Vinblastine and interferon-gamma combination with and without 13-cis retinoic acid for patients with advanced renal cell carcinoma: Results of two phase II clinical trials
The aim of this study is firstly to determine the response rates and toxicity of two regimens containing vinblastine (VBL) in combination with interferon-gamma (IFN-gamma) in the treatment of patients with advanced renal cell carcinoma (RCC), and secondly to evaluate the additional efficacy of 13-ci...
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| Veröffentlicht in: | Oncology 2002-01, Vol.63 (2), p.130-138 |
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| creator | BACOYIANNIS, C DIMOPOULOS, M. A PAVLIDIS, N TRIANTAFILLIDIS, A KOSMIDIS, P KALOFONOS, H. P NICOLAIDES, C ARAVANTINOS, G BAFALOUKOS, D SAMELIS, G ONYENADUM, A KIAMOURIS, Ch SKARLOS, D |
| description | The aim of this study is firstly to determine the response rates and toxicity of two regimens containing vinblastine (VBL) in combination with interferon-gamma (IFN-gamma) in the treatment of patients with advanced renal cell carcinoma (RCC), and secondly to evaluate the additional efficacy of 13-cis retinoic acid (13-CRA) in RCC.
Twenty-nine patients were included in the first trial (Trial 1) and 40 in the second one (Trial 2). The therapy given in Trial 1 consisted of VBL 0.15 mg/kg i.v. every 2 weeks and IFN-gamma 100 microg s.c. 3 times weekly. In Trial 2, the therapy consisted of the same two drugs, in the same doses, plus oral 13-CRA 40 mg/day.
In Trial 1 there were 3 (10.3%) patients with complete response, 3 (10.3%) patients with partial response, 8 (27.6%) patients with stable disease and 15 (51.7%) patients with progressive disease. In Trial 2, there was no complete response, however, 3 (7.5%) patients had partial response. Additionally, 15 (37.5%) patients maintained stable disease and 14 (35%) patients had progressive disease. In Trial 1, the median survival was 12.56 months (95% CI, 6.8-18.3, range 0.59-42.49) and the median time to progression was 3.21 months (95% CI, 1.7-4.7, range 0.03-42.49). In Trial 2, the median survival was 9.54 months (95% CI, 5.9-13.1, range 0.43-24.1) and the median time to progression was 3.9 months (95% CI, 0.8-7, range 0.26-24.1). In Trial 1, granulocytopenia grade 3 and 4 appeared in 5 (17.2%) patients and anaemia grade 3 in 1 (3.4%) patient. In Trial 2, there were grade 3 toxicities, as granulocytopenia in 5 (12.5%) patients, anemia in 4 (10.0%) patients, stomatitis in 3 (7.5%) patients, fatigue/malaise in 3 (7.5%) patients and 1 (2.5%) had diarrhea. No toxic deaths occurred in both studies.
The use of IFN-gamma does not enhance the low response of VBL-based chemotherapy. The additional administration of 13-CRA with the combination of VBL and IFN-gamma does not add to the efficacy of this combination in patients with advanced renal cell carcinoma. New active agents are needed to treat patients with this disease. |
| doi_str_mv | 10.1159/000063806 |
| format | Article |
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Twenty-nine patients were included in the first trial (Trial 1) and 40 in the second one (Trial 2). The therapy given in Trial 1 consisted of VBL 0.15 mg/kg i.v. every 2 weeks and IFN-gamma 100 microg s.c. 3 times weekly. In Trial 2, the therapy consisted of the same two drugs, in the same doses, plus oral 13-CRA 40 mg/day.
In Trial 1 there were 3 (10.3%) patients with complete response, 3 (10.3%) patients with partial response, 8 (27.6%) patients with stable disease and 15 (51.7%) patients with progressive disease. In Trial 2, there was no complete response, however, 3 (7.5%) patients had partial response. Additionally, 15 (37.5%) patients maintained stable disease and 14 (35%) patients had progressive disease. In Trial 1, the median survival was 12.56 months (95% CI, 6.8-18.3, range 0.59-42.49) and the median time to progression was 3.21 months (95% CI, 1.7-4.7, range 0.03-42.49). In Trial 2, the median survival was 9.54 months (95% CI, 5.9-13.1, range 0.43-24.1) and the median time to progression was 3.9 months (95% CI, 0.8-7, range 0.26-24.1). In Trial 1, granulocytopenia grade 3 and 4 appeared in 5 (17.2%) patients and anaemia grade 3 in 1 (3.4%) patient. In Trial 2, there were grade 3 toxicities, as granulocytopenia in 5 (12.5%) patients, anemia in 4 (10.0%) patients, stomatitis in 3 (7.5%) patients, fatigue/malaise in 3 (7.5%) patients and 1 (2.5%) had diarrhea. No toxic deaths occurred in both studies.
The use of IFN-gamma does not enhance the low response of VBL-based chemotherapy. The additional administration of 13-CRA with the combination of VBL and IFN-gamma does not add to the efficacy of this combination in patients with advanced renal cell carcinoma. New active agents are needed to treat patients with this disease.</description><identifier>ISSN: 0030-2414</identifier><identifier>EISSN: 1423-0232</identifier><identifier>DOI: 10.1159/000063806</identifier><identifier>PMID: 12239447</identifier><language>eng</language><publisher>Basel: Karger</publisher><subject>Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Carcinoma, Renal Cell - drug therapy ; Carcinoma, Renal Cell - mortality ; Carcinoma, Renal Cell - pathology ; Disease Progression ; Disease-Free Survival ; Humans ; Interferon-gamma - administration & dosage ; Interferon-gamma - adverse effects ; Isotretinoin - administration & dosage ; Isotretinoin - adverse effects ; Kidney Neoplasms - drug therapy ; Kidney Neoplasms - mortality ; Kidney Neoplasms - pathology ; Kidneys ; Medical sciences ; Middle Aged ; Neoplasm Staging ; Nephrology. Urinary tract diseases ; Survival Analysis ; Time Factors ; Tumors of the urinary system ; Vinblastine - administration & dosage ; Vinblastine - adverse effects</subject><ispartof>Oncology, 2002-01, Vol.63 (2), p.130-138</ispartof><rights>2002 INIST-CNRS</rights><rights>Copyright 2002 S. Karger AG, Basel</rights><rights>Copyright (c) 2002 S. Karger AG, Basel</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13906805$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12239447$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>BACOYIANNIS, C</creatorcontrib><creatorcontrib>DIMOPOULOS, M. A</creatorcontrib><creatorcontrib>PAVLIDIS, N</creatorcontrib><creatorcontrib>TRIANTAFILLIDIS, A</creatorcontrib><creatorcontrib>KOSMIDIS, P</creatorcontrib><creatorcontrib>KALOFONOS, H. P</creatorcontrib><creatorcontrib>NICOLAIDES, C</creatorcontrib><creatorcontrib>ARAVANTINOS, G</creatorcontrib><creatorcontrib>BAFALOUKOS, D</creatorcontrib><creatorcontrib>SAMELIS, G</creatorcontrib><creatorcontrib>ONYENADUM, A</creatorcontrib><creatorcontrib>KIAMOURIS, Ch</creatorcontrib><creatorcontrib>SKARLOS, D</creatorcontrib><creatorcontrib>Hellenic Cooperative Oncology Group</creatorcontrib><title>Vinblastine and interferon-gamma combination with and without 13-cis retinoic acid for patients with advanced renal cell carcinoma: Results of two phase II clinical trials</title><title>Oncology</title><addtitle>Oncology</addtitle><description>The aim of this study is firstly to determine the response rates and toxicity of two regimens containing vinblastine (VBL) in combination with interferon-gamma (IFN-gamma) in the treatment of patients with advanced renal cell carcinoma (RCC), and secondly to evaluate the additional efficacy of 13-cis retinoic acid (13-CRA) in RCC.
Twenty-nine patients were included in the first trial (Trial 1) and 40 in the second one (Trial 2). The therapy given in Trial 1 consisted of VBL 0.15 mg/kg i.v. every 2 weeks and IFN-gamma 100 microg s.c. 3 times weekly. In Trial 2, the therapy consisted of the same two drugs, in the same doses, plus oral 13-CRA 40 mg/day.
In Trial 1 there were 3 (10.3%) patients with complete response, 3 (10.3%) patients with partial response, 8 (27.6%) patients with stable disease and 15 (51.7%) patients with progressive disease. In Trial 2, there was no complete response, however, 3 (7.5%) patients had partial response. Additionally, 15 (37.5%) patients maintained stable disease and 14 (35%) patients had progressive disease. In Trial 1, the median survival was 12.56 months (95% CI, 6.8-18.3, range 0.59-42.49) and the median time to progression was 3.21 months (95% CI, 1.7-4.7, range 0.03-42.49). In Trial 2, the median survival was 9.54 months (95% CI, 5.9-13.1, range 0.43-24.1) and the median time to progression was 3.9 months (95% CI, 0.8-7, range 0.26-24.1). In Trial 1, granulocytopenia grade 3 and 4 appeared in 5 (17.2%) patients and anaemia grade 3 in 1 (3.4%) patient. In Trial 2, there were grade 3 toxicities, as granulocytopenia in 5 (12.5%) patients, anemia in 4 (10.0%) patients, stomatitis in 3 (7.5%) patients, fatigue/malaise in 3 (7.5%) patients and 1 (2.5%) had diarrhea. No toxic deaths occurred in both studies.
The use of IFN-gamma does not enhance the low response of VBL-based chemotherapy. The additional administration of 13-CRA with the combination of VBL and IFN-gamma does not add to the efficacy of this combination in patients with advanced renal cell carcinoma. New active agents are needed to treat patients with this disease.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Carcinoma, Renal Cell - drug therapy</subject><subject>Carcinoma, Renal Cell - mortality</subject><subject>Carcinoma, Renal Cell - pathology</subject><subject>Disease Progression</subject><subject>Disease-Free Survival</subject><subject>Humans</subject><subject>Interferon-gamma - administration & dosage</subject><subject>Interferon-gamma - adverse effects</subject><subject>Isotretinoin - administration & dosage</subject><subject>Isotretinoin - adverse effects</subject><subject>Kidney Neoplasms - drug therapy</subject><subject>Kidney Neoplasms - mortality</subject><subject>Kidney Neoplasms - pathology</subject><subject>Kidneys</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Survival Analysis</subject><subject>Time Factors</subject><subject>Tumors of the urinary system</subject><subject>Vinblastine - administration & dosage</subject><subject>Vinblastine - adverse effects</subject><issn>0030-2414</issn><issn>1423-0232</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNpFkE1rFTEUhoNY7O3Hwj9QgtDlaL4mM-mulFovFIRS3V7OZE5sykwyTTIt_U3-SaNeMYu8WTxPOOcl5D1nHzlvzSdWj5Y902_IhishGyakeEs2jEnWCMXVITnK-bFSXav0O3LIhZBGqW5Dfn73YZggFx-QQhipDwWTwxRD8wPmGaiN8-ADFB8DffHl4Q_1-xHXQrlsrM80YfWjtxSsH6mLiS5VwFDyXhmfIVgcKxhgohanekGyVZrhgt5hXqfKRkfLS6TLA2Sk2y21kw_eVqEkD1M-IQeuBp7u85h8-3x9f_Wluf16s726vG0WoXVptDPd2DI0vEfJeg5gTS_H1tY2FHYDa93AlVRcGDkYwUzbMe1GdIC9RKbkMfnw998lxacVc9k9xjXVwfNOCNZ3XPdthc720DrMOO6W5GdIr7t_1VbgfA9Arju4VBvw-T8nDdM9a-UviGeIdg</recordid><startdate>20020101</startdate><enddate>20020101</enddate><creator>BACOYIANNIS, C</creator><creator>DIMOPOULOS, M. 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A ; PAVLIDIS, N ; TRIANTAFILLIDIS, A ; KOSMIDIS, P ; KALOFONOS, H. P ; NICOLAIDES, C ; ARAVANTINOS, G ; BAFALOUKOS, D ; SAMELIS, G ; ONYENADUM, A ; KIAMOURIS, Ch ; SKARLOS, D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p266t-6f97d50e918e3081aac983d5c0304e7b05fb14341293b92095706fdefae83e043</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Carcinoma, Renal Cell - drug therapy</topic><topic>Carcinoma, Renal Cell - mortality</topic><topic>Carcinoma, Renal Cell - pathology</topic><topic>Disease Progression</topic><topic>Disease-Free Survival</topic><topic>Humans</topic><topic>Interferon-gamma - administration & dosage</topic><topic>Interferon-gamma - adverse effects</topic><topic>Isotretinoin - administration & dosage</topic><topic>Isotretinoin - adverse effects</topic><topic>Kidney Neoplasms - drug therapy</topic><topic>Kidney Neoplasms - mortality</topic><topic>Kidney Neoplasms - pathology</topic><topic>Kidneys</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Nephrology. 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P</creatorcontrib><creatorcontrib>NICOLAIDES, C</creatorcontrib><creatorcontrib>ARAVANTINOS, G</creatorcontrib><creatorcontrib>BAFALOUKOS, D</creatorcontrib><creatorcontrib>SAMELIS, G</creatorcontrib><creatorcontrib>ONYENADUM, A</creatorcontrib><creatorcontrib>KIAMOURIS, Ch</creatorcontrib><creatorcontrib>SKARLOS, D</creatorcontrib><creatorcontrib>Hellenic Cooperative 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><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & 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>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>Genetics Abstracts</collection><jtitle>Oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>BACOYIANNIS, C</au><au>DIMOPOULOS, M. A</au><au>PAVLIDIS, N</au><au>TRIANTAFILLIDIS, A</au><au>KOSMIDIS, P</au><au>KALOFONOS, H. P</au><au>NICOLAIDES, C</au><au>ARAVANTINOS, G</au><au>BAFALOUKOS, D</au><au>SAMELIS, G</au><au>ONYENADUM, A</au><au>KIAMOURIS, Ch</au><au>SKARLOS, D</au><aucorp>Hellenic Cooperative Oncology Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Vinblastine and interferon-gamma combination with and without 13-cis retinoic acid for patients with advanced renal cell carcinoma: Results of two phase II clinical trials</atitle><jtitle>Oncology</jtitle><addtitle>Oncology</addtitle><date>2002-01-01</date><risdate>2002</risdate><volume>63</volume><issue>2</issue><spage>130</spage><epage>138</epage><pages>130-138</pages><issn>0030-2414</issn><eissn>1423-0232</eissn><abstract>The aim of this study is firstly to determine the response rates and toxicity of two regimens containing vinblastine (VBL) in combination with interferon-gamma (IFN-gamma) in the treatment of patients with advanced renal cell carcinoma (RCC), and secondly to evaluate the additional efficacy of 13-cis retinoic acid (13-CRA) in RCC.
Twenty-nine patients were included in the first trial (Trial 1) and 40 in the second one (Trial 2). The therapy given in Trial 1 consisted of VBL 0.15 mg/kg i.v. every 2 weeks and IFN-gamma 100 microg s.c. 3 times weekly. In Trial 2, the therapy consisted of the same two drugs, in the same doses, plus oral 13-CRA 40 mg/day.
In Trial 1 there were 3 (10.3%) patients with complete response, 3 (10.3%) patients with partial response, 8 (27.6%) patients with stable disease and 15 (51.7%) patients with progressive disease. In Trial 2, there was no complete response, however, 3 (7.5%) patients had partial response. Additionally, 15 (37.5%) patients maintained stable disease and 14 (35%) patients had progressive disease. In Trial 1, the median survival was 12.56 months (95% CI, 6.8-18.3, range 0.59-42.49) and the median time to progression was 3.21 months (95% CI, 1.7-4.7, range 0.03-42.49). In Trial 2, the median survival was 9.54 months (95% CI, 5.9-13.1, range 0.43-24.1) and the median time to progression was 3.9 months (95% CI, 0.8-7, range 0.26-24.1). In Trial 1, granulocytopenia grade 3 and 4 appeared in 5 (17.2%) patients and anaemia grade 3 in 1 (3.4%) patient. In Trial 2, there were grade 3 toxicities, as granulocytopenia in 5 (12.5%) patients, anemia in 4 (10.0%) patients, stomatitis in 3 (7.5%) patients, fatigue/malaise in 3 (7.5%) patients and 1 (2.5%) had diarrhea. No toxic deaths occurred in both studies.
The use of IFN-gamma does not enhance the low response of VBL-based chemotherapy. The additional administration of 13-CRA with the combination of VBL and IFN-gamma does not add to the efficacy of this combination in patients with advanced renal cell carcinoma. New active agents are needed to treat patients with this disease.</abstract><cop>Basel</cop><pub>Karger</pub><pmid>12239447</pmid><doi>10.1159/000063806</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0030-2414 |
| ispartof | Oncology, 2002-01, Vol.63 (2), p.130-138 |
| issn | 0030-2414 1423-0232 |
| language | eng |
| recordid | cdi_proquest_journals_220871685 |
| source | MEDLINE; Karger Journals Complete |
| subjects | Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - mortality Carcinoma, Renal Cell - pathology Disease Progression Disease-Free Survival Humans Interferon-gamma - administration & dosage Interferon-gamma - adverse effects Isotretinoin - administration & dosage Isotretinoin - adverse effects Kidney Neoplasms - drug therapy Kidney Neoplasms - mortality Kidney Neoplasms - pathology Kidneys Medical sciences Middle Aged Neoplasm Staging Nephrology. Urinary tract diseases Survival Analysis Time Factors Tumors of the urinary system Vinblastine - administration & dosage Vinblastine - adverse effects |
| title | Vinblastine and interferon-gamma combination with and without 13-cis retinoic acid for patients with advanced renal cell carcinoma: Results of two phase II clinical trials |
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