Prophylactic cranial irradiation (PCI) may reduce the development of brain metastases among patients with stage III non-small-cell lung cancer (NSCLC), according to a study published in the Journal of Clinical Oncology.1
A distressing consequence among patients with NSCLC that severely affect quality of life (QoL) is brain metastasis, with some figures showing that incidence is approximately 30% 2 years after diagnosis. Previously performed studies in small cell lung cancer and NSCLC have shown that PCI may prevent brain metastases, but have returned conflicting findings on its affect on overall survival (OS) and neurocognitive impairment.
In this phase 3 NVALT-11/DLCRG-02 study (ClinicalTrials.gov Identifier: NCT01290809), researchers randomly assigned 175 patients with stage III NSCLC in a 1:1 fashion to PCI or observation only after concurrent/sequential chemoradiotherapy with or without surgery. Symptoms, toxicity, and measures of QoL were assessed after assignment and were followed up at 4, 3, 6, 12, and 24 weeks, and 36 months or earlier if there were signs and symptoms (eg, intracranial pressure, headache, cognitive or affective disturbances) of brain metastases.
After a median follow-up of 48.5 months, results showed that 7% (6) versus 27.2% (24) of patients assigned to the PCI arm and control arm, respectively, developed symptomatic brain metastases (P = .001). Patients in the PCI arm also had significant prolongations in time before brain metastases formed compared with patients in the observation arm (hazard ratio [HR], 0.23; 95% CI, 0.09-0.56); the median time to metastases development was not reached in either study arm.
No differences in OS were observed.
The most commonly reported adverse effects were grade 1 and 2 memory impairment and cognitive disturbance, which occurred at a significantly higher rate among patients who underwent PCI. Although patients in the PCI arm initially had improvements in QoL, it quickly decreased just 3 months post-PCI and were comparable to those in the observation arm.
The authors concluded that “PCI decreases symptomatic brain metastases with an increase of low-grade adverse effects, a decrease of QoL only after 3 months, and without affecting OS. We therefore believe that the pros and cons of PCI necessitates a shared decision process between patients and physicians about its use.”
- De Ruysscher D, Dingemans AMC, Praag J, et al. Prophylactic cranial irradiation versus observation in radically treated stage III non-small-cell lung cancer: a randomized phase III NVALT-11/DLCRG-02 study [published online May 22, 2018]. doi: 10.1200/JCO.2017.77.5817