Page 47 - Pharma News Letter Vol1 Issue2 - Converted By Dr. Ahmed Rashed
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Research Publications


                                              Pharmacotherapy


                                             First published: 18 May 2023

                      Effect of cilostazol on preventing paclitaxel-induced
                   neuropathy in patients with breast cancer: A randomized

                                                 controlled trial










             Esraa A. Haroun , Noha O. Mansour , Ahmed  evaluated through common terminology criteria
                              1
                                                  1
             Eltantawy  , Mohamed E. E.Shams    1             for  adverse  event  (NCI-CTCAE)  version  4.
                       2
             1   Clinical  Pharmacy  and  Pharmacy  Practice   Secondary endpoints included assessment of the
             Department,  Faculty  of  Pharmacy,  Mansoura    patient’s QoL by the Functional Assessment of
             University,  Mansoura,  Egypt.                   Cancer Therapy/Gynecologic Oncology Group-
                                                              Neurotoxicity  (FACT-GOG-NTx)  subscale.
             2   Medical  Oncology  Unit,  Oncology  Center,   Exploratory  outcome  measures  included
             Mansoura  University,  Mansoura,  Egypt.         changes in serum levels of biomarkers namely
             Abstract                                         nerve growth factor (NGF), and neurofilament

             Study Objective: Paclitaxel-induced peripheral   light  chain  (NfL).
             neuropathy  is  a  significant  clinical  problem   Main Results:  The  incidence  of  grade  2  and
             can  markedly  deteriorate  patient’s  quality  of   3  peripheral  neuropathies  were  significantly
             life  (QoL).  Preclinical  evidence  exists  about   lower in the cilostazol group (40%) compared
             the  preventive  capacity  of  cilostazol  against   to  the  control  group  (86.7%)  (p < 0.001). The
             peripheral neuropathy. However, this hypothesis   incidence  of  clinically  significant  worsening
             has  not  yet  been  clinically  investigated.  This   in  neuropathy-related  QoL  was  higher  in
             proof-of-concept  study  evaluated  the  effect   control group compared to the cilostazol group
             of  cilostazol  on  the  incidence  of  paclitaxel-  (p = 0.001).  A  higher  percent  increase  from
             induced peripheral neuropathy in patients with   baseline  in  serum  NGF  was  observed  in  the
             non-metastatic  breast  cancer.                  cilostazol  group  (p = 0.043).  The  circulating

             Design: This is a parallel randomized placebo-   levels of NfL deemed comparable between the
                                                              two  arms  at  the  end  of  the  study  (p = 0.593).
             controlled trial.
                                                              Conclusion: Adjunctive use of cilostazol is as
             Setting:  The  Oncology  Center  at  Mansoura    a novel option that might reduce the incidence
             University,  Egypt.                              of paclitaxel-induced peripheral neuropathy and
             Patients: Patients with breast cancer scheduled  improve the patients’ QoL. Future larger clinical
             to receive paclitaxel 175 mg/m2 biweekly.        trials are warranted to confirm these findings.
             Interventions:  Patients  were  randomized  to  https://doi.org/10.1002/phar.2830
             either cilostazol group who received cilostazol
             tablets  100 mg  BID,  or  to  control  group  who
             received  placebo  instead.
             Measurements:  The  primary  endpoint  was
             the incidence of paclitaxel-induced neuropathy





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