During the discussion session following his presentation, Dr. Hitt said that patients in the IC arms had considerable toxicity and comorbidity until GM-CSF was added along with chemotherapy. These patients need supportive care, he said.
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August 2009
Leaving out 25% of the patients is a serious problem. In my view, this is not a new standard based on study results.
-Jan B. Vermorken, MD, PhD
Questions Raised
The formal discussant of the trial, Jan B. Vermorken, MD, PhD, of University Hospital in Antwerp, said that this study raised many questions and, in his view, the sequential arm should not be considered a new standard based on results of this trial.
He took issue with the uneven distribution of patients in the trial: 128 in the CRT arm, 156 in the PF arm, and 155 in the TPF arm. He also noted that there were 11 treatment-related deaths in the sequential arm and only two in the concurrent CRT arm.
The summary of efficacy was most disturbing, he said. Eighty-six patients were left out of the analysis [nine in the CRT arm, 33 in the PF arm, and 44 in the TPF arm]. Leaving out 25% of the patients is a serious problem. In my view, this is not a new standard based on study results, said Dr. Vermorken.
©2009 The Triological Society