| Background and purposeOvarian cancer is a disease with the highest fatality rate among gynecological malignancies,and 70%of ovarian cancer patients are in the advanced stage of clinical treatment.Cytoreductive surgery and platinum-based chemotherapy are the first choices for the treatment of ovarian cancer.The recurrence rate of ovarian cancer is extremely high.After initial treatment,70%of patients will relapse within 3 years,and the recurrence is incurable.Patients will experience multiple recurrences and multi-line chemotherapy.Therefore,it is necessary to determine new treatment targets and explore new treatment methods in order to improve patient outcomes.Olaparib is a poly ADP ribose polymerase(PARP)inhibitor,which has been shown to have anti-tumor activity in ovarian cancer.Olaparib has been introduced into China in 2018 and has been applied to the clinic.There is still a lack of relevant data on its application in platinum-sensitive recurrent ovarian cancer.This study comparatively analyzed the effectiveness and safety of Olaparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer,with a view to providing data support and theory for the application of Olaparib maintenance therapy in platinum-sensitive recurrent ovarian cancer patients in China in accordance with.MethodsA total of 70 platinum-sensitive recurrent ovarian cancer patients who received TP chemotherapy in the First Affiliated Hospital of Zhengzhou University from December 2018 to February 2020 were collected and met the inclusion criteria and were excluded by the exclusion criteria.Among them,41 patients who received Olaparib maintenance treatment were in the treatment group,and 29 patients who received only observation and follow-up without any drugs were in the observation group.Collect the clinical characteristics of these patients,the therapeutic effect after recurrence,follow up the changes of tumor markers,imaging changes,lesion progress,and adverse reactions through outpatient follow-up,ward follow-up and telephone follow-up,and analyze Olaparib effectiveness and safety in maintenance treatment of platinum-sensitive recurrent ovarian cancer.Result(1)There was no significant difference in the age,FIGO stage,histological type,whether the tumor cytoreductive surgery was satisfactory,the levels of tumor markers(including CA125,HE4,ROMA1,ROMA2)after chemotherapy,and the outcome after chemotherapy between the two groups of patients.(2)Decline of tumor markers:Among the 41 patients in the treatment group,24 had normal CA125 and 17 had abnormal CA125 after TP,28 had normal CA125 and 13 had abnormal CA125 after the application of Olaparib;among 29 patients in the observation group,after TP,there were 19 people with normal CA125 and 10 people with abnormal CA125,12 people with normal CA125 and 17 people with abnormal CA125 at the end of follow-up.The difference in CA125 between the two groups was statistically significant(χ2=5.024,P=0.025).Among the 41 patients in the treatment group,27 had normal HE4 after TP,14 had abnormal HE4 after TP,31 had normal HE4 and 10 had abnormal HE4 after application of Olaparib;among 29 patients in the observation group,20 had normal HE4 after TP,high Among the 9 normal patients,14 patients had normal HE4 at the deadline of follow-up,15 patients were higher than normal,and there was a statistically significant difference in HE4 between the two groups(χ2=5.528,P=0.019).Among the 41 patients in the treatment group,23 had normal ROMA1 and 18 abnormal after the end of TP,25 normal and 16 abnormal in ROMA 1 after the application of Olaparib;Of the 29 patients in the observation group,14 persons were normal in ROMA1 and 15 were abnormal after the end of TP;as of the follow-up time,10 persons were normal in ROMA1 and 19 persons were abnormal.The difference between the two groups was statistically significant(χ2=4.769,P=0.029).Among the 41 patients in the treatment group,29 had normal ROMA2 and 12 had abnormal ROMA2 after the end of TP;30 had normal ROMA2 after application of Olaparib,which was higher than normal in 11 patients.Among the 29 patients in the observation group,18 had normal ROMA2 and 11 had abnormal ROMA2 after the end of TP;13 had normal ROMA2 and 16 had abnormal ROMA2 at the time of follow-up.The difference between the two groups was statistically significant(χ2=5.759,P=0.016).(3)Imaging changes:As of the date of follow-up,7 of the 41 patients in the treatment group had disease progression,and 7 patients had imaging evidence that showed enlargement or metastasis of the disease,accompanied by abnormal elevation of tumor markers,and 4 of them had new disease.As for the lesion,2 patients had lymph node metastasis and 1 patient had liver metastasis.Of the 29 patients in the observation group,11 patients developed disease progression,and 11 patients had imaging evidence that the lesions were enlarged or metastasized,accompanied by abnormally elevated tumor markers.Among them,5 patients developed new lesions,4 patients developed lymph node metastasis,one patient developed liver metastasis,and one patient developed transseptal metastasis.(4)Efficacy evaluation:As of the follow-up date,41 patients in the treatment group were treated with Olaparib,28 of them had a complete remission,5 had a partial remission,1 had a stable condition,and 7 had progressed.The 29 patients in the observation group did not use any drugs and were only reviewed regularly.11 patients had complete remission,5 had partial remission,2 were stable,and 11 were progressing.There was a statistically significant difference in the progress of the treatment group and the observation group(χ2=3.869,P=0.049).As of the follow-up date,there were 7 relapses in the treatment group and 11 relapses in the observation group.The recurrence time and follow-up time of the two groups were statistically analyzed.The difference in survival analysis between the two groups was statistically significant(χ2=5.203,P=0.023).(5)Safety analysis:After treatment with Olaparib,29 cases of gastrointestinal reactions occurred in 41 patients,including 1 case of grade 3-4(2.4%);26 cases of fatigue,including 1 case of grade 3-4(2.4%);17 cases of anemia occurred,of which 8 cases of grade 3-4(19.5%);15 cases of bone marrow suppression,of which 9 cases of grade 3-4(22.0%);4 cases of headache,liver and kidney damage 3 cases,cough occurred in 1 case,back pain occurred in 1 case,insomnia,arthralgia,dyspnea occurred in 0 cases,medication was stopped in 0 cases,medication was discontinued in 3 cases(7.3%),and medication was reduced in 2 cases(4.9%).Conclusion(1)The disease progression rate of the treatment group using Olaparib was lower than that of the observation group not using any drugs,and the survival analysis with recurrence as the observation endpoint indicated that Olaparib has a significant effect as a maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer.(2)The adverse reactions of Olaparib are mostly grade 1-2,and symptoms can be relieved after symptomatic treatment,and there are fewer discontinuations and dose reduction events caused by adverse reactions,suggesting that Olaparib is a platinum-sensitive recurrent ovarian Maintenance treatment for cancer patients is safe.However,strict management is required,especially attention to anemia,bone marrow suppression,and damage to other important organs. |
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