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DR LOVE: Wally, can you discuss the implications of the EORTC-08993 trial that evaluated the impact of PCI on the reduction of symptomatic brain metastases for patients with extensive-disease SCLC who responded to chemotherapy (Slotman 2007; [4.1])?

DR CURRAN: My concern with this study is that the patients did not undergo meticulous restaging, including brain scans at baseline. At the recent RTOG meeting, we discussed the possibility that these patients were being treated for subclinical brain metastases. I am not comfortable with a randomized trial in which you don’t evaluate the brain before you treat it. I have to assume there’s a 10 to 25 percent risk of subclinical disease. Also, their definition of chemotherapy response to continue on to the randomization was not particularly rigorous.

The positive results are an interesting observation, but it is not up to American clinical research standards. The magnitude of survival benefit is puzzling. How can the survival benefit be greater than in limited disease?

DR HANNA: I agree with Wally about the criticism that they should have obtained baseline brain imaging studies on all patients. However, if the patient met certain criteria that raised suspicion of brain metastases, they did require baseline brain imaging. They didn’t tell us how many patients had undergone baseline brain imaging, which would have been useful. There was also an imbalance in the proportion of patients who had other sites of metastases, presumably liver and adrenal, which was worse in the observation arm.

The problem I have isn’t that the study is not provocative and we probably ought to be doing it for some patients; it’s that the author’s conclusion was PCI is now the standard practice for all patients with extensive-stage SCLC who are responding. If you have a patient with liver and adrenal metastases that has some response to initial chemotherapy, it’s ridiculous to use PCI.

DR LOVE: Describe the patient whom you would treat with PCI.

DR HANNA: I would use it with the patient who is free of bulky liver, adrenal or bone metastases or the patient who has an excellent response to chemotherapy and based on clinical intuition is going to survive for a while. Those are the patients who will suffer from symptomatic brain metastases.

DR GRECO: I believe selected patients can benefit, and this study would support that. Most studies — even the large trials — don’t tell us about individual patients. You use that information in the context of the patient you see in your office that day. You don’t just say, “This study showed a survival benefit, so I’m going to use this therapy for every patient with extensive-stage SCLC.”

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