Induction chemotherapy (IC) followed by radiotherapy (RT) versus cetuximab plus IC and RT in advanced laryngeal/hypopharyngeal cancer resectable only by total laryngectomy—final results of the larynx organ preservation trial DeLOS-II
| Autor: | K. Vogel, M. Münter, U. Schroeder, O. Kölbl, Thomas Lenarz, Gunnar Wichmann, J. Bünzel, Ulrich Keilholz, F Schreiber, S. Remmert, Jens Peter Klussmann, M. Knödler, Michael Flentje, U. Bockmühl, J Strutz, Florian Lordick, Holger Sudhoff, Hans Juergen Welkoborsky, Martin Görner, Swantje Held, Volker Budach, Dirk Esser, Christian Sittel, M. de Wit, Barbara Wollenberg, Andreas Dietz, Georg Maschmeyer, Orlando Guntinas-Lichius, Matthias Scheich, R Hagen, Petra Feyer, Hans-Theodor Eich, Andreas Boehm, C Rudack, Thomas Foerg, D. Thurnher, Martin Westhofen, S Preyer, Matthias G. Hautmann, Susanne Wiegand, Markus Jungehülsing, Thomas Kuhnt, V Schilling, Leo Pfreundner |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.medical_treatment Urology Cetuximab Salvage therapy Laryngectomy Docetaxel 03 medical and health sciences 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans 030223 otorhinolaryngology Laryngeal Neoplasms Survival rate Aged Salvage Therapy Hypopharyngeal Neoplasms Radiotherapy business.industry Head and neck cancer Induction chemotherapy Hypopharyngeal cancer Chemoradiotherapy Induction Chemotherapy Hematology Middle Aged Prognosis medicine.disease Combined Modality Therapy Survival Rate Oncology 030220 oncology & carcinogenesis Female Fluorouracil Cisplatin business Organ Sparing Treatments Follow-Up Studies medicine.drug |
| DOI: | 10.1093/annonc/mdy332 |
| Popis: | Background The German multicenter randomized phase II larynx organ preservation (LOP) trial DeLOS-II was carried out to prove the hypothesis that cetuximab (E) added to induction chemotherapy (IC) and radiotherapy improves laryngectomy-free survival (LFS; survival with preserved larynx) in locally advanced laryngeal/hypopharyngeal cancer (LHSCC). Patients and methods Treatment-naive patients with stage III/IV LHSCC amenable to total laryngectomy (TL) were randomized to three cycles IC with TPF [docetaxel (T) and cisplatin (P) 75 mg/m2/day 1, 5-FU (F) 750 mg/m2/day days 1–5] followed by radiotherapy (69.6 Gy) without (A) or with (B) standard dose cetuximab for 16 weeks throughout IC and radiotherapy (TPFE). Response to first IC-cycle (IC-1) with ≥30% endoscopically estimated tumor surface shrinkage (ETSS) was used to define early responders; early salvage TL was recommended to non-responders. The primary objective was 24 months LFS above 35% in arm B. Results Of 180 patients randomized (July 2007 to September 2012), 173 fulfilled eligibility criteria (A/B: larynx 44/42, hypopharynx 41/46). Because of 4 therapy-related deaths among the first 64 randomized patients, 5-FU was omitted from IC in the subsequent 112 patients reducing further fatal toxicities. Thus, IC was TPF in 61 patients and TP in 112 patients, respectively. The primary objective (24 months LFS above 35%) was equally met by arms A (40/85, 47.1%) as well as B (41/88, 46.6%). One hundred and twenty-three early responders completed IC+RT; their overall response rates (TPF/TP) were 94.7%/87.2% in A versus 80%/86.0% in B. The 24 months overall survival (OS) rates were 68.2% and 69.3%. Conclusions Despite being accompanied by an elevated frequency in adverse events, the IC with TPF/TP plus cetuximab was feasible but showed no superiority to IC with TPF/TP regarding LFS and OS at 24 months. Both early response and 24 months LFS compare very well to previous LOP trials and recommend effective treatment selection and stratification by ETSS. Clinical trial information NCT00508664. |
| Databáze: | OpenAIRE |
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