CC BY-NC-ND 4.0 · Laryngorhinootologie 2018; 97(S 02): S84
DOI: 10.1055/s-0038-1640003
Abstracts
Onkologie: Oncology

Induction chemotherapy (IC) followed by radiotherapy (RT) vs. cetuximab plus IC and R in resectable advanced laryngeal/hypopharyngeal cancer (LHSCC) – final results from the randomized DeLOS-II trial

A Dietz
1   Univ. HNO-Klinik, Leipzig
,
R Hagen
2   Univ. HNO-Klinik, Würzburg
,
D Eßer
3   Helios-Kliniken, HNO-Klinik, Erfurt
,
F Schreiber
4   Klinikum, Kassel
,
V Schilling
5   Vivantes Klin. Neukölln, HNO-Klinik, Berlin
,
M Jungehülsing
6   Klinikum E. v. Bergmann, HNO-Klinik, Potsdam
,
J Strutz
7   Univ. HNO-Klinik, Regensburg
,
U Schröder
8   Univ. HNO-Klinik, Lübeck
,
U Keilholz
9   CCC Charité, Berlin
,
G Wichmann
1   Univ. HNO-Klinik, Leipzig
› Author AffiliationsInvestigator Initiated Trial; Merck Serono, Sanofi Aventis
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Introduction:

The German multicenter randomized phase-II larynx-organ preservation trial DeLOS-II was performed to investigate the impact of cetuximab (E) added throughout induction chemotherapy (IC) and radiation (R) on laryngectomy-free survival (LFS) in LHSCC.

Patients and methods:

Untreated patients stage III/IV LHSCC amenable to total laryngectomy (TL) were randomized to three cycles IC with TPF (docetaxel and cisplatin 75 mg/m2/day 1 and 5-FU 750 mg/m2/day days 1 – 5) followed by RT (69.6 Gy) without (A) or with (B) standard dose cetuximab for 16 weeks throughout IC and RT. Response to first IC-cycle (IC-1) with ≥30% endoscopically estimated tumor surface shrinkage (ETSS) was used to define early responders (ER); early salvage laryngectomy (eSTL) was recommended to non-responders. The primary objective of DeLOS-II was a 24-months LFS above 35% in arm B.

Results:

Of 180 patients randomized (7/2007 – 9/2012), 173 fulfilled ITT criteria (A/B: larynx 44/42, hypopharynx 41/46). Because of 4 therapy related deaths among 64 randomized patients, F was omitted from IC preventing further treatment related deaths. Consequently, IC was TPF 30/31 and TP 55/57, respectively. 58 (68.2%, 63.3%/70.9%) and 68 patients (77.3%, 80.6%/75.4%) in A vs. B were ER; 31.8% (36.7%/29.1%) vs. 22.7% (19.4%/24.6%) were non-responders. 123 ER patients completed IC+RT; their overall response rates (TPF/TP) were 94.7%/87.2% in A vs. 80%/86.0% in B. The 24-months overall survival (OS) rates were 68.2% and 69.3%. The primary objective (24-months LFS above 35%) was equally met by arms A (40/85, 47.1%) and B (41/88, 46.6%).

Conclusions:

Despite being accompanied by an elevated frequency in adverse events the IC with TPFE/TPE was feasible but showed no superiority to IC with TPF/TP regarding LFS and OS.



Publication History

Publication Date:
18 April 2018 (online)

© 2018. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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