Chemoradiation or standard radiation followed by adjuvant temozolomide (TMZ) and 13-cis-retinoic acid (CRA) for high grade glioma in adults - a regional cancer centre study

1557 Background: A recent phase II study reported activity of TMZ and cRA for recurrent/progressive malignant gliomas with 43% 6 month progression-free survival (PFS); 32% for glioblastoma multiforme (GBM) patients (Jaeckle KA et al, 2003). Methods: From 2000–2003, we retrospectively analyzed adults with malignant glioma who received, following surgery and radiation therapy (RT) ± low dose TMZ (75 mg/m2/d x 42d), TMZ (150–200mg/m2/d, d1–5) and cRA (100 mg/m2/d, d1–21) every 28d for up to 24 cycles or until progression on neuroimaging. Time to progression (TTP) was the primary end-point and overall survival (OS) was the secondary end-point. Results: Of 33 patients (29 GBM, 2 anaplastic astrocytoma, AA, 2 malignant glioma, MG), 18 remain alive. The 33 patients received 308 cycles of TMZ/cRA (mean 9.3 cycles); 9 patients received greater than 10 cycles, but only 2 completed more than 15 cycles. Responses to TMZ/cRA were documented in 15/33 (45%) patients (10 partial responses/5 stable disease). For all patients, median TTP was 38.6 weeks, 50.5 weeks for chemoradiation patients and 27.1 weeks for those who received RT alone prior to TMZ/cRA, NS). Median OS was 103.2 for all 33 patients, 55.3 weeks for RT alone and median time not yet reached for RT/low dose TMZ, p=0.01). 6, 12 and 24 month TTP was 63%/39%/39% (53%/27%/27% for RT alone and 72%/49%/49% for RT/low dose TMZ). OS at 6, 12 and 24 months was 94%, 69% and 43%, respectively, for all 33 patients (86%/50%/25% for RT alone and 100%/86%/75% for RT/low dose TMZ). Conclusions: Our data for malignant glioma patients who received concurrent low dose temozolomide with RT prior to adjuvant temozolomide/cRA compares favourably with the results of the recently completed EORTC/NCIC trial (Stupp R et al, ASCO 2004). The chemoradiation strategy using concurrent low dose temozolomide provides a significant survival advantage when compared to radiation alone. Our study demonstrates that TMZ/cRA prolongs TTP for patients with malignant gliomas when compared to historical controls and supports use of this regimen in a Phase III clinical trial. No significant financial relationships to disclose.

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