Boron neutron capture therapy in the treatment of locally recurred head-and-neck cancer: Final analysis of a phase I/II trial

Leena Kankaanranta, Tiina Seppälä, Hanna Koivunoro, Kauko Saarilahti, Timo Atula, Juhani Collan, Eero Salli, Mika Kortesniemi, Jouni Uusi-Simola, Petteri Välimäki, Antti Mäkitie, Marko Seppänen, Heikki Minn, Hannu Revitzer, Mauri Kouri, Petri Kotiluoto, Tom Seren, Iiro Auterinen, Sauli Savolainen, Heikki Joensuu (Corresponding Author)

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    Abstract

    Purpose: To investigate the efficacy and safety of boron neutron capture therapy (BNCT) in the treatment of inoperable head-and-neck cancers that recur locally after conventional photon radiation therapy. Methods and Materials: In this prospective, single-center Phase I/II study, 30 patients with inoperable, locally recurred head-and-neck cancer (29 carcinomas and 1 sarcoma) were treated with BNCT. Prior treatments consisted of surgery and conventionally fractionated photon irradiation to a cumulative dose of 50 to 98 Gy administered with or without concomitant chemotherapy. Tumor responses were assessed by use of the RECIST (Response Evaluation Criteria in Solid Tumors) and adverse effects by use of the National Cancer Institute common terminology criteria version 3.0. Intravenously administered L-boronophenylalanine-fructose (400 mg/kg) was administered as the boron carrier. Each patient was scheduled to be treated twice with BNCT. Results: Twenty-six patients received BNCT twice; four were treated once. Of the 29 evaluable patients, 22 (76%) responded to BNCT, 6 (21%) had tumor growth stabilization for 5.1 and 20.3 months, and 1 (3%) progressed. The median progression-free survival time was 7.5 months (95% confidence interval, 5.4-9.6 months). Two-year progression-free survival and overall survival were 20% and 30%, respectively, and 27% of the patients survived for 2 years without locoregional recurrence. The most common acute Grade 3 adverse effects were mucositis (54% of patients), oral pain (54%), and fatigue (32%). Three patients were diagnosed with osteoradionecrosis (each Grade 3) and one patient with soft-tissue necrosis (Grade 4). Late Grade 3 xerostomia was present in 3 of the 15 evaluable patients (20%). Conclusions: Most patients who have inoperable, locally advanced head-and-neck carcinoma that has recurred at a previously irradiated site respond to boronophenylalanine-mediated BNCT, but cancer recurrence after BNCT remains frequent. Toxicity was acceptable. Further research on novel modifications of the method is warranted.

    Original languageEnglish
    Pages (from-to)e67-e75
    Number of pages9
    JournalInternational Journal of Radiation Oncology Biology Physics
    Volume82
    Issue number1
    DOIs
    Publication statusPublished - 1 Jan 2012
    MoE publication typeA1 Journal article-refereed

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    Keywords

    • Boron neutron capture therapy
    • Boronophenylalanine
    • Head-and-neck cancer
    • Radiotherapy

    Cite this

    Kankaanranta, L., Seppälä, T., Koivunoro, H., Saarilahti, K., Atula, T., Collan, J., Salli, E., Kortesniemi, M., Uusi-Simola, J., Välimäki, P., Mäkitie, A., Seppänen, M., Minn, H., Revitzer, H., Kouri, M., Kotiluoto, P., Seren, T., Auterinen, I., Savolainen, S., & Joensuu, H. (2012). Boron neutron capture therapy in the treatment of locally recurred head-and-neck cancer: Final analysis of a phase I/II trial. International Journal of Radiation Oncology Biology Physics, 82(1), e67-e75. https://doi.org/10.1016/j.ijrobp.2010.09.057