LBA3_PR – An international randomized trial, comparing post-operative conformal radiotherapy (PORT) to no PORT, in patients with completely resected non-small cell lung cancer (NSCLC) and mediastinal N2 involvement. Primary end-point analysis of Lung ART (IFCT-0503, UK NCRI, SAKK) NCT00410683.<\/p>\n
C. Le Pechoux1<\/sup>, N. Pourel2<\/sup>, F. Barlesi3<\/sup>, C. Faivre-Finn4<\/sup>, D. Lerouge5<\/sup>, G. Zalcman6<\/sup>, D. Antoni7<\/sup>, B. Lamezec8<\/sup>, U. Nestle9<\/sup>, P. Boisselier10<\/sup>, F. Thillays11<\/sup>, A. Paumier12<\/sup>, E. Dansin13<\/sup>, K. Peignaux14<\/sup>, J. Madelaine15<\/sup>, E. Pichon16<\/sup>, A. Larrouy17<\/sup>, O. Riesterer18<\/sup>, A. Lavole19<\/sup>, A. Bardet20<\/sup> Background: <\/strong>Adjuvant PORT has been controversial since publication of a meta-analysis showing PORT could be deleterious especially in pN0 pN1 pts. However, changes have taken place in the management of stage IIIAN2 NSCLC pts including use of adjuvant chemotherapy (CT), patients\u2019 workup, quality of surgery and radiotherapy. Therefore the role of PORT warranted further investigations in high risk pts.<\/p>\n Methods: <\/strong>LungART is a multi-institutional randomized phase III trial comparing mediastinal PORT (54 Gy\/27-30 fractions) to no PORT. Pts were eligible if they were PS 0-2, had a complete resection with nodal exploration, proven N2 disease; prior (neo)-adjuvant CT was allowed. The main end-point was disease-free survival (DFS). 500 pts and 292 events were required to show an improvement in DFS from 30% to 42% with PORT (bilateral test). Secondary endpoints included toxicity, local control, patterns of recurrence, overall survival (OS), second cancers, prognostic and predictive factors of treatment effect.<\/p>\n Results: <\/strong>Between August 2007 and July 2018, 501 patients were randomized after surgery or after CT: 252 pts allocated to PORT, and 249 to CA. Median age was 61 (range=36-85), 66% male, histology: mostly adenocarcinoma (73%) and work-up included PET scan in 91% pts. Most patients received CT (post op 77%, pre-op 18%). Analysis for DFS was performed with a median FU of 4.8 yrs; toxicity evaluated on 487 pts (246 in CA). Early and late Gr 3-5 cardio-pulmonary toxicity was respectively 7 and 20% in PORT vs 3,2 and 7,7 % in CA. DFS hazard ratio was 0.85 (95% CI 0.67; 1.07); p=0.16; median DFS was 30.5 months in PORT arm [24;48] and 22.8 in CA [17;37]; 3-year DFS was 47.1% with PORT vs 43.8% with no PORT. 3-year OS was 66.5% with PORT vs 68.5% with no PORT.<\/p>\n Conclusions: <\/strong>LungART is the first European randomized study evaluating modern PORT after complete resection, in pts selected predominantly with PET scan and having received (neo)adjuvant CT. 3-year DFS was higher than expected in both arms and PORT was associated with a non-statistically significant 15% increase in DFS among stage IIIAN2 pts.<\/p>\n Clinical trial identification: <\/strong>NCT00410683 Disclosure: <\/strong>C. Le Pechoux: Honoraria (institution): Amgen; Honoraria (institution), Advisory\/Consultancy: Astra Zeneca; Honoraria (institution): Lilly; Honoraria (self): PrimeOncology; Honoraria (institution): Medscape; Honoraria (institution), Advisory\/Consultancy: Roche; Honoraria (institution), Advisory\/Consultancy: Nanobiotix. F. Barlesi: Honoraria (self), Personal Fees: Astra Zeneca; Honoraria (self): Bayer; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Boehringer\u2013Ingelheim; Honoraria (self): Eli Lilly Oncology; Honoraria (self): F. Hoffmann\u2013La Roche Ltd; Honoraria (self): Novartis; Honoraria (self): Merck; Honoraria (self): MSD; Honoraria (self): Pierre Fabre; Honoraria (self): Pfizer ; Honoraria (self): Takeda. C. Faivre-Finn: Advisory\/Consultancy, Research grant\/Funding (institution): Astra Zeneca; Research grant\/Funding (institution): Elekta. G. Zalcman: Research grant\/Funding (institution): Fondation Roche; Honoraria (self), Travel\/Accommodation\/Expenses: Astra Zeneca; Honoraria (self), Travel\/Accommodation\/Expenses: BMS; Honoraria (self): MSD; Honoraria (self), Advisory\/Consultancy: Inventiva; Travel\/Accommodation\/Expenses: Roche; Travel\/Accommodation\/Expenses: Abbvie; Travel\/Accommodation\/Expenses: Pfizer; Advisory\/Consultancy: Da Volterra. J. Madelaine: Honoraria (self), Dr JM received support: Astra Zeneca; Honoraria (self): Chugai Pharma; Honoraria (self): Pfizer; Honoraria (self): Boehringer Ingelheim; Honoraria (self): MSD France; Honoraria (self): Roche SAS; Honoraria (self): Actelion; Honoraria (self): GSK; Honoraria (self): Bristol-Myers Squibb. A. Bardet: Advisory\/Consultancy: Roche. All other authors have declared no conflicts of interest.<\/p>\n<\/div>\n
1<\/sup>Radiation Oncology, Gustave Roussy, Villejuif, France, 2<\/sup>Radiation Oncology, Institut Sainte Catherine, Avignon, France, 3<\/sup>France and Institut Gustave Roussy, Aix Marseille Universit\u00e9, Aix-Marseille University, CRCM, APHM, Marseille, Villejuif, CEDEX 20, France, 4<\/sup>Clinical Oncology, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK, 5<\/sup>Radiation Oncology, Centre Baclesse, Caen, France, 6<\/sup>Department of Thoracic Oncology and CIC1425, H\u00f4pital Bichat-Claude Bernard, Assistance Publique H\u00f4pitaux de Paris, Universit\u00e9 Paris-Diderot, Paris, France, 7<\/sup>Radiation Oncology, Institut de Cancerologie Strasbourg Europe, Strasbourg, France, 8<\/sup>Radiation Oncology, Clinique Armoricaine de Radiologie, St. Brieuc, France, 9<\/sup>Radiation Oncology, Universit\u00e4tsklinikum Freiburg Klinik f\u00fcr Innere Medizin H\u00e4matologie, Onkologie und Stammzelltransplantation, Freiburg Im Breisgau, Germany, 10<\/sup>Radiation Oncology, ICM Regional Cancer Institute of Montpellier, Montpellier, CEDEX 5, France, 11<\/sup>Radiation Oncology, Institut de Canc\u00e9rologie de l\u2019ouest,, Saint Herblain, France, 12<\/sup>Radiation Oncology, ICO Site Paul Papin, Angers, France, 13<\/sup>Medical Oncology, Centre Oscar Lambret, Lille, CEDEX, France, 14<\/sup>Radiation Oncology, Centre Georges Francois Leclerc, Dijon, France, 15<\/sup>Medical Oncology, Centre Hospitalier Caen, Caen, France, 16<\/sup>Pneumology, CHRU Bretonneau, Tours, CEDEX 9, France, 17<\/sup>Radiation Oncology, Centre de Cancerologie Paris Nord, Sarcelles, France, 18<\/sup>Radiation Oncology, University Hospital Zurich and Center for Radiation Oncology KSA-KSB, Cantonal Hospital Aurau, Zurich, Switzerland, 19<\/sup>Pneumology, Hopital Tenon, Paris, France, 20<\/sup>Biostatistics, Institut Gustave Roussy, Villejuif, France<\/p>\n
Legal entity responsible for the study: <\/strong>Gustave Roussy
Funding: <\/strong>French National Cancer Institute (INCa), French Health Ministry (PHRC), Gustave Roussy and CRUK grant (A13969).<\/p>\n