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

8 de dezembro de 2021 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Antecipado)

50

Contactos e Locais

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Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
1-yr PFS rate
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
2-yr PFS rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: The proportion of concomitant therapy
The proportion of concomitant therapy
The proportion of concomitant therapy

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

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

Investigadores

  • Cadeira de estudo: Zhong-qiu Lin, MD, PhD,Professor, Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Investigador principal: Jing Li, MD, PhD,Professor, Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

1 de abril de 2022

Conclusão Primária (Antecipado)

1 de setembro de 2022

Conclusão do estudo (Antecipado)

1 de dezembro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

8 de dezembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de dezembro de 2021

Primeira postagem (Real)

10 de dezembro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de dezembro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de dezembro de 2021

Última verificação

1 de dezembro de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ESR-20-20889-02

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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