuu, Timo K.</creator><creator>Kiviluoto, Tuula</creator><creator>Kärkkäinen, Päivi</creator><creator>Vento, Pälvi</creator><creator>Kivisaari, Leena</creator><creator>Tenhunen, Mikko</creator><creator>Westberg, Ronny</creator><creator>Elomaa, Inkeri</creator><general>Elsevier Inc</general><general>Elsevier</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>7T5</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope></search><sort><creationdate>20041001</creationdate><title>Phase I-II trial of twice-weekly gemcitabine and concomitant irradiation in patients undergoing pancreaticoduodenectomy with extended lymphadenectomy for locally advanced pancreatic cancer</title><author>Joensuu, Timo K. ; Kiviluoto, Tuula ; Kärkkäinen, Päivi ; Vento, Pälvi ; Kivisaari, Leena ; Tenhunen, Mikko ; Westberg, Ronny ; Elomaa, Inkeri</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c419t-bb56a3389c61c5ffe51827ca39913feee437f70098ef3475432a2c90867107453</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antimetabolites, Antineoplastic - administration & dosage</topic><topic>Antimetabolites, Antineoplastic - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Carcinoma, Pancreatic Ductal - drug therapy</topic><topic>Carcinoma, Pancreatic Ductal - pathology</topic><topic>Carcinoma, Pancreatic Ductal - radiotherapy</topic><topic>Carcinoma, Pancreatic Ductal - surgery</topic><topic>Combined Modality Therapy</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Female</topic><topic>Gemcitabine</topic><topic>Humans</topic><topic>Lymph Node Excision</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoadjuvant chemoradiotherapy</topic><topic>Neoadjuvant Therapy</topic><topic>Pancreatectomy</topic><topic>Pancreatic cancer</topic><topic>Pancreatic Neoplasms - drug therapy</topic><topic>Pancreatic Neoplasms - pathology</topic><topic>Pancreatic Neoplasms - radiotherapy</topic><topic>Pancreatic Neoplasms - surgery</topic><topic>Pancreaticoduodenectomy</topic><topic>Radiation-Sensitizing Agents - administration & dosage</topic><topic>Radiation-Sensitizing Agents - adverse effects</topic><topic>Radical surgery</topic><topic>Radiotherapy Dosage</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Technology. Biomaterials. Equipments. Material. Instrumentation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Joensuu, Timo K.</creatorcontrib><creatorcontrib>Kiviluoto, Tuula</creatorcontrib><creatorcontrib>Kärkkäinen, Päivi</creatorcontrib><creatorcontrib>Vento, Pälvi</creatorcontrib><creatorcontrib>Kivisaari, Leena</creatorcontrib><creatorcontrib>Tenhunen, Mikko</creatorcontrib><creatorcontrib>Westberg, Ronny</creatorcontrib><creatorcontrib>Elomaa, Inkeri</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>Immunology Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>International journal of radiation oncology, biology, physics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Joensuu, Timo K.</au><au>Kiviluoto, Tuula</au><au>Kärkkäinen, Päivi</au><au>Vento, Pälvi</au><au>Kivisaari, Leena</au><au>Tenhunen, Mikko</au><au>Westberg, Ronny</au><au>Elomaa, Inkeri</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I-II trial of twice-weekly gemcitabine and concomitant irradiation in patients undergoing pancreaticoduodenectomy with extended lymphadenectomy for locally advanced pancreatic cancer</atitle><jtitle>International journal of radiation oncology, biology, physics</jtitle><addtitle>Int J Radiat Oncol Biol Phys</addtitle><date>2004-10-01</date><risdate>2004</risdate><volume>60</volume><issue>2</issue><spage>444</spage><epage>452</epage><pages>444-452</pages><issn>0360-3016</issn><eissn>1879-355X</eissn><coden>IOBPD3</coden><abstract>Define the maximum tolerated dose (MTD), tolerability, and efficacy of gemcitabine given concomitantly with radiotherapy in patients with locally advanced pancreatic cancer.
Patients were required to have locally advanced T1–T3 resectable pancreatic cancer. Gemcitabine, given twice weekly before irradiation as a 30-min infusion, was tested at 3 dose levels: 20, 50, and 100 mg/m
2. The radiation dose was 50.4 Gy (ICRU) in 28 fractions. The targeted irradiation volume included the tumor, edema, and a 1-cm margin.
Twenty-eight of 34 patients was eligible for analysis of the treatment. The median age was 67 years (range 38–82). Six patients had T1, 9 had T2, and 19 had T3 diseases (AJCC). Dose-limiting toxicities were Grade 4, fatigue and nausea; Grade 3, thrombocytopenia, diarrhea, and infection. The MTD established was at the 50-mg/m
2 gemcitabine dose. A total of 21 of 28 patients underwent surgery: 18 had pancreaticoduodenectomy, 2 had total pancreatectomy, and 1 for palliative surgery. At the time of analysis, 13 of 28 (46%) were disease-free. The estimated median survival was 25 months and overall survival rate at 2 years (Kaplan-Meier) was 55%.
Gemcitabine 50 mg/m
2 given twice weekly with concomitant irradiation induces acceptable and manageable toxicity and might prolong survival.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>15380578</pmid><doi>10.1016/j.ijrobp.2004.03.026</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0360-3016 |
| ispartof | International journal of radiation oncology, biology, physics, 2004-10, Vol.60 (2), p.444-452 |
| issn | 0360-3016 1879-355X |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Aged Aged, 80 and over Antimetabolites, Antineoplastic - administration & dosage Antimetabolites, Antineoplastic - adverse effects Biological and medical sciences Carcinoma, Pancreatic Ductal - drug therapy Carcinoma, Pancreatic Ductal - pathology Carcinoma, Pancreatic Ductal - radiotherapy Carcinoma, Pancreatic Ductal - surgery Combined Modality Therapy Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Female Gemcitabine Humans Lymph Node Excision Male Maximum Tolerated Dose Medical sciences Middle Aged Neoadjuvant chemoradiotherapy Neoadjuvant Therapy Pancreatectomy Pancreatic cancer Pancreatic Neoplasms - drug therapy Pancreatic Neoplasms - pathology Pancreatic Neoplasms - radiotherapy Pancreatic Neoplasms - surgery Pancreaticoduodenectomy Radiation-Sensitizing Agents - administration & dosage Radiation-Sensitizing Agents - adverse effects Radical surgery Radiotherapy Dosage Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Technology. Biomaterials. Equipments. Material. Instrumentation |
| title | Phase I-II trial of twice-weekly gemcitabine and concomitant irradiation in patients undergoing pancreaticoduodenectomy with extended lymphadenectomy for locally advanced pancreatic cancer |
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