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101. 1272P First results of the early onset lung cancer (EOLUNG) study to characterize genomic alterations using FoundationOne CDx in young patients with non-small cell lung cancer

Author

Casulleras, M. Jove, primary, Barrera, J. Bosch, additional, Sais, E., additional, Hernandez, A., additional, Gasusachs, M., additional, Carcereny, E., additional, Moran, T., additional, Vinolas, M. Domenech, additional, Palmero, R., additional, Brenes, J., additional, Vilariño, N., additional, Ruffinelli, J.C.C., additional, Fina, C., additional, Lorente, S., additional, Teule, A., additional, Lazaro, C., additional, and Nadal, E., additional

Published
2021
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102. 1172MO Durvalumab consolidation in patients with stage III non-resecable NSCLC with driver genomic alterations

Author

Melia, M. Riudavets, primary, Auclin, E., additional, Lamas, M.A. Mosteiro, additional, Dempsey, N., additional, Majem, M., additional, Lobefaro, R., additional, Castro, R. Lopez, additional, Barrera, J. Bosch, additional, Pilotto, S., additional, Martín, E. Escalera, additional, Tagliamento, M., additional, Martinez, J. Mosquera, additional, Zalcman, G., additional, Nadal, E., additional, Lopes, G., additional, Signorelli, D., additional, Campelo, M.R. Garcia, additional, Besse, B., additional, Planchard, D., additional, and Mezquita, L., additional

Published
2021
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103. 1366TiP Tepotinib + osimertinib for EGFR-mutant NSCLC with resistance to first-line osimertinib due to MET amplification (METamp): INSIGHT 2

Author

Wu, Y-L., primary, Dooms, C., additional, Nadal, E., additional, Raskin, J., additional, Demedts, I., additional, Mazieres, J., additional, Wislez, M., additional, Shukor, S. Abdul, additional, Tho, L.M., additional, Wang, C-C., additional, Viteri, S., additional, Le, X., additional, How, S.H., additional, Tan, D., additional, Takeda, M., additional, Veillon, R., additional, Karachaliou, N., additional, Ellers-Lenz, B., additional, and Smit, E.F.F., additional

Published
2021
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105. Pre-treatment tissue TCR repertoire evenness is associated with complete pathological response in patients with NSCLC receiving neoadjuvant chemoimmunotherapy

Author

Casarrubios M, Cruz-Bermudez A, Nadal E, Insa A, Garcia-Campelo R, Lazaro M, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, de Castro-Carpeno J, Cobo M, Lopez-Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Massuti B, Barquin M, Laza-Briviesca R, Sierra-Rodero B, Parra E, Sanchez-Espiridion B, Rocha P, Kadara H, Wistuba I, Romero A, Calvo V, and Provencio M

Abstract

PURPOSE: Characterization of the T-cell receptor (TCR) repertoire may be a promising source for predictive biomarkers of pathological response to immunotherapy in locally-advanced non-small cell lung cancer (NSCLC). EXPERIMENTAL DESIGN: In this study, next-generation TCR sequencing was performed in peripheral blood and tissue samples of 40 NSCLC patients, before and after neoadjuvant chemoimmunotherapy (NADIM clinical trial, NCT03081689), considering their complete pathologic response (CPR) or non-CPR. Beyond TCR metrics, tissue clones were ranked by their frequency and spatiotemporal evolution of top 1% clones was determined. RESULTS: We have found a positive association between an uneven TCR repertoire in tissue samples at diagnosis and CPR at surgery. Moreover, TCR most frequent-ranked clones (top 1%) present in diagnostic biopsies occupied greater frequency in the total clonal space of CPR patients, achieving an AUC ROC to identify CPR patients of 0.967 (95% CI, 0.897 to 1.000; p=0.001), and improving the results of PD-L1 TPS (AUC 0.767; p=0.026) or TMB (AUC 0.550; p=0.687). Furthermore, tumors with high pre-treatment top 1% clonal space showed similar immune cell populations but a higher immune reactive gene expression profile. Finally, the selective expansion of pre-treatment tissue top 1% clones in peripheral blood of CPR patients suggests also a peripheral immunosurveillance, which could explain the high survival rate of these patients. CONCLUSIONS: We have identified two parameters derived from TCR repertoire analysis that could outperform PD-L1 TPS and TMB as predictive biomarkers of CPR after neoadjuvant chemoimmunotherapy, and unraveled possible mechanisms of CPR involving enhanced tumor immunogenicity and peripheral immunosurveillance.

Published
2021

106. Progression-Free and Overall Survival for Concurrent Nivolumab With Standard Concurrent Chemoradiotherapy in Locally Advanced Stage IIIA-B NSCLC: Results From the European Thoracic Oncology Platform NICOLAS Phase II Trial (European Thoracic Oncology Platform 6-14)

Author

Peters, S. Felip, E. Dafni, U. Tufman, A. Guckenberger, M. Álvarez, R. Nadal, E. Becker, A. Vees, H. Pless, M. Martinez-Marti, A. Lambrecht, M. Andratschke, N. Tsourti, Z. Piguet, A.-C. Roschitzki-Voser, H. Gasca-Ruchti, A. Vansteenkiste, J. Stahel, R.A. De Ruysscher, D.

Abstract

Introduction: The NICOLAS study is the first completed single-arm phase II trial in stage III NSCLC evaluating hierarchically first the safety and then the efficacy of adding nivolumab concurrently to standard definitive concurrent chemoradiotherapy. The safety end point was reported earlier; here, we present the efficacy results. Methods: Stage IIIA-B unresectable treatment-naive patients with NSCLC received three cycles of platinum-based chemotherapy and concurrent radiotherapy (66 Gy, 33 fractions), along with nivolumab (360 mg, 3-weekly). Nivolumab was continued as monotherapy consolidation for a maximum of 1 year (480 mg, 4-weekly). The primary end point was 1-year progression-free survival (PFS), with a target improvement compared with historical data of at least 15%, from 45% to 60%. To test this efficacy hypothesis, a sample size of 74 assessable patients provided a power of 83% with a one-sided alpha of 5%. Results: A total of 79 patients were enrolled with a median follow-up of 21.0 months (interquartile range: 15.8–25.8 mo) for the primary PFS analysis. A total of 35.4% of the patients had stage IIIA, and 63.3% had stage IIIB disease. The 1-year PFS was 53.7% (95% confidence interval [CI]: 42.0%–64.0%) and the median PFS was 12.7 months (95% CI: 10.1–22.8 mo). Because 37 PFS events occurred in the first year posttreatment among the first 74 assessable patients, a 1-year PFS rate of at least 45% could not be rejected (p = 0.23). At an extended follow-up (median 32.6 mo), 37 deaths have been recorded, with a median overall survival (OS) of 38.8 months (95% CI: 26.8 mo–not estimable) and a 2-year OS rate of 63.7% (95% CI: 51.9%–73.4%). The OS of patients with stage IIIA disease was found to be significantly higher than patients with stage IIIB disease, with a 2-year OS of 81% and 56%, respectively (p = 0.037). Conclusions: PFS and OS are arithmetically higher in studies involving the same population. However, on the basis of the formal hierarchical efficacy analysis, we could not reject that the 1-year PFS rate is at least 45%. © 2020

Published
2021

108. LIPI and outcomes of durvalumab as consolidation therapy after ChRT in patients with locally-advanced NSCLC [MA08.04]

Author

Riudavets, M., Mezquita, L., Auclin, E., Benitez, J.C., Le Pechoux, C., Majem, M., Dempsey, N., Lobefaro, R., Nadal, E., Amores, A., Menis, J., Tagliamento, M., López-Castro, R., Ponce, S., Bosch-Barrera, J., Aboubakar Nana, Frank, Mosquera, J., Pilotto, S., Reyes, R., Mielgo, X., Duchemann, B., Mosteiro, M., Mussat, E., De Giglio, A., Scheffler, M., Campayo, M., Botticella, A., Naltet, C., Lavaud, P., Lopes, G., Signorelli, D., Garcia-Campelo, R., Besse, B., Planchard, D., 2020 World Conference on Lung Cancer, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, and UCL - (SLuc) Service de pneumologie

Subjects
Pulmonary and Respiratory Medicine, Oncology
Abstract

INTRODUCTION : The lung immune prognostic index (LIPI), which combines pretreatment derived neutrophils/[leukocytes minus neutrophils] ratio (dNLR) >3 and lactate dehydrogenase (LDH) > upper limit of normal (ULN), is associated with outcomes in advanced non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICI). We aimed to assess whether pretreatment LIPI correlates with durvalumab efficacy after concurrent chemoradiotherapy in the locally advanced setting.

Published
2021

109. Lung Immune Prognostic Index (LIPI) in Advanced NSCLC Patients Treated with Immunotherapy, Chemotherapy and both Combined Upfront [FP07.06]

Author

Blanc-Durand, F., Mielgo Rubio, X., Auclin, E., Ponce-Aix, S., Lopez Castro, R., Nadal, E., Planchard, D., Routy, B., Hendriks, L., Sullivan, I., Dempsey, N., Pilotto, S., Aboubakar Nana, Frank, Pinato, D.J., Castonguay, M., Rodriguez, A., Amores, A., Bluthgen, M.V., Duchemann, B., Castellano, P. Cruz, Aguado De La Rosa, C., Sereno Moyano, M., Ruffinelli, J., Lopez, G., Caramella, C., Besse, B., Mezquita, L., 2020 World Conference on Lung Cancer, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, and UCL - (SLuc) Service de pneumologie

Subjects
Pulmonary and Respiratory Medicine, Oncology
Abstract

INTRODUCTION : The Lung Immune Prognostic Index (LIPI) that combines the neutrophils/[leucocytes minus neutrophils] ratio (dNLR) and lactate dehydrogenase (LDH), is associated with outcomes in pretreated advanced NSCLC patients receiving single agent immune checkpoint inhibitors (ICI). However, its role in first line treatment of advanced NSCLC patients has not been explored yet. We assessed the value of baseline LIPI in the first line setting, for ICI-monotherapy, ICI-combination or platinum-based chemotherapy alone (CT). [...]

Published
2021

110. LIPI and outcomes of durvalumab as consolidation therapy after ChRT in patients with locally-advanced NSCLC [MA08.04]

Author

UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (SLuc) Service de pneumologie, Riudavets, M., Mezquita, L., Auclin, E., Benitez, J.C., Le Pechoux, C., Majem, M., Dempsey, N., Lobefaro, R., Nadal, E., Amores, A., Menis, J., Tagliamento, M., López-Castro, R., Ponce, S., Bosch-Barrera, J., Aboubakar Nana, Frank, Mosquera, J., Pilotto, S., Reyes, R., Mielgo, X., Duchemann, B., Mosteiro, M., Mussat, E., De Giglio, A., Scheffler, M., Campayo, M., Botticella, A., Naltet, C., Lavaud, P., Lopes, G., Signorelli, D., Garcia-Campelo, R., Besse, B., Planchard, D., 2020 World Conference on Lung Cancer, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (SLuc) Service de pneumologie, Riudavets, M., Mezquita, L., Auclin, E., Benitez, J.C., Le Pechoux, C., Majem, M., Dempsey, N., Lobefaro, R., Nadal, E., Amores, A., Menis, J., Tagliamento, M., López-Castro, R., Ponce, S., Bosch-Barrera, J., Aboubakar Nana, Frank, Mosquera, J., Pilotto, S., Reyes, R., Mielgo, X., Duchemann, B., Mosteiro, M., Mussat, E., De Giglio, A., Scheffler, M., Campayo, M., Botticella, A., Naltet, C., Lavaud, P., Lopes, G., Signorelli, D., Garcia-Campelo, R., Besse, B., Planchard, D., and 2020 World Conference on Lung Cancer

Abstract

INTRODUCTION : The lung immune prognostic index (LIPI), which combines pretreatment derived neutrophils/[leukocytes minus neutrophils] ratio (dNLR) >3 and lactate dehydrogenase (LDH) > upper limit of normal (ULN), is associated with outcomes in advanced non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICI). We aimed to assess whether pretreatment LIPI correlates with durvalumab efficacy after concurrent chemoradiotherapy in the locally advanced setting.

Published
2021

111. Lung Immune Prognostic Index (LIPI) in Advanced NSCLC Patients Treated with Immunotherapy, Chemotherapy and both Combined Upfront [FP07.06]

Author

UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (SLuc) Service de pneumologie, Blanc-Durand, F., Mielgo Rubio, X., Auclin, E., Ponce-Aix, S., Lopez Castro, R., Nadal, E., Planchard, D., Routy, B., Hendriks, L., Sullivan, I., Dempsey, N., Pilotto, S., Aboubakar Nana, Frank, Pinato, D.J., Castonguay, M., Rodriguez, A., Amores, A., Bluthgen, M.V., Duchemann, B., Castellano, P. Cruz, Aguado De La Rosa, C., Sereno Moyano, M., Ruffinelli, J., Lopez, G., Caramella, C., Besse, B., Mezquita, L., 2020 World Conference on Lung Cancer, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (SLuc) Service de pneumologie, Blanc-Durand, F., Mielgo Rubio, X., Auclin, E., Ponce-Aix, S., Lopez Castro, R., Nadal, E., Planchard, D., Routy, B., Hendriks, L., Sullivan, I., Dempsey, N., Pilotto, S., Aboubakar Nana, Frank, Pinato, D.J., Castonguay, M., Rodriguez, A., Amores, A., Bluthgen, M.V., Duchemann, B., Castellano, P. Cruz, Aguado De La Rosa, C., Sereno Moyano, M., Ruffinelli, J., Lopez, G., Caramella, C., Besse, B., Mezquita, L., and 2020 World Conference on Lung Cancer

Abstract

INTRODUCTION : The Lung Immune Prognostic Index (LIPI) that combines the neutrophils/[leucocytes minus neutrophils] ratio (dNLR) and lactate dehydrogenase (LDH), is associated with outcomes in pretreated advanced NSCLC patients receiving single agent immune checkpoint inhibitors (ICI). However, its role in first line treatment of advanced NSCLC patients has not been explored yet. We assessed the value of baseline LIPI in the first line setting, for ICI-monotherapy, ICI-combination or platinum-based chemotherapy alone (CT). [...]

Published
2021

112. Progression-free and overall survival for concurrent nivolumab with standard concurrent chemo-radiotherapy in locally advanced stage IIIA/B NSCLC: Results from the European Thoracic Oncology Platform NICOLAS phase II trial (ETOP 6-14)

Author

Peters, S, Felip, E, Dafni, U, Tufman, A, Guckenberger, Matthias; https://orcid.org/0000-0002-7146-9071, Álvarez, R, Nadal, E, Becker, A, Vees, H, Pless, M, Martinez-Marti, A, Lambrecht, M, Andratschke, Nicolaus; https://orcid.org/0000-0003-3647-5916, Tsourti, Z, Piguet, A-C, Roschitzki-Voser, H, Gasca-Ruchti, A, Vansteenkiste, J, Stahel, Rolf A; https://orcid.org/0000-0003-4815-8870, De Ruysscher, Dirk, Peters, S, Felip, E, Dafni, U, Tufman, A, Guckenberger, Matthias; https://orcid.org/0000-0002-7146-9071, Álvarez, R, Nadal, E, Becker, A, Vees, H, Pless, M, Martinez-Marti, A, Lambrecht, M, Andratschke, Nicolaus; https://orcid.org/0000-0003-3647-5916, Tsourti, Z, Piguet, A-C, Roschitzki-Voser, H, Gasca-Ruchti, A, Vansteenkiste, J, Stahel, Rolf A; https://orcid.org/0000-0003-4815-8870, and De Ruysscher, Dirk

Abstract

Background: NICOLAS is the first completed single-arm phase II trial in stage III NSCLC examining hierarchically first the safety and then the efficacy of adding nivolumab concurrently to standard definitive concurrent chemo-radiotherapy. The safety endpoint was reported earlier; here we present the efficacy results. Methods: Stage IIIA/B unresectable treatment-naive NSCLC patients received 3 cycles of platinum-based chemotherapy and concurrent radiotherapy (66Gy/33fractions), along with nivolumab (360mg/Q3W). Nivolumab was continued as monotherapy consolidation for a maximum of one year (480mg/Q4W). The primary endpoint was 1-year PFS, with a target improvement compared to historical data of at least 15%, from 45% to 60%. For testing this efficacy hypothesis, a sample size of 74 evaluable patients provides power 83%, at 1-sided alpha 5%. Findings: 79 patients were enrolled with median follow-up 21.0 months (m) (Interquartile Range:15.8m-25.8m) for the primary PFS analysis. 35.4% of patients had stage IIIA and 63.3% stage IIIB. The 1-year PFS was 53.7% (95%CI[42.0%-64.0%]), the median PFS 12.7m (95%CI[10.1m-22.8m]). Since among the 74 first evaluable patients, 37 PFS events occurred in the first year post-treatment, a 1-year PFS rate of ≤45% could not be rejected (p-value=0.23). At an extended follow-up (32.6m median), 37 deaths have been recorded, with a median OS 38.8m(95%CI[26.8m-Not Estimable]) and a 2-year OS rate of 63.7% (95%CI[51.9%-73.4%]). The OS of stage IIIA patients was found to be significantly higher than stage IIIB patients, with 2-year OS 81% and 56% respectively (p=0.037). Conclusion: PFS and OS are arithmetically higher to studies in the same population, however, based on the formal hierarchical efficacy analysis, we could not reject that the 1-year PFS rate is ≤45%.

Published
2021

113. 1278P ORIGEN: Multicenter study on the prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain

Author

Nadal, E., Fernandez, C. Alvarez, Arasanz, H., Muñoz, S. Peralta, Quintela, M. Lázaro, Teixido, C., Calvo de Juan, V., Alvarez, R.M., Espinar, J. Baena, Valdivia-Bautista, J., Arriola, E., Lastra, R., Caro, R. Bernabe, Camacho, C., Cordellat, A. Blasco, Sureda, B. Massuti, Guillaumes, M. Campayo, Dols, M. Cobo, Manrique, T. Garcia, and Marquez, G.J.

Published
2023
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116. 1509TiP The 1825-EORTC, ALKALINE: Activity of lorlatinib based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with second generation ALK inhibitor

Author

Mezquita, L., Xenophontos, E., Pretzenbaher, Y., Sureda, C., Nadal, E., Al-Rabi, K., Rousseau Bussac, G., Ponce Aix, S., Sullivan, I.G., Calles Blanco, A., Cloarec, N., De Langen, J., Berghmans, T., Descourt, R., Hendriks, L., Garrido Lopez, P., Helland, A., Carcereny, E., Besse, B., and Dingemans, A-M.C.

Published
2023
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118. 1361P Alectinib for treatment-naïve advanced ALK+ NSCLC selected via blood-based NGS: Updated analyses of outcomes, circulating tumour (ct)DNA and biomarker subgroups from BFAST Cohort A

Author

Gadgeel, S.M., Mok, T.S.K., Peters, S., Nadal, E., Han, J-Y., Alatorre Alexander, J.A., Leighl, N., Sriuranpong, V., Pérol, M., Castro, G.D., de Marinis, F., Tan, D.S.W., Paul, S., Assaf, Z.J., MacLennan, M., Lohmann, T.O., Slade, M., Mathisen, M.S., Bhagawati-Prasad, V., and Dziadziuszko, R.

Published
2023
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122. 81P Predictive molecular parameters of pneumonitis development in stage IIIa NSCLC patients treated with neo-adjuvant chemo-immunotherapy from NADIM clinical trial

Author

Sierra-Rodero, B., primary, Garitaonaindia, Y., additional, Martinez-Cutillas, M., additional, Nadal, E., additional, Insa, A., additional, Campelo, M.R. Garcia, additional, Rubio, J. Casal, additional, Gomez, M. Domine, additional, Tarruella, M. Majem, additional, Abreu, D. Rodriguez, additional, Martinez-Marti, A., additional, De Castro Carpeno, J., additional, del Barco, E., additional, Viñolas, N., additional, Aranda, I.C. Barneto, additional, Sureda, B. Massuti, additional, Casarrubios, M., additional, Laza-Briviesca, R., additional, Cruz-Bermudez, A., additional, and Provencio, M., additional

Published
2021
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124. MA01.06 Phase 2 of Pro-Autophagic Drug ABTL0812 in Combination With First-Line Paclitaxel and Carboplatin in IIIb/IV Squamous NSCLC

Author

Bosch-Barrera, J., primary, Moran, T., additional, Estévez-García, P., additional, Martin-Martorell, P., additional, Sabatier, R., additional, Nadal, E., additional, Sais, E., additional, Garralda, E., additional, Lizcano, J.M., additional, Muñoz Guardiola, P., additional, Pérez-Montoyo, H., additional, Yeste-Velasco, M., additional, Cortal, M., additional, Domènech, C., additional, Alfon, J., additional, and Rodon, J., additional

Published
2021
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125. P60.07 TMB and Selected Mutations in Resectable Stage IIIA NSCLC Patients Receiving Neo-Adjuvant Chemo-Immunotherapy from NADIM Trial

Author

Cruz-Bermudez, A., primary, Casarrubios, M., additional, Briviesca, R. Laza, additional, Nadal, E., additional, Insa, A., additional, Mosquera, J., additional, Huidobro, G., additional, Gómez, M. Dómine, additional, Massuti, B., additional, Tarruella, M. Majem, additional, Rodríguez-Abreu, D., additional, Martinez-Marti, A., additional, De Castro Campeño, J., additional, Dols, M. Cobo, additional, Vivanco, G. López, additional, Del Barco, E., additional, Caro, R. Bernabé, additional, Viñolas, N., additional, Barneto, I., additional, Viteri, S., additional, Jove, M., additional, Romero, A., additional, Franco, F., additional, and Provencio, M., additional

Published
2021
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126. FP12.09 Molecular Insight into NADIM Clinical Trial: Potential Immune Biomarkers of Pathological Response for NSCLC Patients.

Author

Laza Briviesca, R., primary, Nadal, E., additional, Casarrubios, M., additional, Insa, A., additional, Sierra-Rodero, B., additional, Garcia Campelo, M.R., additional, Huidobro, G., additional, Dómine Gómez, M., additional, Massuti, B., additional, Majem, M., additional, Rodríguez-Abreu, D., additional, Martinez-Marti, A., additional, De Castro Campeño, J., additional, Cobo Dols, M., additional, López Vivanco, G., additional, Del Barco, E., additional, Bernabé Caro, R., additional, Viñolas, N., additional, Barneto, I., additional, Viteri, S., additional, Cruz-Bermudez, A., additional, and Provencio, M., additional

Published
2021
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127. P60.11 TCR Repertoire Predicts Pathological Response in NSCLC Patients Receiving Neoadjuvant Chemoimmunotherapy from NADIM Trial

Author

Casarrubios, M., primary, Nadal, E., additional, Cruz-Bermudez, A., additional, Insa, A., additional, Briviesca, R. Laza, additional, Campelo, M.R. Garcia, additional, Sierra-Rodero, B., additional, Casal, J., additional, Dómine, M., additional, Massuti, B., additional, Tarruella, M. Majem, additional, Rodríguez-Abreu, D., additional, Martinez-Marti, A., additional, De Castro Campeño, J., additional, Dols, M. Cobo, additional, Vivanco, G. López, additional, Del Barco, E., additional, Caro, R. Bernabé, additional, Viñolas, N., additional, Barneto, I., additional, Viteri, S., additional, Jove, M., additional, Franco, F., additional, and Provencio, M., additional

Published
2021
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128. MA06.03 Phosphorylated Ribosomal Protein S6, Correlation With Characteristics and Clinical Outcome in Patients With MPM: Results from ETOP Mesoscape

Author

Opitz, I., primary, Rüschoff, J.H., additional, Haberecker, M., additional, Tsourti, Z., additional, Nackaerts, K., additional, Ampollini, L., additional, De Perrot, M., additional, Brcic, L., additional, Nadal, E., additional, Gray, S., additional, Aerts, J., additional, Verbeken, E., additional, Silini, E., additional, Zaeimi, F., additional, Samarzija, M., additional, Llatjos, R., additional, Tsimpoukis, S., additional, Von Der Thüsen, J., additional, Finn, S., additional, Monkhorst, K., additional, Marti, N., additional, Dimopoulou, G., additional, Kammler, R., additional, Peters, S., additional, Baas, P., additional, Stahel, R., additional, and Mesoscape Consortium, F., additional

Published
2021
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129. FP07.06 Lung Immune Prognostic Index (LIPI) in Advanced NSCLC Patients Treated with Immunotherapy, Chemotherapy and both Combined Upfront.

Author

Blanc-Durand, F., primary, Mielgo Rubio, X., additional, Auclin, E., additional, Ponce-Aix, S., additional, Lopez Castro, R., additional, Nadal, E., additional, Planchard, D., additional, Routy, B., additional, Hendriks, L., additional, Sullivan, I., additional, Dempsey, N., additional, Pilotto, S., additional, Aboubakar, F., additional, Pinato, D.J., additional, Castonguay, M., additional, Rodriguez, A., additional, Amores, A., additional, Bluthgen, M.V., additional, Duchemann, B., additional, Castellano, P. Cruz, additional, Aguado De La Rosa, C., additional, Sereno Moyano, M., additional, Ruffinelli, J., additional, Lopez, G., additional, Caramella, C., additional, Besse, B., additional, and Mezquita, L., additional

Published
2021
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130. MA08.04 LIPI and outcomes of durvalumab as consolidation therapy after ChRT in patients with locally-advanced NSCLC

Author

Riudavets, M., primary, Mezquita, L., additional, Auclin, E., additional, Benitez, J.C., additional, Le Pechoux, C., additional, Majem, M., additional, Dempsey, N., additional, Lobefaro, R., additional, Nadal, E., additional, Amores, A., additional, Menis, J., additional, Tagliamento, M., additional, López-Castro, R., additional, Ponce, S., additional, Bosch-Barrera, J., additional, Aboubakar, F., additional, Mosquera, J., additional, Pilotto, S., additional, Reyes, R., additional, Mielgo, X., additional, Duchemann, B., additional, Mosteiro, M., additional, Mussat, E., additional, De Giglio, A., additional, Scheffler, M., additional, Campayo, M., additional, Botticella, A., additional, Naltet, C., additional, Lavaud, P., additional, Lopes, G., additional, Signorelli, D., additional, Garcia-Campelo, R., additional, Besse, B., additional, and Planchard, D., additional

Published
2021
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133. A multicentre randomised phase III trial comparing pembrolizumab versus single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial

Author

Popat, S. Curioni-Fontecedro, A. Dafni, U. Shah, R. O'Brien, M. Pope, A. Fisher, P. Spicer, J. Roy, A. Gilligan, D. Gautschi, O. Nadal, E. Janthur, W.D. López Castro, R. García Campelo, R. Rusakiewicz, S. Letovanec, I. Polydoropoulou, V. Roschitzki-Voser, H. Ruepp, B. Gasca-Ruchti, A. Peters, S. Stahel, R.A.

Abstract

Background: Malignant pleural mesothelioma (MPM) is an aggressive malignancy characterised by limited treatment options and a poor prognosis. At relapse after platinum-based chemotherapy, single-agent chemotherapy is commonly used and single-arm trials of immune-checkpoint inhibitors have demonstrated encouraging activity. Patients and methods: PROMISE-meso is an open-label 1:1 randomised phase III trial investigating the efficacy of pembrolizumab (200 mg/Q3W) versus institutional choice single-agent chemotherapy (gemcitabine or vinorelbine) in relapsed MPM patients with progression after/on previous platinum-based chemotherapy. Patients were performance status 0–1 and unselected for programmed cell death ligand 1 (PD-L1) status. At progression, patients randomly assigned to receive chemotherapy were allowed to crossover to pembrolizumab. The primary end point was progression-free survival (PFS), assessed by blinded independent central review (BICR). Secondary end points were overall survival (OS), investigator-assessed PFS, objective response rate (ORR), and safety. Efficacy by PD-L1 status was investigated in exploratory analyses. Results: Between September 2017 and August 2018, 144 patients were randomly allocated (pembrolizumab: 73; chemotherapy: 71). At data cut-off [20 February 2019, median follow-up of 11.8 months (interquartile range: 9.9–14.5)], 118 BICR-PFS events were observed. No difference in BICR-PFS was detected [hazard ratio = 1.06, 95% confidence interval (CI): 0.73–1.53; P = 0.76], and median BICR-PFS (95% CI) for pembrolizumab was 2.5 (2.1–4.2), compared with 3.4 (2.2–4.3) months for chemotherapy. A difference in ORR for pembrolizumab was identified (22%, 95% CI: 13% to 33%), over chemotherapy (6%, 95% CI: 2% to 14%; P = 0.004). Forty-five patients (63%) assigned to chemotherapy received pembrolizumab at progression. With follow-up to 21 August 2019 [17.5 months: (14.8–19.7)], no difference in OS was detected between groups (HR = 1.12, 95% CI: 0.74–1.69; P = 0.59), even after adjusting for crossover. Pembrolizumab safety was consistent with previous observations. Exploratory efficacy analyses by PD-L1 status demonstrated no improvements in ORR/PFS/OS. Conclusion: This is the first randomised trial evaluating the efficacy of pembrolizumab in MPM patients progressing after/on previous platinum-based chemotherapy. In biologically unselected patients, although associated with an improved ORR, pembrolizumab improves neither PFS nor OS over single-agent chemotherapy. © 2020 European Society for Medical Oncology

Published
2020

135. The Role of the Liquid Biopsy in Decision-Making for Patients with Non-Small Cell Lung Cancer

Author

Akhoundova, D, Mosquera Martinez, J, Musmann, L E, Britschgi, C, Rütsche, C; https://orcid.org/0000-0002-1868-5672, Rechsteiner, M, Nadal, E, Garcia Campelo, M R, Curioni-Fontecedro, A, Akhoundova, D, Mosquera Martinez, J, Musmann, L E, Britschgi, C, Rütsche, C; https://orcid.org/0000-0002-1868-5672, Rechsteiner, M, Nadal, E, Garcia Campelo, M R, and Curioni-Fontecedro, A

Abstract

Liquid biopsy is a rapidly emerging tool of precision oncology enabling minimally invasive molecular diagnostics and longitudinal monitoring of treatment response. For the clinical management of advanced stage lung cancer patients, detection and quantification of circulating tumor DNA (ctDNA) is now widely adopted into clinical practice. Still, interpretation of results and validation of ctDNA-based treatment decisions remain challenging. We report here our experience implementing liquid biopsies into the clinical management of lung cancer. We discuss advantages and limitations of distinct ctDNA assay techniques and highlight our approach to the analysis of recurrent molecular alterations found in lung cancer. Moreover, we report three exemplary clinical cases illustrating the complexity of interpreting liquid biopsy results in clinical practice. These cases underscore the potential and current limitations of liquid biopsy, focusing on the difficulty of interpreting discordant findings. In our view, despite all current limitations, the analysis of ctDNA in lung cancer patients is an essential and highly versatile complementary diagnostic tool for the clinical management of lung cancer patients in the era of precision oncology.

Published
2020

144. 187P Tissue B-cell receptor repertoire as biomarker of complete pathological response in NSCLC patients treated with neoadjuvant chemoimmunotherapy (NADIM trials)

Author

Sierra-Rodero, B., Martínez-Toledo, C., Molina-Alejandre, M., Calvo, V., Nadal, E., Sureda, B. Massuti, Campelo, R. García, Ojea, C. Gonzalez, Martinez-Marti, A., Gomez, M. Domine, Aix, S. Ponce, Molla, M.A. Insa, De Castro Carpeno, J., Majem, M., Aranda, I.C. Barneto, Rodriguez-Abreu, D., del Barco, E., Dols, M. Cobo, Pulla, M. Provencio, and Cruz-Bermudez, A.

Published
2023
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