A randomized phase III study comparing dacarbazine, BCNU, cisplatin and tamoxifen with dacarbazine and interferon in advanced melanoma.

2.50
Hdl Handle:
http://hdl.handle.net/10541/86519
Title:
A randomized phase III study comparing dacarbazine, BCNU, cisplatin and tamoxifen with dacarbazine and interferon in advanced melanoma.
Authors:
Middleton, Mark R; Lorigan, Paul C ( 0000-0002-8875-2164 ) ; Owen, J; Ashcroft, Linda; Lee, S M; Harper, P; Thatcher, Nick
Abstract:
The purpose of this study was to compare the response rate, overall and 1-year survival in patients with advanced melanoma treated with a standard therapy, dacarbazine and interferon-alpha (DTIC/IFN), or combination chemotherapy, consisting of dacarbazine, BCNU, cisplatin and tamoxifen (DBCT). Treatment toxicity and time spent in hospital were secondary end points. One hundred and five patients (of whom 100 were eligible) were randomized to receive either DTIC/IFN or DBCT. The trial was designed to detect a 25% absolute difference in response rate or in 1-year survival with 80% power. There was no significant difference in response rate: this was 17.3% with DTIC/IFN and 26.4% with DBCT. Median overall survival was similar at 199 and 202 days respectively. One-year survival rate favoured standard treatment (30.6 vs 22.6%), but did not differ significantly between arms. DBCT was associated with significantly greater haematological toxicity, and a greater need for time spent in hospital (5.75 days/treatment cycle vs 2.29 with dacarbazine and interferon). DBCT combination therapy cannot be recommended as standard treatment for advanced melanoma. Dacarbazine remains the standard chemotherapy for this condition.
Affiliation:
CRC Department of Medical Oncology, Christie Hospital NHS Trust, Manchester, UK.
Citation:
A randomized phase III study comparing dacarbazine, BCNU, cisplatin and tamoxifen with dacarbazine and interferon in advanced melanoma. 2000, 82 (6):1158-62 Br. J. Cancer
Journal:
British Journal of Cancer
Issue Date:
Mar-2000
URI:
http://hdl.handle.net/10541/86519
DOI:
10.1054/bjoc.1999.1056
PubMed ID:
10735499
Type:
Article
Language:
en
ISSN:
0007-0920
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorMiddleton, Mark Ren
dc.contributor.authorLorigan, Paul Cen
dc.contributor.authorOwen, Jen
dc.contributor.authorAshcroft, Lindaen
dc.contributor.authorLee, S Men
dc.contributor.authorHarper, Pen
dc.contributor.authorThatcher, Nicken
dc.date.accessioned2009-11-19T16:46:51Z-
dc.date.available2009-11-19T16:46:51Z-
dc.date.issued2000-03-
dc.identifier.citationA randomized phase III study comparing dacarbazine, BCNU, cisplatin and tamoxifen with dacarbazine and interferon in advanced melanoma. 2000, 82 (6):1158-62 Br. J. Canceren
dc.identifier.issn0007-0920-
dc.identifier.pmid10735499-
dc.identifier.doi10.1054/bjoc.1999.1056-
dc.identifier.urihttp://hdl.handle.net/10541/86519-
dc.description.abstractThe purpose of this study was to compare the response rate, overall and 1-year survival in patients with advanced melanoma treated with a standard therapy, dacarbazine and interferon-alpha (DTIC/IFN), or combination chemotherapy, consisting of dacarbazine, BCNU, cisplatin and tamoxifen (DBCT). Treatment toxicity and time spent in hospital were secondary end points. One hundred and five patients (of whom 100 were eligible) were randomized to receive either DTIC/IFN or DBCT. The trial was designed to detect a 25% absolute difference in response rate or in 1-year survival with 80% power. There was no significant difference in response rate: this was 17.3% with DTIC/IFN and 26.4% with DBCT. Median overall survival was similar at 199 and 202 days respectively. One-year survival rate favoured standard treatment (30.6 vs 22.6%), but did not differ significantly between arms. DBCT was associated with significantly greater haematological toxicity, and a greater need for time spent in hospital (5.75 days/treatment cycle vs 2.29 with dacarbazine and interferon). DBCT combination therapy cannot be recommended as standard treatment for advanced melanoma. Dacarbazine remains the standard chemotherapy for this condition.en
dc.language.isoenen
dc.subjectSkin Canceren
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshCarmustine-
dc.subject.meshCisplatin-
dc.subject.meshCombined Modality Therapy-
dc.subject.meshDacarbazine-
dc.subject.meshDisease Progression-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshInterferon-alpha-
dc.subject.meshMale-
dc.subject.meshMelanoma-
dc.subject.meshMiddle Aged-
dc.subject.meshSkin Neoplasms-
dc.subject.meshSurvival Analysis-
dc.subject.meshTamoxifen-
dc.subject.meshTreatment Outcome-
dc.titleA randomized phase III study comparing dacarbazine, BCNU, cisplatin and tamoxifen with dacarbazine and interferon in advanced melanoma.en
dc.typeArticleen
dc.contributor.departmentCRC Department of Medical Oncology, Christie Hospital NHS Trust, Manchester, UK.en
dc.identifier.journalBritish Journal of Canceren

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