Real-World Efficacy and Safety of Bevacizumab in the First-Line Treatment of Metastatic Cervical Cancer: A Cohort Study in the Total Population of Croatian Patients.

Dora Čerina,Branka Petrić-Miše,Ivana Canjko,Ingrid Belac Lovasić,Višnja Matković,Kristina Katić,Blanka Jakšić,Eduard Vrdoljak,Robert Šeparović,Marijo Boban,Žarko Bajić,Achuthan Chathrattil Raghavamenon

doi:10.1155/2021/2815623

Abstract

Background Although today it is almost preventable, cervical cancer still represents a significant cancer burden, especially in some developing parts of the world. Since the introduction of bevacizumab in the first-line treatment of metastatic disease, improvements of the outcomes were noted. However, results from randomized controlled trials are often hard to recreate in the real-world setting. Objective To assess the real-world efficacy and safety of bevacizumab as a first-line treatment of advanced cervical cancer. Methods We conducted a retrospective cohort study on the total population of Croatian patients diagnosed with metastatic cervical cancer from 2016 to 2019 who were treated with bevacizumab in combination with cisplatin and paclitaxel (TCB) in the first line. The comparison group was the consecutive sample of patients treated with chemotherapy alone. The primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS), objective response rate, incidence of adverse events, and the proportion of treatment discontinuation. Results We enrolled 67 patients treated with TCB and a control group of 62 patients treated with chemotherapy alone. The TCB cohort had significantly longer unadjusted OS with a median of 27.0 (95% CI 18.5; not calculable) months, compared to 15.5 (10.7; 30.1) months in the chemotherapy-alone cohort. Adjusted OS was not significantly different. PFS was significantly longer for the TCB cohort, with a median of 10.6 (95% CI 8.5; 15.4) months, than for the chemotherapy-alone cohort, with a median of 5.4 (95% CI 3.9; 9.1) months, even after adjustment for baseline covariates (HRadjusted = 0.60; 95% CI 0.39; 0.94; p=0.027; false discovery rate <5%). Conclusions In a real-world setting, TCB as a first-line treatment of metastatic cervical cancer was associated with longer PFS, better objective disease control rate, and acceptable toxicity profile in comparison to chemotherapy alone. These results may indicate its utility and potential applicability in other parts of the developing world.

Highlights

Cervical cancer ranks fourth in both cancer incidence and mortality among women, with approximately 604,000 newly diagnosed patients and an estimated 342,000 deaths worldwide in 2020
We conducted a retrospective cohort study on the total population of patients diagnosed with metastatic cervical cancer between 2016 and 2020 in all Croatian oncology centers who were treated with bevacizumab in combination with cisplatin and paclitaxel backbone chemotherapy (TCB) in first-line therapy since its reimbursement status. e control group was the consecutive sample of patients treated with first-line chemotherapy alone for metastatic disease between 2014 and 2019
We enrolled 67 patients diagnosed with metastatic cervical cancer who were treated with TCB in the first-line setting and 62 who were treated with chemotherapy alone. e two cohorts were of comparable age (Table 1), menopausal status, body mass index, and no previous therapy for local disease

Summary

Introduction

Cervical cancer ranks fourth in both cancer incidence and mortality among women, with approximately 604,000 newly diagnosed patients and an estimated 342,000 deaths worldwide in 2020. The aim of this study was to assess the real-world efficacy and safety of bevacizumab as a first-line treatment of advanced cervical cancer in the total population of one of the transitioning countries, namely, Croatia. Today it is almost preventable, cervical cancer still represents a significant cancer burden, especially in some developing parts of the world. In a real-world setting, TCB as a first-line treatment of metastatic cervical cancer was associated with longer PFS, better objective disease control rate, and acceptable toxicity profile in comparison to chemotherapy alone. In a real-world setting, TCB as a first-line treatment of metastatic cervical cancer was associated with longer PFS, better objective disease control rate, and acceptable toxicity profile in comparison to chemotherapy alone. ese results may indicate its utility and potential applicability in other parts of the developing world

Objectives

Methods

Results