Rojo-Todo, F. (Federico)
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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.
- Assessment of a New ROS1 Immunohistochemistry Clone (SP384) for the Identification of ROS1 Rearrangements in Patients with Non–Small Cell Lung Carcinoma: the ROSING Study(Elsevier BV, 2019) Gonzalez-Larriba, J.L. (José Luis); Plaza, M.L. (María Luz); Rodríguez-Abreu, D. (Delvys); Domine, M. (Manuel); Lozano, M.D. (María Dolores); García-González, J (Jorge); Enguita, A.B. (Ana Belén); Gomez-Roman, J. (Javier); Lázaro-Quintela, M. (Martín); Aguiar, D. (David); Saiz, M. (Mónica); Felip, E. (Enriqueta); Muriel, A. (Alfonso); López-Brea, M. (Marta); Mancheño, N. (Nuria); Arriola, E. (Edurne); Conde, E. (Esther); Garrido, P. (Pilar); Atienza-Cuevas, L. (Lidia); González-Piñeiro, A. (Ana); Jiménez, B. (Beatriz); Gurpide, A. (Alfonso); Martínez-Turrillas, R. (Rebeca); Arriola-Arellano, E. (Esperanza); Esteban-Rodríguez, I. (Isabel); Teixidó, C. (Cristina); Company, A. (Amparo); Aranda, I. (Ignacio); Hernández, S. (Susana); Moran, T. (Teresa); Castro, J. (Javier) de; Camacho, C. (Carmen); Benito, A. (Amparo); Álvarez, R. (Ramiro); Paz-Ares, L. (Luis); Mate, J.L. (Jose Luis); Sansano, I. (Irene); Reguart, N. (Noemi); López-Ríos, F. (Fernando); Artal, Á. (Ángel); Angulo, B. (Bárbara); Juan, O. (Oscar); García, F. (Felip); Abdulkader, I. (Ihab); Salido, M. (Marta); Sanz, J. (Julián); Collazo-Lorduy, A. (Ana); Rojo-Todo, F. (Federico); Insa, A. (Amelia); Pijuan, L. (Lara); Massuti, B. (Bartomeu); Azcona, E. (Eider)Introduction: The ROS1 gene rearrangement has become an important biomarker in NSCLC. The College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology testing guidelines support the use of ROS1 immunohistochemistry (IHC) as a screening test, followed by confirmation with fluorescence in situ hybridization (FISH) or a molecular test in all positive results. We have evaluated a novel anti-ROS1 IHC antibody (SP384) in a large multicenter series to obtain real-world data. Methods: A total of 43 ROS1 FISH-positive and 193 ROS1 FISH-negative NSCLC samples were studied. All specimens were screened by using two antibodies (clone D4D6 from Cell Signaling Technology and clone SP384 from Ventana Medical Systems), and the different interpretation criteria were compared with break-apart FISH (Vysis). FISH-positive samples were also analyzed with next-generation sequencing (Oncomine Dx Target Test Panel, Thermo Fisher Scientific). Results: An H-score of 150 or higher or the presence of at least 70% of tumor cells with an intensity of staining of 2+ or higher by the SP384 clone was the optimal cutoff value (both with 93% sensitivity and 100% specificity). The D4D6 clone showed similar results, with an H-score of at least 100 (91% sensitivity and 100% specificity). ROS1 expression in normal lung was more frequent with use of the SP384 clone (p < 0.0001). The ezrin gene (EZR)-ROS1 variant was associated with membranous staining and an isolated green signal FISH pattern (p = 0.001 and p = 0.017, respectively). Conclusions: The new SP384 ROS1 IHC clone showed excellent sensitivity without compromising specificity, so it is another excellent analytical option for the proposed testing algorithm.
- 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.
- Combination of KIR2DS4 and FcγRIIa polymorphisms predicts the response to cetuximab in KRAS mutant metastatic colorectal cancer(Nature Publishing Group, 2019) Hernandez, I. (I.); Cervantes, A. (Andrés); Rodríguez, J. (J.); Puime-Otin, A. (A.); Valladares, M. (M.); Vega-Bravo, R. (R.); Cebrián, A. (A.); Borrero-Palacios, A. (A.); Garcia-Alfonso, P. (P.); Vieitez, J.M. (J. M.); Rodríguez-Remírez, M. (M.); Garcia-Foncillas, J. (Jesús); López-López, R. (Rafael); García-Carbonero, R. (R.); Martinez-Useros, J. (Javier); García, J.L. (J. L.); Nadal, C. (C.); Guillén-Ponce, C. (C.); Rincón, R. (R.); Rojo-Todo, F. (Federico); Elez, E. (E.); Puerto-Nevado, L. (L.) del; Aranda, E. (E.)Cetuximab is a standard-of-care treatment for RAS wild-type metastatic colorectal cancer (mCRC) but not for those harbor a KRAS mutation since MAPK pathway is constitutively activated. Nevertheless, cetuximab also exerts its effect by its immunomodulatory activity despite the presence of RAS mutation. The aim of this study was to determine the impact of polymorphism FcγRIIIa V158F and killer immunoglobulin-like receptor (KIR) genes on the outcome of mCRC patients with KRAS mutations treated with cetuximab. This multicenter Phase II clinical trial included 70 mCRC patients with KRAS mutated. We found KIR2DS4 gene was significantly associated with OS (HR 2.27; 95% CI, 1.08-4.77; P = 0.03). In non-functional receptor homozygotes the median OS was 2.6 months longer than in carriers of one copy of full receptor. Multivariate analysis confirmed KIR2DS4 as a favorable prognostic marker for OS (HR 6.71) in mCRC patients with KRAS mutation treated with cetuximab. These data support the potential therapeutic of cetuximab in KRAS mutated mCRC carrying non-functional receptor KIR2DS4 since these patients significantly prolong their OS even after heavily treatment. KIR2DS4 typing could be used as predictive marker for identifying RAS mutated patients that could benefit from combination approaches of anti-EGFR monoclonal antibodies and other immunotherapies to overcome the resistance mediated by mutation in RAS.