Outcomes of First-line Olaparib Mono-maintenance therapy-a Multicenter, Retrospective Study Using Data From Real-world Clinical Setting
2021年12月8日 更新者：Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcomes of First-line Olaparib Mono-maintenance Therapy in Newly Diagnosed Ovarian Cancer Patients With tBRCA Wild-type Tumors: a Realworld Study
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
50
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhong-qiu Lin, MD, PhD, Professor
- 电话号码：(86) 020-34078521
- 邮箱：zhongqiu_lin163@163.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Patients diagnosed with HGSOC who started first-line PARPi maintenance therapy from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) will be identified from the electronic medical record system.
描述
Inclusion Criteria:
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.
Exclusion Criteria:
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
|
Olaparib mono-maintenance therapy in patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer is defined as drug exposure.
At least one dose of olaparib tablets monotherapy as maintenance therapy will be required.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
1-yr PFS rate
大体时间：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.
|
12 months after date of first dose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
2-yr PFS rate
大体时间：24 months after date of first dose
|
The proportion of patients alive and progression free by 2 years by investigator assessed clinical progression
|
24 months after date of first dose
|
|
Median PFS
大体时间：Median time from date of first dose until disease progression
|
Median time from date of first dose until disease progression per clinical progression (mPFS) as assessed by the investigator at local site or death due to any cause (if this occurs before disease progression)
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Median time from date of first dose until disease progression
|
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mTFST
大体时间：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
|
Median Time to First Subsequent Therapy or death
|
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
大体时间：The proportion of patients receiving each treatment after first progression
|
The proportion of patients receiving each treatment after first progression
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The proportion of patients receiving each treatment after first progression
|
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Reason for olaparib dose adjustment, dose interruptions, and dose discontinuations
大体时间：The proportion of olaparib dose adjustment, dose interruptions, and dose discontinuations
|
The proportion of olaparib dose adjustment, dose interruptions, and dose discontinuations
|
The proportion of olaparib dose adjustment, dose interruptions, and dose discontinuations
|
|
Reason for use of concomitant therapy
大体时间：The proportion of concomitant therapy
|
The proportion of concomitant therapy
|
The proportion of concomitant therapy
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Zhong-qiu Lin, MD, PhD,Professor、Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- 首席研究员：Jing Li, MD, PhD,Professor、Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年4月1日
初级完成 (预期的)
2022年9月1日
研究完成 (预期的)
2022年12月1日
研究注册日期
首次提交
2021年12月8日
首先提交符合 QC 标准的
2021年12月8日
首次发布 (实际的)
2021年12月10日
研究记录更新
最后更新发布 (实际的)
2021年12月10日
上次提交的符合 QC 标准的更新
2021年12月8日
最后验证
2021年12月1日
更多信息
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