A phase I study of combined radiation therapy with 5-fluorouracil and low dose folinic acid in patients with locally advanced pancreatic or biliary carcinoma
To evaluate the toxicities of a Phase I study of radiation therapy with concurrent 5-fluorouracil (5FU) and low dose folinic acid in patients with locally advanced pancreatic or biliary carcinoma. Twenty-seven patients with locally advanced carcinoma of the pancreas (n = 19), bile duct (n = 7), and...
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| Veröffentlicht in: | International journal of radiation oncology, biology, physics biology, physics, 1996-01, Vol.34 (2), p.445-450 |
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| container_issue | 2 |
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| container_title | International journal of radiation oncology, biology, physics |
| container_volume | 34 |
| creator | Hsue, Victor Wong, C.Shun Moore, Malcolm Erlichman, Charles Cummings, Bernard J. MacLeod, Marcia |
| description | To evaluate the toxicities of a Phase I study of radiation therapy with concurrent 5-fluorouracil (5FU) and low dose folinic acid in patients with locally advanced pancreatic or biliary carcinoma.
Twenty-seven patients with locally advanced carcinoma of the pancreas (n = 19), bile duct (n = 7), and gall bladder (n = 1) were entered into a Phase I study of combined radiation therapy, 5FU, and folinic acid. Radiation was given as a split course of 40 Gy in 20 daily fractions with a gap of 2 weeks after 20 Gy. 5-Fluorouracil, 300 to 375 mg/m2/day and folinic acid, 20 mg/m2/day were given as an i.v. bolus daily for 5 days beginning on day 1 and again on day 29.
Eight patients developed Grade 3 or 4 toxicities (National Cancer Institute common toxicity criteria) including nausea and vomiting (n = 4), oral mucositis (n = 4), myelosuppression (n = 2), infection (n = 2), and diarrhea (n = 1). Four patients did not complete the planned protocol due to treatment toxicities. There were two treatment deaths secondary to septic neutropenia. Treatment toxicity appeared to be related to age (> 70), performance status (ECOG = 2), and 5FU dose (> 350 mg/m2/day).
This protocol is poorly tolerated by elderly patients or those with poor performance status, and 350 mg/m2/day is our recommended dose for 5FU as given in this protocol. |
| doi_str_mv | 10.1016/0360-3016(95)02032-2 |
| format | Article |
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Twenty-seven patients with locally advanced carcinoma of the pancreas (n = 19), bile duct (n = 7), and gall bladder (n = 1) were entered into a Phase I study of combined radiation therapy, 5FU, and folinic acid. Radiation was given as a split course of 40 Gy in 20 daily fractions with a gap of 2 weeks after 20 Gy. 5-Fluorouracil, 300 to 375 mg/m2/day and folinic acid, 20 mg/m2/day were given as an i.v. bolus daily for 5 days beginning on day 1 and again on day 29.
Eight patients developed Grade 3 or 4 toxicities (National Cancer Institute common toxicity criteria) including nausea and vomiting (n = 4), oral mucositis (n = 4), myelosuppression (n = 2), infection (n = 2), and diarrhea (n = 1). Four patients did not complete the planned protocol due to treatment toxicities. There were two treatment deaths secondary to septic neutropenia. Treatment toxicity appeared to be related to age (> 70), performance status (ECOG = 2), and 5FU dose (> 350 mg/m2/day).
This protocol is poorly tolerated by elderly patients or those with poor performance status, and 350 mg/m2/day is our recommended dose for 5FU as given in this protocol.</description><identifier>ISSN: 0360-3016</identifier><identifier>EISSN: 1879-355X</identifier><identifier>DOI: 10.1016/0360-3016(95)02032-2</identifier><identifier>PMID: 8567347</identifier><identifier>CODEN: IOBPD3</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>5-Fluorouracil ; Adult ; Aged ; Aged, 80 and over ; Antidotes - therapeutic use ; Antimetabolites, Antineoplastic - adverse effects ; Antimetabolites, Antineoplastic - therapeutic use ; Bile Duct Neoplasms - drug therapy ; Bile Duct Neoplasms - radiotherapy ; Biological and medical sciences ; Combined Modality Therapy ; Female ; Fluorouracil - adverse effects ; Fluorouracil - therapeutic use ; Folinic acid ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Leucovorin - therapeutic use ; Liver. Biliary tract. Portal circulation. Exocrine pancreas ; Male ; Medical sciences ; Middle Aged ; Pancreatic carcinoma ; Pancreatic Neoplasms - drug therapy ; Pancreatic Neoplasms - radiotherapy ; Radiotherapy ; Radiotherapy Dosage ; Survival Analysis ; Tumors</subject><ispartof>International journal of radiation oncology, biology, physics, 1996-01, Vol.34 (2), p.445-450</ispartof><rights>1996</rights><rights>1996 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c417t-f5fa1a45e56fb5dc24c16d3d2379ac60da8d1287561b0e74071aedbf321f780e3</citedby><cites>FETCH-LOGICAL-c417t-f5fa1a45e56fb5dc24c16d3d2379ac60da8d1287561b0e74071aedbf321f780e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/0360-3016(95)02032-2$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,781,785,3551,27929,27930,46000</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2991963$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/8567347$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hsue, Victor</creatorcontrib><creatorcontrib>Wong, C.Shun</creatorcontrib><creatorcontrib>Moore, Malcolm</creatorcontrib><creatorcontrib>Erlichman, Charles</creatorcontrib><creatorcontrib>Cummings, Bernard J.</creatorcontrib><creatorcontrib>MacLeod, Marcia</creatorcontrib><title>A phase I study of combined radiation therapy with 5-fluorouracil and low dose folinic acid in patients with locally advanced pancreatic or biliary carcinoma</title><title>International journal of radiation oncology, biology, physics</title><addtitle>Int J Radiat Oncol Biol Phys</addtitle><description>To evaluate the toxicities of a Phase I study of radiation therapy with concurrent 5-fluorouracil (5FU) and low dose folinic acid in patients with locally advanced pancreatic or biliary carcinoma.
Twenty-seven patients with locally advanced carcinoma of the pancreas (n = 19), bile duct (n = 7), and gall bladder (n = 1) were entered into a Phase I study of combined radiation therapy, 5FU, and folinic acid. Radiation was given as a split course of 40 Gy in 20 daily fractions with a gap of 2 weeks after 20 Gy. 5-Fluorouracil, 300 to 375 mg/m2/day and folinic acid, 20 mg/m2/day were given as an i.v. bolus daily for 5 days beginning on day 1 and again on day 29.
Eight patients developed Grade 3 or 4 toxicities (National Cancer Institute common toxicity criteria) including nausea and vomiting (n = 4), oral mucositis (n = 4), myelosuppression (n = 2), infection (n = 2), and diarrhea (n = 1). Four patients did not complete the planned protocol due to treatment toxicities. There were two treatment deaths secondary to septic neutropenia. Treatment toxicity appeared to be related to age (> 70), performance status (ECOG = 2), and 5FU dose (> 350 mg/m2/day).
This protocol is poorly tolerated by elderly patients or those with poor performance status, and 350 mg/m2/day is our recommended dose for 5FU as given in this protocol.</description><subject>5-Fluorouracil</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antidotes - therapeutic use</subject><subject>Antimetabolites, Antineoplastic - adverse effects</subject><subject>Antimetabolites, Antineoplastic - therapeutic use</subject><subject>Bile Duct Neoplasms - drug therapy</subject><subject>Bile Duct Neoplasms - radiotherapy</subject><subject>Biological and medical sciences</subject><subject>Combined Modality Therapy</subject><subject>Female</subject><subject>Fluorouracil - adverse effects</subject><subject>Fluorouracil - therapeutic use</subject><subject>Folinic acid</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Leucovorin - therapeutic use</subject><subject>Liver. Biliary tract. Portal circulation. Exocrine pancreas</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pancreatic carcinoma</subject><subject>Pancreatic Neoplasms - drug therapy</subject><subject>Pancreatic Neoplasms - radiotherapy</subject><subject>Radiotherapy</subject><subject>Radiotherapy Dosage</subject><subject>Survival Analysis</subject><subject>Tumors</subject><issn>0360-3016</issn><issn>1879-355X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1996</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc9q3DAQh0VpSDdp36CFOZSSHtxKlmXZl0IIbRMI5NJCb2KsP6yKbLmSnbAPk3ettrvssacRzPcbDd8Q8pbRT4yy9jPlLa14eV314iOtKa-r-gXZsE72FRfi10uyOSGvyEXOvymljMnmnJx3opW8kRvyfA3zFrOFO8jLanYQHeg4Dn6yBhIaj4uPEyxbm3DewZNftiAqF9aY4ppQ-wA4GQjxCUwsY1wMfvIaSseAn2AueTst-ZAMUWMIO0DziJMuP8ylJFsYDTHB4IPHtAONSfspjvianDkM2b451kvy89vXHze31f3D97ub6_tKN0wulRMOGTbCitYNwui60aw13NRc9qhbarAzrO6kaNlArWyoZGjN4HjNnOyo5Zfkw2HunOKf1eZFjT5rGwJONq5ZMUlpI1hbwOYA6hRzTtapOfmx7KwYVfurqL1ytVeueqH-XUXVJfbuOH8dRmtOoeMZSv_9sY-5GHKpaPH5hNV9z_qWF-zLAbPFxaO3SWVd7BaRPlm9KBP9__f4CxPkqzE</recordid><startdate>19960115</startdate><enddate>19960115</enddate><creator>Hsue, Victor</creator><creator>Wong, C.Shun</creator><creator>Moore, Malcolm</creator><creator>Erlichman, Charles</creator><creator>Cummings, Bernard J.</creator><creator>MacLeod, Marcia</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>7U7</scope><scope>C1K</scope></search><sort><creationdate>19960115</creationdate><title>A phase I study of combined radiation therapy with 5-fluorouracil and low dose folinic acid in patients with locally advanced pancreatic or biliary carcinoma</title><author>Hsue, Victor ; Wong, C.Shun ; Moore, Malcolm ; Erlichman, Charles ; Cummings, Bernard J. ; MacLeod, Marcia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c417t-f5fa1a45e56fb5dc24c16d3d2379ac60da8d1287561b0e74071aedbf321f780e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1996</creationdate><topic>5-Fluorouracil</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antidotes - therapeutic use</topic><topic>Antimetabolites, Antineoplastic - adverse effects</topic><topic>Antimetabolites, Antineoplastic - therapeutic use</topic><topic>Bile Duct Neoplasms - drug therapy</topic><topic>Bile Duct Neoplasms - radiotherapy</topic><topic>Biological and medical sciences</topic><topic>Combined Modality Therapy</topic><topic>Female</topic><topic>Fluorouracil - adverse effects</topic><topic>Fluorouracil - therapeutic use</topic><topic>Folinic acid</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Leucovorin - therapeutic use</topic><topic>Liver. Biliary tract. Portal circulation. Exocrine pancreas</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pancreatic carcinoma</topic><topic>Pancreatic Neoplasms - drug therapy</topic><topic>Pancreatic Neoplasms - radiotherapy</topic><topic>Radiotherapy</topic><topic>Radiotherapy Dosage</topic><topic>Survival Analysis</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hsue, Victor</creatorcontrib><creatorcontrib>Wong, C.Shun</creatorcontrib><creatorcontrib>Moore, Malcolm</creatorcontrib><creatorcontrib>Erlichman, Charles</creatorcontrib><creatorcontrib>Cummings, Bernard J.</creatorcontrib><creatorcontrib>MacLeod, Marcia</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>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>International journal of radiation oncology, biology, physics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hsue, Victor</au><au>Wong, C.Shun</au><au>Moore, Malcolm</au><au>Erlichman, Charles</au><au>Cummings, Bernard J.</au><au>MacLeod, Marcia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase I study of combined radiation therapy with 5-fluorouracil and low dose folinic acid in patients with locally advanced pancreatic or biliary carcinoma</atitle><jtitle>International journal of radiation oncology, biology, physics</jtitle><addtitle>Int J Radiat Oncol Biol Phys</addtitle><date>1996-01-15</date><risdate>1996</risdate><volume>34</volume><issue>2</issue><spage>445</spage><epage>450</epage><pages>445-450</pages><issn>0360-3016</issn><eissn>1879-355X</eissn><coden>IOBPD3</coden><abstract>To evaluate the toxicities of a Phase I study of radiation therapy with concurrent 5-fluorouracil (5FU) and low dose folinic acid in patients with locally advanced pancreatic or biliary carcinoma.
Twenty-seven patients with locally advanced carcinoma of the pancreas (n = 19), bile duct (n = 7), and gall bladder (n = 1) were entered into a Phase I study of combined radiation therapy, 5FU, and folinic acid. Radiation was given as a split course of 40 Gy in 20 daily fractions with a gap of 2 weeks after 20 Gy. 5-Fluorouracil, 300 to 375 mg/m2/day and folinic acid, 20 mg/m2/day were given as an i.v. bolus daily for 5 days beginning on day 1 and again on day 29.
Eight patients developed Grade 3 or 4 toxicities (National Cancer Institute common toxicity criteria) including nausea and vomiting (n = 4), oral mucositis (n = 4), myelosuppression (n = 2), infection (n = 2), and diarrhea (n = 1). Four patients did not complete the planned protocol due to treatment toxicities. There were two treatment deaths secondary to septic neutropenia. Treatment toxicity appeared to be related to age (> 70), performance status (ECOG = 2), and 5FU dose (> 350 mg/m2/day).
This protocol is poorly tolerated by elderly patients or those with poor performance status, and 350 mg/m2/day is our recommended dose for 5FU as given in this protocol.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>8567347</pmid><doi>10.1016/0360-3016(95)02032-2</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0360-3016 |
| ispartof | International journal of radiation oncology, biology, physics, 1996-01, Vol.34 (2), p.445-450 |
| issn | 0360-3016 1879-355X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_17004516 |
| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | 5-Fluorouracil Adult Aged Aged, 80 and over Antidotes - therapeutic use Antimetabolites, Antineoplastic - adverse effects Antimetabolites, Antineoplastic - therapeutic use Bile Duct Neoplasms - drug therapy Bile Duct Neoplasms - radiotherapy Biological and medical sciences Combined Modality Therapy Female Fluorouracil - adverse effects Fluorouracil - therapeutic use Folinic acid Gastroenterology. Liver. Pancreas. Abdomen Humans Leucovorin - therapeutic use Liver. Biliary tract. Portal circulation. Exocrine pancreas Male Medical sciences Middle Aged Pancreatic carcinoma Pancreatic Neoplasms - drug therapy Pancreatic Neoplasms - radiotherapy Radiotherapy Radiotherapy Dosage Survival Analysis Tumors |
| title | A phase I study of combined radiation therapy with 5-fluorouracil and low dose folinic acid in patients with locally advanced pancreatic or biliary carcinoma |
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