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1. SEOM-GEM clinical guidelines for cutaneous melanoma (2023)

Author

Márquez-Rodas, Iván, Muñoz Couselo, Eva, Rodríguez Moreno, Juan F., Arance Fernández, Ana Mª, Berciano Guerrero, Miguel Ángel, Campos Balea, Begoña, de la Cruz Merino, Luis, Espinosa Arranz, Enrique, García Castaño, Almudena, and Berrocal Jaime, Alfonso

Published
2024
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3. Technical considerations for isolated limb perfusion: A consensus paper

Author

Hayes, Andrew J., Coker, David J., Been, Lukas, Boecxstaens, Veerle WSM., Bonvalot, Sylvie, De Cian, Franco, de la Cruz-Merino, Luis, Duarte, Carlos, Eggermont, Alexander, Farricha, Victor, Fiore, Marco, Grünhagen, Dirk, Grützmann, Robert, Honoré, Charles, Jakob, Jens, Hocevar, Marko, van Houdt, Winan, Klauzner, Joseph, Kettelhack, Christoph, Märten, Angela, Martinez-Said, Hector, Matter, Maurice, Michot, Audrey, Niethard, Maya, Pennacchioli, Elisabetta, Podleska, Lars E., Rabago, Gregorio, Rastrelli, Marco, Reijers, Sophie, Ribeiro, Matilde, Schwarzbach, Matthias, Snow, Hayden A., Spacek, Miroslav, Stoldt, Stephan, Testori, Alessandro, Zoras, Odysseas, and Olofsson Bagge, Roger

Published
2024
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4. 5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation–Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study5-Year Outcomes with Cobimetinib + Vemurafenib in Melanoma

Author

Ascierto, Paolo A, Dréno, Brigitte, Larkin, James, Ribas, Antoni, Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Atkinson, Victoria, Dutriaux, Caroline, Garbe, Claus, Hsu, Jessie, Jones, Surai, Li, Haocheng, McKenna, Edward, Voulgari, Athina, and McArthur, Grant A

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Combined Chemotherapy Protocols, Azetidines, Follow-Up Studies, Humans, Melanoma, Mutation, Piperidines, Proto-Oncogene Proteins B-raf, Skin Neoplasms, Vemurafenib, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe randomized phase III coBRIM study (NCT01689519) demonstrated improved progression-free survival (PFS) and overall survival (OS) with addition of cobimetinib to vemurafenib compared with vemurafenib in patients with previously untreated BRAFV600 mutation-positive advanced melanoma. We report long-term follow-up of coBRIM, with at least 5 years since the last patient was randomized.Patients and methodsEligible patients were randomized 1:1 to receive either oral cobimetinib (60 mg once daily on days 1-21 in each 28-day cycle) or placebo in combination with oral vemurafenib (960 mg twice daily).Results495 patients were randomized to cobimetinib plus vemurafenib (n = 247) or placebo plus vemurafenib (n = 248). Median follow-up was 21.2 months for cobimetinib plus vemurafenib and 16.6 months for placebo plus vemurafenib. Median OS was 22.5 months (95% CI, 20.3-28.8) with cobimetinib plus vemurafenib and 17.4 months (95% CI, 15.0-19.8) with placebo plus vemurafenib; 5-year OS rates were 31% and 26%, respectively. Median PFS was 12.6 months (95% CI, 9.5-14.8) with cobimetinib plus vemurafenib and 7.2 months (95% CI, 5.6-7.5) with placebo plus vemurafenib; 5-year PFS rates were 14% and 10%, respectively. OS and PFS were longest in patients with normal baseline lactate dehydrogenase levels and low tumor burden, and in those achieving complete response. The safety profile remained consistent with previously published reports.ConclusionsExtended follow-up of coBRIM confirms the long-term clinical benefit and safety profile of cobimetinib plus vemurafenib compared with vemurafenib monotherapy in patients with BRAFV600 mutation-positive advanced melanoma.

Published
2021

5. Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study

Author

Dummer, Reinhard, Queirolo, Paola, Gerard Duhard, Pauline, Hu, Youyou, Wang, Dao, de Azevedo, Sergio Jobim, Robert, Caroline, Ascierto, Paolo Antonio, Chiarion-Sileni, Vanna, Pronzato, Paolo, Spagnolo, Francesco, Mujika Eizmendi, Karmele, Liszkay, Gabriella, de la Cruz Merino, Luis, and Tawbi, Hussein

Published
2023
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7. Plasma mutational burden in PIK3CA and TP53 independently predicts early progression in patients with HR+/HER2- metastatic breast cancer (MBC) enrolled in the GEICAM/2014-12 FLIPPER trial.

Author

Rojo Todo, Federico Gustavo, primary, Meier, Lara, additional, Martínez, Maria Teresa, additional, Esteban López, María, additional, Paris, Lorena, additional, O'Connor, Miriam, additional, De la Cruz Merino, Luis, additional, Santaballa, Ana, additional, Martinez-Jañez, Noelia, additional, Moreno Antón, Fernando, additional, Fernández, Isaura, additional, Alarcón Company, Jesús, additional, Keane, Maccon, additional, Garcia-Palomo, Andrés, additional, Starus, Anna, additional, Portela, Marta, additional, Herranz, Jesús, additional, Caballero, Rosalia, additional, Jones, Frederick, additional, and Albanell, Joan, additional

Published
2024
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8. Use of liquid biomarker thymidine kinase activity (TKa) to predict outcome and progression in patients with metastatic breast cancer (MBC) in the GEICAM/2014-12 FLIPPER trial.

Author

Albanell, Joan, primary, Williams, Amy, additional, Martínez, Maria Teresa, additional, Ritzen, Hanna, additional, Paris, Lorena, additional, O'Connor, Miriam, additional, De la Cruz Merino, Luis, additional, Santaballa, Ana, additional, Martinez-Jañez, Noelia, additional, Moreno Antón, Fernando, additional, Fernández, Isaura, additional, Alarcón Company, Jesús, additional, Guerra, Juan Antonio, additional, Ruiz-Borrego, Manuel, additional, Morris, Patrick G., additional, Portela, Marta, additional, Herranz, Jesús, additional, Caballero, Rosalia, additional, Bergqvist, Mattias, additional, and Rojo Todo, Federico Gustavo, additional

Published
2024
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9. On-treatment (tx) dynamic circulating tumor DNA changes (∆ctDNA) associated with progression-free survival (PFS) and overall survival (OS) of patients (pts) with HR+/HER2− advanced breast cancer (ABC) in MONALEESA-3 (ML-3).

Author

Chia, Stephen K. L., primary, Solovieff, Nadia, additional, Joshi, Mukta, additional, Im, Seock-Ah, additional, Bianchi, Giulia Valeria, additional, de la Cruz-Merino, Luis, additional, Jerusalem, Guy Heinrich Maria, additional, Sonke, Gabe S., additional, Nusch, Arnd, additional, Beck, J. Thaddeus, additional, Slamon, Dennis J., additional, Wang, Craig, additional, Zarate, Juan Pablo, additional, Su, Fei, additional, and Neven, Patrick, additional

Published
2024
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10. Everolimus for advanced breast cancer: Is the histological subtype important?

Author

Vargas, Alicia, primary, Flores Paco, Pablo, additional, De La Haba, Juan, additional, Morales-Estevez, Cristina, additional, Rodríguez-Alonso, Beatriz, additional, Porras, Ignacio, additional, de la Cruz-Merino, Luis, additional, Muñoz, Clara, additional, Lorente, Margarita, additional, González Flores, Encarnación, additional, Sanchez-Rovira, Pedro, additional, Arenas, Rafael, additional, Armenta, Ana, additional, and Aranda, Enrique, additional

Published
2024
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11. Pembrolizumab Versus Placebo as Adjuvant Therapy in Resected Stage IIB or IIC Melanoma: Final Analysis of Distant Metastasis-Free Survival in the Phase III KEYNOTE-716 Study

Author

Luke, Jason J., primary, Ascierto, Paolo A., additional, Khattak, Muhammad A., additional, de la Cruz Merino, Luis, additional, Del Vecchio, Michele, additional, Rutkowski, Piotr, additional, Spagnolo, Francesco, additional, Mackiewicz, Jacek, additional, Chiarion-Sileni, Vanna, additional, Kirkwood, John M., additional, Robert, Caroline, additional, Grob, Jean-Jacques, additional, de Galitiis, Federica, additional, Schadendorf, Dirk, additional, Carlino, Matteo S., additional, Wu, Xi Lawrence, additional, Fukunaga-Kalabis, Mizuho, additional, Krepler, Clemens, additional, Eggermont, Alexander M.M., additional, and Long, Georgina V., additional

Published
2024
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12. Adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study

Author

Khattak, Muhammad A., Luke, Jason J., Long, Georgina V., Ascierto, Paolo A., Rutkowski, Piotr, Schadendorf, Dirk, Robert, Caroline, Grob, Jean-Jacques, de la Cruz Merino, Luis, Del Vecchio, Michele, Spagnolo, Francesco, Mackiewicz, Jacek, Chiarion-Sileni, Vanna, Carlino, Matteo S., Mohr, Peter, De Galitiis, Federica, Ross, Merrick I., Eroglu, Zeynep, Chen, Ke, Jiang, Ruixuan, Fukunaga-Kalabis, Mizuho, Krepler, Clemens, Eggermont, Alexander M.M., and Kirkwood, John M.

Published
2022
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13. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trial

Author

Long, Georgina V, Luke, Jason J, Khattak, Muhammad A, de la Cruz Merino, Luis, Del Vecchio, Michele, Rutkowski, Piotr, Spagnolo, Francesco, Mackiewicz, Jacek, Chiarion-Sileni, Vanna, Kirkwood, John M, Robert, Caroline, Grob, Jean-Jacques, de Galitiis, Federica, Schadendorf, Dirk, Carlino, Matteo S, Mohr, Peter, Dummer, Reinhard, Gershenwald, Jeffrey E, Yoon, Charles H, Wu, Xi Lawrence, Fukunaga-Kalabis, Mizuho, Krepler, Clemens, Eggermont, Alexander M M, and Ascierto, Paolo A

Published
2022
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14. Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria

Author

Larkin, James, Weber, Jeffrey, Del Vecchio, Michele, Gogas, Helen, Arance, Ana M., Dalle, Stephane, Cowey, C. Lance, Schenker, Michael, Grob, Jean-Jacques, Chiarion-Sileni, Vanna, Márquez-Rodas, Iván, Butler, Marcus O., Di Giacomo, Anna Marie, Middleton, Mark R., De la Cruz-Merino, Luis, Arenberger, Petr, Atkinson, Victoria, Hill, Andrew, Fecher, Leslie A., Millward, Michael, Khushalani, Nikhil I., Queirolo, Paola, Long, Georgina V., Lobo, Maurice, Askelson, Margarita, Ascierto, Paolo A., and Mandalá, Mario

Published
2022
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15. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial

Author

Luke, Jason J, Rutkowski, Piotr, Queirolo, Paola, Del Vecchio, Michele, Mackiewicz, Jacek, Chiarion-Sileni, Vanna, de la Cruz Merino, Luis, Khattak, Muhammad A, Schadendorf, Dirk, Long, Georgina V, Ascierto, Paolo A, Mandala, Mario, De Galitiis, Federica, Haydon, Andrew, Dummer, Reinhard, Grob, Jean-Jacques, Robert, Caroline, Carlino, Matteo S, Mohr, Peter, Poklepovic, Andrew, Sondak, Vernon K, Scolyer, Richard A, Kirkwood, John M, Chen, Ke, Diede, Scott J, Ahsan, Sama, Ibrahim, Nageatte, and Eggermont, Alexander M M

Published
2022
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17. Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation–positive melanoma

Author

Dréno, Brigitte, Ascierto, Paolo A, Atkinson, Victoria, Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Dutriaux, Caroline, Garbe, Claus, Bartley, Karen, Karagiannis, Thomas, Chang, Ilsung, Rooney, Isabelle, Koralek, Daniel O, Larkin, James, McArthur, Grant A, and Ribas, Antoni

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Antineoplastic Combined Chemotherapy Protocols, Azetidines, Double-Blind Method, Female, Humans, Longitudinal Studies, Male, Melanoma, Mutation, Piperidines, Placebos, Proto-Oncogene Proteins B-raf, Quality of Life, Vemurafenib, vemurafenib, cobimetinib, MEK inhibitor, BRAF inhibitor, HRQOL, EORTC QLQ-C30, metastatic melanoma, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundIn the coBRIM study, cobimetinib plus vemurafenib (C+V) significantly improved survival outcomes vs placebo and vemurafenib (P+V) in patients with advanced/metastatic BRAFV600-mutated melanoma. An analysis of health-related quality of life (HRQOL) from coBRIM is reported.MethodsPatients completing the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline and ⩾1 time point thereafter constituted the analysis population. Change from baseline ⩾10 points was considered clinically meaningful.ResultsMean baseline scores for all QLQ-C30 domains were similar between arms. Most on-treatment scores for QLQ-C30 domains were also comparable between arms. A transient deterioration in role function in cycle 1 day 15 (C1D15; -14.7 points) in the P+V arm and improvement in insomnia in the C+V arm at C2D15 (-12.4 points) was observed. Among patients who experienced a ⩾10-point change from baseline (responders), between-group differences were greatest for insomnia (16%), social functioning (10%), fatigue (9%) and pain (7%), all favouring C+V. Diarrhoea, photosensitivity reaction, pyrexia, and rash did not meaningfully affect global health status (GHS). Serous retinopathy was associated with a transient decrease in GHS at C1D15 assessment.ConclusionsIn patients with advanced/metastatic BRAFV600-mutated melanoma, treatment with C+V maintained HRQOL compared with P+V, with superior efficacy.

Published
2018

18. Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study

Author

de la Cruz-Merino, Luis, Di Guardo, Lorenza, Grob, Jean-Jacques, Venosa, Alfredo, Larkin, James, McArthur, Grant A, Ribas, Antoni, Ascierto, Paolo A, Evans, Jeffrey TR, Gomez-Escobar, Antonio, Barteselli, Giulio, Eng, Susan, Hsu, Jessie J, Uyei, Anne, and Dréno, Brigitte

Subjects
Eye Disease and Disorders of Vision, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Eye, Adult, Aged, Azetidines, Central Serous Chorioretinopathy, Female, Humans, Indoles, Male, Melanoma, Middle Aged, Mutation, Piperidines, Proto-Oncogene Proteins B-raf, Recurrence, Skin Neoplasms, Sulfonamides, Time Factors, Vemurafenib, Cobimetinib, MEK inhibition, Serous retinopathy, Visual disturbance, Medical and Health Sciences, Immunology
Abstract

BackgroundSerous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with BRAF V600-mutated melanoma treated in the Phase III coBRIM study.MethodsIn the coBRIM study, 493 patients were treated in two randomly assigned treatment groups: cobimetinib and vemurafenib (n = 247) or vemurafenib (n = 246). All patients underwent prospective ophthalmic examinations at screening, at regular intervals during the study, and whenever ocular symptoms developed. Patients with serous retinopathy were identified in the study database using a group of relevant and synonymous adverse event terms.ResultsEighty-six serous retinopathy events were reported in 70 patients (79 events in 63 cobimetinib and vemurafenib-treated patients vs seven events in seven vemurafenib-treated patients). Most patients with serous retinopathy identified by ophthalmic examination had no symptoms or had mild symptoms, among them reduced visual acuity, blurred vision, dyschromatopsia, and photophobia. Serous retinopathy usually occurred early during cobimetinib and vemurafenib treatment; median time to onset was 1.0 month. Most events were managed by observation and continuation of cobimetinib without dose modification and resolved or were resolving by the data cutoff date (19 Sept 2014).ConclusionsCobimetinib treatment was associated with serous retinopathy in patients with BRAF V600-mutated melanoma. Retinopathy was generally asymptomatic or mild. Periodic ophthalmologic evaluations at regular intervals and at the manifestation of any visual disturbance are recommended to facilitate early detection and resolution of serous retinopathy while patients are taking cobimetinib. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012.

Published
2017

19. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Outcomes in histopathologic subgroups from the randomized, double-blind, phase 3 KEYNOTE-716 trial

Author

Schadendorf, Dirk, primary, Luke, Jason John, additional, Ascierto, Paolo A, additional, Long, Georgina V, additional, Rutkowski, Piotr, additional, Khattak, Adnan, additional, Del Vecchio, Michele, additional, de la Cruz-Merino, Luis, additional, Mackiewicz, Jacek, additional, Sileni, Vanna Chiarion, additional, Kirkwood, John M, additional, Robert, Caroline, additional, Grob, Jean-Jacques, additional, Dummer, Reinhard, additional, Carlino, Matteo S, additional, Zhao, Yujie, additional, Kalabis, Mizuho, additional, Krepler, Clemens, additional, Eggermont, Alexander, additional, and Scolyer, Richard A, additional

Published
2024
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20. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Outcomes in histopathologic subgroups from the randomized, double-blind, phase 3 KEYNOTE-716 trial

Author

Schadendorf, Dirk; https://orcid.org/0000-0003-3524-7858, Luke, Jason John; https://orcid.org/0000-0002-1182-4908, Ascierto, Paolo A; https://orcid.org/0000-0002-8322-475X, Long, Georgina V; https://orcid.org/0000-0001-8894-3545, Rutkowski, Piotr; https://orcid.org/0000-0002-8920-5429, Khattak, Adnan, Del Vecchio, Michele, de la Cruz-Merino, Luis; https://orcid.org/0000-0002-5333-0535, Mackiewicz, Jacek, Sileni, Vanna Chiarion, Kirkwood, John M; https://orcid.org/0000-0002-3570-4476, Robert, Caroline; https://orcid.org/0000-0002-9493-0238, Grob, Jean-Jacques; https://orcid.org/0000-0002-0667-153X, Dummer, Reinhard; https://orcid.org/0000-0002-2279-6906, Carlino, Matteo S, Zhao, Yujie; https://orcid.org/0000-0003-2896-4955, Kalabis, Mizuho, Krepler, Clemens, Eggermont, Alexander, Scolyer, Richard A; https://orcid.org/0000-0002-8991-0013, Schadendorf, Dirk; https://orcid.org/0000-0003-3524-7858, Luke, Jason John; https://orcid.org/0000-0002-1182-4908, Ascierto, Paolo A; https://orcid.org/0000-0002-8322-475X, Long, Georgina V; https://orcid.org/0000-0001-8894-3545, Rutkowski, Piotr; https://orcid.org/0000-0002-8920-5429, Khattak, Adnan, Del Vecchio, Michele, de la Cruz-Merino, Luis; https://orcid.org/0000-0002-5333-0535, Mackiewicz, Jacek, Sileni, Vanna Chiarion, Kirkwood, John M; https://orcid.org/0000-0002-3570-4476, Robert, Caroline; https://orcid.org/0000-0002-9493-0238, Grob, Jean-Jacques; https://orcid.org/0000-0002-0667-153X, Dummer, Reinhard; https://orcid.org/0000-0002-2279-6906, Carlino, Matteo S, Zhao, Yujie; https://orcid.org/0000-0003-2896-4955, Kalabis, Mizuho, Krepler, Clemens, Eggermont, Alexander, and Scolyer, Richard A; https://orcid.org/0000-0002-8991-0013

Abstract

Background: Adjuvant pembrolizumab significantly improved recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) versus placebo in the phase 3 KEYNOTE-716 study of resected stage IIB or IIC melanoma. At the prespecified third interim analysis (data cut-off, January 4, 2022), the HR for RFS in the overall population was 0.64 (95% CI, 0.50 to 0.84) and the HR for DMFS was 0.64 (95% CI, 0.47 to 0.88). We present a post hoc analysis of efficacy by subtypes defined by histopathologic characteristics. Methods: Patients aged ≥12 years with newly diagnosed, resected stage IIB or IIC melanoma were randomly assigned (1:1) to pembrolizumab 200 mg every 3 weeks (2 mg/kg up to 200 mg for pediatric patients) or placebo. The primary end point was RFS per investigator review; DMFS per investigator review was secondary. Subgroups of interest were melanoma subtype (nodular vs non-nodular), tumor thickness (≤4 mm vs >4 mm), presence of ulceration (yes vs no), mitotic rate (<5 per mm$^{2}$(median) vs ≥5 per mm$^{2}$), and presence of tumor-infiltrating lymphocytes (TILs; absent vs present). Results: Between September 23, 2018, and November 4, 2020, 976 patients were assigned to pembrolizumab (n=487) or placebo (n=489). Median follow-up was 27.4 months (range, 14.0–39.4). The HR (95% CI) for RFS was 0.54 (0.37 to 0.79) for nodular and 0.77 (0.53 to 1.11) for non-nodular melanoma; 0.57 (0.37 to 0.89) for thickness ≤4 mm and 0.69 (0.50 to 0.96) for >4 mm; 0.66 (0.50 to 0.89) for ulceration and 0.57 (0.32 to 1.03) for no ulceration; 0.57 (0.35 to 0.92) for mitotic rate <5 per mm$^{2}$and 0.57 (0.40 to 0.80) for ≥5 per mm$^{2}$; and 0.89 (0.52 to 1.54) for TILs absent and 0.51 (0.34 to 0.76) for TILs present. DMFS results were similar. In a Cox multivariate analysis, treatment arm, tumor thickness, and mitotic rate were significant independent factors for RFS, and treatment arm and mitotic rate were significant independent factors for DMFS. Conclusions: In this post hoc

Published
2024

21. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Outcomes in histopathologic subgroups from the randomized, double-blind, phase 3 KEYNOTE-716 trial

Author

Schadendorf, Dirk, Luke, Jason J., Ascierto, Paolo A., Long, Georgina V., Rutkowski, Piotr, Khattak, Adnan, Del Vecchio, Michele, De La Cruz-Merino, Luis, Mackiewicz, Jacek, Sileni, Vanna C., Kirkwood, John M., Robert, Caroline, Grob, Jean-Jacques, Dummer, Reinhard, Carlino, Matteo S., Zhao, Yujie, Kalabis, Mizuho, Krepler, Clemens, Eggermont, Alexander, Scolyer, Richard A., Schadendorf, Dirk, Luke, Jason J., Ascierto, Paolo A., Long, Georgina V., Rutkowski, Piotr, Khattak, Adnan, Del Vecchio, Michele, De La Cruz-Merino, Luis, Mackiewicz, Jacek, Sileni, Vanna C., Kirkwood, John M., Robert, Caroline, Grob, Jean-Jacques, Dummer, Reinhard, Carlino, Matteo S., Zhao, Yujie, Kalabis, Mizuho, Krepler, Clemens, Eggermont, Alexander, and Scolyer, Richard A.

Abstract

Background Adjuvant pembrolizumab significantly improved recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) versus placebo in the phase 3 KEYNOTE-716 study of resected stage IIB or IIC melanoma. At the prespecified third interim analysis (data cut-off, January 4, 2022), the HR for RFS in the overall population was 0.64 (95% CI, 0.50 to 0.84) and the HR for DMFS was 0.64 (95% CI, 0.47 to 0.88). We present a post hoc analysis of efficacy by subtypes defined by histopathologic characteristics. Methods Patients aged ≥ 12 years with newly diagnosed, resected stage IIB or IIC melanoma were randomly assigned (1:1) to pembrolizumab 200 mg every 3 weeks (2 mg/kg up to 200 mg for pediatric patients) or placebo. The primary end point was RFS per investigator review; DMFS per investigator review was secondary. Subgroups of interest were melanoma subtype (nodular vs non-nodular), tumor thickness ( ≤ 4 mm vs > 4 mm), presence of ulceration (yes vs no), mitotic rate ( < 5 per mm 2 (median) vs ≥ 5 per mm 2), and presence of tumor-infiltrating lymphocytes (TILs; absent vs present). Results Between September 23, 2018, and November 4, 2020, 976 patients were assigned to pembrolizumab (n=487) or placebo (n=489). Median follow-up was 27.4 months (range, 14.0-39.4). The HR (95% CI) for RFS was 0.54 (0.37 to 0.79) for nodular and 0.77 (0.53 to 1.11) for non-nodular melanoma; 0.57 (0.37 to 0.89) for thickness ≤ 4 mm and 0.69 (0.50 to 0.96) for > 4 mm; 0.66 (0.50 to 0.89) for ulceration and 0.57 (0.32 to 1.03) for no ulceration; 0.57 (0.35 to 0.92) for mitotic rate < 5 per mm 2 and 0.57 (0.40 to 0.80) for ≥ 5 per mm 2; and 0.89 (0.52 to 1.54) for TILs absent and 0.51 (0.34 to 0.76) for TILs present. DMFS results were similar. In a Cox multivariate analysis, treatment arm, tumor thickness, and mitotic rate were significant independent factors for RFS, and treatment arm and mitotic rate were significant independent factors for DMFS. Conclusions In this post hoc analysi

Published
2024

22. Adjuvant nivolumab versus ipilimumab in resected stage IIIB–C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial

Author

Ascierto, Paolo A, Del Vecchio, Michele, Mandalá, Mario, Gogas, Helen, Arance, Ana M, Dalle, Stephane, Cowey, C Lance, Schenker, Michael, Grob, Jean-Jacques, Chiarion-Sileni, Vanna, Márquez-Rodas, Iván, Butler, Marcus O, Maio, Michele, Middleton, Mark R, de la Cruz-Merino, Luis, Arenberger, Petr, Atkinson, Victoria, Hill, Andrew, Fecher, Leslie A, Millward, Michael, Khushalani, Nikhil I, Queirolo, Paola, Lobo, Maurice, de Pril, Veerle, Loffredo, John, Larkin, James, and Weber, Jeffrey

Published
2020
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24. Cancer Nano-Immunotherapy: The Novel and Promising Weapon to Fight Cancer

Author

García-Domínguez, Daniel J., primary, López-Enríquez, Soledad, additional, Alba, Gonzalo, additional, Garnacho, Carmen, additional, Jiménez-Cortegana, Carlos, additional, Flores-Campos, Rocío, additional, de la Cruz-Merino, Luis, additional, Hajji, Nabil, additional, Sánchez-Margalet, Víctor, additional, and Hontecillas-Prieto, Lourdes, additional

Published
2024
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26. Circulating myeloid-derived suppressor cells may be a useful biomarker in the follow-up of unvaccinated COVID-19 patients after hospitalization

Author

Jiménez-Cortegana, Carlos, primary, Salamanca, Elena, additional, Palazón-Carrión, Natalia, additional, Sánchez-Jiménez, Flora, additional, Pérez-Pérez, Antonio, additional, Vilariño-García, Teresa, additional, Fuentes, Sandra, additional, Martín, Salomón, additional, Jiménez, Marta, additional, Galván, Raquel, additional, Rodríguez-Chacón, Carmen, additional, Sánchez-Mora, Catalina, additional, Moreno-Mellado, Elisa, additional, Gutiérrez-Gutiérrez, Belén, additional, Álvarez, Nerissa, additional, Sosa, Alberto, additional, Garnacho-Montero, José, additional, de la Cruz-Merino, Luis, additional, Rodríguez-Baño, Jesús, additional, and Sánchez-Margalet, Víctor, additional

Published
2023
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32. Supplementary Data 1 from Adjuvant Nivolumab versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results from CheckMate 238

Author

Larkin, James, primary, Del Vecchio, Michele, primary, Mandalá, Mario, primary, Gogas, Helen, primary, Arance Fernandez, Ana M., primary, Dalle, Stéphane, primary, Cowey, Charles Lance, primary, Schenker, Michael, primary, Grob, Jean-Jacques, primary, Chiarion-Sileni, Vanna, primary, Marquez-Rodas, Ivan, primary, Butler, Marcus O., primary, Di Giacomo, Anna Maria, primary, Middleton, Mark R., primary, Lutzky, Jose, primary, de la Cruz-Merino, Luis, primary, Arenberger, Petr, primary, Atkinson, Victoria, primary, Hill, Andrew G., primary, Fecher, Leslie A., primary, Millward, Michael, primary, Nathan, Paul D., primary, Khushalani, Nikhil I., primary, Queirolo, Paola, primary, Ritchings, Corey, primary, Lobo, Maurice, primary, Askelson, Margarita, primary, Tang, Hao, primary, Dolfi, Sonia, primary, Ascierto, Paolo A., primary, and Weber, Jeffrey, primary

Published
2023
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33. Data from Adjuvant Nivolumab versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results from CheckMate 238

Author

Larkin, James, primary, Del Vecchio, Michele, primary, Mandalá, Mario, primary, Gogas, Helen, primary, Arance Fernandez, Ana M., primary, Dalle, Stéphane, primary, Cowey, Charles Lance, primary, Schenker, Michael, primary, Grob, Jean-Jacques, primary, Chiarion-Sileni, Vanna, primary, Marquez-Rodas, Ivan, primary, Butler, Marcus O., primary, Di Giacomo, Anna Maria, primary, Middleton, Mark R., primary, Lutzky, Jose, primary, de la Cruz-Merino, Luis, primary, Arenberger, Petr, primary, Atkinson, Victoria, primary, Hill, Andrew G., primary, Fecher, Leslie A., primary, Millward, Michael, primary, Nathan, Paul D., primary, Khushalani, Nikhil I., primary, Queirolo, Paola, primary, Ritchings, Corey, primary, Lobo, Maurice, primary, Askelson, Margarita, primary, Tang, Hao, primary, Dolfi, Sonia, primary, Ascierto, Paolo A., primary, and Weber, Jeffrey, primary

Published
2023
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36. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results from CheckMate 238

Author

Larkin, James, primary, Del Vecchio, Michele, additional, Mandalá, Mario, additional, Gogas, Helen, additional, Arance Fernandez, Ana M., additional, Dalle, Stéphane, additional, Cowey, Charles Lance, additional, Schenker, Michael, additional, Grob, Jean-Jacques, additional, Chiarion-Sileni, Vanna, additional, Marquez-Rodas, Ivan, additional, Butler, Marcus O., additional, Di Giacomo, Anna Maria, additional, Middleton, Mark R., additional, Lutzky, Jose, additional, de la Cruz-Merino, Luis, additional, Arenberger, Petr, additional, Atkinson, Victoria, additional, Hill, Andrew G., additional, Fecher, Leslie A., additional, Millward, Michael, additional, Nathan, Paul D., additional, Khushalani, Nikhil I., additional, Queirolo, Paola, additional, Ritchings, Corey, additional, Lobo, Maurice, additional, Askelson, Margarita, additional, Tang, Hao, additional, Dolfi, Sonia, additional, Ascierto, Paolo A., additional, and Weber, Jeffrey, additional

Published
2023
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37. Supplementary Data from Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis

Author

Palazón-Carrión, Natalia, primary, Martín García-Sancho, Alejandro, primary, Nogales-Fernández, Esteban, primary, Jiménez-Cortegana, Carlos, primary, Carnicero-González, Fernando, primary, Ríos-Herranz, Eduardo, primary, de la Cruz-Vicente, Fátima, primary, Rodríguez-García, Guillermo, primary, Fernández-Álvarez, Rubén, primary, Martínez-Banaclocha, Natividad, primary, Gumà-Padrò, Josep, primary, Gómez-Codina, José, primary, Salar-Silvestre, Antonio, primary, Rodríguez-Abreu, Delvys, primary, Gálvez-Carvajal, Laura, primary, Labrador, Jorge, primary, Guirado-Risueño, María, primary, García-Domínguez, Daniel J., primary, Hontecillas-Prieto, Lourdes, primary, Espejo-García, Pablo, primary, Fernández-Román, Isabel, primary, Provencio-Pulla, Mariano, primary, Sánchez-Beato, Margarita, primary, Navarro, Marta, primary, Marylene, Lejeune, primary, Álvaro-Naranjo, Tomás, primary, Casanova-Espinosa, Maria, primary, Sánchez-Margalet, Victor, primary, Rueda-Domínguez, Antonio, primary, and de la Cruz-Merino, Luis, primary

Published
2023
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40. Abstract PD11-04: PD11-04 Primary results of SOLTI-1503 PROMETEO phase 2 trial of Combination of Talimogene Laherparepvec (T-VEC) with Atezolizumab in patients with residual breast cancer after standard neoadjuvant multi-agent chemotherapy

Author

Pascual, Tomás, primary, Vidal, Maria, additional, Cejalvo, Juan Miguel, additional, Vega, Estela, additional, Sanfeliu, Esther, additional, Ganau, Sergi, additional, Julve, Ana, additional, Zamora, Esther, additional, Miranda, Ignacio, additional, Delgado, Ana, additional, Bermejo, Begoña, additional, de la Cruz-Merino, Luis, additional, Juan, Manel, additional, Galván, Patricia, additional, Gonzalez-Farré, Xavier, additional, Ferrero-Cafiero, Juan Manuel, additional, Villagrasa, Patricia, additional, Oliveira, Mafalda, additional, and Prat, Aleix, additional

Published
2023
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41. Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial

Author

Ascierto, Paolo A, McArthur, Grant A, Dréno, Brigitte, Atkinson, Victoria, Liszkay, Gabrielle, Di Giacomo, Anna Maria, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Dutriaux, Caroline, Garbe, Claus, Yan, Yibing, Wongchenko, Matthew, Chang, Ilsung, Hsu, Jessie J, Koralek, Daniel O, Rooney, Isabelle, Ribas, Antoni, and Larkin, James

Published
2016
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44. Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915)

Author

Weber, Jeffrey S., primary, Schadendorf, Dirk, additional, Del Vecchio, Michele, additional, Larkin, James, additional, Atkinson, Victoria, additional, Schenker, Michael, additional, Pigozzo, Jacopo, additional, Gogas, Helen, additional, Dalle, Stéphane, additional, Meyer, Nicolas, additional, Ascierto, Paolo A., additional, Sandhu, Shahneen, additional, Eigentler, Thomas, additional, Gutzmer, Ralf, additional, Hassel, Jessica C., additional, Robert, Caroline, additional, Carlino, Matteo S., additional, Di Giacomo, Anna Maria, additional, Butler, Marcus O., additional, Muñoz-Couselo, Eva, additional, Brown, Michael P., additional, Rutkowski, Piotr, additional, Haydon, Andrew, additional, Grob, Jean-Jacques, additional, Schachter, Jacob, additional, Queirolo, Paola, additional, de la Cruz-Merino, Luis, additional, van der Westhuizen, Andre, additional, Menzies, Alexander M., additional, Re, Sandra, additional, Bas, Tuba, additional, de Pril, Veerle, additional, Braverman, Julia, additional, Tenney, Daniel J., additional, Tang, Hao, additional, and Long, Georgina V., additional

Published
2023
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45. Prognostic Implications of the Residual Tumor Microenvironment after Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer Patients without Pathological Complete Response

Author

Lejeune, Marylène, primary, Reverté, Laia, additional, Sauras, Esther, additional, Gallardo, Noèlia, additional, Bosch, Ramon, additional, Roso, Albert, additional, Petit, Anna, additional, Peg, Vicente, additional, Riu, Francisco, additional, García-Fontgivell, Joan, additional, Ibáñez, José, additional, Relea, Fernanda, additional, Vieites, Begoña, additional, Bor, Catherine, additional, de la Cruz-Merino, Luis, additional, Arenas, Meritxell, additional, Rodriguez, Valerie, additional, Galera, Juana, additional, Korzynska, Anna, additional, Belhomme, Philippe, additional, Plancoulaine, Benoît, additional, Álvaro, Tomás, additional, and López, Carlos, additional

Published
2023
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46. Phase II LEAP-004 Study of Lenvatinib Plus Pembrolizumab for Melanoma With Confirmed Progression on a Programmed Cell Death Protein-1 or Programmed Death Ligand 1 Inhibitor Given as Monotherapy or in Combination

Author

Arance, Ana, primary, de la Cruz-Merino, Luis, additional, Petrella, Teresa M., additional, Jamal, Rahima, additional, Ny, Lars, additional, Carneiro, Ana, additional, Berrocal, Alfonso, additional, Márquez-Rodas, Ivan, additional, Spreafico, Anna, additional, Atkinson, Victoria, additional, Costa Svedman, Fernanda, additional, Mant, Andrew, additional, Khattak, Muhammad A., additional, Mihalcioiu, Catalin, additional, Jang, Sekwon, additional, Cowey, C. Lance, additional, Smith, Alan D., additional, Hawk, Natalyn, additional, Chen, Ke, additional, Diede, Scott J., additional, Krepler, Clemens, additional, and Long, Georgina V., additional

Published
2023
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47. Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial

Author

Tibau, Ariadna, primary, Martínez, M. Teresa, additional, Ramos, Manuel, additional, De La Cruz-Merino, Luis, additional, Santaballa, Ana, additional, O’Connor, Miriam, additional, Martínez-Jañez, Noelia, additional, Moreno, Fernando, additional, Fernández, Isaura, additional, Virizuela, Juan Antonio, additional, Alarcón, Jesús, additional, de La Haba-Rodríguez, Juan, additional, Sánchez-Rovira, Pedro, additional, Albacar, Cinta Rosa, additional, Bueno Muiño, Coralia, additional, Kelly, Catherine, additional, Casas, Maribel, additional, Bezares, Susana, additional, Rosell, Libertad, additional, and Albanell, Joan, additional

Published
2023
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48. Obesity and Risk for Lymphoma: Possible Role of Leptin

Author

Jiménez-Cortegana, Carlos, primary, Hontecillas-Prieto, Lourdes, additional, García-Domínguez, Daniel J., additional, Zapata, Fernando, additional, Palazón-Carrión, Natalia, additional, Sánchez-León, María L., additional, Tami, Malika, additional, Pérez-Pérez, Antonio, additional, Sánchez-Jiménez, Flora, additional, Vilariño-García, Teresa, additional, de la Cruz-Merino, Luis, additional, and Sánchez-Margalet, Víctor, additional

Published
2022
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49. Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2– advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial

Author

Salvador Bofill, Javier, primary, Moreno Anton, Fernando, additional, Rodriguez Sanchez, Cesar Augusto, additional, Galve Calvo, Elena, additional, Hernando Melia, Cristina, additional, Ciruelos Gil, Eva Maria, additional, Vidal, Maria, additional, Jiménez-Rodriguez, Begoña, additional, De la Cruz Merino, Luis, additional, Martínez Jañez, Noelia, additional, Villanueva Vazquez, Rafael, additional, de Toro Salas, Ruben, additional, Anton Torres, Antonio, additional, Alvarez Lopez, Isabel Manuela, additional, Gavila Gregori, Joaquin, additional, Quiroga Garcia, Vanesa, additional, Vicente Rubio, Elena, additional, De la Haba-Rodriguez, Juan, additional, Gonzalez-Santiago, Santiago, additional, Diaz Fernandez, Nieves, additional, Barnadas Molins, Agusti, additional, Cantos Sanchez de Ibargüen, Blanca, additional, Delgado Mingorance, Juan Ignacio, additional, Bellet Ezquerra, Meritxell, additional, de Casa, Sonia, additional, Gimeno, Asuncion, additional, and Martin, Miguel, additional

Published
2022
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