Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Aug;12(16):17403-17412.
doi: 10.1002/cam4.6361. Epub 2023 Aug 17.

The effects of tislelizumab treatment on the health-related quality of life of patients with advanced non-small cell lung cancer

Dingzhi Huang  1 , Caicun Zhou  2 , Gisoo Barnes  3 , Yiyuan Ma  4 , Songzi Li  4 , Lin Zhan  3 , Boxiong Tang  3
Affiliations
Randomized Controlled Trial

The effects of tislelizumab treatment on the health-related quality of life of patients with advanced non-small cell lung cancer

Dingzhi Huang et al. Cancer Med. 2023 Aug.

Abstract

This study examined the health-related quality of life (HRQoL) of patients with advanced non-small cell lung cancer (NSCLC) receiving tislelizumab versus docetaxel in the open-label, multicenter, Phase 3 trial called RATIONALE-303 (NCT03358875). HRQoL was assessed with the EORTC QLQ-C30, EORTC QLQ-LC13, and the EQ-5D-5L instruments. A longitudinal analysis of covariance assessed the change from baseline to Week 12 and from baseline to Week 18. A time to deterioration analysis was also performed using the Kaplan-Meier method. Eight hundred and five patients were randomized to either tislelizumab (n = 535) or docetaxel, respectively (535 and 270 to tislelizumab and docetaxel, respectively). The tislelizumab arm improved while the docetaxel arm worsened in the QLQ-C30 global health status/QoL scale score (difference LS mean change Week 18: 5.7 [95% CI: 2.38, 9.07, p = 0.0008]), fatigue (Week 12: -3.2 [95% CI: -5.95, -0.37, p < 0.0266]; Week 18: -4.9 [95% CI: -8.26, -1.61, p = 0.0037]), and QLQ-LC13 symptom index score (Week 12: -5.5 [95% CI: -6.93, -4.04, P < 0.0001]; Week 18: -6.6 [95% CI: -8.25, -4.95, p < 0.0001]). The tislelizumab arm had improvements in coughing versus the docetaxel arm (Week 12: -4.7 [95% CI: -8.57, -0.78, p = 0.0188]; Week 18: -8.3 [95% CI: -13.02, -3.51, p = 0.0007]). The patients who received tislelizumab were less at risk for clinically meaningful worsening in the overall lung cancer symptom index scale (hazard ratio (HR): 0.24 [95% CI: 0.162, 0.356], p < 0.0001), dyspnea (HR: 0.74 [95% CI: 0.567, 0.958], p = 0.0109), coughing (HR: 0.74 [95% CI: 0.534, 1.019], p = 0.0309), and peripheral neuropathy (HR: 0.55 [95% CI: 0.370, 0.810] p = 0.0011). In general, tislelizumab versus docetaxel was associated with improved HRQoL and symptoms of lung cancer in patients who previously failed treatment with platinum-containing chemotherapy.

Keywords: docetaxel; health-related quality of life; non-small cell lung cancer; patient-reported outcomes; programmed cell death protein-1 inhibitor.

PubMed Disclaimer

Conflict of interest statement

GB, SL, LZ, and BT are employees of and own stock in BeiGene Ltd. DH reports no disclosures. YM is a former employee of Beigene and is now an employee of Boehringer International Ingelheim GmbH. CZ reports personal fees from Lily China, personal fees from BI, personal fees from Roche China, personal fees from MSD, personal fees from Qilu, personal fees from Hengrui, personal fees from Innovent Biologics, personal fees from C‐stone, personal fees from LUYE Pharma, personal fees from TopAlliance Biosciences Inc, personal fees from Amoy Diagnoistics, outside the submitted work.

Figures

FIGURE 1
FIGURE 1
Change from Baseline for EORTC QLQ‐C30. CI, confidence interval; EORTC QLQ‐C30, European Organization for Treatment of Cancer Quality of Life Questionnaire Core 30 items; GHS/QOL, global health status/quality of life; LS, least squares.
FIGURE 2
FIGURE 2
Change from Baseline for EORTC QLQ‐LC13. CI, confidence interval, EORTC QLQ‐LC13, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 items; LS, least squares.
See this image and copyright information in PMC

References

    1. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209‐249. doi:10.3322/caac.21660 - DOI - PubMed
    1. Dai YL, Yang CT, Chen KH, Tang ST. Changes in and determinants of quality of life in patients with advanced non‐small‐cell lung cancer undergoing initial chemotherapy. J Nurs Res. 2017;25(3):203‐215. doi:10.1097/jnr.0000000000000148 - DOI - PubMed
    1. Gralla RJ, Hollen PJ, Msaouel P, Davis BV, Petersen J. An evidence‐based determination of issues affecting quality of life and patient‐reported outcomes in lung cancer: results of a survey of 660 patients. J ThoracOncol. 2014;9(9):1243‐1248. doi:10.1097/jto.0000000000000244 - DOI - PubMed
    1. Iyer S, Roughley A, Rider A, Taylor‐Stokes G. The symptom burden of non‐small cell lung cancer in the USA: a real‐world cross‐sectional study. Support Care Cancer. 2014;22(1):181‐187. doi:10.1007/s00520-013-1959-4 - DOI - PubMed
    1. Iyer S, Taylor‐Stokes G, Roughley A. Symptom burden and quality of life in advanced non‐small cell lung cancer patients in France and Germany. Lung Cancer. 2013;81(2):288‐293. doi:10.1016/j.lungcan.2013.03.008 - DOI - PubMed

Publication types

Associated data