Evidence map›Paper›PMID 40279883›Full record

Trial reportESMO open2025

Olaparib as a rescue treatment in platinum-refractory germ-cell tumors: the IGG-02 phase II trial.

G Schepisi, M Urbini, C Casadei, V Gallà, S Rossetti, U Basso, C Lolli, G Gurioli, E Petracci, S C Cecere and 10 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02533765 (Olaparib as Salvage Treatment for Cisplatin-resistant Germ Cell Tumor), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

NCT02533765 phase2completednot on this map

Olaparib as Salvage Treatment for Cisplatin-resistant Germ Cell Tumor

TypeinterventionalSponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSRan2015 to 2023Enrolled18ConditionsNeoplasms, Germ Cell and EmbryonalArmsOlaparib
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. Article
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

20 authors.

G SchepisiDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy. Electronic address: giuseppe.schepisi@irst.emr.it.
M UrbiniBiosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
C CasadeiDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
V GallàUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
S RossettiDepartment of Urogynaecological Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione G Pascale' IRCCS, Naples, Italy.
U BassoMedical Oncology Unit 1, Istituto Oncologico Veneto IOV IRCCS, Padua, Italy.
C LolliDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
G GurioliBiosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
E PetracciUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
S C CecereDepartment of Urogynaecological Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione G Pascale' IRCCS, Naples, Italy.
J VentrigliaDepartment of Urogynaecological Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione G Pascale' IRCCS, Naples, Italy.
V ZampigaBiosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
A MiserocchiUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
I CanginiBiosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
I De SantisUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
M Di NapoliDepartment of Urogynaecological Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione G Pascale' IRCCS, Naples, Italy.
C MennaDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
G MambelliUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.
S PignataDepartment of Urogynaecological Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione G Pascale' IRCCS, Naples, Italy.
U De GiorgiDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTherapeutic options for patients with advanced germ-cell tumors (GCTs) after multiple relapses or resistant disease are limited. Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP), an enzyme involved in DNA repair. PATIENTS AND

methodsIn this proof-of principle open-label, single-arm, phase II trial of olaparib 300 mg twice daily in patients with relapsed/refractory metastatic germ-cell cancer [IGG-02 study (NCT02533765)], patient eligibility included failure after high-dose chemotherapy or after at least two different cisplatin-based regimens.

resultsBetween September 2015 and February 2019, 18 patients, with a median age of 39 years (range 22-61 years) were enrolled. Severe adverse events (AEs) were observed in seven patients. There were no partial responses, five cases (27.8%) with stable disease (SD) lasting 3, 4, 4, 7 and 43 months, and 13 (72.2%) progressive disease. A germline DNA repair profile panel showed only a BRCA1-mutated case associated with an SD lasting for 4 months. The long-lasting patient on olaparib (43 months) experienced a myelodisplastic syndrome (MDS) associated with the onset of a pathogenic mutation affecting PPM1D.

conclusionsOlaparib as a single agent demonstrated no activity in heavily pretreated GCT patients. Future studies with PARP inhibitors should be planned in less-pretreated GCT patients based on molecular analysis to support better patient selection.

Indexed as

Antineoplastic AgentsNeoplasms, Germ Cell and EmbryonalPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsAdultDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedYoung AdultAntineoplastic AgentsolaparibPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase Inhibitorsgerm-cell tumorsolaparibPARPsalvage therapytesticular cancer

Identifiers

PMID40279883
PMCPMC12245464

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.