1276P - EXcellenT (exercise in extended oncogene addicted lung cancer in active treatment) trial: Preliminary results on impact of physical activity (PA) on emotional, metabolic and immune status

Background

EXcellenT (NCT05306652) is a prospective randomized trial on PA in oncogene-addicted advanced NSCLC pts in active treatment with TKIs. These pts are often young, keen to regain their pre-disease QoL and have prolonged survival. Depression may hamper compliance and response to treatment and delay social life recovery. This trial evaluates if tailored PA have an impact on QoL, metabolic and immune status.

Methods

Pts are randomized in an interventional arm of a personalized supervised PA prescription (arm A) or a counseling on home-based exercise (arm B). Depression is assessed by Beck’s Depression Inventory (BDI) questionnaires administered at week (wk) 0 and 12. Blood samples are collected at baseline, wk 4 and 12 for metabolic and immune status evaluation. Fatty acid (FA) composition is carried out using gas liquid chromography with flame ionization detection and liquid chromatography-mass spectrometry; immune cell composition through flow cytometry.

Results

Preliminary data on personalized PA influence on depression are available for 22 pts enrolled, FA analysis and immune cells count for 4 and 3 pts, respectively. Pts characteristics are: median age 53 yo, 53% female, 80% ECOG PS 0, 52% pre-diagnosis leisure-time PA; ALK+ 53%, EGFR+ 31%, BRAF+ 13%, RET+ 3%, ROS1+ 16%. In arm A depressive symptoms improved at wk 12 vs wk 0 (BDI mean difference: 6 points [IQR 4-9], p=0.0039). Only a trend to improvement was found in arm B (p=0.1270). The extent of improvement between the 2 time points was more sustained in arm A than arm B (p=0.0237). Plasma analysis showed a significant increase in Mono-Unsaturated Fatty Acids (p=0.0329) whereas FACS analysis highlighted reduction in circulating CD34+ hematopoietic stem cell (p=0.0112, ANOVA, Tukey’s multiple comparisons) and parallel increase in mature CD66b+CD10+ neutrophils.

Conclusions

The preliminary analysis of our trial confirms that a tailored PA program can significantly improve depression state, increase mature immune cell precursors and enhance metabolic state. A personalized PA program should be integrated to standard oral therapies to enhance NSCLC pts well-being and not only treat their disease.

Clinical trial identification

NCT05306652.

Editorial acknowledgement

Legal entity responsible for the study

AUSL della Romagna.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.