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Do patients with reduced or excellent performance status derive the same clinical benefit from novel systemic cancer

Sierra Cheng1, Mahin Qureshi1, Eleanor Pullenayegum2,3

  • 1Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.

ESMO Open
|December 7, 2017
PubMed
Abstract

Insights

Patients with reduced performance status (PS) show similar efficacy with novel cancer therapies compared to those with excellent PS. Further research should include more patients with borderline low PS in clinical trials.

Area of Science:

  • Oncology
  • Clinical Trials
  • Pharmacoeconomics

Background:

  • The net clinical benefit of novel anticancer therapies for patients with varying performance status (PS) remains unclear.
  • Performance status is a key factor in patient eligibility and outcomes for cancer clinical trials.

Purpose of the Study:

  • To determine if patients with excellent versus reduced performance status (PS) derive different net clinical benefits from novel anticancer systemic therapies.
  • To analyze efficacy data based on performance status subgroups in randomized controlled trials (RCTs).

Main Methods:

  • Systematic review of RCTs used for drug approvals by major regulatory agencies (FDA, EMA, Health Canada) between 2006 and August 2015.
  • Meta-analyses of overall survival (OS) and progression-free survival (PFS) were conducted, dichotomizing patients into excellent and reduced PS subgroups.

Main Results:

  • 110 RCTs were identified; 66 (60%) reported efficacy data for 44,511 patients, with no PS subgroup analyses for toxicity.
  • Pooled hazard ratios for efficacy showed no significant difference between excellent (0.65) and reduced (0.67) PS groups (p=0.68).
  • Sensitivity analyses by drug type, cancer type, or endpoint (OS/PFS) yielded similar results.

Conclusions:

  • Novel systemic therapies demonstrate comparable relative efficacy in patients with reduced PS compared to those with excellent PS within modern RCTs.
  • Future RCTs should report PS subgroup analyses for toxicity and increase inclusion of patients with borderline low PS for a comprehensive understanding of treatment benefits.
Keywords:
Performance statuschemotherapymeta-analysissystematic reviewsystemic therapytargeted therapy

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