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.

OBJECTIVE

In the phase 3, multi-national, open-label, randomized innovaTV 301/ENGOT-cx12/GOG-3057 trial (NCT04697628), tisotumab vedotin as second- or third-line therapy significantly improved survival versus chemotherapy in patients with recurrent or metastatic cervical cancer. We report a post hoc analysis of patient-reported outcomes on health-related quality of life from innovaTV 301.

METHODS

Patients were randomized 1:1 to tisotumab vedotin or investigator's choice of chemotherapy. Pre-specified secondary end points included assessment of health-related quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cervical Cancer Module, and EuroQol 5-Dimension 5-Level. This post hoc analysis assessed change from baseline to cycle 13 using a mixed model for repeated measures and time to clinically meaningful deterioration (≥10-point change) or disease progression/death using a Cox proportional hazards model in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module subscales, both adjusted for baseline factors. Proportion of patients with ≥10-point change from baseline in subscales were compared between arms.

RESULTS

Mean compliance rates across patient-reported outcome instruments were high (>82%) from baseline to cycle 13. Mixed model for repeated measures analyses showed that patient-reported health-related quality of life, functioning, and symptoms were maintained with tisotumab vedotin therapy over the course of treatment, with no differences by arm. The proportion of patients reporting clinically meaningful (≥10-point) improvement was greater with tisotumab vedotin versus chemotherapy for most European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module subscales. In patients who showed deterioration, time to clinically meaningful deterioration was slower with tisotumab vedotin versus chemotherapy for most European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module subscales, most notably nausea/vomiting, pain, dyspnea, insomnia, symptom experience, and lymphedema.

CONCLUSIONS

Results suggest tisotumab vedotin maintained health-related quality of life in patients with previously treated recurrent or metastatic cervical cancer and, together with clinical outcomes with innovaTV 301, support tisotumab vedotin as a treatment option in this setting.

TRIAL REGISTRATION NUMBER: NCT04697628.