Temozolomide and 13-cis retinoic acid in patients with anaplastic gliomas: a prospective single-arm monocentric phase-II study (RNOP-05)
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...
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
4 March 2011
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| In: |
Journal of neuro-oncology
Year: 2011, Volume: 104, Issue: 3, Pages: 801-809 |
| ISSN: | 1573-7373 |
| DOI: | 10.1007/s11060-011-0548-y |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1007/s11060-011-0548-y Verlag, lizenzpflichtig, Volltext: https://link.springer.com/article/10.1007/s11060-011-0548-y 
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| Author Notes: | Oliver Grauer, Christina Pascher, Christian Hartmann, Florian Zeman, Michael Weller, Martin Proescholdt, Alexander Brawanski, Thorsten Pietsch, Wolfgang Wick, Ulrich Bogdahn, Peter Hau |
| Summary: | 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. |
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| Item Description: | Gesehen am 11.07.2022 |
| Physical Description: | Online Resource |
| ISSN: | 1573-7373 |
| DOI: | 10.1007/s11060-011-0548-y |