Clinical Studies
Bester
Hendlisz
Seidensticker
Which Paper(s)
100
At P=0.05 the difference between the two groups have only a ___% probability of occurring by chance alone.
5%
100
What was the median overall survival (SIRT versus control)?
12.0 months versus 6.3 months
100
How was response measured?
RECIST 1.0
100
What was OS in both groups and what was the P-value?
8.3 months vs 3.5 months P<0.001
100
Which of the papers provides information on the median dose given?
All three
200
The ______ is a sum of values measured for a given variable divided by the number of values.
Mean
200
How many patients experienced Cholecystitis at 3 months after RE?
6 patients (1.8%)
200
What was the maximum allowed bilirubin level to have patients included?
It had to be normal
200
How many lines of chemo did patients have prior to SIRT (mean and range)?
2-6 lines (mean 3)
200
Which studies report grade 3 adverse events?
All three
300
P values convey, how likely it is that there is an effect at all.
True
300
How did patients end up in standard-care control group?
Variant arterial anatomy, refused consent, chose other treatment option
300
What was the maximum allowed ECOG performance status to include patients?
2 or less
300
What was the 12 months survival in both groups?
24% (SIRT arm) and 0% (control arm)
300
Which of the studies was a randomised prospective study?
Hendlisz
400
P values and 95% confidence intervals are not related.
False
400
How many patients had a bilobar disease?
67%
400
How many patients had their GDA and RGA occluded?
All
400
From which point has survival been calculated from?
Date of progression before SIRT
400
Which studies report grade 4 adverse events?
Hendlisz (6 pts. in arm A and 1 pt. in arm B with SIRT due to progression)
500
Confidence intervals can be used in single arm studies.
True
500
Besides SIRT, what were the other two significant prognostic factors for survival?
Extend of hepatic disease and previous chemotherapy
500
What was the 5 FU-dosage regimen in arm B?
SIRT + 225 md/sqm over 14 days  1 week of rest  300 mg/sqm over 14 days every 3 weeks
500
The progression after BSC in the control group was evaluated at the discretion of the oncologist (imaging not mandatory) by?
Significant increase of TU markers , weight loss, decrease of performance status
500
Which studies mention cholecystitis?
Bester