ABSTRACT
BACKGROUND: The Head and Neck Cancer Group (HNCG) of the EORTC conducted a quality assurance program in the EORTC 24954 trial on larynx preservation. In this multicentre study, patients with resectable advanced squamous cell carcinoma of the larynx or hypopharynx were randomly assigned for treatment with sequential or alternating chemoradiation. The need for a quality assurance program is the evaluation and prevention of differences in treatments between centres in this multidisciplinary study. METHOD: The surgical subcommittee of the HNCG prepared a questionnaire, and clinical records of all patients were verified during audits of independent teams. Data relating institutional practices were collected during a face to face interview with members of the local team. RESULTS: 271 clinical records from the nine main contributing centres were reviewed. The main difference between centres was the time interval between first consultation and treatment initiation, with a mean of 45 days. On the pathology report the nodal involvement was described by level in 36% of the cases according to the American Academy of Otolaryngology-Head and Neck Surgery classification. Extranodal spread was not always described in neck dissection specimens. CONCLUSION: The EORTC 24954 trial on larynx preservation was the first prospective trial with a quality assurance program in head and neck surgical oncology. The analysis shows similarities in practices, but also points out some important differences between centres. Operation reports were fairly complete, but uniformity in pathology reports should be improved.
Subject(s)
Carcinoma, Squamous Cell/therapy , Chemoradiotherapy, Adjuvant/standards , Hypopharyngeal Neoplasms/therapy , Laryngeal Neoplasms/therapy , Randomized Controlled Trials as Topic/standards , Carcinoma, Squamous Cell/pathology , Combined Modality Therapy , Europe , Humans , Hypopharyngeal Neoplasms/pathology , Laryngeal Neoplasms/pathology , Laryngectomy , Medical Audit , Multicenter Studies as Topic/standards , Organ Sparing Treatments/standards , Otolaryngology/standards , Pathology, Surgical/standards , Pharyngectomy , Quality Assurance, Health Care , Remission InductionABSTRACT
Keypoints * Chemo-electroporation therapy with bleomycin is a locoregional treatment modality for head and neck and skin cancer, with the potential to preserve function. * In our institution, chemo-electroporation therapy is used for patients that can no longer be treated by surgery or radiotherapy, or for whom surgical treatment would be very extensive and thus declined by the patient. * This paper describes in detail the technique of bleomycin-electroporation therapy. The literature is reviewed and preliminary results of the clinical trial are presented. * The main focus of the trial is to determine the safety, effectiveness, and burden of bleomycin-electroporation therapy for the patient. * All 17 tumours responded to therapy. Local tumour control was reached in 14 of the 17 (82.4 %) tumours. * Based on the outcome of the clinical trial, bleomycin-electroporation therapy has the potential to become a valuable addition to the late-stage treatment options for patients with head and neck or skin tumours.
