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Treatment > Temozolomide Clinical Trials


Cancer, Volume 97, Issue 3, 2003. Pages: 657-662 (Clinical Study)
Published Online: 17 Jan 2003



Abstract

A prospective study on glioblastoma in the elderly

Alba A. Brandes, M.D. 1, Francesca Vastola, M.D. 1, Umberto Basso, M.D. 1, Franco Berti, M.D. 2, Giampietro Pinna, M.D. 3, Antonino Rotilio, M.D. 4, Marina Gardiman, M.D. 5, Renato Scienza, M.D. 4, Silvio Monfardini, M.D. 1, Mario Ermani, M.D. 6

1Department of Medical Oncology, Azienda Ospedale-Università, Padova, Italy; 2Department of Radiotherapy, Azienda Ospedale-Università, Padova, Italy; 3Department of Neurosurgery, Ospedale Brotzu, Cagliari, Italy; 4Department of Neurosurgery, Azienda Ospedale-Università, Padova, Italy; 5Department of Pathology, Azienda Ospedale-Università, Padova, Italy; 6Department of Neurological Sciences, Azienda Ospedale-Università, Padova, Italy.
*Correspondence to Alba A. Brandes, Divisione di Oncologia Medica-Direzione, Azienda Ospedale-Università, Ospedale Busonera, via Gattamelata 64, 35100 Padova, Italy. Email: Alba A. Brandes (aabrandes@unipd.it).
°Fax: 011 (39) 0498215932.

Background. Elderly patients (age > 65 years) with glioblastoma multiforme frequently are excluded from clinical studies, and prospective trials for patients with this age group do not exist to date. 

Methods. The authors conducted a prospective trial in 79 consecutive elderly patients with glioblastoma who underwent surgery and received radiotherapy (59.44 grays in 33 fractions; Group A; n = 24 patients) or received the same radiotherapy plus adjuvant chemotherapy with procarbazine, lomustine, and vincristine (PCV; lomustine 110 mg/m2 on Day 1, procarbazine 60 mg/m2 on Days 8-21, and vincristine 1.4 mg/m2 on Days 8 and 29 every 42 days; Group B; n = 32 patients), or received the same radiotherapy plus adjuvant temozolomide (150 mg/m2 for 5 days every 28 days; Group C; n = 22 patients). 

Results. The median time to disease progression (TTP) and median survival MST were 7.2 months (95% confidence interval [95%CI], 6.34-8.64) and 12.5 months (95%CI, 11.6-14.8), respectively.
The TTP was significantly better for Group C compared with Groups A and B (10.7 months vs. 5.3 months and 6.9 months, respectively; P = 0.0002).
Karnofsky performance status (KPS) (P < 0.001) and temozolomide (P < 0.001) were the only independent prognostic factors.
Overall survival was better in Group C compared with Group A (14.9 months vs. 11.2 months; P = 0.002), but there were no statistical differences found between Groups A and B or between Groups B and C.
Only KPS (P < 0.001) was predictive of overall survival, even if temozolomide chemotherapy was very close to the significance level (P = 0.058).
Hematologic Grade 3-4 toxicity was higher with the PCV chemotherapy regimen compared with the temozolomide chemotherapy regimen.

Conclusions. Age alone should not preclude appropriate treatment in elderly patients with good performance status, for whom definitive radiation therapy and adjuvant chemotherapy with temozolomide is advised.

Copyright © 2003 American Cancer Society

Source: http://www3.interscience.wiley.com/cgi-bin/abstract/102525510/START


 

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