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Tytuł pozycji:

Olaparib beyond progression compared with platinum chemotherapy after secondary cytoreductive surgery in patients with recurrent ovarian cancer: phase III randomized, open-label MITO 35b study, a project of the MITO-MANGO groups.

Tytuł:
Olaparib beyond progression compared with platinum chemotherapy after secondary cytoreductive surgery in patients with recurrent ovarian cancer: phase III randomized, open-label MITO 35b study, a project of the MITO-MANGO groups.
Autorzy:
Schettino C; Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, 'Fondazione Giovanni Pascale', Naples, Italy.
Musacchio L; Department of Women and Child Health, Division of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, Rome, Italy.
Bartoletti M; Unit of Medical Oncology and Cancer Prevention, Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, Aviano, Italy.
Chiodini P; Department of Mental Health and Public Medicine, Section of Statistics, Università degli Studi della Campania Luigi Vanvitelli, Naples, Italy.
Arenare L; Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, 'Fondazione Giovanni Pascale', Naples, Italy.
Baldassarre G; Division of Molecular Oncology, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, Aviano, Italy.
Califano D; Microenvironment Molecular Targets Unit, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Naples, Italy.
Capoluongo E; Department of Molecular Medicine and Medical Biotechnology, Università degli Studi di Napoli Federico II, Naples, Italy.; Azienda Ospedaliera per L'Emergenza, Cannizzaro, Catania, Italy.
Costi MP; Department of Life Sciences, University of Modena and Reggio Emilia, Modena, Italy.
D'Incalci M; Laboratory of Molecular Pharmacology, Group of Cancer Pharmacology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Marchini S; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Mezzanzanica D; Molecular Therapies Unit, Department of Research, Istituto Nazionale dei Tumori IRCCS, Milan, Italy.
Normanno N; Cell Biology and Biotherapy Unit, Istituto Nazionale Tumori 'Fondazione Giovanni Pascale', Naples, Florida, USA.
Scala S; Microenvironment Molecular Targets Unit, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Naples, Italy.
Greggi S; Gynecologic Oncology Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.
Perrone F; Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, 'Fondazione Giovanni Pascale', Naples, Italy.
Pignata S; Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS 'Fondazione Giovanni Pascale', Naples, Italy, 80131 .
Źródło:
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society [Int J Gynecol Cancer] 2022 Jun 06; Vol. 32 (6), pp. 799-803. Date of Electronic Publication: 2022 Jun 06.
Typ publikacji:
Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
Język:
English
Imprint Name(s):
Publication: 2019- : [London] : BMJ
Original Publication: Cambridge, MA, USA : Blackwell Scientific Publications, c1991-
MeSH Terms:
Antineoplastic Agents*/therapeutic use
Mangifera*
Ovarian Neoplasms*/drug therapy
Ovarian Neoplasms*/surgery
Adenosine Diphosphate/therapeutic use ; Carcinoma, Ovarian Epithelial/drug therapy ; Carcinoma, Ovarian Epithelial/surgery ; Cytoreduction Surgical Procedures ; Female ; Humans ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/surgery ; Phthalazines ; Piperazines ; Platinum/therapeutic use ; Poly(ADP-ribose) Polymerase Inhibitors ; Ribose/therapeutic use
Contributed Indexing:
Keywords: BRCA1 protein; BRCA2 protein; ovarian cancer
Molecular Sequence:
ClinicalTrials.gov NCT05255471
Substance Nomenclature:
0 (Antineoplastic Agents)
0 (Phthalazines)
0 (Piperazines)
0 (Poly(ADP-ribose) Polymerase Inhibitors)
49DFR088MY (Platinum)
61D2G4IYVH (Adenosine Diphosphate)
681HV46001 (Ribose)
WOH1JD9AR8 (olaparib)
Entry Date(s):
Date Created: 20220323 Date Completed: 20220608 Latest Revision: 20220725
Update Code:
20240104
DOI:
10.1136/ijgc-2022-003435
PMID:
35318277
Czasopismo naukowe
Background: Poly (ADP-ribose) polymerase inhibitors have transformed the management landscape for patients with ovarian cancer, demonstrating remarkable improvements in progression-free survival and overall survival. Unfortunately, most relapses are due to an acquired mechanism of resistance to these agents. We hypothesize that secondary cytoreductive surgery, removing resistant clones, might help to overcome the development of resistance to poly (ADP-ribose) polymerase inhibitors, prolonging their therapeutic effect.
Primary Objective: To determine the efficacy of olaparib beyond progression compared with standard platinum-based chemotherapy in patients with recurrent ovarian cancer progressed during or after poly (ADP-ribose) polymerase inhibitor maintenance therapy after secondary cytoreductive surgery.
Study Hypothesis: Olaparib administered beyond progression is more effective in increasing progression-free survival and progression-free survival 2 compared with second-line platinum-based chemotherapy in patients after secondary cytoreductive surgery.
Trial Design: Phase III, randomized, open-label, multicenter trial. Eligible patients will be randomized in a 1:1 ratio to receive olaparib or platinum-based chemotherapy of the investigator's choice.
Major Eligibility Criteria: Eligible patients must have high-grade serous or endometrioid ovarian cancer progressed during or after first-line poly (ADP-ribose) polymerase inhibitor maintenance therapy and must have undergone secondary cytoreductive surgery.
Primary Endpoint: The dual primary endpoints will include progression-free survival and progression-free survival 2. Progression-free survival is defined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as the time between randomization and progression or death from any cause. Progression-free survival 2 is defined by the investigator using RECIST version 1.1 as the time frame from randomization to the second progression or death from any cause after subsequent treatment.
Sample Size: Approximately 200 patients will be enrolled in this study.
Estimated Dates for Completing Accrual and Presenting Results: Enrollment will be completed in 2024. Results will be presented in 2026.
Trial Registration: EudraCT 2021-000245-41 NCT05255471.
Competing Interests: Competing interests: FP reports honoraria for educational and advisory activity from Incyte, GSK, Eli Lilly, Ipsen, Astellas, AstraZeneca, Roche, BMS, Bayer, Clovis, Pierre Fabre and grants for clinical trials to his institution from Roche, AstraZeneca, Pfizer, MSD, Bayer, Incyte Taiho, Janssen, Exelixis, Ailenor, Daiichi Sankyo. SP reports honoraria from AstraZeneca, MSD, Roche, Pfizer, Clovis, GSK, Pharmamar and research funding from MSD, Roche, AstraZeneca and Pfizer. NN reports personal financial interests (speaker’s fee and/or advisory boards): MSD, Qiagen, Bayer, Biocartis, Illumina, Incyte, Roche, BMS, MERCK, Thermofisher, AstraZeneca, Sanofi, Eli Lilly, Novartis and institutional financial interests (financial support to research projects) from MERCK, Thermofisher, QIAGEN, Roche, AstraZeneca, Biocartis, Illumina, Blueprint.
(© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

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