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Prophylactic cranial irradiation effective for stage IIIA-N2 NSCLC
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Prophylactic cranial radiation significantly extended DFS compared with observation in patients with fully resected stage IIIA-N2 non–small cell lung cancer, according to results of an open-label, randomized phase 3 trial.
Prophylactic cranial radiation (PCI) also decreased incidence of brain metastases in that same patient population, results showed.
The analysis included 156 patients with fully resected, postoperative pathologically confirmed stage IIIA-N2 NSCLC at high risk for cerebral metastases. Patients underwent postoperative adjuvant chemotherapy without recurrence.
Ning Li, MD, of the department of thoracic surgery at Sun Yat-sen University Cancer Center in China, and colleagues randomly assigned 81 patients to PCI (30 Gy in 10 fractions). The other 75 patients were assigned to observation.
DFS served as the primary endpoint. Secondary endpoints included incidence of brain metastases, OS, toxicity and quality of life.
Patients assigned PCI demonstrated significantly longer median DFS (28.5 months vs. 21.2 months; HR=0.67; 95% CI, 0.46-0.98), as well as longer median OS (31.2 months vs. 27.4 months; HR=0.81; 95% CI, 0.56-1.16).
Patients assigned PCI also demonstrated reduced risk for brain metastases. The actuarial 5-year rate of brain metastases was 20.3% among those assigned PCI vs. 49.9% among those assigned observation (HR=0.28; 95% CI, 0.14-0.57).
The most common toxicities in the PCI group were headache, nausea/vomiting and fatigue. Most toxicities were mild, according to researchers.
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