| Objective: To observe the efficacy and safety of maintenance therapy with fluzoparib in patients with platinum-sensitive recurrent ovarian cancer.Methods: The clinical data of 42 ovarian cancer patients with platinum sensitive recurrence(PSR)who reached CR or PR after the last platinum containing chemotherapy in our hospital from December 2020 to January 2022 were collected retrospectively(including age,ECOG score,FIGO stage at the time of diagnosis,BRCA1 / 2 mutation status,number of previous platinum containing treatments,progression free interval after the penultimate platinum containing treatment,remission status of the last platinum containing chemotherapy,occurrence of adverse reactions and changes of serum tumor markers before and after treatment).Because of the different between two treatment methods,observation group and control group were divided.The efficacy was evaluated according to RECIST criteria.The main end points were orr,DCR and median PFS.The patients were followed up at least once a month through outpatient service,wechat or telephone to observe the occurrence of adverse reactions and the changes of serum tumor markers before and after treatment.Results:1.This study has analysis 42 patients.The short-term efficacy of the two treatment schemes:the observation group(n = 21): QRR was 14.29%,DCR was85.71%;Control group(n = 21): ORRwas 4.76%,DCR was 71.43%.Compared with chi square test,DCR in the control group was lower than that in the observation group,and the difference was statistically significant(P < 0.05);The ORR of the control group was lower than that of the observation group,but the difference was not statistically significant(P > 0.05).Long-term effect of the two groups: the median PFS of the two groups was analyzed by Kaplan Meier analysis.The median PFS in the observation group was 12.0 months(8.57-15.44),and that in the control group was 6.0 months(4.70-7.30).The difference was statistically significant(P < 0.05);According to whether there is BRCA1 / 2 mutation in the observation group,it is divided into BRCA1 / 2 mutation positive group and BRCA1 / 2 mutation negative group.The 12-month PFS rate of BRCA1 / 2 mutation positive group is 66.7%,and the 12-month PFS rate of BRCA1 / 2 mutation negative group is 25.4%.2.Comparison of adverse reactions between the two groups: the main adverse reactions of the observation group were anemia(52.38%),nausea(47.62%),fatigue(42.86%),decreased platelet count(38.1%),decreased leukocyte count(38.1%),decreased neutrophil count(33.33%),decreased appetite(33.33%),followed by elevated transaminase(14.29%),vomiting(14.29%),hypertension(14.29%)and diarrhea(9.52%).The main adverse reactions in the control group were anemia(19.05%),nausea(14.29%),decreased appetite(14.29%),fatigue(9.52%),decreased leukocyte count(9.52%),decreased platelet count(9.52%),increased transaminase(9.52%),decreased neutrophil count,vomiting and low incidence of hypertension.There were significant differences in the incidence of adverse reactions between the two groups,including anemia,fatigue,decreased leukocyte count,nausea,decreased platelet count and decreased neutrophil count(P < 0.05),but there were no significant differences in decreased appetite,increased transaminase,diarrhea,vomiting and hypertension(P > 0.05).3.Changes of serum tumor markers of the two treatment regimens: in this study,there was meaningless difference in HE4 and CA125 between the two groups before receiving the two treatment methods(P > 0.05).After treatment,the levels of CA125 and HE4 in the observation group were significantly lower than those before treatment(P < 0.05);in the control group,the level of CA125 was slightly higher than that before treatment,and the difference was not statistically significant(P >0.05),while the level of HE4 after treatment was significantly higher than that before treatment(P < 0.05).Conclusions:For patients with platinum sensitive recurrent ovarian cancer who reached PR or Cr after the last platinum containing chemotherapy,fluzoparil treatment can improve the DCR,prolong PFS and delay the recurrence of ovarian cancer,and the curative effect in patients with BRCA1 / 2 mutation positive is better than that in patients with BRCA1 / 2 mutation negative;Fluzopari can reduce the level of serum tumor markers;The main adverse reactions of fluzopari include anemia,nausea,fatigue,decreased platelet count,decreased leukocyte count,decreased neutrophil count and decreased appetite.Although the incidence is high,the overall safety is good and controllable. |
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