Avastin in combination with paclitaxel or Xeloda has a well-defined and manageable safety profile
The incidences of AEs(Symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study) of special interest with Avastin – hypertension(High blood pressure), proteinuria(The presence of an excess of serum proteins in the urine), arterial thromboembolic events(An event pertaining to or emanating from the formation of a clot (thrombus) in an artery), bleeding, cardiac toxicity and GI(Complete penetration of the wall of the stomach, small intestine or large bowel, resulting in intestinal contents flowing into the abdominal cavity) perforation(Complete penetration of the wall of the stomach, small intestine or large bowel, resulting in intestinal contents flowing into the abdominal cavity) – were within the range previously reported.1,2
Incidence of selected AEs in the E2100 and RIBBON-1 trials1,2
| E21001 | RIBBON-12 | |||
|---|---|---|---|---|
| Paclitaxel (n=348; %) |
Avastin + paclitaxel* (n=363; %) |
Xeloda + placebo (n=201; %) |
Avastin + Xeloda (n=404; %) |
|
| Common chemotherapy-associated (grades 3 and 4) Sensory neuropathy Fatigue |
17.5 5.2 |
24.2 10.7 |
0.5 NR |
3.0 NR |
| AEs of special interest with Avastin (grades 3 and 4) Hypertension Arterial thromboembolic events Venous thromboembolic events Bleeding Proteinuria Cardiac toxicity GI perforation |
1.4 0.0 4.3‡ 0.3 0.0 0.3‡ 0.0 |
16.0 3.6‡ 3.0‡ 2.3 3.0 2.2‡ 0.6‡ |
1.0 1.5 3.5 0.5 0.0 0.5 0.0 |
10.1 1.5 5.0 0.2 2.2 1.5 0.0 |
| *Includes NCI AdEERS mandatory collection in the Avastin + paclitaxel arm only, which does not allow valid comparison between the two arms; ‡Grade ≥3 events; NR = not reported | ||||
Summary of safety of Avastin in combination with paclitaxel or Xeloda for first-line mBC
Avastin has a well-defined and manageable safety profile
In breast cancer, the safety profile for Avastin is consistent between E2100 and RIBBON-1, and has been confirmed in ATHENA, a large open-label(A type of clinical trial in which both the researchers and participants know which treatment is being administered) clinical trial that mimicked daily oncology practice in over 2,000 patients.*
The safety profile for Avastin has been characterised in over 1,000,000 patients worldwide, across multiple tumour(An abnormal growth of cells, forming a mass of tissue) types and with multiple combination partners.3
*Refers to data with Avastin plus paclitaxel from the open-label ATHENA study; other taxane-based chemotherapies studied in ATHENA are not included in the current label for Avastin.
References
- Miles D. Eur J Cancer Suppl 2008;6:29–39.
- Robert NJ, Dieras V, Glaspy J, et al. J Clin Oncol 2011;29:1252–60.
- Avastin PSUR 2011 [RDR 1041900] submitted to EMA on 27 April, 2011.