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Hargrave, Darren R.; Bouffet, Eric; Tabori, Uri; Broniscer, Alberto; Cohen, Kenneth J.; Hansford, Jordan R.; Geoerger, Birgit; Hingorani, Pooja; Dunkel, Ira J.; Russo, Mark W.; Tseng, Lillian; Dasgupta, Kohinoor; Gasal, Eduard; Whitlock, James A.; Kieran, Mark W.

Efficacy and Safety of Dabrafenib in Pediatric Patients with BRAF V600 Mutation–Positive Relapsed or Refractory Low-Grade Glioma: Results from a Phase I/IIa Study

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  • Medientyp: E-Artikel
  • Titel: Efficacy and Safety of Dabrafenib in Pediatric Patients with BRAF V600 Mutation–Positive Relapsed or Refractory Low-Grade Glioma: Results from a Phase I/IIa Study
  • Beteiligte: Hargrave, Darren R.; Bouffet, Eric; Tabori, Uri; Broniscer, Alberto; Cohen, Kenneth J.; Hansford, Jordan R.; Geoerger, Birgit; Hingorani, Pooja; Dunkel, Ira J.; Russo, Mark W.; Tseng, Lillian; Dasgupta, Kohinoor; Gasal, Eduard; Whitlock, James A.; Kieran, Mark W.
  • Erschienen: American Association for Cancer Research (AACR), 2019
  • Erschienen in: Clinical Cancer Research, 25 (2019) 24, Seite 7303-7311
  • Sprache: Englisch
  • DOI: 10.1158/1078-0432.ccr-19-2177
  • ISSN: 1557-3265; 1078-0432
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: Abstract Purpose: Pediatric low-grade glioma (pLGG) is the most prevalent childhood brain tumor. Patients with BRAF V600 mutation–positive pLGG may benefit from treatment with dabrafenib. Part 2 of a phase I/IIa study, open-label study (NCT01677741) explores the activity and safety of dabrafenib treatment in these patients. Patients and Methods: Patients ages 1 to <18 years who had BRAF V600–mutant solid tumors (≥1 evaluable lesion) with recurrent, refractory, or progressive disease after ≥1 standard therapy were treated with oral dabrafenib 3.0 to 5.25 mg/kg/day (part 1) or at the recommended phase II dose (RP2D; part 2). Primary objectives were to determine the RP2D (part 1, results presented in a companion paper) and assess clinical activity (part 2). Here, we report the clinical activity, including objective response rates (ORRs) using Response Assessment in Neuro-Oncology criteria and safety across parts 1 and 2. Results: Overall, 32 patients with pLGG were enrolled (part 1, n = 15; part 2, n = 17). Minimum follow-up was 26.2 months. Among all patients, the ORR was 44% [95% confidence interval (CI), 26–62] by independent review. The 1-year progression-free survival rate was 85% (95% CI, 64–94). Treatment-related adverse events (AE) were reported in 29 patients (91%); the most common was fatigue (34%). Grade 3/4 treatment-related AEs were reported in 9 patients (28%). Conclusions: Dabrafenib demonstrated meaningful clinical activity and acceptable tolerability in patients with BRAF V600–mutant pLGG.
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