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Prophylactic radiation therapy reduces brain metastases in lung cancer

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CHICAGO – Prophylactic cranial irradiation reduced the development of symptomatic brain metastases among patients with non-small cell lung cancer, although it did not affect OS, according to findings presented at the ASCO Annual Meeting.

In addition, while prophylactic cranial irradiation was associated with a decline in 3-month global quality of life measures, the decrease did not persist beyond 3 months.

“Brain metastases are a major site of treatment failure in patients with non-small cell lung cancer,” Harry JM Groen, MD, PhD, of the University of Groningen in the Netherlands, said during a presentation. “Prophylactic cranial irradiation has reduced the incidence of brain metastases in these patients. However, the exact value of this treatment in patients treated with chemotherapy and radiation with or without surgery remains undetermined.”

Groen and colleagues randomly assigned patients to either observation or prophylactic cranial irradiation (PCI) following concurrent or sequential chemotherapy-radiation with or without surgery. PCI dose (36 Gy/18F, 30 Gy/12F or 30 Gy/10F) was determined by the physician. Registration was conducted prior to PCI randomization; patients who experienced disease progression following chemotherapy-radiation were not included.

Patients were observed for signs of symptomatic brain metastases, which included increased intracranial pressure, headache, nausea, vomiting, cognitive or affective disturbances, seizures, focal neurological symptoms and evidence on MRI/CT. Side effects, survival and quality of life (as measured by the EuroQol 5 Dimensions and European Organization for Research and Treatment of Cancer 30 item Quality of Life questionnaires) were also monitored.

The primary endpoint of the study was the number of patients who developed a symptomatic brain metastases. With 300 patients randomly assigned to treatment or observation, the study had 90% power (2-sided; P = .05) to identify a 17% decline in the number of patients who developed a metastasis at 24 months.

Between 2009 and 2015, the researchers registered 195 patients; 175 were randomly assigned to a treatment arm. Treatment was almost equally divided between the two arms, with 87 patients receiving PCI and 88 in the observation arm. One patient in the PCI arm withdrew from the study after randomization was completed.

In 2013, because of slow accrual, the number of randomized patients was reduced to 175. At this number, with 75 events, a 2-sided log-rank test would have 80% power to identify an HR of 0.52 and an alpha of 0.05.

More than half of patients (n = 114; 66%) were men. Adenocarcinoma was the most frequent diagnosis (n = 72; 41%), followed by squamous cell carcinoma (n = 62; 36%) and other (n = 40; 23%). Stage IIIA disease (n = 93) was more common than stage IIIB disease (n = 80; 53% vs. 46%). One patient’s disease stage was unknown (1%).

The median length of follow-up was 48.5 months (95% CI, 39-54 months). A performance status of 0 was noted in 66 patients (38%). Ninety-nine patients (57%) had a performance status of 1 and 9 patients (5%) had a performance status of 2.

More patients in the observation arm (25 out of 88; 28.4%) than in the PCI arm (4 out of 86; 4.6%) developed symptomatic brain metastases (P < .00001). Brain metastases on imaging were also more likely in the observation arm compared with the PCI arm (26 patients vs. 7 patients; 29.7% vs. 8.1%; P < .001).

The difference in the development of brain metastases between the two groups was “huge,” according to Groen.

Neither treatment arm reached the median time to symptomatic brain metastases. Median OS was 24.2 months in the PCI arm vs. 21.9 months in the observation arm (P = .52). Global quality of life scores at 3 months were poorer in the PCI arm compared with the observation arm (P = .02), but did not remain worse after the 3-month mark.

“PCI delayed the development of brain metastases. It works,” Groen said during his presentation. “However, PCI does not promote OS, and it decreases quality of life at 3 months, although we did not observe any differences thereafter.” – by Julia Ernst, MS

Reference:

Groen HJM, et al. Abstract 8502. Presented at: ASCO Annual Meeting; June 2-6, 2017; Chicago.

Disclosures: Groen reports he is a consultant or advisor through his institution for AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD Oncology, Novartis, Pfizer and Roche/Genentech and receives research funding through his institution from Eli Lilly and Roche. Please see the full study for a list of all other researchers’ relevant financial disclosures.