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humberto_iskjh

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ELTX·2 months agoStudy on track for success

For me, one of the most interesting reference points would be the mFOLFIRINOX arm from the PRODIGE 24 trial (mDFS ~21 months). Considering that arm was enriched with fitter patients able to tolerate the treatment, and that Gem and GemCap are still widely used in real-world practice, it probably wouldn’t be unreasonable to subtract at least 2–3 months from that benchmark. That would make the timing analysis end up quite close to the conclusion you originally reached using the 6-month adjustment. The one thing we still don’t know there is the MRD distribution. In any case, the time-to-event ratio certainly looks very favorable. Thanks as well for your analyses — they’re very insightful.

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ELTX·2 months agoStudy on track for success

If enrollment was allowed up to 6 months after chemo, wouldn’t it be more realistic to use an average adjustment of ~3 months to account for the timing gap between the reference points? Thanks in advance.

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