Grauer, Oliver and Pascher, Christina and Hartmann, Christian and Zeman, Florian and Weller, Michael and Proescholdt, Martin and Brawanski, Alexander and Pietsch, Thorsten and Wick, Wolfgang and Bogdahn, Ulrich and Hau, Peter (2011) Temozolomide and 13-cis retinoic acid in patients with anaplastic gliomas: a prospective single-arm monocentric phase-II study (RNOP-05). JOURNAL OF NEURO-ONCOLOGY, 104 (3). pp. 801-809. ISSN 0167-594X, 1573-7373
Full text not available from this repository. (Request a copy)Abstract
The objective of this prospective, monocentric phase-II pilot study was to evaluate toxicity and efficacy of neoadjuvant temozolomide (TMZ) and 13-cis retinoic acid (13-cRA) treatment in patients with newly diagnosed anaplastic gliomas after total or subtotal tumor resection. The primary endpoint of the study was median progression-free survival (PFS). Secondary endpoints were toxicity and PFS rates at 6, 12 and 24 months. Thirty-two adult patients were included in the study and treated with a median number of 10 TMZ and 13-cRA cycles (range 1-26). The majority of patients had favorable prognostic factors characterized by young age, complete resection, oligodendroglial histology, 1p/19q co-deletion, O6-methylguanine-DNA methyltransferase (MGMT) promotor methylation and isocitrate dehydrogenase 1 (IDH1) mutation. Grade 3/4 myelotoxicity occurred in 5/32 patients, and about 90% of patients suffered from grade 2/3 adverse events attributable to 13-cRA. The median PFS was 37.8 months (95% CI 22.2-53.4). The 6-, 12- and 24-month PFS rates were 84.4, 75 and 42.4%. The extent of tumor resection was the only prognostic factor associated with better PFS. TMZ and 13-cRA treatment did not improve PFS when retrospectively compared to the TMZ-treated group within the randomized NOA-04 phase-III trial. In conclusion, 13-cRA addition to TMZ in a neoadjuvant setting showed acceptable toxicity, but did not yield an advantage in PFS in patients with newly diagnosed anaplastic gliomas after total or subtotal tumor resection.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SUPRATENTORIAL MALIGNANT GLIOMA; ADJUVANT TEMOZOLOMIDE; 13-CIS-RETINOIC ACID; GLIOBLASTOMA-MULTIFORME; CELL-PROLIFERATION; BRAIN-TUMORS; 1ST RELAPSE; RADIATION; TRIAL; OLIGODENDROGLIOMA; Anaplastic glioma; Temozolomide; 13-cis retinoic acid; MGMT; 1p/19q co-deletion; IDH1 |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurochirurgie Medicine > Lehrstuhl für Neurologie Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 02 Jun 2020 08:58 |
| Last Modified: | 02 Jun 2020 08:58 |
| URI: | https://pred.uni-regensburg.de/id/eprint/20313 |
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