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@ARTICLE{Boehmerle:277974,
      author       = {Boehmerle, Wolfgang and Hagenacker, Tim and Leo, Markus and
                      Schmitt, Linda-Isabell and Lehmann, Helmar C and Klein, Ines
                      and Stegherr, Regina and Konietschke, Frank and Endres,
                      Matthias and Huehnchen, Petra},
      title        = {{R}esults of the preclinical multicenter randomized
                      controlled paclitaxel-induced neuropathy prevention
                      replication study ({PINPRICS}).},
      journal      = {BMC Research Notes},
      volume       = {18},
      number       = {1},
      issn         = {1756-0500},
      address      = {London},
      publisher    = {[Verlag nicht ermittelbar]},
      reportid     = {DZNE-2025-00506},
      pages        = {145},
      year         = {2025},
      abstract     = {Chemotherapy-induced peripheral neuropathy (CIPN) is a
                      frequent and serious side effect of many cytotoxic drugs,
                      including paclitaxel. Despite the identification of
                      treatment options in animal models, clinical trials for the
                      treatment or prevention of CIPN have been negative. Major
                      challenges for successful clinical translation of
                      preclinical data include a lack of reproducibility and
                      randomization, small sample sizes and insufficient
                      statistical tests. We therefore conducted a confirmatory,
                      preclinical multicenter randomized controlled replication
                      trial to test the safety and efficacy of three drugs for
                      preventing paclitaxel-induced polyneuropathy: (1) nilotinib,
                      (2) lithium carbonate and (3) interleukin-6-neutralizing
                      antibodies. We preregistered the data analysis plan as well
                      as the two-step study protocol: the optimal doses of the
                      three compounds were assessed first and then tested in a
                      mouse breast cancer xenograft model to compare safety and
                      efficacy.Unfortunately, toxicity of intraperitoneally
                      administered nilotinib in combination with paclitaxel was
                      observed, and higher-than-expected tumor growth resulted in
                      a lack of power when the trial was analyzed. Thus, although
                      lithium carbonate and IL-6-neutralizing antibodies tended
                      toward neuroprotection, the differences between these groups
                      were not statistically significant. However, the PINPRICS
                      study ultimately still provides important lessons with
                      regard to the planning and conduction of multicenter
                      preclinical trials.},
      keywords     = {Paclitaxel: adverse effects / Animals / Mice / Female /
                      Lithium Carbonate: pharmacology / Lithium Carbonate:
                      therapeutic use / Lithium Carbonate: administration $\&$
                      dosage / Pyrimidines: therapeutic use / Pyrimidines:
                      pharmacology / Pyrimidines: administration $\&$ dosage /
                      Humans / Peripheral Nervous System Diseases: chemically
                      induced / Peripheral Nervous System Diseases: prevention
                      $\&$ control / Antibodies, Neutralizing: pharmacology /
                      Antibodies, Neutralizing: therapeutic use / Interleukin-6:
                      immunology / Interleukin-6: antagonists $\&$ inhibitors /
                      Antineoplastic Agents, Phytogenic: adverse effects / Cell
                      Line, Tumor / Xenograft Model Antitumor Assays / Breast
                      Neoplasms: drug therapy / Breast Neoplasms: pathology /
                      Chemotherapy-induced polyneuropathy (Other) / Neuropathic
                      pain (Other) / Neuroprotection (Other) / Preclinical
                      replication study (Other) / Paclitaxel (NLM Chemicals) /
                      Lithium Carbonate (NLM Chemicals) / Pyrimidines (NLM
                      Chemicals) / nilotinib (NLM Chemicals) / Antibodies,
                      Neutralizing (NLM Chemicals) / Interleukin-6 (NLM Chemicals)
                      / Antineoplastic Agents, Phytogenic (NLM Chemicals)},
      cin          = {AG Endres},
      ddc          = {570},
      cid          = {I:(DE-2719)1811005},
      pnm          = {353 - Clinical and Health Care Research (POF4-353)},
      pid          = {G:(DE-HGF)POF4-353},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40200318},
      doi          = {10.1186/s13104-025-07206-2},
      url          = {https://pub.dzne.de/record/277974},
}