Lung Cancer Update, Issue 3, 2016 (Video Program) - Video 1LUX-Lung 7 trial: Gefitinib versus afatinib as first-line therapy for EGFR mutation-positive NSCLC
1:44 minutes.
TRANSCRIPTION:
DR LOVE: Another thing I want to ask you about is a study that you did that I’m not sure really got the attention that it should have. But it was the trial that compared afatinib to gefitinib up front. We’ve always had this vision — I mean, we started to think a little bit. We started to see the afatinib data with exon 19 with the survival benefit. But can you talk about what you saw in this study? DR MOK: Right. You are referring to the LUX-Lung 7 study, which is actually a randomized Phase IIb study, not a III, not a randomized Phase III, comparing afatinib at 40 mg to gefitinib at 250 mg. So the study was positive with progression-free survival, but I have to remind you, in this particular study, they got 3 coprimary endpoints: time to failure, progression-free survival and overall survival. But that in general is not really powered sufficiently for these three endpoints. So they do observe a difference in progression-free survival. However, the medians are very similar, 10.9 versus the 11. One of the reasons is that actually the first 10 months, actually the 2 survival curves, progression-free survival curves, are actually overlapping. Only toward the end there is a population that seemed to be doing better. And so overall, they got a positive hazard ratio. Now, whether that is going to translate into practice change is debatable. Yes, it’s a positive study. But on the other hand, the difference is not huge. And due to some of the toxicity concern, especially the skin rash and some of the GI toxicity and mucositis, sometimes you just have to be selective. So I’ve no problem using afatinib at all. However, I’m not going to say that that will replace all the first-generation TKIs. |