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@ARTICLE{Sprave:301518,
      author       = {T. Sprave$^*$ and J. Sahlmann and A. R. Thomsen$^*$ and D.
                      Klein and H. Schäfer$^*$ and R. Stoian$^*$ and V. Verma and
                      A.-L. Grosu$^*$ and E. B. M. Ordonez$^*$},
      title        = {{D}oes severe mucositis impair oncological outcome in head
                      and neck cancer patients? {A} pooled analysis of two
                      prospective studies with long-term follow-up.},
      journal      = {BMC cancer},
      volume       = {25},
      number       = {1},
      issn         = {1471-2407},
      address      = {London},
      publisher    = {BioMed Central},
      reportid     = {DKFZ-2025-01055},
      pages        = {909},
      year         = {2025},
      abstract     = {Oral mucositis (OM) is a frequently reported radiotherapy
                      (RT)-induced acute toxicity in head and neck $(H\&N)$ cancer
                      patients. Severe OM may be a dose-limiting condition, which
                      can affect oncological outcomes. Therefore, we conducted a
                      pooled analysis of two prospective studies with long-term
                      follow-up to evaluate the impact of grade ≥3 OM on
                      outcomes.This pooled analysis included 253 $H\&N$ cancer
                      patients who received primary definitive or adjuvant
                      chemoradiotherapy at the University of Freiburg Medical
                      Center. Kaplan-Meier analyses with log-rank tests stratified
                      for the presence of grade 3 OM were performed for overall
                      survival (OS), local recurrence-free survival (LRFS), and
                      distant-metastasis free survival (DMFS). Univariate Cox
                      proportional hazards regression was performed to identify
                      prognostic factors for OS, LRFS, and DMFS.The majority of
                      participants had locally advanced disease: UICC stage IVA in
                      157 $(62.1\%)$ and IVB in 31 $(12.3\%).$ During treatment,
                      168 $(66.4\%)$ participants developed grade 3 OM. After a
                      median follow-up of 73.6 months, the median OS was 64.6
                      months $(95\%$ CI, 47.6-83.7), and the median LRFS and DMFS
                      had not yet been reached. Advanced disease stages had a
                      significant impact on OS as follows: UICC IVb vs. I, HR 4.62
                      $(95\%-CI:$ 1.364-5.637, SE 0.6, p = 0.014) and UICC IVc vs.
                      I, HR 9.01 $(95\%-CI:$ 1.500-54.1643, SE = 0.9, p = 0.016).
                      Previous surgery also has a significant impact on OS with an
                      HR 0.65 $(95\%$ CI: 0.440-0.948, SE 0.2, p = 0.026). RT
                      duration also showed a significant impact on OS with HR 1.03
                      $(95\%$ CI: 1.002-1.067, SE = 0, p = 0.040). For LRFS, prior
                      surgery had a significant impact with an HR of 0.46 $(95\%$
                      CI: 0.247-0.857, SE 0.3, p = 0.014). Furthermore, the
                      cumulative RT dose had a measurable impact on LRFS with HR
                      1.10 $(95\%$ CI: 1.022-1.189, SE = 0.03, p = 0.012). Smoker
                      status showed a significant effect on DMFS with an HR 3.29
                      $(95\%$ CI: 1.090-9.872, SE 0.561, p = 0.034). The presence
                      of grade 3 OM has no significant impact on LRFS, OS, or
                      DMFS.Severe acute grade 3 OM shows no long-term impact on
                      oncological endpoints. Validation in larger multicenter
                      cohorts is recommended.},
      keywords     = {Humans / Head and Neck Neoplasms: therapy / Head and Neck
                      Neoplasms: mortality / Head and Neck Neoplasms: pathology /
                      Head and Neck Neoplasms: complications / Male / Middle Aged
                      / Female / Aged / Prospective Studies / Follow-Up Studies /
                      Stomatitis: etiology / Stomatitis: pathology / Adult /
                      Treatment Outcome / Prognosis / Aged, 80 and over /
                      Chemoradiotherapy: adverse effects / Neoplasm Staging /
                      Mucositis: etiology / Kaplan-Meier Estimate / Head and neck
                      cancer (Other) / Mucositis (Other) / Radiation therapy
                      (Other)},
      cin          = {FR01},
      ddc          = {610},
      cid          = {I:(DE-He78)FR01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40399815},
      doi          = {10.1186/s12885-025-14293-8},
      url          = {https://inrepo02.dkfz.de/record/301518},
}