In a previous post I described the open question about whether patients with locally advanced NSCLC should receive prophylactic cranial irradiation (PCI) after completing chemo and chest irradiation. The benefit of PCI for LD-SCLC is established, and it is a standard of care in that setting, and a new report from ASCO 2007 that I described in a recent post also highlights the value of PCI for patients who respond to chemo for ED-SCLC. Why is this approach tempting for locally advanced (stage III) NSCLC? Because we see 20-40% of patients go through chemo/radiation and then have recurrence in the brain first, or brain only, because the brain can be a sanctuary site where our chemo can't effectively get in and eradicate micrometastatic disease our scans can't pick up. But the few previous trials that have evaluated PCI in NSCLC haven't shown any real benefit, although they weren't large enough to say anything meaningful either way; given the possibility (small, but real) of real detrimental effects that can be long-lasting from PCI, most oncologists have not been inclined to recommend PCI routinely in this setting.

The Radiation Therapy Oncology Group (RTOG) has been trying to answer this question with the clinical trial designated RTOG 0214, which I described in a prior post, but basically randomizes patients to either PCI or observation after standard treatment for locally advanced NSCLC. Unfortunately, I just learned that this trial will be closing early, due to slow accrual (a common problem for trials that randomize patients to treatment or no treatment, which patients often don't want to go on) with about 350 patients enrolled thus far. It was designed to enroll over 1000 patients, so that it could detect a difference in survival, but at the lower enrollment of around 350 patients should still be able to detect an improvement in rate of development of brain metastases, and it may also still show survival differences. If we see just trends, though, it likely will not be enough to change our treatment practices, and we may have missed our best chance to answer this question definitively and potentially improve patient outcomes for locally advanced NSCLC.