Safety data from the GOG-0218 trial1
GOG-0218 was a randomised(How subjects are assigned to a treatment arm in a study. The treatment a subject receives is determined by chance alone), double-blind(A study in which both the investigator and the participant are blind to (unaware of) the nature of the treatment the participant is receiving), placebo-controlled(A way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designed to have no real effect), three-arm phase III trial conducted by the Gynecology Oncology Group (GOG)1 examining the efficacy(The capacity for beneficial change (or therapeutic effect) of a given intervention) and safety of front-line Avastin combined with chemotherapy and continued as a single agent in women with newly diagnosed stage III or IV ovarian cancer. Patients eligible for the trial were required to have optimally debulked (macroscopic) stage III, suboptimally debulked stage III or stage IV epithelial ovarian, primary peritoneal or fallopian tube cancer.
GOG-0218: Avastin front-line has manageable side effects both when combined with chemotherapy and when continued as a single agent1
With a duration of therapy of a maximum of 15 months, the tolerability of Avastin is an important consideration. Furthermore, the impact of Avastin on the overall safety profile of the combination regimen is of interest.
Data show that when Avastin was given in combination with carboplatin/paclitaxel, the incidence of side effects was as expected based on the well-defined safety profile of Avastin.1
GOG-0218: key side effects observed when Avastin was administered in combination with chemotherapy1
Adverse events occurring between cycle 2 (the start of Avastin or placebo therapy) and cycle 6 (completion of chemotherapy) in GOG-0218.1
Grade ≥2 hypertension(High blood pressure), a known side effect of anti-angiogenic therapy, was more common with Avastin-based therapy than with chemotherapy alone, as expected. No difference in the incidence of venous or arterial thromboembolic events(An event pertaining to or emanating from the formation of a clot (thrombus) in an artery) between the arms was observed, and the incidence of neutropenia and febrile neutropenia was also similar.
The incidence of adverse events(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) first occurring during the continued single-agent Avastin phase was again as expected. Hypertension and proteinuria(The presence of an excess of serum proteins in the urine) were increased in incidence, but the data confirm the tolerability of continued single-agent Avastin.
GOG-0218: continued single-agent Avastin was well tolerated1
Select adverse events (grade when limited) occurring in cycles 7-22 (single-agent Avastin or placebo phase) of GOG-0218.1
GOG-0218 safety summary
In summary, there were no new safety concerns for women with advanced ovarian cancer when Avastin was administered for a maximum of 15 months at a dose of 15mg/kg every 3 weeks.1
References
- Burger RA, Brady MF, Bookman MA, et al. N Engl J Med 2011;365:2473-83 and supplementary material available at NEJM.