Helpful Resources

Avastin-based Therapy in First-line Non-small Cell Lung Cancer (NSCLC): A Preferred First-line Treatment

A recognized advance in first-line NSCLC for appropriate patient types

  • Avastin plus PC is recognized by NCCN as a new standard of care in first-line treatment for metastatic NSCLC1
NCCN guidelines for first-line NSCLC treatment1

  • "[Avastin plus PC] is now the ECOG reference standard for the first-line treatment of advanced, non-squamous cell NSCLC"2

    • Sandler et al, ASCO 2005

  • Important safety information—Hemorrhage: Severe, and in some cases fatal, pulmonary hemorrhage has occurred 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 severe hemorrhage (ie, requiring medical intervention) and initiate aggressive medical management3

Avastin Plus PC: A Significant Advance in First-line NSCLC Treatment

  • A significant advance over PC alone makes Avastin-based therapy a preferred treatment for appropriately selected first-line NSCLC patients4

    • Clinical benefits were observed with Avastin 15 mg/kg q3w continued until disease progression or unacceptable toxicity

Median overall survival: 12.3 vs 10.3 months (HR=0.80,* P=0.013)3

  • *95% CI, 0.68 to 0.94.

  • Most common adverse events in Study E4599: 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 hemorrhage3

Next: Benefit-risk Ratio

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. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology-v.2.2008. Non-Small Cell Lung Cancer. Available at: http://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf. Accessed February 8, 2008.
  2. Sandler AB,Gray R, Brahmer J, et al. A randomized phase III trial of paclitaxel plus carboplatin with or without bevacizumab in patients with advanced non-squamous non-small cell lung cancer: An Eastern Cooperative Oncology Group Trial—E4599. Slides presented at: American Society of Clinical Oncology; May 13-17, 2005; Orlando, Fla.
  3. Avastin Prescribing Information. Genentech, Inc. March 2008.
  4. Sandler A, Gray R, Perry MC, et al. N Engl J Med. 200;355:2542-2550.