Outcomes of First-line Olaparib Combined With Bevacizumab Maintenance Therapy in Newly Diagnosed Ovarian Cancer Patients With tBRCA Wild-type Tumors: a Real-world Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- 1-yr PFS rate
研究概览
简要总结
Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib plus bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION（ NMPA） -approved agent for ovarian cancer patients. In this setting, there is no olaparib plus bevacizumab maintenance therapy RWS data amongst 1st tBRCAwt patients in China, while this treatment regimen has been used in Chinese clinical practise by some doctors based on above-mentioned data.
详细描述
The main objective is to evaluate the outcome of olaparib plus bevacizumab combination maintenance therapy by proportion of patients alive and progression free at 1 year (1-yr PFSrate) We hypothesize that olaparib plus bevacizumab maintenance therapy could be beneficial for tBRCAwt high-grade serous ovarian cancer (HGSOC) patients who are treated with platinum-based first-line chemotherapy.
The secondary objectives are to evaluate the outcomes of olaparib plus bevacizumab maintenance therapy by: 1) 2-yr PFS rate; 2) median PFS; 3) median Time to First Subsequent Therapy or death (mTFST) ; 4) post-progression treatment after first progression; 5) reason for olaparib plus bevacizumab dose adjustment, dose interruptions, and dose discontinuations; 6) Reason for use of concomitant therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female Patients must be ≥18 years old at diagnosis.
- •Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer and received olaparib and plus bevacizumab from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required)
- •Patients must have a tumor BRCA testing result which is tBRCAwt, defined as tumor BRCA wild type (patients without evidence of BRCA 1 and/or BRCA 2 deleterious or suspected deleterious mutations)
- •Patients who have completed first-line platinum-based chemotherapy and were in clinical complete response (CR) or in partial response (PR)
- •Patients who were still in CR or PR before receiving maintenance therapy
- •Patients who received at least one dose of olaparib plus bevacizumab maintenance therapy within three months after platinum-based chemotherapy and without disease progression
排除标准
- •Patient with multiple primary cancers as reported in EMR
- •Concomitant any anti- cancer therapy (chemotherapy, immunotherapy, hormonal therapy (Hormone replacement therapy (HRT) is acceptable), radiotherapy, biological therapy or other novel agent) during olaparib plus bevacizumab maintenance therapy.
- •Any previous treatment with PARP inhibitor.
- •Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
- •Patients with symptomatic uncontrolled brain metastases.
- •Any other concerns related to decreased efficacy and safety of maintenance therapy.
研究组 & 干预措施
olaparib plus bevacizumab treatment group
olaparib plus bevacizumab maintenance therapy in clinical practice and will be conducted in patients with tBRCAwt newly diagnosed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy following the standard of care from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) at tertiary-referral university hospitals and main cancer centers in China.
干预措施: olaparib plus bevacizumab maintenance therapy (Drug)
结局指标
主要结局
1-yr PFS rate
时间窗: 12 months after date of first dose
the investigator assessed progression-free survival (PFS) at 1 year
次要结局
- 2-yr PFS rate(24 months after date of first dose)
- Median PFS(Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
- mTFST(Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
- Post-progression treatment(Through study completion, an average of 1 year)