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Annals of Oncology Advance Access published online on September 18, 2009
Annals of Oncology, doi:10.1093/annonc/mdp343
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
The online version of this article has been published under an open access model. users are entitle to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that: the original authorship is properly and fully attributed; the Journal and the European Society for Medical Oncology are attributed as the original place of publication with the correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org

Dose-dense temozolomide regimen for the treatment of brain metastases from melanoma, breast cancer, or lung cancer not amenable to surgery or radiosurgery: a multicenter phase II study

S. Siena1,*, L. Crinò2, M. Danova3, S. Del Prete4, S. Cascinu5, S. Salvagni6, I. Schiavetto1, M. Vitali7 and E. Bajetta7

1 Divisione Oncologia Falck, Ospedale Niguarda Ca'Granda, Milan
2 Divisione Oncologia Medica, Policlinico Regionale Silvestrini, Perugia
3 Divisione Oncologia Medica, Istituto Ricerca e Cura a Carattere Scientifico Policlinico San Matteo, Pavia
4 Divisione Oncologia Medica, Ospedale San Giovanni di Dio, Frattamaggiore (Naples)
5 Clinica Oncologica Medica, Ospedali Riuniti Umberto I-Salesi, Torrette (Ancona)
6 Dipartimento Oncologia Medica, Ospedale di Parma, Parma
7 Divisione Oncologia Medica B, Istituto Nazionale Tumori, Fondazione Istituto Ricerca e Cura a Carattere Scientifico, Milan, Italy

* Correspondence to: Dr S. Siena, Ospedale Niguarda Ca'Granda, Piazza Ospedale Maggiore 3, 20162 Milan, Italy. Tel: +39-02-6444-2291; Fax: +39-02-6444-2957; E-mail: salvatore.siena{at}ospedaleniguarda.it

Background: Brain metastases reduce survival because therapeutic options are limited. This phase II study evaluated the efficacy of single-agent therapy with alternating weekly, dose-dense temozolomide in pretreated patients with brain metastases prospectively stratified by primary tumor type.

Methods: Eligible patients had bidimensionally measurable brain metastases from histologically/cytologically confirmed melanoma, breast cancer (BC), or non-small-cell lung cancer (NSCLC). Prior chemotherapy, radiotherapy, and whole-brain radiotherapy (WBRT) were allowed. Patients received temozolomide 150 mg/m2/day (days 1–7 and 15–21 every 28- or 35-day cycle).

Results: In the intent-to-treat population (N = 157; 53 melanoma, 51 BC, and 53 NSCLC), one patient had complete response, nine (6%) had partial responses, and 31 (20%) had stable disease in the brain. Median progression-free survival was 56, 58, and 66 days for melanoma, BC, and NSCLC, respectively. Median overall survival was 100 days for melanoma, 172 days for NSCLC, and not evaluable in the BC group. Thrombocytopenia was the most common adverse event causing dose modification or treatment discontinuation. Grade 4 toxic effects were rare.

Conclusions: This alternating weekly, dose-dense temozolomide regimen was well tolerated and clinically active in heavily pretreated patients with brain metastases, particularly in patients with melanoma. Combining temozolomide with WBRT or other agents may improve clinical outcomes.

brain metastases, breast cancer, dose dense, melanoma, NSCLC, temozolomide

Received for publication December 23, 2008. Revision received May 27, 2009. Accepted for publication June 4, 2009.


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