Evidence map›Paper›PMID 26026818›Full record

Trial reportWorld journal of urology2016

Efficacy and safety of a new device for intravesical thermochemotherapy in non-grade 3 BCG recurrent NMIBC: a phase I-II study.

Francesco Soria, Paola Milla, Chiara Fiorito, Francesca Pisano, Filippo Sogni, Massimiliano Di Marco, Vincenzo Pagliarulo, Franco Dosio, Paolo Gontero

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 6% 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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Device-Assisted Therapy in Non-Muscle-Invasive Bladder Cancer.Bladder cancer (Amsterdam, Netherlands) · 2024
    Review
  9. Review
  10. Review
  11. Identification ofFrontiers in immunology · 2022
    Article
  12. Article
  13. Heated Intravesical Chemotherapy: Biology and Clinical Utility.The Urologic clinics of North America · 2020
    Review
  14. Article
  15. Article
  16. Heating technology for malignant tumors: a review.International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group · 2020
    Review
  17. Review
  18. Review
  19. Review
  20. Review
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

9 authors at 2 institutions in 1 country.

Francesco SoriaDivision of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, C.so Bramante 88/90, 10126, Turin, Italy.
Paola MillaDepartment of Pharmacology, University of Studies of Torino, Turin, Italy.
Chiara FioritoDivision of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, C.so Bramante 88/90, 10126, Turin, Italy.
Francesca PisanoDivision of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, C.so Bramante 88/90, 10126, Turin, Italy.
Filippo SogniUrology Clinic, Maggiore della Carità Hospital, Novara, Italy.
Massimiliano Di MarcoUrology Unit, Casa di Cura Guarnieri, Rome, Italy.
Vincenzo PagliaruloUrology Clinic, Policlinico of Bari, Bari, Italy.
Franco DosioDepartment of Pharmacology, University of Studies of Torino, Turin, Italy.
Paolo GonteroDivision of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, C.so Bramante 88/90, 10126, Turin, Italy. paolo.gontero@unito.it.
Azienda Ospedaliero Universitaria San Giovanni Battista · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe report for the first time the activity and safety of Unithermia(®) (Elmedical Ltd, Hod-Hasharon, Israel), a novel device for administration of MMC-C with hyperthermia (HT), that employs conductive heating, in a series of non-grade 3 non-muscle-invasive bladder cancer (NMIBC) that failed Bacillus Calmette-Guerin (BCG).

methodsPatients with non-grade 3 NMIBC recurring after at least a full induction course of BCG were eligible for this phase I-II prospective single-arm study. Six weekly instillations with Unithermia(®) were scheduled following complete TUR. Primary end points were treatment safety and response rate (RR), and the latter defined as the absence of any unfavourable outcome at 12 months. Any grade 3 and/or muscle-invasive (T > 1) recurrence was considered disease progression. Kaplan-Meier estimation of the time to recurrence and progression, cancer-specific survival and overall survival was taken as secondary end points.

resultsThirty-four eligible patients entered the study between January 2009 and April 2011. RR was documented in 20/34 (59%). Among the 14/34 (41%) non-responders, four developed G3 disease, one developed carcinoma in situ, and one progressed to muscle-invasive bladder cancer, with an overall 18% progression rate at 1 year. At a median follow-up of 41 months, recurrence and progression rates were 35.3 and 23.5%, respectively. Toxicity did not go beyond grade 2 except in five cases.

conclusionsInitial experience with MMC-HT with Unithermia(®) showed an interesting activity and safety profile in non-grade 3 NMIBC recurring after BCG, suggesting a role as second-line therapy in this selected subgroup of NMIBC.

Indexed as

Adjuvants, ImmunologicAdministration, IntravesicalAdolescentAdultAgedAged, 80 and overBCG VaccineCarcinoma, Transitional CellDisease-Free SurvivalDisease ProgressionEquipment DesignFemaleFollow-Up StudiesHumansHyperthermia, InducedItalyAdjuvants, ImmunologicBCG VaccineBCG failureBladder cancerDevice assistedIntravesical chemotherapyThermochemotherapy

Identifiers

PMID26026818
OpenAlexW410120067

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.