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Multicenter pilot study of radio-chemotherapy as first-line treatment for adults with medulloblastoma (NOA-07)

Neuro-Oncology Aug 25, 2017

Dagmar D, et al. – In a prospective descriptive multicenter single–arm Phase II trial, radio–polychemotherapy was appraised regarding feasibility and toxicity. Throughout the first four chemotherapy cycles, experts reported considerable toxicity caused by radio–polychemotherapy, it was also associated with high amount of dose reductions. It appeared to impact efficacy. Hence, frequent patient surveillance using this regimen was suggested.

Methods

  • Followed by eight cycles of cisplatin, lomustine and vincristine, the NOA-07 trial combined cranio-spinal irradiation with vincristine.
  • Assessment was done for adverse events, imaging and progression patterns, histological and genetic markers, health-related quality of life (HRQoL) and cognition.
  • In addition, primary endpoint was the rate of toxicity-related treatment terminations after four chemotherapy cycles, and the toxicity profile.
  • If at least 45% of patients received at least 4 cycles of maintenance chemotherapy, the feasibility goal was reached.

Results

  • As per findings, thirty patients were evaluable.
  • Classic and desmoplastic-nodular histology were observed in each 50% percent.
  • They classified sixty-seven percent into the sonic hedgehog (SHH) subgroup without TP53 alterations, 13% in wingless (WNT), and 17% in Non-WNT/Non-SHH.
  • In the majority, four cycles of chemotherapy were feasible (n=21; 70.0%).
  • Prevalent toxicities were hematological side effects and polyneuropathy.
  • They noticed significant improvement in HRQoL and verbal fluency, during the active treatment period.
  • 66.6% was the 3-year event-free survival rate (EFS) at the time of databank lock.

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