Helpful Resources

Histological Considerations with Avastin in NSCLC

In the pivotal Phase III trial (Study E4599), tumor histology was characterized by the predominant cell type1,2

  • Non-small cell lung cancer (NSCLC) patients with mixed histology were eligible for Avastin if the predominant cell type was other than squamous1,2

  • Patients were not excluded from Study E4599 due to tumor location1,2

Histology and patient eligibility in Study E45991,2

By using these selection criteria, the incidence of severe and sometimes fatal pulmonary hemorrhage with Avastin plus PC in Study E4599 was 2.3% vs 0.5% with PC alone.1

A significant survival benefit over chemotherapy alone

  • In Study E4599, Avastin plus PC resulted in a significant increase in median overall survival vs PC alone (12.3 vs 10.3 months; HR=0.80, P=0.013)1

    • An increase in progression-free survival, though not independently verified, was also reported based on investigator assessment

The most common severe (grade 3–5) adverse events in Study E4599, occurring at a ≥2% higher incidence in Avastin-treated patients vs controls, were neutropenia, fatigue, hypertension, infection, and hemorrhage.1

Next: Standard of Care

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. Data on file. Genentech, Inc.