Sebastian Adeberg1, Sati Akbaba2, Kristin Lang2, Thomas Held3, Vivek Verma4, Anna Nikoghosyan5, Denise Bernhardt2, Marc Münter6, Kolja Freier7, Peter Plinkert8, Henrik Hauswald3, Klaus Herfarth9, Stefan Rieken10, Juergen Debus9, Alexandra Desire Jensen11. 1. Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg Institute for Radiation Oncology (HIRO), Heidelberg, Germany; Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg Ion-Beam Therapy Center (HIT), Heidelberg, Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany. Electronic address: sebastian.adeberg@med.uni-heidelberg.de. 2. Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg Institute for Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg Ion-Beam Therapy Center (HIT), Heidelberg, Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany. 3. Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg Institute for Radiation Oncology (HIRO), Heidelberg, Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany. 4. Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania. 5. Department of Radiation Oncology, Helios Klinikum Berlin-Buch, Berlin, Germany. 6. Department of Radiation Oncology, Katharinenhospital, Stuttgart, Germany. 7. Department of Oral and Maxillofacial Surgery, Heidelberg University Hospital, Heidelberg, Germany. 8. Department of Otorhinolaryngology, Heidelberg University Hospital, Heidelberg, Germany. 9. Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg Institute for Radiation Oncology (HIRO), Heidelberg, Germany; Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg Ion-Beam Therapy Center (HIT), Heidelberg, Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany. 10. Heidelberg Institute for Radiation Oncology (HIRO), Heidelberg, Germany; Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg Ion-Beam Therapy Center (HIT), Heidelberg, Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany. 11. Department of Radiation Oncology, University Hospital Gießen and Marburg (UKGM), Marburg, Germany.
Abstract
PURPOSE: The adenoid cystic carcinoma (ACC), Erbitux, and Particle Therapy (ACCEPT) phase 1/2 trial (NCT01192087) evaluated a combined-modality approach (concurrent cetuximab and intensity modulated radiation therapy with carbon ion boost) for newly diagnosed nonmetastatic head and neck ACC. METHODS AND MATERIALS: Twenty-three patients with ACC were enrolled between June 2012 and June 2017 after initial diagnosis or postoperatively. All received a 400 mg/m2 cetuximab loading dose a week before radiation therapy, followed by weekly 250 mg/m2 doses starting on the first day of radiation therapy. The carbon ion radiation therapy boost was 24 Gy (relative biological effectiveness) in 8 daily fractions, followed by intensity modulated radiation therapy (54 Gy). The primary endpoint was safety and feasibility (defined based on Common Terminology Criteria for Adverse Events grade ≥3 events). Secondary endpoints included local and distant relapse, disease-free survival, and overall survival. RESULTS: Disease was most commonly in the paranasal sinuses (30%), palate (17%), and nasopharynx (17%). Nine (39%) patients underwent surgery (R1: 22%, R2: 78%). Median follow-up was 38.5 months. No patients experienced grade 4 to 5 events. Rates of grade 3 rash and radiation dermatitis were 17% and 22%, respectively. Grade 2 and 3 mucositis and dysgeusia occurred in 43% and 48% and in 9% and 0%, respectively. Grade 2 to 3 dysphagia and xerostomia were present in 43% and 4% and in 26% and 0%, respectively. At last follow-up, 5 (22%) patients experienced in-field relapse and 6 (26%) developed distant metastases. The 3-year disease-free survival was 67%, and median overall survival was 54 months. CONCLUSIONS: Outcomes of this trial were satisfactory. Although the trial did not meet the predefined criteria of feasibility owing to the comparatively high rates of grade 3 dermatitis, numbers are comparable to existing data on cetuximab + radiation therapy.
PURPOSE: The adenoid cystic carcinoma (ACC), Erbitux, and Particle Therapy (ACCEPT) phase 1/2 trial (NCT01192087) evaluated a combined-modality approach (concurrent cetuximab and intensity modulated radiation therapy with carbon ion boost) for newly diagnosed nonmetastatic head and neck ACC. METHODS AND MATERIALS: Twenty-three patients with ACC were enrolled between June 2012 and June 2017 after initial diagnosis or postoperatively. All received a 400 mg/m2 cetuximab loading dose a week before radiation therapy, followed by weekly 250 mg/m2 doses starting on the first day of radiation therapy. The carbon ion radiation therapy boost was 24 Gy (relative biological effectiveness) in 8 daily fractions, followed by intensity modulated radiation therapy (54 Gy). The primary endpoint was safety and feasibility (defined based on Common Terminology Criteria for Adverse Events grade ≥3 events). Secondary endpoints included local and distant relapse, disease-free survival, and overall survival. RESULTS: Disease was most commonly in the paranasal sinuses (30%), palate (17%), and nasopharynx (17%). Nine (39%) patients underwent surgery (R1: 22%, R2: 78%). Median follow-up was 38.5 months. No patients experienced grade 4 to 5 events. Rates of grade 3 rash and radiation dermatitis were 17% and 22%, respectively. Grade 2 and 3 mucositis and dysgeusia occurred in 43% and 48% and in 9% and 0%, respectively. Grade 2 to 3 dysphagia and xerostomia were present in 43% and 4% and in 26% and 0%, respectively. At last follow-up, 5 (22%) patients experienced in-field relapse and 6 (26%) developed distant metastases. The 3-year disease-free survival was 67%, and median overall survival was 54 months. CONCLUSIONS: Outcomes of this trial were satisfactory. Although the trial did not meet the predefined criteria of feasibility owing to the comparatively high rates of grade 3 dermatitis, numbers are comparable to existing data on cetuximab + radiation therapy.
Authors: Paweł Polanowski; Dorota Księżniak-Baran; Aleksandra Grządziel; Agnieszka Pietruszka; Ewa Chmielik; Bolesław Pilecki; Natalia Amrogowicz; Karolina Gajda; Krzysztof Składowski Journal: Case Rep Oncol Date: 2021-03-09
Authors: Sebastian Adeberg; Paul Windisch; Felix Ehret; Melissa Baur; Sati Akbaba; Thomas Held; Denise Bernhardt; Matthias F Haefner; Juergen Krauss; Steffen Kargus; Christian Freudlsperger; Peter Plinkert; Christa Flechtenmacher; Klaus Herfarth; Juergen Debus; Stefan Rieken Journal: Front Oncol Date: 2019-12-20 Impact factor: 6.244