EORTC trial 11001: distribution of two 10B-compounds in patients with squamous cell carcinoma of head and neck, a translational research/phase 1 trial.
Boron neutron capture therapy (BNCT) provides highly targeted delivery of radiation through the limited spatial distribution of its effects. This translational research/phase I clinical trial investigates whether BNCT might be developed as a treatment option for squamous cell carcinoma of head and neck (SCCHN) relying upon preferential uptake of the two compounds, sodium mercaptoundecahydro-closo-dodecaborate (BSH) or L-para-boronophenylalanine (BPA) in the tumour. Before planned tumour resection, three patients received BSH and three patients received BPA. The (10)B-concentration in tissues and blood was measured with prompt gamma ray spectroscopy. Adverse effects from compounds did not occur. After BPA infusion the (10)B-concentration ratio of tumour/blood was 4.0 +/- 1.7. (10)B-concentration ratios of tumour/normal tissue were 1.3 +/- 0.5 for skin, 2.1 +/- 1.2 for muscle and 1.4 +/- 0.01 for mucosa. After BSH infusion the (10)B-concentration ratio of tumour/blood was 1.2 +/- 0.4. (10)B-concentration ratios of tumour/normal tissue were 3.6 +/- 0.6 for muscle, 2.5 +/- 1.0 for lymph nodes, 1.4 +/- 0.5 for skin and 1.0 +/- 0.3 for mucosa. BPA and BSH deliver (10)B to SCCHN to an extent that might allow effective BNCT treatment. Mucosa and skin are the most relevant organs at risk.
Wittig
Andrea
A
Department of Radiation Oncology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Collette
Laurence
L
Statistics Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
Appelman
Klaas
K
Nuclear Research and consultancy Group (NRG), Petten, The Netherlands.
Bührmann
Sandra
S
Pharmacy of the University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Jäckel
Martin C
MC
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Jöckel
Karl-Heinz
KH
Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Schmid
Kurt Werner
KW
Institute of Pathology and Neuropathology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Ortmann
Uta
U
Department of Radiation Oncology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Moss
Raymond
R
HFR Unit, Institute for Energy, Joint Research Centre, European Commission, Petten, The Netherlands.
Sauerwein
Wolfgang A G
WAG
Department of Radiation Oncology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
D000328:Adult; D000368:Aged; D001894:Borohydrides / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001896:Boron Compounds / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016754:Boron Neutron Capture Therapy; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy*; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010649:Phenylalanine / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D013438:Sulfhydryl Compounds / Q000493:pharmacokinetics / Q000627:therapeutic use*; D014018:Tissue Distribution
D001894:Borohydrides; D001896:Boron Compounds; D013438:Sulfhydryl Compounds; C014651:mercaptoundecahydrododecaborate; D010649:Phenylalanine; C033685:4-boronophenylalanine