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Phase
II study of temozolomide and cisplatin as primary treatment prior to
radiotherapy in newly diagnosed glioblastoma multiforme patients with
measurable disease. A study of the Spanish Medical Neuro-Oncology
Group (GENOM)
Carmen Balaña, Antonio López-pousa, Alfonso Berrocal, Ricardo
Yaya-tur, Ana Herrero, Jose-luis García, Javier Martín-broto, Manuel Benavides, Miguel Cerdá-nicolás, Rosa Ballester, Josep Balart, Jaume Capellades
Medical Oncology Services,
Institut Catala d'Oncologia, Hospital Universitari Germans Trias i
Pujol, Carretera Canyet sn, Badalona (Barcelona), 08916, Spain (cbalana@ns.hugtip.scs.es) [C.B.]. Medical Oncology Services,
Hospital Santa Creu i Sant Pau, Barcelona, Spain [A.L.-P]. Medical
Oncology Services, Hospital General de Valencia, Spain [A.B.]. Medical
Oncology Services, Instituto Valenciano de Oncología, Valencia, Spain [R.Y.-T.]. Medical Oncology Services,
Hospital Universitario Miguel Servet, Zaragoza, Spain [A.H.]. Medical Oncology Services,
Hospital Ramón y Cajal,
Madrid, Spain [J.-I.G.]. Medical Oncology Services,
Hospital Son Dureta, Palma de Mallorca, Spain [J.M.-B]. Medical
Oncology Services, Hospital Regional Carlos Haya, Málaga, Spain [M.B.]. Pathology Central Review,Departamento de Patologia,
Neuropatologia, Hospital Clínico
Universitario, Valencia, Spain [M.C.-N.]. Oncology-Radiotherapy Services, Institut Catala d' Oncologia,
Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona),
Spain [R.B.]. Oncology-Radiotherapy Services, Hospital Santa Creu i
Sant Pau, Barcelona, Spain [J.B.]. Radiology Central Review,
Institut Diagnostic de la Imatge, Hospital Universitari Germans Trias
i Pujol, Badalona (Barcelona), Spain [J.C.].
This phase II study evaluates
the activity of temozolomide and cisplatin administered before
radiation therapy in newly diagnosed glioblastoma multiforme patients,
in terms of response, time to progression and survival.
Patients and methods. Forty patients with measurable disease after surgery,
a Karnofsky status> 60, and Barthel Index> 10 were included.
They were treated with three cycles of temozolomide 200 mg/m2/day
for 5 days and cisplatin 100 mg/m2 on day 1.
Conventional focal radiation therapy to 60 Gy was administered after
response evaluation.
Results. Three patients were not evaluable for central
reviewed response but all 40 were evaluable for toxicity, time to
progression and survival.
Objective responses by Macdonald criteria on an intent to treat basis
were 45% including complete response in three patients (7.5%), and
partial response in 15 patients (37.5%).
Responses were seen in biopsy-only patients (33.4%) as well as in
partial surgery patients (52%).
Median survival for all patients was 12.5 months.
Biopsy-only patients had a median survival of 12.8 months.
Grade 3 to 4 neutropenia was the most important toxicity, and occurred
in 37.5% of patients.
A delay in 18.2% and a dose reduction in 9.6% of cycles were necessary
due to myelosuppression on day 28.
Two patients had neutropenic fever resulting in one treatment-related
death.
Eighty-two percent of patients received radiotherapy.
Conclusion. This regimen has significant activity, as it induces
objective responses even in biopsy-only patients, appearing to improve
their median survival.
A better combination schedule is needed to improve the toxicity
profile.
Keywords: cisplatin, chemotherapy,
glioblastoma, pre-radiotherapy, temozolomide
Copyright © 2004 Kluwer Academic Publishers.
All rights reserved
Source: http://ipsapp009.kluweronline.com/IPS/content/ext/x/J/5042/I/126/A/10/abstract.htm
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