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CHICAGO -- Progression of platinum-resistant ovarian cancer slowed by more than 50% in patients who received bevacizumab (Avastin) plus chemotherapy compared with nonplatinum chemotherapy alone, results of a randomized trial showed.

Median progression-free survival (PFS) increased from 3.4 months with chemotherapy to 6.7 months with chemotherapy and bevacizumab.

The objective response rate more than doubled with the addition of the angiogenesis inhibitor, Eric Pujade-Lauraine, MD, of Hopital Hotel-Dieu in Paris, reported here at the American Society for Clinical Oncology meeting.

"Bevacizumab plus chemotherapy halves the risk of the disease getting worse in platinum-resistant patients, where there is a high unmet need," said Pujade-Lauraine. "Bevacizumab combined with chemotherapy should be considered a new standard option in platinum-resistant ovarian cancer."

The results constitute a milestone development in the treatment of platinum-resistant ovarian cancer, said Carol Aghajanian, MD, of Memorial Sloan-Kettering Cancer Center in New York City.

"These patients, with the usual therapy ... have a low-level response. The drugs work a little bit for a little while," said Aghajanian, who moderated the press briefing. "This is the first trial to show significant improvement in this group of patients."

The findings came from a randomized trial known as AURELIA, which involved patients with ovarian cancer that progressed within 6 months of receiving the last dose of platinum-based chemotherapy.

All patients received one of three standard chemotherapy regimens for platinum-resistant ovarian cancer -- topotecan, paclitaxel, or pegylated liposomal doxorubicin -- as chosen by the treating physicians. The patients were randomized to placebo or to bevacizumab, given concurrently with chemotherapy.

The primary endpoint was PFS, and secondary endpoints included objective response rate, overall survival, safety, and quality of life.

The final analysis included 361 patients. After a median follow-up of 13.5 months, 91% of patients in the chemotherapy-alone arm had progressed compared with 75% in the chemotherapy-bevacizumab arm. The difference translated into a hazard for progression of 0.48 (P<0.001).

"Wow," Pujade-Lauraine said upon displaying survival curves from the study during an ASCO press briefing. "That's exactly what the investigators said when they saw this graph.

"Separation between the curves clearly indicates that adding bevacizumab to chemotherapy is working very well."

Adverse events occurred more often in the bevacizumab arm but were consistent with known effects of the angiogenesis inhibitor and the different chemotherapeutic agents used in the trial.

The most common adverse events in the bevacizumab arm were grade ≥2 hypertension in 20% of patients and proteinuria in 11%. That compared with 7% and 1%, respectively, in the chemotherapy-only arm.

Thromboembolic adverse events occurred in 5% of bevacizumab-treated patients and 4% of patients in the chemotherapy control arm. Pujade-Lauraine reported that 2% of patients in the bevacizumab arm had arterial clot-related events, versus none in the control group.

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