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

NCT05153603 | Unknown DMC

• 1 other identifier: ESR-20-20889-02
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Neoplasms

Keywords

tBRCA， olaparib

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after date of first dose

Secondary Outcomes (6)

• 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 olaparib dose adjustment, dose interruptions, and dose discontinuations

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

Study Arms (1)

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.

Drug: Olaparib mono-maintenance therapy

Interventions

Olaparib mono-maintenance therapy DRUG

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.

Olaparib mono-maintenance therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Zhong-qiu Lin, MD, PhD,Professor

  Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

  STUDY CHAIR

• Jing Li, MD, PhD,Professor

  Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong-qiu Lin, MD, PhD, Professor

CONTACT

(86) 020-34078521; zhongqiu_lin163@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 10, 2021
• Study Start: April 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 10, 2021

Record last verified: 2021-12