Joint Analysis of Symptom and Progression-Free Survival Endpoints in Previously Treated Malignant Pleural Mesothelioma

• Activity Number: 283
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Michelle D. Hackshaw+ and Mark E. Boye* and Teena M. West and Angela W. Prehn and Wei Shen and Luping Zhao
• Companies: Walden University and Eli Lilly and Company and Eli Lilly and Company and Walden University and Eli Lilly and Company and Eli Lilly and Company
• Keywords: mesothelioma ; survival ; patient-reported outcomes ; joint models

Abstract

BACKGROUND: Traditionally survival and patient-reported outcome (PRO) endpoints have been analyzed separately. Novel techniques are now available to jointly estimate the association between longitudinal changes in PRO measures and survival.

METHODS: We conducted post-hoc analyses of PFS and PRO data from a phase III study of best supportive care (BSC) versus pemetrexed-plus-BSC (pem) in patients treated with second-line therapy for advanced MPM. In the original study, PFS was a secondary end point and PROs were measured using the Lung Cancer Symptom Scale. Statistical methods included use of latent growth curve models (LGCMs) and survival models.

RESULTS/CONCLUSIONS: These novel methods allowed us to validate that worsening of MPM symptoms (PROs) was related to an increase in rate of disease progression, and may help support the use of PFS as an endpoint in oncology clinical trial