OBJECTIVES: We analyzed publicly available data on disease burden, clinical outcomes with novel therapies, and unmet needs for recurrent or metastatic (Rec/Met) cervical cancer (CC) patients.

METHODS: A targeted literature review was conducted in MEDLINE/Embase (January 2010-April 2020) of studies on Rec/Met CC burden and clinical outcomes with therapies including bevacizumab combination therapy (BEVA), pembrolizumab, and topotecan in randomized controlled trials and observational studies.

RESULTS: A total of 41 publications, including 32 unique clinical outcomes studies, were descriptively summarized. The global incidence and mortality rates for CC were 13.1/100,000 and 6.9/100,000 women in 2018, respectively. Metastatic CC patients’ mortality was 3 times higher than nonmetastatic CC (58.7% vs 18.5%; years 2005-2010). Sample size was small in most clinical outcomes studies; 63% of the 32 studies had <30 patients. Among all 32 studies, median progression-free survival (mPFS) ranged from 2.0 (pembrolizumab) to 13.1 (BEVA) months and median overall survival (mOS) ranged from 6.4 (topotecan) to 26.0 (BEVA) months. Only 31% (10/32) of the studies reported clinical outcomes by treatment line. In the first-line setting, mPFS ranged from 6.3-12.0 months, mOS ranged from 13.2-21.5 months, and objective response rate (ORR) ranged from 35%-59% with BEVA; mPFS was 7.1 months, mOS was 13.2 months, and ORR was 35% with topotecan. In studies of second or later lines of therapy, mPFS was 4.1 months and mOS was 5.2 months with BEVA; mPFS was 2.0 months, mOS was 11.0 months, and ORR was 11% (17% in PD-L1–positive patients) with pembrolizumab; mPFS was 2.5 months, mOS was 6.4 and 7.3 months, and ORR was 0% with topotecan.

CONCLUSIONS: Clinical treatment outcomes, including OS, PFS, and ORR, among Rec/Met CC patients are poor and become progressively worse in second and later lines. Innovative treatments are needed to address the unmet needs for Rec/Met CC patients.