Bevacizumab-trabectedin combo safe, effective in recurrent ovarian cancer

The combination of bevacizumab plus trabectedin (BT) appears to be more effective than other platinum- and nonplatinum-based regimens in women with partially platinum-sensitive recurrent ovarian cancer, results of a phase II study have shown.

“The combination with carboplatin needs to be assessed further in a remodulated safer schedule to confirm its apparent strong activity,” the investigators said.

This study included women progressing between 6 and 12 months since their last platinum-based therapy. Patients were randomly assigned to BT every 21 days or BT and carboplatin (BT+C) every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in the BT arm.

Progression free survival (PFS) and severe toxicity (ST) rates at 6 months were the primary endpoints, assuming a PFS ≤35 percent for BT and ≤40 percent for BT+C as not of therapeutic interest and ST ≥30 percent as unacceptable for both arms.

The BT+C arm (n=21 patients) failed to meet the safety criteria for the second stage (ST, 45 percent; 95 percent CI, 23–69 percent), but PFS was 85 percent (62–97 percent). On the other hand, the BT arm (n=50 patients) had a PFS of 75 percent (60–87 percent) and ST of 16 percent (7–30 percent).

“Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment, and this could be synergistic with bevacizumab,” the investigators said.

A previous multicentre, open-label, randomized, phase III trial reported an improved median overall survival with the addition of bevacizumab to standard chemotherapy, followed by maintenance therapy until progression, in patients with platinum-sensitive recurrent ovarian cancer. [Lancet Oncol 2017;18:779-791]