External beam irradiation and the combination of cisplatin and carmustine followed by carmustine alone for the treatment of high-grade glioma: a phase 2 Southwest Oncology Group trial

Cancer. 2008 Aug 1;113(3):559-65. doi: 10.1002/cncr.23585.

Abstract

Background: The poor prognosis reported for patients with high-grade glial neoplasms indicates a need for the development of multimodality therapeutic approaches. The addition of chemotherapy has contributed variably to increased survival. The objective of the current study (Southwest Oncology Group [SWOG] 9016) was to determine whether concurrent radiotherapy and chemotherapy with the combination of carmustine and cisplatin could be given safely in a cooperative group setting. Additional objectives included the estimation of response rate, the rate of disease stabilization, and the probability of 1-year survival.

Methods: SWOG 9016 study included 59 eligible patients with grade III or IV astrocytoma who received radiotherapy concurrently with carmustine/cisplatin chemotherapy. Patients were required to have either measurable or evaluable disease. The therapeutic endpoints were comprised of complete response (CR), partial response (PR), or progressive disease (PD).

Results: Six patients achieved a CR (CR rate of 10%; 95% confidence interval [95% CI], 4-21%), 4 achieved a PR (PR rate of 7%; 95% CI, 2-16%), and 2 patients (3%) experienced an unconfirmed response. Twenty-four patients (41%; 95% CI, 28-54%) had stable disease and 10 patients (17%) demonstrated PD. The overall disease stabilization rate (CR + PR + stable disease, excluding unconfirmed response) was 58% (95% CI, 44-70%).

Conclusions: Despite the presence of a cohort of long-term survivors, the results of the current study do not appear to support the additional study or routine use of concurrent cisplatin and carmustine.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Brain Neoplasms / drug therapy*
  • Brain Neoplasms / mortality
  • Brain Neoplasms / pathology
  • Brain Neoplasms / radiotherapy*
  • Carmustine / administration & dosage*
  • Carmustine / adverse effects
  • Cisplatin / administration & dosage*
  • Cisplatin / adverse effects
  • Combined Modality Therapy
  • Female
  • Glioma / drug therapy*
  • Glioma / mortality
  • Glioma / pathology
  • Glioma / radiotherapy*
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Radiotherapy, Conformal / methods
  • Southwestern United States
  • Survival Analysis
  • Treatment Outcome

Substances

  • Cisplatin
  • Carmustine