Outcomes of First-line Olaparib Mono-maintenance therapy-a Multicenter, Retrospective Study Using Data From Real-world Clinical Setting
8 december 2021 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
50
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Zhong-qiu Lin, MD, PhD, Professor
- Telefonnummer: (86) 020-34078521
- E-post: zhongqiu_lin163@163.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
1-yr PFS rate
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
2-yr PFS rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: The proportion of concomitant therapy
|
The proportion of concomitant therapy
|
The proportion of concomitant therapy
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Zhong-qiu Lin, MD, PhD,Professor, Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Huvudutredare: Jing Li, MD, PhD,Professor, Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 april 2022
Primärt slutförande (Förväntat)
1 september 2022
Avslutad studie (Förväntat)
1 december 2022
Studieregistreringsdatum
Först inskickad
8 december 2021
Först inskickad som uppfyllde QC-kriterierna
8 december 2021
Första postat (Faktisk)
10 december 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 december 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 december 2021
Senast verifierad
1 december 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Genitala neoplasmer, hona
- Sjukdomar i det endokrina systemet
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Neoplasmer i endokrina körtel
- Ovariella neoplasmer
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Poly(ADP-ribos) polymerashämmare
- Olaparib
Andra studie-ID-nummer
- ESR-20-20889-02
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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