Patient-reported outcomes with tisotumab vedotin versus chemotherapy in patients with recurrent or metastatic cervical cancer: post hoc analyses from the open-label, randomized, phase 3 ENGOT-cx12/GOG-3057/innovaTV 301 trial.

In 30 seconds

This post hoc analysis of the open-label, randomized, phase 3 innovaTV 301 trial examined patient-reported health-related quality of life among patients receiving second- or third-line treatment for recurrent or metastatic cervical cancer. Patients were assigned to tisotumab vedotin or investigator’s choice of chemotherapy. Across treatment, quality of life, functioning, and symptoms were maintained, with no between-arm differences in these measures. Clinically meaningful improvement was reported by a greater proportion of patients receiving tisotumab vedotin on most questionnaire subscales, and deterioration occurred more slowly on most subscales.

Key findings

• Mean compliance with patient-reported outcome instruments was >82% from baseline to cycle 13.
• Quality of life, functioning, and symptoms were maintained during treatment, with no differences between arms.
• A greater proportion of patients receiving tisotumab vedotin reported ≥10-point improvement on most questionnaire subscales.
• Among patients with deterioration, time to clinically meaningful deterioration was longer with tisotumab vedotin on most subscales, notably for nausea/vomiting, pain, and dyspnea.

Why it matters

Patient-reported outcomes add information about treatment burden and daily functioning alongside survival outcomes. In this trial population, the findings suggest that tisotumab vedotin did not compromise reported quality of life during treatment and may be associated with more improvement or slower deterioration on several symptom and functioning measures.

What to keep in mind

This was a post hoc analysis, and the open-label design may influence patient-reported outcomes. The abstract provides no effect sizes for the reported between-arm differences.