First-line Olaparib Combined With Bevacizumab Maintenance Therapy

NCT05440578UNKNOWNOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

50

Start Date

2022-06-01

Completion Date

2022-09-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

olaparib plus bevacizumab maintenance therapy

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion 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 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

Exclusion Criteria:

* 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.

Outcome Measures

Primary Outcomes

1-yr PFS rate

the investigator assessed progression-free survival (PFS) at 1 year

Time frame: 12 months after date of first dose

Secondary Outcomes

2-yr PFS rate

the investigator assessed progression-free survival (PFS) at 2 year

Time frame: 24 months after date of first dose

Median PFS

median progression-free survival

Time frame: 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 to First Subsequent Therapy or death

Time frame: 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

The proportion of patients receiving each treatment after first progression through study completion, an average of 1 year

Time frame: Through study completion, an average of 1 year

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

First-line Olaparib Combined With Bevacizumab Maintenance Therapy