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24 results on '"Fariñas-Madrid, Lorena"'

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

Author

Zola, Paolo, Casanova, Claudia, Arcangeli, Valentina, Antonuzzo, Lorenzo, Gadducci, Angiolo, Cosio, Stefania, Clamp, Andrew, Persic, Mojca, McNeish, Ian, Tookman, Laura, Redondo Sanchez, Andrés, Choi, Chel Hun, Baldini, Editta, Palaia, Innocenza, Benedetti Panici, Pierluigi, Takahashi, Nobutaka, Lombard, Janine, Ardizzoia, Antonio, Bologna, Alessandra, Herrero Ibáñez, Ana Maria, Musolino, Antonino, Márquez Vázquez, Raúl, Pietzner, Klaus, Braicu, Elena, Heinzelmann-Schwarz, Viola A., Powell, Melanie, Yokoyama, Yoshihito, Baron-Hay, Sally, Abeni, Chiara, Martin Lorente, Cristina, Cueva, Juan Fernando, Trillsch, Fabian, Heitz, Florian, Ataseven, Beyhan, Petru, Edgar, Heubner, MartinLeonhard, Sadozye, Azmat Hassanq, Dubey, Sidharth, Tazbirkova, Andrea, Tiley, Susan, Chrystal, Kathryn, Kim, Sang Wun, Fehr, Mathias, Scatchard, Kate, Anand, Anjana, Taylor, Alexandra, Watary, Hidemichi, Enomoto, Takayuki, Yoshihara, Kosuke, Selva-Nayagam, Sudarsha, Karki, Bhaskar, Harrison, Michelle, Wilkinson, Kate, Goh, Jeffrey, Glasgow, Amanda, Chantrill, Lorraine, Lee, Chulmin, Bertolini, Alessandro, Narducci, Filomena, Bellotti, Giovanna, Fusco, Vittorio, Aebi, Stefan, Del Grande, Maria, Colombo, Ilaria, Tokunaga, Hideki, Shigeta, Shogo, Goss, Geraldine, Siow, Zhen Rong, Steer, Christopher, Lin, Hao, Lee, Kwang-Beom, Di Meglio, Giovanni, Massa, Elena, De Marino, Elvira, Tortora, Vincenzo, Palacio Vazquez, Isabel, Tsuji, Kosuke, Tominaga, Eiichiro, Black, Allison, So, Kyeong A, Suh, Dong Hoon, Lee, Keun Ho, Kim, Yong Man, Fossati, Roldano, Carlucci, Luciano, Barberis, Massimo, Torri, Valter, Santoni, Anna, Colombo, Nicoletta, Biagioli, Elena, Harano, Kenichi, Galli, Francesca, Hudson, Emma, Antill, Yoland, Rabaglio, Manuela, Marmé, Frederic, Marth, Christian, Parma, Gabriella, Fariñas-Madrid, Lorena, Nishio, Shin, Allan, Karen, Lee, Yeh Chen, Piovano, Elisa, Pardo, Beatriz, Nakagawa, Satoshi, McQueen, John, Zamagni, Claudio, Manso, Luis, Takehara, Kazuhiro, Tasca, Giulia, Ferrero, Annamaria, Tognon, Germana, Lissoni, Andrea Alberto, Petrella, Mariacristina, Laudani, Maria Elena, Rulli, Eliana, Uggeri, Sara, and Barretina Ginesta, M Pilar

Published
2024
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2. Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study

Author

Makker, Vicky, Perez-Fidalgo, Jose Alejandro, Valabrega, Giorgio, Hamilton, Erika, Van Gorp, Toon, Sehouli, Jalid, Regináčová, Klaudia, Richardson, Debra L., Perri, Tamar, Oza, Amit M., Miller, David S., Alía, Eva Maria Guerra, De Giorgi, Ugo, Henry, Stephanie, Spitz, Daniel L., Wimberger, Pauline, Bednaříková, Markéta, Chon, Hye Sook, Martínez-Garcia, Jerónimo, Pisano, Carmela, Berek, Jonathan S., Romero, Ignacio, Scambia, Giovanni, Fariñas-Madrid, Lorena, Buscema, Joseph, Schochter, Fabienne, Li, Kai, Kalyanapu, Pratheek, Walker, Christopher J., and Vergote, Ignace

Published
2024
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3. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial

Author

Abadie-Lacourtoisie, Sophie, Andreetta, Claudia, Anzizar, Nerea, Aoki, Daiseuke, Barretina-Ginesta, Maria-Pilar, Battista, Marco, Bellier, Charlotte, Bentzen, Anne Gry, Berton, Dominique, Billemont, Bertrand, Bjørge, Line, Bjurberg, Maria, Black, Destin, Bologna, Alessandra, Braicu, Elena Ioana, Casanova, Claudia, Chekerov, Radoslav, Chevalier, Annick, Cueva, Juan Fernando, Czogalla, Bastian, Delanoy, Nicolas, Denschlag, Dominik, Derke, Oscar, Eichbaum, Michael, Enomoto, Takayuki, Esteban, Carmen, Fabbro, Michel, Fehm, Tanja, Ferrero, Annamaria, Fleisch, Markus, Floquet, Anne, Frassoldati, Antonio, Gaba, Lydia, Gadducci, Angiolo, García, Yolanda, Geuna, Elena, Guerra, Eva, Hanker, Lars, Hardy-Bessard, Anne-Claire, Harter, Philipp, Hasegawa, Kosei, Hellman, Kristina, Herrero, Ana, Hilpert, Felix, Katsaros, Dionyssios, Koegel, Matthias, Koliadi, Anthoula, Kurtz, Jean-Emmanuel, Lampe, Bjoern, Lissoni, Andrea Alberto, Lortholary, Alain, Mangili, Giorgia, Mansi, Laura, Marmé, Frederik, Mathews, Cara, Mina, William, Minobe, Shinichiro, Moxley, Katherine, Nagao, Shoji, Nicoletto, Ornella, Nishino, Koji, Nishio, Hiroshi, Nishio, Shin, Oaknin, Ana, Onstad, Michaela, Pardo, Beatriz, Pérez-Fidalgo, J Alejandro, Pisano, Carmela, Poveda, Andrés, Radosa, Julia, Randall, Leslie M., Ray-Coquard, Isabelle, Redondo, Andrés, Richardson, Debra, Romero, Ignacio, Ronzino, Graziana, Rubio, Maria Jesús, Selle, Frederic, Takekuma, Munetaka, Takeshima, Nobuhiro, Tasca, Giulia, Tewari, Krishnansu, Todo, Yukiharu, Valabrega, Giorgio, Wimberger, Pauline, Woelber, Linn, Yamaguchi, Satoshi, You, Benoît, Yunokawa, Mayu, Gladieff, Laurence, Martínez-García, Jerónimo, Villacampa, Guillermo, De Giorgi, Ugo, Lindemann, Kristina, Colombo, Nicoletta, Duska, Linda, Leary, Alexandra, Godoy-Ortiz, Ana, Angelergues, Antoine, Fariñas-Madrid, Lorena, Lorusso, Domenica, Manso, Luis, Joly, Florence, Alarcón, Jesús, Follana, Philippe, Lebreton, Coriolan, Dahlstrand, Hanna, D'Hondt, Véronique, and Randall, Leslie M

Published
2024
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5. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial

Author

Oaknin, A, Gladieff, L, Martínez-García, J, Villacampa, G, Takekuma, M, De Giorgi, U, Lindemann, K, Woelber, L, Colombo, N, Duska, L, Leary, A, Godoy-Ortiz, A, Nishio, S, Angelergues, A, Rubio, M, Fariñas-Madrid, L, Yamaguchi, S, Lorusso, D, Ray-Coquard, I, Manso, L, Joly, F, Alarcón, J, Follana, P, Romero, I, Lebreton, C, Pérez-Fidalgo, J, Yunokawa, M, Dahlstrand, H, D'Hondt, V, Randall, L, Oaknin, Ana, Gladieff, Laurence, Martínez-García, Jerónimo, Villacampa, Guillermo, Takekuma, Munetaka, De Giorgi, Ugo, Lindemann, Kristina, Woelber, Linn, Colombo, Nicoletta, Duska, Linda, Leary, Alexandra, Godoy-Ortiz, Ana, Nishio, Shin, Angelergues, Antoine, Rubio, Maria Jesús, Fariñas-Madrid, Lorena, Yamaguchi, Satoshi, Lorusso, Domenica, Ray-Coquard, Isabelle, Manso, Luis, Joly, Florence, Alarcón, Jesús, Follana, Philippe, Romero, Ignacio, Lebreton, Coriolan, Pérez-Fidalgo, J Alejandro, Yunokawa, Mayu, Dahlstrand, Hanna, D'Hondt, Véronique, Randall, Leslie M, Oaknin, A, Gladieff, L, Martínez-García, J, Villacampa, G, Takekuma, M, De Giorgi, U, Lindemann, K, Woelber, L, Colombo, N, Duska, L, Leary, A, Godoy-Ortiz, A, Nishio, S, Angelergues, A, Rubio, M, Fariñas-Madrid, L, Yamaguchi, S, Lorusso, D, Ray-Coquard, I, Manso, L, Joly, F, Alarcón, J, Follana, P, Romero, I, Lebreton, C, Pérez-Fidalgo, J, Yunokawa, M, Dahlstrand, H, D'Hondt, V, Randall, L, Oaknin, Ana, Gladieff, Laurence, Martínez-García, Jerónimo, Villacampa, Guillermo, Takekuma, Munetaka, De Giorgi, Ugo, Lindemann, Kristina, Woelber, Linn, Colombo, Nicoletta, Duska, Linda, Leary, Alexandra, Godoy-Ortiz, Ana, Nishio, Shin, Angelergues, Antoine, Rubio, Maria Jesús, Fariñas-Madrid, Lorena, Yamaguchi, Satoshi, Lorusso, Domenica, Ray-Coquard, Isabelle, Manso, Luis, Joly, Florence, Alarcón, Jesús, Follana, Philippe, Romero, Ignacio, Lebreton, Coriolan, Pérez-Fidalgo, J Alejandro, Yunokawa, Mayu, Dahlstrand, Hanna, D'Hondt, Véronique, and Randall, Leslie M

Abstract

Background: The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone. Methods: In this investigator-initiated, randomised, open-label, phase 3 trial, patients from 92 sites in Europe, Japan, and the USA with metastatic (stage IVB), persistent, or recurrent cervical cancer that was measurable, previously untreated, and not amenable to curative surgery or radiation were randomly assigned 1:1 to receive standard therapy (cisplatin 50 mg/m2 or carboplatin area under the curve of 5, paclitaxel 175 mg/m2, and bevacizumab 15 mg/kg, all on day 1 of every 3-week cycle) with or without atezolizumab 1200 mg. Treatment was continued until disease progression, unacceptable toxicity, patient withdrawal, or death. Stratification factors were previous concomitant chemoradiation (yes vs no), histology (squamous cell carcinoma vs adenocarcinoma including adenosquamous carcinoma), and platinum backbone (cisplatin vs carboplatin). Dual primary endpoints were investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumours version 1.1 and overall survival analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03556839, and is ongoing. Findings: Between Oct 8, 2018, and Aug 20, 2021, 410 of 519 patients assessed for eligibility were enrolled. Median progression-free survival was 13·7 months (95% CI 12·3–16·6) with atezolizumab and 10·4 months (9·7–11·7) with standard therapy (hazard ratio [HR]=0·62 [95% CI 0·49–0·78]; p<0·0001); at the interim overall survival analysis, median overall survival was 32·1 months (95% CI 25·3–36·8) versus 22·8 months (20·3–28·0), respectively (HR 0·68 [95% CI 0·52–0·88]; p=0·0046). Grade 3 or worse adverse events occurred in 79% of patient

Published
2024

8. Supplementary Table from EVOLVE: A Multicenter Open-Label Single-Arm Clinical and Translational Phase II Trial of Cediranib Plus Olaparib for Ovarian Cancer after PARP Inhibition Progression

Author

Lheureux, Stephanie, primary, Oaknin, Ana, primary, Garg, Swati, primary, Bruce, Jeffrey P., primary, Madariaga, Ainhoa, primary, Dhani, Neesha C., primary, Bowering, Valerie, primary, White, Justin, primary, Accardi, Sarah, primary, Tan, Qian, primary, Braunstein, Marsela, primary, Karakasis, Katherine, primary, Cirlan, Iulia, primary, Pedersen, Stephanie, primary, Li, Tiantiam, primary, Fariñas-Madrid, Lorena, primary, Lee, Yeh Chen, primary, Liu, Zhihui (Amy), primary, Pugh, Trevor J., primary, and Oza, Amit M., primary

Published
2023
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9. Supplementary Figures from EVOLVE: A Multicenter Open-Label Single-Arm Clinical and Translational Phase II Trial of Cediranib Plus Olaparib for Ovarian Cancer after PARP Inhibition Progression

Author

Lheureux, Stephanie, primary, Oaknin, Ana, primary, Garg, Swati, primary, Bruce, Jeffrey P., primary, Madariaga, Ainhoa, primary, Dhani, Neesha C., primary, Bowering, Valerie, primary, White, Justin, primary, Accardi, Sarah, primary, Tan, Qian, primary, Braunstein, Marsela, primary, Karakasis, Katherine, primary, Cirlan, Iulia, primary, Pedersen, Stephanie, primary, Li, Tiantiam, primary, Fariñas-Madrid, Lorena, primary, Lee, Yeh Chen, primary, Liu, Zhihui (Amy), primary, Pugh, Trevor J., primary, and Oza, Amit M., primary

Published
2023
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10. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial

Author

Oaknin, Ana, Gladieff, Laurence, Martínez-García, Jerónimo, Villacampa, Guillermo, Takekuma, Munetaka, De Giorgi, Ugo, Lindemann, Kristina, Woelber, Linn, Colombo, Nicoletta, Duska, Linda, Leary, Alexandra, Godoy-Ortiz, Ana, Nishio, Shin, Angelergues, Antoine, Rubio, Maria Jesús, Fariñas-Madrid, Lorena, Yamaguchi, Satoshi, Lorusso, Domenica, Ray-Coquard, Isabelle, Manso, Luis, Joly, Florence, Alarcón, Jesús, Follana, Philippe, Romero, Ignacio, Lebreton, Coriolan, Pérez-Fidalgo, J Alejandro, Yunokawa, Mayu, Dahlstrand, Hanna, D'Hondt, Véronique, Randall, Leslie M, Abadie-Lacourtoisie, Sophie, Andreetta, Claudia, Anzizar, Nerea, Aoki, Daiseuke, Barretina-Ginesta, Maria-Pilar, Battista, Marco, Bellier, Charlotte, Bentzen, Anne Gry, Berton, Dominique, Billemont, Bertrand, Bjørge, Line, Bjurberg, Maria, Black, Destin, Bologna, Alessandra, Braicu, Elena Ioana, Casanova, Claudia, Chekerov, Radoslav, Chevalier, Annick, Cueva, Juan Fernando, Czogalla, Bastian, Delanoy, Nicolas, Denschlag, Dominik, Derke, Oscar, Eichbaum, Michael, Enomoto, Takayuki, Esteban, Carmen, Fabbro, Michel, Fehm, Tanja, Ferrero, Annamaria, Fleisch, Markus, Floquet, Anne, Frassoldati, Antonio, Gaba, Lydia, Gadducci, Angiolo, García, Yolanda, Geuna, Elena, Guerra, Eva, Hanker, Lars, Hardy-Bessard, Anne-Claire, Harter, Philipp, Hasegawa, Kosei, Hellman, Kristina, Herrero, Ana, Hilpert, Felix, Katsaros, Dionyssios, Koegel, Matthias, Koliadi, Anthoula, Kurtz, Jean-Emmanuel, Lampe, Bjoern, Lissoni, Andrea Alberto, Lortholary, Alain, Mangili, Giorgia, Mansi, Laura, Marmé, Frederik, Mathews, Cara, Mina, William, Minobe, Shinichiro, Moxley, Katherine, Nagao, Shoji, Nicoletto, Ornella, Nishino, Koji, Nishio, Hiroshi, Nishio, Shin, Oaknin, Ana, Onstad, Michaela, Pardo, Beatriz, Pérez-Fidalgo, J Alejandro, Pisano, Carmela, Poveda, Andrés, Radosa, Julia, Randall, Leslie M., Ray-Coquard, Isabelle, Redondo, Andrés, Richardson, Debra, Romero, Ignacio, Ronzino, Graziana, Rubio, Maria Jesús, Selle, Frederic, Takekuma, Munetaka, Takeshima, Nobuhiro, Tasca, Giulia, Tewari, Krishnansu, Todo, Yukiharu, Valabrega, Giorgio, Wimberger, Pauline, Woelber, Linn, Yamaguchi, Satoshi, You, Benoît, and Yunokawa, Mayu

Abstract

The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone.

Published
2024
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11. Copy number features as a novel biomarker of homologous recombination (HR) status in high-grade serous ovarian cancer (HGSOC).

Author

Romero Lozano, Paula, primary, Vila-Casadesús, Maria, additional, Matito, Judit, additional, García-Duran, Carmen, additional, Lo Giacco, Deborah Grazia, additional, Gómez-Rey, Marina, additional, Grau, Juan Francisco, additional, Fariñas-Madrid, Lorena, additional, Hernández-Illán, Eva, additional, Martin, Agatha, additional, García, Cecília, additional, Castillo, Ester, additional, Aymar, Josep Maria Miquel, additional, Tabernero, Josep, additional, Oaknin, Ana, additional, and Vivancos, Ana, additional

Published
2022
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12. Phase 2 Trial (POLA Study) of Lurbinectedin plus Olaparib in Patients with Advanced Solid Tumors : Results of Efficacy, Tolerability, and the Translational Study

Author

Poveda, Andres, Lopez-Reig, Raquel, Oaknin, Ana, Redondo, Andres, Rubio, Maria Jesus, Guerra, Eva, Fariñas-Madrid, Lorena, Gallego, Alejandro, Rodriguez-Freixinos, Victor, Fernandez-Serra, Antonio, Juan, Oscar, Romero, Ignacio, Lopez-Guerrero, Jose A., Poveda, Andres, Lopez-Reig, Raquel, Oaknin, Ana, Redondo, Andres, Rubio, Maria Jesus, Guerra, Eva, Fariñas-Madrid, Lorena, Gallego, Alejandro, Rodriguez-Freixinos, Victor, Fernandez-Serra, Antonio, Juan, Oscar, Romero, Ignacio, and Lopez-Guerrero, Jose A.

Abstract

Genomic instability (GI) is a transversal phenomenon in oncology, constituting a hallmark of cancer. In gynecological malignancies, the predictive value of GI has been described and is mainly caused by alterations in the homologous recombination repair (HRR) genes, such as BRCA1/2. The POLA clinical trial constitutes an ideal substrate used to study the correlation between GI and response to combined therapy of lurbinectedin plus olaparib in solid tumors. In this context, we developed an approach based on next-generation sequencing, capable of shedding information about Copy Number Variations (CNV) as a surrogate of GI and genotyping of homologous recombination repair genes. Additionally, some algorithms used to extract GI parameters were tested and benchmarked, selecting the most informative mutational and GI features as potential predictive biomarkers for the drug combination explored in the POLA trial. We hypothesized that the combination of olaparib and lurbinectedin maximizes DNA damage, thus increasing its efficacy. The POLA phase 1 trial established the recommended phase 2 dose of lurbinectedin as being 1.5 mg (day 1) and that of olaparib as being 250 mg/12 h (days 1-5) for a 21-day cycle. In phase 2, we explore the efficacy of the combination in terms of clinical response and its correlation with mutations in the HRR genes and the genomic instability (GI) parameters. Results: A total of 73 patients with high-grade ovarian (n = 46), endometrial (n = 26), and triple-negative breast cancer (n = 1) were treated with lurbinectedin and olaparib. Most patients (62%) received ≥3 lines of prior therapy. The overall response rate (ORR) and disease control rate (DCR) were 9.6% and 72.6%, respectively. The median progression-free survival (PFS) was 4.54 months (95% CI 3.0-5.2). Twelve (16.4%) patients were considered long-term responders (LTR), with a median PFS of 13.3 months. No clinical benefit was observed for cases with HRR gene mutation. In ovarian LTRs, although

Published
2022

13. Phase 2 Trial (POLA Study) of Lurbinectedin plus Olaparib in Patients with Advanced Solid Tumors: Results of Efficacy, Tolerability, and the Translational Study

Author

Poveda, Andres, primary, Lopez-Reig, Raquel, additional, Oaknin, Ana, additional, Redondo, Andres, additional, Rubio, Maria Jesus, additional, Guerra, Eva, additional, Fariñas-Madrid, Lorena, additional, Gallego, Alejandro, additional, Rodriguez-Freixinos, Victor, additional, Fernandez-Serra, Antonio, additional, Juan, Oscar, additional, Romero, Ignacio, additional, and Lopez-Guerrero, Jose A., additional

Published
2022
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14. Prevalence, Dynamics and Clinical Significance of Clonal Hematopoiesis of Indeterminate Potential (CHIP) in Newly Diagnosed Cancer Patients

Author

Pérez González, Ana, Pellín Jou, Clàudia, Palomo, Laura, Navarro Garces, Victor, Calvete, Oriol, Zamora, Esther, Saoudí Gonzalez, Nadia, Fariñas-Madrid, Lorena, Assaf, Juan David, Rivero, María Eugenia, Molero Yordi, Antonieta, Salamero, Olga, Jerez, Andres, Garrido Paniagua, Sara, Sola, Maria, Novoa Jáuregui, Sandra, Jiménez, Moraima, Beas, Francisco, Sole, Francesc, Diez-Campelo, Maria, Pierola, Ana Alfonso, Bosch, Francesc, Montoro, Julia, and Valcarcel Ferreiras, David

Published
2023
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15. Laboratory cross-comparison of homologous recombination repair mutation analysis in tumor in a multicenter epithelial ovarian cancer series: The BORNEO GEICO 60-0 study.

Author

Romero, Ignacio, primary, Oaknin, Ana, additional, Garcia-Casado, Zaida, additional, Marquez, Raul, additional, Yubero Esteban, Alfonso, additional, Gallego, Alejandro, additional, Sanchez, Ana Beatriz, additional, Pérez Segura, Cristina, additional, Alarcon Company, Jesus, additional, Barretina Ginesta, Pilar, additional, Palacio Vázquez, Isabel, additional, Fariñas Madrid, Lorena, additional, Cueva, Juan Fernando, additional, Matito, Judit, additional, Poveda, Andres, additional, Lopez-Guerrero, Jose Antonio, additional, and Vivancos, Ana, additional

Published
2021
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16. EVOLVE: A Multicenter Open-Label Single-Arm Clinical and Translational Phase II Trial of Cediranib Plus Olaparib for Ovarian Cancer after PARP Inhibition Progression

Author

Lheureux, Stephanie, primary, Oaknin, Ana, additional, Garg, Swati, additional, Bruce, Jeffrey P., additional, Madariaga, Ainhoa, additional, Dhani, Neesha C., additional, Bowering, Valerie, additional, White, Justin, additional, Accardi, Sarah, additional, Tan, Qian, additional, Braunstein, Marsela, additional, Karakasis, Katherine, additional, Cirlan, Iulia, additional, Pedersen, Stephanie, additional, Li, Tiantiam, additional, Fariñas-Madrid, Lorena, additional, Lee, Yeh Chen, additional, Liu, Zhihui (Amy), additional, Pugh, Trevor J., additional, and Oza, Amit M., additional

Published
2020
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17. Immune profile and outcomes of patients (pts) with gynecological malignancies (GYN) enrolled in early phases immunotherapy (IO) trials.

Author

Rodriguez Freixinos, Victor, primary, Garcia, Angel, additional, Fasani, Roberta, additional, Castellvi, Josep, additional, Ruiz-Pace, Fiorella, additional, Viaplana, Cristina, additional, Fariñas-Madrid, Lorena, additional, Casal, Cristina, additional, Matos, Ignacio, additional, Martin-Liberal, Juan, additional, Braña, Irene, additional, Hierro, Cinta, additional, Jimenez, Jose, additional, Garralda, Elena, additional, Nuciforo, Paolo, additional, Dienstmann, Rodrigo, additional, and Oaknin, Ana, additional

Published
2018
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18. Phase I study to evaluate the tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) of PM01183 (Lurbinectedin) in combination with olaparib in patients with advanced solid tumors.

Author

Poveda, Andres, primary, Oaknin, Ana, additional, Romero, Ignacio, additional, Guerrero, Angel, additional, Fariñas-Madrid, Lorena, additional, Rodriguez-Freixinos, Victor, additional, Soto-Matos, Arturo, additional, Peris, Carlos, additional, Teruel, Marisa, additional, Lopez-Reig, Raquel, additional, and Lopez-Guerrero, Jose Antonio, additional

Published
2017
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20. Challenges in the management of neuroendocrine cervical cancer during pregnancy: A case report.

Author

Gil-Ibañez, Blanca, Regueiro, Purificacion, Llurba, Elisa, Fariñas-Madrid, Lorena, Garcia, Angel, and Diaz-Feijoo, Berta

Subjects
LYMPHADENECTOMY, CERVICAL cancer, PREGNANCY complications
Abstract

Large-cell neuroendocrine carcinoma (LCNEC) is an uncommon histological subtype of cervical cancer that is associated with poor survival and its occurrence during pregnancy is particularly rare. We herein present the case of a female patient who was diagnosed with cervical LCNEC during pregnancy. The patient declined pregnancy termination and was treated with neoadjuvant chemotherapy with cisplatin and etoposide, without associated toxicity and with good fetal development. At 31.4 weeks of gestation, the fetus was delivered by caesarean section, and the patient underwent radical nerve-sparing hysterectomy with bilateral adnexectomy, along with pelvic and inframesenteric para-aortic lymphadenectomy. The patient received adjuvant chemoradiotherapy and there was no evidence of recurrence or metastasis at 38 months postoperatively. The baby has also been followed up, without any signs of neurodevelopmental disorders. To the best of our knowledge, the present report describes the first case of LCNEC with pregnancy-preserving management in the literature to date. [ABSTRACT FROM AUTHOR]

Published
2018
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21. Non-comparative, open-label, international, multicenter phase I/II study of nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with recurrent/metastatic merkel cell carcinoma (MCC) (CheckMate 358).

Author

Bhatia, Shailender, Topalian, Suzanne Louise, Sharfman, William Howard, Meyer, Tim, Lao, Christopher D., Fariñas-Madrid, Lorena, Devriese, Lot A., Aljumaily, Raid, Ferris, Robert L., Honma, Yoshitaka, Khan, Tariq Aziz, Srirangam, Anjaiah, Garnett-Benson, Charlie, Lee, Michelle, and Nghiem, Paul

Published
2023
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22. Luveltamab tazevibulin (STRO-002), an anti-folate receptor alpha (FolRα) antibody drug conjugate (ADC), safety and efficacy in a broad distribution of FolRα expression in patients with recurrent epithelial ovarian cancer (OC): Update of...

Author

Oaknin, Ana, Fariñas-Madrid, Lorena, García-Duran, Carmen, Martin, Lainie P., O'Malley, David M., Schilder, Russell J., Uyar, Denise, Moroney, John William, Diaz, John Paul, Spira, Alexander I., Garcia-Donas, Jesus, Palumbo, Michael, Dokainish, Hatem, Liu, Lin, Berman, Craig Jerome, and Naumann, R. Wendel

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

Author

Colombo, Nicoletta, Biagioli, Elena, Harano, Kenichi, Galli, Francesca, Hudson, Emma, Antill, Yoland, Choi, Chel Hun, Rabaglio, Manuela, Marmé, Frederic, Marth, Christian, Parma, Gabriella, Fariñas-Madrid, Lorena, Nishio, Shin, Allan, Karen, Lee, Yeh Chen, Piovano, Elisa, Pardo, Beatriz, Nakagawa, Satoshi, McQueen, John, and Zamagni, Claudio

Subjects
*CANCER chemotherapy, *CLINICAL trials, *OVERALL survival, *ADVERSE health care events, *PROGRESSION-free survival
Abstract

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. 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. Between Oct 3, 2018, and Jan 7, 2022, 551 patients were randomly assigned to atezolizumab (n=362) or placebo (n=189). Two patients in the atezolizumab group were excluded from all analyses due to lack of consent. Median follow-up was 28·3 months (IQR 21·2–37·6). 81 (23%) patients in the atezolizumab group and 44 (23%) patients in the placebo group had dMMR disease by central assessment. In the dMMR population, median progression-free survival was not estimable (95% CI 12·4 months–not estimable [NE]) in the atezolizumab group and 6·9 months (6·3–10·1) in the placebo group (hazard ratio [HR] 0·36, 95% CI 0·23–0·57; p=0·0005). In the overall population, median progression-free survival was 10·1 months (95% CI 9·5–12·3) in the atezolizumab group and 8·9 months (8·1–9·6) in the placebo group (HR 0·74, 95% CI 0·61–0·91; p=0·022). Median overall survival was 38·7 months (95% CI 30·6–NE) in the atezolizumab group and 30·2 months (25·0–37·2) in the placebo group (HR 0·82, 95% CI 0·63–1·07; log-rank p=0·048). The p value for the interim analysis of overall survival did not cross the stopping boundary; therefore, the trial will continue until the required number of events are recorded. The most common grade 3–4 adverse events were neutropenia (97 [27%] of 356 patients in the atezolizumab group vs 51 [28%] of 185 in the placebo group) and anaemia (49 [14%] vs 24 [13%]). Treatment-related serious adverse events occurred in 46 (13%) patients in the atezolizumab group and six (3%) patients in the placebo group. Treatment-related deaths occurred in two patients (pneumonia in one patient in each group). Atezolizumab plus chemotherapy increased progression-free survival in patients with advanced or recurrent endometrial carcinoma, particularly in those with dMMR carcinomas, suggesting the addition of atezolizumab to standard chemotherapy as first-line treatment in this specific subgroup. F Hoffmann-La Roche. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Oral Selinexor as Maintenance Therapy After First-Line Chemotherapy for Advanced or Recurrent Endometrial Cancer.

Author

Vergote I, Pérez-Fidalgo JA, Hamilton EP, Valabrega G, Van Gorp T, Sehouli J, Cibula D, Levy T, Welch S, Richardson DL, Guerra EM, Scambia G, Henry S, Wimberger P, Miller DS, Klat J, Martínez-Garcia J, Raspagliesi F, Pothuri B, Romero I, Bergamini A, Slomovitz B, Schochter F, Høgdall E, Fariñas-Madrid L, Monk BJ, Michel D, Kauffman MG, Shacham S, Mirza MR, and Makker V

Subjects
Humans, Female, Prospective Studies, Triazoles adverse effects, Double-Blind Method, Antineoplastic Combined Chemotherapy Protocols adverse effects, Hydrazines adverse effects, Endometrial Neoplasms drug therapy
Abstract

Purpose: Selinexor inhibits exportin-1 (XPO1) resulting in nuclear accumulation of tumor suppressor proteins including p53 and has clinical activity in endometrial cancer (EC). The primary end point was to assess progression-free survival (PFS) with once-weekly oral selinexor in patients with advanced or recurrent EC., Patients and Methods: ENGOT-EN5/GOG-3055/SIENDO was a randomized, prospective, multicenter, double-blind, placebo-controlled, phase III study at 107 sites in 10 countries. Patients 18 years or older with histologically confirmed EC were enrolled. All had completed a single line of at least 12 weeks of taxane-platinum combination chemotherapy and achieved partial or complete response. Patients were assigned to receive 80 mg oral selinexor once weekly or placebo with 2:1 random assignment (ClinicalTrials.gov identifier: NCT03555422)., Results: Between January 2018 and December 2021, 263 patients were randomly assigned, with 174 allocated to selinexor and 89 to placebo. The median PFS was 5.7 months (95% CI, 3.81 to 9.20) with selinexor versus 3.8 months (95% CI, 3.68 to 7.39) with placebo (hazard ratio [HR], 0.76 [95% CI, 0.54 to 1.08]; two-sided P = .126), which did not meet the criteria for statistical significance in the intent-to-treat population. Incorrect chemotherapy response stratification data for 7 (2.7%) patients were identified. In a prespecified exploratory analysis of PFS in audited stratification data, PFS for selinexor met the threshold for statistical significance (HR, 0.71; 95% CI, 0.499 to 0.996; two-sided P = .049). Furthermore, patients with the TP53 wild-type (wt) EC had a median PFS of 13.7 and 3.7 months with selinexor and placebo. The most common grade 3 treatment-related adverse events were nausea (9%), neutropenia (9%), and thrombocytopenia (7%)., Conclusion: The significance level for PFS was only met in the audited analysis. However, a preliminary analysis of a prespecified exploratory subgroup of patients with TP53 wt EC showed promising results with selinexor maintenance therapy.

Published
2023
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