Page 57 - Practical Approaches to Managing Castration-Resistant Prostate Cancer (CRPC)
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Rash

        Description of Apalutamide-Associated Rash (SPARTAN trial)
          • Most commonly described as macular or maculo-papular
          • Occurred in ~25% of patients treated with apalutamide (rate of grade 3 rash
             was ~5%)
          • Onset was ~80 days
          • Resolved ~60 days from onset for 80% of patients; grade 1 rashes resolved
             more quickly (36 days)
          • Dose modifications due to rash in SPARTAN
               –  28% dose interruption
               –  12% dose reduction
               –  9% discontinuation
          • Rash recurred with re-challenge in ~50%, with no serious allergic reactions

        Assessment and Treatment of Maculo-Papular Rash Associated with Apalutamide
          • Rash characterized by the presence of macules (flat) and papules (elevated)

          • Frequently affecting the upper trunk, spreading centripetally and associated
             with pruritus


                      Grade 1          Grade 2         Grade 3
          Description  •  Macules/papules   •  Macules/papules   •  Macules/
                        covering <10%      covering 10-30%     papules covering
                        body surface        BSA with or       >30% BSA with or
                        area (BSA) with      without symptoms     without
                        or without        (eg, pruritus,        associated
                        symptoms         burning,        symptoms;
                        (eg, pruritus,        tightness);      limiting self care
                        burning,         limiting        activities of daily
                        tightness)       instrumental        living
                                         activities of daily
                                         living

          Rash        •  Continue      •  Hold apalutamide •  Hold apalutamide
          Treatment     apalutamide    •  Initiate steroid     •  Initiate steroid
                      •  Initiate topical       cream and oral     cream and oral
                        steroid cream       antihistamines     antihistamines
                        and oral        •  Reinitiate      •  If rash is same
                        antihistamines    apalutamide      or has worsened,
                      •  Monitor for        when rash is      initiate oral
                        change           ≤ grade 1       steroids and refer
                                       •  Consider dose        to a dermatologist
                                         reduction     •  Reinitiate
                                                         apalutamide when
                                                         rash is ≤ grade 1
                                                       •  Consider dose
                                                         reduction




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