Dose-Dense Temozolomide in Patients with MGMT-Silenced Chemorefractory Colorectal Cancer.

Background: In a phase II study, we showed that temozolomide (TMZ) was tolerable and active in heavily pre-treated patients with advanced colorectal cancer (CRC) and MGMT methylation. A schedule of dose-dense TMZ may have enhanced activity due to the higher cumulative dose and induction of MGMT depl...

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Publicado en:Targeted Oncology Vol. 11; no. 3; pp. 337 - 344
Autores principales: Pietrantonio, Filippo, de Braud, Filippo, Milione, Massimo, Maggi, Claudia, Iacovelli, Roberto, Dotti, Katia, Perrone, Federica, Tamborini, Elena, Caporale, Marta, Berenato, Rosa, Leone, Giorgia, Pellegrinelli, Alessio, Bossi, Ilaria, Festinese, Fabrizio, Federici, Stefano, Di Bartolomeo, Maria, Dotti, Katia Fiorella
Formato: pictorial research tables/charts Journal Article
Publicado: Springer Nature Jun2016
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Springer Nature
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        atl: Dose-Dense Temozolomide in Patients with MGMT-Silenced Chemorefractory Colorectal Cancer.
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          Pietrantonio, Filippo
          de Braud, Filippo
          Milione, Massimo
          Maggi, Claudia
          Iacovelli, Roberto
          Dotti, Katia
          Perrone, Federica
          Tamborini, Elena
          Caporale, Marta
          Berenato, Rosa
          Leone, Giorgia
          Pellegrinelli, Alessio
          Bossi, Ilaria
          Festinese, Fabrizio
          Federici, Stefano
          Di Bartolomeo, Maria
          Dotti, Katia Fiorella
        affil: Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1 - 20133 Milan Italy
      sug:
        subj:
          Colorectal Neoplasms Drug Therapy
          Antineoplastic Agents, Alkylating Therapeutic Use
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          Antineoplastic Agents, Alkylating Administration and Dosage
          Dacarbazine Pharmacodynamics
          Adult
          Aged, 80 and Over
          Colorectal Neoplasms Pathology
          Dacarbazine Therapeutic Use
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          Human
          Aged: 65+ years
          Adult: 19-44 years
          Aged, 80 & over
          Middle Aged: 45-64 years
      ab: Background: In a phase II study, we showed that temozolomide (TMZ) was tolerable and active in heavily pre-treated patients with advanced colorectal cancer (CRC) and MGMT methylation. A schedule of dose-dense TMZ may have enhanced activity due to the higher cumulative dose and induction of MGMT depletion, even in resistant tumors.Methods: Thirty-two patients with chemorefractory MGMT-methylated CRC were treated with TMZ at a daily dose of 75 mg/m(2) for 21 consecutive days every 4 weeks, for up to six cycles or until the occurrence of progressive disease/unacceptable toxicity. The primary endpoint was treatment activity in terms of objective response rate (ORR). MGMT protein expression was tested by immunohistochemistry (IHC) on two pooled cohorts: patients from the previous study of standard-dose TMZ and those from the current investigation.Results: From November 2013 to December 2014, 32 patients were treated at Fondazione IRCCS Istituto Nazionale dei Tumori. We observed only three episodes of grade 3 asthenia and no significant myelotoxicity. The ORR was 16 % (all partial responses occurring in RAS-BRAF-mutated tumors). Median progression-free survival (PFS) and overall survival (OS) were 2.3 and 6.7 months, respectively. Patients with MGMT-low expression by IHC had a significantly higher ORR (p < 0.0001) and PFS (p = 0.001) compared to those with MGMT-high expression, while no difference was observed in OS.Conclusions: Our data confirm the encouraging activity of TMZ in chemorefractory CRC patients selected for MGMT silencing, even in the RAS-BRAF-mutated population. The role of MGMT IHC as a biomarker for improving patient selection warrants further prospective confirmation.
      pubtype: Academic Journal
      doctype:
        pictorial
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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