Phase II randomized study of dacarbazine, carmustine, cisplatin and tamoxifen versus dacarbazine alone in advanced melanoma patients.

Abstract:

:This randomized phase II trial was performed to define the activity and toxicity of the combination of dacarbazine (DTIC), carmustine (BCNU), cisplatin (DDP) and tamoxifen (DBDT regimen) versus DTIC alone in patients with metastatic melanoma. Sixty patients with metastatic melanoma were randomly assigned to receive BCNU 150 mg/m2 intravenously (i.v.) on day 1, cisplatin 25 mg/m2 i.v. daily on days 1 to 3, DTIC 220 mg/m2 i.v. daily on days 1 to 3 and tamoxifen 160 mg orally daily for 7 days prior to chemotherapy (DBDT arm; arm A). Treatment cycles were repeated every 28 days, while BCNU was given every two cycles. The DTIC arm (arm B) patients received DTIC alone 1200 mg/m2 i.v. on day 1, repeated every 21 days. Patients were evaluated every two cycles; responding patients continued the treatment for a maximum of 12 cycles. The overall response rate was 26% in the DBDT arm and 5% in the DTIC arm. Complete responses were 2.5% for DBDT and 0% for DTIC. The median progression-free survival and the median survival were 4 and 9 months, respectively for DBDT, and 2 and 7 months for DTIC. DBDT was associated with significant haematological toxicity: 33% of the patients experienced a grade III or IV neutropenia and 28% a grade III or IV thrombocytopenia. In conclusion, the overall response rate obtained with DBDT was greater than that obtained with DTIC alone; however, this combination increases toxicity with limited impact on overall survival.

journal_name

Melanoma Res

journal_title

Melanoma research

authors

Chiarion Sileni V,Nortilli R,Aversa SM,Paccagnella A,Medici M,Corti L,Favaretto AG,Cetto GL,Monfardini S

doi

10.1097/00008390-200104000-00015

subject

Has Abstract

pub_date

2001-04-01 00:00:00

pages

189-96

issue

2

eissn

0960-8931

issn

1473-5636

journal_volume

11

pub_type

临床试验,杂志文章,随机对照试验
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    更新日期:1996-08-01 00:00:00

  • In vitro evaluation of fotemustine as a potential agent for limb perfusion in melanoma.

    abstract::The mechanism of action of fotemustine, a relatively new chloroethylnitrosourea, was evaluated in human melanoma cells in order to assess its potential as an agent for hyperthermic limb perfusion. Fotemustine was more toxic to O6-alkylguanine methyl transferase (AGT) deficient (Mer-) cells than Mer+ cells, implicating...

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    doi:10.1097/00008390-199802000-00012

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    更新日期:1998-02-01 00:00:00

  • Cytoplasmic expression of nm23 predicts the potential for cerebral metastasis in patients with primary cutaneous melanoma.

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    journal_title:Melanoma research

    pub_type: 杂志文章

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    authors: Sarris M,Scolyer RA,Konopka M,Thompson JF,Harper CG,Lee CS

    更新日期:2004-02-01 00:00:00

  • Different expression of lysosome-associated membrane protein-1 in human melanomas and benign melanocytic lesions.

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    pub_type: 杂志文章

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    pub_type: 杂志文章

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    authors: Avril MF,Chompret A,Verne-Fourment L,Terrier-Lacombe MJ,Spatz A,Fizazi K,Bressac-de Paillerets B,Demenais F,Théodore C

    更新日期:2001-04-01 00:00:00

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    pub_type: 临床试验,杂志文章

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    更新日期:1993-06-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/CMR.0b013e328329ae49

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    更新日期:2009-04-01 00:00:00

  • Treatment of metastatic melanoma using electroporation therapy with bleomycin (electrochemotherapy).

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    journal_title:Melanoma research

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1097/00008390-200502000-00008

    authors: Byrne CM,Thompson JF,Johnston H,Hersey P,Quinn MJ,Michael Hughes T,McCarthy WH

    更新日期:2005-02-01 00:00:00

  • Tyrosinase transfection produces melanin synthesis and growth retardation in glioma cells.

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    journal_title:Melanoma research

    pub_type: 杂志文章

    doi:10.1097/00008390-199812000-00003

    authors: Singh MV,Jimbow K

    更新日期:1998-12-01 00:00:00

  • Successful palliation of stenosing anorectal melanoma by intratumoral injections with natural interferon-beta.

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    pub_type: 杂志文章

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    pub_type: 杂志文章

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    pub_type: 杂志文章

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    pub_type: 临床试验,杂志文章

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    doi:10.1097/CMR.0000000000000304

    authors: Adams G,Foote M,Brown S,Burmeister B

    更新日期:2017-02-01 00:00:00

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    更新日期:2005-04-01 00:00:00