_____ months was in the increase seen in median PFS in the aurelia trial
was is 3.4 months.
100
Serious and sometimes fatal GI perforation occurs at a hight incidence ..up to what? in Avastin treated patients compared to controls.
what is 3.2%
100
FDA approved prescribing information for the duration of Avastin Treatment….
What is patients should continue treatment until disease progression or unacceptable toxicity?
100
Patients who progress within____ months after platinum therapy cessation are considered platinum resistant.
< 6 months.
200
What is the indication for Avastin in Ovarian Cancer?
Indicated for the treatment of patients with platinum-resitant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemo regimens.
200
ORR response rate seen in the ITT population was?
what is 28% vs 13%
200
Grade 3-4 Adverse events observed in the Aurelia study with 2% or higher incidence in the Avastin plus chemo arm.
What is Hypertension and Palmar-plantar erythrodysaesthesia syndrome (hand foot syndrome)
200
Dose and duration of Avastin per FDA approval.
what is 10mg/kg IV every 2 weeks with weekly paclitaxel, PLD, and weekly topotecan.
and
15mg/kg every 3 weeks with topotecan every 3 weeks.
200
Primary and 2nd endpoints for Aureila were
what is PFS 1st
2nd: ORR and OS.
300
Avastin plus chemotherapy is the first biologic regimen to demonstrate what valuable end point in Plat resistant Ovarian Cancer?
What is significant increase in PFS
300
In the Avastin+ Paclitaxel arm, the median OS seen in the patients was
What is 22.4 months vs 13.2
300
Grade 2-4 AE observed in the Aurelia study with 5% or higher incidence in the Avastin plus chemo arm.
name 3
Blood and Lymphatic System disorders( neutropenia)
Hypertension
Peripheral Sensory Neuropathy
Administration site inflammation
Proteinuria
hand foot syndrome
Infection
Epistaxis
300
dosing of Avastin for Cervical cancer
What is 15mg/kg IV every 3 weeks?
300
inclusion criteria for Aurelia study..name 2 of the 3
What is :
<2 prior chemo regimens
ECOG PS 0-2
No evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms or bowel obstruction
400
Median age of women in the Aurelia trial
What is 61 years of age.
400
Can we say which arm is better for the patents to use? which chemo is the better combination.
the analysis was not designed to evaluate statistical significance between treatment arms or compare among the 3 chemo cohorts.
400
Across all studies, Avastin was discontinued in patents how often because of adverse events?
What is 8.4 - 21% of patients
400
For Ovarian cancer, Avastin is diluted in what solution and given over what time period?
What is normal saline and what is 90, 60 and 30 mins for 1,2 and 3rd doses and thereafter.
400
ECOG stands for what?
Eastern Cooperative Oncology Group
500
Avastin gained its approval in Platinum resistant Ovarian cancer based on this trial?
Aurelia study.
500
The hazard ratio for the PFS ITT results revealed what % reduction in risk of progression
62% reduction in the risk of progression.
500
How many grade 5 adverse reactions occurred at a higher incidence (>2%) in patients getting Avastin + chemo compared to chemo alone?
What is none?
500
Dose modifications or reductions in Platinum Resistant Ovarian cancer for Avastin
What is there are no recommended dose reductions or modifications?
500
_____% of patents in the chemotherapy alone arm received Avastin mono therapy upon progression.