Evidence map›Paper›PMID 26542177›Full record

ArticleClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2016

GEINOFOTE: efficacy and safety of fotemustine in patients with high-grade recurrent gliomas and poor performance status.

P Pérez-Segura, R Manneh, I Ceballos, A García, M Benavides, J Fuster, M A Vaz, J M Cano, J P Berros, M Covela and 5 more

Abstract read
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In one paragraph

Article in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 32% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Guideline
  2. Trial
  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

15 authors at 14 institutions in 1 country.

P Pérez-SeguraHospital Clínico San Carlos, Madrid, Spain. pedro.perez@salud.madrid.org.
R MannehHospital 12 de octubre, Madrid, Spain.
I CeballosHospital Universitario, Canarias, Spain.
A GarcíaHospital Marqués de Valdecilla, Santander, Spain.
M BenavidesHospital Carlos Haya, Málaga, Spain.
J FusterHospital Son Espases, Palma de Mallorca, Spain.
M A VazHospital Ramón y Cajal, Madrid, Spain.
J M CanoHospital General, Ciudad Real, Spain.
J P BerrosHospital Central, Asturias, Spain.
M CovelaHospital Lucus Augusti, Lugo, Spain.
V MorenoHospital La Paz, Madrid, Spain.
T QuintanarHospital Universitario, Elche, Spain.
J M García BuenoHospital General, Albacete, Spain.
I FernándezComplejo Hospitalario, Vigo, Spain.
J SepúlvedaHospital 12 de octubre, Madrid, Spain.
Research Institute Hospital 12 de Octubre · ESHospital Clínico San Carlos · ESHospital Doctor José Molina Orosa · ESHospital General Universitario de Albacete · ESHospital General Universitario de Ciudad Real · ESHospital General Universitario de Elche · ESHospital Universitario Central de Asturias · ESHospital Universitario de Canarias · ESHospital Universitario La Paz · ESHospital Universitario Lucus Augusti · ESHospital Universitario Ramón y Cajal · ESHospital Universitario Son Espases · ESMarqués de Valdecilla University Hospital · ESUniversity Hospital Complex Of Vigo · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe treatment of recurrent high-grade gliomas (HGG) is controversial. There are different therapeutic schedules but without a clear orientation about which of them should be used in each clinical situation. In addition, when patients suffer a second recurrence or they have poor performance status, they are excluded from clinical trials, although second recurrences and poor performance status are indeed more and more real and common situations in the clinical setting. In this study, we assessed the efficacy and safety of fotemustine (FTM) in HGG [fundamentally, glioblastomas (GB)], independent of time of recurrence or performance status. METHODS/PATIENTS: Retrospective study in HGG patients treated with FTM in second or further line according to standard, the Addeo or any other scheme, starting treatment prior to 30 November 2012. Included patients reflect the regular situation in which the drug is used in terms of comorbidities and analytic situation (hematologic, renal and hepatic functions). Response assessment was performed by MRI and according to the clinical protocols of each center (every 8-12 weeks). Clinical situation and supportive care drugs were evaluated in each medical consultation. Clinical end-points analyzed, among others, were: PFS-6, PFS, OS, response rates, toxicity, quality of life and neurocognitive impact.

resultsIn terms of activity, an overall response rate of 8 % was observed: partial response 6 % (7 patients) and complete response 2 % (2 patients). The median time to achieve the greater response with FTM was 73 days (4-841 days). Patients treated according to the Addeo schedule had a shorter time to greater response in comparison with other schedules (85.9 vs 114 days), although without statistical significance. There were no significant differences in progression-free survival (PFS) when comparing different FTM schedules or using FTM in first or second recurrence. Median PFS: 3 months. PFS-6: 30.3 %. Overall survival (OS): although without significant differences, a tendency to better survival when using the Addeo schedule versus other schedules was observed (at 6 months, 44.6 vs 34.5 %; at 12 months, 25 vs 23.6 %; at 18 months, 11.5 vs 7.9 %), as well as if earlier use (second vs third line) concerning OS-12 (33.7 vs 18.2 %). Median OS: 5.2 months. Grades 3-4 toxicity was 28 % (31 patients), being neutropenia (4 %) and thrombocytopenia (17 %) the most frequent adverse reactions. From quality of life and neuro-cognitive function perspectives, 11 patients (10 %) and 16 (14 %) improved the Karnofsky Index and neurological impairment, respectively, after FTM treatment.

conclusionThis study has shown that FTM is safe and has a comparable activity with other available therapeutic options of use in the treatment of recurrent HGG.

Indexed as

AdultAgedAntineoplastic AgentsBrain NeoplasmsFemaleGliomaHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm Recurrence, LocalNitrosourea CompoundsOrganophosphorus CompoundsRetrospective StudiesTreatment OutcomeYoung AdultAntineoplastic AgentsfotemustineNitrosourea CompoundsOrganophosphorus CompoundsFotemustineGlioblastomaHigh-grade gliomaPoor PSRelapse

Identifiers

PMID26542177
OpenAlexW2115732717

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.