Panobinostat vs Placebo: Patient-Reported Outcomes Comparable in Multiple Myeloma
Phase 3 PANORAMA-1 study data demonstrated that adding PAN to BTZ+DEX leads to significant prolongation of PFS among patients with RRMM.
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Good patient-reported outcomes (PROs) were achieved with panobinostat (PAN) and bortezomib (BTZ) plus dexamethasone (DEX) with minimal impact on patient quality-of-life (QOL), according to a study published in the British Journal of Haematology.
Results from the phase 3 PANORAMA-1 study demonstrated that adding PAN to BTZ+DEX leads to significant prolongation of progression-free survival (PFS) among patients with relapsed/refractory multiple myeloma (RRMM). Despite this improvement, the impact on health-related QOL for this patient population has not been fully elucidated.
For this study, investigators assessed the PROs of 147 patients with RRMM who were enrolled in the PANORAMA-1 study; patients were randomly assigned to receive PAN or placebo (PBO) and BTZ+DEX. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐Core 30 (EORTC QLQ‐C30), EORTC QLQ‐Myeloma Module (EORTC QLQ‐MY20), and Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group‐Neurotoxicity (FACT/GOG‐Ntx) were completed at baseline, and every 6 weeks until the end of treatment.
Results showed that EORTC QLQ-C30 QOL scores declined during the first 24 weeks among patients assigned to the PAN arm but approached baseline scores and was maintained for the next 24 weeks. By week 48, there were no differences observed between the PAN and PBO arms.
The EORTC QLQ-MY20 — a myeloma-specific QOL measure — showed an initial improvement and stabilization of disease symptoms among all patients. Treatment-related adverse effect (TRAE) scores initially got worse and then improved; patients assigned to the PAN arm had a greater worsening and slower recovery of TRAE scores.
FACT/GOG‐Ntx scores — a measure of treatment-related neurotoxicity, a commonly occurring TRAE in MM — was generally stable and comparable in both study arms, but patients in the PBO arm had some improvement starting at week 24.
The authors concluded that “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.”
Richardson PG, Schlossman RL, Roy AN, et al. 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-1 trial [published online May 17, 2018]. Br J Haematol. doi: 10.111/bjh.15248