Evidence map›Paper›PMID 34329939›Full record

Trial reportESMO open2021

Olaparib in combination with pegylated liposomal doxorubicin for platinum-resistant ovarian cancer regardless of BRCA status: a GEICO phase II trial (ROLANDO study).

J A Perez-Fidalgo, A Cortés, E Guerra, Y García, M Iglesias, U Bohn Sarmiento, E Calvo García, L Manso Sánchez, A Santaballa, A Oaknin and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03161132 (Multicentric Single Arm Phase II Clinical Trial, to Evaluate Safety and Efficacy of the Combination of Olaparib and PLD for Platinum Resistant Ovarian Primary Peritoneal Carcinoma, and Fallopian Tube Cancer Patients.), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.8field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03161132 phase2completednot on this map

Multicentric Single Arm Phase II Clinical Trial, to Evaluate Safety and Efficacy of the Combination of Olaparib and PLD for Platinum Resistant Ovarian Primary Peritoneal Carcinoma, and Fallopian Tube Cancer Patients.

TypeinterventionalSponsorGrupo Español de Investigación en Cáncer de OvarioRan2017 to 2022Enrolled32ConditionsAdvanced Ovarian CancerArmsOlaparib, Pegylated Liposomal Doxorubicin
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 30 citations in OpenAlex.

  1. Article
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  11. Nanoparticle-Based Combination Therapy for Ovarian Cancer.International journal of nanomedicine · 2023
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 12 institutions in 1 country.

J A Perez-FidalgoDepartment of Medical Oncology, Hospital Clínico Universitario de Valencia, Valencia, Spain. Electronic address: japfidalgo@msn.com.
A CortésDepartment of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain.
E GuerraDepartment of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Y GarcíaDepartment of Medical Oncology, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona, Sabadell, Spain.
M IglesiasDepartment of Medical Oncology, Hospital Son Llatzer, Palma De Mallorca, Spain.
U Bohn SarmientoDepartment of Medical Oncology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas De Gran Canaria, Spain.
E Calvo GarcíaDepartment of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
L Manso SánchezDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
A SantaballaDepartment of Medical Oncology, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
A OakninDepartment of Medical Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
A RedondoDepartment of Medical Oncology, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.
M J RubioDepartment of Medical Oncology, Hospital Universitario Reina Sofia, Córdoba, Spain.
A González-MartínDepartment of Medical Oncology Department, Clínica Universidad de Navarra, Madrid, Spain.
Hospital Universitario Ramón y Cajal · ESClinica Universidad de Navarra · ESHospital Clínico Universitario de Valencia · ESHospital Son Llatzer · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario 12 De Octubre · ESHospital Universitario de Gran Canaria Doctor Negrín · ESHospital Universitario La Paz · ESHospital Universitario Reina Sofía · ESHospital Universitario Virgen del Rocío · ESInstitute of Research and Innovation Parc Tauli · ESVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is limited evidence for the benefit of olaparib in platinum-resistant ovarian cancer (PROC) patients with BRCA wild-type tumors. This study investigated whether this combination of a DNA-damaging chemotherapy plus olaparib is effective in PROC regardless BRCA status. PATIENTS AND

methodsPatients with high-grade serous or endometrioid ovarian carcinoma and one previous PROC recurrence were enrolled regardless of BRCA status. Patients with ≤4 previous lines (up to 5 in BRCA-mut) with at least one previous platinum-sensitive relapse were included; primary PROC was allowed only in case of BRCA-mut. Patients initially received six cycles of olaparib 300 mg b.i.d. (biduum) + intravenous pegylated liposomal doxorubicin (PLD) 40 mg/m

resultsFrom 2017 to 2020, 31 PROC patients were included. BRCA mutations were present in 16%. The median of previous lines was 2 (range 1-5). The overall disease control rate was 77% (partial response rate of 29% and stable disease rate of 48%). After a median follow-up of 10 months, the 6m-PFS and median PFS were 47% and 5.8 months, respectively. Grade ≥3 treatment-related adverse events occurred in 74% of patients, with neutropenia/anemia being the most frequent. With PLD30 serious AEs were less frequent than with PLD40 (21% versus 47%, respectively); moreover, PLD30 was associated with less PLD delays (32% versus 38%) and reductions (16% versus 22%).

conclusionsThe PLD-olaparib combination has shown significant activity in PROC regardless of BRCA status. PLD at 30 mg/m

Indexed as

Ovarian NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDoxorubicinFemaleHumansNeoplasm Recurrence, LocalPhthalazinesPiperazinesPolyethylene GlycolsDoxorubicinliposomal doxorubicinolaparibPhthalazinesPiperazinesPolyethylene GlycolsBRCA wild-typeolaparibPARP inhibitorpegylated liposomal doxorubicinplatinum-resistant recurrent ovarian cancer

Identifiers

PMID34329939
PMCPMC8446804
OpenAlexW3186266916

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.