Abstract 174P
Background
Recently, underassessment and underreporting of HRQoL have been shown in trials involving advanced tumors. However, evaluation and preservation of good HRQoL are also both critically important in trials including patients in curative setting. Herein, we evaluated whether HRQoL was adequately investigated and reported in trials testing ICIs and TKIs in resectable NSCLC.
Methods
Systematic search was performed on Embase and PubMed, to identify Randomized Clinical Trials (RCTs) testing TKIs or ICIs in resectable NSCLC. We selected full articles and abstracts from major meetings. Data on assessment and reporting of HRQoL were collected.
Results
As of Dec 2024, we identified 25 RCTs. Primary endpoint was overall survival for 2 (8%) RCTs, while 21 and 7 RCTs evaluated risk of recurrence and tumour response, respectively. Nine trials (36%) were phase II while 16 (64%) were phase III. Twelve RCTs (48%) did not assess HRQoL as an endpoint and 13 (52%) included HRQoL evaluation as secondary or exploratory endpoint. Most common questionnaires 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 percentage thanphase 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 subsequent publications, and 2 of them presented data in meeting abstracts. Lastly, 15 (68%) RCTs did not report any information on HRQoL evaluation.
Table 174P| Articles N | HRQoL evaluated N (%) | HRQoL reported N (%) | |
| Whole séries | 25 | 13 (52) | 8 (32) |
| Masking | |||
| Blinded | 9 | 6(67) | 4 (44) |
| Open label | 16 | 7 (44) | 4 (25) |
| Study design | |||
| Phase II | 9 | 3 (33) | 0 (0) |
| Phase III | 16 | 10 (62) | 8 (50) |
| Setting | |||
| Adjuvant | 16 | 7 (44) | 4 (25) |
| Neoadjuvant | 3 | 2 (67) | 1 (33) |
| Perioperative | 6 | 4 (67) | 3 (50) |
| Experimental therapy | |||
| ICI | 10 | 6 (60) | 4 (40) |
| TKI | 15 | 7 (47) | 4 (26) |
Conclusions
We revealed suboptimal evaluation and underreporting of HRQoL in patients treated with novel agents in resectable NSCLC.
Systematic evaluation and reporting of HRQoL should be prioritized in future trials.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
M. Di Maio: Financial Interests, Personal, Advisory Board, Consultancy about clinical trial methodology and clinical trial results interpretation: Novartis; Financial Interests, Personal, Advisory Board, Consultancy about immunotherapy in SCLC: Roche; Financial Interests, Personal, Advisory Board, Consultancy about role and interpretation of patient-reported outcomes and quality of life in clinical trials: Takeda; Financial Interests, Personal, Advisory Board, Advisory board about the role of chemotherapy and hormonal treatment in hormone-sensitive prostate cancer: Janssen; Financial Interests, Personal, Advisory Board, Consultancy about the results obtained with lorlatinib and dacomitinib in advanced non-small cell lung cancer: Pfizer; Financial Interests, Personal, Advisory Board, Consultancy about role of osimertinib as adjuvant treatment of NSCLC: AstraZeneca; Financial Interests, Personal, Advisory Board, Participation in advisory boards about olaparib in pancreatic cancer, about olaparib in prostate cancer, and about immunotherapy in lung cancer: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board, Consultant for the new indication of avelumab in urothelial cancer: Merck Serono; Financial Interests, Personal, Advisory Board, Advisory board about treatment of gastric cancer: Amgen; Financial Interests, Personal, Advisory Board, Lesson for the personnel of the drug company about quality of life, patient-reported outcomes and methodological aspects of clinical trials: GSK; Financial Interests, Personal, Advisory Board, Advisory board about trastuzumab deruxtecan in gastric cancer: Daiichi Sankyo; Financial Interests, Personal, Advisory Board, Advisory board about Moovcare and remote monitoring of symptoms in patients with cancer: Viatris; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Institutional, Research Grant, Financial support and drug supply for the Meet-URO12 trial (niraparib as maintenance treatment of urothelial carcinoma after first-line treatment with platinum-based chemotherapy): Tesaro - GSK; Financial Interests, Institutional, Invited Speaker, Local PI of trial with tislelizumab in hepatocellular carcinoma: BeiGene; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with cabozantinib and atezolizumab in advanced HCC: Exelixis; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with atezolizumab and bevacizumab in advanced HCC: Roche; Financial Interests, Institutional, Invited Speaker, Local PI of trials with pembrolizumab in hepatocellular carcinoma: Merck Sharp & Dohme; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with sasanlimab in NMI bladder cancer: Pfizer; Non-Financial Interests, Personal, Leadership Role, President Elect (2023–2025): AIOM (Italian Association of Medical Oncology). C. Pompili: Financial Interests, Personal, Advisory Board: AstraZeneca, Medela, Roche, BMS, Johnson & Johnson. All other authors have declared no conflicts of interest.