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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.


ABSTRACT: 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.

SUBMITTER: Hauswald H 

PROVIDER: S-EPMC6199783 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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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.

Hauswald H H   Jensen A D AD   Krauss J J   Haselmann R R   Lossner K K   Hartmann S S   Windemuth-Kieselbach C C   Münter M W MW   Debus J J  

Clinical and translational radiation oncology 20180921


<h4>Purpose</h4>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.<h4>Methods</h4>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 f  ...[more]

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