Bevacizumab Combined with Chemotherapy Receives FDA Approval for Ovarian Cancer Treatment

On 13 June 2018, the United States Food and Drug Administration FDAapproved, for stage 3 and 4 ovarian, fallopian tube or primary peritoneal cancer after initial surgery, bevacizumab (Altuzan) combined with carboplatin and paclitaxel and then as a single agent.

Approval was based on stage 3 or 4 epithelial ovarian, fallopian tube and peritoneal cancer after initial surgery, adding bevacizumab to the carboplatin and paclitaxel doublet chemotherapy regimen , evaluated in a multicenter, randomized, double-blind, placebo -controlled three-arm trial called GOG-0218.

The 1873 patients were randomized into 3 arms:

• Carboplatin plus paclitaxel without bevacizumab,
• Carboplatin plus paclitaxel with bevacizumab (up to 6 cycles)
• Carboplatin plus paclitaxel with bevacizumab for up to 6 cycles, followed by single-agent bevacizumab for 16 cycles.

Bevacizumab was administered intravenously every three weeks at 15 mg/kg. In the study, 1215 patients received at least one dose.

The primary efficacy endpoint was progression-free survival (duration of disease control with treatment), and the secondary endpoint overall survival . According to the study results;

• Estimated median progression-free survival was 18.2 months with chemotherapy plus bevacizumab followed by bevacizumab alone. With chemotherapy plus bevacizumab but no single-agent continuation, it was 12.8 months (not statistically significant). With chemotherapy without bevacizumab, it was 12 months.
• Estimated median overall survival was 43.8 months with chemotherapy plus bevacizumab followed by bevacizumab alone, versus 40.6 months with chemotherapy alone.

In GOG-0218, bevacizumab patients experienced side effects at a frequency of at least %5, including diarrhea, nausea, stomatitis, fatigue, arthralgia, muscle weakness, extremity pain, dysarthria (speech impairment), headache, dyspnea, nosebleeds, nasal mucosal disorders and hypertension. Severe (grade 3 and 4) effects more frequent in bevacizumab arms than controls were fatigue, hypertension, decreased platelets and decreased white blood cell counts .

After initial surgery, for stage 3 or 4 ovarian, fallopian tube or primary peritoneal cancer, the recommended bevacizumab doseis every 3 weeks with carboplatin and paclitaxel at 15 mg / kg, followed every 3 weeks by 15 mg / kg alone. Up to 22 total cycles.

A monoclonal antibody drug, bevacizumab is marketed as Altuzan in our country and Avastin in the United States. It previously received approval in 2014 for platinum-resistant and in 2016 for platinum-sensitive recurrent ovarian cancer.