Manzano, J.L. (José Luis)
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- Axitinib treatment in advanced RAI-resistant differentiated thyroid cancer (DTC) and refractory medullary thyroid cancer (MTC)(Oxford University Press, 2017) Grande, E. (Enrique); Zafón, C. (Carles); Porras, I. (Ignacio); Palacios, N. (Nuria); Matos, I. (Ignacio); Medina-Martínez, J. (Javier); Ramon-y-Cajal, T. (Teresa); González-Astorga, B. (Beatriz); Aller, J. (Javier); Trigo, J.M. (Jose Manuel); Manzano, J.L. (José Luis); García-Adrián, S. (Silvia); Cillán, E. (Elena); Duran-Poveda, M. (Manuel); Bohn, U. (Uriel); Reina, J.J. (Juan Jose); Reig, Ó. (Ó.); López-Alfonso, A. (Ana); Capdevila, J. (Jaume); Grau, J.J. (Juan Jose)Background Axitinib, an antiangiogenic multikinase inhibitor (MKI), was evaluated in the compassionate use programme (CUP) in Spain (October 2012–November 2014). Subjects and Methods 47 patients with advanced radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC, n = 34) or medullary thyroid cancer (MTC, n = 13) with documented disease progression were treated with axitinib 5 mg b.i.d. The primary efficacy endpoint was objective response rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Progression-free survival (PFS) and adverse events (AEs) were secondary objectives. Regulatory authorities validated the CUP, and all patients signed informed consent form. Results Axitinib was administered as first-line therapy in 17 patients (36.2%), as second-line in 18 patients (38.3%) and as third/fourth-line in 12 patients (25.5%). With a median follow-up of 11.5 months (0–24.3), ORR was 27.7% (DTC: 29.4% and MTC: 23.1%) and median PFS was 8.1 months (95% CI: 4.1–12.2) (DTC: 7.4 months (95% CI: 3.1–11.8) and MTC: 9.4 months (95% CI: 4.8–13.9)). Better outcomes were reported with first-line axitinib, with an ORR of 53% and a median PFS of 13.6 months compared with 16.7% and 10.6 months as second-line treatment. Twelve (25.5%) patients required dose reduction to 3 mg b.i.d. All-grade AEs included asthenia (53.2%), diarrhoea (36.2%), hypertension (31.9%) and mucositis (29.8%); grade 3/4 AEs included anorexia (6.4%), diarrhoea (4.3%) and cardiac toxicity (4.3%). Conclusion Axitinib had a tolerable safety profile and clinically meaningful activity in refractory and progressive thyroid cancer regardless of histology as first-line therapy. To our knowledge, this is the first time that cross-resistance between MKIs is suggested in thyroid cancer, highlighting the importance of prospective sequential clinical studies.
- SARS-CoV-2 infection in patients with melanoma: results of the Spanish Melanoma Group registry(2023) López-Criado, P. (Pilar); Fernández-Morales, L.A. (Luis Antonio); Boada, A. (Aram); Feito-Rodríguez, M. (Marta); Carrera, C. (Cristina); Yelamos, O. (Oriol); Gonzalez-Cao, M. (María); Luna-Fra, P. (Pablo); Soria, A. (Ainara); Valles, L. (Lara); Antoñanzas-Basa, M. (Mónica); Martin-Algarra, S. (Salvador); Sequero, S. (Silvia); Martin-Liberal, J. (Juan); Villalobos, L. (Laura); Aguayo-Zamora, C. (Cristina); Cruz, R. (Raquel); Marquez-Rodas, I. (Iván); Maldonado-Seral, C. (Cayetana); Manzano, J.L. (José Luis); García-Castaño, A. (Almudena); Puig, S. (Susana); González-Barrallo, I. (Inés); López-Castro, R. (Rafael); Cerezuela, P. (Pablo); Muñoz, E. (Eva); Gardeazabal, J. (Jesús); Rubio, B. (Belén); Feltes-Ochoa, R. (Rosa); Puertolas, T. (Teresa); Drozdowskyj, A. (Ana); Rodrigo, A. (Alberto); Rodríguez-Jiménez, P. (Pedro); Provencio, M. (Mariano); Martínez-Vila, C. (Clara); Berrocal, A. (Alfonso); Crespo, G. (Guillermo); Rodríguez-Moreno, J.F. (Juan Francisco); Mujica, K. (Karmele); Ayala-De-Miguel, P. (Pablo)Background The Spanish Melanoma Group (GEM) developed a national registry of patients with melanoma infected by SARS-CoV-2 ( GRAVID ).Methods The main objective was to describe the COVID-19 fatality rate in patients with melanoma throughout the pandemic, as well as to explore the effect of melanoma treatment and tumor stage on the risk of COVID-19 complications. These are the final data of the register, including cases from February 2020 to September 2021.Results One hundred-fifty cases were registered. Median age was 68 years (range 6-95), 61 (40%) patients were females, and 63 (42%) patients had stage IV. Thirty-nine (26%) were on treatment with immunotherapy, and 17 (11%) with BRAF-MEK inhibitors. COVID-19 was resolved in 119 cases, including 85 (57%) patients cured, 15 (10%) that died due to melanoma, and 20 (13%) that died due to COVID-19. Only age over 60 years, cardiovascular disorders, and diabetes mellitus increased the risk of death due to COVID-19, but not advanced melanoma stage nor melanoma systemic therapies. Three waves have been covered by the register: February-May 2020, August-November 2020, and December 2020-April 2021. The first wave had the highest number of registered cases and COVID-19 mortality.Conclusion Tumor stage or melanoma treatments are non-significant prognostic factors for COVID-19 mortality. During the pandemic in Spain there was a downward trend in the number of patients registered across the waves, as well as in the severity of the infection.
- Phase II study of weekly Kahalalide F in patients with advanced malignant melanoma(Elsevier BV, 2009) Martin-Algarra, S. (Salvador); Plazaola, A. (Arrate); Manzano, J.L. (José Luis); López-López, J.; Carrión, L.A. (Lorenzo Alonso); Paz-Ares, L. (Luis); Espinosa, E. (Enrique); Tanovic, A. (Adnan); Rubio, J. (Jordi)This phase II clinical trial evaluated the antitumour response of Kahalalide F (KF) 650 lg/m2 given as a 1-h weekly infusion in advanced malignant melanoma patients, both untreated and those who relapsed or progressed after one line of systemic therapy. Of 24 enrolled patients (median age, 55 years; range, 28–89), 14 patients had been previously treated with chemotherapy or biological therapy. No RECIST responses occurred; five chemotherapynaı¨ve patients with cutaneous melanoma had disease stabilisation for P3 months; median progression-free survival was 1.7 months (95% CI, 1.2–1.9 months); and median overall survival was 10.8 months (95% CI, 5.0-upper limit not reached). The most common laboratory toxicities were non-cumulative increase of transaminases (ALT/AST) and gamma-glutamyltransferase (GGT). No patients experienced leukopenia and thrombocytopenia during the study. KF was a well-tolerated and safe chemotherapy regimen. Despite a favourable safety profile, this trial was closed after the first stage because of the lack of objective response in patients with malignant melanoma