Colorectal Cancer: Avastin Safety Profile
Metastatic colorectal cancer (MCRC)
Avastin, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first‑ or second‑line treatment of patients with metastatic colorectal cancer.
Avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen.
Limitation of Use: Avastin is not indicated for adjuvant treatment of colon cancer.
Consistent safety profile demonstrated in 3 large Phase III trials
Safety evaluated in 2919 patients receiving Avastin in clinical trials across indications
First-line Study 2107: Avastin plus 5-fluorouracil (5-FU)/leucovorin (LV)/irinotecan (IFL)
Grade 3–4 adverse events in MCRC patients (≥2% higher incidence in the Avastin arm)
|National Cancer Institute Common Terminology Criteria (NCI-CTC) grade 3–4 events||Patients (%)|
|Avastin + IFL (n=392)||Placebo + IFL (n=396)|
|Deep vein thrombosis||9||5|
*Central laboratories were collected on days 1 and 21 of each cycle. Neutrophil counts were available in 303 patients receiving placebo plus IFL and 276 patients receiving Avastin plus IFL.
Second-line Avastin-naive Study E3200: Avastin plus 5-FU/LV/oxaliplatin (FOLFOX4)
Grade 3–5 adverse events (≥2% higher incidence in the Avastin arm)†
|NCI-CTC grade 3–5 (nonhematologic) and grade 4–5 (hematologic) events||Patients (%)|
|Avastin + FOLFOX4 (n=287)||FOLFOX4 alone (n=285)|
†These data are likely to underestimate the true adverse event rates due to the reporting mechanisms used in this study.
The TML‡ study: Avastin plus fluoropyrimidine-based chemotherapy§
No new safety signals were observed in the TML study (ML18147) when Avastin was administered in second-line MCRC patients who progressed on an Avastin containing regimen in first-line MCRC. The safety data was consistent with the known safety profile established in first- and second-line MCRC.
‡TML=Treatment through Multiple Lines (first and second
§Chemotherapy combinations included either an irinotecan- or oxaliplatin-containing regimen.