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Avastin-based Therapy in First-line Non-small Cell Lung Cancer (NSCLC): A Significant Overall Survival Benefit

More than half of Avastin-treated patients in Study E4599 were alive at 1 year

Median overall survival: 12.3 vs 10.3 months (HR=0.80,* P=0.013)1

  • *95% CI, 0.68 to 0.94.

  • Avastin plus PC was the first treatment regimen to demonstrate median overall survival >1 year in any Phase III metastatic NSCLC trial1

    • 23% of Avastin-treated patients were alive at 2 years2

  • Avastin is the first biologic therapy proven to extend survival when added to a conventional chemotherapy doublet in the first-line treatment of metastatic NSCLC1

  • Key exclusion criteria: squamous cell histology, mixed-cell–type tumors with predominant squamous cell histology, CNS metastases, current use of therapeutic anticoagulants (INR >1.5), history of gross hemoptysis (≥1/2 tsp of red blood), or unstable angina1,3

Avastin Plus Paclitaxel/Carboplatin (PC): A Significant Advance in First-line NSCLC Treatment

Significant survival benefit achieved with Avastin plus chemotherapy given first line and at the evidence-based dose

Established dose in the pivotal NSCLC Phase III trial1

  • Important adverse events in Study E4599: Severe or fatal hemorrhage occurred in 4.7% of Avastin-treated patients vs 1.1% of control patients. Pulmonary hemorrhage occurred in 2.3% of the patients treated with Avastin vs 0.5% with PC alone. Other serious events of interest occurring at higher rates with Avastin plus PC vs PC alone included GI perforation (0.9% vs 0%) and arterial thromboembolic events (3.0% vs 1.4%). The most common severe (grade 3–5) adverse events, occurring at a ≥2% higher incidence in Avastin-treated patients vs controls, were neutropenia, fatigue, hypertension, infection, and hemorrhage1

Next: Histological Considerations

Boxed WARNINGS and Additional Important Safety Information

Gastrointestinal (GI) perforation: Avastin administration can result in the development of GI perforation, in some cases resulting in fatality. GI perforation, sometimes associated with intra-abdominal abscess, occurred throughout treatment with Avastin. Permanently discontinue Avastin therapy in patients with GI perforation.

Wound healing complication: Avastin administration can result in the development of wound dehiscence, in some instances resulting in fatality. Permanently discontinue Avastin therapy in patients with wound dehiscence requiring medical intervention. The appropriate interval between termination of Avastin and subsequent elective surgery has not been determined.

Hemorrhage: Severe, and in some cases fatal, pulmonary hemorrhage can occur in patients with NSCLC treated with chemotherapy and Avastin. Do not administer Avastin to patients with recent hemoptysis (≥1/2 tsp of red blood). Permanently discontinue Avastin in patients with serious hemorrhage and initiate aggressive medical management.

Additional serious adverse events included non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, neutropenia and infection, nephrotic syndrome, and congestive heart failure.

The most common grade 3–5 (nonhematologic) and 4–5 (hematologic) events that may have occurred in Avastin indications (first-line NSCLC, first- and second-line MCRC) included neutropenia, fatigue, hypertension, infection, hemorrhage, asthenia, abdominal pain, pain, deep vein thrombosis, intra-abdominal thrombosis, syncope, diarrhea, constipation, leukopenia, nausea, vomiting, dehydration, ileus, neuropathy–sensory, neurologic–other, and headache.

Please see full Prescribing Information, including Boxed WARNINGS, for additional safety information.

References
  1. Avastin Prescribing Information. Genentech, Inc. March 2008.
  2. Sandler A, Gray R, Perry MC, et al. N Engl J Med. 2006;355:2542-2550.
  3. Data on file. Genentech, Inc.