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Elise Kohn.
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Forums › Topic Group 1 › to do or not to do: interval debulking in NACT patients
At least patients should not be progressing on NACT !!
Agree. Patients who do not have protocol time- mandated surgery will still be included in intention to treat analyses but the proportion is likely to be much more consistent across surgeons and centres
I support the statement on recommendation for attempt at IDS. As Ignace mentioned, depending on the timing of randomziation / nature of the trial, patients who do not go on to IDS should be excluded or evaluated as a separate group.
Yes, Nicoletta–As long as everyone gets assessed at the same time, whether PDS or NACT, anyone with clear progression of disease would be off treatment by standard criteria. That would leave IDS a clinical decision not a clinical trial decision.
What about patients who have IDS after receiving only Platinum and not taxol for various reasons including poor performance status at presentation but improvement before surgery. They seem to have poor CRS/ observed chemotherapy response during surgery compared to C+T ( depending on biology) and also the maximal effort given during surgery and may need consideration for stratification/ adjustment depending on the trial hypothesis?
Great question, and something to consider when writing eligibility and stratification criteria for a switch maintenance study.