Clinical trial NCT01844986: Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Official title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Newly Diagnosed
Advanced Ovarian Cancer
FIGO Stage III-IV
BRCA Mutation
Complete Response
Partial Response
First Line Platinum Chemotherapy
Keywords: BRCA
Ovarian Cancer
Chemotherapy
PARP inhibitor
First Line
FIGO Stage III
FIGO Stage IV
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
name: Myriad Genetic Laboratories, Inc.
name: Merck Sharp & Dohme LLC
First posted: 2013-05-03
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Detailed description: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal).
* Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery.
* Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
* Patients who have completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation:
* Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study.
* Patients must be randomized within 8 weeks of their last dose of chemotherapy

Exclusion Criteria:

* BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism" etc).
* Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC)
* Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment.
* Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible).
* Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer.
* Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease).
* Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage \<2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.

Primary outcomes:
measure: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
timeFrame: Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018
Secondary outcomes:
measure: Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival
timeFrame: Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
measure: Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death
timeFrame: CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018
measure: Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
timeFrame: Following first progression disease then assessed per local practice every 12 weeks until second progression.
measure: Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
timeFrame: Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported
measure: Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)
timeFrame: Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
measure: Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)
timeFrame: Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
measure: Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)
timeFrame: Time elapsed from randomization to study treatment discontinuation or death. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
measure: Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS
timeFrame: Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Anchorage
country: United States
facility: Providence Cancer Center
state: Alaska
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: Roseville
country: United States
facility: Kaiser Permanente
state: California
city: Stanford
country: United States
facility: Stanford Women's Cancer Center
state: California
city: Walnut Creek
country: United States
facility: Babak Edraki
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Farmington
country: United States
facility: Univ of Connecticut Health Center
state: Connecticut
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven
state: Connecticut
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Gynecologic Cancer Center
state: Florida
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Savannah
country: United States
facility: Nancy N. & J.C. Lewis Cancer and Research Pavillion
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Univ Chicago Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital & Health Care Center
state: Indiana
city: Mishawaka
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, P.C.
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Institute Research
state: Kentucky
city: Scarborough
country: United States
facility: Maine Medical Partners
state: Maine
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Gynecologic Oncology of West MI, PLLC
state: Michigan
city: Edina
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester, MN
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Missouri Valley Cancer Consortium CCOP
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Las Vegas
country: United States
facility: Womens Cancer Center of Nevada
state: Nevada
city: Camden
country: United States
facility: MD Anderson at Cooper Cancer Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Albany
country: United States
facility: Women's Cancer Care Associates
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center - New York
state: New York
city: New York
country: United States
facility: Perlmutter Cancer Center
state: New York
city: Asheville
country: United States
facility: Hope Women's Cancer Centers
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center at Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: The University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
city: Columbia
country: United States
facility: South Carolina Oncology Associates, PA
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Clinic Women's Health
state: South Dakota
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center of Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic Gynecological Oncology
state: Virginia
city: Green Bay
country: United States
facility: Aurora Baycare Medical Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Memorial Hospital
state: Wisconsin
city: Heidelberg
country: Australia
facility: Mercy Hospital for Women
city: Parkville
country: Australia
facility: The Royal Womens Hospital
city: Randwick
country: Australia
facility: Prince of Wales Hospital
city: Barretos
country: Brazil
facility: Centro Diagnóstico Barretos
city: Goiânia
country: Brazil
facility: Hospital Araujo Jorge
city: Itajai
country: Brazil
facility: Centro de Novos Tratamentos Itajai
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alagre
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base São José do Rio Preto
city: São Paulo
country: Brazil
facility: Centro de Referencia da Saude da Mulher
city: São Paulo
country: Brazil
facility: Instituto do Câncer de São Paulo
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Hopital Norte-Dame
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Quebec
country: Canada
facility: Hotel-Dieu de Quebec
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: The Tumor Hospital affiliated to China Medical Science Insti
city: Changchun
country: China
facility: 1st Hospital of Jilin university
city: Changchun
country: China
facility: Jilin Provincial Cancer Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital Affiliated to Sichuan University
city: Chongqing
country: China
facility: ChongQing Cancer Hospital
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Women's Hospital, Zhejaing University School of Medicine
city: Harbin
country: China
facility: The Tumour Hospital of Harbin Medical University
city: Huangzhou
country: China
facility: Zhejiang Cancer Hospital, Huangzhou
city: Ji Nan
country: China
facility: JINAN, Qi Lu Hosp. of SD Univ.
city: Shanghai
country: China
facility: Obstetris and Gynecology Hospital of Fudan University
city: Shanghai
country: China
facility: Shanghai Cancer Hospital of Fudan University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow Universit
city: Xian
country: China
facility: First affiliated hospital college of XianJiaotong University
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen Cedex
country: France
facility: CAC François Baclesse
city: Lyon Cedex 08
country: France
facility: 69LYON, C Bérard, Onco
city: Nantes,
country: France
facility: Centre Catherine de Sienne
city: Paris
country: France
facility: 75PARIS, H Tenon, Onco
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Kfar Saba
country: Israel
facility: Sapir Medical Centre
city: Petach Tikva
country: Israel
facility: Rabin MC
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Centre
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourkasy Medical Center
city: Bari
country: Italy
facility: Bari- Istituto Tumori Giovanni Paolo II
city: Catania
country: Italy
facility: Azienda Ospedaliera "Cannizzaro"
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Istituto Nazionale Per Cura Tumori - Milano
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto Irccs
city: Roma
country: Italy
facility: Istituto Regina Elena-Polo Oncologico Ifo
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli
city: Akashi-shi
country: Japan
facility: Hyogo CC
city: Chuo-ku
country: Japan
facility: National Cancer Center Hosp
city: Fukuoka
country: Japan
facility: NHO Kyushu CC
city: Hidaka-shi
country: Japan
facility: Saitama Med. Univ. Int. Med. C
city: Matsuyama-shi
country: Japan
facility: NHO Shikoku Cancer Center
city: Niigata-shi
country: Japan
facility: Niigata Univ. Med. Dent.
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Grzepnica
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
city: Olsztyn
country: Poland
facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
city: Olsztyn
country: Poland
facility: Wojewódzki Szpital Specjalistyczny w Olsztynie
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
city: Izhevsk
country: Russian Federation
facility: Udmurtia Republic Clinical Oncology Center
city: Moscow
country: Russian Federation
facility: Chemotherapy Department, Russian Cancer Research Centre
city: Omsk
country: Russian Federation
facility: State Institution of Heath Omsk Regional Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Cancer Research Institute
city: Saint Petersburg
country: Russian Federation
facility: St.Petersburg City Oncology Dispensary, Dept. Gynecology
city: St.Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
city: Tomsk
country: Russian Federation
facility: Research Institute of Oncology RAMS
city: Barcelona
country: Spain
facility: Barcelona,H.Vall d´Hebrón,Oncología
city: Córdoba
country: Spain
facility: Córdoba,H.Reina Sofía,Oncología
city: Hospitalet deLlobregat(Barcelo
country: Spain
facility: H.Llobregat,ICO-Duran i Reynals,Oncología
city: Madrid
country: Spain
facility: Madrid, MD Anderson, Oncología
city: Madrid
country: Spain
facility: Madrid,H.U.La Paz,Oncología
city: Valencia
country: Spain
facility: Valencia, IVO, Oncología
city: Valencia
country: Spain
facility: Valencia,H.C.U.Valencia,Oncología
city: Birmingham
country: United Kingdom
facility: City Hospital, Birmingham, Cancer Trials Team
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Coventry
country: United Kingdom
facility: Arden Cancer Centre
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Research UK Centre
city: London
country: United Kingdom
facility: Cancer Research UK and UCL Cancer Trials Centre
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital and Institute of Cancer Research
Study officials:
affiliation: Women & Infants Hospital, Providence, Rhode Island, USA
name: Prof Paul DiSilvestro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, USA
name: Prof Kathleen Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DiSilvestro P, Banerjee S, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, McNamara J, Lowe ES, Ah-See ML, Moore KN; SOLO1 Investigators. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol. 2023 Jan 20;41(3):609-617. doi: 10.1200/JCO.22.01549. Epub 2022 Sep 9.
citation: Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
citation: Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. doi: 10.1016/S1470-2045(21)00531-3. Epub 2021 Oct 26.
citation: Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. doi: 10.1016/S1470-2045(21)00098-X. Epub 2021 Apr 13.
citation: Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. doi: 10.1056/NEJMoa1810858. Epub 2018 Oct 21.