Patient‐reported outcomes of multiple myeloma patients treated with panobinostat after ≥2 lines of therapy based on the international phase 3, randomized, double‐blind, placebo‐controlled PANORAMA PANORAMA ‐1 trial

摘要

Summary The phase 3 PANORAMA ‐1 trial led to regulatory approvals of panobinostat ( PAN ) in combination with bortezomib ( BTZ ) and dexamethasone ( DEX ) for the treatment of multiple myeloma after ≥2 prior regimens, including BTZ and an immunomodulatory drug. Patient‐reported outcomes ( PRO s) were assessed in PANORAMA ‐1, with data available for 73 patients in the PAN ?+? BTZ ?+? DEX arm and 74 patients in the placebo ( PBO )?+? BTZ ?+? DEX arm. Per the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐Core 30 ( EORTC QLQ ‐C30), global health status/quality of life (QoL) scores initially declined with PAN ?+? BTZ ?+? DEX during the first 24?weeks before approaching baseline scores and remaining steady during the next 24?weeks, with no difference between arms at Week 48. The EORTC QLQ ‐Myeloma module ( EORTC QLQ ‐ MY 20) demonstrated initial improvements and subsequent stabilization of disease symptom scores in both arms and initial worsening and subsequent improvement of side effects of treatment scores, with the initial worsening more pronounced and recovery less pronounced with PAN ?+? BTZ ?+? DEX . Functional Assessment of Cancer Therapy/Gynecologic Oncology Group‐Neurotoxicity scores remained relatively stable and similar between the arms. Overall, these PRO findings support the addition of PAN to the BTZ + DEX regimen as an efficacious treatment option, with limited symptomatology and impact on patients’ QoL. The reported results are based on a descriptive analysis of the data. No formal statistical tests have been performed.