RT Journal Article
SR Electronic
T1 741 Safety Profile of Keytruda (pembrolizumab) for the treatment of patients with advanced PD-L1 positive cervical cancer
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP A42
OP A43
DO 10.1136/ijgc-2021-ESGO.63
VO 31
IS Suppl 3
A1 F Ahmed
A1 I Khan
A1 Z Shah
A1 R Garimella
A1 S Mishra
A1 A Bhatnagar
A1 K Andrews
A1 S Zaidi
A1 U Salman
A1 SH Bobba
A1 S Gudapati
A1 Z Yukselen
A1 P Guntipalli
A1 J Michel
A1 S Ahmad
A1 R Zarrar
A1 G Enebong Nya
YR 2021
UL http://ijgc.bmj.com/content/31/Suppl_3/A42.abstract
AB 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.