Rivoceranib-Based Therapy Improves Outcomes in Recurrent Ovarian Cancer

Treatment with Rivoceranib (apatinib) plus pegylated liposomal doxorubicin (PLD) improved outcomes over PLD alone and elicited manageable side effects for patients with recurrent ovarian cancer that was resistant to platinum-based chemotherapy, according to findings from the phase 2 APPROVE clinical trial.

At a median follow-up of 8.7 months, the average progression-free survival, which is the time from treatment until disease worsens, was 5.8 months in the Rivoceranib group, compared with 3.3 months for PLD alone. The median overall survival (time from treatment until death of any cause) in the Rivoceranib group was 23 months, compared with 14.4 months in the group that received PLD alone.

At a median follow-up of 8.7 months, the average progression-free survival, which is the time from treatment until disease worsens, was 5.8 months in the Rivoceranib group, compared with 3.3 months for PLD alone. The median overall survival (time from treatment until death of any cause) in the Rivoceranib group was 23 months, compared with 14.4 months in the group that received PLD alone.

A total of 152 patients were enrolled in the trial and randomly assigned to either the Rivoceranib group (78 patients) or the PLD alone group (74 patients). Disease progression or death was experienced in 47.4% of patients in the Rivoceranib group and 67.6% in the PLD alone group.

The objective response rate, which measures how much a therapy shrinks tumors, was 83.3% in the Rivoceranib group and 86.5% in the PLD alone group. Additionally, an unconfirmed objective response was observed in 43.1% of patients in the Rivoceranib group and 10.9% in the PLD alone group.

In the Rivoceranib group, there was a disease control rate (patients whose disease shrunk, disappeared or is stable from treatment) of 81.5%, compared to 53.1% in the PLD alone group.

In the Rivoceranib and PLD groups, the median time to response was 2.1 months. Additionally, of those who possessed measurable lesions and underwent at least one post-baseline imaging assessment, 87.8% in the Rivoceranib group and 39.2% in the PLD alone group had target lesion reduction.

Rivoceranib dose reductions were necessary in 12.2% of patients and 6.8% required PLD dose reductions. At least one dose interruption was noted in 29.7% of patients overall. In the Rivoceranib group, 3.8% of patients discontinued treatment because of side effects.

The majority of patients (93.2%) experienced at least one side effect from Rivoceranib treatment. Similarly, 84.7% experienced one or more side effect in the PLD group.

The most common side effects were decreased white blood cell count (60.8% versus 50%) and decreased neutrophil counts (59.5% versus 37.5%) in the Rivoceranib and PLD alone groups, respectively.

Those treated with Rivoceranib had an increase in any-severity hand-foot syndrome (25.7% versus 2.8%), high blood pressure (17.6% versus 1.4%) and proteinuria, a condition where there are increased levels of protein in the urine (14.9% versus 2.8%) compared with the PLD alone group.

Of note, hand-foot syndrome is a skin reaction that may cause redness, swelling and blistering on the palms of the hands and soles of the feet.

The most common serious, severe or fatal side effects observed were decreased neutrophil counts (14.9% versus 8.3%), high blood pressure (8.1% versus 0%), and decreased white blood cell counts (6.8% vs 4.2%) between the Rivoceranib and PLD alone group, respectively.

Serious side effects occurred in 12.2% of patients in the Rivoceranib treatment group, with the most common being incomplete bowel obstruction (2.7%) and leaking of the stomach or intestines (2.7%). Moreover, 4.2% of patients in the PLD alone group experienced one instance each of infection, vomiting or nausea, and acute pancreatitis. No patients died from side effects.

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