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1. S205: ZANUBRUTINIB + OBINUTUZUMAB (ZO) VS OBINUTUZUMAB (O) MONOTHERAPY IN PATIENTS (PTS) WITH RELAPSED OR REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL): PRIMARY ANALYSIS OF THE PHASE 2 RANDOMIZED ROSEWOOD TRIAL

Author

P. L. Zinzani, J. Mayer, R. Auer, F. Bijou, A. C. de Oliveira, C. R. Flowers, M. Merli, K. Bouabdallah, P. S. Ganly, Y. Song, H. Zhang, R. Johnson, A. M García-Sancho, M. Provencio, M. Trněný, S. Yuen, H. Tilly, E. Kingsley, G. Tuyman, S. E. Assouline, E. Ivanova, P. Kim, J. Huang, R. Delarue, and J. Trotman

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2022
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2. ZANUBRUTINIB PLUS OBINUTUZUMAB VERSUS OBINUTUZUMAB IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA: UPDATED ANALYSIS OF THE ROSEWOOD STUDY

Author

Zinzani, P. L., primary, Mayer, J., additional, Trotman, J., additional, Bijou, F., additional, de Oliveira, A. C., additional, Song, Y., additional, Zhang, Q., additional, Merli, M., additional, Bouabdallah, K., additional, Ganly, P. S., additional, Zhang, H., additional, Johnson, R., additional, Garcia‐Sancho, A. M., additional, Pulla, M. Provencio, additional, Trněný, M., additional, Yuen, S., additional, Assouline, S. E., additional, Auer, R., additional, Ivanoa, E., additional, Kim, P., additional, Greenbaum, A., additional, Huang, S., additional, Delarue, R., additional, and Flowers, C. R., additional

Published
2023
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3. A randomised phase II study of osimertinib and bevacizumab versus osimertinib alone as second-line targeted treatment in advanced NSCLC with confirmed EGFR and acquired T790M mutations

Author

R.A. Soo, J.-Y. Han, U. Dafni, B.C. Cho, C.M. Yeo, E. Nadal, E. Carcereny, J. de Castro, M.A. Sala, R. Bernabé, L. Coate, M. Provencio Pulla, R. Garcia Campelo, S. Cuffe, S.M.S. Hashemi, M. Früh, B. Massuti, J. Garcia-Sanchez, M. Dómine, M. Majem, J.-M. Sanchez-Torres, C. Britschgi, M. Pless, G. Dimopoulou, H. Roschitzki-Voser, B. Ruepp, R. Rosell, R.A. Stahel, S. Peters, Rolf Stahel, Solange Peters, Ross Soo, Ji-Youn Han, Martin Früh, Mariano Provencio, Linda Coate, Urania Dafni, Anita Hiltbrunner, Barbara Ruepp, Heidi Roschitzki-Voser, Adriana Gasca-Ruchti, Nino Giacomelli, Rosita Kammler, Nesa Marti, Lionel Nobs, Mariana Pardo-Contreras, Rita Pfister, Anne-Christine Piguet, Sabrina Ribeli-Hofmann, Virginia Rodriguez Martinez, Susanne Roux, Magdalena Sanchez-Hohl, Mirjam Schneider, Robin Schweri, Sandra Troesch, Isabel Zigomo, Zoi Tsourti, Panagiota Zygoura, Marie Kassapian, Katerina Vervita, Georgia Dimopoulou, Charitini Andriakopoulou, Maria Fernandez, Eva Pereira, Carolina Simona, Lisa Tucker, Jillian Burnes, Aisling Barrett, Meghan McGrillen, Catherine Berset, Christine Biaggi, Martin Reist, Priska Rentsch, Sinead Cuffe, Sayed Hashemi, Ernest Nadal, Enric Carcereny, Javier de Castro, Maria Angeles Sala, Bernabé Reyes, Mariano Provencio Pulla, Rosario Garcia Campelo, Bartomeu Massutí, Jose Garcia, Manuel Dómine, Margarita Majem, Jose Miguel Sanchez, Christian Britschgi, Miklos Pless, Chong Ming Yeo, Byoung Chul Cho, Pulmonary medicine, and CCA - Cancer Treatment and quality of life

Subjects
Oncology, medicine.medical_specialty, Lung Neoplasms, Bevacizumab, Population, Phases of clinical research, bevacizumab, NSCLC, law.invention, T790M, Randomized controlled trial, law, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Osimertinib, education, Protein Kinase Inhibitors, education.field_of_study, Acrylamides, Aniline Compounds, business.industry, Standard treatment, Hematology, EGFR mutations, ErbB Receptors, osimertinib, Mutation, business, randomised controlled trial, medicine.drug
Abstract

Background: While osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is the standard treatment in patients with advanced non-small-cell lung cancer (NSCLC) with sensitising EGFR and acquired T790M mutations, progression inevitably occurs. The angiogenic pathway is implicated in EGFR TKI resistance. Patients and methods: BOOSTER is an open-label randomised phase II trial investigating the efficacy and safety of combined osimertinib 80 mg daily and bevacizumab 15 mg/kg every 3 weeks, versus osimertinib alone, in patients with EGFR-mutant advanced NSCLC and acquired T790M mutations after failure on previous EGFR TKI therapy. Primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR) and adverse events (AEs). Results: Between May 2017 and February 2019, 155 patients were randomised (combination: 78; osimertinib: 77). At data cut-off of 22 February 2021, median follow-up was 33.8 months [interquartile range (IQR): 26.5-37.6 months] and 129 (83.2%) PFS events were reported in the intention-to-treat population. There was no difference in median PFS between the combination [15.4 months; 95% confidence interval (CI) 9.2-18.0 months] and osimertinib arm (12.3 months; 95% CI 6.2-17.2 months; stratified log-rank P = 0.83), [hazard ratio (HR) = 0.96; 95% CI 0.68-1.37]. Median OS was 24.0 months (95% CI 17.8- 32.1 months) in the combination arm and 24.3 months (95% CI 16.9-37.0 months) in the osimertinib arm (stratified log-rank P = 0.91), (HR = 1.03; 95% CI 0.67-1.56). Exploratory analysis revealed a significant interaction of smoking history with treatment for PFS (adjusted P = 0.0052) with a HR of 0.52 (95% CI 0.30-0.90) for smokers, and 1.47 (95% CI 0.92-2.33) for never smokers. ORR was 55% in both arms and the median time to treatment failure was significantly shorter in the combination than in the osimertinib arm, 8.2 months versus 10.8 months, respectively (P = 0.0074). Safety of osimertinib and bevacizumab was consistent with previous reports with grade >= 3 treatment-related AEs (TRAEs) reported in 47% and 18% of patients on combination and osimertinib alone, respectively. Conclusions: No difference in PFS was observed between osimertinib plus bevacizumab and osimertinib alone. Grade >= 3 TRAEs were more common in patients on combination.

Published
2022

5. 187P Tissue B-cell receptor repertoire as biomarker of complete pathological response in NSCLC patients treated with neoadjuvant chemoimmunotherapy (NADIM trials)

Author

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

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2023

7. EP16.04-014 NTRK in Lung Cancer Patients with History of Hodgkin's Lymphoma

Author

Clemente, M. Blanco, primary, García, B. Núñez, additional, Calvo de Juan, V., additional, Lourdy, A. Collazo, additional, Díaz, Y. Garitaonaindía, additional, Cutillas, M. Martínez, additional, Puchol, C. Traseira, additional, Noya, R. Aguado, additional, Ceballos, G. Visedo, additional, González, S.C. González, additional, García, M. Méndez, additional, González, J.C. Sánchez, additional, Sánchez de Ibargüen, B. Cantos, additional, Parejo, C., additional, and Pulla, M. Provencio, additional

Published
2022
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8. 939P Changes in immune gene signatures after neoadjuvant chemoimmunotherapy treatment in NSCLC patients from NADIM trial

Author

Casarrubios, M., primary, Cruz-Bermudez, A., additional, Sierra-Rodero, B., additional, Martinez, C., additional, Nadal, E., additional, Insa Molla, M.A., additional, Martinez, J. Mosquera, additional, Ojea, C. Gonzalez, additional, Gomez, M. Domine, additional, Tarruella, M. Majem, additional, Abreu, D. Rodriguez, additional, Martinez-Marti, A., additional, De Castro Carpeno, J., additional, Dols, M. Cobo, additional, Vivanco, G. Lopez, additional, Caro, R. Bernabe, additional, Segarra, N. Vinolas, additional, Aranda, I.C. Barneto, additional, Sureda, B. Massuti, additional, and Pulla, M. Provencio, additional

Published
2022
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9. LBA50 Analysis of pathological features and efficacy outcomes with neoadjuvant nivolumab (N) plus platinum-doublet chemotherapy (C) for resectable non-small cell lung cancer (NSCLC) in CheckMate 816

Author

Deutsch, J.S., primary, Cimino-Mathews, A., additional, Thompson, E.D., additional, Wang, D., additional, Anders, R.A., additional, Gabrielson, E., additional, Illei, P., additional, Jedrych, J., additional, Danilova, L., additional, Spicer, J., additional, Pulla, M. Provencio, additional, Forde, P.M., additional, Pandya, D., additional, Tran, M.P., additional, Fiore, J., additional, Devas, V., additional, Cottrell, T.R., additional, Baras, A.S., additional, and Taube, J.M., additional

Published
2022
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11. 1630P Effectivity and safety of anti-SARS-CoV2 vaccination in patients with lung cancer: The VAC-CaP observational study (GECP 21/01)

Author

E. Nadal, M.T. Moran Bueno, D. Rodriguez Abreu, Z. Vidales Sepulveda, M.A. Sala Gonzalez, M. Antonanzas Basa, J.J. Garcia Gonzalez, P. Diz Tain, M. Martinez Kareaga, G. Lopez Vivanco, J. Baena Espinar, B. Campos Balea, D. Cumplido Buron, S. Cerezo Gonzalez, A. Diaz, M. Guirado, X. Mielgo Rubio, O.J. Juan Vidal, M. Saigi Morgui, and M. Provencio Pulla

Subjects
Oncology, Hematology
Published
2022

14. PL03.12 Progression Free Survival and Overall Survival in NADIM II Study

Author

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

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2022

20. 932MO Nivolumab (NIVO) plus platinum-doublet chemotherapy (chemo) versus chemo as neoadjuvant treatment for resectable non-small cell lung cancer (NSCLC): Health-related quality of life (HRQoL) outcomes from CheckMate 816

Author

E. Felip, C. Wang, T-E. Ciuleanu, G. Saylors, F. Tanaka, K-N. Chen, H. Ito, N. Girard, S. Lu, M. Provencio Pulla, T. Mitsudomi, M. Awad, P.M. Forde, R. Lawrance, F. Taylor, G. Worthy, S.I. Blum, L. Vo, J.L. Cai, and J. Spicer

Subjects
Oncology, Hematology
Published
2022

21. LBA50 Analysis of pathological features and efficacy outcomes with neoadjuvant nivolumab (N) plus platinum-doublet chemotherapy (C) for resectable non-small cell lung cancer (NSCLC) in CheckMate 816

Author

J.S. Deutsch, A. Cimino-Mathews, E.D. Thompson, D. Wang, R.A. Anders, E. Gabrielson, P. Illei, J. Jedrych, L. Danilova, J. Spicer, M. Provencio Pulla, P.M. Forde, D. Pandya, M.P. Tran, J. Fiore, V. Devas, T.R. Cottrell, A.S. Baras, and J.M. Taube

Subjects
Oncology, Hematology
Published
2022

22. P2.07-02 RET Fusion Testing with FISH and Real-Time PCR: a Comparison with RNA-Based Next-Generation Sequencing in RET Positive NSCLC

Author

S. Hernandez, J.L. Rodriguez Carrillo, A. Caminoa, A. Benito, R. Martinez, M. Alonso, S. Clave, E. Arriola, I. Esteban-Rodriguez, J. De Castro, I. Sansano, E. Felip, I. Abdulkader, J. Garcia, F. Rojo, M. Domine, C. Teixido, N. Reguart, D. Compañ, A. Insa, N. Mancheño, S. Palanca, O. Juan, N. Baixeras, E. Nadal, M. Cebollero, A. Calles, P. Martin, C. Salas, M. Provencio, I. Aranda, B. Massuti, L. Lopez-Vilaro, M. Majem, P. Garrido, L. Paz-Ares, F. Lopez-Rios, and E. Conde

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2022

23. OA02.03 Tumor Bulk-RNA Seq Identifies Patients at High Risk of Progression in Non-complete Pathological Responders from NADIM Trial

Author

M. Casarrubios, A. Cruz-Bermúdez, B. Sierra-Rodero, C. Martinez, E. Nadal, V. Calvo, A. Insa, M.d.R. García- Campelo, C. Gonzalez Ojea, M. Dómine, M. Majem, D. Rodríguez-Abreu, A. Martínez-Martí, J. De Castro Carpeño, M. Cobo, G. López-Vivanco, E. Del Barco, R. Bernabé, B. Massutí, and M. Provencio

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2022

25. 939P Changes in immune gene signatures after neoadjuvant chemoimmunotherapy treatment in NSCLC patients from NADIM trial

Author

M. Casarrubios, A. Cruz-Bermudez, B. Sierra-Rodero, C. Martinez, E. Nadal, M.A. Insa Molla, J. Mosquera Martinez, C. Gonzalez Ojea, M. Domine Gomez, M. Majem Tarruella, D. Rodriguez Abreu, A. Martinez-Marti, J. De Castro Carpeno, M. Cobo Dols, G. Lopez Vivanco, R. Bernabe Caro, N. Vinolas Segarra, I.C. Barneto Aranda, B. Massuti Sureda, and M. Provencio Pulla

Subjects
Oncology, Hematology
Published
2022

27. VP3-2021: A randomized phase II study of second-line osimertinib (Osi) and bevacizumab (Bev) versus Osi in advanced non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and T790M mutations (mt): Results from the ETOP BOOSTER trial

Author

Linda Coate, C.M. Yeo, G. Dimopoulou, J. de Castro, H. Roschitzki-Voser, Martin Früh, Solange Peters, E. Nadal, Rolf A. Stahel, S.M.S. Hashemi, Ross A. Soo, R. Bernabé, M. Provencio, Byoung Chul Cho, M.A. Sala, Sinead Cuffe, Barbara Ruepp, J-Y. Han, R. Garcia Campelo, and Enric Carcereny

Subjects
Booster (rocketry), biology, Bevacizumab, business.industry, non-small cell lung cancer (NSCLC), Phases of clinical research, Hematology, medicine.disease, T790M, Second line, Oncology, Cancer research, biology.protein, Medicine, Osimertinib, Epidermal growth factor receptor, business, medicine.drug
Published
2021

28. Impact of Covid-19 in the field of oncology

Author

Virginia Calvo, M. Provencio, and Ana Collazo-Lorduy

Subjects
Physics, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Field (physics), medicine, Medical physics, General Medicine
Abstract

The outbreak of the new coronavirus disease (COVID-19) has become the greatest threat to public health worldwide. Oncological patients have an increased risk of infection due to their oncological disease, which supresses the immune system and mielosupressive effects of antincancer treatments. Throughout this article, the impact of COVID-19 in the oncological field will be reviewed, centering in diagnosis (susceptibility, differential diagnoses, delays in diagnosis in post-COVID era, triage systems); treatment (treatment of COVID-19 infection, surgeries, oncological treatments); impact in mortality and emotional impact. Maintaining quality of care in patients as vulnerable as cancer patients is a huge challenge in the face of possible outbreaks or future times when we have to face living with the infection but maintaining quality standards in healthcare.

Published
2020

29. Nivolumab (NIVO) + doublet de chimiothérapie à base de sels de platine (chimio) versus chimio, en traitement néoadjuvant du cancer bronchique non à petites cellules (CBNPC) résécable (IB-IIIA) : corrélation entre survie sans évènement (EFS) et régression pathologique dans l’étude CheckMate 816

Author

N. Girard, M. Provencio-Pulla, J. Spicer, J.M. Taube, C. Martin, D.R. Spigel, C. Wang, S. Lu, T. Mitsudomi, M.M. Awad, E. Felip, J.R. Brahmer, S. Broderick, S.J. Swanson, K. Kerr, L. Li, J. Cai, J. Bushong, P. Tran, and P.M. Forde

Subjects
Pulmonary and Respiratory Medicine
Published
2023

30. Consolidation nivolumab and ipilimumab versus observation in limited-disease small-cell lung cancer after chemo-radiotherapy - results from the randomised phase II ETOP/IFCT 4-12 STIMULI trial

Author

S. Peters, J.-L. Pujol, U. Dafni, M. Dómine, S. Popat, M. Reck, J. Andrade, A. Becker, D. Moro-Sibilot, A. Curioni-Fontecedro, O. Molinier, K. Nackaerts, A. Insa Mollá, R. Gervais, G. López Vivanco, J. Madelaine, J. Mazieres, M. Faehling, F. Griesinger, M. Majem, J.L. González Larriba, M. Provencio Pulla, K. Vervita, H. Roschitzki-Voser, B. Ruepp, P. Mitchell, R.A. Stahel, C. Le Pechoux, D. De Ruysscher, R. Stahel, A. Hiltbrunner, M. Pardo-Contreras, A. Gasca-Ruchti, N. Giacomelli, R. Kammler, N. Marti, R. Pfister, A.C. Piguet, S. Roux, S. Troesch, M. Schneider, R. Schweri, I. Zigomo, Z. Tsourti, P. Zygoura, S. Tsouprou, M. Kassapian, G. Dimopoulou, C. Andriakopoulou, F. Morin, E. Amour, G. Mariaule, N. Archirel, M. Fernandez, E. Pereira, L. Benito, K. Lopez, A. Hernández, S. Chinchen, H. Jurkovic, A. Livingstone, J. Mitchell, M. Walker, S. Ng, C. Steer, K. Briscoe, A. Saqib, E. Abdi, B. Houghton, K. O’Byrne, B.R. Chittajallu, B.G. Hughes, A. Black, H. Werner, G. Zalcman, F. Vaylet, P. Merle, I. Monnet, N. Girard, P.-J. Souquet, F. Barlesi, D. Debieuvre, H. Senellart, M. Poudenx, A. Dixmier, D. Pouessel, J. Cadranel, H. Lena, E. Quoix, S. Friard, C. Audigier-Valette, E. Pichon, K. Kokowski, H. Kirchen, A. Tufman, C. De-Colle, J. de Langen, A. Insa, B. Massutí, M.P. Pulla, S.P. Aix, N. Villanueva, G.L. Vivanco, K. Franks, R. Califano, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Radiotherapie, Pulmonary medicine, CCA - Cancer Treatment and quality of life, CCA - Cancer biology and immunology, University of Zurich, and Stahel, R A

Subjects
Male, medicine.medical_specialty, Lung Neoplasms, 2720 Hematology, MULTICENTER, 610 Medicine & health, Ipilimumab, Randomised clinical trial, randomised clinical trial, 1ST-LINE NIVOLUMAB, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, small-cell lung cancer, Humans, RECURRENT, ipilimumab, Lung cancer, nivolumab, Limited disease, Performance status, Small cell lung cancer, business.industry, Standard treatment, Hazard ratio, PLUS IPILIMUMAB, SCLC, Hematology, Chemoradiotherapy, Middle Aged, medicine.disease, OPEN-LABEL, Nivolumab, Oncology, 10032 Clinic for Oncology and Hematology, limited disease, CHECKMATE 032, 2730 Oncology, Female, Prophylactic cranial irradiation, business, medicine.drug
Abstract

BACKGROUND: Concurrent chemotherapy and thoracic radiotherapy followed by prophylactic cranial irradiation (PCI) is the standard treatment in limited-disease small-cell lung cancer (LD-SCLC), with 5-year overall survival (OS) of only 25% to 33%. PATIENTS AND METHODS: STIMULI is a 1:1 randomised phase II trial aiming to demonstrate superiority of consolidation combination immunotherapy versus observation after chemo-radiotherapy plus PCI (protocol amendment-1). Consolidation immunotherapy consisted of four cycles of nivolumab [1 mg/kg, every three weeks (Q3W)] plus ipilimumab (3 mg/kg, Q3W), followed by nivolumab monotherapy (240 mg, Q2W) for up to 12 months. Patient recruitment closed prematurely due to slow accrual and the statistical analyses plan was updated to address progression-free survival (PFS) as the only primary endpoint. RESULTS: Of the 222 patients enrolled, 153 were randomised (78: experimental; 75: observation). Among the randomised patients, median age was 62 years, 60% males, 34%/65% current/former smokers, 31%/66% performance status (PS) 0/1. Up to 25 May 2020 (median follow-up 22.4 months), 40 PFS events were observed in the experimental arm, with median PFS 10.7 months [95% confidence interval (CI) 7.0-not estimable (NE)] versus 42 events and median 14.5 months (8.2-NE) in the observation, hazard ratio (HR)= 1.02 (0.66-1.58), two-sided P= 0.93. With updated follow-up (03 June 2021; median: 35 months), median OS was not reached in the experimental arm, while it was 32.1 months (26.1-NE) in observation, with HR= 0.95 (0.59-1.52), P= 0.82. In the experimental arm, median time-to-treatment-discontinuation was only 1.7 months. CTCAE v4 grade =3 adverse events were experienced by 62% of patients in the experimental and 25% in the observation arm, with 4 and 1 fatal, respectively. CONCLUSIONS: The STIMULI trial did not meet its primary endpoint of improving PFS with nivolumab-ipilimumab consolidation after chemo-radiotherapy in LD-SCLC. A short period on active treatment related to toxicity and treatment discontinuation likely affected the efficacy results.

Published
2021

31. 42P Real-life data on treatment with poly (ADP-ribose) polymerase inhibitor (iPARP), in patients over 65 years of age with ovarian cancer: A current need

Author

M. Martinez Cutillas, Y. Garitaonaindia Diaz, B. Nunez Garcia, M. Blanco Clemente, C. Traseira Puchol, R. Aguado, G. Visedo, A. Gónzalez Sánchez, D.I. Ruiz de Domingo, M.M. Sánchez Del Corral, M.A. Gonzalez Del Alba Baamonde, J.C. Sanchez Gonzalez, B. Cantos Sanchez de Ibarguen, M. Mendez Garcia, M. Provencio Pulla, and C. Maximiano Alonso

Subjects
Oncology, Hematology
Published
2022

32. P84.16 Treatment Options for Patients with Brain Metastases in Oncogene-Driven Non-Small Cell Lung Cancer

Author

A. Sánchez, M. Provencio, A. Morito, Manuel Martínez, A. Collazo, Virginia Calvo, B. Nunez-Garcia, M. Blanco Clemente, B. Menchen, R. Aguado, C. Traseira, F. Franco, Y. Garitaonaindia, and G. Visedo

Subjects
Pulmonary and Respiratory Medicine, Oncology, Oncogene, business.industry, medicine, Cancer research, Treatment options, Non small cell, Lung cancer, medicine.disease, business
Published
2021

33. P09.12 SARS- CoV2 Impact in a Spanish Lung Cancer Cohort?

Author

B. Nunez-Garcia, B. Nuñez-Garcia, A. Morito, M. Martínez, C. Traseira, R. Aguado, Y. Garitaonaindía, G. Visedo, F. Franco, V. Calvo, and M. Provencio

Subjects
Pulmonary and Respiratory Medicine, 2019-20 coronavirus outbreak, Oncology, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Cohort, Medicine, business, Lung cancer, medicine.disease, Virology, Article
Published
2021

34. P25.06 Malignant Pleural Mesothelioma: Patient Characteristics, Treatments and Outcomes from a Spanish Center

Author

M. Provencio, C. Alfaro, A. Morito, Virginia Calvo, G. Visedo, Manuel Martínez, A. Collazo, F. Franco, Y. Garitaonaindía, B. Nunez-Garcia, C. Traseira, R. Aguado, M. Blanco Clemente, and J. Martin

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Oncology, Pleural mesothelioma, business.industry, medicine, Patient characteristics, Center (algebra and category theory), Radiology, business
Published
2021

35. EP16.04-014 NTRK in Lung Cancer Patients with History of Hodgkin's Lymphoma

Author

M. Blanco Clemente, B. Núñez García, V. Calvo de Juan, A. Collazo Lourdy, Y. Garitaonaindía Díaz, M. Martínez Cutillas, C. Traseira Puchol, R. Aguado Noya, G. Visedo Ceballos, S.C. González González, M. Méndez García, J.C. Sánchez González, B. Cantos Sánchez de Ibargüen, C. Parejo, and M. Provencio Pulla

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2022

36. P1.09-03 Multidisciplinary Thoracic Tumors Board Survey in Spain

Author

B. Massutí, E. Nadal, C. Camps, E. Carcereny, M. Cobo, M. Domine, M.R. Garcia-Campelo, J.L. Gonzalez-Larriba, M. Guirado, F. Hernando-Trancho, D. Rodriguez-Abreu, A. Sanchez, I. Sullivan, and M. Provencio

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2022

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

Author

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

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2022

42. Résultats chirurgicaux de l’essai de phase 3 CheckMate 816 (CM 816) : Nivolumab (N) + doublet de chimiothérapie à base de sels de platine (CT) vs CT comme traitement néo-adjuvant du cancer bronchique non à petites cellules (CBNPC) résécable

Author

N. Girard, J. Spicer, C. Wang, F. Tanaka, G.B. Saylors, K.N. Chen, M. Liberman, E. Vokes, S. Lu, M. Provencio, T. Mitsudomi, M.M. Awad, E. Felip, P.M. Forde, S.J. Swanson, J.R. Brahmer, K. Kerr, C. Dorange, J. Cai, and S. Broderick

Subjects
Pulmonary and Respiratory Medicine
Published
2022

43. Author response for 'NGS‐based liquid biopsy profiling identifies mechanisms of resistance to ALK inhibitors: a step toward personalized NSCLC treatment'

Author

Bartomeu Massuti, Manuel Dómine Gomez, Roberto Serna-Blasco, Virginia Calvo, Magdalena Arnal, Noemí Reguart, Carlos Camps, Atocha Romero, Dietmar Fernández‐Orth, Rosario García-Campelo, Eloisa Jantus-Lewintre, Estela Sánchez-Herrero, Silvia Calabuig-Fariñas, Sandra Sanz-Moreno, M. Provencio, Jose Miguel Sanchez, Vadym Ivanchuk, and Víctor González‐Rumayor

Subjects
business.industry, Cancer research, Profiling (information science), Medicine, Liquid biopsy, business
Published
2021

44. Influence of BRAF and PIK3CA mutations on the efficacy of FOLFIRI plus bevacizumab or cetuximab as first-line therapy in patients with RAS wild-type metastatic colorectal carcinoma and <3 baseline circulating tumour cells: the randomised phase II VISNÚ-2 study

Author

J. Sastre, P. García-Alfonso, J.M. Viéitez, M.T. Cano, F. Rivera, J.J. Reina-Zoilo, A. Salud-Salvia, G. Quintero, L. Robles-Díaz, M.J. Safont, A. La Casta, S. Gil, E. Polo, E. Asensio-Martínez, B. García-Paredes, R.L. López, M. Guillot, M. Valladares-Ayerbes, E. Aranda, E. Díaz-Rubio, P. Jiménez, E. Aranda Aguilar, A. Gómez, S. Gil Calle, A. Salud, M. Valladares, B. Graña, J.J. Reina, E. González Flores, M. Salgado, E. Grande, C. Guillén, R. Garcia Carbonero, M.J. Flor, S. Arévalo, R. López López, H. Manzano, X. Hernández Yagüe, A. Arrivi, E. Falcó, J. Gallego, P. Escudero, I. Cabezas, A. Juárez, E. Gálvez, C. Grávalos, L. Robles, R. Dueñas, J.M. Campos, A. Albert, P. Salinas, C. Montagut, M. Provencio, A. Ruiz Casado, J. Muñoz, M. Gil Raga, M.R. Chilet, F.J. González González, B. Massutí, A. López, J. Aparicio, M. Marín, J. Alfaro, M. Zanui, D. Gutiérrez Abad, A.M. García Tapiador, C. García-Girón, J. Molina Saera, E. Torres Sánchez, I. López, C. Bosch, J. Valero, P. Martínez de Prado, Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), [Sastre,J, García-Paredes,B, Díaz-Rubio,E] Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clínico San Carlos (IdISSC). [García-Alfonso,P] Medical Oncology, Hospital Universitario Gregorio Marañón, Madrid. [Viéitez,JM] Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, [Cano,MT, Aranda,E] Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Cordoba. [Rivera,F] Medical Oncology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander. [Reina-Zoilo,JJ] Medical Oncology, Complejo Hospitalario Virgen de la Macarena, Seville. [Salud-Salvia,A] Hospital Universitario Arnau de Vilanova de Lleida, Lleida. [Quintero,G] Medical Oncology, Hospital Lucus Augusti, Lugo. [Robles-Díaz,L] Medical Oncology, Hospital 12 de Octubre, Madrid. [Safont,MJ] Medical Oncology, Hospital General Universitario de Valencia, Valencia. [La Casta,A] Medical Oncology, Hospital de Donostia, Guipúzcoa. [Gil,S] Medical Oncology, Hospital Universitario Regional y Virgen de la Victoria, Malaga. [Polo,E] Medical Oncology, Hospital Miguel Servet, Zaragoza. [Asensio-Martínez,E] Medical Oncology, Hospital General Universitario de Elche, Alicante. [López,RL] Medical Oncology, University Clinical Hospital and Health Research Institute (IDIS), CIBERONC, Santiago de Compostela University School of Medicine, Santiago de Compostela. [Guillot,M] Medical Oncology, Hospital Son Espases, Palma de Mallorca. [Valladares-Ayerbes,M] Medical Oncology, Complejo Hospitalario Universitario A Coruña, Instituto de Investigación Biomédica (INIBIC), A Coruña, Spain., This work was supported by Roche Farma S.A (no grant number). Medical writing support was funded by Roche Farma S.A and provided by H. Lamb and L. Miller of Miller Medical Communications Ltd., and UAM. Departamento de Medicina

Subjects
Oncology, Cancer Research, Colorectal cancer, Terapia dirigida, Cetuximab, Phases of clinical research, Chemicals and Drugs::Heterocyclic Compounds::Alkaloids::Camptothecin [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Confidence Intervals [Medical Subject Headings], Targeted therapy, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Neoplasias colorrectales, Antineoplastic Combined Chemotherapy Protocols, Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyrimidines::Pyrimidinones::Uracil::Fluorouracil [Medical Subject Headings], Original Research, Hazard ratio, Neoplastic Cells, Circulating, targeted therapy, Bevacizumab, Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Transferases::Phosphotransferases::Phosphotransferases (Alcohol Group Acceptor)::Phosphatidylinositol 3-Kinases::Phosphatidylinositol 3-Kinase::Class I Phosphatidylinositol 3-Kinases [Medical Subject Headings], FOLFIRI, Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Leukopenia::Agranulocytosis::Neutropenia [Medical Subject Headings], Colorectal Neoplasms, Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Asthenia [Medical Subject Headings], medicine.drug, Diseases::Neoplasms::Neoplastic Processes::Neoplasm Metastasis::Neoplastic Cells, Circulating [Medical Subject Headings], Proto-Oncogene Proteins B-raf, medicine.medical_specialty, Medicina, Class I Phosphatidylinositol 3-Kinases, colorectal cancer, Neutropenia, Neoplastic cells circulating, BRAF, Internal medicine, medicine, Humans, neoplasms, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Antineoplastic Protocols::Antineoplastic Combined Chemotherapy Protocols [Medical Subject Headings], business.industry, Chemicals and Drugs::Enzymes and Coenzymes::Coenzymes::Tetrahydrofolates::Formyltetrahydrofolates::Leucovorin [Medical Subject Headings], Diseases::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms [Medical Subject Headings], PIK3CA, medicine.disease, digestive system diseases, Irinotecan, Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Signs and Symptoms, Digestive::Diarrhea [Medical Subject Headings], Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Transferases::Phosphotransferases::Phosphotransferases (Alcohol Group Acceptor)::Protein Kinases::Protein-Serine-Threonine Kinases::MAP Kinase Kinase Kinases::raf Kinases::Proto-Oncogene Proteins B-raf [Medical Subject Headings], Camptothecin, business, Células neoplásicas circulantes, RAS
Abstract

Artículo escrito por un elevado número de autores, solo se referencian el que aparece en primer lugar, el nombre del grupo de colaboración, si le hubiere, y los autores pertenecientes a la UAM, Background We explored the influence of BRAF and PIK3CA mutational status on the efficacy of bevacizumab or cetuximab plus 5-fluorouracil/leucovorin and irinotecan (FOLFIRI) as first-line therapy in patients with RAS wild-type metastatic colorectal cancer (mCRC). Patients and methods VISNÚ-2 was a multicentre, randomised, phase II study. Patients with RAS wild-type mCRC and 1), and allocated to bevacizumab (5 mg/kg every 2 weeks) or cetuximab (400 mg/m2 then 250 mg/m2 weekly) plus FOLFIRI [irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil 400 mg/m2 (bolus) then 2400 mg/m2 (46-h continuous infusion) every 2 weeks]. The primary endpoint was progression-free survival (PFS). All analyses were exploratory. Results Two hundred and forty patients with BRAF/PIK3CA wild-type (n = 196) or BRAF- and/or PIK3CA-mutated tumours (n = 44) were enrolled. Median PFS was 12.7 and 8.8 months in patients with BRAF/PIK3CA wild-type and BRAF/PIK3CA-mutated tumours, respectively [hazard ratio (HR) = 1.22; 95% confidence interval (CI) 0.80-1.85; P = 0.3602]. In the BRAF- and/or PIK3CA-mutated cohort, median PFS was 2.8, 8.8 and 15.0 months in patients with BRAF/PI3KCA-mutated (n = 8), BRAF-mutated/PI3KCA wild-type (n = 16) and BRAF wild-type/PI3KCA-mutated (n = 20) tumours, respectively (P = 0.0002). PFS was similar with bevacizumab plus FOLFIRI versus cetuximab plus FOLFIRI in BRAF/PIK3CA wild-type (HR = 0.99; 95% CI 0.67-1.45; P = 0.9486) and BRAF/PIK3CA-mutated tumours (HR = 1.11; 95% CI 0.53-2.35; P = 0.7820). The most common grade 3/4 treatment-related adverse events were neutropenia, diarrhoea and asthenia in both treatment groups. Conclusions BRAF/PIK3CA status influences outcomes in patients with RAS wild-type mCRC but does not appear to assist with the selection of first-line targeted therapy, This work was supported by Roche Farma S.A (no grant number). Medical writing support was funded by Roche Farma S.A and provided by H. Lamb and L. Miller of Miller Medical Communications Ltd.

Published
2021

45. 1ISG-025 Budget impact analysis of biosimilar adalimumab versus reference adalimumab

Author

M Provencio Del Olmo, C Bustos Morell, N Labrador Andujar, MP Monforte Gasque, JM Gonzalez Puyuelo, and EM Lazaro Gallardo

Subjects
Old patients, business.industry, Incidence (epidemiology), Adalimumab, Medicine, Biosimilar, Budget impact, business, Sensitivity analyses, Demography, Healthcare system, medicine.drug
Abstract

Background and importance Biological treatments represent a great opportunity but their increasing and widespread use is causing sustainability problems in health systems due to their high cost. Emergence of biosimilars can lead to significant savings for health systems. Aim and objectives The aim of this study is to analyse the impact of the introduction of the biosimilar adalimumab (BA) (Hyrimoz) in three different scenarios, to choose the most convenient. Material and methods Firstly, we took into account all patients treated with the reference adalimumab (RA) between 2013 and 2018 to calculate the average incidence for every quarter. Also, we calculated prevalence on 31 December 2018. We then made a quarterly consumption forecast for the next three years (2019–2021). Secondly, we created an excel model for three possible scenarios: (1) all patients treated with RA, (2) the introduction of BA only in new patients with old patients continuing with RA or (3) all patients treated with BA. In every scenario, we calculate costs of buying adalimumab in each year. Finally, to assess the robustness of the data, different deterministic sensitivity analyses were conducted changing ±10% the three variables considered to have more impact in our model (price of adalimumab, incidence and prevalence). Also, an extreme analysis was performed for the best and worst conditions. Results Despite the increasing costs in all scenarios due to a growing incidence, costs would vary from 4 million in 3 years (scenario 1), 3.5 million (scenario 2), to 2.7 million (scenario 3). The choice of the different scenarios would mean savings of 11.5–31.8%, depending on the number of patients who were treated with BA. Sensitivity analyses showed that the cost of adalimumab was the most important factor in the final cost results. Analysis of extreme conditions showed a 20% variation from base case with savings of about 11.5% (scenario 2) and 30% (scenario 3). The most convenient was scenario 3 (change patients already treated with RA and treat new patients with BA). Conclusion and relevance Despite scenario 3 providing the greatest savings (making it possible to treat a large number of patients), the authorities decided not to change patients currently treated with RA, loosing savings of about 20.33%. References and/or acknowledgements Conflict of interest No conflict of interest

Published
2021

46. P40.10 Brain Metastases in Patients With Non-Small Cell Lung Cancer Treated With Immunotherapy. Real World Data From a Tertiary Hospital in Spain

Author

F. Franco, Y. Garitaonaindia, C. Traseira, Virginia Calvo, A. Collazo-Lorduy, M. Provencio, and M. Martínez-Cutillas

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, business.industry, medicine.medical_treatment, Immunotherapy, medicine.disease, Internal medicine, medicine, In patient, Non small cell, Lung cancer, business, Real world data
Published
2021

47. OA14.01 Family History of Cancer and Lung Cancer: Information from the Thoracic Tumors Registry (TTR Study)

Author

J.L. González Larriba, R. Bernabé, B. Massuti, D. Rodriguez Abreu, R. López-Castro, J. Mosquera, M. Cucurull, Manuel Domine, Ana Ortega, Oscar Juan, M. Provencio, M. Cobo, A. Collazo-Lorduy, V. Calvo, M. Guirado, Enric Carcereny, M. Martínez-Cutillas, E. Del Barco, Carlos Camps, J. Bosch Barrera, Gustavo Benítez, and C. Gonzalez Ojeda

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, biology, business.industry, Cancer, medicine.disease, Transthyretin, Internal medicine, biology.protein, Medicine, Family history, business, Lung cancer
Published
2021

48. P40.12 Cardiotoxicity in Lung Cancer Patients Treated With Immune-Checkpoints Inhibitors

Author

B. De La Puente, C. Traseira, M. Martínez-Cutillas, R. Aguado, Y. Garitaonaindia, V. Calvo, M. Provencio, A. Collazo-Lorduy, G. Visedo, M. Torrente, M. Blanco Clemente, A. Morito, and F. Franco

Subjects
Pulmonary and Respiratory Medicine, Cardiotoxicity, Immune system, Oncology, business.industry, Cancer research, medicine, Lung cancer, medicine.disease, business
Published
2021

49. P31.03 The Impact of the COVID-19 Pandemic on a Thoracic Tumor Unit of a Tertiary Hospital in Spain

Author

M. Martínez-Cutillas, R. Aguado, Virginia Calvo, F. Franco, Y. Garitaonaindia, L. Cudero, M. Provencio, A. Collazo-Lorduy, and C. Traseira

Subjects
Pulmonary and Respiratory Medicine, 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Thoracic Tumor, Unit (housing), Oncology, P31 Management of Lung Cancer in the Era of Covid-19 - Impact of Covid-19 in Lung Cancer Management, Pandemic, Emergency medicine, medicine, business
Published
2021

50. OA20.02 Pre-Treatment Levels of ctDNA for Long-Term Survival Prediction in Stage IIIA NSCLC Treated With Neoadjuvant Chemo-Immunotherapy

Author

R. Laza Briviesca, Maria Rosario Garcia Campelo, Delvys Rodriguez Abreu, Margarita Majem, Roberto Serna, A. Insa, Manuel Domine, Guillermo López Vivanco, Ana Royuela, V. Calvo, B. Massuti, C. Benito, Isidoro Barneto, E. Pereira, R. Bernabé, Amândio Cruz, Estela Sánchez-Herrero, E. Del Barco, M. Casarrubios, Alex Martinez-Marti, E. Nadal, M. Cobo, M. Provencio, Nuria Viñolas, Amalia Pérez Romero, J. de Castro, and Santiago Viteri

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Multivariate analysis, business.industry, medicine.disease, Clinical trial, Chemoimmunotherapy, Internal medicine, Stage IIIA NSCLC, Long term survival, medicine, Nivolumab, Lung cancer, business, Chemo immunotherapy
Abstract

Introduction: There are currently no predictive biomarkers for long-term survival after neoadjuvant chemoimmunotherapy. However, the identification of non-small lung cancer (NSCLC) patients who obtain long-term benefit from chemoimmunotherapy is essential to optimize therapies. Methods: Using samples from NADIM clinical trial (NCT03081689), in which resectable stage IIIA NSCLC patients were treated with neoadjuvant chemo-immunotherapy with nivolumab, we have evaluated the capacity of ctDNA levels before treatment initiation to predict overall survival (OS) and progression-free survival (PFS) by calculating Harrell’s C-statistic and we compare its predictive value with classical survival surrogates as the pathological response and clinical response assessed according to RECIST criteria v.1.1. The ctDNA was analyzed by NGS, using the Oncomine Pan-Cancer Cell-Free Assay™ (Thermo Fisher Scientific®). To explore the prognostic value of the amount of ctDNA at baseline, for each positive plasma sample, we calculated the sum of the mutant allele frequency (MAF) for all detected mutations. Patients who died from COVID19 were excluded from this analysis. Results: In our study, clinical responses based on RECIST criteria were not predictive for OS or PFS. On the contrary, in the multivariate analysis, patients with low ctDNA levels (

Published
2021

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