AVASTIN JEOPARDY

NSCLC

100

Avastin is indicated for the 1L treatment of unresectable, locally advanced, recurrent or metastatic nsNSCLC in combination with ___ and ___.

carboplatin and paclitaxel

200

In 1L Study E4599 Avastin + PC significantly increased median OS by 19% ( ___ vs ___ months with PC alone).

12.3 vs 10.3

300

In E4599, Avastin + PC had a response rate of ___% vs ___% with PC alone, based on investigator assessment.

35% vs 15%

400

In Study E4599, patients in the Avastin + PC arm received an average of ___ cycles of study treatment.

8.9

500

E4599 outcomes were evaluated in an ITT population which included the full range of ___ NSCLC histologies. The majority (69%) of patients had ___ histology.

Nonsquamous; adenocarcinoma

mCRC

100

Avastin is the only biologic with proven ___ benefits in ___ large Phase III mCRC clinical trials.

survival; 3

200

1L Study 2107 included patients with previously ___ mCRC.

untreated

300

The first- through second-line TML study included patients previously treated with a first-line ___-containing regimen.

Avastin

400

Significant increase in OS was achieved in 1L study 2107 ( ___ vs ___ months in Avastin-treated patients vs those receiving placebo _ IFL.

20.3; 15.6

500

When continued through first- and second-line mCRC, Avastin demonstrated OS benefits in combination with both ___- and ___- containing chemo that were consistent with the ITT population months in Avastin-treated patients vs fluoropyrimidine-based chemo alone.

oxaliplatin; irinotecen

SAFETY

100

Across indications, the most common adverse reactions observed in Avastin patients at a rate of >10% and at least twice the control arm were: (list at least 5)

epistaxis; headache; HTN; rhinitis; proteinuria; taste alteration; dry skin; rectal hemorrhage; lacrimation disorder; back pain; exfoliative dermatitis

200

Avastin should be temporarily suspended in patients with ___ hypertension that is not controlled with medical management. Discontinue Avastin in patients with hypertensive ___ or hypertensive ___.

severe; crisis; encephalopathy

300

Patients with 2+ or greater urine dipstick reading should undergo further assessment with a 24-hour urine collection; suspend Avastin administration for ___ grams of proteinuria/24 hours and resume when proteinuria is ___ grams/24 hours; discontinue Avastin in patients with ___ ___.

≥2; <2; nephrotic syndrome

400

Serious and sometimes fatal GI Perforation occurs at a higher incidence (up to ___%) in Avastin-treated patients compared to controls. ___ Avastin for a GI Perforation.

3.2%; discontinue

500

The 3 Boxed Warnings include: ___, ___, and ___. Discontinue Avastin at least ___ days prior to elective surgery; do not initiate Avastin for at least ___ days after surgery and until the surgical wound is fully healed.

GI Perforation; Surgery & wound healing complications; Hemorrhage; 28; 28

MOA

100

___ is a pro-angiogenic factor that is present throughout tumor progression.

VEGF

200

Avastin directly binds VEGF to inhibit ___; it may ___ existing tumor vasculature and ___ new and recurrent tumor vessel growth.

Angiogenesis; regress; inhibit

300

Proposed early and later effects of Avastin include ___ effects and ___.

Anti-vascular; anti-angiogenesis

400

Cessation of anti-VEGF activity diminishes impact on tumors. Basement membrane ghosts may remain after VEGF inhibition and can serve as "___" for regrowth of tumor vasculature.

"scaffolding"

500

In preclinical models withdrawal of anti-VEGF antibodies resulted in resumed ___ and ___ regrowth.

Angiogenesis; tumor

Dosing & Admin

100

Across all indications, study results were achieved with Avastin given at the approved dose until ___.

disease progression or unacceptable toxicity.

200

Avastin should be diluted for infusion in ___.

A total volume of 100 ml of 0.9% Sodium Chloride Injection, USP

300

List the approved dosing and schedule for: 1L mCRC: ___ 1L NSCLC: ___

5 mg/kg IV q2w; 15 mg/kg IV q3w

400

How long is diluted Avastin solution stable?

Up to 8 hours refrigerated

500

In clinical studies, infusion reactions with the first dose of Avastin were uncommon ( ___%), and severe reactions occurred in ___% of patients.

<3%; 0.2%