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Tolerability of Adjuvant High-dose Interferon Alfa-2b: 1 Month Versus 1 Year-A Hellenic Cooperative Oncology Group Study
Background: High-dose interferon alfa-2b (IFN-α2b) as adjuvant therapy for melanoma is associated with substantial dose-limiting toxicity. It has been suggested that the 1-month intravenous (i.v.) induction regimen may be sufficient to reduce the risk of relapse and death. Patients and Methods: The...
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Published in: | Anticancer research 2004-05, Vol.24 (3B), p.1947-1952 |
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creator | GOGAS, Helen BAFALOUKOS, Dimitrios FRANGIA, Konstantina PETRAKOPOULOU, Theodora PECTASIDES, Dimitrios IOANNOVICH, John SKARLOS, Dimosthenis POLYZOS, Aris FOUNTZILAS, George KALOFONOS, Haralambos P ARAVANTINOS, Gerassimos TSOUTSOS, Dimosthenis PANAGIOTOU, Petros |
description | Background: High-dose interferon alfa-2b (IFN-α2b) as adjuvant therapy for melanoma is associated with substantial dose-limiting
toxicity. It has been suggested that the 1-month intravenous (i.v.) induction regimen may be sufficient to reduce the risk
of relapse and death. Patients and Methods: The Hellenic Cooperative Oncology Group is conducting a multicenter, randomized
trial of 1-month i.v. induction versus 1 year of adjuvant IFN-α2b therapy in patients with stage IIB/III melanoma. Adverse
events reported by the first 200 patients to complete therapy are described. Results: Both induction and maintenance regimens
were well tolerated. The most common toxicities were flu-like and gastrointestinal symptoms, neutropenia, liver toxicity,
and neurologic toxicity. The incidence of grade 3/4 toxicity was low and occurred mainly during the induction phase in both
arms. Dose was reduced in 31% of patients during induction. Only 2% of patients discontinued. Dose was reduced in 8% of patients
during maintenance and only 5% of patients discontinued. Conclusion: Intravenous induction with 15 MIU/m 2 /day IFN-α2b is well tolerated. Efficacy results from this trial are eagerly anticipated. |
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toxicity. It has been suggested that the 1-month intravenous (i.v.) induction regimen may be sufficient to reduce the risk
of relapse and death. Patients and Methods: The Hellenic Cooperative Oncology Group is conducting a multicenter, randomized
trial of 1-month i.v. induction versus 1 year of adjuvant IFN-α2b therapy in patients with stage IIB/III melanoma. Adverse
events reported by the first 200 patients to complete therapy are described. Results: Both induction and maintenance regimens
were well tolerated. The most common toxicities were flu-like and gastrointestinal symptoms, neutropenia, liver toxicity,
and neurologic toxicity. The incidence of grade 3/4 toxicity was low and occurred mainly during the induction phase in both
arms. Dose was reduced in 31% of patients during induction. Only 2% of patients discontinued. Dose was reduced in 8% of patients
during maintenance and only 5% of patients discontinued. Conclusion: Intravenous induction with 15 MIU/m 2 /day IFN-α2b is well tolerated. Efficacy results from this trial are eagerly anticipated.</description><identifier>ISSN: 0250-7005</identifier><identifier>EISSN: 1791-7530</identifier><identifier>PMID: 15274382</identifier><language>eng</language><publisher>Attiki: International Institute of Anticancer Research</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Biological and medical sciences ; Chemotherapy, Adjuvant ; Dermatology ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Humans ; Interferon-alpha - administration & dosage ; Interferon-alpha - adverse effects ; Male ; Medical sciences ; Melanoma - drug therapy ; Melanoma - pathology ; Middle Aged ; Neoplasm Staging ; Recombinant Proteins ; Remission Induction ; Skin Neoplasms - drug therapy ; Skin Neoplasms - pathology ; Tumors ; Tumors of the skin and soft tissue. Premalignant lesions</subject><ispartof>Anticancer research, 2004-05, Vol.24 (3B), p.1947-1952</ispartof><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15963866$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15274382$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>GOGAS, Helen</creatorcontrib><creatorcontrib>BAFALOUKOS, Dimitrios</creatorcontrib><creatorcontrib>FRANGIA, Konstantina</creatorcontrib><creatorcontrib>PETRAKOPOULOU, Theodora</creatorcontrib><creatorcontrib>PECTASIDES, Dimitrios</creatorcontrib><creatorcontrib>IOANNOVICH, John</creatorcontrib><creatorcontrib>SKARLOS, Dimosthenis</creatorcontrib><creatorcontrib>POLYZOS, Aris</creatorcontrib><creatorcontrib>FOUNTZILAS, George</creatorcontrib><creatorcontrib>KALOFONOS, Haralambos P</creatorcontrib><creatorcontrib>ARAVANTINOS, Gerassimos</creatorcontrib><creatorcontrib>TSOUTSOS, Dimosthenis</creatorcontrib><creatorcontrib>PANAGIOTOU, Petros</creatorcontrib><creatorcontrib>Hellenic Coperative Oncology Group</creatorcontrib><title>Tolerability of Adjuvant High-dose Interferon Alfa-2b: 1 Month Versus 1 Year-A Hellenic Cooperative Oncology Group Study</title><title>Anticancer research</title><addtitle>Anticancer Res</addtitle><description>Background: High-dose interferon alfa-2b (IFN-α2b) as adjuvant therapy for melanoma is associated with substantial dose-limiting
toxicity. It has been suggested that the 1-month intravenous (i.v.) induction regimen may be sufficient to reduce the risk
of relapse and death. Patients and Methods: The Hellenic Cooperative Oncology Group is conducting a multicenter, randomized
trial of 1-month i.v. induction versus 1 year of adjuvant IFN-α2b therapy in patients with stage IIB/III melanoma. Adverse
events reported by the first 200 patients to complete therapy are described. Results: Both induction and maintenance regimens
were well tolerated. The most common toxicities were flu-like and gastrointestinal symptoms, neutropenia, liver toxicity,
and neurologic toxicity. The incidence of grade 3/4 toxicity was low and occurred mainly during the induction phase in both
arms. Dose was reduced in 31% of patients during induction. Only 2% of patients discontinued. Dose was reduced in 8% of patients
during maintenance and only 5% of patients discontinued. Conclusion: Intravenous induction with 15 MIU/m 2 /day IFN-α2b is well tolerated. Efficacy results from this trial are eagerly anticipated.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Chemotherapy, Adjuvant</subject><subject>Dermatology</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Humans</subject><subject>Interferon-alpha - administration & dosage</subject><subject>Interferon-alpha - adverse effects</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Melanoma - drug therapy</subject><subject>Melanoma - pathology</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Recombinant Proteins</subject><subject>Remission Induction</subject><subject>Skin Neoplasms - drug therapy</subject><subject>Skin Neoplasms - pathology</subject><subject>Tumors</subject><subject>Tumors of the skin and soft tissue. Premalignant lesions</subject><issn>0250-7005</issn><issn>1791-7530</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><recordid>eNpN0E9LwzAYx_EgipvTtyC56K2QP23SeqtDt8FkB6fgqaTtk7Uja0rSTvvuLWyCp4cHPnwPvws0pTKhgYw4uURTwiISSEKiCbrxfk-IEEnMr9GERkyGPGZT9LO1BpzKa1N3A7Yap-W-P6qmw8t6VwWl9YBXTQdOg7MNTo1WAcufMMVvtukq_AnO9358v0C5IMVLMAaausBza9sx3NVHwJumsMbuBrxwtm_xe9eXwy260sp4uDvfGfp4fdnOl8F6s1jN03VQMRF3gYw5l5wWuc4ZkSzRpBBC0xIiKCSPS0ryUGgSC8KIyIWgRUIVKKAxaEmZ4jN0f-q2fX6AMmtdfVBuyP4mGMHDGShfKKOdaora_3OJ4LEQo3s8uWoc5rt2kPmDMmbM8kw5Fmb8OaNJKPkvbk5yaw</recordid><startdate>20040501</startdate><enddate>20040501</enddate><creator>GOGAS, Helen</creator><creator>BAFALOUKOS, Dimitrios</creator><creator>FRANGIA, Konstantina</creator><creator>PETRAKOPOULOU, Theodora</creator><creator>PECTASIDES, Dimitrios</creator><creator>IOANNOVICH, John</creator><creator>SKARLOS, Dimosthenis</creator><creator>POLYZOS, Aris</creator><creator>FOUNTZILAS, George</creator><creator>KALOFONOS, Haralambos P</creator><creator>ARAVANTINOS, Gerassimos</creator><creator>TSOUTSOS, Dimosthenis</creator><creator>PANAGIOTOU, Petros</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></search><sort><creationdate>20040501</creationdate><title>Tolerability of Adjuvant High-dose Interferon Alfa-2b: 1 Month Versus 1 Year-A Hellenic Cooperative Oncology Group Study</title><author>GOGAS, Helen ; BAFALOUKOS, Dimitrios ; FRANGIA, Konstantina ; PETRAKOPOULOU, Theodora ; PECTASIDES, Dimitrios ; IOANNOVICH, John ; SKARLOS, Dimosthenis ; POLYZOS, Aris ; FOUNTZILAS, George ; KALOFONOS, Haralambos P ; ARAVANTINOS, Gerassimos ; TSOUTSOS, Dimosthenis ; PANAGIOTOU, Petros</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h268t-7833731cbfb20729f0c66f1de5ec738d10b46f0860206b661c91aeae18ef712a3</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>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Chemotherapy, Adjuvant</topic><topic>Dermatology</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Humans</topic><topic>Interferon-alpha - administration & dosage</topic><topic>Interferon-alpha - adverse effects</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Melanoma - drug therapy</topic><topic>Melanoma - pathology</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Recombinant Proteins</topic><topic>Remission Induction</topic><topic>Skin Neoplasms - drug therapy</topic><topic>Skin Neoplasms - pathology</topic><topic>Tumors</topic><topic>Tumors of the skin and soft tissue. Premalignant lesions</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>GOGAS, Helen</creatorcontrib><creatorcontrib>BAFALOUKOS, Dimitrios</creatorcontrib><creatorcontrib>FRANGIA, Konstantina</creatorcontrib><creatorcontrib>PETRAKOPOULOU, Theodora</creatorcontrib><creatorcontrib>PECTASIDES, Dimitrios</creatorcontrib><creatorcontrib>IOANNOVICH, John</creatorcontrib><creatorcontrib>SKARLOS, Dimosthenis</creatorcontrib><creatorcontrib>POLYZOS, Aris</creatorcontrib><creatorcontrib>FOUNTZILAS, George</creatorcontrib><creatorcontrib>KALOFONOS, Haralambos P</creatorcontrib><creatorcontrib>ARAVANTINOS, Gerassimos</creatorcontrib><creatorcontrib>TSOUTSOS, Dimosthenis</creatorcontrib><creatorcontrib>PANAGIOTOU, Petros</creatorcontrib><creatorcontrib>Hellenic Coperative Oncology Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Anticancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>GOGAS, Helen</au><au>BAFALOUKOS, Dimitrios</au><au>FRANGIA, Konstantina</au><au>PETRAKOPOULOU, Theodora</au><au>PECTASIDES, Dimitrios</au><au>IOANNOVICH, John</au><au>SKARLOS, Dimosthenis</au><au>POLYZOS, Aris</au><au>FOUNTZILAS, George</au><au>KALOFONOS, Haralambos P</au><au>ARAVANTINOS, Gerassimos</au><au>TSOUTSOS, Dimosthenis</au><au>PANAGIOTOU, Petros</au><aucorp>Hellenic Coperative Oncology Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tolerability of Adjuvant High-dose Interferon Alfa-2b: 1 Month Versus 1 Year-A Hellenic Cooperative Oncology Group Study</atitle><jtitle>Anticancer research</jtitle><addtitle>Anticancer Res</addtitle><date>2004-05-01</date><risdate>2004</risdate><volume>24</volume><issue>3B</issue><spage>1947</spage><epage>1952</epage><pages>1947-1952</pages><issn>0250-7005</issn><eissn>1791-7530</eissn><abstract>Background: High-dose interferon alfa-2b (IFN-α2b) as adjuvant therapy for melanoma is associated with substantial dose-limiting
toxicity. It has been suggested that the 1-month intravenous (i.v.) induction regimen may be sufficient to reduce the risk
of relapse and death. Patients and Methods: The Hellenic Cooperative Oncology Group is conducting a multicenter, randomized
trial of 1-month i.v. induction versus 1 year of adjuvant IFN-α2b therapy in patients with stage IIB/III melanoma. Adverse
events reported by the first 200 patients to complete therapy are described. Results: Both induction and maintenance regimens
were well tolerated. The most common toxicities were flu-like and gastrointestinal symptoms, neutropenia, liver toxicity,
and neurologic toxicity. The incidence of grade 3/4 toxicity was low and occurred mainly during the induction phase in both
arms. Dose was reduced in 31% of patients during induction. Only 2% of patients discontinued. Dose was reduced in 8% of patients
during maintenance and only 5% of patients discontinued. Conclusion: Intravenous induction with 15 MIU/m 2 /day IFN-α2b is well tolerated. Efficacy results from this trial are eagerly anticipated.</abstract><cop>Attiki</cop><pub>International Institute of Anticancer Research</pub><pmid>15274382</pmid><tpages>6</tpages></addata></record> |
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subjects | Adult Aged Aged, 80 and over Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Biological and medical sciences Chemotherapy, Adjuvant Dermatology Dose-Response Relationship, Drug Drug Administration Schedule Female Humans Interferon-alpha - administration & dosage Interferon-alpha - adverse effects Male Medical sciences Melanoma - drug therapy Melanoma - pathology Middle Aged Neoplasm Staging Recombinant Proteins Remission Induction Skin Neoplasms - drug therapy Skin Neoplasms - pathology Tumors Tumors of the skin and soft tissue. Premalignant lesions |
title | Tolerability of Adjuvant High-dose Interferon Alfa-2b: 1 Month Versus 1 Year-A Hellenic Cooperative Oncology Group Study |
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