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3. Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo-controlled randomized trial in healthcare workers

Author

Julia del Amo, Polo, Rosa, Moreno, Santiago, Berenguer, Juan, Martínez, Esteban, Hernán, Miguel, Martínez de Salazar, Pablo, García de Albéniz, Xabier, García-Albéniz, Xabier, Terán, Carolina, Morales, Miguel, Rial-Crestelo, David, Garcinuño, M. Angeles, García del Toro, Miguel, Hita, César, Gómez-Sirvent, Juan Luis, Buzón, Luis, Díaz de Santiago, Alberto, Arellano, Jose Pérez, Sanz, Jesus, Bachiller, Pablo, Alfaro, Elisa Martínez, Díaz-Brito, Vicente, Masiá, Mar, Hernández-Torres, Alicia, Guerra, Jose M., Santos, Jesús, Arazo, Piedad, Muñoz, Leopoldo, Arribas, Jose Ramon, Hernán, Miguel A., and Del Amo, Julia

Published
2023
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6. Perioperative Transfusion Management in Gastric Cancer Surgery: Analysis of the Spanish Subset of the EURECCA Oesophago-Gastric Cancer Registry

Author

Osorio, Javier, Jericó, Carlos, Miranda, Coro, Garsot, Elisenda, Luna, Alexis, Miró, Mónica, Santamaría, Maite, Artigau, Eva, Rodríguez-Santiago, Joaquín, Castro, Sandra, Feliu, Josep, Aldeano, Aurora, Olona, Carles, Momblan, Dulce, Ruiz, David, Galofré, Gonzalo, Pros, Inmaculada, García-Albéniz, Xabier, Lozano, Miguel, and Pera, Manuel

Published
2018
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7. Conducta transfusional perioperatoria en la cirugía del cáncer gástrico: análisis del registro del grupo español EURECCA de cáncer esófago-gástrico

Author

Osorio, Javier, Jericó, Carlos, Miranda, Coro, Garsot, Elisenda, Luna, Alexis, Miró, Mónica, Santamaría, Maite, Artigau, Eva, Rodríguez-Santiago, Joaquín, Castro, Sandra, Feliu, Josep, Aldeano, Aurora, Olona, Carles, Momblan, Dulce, Ruiz, David, Galofré, Gonzalo, Pros, Inmaculada, García-Albéniz, Xabier, Lozano, Miguel, and Pera, Manuel

Published
2018
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8. Coexpression of p-IGF-1R and MMP-7 Modulates Panitumumab and Cetuximab Efficacy in RAS Wild-Type Metastatic Colorectal Cancer Patients

Author

Alonso, Vicente, Escudero, Pilar, Fernández-Martos, Carlos, Salud, Antonia, Méndez, Miguel, Gallego, Javier, Rodriguez, Jose-R., Martín-Richard, Marta, Fernández-Plana, Julen, Manzano, Hermini, Méndez, José-Carlos, Zanui, Monserrat, Falcó, Esther, Gil-Raga, Mireia, Rojo, Federico, Cuatrecasas, Miriam, Feliu, Jaime, García-Albéniz, Xabier, and Maurel, Joan

Published
2018
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9. Avoidable flaws in observational analyses: an application to statins and cancer

Author

Dickerman, Barbra A., García-Albéniz, Xabier, Logan, Roger W., Denaxas, Spiros, and Hernán, Miguel A.

Subjects
Observational studies -- Usage, Statins -- Usage, Medical records -- Usage -- Technology application, Clinical trials -- Analysis, Technology application, Biological sciences, Health
Abstract

The increasing availability of large healthcare databases is fueling an intense debate on whether real-world data should play a role in the assessment of the benefit-risk of medical treatments. In many observational studies, for example, statin users were found to have a substantially lower risk of cancer than in meta-analyses of randomized trials. Although such discrepancies are often attributed to a lack of randomization in the observational studies, they might be explained by flaws that can be avoided by explicitly emulating a target trial (the randomized trial that would answer the question of interest). Using the electronic health records of 733,804 UK adults, we emulated a target trial of statins and cancer and compared our estimates with those obtained using previously applied analytic approaches. Over the 10-yr follow-up, 28,408 individuals developed cancer. Under the target trial approach, estimated observational analogs of intention-to-treat and per-protocol 10-yr cancer-free survival differences were -0.5% (95% confidence interval (CI) -1.0%, 0.0%) and -0.3% (95% CI -1.5%, 0.5%), respectively. By contrast, previous analytic approaches yielded estimates that appeared to be strongly protective. Our findings highlight the importance of explicitly emulating a target trial to reduce bias in the effect estimates derived from observational analyses. Explicitly emulating a target trial using real-world data can avoid common biases in observational studies., Author(s): Barbra A. Dickerman [sup.1] , Xabier García-Albéniz [sup.1] [sup.2] , Roger W. Logan [sup.1] , Spiros Denaxas [sup.3] [sup.4] [sup.5] , Miguel A. Hernán [sup.1] [sup.6] [sup.7] Author Affiliations: [...]

Published
2019
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11. Outcomes after neoadjuvant treatment with gemcitabine and erlotinib followed by gemcitabine–erlotinib and radiotherapy for resectable pancreatic cancer (GEMCAD 10-03 trial)

Author

Maurel, Joan, Sánchez-Cabús, Santiago, Laquente, Berta, Gaba, Lydia, Visa, Laura, Fabregat, Joan, Povés, Ignacio, Roselló, Susana, Díaz-Beveridge, Roberto, Martín-Richard, Marta, Rodriguez, Javier, Sabater, Luis, Conill, Carles, Cambray, María, Reig, Ana, Ayuso, Juan Ramón, Valls, Carlos, Ferrández, Antonio, Bombí, Josep Antoni, Ginés, Angels, García-Albéniz, Xabier, and Fernández-Cruz, Laureano

Published
2018
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12. Total neoadjuvant therapy with or without aflibercept in rectal cancer: Three-year results of GEMCAD-1402

Author

Pesántez, David, primary, ten Hoorn, Sanne, additional, Machado, Isidro, additional, García-Albéniz, Xabier, additional, Rodríguez-Salas, Nuria, additional, Heredia-Soto, Victoria, additional, Viñal, David, additional, Pericay, Carles, additional, García-Carbonero, Rocio, additional, Losa, Ferran, additional, Alonso, Vicente, additional, Vera, Ruth, additional, Feliu Batlle, Jaime, additional, Gallego, Javier, additional, Salud, Antonieta, additional, Nogué, Miquel, additional, Layos, Laura, additional, Montagut, Clara, additional, Capdevila, Jaume, additional, Vermeulen, Louis, additional, Maurel, Joan, additional, and Fernandez-Martos, Carlos, additional

Published
2023
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14. Phase II randomised trial of autologous tumour lysate dendritic cell plus best supportive care compared with best supportive care in pre-treated advanced colorectal cancer patients

Author

Caballero-Baños, Miguel, Benitez-Ribas, Daniel, Tabera, Jaime, Varea, Sara, Vilana, Ramon, Bianchi, Luis, Ayuso, Juan Ramón, Pagés, Mario, Carrera, Gemma, Cuatrecasas, Miriam, Martin-Richard, Marta, Cid, Joan, Lozano, Miguel, Castells, Antoni, García-Albéniz, Xabier, Maurel, Joan, and Vilella, Ramon

Published
2016
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16. Total neoadjuvant therapy with or without aflibercept in rectal cancer: 3-year results of GEMCAD-1402.

Author

Pesántez, David, Hoorn, Sanne ten, Machado, Isidro, García-Albéniz, Xabier, Rodríguez-Salas, Nuria, Heredia-Soto, Victoria, Viñal, David, Pericay, Carles, García-Carbonero, Rocio, Losa, Ferran, Alonso, Vicente, Vera, Ruth, Batlle, Jaime Feliu, Gallego, Javier, Salud, Antonieta, Nogué, Miquel, Layos, Laura, Montagut, Clara, Capdevila, Jaume, and Vermeulen, Louis

Subjects
RECTAL cancer, NEOADJUVANT chemotherapy, AFLIBERCEPT, MAGNETIC resonance, PROGRESSION-free survival, CHEMORADIOTHERAPY
Abstract

Background The results of the Grupo Español Multidisciplinar en Cáncer Digestivo (GEMCAD)-1402 phase II randomized trial suggested that adding aflibercept to modified fluorouracil, oxaliplatin, and leucovorin (mFOLFOX6) induction, followed by chemoradiation and surgery, could increase the pathological complete response (pCR) rate in patients with high-risk, locally advanced rectal cancer. Here we update results up to 3 years of follow-up and evaluate the predictive value of consensus molecular subtypes identified with immunohistochemistry (IHC). Methods Patients with magnetic resonance imaging–defined T3c-d and/or T4 and/or N2 rectal adenocarcinoma in the middle or distal third were randomly assigned to mFOLFOX6 induction, with aflibercept (mF+A; n   =   115) or without aflibercept (mF; n   =   65), followed by capecitabine plus radiotherapy and surgery. The risk local relapse, distant metastases, disease-free survival (DFS), and overall survival (OS) were estimated at 3 years. Selected samples were classified via IHC into immune-infiltrate, epithelial, or mesenchymal subtypes. Results mF+A and mF had 3-year DFS of 75.2% (95% confidence interval [CI] = 66.1% to 82.2%) and 81.5% (95% CI = 69.8% to 89.1%), respectively; 3-year OS of 89.3% (95% CI = 82.0% to 93.8%) and 90.7% (95% CI = 80.6% to 95.7%), respectively; 3-year cumulative local relapse incidences of 5.2% (95% CI = 1.9% to 11.0%) and 6.1% (95% CI = 1.7% to 15.0%), respectively; and 3-year cumulative distant metastases rates of 17.3% (95% CI = 10.9% to 25.5%) and 16.9% (95% CI = 8.7% to 28.2%), respectively. pCRs were achieved in 27.5% (n   =   22 of 80) and 0% (n   =   0 of 10) of patients with epithelial and mesenchymal subtypes, respectively. Conclusion Adding aflibercept to mFOLFOX6 induction was not associated with improved DFS or OS. Our findings suggested that consensus molecular subtypes identified with IHC subtypes could be predictive of pCR with this treatment. [ABSTRACT FROM AUTHOR]

Published
2023
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30. Clinical Impact of Circulating Tumor RAS and BRAF Mutation Dynamics in Patients With Metastatic Colorectal Cancer Treated With First-Line Chemotherapy Plus Anti–Epidermal Growth Factor Receptor Therapy

Author

Maurel, Joan, primary, Alonso, Vicente, additional, Escudero, Pilar, additional, Fernández-Martos, Carlos, additional, Salud, Antonieta, additional, Méndez, Miguel, additional, Gallego, Javier, additional, Rodriguez, Jose Ramon, additional, Martín-Richard, Marta, additional, Fernández-Plana, Julen, additional, Manzano, Hermini, additional, Méndez, José Carlos, additional, Zanui, Montserrat, additional, Falcó, Esther, additional, Gil-Raga, Mireia, additional, Aparicio, Jorge, additional, Feliu, Jaime, additional, García-Albéniz, Xabier, additional, Torres, Ferràn, additional, Rojo, Federico, additional, Bellosillo, Beatriz, additional, Mendiola, Marta, additional, Fernández, Veronica, additional, Reig, Oscar, additional, Claes, Bart, additional, Maertens, Geert, additional, Sablon, Erwin, additional, Jacobs, Bart, additional, and Montagut, Clara, additional

Published
2019
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31. Prospective Biomarker Study in Advanced RAS Wild-Type Colorectal Cancer: POSIBA Trial (GEMCAD 10-02)

Author

García-Albéniz, Xabier, primary, Alonso, Vicente, additional, Escudero, Pilar, additional, Méndez, Miguel, additional, Gallego, Javier, additional, Rodríguez, Jose Ramon, additional, Salud, Antonia, additional, Fernández-Plana, Julen, additional, Manzano, Hermini, additional, Zanui, Montserrat, additional, Falcó, Ester, additional, Feliu, Jaime, additional, Gil, Mireia, additional, Fernández-Martos, Carlos, additional, Bohn, Uriel, additional, Alonso, Carmen, additional, Calderero, Verónica, additional, Rojo, Federico, additional, Cuatrecasas, Miriam, additional, and Maurel, Joan, additional

Published
2019
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33. RIA: Randomized phase II study comparing induction (I) mFOLFOX6 with or without aflibercept followed by chemoradiation (CRT) and total mesorectal excision (TME) in high risk-rectal cancer. GEMCAD 14-02 trial.

Author

Fernandez-Martos, Carlos, primary, Pericay, Carles, additional, Losa, Ferran, additional, Garcia-Carbonero, Rocio, additional, Layos, Laura, additional, Rodriguez Salas, Nuria, additional, Martin, Marta, additional, Alonso, Vicente, additional, Vera, Ruth, additional, Gallego, Javier, additional, Capdevila, Jaume, additional, Salud, Antonieta, additional, Nogue, Miquel, additional, Maurel, Juan, additional, Guasch, Inmaculada, additional, Montagut Viladot, Clara, additional, López-López, Carlos, additional, Cañas, Mª Ángeles, additional, Macias Declara, Ismael, additional, and García-Albéniz, Xabier, additional

Published
2018
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35. Nuclear IGF-1R predicts chemotherapy and targeted therapy resistance in metastatic colorectal cancer

Author

Codony-Servat, Jordi, primary, Cuatrecasas, Miriam, additional, Asensio, Elena, additional, Montironi, Carla, additional, Martínez-Cardús, Anna, additional, Marín-Aguilera, Mercedes, additional, Horndler, Carlos, additional, Martínez-Balibrea, Eva, additional, Rubini, Michele, additional, Jares, Pedro, additional, Reig, Oscar, additional, Victoria, Iván, additional, Gaba, Lydia, additional, Martín-Richard, Marta, additional, Alonso, Vicente, additional, Escudero, Pilar, additional, Fernández-Martos, Carlos, additional, Feliu, Jaime, additional, Méndez, Jose Carlos, additional, Méndez, Miguel, additional, Gallego, Javier, additional, Salud, Antonieta, additional, Rojo, Federico, additional, Castells, Antoni, additional, Prat, Aleix, additional, Rosell, Rafael, additional, García-Albéniz, Xabier, additional, Camps, Jordi, additional, and Maurel, Joan, additional

Published
2017
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37. Why post progression survival and post relapse survival are not appropriate measures of efficacy in cancer randomized clinical trials

Author

García-Albéniz, Xabier, Maurel, Joan, and Hernán, Miguel A.

Subjects
Models, Statistical, Neoplasms, Disease Progression, Humans, Neoplasm Recurrence, Local, Survival Analysis, Article, Randomized Controlled Trials as Topic
Abstract

Comparisons of post-relapse survival (PRS) and post-progression survival have been used to measure efficacy in some cancer clinical trials. These comparisons are an attempt to account for second-line therapies and to identify benefits that do not translate in longer overall survival. However, the use of PRS comparisons can be misleading (either a longer or shorter PRS may indicate a benefit, depending on the circumstances) and can result in biased estimates (because of selection). Here, we describe the problems surrounding PRS comparisons and propose alternative approaches to deal with non-randomized therapies administered after progression to the experimental treatment.

Published
2014

38. Infective endocarditis and cancer in the elderly

Author

Institute for Medical Engineering and Science, Harvard University--MIT Division of Health Sciences and Technology, Hernan, Miguel Angel, García-Albéniz, Xabier, Hsu, John, Lipsitch, Marc, Hernández-Díaz, Sonia, Logan, Roger W., Institute for Medical Engineering and Science, Harvard University--MIT Division of Health Sciences and Technology, Hernan, Miguel Angel, García-Albéniz, Xabier, Hsu, John, Lipsitch, Marc, Hernández-Díaz, Sonia, and Logan, Roger W.

Abstract

Little is known about the magnitude of the association between infective endocarditis and cancer, and about the natural history of cancer patients with concomitant diagnosis of infective endocarditis. We used the SEER-Medicare linked database to identify individuals aged 65 years or more diagnosed with colorectal, lung, breast, or prostate cancer, and without any cancer diagnosis (5 % random Medicare sample from SEER areas) between 1992 and 2009. We identified infective endocarditis from the ICD-9 diagnosis of each admission recorded in the Medpar file and its incidence rate 90 days around cancer diagnosis. We also estimated the overall survival and CRC-specific survival after a concomitant diagnosis of infective endocarditis. The peri-diagnostic incidence of infective endocarditis was 19.8 cases per 100,000 person-months for CRC, 5.7 cases per 100,000 person-months for lung cancer, 1.9 cases per 100,000 person-months for breast cancer, 4.1 cases per 100,000 person-months for prostate cancer and 2.4 cases per 100,000 person-months for individuals without cancer. Two-year overall survival was 46.4 % (95 % CI 39.5, 54.5 %) for stage I–III CRC patients with concomitant endocarditis and 73.1 % (95 % CI 72.9, 73.3 %) for those without it. In this elderly population, the incidence of infective endocarditis around CRC diagnosis was substantially higher than around the diagnosis of lung, breast and prostate cancers. A concomitant diagnosis of infective endocarditis in patients with CRC diagnosis is associated with shorter survival.

Published
2016

41. Phosphorylated-insulin growth factor I receptor (p-IGF1R) and metalloproteinase-3 (MMP3) expression in advanced gastrointestinal stromal tumors (GIST). A GEIS 19 study

Author

Maurel, Joan, primary, López-Pousa, Antonio, additional, Calabuig, Silvia, additional, Bagué, Silvia, additional, del Muro, Xavier Garcia, additional, Sanjuan, Xavier, additional, Rubió-Casadevall, Jordi, additional, Cuatrecasas, Miriam, additional, Martinez-Trufero, Javier, additional, Horndler, Carlos, additional, Fra, Joaquin, additional, Valverde, Claudia, additional, Redondo, Andrés, additional, Poveda, Andrés, additional, Sevilla, Isabel, additional, Lainez, Nuria, additional, Rubini, Michele, additional, García-Albéniz, Xabier, additional, Martín-Broto, Javier, additional, and de Alava, Enrique, additional

Published
2016
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47. Abstract 2546: IGR-1R pathway role in oxaliplatin acquired resistance in colon cancer cell lines and its regulation by MMP-7 and IGFBP-2

Author

Codony-Servat, Jordi, primary, Martínez-Cardús, Anna, additional, Marín-Aguilera, Mercedes, additional, García-Albéniz, Xabier, additional, Augé, Josep Maria, additional, Gallego, Rosa, additional, Pineda, Estela, additional, Ginés, Alba, additional, Abad, Albert, additional, Gascón, Pere, additional, Martínez-Balibrea, Eva, additional, and Maurel, Joan, additional

Published
2010
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50. CYP24A1 variant modifies the association between use of oestrogen plus progestogen therapy and colorectal cancer risk

Author

Garcia-Albeniz, Xabier, Rudolph, Anja, Hutter, Carolyn, White, Emily, Lin, Yi, Rosse, Stephanie A, Figueiredo, Jane C, Harrison, Tabitha A, Jiao, Shuo, Brenner, Hermann, Casey, Graham, Hudson, Thomas J, Thornquist, Mark, Le Marchand, Loic, Potter, John, Slattery, Martha L, Zanke, Brent, Baron, John A, Caan, Bette J, Chanock, Stephen J, Berndt, Sonja I, Stelling, Deanna, Fuchs, Charles S, Hoffmeister, Michael, Butterbach, Katja, Du, Mengmeng, James Gauderman, W, Gunter, Marc J, Lemire, Mathieu, Ogino, Shuji, Lin, Jennifer, Hayes, Richard B, Haile, Robert W, Schoen, Robert E, Warnick, Greg S, Jenkins, Mark A, Thibodeau, Stephen N, Schumacher, Fredrick R, Lindor, Noralane M, Kolonel, Laurence N, Hopper, John L, Gong, Jian, Seminara, Daniela, Pflugeisen, Bethann M, Ulrich, Cornelia M, Qu, Conghui, Duggan, David, Cotterchio, Michelle, Campbell, Peter T, Carlson, Christopher S, Newcomb, Polly A, Giovannucci, Edward, Hsu, Li, Chan, Andrew T, Peters, Ulrike, and Chang-Claude, Jenny

Subjects
GWAS, colorectal cancer, menopausal hormone therapy, polymorphisms, gene–environment interaction, cytochrome
Abstract

Background: Menopausal hormone therapy (MHT) use has been consistently associated with a decreased risk of colorectal cancer (CRC) in women. Our aim was to use a genome-wide gene–environment interaction analysis to identify genetic modifiers of CRC risk associated with use of MHT. Methods: We included 10 835 postmenopausal women (5419 cases and 5416 controls) from 10 studies. We evaluated use of any MHT, oestrogen-only (E-only) and combined oestrogen–progestogen (E+P) hormone preparations. To test for multiplicative interactions, we applied the empirical Bayes (EB) test as well as the Wald test in conventional case–control logistic regression as primary tests. The Cocktail test was used as secondary test. Results: The EB test identified a significant interaction between rs964293 at 20q13.2/CYP24A1 and E+P (interaction OR (95% CIs)=0.61 (0.52–0.72), P=4.8 × 10−9). The secondary analysis also identified this interaction (Cocktail test OR=0.64 (0.52–0.78), P=1.2 × 10−5 (alpha threshold=3.1 × 10−4). The ORs for association between E+P and CRC risk by rs964293 genotype were as follows: C/C, 0.96 (0.61–1.50); A/C, 0.61 (0.39–0.95) and A/A, 0.40 (0.22–0.73), respectively. Conclusions: Our results indicate that rs964293 modifies the association between E+P and CRC risk. The variant is located near CYP24A1, which encodes an enzyme involved in vitamin D metabolism. This novel finding offers additional insight into downstream pathways of CRC etiopathogenesis.

Published
2016
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