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2. Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040.

Author

Harrington, Kevin J, Soulières, Denis, Le Tourneau, Christophe, Dinis, Jose, Licitra, Lisa F, Ahn, Myung-Ju, Soria, Ainara, Machiels, Jean-Pascal H, Mach, Nicolas, Mehra, Ranee, Burtness, Barbara, Ellison, Misoo C, Cheng, Jonathan D, Chirovsky, Diana Romana, Swaby, Ramona F, and Cohen, Ezra EW

Subjects
Clinical Research, Rare Diseases, Cancer, Dental/Oral and Craniofacial Disease, Good Health and Well Being, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Cetuximab, Disease-Free Survival, Docetaxel, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Patient Reported Outcome Measures, Quality of Life, Squamous Cell Carcinoma of Head and Neck, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundHead and neck squamous cell carcinoma (HNSCC) affects health-related quality of life (HRQoL); few treatments have demonstrated clinically meaningful HRQoL benefit. KEYNOTE-040 evaluated pembrolizumab vs standard of care (SOC) in patients with recurrent and/or metastatic HNSCC whose disease recurred or progressed after platinum-containing regimen.MethodsPatients received pembrolizumab 200 mg or SOC (methotrexate, docetaxel, or cetuximab). Exploratory HRQoL analyses used European Organisation for Research and Treatment of Cancer (EORTC) 30 quality-of-life, EORTC 35-question quality-of-life head and neck cancer-specific module, and EuroQoL 5-dimensions questionnaires.ResultsThe HRQoL population comprised 469 patients (pembrolizumab = 241, SOC = 228). HRQoL compliance for patients in the study at week 15 was 75.3% (116 of 154) for pembrolizumab and 74.6% (85 of 114) for SOC. The median time to deterioration in global health status (GHS) and QoL scores were 4.8 months with pembrolizumab and 2.8 months with SOC (hazard ratio = 0.79, 95% confidence interval [CI] = 0.59 to 1.05). At week 15, GHS / QoL scores were stable for pembrolizumab (least squares mean [LSM] = 0.39, 95% CI = -3.00 to 3.78) but worsened for SOC (LSM = -5.86, 95% CI = -9.68 to -2.04); the LSM between-group difference was 6.25 points (95% CI = 1.32 to 11.18; nominal 2-sided P = .01). A greater difference in the LSM for GHS / QoL score occurred with pembrolizumab vs docetaxel (10.23, 95% CI = 3.15 to 17.30) compared with pembrolizumab vs methotrexate (6.21, 95% CI = -4.57 to 16.99) or pembrolizumab vs cetuximab (-1.44, 95% CI = -11.43 to 8.56). Pembrolizumab-treated patients had stable functioning and symptoms at week 15, with no notable differences from SOC.ConclusionsGHS / QoL scores were stable with pembrolizumab but declined with SOC in patients at week 15, supporting the clinically meaningful benefit of pembrolizumab in recurrent and/or metastatic HNSCC.

Published
2021

3. Validation of a prognostic nomogram for locally advanced oropharyngeal carcinoma (OPC) treated with intensity modulated radiation therapy (IMRT) ± systemic therapy (ST).

Author

Bossi, Paolo, primary, Gili, Riccardo, additional, Calza, Stefano, additional, Licitra, Lisa F., additional, Maddalo, Marta, additional, Bacigalupo, Almalina, additional, Belgioia, Liliana, additional, Cacicedo, Jon, additional, Facchinetti, Nadia, additional, Garcia, Almudena, additional, Oliva, Marc, additional, Bonomo, Pierluigi, additional, Sanguineti, Giuseppe, additional, Franco, Pierfrancesco, additional, Argiris, Athanassios, additional, Psyrri, Amanda, additional, and Orlandi, Ester, additional

Published
2024
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5. Rationale and design of LUX-Head & Neck 1: a randomised, Phase III trial of afatinib versus methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who progressed after platinum-based therapy

Author

Machiels, Jean-Pascal H, Licitra, Lisa F, Haddad, Robert I, Tahara, Makoto, and Cohen, Ezra EW

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Rare Diseases, Cancer, Orphan Drug, Dental/Oral and Craniofacial Disease, Clinical Research, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Afatinib, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Clinical Protocols, Disease Progression, Head and Neck Neoplasms, Humans, Methotrexate, Neoplasm Metastasis, Neoplasm Recurrence, Local, Platinum, Quinazolines, Retreatment, Squamous Cell Carcinoma of Head and Neck, Head and neck, Phase III, Recurrent, Metastatic, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Epidemiology
Abstract

BackgroundPatients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) receiving platinum-based chemotherapy as their first-line treatment have a dismal prognosis, with a median overall survival (OS) of ~7 months. Methotrexate is sometimes used following platinum failure or in patients not fit enough for platinum therapy, but this agent has not demonstrated any OS improvement. Targeted therapies are a novel approach, with the EGFR-targeting monoclonal antibody cetuximab (plus platinum-based chemotherapy) approved in the US and Europe in the first-line R/M setting, and as monotherapy following platinum failure in the US. However, there is still a high unmet medical need for new treatments that improve outcomes in the second-line R/M setting following failure on first-line platinum-containing regimens. Afatinib, an irreversible ErbB family blocker, was recently approved for the first-line treatment of EGFR mutation-positive metastatic non-small cell lung cancer. Afatinib has also shown clinical activity similar to cetuximab in a Phase II proof-of-concept HNSCC trial. Based on these observations, the Phase III, LUX-Head & Neck 1 study is evaluating afatinib versus methotrexate in R/M HNSCC patients following progression on platinum-based chemotherapy in the R/M setting.Methods/designPatients with progressive disease after one first-line platinum-based chemotherapy are randomised 2:1 to oral afatinib (starting dose 40 mg once daily) or IV methotrexate (starting dose 40 mg/m(2) once weekly) administered as monotherapy with best supportive care until progression or intolerable adverse events. Efficacy of afatinib versus methotrexate will be assessed in terms of progression-free survival (primary endpoint). Disease progression will be evaluated according to RECIST v1.1 by investigator and independent central review. Secondary endpoints include OS, tumour response and safety. Health-related quality of life and biomarker assessments will also be performed.DiscussionIf the LUX-Head & Neck 1 trial meets its primary endpoint, it will demonstrate the ability of afatinib to elicit an improved treatment benefit versus a commonly used chemotherapy agent in the second-line treatment of R/M HNSCC patients who have failed on first-line platinum-based therapy, confirm the clinical efficacy of afatinib observed in the Phase II proof-of-concept study, and establish a new standard of care for this patient population.

Published
2014

6. Data Set for the Reporting of Carcinomas of the Nasal Cavity and Paranasal Sinuses: Explanations and Recommendations of the Guidelines From the International Collaboration on Cancer Reporting

Author

Franchi, Alessandro, Bishop, Justin A., Coleman, Hedley, Flucke, Uta, Licitra, Lisa F., Pendas, Jose Luis Llorente, Stelow, Edward B., Toner, Mary, Weinreb, Ilan, Wenig, Bruce M., and Thompson, Lester D.R.

Subjects
Cancer -- Reports -- Care and treatment, Paranasal sinuses -- Research, Surgery, Data collection, Tumors, Health
Abstract

The International Collaboration on Cancer Reporting was established to internationally unify and standardize the pathologic reporting of cancers based on collected evidence, as well as to allow systematic multi-institutional intercountry data collection to guide cancer care in the future. This data set has been developed by the collaborative efforts of an international multidisciplinary panel of experts involved in the care of patients with carcinomas of the nasal cavity and paranasal sinuses (sinonasal tract). The nasal cavity and paranasal sinuses (including frontal, sphenoid, ethmoid, and maxillary sinuses) comprise a very complex anatomic area of the head and neck, affected by a sometimes bewildering array of neoplasms. Management of malignancies in this anatomic region involves complex surgery because of the anatomic confines and close proximity to many vital structures. Given a multidisciplinary approach, the standardized reporting of the carcinomas that develop in this anatomic region include both required (core) and recommended (noncore) elements in pathology reporting in order to be able to identify critical prognostic factors, often requiring clinical and radiologic correlation. A summary of the International Collaboration on Cancer Reporting guidelines and clinically relevant elements, along with additional explanatory notes, are provided, based on evidentiary support from the literature, set in the context of practical application. (Arch Pathol Lab Med. 2019;143:424-431; doi: 10.5858/arpa.2018-0404-SA), Sinonasal malignancies are rare and aggressive tumors, with an incidence of less than 1 case per 100 000 population annually, representing 3% to 5% of all head and neck cancers. [...]

Published
2019
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7. Supplementary Data_Figures 1 from Tumor Microenvironment Modifications Induced by Afatinib in Squamous Cell Carcinoma of the Head and Neck: A Window-of-Opportunity Study (EORTC-90111–24111)

Author

Beyaert, Simon P., primary, Loriot, Axelle E., primary, Huyghe, Nicolas D., primary, Goebbels, Rose-Marie, primary, Mendola, Antonella, primary, Govaerts, Anne-Sophie, primary, Fortpied, Catherine, primary, Baldin, Pamela, primary, Licitra, Lisa F., primary, Lalami, Yassine, primary, Clement, Paul M., primary, Machiels, Jean-Pascal H., primary, and Schmitz, Sandra, primary

Published
2023
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8. Tables 3 from Tumor Microenvironment Modifications Induced by Afatinib in Squamous Cell Carcinoma of the Head and Neck: A Window-of-Opportunity Study (EORTC-90111–24111)

Author

Beyaert, Simon P., primary, Loriot, Axelle E., primary, Huyghe, Nicolas D., primary, Goebbels, Rose-Marie, primary, Mendola, Antonella, primary, Govaerts, Anne-Sophie, primary, Fortpied, Catherine, primary, Baldin, Pamela, primary, Licitra, Lisa F., primary, Lalami, Yassine, primary, Clement, Paul M., primary, Machiels, Jean-Pascal H., primary, and Schmitz, Sandra, primary

Published
2023
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9. Data from Tumor Microenvironment Modifications Induced by Afatinib in Squamous Cell Carcinoma of the Head and Neck: A Window-of-Opportunity Study (EORTC-90111–24111)

Author

Beyaert, Simon P., primary, Loriot, Axelle E., primary, Huyghe, Nicolas D., primary, Goebbels, Rose-Marie, primary, Mendola, Antonella, primary, Govaerts, Anne-Sophie, primary, Fortpied, Catherine, primary, Baldin, Pamela, primary, Licitra, Lisa F., primary, Lalami, Yassine, primary, Clement, Paul M., primary, Machiels, Jean-Pascal H., primary, and Schmitz, Sandra, primary

Published
2023
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10. Tables 2 from Tumor Microenvironment Modifications Induced by Afatinib in Squamous Cell Carcinoma of the Head and Neck: A Window-of-Opportunity Study (EORTC-90111–24111)

Author

Beyaert, Simon P., primary, Loriot, Axelle E., primary, Huyghe, Nicolas D., primary, Goebbels, Rose-Marie, primary, Mendola, Antonella, primary, Govaerts, Anne-Sophie, primary, Fortpied, Catherine, primary, Baldin, Pamela, primary, Licitra, Lisa F., primary, Lalami, Yassine, primary, Clement, Paul M., primary, Machiels, Jean-Pascal H., primary, and Schmitz, Sandra, primary

Published
2023
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11. Supplementary Data - "Tables 1" from Tumor Microenvironment Modifications Induced by Afatinib in Squamous Cell Carcinoma of the Head and Neck: A Window-of-Opportunity Study (EORTC-90111–24111)

Author

Beyaert, Simon P., primary, Loriot, Axelle E., primary, Huyghe, Nicolas D., primary, Goebbels, Rose-Marie, primary, Mendola, Antonella, primary, Govaerts, Anne-Sophie, primary, Fortpied, Catherine, primary, Baldin, Pamela, primary, Licitra, Lisa F., primary, Lalami, Yassine, primary, Clement, Paul M., primary, Machiels, Jean-Pascal H., primary, and Schmitz, Sandra, primary

Published
2023
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12. Tumor Microenvironment Modifications Induced by Afatinib in Squamous Cell Carcinoma of the Head and Neck: A Window-of-Opportunity Study (EORTC-90111–24111)

Author

Beyaert, Simon P., primary, Loriot, Axelle E., additional, Huyghe, Nicolas D., additional, Goebbels, Rose-Marie, additional, Mendola, Antonella, additional, Govaerts, Anne-Sophie, additional, Fortpied, Catherine, additional, Baldin, Pamela, additional, Licitra, Lisa F., additional, Lalami, Yassine, additional, Clement, Paul M., additional, Machiels, Jean-Pascal H., additional, and Schmitz, Sandra, additional

Published
2023
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14. Development and External Validation of a PET Radiomic Model for Prognostication of Head and Neck Cancer

Author

Noortman, Wyanne A., primary, Aide, Nicolas, additional, Vriens, Dennis, additional, Arkes, Lisa S., additional, Slump, Cornelis H., additional, Boellaard, Ronald, additional, Goeman, Jelle J., additional, Deroose, Christophe M., additional, Machiels, Jean-Pascal, additional, Licitra, Lisa F., additional, Lhommel, Renaud, additional, Alessi, Alessandra, additional, Woff, Erwin, additional, Goffin, Karolien, additional, Le Tourneau, Christophe, additional, Gal, Jocelyn, additional, Temam, Stéphane, additional, Delord, Jean-Pierre, additional, van Velden, Floris H. P., additional, and de Geus-Oei, Lioe-Fee, additional

Published
2023
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15. Impact of cisplatin dose intensity on human papillomavirus-related and -unrelated locally advanced head and neck squamous cell carcinoma

Author

Spreafico, Anna, Huang, Shao Hui, Xu, Wei, Granata, Roberta, Liu, Chen-Shin, Waldron, John N., Chen, Eric, Ringash, Jolie, Bayley, Andrew, Chan, Kelvin K.W., Hope, Andrew J., Cho, John, Razak, Albiruni A.R., Hansen, Aaron, Jang, Raymond, Perez-Ordonez, Bayardo, Weinreb, Ilan, Bossi, Paolo, Orlandi, Ester, Licitra, Lisa F., Song, Yuyao, O'Sullivan, Brian, Siu, Lillian L., and Kim, John

Published
2016
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16. Development and External Validation of a PET Radiomic Model for Prognostication of Head and Neck Cancer.

Author

Noortman, Wyanne WA, Aide, Nicolas, Vriens, Dennis, Arkes, Lisa LS, Slump, Cornelis CH, Boellaard, Ronald, Goeman, Jelle J, Deroose, Christophe Michel, Machiels, Jean-Pascal, Licitra, Lisa F, Lhommel, Renaud, Alessi, Alessandra, Woff, Erwin, Goffin, Karolien, Le Tourneau, Christophe, Gal, Jocelyn, Temam, Stéphane, Delord, Jean Pierre, van Velden, Floris FHP, de Geus-Oei, Lioe-Fee, Noortman, Wyanne WA, Aide, Nicolas, Vriens, Dennis, Arkes, Lisa LS, Slump, Cornelis CH, Boellaard, Ronald, Goeman, Jelle J, Deroose, Christophe Michel, Machiels, Jean-Pascal, Licitra, Lisa F, Lhommel, Renaud, Alessi, Alessandra, Woff, Erwin, Goffin, Karolien, Le Tourneau, Christophe, Gal, Jocelyn, Temam, Stéphane, Delord, Jean Pierre, van Velden, Floris FHP, and de Geus-Oei, Lioe-Fee

Abstract

To build and externally validate an [18F]FDG PET radiomic model to predict overall survival in patients with head and neck squamous cell carcinoma (HNSCC)., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2023

17. Data from A Phase II Trial of the Multitargeted Tyrosine Kinase Inhibitor Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer

Author

Schlumberger, Martin, primary, Jarzab, Barbara, primary, Cabanillas, Maria E., primary, Robinson, Bruce, primary, Pacini, Furio, primary, Ball, Douglas W., primary, McCaffrey, Judith, primary, Newbold, Kate, primary, Allison, Roger, primary, Martins, Renato G., primary, Licitra, Lisa F., primary, Shah, Manisha H., primary, Bodenner, Donald, primary, Elisei, Rossella, primary, Burmeister, Lynn, primary, Funahashi, Yasuhiro, primary, Ren, Min, primary, O'Brien, James P., primary, and Sherman, Steven I., primary

Published
2023
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18. Supplementary Figure 1 from A Phase II Trial of the Multitargeted Tyrosine Kinase Inhibitor Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer

Author

Schlumberger, Martin, primary, Jarzab, Barbara, primary, Cabanillas, Maria E., primary, Robinson, Bruce, primary, Pacini, Furio, primary, Ball, Douglas W., primary, McCaffrey, Judith, primary, Newbold, Kate, primary, Allison, Roger, primary, Martins, Renato G., primary, Licitra, Lisa F., primary, Shah, Manisha H., primary, Bodenner, Donald, primary, Elisei, Rossella, primary, Burmeister, Lynn, primary, Funahashi, Yasuhiro, primary, Ren, Min, primary, O'Brien, James P., primary, and Sherman, Steven I., primary

Published
2023
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19. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial

Author

Machiels, Jean-Pascal H, Haddad, Robert I, Fayette, Jérôme, Licitra, Lisa F, Tahara, Makoto, Vermorken, Jan B, Clement, Paul M, Gauler, Thomas, Cupissol, Didier, Grau, Juan José, Guigay, Joël, Caponigro, Francesco, de Castro, Gilberto, Jr, de Souza Viana, Luciano, Keilholz, Ulrich, del Campo, Joseph M, Cong, Xiuyu Julie, Ehrnrooth, Eva, and Cohen, Ezra E W

Published
2015
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22. Long-lasting responses with chemotherapy followed by T-cell therapy in recurrent or metastatic EBV-related nasopharyngeal carcinoma.

Author

Secondino, Simona, Pedrazzoli, Paolo, Basso, Sabrina, Bossi, Paolo, Bianco, Alba, Imarisio, Ilaria, Pagani, Anna, De Cicco, Marica, Muscianisi, Stella, Casanova, Michela, Morosi, Carlo, Bergamini, Cristiana, Benazzo, Marco, Rocca, Maria Cossu, Perotti, Cesare, Baldanti, Fausto, Zecca, Marco, Licitra, Lisa F., and Comoli, Patrizia

Subjects
NASOPHARYNX cancer, T cells, CANCER chemotherapy, DISEASE remission, METASTASIS, NASOPHARYNX tumors, RENAL cell carcinoma
Abstract

Background: Refractory or metastatic nasopharyngeal carcinoma (NPC) patients have a poor prognosis due to the lack of effective salvage treatments and prolonged survival by means of combination chemotherapy being described only for a minority of younger patients with oligometastatic disease. Targeting the Epstein - Barr virus (EBV) proteins expressed in NPC cells has been shown to be a feasible strategy that could help control systemic disease. Patients and Methods: Between 2011 and 2014, 16 patients with recurrent/metastatic EBV-NPC received first-line chemotherapy (CT) followed by 2 doses of autologous cytotoxic EBV specific T-lymphocytes (15-25 x 107 total cells/dose, 2 weeks apart), based on our previous studies showing the feasibility and efficacy of this infusion regimen. Cumulative overall survival (OS) and median OS were analysed in the whole population and according to specific clinical and biological parameters. Results: All patients received the planned T-cell therapy schedule, 9 after reaching partial (n=5) or complete (n=4) disease remission with CT, and 7 after failing to obtain benefit from chemotherapy. No severe adverse events were recorded. Patients who received cytotoxic T-lymphocytes (CTLs) had a cumulative 10-year OS of 44%, with a median OS of 60 months (95% CI 42-62). Patients responding to CT, with oligometastatic disease (<3 disease sites), and plasma EBV-DNA <1000 copies/mL had a better outcome. Conclusions: Autologous EBV-specific CTLs transplanted following conventional first-line CT demonstrated promising efficacy with several patients obtaining long-lasting disease control. The rationale provided by this study, with the crucial role likely played by the timing of CTL administration when trying to induce synergy with conventional treatment needs to be confirmed in a prospective controlled trial. [ABSTRACT FROM AUTHOR]

Published
2023
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23. Immunotherapy followed by cetuximab in locally advanced/metastatic (LA/M) cutaneous squamous cell carcinomas (cSCC): The I-TACKLE trial.

Author

Bossi, Paolo, primary, Alberti, Andrea, additional, Bergamini, Cristiana, additional, Resteghini, Carlo, additional, Locati, Laura Deborah, additional, Alfieri, Salvatore, additional, Cavalieri, Stefano, additional, Colombo, Elena, additional, Gurizzan, Cristina, additional, Lorini, Luigi, additional, Tovazzi, Valeria, additional, Zamparini, Manuel, additional, Ravanelli, Marco, additional, Ascierto, Paolo Antonio, additional, Rampinelli, Vittorio, additional, Grammatica, Alberto, additional, Patuzzo, Roberto, additional, Maurichi, Andrea, additional, and Licitra, Lisa F., additional

Published
2022
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24. Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design

Author

Bourhis, Jean, primary, Burtness, Barbara, additional, Licitra, Lisa F, additional, Nutting, Christopher, additional, Schoenfeld, Jonathan D, additional, Omar, Mokhtar, additional, Bouisset, Florilene, additional, Nauwelaerts, Heidi, additional, Urfer, Yulia, additional, Zanna, Claudio, additional, and Cohen, Ezra EW, additional

Published
2022
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25. The association of cemiplimab plus sonidegib for synchronous cutaneous squamous cell carcinoma and basal cell carcinoma of the head and neck: Two case reports.

Author

Colombo, Elena, Gurizzan, Cristina, Ottini, Arianna, Caspani, Francesca, Bergamini, Cristiana, Locati, Laura D., Marchiselli, Chiara, Alberti, Andrea, Lorini, Luigi, Licitra, Lisa F., Bossi, Paolo, and Resteghini, Carlo

Subjects
BASAL cell carcinoma, SQUAMOUS cell carcinoma, CEMIPLIMAB, SKIN cancer, HEAD & neck cancer, OLDER patients, NECK
Abstract

Basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) are the most frequent cancers in humans, with cumulative ultraviolet radiation exposure, aging, and immunodepression as the main risk factors. In most cases, these malignancies arise in the head and neck area, and they can be treated with locoregional therapies. A minority of cases require systemic therapy. Currently, Sonic Hedgehog inhibitors (i.e., vismodegib and sonidegib) have been approved for advanced BCC, while the PD-1 checkpoint inhibitor cemiplimab has been approved as a first-line treatment for cSCC and as a second-line treatment for BCC. Nevertheless, there is a clinical need for an effective and safe systemic therapies for advanced synchronous (syn) BCC/cSCC not amenable to local treatments. International guidelines do not provide specific recommendations for patients affected by this condition, and no case reports on the full-dose association of these medications have been previously reported. Here, we present the cases of two elderly patients affected by synBCC/cSCC of the head and neck, who received combined therapy with cemiplimab and sonidegib at full dose and standard schedule, achieving remarkable clinical benefit and long-term responses, without major adverse events. The instance of a feasible treatment for patients with advanced synBCC/cSCC will become increasingly frequent with the advancement of life expectancy in the global population, and the synergistic activity of targeted therapies and immunotherapy —administered either in association or sequentially—deserves to be further explored. [ABSTRACT FROM AUTHOR]

Published
2023
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26. A phase 2 trial of lenvatinib (E7080) in advanced, progressive, radioiodine-refractory, differentiated thyroid cancer: A clinical outcomes and biomarker assessment

Author

Cabanillas, Maria E., Schlumberger, Martin, Jarzab, Barbara, Martins, Renato G., Pacini, Furio, Robinson, Bruce, McCaffrey, Judith C., Shah, Manisha H., Bodenner, Donald L., Topliss, Duncan, Andresen, Corina, OʼBrien, James P., Ren, Min, Funahashi, Yasuhiro, Allison, Roger, Elisei, Rossella, Newbold, Kate, Licitra, Lisa F., Sherman, Steven I., and Ball, Douglas W.

Published
2015
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28. Prognostic role of pre-treatment magnetic resonance imaging (MRI)-based radiomic analysis in effectively cured head and neck squamous cell carcinoma (HNSCC) patients

Author

Alfieri, Salvatore, primary, Romanò, Rebecca, additional, Bologna, Marco, additional, Calareso, Giuseppina, additional, Corino, Valentina, additional, Mirabile, Aurora, additional, Ferri, Andrea, additional, Bellanti, Luca, additional, Poli, Tito, additional, Marcantoni, Alessandra, additional, Grosso, Enrica, additional, Tarsitano, Achille, additional, Battaglia, Salvatore, additional, Blengio, Fulvia, additional, De Martino, Iolanda, additional, Valerini, Sara, additional, Vecchio, Stefania, additional, Richetti, Antonella, additional, Deantonio, Letizia, additional, Martucci, Francesco, additional, Grammatica, Alberto, additional, Ravanelli, Marco, additional, Ibrahim, Toni, additional, Caruso, Damiano, additional, Locati, Laura Deborah, additional, Orlandi, Ester, additional, Bossi, Paolo, additional, Mainardi, Luca, additional, and Licitra, Lisa F., additional

Published
2021
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30. TrilynX: A phase 3 trial of xevinapant and concurrent chemoradiation for locally advanced head and neck cancer.

Author

Bourhis, Jean, primary, Burtness, Barbara, additional, Licitra, Lisa F., additional, Nutting, Christopher, additional, Schoenfeld, Jonathan D., additional, Ait Sarkouh, Rafik, additional, Bouisset, Florilene, additional, Nauwelaerts, Heidi, additional, Urfer, Yulia, additional, Zanna, Claudio, additional, and Cohen, Ezra E.W., additional

Published
2021
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31. The SINTART 1 study: A phase II trial of induction chemotherapy (IC), surgery, photon-, proton-and carbon ion-based radiotherapy (RT) integration in locally advanced operable sinonasal epithelial tumors patients (pts).

Author

Resteghini, Carlo, primary, Castelnuovo, Paolo, additional, Nicolai, Piero, additional, Orlandi, Ester, additional, Bossi, Paolo, additional, Vischioni, Barbara, additional, Schreiber, Alberto, additional, Iacovelli, Nicola Alessandro, additional, Battaglia, Paolo, additional, Mattavelli, Davide, additional, Facchinetti, Nadia, additional, Gambazza, Simone, additional, Calareso, Giuseppina, additional, Ravanelli, Marco, additional, Facco, Carla, additional, Tartaro, Tiziana, additional, Sponghini, Andrea Pietro, additional, Pagella, Fabio, additional, Mariani, Luigi, additional, and Licitra, Lisa F., additional

Published
2021
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32. Radiomics-based prediction of response to multikinase inhibitors in radioiodine-refractory differentiated thyroid cancer patients.

Author

Corino, Valentina, primary, Colombo, Elena, additional, Bologna, Marco, additional, Calareso, Giuseppina, additional, Mainardi, Luca, additional, Cavalieri, Stefano, additional, Filippini, Daria Maria, additional, Resteghini, Carlo, additional, Bergamini, Cristiana, additional, Licitra, Lisa F., additional, and Locati, Laura Deborah, additional

Published
2021
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33. The AIM-HN Study: A pivotal study evaluating the efficacy of tipifarnib in patients with recurrent or metastatic head and neck squamous cell carcinoma with HRAS mutations.

Author

Haddad, Robert I., primary, Adkins, Douglas, additional, Licitra, Lisa F., additional, Bruce, Justine Yang, additional, Gillison, Maura L., additional, Ahn, Myung-Ju, additional, Hsieh, Ching-Yun, additional, Wang, Hung-Ming, additional, Psyrri, Amanda, additional, Machiels, Jean-Pascal H., additional, Balsara, Binaifer, additional, Leoni, Mollie, additional, Harrington, Kevin Joseph, additional, Saba, Nabil F., additional, and Ho, Alan Loh, additional

Published
2021
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34. Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040.

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'oto-rhino-laryngologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Harrington, Kevin J, Soulières, Denis, Le Tourneau, Christophe, Dinis, Jose, Licitra, Lisa F, Ahn, Myung-Ju, Soria, Ainara, Machiels, Jean-Pascal, Mach, Nicolas, Mehra, Ranee, Burtness, Barbara, Ellison, Misoo C, Cheng, Jonathan D, Chirovsky, Diana Romana, Swaby, Ramona F, Cohen, Ezra E W, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'oto-rhino-laryngologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Harrington, Kevin J, Soulières, Denis, Le Tourneau, Christophe, Dinis, Jose, Licitra, Lisa F, Ahn, Myung-Ju, Soria, Ainara, Machiels, Jean-Pascal, Mach, Nicolas, Mehra, Ranee, Burtness, Barbara, Ellison, Misoo C, Cheng, Jonathan D, Chirovsky, Diana Romana, Swaby, Ramona F, and Cohen, Ezra E W

Abstract

Head and neck squamous cell carcinoma (HNSCC) affects health-related quality of life (HRQoL); few treatments have demonstrated clinically meaningful HRQoL benefit. KEYNOTE-040 evaluated pembrolizumab vs standard of care (SOC) in patients with recurrent and/or metastatic HNSCC whose disease recurred or progressed after platinum-containing regimen. Patients received pembrolizumab 200 mg or SOC (methotrexate, docetaxel, or cetuximab). Exploratory HRQoL analyses used European Organisation for Research and Treatment of Cancer (EORTC) 30 quality-of-life, EORTC 35-question quality-of-life head and neck cancer-specific module, and EuroQoL 5-dimensions questionnaires. The HRQoL population comprised 469 patients (pembrolizumab = 241, SOC = 228). HRQoL compliance for patients in the study at week 15 was 75.3% (116 of 154) for pembrolizumab and 74.6% (85 of 114) for SOC. The median time to deterioration in global health status (GHS) and QoL scores were 4.8 months with pembrolizumab and 2.8 months with SOC (hazard ratio = 0.79, 95% confidence interval [CI] = 0.59 to 1.05). At week 15, GHS / QoL scores were stable for pembrolizumab (least squares mean [LSM] = 0.39, 95% CI = -3.00 to 3.78) but worsened for SOC (LSM = -5.86, 95% CI = -9.68 to -2.04); the LSM between-group difference was 6.25 points (95% CI = 1.32 to 11.18; nominal 2-sided P = .01). A greater difference in the LSM for GHS / QoL score occurred with pembrolizumab vs docetaxel (10.23, 95% CI = 3.15 to 17.30) compared with pembrolizumab vs methotrexate (6.21, 95% CI = -4.57 to 16.99) or pembrolizumab vs cetuximab (-1.44, 95% CI = -11.43 to 8.56). Pembrolizumab-treated patients had stable functioning and symptoms at week 15, with no notable differences from SOC. GHS / QoL scores were stable with pembrolizumab but declined with SOC in patients at week 15, supporting the clinically meaningful benefit of pembrolizumab in recurrent and/or metastatic HNSCC.

Published
2021

35. The AIM-HN and SEQ-HN study: A pivotal study evaluating the efficacy of tipifarnib in patients with head and neck squamous cell carcinoma (HNSCC) with hras mutations (AIM-HN) and the impact of hras mutations on response to first line systemic therapies for HNSCC (SEQ-HN).

Author

Haddad, Robert I., primary, Harrington, Kevin Joseph, additional, Licitra, Lisa F., additional, Psyrri, Amanda, additional, Saba, Nabil F., additional, Rajicic, Natasa, additional, Balsara, Binaifer, additional, Kurman, Michael R., additional, Scholz, Catherine Rose, additional, Gualberto, Antonio, additional, and Ho, Alan Loh, additional

Published
2020
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36. Prognostic role of pre-treatment magnetic resonance imaging (MRI) radiomic analysis in patients with squamous cell carcinoma of the head and neck (SCCHN).

Author

Alfieri, Salvatore, primary, Romanò, Rebecca, additional, Bologna, Marco, additional, Calareso, Giuseppina, additional, Mirabile, Aurora, additional, Ferri, Andrea, additional, Marcantoni, Alessandra, additional, Grosso, Enrica, additional, Tarsitano, Achille, additional, Valerini, Sara, additional, Vecchio, Stefania, additional, Deantonio, Letizia, additional, Blengio, Fulvia, additional, Ibrahim, Toni, additional, Mancinelli, Moela, additional, Ascoli, Francesco, additional, Bossi, Paolo, additional, Locati, Laura Deborah, additional, Mainardi, Luca, additional, and Licitra, Lisa F., additional

Published
2020
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37. Plasma-based tumor mutational burden (bTMB) as predictor for survival in phase III EAGLE study: Durvalumab (D) ± tremelimumab (T) versus chemotherapy (CT) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) after platinum failure.

Author

Li, Weimin, primary, Wildsmith, Sophie, additional, Ye, Jiabu, additional, Si, Han, additional, Morsli, Nassim, additional, He, Philip, additional, Shetty, Jagdish, additional, Yovine, Alejandro Javier, additional, Holoweckyj, Nicholas, additional, Raja, Rajiv, additional, Real, Katia, additional, Scorer, Paul, additional, Hembrough, Todd, additional, Walker, Jill, additional, Zhang, Qu, additional, Mesia, Ricard, additional, Haddad, Robert I., additional, Licitra, Lisa F., additional, and Ferris, Robert L., additional

Published
2020
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38. BRAF V600E-mutated anaplastic thyroid carcinoma (ATC) and treatment with BRAF-inhibitors: Real-world data from a single-institution, still far from the cure.

Author

Platini, Francesca, primary, Ortolan, Elisa, additional, Cavalieri, Stefano, additional, Massa, Giacomo, additional, Filippini, Daria Maria, additional, Alfieri, Salvatore, additional, Bergamini, Cristiana, additional, Resteghini, Carlo, additional, Orlandi, Ester, additional, Paolini, Biagio, additional, Piazza, Cesare, additional, Perrone, Federica, additional, Tamborini, Elena, additional, Ferrarini, Linda, additional, Serafini, Mara Serena, additional, Cappelletti, Vera, additional, Daidone, Maria Grazia, additional, Licitra, Lisa F., additional, and Locati, Laura Deborah, additional

Published
2020
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39. Phase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Author

Siu, Lillian L., primary, Burtness, Barbara, additional, Cohen, Ezra E.W., additional, Harrington, Kevin Joseph, additional, Licitra, Lisa F., additional, Rischin, Danny, additional, Zhu, Ying, additional, Lee, Chooi Peng, additional, Pinheiro, Cecilia, additional, Swaby, Ramona F., additional, Machiels, Jean-Pascal H., additional, and Tahara, Makoto, additional

Published
2020
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40. Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040

Author

Harrington, Kevin J, primary, Soulières, Denis, additional, Le Tourneau, Christophe, additional, Dinis, Jose, additional, Licitra, Lisa F, additional, Ahn, Myung-Ju, additional, Soria, Ainara, additional, Machiels, Jean-Pascal H, additional, Mach, Nicolas, additional, Mehra, Ranee, additional, Burtness, Barbara, additional, Ellison, Misoo C, additional, Cheng, Jonathan D, additional, Chirovsky, Diana Romana, additional, Swaby, Ramona F, additional, and Cohen, Ezra E W, additional

Published
2020
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41. Patients with adenoid cystic carcinomas of the salivary glands treated with lenvatinib: Activity and quality of life

Author

Locati, Laura D., primary, Galbiati, Donata, additional, Calareso, Giuseppina, additional, Alfieri, Salvatore, additional, Singer, Susanne, additional, Cavalieri, Stefano, additional, Bergamini, Cristiana, additional, Bossi, Paolo, additional, Orlandi, Ester, additional, Resteghini, Carlo, additional, Platini, Francesca, additional, Granata, Roberta, additional, Quattrone, Pasquale, additional, Mancinelli, Moela, additional, Mariani, Luigi, additional, Lo Vullo, Salvatore, additional, and Licitra, Lisa F., additional

Published
2020
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42. Retrospective analysis of baseline clinical factors associated to CDDP-nephrotoxicity in locally advanced head and neck cancer (LAHNC) patients.

Author

Platini, Francesca, primary, Barretta, Francesco, additional, Alfieri, Salvatore, additional, Cavalieri, Stefano, additional, Resteghini, Carlo, additional, Galbiati, Donata, additional, Locati, Laura Deborah, additional, Bergamini, Cristiana, additional, Granata, Roberta, additional, Calareso, Giuseppina, additional, Iacovelli, Nicola Alessandro, additional, Quattrone, Pasquale, additional, Incandela, Fabiola, additional, Bossi, Paolo, additional, and Licitra, Lisa F., additional

Published
2019
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43. Pembrolizumab (pembro) for recurrent head and neck squamous cell carcinoma (HNSCC): Post hoc analyses of phase 3 KEYNOTE-040 prior radiation treatment (RT) and disease state.

Author

Harrington, Kevin J., primary, Cohen, Ezra E.W., additional, Soulieres, Denis, additional, Dinis, José, additional, Licitra, Lisa F., additional, Ahn, Myung-Ju, additional, Soria, Ainara, additional, Machiels, Jean-Pascal H., additional, Mach, Nicolas, additional, Mehra, Ranee, additional, Burtness, Barbara, additional, Lin, Jianxin, additional, Cheng, Jonathan D., additional, Swaby, Ramona F., additional, and Le Tourneau, Christophe, additional

Published
2019
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44. EAGLE: A phase 3, randomized, open-label study of durvalumab (D) with or without tremelimumab (T) in patients (pts) with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Author

Licitra, Lisa F., primary, Haddad, Robert I., additional, Even, Caroline, additional, Tahara, Makoto, additional, Dvorkin, Mikhail, additional, Ciuleanu, Tudor-Eliade, additional, Clement, Paul M., additional, Mesia, Ricard, additional, Kutukova, Svetlana I., additional, Zholudeva, Lyubov, additional, Daste, Amaury, additional, Caballero, Javier Daroqui, additional, Keam, Bhumsuk, additional, Vynnychenko, Ihor, additional, Lafond, Cedrik, additional, Shetty, Jagdish, additional, Morsli, Nassim, additional, Mann, Helen, additional, Fayette, Jerome, additional, and Ferris, Robert L., additional

Published
2019
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45. Hyperprogressive disease (HPD) in head and neck squamous cell carcinoma (HNSCC) patients treated with immune checkpoint inhibitors (ICI).

Author

Alfieri, Salvatore, primary, Ferrara, Roberto, additional, Calareso, Giuseppina, additional, Cavalieri, Stefano, additional, Platini, Francesca, additional, Mancinelli, Moela, additional, Resteghini, Carlo, additional, Orlandi, Ester, additional, Iacovelli, Nicola Alessandro, additional, Ferella, Letizia, additional, Piazza, Cesare, additional, Apollonio, Giulia, additional, Galbiati, Donata, additional, Bossi, Paolo, additional, Bergamini, Cristiana, additional, Locati, Laura Deborah, additional, and Licitra, Lisa F., additional

Published
2019
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46. Clinical prognostic factors in patients with recurrent or metastatic carcinoma of the head and neck treated with immune checkpoints therapies.

Author

Resteghini, Carlo, primary, Cavalieri, Stefano, additional, Rametta, Alessandro, additional, Alfieri, Salvatore, additional, Galbiati, Donata, additional, Platini, Francesca, additional, Locati, Laura Deborah, additional, Bossi, Paolo, additional, Bergamini, Cristiana, additional, Granata, Roberta, additional, Orlandi, Ester, additional, Piazza, Cesare, additional, Mancinelli, Moela, additional, and Licitra, Lisa F., additional

Published
2019
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47. Data Set for the Reporting of Carcinomas of the Nasal Cavity and Paranasal Sinuses: Explanations and Recommendations of the Guidelines From the International Collaboration on Cancer Reporting

Author

Franchi, Alessandro, primary, Bishop, Justin A., additional, Coleman, Hedley, additional, Flucke, Uta, additional, Licitra, Lisa F., additional, Pendás, José Luis Llorente, additional, Stelow, Edward B., additional, Toner, Mary, additional, Weinreb, Ilan, additional, Wenig, Bruce M., additional, and Thompson, Lester D. R., additional

Published
2018
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48. Druggable molecular targets in skin adnexal malignancies.

Author

Cavalieri, Stefano, primary, Perrone, Federica, additional, Quattrone, Pasquale, additional, Locati, Laura, additional, Bergamini, Cristiana, additional, Granata, Roberta, additional, Alfieri, Salvatore, additional, Resteghini, Carlo, additional, Galbiati, Donata, additional, Platini, Francesca, additional, Calareso, Giuseppina, additional, Licitra, Lisa F., additional, and Bossi, Paolo, additional

Published
2018
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49. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs standard of care (SOC) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in KEYNOTE-040.

Author

Cohen, Ezra E.W., primary, Soulieres, Denis, additional, Le Tourneau, Christophe, additional, Dinis, Jose, additional, Licitra, Lisa F., additional, Ahn, Myung-Ju, additional, Soria, Ainara, additional, Machiels, Jean-Pascal H., additional, Mach, Nicolas, additional, Mehra, Ranee, additional, Burtness, Barbara, additional, Ellison, Misoo C., additional, Cheng, Jonathan D., additional, Chirovsky, Diana Romana, additional, Swaby, Ramona F., additional, and Harrington, Kevin J., additional

Published
2018
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50. Pembrolizumab plus chemoradiation vs chemoradiation alone for locally advanced head and neck squamous cell carcinoma: The phase 3 KEYNOTE-412 study.

Author

Machiels, Jean-Pascal H., primary, Licitra, Lisa F., additional, Tao, Yungan, additional, Yen, Chia-Jui, additional, Rischin, Danny, additional, Waldron, John, additional, Burtness, Barbara, additional, Gregoire, Vincent, additional, Agarwala, Sanjiv S., additional, Yorio, Jeffrey, additional, Delord, Jean-Pierre, additional, Aksoy, Sercan, additional, Ikeda, Sadakatsu, additional, Hong, Ruey-Long, additional, Ge, Joy Yang, additional, Brown, Holly M., additional, Bidadi, Behzad, additional, and Siu, Lillian L., additional

Published
2018
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