pbj11
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 Posted: Tue Jun 02, 2009 6:27 pm Post subject: 2009 ASCO Conference -- PCI study in NSCLC patients |
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Prophylactic Cranial Irradiation Has No Impact on Overall Survival in Patients With NSCLC Brain Metastases: Presented at ASCO
By Emma Hitt, PhD
ORLANDO, Fla -- June 2, 2009 -- Prophylactic cranial irradiation (PCI) in patients without progressive disease after locoregional therapy for stage III non-small-cell lung cancer (NSCLC) significantly decreases the rate of central nervous system (CNS) metastases, although the study did not show a statistically significant difference in overall or disease-free survival.
Elizabeth M. Gore, MD, Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin, reported the findings here on June 1 at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).
According to the researchers, as systemic treatment for NSCLC improves, the incidence of the brain as site of relapse is increasing, and there is currently no consensus on how to address this risk.
The Radiation Therapy Oncology Group 0214 trial included patients with stage III NSCLC without progression of disease after locoregional treatment with surgery and/or radiation therapy with or without chemotherapy.
Patients were randomised to receive either PCI, given once daily at 2 Gy per fraction to a maximum of 30 Gy, or observation. The study had accrued 356 of a total of 1,058 patients and was closed early due to slow accrual.
Among the 340 evaluable patients, the primary endpoint of 1-year overall survival was 75.6% versus 76.9% for PCI versus observation, respectively, which was not a significant difference. One-year disease-free survival was also not significantly different.
However, the rate of CNS metastases at 1 year was decreased with the use of PCI: 7.7% with PCI versus 18% for observation (P = .004). "Patients in the observation arm were about 2.5 times more likely to develop CNS metastases," Dr. Gore noted.
Acute and late toxicity was acceptable and limited to grade 1 or 2 adverse events, Dr. Gore noted.
During the session, Charles M. Rudin, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, noted that "this was a reasonable study and a rational study," since patients with SCLC, including in the extensive stage, "derive a definitive benefit from PCI," and other data suggest good CNS control with PCI in operable stage III NSCLC.
However, he noted that quality of life and neurocognitive data would be important. "Without a survival benefit or major impact on quality of life, the study is unlikely to change the standard of care," he said.
According to Dr. Gore, quality of life and neurocognitive endpoints will be presented at the upcoming World Congress for Lung Cancer Conference in 2009.
[Presentation 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. Abstract 7506] |
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