Introduction/Background*Cervical cancer is the fourth most common cause of cancer-related deaths in women worldwide. With screening for precancerous lesions and vaccination for preventive human papillomavirus (HPV), a survival improvement has been observed in these patients in developed countries. In recent years, U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with advanced cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1. Herein, we present the first systematic review discussing the safety profile of this drug.

Methodology A systematic literature search was performed on March 2021 according to PRISMA statement using PubMed, Embase, Scopus, CINAHL, Cochrane, Google Scholar, and Clinicaltrials.gov databases without any filters. The medical search terms (MeSH) utilized to conduct the search are, ‘ uterine cervical neoplasms’ AND ’Pembrolizumab’. After a detailed primary and secondary screening done by two members of 188 studies, only 4 studies were found that discussed the safety profile of pembrolizumab.

Result(s)*A total of 337 patients, mean age 48 years (21-76) with advanced cervical cancer who had received a median range of 1-7 previous lines of therapies, were included. In all studies, pembrolizumab was used as a single agent with a regimen of 200mg IV every 3 weeks. Cumulative treatment related adverse effect (AE) was reported in 60% (n=201/337). Most common grade 1-2 AEs were hypothyroidism 9.2%(n=29/313), diarrhea 8%(n=22/337), fatigue 6.59% (n=22/337) and rash 7% (n= 10/141). Treatment related grade ≥ 3 adverse reaction was reported in 8.6%. Most common grade 3-4 AEs presented were transaminitis, neutropenia, rash, colitis, Guillain-Barré syndrome (GBS), and proteinuria. Also, 3.5% of patient population (n= 5/141) discontinued therapy due to treatment-related adverse events. Immune-mediated AEs were seen in 27% (n= 31/118). The most common immune-mediated AEs were hypothyroidism, hyperthyroidism, rash, colitis and GBS.

Conclusion*While early-stage cervical cancer can be curable with surgery, prognosis of patients who recur remains poor, with limited treatment options. New effective treatments are therefore much needed in this setting. Pembrolizumab (Keytruda) monotherapy demonstrated manageable safety profile in patients with advanced cervical cancer. However, more randomized clinical trials are required to establish strong conclusions.