Outcomes of First-line Olaparib Mono-maintenance Therapy in Newly Diagnosed Ovarian Cancer Patients With tBRCA Wild-type Tumors: a Realworld 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 + 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, olaparib mono-maintenance therapy has been implemented among patients with BRCA-wild type tumors in clinical practice in China.
详细描述
The main objective is to evaluate the outcome of olaparib-based maintenance therapy by proportion of patients alive and progression free at 1 year (1-yr PFS rate) We hypothesize that olaparib monotherapy 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-based 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 dose adjustment, dose interruptions, and dose discontinuations; 6) Reason for use of concomitant therapy.
The exploratory objective is to evaluate the status quo of genetic testing, R0 resection and related outcomes.
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
- •Patients are eligible to be included in the study only if they met all the following criteria:
- •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 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 tablets monotherapy as maintenance therapy within three months after platinum-based chemotherapy and without disease progression.
排除标准
- •Patients are excluded if any of the following factors were present:
- •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 maintenance.
- •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 mono-maintenance therapy group
Olaparib monotherapy 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 mono-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 main objective is to evaluate the outcome of olaparib-based maintenance therapy by proportion of patients alive and progression free 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 first dose until disease progression)
- mTFST(Median time from date of first dose to the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of treatment or death due to any cause)
- post-progression treatment after first progression(The proportion of patients receiving each treatment after first progression)
- Reason for use of concomitant therapy(The proportion of concomitant therapy)
- Reason for olaparib dose adjustment, dose interruptions, and dose discontinuations(The proportion of olaparib dose adjustment, dose interruptions, and dose discontinuations)