Prophylactic Cranial Irradiation in Stage III NSCLC
In a Dutch phase III trial reported in the Journal of Clinical Oncology, De Ruysscher et al found that prophylactic cranial irradiation (PCI) prevented symptomatic brain metastases vs observation in patients with stage III non–small cell lung cancer (NSCLC) receiving treatment with curative intent.
Study Details
In the study, 175 patients were randomized between 2009 and 2015 to receive PCI (n = 87) or observation (n = 88) after concurrent or sequential chemoradiotherapy with or without surgery. The PCI dose was 36 Gy in 18 fractions, 30 Gy in 12 fractions, or 30 Gy in 10 fractions as selected by study site.
The primary endpoint was development of symptomatic brain metastases at 24 months, defined by positive magnetic resonance imaging or computed tomography and presence of one or more signs of increased intracranial pressure, headache, nausea and vomiting, cognitive or affective disturbances, seizures, and focal neurologic symptoms.
Reduced Risk of Symptomatic Metastasis
Median follow-up was 48.5 months. At 2 years, symptomatic brain metastases had developed in 6 patients (7.0%) in the PCI group vs 24 (27.2%) in the control group (odds ratio = 4.96, P = .001), with time to development of symptomatic metastases being significantly increased with PCI (hazard ratio [HR] = 0.23, P = .0012).
Median time to development of brain metastases was not reached in either group. Median overall survival was 24.2 months in the PCI group vs 21.9 months in the observation group (HR = 0.9, P = .56).
Adverse Events
Grade 1 and 2 memory impairment (30% vs 8%) and cognitive disturbance (19% vs 3%) were significantly more common in the PCI group, as were any grade alopecia, fatigue, and headache.
Quality of life, assessed by the EORTC Quality of Life Questionnaire C30, was poorer in the PCI group at 3 months (P = .0017 for physical functioning), but similar in the 2 groups at 6, 12, and 18 months; a small nonsignificant advantage was observed in the control group at 24, 36, and 48 months.
The investigators concluded, “PCI significantly decreased the proportion of patients who developed symptomatic brain metastases with an increase of low-grade toxicity.”
The study was supported by the Dutch Cancer Society.
Dirk De Ruysscher MD, PhD, of Maastricht University Medical Center, is the corresponding author for the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
