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Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review

Luca G. Campana
Luca G. Campana
, 
A. James P. Clover
A. James P. Clover
, 
Sara Valpione
Sara Valpione
, 
Pietro Quaglino
Pietro Quaglino
, 
Julie Gehl
Julie Gehl
, 
Christian Kunte
Christian Kunte
, 
Marko Snoj
Marko Snoj
, 
Maja Cemazar
Maja Cemazar
, 
Carlo R. Rossi
Carlo R. Rossi
, 
Damijan Miklavcic
Damijan Miklavcic
 oraz 
Gregor Sersa
Gregor Sersa
   | 16 lut 2016
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Article Category: Review
Data publikacji: 16 lut 2016
Zakres stron: 1 - 13
Otrzymano: 14 gru 2015
Przyjęty: 11 sty 2016
DOI: https://doi.org/10.1515/raon-2016-0006
Słowa kluczowe
© 2016 Radiol Oncol
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Figure 1.

Search in Web of Science demonstrates a steady increase in number of publications under the key word “electrochemotherapy” (A,B) as well under the “electrochemotherapy, clinical” (C,D). The Meta data indicate the expanding field.
Search in Web of Science demonstrates a steady increase in number of publications under the key word “electrochemotherapy” (A,B) as well under the “electrochemotherapy, clinical” (C,D). The Meta data indicate the expanding field.

Figure 2.

PRISMA flow diagram of identification, screening, eligibility and inclusion of studies.
PRISMA flow diagram of identification, screening, eligibility and inclusion of studies.

Figure 3.

Assessment of published studies according to quality criteria concerning trial design.
Assessment of published studies according to quality criteria concerning trial design.

Figure 4.

Assessment of published studies according to quality criteria conceming description of patient population.
Assessment of published studies according to quality criteria conceming description of patient population.

Figure 5.

Assessment of published studies according to quality criteria conceming treatment delivery and outcome assessment.ECT = electrochemotherapy; EP = electric pulses.
Assessment of published studies according to quality criteria conceming treatment delivery and outcome assessment.ECT = electrochemotherapy; EP = electric pulses.

Figure 6.

Assessment of published studies according to quality criteria conceming analysis of results and interpretation.COI = conflict of interest statement; PRO = patient reported outcomes; QoL = quality of life.
Assessment of published studies according to quality criteria conceming analysis of results and interpretation.COI = conflict of interest statement; PRO = patient reported outcomes; QoL = quality of life.

Figure 7.

Importance of covering whole tumor area along with safety margins. Reporting of the type of electrode applied is essential.
Importance of covering whole tumor area along with safety margins. Reporting of the type of electrode applied is essential.

Trials identified included in the qualitative analysis

Study, yearSettingNo of ptsTumor histotypeECT protocol
Rotunno, 201537Two-center, Italy55non-melanoma SCESOPE
Cabula, 201538Multi-center, Italy125BCESOPE
Mozzillo, 201539Single-center, Italy15melanomaESOPE
Landstrom, 201540Single-center, Sweden19HNSCCOther

Intratumoral BLM injection (1000 IU/cm3 and tumor electroporation by means of six 1100 V/cm square wave pulses with 0.1 ms duration

Granata, 201541Single-center, Italy13pancreatic cancerESOPE
Kreuter, 201542Multi-center, Germany56variousESOPE
Quaglino, 201543Multi-center, Europe121variousESOPE
Mir-Bonafé, 201544Single-center, Spain31melanomaESOPE
Campana, 201445Single-center, Italy39HNSCCESOPE
Ricotti, 201446Single-center, Italy30melanomaESOPE
Campana, 201447Single-center, Italy55BCESOPE
Edhemovic, 201429Single-center, Slovenia16CRC-liver mtsESOPE

In this trial, the ESOPE protocol was integrated by the application of variable geometry electrodes for the treatment of deep visceral metastases.

Seccia, 201448Single-center, Italy9HNSCCESOPE
Campana, 201450Two-center, Italy34STSESOPE
Solari, 201451Single-center, Italy39variousESOPE
Di Monta, 201452Single-center, Italy19KSESOPE
Caracò, 201349Single-center, Italy60melanomaESOPE
Perrone, 201353Single-center, Italy9V-SCCESOPE
Benevento, 201254Single-center, Italy12BCESOPE
Mevio, 201255Single-center, Italy15HNSCCESOPE
Campana, 201220Single-center, Italy35BCESOPE
Latini, 201256Single-center, Italy18KSESOPE
Matthiessen, 201257Single-center, Denmark12BCESOPE
Gargiulo, 201258Single-center, Italy52non-melanoma SCESOPE
Campana, 201221Single-center, Italy85melanomaESOPE
Curatolo, 201259Two-center, Italy23KSESOPE
Kis, 201160Single-center, Hungary9melanomaESOPE
Matthiessen, 201122Two-center, Denmark-UK52variousESOPE
Skarlatos I, 201161Multi-center, Greece52variousESOPE
Campana, 200962Single-center, Italy52variousESOPE
Quaglino, 200863Single-center, Italy14melanomaESOPE
Larkin, 200764Single-center, Ireland30variousESOPE
Gaudy, 200665Single-center, France12melanomaOther

Intratumoral BLM injection (concentration, 4 mg/mL; dose, 1 mg/cm3 of tumor volume was followed, after 10 minutes, by the application of electric pulses (six 100 μsec-long pulses, 4 pulses/sec, electric field >600V/cm

Manuscript quality criteria

Manuscript quality criteria
Trial designDescription of Patient populationTreatment delivery and outcome assessmentAnalysis of results and interpretation
1. Prospective trial1. Setting (curative / palliative)1. Type of anaesthesia1. Summary of trial endpoints
2. Trial registration2. Drug route and dosages
3. Comparative trial2. Demographic data (in tabular form)3. Pulse generator2. Predictive factors
4. Mention of trial design4. EP parameters
5. Multicenter study3. No of tumors5. Electrode description3. Other patient outcome parameters
6. Mention of sponsor6. Tumor safety margins indicated
7. Trail hypothesis and sample size4. Tumor location7. Deviation from SOPs4. Results interpretation
8. Informed consent5. Tumor histotype9. Criteria for retreatment5. Comparison to historical controls
9. EC approval8. Tumor coverage with EP
10. Structured abstract10. Total No of ECT sessions
11. Rationale of the trial6. Tumor size11. ECT sessions required

Number of electrochemotherapy (ECT) sessions required for achieving response (either complete or partial) on baseline tumors

6. Future directions
12. A priori inclusion criteria12. Toxicity criteria
13. Follow-up dates7. Visceral mts indicated13. Response criteria7. COI statement
14. Statistical methods14. Evaluation of tumor control
15. Software used8. Concomitant treatments15. ECT success

Decision rule for determining ECT success

16. C.I., p-values16. Keep track of patients lost to follow-up
eISSN:
1581-3207
Język:
Angielski
Częstotliwość wydawania:
4 razy w roku
Dziedziny czasopisma:
Medicine, Clinical Medicine, Internal Medicine, Haematology, Oncology, Radiology
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