Development and validation of 11 symptom indexes to evaluate response to chemotherapy for advanced cancer.

Published

Journal Article

Recent guidance from the FDA discusses patient-reported outcomes as end points in clinical trials. Using methods consistent with this guidance, the authors developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from NCCN Member Institutions and 4 nonprofit social service organizations. Diagnoses included bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreatic, kidney, lung, ovarian, and prostate cancers and lymphoma. Physician experts in each of these diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results are evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also implemented at NCCN Member Institutions. Final results are 11 symptom indexes that reflect the highest priorities of people affected by these 11 advanced cancers and the experienced perspective of the people who provide their medical treatment. Beyond the clinical value of such indexes, they may also contribute significantly to satisfying regulatory requirements for a standardized tool to evaluate drug efficacy with respect to symptomatology.

Full Text

Cited Authors

  • Cella, D; Rosenbloom, SK; Beaumont, JL; Yount, SE; Paul, D; Hampton, D; Abernethy, AP; Jacobsen, PB; Syrjala, K; Von Roenn, JH

Published Date

  • March 2011

Published In

Volume / Issue

  • 9 / 3

Start / End Page

  • 268 - 278

PubMed ID

  • 21393439

Pubmed Central ID

  • 21393439

Electronic International Standard Serial Number (EISSN)

  • 1540-1413

International Standard Serial Number (ISSN)

  • 1540-1405

Digital Object Identifier (DOI)

  • 10.6004/jnccn.2011.0026

Language

  • eng