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Outcomes of First-line Olaparib Mono-maintenance therapy-a Multicenter, Retrospective Study Using Data From Real-world Clinical Setting

NCT05153603UNKNOWNOBSERVATIONAL

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 + 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.

Key Facts

Lead Sponsor

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

Enrollment

Start Date

2022-04-01

Completion Date

2022-09-01

Study Type

OBSERVATIONAL

Official Title

Outcomes of First-line Olaparib Mono-maintenance Therapy in Newly Diagnosed Ovarian Cancer Patients With tBRCA Wild-type Tumors: a Realworld Study

Interventions

Olaparib mono-maintenance therapy

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

1-yr PFS rate

The main objective is to evaluate the outcome of olaparib-based maintenance therapy by proportion of patients alive and progression free at 1 year.

Time frame: 12 months after date of first dose

Secondary Outcomes

2-yr PFS rate

The proportion of patients alive and progression free by 2 years by investigator assessed clinical progression

Time frame: 24 months after date of first dose

Median PFS

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)

Time frame: Median time from date of first dose until disease progression

mTFST

Median Time to First Subsequent Therapy or death

Time frame: 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

Time frame: The proportion of patients receiving each treatment after first progression

Reason for olaparib dose adjustment, dose interruptions, and dose discontinuations

The proportion of olaparib dose adjustment, dose interruptions, and dose discontinuations

Time frame: The proportion of olaparib dose adjustment, dose interruptions, and dose discontinuations

Reason for use of concomitant therapy

The proportion of concomitant therapy

Time frame: The proportion of concomitant therapy

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.