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A phase III comparison of prophylactic cranial irradiation versus observation in patients with locally advanced non-small cell lung cancer: Initial analysis of Radiation Therapy Oncology Group 0214

Carolyn Vachani, RN, MSN, AOCN
Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 8, 2009

Title: A phase III comparison of prophylactic cranial irradiation versus observation in patients with locally advanced non-small cell lung cancer: Initial analysis of Radiation Therapy Oncology Group 0214
Reviewer: Arpi Thukral, MD
Presenter: Elizabeth M. Gore, MD
Affiliation: Medical College of Wisconsin

The brain is a frequent site of metastasis for non-small cell lung cancer (NSCLC). Prophylactic cranial radiation (PCI) – that is, radiation to the whole brain to prevent metastases- is standard practice in small cell lung cancer patients who have responded to therapy, and it has shown significant survival benefit. This study looked at the use of PCI in NSCLC.

340 participants with stage IIIA & IIIB NSCLC were randomized to receive either PCI or observation. There was no statistically significant difference in overall survival or disease free survival between the groups at one year. However, there was a significant difference in the rate of brain metastases; 7.7% for PCI and 18% for observation (p=0.004). The patients in the observation arm were 2.52 times as likely to develop brain metastases. Side effects of PCI included nausea, headaches, fatigue and hair loss.

The RTOG plans to present data on the neuropsychological function and quality of life from this study later this summer, which will be important to the evaluation of PCI. One major problem in this study was poor accrual. The study had planned to enroll over 1000 patients, but closed early due to a slow accrual. In addition, it is not known if a survival difference will develop in longer follow up. Continued follow up and study are needed before any change in practice.

Also see Interpreting a Cancer Research Study