Phase III trial of chemoradiotherapy for anaplastic oligodendroglioma: long-term results of RTOG 9402

J Clin Oncol. 2013 Jan 20;31(3):337-43. doi: 10.1200/JCO.2012.43.2674. Epub 2012 Oct 15.

Abstract

Purpose: Anaplastic oligodendrogliomas, pure (AO) and mixed (anaplastic oligoastrocytoma [AOA]), are chemosensitive, especially if codeleted for 1p/19q, but whether patients live longer after chemoradiotherapy is unknown.

Patients and methods: Eligible patients with AO/AOA were randomly assigned to procarbazine, lomustine, and vincristine (PCV) plus radiotherapy (RT) versus RT alone. The primary end point was overall survival (OS).

Results: Two hundred ninety-one eligible patients were randomly assigned: 148 to PCV plus RT and 143 to RT. For the entire cohort, there was no difference in median survival by treatment (4.6 years for PCV plus RT v 4.7 years for RT; hazard ratio [HR] = 0.79; 95% CI, 0.60 to 1.04; P = .1). Patients with codeleted tumors lived longer than those with noncodeleted tumors (PCV plus RT: 14.7 v 2.6 years, HR = 0.36, 95% CI, 0.23 to 0.57, P < .001; RT: 7.3 v 2.7 years, HR = 0.40, 95% CI, 0.27 to 0.60, P < .001), and the median survival of those with codeleted tumors treated with PCV plus RT was twice that of patients receiving RT (14.7 v 7.3 years; HR = 0.59; 95% CI, 0.37 to 0.95; P = .03). For those with noncodeleted tumors, there was no difference in median survival by treatment arm (2.6 v 2.7 years; HR = 0.85; 95% CI, 0.58 to 1.23; P = .39). In Cox models that included codeletion status, the adjusted OS for all patients was prolonged by PCV plus RT (HR = 0.67; 95% CI, 0.50 to 0.91; P = .01).

Conclusion: For the subset of patients with 1p/19q codeleted AO/AOA, PCV plus RT may be an especially effective treatment, although this observation was derived from an unplanned analysis.

Trial registration: ClinicalTrials.gov NCT00002569.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Brain Neoplasms / genetics
  • Brain Neoplasms / mortality*
  • Brain Neoplasms / therapy*
  • Chemoradiotherapy / methods*
  • Chromosomes, Human, Pair 1 / genetics
  • Chromosomes, Human, Pair 19 / genetics
  • Disease-Free Survival
  • Gene Deletion
  • Humans
  • Kaplan-Meier Estimate
  • Lomustine / administration & dosage
  • Lomustine / adverse effects
  • Oligodendroglioma / genetics
  • Oligodendroglioma / mortality*
  • Oligodendroglioma / therapy*
  • Procarbazine / administration & dosage
  • Procarbazine / adverse effects
  • Proportional Hazards Models
  • Radiotherapy
  • Time
  • Vincristine / administration & dosage
  • Vincristine / adverse effects

Substances

  • Procarbazine
  • Vincristine
  • Lomustine

Associated data

  • ClinicalTrials.gov/NCT00002569