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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dc.contributor.authorBacoyiannis, C.en
dc.contributor.authorDimopoulos, M. A.en
dc.contributor.authorKalofonos, H. P.en
dc.contributor.authorNicolaides, C.en
dc.contributor.authorAravantinos, G.en
dc.contributor.authorBafaloukos, D.en
dc.contributor.authorSamelis, G.en
dc.contributor.authorOnyenadum, A.en
dc.contributor.authorKiamouris, Chen
dc.contributor.authorSkarlos, D.en
dc.contributor.authorPavlidis, N.en
dc.contributor.authorTriantafillidis, A.en
dc.contributor.authorKosmidis, P.en
dc.date.accessioned2015-11-24T19:43:27Z
dc.date.available2015-11-24T19:43:27Z
dc.identifier.issn0030-2414-
dc.identifier.urihttps://olympias.lib.uoi.gr/jspui/handle/123456789/24760
dc.rightsDefault Licence-
dc.subjectAdulten
dc.subjectAgeden
dc.subjectAntineoplastic Combined Chemotherapy Protocols/*adverse effects/*therapeutic useen
dc.subjectCarcinoma, Renal Cell/*drug therapy/mortality/pathologyen
dc.subjectDisease Progressionen
dc.subjectDisease-Free Survivalen
dc.subjectHumansen
dc.subjectInterferon-gamma/administration & dosage/adverse effectsen
dc.subjectIsotretinoin/*administration & dosage/adverse effectsen
dc.subjectKidney Neoplasms/*drug therapy/mortality/pathologyen
dc.subjectMiddle Ageden
dc.subjectNeoplasm Stagingen
dc.subjectSurvival Analysisen
dc.subjectTime Factorsen
dc.subjectVinblastine/administration & dosage/adverse effectsen
dc.titleVinblastine and interferon-gamma combination with and without 13-cis retinoic acid for patients with advanced renal cell carcinoma. Results of two phase II clinical trialsen
heal.abstractBACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.en
heal.accesscampus-
heal.fullTextAvailabilityTRUE-
heal.identifier.secondaryhttp://www.ncbi.nlm.nih.gov/pubmed/12239447-
heal.identifier.secondaryhttp://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ArtikelNr=000063806&Ausgabe=228489&ProduktNr=223857&filename=000063806.pdf-
heal.journalNameOncologyen
heal.journalTypepeer-reviewed-
heal.languageen-
heal.publicationDate2002-
heal.recordProviderΠανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικήςel
heal.typejournalArticle-
heal.type.elΆρθρο Περιοδικούel
heal.type.enJournal articleen

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