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1. Effect of the Factor XIa Inhibitor Asundexian According to Baseline Infarct Pattern and on MRI Covert Infarct Outcomes

Author

Smith, Eric E., Shoamanesh, Ashkan, Xu, Lizhen, Heenan, Laura, Saad, Feryal, Colorado, Pablo, Chen, Chih-Hao, Lemmens, Robin, De Marchis, Gian Marco, Caso, Valeria, Masjuan, Jaime, Hirano, Teruyuki, Milanov, Ivan, Campbell, Bruce C.V., Mas, Jean-Louis, Connolly, Stuart J., Mundl, Hardi, Hart, Robert G., Bailey, P., Kleinig, T., Cordato, D., Choi, P., Garcia-Esperon, C., Chew, A., Cloud, G., Stanislaus, V., Krause, M., Priglinger, M., Grimley, R., Ghia, D., Sahathevan, R., Brown, H., Kwan, C., Devlin, M., Greisenegger, S., Bonelli-Nauer, S., Rath, J., Langer, A., Marko, M., Ferrari, J., Bernegger, A., Baumgartinger, M., Vigl, M., Krebs, S., Lang, W., Knoflach, M., Dejakum, B., Kiechl, S., Töll, T., Domig, L., Mutzenbach, J.S., Ganser, B., Hecker, C., Rösler, C., Bubel, N., Pikija, S., Zellner, T., Leitner, U., Berger, O., Surböck, B., Beirer, S., Staykov, D., Schrammel, D., Halilovic, A., Frattner, M., Barmherzigen, D., Lampl, C., Höfer, C., Nagl, S., Bocksrucker, C., Demeestere, J., Desfontaines, P., Ciobanu, C., De Pauw, A., Terwecoren, A., Hasenbroekx, M.C., Clement, F., De Klippel, N., Soors, P., Hermans, S., De Raedt, S., Vandervorst, F., Seynaeve, L., Fockaert, N., Smet, S., Rutgers, M., Del Gaudio, N., Paindeville, P., Staikov, I., Simeonova, A., Stoyanova, I., Cholakova, M., Mihnev, N., Petrova, T., Koralova, A., Dimov, D., Kuzev, Y., Danovska, M., Marinova, D., Marinova-Trifonova, D., Ovcharova, E., Mladenovski, I., Yanakieva, M., Stoev, P., Dimitrova, M., Todorova-Georgieva, S., Haralanov, L., Milkov, B., Solakov, D., Petkova, N., Ignatova-Valkova, V., Karabinov, V., Marinova, V., Miteva, Y., Andonova, V., Kasabova, D., Kostadinova, E., Shopova-Vrabcheva, Y., Gatev, D., Semova, D., Halil, E., Kaprelyan, A., Ivanov, B., Panov, G., Grudkova, M., Syuleyman, N., Kalpachki, R., Alexiev, F., Ivanova, I., Kancheva, K., Sakelarova, T., Maslarov, D., Drenska, D., Georgiev, V., Petrova, K., Petrova, N., Ivanova, I., Semerdjieva, N., Zhelyazkov, P., Spasova-Markova, S., Dong, X., Wang, D., Wang, S., Huang, W., Zhao, H., Wang, C., Jie, L., Xinyang, Y., Ping, Z., Dong, Q., Wang, Y., Fuling, Y., Yue, W., Liu, R., Yang, Y., Stetkarova, I., Mikulenka, P., Vasko, P., Peisker, T., Bar, M., Roubec, M., Mikulik, R., Cabukova, M., Vinklarek, J., Kovar, M., Pansky, M., Mencl, P., Skoda, O., Carek, M., Pernicka, M., Skodova, M., Geier, P., Cepkova, J., Drlik, J., Prax, T., Herzig, R., Krajickova, D., Vitkova, E., Haluskova, S., Vaclavik, D., Martinkova, J., Blejcharova, K., Tkacova, M., Pavlik, O., Nevšímalová, M., Rosol, J., Nevsimalova, M., Hruby, R., Iversen, H., Andersen, A.V., Rahimi, D., Christensen, H., Grundtvig, J., Hjort, N., Andersen, G., Sandal, B., Stilund, M., Modrau, B., Strade, A., Porobic, M., Andersen, S.D., Kruuse, C., Ölmestig, J., Kolmos, M., Parvez, A., Christensen, T., Stokholm, J., Jensen, H.B., Putaala, J., Strbian, D., Sibolt, G., Tiainen, M., Martinez-Majander, N., Curtze, S., Raty, S., Kraemer, Y., Roine, R., Aivo, J., Ruuskanen, J., Ylikotila, P., Roine, S., Hallikainen, M., Jakala, P., Kurl, S., Julkunen, V., Sibon, I., Olindo, S., Richard, S., Larrue, V., Gollion, C., Catala, H., Henon, H., Lucie, D.S., Nelly, D., Calvet, D., Malbranque, A., Mazé, B., Barbieux-Ghitu, C., Rosso, C., Samson, Y., Vannier, S., Moulin, T., Bonnet, L., Reiner, P., Buffon, F., Denier, C., Amri, K., Legris, N., Chassin, O., Selli, N., Mariana, S., Berrouschot, J., Stoll, A., Klunk, D., Keilitz, J., Neustadt, M., Zerrenner, S., Veltkamp, R., Hajjar, K., Heeger, A., Winezki, E., Apel, L., Pompsch, M., Mueller, P., Rappard, P., Auer, R., Ringleb, P.A., Berberich, A., Heyse, M., Mundiyanapurath, S., Reiff, T., Poli, S., Gomez-Exposito, A., Mengel, A., Tünnerhoff, J., Adeyemi, K., Poli, K., Kusch, V., Pelz, J., Michalski, D., Wartenberg, K., Althaus, K., Tavares, F., Mueller, S., Soda, H., Rascher, A., Hiermann, E., Weinhardt, R., Weissenborn, K., Leotescu, A., Grosse, G., Worthmann, H., Ernst, J., Gabriel, M., Schuppner, R., Schäfer, J.H., Charisse, D., Gruber, K., Kurka, N., Reitz, S.C., Pfeilschifter, W., Lee, J.I., Gliem, M., Moll, M., Steiner, T., Segura, L., Szegedi, N., Barandi, D., Uhrinakova, L., Czencz, M., Pasztor, M., Gyuker, N., Bartha, N.E., May, Z., Simony, Z., Szasz, G., Kakuk, I., Pető, N., Panczel, G.F., Olah, A., Racz, O., Balla, T., Horvath, B., Tuba, K., Czinderi, V., Klivenyi, P., Annus, A., Hertelendy, P., Szapary, L., Bosnyak, E., Kalmar, P., Karadi, Z., Cziba, L., Olah, L., Berki, A., Hudak, L., Kozák, M., Babel, S., Nemeth, L., Molnár, B., Simon, Z., Roveri, L., Cerri, F., Giacalone, G., Zini, A., Mauro, G., Asioli, G.M., Forlivesi, S., Arnone, G., Fiaccadori, A., Maria Fontana Francesca, E., Allegra, G., Mosconi, M.G., Longoni, M., Terlizzi, R., Paolucci, M., Tassi, R., Franci, B., Lucani, B., Domenichelli, C., Paoletti, D., Acampa, M., Zedde, M.L., Pezzella, F.R., Mangiardi, M., Galizia, P., Anticoli, S., Scalise, S., Lattanzi, S., Norata, D., Cannuccia, M., Cavallini, A., Federica, F., Denaro, M.F., Tosi, P., Sonoda, K., Kawajiri, M., Kusano, Y., Haraguchi, K., Kawano, H., Terasaki, T., Kaneko, C., Murase, S., Kumagai, M., Murai, N., Miyazaki, Y., Mori, T., Hatano, T., Kawanishi, M., Ochiai, J., Ishihara, S., Uehara, T., Yasaka, M., Nakagawa, H., Makino, M., Yonehara, T., Fukushima, Y., Hirotsune, N., Sakai, N., Yamasaki, M., Coutinho, J., Wouters, A., den Hertog, H., Zwartbol, R., Beumer, D., Kerklaan, J., Hilkens, P., Schreuder, T., Propper, D., Slowik, A., Wlodarczyk, E., Wrona, P., Pulyk, R., Lasek-Bal, A., Kosarz-Lanczek, K., Puz, P., Bilik, M., Magielska, A., Zamiela – Żółciak, A., Ochocinska, L., Bahdasaryan, S., Stępień, A., Dębiec, A., Joanna, K., Pawel, M., Jacek, S., Daniel, P., Marta, S., Rejdak, K., Wojczal, J., Luchowski, P., Fryze, W., Wisniewska, A., Krzyzanowska, M., Skowron, P., Wolosz, A., Galan, A., Grzymala, K., Krajewska, M., Nowak, R., Kłos, M., Cruz, V., Castro, P., Ferro, J., Canhão, P., Gouveia, R., Inácio, N., Rodrigues, M., Rachão, A., Ionel, C., Pereira, L., Viana-Baptista, M., Machado, C., Fernandes, C., Sargento, J., Inácio, N., Timchenko, L., Mironova, J., Zhadan, O., Torgashova, A., Bazhenova, O., Barashenkova, M., Kireeva, M., Romadina, N., Stepanova, I., Lenskaya, L., Lukinykh, L., Vorontsova, T., Agafina, A., Fedorova, A., Yashina, A., Alasheev, A., Smolkin, A., Prazdnichkova, E., Lutskovich, O., Gonysheva, Y., Mordvintseva, E., Nechaev, A., Martynova, E., Fedoraeva, N., Vishnyakova, T., Popov, D., Merzliakova, A., Margarita, K., Rechkalova, L., Ilyina, A., Kurenkova, N., Barbarash, O., Bazdyrev, E., Zvereva, T., Hromova, A., Morkvenas, A., Postnikova, E., Kovalenko, G., Taran, I., Pavlov, L., Ott, M., Chernitsova, N., Vodopyanova, N., Drozdova, E., Korebo, E., Lobanova, M., Lazareva, N., Snegova, N., Nikolaeva, O., Kolesnikov, Y., Kosheleva, Y., Krastev, G., Tomasova, K., Danis, M., Mako, M., Jankovicova, Z., Stevkova, Z., Kovacik, M., Kubikova, T., Jarosova, A., Serdahely, V., Cilingova, I., Pribulova, I., Sedlak, J., Slebodova, K., Paldaufova, M., Risnovsky, R., Berndtova, B., Urbanova, I., Junas, R., Karapetian, S., Gurcik, L., Vantrobova, A., Verbovsky, F., Vanacka, K., Ferenc, M., Galik, P., Bucakova, S., Ferencova, M., Kubalova, P., Boksanska, Z., Zacharova, E., Mahundi, E., Judita, H., Bachnak, M., Turcani, P., Kvasnicova Kamenska, A., Jurik, M., Vestenicka, V., Kycina, M., Sagatova, E., Dvorak, M., Hlubekova, A., Kucera, C., Gernath, L., Ferenc, M., Frimmelova, P., Slebodnikova, J., Aksteinerova, N., Horny, V., Gregova, Z., Segura, T., Romero, C., Ayo, O., Masjuan Vallejo, J., Cruz, A., De felipe, A, Matute, M.C., Garcia, S., Tembl Ferrairo, J., Vielba, I., Morales Caba, L., Molina, C., Garcia-Tornel García-Camba, Á., Requena Ruiz, M., Noelia, R., Rodriguez-Yañez, M., Rodriguez Castro, E., Lopez, I., Santamaria, M., Arias, S., Purroy García, F., Vázquez Justes, D., Mauri Capdevila, G., Vicente Pascual, M., Martí Fabregas, J., Camps Renom, P., Rodríguez Campello, A., Giralt, E., Krupinski, J., Molina, J., Trillo Senin, C. Ramos Martin, S., De La Fuente Sanz, E., Moniche, F., Manuel, M.R., Pardo, B., Martínez, I., Hernández Pérez, M., Arenillas Lara, J.F., De Lera, M., Egido, J.A., Gomez Escalonilla, C., Guillan, M., Martinez, J., Lindgren, A., Andsberg, G., Wictor, L., Leonidou, M., Stenman, M., Dalberg, N., Laska, A.C., Grünfeldt, A., Lundström, A., Nadzjafov, E., Rooth, E., Dalenbring, I., Sandén, P., Johansson, E., Thomas, G., Zietz, A.V., Rudin, S., Dittrich, T.D., Lilian, K., Kägi, G., Vehoff, J., Arnold, M., Scutelnic, A., Clénin, L., Beyeler, M., Madlaine, M., Maamari, B., Siepen, B., Vynckier, J., Tarnutzer, A., Bertschi, D., Luciani, M., Cereda, C., Maulucci, F., Bianco, G., Shairin, S., Pihan, H.A., Salmen, S., Quinn, T., McAlpine, C., Wright, F., Kalladka, D., Taylor, E., Sohaa, J., Brown, Z., Dawson, J., Cameron, A., Muir, S., Dima, S., Khan, U., Zhang, L., Warburton, E., Chatterjee, K., Nallasivan, A., Curran, D., Haider, S., Ghani, U., Kenton, A., Dallol, B., Mirza, M., Menezes, B., Davies, R., Robinson, T.G., Manning, L., Sztriha, L., Phinney, T., Sethi, P., Altafullah, I., Sharaf, A., Ostrander, M., Renati, S., Burgin, W.S., Olds, K., Delio, P., Malek, A., Dissin, J., Khatri, P., Flaherty, M., Demel, S., and Dofitas, S.

Published
2024
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2. INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

Author

Colombo, N., Gadducci, A., Sehouli, J., Rulli, E., Mäenpää, J., Sessa, C., Montes, A., Ottevanger, N. B., Berger, R., Vergote, I., D’Incalci, M., Churruca Galaz, C., Chekerov, R., Nyvang, G. B., Riniker, S., Herbertson, R., Fossati, R., Barretina-Ginesta, M. P., Deryal, M., Mirza, M. R., Biagioli, E., Iglesias, M., Funari, G., Romeo, M., Tasca, G., Pardo, B., Tognon, G., Rubio-Pérez, M. J., DeCensi, A., De Giorgi, U., Zola, P., Benedetti Panici, P., Aglietta, M., Arcangeli, V., Zamagni, C., Bologna, A., Westermann, A., Heinzelmann-Schwarz, V., Tsibulak, I., Wimberger, P., and Poveda, A.

Published
2023
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3. Atezolizumab and chemotherapy for advanced or recurrent endometrial cancer (AtTEnd): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Colombo, N, Biagioli, E, Harano, K, Galli, F, Hudson, E, Antill, Y, Choi, C, Rabaglio, M, Marmé, F, Marth, C, Parma, G, Fariñas-Madrid, L, Nishio, S, Allan, K, Lee, Y, Piovano, E, Pardo, B, Nakagawa, S, Mcqueen, J, Zamagni, C, Manso, L, Takehara, K, Tasca, G, Ferrero, A, Tognon, G, Lissoni, A, Petrella, M, Laudani, M, Rulli, E, Uggeri, S, Barretina Ginesta, M, Zola, P, Casanova, C, Arcangeli, V, Antonuzzo, L, Gadducci, A, Cosio, S, Clamp, A, Persic, M, Mcneish, I, Tookman, L, Redondo Sanchez, A, Baldini, E, Palaia, I, Benedetti Panici, P, Takahashi, N, Lombard, J, Ardizzoia, A, Bologna, A, Herrero Ibáñez, A, Musolino, A, Márquez Vázquez, R, Pietzner, K, Braicu, E, Heinzelmann-Schwarz, V, Powell, M, Yokoyama, Y, Baron-Hay, S, Abeni, C, Martin Lorente, C, Cueva, J, Trillsch, F, Heitz, F, Ataseven, B, Petru, E, Heubner, M, Sadozye, A, Dubey, S, Tazbirkova, A, Tiley, S, Chrystal, K, Kim, S, Fehr, M, Scatchard, K, Anand, A, Taylor, A, Watary, H, Enomoto, T, Yoshihara, K, Selva-Nayagam, S, Karki, B, Harrison, M, Wilkinson, K, Goh, J, Glasgow, A, Chantrill, L, Lee, C, Bertolini, A, Narducci, F, Bellotti, G, Fusco, V, Aebi, S, Del Grande, M, Colombo, I, Tokunaga, H, Shigeta, S, Goss, G, Siow, Z, Steer, C, Lin, H, Colombo N., Biagioli E., Harano K., Galli F., Hudson E., Antill Y., Choi C. H., Rabaglio M., Marmé F., Marth C., Parma G., Fariñas-Madrid L., Nishio S., Allan K., Lee Y. C., Piovano E., Pardo B., Nakagawa S., McQueen J., Zamagni C., Manso L., Takehara K., Tasca G., Ferrero A., Tognon G., Lissoni A. A., Petrella M., Laudani M. E., Rulli E., Uggeri S., Barretina Ginesta M. P., Zola P., Casanova C., Arcangeli V., Antonuzzo L., Gadducci A., Cosio S., Clamp A., Persic M., McNeish I., Tookman L., Redondo Sanchez A., Baldini E., Palaia I., Benedetti Panici P., Takahashi N., Lombard J., Ardizzoia A., Bologna A., Herrero Ibáñez A. M., Musolino A., Márquez Vázquez R., Pietzner K., Braicu E., Heinzelmann-Schwarz V. A., Powell M., Yokoyama Y., Baron-Hay S., Abeni C., Martin Lorente C., Cueva J. F., Trillsch F., Heitz F., Ataseven B., Petru E., Heubner M. L., Sadozye A. H., Dubey S., Tazbirkova A., Tiley S., Chrystal K., Kim S. W., Fehr M., Scatchard K., Anand A., Taylor A., Watary H., Enomoto T., Yoshihara K., Selva-Nayagam S., Karki B., Harrison M., Wilkinson K., Goh J., Glasgow A., Chantrill L., Lee C., Bertolini A., Narducci F., Bellotti G., Fusco V., Aebi S., Del Grande M., Colombo I., Tokunaga H., Shigeta S., Goss G., Siow Z. R., Steer C., Lin H., Colombo, N, Biagioli, E, Harano, K, Galli, F, Hudson, E, Antill, Y, Choi, C, Rabaglio, M, Marmé, F, Marth, C, Parma, G, Fariñas-Madrid, L, Nishio, S, Allan, K, Lee, Y, Piovano, E, Pardo, B, Nakagawa, S, Mcqueen, J, Zamagni, C, Manso, L, Takehara, K, Tasca, G, Ferrero, A, Tognon, G, Lissoni, A, Petrella, M, Laudani, M, Rulli, E, Uggeri, S, Barretina Ginesta, M, Zola, P, Casanova, C, Arcangeli, V, Antonuzzo, L, Gadducci, A, Cosio, S, Clamp, A, Persic, M, Mcneish, I, Tookman, L, Redondo Sanchez, A, Baldini, E, Palaia, I, Benedetti Panici, P, Takahashi, N, Lombard, J, Ardizzoia, A, Bologna, A, Herrero Ibáñez, A, Musolino, A, Márquez Vázquez, R, Pietzner, K, Braicu, E, Heinzelmann-Schwarz, V, Powell, M, Yokoyama, Y, Baron-Hay, S, Abeni, C, Martin Lorente, C, Cueva, J, Trillsch, F, Heitz, F, Ataseven, B, Petru, E, Heubner, M, Sadozye, A, Dubey, S, Tazbirkova, A, Tiley, S, Chrystal, K, Kim, S, Fehr, M, Scatchard, K, Anand, A, Taylor, A, Watary, H, Enomoto, T, Yoshihara, K, Selva-Nayagam, S, Karki, B, Harrison, M, Wilkinson, K, Goh, J, Glasgow, A, Chantrill, L, Lee, C, Bertolini, A, Narducci, F, Bellotti, G, Fusco, V, Aebi, S, Del Grande, M, Colombo, I, Tokunaga, H, Shigeta, S, Goss, G, Siow, Z, Steer, C, Lin, H, Colombo N., Biagioli E., Harano K., Galli F., Hudson E., Antill Y., Choi C. H., Rabaglio M., Marmé F., Marth C., Parma G., Fariñas-Madrid L., Nishio S., Allan K., Lee Y. C., Piovano E., Pardo B., Nakagawa S., McQueen J., Zamagni C., Manso L., Takehara K., Tasca G., Ferrero A., Tognon G., Lissoni A. A., Petrella M., Laudani M. E., Rulli E., Uggeri S., Barretina Ginesta M. P., Zola P., Casanova C., Arcangeli V., Antonuzzo L., Gadducci A., Cosio S., Clamp A., Persic M., McNeish I., Tookman L., Redondo Sanchez A., Baldini E., Palaia I., Benedetti Panici P., Takahashi N., Lombard J., Ardizzoia A., Bologna A., Herrero Ibáñez A. M., Musolino A., Márquez Vázquez R., Pietzner K., Braicu E., Heinzelmann-Schwarz V. A., Powell M., Yokoyama Y., Baron-Hay S., Abeni C., Martin Lorente C., Cueva J. F., Trillsch F., Heitz F., Ataseven B., Petru E., Heubner M. L., Sadozye A. H., Dubey S., Tazbirkova A., Tiley S., Chrystal K., Kim S. W., Fehr M., Scatchard K., Anand A., Taylor A., Watary H., Enomoto T., Yoshihara K., Selva-Nayagam S., Karki B., Harrison M., Wilkinson K., Goh J., Glasgow A., Chantrill L., Lee C., Bertolini A., Narducci F., Bellotti G., Fusco V., Aebi S., Del Grande M., Colombo I., Tokunaga H., Shigeta S., Goss G., Siow Z. R., Steer C., and Lin H.

Abstract

Background: At the time of AtTEnd trial design, standard treatment for advanced or recurrent endometrial cancer included carboplatin and paclitaxel chemotherapy. This trial assessed whether combining atezolizumab with chemotherapy might improve outcomes in this population. Methods: AtTEnd was a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial done in 89 hospitals in 11 countries across Europe, Australia, New Zealand, and Asia. Enrolled patients were aged 18 years or older, and had advanced or recurrent endometrial carcinoma or carcinosarcoma, an Eastern Cooperative Oncology Group performance status of 0–2, and received no previous systemic chemotherapy for recurrence. Patients were randomly assigned (2:1) using an interactive web response system (block size of six) to either atezolizumab 1200 mg or placebo given intravenously with chemotherapy (carboplatin at area under the curve of 5 or 6 and paclitaxel 175 mg/m2 intravenously on day 1 every 21 days) for 6–8 cycles, then continued until progression. Stratification factors were country, histological subtype, advanced or recurrent status, and mismatch repair (MMR) status. Participants and treating clinicians were masked to group allocation. The hierarchically tested co-primary endpoints were progression-free survival (in patients with MMR-deficient [dMMR] tumours, and in the overall population) and overall survival (in the overall population). Primary analyses were done in the intention-to-treat population, defined as all randomly assigned patients who gave their full consent to participation in the study and data processing. Safety was assessed in all patients included in the intention-to-treat population who received at least one dose of study treatment. Here, we report the primary progression-free survival and the interim overall survival results. This study is ongoing and is registered with ClinicalTrials.gov, NCT03603184. Findings: Between Oct 3, 2018, and Jan 7, 2022, 551 patients were r

Published
2024

8. INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

Author

INOVATYON study group, Colombo, N., Gadducci, A., Sehouli, J., Rulli, E., Mäenpää, J., Sessa, C., Montes, A., Ottevanger, N. B., Berger, R., Vergote, I., D'Incalci, M., Churruca Galaz, C., Chekerov, R., Nyvang, G. B., Riniker, S., Herbertson, R., Fossati, R., Barretina-Ginesta, M. P., Deryal, M., Mirza, M. R., Biagioli, E., Iglesias, M., Funari, G., Romeo, M., Tasca, G., Pardo, B., Tognon, G., Rubio-Pérez, M. J., DeCensi, A., De Giorgi, U., Zola, P., Benedetti Panici, P., Aglietta, M., Arcangeli, V., Zamagni, C., Bologna, A., Westermann, A., Heinzelmann-Schwarz, V., Tsibulak, I., Wimberger, P., Poveda, A., Tampere University, Clinical Medicine, Department of Gynaecology and Obstetrics, Colombo, N, Gadducci, A, Sehouli, J, Rulli, E, Mäenpää, J, Sessa, C, Montes, A, Ottevanger, N, Berger, R, Vergote, I, D'Incalci, M, Churruca Galaz, C, Chekerov, R, Nyvang, G, Riniker, S, Herbertson, R, Fossati, R, Barretina-Ginesta, M, Deryal, M, Mirza, M, Biagioli, E, Iglesias, M, Funari, G, Romeo, M, Tasca, G, Pardo, B, Tognon, G, Rubio-Pérez, M, Decensi, A, De Giorgi, U, Zola, P, Benedetti Panici, P, Aglietta, M, Arcangeli, V, Zamagni, C, Bologna, A, Westermann, A, Heinzelmann-Schwarz, V, Tsibulak, I, Wimberger, P, and Poveda, A

Subjects
Cancer Research, All institutes and research themes of the Radboud University Medical Center, Oncology, 3123 Gynaecology and paediatrics, 3122 Cancers, platinum-free interval, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
Abstract

Background This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC). Methods Patients with OC (up to two previous platinum-based lines), with a TFIp of 6–12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75). Results The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94–1.35; p = 0.197). Grade 3–5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP). Conclusions This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6–12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities. Clinical trial registration ClinicalTrials.gov, number NCT01379989.

Published
2023

11. Genetic markers associated with divergent selection against the parasite Marteilia cochillia in common cockle (Cerastoderma edule) using transcriptomics and population genomics data

Author

Pampín, M., primary, Casanova, A., additional, Fernández, C., additional, Blanco, A., additional, Hermida, M., additional, Vera, M., additional, Pardo, B. G., additional, Coimbra, R. M., additional, Cao, A., additional, Iglesias, D., additional, Carballal, M.J., additional, Villalba, A., additional, and Martínez, P., additional

Published
2023
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13. Recovery of eutrophized marine ecosystems using the European flat oyster, Ostrea edulis

Author

Fundación Biodiversidad, Ministerio para la Transición Ecológica y el Reto Demográfico (España), Gobierno de la Región de Murcia, Agencia Estatal de Investigación (España), Albentosa, Marina [0000-0003-4771-5137], Galimany, Eve [0000-0003-1493-2944], Da Costa, Fiz [0000-0002-7225-7177], Vázquez-Luis, Maite [0000-0002-2733-2801], Hernández-Contreras, Ángel [0000-0003-0662-8563], Hernandis, Sebastián [0000-0002-1756-297X], Albentosa, Marina, Akinyemi, M. I., Vera, M., Ibarrola, I., Filgueira, R., Galimany, Eve, Da Costa, Fiz, Pardo, B. G., Vázquez-Luis, Maite, Hernández-Contreras, Ángel, Hernandis, Sebastián, Martínez, P., Fundación Biodiversidad, Ministerio para la Transición Ecológica y el Reto Demográfico (España), Gobierno de la Región de Murcia, Agencia Estatal de Investigación (España), Albentosa, Marina [0000-0003-4771-5137], Galimany, Eve [0000-0003-1493-2944], Da Costa, Fiz [0000-0002-7225-7177], Vázquez-Luis, Maite [0000-0002-2733-2801], Hernández-Contreras, Ángel [0000-0003-0662-8563], Hernandis, Sebastián [0000-0002-1756-297X], Albentosa, Marina, Akinyemi, M. I., Vera, M., Ibarrola, I., Filgueira, R., Galimany, Eve, Da Costa, Fiz, Pardo, B. G., Vázquez-Luis, Maite, Hernández-Contreras, Ángel, Hernandis, Sebastián, and Martínez, P.

Abstract

The development of tourism and intensification of agriculture has released large amounts of nitrogen and phosphorus into the Mar Menor coastal lagoon in South-east Spain, resulting in a phytoplankton bloom in 2016. This bloom turned the clear and transparent waters turbid and greenish, and killed approximately 85% of benthic macrophytes. Nutrient bioextraction by flat oysters, Ostrea edulis, has been proposed for remediation of these eutrophication events and water quality recovery. This research aims to quantify the clearance rate and investigate the genetic origin of Mar Menor oysters under eutrophized conditions for potential applications to bioremediation projects. Oligotrophic and eutrophic conditions were replicated in the laboratory, and oyster feeding behaviour (i.e. clearance rates, ingestion rates, absorption efficiency and absorption rates) were studied using a flow-through system. The genetic characterization of oysters showed no significant difference between individuals from the Mar Menor and individuals collected from a nearby Mediterranean bed (Tabarca Island). Based on the physiological results observed, oysters were grouped into high-feeder (HF) and low-feeder (LF) categories according to their clearance rate, that was 3-fold higher in the HF group. Different responses in feeding behaviour were observed under eutrophic conditions in both oyster groups. Constraints in the absorption capacity of LF oysters seemed to be related to their reduced filtering activity. Lower body condition of LF oysters was evidenced by their negative scope for growth value. From this work, several conclusions can be drawn for future restoration/bioextraction actions: (i) the recovery of half of the oyster population that existed in the past would act as an effective top-down control on the phytoplankton community; (ii) using clearance rate measurements is recommended to select oysters as broodstock; and (iii) Mediterranean oysters could be used as broodstock in the event

Published
2023

14. Maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer: Outcomes by somatic and germline BRCA and other homologous recombination repair gene mutation status in the ORZORA trial

Author

Pignata, S, Oza, A, Hall, G, Pardo, B, Madry, R, Cibula, D, Klat, J, Montes, A, Glasspool, R, Colombo, N, Pete, I, Herrero Ibáñez, A, Marín, M, Ilieva, R, Timcheva, C, Di Maio, M, Blakeley, C, Taylor, R, Barnicle, A, Clamp, A, Pignata, S, Oza, A, Hall, G, Pardo, B, Madry, R, Cibula, D, Klat, J, Montes, A, Glasspool, R, Colombo, N, Pete, I, Herrero Ibáñez, A, Marín, M, Ilieva, R, Timcheva, C, Di Maio, M, Blakeley, C, Taylor, R, Barnicle, A, and Clamp, A

Abstract

Background: The open-label, single-arm, multicenter ORZORA trial (NCT02476968) evaluated the efficacy and safety of maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer (PSR OC) who had tumor BRCA mutations (BRCAm) of germline (g) or somatic (s) origin or non-BRCA homologous recombination repair mutations (HRRm) and were in response to their most recent platinum-based chemotherapy after ≥2 lines of treatment. Methods: Patients received maintenance olaparib capsules (400 mg twice daily) until disease progression. Prospective central testing at screening determined tumor BRCAm status and subsequent testing determined gBRCAm or sBRCAm status. Patients with predefined non-BRCA HRRm were assigned to an exploratory cohort. The co-primary endpoints were investigator-assessed progression-free survival (PFS; modified Response Evaluation Criteria in Solid Tumors v1.1) in BRCAm and sBRCAm cohorts. Secondary endpoints included health-related quality of life (HRQoL) and tolerability. Results: 177 patients received olaparib. At the primary data cut-off (17 April 2020), the median follow-up for PFS in the BRCAm cohort was 22.3 months. The median PFS (95% CI) in BRCAm, sBRCAm, gBRCAm and non-BRCA HRRm cohorts was 18.0 (14.3-22.1), 16.6 (12.4-22.2), 19.3 (14.3-27.6) and 16.4 (10.9-19.3) months, respectively. Most patients with BRCAm reported improvements (21.8%) or no change (68.7%) in HRQoL and the safety profile was as expected. Conclusions: Maintenance olaparib had similar clinical activity in PSR OC patients with sBRCAm and those with any BRCAm. Activity was also observed in patients with a non-BRCA HRRm. ORZORA further supports use of maintenance olaparib in all patients with BRCA-mutated, including sBRCA-mutated, PSR OC.

Published
2023

15. INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

Author

Colombo, N, Gadducci, A, Sehouli, J, Rulli, E, Mäenpää, J, Sessa, C, Montes, A, Ottevanger, N, Berger, R, Vergote, I, D'Incalci, M, Churruca Galaz, C, Chekerov, R, Nyvang, G, Riniker, S, Herbertson, R, Fossati, R, Barretina-Ginesta, M, Deryal, M, Mirza, M, Biagioli, E, Iglesias, M, Funari, G, Romeo, M, Tasca, G, Pardo, B, Tognon, G, Rubio-Pérez, M, Decensi, A, De Giorgi, U, Zola, P, Benedetti Panici, P, Aglietta, M, Arcangeli, V, Zamagni, C, Bologna, A, Westermann, A, Heinzelmann-Schwarz, V, Tsibulak, I, Wimberger, P, Poveda, A, Ottevanger, N B, Nyvang, G B, Barretina-Ginesta, M P, Mirza, M R, Rubio-Pérez, M J, DeCensi, A, Colombo, N, Gadducci, A, Sehouli, J, Rulli, E, Mäenpää, J, Sessa, C, Montes, A, Ottevanger, N, Berger, R, Vergote, I, D'Incalci, M, Churruca Galaz, C, Chekerov, R, Nyvang, G, Riniker, S, Herbertson, R, Fossati, R, Barretina-Ginesta, M, Deryal, M, Mirza, M, Biagioli, E, Iglesias, M, Funari, G, Romeo, M, Tasca, G, Pardo, B, Tognon, G, Rubio-Pérez, M, Decensi, A, De Giorgi, U, Zola, P, Benedetti Panici, P, Aglietta, M, Arcangeli, V, Zamagni, C, Bologna, A, Westermann, A, Heinzelmann-Schwarz, V, Tsibulak, I, Wimberger, P, Poveda, A, Ottevanger, N B, Nyvang, G B, Barretina-Ginesta, M P, Mirza, M R, Rubio-Pérez, M J, and DeCensi, A

Abstract

BACKGROUND: This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC). METHODS: Patients with OC (up to two previous platinum-based lines), with a TFIp of 6-12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75). RESULTS: The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94-1.35; p = 0.197). Grade 3-5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP). CONCLUSIONS: This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6-12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT01379989.

Published
2023

18. Recovery of eutrophized marine ecosystems using the European flat oyster, Ostrea edulis.

Author

Albentosa, M., Akinyemi, M. I., Vera, M., Ibarrola, I., Filgueira, R., Galimany, E., da Costa, F., Pardo, B. G., Vázquez‐Luis, M., Hernández, A., Hernandis, S., and Martínez, P.

Subjects
MARINE ecology, OYSTER populations, OYSTERS, AGRICULTURAL intensification, ALGAL blooms, EUTROPHICATION
Abstract

The development of tourism and intensification of agriculture has released large amounts of nitrogen and phosphorus into the Mar Menor coastal lagoon in South‐east Spain, resulting in a phytoplankton bloom in 2016. This bloom turned the clear and transparent waters turbid and greenish, and killed approximately 85% of benthic macrophytes.Nutrient bioextraction by flat oysters, Ostrea edulis, has been proposed for remediation of these eutrophication events and water quality recovery.This research aims to quantify the clearance rate and investigate the genetic origin of Mar Menor oysters under eutrophized conditions for potential applications to bioremediation projects. Oligotrophic and eutrophic conditions were replicated in the laboratory, and oyster feeding behaviour (i.e. clearance rates, ingestion rates, absorption efficiency and absorption rates) were studied using a flow‐through system.The genetic characterization of oysters showed no significant difference between individuals from the Mar Menor and individuals collected from a nearby Mediterranean bed (Tabarca Island).Based on the physiological results observed, oysters were grouped into high‐feeder (HF) and low‐feeder (LF) categories according to their clearance rate, that was 3‐fold higher in the HF group. Different responses in feeding behaviour were observed under eutrophic conditions in both oyster groups. Constraints in the absorption capacity of LF oysters seemed to be related to their reduced filtering activity. Lower body condition of LF oysters was evidenced by their negative scope for growth value.From this work, several conclusions can be drawn for future restoration/bioextraction actions: (i) the recovery of half of the oyster population that existed in the past would act as an effective top‐down control on the phytoplankton community; (ii) using clearance rate measurements is recommended to select oysters as broodstock; and (iii) Mediterranean oysters could be used as broodstock in the event that Mar Menor oysters fail to reproduce. [ABSTRACT FROM AUTHOR]

Published
2023
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19. spatialLIBD: an R/Bioconductor package to visualize spatially-resolved transcriptomics data

Author

Andrew E. Jaffe, Kristen R. Maynard, Keri Martinowich, Stephanie C. Hicks, Leonardo Collado-Torres, Pardo B, Lukas M. Weber, and Abby Spangler

Subjects
Supplementary data, Computer science, business.industry, Spatially resolved, Genomics, computer.software_genre, Bioconductor, Spatial reference system, Genetics, Web application, Data mining, Intact tissue, Transcriptome, business, Interactive visualization, computer, Ecosystem, Software, Biotechnology
Abstract

Background Spatially-resolved transcriptomics has now enabled the quantification of high-throughput and transcriptome-wide gene expression in intact tissue while also retaining the spatial coordinates. Incorporating the precise spatial mapping of gene activity advances our understanding of intact tissue-specific biological processes. In order to interpret these novel spatial data types, interactive visualization tools are necessary. Results We describe spatialLIBD, an R/Bioconductor package to interactively explore spatially-resolved transcriptomics data generated with the 10x Genomics Visium platform. The package contains functions to interactively access, visualize, and inspect the observed spatial gene expression data and data-driven clusters identified with supervised or unsupervised analyses, either on the user’s computer or through a web application. Conclusions spatialLIBD is available at https://bioconductor.org/packages/spatialLIBD. It is fully compatible with SpatialExperiment and the Bioconductor ecosystem. Its functionality facilitates analyzing and interactively exploring spatially-resolved data from the Visium platform.

Published
2022

25. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer

Author

Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Lorusso D., Hilpert F., Gonzalez Martin A., Rau J., Ottevanger P., Greimel E., Luck H. -J., Selle F., Colombo N., Kroep J. R., Mirza M. R., Berger R., Pardo B., Grischke E. -M., Berton-Rigaud D., Martinez-Garcia J., Vergote I., Redondo A., Cardona A., Bastiere-Truchot L., Du Bois A., Kurzeder C., Del Campo J. M., Bover I., Barretina-Ginesta P., Ortega E., Garcia Y., Romero I., Poveda A., Herrero A., Vidal L., Rubio M. J., Romeo M., Mendiola C., Arranz J. A., Santaballa A., Gomez De Liano A., Marme F., Mahner S., Canzler U., Zorr A., Gropp-Meier M., Cayir P., Schmalfeldt B., Rautenberg B., Meier W., Belau A., Gerber B., Rein D., Jackisch C., Janni W., Heubner M., Pautier P., Fabbro M., Floquet A., You B., Favier L., Joly F., Weber B., Hardy-Bessard A. -C., Gadducci A., Tognon G., DeCensi A., Savarese A., PISANO, CARLO MARIA, Sonke G., Reyners A., Kristensen G., Bjurberg M., Rosenberg P., Marth C., Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Lorusso D., Hilpert F., Gonzalez Martin A., Rau J., Ottevanger P., Greimel E., Luck H. -J., Selle F., Colombo N., Kroep J. R., Mirza M. R., Berger R., Pardo B., Grischke E. -M., Berton-Rigaud D., Martinez-Garcia J., Vergote I., Redondo A., Cardona A., Bastiere-Truchot L., Du Bois A., Kurzeder C., Del Campo J. M., Bover I., Barretina-Ginesta P., Ortega E., Garcia Y., Romero I., Poveda A., Herrero A., Vidal L., Rubio M. J., Romeo M., Mendiola C., Arranz J. A., Santaballa A., Gomez De Liano A., Marme F., Mahner S., Canzler U., Zorr A., Gropp-Meier M., Cayir P., Schmalfeldt B., Rautenberg B., Meier W., Belau A., Gerber B., Rein D., Jackisch C., Janni W., Heubner M., Pautier P., Fabbro M., Floquet A., You B., Favier L., Joly F., Weber B., Hardy-Bessard A. -C., Gadducci A., Tognon G., DeCensi A., Savarese A., PISANO, CARLO MARIA, Sonke G., Reyners A., Kristensen G., Bjurberg M., Rosenberg P., and Marth C.

Abstract

Introduction The PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes. Patients and methods Eligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression. Results At database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms. Discussion Consistent with

Published
2019

26. 674 Niraparib as maintenance therapy in platinum-sensitive recurrent ovarian cancer: a GEICO study within the Spanish extended access program

Author

Cueva Bañuelos, JF, primary, Palacio, I, additional, Churruca, C, additional, Herrero-Ibáñez, A, additional, Pardo, B, additional, Constenla, M, additional, Santaballa, A, additional, Manso, L, additional, Estévez, P, additional, Maximiano, C, additional, Legerén, M, additional, Marquina, G, additional, De Juan, A, additional, Quindós, M, additional, Sánchez, L, additional, Barquin, A, additional, Fernández Pérez, I, additional, Martín-Lorente, C, additional, Juárez, A, additional, and González-Martín, A, additional

Published
2021
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29. Peces de la cuenca del río Magdalena, Colombia: diversidad, conservación y uso sostenible

Author

Jorge L. Escobar Cardona, Carlos Rogeliz, Natalia Restrepo Escobar, Anny J. Yepes Acevedo, Kelly Rivera Coley, Juliana Herrera Pérez, Gabriel F. Narváez Campo, Andrés F. Galeano, Ángela L. Gutiérrez C., Paulo Petry, Carlos DoNascimiento, Edna J. Márquez Fernández, Angélica M. Batista Morales, Juliana Delgado, Juan G. Ospina Pabón, Luis C. Gutiérrez Moreno, Juan C. Alonso, Silvia López Casas, Isaí Castaño Tenorio, Sebastián E. Muñoz Duque, Sandra Hernández Barrero, Luisa F. Casas, Jacobo Campuzano, Juan C. Gutiérez C., Héctor Angarita, Jenny Morales, Carlos A. Lasso, Juan C. Narváez Barandica, Ayan Santos Fleischman, Andrés Cárdenas Rozo, Guido Herrera R., Luis J. García Melo, Ana C. Santos, Daniel Valencia Rodríguez, María F. Arboleda, Carlos G. Barreto Reyes, María C. Castellanos, Mauricio Valderrama Barco, Rubén D. Valbuena Villarreal, Luz Jiménez Segura, Jorge E. García Melo, Raúl Pardo B., Juan D. Restrepo, María D. Escobar, Francisco A. Villa Navarro, Víctor Atencio García, Fabio García, Melissa Toro S., Carolina Rincón, Juan F. Paniaguan Arroyave, Tania F. Santos Santos, Carlos García Alzate, Ana C. De la Parra Guerra, María Isabel Ríos Pulgarín, Yesid F. Rondón Martínez, Fernando Campo Zambrano, Diana M. Gualtero Leal, and Daniel Restrepo Santamaría

Abstract

Este libro nos pone al día en tres grandes bloques, uno inicial donde se aborda el estado del conocimiento tanto desde la perspectiva biótica como física de la cuenca, la geología, hidrología, sedimentología y su relación con los ecosistemas y la biodiversidad acuática; los peces, su diversidad taxonómica y genética, ecología e historias de vida y los servicios ecosistémicos que brindan como recursos pesqueros. En la segunda parte se consideran los conflictos ambientales en la cuenca, desde temas como la contaminación y la modificación del hábitat; los peces introducidos (exóticos y trasplantados y la “presión” de una demanda cada vez mayor de la pesca. En la sección tercera, tras una interpretación concienzuda de los capítulos anteriores y el conocimiento de los investigadores, se hace un análisis detallado de todas las amenazas, así como las estrategias de conservación y manejo del recurso íctico. Todo ello, sienta las bases para una serie de recomendaciones para la toma de decisiones que son recogidas al final de la obra.

Published
2021

30. Servicios ecosistémicos generados por los peces de la cuenca del río Magdalena, Colombia

Author

Mauricio Valderrama-Barco, Silvia López-Casas, C C Juan Gutiérrez, B Melissa Toro, Raúl Pardo-B., and Jorge L. Escobar-Cardona

Abstract

En este capítulo se identifican y describen los servicios ecosistémicos generados por las poblaciones de peces en la cuenca del río Magdalena. En lo concerniente a los servicios de aprovisionamiento se valora la pesca artesanal, junto con sus beneficios como el aporte al empleo y a la seguridad alimentaria, presentándose conjuntamente aspectos relacionados con servicios de abastecimiento relacionados con pesca recreativa y deportiva, recursos genéticos y piscicultura. En cuanto a los servicios de regulación y mantenimiento, se describen los aportes a la regulación en la dinámica de la red trófica y el balance de nutrientes, a la reducción de contaminantes, a la transformación de materia orgánica en los sistemas de interacción peces-hábitat, bioturbación, transporte de los nutrientes-carbón-minerales, energía y la dispersión de semillas, junto con control biológico de plagas y enfermedades tropicales. Con relación a los servicios culturales se contemplan los relacionados con interacciones físicas e intelectuales asociados con la demanda para la educación e información y conocimiento local, y aquellos asociados con interacciones espirituales y simbólicas. Se concluye que el grado de desarrollo actual del conocimiento en la cuenca subestima los servicios ecosistémicos brindados por los peces, se enfatiza en la necesidad de modificar los paradigmas de manejo tradicional y se presentan recomendaciones para propender por su materialización.

Published
2021

32. Generation of mitochondrial reactive oxygen species is controlled by ATPase inhibitory factor 1 and regulates cognition

Author

Esparza-Moltó PB, Romero-Carramiñana I, Núñez de Arenas C, Pereira MP, Blanco N, Pardo B, Bates GR, Sánchez-Castillo C, Artuch-Iriberri R, Murphy MP, Esteban JA, and Cuezva JM

Abstract

The mitochondrial ATP synthase emerges as key hub of cellular functions controlling the production of ATP, cellular signaling, and fate. It is regulated by the ATPase inhibitory factor 1 (IF1), which is highly abundant in neurons. Herein, we ablated or overexpressed IF1 in mouse neurons to show that IF1 dose defines the fraction of active/inactive enzyme in vivo, thereby controlling mitochondrial function and the production of mitochondrial reactive oxygen species (mtROS). Transcriptomic, proteomic, and metabolomic analyses indicate that IF1 dose regulates mitochondrial metabolism, synaptic function, and cognition. Ablation of IF1 impairs memory, whereas synaptic transmission and learning are enhanced by IF1 overexpression. Mechanistically, quenching the IF1-mediated increase in mtROS production in mice overexpressing IF1 reduces the increased synaptic transmission and obliterates the learning advantage afforded by the higher IF1 content. Overall, IF1 plays a key role in neuronal function by regulating the fraction of ATP synthase responsible for mitohormetic mtROS signaling.

Published
2021

33. An integrated emergency department/hospital at home model in mild COVID-19 pneumonia: feasibility and outcomes after discharge from the emergency department

Author

Llorens P, Moreno-Pérez O, Espinosa B, García T, Payá AB, Sola S, Molina F, Román F, Jiménez I, Guzman S, Gil-Rodrigo A, Peña-Pardo B, Merino E, Gil J, San-Inocencio D, Andrés M, and Sánchez-Payá J

Subjects
COVID-19, Emergency department, Hospital based home cares, Pneumonia
Abstract

To evaluate the effectiveness of an integrated emergency department (ED)/hospital at home (HH) medical care model in mild COVID-19 pneumonia and evaluate baseline predictors of major outcomes and potential savings. Retrospective cohort study with patients evaluated for COVID-19 pneumonia in the ED, from March 3 to April 30, 2020. All of them were discharged home and controlled by HH. The main outcomes were ED revisit and the need for deferred hospital admission (protocol failure). Outcome predictors were analyzed by simple logistic regression model (OR; 95% CI). Potential savings of this medical care model were estimated. Of the 377 patients attended in the ED, 109 were identified as having mild pneumonia and were included in the ED/HH medical care model. Median age was 50.0 years, 52.3% were males and 57.8% had Charlson index = 1. The median HH stay was 8 (IQR 3.7-11) days. COVID-19-related ED revisit was 19.2% (n = 21) within 6 days (IQR 3-12.5) after discharge from ED. Overall protocol failure (deferred hospital admission) was 6.4% (n = 7), without ICU admission. The ED/HH model provided potential cost savings of 77% compared to traditional stay, due to the costs of home care entails 23% of the expenses generated by a conventional hospital stay. 789 days of hospital stay were avoided by HH, rather than hospital admission. An innovative ED/HH model for selected patients with mild COVID-19 pneumonia is feasible, safe and effective. Less than 6.5% of patients requiring deferred hospital admission and potential savings were generated due to hospitalization.

Published
2021

34. Effective therapeutic strategies in a preclinical mouse model of Charcot-Marie-Tooth disease

Author

Nuevo-Tapioles C, Santacatterina F, Sánchez-Garrido B, Arenas CN, Robledo-Bérgamo A, Martínez-Valero P, Cantarero-Abad L, Pardo B, Hoenicka J, Murphy MP, Satrústegui J, Palau F, and Cuezva JM

Subjects
congenital, hereditary, and neonatal diseases and abnormalities
Abstract

Charcot-Marie-Tooth (CMT) disease is a neuropathy that lacks effective therapy. CMT patients show degeneration of peripheral nerves, leading to muscle weakness and loss of proprioception. Loss of mitochondrial oxidative phosphorylation proteins and enzymes of the antioxidant response accompany degeneration of nerves in skin biopsies of CMT patients. Herein, we followed a drug-repurposing approach to find drugs in a Food and Drug Administration-approved library that could prevent development of CMT disease in the Gdap1-null mouse model. We found that the antibiotic florfenicol is a mitochondrial uncoupler that prevents the production of reactive oxygen species and activates respiration in human GDAP1-knockdown neuroblastoma cells and in dorsal root ganglion neurons of Gdap1-null mice. Treatment of CMT-affected Gdap1-null mice with florfenicol has no beneficial effect in the course of the disease. However, administration of florfenicol, or the antioxidant MitoQ, to pre-symptomatic GDAP1-null mice prevented weight gain and ameliorated the motor coordination deficiencies that developed in the Gdap1-null mice. Interestingly, both florfenicol and MitoQ halted the decay in mitochondrial and redox proteins in sciatic nerves of Gdap1-null mice, supporting that oxidative damage is implicated in the etiology of the neuropathy. These findings support the development of clinical trials for translation of these drugs for treatment of CMT patients.

Published
2021

38. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer

Author

Lorusso, D., Hilpert, F., Martin, A.G., Rau, J., Ottevanger, P., Greimel, E., Luck, H.J., Selle, F., Colombo, N., Kroep, J.R., Mirza, M.R., Berger, R., Pardo, B., Grischke, E.M., Berton-Rigaud, D., Martinez-Garcia, J., Vergote, I., Redondo, A., Cardona, A., Bastiere-Truchot, L., Bois, A. du, Kurzeder, C., Campo, J.M. del, Bover, I., Barretina-Ginesta, P., Ortega, E., Garcia, Y., Romero, I., Poveda, A., Herrero, A., Vidal, L., Rubio, M.J., Romeo, M., Mendiola, C., Arranz, J.A., Santaballa, A., Liano, A.G. de, Marme, F., Mahner, S., Canzler, U., Zorr, A., Gropp-Meier, M., Cayir, P., Schmalfeldt, B., Rautenberg, B., Meier, W., Belau, A., Gerber, B., Rein, D., Jackisch, C., Janni, W., Heubner, M., Pautier, P., Fabbro, M., Floquet, A., You, B., Favier, L., Joly, F., Weber, B., Hardy-Bessard, A.C., Gadducci, A., Tognon, G., DeCensi, A., Savarese, A., Pisano, C., Sonke, G., Reyners, A., Kristensen, G., Bjurberg, M., Rosenberg, P., Marth, C., PENELOPE Trial Investigators, Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Targeted Gynaecologic Oncology (TARGON), and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
Oncology, Receptor, ErbB-3, medicine.medical_treatment, Carcinoma, Ovarian Epithelial, Deoxycytidine, 0302 clinical medicine, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Aged, 80 and over, Ovarian Neoplasms, 0303 health sciences, education.field_of_study, Obstetrics and Gynecology, Middle Aged, Progression-Free Survival, ovarian cancer, patient-reported outcomes, 030220 oncology & carcinogenesis, Female, Pertuzumab, medicine.drug, Adult, medicine.medical_specialty, Paclitaxel, overall survival, Population, Placebo, patient-reported outcome, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Double-Blind Method, HER3, pertuzumab, Internal medicine, medicine, Humans, Patient Reported Outcome Measures, RNA, Messenger, education, 030304 developmental biology, Aged, Chemotherapy, business.industry, medicine.disease, Gemcitabine, Drug Resistance, Neoplasm, Topotecan, business, Ovarian cancer
Abstract

IntroductionThe PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes.Patients and methodsEligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression.ResultsAt database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms.DiscussionConsistent with the primary results, adding pertuzumab to chemotherapy for low tumor HER3 mRNA-expressing platinum-resistant ovarian cancer did not improve overall survival, but showed trends in some cohorts. Except for increased diarrhea symptoms, pertuzumab had no impact on patient-reported outcomes.ClinicalTrials.gov:ClinicalTrials.gov:NCT01684878.

Published
2019

41. Clinical findings, risk factors, and final outcome in patients diagnosed with pulmonary thromboembolism and COVID-19 in hospital emergency departments

Author

Hernandez S, Polo L, Cuquerella G, Pardo B, Espinosa B, Cardozo C, Tejedo A, Soriano P, and Miro O

Subjects
Pulmonary embolism, COVID-19, Hospital emergency department
Abstract

Objective. To analyze clinical, laboratory, and radiologic findings and final health outcomes in patients with pulmonary embolism and coronavirus disease 2019 (COVID-19). To compare them to findings and outcomes in patients with pulmonary embolism without COVID-19. Methods. Multicenter, observational, retrospective study in 4 Spanish hospital emergency departments (EDs) from January 15 to April 15, 2020. Cases were located by reviewing all ED requests for pulmonary computed tomography angiography (CTA) procedures. Clinical, laboratory, and radiologic findings; medical histories and comorbidity; risk factors; and outcomes were compared between the 2 groups of patients (with or without COVID-19). Results. A total of 399 CTAs were ordered; 88 pulmonary embolisms were diagnosed, 28 of them (32%) in patients with COVID-19. This group had more men, and a history of thromboembolic disease was more common. We found no between-group differences in clinical presentation, laboratory, or radiologic findings; nor were there differences in final outcomes. In-hospital mortality was 7% (2 cases) in patients with COVID-19 and 17% (10 cases) in patients without the virus (odds ratio for death in patients with pulmonary embolism and COVID-19, 0.38; 95% CI, 0.08-1.89). Conclusions. We found no clinically important differences in the clinical, laboratory, or radiologic findings between patients with or without COVID-19 who were treated for pulmonary embolism in our hospital EDs. Final outcomes also did not differ.

Published
2020

43. La Chicha

Author

Pardo B., Oriana, Pizarro T., José Luis, Pardo B., Oriana, and Pizarro T., José Luis

Published
2020

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