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1. The current and future role of the medical oncologist in the professional care for cancer patients

Author

Popescu, R. A., Schäfer, R., Califano, R., Eckert, R., Coleman, R., Douillard, J.-Y., Cervantes, A., Casali, Paolo G., Sessa, Cristiana, Cutsem, E. van, Vries, Elisabeth G. E. de, Pavlidis, Nicholas, Fumasoli, K., Wörmann, B., Samonigg, H., Cascinu, S., Hernández, J. J. C., Howard, A. J., Ciardiello, F., Stahel, R. A., Piccart, M., Popescu, Ra, Schäfer, R, Califano, R, Eckert, R, Coleman, R, Douillard, Jy, Cervantes, A, Casali, Pg, Sessa, C, Van Cutsem, E, de Vries, E, Pavlidis, N, Fumasoli, K, Wörmann, B, Samonigg, H, Cascinu, S, Cruz Hernández, Jj, Howard, Aj, Ciardiello, Fortunato, Stahel, Ra, Piccart, M., Popescu, R. A., Schäfer, R., Califano, R., Eckert, R., Coleman, R., Douillard, J. -Y., Cervantes, A., Casali, P. G., Sessa, C., van Cutsem, E., de Vries, E., Pavlidis, N., Fumasoli, K., Wörmann, B., Samonigg, H., Cascinu, S., Hernández, J. J. Cruz, Howard, A. J., Ciardiello, F., Stahel, R. A., University of Zurich, Popescu, R A, Pavlidis, Nicholas [0000-0002-2195-9961], and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
Oncology, Political participation, Work environment, diagnosis, 2720 Hematology, Cancer prevention, Profession, Continuing medical education, Neoplasms, Health care, Diagnosis, Drug use, Priority journal, Evidence-Based Medicine, Cost effectiveness analysis, treatment, Medical oncologist, Professional development, Professional standard, Cancer diagnosis, Hematology, Professional practice, medical oncology, Europe, Patient safety, 2730 Oncology, Multidisciplinary team (MDT), multidisciplinary team (MDT), Diagnosi, Human, Quality of life, Medical education, medicine.medical_specialty, Medical oncology, education, Specialty, Translational research, 610 Medicine & health, Cancer research, Patient care, Article, Research, Treatment, Humans, Interdisciplinary Communication, Medical Oncology, Physician-Patient Relations, Quality of Health Care, Physician's Role, Nursing, Internal medicine, medicine, profession, research, Physician-Patient Relation, business.industry, Physician attitude, Cancer, Evidence-based medicine, Physician-patient relations, medicine.disease, Personalized medicine, Family medicine, Evidence based medicine, 10032 Clinic for Oncology and Hematology, Position paper, Cancer patient, Neoplasm, business
Abstract

The number of cancer patients in Europe is rising and significant advances in basic and applied cancer research are making the provision of optimal care more challenging. The concept of cancer as a systemic, highly heterogeneous and complex disease has increased the awareness that quality cancer care should be provided by a multidisciplinary team (MDT) of highly qualified healthcare professionals. Cancer patients also have the right to benefit from medical progress by receiving optimal treatment from adequately trained and highly skilled medical professionals. Built on the highest standards of professional training and continuing medical education, medical oncology is recognised as an independent medical specialty in many European countries. Medical oncology is a core member of the MDT and offers cancer patients a comprehensive and systemic approach to treatment and care, while ensuring evidence-based, safe and cost-effective use of cancer drugs and preserving the quality of life of cancer patients through the entire 'cancer journey'. Medical oncologists are also engaged in clinical and translational research to promote innovation and new therapies and they contribute to cancer diagnosis, prevention and research, making a difference for patients in a dynamic, stimulating professional environment. Medical oncologists play an important role in shaping the future of healthcare through innovation and are also actively involved at the political level to ensure a maximum contribution of the profession to Society and to tackle future challenges. This position paper summarises the multifarious and vital contributions of medical oncology and medical oncologists to today's and tomorrow's professional cancer care.© The Author 2013.Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. 25 1 9 15

Published
2014

2. Phylogenetic ctDNA analysis depicts early stage lung cancer evolution

Author

Abbosh, C, Birkbak, NJ, Wilson, GA, Jamal-Hanjani, M, Constantin, T, Salari, R, Quesne, JL, Moore, DA, Veeriah, S, Rosenthal, R, Marafioti, T, Kirkizlar, E, Watkins, TBK, McGranahan, N, Ward, S, Martinson, L, Riley, J, Fraioli, F, Bakir, MA, GrÖnroos, E, Zambrana, F, Endozo, R, Bi, WL, Fennessy, FM, Sponer, N, Johnson, D, Laycock, J, Shafi, S, Czyzewska-Khan, J, Rowan, A, Chambers, T, Matthews, N, Turajlic, S, Hiley, C, Lee, SM, Forster, MD, Ahmad, T, Falzon, M, Borg, E, Lawrence, D, Hayward, M, Kolvekar, S, Panagiotopoulos, N, Janes, SM, Thakrar, R, Ahmed, A, Blackhall, F, Summers, Y, Hafez, D, Naik, A, Ganguly, A, Kareht, S, Shah, R, Joseph, L, Quinn, AM, Crosbie, P, Naidu, B, Middleton, G, Langman, G, Trotter, S, Nicolson, M, Remmen, H, Kerr, K, Chetty, M, Gomersall, L, Fennell, DA, Nakas, A, Rathinam, S, Anand, G, Khan, S, Russell, P, Ezhil, V, Ismail, B, Irvin-sellers, M, Prakash, V, Lester, JF, Kornaszewska, M, Attanoos, R, Adams, H, Davies, H, Oukrif, D, Akarca, AU, Hartley, JA, Lowe, HL, Lock, S, Iles, N, Bell, H, Ngai, Y, Elgar, G, Szallasi, Z, Schwarz, RF, Herrero, J, Stewart, A, Quezada, SA, Van Loo, P, Dive, C, Lin, CJ, Rabinowitz, M, Aerts, HJWL, Hackshaw, A, Shaw, JA, Zimmermann, BG, Swanton, C, Bosshard-Carter, L, Goh, G, Gorman, P, Murugaesu, N, Hynds, RE, Wilson, G, Horswell, S, Al Bakir, M, Mitter, R, Escudero, M, Xu, H, Goldman, J, Stone, RK, Denner, T, Biggs, J, Costa, M, Begum, S, Phillimore, B, Nye, E, Graca, S, Joshi, K, Furness, A, Aissa, AB, Wong, YNS, Georgiou, A, Quezada, S, Simeon, C, Hector, G, Smith, A, Aranda, M, Novelli, M, Forster, M, Papadatos-Pastos, D, Carnell, D, Mendes, R, George, J, Navani, N, Taylor, M, Choudhary, J, Califano, R, Taylor, P, Krysiak, P, Rammohan, K, Fontaine, E, Booton, R, Evison, M, Moss, S, Idries, F, Bishop, P, Chaturved, A, Marie Quinn, A, Doran, H, leek, A, Harrison, P, Moore, K, Waddington, R, Novasio, J, Rogan, J, Smith, E, Tugwood, J, Brady, G, Rothwell, DG, Chemi, F, Pierce, J, Gulati, S, Bellamy, M, Bancroft, H, Kerr, A, Kadiri, S, Webb, J, Djearaman, M, Fennell, D, Le Quesne, J, Moore, D, Thomas, A, Walter, H, Monteiro, W, Marshall, H, Nelson, L, Bennett, J, Primrose, L, Amadi, A, Palmer, S, Miller, J, Buchan, K, Lester, J, Edwards, A, Morgan, F, Verjee, A, MacKenzie, M, Wilcox, M, Smith, S, Gower, N, Ottensmeier, C, Chee, S, Johnson, B, Alzetani, A, Shaw, E, Lim, E, De Sousa, P, Tavares Barbosa, M, Bowman, A, Jordan, S, Rice, A, Raubenheimer, H, Proli, C, Elena Cufari, M, Ronquillo, JC, Kwayie, A, Bhayani, H, Hamilton, M, Bakar, Y, Mensah, N, Ambrose, L, Devaraj, A, Buderi, S, Finch, J, Azcarate, L, Chavan, H, Green, S, Mashinga, H, Nicholson, AG, Lau, K, Sheaff, M, Schmid, P, Conibear, J, Light, T, Horey, T, Danson, S, Bury, J, Edwards, J, Hill, J, Matthews, S, Kitsanta, Y, Suvarna, K, Fisher, P, Keerio, AD, Shackcloth, M, Gosney, J, Postmus, P, Feeney, S, Asante-Siaw, J, Constatin, T, Zimmermann, B, Dentro, S, Dessimoz, C, Shiu, K-K, Bridgewater, J, Hochauser, D, Beck, S, Parker, P, Walczak, H, Enver, T, Proctor, I, Sinclair, R, Lok, C-W, Mitchison, M, Trevisan, G, Lynch, M, Brandner, S, Gishen, F, Tookman, A, Stone, P, Sterling, C, Larkin, J, Attard, G, Eeles, R, Foster, C, Bova, S, Sottoriva, A, Chowdhury, S, Ashish, C, Spicer, J, Stares, M, Lynch, J, Caldas, C, Brenton, J, Fitzgerald, R, Jimenez-Linan, M, Provenzano, E, Cluroe, A, Stewart, G, Watts, C, Gilbertson, R, McDermott, U, Tavare, S, Maughan, T, Tomlinson, I, Campbell, P, McNeish, I, Biankin, A, Chambers, A, Fraser, S, Oien, K, Krebs, M, Marais, R, Carter, L, Nonaka, D, Dhomen, N, Shaw, J, Baijal, S, Tanchel, B, Collard, M, Cockcroft, P, Taylor, J, Colloby, P, Olisemeke, B, Wilson, R, Harrison, D, Loda, M, Flanagan, A, McKenzie, M, Lederman, J, Sharp, A, and Farrelly, L

Subjects
0301 basic medicine, Oncology, Lung Neoplasms, IMPACT, Biopsy, DNA Mutational Analysis, Drug resistance, Metastasis, 0302 clinical medicine, Limit of Detection, Carcinoma, Non-Small-Cell Lung, Medicine, Neoplasm Metastasis, Early Detection of Cancer, Multidisciplinary, medicine.diagnostic_test, Phylogenetic tree, DNA, Neoplasm, STATISTICS, 3. Good health, Tumor Burden, Multidisciplinary Sciences, Cell Tracking, PEACE consortium, 030220 oncology & carcinogenesis, Disease Progression, Science & Technology - Other Topics, medicine.medical_specialty, CARCINOMA, Tumour heterogeneity, General Science & Technology, Early detection, Evolution, Molecular, 03 medical and health sciences, Internal medicine, MD Multidisciplinary, Carcinoma, Humans, Cell Lineage, Lung cancer, Postoperative Care, Science & Technology, MUTATIONS, TRACERx consortium, business.industry, CIRCULATING TUMOR DNA, Reproducibility of Results, medicine.disease, R1, NEGATIVE BREAST-CANCER, Clone Cells, 030104 developmental biology, Drug Resistance, Neoplasm, UPTAKE RATIO, Immunology, FDG PET, Neoplasm Recurrence, Local, business, Multiplex Polymerase Chain Reaction
Abstract

The early detection of relapse following primary surgery for non-small-cell lung cancer and the characterization of emerging subclones, which seed metastatic sites, might offer new therapeutic approaches for limiting tumour recurrence. The ability to track the evolutionary dynamics of early-stage lung cancer non-invasively in circulating tumour DNA (ctDNA) has not yet been demonstrated. Here we use a tumour-specific phylogenetic approach to profile the ctDNA of the first 100 TRACERx (Tracking Non-Small-Cell Lung Cancer Evolution Through Therapy (Rx)) study participants, including one patient who was also recruited to the PEACE (Posthumous Evaluation of Advanced Cancer Environment) post-mortem study. We identify independent predictors of ctDNA release and analyse the tumour-volume detection limit. Through blinded profiling of postoperative plasma, we observe evidence of adjuvant chemotherapy resistance and identify patients who are very likely to experience recurrence of their lung cancer. Finally, we show that phylogenetic ctDNA profiling tracks the subclonal nature of lung cancer relapse and metastasis, providing a new approach for ctDNA-driven therapeutic studies.

Published
2017

3. Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer

Author

Rafael Rosell, Alice T. Shaw, Ali Zeaiter, Shirish M. Gadgeel, Emmanuel Mitry, Bogdana Balas, Jin S. Ahn, Maurice Perol, Johannes Noe, Sai-Hong Ignatius Ou, Peter N. Morcos, D. Ross Camidge, Solange Peters, Tony Mok, Dong Wan Kim, Rafal Dziadziuszko, Sophie Golding, ALEX Trial Investigators, Nordman, I., Pittman, K., Dear, R., Lwin, Z., Briggs, P., Pavlakis, N., Ceric, T., Mehic, B., Stanetic, M., Franke, F.A., Castro, G., Santo Borges, G., Pereira, J., Brust, L., Santos, L., Cruz, M., Ribeiro, R., De Azevedo, S., Neron, Y.V., Sangha, R., Cohen, V., Burkes, R., Abdelsalam, M., Yadav, S., Cheema, P., Yanez, E., Aren, O., Zhou, C., Zhang, L., Liu, X., Corrales Rodriguez, L., Meldgaard, P., Soerensen, J.B., McCulloch, T., Rodriguez, N., Gaafar, R., Abdel Azeem, H., Coudert, B., Moro-Sibilot, D., Lena, H., Bennouna, J., Cortot, A., Veillon, R., Cadranel, J., Barlesi, F., Reck, M., Mezger, J., von Pawel, J., Fischer, J.R., Dickgreber, N.K., Zarogoulidis, K., Syrigos, K., Georgoulias, V., Agelaki, S., Castro-Salguero, H., Ho, J., Chan, S.H., Cheng, C.K., Ng, A., Stemmer, S., Wollner, M., Gottfried, M., Dudnik, J., Cyjon, A., Heching, N., Novello, S., Tiseo, M., Platania, M., Misino, A., Gridelli, C., Ciardiello, F., Favaretto, A., De Marinis, F., Longo, F., Bordonaro, R., Dazzi, C., Chiari, R., Mercuri, E., Macedo, E., Rodriguez Cid, J.R., McKeage, M., Vera, L., Morón Escobar, H.D., Rodriguez, M., Mas, L., Ramlau, R., Kowalski, D., Szczesna, A., Kazarnowicz, A., Milanowski, J., Luboch-Kowal, J., Oliveira, J., Barata, F., Almodovar, T., Lee, J.S., Cho, B.C., Kim, S.W., Han, J.Y., Karaseva, N., Stroyakovskii, D., Kuzmin, A., Smolin, A., Laktionov, K., Ragulin, Y., Filippov, A., Levchenko, E., Jovanovic, D., Perin, B., Andric, Z., Soo, R., Tan, E.H., De Castro Carpeno, J., Provencio Pulla, M., Garrido Lopez, P., Felip Font, E., Morano Bueno, T., Sanchez, A., Isla Casado, D., Ponce Aix, S., Reguart Aransay, N., Viteri Ramirez, S., Rodriguez Abreu, D., Sanchez Torres, J.M., Massuti Sureda, B., Ramos Vazquez, M., Tabernero, J.M., Curioni, A., Rothschild, S., Scherz, A., Chiu, C.H., Su, W.C., Yang, CHJ, Chang, G.C., Hsia, T.C., Yang, C.T., Tharavichitkul, E., Pongthai, P., Arpornwirat, W., Geater, S., Srimuninnimit, V., Sriuranpong, V., Demirkazik, A., Goker, E., Harputluoglu, H., Cicin, I., Kose, F., Erman, M., Bondarenko, I., Vinnyk, Y., Shparyk, Y., Golovko, Y., Lal, R., Forster, M., Califano, R., Skailes, G., Thompson, J., Mekhail, T., Polikoff, J., Spigel, D., Waqar, S., Hermann, R., Deo, E., Simon, G., Rybkin, I., Kaywin, P.R., Uyeki, J., Gubens, M., Limaye, S., Gerber, D.E., Leal, T., Spira, A.I., Bazhenova, L., Cetnar, J., Socinski, M., Jahanzeb, M., Kabbinavar, F., Lawler, W.E., Hancock, M.R., Raez, L.E., DiCarlo, B.A., Lowe, T.E., Fidler, M., Ross, H., Davidson, S.J., Sanchez, J.D., Hamm, J., Kerr, S., Belman, N., Baker, S., Naraev, B., Jung, G., Edelman, M., Feldman, L., Belani, C., and Pakkala, S.

Subjects
Adult, Male, 0301 basic medicine, Oncology, Alectinib, medicine.medical_specialty, Pathology, Lung Neoplasms, Brigatinib, Pyridines, medicine.drug_class, Carbazoles, Antineoplastic Agents, Kaplan-Meier Estimate, Aged, 80 and over, Animals, Antineoplastic Agents/adverse effects, Antineoplastic Agents/therapeutic use, Carbazoles/adverse effects, Carbazoles/therapeutic use, Carcinoma, Non-Small-Cell Lung/drug therapy, Carcinoma, Non-Small-Cell Lung/mortality, Central Nervous System Neoplasms/drug therapy, Central Nervous System Neoplasms/secondary, Disease-Free Survival, Female, Follow-Up Studies, Humans, Intention to Treat Analysis, Lung Neoplasms/drug therapy, Lung Neoplasms/mortality, Middle Aged, Piperidines/adverse effects, Piperidines/therapeutic use, Protein Kinase Inhibitors/adverse effects, Protein Kinase Inhibitors/therapeutic use, Pyrazoles/adverse effects, Pyrazoles/therapeutic use, Pyridines/adverse effects, Pyridines/therapeutic use, Receptor Protein-Tyrosine Kinases/analysis, Receptor Protein-Tyrosine Kinases/antagonists & inhibitors, Young Adult, Central Nervous System Neoplasms, 03 medical and health sciences, 0302 clinical medicine, Piperidines, Carcinoma, Non-Small-Cell Lung, hemic and lymphatic diseases, Internal medicine, medicine, Anaplastic lymphoma kinase, Lung cancer, Protein Kinase Inhibitors, Crizotinib, Ceritinib, business.industry, Receptor Protein-Tyrosine Kinases, General Medicine, medicine.disease, Lorlatinib, ALK inhibitor, 030104 developmental biology, 030220 oncology & carcinogenesis, Pyrazoles, business, medicine.drug
Abstract

Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. In a randomized, open-label, phase 3 trial, we randomly assigned 303 patients with previously untreated, advanced ALK-positive NSCLC to receive either alectinib (600 mg twice daily) or crizotinib (250 mg twice daily). The primary end point was investigator-assessed progression-free survival. Secondary end points were independent review committee-assessed progression-free survival, time to CNS progression, objective response rate, and overall survival. During a median follow-up of 17.6 months (crizotinib) and 18.6 months (alectinib), an event of disease progression or death occurred in 62 of 152 patients (41%) in the alectinib group and 102 of 151 patients (68%) in the crizotinib group. The rate of investigator-assessed progression-free survival was significantly higher with alectinib than with crizotinib (12-month event-free survival rate, 68.4% [95% confidence interval (CI), 61.0 to 75.9] with alectinib vs. 48.7% [95% CI, 40.4 to 56.9] with crizotinib; hazard ratio for disease progression or death, 0.47 [95% CI, 0.34 to 0.65]; P

Published
2017
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4. Professional burnout in European young oncologists: results of the European Society for Medical Oncology (ESMO) Young Oncologists Committee Burnout Survey

Author

Giannis Mountzios, L. De Mattos-Arruda, Valentina Guarneri, Javier Corral, Raffaele Califano, M N M Volkov, Maya Biserova Petrova, Camilla Qvortrup, Sophie Postel-Vinay, Margaret Hutka, Josep Tabernero, Mehmet Akif Ozturk, David Olmos, Erika Martinelli, Matthias Preusser, Karin Jordan, M. Strijbos, Sutanuka Banerjee, E. de Azambuja, Banerjee, S., Califano, R., Corral, J., de Azambuja, E., De Mattos-Arruda, L., Guarneri, V., Hutka, M., Jordan, K., Martinelli, E., Mountzios, G., Ozturk, M. A., Petrova, M., Postel-Vinay, S., Preusser, M., Qvortrup, C., Volkov, M. N. M., Tabernero, J., Olmos, D., and Strijbos, M. H.

Subjects
Male, Health Knowledge, Attitudes, Practice, health care facilities, manpower, and services, Emotions, Sex Factor, Burnout, work-life balance, Occupational safety and health, 0302 clinical medicine, Risk Factors, Health care, Depersonalization, Age Factor, 030212 general & internal medicine, Emotional exhaustion, Multivariate Analysi, Burnout, Professional, Oncologists, Practice, burnout, Health Knowledge, Work–life balance, Age Factors, Hematology, Health Survey, Europe, Oncology, Burnout, Professional/diagnosis, 030220 oncology & carcinogenesis, Linear Model, Female, Job satisfaction, medicine.symptom, psychological phenomena and processes, Human, Adult, medicine.medical_specialty, Logistic Model, Attitude of Health Personnel, young oncologist, education, European, young oncologists, Chi-Square Distribution, Health Surveys, Humans, Job Satisfaction, Linear Models, Logistic Models, Multivariate Analysis, Patient Acceptance of Health Care, Quality of Life, Sex Factors, Work-Life Balance, Occupational Health, Oncologists/psychology, Europe/epidemiology, 03 medical and health sciences, Quality of life (healthcare), health services administration, Professional, Journal Article, medicine, Emotion, business.industry, Risk Factor, Attitudes, Family medicine, business
Abstract

Background: Burnout in health care professionals could have serious negative consequences on quality of patient care, professional satisfaction and personal life. Our aim was to investigate the burnout prevalence, work and lifestyle factors potentially affecting burnout amongst European oncologists ≤40 (YOs).Methods: A survey was conducted using the validated Maslach Burnout Inventory (MBI) and additional questions exploring work/lifestyle factors. Statistical analyses were carried out to identify factors associated with burnout.Results: Total of 737 surveys (all ages) were collected from 41 European countries. Countries were divided into six regions. Results from 595 (81%) YOs were included (81% medical oncologists; 52% trainees, 62% women). Seventy-one percent of YOs showed evidence of burnout (burnout subdomains: depersonalization 50%; emotional exhaustion 45; low accomplishment 35%). Twenty-two percent requested support for burnout during training and 74% reported no hospital access to support services. Burnout rates were significantly different across Europe (P Conclusions: This is the largest burnout survey in European Young Oncologists. Burnout is common amongst YOs and rates vary across Europe. Achieving a good work/life balance, access to support services and adequate vacation time may reduce burnout levels. Raising awareness, support and interventional research are needed.

Published
2017
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5. CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

Author

Ang Li, Renata Duchnowska, Konstantin Laktionov, Enriqueta Felip, Dolores Isla, Jacek Jassem, Juergen Wolf, Jan P. van Meerbeeck, Mária Szilasi, W. Appel, Andrea Ardizzoni, Miriam Alonso Garcia, Janusz Milanowski, Enric Carcereny, Richard Griffiths, Luis Paz-Ares, Raffaele Califano, Manuel Cobo, Tudor Ciuleanu, Angelic Acevedo, Sanjay Popat, Institut Català de la Salut, [Felip E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Ardizzoni A] Division of Medical Oncology, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, 40138, Italy. [Ciuleanu T] The Oncology Institute Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, RO-400015, Romania. [Cobo M] Hospital Regional Universitario de Málaga and IBIMA, Malaga, 29010, Spain. [Laktionov K] N.N. Blokhin Russian Cancer Research Center, Moscow, 115478, Russia. [Szilasi M] University of Debrecen, Department for Pulmonology, Debrecen, H-4032, Hungary, Vall d'Hebron Barcelona Hospital Campus, Felip E., Ardizzoni A., Ciuleanu T., Cobo M., Laktionov K., Szilasi M., Califano R., Carcereny E., Griffiths R., Paz-Ares L., Duchnowska R., Garcia M.A., Isla D., Jassem J., Appel W., Milanowski J., Van Meerbeeck J.P., Wolf J., Li A., Acevedo A., and Popat S.

Subjects
0301 basic medicine, Oncology, Male, Cancer Research, Lung Neoplasms, medicine.medical_treatment, Comorbidity, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Persones grans, Carboplatin, 0302 clinical medicine, Elderly, Non-small cell lung cancer, Retrospective Studie, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Aged, 80 and over, education.field_of_study, Incidence (epidemiology), Respiratory Tract Diseases::Lung Diseases::Lung Neoplasms::Carcinoma, Bronchogenic::Respiratory Tract Diseases::Carcinoma, Non-Small-Cell Lung [DISEASES], Middle Aged, Prognosis, enfermedades respiratorias::enfermedades pulmonares::neoplasias pulmonares::carcinoma broncogénico::enfermedades respiratorias::carcinoma de pulmón de células no pequeñas [ENFERMEDADES], Health status indicators, Survival Rate, Nivolumab, Tolerability, 030220 oncology & carcinogenesis, Persons::Age Groups::Adult::Aged [NAMED GROUPS], Carcinoma, Squamous Cell, Female, Human, Adult, medicine.medical_specialty, Prognosi, Population, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Health status indicator, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Humans, Pulmons - Càncer - Quimioteràpia, education, Adverse effect, personas::Grupos de Edad::adulto::anciano [DENOMINACIONES DE GRUPOS], Pneumonitis, Aged, Retrospective Studies, Chemotherapy, Antineoplastic Combined Chemotherapy Protocol, business.industry, medicine.disease, Lung Neoplasm, Clinical trial, 030104 developmental biology, Human medicine, business, Follow-Up Studies
Abstract

Gent gran; Nivolumab; Càncer de pulmó de cèl·lules no petites Anciano; Nivolumab; Cáncer de pulmón de células no pequeñas Elderly; Nivolumab; Non-small cell lung cancer Background CheckMate 171 (NCT02409368) is an open-label, multicentre, phase 2 trial of nivolumab in previously treated advanced squamous non-small cell lung cancer (NSCLC), conducted as part of a post-approval commitment to the European Medicines Agency (EMA). We report outcomes from this trial. Methods Patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0–2 and disease progression during/after ≥1 systemic treatment (≥1 being platinum-based chemotherapy) for advanced or metastatic disease were treated with nivolumab 3 mg/kg every 2 weeks until progression or unacceptable toxicity. The primary end-point was incidence of grade 3–4 treatment-related select adverse events (AEs). Other end-points included overall survival (OS) and safety. Results Of 811 patients treated, 103 had ECOG PS 2; 278 were aged ≥70 years and 125 were ≥75 years of age. Minimum follow-up was ~18 months. Safety was similar across populations; the most frequent grade 3–4 treatment-related select AEs in all treated patients were diarrhoea (1%), increased alanine aminotransferase (ALT, 1%), pneumonitis (0.7%), colitis (0.6%) and increased aspartate aminotransferase (AST, 0.5%). Median OS was similar in all treated patients and those aged ≥70 and ≥75: 10.0 months, 10.0 months and 11.2 months, respectively. Median OS was 5.2 months in patients with ECOG PS 2. Conclusion These results suggest that nivolumab is well tolerated and active in patients with advanced, relapsed squamous NSCLC, including the elderly, with OS outcomes consistent with phase 3 data. In patients with ECOG PS 2, nivolumab had similar tolerability, but outcomes were worse, as expected in this difficult-to-treat, poor prognosis population. Funded by Bristol-Myers Squibb.

Published
2019

6. Allele-Specific HLA Loss and Immune Escape in Lung Cancer Evolution

Author

Nicholas McGranahan, Rachel Rosenthal, Crispin T. Hiley, Andrew J. Rowan, Thomas B.K. Watkins, Gareth A. Wilson, Nicolai J. Birkbak, Selvaraju Veeriah, Peter Van Loo, Javier Herrero, Charles Swanton, Mariam Jamal-Hanjani, Seema Shafi, Justyna Czyzewska-Khan, Diana Johnson, Joanne Laycock, Leticia Bosshard-Carter, Pat Gorman, Robert E. Hynds, Gareth Wilson, Stuart Horswell, Richard Mitter, Mickael Escudero, Aengus Stewart, Andrew Rowan, Hang Xu, Samra Turajlic, Crispin Hiley, Christopher Abbosh, Jacki Goldman, Richard Kevin Stone, Tamara Denner, Nik Matthews, Greg Elgar, Sophia Ward, Marta Costa, Sharmin Begum, Ben Phillimore, Tim Chambers, Emma Nye, Sofia Graca, Maise Al Bakir, Kroopa Joshi, Andrew Furness, Assma Ben Aissa, Yien Ning Sophia Wong, Andy Georgiou, Sergio Quezada, John A. Hartley, Helen L. Lowe, David Lawrence, Martin Hayward, Nikolaos Panagiotopoulos, Shyam Kolvekar, Mary Falzon, Elaine Borg, Teresa Marafioti, Celia Simeon, Gemma Hector, Amy Smith, Marie Aranda, Marco Novelli, Dahmane Oukrif, Sam M. Janes, Ricky Thakrar, Martin Forster, Tanya Ahmad, Siow Ming Lee, Dionysis Papadatos-Pastos, Dawn Carnell, Ruheena Mendes, Jeremy George, Neal Navani, Asia Ahmed, Magali Taylor, Junaid Choudhary, Yvonne Summers, Raffaele Califano, Paul Taylor, Rajesh Shah, Piotr Krysiak, Kendadai Rammohan, Eustace Fontaine, Richard Booton, Matthew Evison, Phil Crosbie, Stuart Moss, Faiza Idries, Leena Joseph, Paul Bishop, Anshuman Chaturved, Anne Marie Quinn, Helen Doran, Angela Leek, Phil Harrison, Katrina Moore, Rachael Waddington, Juliette Novasio, Fiona Blackhall, Jane Rogan, Elaine Smith, Caroline Dive, Jonathan Tugwood, Ged Brady, Dominic G. Rothwell, Francesca Chemi, Jackie Pierce, Sakshi Gulati, Babu Naidu, Gerald Langman, Simon Trotter, Mary Bellamy, Hollie Bancroft, Amy Kerr, Salma Kadiri, Joanne Webb, Gary Middleton, Madava Djearaman, Dean Fennell, Jacqui A. Shaw, John Le Quesne, David Moore, Apostolos Nakas, Sridhar Rathinam, William Monteiro, Hilary Marshall, Louise Nelson, Jonathan Bennett, Joan Riley, Lindsay Primrose, Luke Martinson, Girija Anand, Sajid Khan, Anita Amadi, Marianne Nicolson, Keith Kerr, Shirley Palmer, Hardy Remmen, Joy Miller, Keith Buchan, Mahendran Chetty, Lesley Gomersall, Jason Lester, Alison Edwards, Fiona Morgan, Haydn Adams, Helen Davies, Malgorzata Kornaszewska, Richard Attanoos, Sara Lock, Azmina Verjee, Mairead MacKenzie, Maggie Wilcox, Harriet Bell, Allan Hackshaw, Yenting Ngai, Sean Smith, Nicole Gower, Christian Ottensmeier, Serena Chee, Benjamin Johnson, Aiman Alzetani, Emily Shaw, Eric Lim, Paulo De Sousa, Monica Tavares Barbosa, Alex Bowman, Simon Jordan, Alexandra Rice, Hilgardt Raubenheimer, Chiara Proli, Maria Elena Cufari, John Carlo Ronquillo, Angela Kwayie, Harshil Bhayani, Morag Hamilton, Yusura Bakar, Natalie Mensah, Lyn Ambrose, Anand Devaraj, Silviu Buderi, Jonathan Finch, Leire Azcarate, Hema Chavan, Sophie Green, Hillaria Mashinga, Andrew G. Nicholson, Kelvin Lau, Michael Sheaff, Peter Schmid, John Conibear, Veni Ezhil, Babikir Ismail, Melanie Irvin-sellers, Vineet Prakash, Peter Russell, Teresa Light, Tracey Horey, Sarah Danson, Jonathan Bury, John Edwards, Jennifer Hill, Sue Matthews, Yota Kitsanta, Kim Suvarna, Patricia Fisher, Allah Dino Keerio, Michael Shackcloth, John Gosney, Pieter Postmus, Sarah Feeney, Julius Asante-Siaw, Hugo J.W.L. Aerts, Stefan Dentro, Christophe Dessimoz, TRACERx Consortium, Swanton, C., Jamal-Hanjani, M., Veeriah, S., Shafi, S., Czyzewska-Khan, J., Johnson, D., Laycock, J., Bosshard-Carter, L., Rosenthal, R., Gorman, P., Hynds, R.E., Wilson, G., Birkbak, N.J., Watkins, TBK, McGranahan, N., Horswell, S., Mitter, R., Escudero, M., Stewart, A., Van Loo, P., Rowan, A., Xu, H., Turajlic, S., Hiley, C., Abbosh, C., Goldman, J., Stone, R.K., Denner, T., Matthews, N., Elgar, G., Ward, S., Costa, M., Begum, S., Phillimore, B., Chambers, T., Nye, E., Graca, S., Al Bakir, M., Joshi, K., Furness, A., Ben Aissa, A., Wong, YNS, Georgiou, A., Quezada, S., Hartley, J.A., Lowe, H.L., Herrero, J., Lawrence, D., Hayward, M., Panagiotopoulos, N., Kolvekar, S., Falzon, M., Borg, E., Marafioti, T., Simeon, C., Hector, G., Smith, A., Aranda, M., Novelli, M., Oukrif, D., Janes, S.M., Thakrar, R., Forster, M., Ahmad, T., Lee, S.M., Papadatos-Pastos, D., Carnell, D., Mendes, R., George, J., Navani, N., Ahmed, A., Taylor, M., Choudhary, J., Summers, Y., Califano, R., Taylor, P., Shah, R., Krysiak, P., Rammohan, K., Fontaine, E., Booton, R., Evison, M., Crosbie, P., Moss, S., Idries, F., Joseph, L., Bishop, P., Chaturved, A., Quinn, A.M., Doran, H., Leek, A., Harrison, P., Moore, K., Waddington, R., Novasio, J., Blackhall, F., Rogan, J., Smith, E., Dive, C., Tugwood, J., Brady, G., Rothwell, D.G., Chemi, F., Pierce, J., Gulati, S., Naidu, B., Langman, G., Trotter, S., Bellamy, M., Bancroft, H., Kerr, A., Kadiri, S., Webb, J., Middleton, G., Djearaman, M., Fennell, D., Shaw, J.A., Le Quesne, J., Moore, D., Nakas, A., Rathinam, S., Monteiro, W., Marshall, H., Nelson, L., Bennett, J., Riley, J., Primrose, L., Martinson, L., Anand, G., Khan, S., Amadi, A., Nicolson, M., Kerr, K., Palmer, S., Remmen, H., Miller, J., Buchan, K., Chetty, M., Gomersall, L., Lester, J., Edwards, A., Morgan, F., Adams, H., Davies, H., Kornaszewska, M., Attanoos, R., Lock, S., Verjee, A., MacKenzie, M., Wilcox, M., Bell, H., Hackshaw, A., Ngai, Y., Smith, S., Gower, N., Ottensmeier, C., Chee, S., Johnson, B., Alzetani, A., Shaw, E., Lim, E., De Sousa, P., Barbosa, M.T., Bowman, A., Jordan, S., Rice, A., Raubenheimer, H., Proli, C., Cufari, M.E., Ronquillo, J.C., Kwayie, A., Bhayani, H., Hamilton, M., Bakar, Y., Mensah, N., Ambrose, L., Devaraj, A., Buderi, S., Finch, J., Azcarate, L., Chavan, H., Green, S., Mashinga, H., Nicholson, A.G., Lau, K., Sheaff, M., Schmid, P., Conibear, J., Ezhil, V., Ismail, B., Irvin-Sellers, M., Prakash, V., Russell, P., Light, T., Horey, T., Danson, S., Bury, J., Edwards, J., Hill, J., Matthews, S., Kitsanta, Y., Suvarna, K., Fisher, P., Keerio, A.D., Shackcloth, M., Gosney, J., Postmus, P., Feeney, S., Asante-Siaw, J., Aerts, HJWL, Dentro, S., and Dessimoz, C.

Subjects
Male, immune-editing, 0301 basic medicine, DOWN-REGULATION, immune-escape, Lung Neoplasms, Loss of Heterozygosity, Cohort Studies, Loss of heterozygosity, HLA Antigens, Carcinoma, Non-Small-Cell Lung, Chromosome instability, MUTATIONAL PROCESSES, 11 Medical and Health Sciences, Aged, 80 and over, Antigen Presentation, cancer evolution, Manchester Cancer Research Centre, bioinformatics, Middle Aged, 3. Good health, Female, loss of heterozygosity, SENSITIVITY, Life Sciences & Biomedicine, Adult, Biochemistry & Molecular Biology, chromosomal instability, Antigen presentation, Locus (genetics), NEOANTIGENS, Human leukocyte antigen, Biology, Polymorphism, Single Nucleotide, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, Immune system, copy number, medicine, Humans, Lung cancer, Aged, Science & Technology, ResearchInstitutes_Networks_Beacons/mcrc, CTLA-4 BLOCKADE, Cell Biology, 06 Biological Sciences, medicine.disease, PD-1 BLOCKADE, neoantigen, lung cancer, 030104 developmental biology, Carcinoma, Non-Small-Cell Lung/genetics, Carcinoma, Non-Small-Cell Lung/immunology, Carcinoma, Non-Small-Cell Lung/pathology, Carcinoma, Non-Small-Cell Lung/therapy, HLA Antigens/genetics, HLA Antigens/immunology, Lung Neoplasms/genetics, Lung Neoplasms/immunology, Lung Neoplasms/pathology, Lung Neoplasms/therapy, Mutation, Tumor Escape, heterogeneity, TRACERx Consortium, DISCOVERY, CELLS, Immunology, RESISTANCE, Developmental Biology
Abstract

Immune evasion is a hallmark of cancer. Losing the ability to present neoantigens through human leukocyte antigen (HLA) loss may facilitate immune evasion. However, the polymorphic nature of the locus has precluded accurate HLA copy-number analysis. Here, we present loss of heterozygosity in human leukocyte antigen (LOHHLA), a computational tool to determine HLA allele-specific copy number from sequencing data. Using LOHHLA, we find that HLA LOH occurs in 40% of non-small-cell lung cancers (NSCLCs) and is associated with a high subclonal neoantigen burden, APOBEC-mediated mutagenesis, upregulation of cytolytic activity, and PD-L1 positivity. The focal nature of HLA LOH alterations, their subclonal frequencies, enrichment in metastatic sites, and occurrence as parallel events suggests that HLA LOH is an immune escape mechanism that is subject to strong microenvironmental selection pressures later in tumor evolution. Characterizing HLA LOH with LOHHLA refines neoantigen prediction and may have implications for our understanding of resistance mechanisms and immunotherapeutic approaches targeting neoantigens. VIDEO ABSTRACT.

Published
2017
Full Text
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7. Type III or allosteric kinase inhibitors for the treatment of non-small cell lung cancer

Author

Carminia Maria Della Corte, Annalisa Capuano, Fortunato Ciardiello, Morena Fasano, Floriana Morgillo, Raffaele Califano, Erika Martinelli, Teresa Troiani, Fasano, M, DELLA CORTE, Carminia Maria, Califano, R, Capuano, Annalisa, Troiani, Teresa, Martinelli, Erika, Ciardiello, Fortunato, and Morgillo, Floriana

Subjects
Lung Neoplasms, Drug Evaluation, Preclinical, Biology, MAP2K7, Adenosine Triphosphate, Allosteric Regulation, Double-Blind Method, TANK-binding kinase 1, Carcinoma, Non-Small-Cell Lung, Animals, Humans, Pharmacology (medical), Prospective Studies, c-Raf, Kinase activity, Protein Kinase Inhibitors, Randomized Controlled Trials as Topic, Pharmacology, Clinical Trials as Topic, Cyclin-dependent kinase 4, Cyclin-dependent kinase 2, General Medicine, Biochemistry, biology.protein, Cyclin-dependent kinase 9, Janus kinase
Abstract

In recent times, there has been much interest in the development of pharmacological kinase inhibitors that treat NSCLC. Furthermore, treatment options have been guided by the development of a wide panel of synthetic small molecule kinase inhibitors. Most of the molecules developed belong to the type I class of inhibitors that target the ATP-binding site in its active conformation. The high sequence similarity in the ATP-binding site among members of the kinase families often results in low selectivity and additional toxicities. Also, second mutations in the ATP-binding site, such as threonine to methionine at position 790, have been described as a mechanism of resistance to ATP-competitive kinase inhibitors. For these reasons, alternative drug development approaches targeting sites other than the ATP cleft are being pursued. The class III or allosteric inhibitors, which bind outside the ATP-binding site, have been shown to negatively modulate kinase activity.In this review, the authors discuss the most well-characterised allosteric inhibitors that have reached clinical development in NSCLC.Great progress has made in developing inhibitors with entirely new modes of action. That being said, it is important to highlight that despite their apparent simplicity, biochemical assays will remain at the core of drug discovery activities to better explore these new opportunities.

Published
2014
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8. Immune Checkpoint Blockade: A New Era for Non-Small Cell Lung Cancer

Author

Antonio Rossi, Giuseppe Lo Russo, Floriana Morgillo, Keith M. Kerr, Robert D. Morgan, Raffaele Califano, Marina Chiara Garassino, Califano, R., Kerr, K., Morgan, R. D., Russo, G. L., Garassino, M., Morgillo, F., and Rossi, A.

Subjects
0301 basic medicine, PD-L1, Prognosi, medicine.medical_treatment, Pembrolizumab, Bioinformatics, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, 0302 clinical medicine, Immune system, Atezolizumab, CTLA-4, Durvalumab, immune checkpoint, Nivolumab, non-small cell lung cancer, PD-1, antibodies, monoclonal, antibodies monoclonal, humanized, carcinoma, non-small-cell lung, cell cycle checkpoints, humans, prognosis, immunotherapy, oncology, Non-small cell lung cancer, Cell Cycle Checkpoint, Carcinoma, Non-Small-Cell Lung, medicine, Humans, Lung cancer, business.industry, Antibodies, Monoclonal, Immunotherapy, Cell Cycle Checkpoints, medicine.disease, Prognosis, Immune checkpoint, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, business, Human
Abstract

Despite better understanding of it's molecular biology, non-small cell lung cancer (NSCLC) remains a challenging disease to treat. Unfortunately, treatment options are still very limited and prognosis for advanced disease is poor. Immune surveillance plays a crucial role in a host's defence against tumour cells, and this is particular relevant for lung cancer due to it's high somatic mutational load, which increases the chances for the immune system to recognize cancer cells as 'non-self'. Novel immunotherapies are emerging as an effective treatment for this disease. In this review, we present the data on immune checkpoint inhibitors for NSCLC, describing their mechanism of action, data efficacy from recent clinical trials, and strategies to select patients more likely to benefit from these agents.

Published
2016

9. Therapies in the pipeline for small-cell lung cancer

Author

Ourania, Romanidou, Martina, Imbimbo, Giannis, Mountzios, Aidalena, Abidin, Floriana, Morgillo, Raffaele, Califano, Romanidou, O., Imbimbo, M., Mountzios, G., Abidin, A., Morgillo, F., and Califano, R.

Subjects
Lung Neoplasms, rechallenge, Platinum Compounds, Platinum Compound, chemotherapy, Brain Neoplasm, Antineoplastic Combined Chemotherapy Protocols, targeted therapie, small-cell lung cancer, Humans, Neoplasm Staging, Organ Sparing Treatment, Antineoplastic Combined Chemotherapy Protocol, liquid biopsy, Brain Neoplasms, Chemoradiotherapy, Survival Analysis, Combined Modality Therapy, Small Cell Lung Carcinoma, United Kingdom, Lung Neoplasm, Treatment Outcome, Survival Analysi, Cisplatin, Cranial Irradiation, Neoplasm Recurrence, Local, Organ Sparing Treatments, thoracic radiotherapy, Human
Abstract

Introduction or background Small-cell lung cancer (SCLC) represents ~15% of all cases of lung cancer and is characterized by a rapid tumour doubling time, early onset disease dissemination and high sensitivity to chemotherapy. Sources of data We searched MEDLINE and OVID databases for articles in English published from January 1980 to February 2015. Areas of agreement Platinum-based chemotherapy, thoracic radiotherapy and prophylactic cranial irradiation are standard of care. Benefit from second-line chemotherapy is limited. Areas of controversy The role of platinum/irinotecan chemotherapy in the Western population and the role of maintenance therapies remain to be established. Growing points Knowledge of the biology of SCLC has expanded exponentially and many potential therapeutic targets have been identified. Areas timely for developing research The use of circulating tumour cells can help investigating molecular alterations occurring within tumour cells, understanding drug resistance mechanisms and evaluating new treatments.

Published
2016

10. Use of adjuvant chemotherapy (CT) and radiotherapy (RT) in incompletely resected (R1) early stage Non-Small Cell Lung Cancer (NSCLC): A European survey conducted by the European Society for Medical Oncology (ESMO) Young Oncologists Committee

Author

Jesus Corral, Margaret Hutka, Karin Jordan, Konstantinos Kamposioras, Susana Banerjee, Matthias Preusser, Michalis V. Karamouzis, E. de Azambuja, Raffaele Califano, S. Postel-Vinay, Erika Martinelli, Valter Torri, Valentina Guarneri, Luca Porcu, Califano, R., Karamouzis, M. V., Banerjee, S., de Azambuja, E., Guarneri, V., Hutka, M., Jordan, K., Kamposioras, K., Martinelli, E., Corral, J., Postel-Vinay, S., Preusser, M., Porcu, L., and Torri, V.

Subjects
Pulmonary and Respiratory Medicine, Oncology, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Decision Making, Specialty, non-small cell lung cancer (NSCLC), Vinorelbine, Medical Oncology, Surveys and Questionnaires, Internal medicine, Carcinoma, Non-Small-Cell Lung, Physicians, medicine, Humans, Surveys and Questionnaire, Stage (cooking), Practice Patterns, Physicians', Lung cancer, Survey, Univariate analysis, business.industry, medicine.disease, R1, Gemcitabine, Adjuvant chemotherapy, Non-Small Cell Lung Cancer, Radiation therapy, Europe, Lung Neoplasm, Incomplete resection, Chemotherapy, Adjuvant, Practice Guidelines as Topic, Female, Radiotherapy, Adjuvant, Adjuvant radiotherapy, business, medicine.drug, Human
Abstract

Background: Early stage Non-Small Cell Lung Cancer (NSCLC) is potentially curable with surgery. ESMO guidelines recommend cisplatin-based adjuvant chemotherapy (CT) for completely resected stage II-III NSCLC. There is limited evidence for the use of adjuvant CT and/or radiotherapy (RT) in incompletely resected (R1) early stage NSCLC. Materials and methods: A European survey of thoracic oncologists was conducted to evaluate use of adjuvant CT and RT for R1-resected NSCLC and to identify factors influencing treatment decisions. Demographics and information on clinical stage, regimens, cycles planned, radiotherapy sites, multidisciplinary management and discussion about inconclusive evidence with the patient were collected. Univariate and multivariate analyses were performed. Results: 768 surveys were collected from 41 European countries. 82.9% of participants were medical oncologists; 49.3% ESMO members; 37.1% based in University Hospitals; 32.6% practicing oncology for over 15 years and 81.4% active in research. 91.4% of participants prescribed adjuvant CT and mostly cisplatin/vinorelbine (81.2%) or cisplatin/gemcitabine (42.9%). 85% discussed limited clinical evidence with the patient. In the univariate analysis, a statistically significant association with CT prescription was found for medical oncology specialty (p

Published
2014

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