http://ir.aezsinc.com/sites/...ntly_Asked_Questions_Final_5-17-17.pdf
Q. What did the DSMB say following its second interim review of the preliminary data from the ZoptEC trial?
second interim review = 192
A. The DSMB stated: “There are currently no safety concerns noted by the Committee nor is there any significant reason based upon efficacy differences to justify discontinuation of assigned therapy in the 43 patients who remain on active therapy.”
Wie soll das denn gehen?
Bedeutet doch, das nach der 2 Überprüfung (192), nur noch 43 Patienten im Zoptrex Arm behandlt wurden. 2 Monate vorher waren doch alle 500 Patienten eingeschrieben! Wo liegt mein Fehler??? Bei 384 sollen es noch 60 Patienten gewesen sein???
Q. The trial was stopped and the median overall survival was calculated following 384 events. How many patients were in the Zoptrex arm of the trial when the trial was stopped? Is it correct to assume that the remaining patients were in the doxorubicin arm?
A. Of the 384 events, 196 were enrolled in the Zoptrex™ arm and 188 in the doxorubicin arm. When the trial was stopped, 60 and 67 patients were still alive in the Zoptrex™ and in the doxorubicin treatment arms respectively.
196 + 188 + 60 + 67 = 511 OK, die nehmen das mit den Zahlen nicht so eng! :-)))
Q. A total of 512 patients were enrolled in the trial, yet it was stopped at 384 events. Why?
A. The study was designed to achieve a high level of statistical confidence following 384 events.
Q. How do you explain the delay in the completion of the trial? You announced during the fall of 2016 that the rate of events had slowed greatly. How do you explain that?
A. Whereas recruitment and treatment period were performed according to plan and reached the anticipated milestones, the followup phase after completion of treatment and until the 384 events were reached was longer than initially estimated based on reasonable assumptions and statistical prediction. In other words, the length of time it took to actually complete the trial was longer than was originally estimated.
OK, und die Ursache dafür?
Q. How is it possible that the median overall survival of participants was only 10.9 months for Zoptrex™, considering
(i) the last patient admitted to the trial received his or her final dose of the assigned therapy in December 2015;
(ii) the 384th event did not occur until around the end of January 2017; and
(iii) at that time, 127 patients were still alive?
A. In our study, median overall survival is the length of time from the respective date of patient randomization, when half of the patients in a treatment arm are still aliv
Genau das ist der Punkt, das der Kaplan–Meier estimator eventuell ein verfälschtes OS wiederspiegelt. Damit müsste aber fachliche Inkompetenz oder stures Berechnen ohne TFI vorliegen.
Q. Is it possible that some undetected differences between the patients in the Zoptrex™ arm of the study and the doxorubicin arm of the study caused the study to fail?
A. We do not believe so. The study populations in both treatment arms were remarkably similar in all aspects: age, weight, ethnicity and history and stage of endometrial cancer.
Wieso haben sie nicht den wichtigsten, den treatment-free interval angegeben?
Alter, Gewicht....beeinflussen das OS, aber nicht so stark wie der TFI!
Das ist mir alles sehr suspekt. Hift aber auch nicht weiter.
Das größte Ding was sie sich geleistet haben!
Q. Is it true that patients whose tumor did not express the LHRH receptor were enrolled in the study? Why?
A. It is true that patients whose tumor may not express the LHRH receptor were enrolled in the study. This was done because the FDA required us to admit all patients with the disease specified in the protocol. There were two reasons for the FDA’s position. First, at the start of the trial there was no validated companion diagnostic tool available to determine whether a tumor expresses the LHRH receptor (and we were not able to develop such a tool during the trial). Second, the consensus am ong oncologists is that most tumors associated with the disease specified in the protocol express LHRH receptors.
Das so was nicht vorher bekannt gegeben wurde!!!!!!!!!!!!!! Ein Zoptplazebo für die nicht LHRH-Patienten! Für mich grenzwertig!
Fazit: Abwarten!
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