Weekly Irinotecan Plus Protracted Venous Fluorouracil Infusion (WI-FI) in Advanced Colorectal Cancer: A Phase II Study
Background: Irinotecan (IRI) is a topoisomerase I inhibitor active as first- or second-line chemotherapy in advanced colorectal cancer (ACRC). Its combination with fluorouracil (FU) increases the response rate and prolongs survival. In order to identify a new effective and less toxic schedule of adm...
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| Veröffentlicht in: | Anticancer research 2008-07, Vol.28 (4C), p.2327-2332 |
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| creator | OLIVA, Cristiano POCHETTINO, Paolo COMANDONE, Alessandro BERGNOLO, Paola BOGLIONE, Antonella CHIADO CUTIN, Simona INGUI, Manuela DAL CANTON, Orietta GARETTO, Ferdinando BISCARDI, Manuela BERNO, Elisa |
| description | Background: Irinotecan (IRI) is a topoisomerase I inhibitor active as first- or second-line chemotherapy in advanced colorectal
cancer (ACRC). Its combination with fluorouracil (FU) increases the response rate and prolongs survival. In order to identify
a new effective and less toxic schedule of administration, we planned this phase II study with weekly IRI and protracted venous
infusion of FU (WI-FI regimen). The primary endpoint was the objective response rate. Secondary aims were to detect toxicity,
progression-free survival (PFS) and overall survival (OS) of patients (pts). Materials and Methods: On May 2000, a monoinstitutional
study commenced with the following schedule of administration: IRI 80 mg/m 2 on days 1, 8, 15, 22, 29 plus a 28-day protracted venous infusion of FU 200 mg/m 2 /day. The treatment was repeated every 35 days. Cycles were administered until a maximum of 6 courses, disease progression
or unacceptable toxicity. Results: By March 2005, 52 patients (30 males and 22 females) had entered the study. Their median
age was 61.5 years and the median ECOG PS was 1. In total, 223 courses were administered (median 5 cycles/patient). Toxicity
was low: neutropenia G3 and asthenia G3 were the most observed toxicities (5 pts each). No other grade 3-4 toxic side-effects
were seen. Weekly IRI was interrupted in 11 pts, mostly related to problems with the central venous catheter. Following RECIST
criteria, we observed 5 complete responses, 15 partial responses, 17 pts had stable disease, while in 15 disease progressed.
The overall response rate was 38.5% and the disease control rate was 71.2% . Thirteen pts underwent surgical resection of
their relapsing disease. The median PFS was 8.2 months and the median OS was 16.3 months. Conclusion: The WI-FI regimen is
an active treatment with a good safety profile in patients with CRC. The low incidence of grade 3-4 toxicities justifies further
evaluation of this combination. |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_21247685</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>21247685</sourcerecordid><originalsourceid>FETCH-LOGICAL-h301t-7e0aef64d20e77113721f4ecd695b7ca1cdfb91fa664dd1f5437ac31b5f946d63</originalsourceid><addsrcrecordid>eNpFkF1LwzAYhYsobk7_guRG0YtCPtpm9W4Up4WBAz92WbLkjYtmzUzayf69EadevXB43nM45yAZEl6SlOcMHyZDTHOccozzQXISwhvGRVGO2XEyIGOek4xkw2S7AHi3O1R707oOpGjR3PYBzb3rvJAdKPQCrYvK1PbOuz6KxqK61X0wrkVXizqd1tfItGiitqKV8aFy1nmQnbCo-lb8DZqg-UoEQHWNHrte7U6TIy1sgLP9HSXP09un6j6dPdzV1WSWrhgmXcoBC9BFpigGzglhnBKdgVRFmS-5FEQqvSyJFkVkFNF5xriQjCxzXWaFKtgoufzx3Xj30UPomrUJEqwVLcRSDSU048U4j-D5HuyXa1DNxpu18Lvmd6kIXOwBEaSw2sdmJvxxFMfskpP_xJV5XX0aD01YC2ujLWuEp-MmqxrKKGdfkqB_gA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>21247685</pqid></control><display><type>article</type><title>Weekly Irinotecan Plus Protracted Venous Fluorouracil Infusion (WI-FI) in Advanced Colorectal Cancer: A Phase II Study</title><source>MEDLINE</source><source>EZB Electronic Journals Library</source><creator>OLIVA, Cristiano ; POCHETTINO, Paolo ; COMANDONE, Alessandro ; BERGNOLO, Paola ; BOGLIONE, Antonella ; CHIADO CUTIN, Simona ; INGUI, Manuela ; DAL CANTON, Orietta ; GARETTO, Ferdinando ; BISCARDI, Manuela ; BERNO, Elisa</creator><creatorcontrib>OLIVA, Cristiano ; POCHETTINO, Paolo ; COMANDONE, Alessandro ; BERGNOLO, Paola ; BOGLIONE, Antonella ; CHIADO CUTIN, Simona ; INGUI, Manuela ; DAL CANTON, Orietta ; GARETTO, Ferdinando ; BISCARDI, Manuela ; BERNO, Elisa ; Italian Group for Rare Tumors</creatorcontrib><description>Background: Irinotecan (IRI) is a topoisomerase I inhibitor active as first- or second-line chemotherapy in advanced colorectal
cancer (ACRC). Its combination with fluorouracil (FU) increases the response rate and prolongs survival. In order to identify
a new effective and less toxic schedule of administration, we planned this phase II study with weekly IRI and protracted venous
infusion of FU (WI-FI regimen). The primary endpoint was the objective response rate. Secondary aims were to detect toxicity,
progression-free survival (PFS) and overall survival (OS) of patients (pts). Materials and Methods: On May 2000, a monoinstitutional
study commenced with the following schedule of administration: IRI 80 mg/m 2 on days 1, 8, 15, 22, 29 plus a 28-day protracted venous infusion of FU 200 mg/m 2 /day. The treatment was repeated every 35 days. Cycles were administered until a maximum of 6 courses, disease progression
or unacceptable toxicity. Results: By March 2005, 52 patients (30 males and 22 females) had entered the study. Their median
age was 61.5 years and the median ECOG PS was 1. In total, 223 courses were administered (median 5 cycles/patient). Toxicity
was low: neutropenia G3 and asthenia G3 were the most observed toxicities (5 pts each). No other grade 3-4 toxic side-effects
were seen. Weekly IRI was interrupted in 11 pts, mostly related to problems with the central venous catheter. Following RECIST
criteria, we observed 5 complete responses, 15 partial responses, 17 pts had stable disease, while in 15 disease progressed.
The overall response rate was 38.5% and the disease control rate was 71.2% . Thirteen pts underwent surgical resection of
their relapsing disease. The median PFS was 8.2 months and the median OS was 16.3 months. Conclusion: The WI-FI regimen is
an active treatment with a good safety profile in patients with CRC. The low incidence of grade 3-4 toxicities justifies further
evaluation of this combination.</description><identifier>ISSN: 0250-7005</identifier><identifier>EISSN: 1791-7530</identifier><identifier>PMID: 18751414</identifier><language>eng</language><publisher>Attiki: International Institute of Anticancer Research</publisher><subject>Adenocarcinoma - drug therapy ; Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Biological and medical sciences ; Camptothecin - administration & dosage ; Camptothecin - adverse effects ; Camptothecin - analogs & derivatives ; Catheterization, Central Venous ; Colorectal Neoplasms - drug therapy ; Drug Administration Schedule ; Female ; Fluorouracil - administration & dosage ; Fluorouracil - adverse effects ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Infusions, Intravenous ; Male ; Medical sciences ; Middle Aged ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Tumors</subject><ispartof>Anticancer research, 2008-07, Vol.28 (4C), p.2327-2332</ispartof><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20543971$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18751414$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>OLIVA, Cristiano</creatorcontrib><creatorcontrib>POCHETTINO, Paolo</creatorcontrib><creatorcontrib>COMANDONE, Alessandro</creatorcontrib><creatorcontrib>BERGNOLO, Paola</creatorcontrib><creatorcontrib>BOGLIONE, Antonella</creatorcontrib><creatorcontrib>CHIADO CUTIN, Simona</creatorcontrib><creatorcontrib>INGUI, Manuela</creatorcontrib><creatorcontrib>DAL CANTON, Orietta</creatorcontrib><creatorcontrib>GARETTO, Ferdinando</creatorcontrib><creatorcontrib>BISCARDI, Manuela</creatorcontrib><creatorcontrib>BERNO, Elisa</creatorcontrib><creatorcontrib>Italian Group for Rare Tumors</creatorcontrib><title>Weekly Irinotecan Plus Protracted Venous Fluorouracil Infusion (WI-FI) in Advanced Colorectal Cancer: A Phase II Study</title><title>Anticancer research</title><addtitle>Anticancer Res</addtitle><description>Background: Irinotecan (IRI) is a topoisomerase I inhibitor active as first- or second-line chemotherapy in advanced colorectal
cancer (ACRC). Its combination with fluorouracil (FU) increases the response rate and prolongs survival. In order to identify
a new effective and less toxic schedule of administration, we planned this phase II study with weekly IRI and protracted venous
infusion of FU (WI-FI regimen). The primary endpoint was the objective response rate. Secondary aims were to detect toxicity,
progression-free survival (PFS) and overall survival (OS) of patients (pts). Materials and Methods: On May 2000, a monoinstitutional
study commenced with the following schedule of administration: IRI 80 mg/m 2 on days 1, 8, 15, 22, 29 plus a 28-day protracted venous infusion of FU 200 mg/m 2 /day. The treatment was repeated every 35 days. Cycles were administered until a maximum of 6 courses, disease progression
or unacceptable toxicity. Results: By March 2005, 52 patients (30 males and 22 females) had entered the study. Their median
age was 61.5 years and the median ECOG PS was 1. In total, 223 courses were administered (median 5 cycles/patient). Toxicity
was low: neutropenia G3 and asthenia G3 were the most observed toxicities (5 pts each). No other grade 3-4 toxic side-effects
were seen. Weekly IRI was interrupted in 11 pts, mostly related to problems with the central venous catheter. Following RECIST
criteria, we observed 5 complete responses, 15 partial responses, 17 pts had stable disease, while in 15 disease progressed.
The overall response rate was 38.5% and the disease control rate was 71.2% . Thirteen pts underwent surgical resection of
their relapsing disease. The median PFS was 8.2 months and the median OS was 16.3 months. Conclusion: The WI-FI regimen is
an active treatment with a good safety profile in patients with CRC. The low incidence of grade 3-4 toxicities justifies further
evaluation of this combination.</description><subject>Adenocarcinoma - drug therapy</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Camptothecin - administration & dosage</subject><subject>Camptothecin - adverse effects</subject><subject>Camptothecin - analogs & derivatives</subject><subject>Catheterization, Central Venous</subject><subject>Colorectal Neoplasms - drug therapy</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Fluorouracil - adverse effects</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Tumors</subject><issn>0250-7005</issn><issn>1791-7530</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkF1LwzAYhYsobk7_guRG0YtCPtpm9W4Up4WBAz92WbLkjYtmzUzayf69EadevXB43nM45yAZEl6SlOcMHyZDTHOccozzQXISwhvGRVGO2XEyIGOek4xkw2S7AHi3O1R707oOpGjR3PYBzb3rvJAdKPQCrYvK1PbOuz6KxqK61X0wrkVXizqd1tfItGiitqKV8aFy1nmQnbCo-lb8DZqg-UoEQHWNHrte7U6TIy1sgLP9HSXP09un6j6dPdzV1WSWrhgmXcoBC9BFpigGzglhnBKdgVRFmS-5FEQqvSyJFkVkFNF5xriQjCxzXWaFKtgoufzx3Xj30UPomrUJEqwVLcRSDSU048U4j-D5HuyXa1DNxpu18Lvmd6kIXOwBEaSw2sdmJvxxFMfskpP_xJV5XX0aD01YC2ujLWuEp-MmqxrKKGdfkqB_gA</recordid><startdate>20080701</startdate><enddate>20080701</enddate><creator>OLIVA, Cristiano</creator><creator>POCHETTINO, Paolo</creator><creator>COMANDONE, Alessandro</creator><creator>BERGNOLO, Paola</creator><creator>BOGLIONE, Antonella</creator><creator>CHIADO CUTIN, Simona</creator><creator>INGUI, Manuela</creator><creator>DAL CANTON, Orietta</creator><creator>GARETTO, Ferdinando</creator><creator>BISCARDI, Manuela</creator><creator>BERNO, Elisa</creator><general>International Institute of Anticancer Research</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>20080701</creationdate><title>Weekly Irinotecan Plus Protracted Venous Fluorouracil Infusion (WI-FI) in Advanced Colorectal Cancer: A Phase II Study</title><author>OLIVA, Cristiano ; POCHETTINO, Paolo ; COMANDONE, Alessandro ; BERGNOLO, Paola ; BOGLIONE, Antonella ; CHIADO CUTIN, Simona ; INGUI, Manuela ; DAL CANTON, Orietta ; GARETTO, Ferdinando ; BISCARDI, Manuela ; BERNO, Elisa</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h301t-7e0aef64d20e77113721f4ecd695b7ca1cdfb91fa664dd1f5437ac31b5f946d63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Camptothecin - administration & dosage</topic><topic>Camptothecin - adverse effects</topic><topic>Camptothecin - analogs & derivatives</topic><topic>Catheterization, Central Venous</topic><topic>Colorectal Neoplasms - drug therapy</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Fluorouracil - administration & dosage</topic><topic>Fluorouracil - adverse effects</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>OLIVA, Cristiano</creatorcontrib><creatorcontrib>POCHETTINO, Paolo</creatorcontrib><creatorcontrib>COMANDONE, Alessandro</creatorcontrib><creatorcontrib>BERGNOLO, Paola</creatorcontrib><creatorcontrib>BOGLIONE, Antonella</creatorcontrib><creatorcontrib>CHIADO CUTIN, Simona</creatorcontrib><creatorcontrib>INGUI, Manuela</creatorcontrib><creatorcontrib>DAL CANTON, Orietta</creatorcontrib><creatorcontrib>GARETTO, Ferdinando</creatorcontrib><creatorcontrib>BISCARDI, Manuela</creatorcontrib><creatorcontrib>BERNO, Elisa</creatorcontrib><creatorcontrib>Italian Group for Rare Tumors</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>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Anticancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>OLIVA, Cristiano</au><au>POCHETTINO, Paolo</au><au>COMANDONE, Alessandro</au><au>BERGNOLO, Paola</au><au>BOGLIONE, Antonella</au><au>CHIADO CUTIN, Simona</au><au>INGUI, Manuela</au><au>DAL CANTON, Orietta</au><au>GARETTO, Ferdinando</au><au>BISCARDI, Manuela</au><au>BERNO, Elisa</au><aucorp>Italian Group for Rare Tumors</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Weekly Irinotecan Plus Protracted Venous Fluorouracil Infusion (WI-FI) in Advanced Colorectal Cancer: A Phase II Study</atitle><jtitle>Anticancer research</jtitle><addtitle>Anticancer Res</addtitle><date>2008-07-01</date><risdate>2008</risdate><volume>28</volume><issue>4C</issue><spage>2327</spage><epage>2332</epage><pages>2327-2332</pages><issn>0250-7005</issn><eissn>1791-7530</eissn><abstract>Background: Irinotecan (IRI) is a topoisomerase I inhibitor active as first- or second-line chemotherapy in advanced colorectal
cancer (ACRC). Its combination with fluorouracil (FU) increases the response rate and prolongs survival. In order to identify
a new effective and less toxic schedule of administration, we planned this phase II study with weekly IRI and protracted venous
infusion of FU (WI-FI regimen). The primary endpoint was the objective response rate. Secondary aims were to detect toxicity,
progression-free survival (PFS) and overall survival (OS) of patients (pts). Materials and Methods: On May 2000, a monoinstitutional
study commenced with the following schedule of administration: IRI 80 mg/m 2 on days 1, 8, 15, 22, 29 plus a 28-day protracted venous infusion of FU 200 mg/m 2 /day. The treatment was repeated every 35 days. Cycles were administered until a maximum of 6 courses, disease progression
or unacceptable toxicity. Results: By March 2005, 52 patients (30 males and 22 females) had entered the study. Their median
age was 61.5 years and the median ECOG PS was 1. In total, 223 courses were administered (median 5 cycles/patient). Toxicity
was low: neutropenia G3 and asthenia G3 were the most observed toxicities (5 pts each). No other grade 3-4 toxic side-effects
were seen. Weekly IRI was interrupted in 11 pts, mostly related to problems with the central venous catheter. Following RECIST
criteria, we observed 5 complete responses, 15 partial responses, 17 pts had stable disease, while in 15 disease progressed.
The overall response rate was 38.5% and the disease control rate was 71.2% . Thirteen pts underwent surgical resection of
their relapsing disease. The median PFS was 8.2 months and the median OS was 16.3 months. Conclusion: The WI-FI regimen is
an active treatment with a good safety profile in patients with CRC. The low incidence of grade 3-4 toxicities justifies further
evaluation of this combination.</abstract><cop>Attiki</cop><pub>International Institute of Anticancer Research</pub><pmid>18751414</pmid><tpages>6</tpages></addata></record> |
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| subjects | Adenocarcinoma - drug therapy Adolescent Adult Aged Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Biological and medical sciences Camptothecin - administration & dosage Camptothecin - adverse effects Camptothecin - analogs & derivatives Catheterization, Central Venous Colorectal Neoplasms - drug therapy Drug Administration Schedule Female Fluorouracil - administration & dosage Fluorouracil - adverse effects Gastroenterology. Liver. Pancreas. Abdomen Humans Infusions, Intravenous Male Medical sciences Middle Aged Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Tumors |
| title | Weekly Irinotecan Plus Protracted Venous Fluorouracil Infusion (WI-FI) in Advanced Colorectal Cancer: A Phase II Study |
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