Health-related quality of life assessment in trials testing tyrosine kinase inhibitors or immune checkpoints inhibitors in early-stage NSCLC

TL;DR

This study finds that health-related quality of life is often not properly assessed or reported in clinical trials for early-stage lung cancer treatments.

Contribution

The study is the first to systematically evaluate HRQoL assessment in RCTs of resectable NSCLC with novel therapies.

Findings

Only 52% of trials included HRQoL as a secondary or exploratory endpoint.

Phase II and adjuvant trials evaluated HRQoL at lower rates compared to phase III and neoadjuvant trials.

68% of trials did not report HRQoL results in primary publications or elsewhere.

Abstract

Health-related quality of life (HRQoL) remains underassessed and underreporting in randomized clinical trials (RCTs) evaluating new therapies in metastatic non-small cell lung cancer (NSCLC). However, evaluation and preservation of favorable HRQoL are critically important in trials including patients in early-stage settings, in which the primary objective is cure. Herein, we evaluated whether HRQoL was adequately evaluated and reported in trials including immune checkpoint inhibitors (ICIs) and tyrosine kinase inhibitors (TKIs) in resectable NSCLC.

A systematic search was performed on Embase and PubMed to identify RCTs testing TKIs or ICIs in resectable NSCLC. We selected full articles and abstracts from major meetings. Risk of bias and reporting assessment of HRQoL were collected.

As of October 2024, we identified 25 RCTs. The primary endpoint was overall survival for 2 RCTs, while 21 and 7 RCTs evaluated risk of recurrence and tumour response as (co)-primary endpoints, respectively. Twelve RCTs (48%) did not assess HRQoL as an endpoint, while 13 (52%) included HRQoL evaluation as a secondary or exploratory endpoint. The most common tools utilized were FACT-L (6/13; 46%), EORTC-QLQ30/LC13 (4/13; 30%) and SF-36 (2/13; 15%). Phase II (33%) and adjuvant (44%) trials evaluated HRQoL in a lower rate than phase III (62%) and neoadjuvant/perioperative (66%) RCTs. Three out of 22 RCTs (14%) with available full-texts reported HRQoL results in the primary publication. Two out of the 19 remaining RCTs reported HRQoL in an indipendent publications, and 2 of them presented data in meeting abstracts. Remarkably, for 15 (68%) RCTs HRQoL evaluation is not available.

Our systematic evaluation revealed suboptimal evaluation and underreporting of HRQoL in patients treated with novel agents and combinations in resectable NSCLC. Systematic evaluation and reporting of HRQoL should be prioritized in future trials.

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