Neurotoxicity of FOLFOX-4 as adjuvant treatment for patients with colon and gastric cancer: a randomized study of two different schedules of oxaliplatin

Purpose The dose limiting toxicity of oxaliplatin (l-HOP) is neurotoxicity, which is characterized by an acute neuropathy and a clinically distinct chronic neuropathy. This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and po...

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Veröffentlicht in:Cancer chemotherapy and pharmacology 2008-01, Vol.61 (1), p.105-111
Hauptverfasser: Petrioli, Roberto, Pascucci, Alessandra, Francini, Edoardo, Marsili, Stefania, Sciandivasci, Angela, Tassi, Rossana, Civitelli, Serenella, Tanzini, Gabriello, Lorenzi, Marco, Francini, Guido
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container_issue 1
container_start_page 105
container_title Cancer chemotherapy and pharmacology
container_volume 61
creator Petrioli, Roberto
Pascucci, Alessandra
Francini, Edoardo
Marsili, Stefania
Sciandivasci, Angela
Tassi, Rossana
Civitelli, Serenella
Tanzini, Gabriello
Lorenzi, Marco
Francini, Guido
description Purpose The dose limiting toxicity of oxaliplatin (l-HOP) is neurotoxicity, which is characterized by an acute neuropathy and a clinically distinct chronic neuropathy. This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and possibly chronic l-HOP induced neurotoxicity in colon and gastric cancer patients receiving l-HOP-based regimen as adjuvant chemotherapy. Methods Sixty-four patients were randomly assigned to group A (26 colon and 6 gastric cancer) and to group B (23 colon and 9 gastric cancer). Chemotherapy in both groups consisted of l-HOP 85 mg/m 2 i.v. only on day 1, with leucovorin 100 mg/m 2 i.v. as a 2-h infusion followed by bolus 5-fluorouracil (5-FU) 400 mg/m 2 /day and a 22-h infusion of 5-FU 600 mg/m 2 /day, repeated for two consecutive days every 2 weeks for a maximum of 12 cycles. Patients in group A received l-HOP as a continuous 6-h i.v. infusion, and patients in group B received l-HOP as the conventional 2-h i.v. infusion. Results The percentage of patients presenting with grade ≥2 neurotoxicity was statistically lower in group A than in group B (28.1% vs. 59.3%: P  = 0.02). There was a statistically lower percentage of cycles with grade ≥2 neurotoxicity in group A (6.1%) than in group B (18.5%) ( P  
doi_str_mv 10.1007/s00280-007-0454-3
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This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and possibly chronic l-HOP induced neurotoxicity in colon and gastric cancer patients receiving l-HOP-based regimen as adjuvant chemotherapy. Methods Sixty-four patients were randomly assigned to group A (26 colon and 6 gastric cancer) and to group B (23 colon and 9 gastric cancer). Chemotherapy in both groups consisted of l-HOP 85 mg/m 2 i.v. only on day 1, with leucovorin 100 mg/m 2 i.v. as a 2-h infusion followed by bolus 5-fluorouracil (5-FU) 400 mg/m 2 /day and a 22-h infusion of 5-FU 600 mg/m 2 /day, repeated for two consecutive days every 2 weeks for a maximum of 12 cycles. Patients in group A received l-HOP as a continuous 6-h i.v. infusion, and patients in group B received l-HOP as the conventional 2-h i.v. infusion. Results The percentage of patients presenting with grade ≥2 neurotoxicity was statistically lower in group A than in group B (28.1% vs. 59.3%: P  = 0.02). There was a statistically lower percentage of cycles with grade ≥2 neurotoxicity in group A (6.1%) than in group B (18.5%) ( P  &lt; 0.001). Conclusions This study suggests that l-HOP as a continuous 6-h infusion is useful in preventing and reducing acute l-HOP induced neurotoxicity in patients with colon and gastric cancer receiving FOLFOX-4 regimen as adjuvant treatment.</description><identifier>ISSN: 0344-5704</identifier><identifier>EISSN: 1432-0843</identifier><identifier>DOI: 10.1007/s00280-007-0454-3</identifier><identifier>PMID: 17429632</identifier><identifier>CODEN: CCPHDZ</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer-Verlag</publisher><subject>Acute Disease ; Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - administration &amp; dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Cancer Research ; Colonic Neoplasms - drug therapy ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Fluorouracil - administration &amp; dosage ; Fluorouracil - adverse effects ; Follow-Up Studies ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Infusions, Intravenous ; Leucovorin - administration &amp; dosage ; Leucovorin - adverse effects ; Male ; Maximum Tolerated Dose ; Medical sciences ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Neurotoxicity Syndromes - etiology ; Oncology ; Organoplatinum Compounds - administration &amp; dosage ; Organoplatinum Compounds - adverse effects ; Original Article ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Stomach Neoplasms - drug therapy ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Tumors</subject><ispartof>Cancer chemotherapy and pharmacology, 2008-01, Vol.61 (1), p.105-111</ispartof><rights>Springer-Verlag 2007</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c430t-e5ad1c7fd6cb56bd750d2788c7b3de6efd1b1009e41fcea27d0476edd0abb0183</citedby><cites>FETCH-LOGICAL-c430t-e5ad1c7fd6cb56bd750d2788c7b3de6efd1b1009e41fcea27d0476edd0abb0183</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/s00280-007-0454-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00280-007-0454-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=19946927$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17429632$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Petrioli, Roberto</creatorcontrib><creatorcontrib>Pascucci, Alessandra</creatorcontrib><creatorcontrib>Francini, Edoardo</creatorcontrib><creatorcontrib>Marsili, Stefania</creatorcontrib><creatorcontrib>Sciandivasci, Angela</creatorcontrib><creatorcontrib>Tassi, Rossana</creatorcontrib><creatorcontrib>Civitelli, Serenella</creatorcontrib><creatorcontrib>Tanzini, Gabriello</creatorcontrib><creatorcontrib>Lorenzi, Marco</creatorcontrib><creatorcontrib>Francini, Guido</creatorcontrib><title>Neurotoxicity of FOLFOX-4 as adjuvant treatment for patients with colon and gastric cancer: a randomized study of two different schedules of oxaliplatin</title><title>Cancer chemotherapy and pharmacology</title><addtitle>Cancer Chemother Pharmacol</addtitle><addtitle>Cancer Chemother Pharmacol</addtitle><description>Purpose The dose limiting toxicity of oxaliplatin (l-HOP) is neurotoxicity, which is characterized by an acute neuropathy and a clinically distinct chronic neuropathy. This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and possibly chronic l-HOP induced neurotoxicity in colon and gastric cancer patients receiving l-HOP-based regimen as adjuvant chemotherapy. Methods Sixty-four patients were randomly assigned to group A (26 colon and 6 gastric cancer) and to group B (23 colon and 9 gastric cancer). Chemotherapy in both groups consisted of l-HOP 85 mg/m 2 i.v. only on day 1, with leucovorin 100 mg/m 2 i.v. as a 2-h infusion followed by bolus 5-fluorouracil (5-FU) 400 mg/m 2 /day and a 22-h infusion of 5-FU 600 mg/m 2 /day, repeated for two consecutive days every 2 weeks for a maximum of 12 cycles. Patients in group A received l-HOP as a continuous 6-h i.v. infusion, and patients in group B received l-HOP as the conventional 2-h i.v. infusion. Results The percentage of patients presenting with grade ≥2 neurotoxicity was statistically lower in group A than in group B (28.1% vs. 59.3%: P  = 0.02). There was a statistically lower percentage of cycles with grade ≥2 neurotoxicity in group A (6.1%) than in group B (18.5%) ( P  &lt; 0.001). Conclusions This study suggests that l-HOP as a continuous 6-h infusion is useful in preventing and reducing acute l-HOP induced neurotoxicity in patients with colon and gastric cancer receiving FOLFOX-4 regimen as adjuvant treatment.</description><subject>Acute Disease</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration &amp; dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Cancer Research</subject><subject>Colonic Neoplasms - drug therapy</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Fluorouracil - administration &amp; dosage</subject><subject>Fluorouracil - adverse effects</subject><subject>Follow-Up Studies</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Leucovorin - administration &amp; dosage</subject><subject>Leucovorin - adverse effects</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Neurotoxicity Syndromes - etiology</subject><subject>Oncology</subject><subject>Organoplatinum Compounds - administration &amp; dosage</subject><subject>Organoplatinum Compounds - adverse effects</subject><subject>Original Article</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. 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Anus</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Petrioli, Roberto</creatorcontrib><creatorcontrib>Pascucci, Alessandra</creatorcontrib><creatorcontrib>Francini, Edoardo</creatorcontrib><creatorcontrib>Marsili, Stefania</creatorcontrib><creatorcontrib>Sciandivasci, Angela</creatorcontrib><creatorcontrib>Tassi, Rossana</creatorcontrib><creatorcontrib>Civitelli, Serenella</creatorcontrib><creatorcontrib>Tanzini, Gabriello</creatorcontrib><creatorcontrib>Lorenzi, Marco</creatorcontrib><creatorcontrib>Francini, Guido</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 &amp; 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 &amp; Medical Complete (Alumni)</collection><collection>Health &amp; 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><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Cancer chemotherapy and pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Petrioli, Roberto</au><au>Pascucci, Alessandra</au><au>Francini, Edoardo</au><au>Marsili, Stefania</au><au>Sciandivasci, Angela</au><au>Tassi, Rossana</au><au>Civitelli, Serenella</au><au>Tanzini, Gabriello</au><au>Lorenzi, Marco</au><au>Francini, Guido</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Neurotoxicity of FOLFOX-4 as adjuvant treatment for patients with colon and gastric cancer: a randomized study of two different schedules of oxaliplatin</atitle><jtitle>Cancer chemotherapy and pharmacology</jtitle><stitle>Cancer Chemother Pharmacol</stitle><addtitle>Cancer Chemother Pharmacol</addtitle><date>2008-01-01</date><risdate>2008</risdate><volume>61</volume><issue>1</issue><spage>105</spage><epage>111</epage><pages>105-111</pages><issn>0344-5704</issn><eissn>1432-0843</eissn><coden>CCPHDZ</coden><abstract>Purpose The dose limiting toxicity of oxaliplatin (l-HOP) is neurotoxicity, which is characterized by an acute neuropathy and a clinically distinct chronic neuropathy. This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and possibly chronic l-HOP induced neurotoxicity in colon and gastric cancer patients receiving l-HOP-based regimen as adjuvant chemotherapy. Methods Sixty-four patients were randomly assigned to group A (26 colon and 6 gastric cancer) and to group B (23 colon and 9 gastric cancer). Chemotherapy in both groups consisted of l-HOP 85 mg/m 2 i.v. only on day 1, with leucovorin 100 mg/m 2 i.v. as a 2-h infusion followed by bolus 5-fluorouracil (5-FU) 400 mg/m 2 /day and a 22-h infusion of 5-FU 600 mg/m 2 /day, repeated for two consecutive days every 2 weeks for a maximum of 12 cycles. Patients in group A received l-HOP as a continuous 6-h i.v. infusion, and patients in group B received l-HOP as the conventional 2-h i.v. infusion. Results The percentage of patients presenting with grade ≥2 neurotoxicity was statistically lower in group A than in group B (28.1% vs. 59.3%: P  = 0.02). There was a statistically lower percentage of cycles with grade ≥2 neurotoxicity in group A (6.1%) than in group B (18.5%) ( P  &lt; 0.001). Conclusions This study suggests that l-HOP as a continuous 6-h infusion is useful in preventing and reducing acute l-HOP induced neurotoxicity in patients with colon and gastric cancer receiving FOLFOX-4 regimen as adjuvant treatment.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer-Verlag</pub><pmid>17429632</pmid><doi>10.1007/s00280-007-0454-3</doi><tpages>7</tpages></addata></record>
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issn 0344-5704
1432-0843
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source MEDLINE; SpringerLink Journals
subjects Acute Disease
Adult
Aged
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Cancer Research
Colonic Neoplasms - drug therapy
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Fluorouracil - administration & dosage
Fluorouracil - adverse effects
Follow-Up Studies
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Infusions, Intravenous
Leucovorin - administration & dosage
Leucovorin - adverse effects
Male
Maximum Tolerated Dose
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
Neurotoxicity Syndromes - etiology
Oncology
Organoplatinum Compounds - administration & dosage
Organoplatinum Compounds - adverse effects
Original Article
Pharmacology. Drug treatments
Pharmacology/Toxicology
Stomach Neoplasms - drug therapy
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Tumors
title Neurotoxicity of FOLFOX-4 as adjuvant treatment for patients with colon and gastric cancer: a randomized study of two different schedules of oxaliplatin
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