Frontiers in Oncology (Aug 2024)
The European Larynx Organ Preservation Study [MK-3475-C44]
- Gunnar Wichmann,
- Gunnar Wichmann,
- Theresa Wald,
- Theresa Wald,
- Markus Pirlich,
- Markus Pirlich,
- Joanna Napp,
- Ina Münter,
- Thomas Asendorf,
- Ralf Tostmann,
- Jeannette Vogt,
- Jeannette Vogt,
- Kathrin Vogel,
- Kathrin Vogel,
- Sylvia Meuret,
- Sylvia Meuret,
- Matthaeus Stoehr,
- Matthaeus Stoehr,
- Veit Zebralla,
- Veit Zebralla,
- Nils Henrik Nicolay,
- Nils Henrik Nicolay,
- Thomas Kuhnt,
- Thomas Kuhnt,
- Peter Hambsch,
- Peter Hambsch,
- Orlando Guntinas-Lichius,
- Orlando Guntinas-Lichius,
- Jens Peter Klußmann,
- Susanne Wiegand,
- Susanne Wiegand,
- Susanne Wiegand,
- Andreas Dietz,
- Andreas Dietz
Affiliations
- Gunnar Wichmann
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Gunnar Wichmann
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Theresa Wald
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Theresa Wald
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Markus Pirlich
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Markus Pirlich
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Joanna Napp
- Clinical Trial Unit, University Medical Center Goettingen, Göttingen, Germany
- Ina Münter
- Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany
- Thomas Asendorf
- Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany
- Ralf Tostmann
- Clinical Trial Unit, University Medical Center Goettingen, Göttingen, Germany
- Jeannette Vogt
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Jeannette Vogt
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Kathrin Vogel
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Kathrin Vogel
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Sylvia Meuret
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Sylvia Meuret
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Matthaeus Stoehr
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Matthaeus Stoehr
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Veit Zebralla
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Veit Zebralla
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Nils Henrik Nicolay
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Nils Henrik Nicolay
- Clinic for Radiation Oncology, University Hospital Leipzig, Leipzig, Germany
- Thomas Kuhnt
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Thomas Kuhnt
- Clinic for Radiation Oncology, University Hospital Leipzig, Leipzig, Germany
- Peter Hambsch
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Peter Hambsch
- Clinic for Radiation Oncology, University Hospital Leipzig, Leipzig, Germany
- Orlando Guntinas-Lichius
- ENT Department, Jena University Hospital, Jena, Germany
- Orlando Guntinas-Lichius
- The Comprehensive Cancer Center Central Germany, Jena University Hospital, Jena, Germany
- Jens Peter Klußmann
- Department of Oto-Rhino-Laryngology Head and Neck Surgery, University of Cologne, Cologne, Germany
- Susanne Wiegand
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Susanne Wiegand
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- Susanne Wiegand
- Department of Otorhinolaryngology, Head and Neck Surgery, Christian-Albrechts-University Kiel, Kiel, Germany
- Andreas Dietz
- Clinic for Otorhinolaryngology and Head and Neck Surgery, Department of Head Medicine and Oral Health, University of Leipzig, Leipzig, Germany
- Andreas Dietz
- The Comprehensive Cancer Center Central Germany, Leipzig University Hospital, Leipzig, Germany
- DOI
- https://doi.org/10.3389/fonc.2024.1433238
- Journal volume & issue
-
Vol. 14
Abstract
The European Larynx Organ Preservation Study (ELOS; NCT06137378) is a prospective, randomized, open-label, two-armed parallel group controlled, phase II multicenter larynx organ preservation (LOP) trial in locoregionally advanced (LA) stage III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx (LHSCC) amenable for total laryngectomy (TL) with PD-L1 expression within tumor tissue biopsy, calculated as CPS ≥ 1. Induction chemotherapy (IC) with docetaxel and cisplatin (TP) followed by radiation will be compared to TP plus PD-1 inhibition by pembrolizumab (MK-3475; 200 mg i.v. starting day 1 q3w for 17 cycles). After a short induction early response evaluation (ERE) 21 ± 3 days after the first cycle of IC (IC-1), responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥30% will get an additional two cycles of IC followed by intensity-modulated radiotherapy 70–72 Gy (EQD2/α/β = 10) aiming at LOP. Nonresponders (ETSS < 30% or progressing disease) will receive TL and bilateral neck dissection followed by postoperative radiation or chemoradiation as recommended by the clinic’s multidisciplinary tumor board. Pembrolizumab treatment will be continued in the intervention arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent of subsequent decisions on adjuvant therapy after TL.Clinical Trial Registrationclinicaltrials.gov, identifier NCT06137378.
Keywords
- head and neck squamous cell carcinoma (HNSCC)
- larynx and hypopharynx cancer (LHSCC)
- larynx organ preservation (LOP)
- total laryngectomy (TL)
- inductionchemotherapy (IC)
- randomized controlled trial (RCT)
