What methods did the polivy study use to measure treatment outcomes?

Primary Endpoint in the POLARIX Study

The POLARIX phase 3 trial (NCT03274492) for Polivy (polatuzumab vedotin) plus R-CHP measured its main outcome using progression-free survival (PFS). This was defined as time from randomization to disease progression per Independent Review Committee (IRC) assessment via Lugano 2014 criteria, or death from any cause. IRC used PET-CT scans, CT scans, and biopsies for blinded, independent evaluation.[1][2]

Key Secondary Endpoints

• Event-free survival (EFS): Time to progression, relapse, initiation of new anti-lymphoma therapy, or death, assessed by IRC.
  
• Overall survival (OS): Time to death from any cause.
  
• Complete response (CR) rate: PET-CT negativity (Deauville score 1-3) plus bone marrow negativity if previously involved.
  
• Objective response rate (ORR): Partial or complete response per IRC.
  These used the same Lugano criteria, with assessments at cycle 6-8, end of treatment, every 18 weeks for 2 years, then every 36 weeks.[1][3]
  
  

Safety and Quality-of-Life Measures

Adverse events followed NCI CTCAE v4.03 grading, with neuropathy assessed via patient-reported EORTC QLQ-C30/QLQ-LY20 questionnaires. PET-CT was central for efficacy imaging.[1][2]

How Assessments Were Scheduled

Patients underwent PET-CT or CT every 6-8 cycles during treatment (21-day cycles), then periodically post-treatment. Minimum follow-up was 24 months.[1]

[1]: NEJM: Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma
[2]: ClinicalTrials.gov: POLARIX (NCT03274492)
[3]: FDA Label: Polivy