Evidence map›Paper›PMID 20694830›Full record

Trial reportJournal of neuro-oncology2011

A new schedule of fotemustine in temozolomide-pretreated patients with relapsing glioblastoma.

Raffaele Addeo, Michele Caraglia, M Serena De Santi, Liliana Montella, Alberto Abbruzzese, Ciro Parlato, Bruno Vincenzi, Marco Carraturo, Vincenzo Faiola, Michele Genovese and 2 more

Erratum issuedOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Journal of neuro-oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 14% 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

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 69 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
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  7. Article
  8. Article
  9. Review
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  11. Article
  12. Article
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  15. Review
  16. Article
  17. E2F transcription factors associated with up-regulated genes in glioblastoma.Cancer biomarkers : section A of Disease markers · 2017
    Article
  18. GEINOFOTE: efficacy and safety of fotemustine in patients with high-grade recurrent gliomas and poor performance status.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2016
    Article
  19. Article
  20. Nitrosoureas in the Management of Malignant Gliomas.Current neurology and neuroscience reports · 2016
    Review
4 · The record

Corrections and comments

  • Erratum issued
    Dosage error in published abstract; MEDLINE/PubMed abstract corrected
5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Raffaele AddeoOncology Department, "S. Giovanni di Dio" Hospital, ASL Napoli2 Nord Via Giovanni XXIII, 80028 Frattaminore, Naples, Italy. lelloaddeo@alice.it
Michele Caraglia
M Serena De Santi
Liliana Montella
Alberto Abbruzzese
Ciro Parlato
Bruno Vincenzi
Marco Carraturo
Vincenzo Faiola
Michele Genovese
Gregorio Cennamo
Salvatore Del Prete
Nuovo Ospedale San Giovanni di Dio · ITOspedali Riuniti Umberto I · ITUniversity of Naples Federico II · ITOspedali Riuniti San Giovanni di Dio e Ruggi d'Aragona · ITUniversità Campus Bio-Medico · ITUniversity of Campania "Luigi Vanvitelli" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the present study we investigated the feasibility and effectiveness of a new biweekly schedule of fotemustine (FTM) in patients with recurrent glioblastoma, after at least one previous treatment. The primary endpoint was progression-free survival at 6 months; secondary objectives were clinical response, overall survival, disease-free survival, and toxicity. Forty patients (median age 52.8 years; median Karnofsky Performance Status at progression 90) underwent second-line chemotherapy with FTM. Selected patients were previously treated with a standard radiotherapy course with concomitant temozolomide (TMZ). After tumor relapse or progression proven by magnetic resonance imaging (MRI), all patients underwent chemotherapy with FTM, given intravenously at dose of 80 mg/m(2) every 2 weeks for five consecutive administrations (induction phase), and then every 4 weeks at 80 [DOSAGE ERROR CORRECTED] mg/m(2) as maintenance. A total of 329 infusions were administered; the median number of cycles administered was 8. All patients completed the induction phase, and 29 patients received at least one maintenance infusion. Response to treatment was assessed using MacDonald criteria. One complete response [2.5%, 95% confidence interval (CI): 0-10%], 9 partial responses (22.5%, 95% CI: 15-37%), and 16 stable diseases (40%, 95% CI: 32-51%) were observed. Median time to progression was 6.7 months (95% CI: 3.9-9.1 months). Progression-free survival at 6 months was 61%. Median survival from beginning of FTM chemotherapy was 11.1 months. The schedule was generally well tolerated; the main toxicities were hematologic (grade 3 thrombocytopenia in two cases). To the best of our knowledge, this is the first report specifically dealing with the use of a biweekly induction schedule of FTM. The study demonstrates that FTM has therapeutic efficacy as single-drug second-line chemotherapy with a favorable safety profile.

Indexed as

AdultAgedAntineoplastic AgentsBrain NeoplasmsConfidence IntervalsDacarbazineDisease-Free SurvivalDrug Administration ScheduleFemaleFollow-Up StudiesGlioblastomaHumansMagnetic Resonance ImagingMaleMiddle AgedNeoplasm Recurrence, LocalAntineoplastic AgentsDacarbazinefotemustineNitrosourea CompoundsOrganophosphorus CompoundsTemozolomide

Identifiers

PMID20694830
PMCPMC3089727
OpenAlexW1991871891

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.