Validating the Total Illness Burden Index for Prostate Cancer (TIBI-CaP) in Men with Castration-Resistant Prostate Cancer: Data from TRUMPET

Abstract

Aim: To validate the total illness burden index for prostate cancer (TIBI-CaP) in castration-resistant prostate cancer (CRPC) patients. Patients & methods: Baseline comorbidity scores collected using the TIBI-CaP were compared with the baseline patient-reported health-related quality of life using the SF-12v2 and FACT-P questionnaires in 302 patients enrolled in the Treatment Registry for Outcomes in CRPC Patients (TRUMPET). Results: Baseline TIBI-CaP scores were negatively correlated with all baseline SF-12v2 domain/composite (p < 0.001) and FACT-P subscale/total (p < 0.020) scores. There was a significant decreasing linear trend in SF12v2 and FACT-P scores over the categories based on TIBI-CaP quartiles of comorbidity burden (from ‘least’ to ‘severe’). Conclusion: The TIBI-CaP is a valid measure of comorbidity burden in patients with CRPC in the real world.

Lay abstract

This study aimed to validate the total illness burden index for prostate cancer (TIBI-CaP), a patient-reported measure of comorbidity burden, in a cohort of men enrolled in the Treatment Registry for Outcomes in Castration-resistant Prostate Cancer (CRPC) Patients (TRUMPET). Results from this study demonstrate that the TIBI-CaP is a valid measure of comorbidity burden in CRPC patients in the real world and a useful research tool for risk adjustment in CRPC studies.

Keywords::

• castration-resistant prostate cancer
• CRPC
• TIBI-CaP
• total illness burden index for prostate cancer
• TRUMPET registry

Financial & competing interests disclosure

The authors meet the criteria for authorship as recommended by the International Committee of Medical Journal Editors. The authors take full responsibility for the scope, direction and content of the manuscript, and have approved the submitted manuscript. The authors received no compensation related to the development of the manuscript.

S Flanders is an employee of Astellas Pharma, Inc. and owns stock holdings from Johnson and Johnson, Abbott Labs, and AbbVie. J Kim, S Wilson and J Braziunas are employees of Astellas Pharma, Inc. S Greenfield collaborates with Astellas Pharma, Inc. and Pfizer on scientific projects. J Billimek is a consultant for Rubicon Biotechnology and Lyntek Medical. S Lechpammer is an employee of Medivation, Inc., which was acquired by Pfizer, Inc. in September 2016 and owns stock holdings from Jazz Pharmaceuticals and Tesaro, Inc. L Karsh is a consultant and speaker at Astellas Pharma, Inc., Pfizer, Janssen, Bayer, Sanofi, and Spectrum and owns stock holdings from Swan Valley Medical. DI Quinn has provided remunerated advisory board and education services for Astellas Pharma, Inc. and Pfizer. D Shevrin has provided services to Sanofi and Astellas Pharma, Inc. ND Shore is a consultant for Astellas Pharma, Inc., Bayer, Ferring, Janssen, Sanofi, Tolmar, Valeant, and Medivation, Inc., which was acquired by Pfizer, Inc. in September 2016. J Symanowski has provided consulting and advisory services to Antigen Express, Astellas Pharma, Inc., Endocyte, Eli Lilly, ProNAi, and Ra Pharma. D Penson collaborates with Astellas Pharma, Inc., Medivation, Inc., which was acquired by Pfizer, Inc. in September 2016, and Dendreon. This study was funded by Astellas Pharma, Inc. and Medivation, Inc., which was acquired by Pfizer, Inc. in September 2016, the co-developers of enzalutamide. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors wish to acknowledge the medical writing assistance of J Kondejewski of SNELL Medical Communication, Inc. and the editorial assistance provided by L Smith of Complete HealthVizion, both funded by the study sponsors.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. No formal consent was required for this retrospective study and data was de-identified to protect patients’ confidentiality.

Additional information

Funding

The authors meet the criteria for authorship as recommended by the International Committee of Medical Journal Editors. The authors take full responsibility for the scope, direction and content of the manuscript, and have approved the submitted manuscript. The authors received no compensation related to the development of the manuscript. S Flanders is an employee of Astellas Pharma, Inc. and owns stock holdings from Johnson and Johnson, Abbott Labs, and AbbVie. J Kim, S Wilson and J Braziunas are employees of Astellas Pharma, Inc. S Greenfield collaborates with Astellas Pharma, Inc. and Pfizer on scientific projects. J Billimek is a consultant for Rubicon Biotechnology and Lyntek Medical. S Lechpammer is an employee of Medivation, Inc., which was acquired by Pfizer, Inc. in September 2016 and owns stock holdings from Jazz Pharmaceuticals and Tesaro, Inc. L Karsh is a consultant and speaker at Astellas Pharma, Inc., Pfizer, Janssen, Bayer, Sanofi, and Spectrum and owns stock holdings from Swan Valley Medical. DI Quinn has provided remunerated advisory board and education services for Astellas Pharma, Inc. and Pfizer. D Shevrin has provided services to Sanofi and Astellas Pharma, Inc. ND Shore is a consultant for Astellas Pharma, Inc., Bayer, Ferring, Janssen, Sanofi, Tolmar, Valeant, and Medivation, Inc., which was acquired by Pfizer, Inc. in September 2016. J Symanowski has provided consulting and advisory services to Antigen Express, Astellas Pharma, Inc., Endocyte, Eli Lilly, ProNAi, and Ra Pharma. D Penson collaborates with Astellas Pharma, Inc., Medivation, Inc., which was acquired by Pfizer, Inc. in September 2016, and Dendreon. This study was funded by Astellas Pharma, Inc. and Medivation, Inc., which was acquired by Pfizer, Inc. in September 2016, the co-developers of enzalutamide. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. The authors wish to acknowledge the medical writing assistance of J Kondejewski of SNELL Medical Communication, Inc. and the editorial assistance provided by L Smith of Complete HealthVizion, both funded by the study sponsors.