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Phase II study of temozolomide plus pegylated liposomal doxorubicin in the treatment of brain metastases from solid tumours

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Abstract

Objective: A combination regimen of temozolomide (TMZ) and pegylated liposomal doxorubicin has been evaluated in the treatment of brain metastases from solid tumours. Study design: Nineteen consecutive patients (pts) have been enrolled in a prospective phase II trial and treated with TMZ 200 mg/m2 (days 1–5) and pegylated liposomal doxorubicin 35 mg/m2 (day 1) every 28 days. The study was prospectively projected according to the Simon’s two-stage optimal design. Results: Major toxicities have been grade III neutropenia and thrombocytopenia in one patient (pt) and grade III erythrodisesthesia in two pts. Three pts achieved a complete response (CR) and four a partial response (PR), for an overall response rate of 36.8% (95% CI: 19.1–59.2), which exceeded the target activity in the study design. A significant improvement in quality of life was demonstrated by FACT-G analysis. The median Progression Free Survival (PFS) was 5.5 (95% CI: 2.7–8.2) months while the median Overall Survival (OS) was 10.0 months (95% CI: 6.3–13.7). Conclusions: The TMZ/pegylated liposomal doxorubicin regimen was well tolerated with an encouraging activity in brain metastases from solid tumours.

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Acknowledgements

This work was partially supported by grants from Italian Minister for Research (PRIN2003).

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Authors and Affiliations

  1. Oncology Department, “S.Giovanni di Dio” Hospital, ASL Napoli 3 Via Giovanni XXIII, 80028, Frattaminore, Naples, Italy

    Michele Caraglia, Raffaele Addeo, Raffaele Costanzo, Liliana Montella, Vincenzo Faiola & Salvatore Del Prete

  2. Experimental Pharmacology Unit, National Institute of Tumours “Fondazione G. Pascale” of Naples,  , Italy

    Michele Caraglia & Alfredo Budillon

  3. Department of Biochemistry and Biophysics, II University of Naples, Via Costantinopoli, 16 80138, Naples,  , Italy

    Monica Marra & Alberto Abbruzzese

  4. Department of Molecular and Clinical Endocrinology and Oncology, University “Federico II” of Naples,  , Naples, Italy

    Giovannella Palmieri

  5. Department of Experimental and Clinical Medicine, “Magna Græcia University” of Catanzaro, Catanzaro,  , Italy

    Francesco Grillone, Salvatore Venuta & Pierosandro Tagliaferri

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  1. Michele Caraglia
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  2. Raffaele Addeo
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  3. Raffaele Costanzo
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  4. Liliana Montella
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  6. Monica Marra
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  8. Giovannella Palmieri
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  9. Alfredo Budillon
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  10. Francesco Grillone
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  11. Salvatore Venuta
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  12. Pierosandro Tagliaferri
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  13. Salvatore Del Prete
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Correspondence to Michele Caraglia.

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Caraglia, M., Addeo, R., Costanzo, R. et al. Phase II study of temozolomide plus pegylated liposomal doxorubicin in the treatment of brain metastases from solid tumours. Cancer Chemother Pharmacol 57, 34–39 (2006). https://doi.org/10.1007/s00280-005-0001-z

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  • DOI: https://doi.org/10.1007/s00280-005-0001-z

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