2018 ASCO Annual Meeting!
Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Type: Poster Session
Time: Monday June 4, 8:00 AM to 11:30 AM
Location: Hall A
Quality of life in cutaneous T-cell lymphoma subjects treated with anti-CCR4 monoclonal antibody mogamulizumab versus vorinostat: Results from the phase 3 MAVORIC trial.
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
2018 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #214)
J Clin Oncol 36, 2018 (suppl; abstr 7577)
Author(s): Pierluigi Porcu, Stacie Hudgens, Pietro Quaglino, Richard Cowan, Lysbeth Floden, Mollie Leoni, Stephen Dale, Madeleine Duvic; Thomas Jefferson University, Philadelphia, PA; Clinical Outcomes Solutions, Tucson, AZ; Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy; The Christie NHS Foundation Trust, Manchester, United Kingdom; Kyowa Kirin Pharmaceutical Development, Inc., Princeton, NJ; The University of Texas MD Anderson Cancer Center, Houston, TX
Background: Cutaneous T-cell lymphomas (CTCL) are rare non-Hodgkin’s lymphomas that cause significant morbidity and adversely affect quality of life (QoL), most severely in Sezary syndrome (SS) patients (pts). Methods: A multicenter Phase 3 trial compared mogamulizumab (MOGA) vs vorinostat (VOR) in pts with Stage IB-IV CTCL who had failed ≥ 1 systemic therapy. Progression free survival was the primary endpoint. Validated QoL measurements included the Skindex-29 (SDX-29), Functional Assessment of Cancer Therapy-General (FACT-G) and EuroQol-5D. SDX-29 and FACT-G are reported here. Longitudinal modeling of symptoms, function, and QoL subdomains were evaluated using longitudinal mixed models on prespecified covariates. Meaningful change threshold (MCT) was evaluated and categorical change analyzed by group over time. Time to clinically meaningful worsening was defined using distribution-based minimally important difference thresholds. Results: 372 pts were randomized (186 in each arm). MOGA resulted in symptomatic and functional improvement with differences in SDX-29 Symptoms (Cycle, C3, C5, and C7; p < 0.05) and Functional (C3 and 5; p < 0.05) scales. The proportion of pts who improved by at least the MCT from baseline was significantly greater for MOGA vs VOR on SDX-29 Symptoms at C3 (61.1% vs 45.3%), C5 (64.5% vs 42.4%), C7 (67.1% vs 47.5%), and C11 (84.1% vs 50.0%) and SDX-29 Functioning domain at C5 (54.3% vs 28.8%). Significant difference in the FACT-G Physical Well-Being scale (C1, C3, and C5; p < 0.05) were observed in favor of MOGA and a greater proportion of pts declined by at least the MCT in favor of MOGA vs VOR at C1 (19.3% vs 34.7%), C3 (17.4% vs 42.9%), C5 (13.1% vs 43.3%), and C7 (15.9% vs 37.5%). The median time to worsening of symptoms on SDX-29 was 27.4 m for MOGA vs 6.6 m for Vor. In SS pts, the median time to worsening varied in favor of MOGA (p < 0.005) on all SDX-29 domains. In mycosis fungoides pts, time to worsening did not vary between arms. Conclusions: Symptoms, function, and overall QoL of CTCL pts favored MOGA over VOR across study time points. Pts with highest symptom burden and functional impairment derived the most QOL benefit from MOGA. Clinical trial information: NCT01728805
2. RELEVANCE: Phase III randomized study of lenalidomide plus rituximab (R2) versus chemotherapy plus rituximab, followed by rituximab maintenance, in patients with previously untreated follicular lymphoma.