Temozolomide and 13-cis retinoic acid in patients with anaplastic gliomas

• Verfasst von: Grauer, Oliver Martin [VerfasserIn]
• Verfasst von: Pascher, Christina [VerfasserIn]
• Verfasst von: Hartmann, Christian [VerfasserIn]
• Verfasst von: Zeman, Florian [VerfasserIn]
• Verfasst von: Weller, Michael [VerfasserIn]
• Verfasst von: Proescholdt, Martin [VerfasserIn]
• Verfasst von: Brawanski, Alexander [VerfasserIn]
• Verfasst von: Pietsch, Thorsten [VerfasserIn]
• Verfasst von: Wick, Wolfgang [VerfasserIn]
• Verfasst von: Bogdahn, Ulrich [VerfasserIn]
• Verfasst von: Hau, Peter [VerfasserIn]
• Titel: Temozolomide and 13-cis retinoic acid in patients with anaplastic gliomas
• Titelzusatz: a prospective single-arm monocentric phase-II study (RNOP-05)
• Verf.angabe: Oliver Grauer, Christina Pascher, Christian Hartmann, Florian Zeman, Michael Weller, Martin Proescholdt, Alexander Brawanski, Thorsten Pietsch, Wolfgang Wick, Ulrich Bogdahn, Peter Hau
• E-Jahr: 2011
• Jahr: 4 March 2011
• Umfang: 9 S.
• Fussnoten: Gesehen am 11.07.2022
• Titel Quelle: Enthalten in: Journal of neuro-oncology
• Ort Quelle: Dordrecht [u.a.] : Springer Science + Business Media B.V, 1983
• Jahr Quelle: 2011
• Band/Heft Quelle: 104(2011), 3, Seite 801-809
• ISSN Quelle: 1573-7373
• DOI: doi:10.1007/s11060-011-0548-y
• Datenträger: Online-Ressource
• Sprache: eng
• Bibliogr. Hinweis: Errata: Grauer, Oliver Martin, 1969 - : Erratum to
• Sach-SW: 13-cis retinoic acid
• Sach-SW: 1p/19q co-deletion
• Sach-SW: Anaplastic glioma
• Sach-SW: IDH1
• Sach-SW: MGMT
• Sach-SW: Temozolomide
• K10plus-PPN: 1809699614

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.