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Clinical Trial
. 2025 Jan 1;156(1):154-163.
doi: 10.1002/ijc.35131. Epub 2024 Aug 28.

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)

Affiliations
Clinical Trial

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)

Christina Schulte et al. Int J Cancer. .

Abstract

Over 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.

Keywords: NSCLC; multimodality treatment; operable; stage III; survivorship.

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References

REFERENCES

    1. Eberhardt WE, Pöttgen C, Gauler TC, et al. Phase III study of surgery versus definitive concurrent chemoradiotherapy boost in patients with resectable stage IIIA(N2) and selected IIIB non‐small‐cell lung cancer after induction chemotherapy and concurrent chemoradiotherapy (ESPATUE). J Clin Oncol. 2015;33(35):4194‐4201. doi:10.1200/JCO.2015.62.6812
    1. König D, Schär S, Vuong D, et al. Long‐term outcomes of operable stage III NSCLC in the pre‐immunotherapy era: results from a pooled analysis of the SAKK 16/96, SAKK 16/00, SAKK 16/01, and SAKK 16/08 trials. ESMO Open. 2022;7(2):100455. doi:10.1016/j.esmoop.2022.100455 Erratum in: ESMO Open. 2022;7(3):100494.
    1. Zenke Y, Tsuboi M, Chiba Y, et al. Effect of second‐generation vs third‐generation chemotherapy regimens with thoracic radiotherapy on unresectable stage III non‐small‐cell lung cancer: 10‐year follow‐up of a WJTOG0105 phase 3 randomized clinical trial. JAMA Oncol. 2021;7(6):904‐909. doi:10.1001/jamaoncol.2021.0113
    1. Ozawa Y, Yamamoto N, Yamamoto K, et al. Creation of an integrated clinical trial database and data sharing for conducting new research by the Japan lung cancer society. JTO Clin Res Rep. 2022;3(5):100317. doi:10.1016/j.jtocrr.2022.100317 Erratum in: JTO Clin Res Rep. 2023;4(2):100458.
    1. Abbas MN, Ayoola A, Padman S, et al. Survival and late toxicities following concurrent chemo‐radiotherapy for locally advanced stage III non‐small cell lung cancer: findings of a 10‐year Australian single centre experience with long term clinical follow up. J Thorac Dis. 2019;11(10):4241‐4248. doi:10.21037/jtd.2019.09.56

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