New conversations in an old argument: Lessons learnt from the PIONEER randomised feasibility study in resectable...

Area of Science:

• Oncology
• Clinical Trials
• Thoracic Surgery

Background:

• Stage III-N2 non-small cell lung cancer (NSCLC) presents treatment challenges with unclear survival benefits between surgical and non-surgical approaches.
• Health-related quality of life (HRQoL) impact in resectable stage III-N2 NSCLC is poorly understood.
• The PIONEER trial was designed to assess the feasibility of a phase III randomized controlled trial (RCT) comparing multimodality treatments, with HRQoL as a potential primary outcome.

Purpose of the Study:

• To evaluate the feasibility of conducting a phase III RCT for resectable stage III-N2 NSCLC.
• To assess recruitment rates, treatment adherence, and HRQoL questionnaire completion.
• To inform future research strategies for this patient population.

Main Methods:

• A UK-based, 8-centre feasibility RCT involving patients with resectable stage III-N2 NSCLC.
• Randomization of patients 1:1 to either surgical or non-surgical multimodality treatment.
• Feasibility outcomes included recruitment rate, treatment adherence, and HRQoL data collection.

Main Results:

• Only 19% of screened patients were eligible, with 54% of eligible patients consenting and being randomized.
• Treatment uptake was high (93%), but HRQoL questionnaire completion rates were suboptimal (50% at 3 months, 57% at 6 months).
• Multimodality treatment completion rates were 50% in the surgery arm and 65% in the non-surgical arm; central review identified potential eligibility discrepancies.

Conclusions:

• A future phase III RCT comparing surgical versus non-surgical multimodality treatment for stage III-N2 NSCLC is unlikely to be feasible due to low recruitment and HRQoL data completion.
• Future research should consider utilizing high-quality, real-world data for unselected populations to gain insights into treatment patterns and outcomes.