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The DAHANCA 32 study: Electrochemotherapy for recurrent mucosal head and neck cancer
Author(s) -
Plaschke Christina Caroline,
Johannesen Helle Hjorth,
Hansen Rasmus Hvass,
Hendel Helle Westergren,
Kiss Katalin,
Gehl Julie,
Wessel Irene
Publication year - 2019
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.25454
Subject(s) - electrochemotherapy , medicine , head and neck cancer , adverse effect , clinical endpoint , phases of clinical research , complete response , head and neck , response evaluation criteria in solid tumors , surgery , radiology , radiation therapy , biopsy , clinical trial , chemotherapy , bleomycin
Background Electrochemotherapy is an established treatment for cutaneous tumors. This study aimed at determining efficacy of electrochemotherapy in recurrent head and neck cancer. Methods Phase II clinical trial in patients with recurrent head and neck carcinomas with no curative treatment options. Electrochemotherapy was performed under general anesthesia. Primary endpoint was tumor response (CT scanning) evaluated at week 8. Secondary endpoints included biopsy results, MRI and fluorodeoxyglucose‐positron emission tomography scanning, safety, toxicity, pain score, and quality‐of‐life questionnaires. Results Of 26 patients treated, 5 (19%) achieved complete response, 10 (39%) partial response, resulting in an objective response of 58%. Two responders remain without recurrence. No serious adverse events occurred during treatment. Four events occurred posttreatment: one bleeding episode, two episodes with mucosal swelling, and one patient died due to disease progression. Conclusion Electrochemotherapy is efficient against local recurrence of head and neck cancer with an overall response rate of 58%.