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Despite on-treatment clinical progression, patients treated with Avastin and standard chemotherapy had a median progression-free survival of 11.8 months compared with 8.8 months in those treated with standard chemotherapy alone.
Compared with chemotherapy alone, patients with platinum-sensitive recurrent ovarian cancer had improved progression-free survival when Avastin (bevacizumab) was continued after disease progression in combination with chemotherapy, according to a trial published in Lancet Oncology.
Adding Avastin to chemotherapy is one of the most recent discoveries in the treatment of patients with advanced ovarian cancer, according to the trial’s introduction. With this phase 3 trial, researchers aimed to see whether adding Avastin to chemotherapy can prolong progression-free survival in patients who previously received Avastin as their first-line treatment.
Researchers analyzed data from 406 women previously treated with a first-line platinum-based therapy including Avastin and had recurrent stage 3b or 4 ovarian cancer. Patients were assigned either a carboplatin-based doublet (combination of a platinum compound with a third-generation agent like gemcitabine) with Avastin (203 patients) or a carboplatin-based doublet alone (203 patients). Several factors were monitored throughout the study including safety and progression-free survival, defined as the time from treatment assignment to the first occurrence of disease progression or all-cause death.
After the last dose of platinum-based chemotherapy more than 12 months before the start of the study, disease progression occurred in 64% of patients assigned Avastin compared with 65% of those assigned standard chemotherapy. Disease progression also occurred in 72% of patients in the Avastin group and 72% in the standard chemotherapy group after completing first-line Avastin maintenance. In addition, 79% of patients in the standard chemotherapy group had disease progression along with 70% of those in the Avastin group.
Median progression-free survival in patients assigned standard chemotherapy was 8.8 months compared with 11.8 months in those assigned Avastin.
The most common severe or life-threatening side effects in the standard chemotherapy and Avastin groups included high blood pressure (10% versus 29%, respectively), decrease in platelet count (22% versus 30%) and decrease in neutrophil count (41% versus 40%).
Death occurred in 33% of patients assigned standard chemotherapy compared with 39% of those assigned Avastin. Of these patients, 1% (two deaths) in the standard chemotherapy group and less than 1% (one death) in the Avastin group were potentially related to the treatment.
“The most reasonable bias (from this study) might occur due to more frequent hospital visits in the bevacizumab group (at each administration of maintenance bevacizumab) than in the standard chemotherapy group, possibly increasing the chance of early detection of clinical progression,” the study authors wrote. “Such a bias is conservative with respect to the alternative hypothesis of superiority of the bevacizumab group, favoring the standard chemotherapy group.”
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