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CLINICAL TRIAL article

Front. Oncol.
Sec. Head and Neck Cancer
Volume 14 - 2024 | doi: 10.3389/fonc.2024.1433238
This article is part of the Research Topic Advanced Head and Neck Cancer: from Organ Preservation Strategies to extended resections and reconstruction View all articles

The European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]

Provisionally accepted
Gunnar Wichmann Gunnar Wichmann 1,2*Theresa Wald Theresa Wald 1,2Markus Pirlich Markus Pirlich 1,2Joanna Napp Joanna Napp 3Ina Münter Ina Münter 4Thomas Asendorf Thomas Asendorf 4Ralf Tostmann Ralf Tostmann 3Jeannette Vogt Jeannette Vogt 1,2Kathrin Vogel Kathrin Vogel 1,2Sylvia Meuret Sylvia Meuret 1,2Matthaeus Stoehr Matthaeus Stoehr 1,2Veit Zebralla Veit Zebralla 1,2Nils H. Nicolay Nils H. Nicolay 1,5Thomas Kuhnt Thomas Kuhnt 1,5Peter Hambsch Peter Hambsch 1,5Orlando Guntinas-Lichius Orlando Guntinas-Lichius 6Jens P. Klußmann Jens P. Klußmann 7Susanne Wiegand Susanne Wiegand 1,2,8Andreas Dietz Andreas Dietz 1
  • 1 University Hospital Leipzig, Leipzig, Lower Saxony, Germany
  • 2 Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Leipzig, Leipzig, Lower Saxony, Germany
  • 3 University Medical Center Göttingen, Göttingen, Lower Saxony, Germany
  • 4 Institute of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany
  • 5 Department for Radiation Therapy and Radiation Oncology, University Hospital Leipzig, Leipzig, Lower Saxony, Germany
  • 6 University Hospital Jena, Jena, Germany
  • 7 Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital of Cologne, Cologne, Germany
  • 8 University of Kiel, Kiel, Germany

The final, formatted version of the article will be published soon.

    The European Larynx Organ Preservation Study (ELOS; NCT06137378) is a prospective, randomized, open-label, two-armed parallel group controlled, phase II multicenter larynxorgan 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 short induction early response evaluation (ERE) 21 ± 3 days after first cycle IC (IC-1) responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30% will get additional 2 cycles IC followed by intensity-modulated radiotherapy 70-72 Gy (EQD2/ α/β = 10) aiming on 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 from subsequent decision on adjuvant therapy after TL.

    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), larynx organ function, immune checkpoint blockade PD-1:PD-L1 axis

    Received: 15 May 2024; Accepted: 12 Jul 2024.

    Copyright: © 2024 Wichmann, Wald, Pirlich, Napp, Münter, Asendorf, Tostmann, Vogt, Vogel, Meuret, Stoehr, Zebralla, Nicolay, Kuhnt, Hambsch, Guntinas-Lichius, Klußmann, Wiegand and Dietz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Gunnar Wichmann, University Hospital Leipzig, Leipzig, Lower Saxony, Germany

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