Radiofrequency ablation of stage IA non-small cell lung cancer in patients ineligible for surgery: results of a prospective multicenter phase II trial

J Palussière, F Chomy, M Savina, F Deschamps, J Y Gaubert, A Renault, O Bonnefoy, F Laurent, C Meunier, C Bellera, S Mathoulin-Pelissier, T de Baere, J Palussière, F Chomy, M Savina, F Deschamps, J Y Gaubert, A Renault, O Bonnefoy, F Laurent, C Meunier, C Bellera, S Mathoulin-Pelissier, T de Baere

Abstract

Background: A prospective multicenter phase II trial to evaluate the survival outcomes of percutaneous radiofrequency ablation (RFA) for patients with stage IA non-small cell lung cancer (NSCLC), ineligible for surgery.

Methods: Patients with a biopsy-proven stage IA NSCLC, staging established by a positron emission tomography-computed tomography (PET-CT), were eligible. The primary objective was to evaluate the local control of RFA at 1-year. Secondary objectives were 1- and 3-year overall survival (OS), 3-year local control, lung function (prior to and 3 months after RFA) and quality of life (prior to and 1 month after RFA).

Results: Of the 42 patients (mean age 71.7 y) that were enrolled at six French cancer centers, 32 were eligible and assessable. Twenty-seven patients did not recur at 1 year corresponding to a local control rate of 84.38% (95% CI, [67.21-95.72]). The local control rate at 3 years was 81.25% (95% CI, [54.35-95.95]). The OS rate was 91.67% (95% CI, [77.53-98.25]) at 1 year and 58.33% (95% CI, [40.76-74.49]) at 3 years. The forced expiratory volume was stable in most patients apart from two, in whom we observed a 10% decrease. There was no significant change in the global health status or in the quality of life following RFA.

Conclusion: RFA is an efficient treatment for medically inoperable stage IA NSCLC patients. RFA is well tolerated, does not adversely affect pulmonary function and the 3-year OS rate is comparable to that of stereotactic body radiotherapy, in similar patients.

Trial registration: ClinicalTrials.gov Identifier NCT01841060 registered in November 2008.

Keywords: Ablation; Non-small cell lung cancer; Radiofrequency ablation; Stereotactic body radiotherapy.

Conflict of interest statement

Ethics approval and consent to participate

All patients provided written consent to participate and the study was approved by the institutional and regional ethics boards.

Consent for publication

All participants consented for the publication of this study..

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of patient inclusion
Fig. 2
Fig. 2
a Overall survival and (b) Progression-free survival curves
Fig. 3
Fig. 3
QLQ C30 boxplots depict changes in global health status, functional scales and symptomatic scales
Fig. 4
Fig. 4
PET-CT before (a) and after RFA (b): an incomplete treatment can be seen on the edge of the ablation zone

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