Daniele Santini1, Tea Zeppola1, Marco Russano1, Fabrizio Citarella1, Cecilia Anesi1, Sebastiano Buti2, Marco Tucci3,4, Alessandro Russo5, Maria Chiara Sergi3, Vincenzo Adamo5, Luigia S Stucci3, Melissa Bersanelli2,6, Giulia Mazzaschi2, Francesco Spagnolo7, Francesca Rastelli8, Francesca Chiara Giorgi8, Raffaele Giusti9, Marco Filetti9, Paolo Marchetti9,10,11, Andrea Botticelli10,11, Alain Gelibter11, Marco Siringo11, Marco Ferrari12, Riccardo Marconcini12, Maria Giuseppa Vitale13, Linda Nicolardi14, Rita Chiari14, Michele Ghidini15, Olga Nigro16, Francesco Grossi17, Michele De Tursi18, Pietro Di Marino19, Laura Pala20, Paola Queirolo20, Sergio Bracarda21, Serena Macrini21, Stefania Gori22, Alessandro Inno22, Federica Zoratto23, Enrica T Tanda7,24, Domenico Mallardo25, Maria Grazia Vitale25, Thomas Talbot26, Paolo A Ascierto25, David J Pinato26,27, Corrado Ficorella28,29, Giampiero Porzio28, Alessio Cortellini30,31. 1. Medical Oncology, Campus Bio-Medico University, Rome, Italy. 2. Medical Oncology Unit, University Hospital of Parma, Parma, Italy. 3. Medical Oncology Unit, Department of Biomedical Sciences and Human Oncology, University of Bari, Bari, Italy. 4. National Cancer Research Center, Tumori Institute IRCCS Giovanni PaoloII, Bari, Italy. 5. Medical Oncology, A.O. Papardo & Department of Human Pathology, University of Messina, Messina, Italy. 6. Department of Medicine and Surgery, University of Parma, Parma, Italy. 7. IRCCS Ospedale Policlinico San Martino, Genova, Italy. 8. UOC Oncologia Ascoli Piceno - San Benedetto del Tronto, Area Vasta 5, ASUR Marche, Ancona, Italy. 9. Medical Oncology Unit, Sant' Andrea Hospital of Rome, Rome, Italy. 10. Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy. 11. Medical Oncology (B), Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy. 12. Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 13. Medical Oncology, University Hospital of Modena, Modena, Italy. 14. UOC Oncologia Padova Sud - AULSS6 Euganea, Padova, Italy. 15. Medical Oncology Unit, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan, Italy. 16. Medical Oncology, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi, Varese, Italy. 17. Division of Medical Oncology, University of Insubria, Varese, Italy. 18. Department of Medical, Oral & Biotechnological Sciences, University G. D'Annunzio, Chieti-Pescara, Italy. 19. Clinical Oncology Unit, S.S. Annunziata Hospital, Chieti, Italy. 20. Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, Milan, Italy. 21. S.C. Medical Oncology, Azienda Ospedaliera S. Maria, Terni, Italy. 22. Oncology Unit, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, VR, Italy. 23. Medical Oncology, Santa Maria Goretti Hospital, Latina, Italy. 24. Genetics of Rare Cancers, Department of Internal Medicine and Medical Specialties, University of Genoa, Genoa, Italy. 25. Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori-IRCCS Fondazione "G. Pascale", Naples, Italy. 26. Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Hammersmith Hospital, Du Cane Road, London, W12 0HS, UK. 27. Division of Oncology, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy. 28. Medical Oncology Unit, St. Salvatore Hospital, L'Aquila, Italy. 29. Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy. 30. Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Hammersmith Hospital, Du Cane Road, London, W12 0HS, UK. a.cortellini@imperial.ac.uk. 31. Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy. a.cortellini@imperial.ac.uk.
Abstract
BACKGROUND: The favourable safety profile and the increasing confidence with immune checkpoint inhibitors (ICIs) might have boosted their prescription in frail patients with short life expectancies, who usually are not treated with standard chemotherapy. METHODS: The present analysis aims to describe clinicians' attitudes towards ICIs administration during late stages of life within a multicenter cohort of advanced cancer patients treated with single agent PD-1/PD-L1 checkpoint inhibitors in Italy. RESULTS: Overall, 1149 patients with advanced cancer who received single agent PD-1/PD-L1 checkpoint inhibitors were screened. The final study population consisted of 567 deceased patients. 166 patients (29.3%) had received ICIs within 30 days of death; among them there was a significantly higher proportion of patients with ECOG-PS ≥ 2 (28.3% vs 11.5%, p < 0.0001) and with a higher burden of disease (69.3% vs 59.4%, p = 0.0266). In total, 35 patients (6.2%) started ICIs within 30 days of death; among them there was a higher proportion of patients with ECOG-PS ≥ 2 (45.7% vs 14.5%, p < 0.0001) and with a higher burden of disease (82.9% vs 60.9%, p = 0.0266). Primary tumors were significantly different across subgroups (p = 0.0172), with a higher prevalence of NSCLC patients (80% vs 60.9%) among those who started ICIs within 30 days of death. Lastly, 123 patients (21.7%) started ICIs within 3 months of death. Similarly, within this subgroup there was a higher proportion of patients with ECOG-PS ≥ 2 (29.3% vs 12.8%, p < 0.0001), with a higher burden of disease (74.0% vs 59.0%, p = 0.0025) and with NSCLC (74.0% vs 58.8%, p = 0.0236). CONCLUSION: Our results confirmed a trend toward an increasing ICIs prescription in frail patients, during the late stages of life. Caution should be exercised when evaluating an ICI treatment for patients with a poor PS and a high burden of disease.
BACKGROUND: The favourable safety profile and the increasing confidence with immune checkpoint inhibitors (ICIs) might have boosted their prescription in frail patients with short life expectancies, who usually are not treated with standard chemotherapy. METHODS: The present analysis aims to describe clinicians' attitudes towards ICIs administration during late stages of life within a multicenter cohort of advanced cancerpatients treated with single agent PD-1/PD-L1 checkpoint inhibitors in Italy. RESULTS: Overall, 1149 patients with advanced cancer who received single agent PD-1/PD-L1 checkpoint inhibitors were screened. The final study population consisted of 567 deceased patients. 166 patients (29.3%) had received ICIs within 30 days of death; among them there was a significantly higher proportion of patients with ECOG-PS ≥ 2 (28.3% vs 11.5%, p < 0.0001) and with a higher burden of disease (69.3% vs 59.4%, p = 0.0266). In total, 35 patients (6.2%) started ICIs within 30 days of death; among them there was a higher proportion of patients with ECOG-PS ≥ 2 (45.7% vs 14.5%, p < 0.0001) and with a higher burden of disease (82.9% vs 60.9%, p = 0.0266). Primary tumors were significantly different across subgroups (p = 0.0172), with a higher prevalence of NSCLCpatients (80% vs 60.9%) among those who started ICIs within 30 days of death. Lastly, 123 patients (21.7%) started ICIs within 3 months of death. Similarly, within this subgroup there was a higher proportion of patients with ECOG-PS ≥ 2 (29.3% vs 12.8%, p < 0.0001), with a higher burden of disease (74.0% vs 59.0%, p = 0.0025) and with NSCLC (74.0% vs 58.8%, p = 0.0236). CONCLUSION: Our results confirmed a trend toward an increasing ICIs prescription in frail patients, during the late stages of life. Caution should be exercised when evaluating an ICI treatment for patients with a poor PS and a high burden of disease.
Entities:
Keywords:
Appropriateness; End-of-life; Immune checkpoint inhibitors; Immunotherapy; Palliative care
Authors: Sebastiano Buti; Melissa Bersanelli; Fabiana Perrone; Marcello Tiseo; Marco Tucci; Vincenzo Adamo; Luigia S Stucci; Alessandro Russo; Enrica T Tanda; Francesco Spagnolo; Francesca Rastelli; Federica Pergolesi; Daniele Santini; Marco Russano; Cecilia Anesi; Raffaele Giusti; Marco Filetti; Paolo Marchetti; Andrea Botticelli; Alain Gelibter; Mario Alberto Occhipinti; Marco Ferrari; Maria Giuseppa Vitale; Linda Nicolardi; Rita Chiari; Erika Rijavec; Olga Nigro; Alessandro Tuzi; Michele De Tursi; Pietro Di Marino; Fabio Conforti; Paola Queirolo; Sergio Bracarda; Serena Macrini; Stefania Gori; Federica Zoratto; Enzo Veltri; Barbara Di Cocco; Domenico Mallardo; Maria Grazia Vitale; Matteo Santoni; Leonardo Patruno; Giampiero Porzio; Corrado Ficorella; David J Pinato; Paolo A Ascierto; Alessio Cortellini Journal: Eur J Cancer Date: 2020-11-16 Impact factor: 9.162
Authors: Alessio Cortellini; Melissa Bersanelli; Sebastiano Buti; Katia Cannita; Daniele Santini; Fabiana Perrone; Raffaele Giusti; Marcello Tiseo; Maria Michiara; Pietro Di Marino; Nicola Tinari; Michele De Tursi; Federica Zoratto; Enzo Veltri; Riccardo Marconcini; Francesco Malorgio; Marco Russano; Cecilia Anesi; Tea Zeppola; Marco Filetti; Paolo Marchetti; Andrea Botticelli; Gian Carlo Antonini Cappellini; Federica De Galitiis; Maria Giuseppa Vitale; Francesca Rastelli; Federica Pergolesi; Rossana Berardi; Silvia Rinaldi; Marianna Tudini; Rosa Rita Silva; Annagrazia Pireddu; Francesco Atzori; Rita Chiari; Biagio Ricciuti; Andrea De Giglio; Daniela Iacono; Alain Gelibter; Mario Alberto Occhipinti; Alessandro Parisi; Giampiero Porzio; Maria Concetta Fargnoli; Paolo Antonio Ascierto; Corrado Ficorella; Clara Natoli Journal: J Immunother Cancer Date: 2019-02-27 Impact factor: 13.751
Authors: Alessio Cortellini; Maria G Vitale; Federica De Galitiis; Francesca R Di Pietro; Rossana Berardi; Mariangela Torniai; Michele De Tursi; Antonino Grassadonia; Pietro Di Marino; Daniele Santini; Tea Zeppola; Cecilia Anesi; Alain Gelibter; Mario Alberto Occhipinti; Andrea Botticelli; Paolo Marchetti; Francesca Rastelli; Federica Pergolesi; Marianna Tudini; Rosa Rita Silva; Domenico Mallardo; Vito Vanella; Corrado Ficorella; Giampiero Porzio; Paolo A Ascierto Journal: J Transl Med Date: 2019-11-15 Impact factor: 5.531
Authors: Alessio Cortellini; Marco Tucci; Vincenzo Adamo; Luigia Stefania Stucci; Alessandro Russo; Enrica Teresa Tanda; Francesco Spagnolo; Francesca Rastelli; Renato Bisonni; Daniele Santini; Marco Russano; Cecilia Anesi; Raffaele Giusti; Marco Filetti; Paolo Marchetti; Andrea Botticelli; Alain Gelibter; Mario Alberto Occhipinti; Riccardo Marconcini; Maria Giuseppa Vitale; Linda Nicolardi; Rita Chiari; Claudia Bareggi; Olga Nigro; Alessandro Tuzi; Michele De Tursi; Nicola Petragnani; Laura Pala; Sergio Bracarda; Serena Macrini; Alessandro Inno; Federica Zoratto; Enzo Veltri; Barbara Di Cocco; Domenico Mallardo; Maria Grazia Vitale; David James Pinato; Giampiero Porzio; Corrado Ficorella; Paolo Antonio Ascierto Journal: J Immunother Cancer Date: 2020-11 Impact factor: 13.751
Authors: Mellar P Davis; Erin A Vanenkevort; Alexander Elder; Amanda Young; Irina D Correa Ordonez; Mark J Wojtowicz; Halle Ellison; Carlos Fernandez; Zankhana Mehta; Bertrand Behm; Glen Digwood; Rajiv Panikkar Journal: Support Care Cancer Date: 2022-03-15 Impact factor: 3.603
Authors: Vera S Donnenberg; Patrick L Wagner; James D Luketich; David L Bartlett; Albert D Donnenberg Journal: Front Immunol Date: 2022-02-11 Impact factor: 7.561