Prophylactic cranial irradiation versus observation in radically treated stage III non–small-cell lung cancer : A randomized phase III NVALT-11/DLCRG-02 study

PurposeThe purpose of the current study was to investigate whether prophylactic cranial irradiation (PCI) reduces the incidence of symptomatic brain metastases in patients with stage III non–small-cell lung cancer (NSCLC) treated with curative intention.Patients and MethodsPatients with stage III NSCLC—staged with a contrast-enhanced brain computed tomography or magnetic resonance imaging—were randomly assigned to either observation or PCI after concurrent/sequential chemoradiotherapy with or without surgery. The primary end point—development of symptomatic brain metastases at 24 months—was defined as one or a combination of key symptoms that suggest brain metastases—signs of increased intracranial pressure, headache, nausea and vomiting, cognitive or affective disturbances, seizures, and focal neurologic symptoms—and magnetic resonance imaging or computed tomography demonstrating the existence of brain metastasis. Adverse effects, survival, quality of life, quality-adjusted survival, and health care cost...