1841P - Feasibility of wrist-worn health-tracker data to predict the need for therapy modifications in patients with metastatic cancer

Background

Objective evaluation of a patient’s health status is challenging and may frequently lead to unplanned therapy modifications. Therefore, we aimed to evaluate the feasibility of wrist-worn wearable health device (WAD) to predict objectively the likelihood of therapy modifications in patients with metastatic cancer.

Methods

We prospectively enrolled therapy naïve patients with metastatic solid tumors before their first administration of systemic therapy. Patients were asked to wear a WAD (Garmin Vivosmart 4) for 6 months 8 hours per day and charge it at night. Raw sensor data was read out directly from the WADs. Each cycle, therapy was classified either “planned” or “unplanned” (delay, dose reduction, or omission of a substance).

Results

Overall, 437 patients were screened, and 84 (19.2%) patients gave their consent of which 7 (8.3%) dropped out before completing the 6-month study period. For the interim analysis, we included data from the 50 patients who already completed the study (21 female, 29 male, median age 61 (IQR 51.5, 66.75). Overall, 348 therapy cycles (86.5%) were administered “planned” and 54 (13.5%) were ”unplanned”. Patients wore the WAD in median 46 days (IQR (20, 65 days)) or 30% of the anticipated timeframe (IQR 16-62y). Eight (16%) patients wore the WAD at least 90 days, 6 (12%) on 60-90 days, 19 (38%) on 30-60 days and 17 (34%) 30 days or less. In 96% of worn days, the WAD recorded data for at least 6 hours or more. Average step-count per patient per day was 4628 with a median of 3349 steps (IQR 1,602; 5,203)). The number of worn days per cycle was significantly lower in patients with need for a modified next therapy cycle (median 4 days, IQR (1-8)) than in patients that had their therapy administered as planned (median 8 days, IQR (2, 15), p=0.021). The number of steps taken was not significantly different between these two groups (median “unplanned” 1,519; IQR (395; 4,550), median “planned” 2,962; IQR (973; 6,512), p=0.051).

Conclusions

WADs in oncologic outpatient use are a safe way to gather large amounts of data on parameters such as steps and wear time. Overall wear time was low and significantly associated with the need for therapy modifications (delay, dose reduction, omission of a substance) in the next cycle.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Clinical Division of Oncology Department of Medicine I Medical University of Vienna.

Funding

The financial support by the Austrian Federal Ministry for Digital and Economic Affairs, the National Foundation for Research, Technology and Development and the Christian Doppler Research Association is gratefully acknowledged.

Disclosure

A.S. Berghoff: Financial Interests, Personal, Research Funding: Daiichi Sankyo, Roche; Financial Interests, Personal, Advisory Role, and/or honoraria for lectures/consultation: Roche, Bristol Myers Squibb, Daiichi Sankyo, AstraZeneca, CeCaVa; Financial Interests, Personal, Advisory Role, and/or honoraria for lectures/consultationand/or honoraria for lectures/consultation: Merck; Financial Interests, Personal, Other: Roche, Amgen, AbbVie. A.M. Starzer: Financial Interests, Personal, Invited Speaker, Lecture honoraria: AstraZeneca; Financial Interests, Institutional, Research Grant, Industry partner of institutional Christian Doppler Laboratory: Roche; Non-Financial Interests, Member, National Oncology Society: OeGHO; Non-Financial Interests, Member, Oncology society of USA: ASCO; Other, Other, Travel support for conference participation: MSD, Lilly. M. Preusser: Financial Interests, Personal, Advisory Board, and/or honoraria for lectures/consultation: Bayer; Financial Interests, Personal, Advisory Board, consultation: Bristol Myers Squibb, Novartis, Gerson Lehrman Group, CMC Contrast, GSK, Mundipharma, Roche, BMJ Journals, MedMedia, AstraZeneca, AbbVie, Lilly, Medahead, Daiichi Sankyo, Sanofi, Merck, Sharp & Dome, Tocagen, Adastra, Gan & Lee Pharmaceuticals, Janssen, Servier, Miltenyi, Boehringer Ingelheim, Telix, Medscape. All other authors have declared no conflicts of interest.