Multicenter phase II study of temozolomide therapy for brain metastasis in patients with malignant melanoma, breast cancer......

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2003 ASCO Annual Meeting

Abstract No: 407 Citation: Proc Am Soc Clin Oncol 22: 2003 (abstr 407)

Author(s):S. Siena, G. Landonio, E. Baietta, M. Vitali, L. Crino', M. Danova, A.
Musolino, G. Gardin, P. Foa, G. Fincato; Ospedale Niguarda Ca' Granda,
Milan, Italy; Istituto Nazionale Tumori, Milan, Italy; Ospedale
Maggiore Bellaria, Bologna, Italy; IRCCS San Matteo I, Pavia, Italy;
Ospedale Regionale Torrette, Ancona, Italy; Istutito Nazionale Per la
Ricerca sul Cancro, Genova, Italy; Unita' di Terapia Biomolecolare,
Schering-Plough, Milano, Italy
metastasis is a major factor in reducing the survival of patients with
advanced cancer, especially in patients with lung cancer, breast
cancer, or malignant melanoma. The brain is a frequent site of
metastatic relapse, and since those recurrences are generally the most
refractory sites of disease, more effective therapies are necessary. In
an effort to improve effects of systemic chemotherapy on brain
metastases in patients with advanced non-small cell lung cancer
(NSCLC), breast cancer, and melanoma, a dose-intense regimen of
temozolomide was investigated in a phase II study. An alternating
weekly regimen was chosen based on preclinical evidence that
temozolomide efficacy could be improved by more frequent
A total of 63 patients were enrolled, 21 for each tumor
type, all with measurable brain metastases. Treatment was with oral
temozolomide 150 mg/m2/d on days 1-7 and 15-21 every 28 days, until
disease progression or for 1 year.
For 62 evaluable patients, the
overall response rate for brain metastases (partial responses plus
stable disease) was 24% (24% for NSCLC, 19% for breast cancer, and 40%
for melanoma). The most frequent adverse events were thrombocytopenia
(NSCLC) and vomiting (breast cancer and melanoma), and the most severe
were grade 3-4 thrombocytopenia and leukopenia. The high response rates
for established brain metastases and manageable adverse events warrant
further evaluation of dose-intense temozolomide for treatment of
advanced NSCLC, breast cancer, or melanoma that includes brain