Cruz-Merino, L. (Luis) de la
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- GEICAM Guidelines for the Management of Patients with Breast Cancer During the COVID-19 Pandemic in Spain(2020) Algara, M. (Manel); López-Tarruella, S. (Sara); Cruz, J. (Josefina); Jara, C. (Carlos); Montero, Á. (Ángel); García-Sáenz, J.Á. (José Ángel); Gimenez, J. (Julia); Santisteban, M. (Marta); Moreno, F. (Fernando); Chacón, J.I. (José Ignacio); Cruz-Merino, L. (Luis) de la; Martín, M. (Miguel); Rojo-Todo, F. (Federico); Filipovich, E. (Elena); Alés, J.E. (José Enrique); Guerrero-Zotano, A. (Angel)Breast cancer (BC) is the most common cancer in women in Spain. During the COVID-19 pandemic caused by the SARSCoV-2 virus, patients with BC still require timely treatment and follow-up; however, hospitals are overwhelmed with infected patients and, if exposed, patients with BC are at higher risk for infection and serious complications if infected. Thus, health care providers need to evaluate each BC treatment and in-hospital visit to minimize pandemic-associated risks while maintaining adequate treatment efficacy. Here we present a set of guidelines regarding available options for BC patient management and treatment by BC subtype in the context of the COVID-19 pandemic. Owing to the lack of evidence about COVID-19 infection, these recommendations are mainly based on expert opinion, medical organizations’ and societies’ recommendations, and some published evidence. We consider this a useful tool to facilitate medical decision making in this health crisis situation we are facing.
- Nivolumab plus ipilimumab for treatment-naïve metastatic uveal melanoma: An open-label, multicenter, phase II trial by the spanish multidisciplinary melanoma group (GEM-1402)(Asco, 2020) Varela, M. (Mar); Rodríguez-Abreu, D. (Delvys); Rullan, A.J. (Antonio J.); Martin-Algarra, S. (Salvador); Goma, M. (Montserrat); López-Castro, R. (Rafael); Curiel, T. (Teresa); Carrión, L.A. (Lorenzo Alonso); Redrado, M. (Miriam); Espinosa, E. (Enrique); Piulats, J.M. (José María); Cruz-Merino, L. (Luis) de la; Berrocal, A. (Alfonso); Calvo-González, A. (Alfonso)Purpose: This study aimed to assess the efficacy of the combination of nivolumab (nivo) plus ipilimumab (ipi) as a first-line therapy with respect to the 12-month overall survival (OS) in patients with metastatic uveal melanoma (MUM) who are not eligible for liver resection. Methods: This was a single-arm, phase II trial led by the Spanish Multidisciplinary Melanoma Group (GEM) on nivo plus ipi for systemic treatment-naïve patients of age > 18 years, with histologically confirmed MUM, Eastern Cooperative Oncology Group-PS 0/1, and confirmed progressive metastatic disease (M1). Nivo (1 mg/kg once every 3 weeks) and ipi (3 mg/kg once every 3 weeks) were administered during four inductions, followed by nivo (3 mg/kg once every 2 weeks) until progressive disease, toxicity, or withdrawal. The primary end point was 12-month OS. OS, progression-free survival (PFS), and overall response rate were evaluated every 6 weeks using RECIST (v1.1). Safety was also evaluated. Logistic regression and Cox proportional hazard models comprising relevant clinical factors were used to evaluate the potential association with response to treatment and survival. Cytokines were quantified in serum samples for their putative role in immune modulation/angiogenesis and/or earlier evidence of involvement in immunotherapy. Results: A total of 52 patients with a median age of 59 years (range, 26-84 years) were enrolled. Overall, 78.8%, 56%, and 32% of patients had liver M1, extra-liver M1, and elevated lactate dehydrogenase. Stable disease was the most common outcome (51.9%). The primary end point was 12-month OS, which was 51.9% (95% CI, 38.3 to 65.5). The median OS and PFS were 12.7 months and 3.0 months, respectively. PFS was influenced by higher LDH values. Conclusions: Nivo plus ipi in the first-line setting for MUM showed a modest improvement in OS over historical benchmarks of chemotherapy, with a manageable toxicity profile.
- Pembrolizumab in combination with gemcitabine for patients with HER2‑negative advanced breast cancer: GEICAM/2015–04 (PANGEA‑Breast) study(Springer, 2022) Andrés, R. (R.); Bezares, S. (S.); Cortes, J. (Javier); Caballero, R. (R.); Cruz, J. (J.); Soto, A. (A.); Ceballos, I.(I.); Cortés, A. (A.); Ramos, M. (Marina); Holgado, E. (E.); Benito, S. (S.); Sánchez-Margalet, V. (V.); Rodríguez, L.M. (L. M.); Quiroga, V. (V.); Chiesa, M. (M.); Santisteban, M. (Marta); Palazón‑Carrión, N. (N.); Henao, F. (F.); Casas, M. (M.); Moreno, F. (Fernando); López‑Miranda, E. (E.); Cruz-Merino, L. (Luis) de la; Jiménez‑Cortegana, C. (C.); Alonso‑Romero, J.L. (J. L.); Rojo-Todo, F. (Federico); Gion, M. (M.); Puertes, A. (A.)Background: We evaluated a new chemoimmunotherapy combination based on the anti-PD1 monoclonal antibody pembrolizumab and the pyrimidine antimetabolite gemcitabine in HER2- advanced breast cancer (ABC) patients previously treated in the advanced setting, in order to explore a potential synergism that could eventually obtain long term benefit in these patients. Methods: HER2-negative ABC patients received 21-day cycles of pembrolizumab 200 mg (day 1) and gemcitabine (days 1 and 8). A run-in-phase (6 + 6 design) was planned with two dose levels (DL) of gemcitabine (1,250 mg/m2 [DL0]; 1,000 mg/m2 [DL1]) to determine the recommended phase II dose (RP2D). The primary objective was objective response rate (ORR). Tumor infiltrating lymphocytes (TILs) density and PD-L1 expression in tumors and myeloid-derived suppressor cells (MDSCs) levels in peripheral blood were analyzed. Results: Fourteen patients were treated with DL0, resulting in RP2D. Thirty-six patients were evaluated during the first stage of Simon's design. Recruitment was stopped as statistical assumptions were not met. The median age was 52; 21 (58%) patients had triple-negative disease, 28 (78%) visceral involvement, and 27 (75%) ≥ 2 metastatic locations. Progression disease was observed in 29 patients. ORR was 15% (95% CI, 5-32). Eight patients were treated ≥ 6 months before progression. Fourteen patients reported grade ≥ 3 treatment-related adverse events. Due to the small sample size, we did not find any clear association between immune tumor biomarkers and treatment efficacy that could identify a subgroup with higher probability of response or better survival. However, patients that experienced a clinical benefit showed decreased MDSCs levels in peripheral blood along the treatment. Conclusion: Pembrolizumab 200 mg and gemcitabine 1,250 mg/m2 were considered as RP2D. The objective of ORR was not met; however, 22% patients were on treatment for ≥ 6 months. ABC patients that could benefit of chemoimmunotherapy strategies must be carefully selected by robust and validated biomarkers. In our heavily pretreated population, TILs, PD-L1 expression and MDSCs levels could not identify a subgroup of patients for whom the combination of gemcitabine and pembrolizumab would induce long term benefit. Trial registration: ClinicalTrials.gov and EudraCT (NCT03025880 and 2016-001,779-54, respectively). Registration dates: 20/01/2017 and 18/11/2016, respectively.
- Frequency and characteristics of familial melanoma in Spain: The FAM-GEM-1 Study(Public Library of Science, 2015) Aviles-Izquierdo, J.A. (José Antonio); Spanish Multidisciplinary Group of Melanoma; Gonzalez-Cao, M. (María); Palomar, V. (Virginia); Soria, A. (Ainara); Campos, B. (Begoña); Perez-Ruiz, E. (Elisabeth); Martin-Algarra, S. (Salvador); Galvez, E. (Elisa); Arance, A. (Ana); Maldonado-Seral, C. (Cayetana); Ochoa-de-Olza, M. (María); Gil-Arnaiz, I. (Irene); Nagore, E. (Eduardo); Martin-Carnicero, A. (Alfonso); Gomez-Fernandez, C. (Cristina); Cerezuela, P. (Pablo); Godoy, E. (Elena); Marques-Rodas, I. (Iván); Puertolas, T. (Teresa); Belon, J. (Joaquín); Cruz-Merino, L. (Luis) de la; Martin-Gonzalez, M. (Manuel); Majem-Tarruella, M. (Margarita); Maseda, R. (Rocío)Similar to that observed in other countries, familial melanoma accounts for 6.6% of melanoma diagnoses in Spain. Although no differences in the multivariate analysis were found, some better prognosis factors, such as Breslow index, seem more frequent in familial melanoma, which reflect a better early detection marker and/or a different biological behavior.