European Research on Electrochemotherapy in Head and Neck Cancer (EURECA) project: Results from the treatment of mucosal cancers

Christina Caroline Plaschke; Giulia Bertino; James A McCaul; Juan J Grau; Remco de Bree; Gregor Sersa; Antonio Occhini; Ales Groselj; Cristobal Langdon; Derrek A Heuveling; Maja Cemazar; Primoz Strojan; C Rene Leemans; Marco Benazzo; Francesca De Terlizzi; Irene Wessel; Julie Gehl

doi:10.1016/j.ejca.2017.10.008

European Research on Electrochemotherapy in Head and Neck Cancer (EURECA) project: Results from the treatment of mucosal cancers

Eur J Cancer. 2017 Dec:87:172-181. doi: 10.1016/j.ejca.2017.10.008.

Authors

Christina Caroline Plaschke¹, Giulia Bertino², James A McCaul³, Juan J Grau⁴, Remco de Bree⁵, Gregor Sersa⁶, Antonio Occhini², Ales Groselj⁷, Cristobal Langdon⁴, Derrek A Heuveling⁸, Maja Cemazar⁶, Primoz Strojan⁶, C Rene Leemans⁸, Marco Benazzo², Francesca De Terlizzi⁹, Irene Wessel¹, Julie Gehl¹⁰

Affiliations

¹ Department of Otorhinolaryngology, Head & Neck Surgery and Audiology, Copenhagen University Hospital Rigshospitalet, 9Blegdamsvej, 2100, Copenhagen, Denmark.
² Department of Otolaryngology Head Neck Surgery, University of Pavia, IRCCS Policlinico San Matteo Foundation, P.le Golgi 2, 27100, Pavia, Italy.
³ Head and Neck Unit, Royal Marsden Hospital London, Fulham Rd, London, SW3 6JJ, UK; Maxillofacial Unit London Northwest Healthcare Trust, UK.
⁴ Department of Otolaryngology Head Neck Surgery, Oncologic Service Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain.
⁵ Department of Otolaryngology, Head and Neck Surgery, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands; Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, University Medical Center Utrecht, Heidelberglaan 100, 3484 CX Utrecht, The Netherlands.
⁶ Institute of Oncology Ljubljana, Zaloska 2, SI-1000, Ljubljana, Slovenia.
⁷ Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana, Zaloska 2, Ljubljana, SI-1000, Slovenia.
⁸ Department of Otolaryngology, Head and Neck Surgery, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands.
⁹ IGEA Clinical Biophysics Department, Via Parmenide 10/A, Carpi, 41012, Modena, Italy.
¹⁰ Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Center for Experimental Drug and Gene Electrotransfer (C*EDGE), Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Roskilde, Denmark. Electronic address: kgeh@regionsjaelland.dk.

PMID: 29156298
DOI: 10.1016/j.ejca.2017.10.008

Abstract

Aim: Electrochemotherapy is an effective local treatment for cutaneous tumours and metastases. In this prospective trial, six European institutions investigated electrochemotherapy in recurrent, mucosal head and neck tumours.

Patient and methods: Forty-three patients with recurrent mucosal head and neck tumours and no further curative or reasonably effective palliative treatment options were enrolled and treated with electrochemotherapy. Patients were treated in general anaesthesia using intravenous or local injection of bleomycin followed by delivery of electric pulses to the tumour area. Primary end-point was local tumour response. Secondary end-points were safety and toxicity, overall and progression free survival, and quality-of-life.

Results: Thirty-seven patients were evaluable for tumour response, pain score, side-effects and quality of life questionnaires. Six patients were not evaluable due to lost follow-up, disease progression or death before evaluation. Intention to treat analysis revealed an objective response of 56% (complete response 8 (19%), partial response 16 (37%), stable disease 10 (23%), progressive disease 3 (7%), and not evaluable 6 (14%)). Three patients (7%) remained in complete response at 30, 34, and 84 months post-treatment. The treatment procedure was generally well tolerated. Swelling of the mucosa was observed in the first days after treatment. Pain and use of pain medication rose temporarily; fatigue and dysphagia were also noted in the quality of life assessment.

Conclusion: Electrochemotherapy can be applied to mucosal head and neck recurrent tumours accessible to the procedure with promising objective response, survival and toxicity profile. Attention should be paid to post-treatment swelling and planning of pain medication. These favourable results indicate that electrochemotherapy could play a role in patients with recurrent head and neck cancer.

Keywords: Electrochemotherapy; Head and neck cancer; Palliative treatment; Quality of life; Squamous cell carcinoma.

Publication types

Clinical Trial, Phase II
Multicenter Study
Observational Study

MeSH terms

Aged
Aged, 80 and over
Antibiotics, Antineoplastic / administration & dosage*
Antibiotics, Antineoplastic / adverse effects
Bleomycin / administration & dosage*
Bleomycin / adverse effects
Carcinoma, Squamous Cell / drug therapy*
Carcinoma, Squamous Cell / mortality
Carcinoma, Squamous Cell / secondary
Disease-Free Survival
Electrochemotherapy* / adverse effects
Europe
Female
Head and Neck Neoplasms / drug therapy*
Head and Neck Neoplasms / mortality
Head and Neck Neoplasms / pathology
Humans
Infusions, Intravenous
Injections, Intralesional
Injections, Intravenous
Intention to Treat Analysis
Kaplan-Meier Estimate
Male
Middle Aged
Mucous Membrane / drug effects*
Mucous Membrane / pathology
Neoplasm Recurrence, Local
Prospective Studies
Quality of Life
Squamous Cell Carcinoma of Head and Neck
Time Factors
Treatment Outcome

Substances

Antibiotics, Antineoplastic
Bleomycin