Derivation and External Validation of Objective Performance Status Among Patients With Metastatic Cancer.

Abstract

Purpose: Performance status (PS) assessment is used to determine clinical trial eligibility among patients with cancer, but may be inaccurately assessed by oncology clinicians. Wearable accelerometers may allow objective assessment of physical activity, a proxy for PS. In this analysis of two prospective studies, we derive and externally validate objective PS (OPS) by measuring the association between daily physical activity and overall survival among patients with metastatic cancer.

Materials and methods: For the derivation cohort, we prospectively measured daily physical activity using a wearable accelerometer among patients with metastatic cancer during the screening period for a phase 1 clinical trial in Spain. We used univariable survival analysis, AUCs, and Youden's index to derive an OPS cutoff in mean daily distance walked. We used a multivariable Cox model to calculate the association between OPS and 180-day mortality. We subsequently externally validated OPS in a separate prospective trial of patients with metastatic lung and GI cancers receiving chemotherapy at a large academic health center in the United States.

Results: Full data were available for 123 patients (70 derivation; 53 validation). In the derivation cohort, we defined an OPS cutoff at 1,200 m walked per day. Poor OPS was associated with higher mortality than good OPS in the derivation (180-day mortality, 81.6% v 38.4%; adjusted hazard ratio [aHR], 6.82 [95% CI, 3.44 to 13.5]; P < .001) and external validation cohorts (180-day mortality, 36% v 8%; aHR, 7.07 [95% CI, 1.37 to 36.6]; P = .02).

Conclusion: OPS is an independent, externally validated prognostic indicator and could serve as an objective surrogate for traditional methods of PS assessment in clinical trials and choice of therapy for patients with cancer.