Efficacy in CRC

Avastin-based therapy in first-line MCRC:

Survival Benefit Across All Patient Subgroups1,2,5

The survival benefit of Avastin plus chemotherapy in Study 2107 was observed across all subgroups analyzed, including age and ECOG status. Other patient- and disease-related parameters assessed were gender, race, location of primary tumor, prior adjuvant therapy, number of metastatic disease sites, and duration of metastatic disease.1,2,5

Overall survival in selected patient subgroups (Study 2107)1,2,5

Avastin based therapy - Overall survival in selected patient subgroups (Study 2107)

  • *For race, median survival has not been reported for patients in the Avastin + IFL "others" subgroup.

Overall survival in selected patient subgroups (Study 2107)1,2,5

Avastin based therapy - Overall survival in selected patient subgroups (Study 2107)

  • †The organs with the most frequent occurrence of metastatic disease were liver (78%), lung (48%) and lymph nodes (25%).

Next: In Combination with IV 5-FU/LV

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.
  1. Hurwitz H, Fehrenbacher L, Novotny W, et al. N Engl J Med. 2004;350:2335-2342.
  1. Data on file. Genentech, Inc.