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Original research
Electrochemotherapy with intravenous bleomycin for heavily pre-treated vulvar cancer patients
  1. Anna Myriam Perrone1,2,
  2. Giacomo Corrado3,
  3. Camelia Alexandra Coada2,
  4. Giorgia Garganese4,5,
  5. Simona Maria Fragomeni3,
  6. Luca Tagliaferri6,
  7. Stella Di Costanzo1,
  8. Eugenia De Crescenzo1,2,
  9. Alessio Giuseppe Morganti2,7,
  10. Martina Ferioli2,7,
  11. Francesca De Terlizzi8,
  12. Giovanni Scambia3 and
  13. Pierandrea De Iaco1,2
  1. 1 Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola, Bologna, Italy
  2. 2 Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
  3. 3 UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy
  4. 4 Gynecology and Breast Care Center, Mater Olbia Hospital, Olbia, Italy
  5. 5 Dipartimento Universitario Scienze della Vita e Sanità Pubblica, Sezione di Ginecologia ed Ostetricia, Università Cattolica del Sacro Cuore, Rome, Italy
  6. 6 UOC Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy
  7. 7 Radiation Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
  8. 8 Scientific & Medical Department, IGEA S.p.A, Carpi, Italy
  1. Correspondence to Dr Camelia Alexandra Coada, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy; camelia.coada{at}gmail.com

Abstract

Objective The management of vulvar cancer recurrences is complicated by patients’ advanced age and comorbidities. Bleomycin-based electrochemotherapy is a potential treatment option in this setting. However, no data on long-term outcomes are available. Therefore, a multicenter observational study was designed to evaluate the 5-year results in these patients.

Methods Data about patients and tumor characteristics, electrochemotherapy cycles, clinical response, and follow-up were recorded. Treatment procedures were performed according to the European Standard Operating Procedures of Electrochemotherapy (ESOPE) guidelines. Response was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Results Fifty-one patients (mean age 82.31±7.28 years) with squamous cell vulvar cancer underwent electrochemotherapy (median number of sessions 1; range 1–4). 20 patients had complete response and 32% of these were disease-free after 2 years (median progression-free survival 16.8 months). In 13 patients with partial response the median progression-free survival was 15.36 months, while patients with stable or progressive disease showed tumor relapse after 6.95 and 3.26 months, respectively (p<0.001). Median overall survival was 18.77, 13.07, 6.73, and 11.13 months in patients with complete response, partial response, stable disease, and progressive disease, respectively (p=0.001).

Conclusion Long-term follow-up of vulvar cancer patients showed reasonable tumor control after electrochemotherapy and improved progression-free survival and overall survival in responder subjects compared with non-responders. Further studies aimed at improving local response after electrochemotherapy are warranted. Thus, this approach represents a potential alternative for these patients.

  • Vulvar and Vaginal Cancer
  • Palliative Care
  • Gynecology
  • Carcinoma
  • Neoplasm Recurrence, Local

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

https://doi.org/10.1136/ijgc-2022-004127

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Contributors Conceptualization: AMP, PDI. Data curation: CAC. Formal analysis: FDT, CAC. Investigation: CAC, EDC, GC, SMF. Methodology: AMP. Project administration: AMP, SDC. Supervision: AMP, PDI, GC. Validation: LT, GG, MF. Visualization: CAC. Roles/writing - original draft: AMP; CAC. Writing - review and editing: AMP, PDI, GS, AGM. Guarantor: AMP.

    • Funding This research was partially funded by ALMA IDEA22 line A D.M. 737/2021 from the European Union “NextGenerationEU” CUP J45F21002000001.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • © IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.