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@ARTICLE{Dorman:277145,
      author       = {K. Dorman$^*$ and S. Boeck$^*$ and R. J. Snijder and J.
                      Siveke$^*$ and M. Schenk and J. Mayerle and K. Caca and J.
                      Freiberg-Richter and L. Fischer von Weikersthal and F.
                      Kullmann and A. Reinacher-Schick and M. Fuchs and S. Kanzler
                      and V. Kunzmann and T. J. Ettrich and D. Zhang and S. Held
                      and A. Abdul-Ahad and M. von Bergwelt-Baildon$^*$ and V.
                      Heinemann$^*$ and M. Haas},
      title        = {{I}ntegrated {A}nalysis of the {RASH} {S}tudy with the
                      {U}se of the '{B}urden of {T}herapy' ({BOT}h®{TM})
                      {M}ethodology-{A} {N}ovel {T}ool for {A}ssessing {A}dverse
                      {E}vents in {M}etastatic {P}ancreatic {C}ancer.},
      journal      = {Current oncology},
      volume       = {30},
      number       = {6},
      issn         = {1198-0052},
      address      = {Toronto, Ontario},
      publisher    = {Multimed},
      reportid     = {DKFZ-2023-01307},
      pages        = {5828 - 5834},
      year         = {2023},
      abstract     = {This analysis of the RASH trial (NCT01729481) aimed at
                      gaining a better understanding of the 'Burden of Therapy'
                      (BOTh®TM) in pancreatic ductal adenocarcinoma (PDAC). In
                      the RASH study, 150 patients with newly diagnosed metastatic
                      PDAC were treated with gemcitabine plus erlotinib
                      (gem/erlotinib) for four weeks. Patients who developed a
                      skin rash during this four-week run-in phase continued with
                      the gem/erlotinib treatment, while rash-negative patients
                      were switched to FOLFIRINOX. The study demonstrated a 1-year
                      survival rate of rash-positive patients who received
                      gem/erlotinib as first-line treatment that was comparable to
                      previous reports of patients receiving FOLFIRINOX. To
                      understand whether these comparable survival rates may be
                      accompanied by better tolerability of the gem/erlotinib
                      treatment compared to FOLFIRINOX, the BOTh®TM methodology
                      was used to continuously quantify and depict the burden of
                      therapy generated by treatment emergent events (TEAEs).
                      Sensory neuropathy was significantly more common in the
                      FOLFIRINOX arm, and prevalence as well as severity increased
                      over time. In both arms, the BOTh®TM associated with
                      diarrhea decreased over the course of treatment. The
                      BOTh®TM caused by neutropenia was comparable in both arms
                      but decreased in the FOLFIRINOX arm over time, possibly due
                      to chemotherapy dose reductions. Overall, gem/erlotinib was
                      associated with a slightly higher overall BOTh®TM, but the
                      difference was not statistically significant (p = 0.6735).
                      In summary, the BOTh®TM analysis facilitates the evaluation
                      of TEAEs. In patients fit for intense chemotherapeutic
                      regimens, FOLFIRINOX is associated with a lower BOTh®TM
                      than gem/erlotinib.},
      keywords     = {FOLFIRINOX (Other) / burden of therapy (Other) / erlotinib
                      (Other) / gemcitabine (Other) / pancreatic cancer (Other) /
                      quality of life (Other) / rash (Other)},
      cin          = {MU01 / ED01},
      ddc          = {610},
      cid          = {I:(DE-He78)MU01-20160331 / I:(DE-He78)ED01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37366919},
      pmc          = {pmc:PMC10297548},
      doi          = {10.3390/curroncol30060436},
      url          = {https://inrepo02.dkfz.de/record/277145},
}