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

8. december 2021 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Medicin: Olaparib mono-maintenance therapy
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1-yr PFS rate
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
2-yr PFS rate
Tidsramme: 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
Tidsramme: 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)
Median time from date of first dose until disease progression
mTFST
Tidsramme: 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
Tidsramme: The proportion of patients receiving each treatment after first progression
The proportion of patients receiving each treatment after first progression
The proportion of patients receiving each treatment after first progression
Reason for olaparib dose adjustment, dose interruptions, and dose discontinuations
Tidsramme: 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
Tidsramme: The proportion of concomitant therapy
The proportion of concomitant therapy
The proportion of concomitant therapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Efterforskere

  • Studiestol: Zhong-qiu Lin, MD, PhD,Professor, Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Ledende efterforsker: Jing Li, MD, PhD,Professor, Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. april 2022

Primær færdiggørelse (Forventet)

1. september 2022

Studieafslutning (Forventet)

1. december 2022

Datoer for studieregistrering

Først indsendt

8. december 2021

Først indsendt, der opfyldte QC-kriterier

8. december 2021

Først opslået (Faktiske)

10. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. december 2021

Sidst verificeret

1. december 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ESR-20-20889-02

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Kliniske forsøg med Ovariale neoplasmer

Kliniske forsøg med Olaparib mono-maintenance therapy

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