Survivorship Program Including Long-Term Toxicities and Quality-of-Life Development Over Ten Years within a Randomized Phase-III Trial in Operable Stage III Non-Small-Cell Lung Cancer (ESPATUE)

Abstract

Purpose Over 40% stage-III non-small-cell lung cancer patients experience five-year survival following multimodality treatment. Little is known about relevant late toxicities and quality-of-life (QoL) ten years from diagnosis. Methods We invited long-term follow-up-patients from our randomized phase-III trial (Eberhardt et al., Journal of Clinical Oncology 2015) to participate within a structured survivorship program (SSP) including follow-up imaging, laboratory parameters, cardio-pulmonary investigations and long-term toxicity evaluations. QoL questionnaires at 10-years were compared to baseline and early follow-up on exploratory basis. Results Of 246 patients included, 161 evaluated potentially resectable after induction were randomized to definitive chemoradiation boost (A; 80) or definitive surgery (B; 81) (85 not randomized (C)). 31 of 37 patients (OS > 10 yrs) agreed to the SSP (A:13, B:12, C:6). Significant long-term toxicities of 3°/4° were rarely observed (lung(FEV1) 3° A:0/9, B:1/6, C:0/5; 4° A:1/9, B:0/6, C:1/5; no 3°/4° cardiac toxicity, no 3°/4° chronic kidney disease, no 3°/4° polyneuropathy). A:5/12, B:1/10 and C:1/6 patients showed relevant nutritional disorders (obesity 3°). QoL analysis of both arms showed no relevant signals of worsening compared to earlier and baseline results. Mean QoL in SSP A: 56.41/100 pts., B: 64.39/100 pts., C: 59.72/100 pts. Conclusions Long-term surviving patients following definitive chemoradiation or surgery showed comparable long-term toxicities and QoL assessments. Most patients are in good clinical status. Implications for Cancer Survivors This is the first comprehensive SSP reported in stage-III NSCLC treated within a randomized multimodality trial and may serve as baseline information for physician and patient deciding for a treatment option.