Introduction/Background*Apatinib is emerging as an effective treatment for patients(pts) with gynecological cancer. However, the data of gynecological cancer treated by apatinib in the real-world setting is not reported. In this real-world study, we aim to explore the efficacy and safety of apatinib in the treatment of pts with gynecological cancer.
Methodology This was a prospective, multicenter observational study in a real-world setting. Pts aged ≥18 years with well diagnosed gynecological cancer were included. The pts received apatinib treatment. The dose of apatinib was selected by the investigator. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival rate (OS), objective response rate (ORR), disease control rate (DCR) and safety profile. Tumor response was assessed by RECIST1.1.
From Oct 2020 to May. 2021, 113 well diagnosed gynecological cancer pts were enrolled in this study. Among them, 26 of the enrolled pts were cervical cancer in second-line therapy and above. The treatment regimens were: apatinib combined with chemotherapy (7/26), apatinib monotherapy (7/26), apatinib combined with chemotherapy plus PD-1 antibody drug (2/26), and apatinib combined with PD-1 antibody drug (9/26) and apatinib combined with chemotherapy plus radiotherapy (1/26). The median follow-up time was 5 months. The ORR and DCR were 47.3%(9/19) and 94.7%(18/19). The median PFS was not reached.
In addition, 23 pts with ovarian cancer were enrolled in this study. Among them 15 pts were platinum-sensitive, 8 pts were platinum-resistant. The treatment regimens were: apatinib combined with chemotherapy (19/23), apatinib monotherapy (1/23), apatinib combined with chemotherapy drugs plus PD-1 antibody drug (1/23), apatinib combined with PD-1 antibody drug (1/23) and apatinib combined with PARPi (1/23). The median follow-up time was 6 months.The median PFS was 4 months.The ORR and DCR was 14.3%(3/21) and 85.7%(18/21).
In this real-world study, the incidence of adverse reactions of ovarian cancer and cervical cancer was 79.6%. Grade 3 neutropenia, leukopenia, anemia, proteinuria and thrombocytopenia were observed in 2, 1, 5, 2 and 3 pts.
Conclusion*In this real-world study, apatinib showed a favorable efficacy and safety profile in pts with gynecological cancer. It might lead to better survival benefit in treatment for gynecological cancer pts.
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