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1. Molecular profiling and feasibility using a comprehensive hybrid capture panel on a consecutive series of non-small-cell lung cancer patients from a single centre

Author

Mosteiro, M., Azuara, D., Villatoro, S., Alay, A., Gausachs, M., Varela, M., Baixeras, N., Pijuan, L., Ajenjo-Bauza, M., Lopez-Doriga, A., Teulé, Á., Solanes, A., Palmero, R., Brenes, J., Jové, M., Padrones, S., Moreno, V., Cordero, D., Matías-Guiu, X., Lázaro, C., and Nadal, E.

Published
2023
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2. Genome-wide profiling of non-smoking-related lung cancer cells reveals common RB1 rearrangements associated with histopathologic transformation in EGFR-mutant tumors

Author

Pros, E., Saigi, M., Alameda, D., Gomez-Mariano, G., Martinez-Delgado, B., Alburquerque-Bejar, J.J., Carretero, J., Tonda, R., Esteve-Codina, A., Catala, I., Palmero, R., Jove, M., Lazaro, C., Patiño-Garcia, A., Gil-Bazo, I., Verdura, S., Teulé, A., Torres-Lanzas, J., Sidransky, D., Reguart, N., Pio, R., Juan-Vidal, O., Nadal, E., Felip, E., Montuenga, L.M., and Sanchez-Cespedes, M.

Published
2020
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3. P1.01-01 Frequency of Germline Mutations in Patients with Non-small Cell Lung Cancer (NSCLC) Harboring Actionable DRIVER Alterations (G-DRIVER)

Author

Jové, M., primary, Gausachs, M., additional, Bosch-Barrera, J., additional, Carcereny, E., additional, Teule, A., additional, Mosteiro, M., additional, Pineda, M., additional, Tornero, E., additional, Palmero, R., additional, Vilarino, N., additional, Ruffinelli, J.C., additional, Mesia, C., additional, Saldaña, J., additional, Cuellar, A., additional, Brenes, J., additional, Hernandez, A., additional, Fina, C., additional, Brunet, J., additional, Domenech, M., additional, Moran, T., additional, Sais, E., additional, Lazaro, C., additional, and Nadal, E., additional

Published
2023
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4. P1.27-07 BRAF Mutations Identify Non-small-Cell Lung Cancer Patients Who Benefit from Neoadjuvant Chemo-Immunotherapy

Author

Robado de Lope, L., primary, Nadal, E., additional, Calvo, V., additional, González-Larriba, J.L., additional, Insa, A., additional, Martinez-Marti, A., additional, Massutí, B., additional, González, C., additional, Serna Blasco, R., additional, Bosch-Barrera, J., additional, Garcia-Campelo, M.R., additional, Ponce, S., additional, Reguart, N., additional, Bernabé, R., additional, Cobo, M., additional, De Castro, J., additional, Dómine, M., additional, Camps, C., additional, Barneto, I., additional, López-Vivanco, G., additional, Majem, M., additional, Rodríguez-Abreu, D., additional, Palmero, R., additional, Cruz-Bermudez, A., additional, Romero, A., additional, and Provencio, M., additional

Published
2023
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5. 60 CONTACT-01: Efficacy and safety from a phase III study of atezolizumab (atezo) + cabozantinib (cabo) vs docetaxel (doc) monotherapy in patients (pts) with metastatic NSCLC (mNSCLC) previously treated with checkpoint inhibitors and chemotherapy

Author

Neal, J., primary, Pavlakis, N., additional, Kim, S-W., additional, Goto, Y., additional, Lim, S.M., additional, Mountzios, G., additional, Fountzilas, E., additional, Mochalova, A., additional, Christoph, D.C.C., additional, Bearz, A., additional, Quantin, X., additional, Palmero, R., additional, Antic, V., additional, Chun, E., additional, Edubilli, T. Rao, additional, Lin, Y-C., additional, Huseni, M., additional, Scheffold, C., additional, Vervaet, P., additional, and Newsom-Davis, T., additional

Published
2023
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6. First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study

Author

Lee, S, Schulz, C, Prabhash, K, Kowalski, D, Szczesna, A, Han, B, Rittmeyer, A, Talbot, T, Vicente, D, Califano, R, Cortinovis, D, Le, A, Huang, D, Liu, G, Cappuzzo, F, Contreras, J, Reck, M, Palmero, R, Mak, M, Hu, Y, Morris, S, Höglander, E, Connors, M, Biggane, A, Vollan, H, Peters, S, Lee, SM, Han, BH, Le, AT, Huang, DZ, Contreras, JR, Mak, MP, Hu, YY, Biggane, AM, Vollan, HK, Lee, S, Schulz, C, Prabhash, K, Kowalski, D, Szczesna, A, Han, B, Rittmeyer, A, Talbot, T, Vicente, D, Califano, R, Cortinovis, D, Le, A, Huang, D, Liu, G, Cappuzzo, F, Contreras, J, Reck, M, Palmero, R, Mak, M, Hu, Y, Morris, S, Höglander, E, Connors, M, Biggane, A, Vollan, H, Peters, S, Lee, SM, Han, BH, Le, AT, Huang, DZ, Contreras, JR, Mak, MP, Hu, YY, Biggane, AM, and Vollan, HK

Abstract

Background: Despite immunotherapy advancements for patients with advanced or metastatic non-small-cell lung cancer (NSCLC), pivotal first-line trials were limited to patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) 0–1 and a median age of 65 years or younger. We aimed to compare the efficacy and safety of first-line atezolizumab monotherapy with single-agent chemotherapy in patients ineligible for platinum-based chemotherapy. Methods: This trial was a phase 3, open-label, randomised controlled study conducted at 91 sites in 23 countries across Asia, Europe, North America, and South America. Eligible patients had stage IIIB or IV NSCLC in whom platinum-doublet chemotherapy was deemed unsuitable by the investigator due to an ECOG PS 2 or 3, or alternatively, being 70 years or older with an ECOG PS 0–1 with substantial comorbidities or contraindications for platinum-doublet chemotherapy. Patients were randomised 2:1 by permuted-block randomisation (block size of six) to receive 1200 mg of atezolizumab given intravenously every 3 weeks or single-agent chemotherapy (vinorelbine [oral or intravenous] or gemcitabine [intravenous]; dosing per local label) at 3-weekly or 4-weekly cycles. The primary endpoint was overall survival assessed in the intention-to-treat population. Safety analyses were conducted in the safety-evaluable population, which included all randomised patients who received any amount of atezolizumab or chemotherapy. This trial is registered with ClinicalTrials.gov, NCT03191786. Findings: Between Sept 11, 2017, and Sept 23, 2019, 453 patients were enrolled and randomised to receive atezolizumab (n=302) or chemotherapy (n=151). Atezolizumab improved overall survival compared with chemotherapy (median overall survival 10·3 months [95% CI 9·4–11·9] vs 9·2 months [5·9–11·2]; stratified hazard ratio 0·78 [0·63–0·97], p=0·028), with a 2-year survival rate of 24% (95% CI 19·3–29·4) with atezolizumab compared with 12% (6·7–18·0) with

Published
2023

9. P16.01.A Factors predicting cognitive impairment after intrathecal methotrexate treatment in patients with non-small cell lung cancer and leptomeningeal disease

Author

Vilariño, N, primary, Esparragosa, I, additional, Marín, J, additional, Alemany, M, additional, Velasco, R, additional, Jové, M, additional, Brenes, J, additional, Palmero, R, additional, Brao, I, additional, Arellano, M, additional, Sala, R, additional, Bruna, J, additional, Nadal, E, additional, and Simó, M, additional

Published
2022
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10. PL03.12 Progression Free Survival and Overall Survival in NADIM II Study

Author

Provencio, M., primary, Serna, R., additional, Nadal, E., additional, Glez Larriba, J.L., additional, Martínez-Martí, A., additional, Bernabé, R., additional, Bosch-Barrera, J., additional, Garcia Benito, C., additional, Calvo, V., additional, Insa, A., additional, Ponce, S., additional, Reguart, N., additional, De Castro, J., additional, Massutí, B., additional, Palmero, R., additional, Aguado de la Rosa, C., additional, Mosquera, J., additional, Cobo, M., additional, Aguilar, A., additional, López Vivanco, G., additional, Camps, C., additional, Hernando Trancho, F., additional, López Castro, R., additional, Moran, T., additional, Barneto, I., additional, Rodríguez-Abreu, D., additional, and Romero, A., additional

Published
2022
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11. EP08.02-131 Alectinib after Crizotinib Failure in Patients with Advanced ALK-Positive NSCLC: Results from the Spanish Early Access Program

Author

Bernabé-Caro, R., primary, García-Campelo, R., additional, Garrido, P., additional, Palmero, R., additional, Artal, Á., additional, Bayona, C., additional, Rodríguez-Abreu, D., additional, López-Brea, M., additional, Paredes, A., additional, Vicente, D., additional, Sánchez Torres, J.M., additional, Majem, M., additional, Diz, P., additional, Gordo, R., additional, Coca, M., additional, and de Castro, J., additional

Published
2022
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12. MA06.03 Pre-treatment ctDNA Levels Significantly Predicts of OS and PFS in NADIM II Trial

Author

Romero, A., primary, Serna, R., additional, Nadal, E., additional, Larriba, J.L. Glez, additional, Martínez-Martí, A., additional, Bernabé, R., additional, Bosch-Barrera, J., additional, Fernandez, A. Garrido, additional, Calvo, V., additional, Insa, A., additional, Ponce, S., additional, Reguart, N., additional, De Castro, J., additional, Massutí, B., additional, Palmero, R., additional, Aguado de la Rosa, C., additional, Mosquera, J., additional, Cobo, M., additional, Aguilar, A., additional, Vivanco, G. López, additional, Camps, C., additional, Trancho, F. Hernando, additional, Castro, R. Lopez, additional, Moran, T., additional, Barneto, I., additional, Rodríguez-Abreu, D., additional, Cruz, A., additional, and Provencio, M., additional

Published
2022
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13. EP16.03-027 Routine Molecular Testing Using the TSO500+ NGS Panel in a Cohort of Patients with NSCLC

Author

Lamas, M. Mosteiro, primary, Azuara, D., additional, Palmero, R., additional, Varela, M., additional, Cordero, D., additional, Baixeras, N., additional, Villatoro, S., additional, Alay, A., additional, Pijuán, L., additional, Gausachs, M., additional, Ruffinelli, J.C., additional, Jové, M., additional, Vilariño, N., additional, Teulè, A., additional, Solanes, A., additional, Lázaro, C., additional, Matías-Guiu, X., additional, and Nadal, E., additional

Published
2022
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16. 1315P Impact of high fasting plasma glucose in the clinical outcome of patients with advanced NSCLC with PD-L1 ≥ 50% treated with frontline pembrolizumab

Author

Serna, S. Llop, primary, Puig, E., additional, Palmero, R., additional, Brenes, J., additional, Vilariño, N., additional, Ruffinelli, J.C.C., additional, Barroso, C. Mesia, additional, Cañada, J. Saldaña, additional, Casulleras, M. Jove, additional, Perez, I. Brao, additional, Arellano, M., additional, Mateo, F.N. Luciano, additional, Martínez, I. Peiró, additional, Pinedo, C. Muñoz, additional, and Nadal, E., additional

Published
2021
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17. 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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18. Multiplex RNA-based detection of clinically relevant MET alterations in advanced non-small cell lung cancer

Author

Aguado, C., Teixido, C., Román, R., Reyes, R., Giménez-Capitán, A., Marin, E., Cabrera, C., Viñolas, N., Castillo, S., Muñoz, S., Arcocha, A., López-Vilaró, L., Sullivan, I., Aldeguer, E., Rodríguez, S., Moya, I., Viteri, S., Cardona, A.F., Palmero, R., Sainz, C., Mesa-Guzmán, M., Lozano, M.D., Aguilar-Hernández, A., Martínez-Bueno, A., González-Cao, M., Gonzalvo, E., Leenders, W.P.J., Rosell, R., Montuenga, L.M., Prat, A., Molina-Vila, M.A., Reguart, N., Aguado, C., Teixido, C., Román, R., Reyes, R., Giménez-Capitán, A., Marin, E., Cabrera, C., Viñolas, N., Castillo, S., Muñoz, S., Arcocha, A., López-Vilaró, L., Sullivan, I., Aldeguer, E., Rodríguez, S., Moya, I., Viteri, S., Cardona, A.F., Palmero, R., Sainz, C., Mesa-Guzmán, M., Lozano, M.D., Aguilar-Hernández, A., Martínez-Bueno, A., González-Cao, M., Gonzalvo, E., Leenders, W.P.J., Rosell, R., Montuenga, L.M., Prat, A., Molina-Vila, M.A., and Reguart, N.

Abstract

Contains fulltext : 235656.pdf (Publisher’s version ) (Open Access), MET inhibitors have shown activity in non-small-cell lung cancer patients (NSCLC) with MET amplification and exon 14 skipping (METΔex14). However, patient stratification is imperfect, and thus, response rates have varied widely. Here, we studied MET alterations in 474 advanced NSCLC patients by nCounter, an RNA-based technique, together with next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), and reverse transcriptase polymerase chain reaction (RT-PCR), exploring correlation with clinical benefit. Of the 474 samples analyzed, 422 (89%) yielded valid results by nCounter, which identified 13 patients (3%) with METΔex14 and 15 patients (3.5%) with very-high MET mRNA expression. These two subgroups were mutually exclusive, displayed distinct phenotypes and did not generally coexist with other drivers. For METΔex14, 3/8 (37.5%) samples positive by nCounter tested negative by NGS. Regarding patients with very-high MET mRNA, 92% had MET amplification by FISH and/or NGS. However, FISH failed to identify three patients (30%) with very-high MET RNA expression, among which one received MET tyrosine kinase inhibitor treatment deriving clinical benefit. Our results indicate that quantitative mRNA-based techniques can improve the selection of patients for MET-targeted therapies.

Published
2021

19. Evolution and Clinical Impact of EGFR Mutations in Circulating Free DNA in the BELIEF Trial

Author

Molina-Vila, M.-A. Stahel, R.A. Dafni, U. Jordana-Ariza, N. Balada-Bel, A. Garzón-Ibáñez, M. García-Peláez, B. Mayo-de-las-Casas, C. Felip, E. Curioni Fontecedro, A. Gautschi, O. Peters, S. Massutí, B. Palmero, R. Ponce Aix, S. Carcereny, E. Früh, M. Pless, M. Popat, S. Cuffe, S. Bidoli, P. Kammler, R. Roschitzki-Voser, H. Tsourti, Z. Karachaliou, N. Rosell, R.

Abstract

Introduction: Longitudinal evaluation of mutations in blood samples was a prespecified secondary objective in the BELIEF trial of erlotinib and bevacizumab in advanced EGFR-positive NSCLC. Here, we report the testing results and explore the correlation of EGFR status in blood with clinical outcomes. Methods: Blood samples were prospectively collected from patients at baseline, at response evaluation, and at progression and sent to a central laboratory. Circulating free DNA was purified and EGFR mutations were analyzed with a validated real-time quantitative polymerase chain reaction assay. Results: EGFR exon 19/21 mutations were detected in 55 of 91 baseline blood samples (60.4%) and correlated with a significantly worse progression-free survival: 11.4 months (95% confidence interval [CI]: 9.0−14.8 mo) for the patients who were positive versus 22.9 months (95% CI: 9.5−33.9 mo) for those who were negative (log-rank p = 0.0020). Among the 74 samples at response, exon 19/21 mutations were detected only in three samples (4.1%). In contrast, 29 of 58 patients (50.0%) were exon 19/21 positive at progression and showed a significantly worse median overall survival of 21.7 months (95% CI: 17.0−30.9 mo) compared with 37.4 months (95% CI: 22.6−53.1 mo) for those who were negative (log-rank p = 0.011). Blood samples at the three time points were available for 48 patients. Of those, among 14 exon 19/21 EGFR-negative at presentation, 13 (93%) were persistently negative for the sensitizing mutations after progression and the p.T790M could only be detected in the blood of two patients. Conclusions: Longitudinal testing of EGFR mutations in blood can offer valuable clinical information. In patients of the BELIEF study, detection of EGFR mutations in circulating free DNA at presentation was associated with shorter progression-free survival, whereas positivity at progression correlated with shorter overall survival. Finally, patients negative in blood at presentation were almost invariably negative at relapse. © 2019

Published
2020

20. Clinical Activity of Afatinib in Patients With Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Spanish Retrospective Multicenter Study

Author

Moran, T, Taus, A, Arriola, E, Aguado, C, Domine, M, Rueda, AG, Calles, A, Cedres, S, Vinolas, N, Isla, D, Palmero, R, Sereno, M, Diaz, V, Juan, O, Marse, R, Martorell, PM, and Torres, JMS

Subjects
Retrospective, Afatinib, NSCLC, Uncommon, EGFR mutations
Abstract

We report the results of the molecular and clinical characterization and the efficacy of afatinib in a cohort of patients with advanced nonesmall-cell lung cancer (NSCLC) patients harboring uncommon epidermal growth factor receptor (EGFR) mutations in Spanish clinical practice. In patients with uncommon EGFR-mutant NSCLC, the most common mutations occurred on exon 18 in amino acid G719, either alone or in combination with another mutation; other uncommon mutations were detected in exons 18, 19, 20, 21, and 22. In clinical practice, afatinib was active in patients with uncommon EGFR-mutant NSCLC, particularly in patients with complex and single mutations; however, in patients with EGFR ins20 (EGFR exon 20 insertions), treatment with afatinib provided a lower clinical benefit, indicating that further treatment strategies are needed for patients with this type of uncommon EGFR mutation. Introduction: Uncommon epidermal growth factor receptor (EGFR) mutations (u-EGFRm) are a heterogeneous group of molecular alterations and have also been reported as comutations with other EGFR mutations (complex mutations) in nonesmall-cell lung cancer (NSCLC). Afatinib has shown activity against some u-EGFRm, and we examined its efficacy in Spanish clinical practice. Patients and Methods: Data of 67 patients with advanced NSCLC with u-EGFRm treated with afatinib between 2012 and 2017 at 23 Spanish institutions were reviewed. u-EGFRm were analyzed as complex mutations (group A), EGFR exon 20 insertions (ins20; group B), or single mutations (group C). Efficacy was evaluated in terms of overall survival (OS) and tumor response. Results: Group A complex u-EGFRm consisted of double mutations of G719X+E709F, G719X+S768I, G719X+L861Q, L858R+T790M, L858R+S768I, L858R+S765I, del19+S768I, del19+L747S, or R776C+L861Q. No differences in clinical characteristics were found between groups A (n= 20), B (n= 23), and C (n= 24). Afatinib was administered as first-line therapy in 80% of patients. Median time of receipt of therapy was 4.2 months (range, 2.0-12.9 months). Median OS for the entire cohort was 19.9 months (95% confidence interval, 9.7, 30.1). Hazard ratios for OS were 0.26 (95% confidence interval, 0.10, 0.71; P=.008) and 0.40 (95% confidence interval, 0.17, 0.95; P=.037) for groups A and C compared to B, respectively. Response was significantly higher in groups A (70%) and C (54%) compared to B (13%; pairwise comparison P

Published
2020

21. Evolution and Clinical Impact of EGFR Mutations in Circulating Free DNA in the BELIEF Trial

Author

Molina-Vila, M, Stahel, R, Dafni, U, Jordana-Ariza, N, Balada-Bel, A, Garzón-Ibáñez, M, García-Peláez, B, Mayo-de-Las-Casas, C, Felip, E, Fontecedro, A, Gautschi, O, Peters, S, Massutí, B, Palmero, R, Aix, S, Carcereny, E, Früh, M, Pless, M, Popat, S, Cuffe, S, Bidoli, P, Kammler, R, Roschitzki-Voser, H, Tsourti, Z, Karachaliou, N, Rosell, R, Molina-Vila, MA, Stahel, RA, Fontecedro, AC, Aix, SP, Molina-Vila, M, Stahel, R, Dafni, U, Jordana-Ariza, N, Balada-Bel, A, Garzón-Ibáñez, M, García-Peláez, B, Mayo-de-Las-Casas, C, Felip, E, Fontecedro, A, Gautschi, O, Peters, S, Massutí, B, Palmero, R, Aix, S, Carcereny, E, Früh, M, Pless, M, Popat, S, Cuffe, S, Bidoli, P, Kammler, R, Roschitzki-Voser, H, Tsourti, Z, Karachaliou, N, Rosell, R, Molina-Vila, MA, Stahel, RA, Fontecedro, AC, and Aix, SP

Abstract

Introduction: Longitudinal evaluation of mutations in blood samples was a prespecified secondary objective in the BELIEF trial of erlotinib and bevacizumab in advanced EGFR-positive NSCLC. Here, we report the testing results and explore the correlation of EGFR status in blood with clinical outcomes. Methods: Blood samples were prospectively collected from patients at baseline, at response evaluation, and at progression and sent to a central laboratory. Circulating free DNA was purified and EGFR mutations were analyzed with a validated real-time quantitative polymerase chain reaction assay. Results: EGFR exon 19/21 mutations were detected in 55 of 91 baseline blood samples (60.4%) and correlated with a significantly worse progression-free survival: 11.4 months (95% confidence interval [CI]: 9.0−14.8 mo) for the patients who were positive versus 22.9 months (95% CI: 9.5−33.9 mo) for those who were negative (log-rank p = 0.0020). Among the 74 samples at response, exon 19/21 mutations were detected only in three samples (4.1%). In contrast, 29 of 58 patients (50.0%) were exon 19/21 positive at progression and showed a significantly worse median overall survival of 21.7 months (95% CI: 17.0−30.9 mo) compared with 37.4 months (95% CI: 22.6−53.1 mo) for those who were negative (log-rank p = 0.011). Blood samples at the three time points were available for 48 patients. Of those, among 14 exon 19/21 EGFR-negative at presentation, 13 (93%) were persistently negative for the sensitizing mutations after progression and the p.T790M could only be detected in the blood of two patients. Conclusions: Longitudinal testing of EGFR mutations in blood can offer valuable clinical information. In patients of the BELIEF study, detection of EGFR mutations in circulating free DNA at presentation was associated with shorter progression-free survival, whereas positivity at progression correlated with shorter overall survival. Finally, patients negative in blood at presentation were almost inva

Published
2020

23. 1897P Germline and somatic mutational landscape in a cohort of malignant pleural mesothelioma patients

Author

Gausachs, M., primary, Azuara, D., additional, López-Doriga, A., additional, Cordero, D., additional, Vargas, G., additional, González, S., additional, Pineda, M., additional, Feliubadaló, L., additional, Padrones, S., additional, Rivas, F., additional, Urena, A., additional, Llatjós, R., additional, Palmero, R., additional, Arellano, M., additional, Teule, A., additional, Brunet, J., additional, Capellá, G., additional, Solé, X., additional, Lázaro, C., additional, and Nadal, E., additional

Published
2020
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28. Erlotinib and bevacizumab in patients with advanced non-small-cell lung cancer and activating EGFR mutations (BELIEF): an international, multicentre, single-arm, phase 2 trial

Author

Rosell, R, Dafni, U, Felip, E, Curioni-Fontecedro, A, Gautschi, O, Peters, S, Massuti, B, Palmero, R, Aix, SP, Carcereny, E, Fruh, M, Pless, M, Popat, S, Kotsakis, A, Cuffe, S, Bidoli, P, Favaretto, A, Froesch, P, Reguart, N, Puente, J, Coate, L, Barlesi, F, Rauch, D, Thomas, M, Camps, C, Gomez-Codina, J, Majem, M, Porta, R, Shah, R, Hanrahan, E, Kammler, R, Ruepp, B, Rabaglio, M, Kassapian, M, Karachaliou, N, Tam, R, Shames, DS, Molina-Vila, MA, Stahel, RA, and BELIEF collaborative group

Subjects
respiratory tract diseases
Abstract

BACKGROUND: The tyrosine kinase inhibitor erlotinib improves the outcomes of patients with advanced non-small-cell lung carcinoma (NSCLC) harbouring epidermal growth factor receptor (EGFR) mutations. The coexistence of the T790M resistance mutation with another EGFR mutation in treatment-naive patients has been associated with a shorter progression-free survival to EGFR inhibition than in the absence of the T790M mutation. To test this hypothesis clinically, we developed a proof-of-concept study, in which patients with EGFR-mutant NSCLC were treated with the combination of erlotinib and bevacizumab, stratified by the presence of the pretreatment T790M mutation. METHODS: BELIEF was an international, multicentre, single-arm, phase 2 trial done at 29 centres in eight European countries. Eligible patients were aged 18 years or older and had treatment-naive, pathologically confirmed stage IIIB or stage IV lung adenocarcinoma with a confirmed, activating EGFR mutation (exon 19 deletion or L858R mutation). Patients received oral erlotinib 150 mg per day and intravenous bevacizumab 15 mg/kg every 21 days and were tested centrally for the pretreatment T790M resistance mutation with a peptide nucleic acid probe-based real-time PCR. The primary endpoint was progression-free survival. The primary efficacy analysis was done in the intention-to-treat population and was stratified into two parallel substudies according to the centrally confirmed pretreatment T790M mutation status of enrolled patients (T790M positive or negative). The safety analysis was done in all patients that have received at least one dose of trial treatment. This trial was registered with ClinicalTrials.gov, number NCT01562028. FINDINGS: Between June 11, 2012, and Oct 28, 2014, 109 patients were enrolled and included in the efficacy analysis. 37 patients were T790M mutation positive and 72 negative. The overall median progression-free survival was 13·2 months (95% CI 10·3-15·5), with a 12 month progression-free survival of 55% (95% CI 45-64). The primary endpoint was met only in substudy one (T790M-positive patients). In the T790M-positive group, median progression-free survival was 16·0 months (12·7 to not estimable), with a 12 month progression-free survival of 68% (50-81), whereas in the T790M-negative group, median progression-free survival was 10·5 months (9·4-14·2), with a 12 month progression-free survival of 48% (36-59). Of 106 patients included in the safety analysis, five had grade 4 adverse events (one acute coronary syndrome, one biliary tract infection, one other neoplasms, and two colonic perforations) and one died due to sepsis. INTERPRETATION: The BELIEF trial provides further evidence of benefit for the combined use of erlotinib and bevacizumab in patients with NSCLC harbouring activating EGFR mutations. FUNDING: European Thoracic Oncology Platform, Roche.

Published
2017

29. Erlotinib and bevacizumab in patients with advanced non-small-cell lung cancer and activating EGFR mutations (BELIEF): an international, multicentre, single-arm, phase 2 trial

Author

Rosell, R. Dafni, U. Felip, E. Curioni-Fontecedro, A. Gautschi, O. Peters, S. Massutí, B. Palmero, R. Aix, S.P. Carcereny, E. Früh, M. Pless, M. Popat, S. Kotsakis, A. Cuffe, S. Bidoli, P. Favaretto, A. Froesch, P. Reguart, N. Puente, J. Coate, L. Barlesi, F. Rauch, D. Thomas, M. Camps, C. Gómez-Codina, J. Majem, M. Porta, R. Shah, R. Hanrahan, E. Kammler, R. Ruepp, B. Rabaglio, M. Kassapian, M. Karachaliou, N. Tam, R. Shames, D.S. Molina-Vila, M.A. Stahel, R.A. BELIEF collaborative group

Subjects
respiratory tract diseases
Abstract

Background The tyrosine kinase inhibitor erlotinib improves the outcomes of patients with advanced non-small-cell lung carcinoma (NSCLC) harbouring epidermal growth factor receptor (EGFR) mutations. The coexistence of the T790M resistance mutation with another EGFR mutation in treatment-naive patients has been associated with a shorter progression-free survival to EGFR inhibition than in the absence of the T790M mutation. To test this hypothesis clinically, we developed a proof-of-concept study, in which patients with EGFR-mutant NSCLC were treated with the combination of erlotinib and bevacizumab, stratified by the presence of the pretreatment T790M mutation. Methods BELIEF was an international, multicentre, single-arm, phase 2 trial done at 29 centres in eight European countries. Eligible patients were aged 18 years or older and had treatment-naive, pathologically confirmed stage IIIB or stage IV lung adenocarcinoma with a confirmed, activating EGFR mutation (exon 19 deletion or L858R mutation). Patients received oral erlotinib 150 mg per day and intravenous bevacizumab 15 mg/kg every 21 days and were tested centrally for the pretreatment T790M resistance mutation with a peptide nucleic acid probe-based real-time PCR. The primary endpoint was progression-free survival. The primary efficacy analysis was done in the intention-to-treat population and was stratified into two parallel substudies according to the centrally confirmed pretreatment T790M mutation status of enrolled patients (T790M positive or negative). The safety analysis was done in all patients that have received at least one dose of trial treatment. This trial was registered with ClinicalTrials.gov, number NCT01562028. Findings Between June 11, 2012, and Oct 28, 2014, 109 patients were enrolled and included in the efficacy analysis. 37 patients were T790M mutation positive and 72 negative. The overall median progression-free survival was 13·2 months (95% CI 10·3–15·5), with a 12 month progression-free survival of 55% (95% CI 45–64). The primary endpoint was met only in substudy one (T790M-positive patients). In the T790M-positive group, median progression-free survival was 16·0 months (12·7 to not estimable), with a 12 month progression-free survival of 68% (50–81), whereas in the T790M-negative group, median progression-free survival was 10·5 months (9·4–14·2), with a 12 month progression-free survival of 48% (36–59). Of 106 patients included in the safety analysis, five had grade 4 adverse events (one acute coronary syndrome, one biliary tract infection, one other neoplasms, and two colonic perforations) and one died due to sepsis. Interpretation The BELIEF trial provides further evidence of benefit for the combined use of erlotinib and bevacizumab in patients with NSCLC harbouring activating EGFR mutations. Funding European Thoracic Oncology Platform, Roche. © 2017 Elsevier Ltd

Published
2017

33. P2.03-02 Cell-Free DNA (cfDNA) Testing in Lung Adenocarcinoma (LUAC) Patients: Spanish Lung Liquid Versus Invasive Biopsy Program (SLLIP)

Author

Palmero, R., primary, Taus, A., additional, Viteri, S., additional, Majem, M., additional, Carcereny, E., additional, Garde-Noguera, J., additional, Felip, E., additional, Sampayo, M., additional, Gomez, L., additional, Lopez, N., additional, Olsen, S., additional, Jackson, M., additional, Faull, I., additional, Dix, D., additional, Karachaliou, N., additional, and Rosell, R., additional

Published
2018
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34. Homology-directed repair (HDR)-defective lung adenocarcinomas (LUACs) in circulating tumor DNA (ctDNA)

Author

Karachaliou, N., primary, Lefterova, M., additional, Draper, J.F., additional, Molina, M.-A., additional, Chaib, I., additional, Palmero, R., additional, Taus, A., additional, Viteri, S., additional, González Cao, M., additional, Majem Tarruella, M., additional, Carcereny Costa, E., additional, Moran, T., additional, Garde Noguera, J., additional, Felip Font, E., additional, Olsen, S., additional, Jackson, M., additional, Sampayo, M., additional, Faull, I., additional, Dix, D., additional, and Rosell, R., additional

Published
2018
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35. Evolution and clinical impact of EGFR mutations in circulating free DNA in the BELIEF trial

Author

Curioni, A., primary, Felip, E., additional, Dafni, U., additional, Molina, M.-A., additional, Gautschi, O., additional, Peters, S., additional, Massutí, B., additional, Palmero, R., additional, Ponce, S., additional, Carcereny, E., additional, Früh, M., additional, Pless, M., additional, Popat, S., additional, Cuffe, S., additional, Karachaliou, N., additional, Kammler, R., additional, Kassapian, M., additional, Roschitzki-Voser, H., additional, Stahel, R.A., additional, and Rosell, R., additional

Published
2018
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36. IMpower131: Progression-free survival (PFS) and overall survival (OS) analysis of a randomised phase III study of atezolizumab + carboplatin + paclitaxel or nab-paclitaxel vs carboplatin + nab-paclitaxel in 1L advanced squamous NSCLC

Author

Socinski, M.A., primary, Rittmeyer, A., additional, Shapovalov, D., additional, Orlandi, F., additional, McCleod, M., additional, Soo, R.A., additional, Palmero, R., additional, Kozuki, T., additional, Migliorino, M.R., additional, Koynov, K.D., additional, Berard, H., additional, Hughes, B.G.M., additional, Yu, W., additional, Graupner, V., additional, Sun, S.W., additional, Kowanetz, M., additional, Hoang, T., additional, Lin, W., additional, and Jotte, R.M., additional

Published
2018
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37. P05.21 T1-flair to T1-gadolinium MRI ratio as a predictive value of treatment response in non-small-cell lung cancer (NSCLC) patients affected by multiple brain metastases

Author

Alemany, M, primary, Domènech, M, additional, Vilariño, N, additional, Jové, M, additional, Brao, I, additional, Arellano, M, additional, Lucas, A, additional, Navarro, A, additional, Palmero, R, additional, Simó, M, additional, Velasco, R, additional, Nadal, E, additional, and Bruna, J, additional

Published
2018
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38. Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer

Author

Gerber, D.E., primary, Horn, L., additional, Boyer, M., additional, Sanborn, R., additional, Natale, R., additional, Palmero, R., additional, Bidoli, P., additional, Bondarenko, I., additional, Germonpre, P., additional, Ghizdavescu, D., additional, Kotsakis, A., additional, Lena, H., additional, Losonczy, G., additional, Park, K., additional, Su, W -C, additional, Tang, M., additional, Lai, J., additional, Kallinteris, N.L., additional, Shan, J.S., additional, Reck, M., additional, and Spigel, D.R., additional

Published
2018
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40. P1.01-075 Simultaneous Multiplex Profiling of Gene Fusions, METe14 Mutations and Immune Genes in Advanced NSCLC by NCounter Technology

Author

Reguart, N., primary, Teixidó, C., additional, Giménez-Capitán, A., additional, Vilariño, N., additional, Arcocha, A., additional, Jares, P., additional, Castillo, S., additional, Bernal, X., additional, Muñoz, S., additional, Palmero, R., additional, Sullivan, I., additional, Marginet, M., additional, Viñolas, N., additional, Martinez, D., additional, Baixeras, N., additional, Molina-Vila, M., additional, and Prat, A., additional

Published
2017
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42. P2.08-006 Immunological Biomarkers Characterization in Locally Advanced Non-Small Cell Lung Cancer Treated with Concurrent Chemo-Radiotherapy

Author

Saigi, M., primary, Baixeras, N., additional, Rullan, A., additional, Sirvén, M. Bergamino, additional, Navarro-Martin, A., additional, Arnaiz, M., additional, Ruffinelli, J.C., additional, Mesia, C., additional, Palmero, R., additional, Padrones, S., additional, Cardenal, F., additional, Sanchez-Cespedes, M., additional, and Nadal, E., additional

Published
2017
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43. P1.03-054 A Phase II Randomized Trial of Gefitinib Alone vs Olaparib Plus Gegitinib in Advanced NSCLC EGFRmut + Goal Trial Spanish Lung Cancer Group

Author

Massuti, B., primary, Campelo, R. García, additional, Arrieta, O., additional, Rodríguez-Abreu, D., additional, Granados, A.L. Ortega, additional, Majem, M., additional, Baz, D. Vicente, additional, Lianes, P., additional, Barrera, J. Bosch, additional, Insa, A., additional, Domine, M., additional, Reguart, N., additional, Guirado, M., additional, Sala, M., additional, Vazquez, S., additional, Bernabe, R., additional, Macias, J.A., additional, Palmero, R., additional, Verdu, A., additional, Drozdowskyj, A., additional, and Rosell, R., additional

Published
2017
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45. Final clinical results from SUNRISE: A phase III, randomized, double-blind, placebo-controlled multicenter trial of bavituximab plus docetaxel in patients with previously treated stage IIIb/IV nonsquamous non-small cell lung cancer

Author

Palmero, R., primary, Bidoli, P., additional, Bondarenko, I.M., additional, Boyer, M., additional, Germonpre, P., additional, Ghizdavescu, D., additional, Kotsakis, A., additional, Lena, H., additional, Losonczy, G., additional, Park, K., additional, Reck, M., additional, Su, W.-C., additional, Kallinteris, N., additional, Tang, M., additional, Lai, J., additional, Shan, J., additional, and Spigel, D.R., additional

Published
2017
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47. Top-line results from SUNRISE: A phase III, randomized, double-blind, placebo-controlled multicenter trial of bavituximab plus docetaxel in patients with previously treated stage IIIb/iv non-squamous non-small cell lung cancer

Author

Spigel, D.R., primary, Bondarenko, I., additional, Losonczy, G., additional, Mezger, J., additional, Kalofonos, H., additional, Reck, M., additional, Palmero, R., additional, Jang, T., additional, Natale, R., additional, Sanborn, R.E., additional, Lai, J., additional, Kallinteris, N., additional, Tang, M., additional, Shan, J., additional, and Gerber, D., additional

Published
2016
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48. Recurrence pattern and its prognostic impact following definitive chemo-radiotherapy in stage III non-small cell lung cancer

Author

Morgui, M. Saigi, primary, Iriarte, A.J. Rullan, additional, Bergamino, M., additional, Navarro, A., additional, Arnaiz, M.M., additional, Palmero, R., additional, Serrahima, M. Plana, additional, Mesía, C., additional, Padrones, S., additional, Aso, S., additional, Rodriguez, J. Ruffinelli, additional, Navarro, V., additional, Brao, I., additional, Nadal, E., additional, and Alemany, F. Cardenal, additional

Published
2016
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49. LBA65 - IMpower131: Progression-free survival (PFS) and overall survival (OS) analysis of a randomised phase III study of atezolizumab + carboplatin + paclitaxel or nab-paclitaxel vs carboplatin + nab-paclitaxel in 1L advanced squamous NSCLC

Author

Socinski, M.A., Rittmeyer, A., Shapovalov, D., Orlandi, F., McCleod, M., Soo, R.A., Palmero, R., Kozuki, T., Migliorino, M.R., Koynov, K.D., Berard, H., Hughes, B.G.M., Yu, W., Graupner, V., Sun, S.W., Kowanetz, M., Hoang, T., Lin, W., and Jotte, R.M.

Published
2018
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