Shreyas Kalantri: Evaluating the Planning and Reporting of QoL Endpoints Across 80 Phase III Trials
Shreyas Kalantri/X

Shreyas Kalantri: Evaluating the Planning and Reporting of QoL Endpoints Across 80 Phase III Trials

Shreyas Kalantri, Hematology and Oncology Fellow at University of Louisville, shared on LinkedIn:

“Quality of life is increasingly recognized as an important endpoint in oncology trials. But how often are these outcomes actually reported?

In our new study, now published in JCO Oncology Advances, we evaluated the planning and reporting of quality-of-life (QoL) endpoints across 80 phase III genitourinary cancer trials.

We found that:

  • 85% of trials prespecified a QoL endpoint, but only 47.5% reported QoL results.
  • Among trials that prespecified QoL, 44.1% did not report those results.
  • QoL reporting was more common when the trial’s primary endpoint was positive — 71% vs 31% among trials with prespecified QoL.
  • A positive primary endpoint was independently associated with higher odds of QoL reporting (adjusted OR 4.84; 95% CI, 1.74–14.60).

These findings highlight an important gap between planning and reporting patient-centered outcomes and underscore the need for consistent and transparent QoL reporting, regardless of trial outcome.

Thank you to my coauthors for their collaboration on this work.”

Title: Planning, Reporting, and Selective Disclosure of Quality-of-Life End Points in Phase III Genitourinary Cancer Trials

Authors: Shreyas Kalantri, Shiva Balasubramanian, Jincong Q. Freeman, Tyler Jones, Priyanka Sheth, Srinidhi Karthik, Jason Chesney, Rohit Kumar.

Read the article

Shreyas Kalantri

You can also read: ‘PSMAddition: [177Lu]Lu-PSMA-617 Improves Radiographic PFS in PSMA-Positive mAPMN/S Prostate Cancer

Shreyas Kalantri