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

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.