Phase II study of induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil followed by radioimmunotherapy with cetuximab and intensity-modulated radiotherapy in combination with a carbon ion boost for locally advanced tumors of the oro-, hypopharynx and larynx
Purpose: This phase II trial was designed to evaluate efficacy and safety of a highly intensified therapy in locally advanced squamous cell carcinoma of the oro-, hypopharynx and larynx. Methods: In this prospective, mono-centric, open-label, non-randomized phase II trial the single treatment arm co...
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| Format: | Article |
| Language: | English |
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Elsevier
2018-11-01
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| Series: | Clinical and Translational Radiation Oncology |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S240563081830065X |
| _version_ | 1818611455823446016 |
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| author | H. Hauswald A.D. Jensen J. Krauss R. Haselmann K. Lossner S. Hartmann C. Windemuth-Kieselbach M.W. Münter J. Debus |
| author_facet | H. Hauswald A.D. Jensen J. Krauss R. Haselmann K. Lossner S. Hartmann C. Windemuth-Kieselbach M.W. Münter J. Debus |
| author_sort | H. Hauswald |
| collection | DOAJ |
| description | Purpose: This phase II trial was designed to evaluate efficacy and safety of a highly intensified therapy in locally advanced squamous cell carcinoma of the oro-, hypopharynx and larynx. Methods: In this prospective, mono-centric, open-label, non-randomized phase II trial the single treatment arm consisted of a combined induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil, followed by bioradiation with the monoclonal antibody cetuximab, carbon ion boost (24Gy(RBE) in 8 fractions) and IMRT (50 Gy in 25 fractions). The trial was closed early due to slow accrual. Results: Eight patients (median age 52.5 years) were enrolled into the trial. The median follow-up was 13 months and the 12-months locoregional tumor control, progression-free survival and overall survival rates were 100.0% each. Complete remission was achieved in 7 patients. The most commonly late radiation adverse event was xerostomia (85.7% at 12 months). Five serious adverse events with recovery were documented in 4 patients: mucositis grade 3 (n = 2), decreased lymphocyte count grade 4, febrile neutropenia grade 4 and hypersensitivity grade 3 to cetuximab (n = 1 each). Most symptom scales had their worst value at the last treatment day and recovered until the 4th follow-up visit. Conclusion: The study treatment was tolerable and promising. Reduced quality of life recovered for most aspects until the last follow-up visit. Keywords: Particle therapy, Carbon ion therapy, Cetuximab, LAHNC, SCCHN, Head and neck cancer |
| first_indexed | 2024-12-16T15:30:36Z |
| format | Article |
| id | doaj.art-19a5a8e66edf4bccaa82bb504697e84d |
| institution | Directory Open Access Journal |
| issn | 2405-6308 |
| language | English |
| last_indexed | 2024-12-16T15:30:36Z |
| publishDate | 2018-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Clinical and Translational Radiation Oncology |
| spelling | doaj.art-19a5a8e66edf4bccaa82bb504697e84d2022-12-21T22:26:22ZengElsevierClinical and Translational Radiation Oncology2405-63082018-11-01136473Phase II study of induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil followed by radioimmunotherapy with cetuximab and intensity-modulated radiotherapy in combination with a carbon ion boost for locally advanced tumors of the oro-, hypopharynx and larynxH. Hauswald0A.D. Jensen1J. Krauss2R. Haselmann3K. Lossner4S. Hartmann5C. Windemuth-Kieselbach6M.W. Münter7J. Debus8Department of Radiation Oncology, Heidelberg University Hospital, INF 400, 69120 Heidelberg, Germany; Corresponding author.Department of Radiation Oncology, Heidelberg University Hospital, INF 400, 69120 Heidelberg, GermanyDepartment of Medical Oncology, National Center for Tumor Diseases, University Hospital Heidelberg, 69120 Heidelberg, GermanyDepartment of Radiation Oncology, Heidelberg University Hospital, INF 400, 69120 Heidelberg, GermanyDepartment of Radiation Oncology, Heidelberg University Hospital, INF 400, 69120 Heidelberg, GermanyAlcedis GmbH, Winchesterstr. 3, 35394 Gießen, GermanyAlcedis GmbH, Winchesterstr. 3, 35394 Gießen, GermanyDepartment of Radiation Oncology, Heidelberg University Hospital, INF 400, 69120 Heidelberg, GermanyDepartment of Radiation Oncology, Heidelberg University Hospital, INF 400, 69120 Heidelberg, GermanyPurpose: This phase II trial was designed to evaluate efficacy and safety of a highly intensified therapy in locally advanced squamous cell carcinoma of the oro-, hypopharynx and larynx. Methods: In this prospective, mono-centric, open-label, non-randomized phase II trial the single treatment arm consisted of a combined induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil, followed by bioradiation with the monoclonal antibody cetuximab, carbon ion boost (24Gy(RBE) in 8 fractions) and IMRT (50 Gy in 25 fractions). The trial was closed early due to slow accrual. Results: Eight patients (median age 52.5 years) were enrolled into the trial. The median follow-up was 13 months and the 12-months locoregional tumor control, progression-free survival and overall survival rates were 100.0% each. Complete remission was achieved in 7 patients. The most commonly late radiation adverse event was xerostomia (85.7% at 12 months). Five serious adverse events with recovery were documented in 4 patients: mucositis grade 3 (n = 2), decreased lymphocyte count grade 4, febrile neutropenia grade 4 and hypersensitivity grade 3 to cetuximab (n = 1 each). Most symptom scales had their worst value at the last treatment day and recovered until the 4th follow-up visit. Conclusion: The study treatment was tolerable and promising. Reduced quality of life recovered for most aspects until the last follow-up visit. Keywords: Particle therapy, Carbon ion therapy, Cetuximab, LAHNC, SCCHN, Head and neck cancerhttp://www.sciencedirect.com/science/article/pii/S240563081830065X |
| spellingShingle | H. Hauswald A.D. Jensen J. Krauss R. Haselmann K. Lossner S. Hartmann C. Windemuth-Kieselbach M.W. Münter J. Debus Phase II study of induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil followed by radioimmunotherapy with cetuximab and intensity-modulated radiotherapy in combination with a carbon ion boost for locally advanced tumors of the oro-, hypopharynx and larynx Clinical and Translational Radiation Oncology |
| title | Phase II study of induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil followed by radioimmunotherapy with cetuximab and intensity-modulated radiotherapy in combination with a carbon ion boost for locally advanced tumors of the oro-, hypopharynx and larynx |
| title_full | Phase II study of induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil followed by radioimmunotherapy with cetuximab and intensity-modulated radiotherapy in combination with a carbon ion boost for locally advanced tumors of the oro-, hypopharynx and larynx |
| title_fullStr | Phase II study of induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil followed by radioimmunotherapy with cetuximab and intensity-modulated radiotherapy in combination with a carbon ion boost for locally advanced tumors of the oro-, hypopharynx and larynx |
| title_full_unstemmed | Phase II study of induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil followed by radioimmunotherapy with cetuximab and intensity-modulated radiotherapy in combination with a carbon ion boost for locally advanced tumors of the oro-, hypopharynx and larynx |
| title_short | Phase II study of induction chemotherapy with docetaxel, cisplatin, 5-fluorouracil followed by radioimmunotherapy with cetuximab and intensity-modulated radiotherapy in combination with a carbon ion boost for locally advanced tumors of the oro-, hypopharynx and larynx |
| title_sort | phase ii study of induction chemotherapy with docetaxel cisplatin 5 fluorouracil followed by radioimmunotherapy with cetuximab and intensity modulated radiotherapy in combination with a carbon ion boost for locally advanced tumors of the oro hypopharynx and larynx |
| url | http://www.sciencedirect.com/science/article/pii/S240563081830065X |
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