Impact on quality of life from multi-modality treatment for lung cancer: a randomised controlled feasibility trial of surgery versus no surgery as part of multi-modality treatment in potentially resectable stage III-N2 NSCLC (the PIONEER trial)

Abstract

Introduction: Optimal treatment of stage III-N2 NSCLC requires multi-modality treatment: local treatment (surgery or radiotherapy) and systemic anti-cancer therapy. There is no clear evidence of superiority for survival between surgical and non-surgical approaches and little research has explored quality of life as an endpoint (QOL). Methods: Randomised controlled feasibility study. Patients are randomised to receive multi-modality treatment 1) with surgery OR 2) without surgery. Eligible patients have ‘potentially resectable’ N2 NSCLC and have received an MDT recommendation for multimodality treatment. Sixty-six patients and their carers will be recruited from 8 UK centres. Patient/carer QOL questionnaires will be administered at baseline, weeks 6, 9, 12 and month 6, data will be analysed descriptively. Semi-structured interviews will be conducted and framework analysis applied. Results: Recruitment is ongoing (opened November 2020). Despite COVID-19 related challenges, we have opened six sites, approached 14 patients and successfully recruited nine patients (64% consent rate) and five carers. Four patients and two carers have completed the trial. Five patients (55%) have completed all outcome data to date and eight patients (89%) have received their allocated treatment. NSCLC N2 patients being assessed at MDTs at recruiting sites are being assessed for eligibility. Forty-seven N2 patients have been identified as ineligible. Reasons for ineligibility include: not suitable for surgery; referred for best supportive care; MDT decision regarding most appropriate treatment; patient choice regarding treatment; other. Conclusion: There have been challenges to site opening due to sites focusing on COVID related studies only. Three sites have only opened in the past 6 months and a further two are due to open which should increase recruitment. Despite delays we have successfully recruited nine participants and all but one have received their allocated treatment. Results will inform the design of a future fully powered randomised trial with QOL as the primary outcome.