Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

Table 3 PRO measures supporting label claims in the US and EU

Product (brand name name/generic name)	PRO measure(s) supporting US product label claim(s)	PRO measure(s) supporting EU SmPC claim(s)
Xtandi/enzalutamide	BPI-SF worst pain item^a	BPI-SF worst pain item^a
Zytiga/abiraterone	BPI-SF worst pain item	BPI-SF worst pain and average pain intensity items; FACT-P
Jevtana/cabazitaxel	None	PPI scale from the McGill-Melzack questionnaire^b
Xofigo/radium Ra 223 dichloride	None	FACT-P
Xofigo/radium Ra 223 dichloride	None	EQ-5D with VAS
Provenge/sipuleucel-T	None	None

BPI-SF = Brief Pain Inventory–Short Form; EU = European Union; EQ-5D with VAS = EuroQoL 5 Dimensions with visual analogue scale; FACT-P = Functional Assessment of Cancer Therapy–Prostate Module; PPI = Present Pain Intensity; PRO = patient-reported outcome; SmPC = Summary of Product Characteristics; US = United States.
^aThe BPI was described in four different ways between the US label and EU SmPC for Xtandi (i.e., BPI, BPI-SF, BPI worst pain item and BPI-SF worst pain item). For the purposes of PRO label claim analyses and given other consistencies between descriptions, we assumed the BPI-SF worst pain item was actually implemented in the Xtandi studies for both the US and EU.
^bThe McGill-Melzack questionnaire is also known as the McGill Pain Questionnaire (MPQ).

ISSN: 1477-7525