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@ARTICLE{Gross:284972,
      author       = {N. D. Gross and D. M. Miller and N. I. Khushalani and V.
                      Divi and E. S. Ruiz and E. J. Lipson and F. Meier and Y. B.
                      Su and P. L. Swiecicki and J. Atlas and J. L. Geiger and A.
                      Hauschild and J. H. Choe and B. G. M. Hughes and D.
                      Schadendorf$^*$ and V. A. Patel and J. Homsi and J. M. Taube
                      and A. M. Lim and R. Ferrarotto and S.-Y. Yoo and M. Mathias
                      and H. Han and F. Seebach and I. Lowy and M. G. Fury and D.
                      Rischin},
      title        = {{N}eoadjuvant cemiplimab and surgery for stage {II}-{IV}
                      cutaneous squamous-cell carcinoma: follow-up and survival
                      outcomes of a single-arm, multicentre, phase 2 study.},
      journal      = {The lancet / Oncology},
      volume       = {24},
      number       = {11},
      issn         = {1470-2045},
      address      = {London},
      publisher    = {The Lancet Publ. Group},
      reportid     = {DKFZ-2023-02161},
      pages        = {1196-1205},
      year         = {2023},
      note         = {2023 Nov;24(11):1196-1205},
      abstract     = {We previously reported rates of pathological complete
                      responses $(51\%$ $[95\%$ CI 39-62] per independent central
                      review, the primary endpoint) and major pathological
                      responses $(13\%$ per independent central review, a
                      secondary endpoint) to neoadjuvant cemiplimab (an anti-PD-1
                      inhibitor) among 79 patients with locoregionally advanced,
                      resectable cutaneous squamous cell carcinoma. Here, we
                      present follow-up data, including event-free, disease-free,
                      and overall survival.This single-arm, multicentre, phase 2
                      study included patients aged 18 years or older with
                      resectable stage II-IV (M0) cutaneous squamous cell
                      carcinoma and Eastern Cooperative Oncology Group performance
                      status of 0 or 1. Patients received up to four planned doses
                      of neoadjuvant cemiplimab 350 mg intravenously every 3 weeks
                      followed by curative-intent surgery. After surgery, per
                      investigator discretion, patients received either adjuvant
                      cemiplimab for up to 48 weeks, radiotherapy, or observation
                      alone. Secondary endpoints included in this follow-up
                      analysis are event-free survival, disease-free survival, and
                      overall survival, all summarised using the Kaplan-Meier
                      method. Activity and safety endpoints were analysed for all
                      enrolled patients who received at least one dose of
                      neoadjuvant cemiplimab. In this report, safety data are
                      reported for all patients who received at least one dose of
                      adjuvant cemiplimab. This trial is registered with
                      ClinicalTrials.gov, NCT04154943, has completed enrolment and
                      follow-up is ongoing.Between March 20, 2020, and July 8,
                      2021, 79 patients were enrolled. Median age was 73 years
                      (IQR 66-81), 67 $(85\%)$ patients were male, 12 $(15\%)$
                      were female, 69 $(87\%)$ were White, one was Asian $(1\%),$
                      one was other race $(1\%),$ and race was not reported for
                      eight $(10\%).$ As of data cutoff (Dec 1, 2022), median
                      follow-up was 18·7 months (IQR 15·6-22·1) for all 79
                      patients. Among 70 patients who had surgery, 65 $(93\%)$ had
                      post-surgical management data: 32 $(49\%)$ of 65 were
                      observed postoperatively, 16 $(25\%)$ received adjuvant
                      cemiplimab, and 17 $(26\%)$ received adjuvant radiotherapy.
                      11 $(14\%)$ of 79 patients had event-free survival events,
                      with an estimated 12-month event-free survival of $89\%$
                      $(95\%$ CI 79-94) for all patients. None of 40 patients who
                      had a pathological complete response and one $(10\%)$ of ten
                      patients with major pathological response had recurrence.
                      Six $(9\%)$ of 70 patients who completed surgery had a
                      disease-free survival event, with an estimated 12-month
                      disease-free survival of $92\%$ $(95\%$ CI 82-97). Nine
                      $(11\%)$ of 79 patients died, with an estimated 12-month
                      overall survival for all patients of $92\%$ $(95\%$ CI
                      83-96). Four $(25\%)$ of 16 patients who received adjuvant
                      cemiplimab treatment had grade 3 adverse events, including
                      one $(6\%)$ who had increased blood potassium, one $(6\%)$
                      who had traumatic limb amputation, and two who had serious
                      adverse events (one $[6\%]$ cardiomyopathy and one $[6\%]$
                      hypophysitis). There were no grade 4 adverse events or
                      treatment-related deaths.For patients with resectable stage
                      II-IV cutaneous squamous cell carcinoma, neoadjuvant
                      cemiplimab followed by surgery might be a potential
                      treatment option, addressing a substantial unmet
                      need.Regeneron Pharmaceuticals and Sanofi.},
      cin          = {ED01},
      ddc          = {610},
      cid          = {I:(DE-He78)ED01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37875144},
      doi          = {10.1016/S1470-2045(23)00459-X},
      url          = {https://inrepo02.dkfz.de/record/284972},
}