Lung Cancer Update, Issue 3, 2016 (Video Program) - Video 2IMPRESS: Results of a Phase III trial of gefitinib and chemotherapy versus placebo and chemotherapy for patients with EGFR mutation-positive NSCLC with disease progression on first-line gefitinib
1:40 minutes.
TRANSCRIPTION:
DR MOK: So IMPRESS, turned out it was not too impressive. Our original concept was that continuous TKI with chemotherapy up until progression may be better than chemotherapy alone, considering the fact that there may be tumor heterogeneity. So that’s why we designed a study, patients who had responded for over 4 months with a TKI, and then, at the time of progression, then randomized them to continuation of gefitinib with the chemotherapy of pemetrexed and carbo versus cis/pemetrexed/carbo. We were looking for superiority of progression-free survival, but it turned out that there’s absolutely no difference in the progression-free survival. It’s about 5.4 versus 5.4 months. And this has already been published in Lancet Oncology by John Charles Soria, my co-PI. However, we also took the plasma at the time of enrollment to look into the T790M status. So turned out that the patients who are T790M-positive, there’s absolutely no difference in the progression-free survival. But then for the patients who were T790M-negative, there’s a slight difference: 6.7 months versus about 5.4 months. Statistically it’s not significant — p-value is equal to 0.07, but the sample size is small because there’s a subgroup analysis. So it’s just a signal but not necessarily a change-of-practice type of information. However, there will be something more interesting coming out in ESMO this year, we’re going to present the overall survival data. You should look at those overall survival data. And that might give us further idea whether we should or should not continue with TKIs for this group of patients. |