Meeting
2014 ASCO Annual Meeting
Induction chemotherapy (IC) docetaxel (T), cisplatin (P), 5-fluorouracil (F) (TPF), or TP followed by concomitant boost radiotherapy (R) with or without cetuximab (E) for functional organ preservation (FOP) of resectable laryngeal and hypopharyngeal cancer (LHSCC): First results of the phase II randomized DeLOS-II study.
Authors
Andreas Dietz
University of Leipzig, Leipzig, Germany
Andreas Dietz , Michael Flentje , Rudolf Hagen , Ulrike Bockmuehl , Oliver Koelbl , Volker Schilling , Georg Maschmeyer , Ursula Schroeder , Christian Sittel , Martin Goerner , Thomas Lenarz , Jens Peter Klussmann , Orlando Guntinas-Lichius , Claudia Rudack , Sabine Reinisch , Thomas Foerg , Martin Westhofen , Hans Juergen Welkoborsky , Dirk Esser , Ulrich Keilholz
Organizations
University of Leipzig, Leipzig, Germany, Klinik fuer Strahlentherapie, Wuerzburg, Germany, ENT Department University Würzburg, Würzburg, Germany, ENT Clinic, Kassel, Germany, Radiation Oncology University Regensburg, Regensburg, Germany, ENT Clinic Vivantes, Berlin, Neuköln, Germany, Potsdam Klinikum, Potsdam, Germany, ENT Department University Lübeck, Lübeck, Germany, ENT Department Katharinen Hospital, Stuttgart, Germany, Clinic Hematology Oncology Bielefeld, Bielefeld, Germany, ENT Department MHH Hannover, Hannover, Germany, ENT Department University Gießen, Gießen, Germany, University Hospital Jena, Head and Neck Surgery, Jena, Germany, ENT Department University Münster, Münster, Germany, ENT Department University Graz, Graz, Austria, Department Radiation Oncology, Vincentius Clinic, Karlsruhe, Germany, ENT Department University Aachen, Aachen, Germany, ENT Clinic, Nordstadt, Hannover, Germany, ENT Department, Helios Clinic, Erfurt, Germany, Charité Comprehensive Cancer Center, Berlin, Germany
Research Funding
Pharmaceutical/Biotech Company
Background: The DeLOS-II trial is a German multicenter randomized phase II trial (IIT) investigating IC with or without cetuximab for patients with LHSCC, followed by R assessing FOP. Methods: Previously untreated patients (pts) with resectable stage III/IV LHSCC indicated for total laryngectomy were randomized to three cycles (TP both 75 mg/m² day 1 and F 750 mg/m²/day on days 1-5) without (arm A) or with (arm B) standard dose of cetuximab for 16 weeks. In case of non-response after the first cycle, the study therapy was terminated and salvage laryngectomy was performed. Three cycles of IC were followed by R (69.6Gy). In this first analysis, we report rates of 6-months survival with functional larynx (FOP). Secondary endpoints included feasibility and toxicity. Results: 180 pts were randomized (7/2007-9/2012), 174 fulfilled ITT criteria (85.1% male, 49.4% larynx, 87.4% T3/4N2bc, equally distributed both arms). Due to 4 therapy related deaths among the first 64 pts (3 arm A, 1 B), F was omitted from IC in 2/2009. Interim analysis for response and toxicity of 126 pts in 2011 showed no efficacy differences between TPF vs TP and no more treatment related deaths. Overall, in arm A 31 pts received TPF and 55 TP, in arm B 31 TPFE and 57 TPE IC. 66.7% of pts received complete IC (4.0% two cycles; 29.3% one cycle). Dose reduction (>10%) mainly due to toxicity occurred in 27.9% arm A and 98.9% B (30.7% T, 31.8% P, 18.2% F, 98.9% E). Main early toxicity grade 3/4 was hematotoxicity (81.4% in A, 85.2% B). Early response (CR, PR) after first cycle in arm A was 67.4% (95%-CI: 56.5-77.2) and in arm B 77.3% (67.1-85.5; p=0.15). 126 pts were early responders and suitable for the complete IC and R protocol. Overall response in this group was CR/PR 81.0/8.6% in A, 77.9/5.9% in B. Endpoint (loss of FOP, death) was reached in 31.4% vs. 17.0%, favoring arm B (HR 0.502 [0.267-0.944]; p=0.0289). Conclusions: IC with TPFE/TPE was feasible and more effective compared to TPF/TP for Larynx preservation. TPE was less toxic and similarly effective as TPFE. Clinical trial information: NCT00508664.
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Abstract Details
Session Type
Poster Highlights Session
Session Title
Head and Neck Cancer
Track
Head and Neck Cancer
Sub Track
Head and Neck Cancer
Clinical Trial Registration Number
NCT00508664
Citation
J Clin Oncol 32:5s, 2014 (suppl; abstr 6016^)
DOI
10.1200/jco.2014.32.15_suppl.6016
Abstract #
6016^
Poster Bd #
31
Abstract Disclosures
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