eprintid: 23485 rev_number: 12 eprint_status: archive userid: 1589 dir: disk0/00/02/34/85 datestamp: 2017-09-21 12:09:00 lastmod: 2024-05-25 17:32:42 status_changed: 2017-09-21 12:09:00 type: article metadata_visibility: show creators_name: Dyckhoff, Gerhard creators_name: Plinkert, Peter K. creators_name: Ramroth, Heribert title: A change in the study evaluation paradigm reveals that larynx preservation compromises survival in T4 laryngeal cancer patients subjects: ddc-610 divisions: i-911000 divisions: i-912800 abstract: Background: Larynx preservation (LP) is recommended for up to low-volume T4 laryngeal cancer as an evidence-based treatment option that does not compromise survival. However, a reevaluation of the current literature raises questions regarding whether there is indeed reliable evidence to support larynx preservation for T4 tumor patients. Methods: In an observational cohort study of 810 laryngeal cancer patients, we evaluated the outcomes of all T4 tumor patients treated with primary chemo-radiotherapy (CRT) or primary radiotherapy alone (RT) compared with upfront total laryngectomy followed by adjuvant (chemo)radiotherapy (TL + a[C]RT). Additionally, we reevaluated the studies that form the evidence base for the recommendation of LP for patients with up to T4 tumors (Pfister et al., J Clin Oncol 24:3693–704, 2006). Results: The evaluation of all 288 stage III and IV patients together did not show a significant difference in overall survival (OS) between CRT-LP and TL + a(C)RT (hazard ratio (HR) 1.23; 95% confidence interval (CI): 0.82–1.86; p = 0.31) using a multivariate proportional hazard model. However, a subgroup analysis of T4 tumor patients alone (N = 107; 13.9%) revealed significantly worse OS after CRT compared with TL + a(C)RT (HR 2.0; 95% CI: 1.04–3.7; p = 0.0369). A reevaluation of the subgroup of T4 patients in the 5 LP studies that led to the ASCO clinical practice guidelines revealed that only 21–45 T4 patients had differential data on survival outcome. These data, however, showed a markedly worse outcome for T4 patients after LP. Conclusions: T4 laryngeal cancer patients who reject TL as a treatment option should be informed that their chance of organ preservation with primary conservative treatment is likely to result in a significantly worse outcome in terms of OS. Significant loss of survival in T4 patients after LP is also confirmed in recent literature. date: 2017 publisher: BioMed Central; Springer id_scheme: DOI ppn_swb: 1656463474 own_urn: urn:nbn:de:bsz:16-heidok-234850 language: eng bibsort: DYCKHOFFGEACHANGEINT2017 full_text_status: public publication: BMC Cancer volume: 17 number: 609 place_of_pub: London; Berlin; Heidelberg pagerange: 1-9 issn: 1471-2407 citation: Dyckhoff, Gerhard ; Plinkert, Peter K. ; Ramroth, Heribert (2017) A change in the study evaluation paradigm reveals that larynx preservation compromises survival in T4 laryngeal cancer patients. BMC Cancer, 17 (609). pp. 1-9. ISSN 1471-2407 document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/23485/1/12885_2017_Article_3608.pdf