Survivorship program including long‐term toxicities and quality‐of‐life development over 10 years in a randomized trial in operable stage III non‐small‐cell lung cancer (ESPATUE)

Abstract

AbstractOver 40% stage‐III non‐small‐cell lung cancer (NSCLC) patients (pts) experience 5‐year survival following multimodality treatment. Nevertheless, little is known about relevant late toxicities and quality‐of‐life (QoL) in the further long‐term follow‐up. Therefore, we invited pts from our randomized phase‐III trial (Eberhardt et al., Journal of Clinical Oncology 2015) after 10 years from diagnosis to participate within a structured survivorship program (SSP) including follow‐up imaging, laboratory parameters, cardio‐pulmonary investigations, long‐term toxicity evaluations and QoL questionnaires. Of 246 pts initially accrued, 161 were considered potentially resectable following the induction therapy and were randomized (80 to arm A: definitive chemoradiation; 81 to arm B: definitive surgery; 85 not randomized for different reasons; group C). 31 from 37 pts still alive after 10 years agreed to the SSP (13 in A; 12 in B; 6 in C). Clinically relevant long‐term toxicities (grade 3 and 4) were rarely observed with no signal favoring any of the randomization arms. Furthermore, available data from the global QoL analysis did not show a signal favoring any definitive locoregional approach (Mean QoL in SSP A pts: 56.41/100, B pts: 64.39/100) and no late decline in comparison to baseline and early 1‐year follow‐up. This is the first comprehensive SSP of very late survival follow‐up reported in stage‐III NSCLC treated within a randomized multimodality trial and it may serve as important baseline information for physicians and pts deciding for a locoregional treatment option.