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12 results on '"C. Martin Lorente"'

1. The impact of olaparib dose reduction and treatment interruption on treatment outcome in the SOLO2/ENGOT-ov21 platinum-sensitive recurrent ovarian cancer

Author

K E, Francis, S I, Kim, M, Friedlander, V, Gebski, I, Ray-Coquard, A, Clamp, R T, Penson, A, Oza, T, Perri, T, Huzarski, C, Martin-Lorente, S C, Cecere, N, Colombo, B, Ataseven, K, Fujiwara, G, Sonke, I, Vergote, E, Pujade-Lauraine, J-W, Kim, C K, Lee, Francis, K, Kim, S, Friedlander, M, Gebski, V, Ray-Coquard, I, Clamp, A, Penson, R, Oza, A, Perri, T, Huzarski, T, Martin-Lorente, C, Cecere, S, Colombo, N, Ataseven, B, Fujiwara, K, Sonke, G, Vergote, I, Pujade-Lauraine, E, Kim, J, and Lee, C

Subjects
Ovarian Neoplasms, Drug Tapering, adverse event, relative dose intensity, Hematology, Carcinoma, Ovarian Epithelial, dosage, Piperazines, Treatment Outcome, ovarian cancer, PARP inhibitor, Oncology, Mutation, Humans, Phthalazines, Female, adherence, Neoplasm Recurrence, Local, Poly(ADP-ribose) Polymerases
Abstract

Background: Maintenance treatment with poly (ADP-ribose) polymerase (PARP) inhibitor is now the standard of care in patients with BRCA-mutated platinum-sensitive recurrent ovarian cancer following response to chemotherapy. In the SOLO2 trial, adverse event (AE)-associated olaparib interruption, dose reduction, and discontinuation occurred in 50%, 28%, and 17% of patients, respectively. We used data from the SOLO2 trial to evaluate the impact of dose alterations on survival outcomes and identified baseline characteristics associated with dose alteration. Patients and methods: We computed relative dose intensity (RDI) defined as the received dose as a percentage of the standard dose (300 mg twice a day) during the first 12 weeks on treatment. Patients were categorized into RDI >98%, RDI 90%-98%, and RDI 98% (n = 110), 90%-98% (n = 29), and

Published
2022

2. 674 Niraparib as maintenance therapy in platinum-sensitive recurrent ovarian cancer: a GEICO study within the Spanish extended access program

Author

J. F. Cueva Bañuelos, M Legerén, C Martin-Lorente, I Fernández Pérez, Lizet Sánchez, A Herrero-Ibáñez, Aline Juárez, M Constenla, Beatriz Pardo, C Maximiano, P Estévez, I Palacio, A. Santaballa, Luis Manso, M Quindós, A. De Juan, C. Churruca, Antonio González-Martín, G Marquina, and A Barquin

Subjects
education.field_of_study, medicine.medical_specialty, Bevacizumab, business.industry, Population, Retrospective cohort study, medicine.disease, Placebo, Olaparib, chemistry.chemical_compound, chemistry, Maintenance therapy, Internal medicine, Expanded access, medicine, education, Ovarian cancer, business, medicine.drug
Abstract

Introduction/Background* In the ENGOT-OV16/NOVA trial, niraparib demonstrated a significantly longer PFS in patients (pts) with recurrent platinum-sensitive ovarian cancer (PSOC) vs placebo as maintenance therapy, regardless of gBRCA/HRD status. Niraparib obtained EU approval in 2017 and an expanded access program (EAP) was initiated. Methodology A retrospective study of niraparib maintenance therapy was conducted within the Spanish EAP, at 57 hospitals. Niraparib’s safety, dose adjustments, and effectiveness in real-world setting were assessed. Patient characteristics and starting dose individualizations were also analyzed. EAP’s inclusion required at least 2 previous courses of platinum-containing therapy. For the last course prior to inclusion a response should have been obtained. Although BRCAmut and BRCAwt pts could be included, most were BRCAwt because olaparib was commercialized at that time for pts with BRCAmut and pts were allowed to be included only in specific circumstances. Result(s)* Between September 2020 and March 2021, 316 pts were included. Median age was 63 years (31-88). More common initial FIGO stages were IIIC, IVB, and IVA (50.0%, 13.6%, 11.1%). 5.7% were BRCAmut, 80.4% BRCAwt, and 13.9% unknown. 93.4% had initial surgery and 22.8% after relapse. Previous bevacizumab was given in 40.8% of pts. Before niraparib, pts had ECOG 0-1 (50.3%-47.5%) and 55.7% had measurable disease. Population weights (Kg) were 43-57 (23.1%), 58-76 (52.2%), and 77-105 (17.7%). 19.7% had baseline platelets Conclusion* The use of niraparib as maintenance therapy in pts with recurrent PSOC in real-life setting is safe. The ISD approach improved the safety profile. Results were in accordance with those reported in phase III trials. Overall effectiveness analysis is coming.

Published
2021

3. Association of immune-related adverse (irAEs) with immune-checkpoint inhibitors (ICIs) efficacy in solid tumors

Author

M. Majem Tarruella, L.P. del Carpio, A.C. Virgili Manrique, A. Barba Joaquín, C. Facundo Molas, E. Garcia Planella, P. Maroto Rey, A. Sebio Garcia, I. Genua Trullos, D. Castillo Villegas, A. Barnadas Molins, A. Lopez Pousa, M. Riudavets Melia, O. Gallego Rubio, C. González Blanco, D. Páez López-Bravo, A. Callejo Perez, C. Martin Lorente, G. Anguera Palacios, and I. Gabriela Sullivan

Subjects
Immune system, Oncology, business.industry, Immune checkpoint inhibitors, Immunology, Medicine, Hematology, business
Published
2018

4. A Phase 1/2 Study of Ipilimumab in Women with Metastatic or Recurrent Hpv-Related Cervical Carcinoma: a Study of the Princess Margaret and Chicago N01 Consortia

Author

C. Martin-Lorente, Stephanie Lheureux, S. Udagani, Helen Mackay, P. Ghatage, Gini F. Fleming, Marcus O. Butler, Michelle K. Wilson, H. Hirte, Judy Quintos, Amit M. Oza, Lainie P. Martin, Lisa Wang, Mihaela C. Cristea, and Neesha C. Dhani

Subjects
Oncology, Cervical cancer, medicine.medical_specialty, business.industry, medicine.medical_treatment, Phases of clinical research, Cancer, Ipilimumab, Hematology, Immunotherapy, medicine.disease, Chemotherapy regimen, Surgery, Maintenance therapy, Internal medicine, Multicenter trial, medicine, business, medicine.drug
Abstract

Background: Cervical cancer (CC) is the second cause of cancer-related mortality in women worldwide. Response to second-line chemotherapy is infrequent and the poor outcome of patients with advanced disease (median survival 9 months) warrants novel therapeutic strategies that exploit abnormal tumor biology. Based on new evidence that host-dependent immunologic status and HPV-induced immune evasion are responsible for persistent HPV infection, the prime causal factor of CC, immunotherapy is an attractive emerging strategy to target this disease. Ipilimumab is a fully humanized monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 (CTLA-4), a molecule that acts to downregulate the T cell immune response. Trial design: A 2-step multicenter trial was designed to evaluate ipilimumab IV in metastatic or recurrent HPV-related CC (NCT01693783). Eligible patients require measurable disease progression and at least one previous platinum based line of chemotherapy. A safety phase I cohort was planned with ipilimumab 3 mg/kg every 21 days for four cycles in 6 evaluable patients. After demonstration of safety, a phase II trial was planned with ipilimumab 10 mg/kg at the same schedule; followed by four additional cycles maintenance therapy at the same dose every 12 weeks for patients with radiologic confirmed response or stabilization. The primary objective is to assess the safety and the objective response rate at the end of cycle 4. 18 evaluable patients are scheduled and if at least 1 partial response is seen, additional 14 patients will be enrolled. Immune assessment studies are performed on peripheral blood collected prior to and following ipilimumab therapy and on archived and fresh tumour tissue obtained prior to treatment and within the first week of cycle 2. Current status: This trial was activated in September 2012. The phase I cohort is now completed, and 20 patients have been enrolled in the phase II. The majority of the patients were able to have the pre and post treatment biopsy. Previous presentation ASCO. Disclosure: All authors have declared no conflicts of interest.

Published
2014

5. Phase II Clinical and Pharmacokinetic (PK) Trial of Zalypsis (Z) in Patients with Urothelial Carcinoma (UC) Progressing after a First-Line Platinum-Based Regimen

Author

Pablo Maroto, Cristina Suarez, Joan Carles, Laia Capdevila, Albert Font, Daniel Castellano, Rafael Morales-Barrera, Joaquim Bellmunt, O. Etxaniz, and C. Martin Lorente

Subjects
Oncology, medicine.medical_specialty, Chemotherapy, Nausea, business.industry, medicine.medical_treatment, Phases of clinical research, Hematology, Neutropenia, medicine.disease, Regimen, Internal medicine, Toxicity, medicine, Clinical endpoint, Stage (cooking), medicine.symptom, business
Abstract

Background Platinum-based chemotherapy (CT) is beneficial as first-line treatment of advanced UC. However, the majority of patients develop recurrent disease with poor long-term survival rates[1]. Attempts to improve second-line treatments have evaluated single agents and multi-drug combinations, neither of which has managed to improve survival or achieve durable responses. Z is a cytotoxic agent that induces apoptosis by acting at cell cycle level, has DNA-binding properties and inhibits transcriptional responses. Z has shown anti-tumor activity in vitro and in vivo in xenograft models[2]. Based on the activity observed in a phase I study (1PR and 2 SD) in advanced bladder cancer we have designed a phase II study to explore the efficacy of Z in this setting. Methods Patients with histologically-confirmed advanced or metastatic UC, who had failed one prior line of platinum-based CT, with proven progression or relapse before study entry, were included. Patients were treated with a Z intravenous infusion of 3 mg/m2 over 1-hour and every 3 weeks. A two-stage design was chosen; at least four (of 17) evaluable patients had to reach the primary endpoint during the first stage in order to progress into a second stage of up to 37 patients. The primary endpoint was tumor control rate (TCR): percentage of patients with objective response (OR) of any duration or patients alive and progression-free (PFS) at three months. Results Twenty patients of a median age of 71 years (r: 54–83) were enrolled after a median of one prior treatment line (r:1–2). One patient was considered non-evaluable. No ORs were observed and only one patient had PFS ≥ 3 months. The median time on treatment was 1.68 months (r: 0.76–4.21). Toxicity consisted mostly of grade 1–2 fatigue, anorexia and nausea. Five patients had isolated troponin I increases (with no ECG or LVEF findings). Hematological toxicity was mild, one patient had grade 3 neutropenia and one patient had grade 3 thrombocytopenia. Conclusion Only one patient reached the primary endpoint (TCR) during the first stage; consequently, the study was closed and no further development was considered. Disclosure All authors have declared no conflicts of interest.

Published
2012

6. RANDOMIZED PHASE II STUDY OF FIRST-LINE EVEROLIMUS (EVE) + BEVACIZUMAB (BEV) VERSUS INTERFERON ALFA-2A (IFN) + BEV IN PATIENTS (PTS) WITH METASTATIC RENAL CELL CARCINOMA (MRCC): RECORD-2

Author

Rickard Sandin, Javier Diaz, David Smith, investigators, H. Pandha, A. Damato, M. Del Prete, M. Reckova, E. Korbenfeld, A. Seth, Cristina Suarez, P. Celiz, S. Liskova, R.K. Sahoo, A. Felici, A. Suder, Francesco Cognetti, P. Gronesova, G. Martignoni, M. Jebali, E. Fernández-Parra, C. Bokemeyer, Yingwei Peng, M.C. Sebastia, H. Mullot, Daniele Raggi, D. Urosa Velasco, Begoña Mellado, J. Chester, Corina Andresen, Sally Ellis, N. Nicolai, A. Omar, A. Ambavane, Georg A. Bjarnason, Frank Priou, A. Vieillefond, T. Wahlgren, U. Harmenberg, H. Nemeth, M. Rivoire, Guru Sonpavde, C. Binder, V. Prati, M. Witkowski, R. Delva, J.F. Rodríguez-Moreno, L. Stern, V. Calderero, O. Bauduceau, Andrea Viqueira, K. Kaiser, Maurizio Colecchia, M.P. López Martí, M.E. Lampron, J.T. Hartmann, D. Tunali, Reza Elaidi, V. Galvis, Z. Sycova-Mila, Veg Team, R. von Moos, Jose Carlos Benitez, Simon Chowdhury, H. Mergenthaler, F. Arpaci, S. Cascinu, G. Erdem, A. Comte, J.M. Sepulveda Sanchez, K. Slimane, Mustafa Benekli, Paul Nathan, S. Van Belle, B. Metzner, Hussein M. Khaled, Q. Wang, Denice D. Tsao-Wei, J. Jin, H. Cortes-Funes, N. Clottens, P. Wilson, G. Procopio, A.L. Gentile, L. Burattini, Robert E. Hawkins, R. Montironi, G.R. Pond, Viorel Jinga, B. Ceccaldi, Tanya B. Dorff, S. Lata, Sergio Bracarda, P. Palacka, N. Karadurmus, S. Tumolo, Mario Sznol, A. Guillot, H. Spliid, C. Kahl, Cora N. Sternberg, K. Nagyivanyi, N. Sarwar, G. Krekeler, G. Fischer, S. Le Moulec, Brian I. Rini, R. Casciano, Derek Raghavan, F. Mehmud, N.V. Jensen, Suleyman Buyukberber, J.P. Fusco, Kim Edmonds, C. Messina, H.G. Sayer, Sanjiv S. Agarwala, R.J. Jones, J. Ribeiro, T. Geldart, A. González del Alba, E. López Juarez, G. Mead, Ben Challacombe, I. Brindel, T. M-H, F. Lumachi, S.M. M. Basso, E.Q. Bergan, R. Morales-Barrera, J.L. Perez Gracia, P. Cislo, I. Victoria, B. Sarsık, M. Cakar, S. Lee, Marc Campayo, R. Roy, A. Necchi, M. Ozturk, Hai T. Tran, R. Mondéjar Solís, M. Schmidt, N. Dalal, J. Coombs, Danka Cholujova, Ashok Kumar Gupta, C. Poehlein, S. Ozkan, B. Maughan, W.E. Berdel, C. Masini, F. Pili, A. Vuillemin, R. Martínez-Monge, J.J. Zudaire, F. Orlandi, C. Cianci, J. Bay, J. Thompson, C. Theodore, L. McCann, Anne Gold, N. Muzaffar, A. Houlgatte, L. Bergmann, X. Ren, G.B. Chiara, M. Ktiouet, Muhammad A. Khattak, J. Eymard, N. Nagaraj, J. Yu, Alfredo Falcone, Oezlem Anak, C. Korn, Karim Fizazi, P. Biron, V. Usakova, E. Gökmen, A. Flechon, R.R. Prasad, R. Bianco, M.E. Zudaire, S.J. Park, U. De Giorgi, Brad Rosbrook, F. Selle, A. Zurita-Saavedra, E. Verzoni, Günter Niegisch, J.L. Álvarez-Ossorio, Börje Ljungberg, N. Lainez, T.M. Kim, Irina Proskorovsky, C. Rodriguez-Antona, L. Maute, Komel Khabra, F. Algaba, A.C. Palozzo, L. Bodnar, O. Etxaniz, L. Galli, J.-P. Lotz, S.S. Sridhar, Yongchel Ahn, G. El Hussiny, E. Paze, M. Bianconi, E. Esteban, I. Fernandes, Omid Hamid, V. Kruse, P.F. Geertsen, Laurence Albiges, Joseph C. Cappelleri, M. Gaulet, Mayer Fishman, W. Kong, Aslam Sohaib, L. Formisano, B. Biswas, Heui June Ahn, C. Nicolau, G. Ye, P. Beuzeboc, C. Arqueros, A. Bair, H. Abdel Azim, F. Riet, T. Turker, J. Fouque, John D. Powderly, G. Velasco, J. Areal, G. Papiani, B. Wittig, D.R. Siemens, U. Anido, G. Anguera, J. Medioni, K. Pennert, G.G. Hermann, Igor Puzanov, D. Herchenhorn, James Larkin, B. Bui, P. Srinivasan, I. Waxman, J. Garcia-Donas, M. Ermani, J. Malet, R. Buzzoni, C. Emmanouilides, L. Kumar, Xin-Yun Huang, J. Beaumont, M. Bragagni, F. Fabbri, M. Santoni, A. Castillo, A. Pantuck, S. Imbevaro, G. Chahine, K. Zhang, D. Ondrus, Parminder Singh, Francesco Massari, S. Spanik, Svetozar Gogov, J. Kowalski, N. Pardo, J.M. Miclea, Dae Ho Lee, P. Gerletti, P. Rocca Cossu, H.J. Choi, Stéphane Oudard, J. Guo, A. Berkenblit, Pablo Maroto, A.R. Jazeih, L. Hodge, D. Ye, Daniel Castellano, David Cella, I.G. Sullivan, Vsevolod Matveev, I. Temby, Gwenaelle Gravis, J. Khalil, R. Fougeray, M. Wheater, G. Di Lorenzo, P. Landsman-Blumberg, A.J. Birtle, S. Zanetta, M. Harza, Y. Su, A. Badran, A. Alcaraz, K. Wood, S. Weikert, D. Chen, M. Bonomi, B. Paño, E. Garanzini, L. Ciuffreda, Lisa Derosa, D.J. George, L. Cerbone, J-H Ahn, A.J. McPartlin, E. Barsoum, J. Droz, Antonin Levy, T. Brechenmacher, J. Kim, A. Ozet, S Songül Yalçin, P.A. Zucali, F. Brusa, L. Steelman, J.J. Sánchez, O.E. Carranza, I. Bodrogi, Alain Ravaud, E. Boleti, L. Santomé, I. Chaib, J.V. Heymach, B. Sanchez, E. Matczak, Ying Chen, E. Castanon Alvarez, C. Farfan, J-P. Machiels, J. P. Maroto, J.H. Hong, S. Babakulov, G. Elhussiny, D. Santeufemia, L. Chen, A. Shamseddine, Jacek Pinski, S. Stergiopoulos, J.L. Cuadra Urteaga, A. Boeckenhoff, Viktor Grünwald, P. Sandström, C. Ketchens, S. Rudman, L. Costa, I. Cañamares, Shaowen Qin, M.C. Lopez Lopez, Darrel P. Cohen, A. Cappetta, R. De Vivo, M.J. Méndez-Vidal, Georgia Kollia, U. Kube, K.M. Boucher, Tim O'Brien, Z. Küronya, A.M. Molina, Y.-N. Wong, C. Ferrario, A.M. Gianni, M.D. Michaelson, R. Salvioni, Walter M. Stadler, M. Taron, S. Sarker, B. Kopf, L. Wang, B. Lutiger, Jon M. Wigginton, C. Sacco, J. Shanks, Sarvendra Kumar, C. Buges, L. Wood, M. Domenech, Riccardo Giampieri, M.P. Trojniak, R. Sabbatini, N. Leonhartsberger, R. Lewis, L. Anton-Aparicio, A.J. Zurita Saavedra, Yohann Loriot, D. Giannarelli, M. Cichowicz, M. Aglietta, E. Horn, N. Bonnin, J. Wang, M. Nicodemo, A. Bamias, X. Xiao, M. Calderon, P. Giannatempo, K. Dykstra, Lisa Pickering, Patricia A. English, G. Rosti, J. Ma, G. Guderian, Jean Jacques Patard, Andrew G. Bushmakin, N. Siddqui, P. Sabin Domínguez, C. Chevreau, J. Carles, D. Muskett, I.F. Tannock, A. Scarpa, G. Deplanque, Emilio Bria, L. Védrine, C. Chen, H. Villavicencio, S. Pan, Bohuslav Melichar, J. Palou, W. Kozłowski, Michal Mego, E. Jones, H. Ozturk, J.A. Arranz Arija, A. Benedict, C. Helissey, R. González Beca, G. Kooiman, Yuan Liu, C. May, K. Bíró, E. Hall, S. Vazquez-Estevez, M. Morente, R. Rosa, Raika Durusoy, A. Caty, R. Keyser, A. Shablak, J.A. Williams, D. Burcoveanu, M. Tschaika, S. Navruzov, E. Weith, F. de Braud, R. Kockelbergh, Begoña Perez-Valderrama, A.V. Soerensen, J.A. Peña, Christophe Massard, A. Chandra, M. Staehler, L.E. Abella, W. Arafat, G. Fargues, A. Darwish, E. De Coene, H. Sun, C. Martin Lorente, Robin Wiltshire, Cyrus Chargari, A. Louveau, E. Aitini, L. van Bortel, A. Onofri, A.A. Patel, I. Chirivella Gonzalez, F. Villacampa, J. Rajec, D. Biasoni, C. Szczylik, J. Schmitz, U. Mueller, P.F. Conte, M. Carducci, G. Tapia Rico, Anne Schuckman, Xun Lin, I. Alemany, A. Farnesi, E. Arevalo, Meral Kurt, M.O. Giganti, C. Song, I.G. Schmidt-Wolf, J. Pan, M. De Fromont, M. Schmidinger, K. Das, M. Yaman, C. Teghom, C. Boni, I. Ozer-Stillman, F. Maines, B. Moya Ortega, T.B. Powles, S. Pusceddu, I. Barista, I. Duran, S. Cierniak, M.E. Gore, R. Rosell, Jamal Tarazi, E. Kurt, D. Svetlovska, G. Li, F. Gyergyay, W. Yin, C. Porta, I. Park, M. Smoter, G. Rottenberg, S. Crabb, M. Rizzo, G. Gravis-Mescam, A. Spencer-Shaw, David M. Berman, R. Janciauskiene, F. Pons Valladares, I. Testa, E. Bajetta, Olga Valota, M. Lazaro, B. Esteves, Mario Scartozzi, M. Catanzaro, M. Arzoz, David F. McDermott, E. Sevin, Charles G. Drake, L. Ye, Ugur Coskun, A. Lorch, D. Pelov, D. Xanthaki, L. Nappi, G. Lo Re, Giampaolo Tortora, L. Ruiz, Kolette D. Fly, P. Mendez, M. Johnson, M. Jakobsson, Y. Lin, Sinil Kim, J.Y. Yuan, I. Chiappino, I.A. Muazzam, Xudong Zhang, K.J. Park, Stéphane Culine, C. Papandreou, S. Hauser, B. Paolini, O. Fernandez, D. Kalanovic, L. León, C. De La Piedra, R. Iacovelli, S. Provent, P.D. Simmonds, Michele Milella, D. Jäger, K. Massopust, G. Miolo, J. Neves, D. Amadori, F.L. Lim, M. Ramos Vazquez, A. De Both, S. Ozaydin, O. Reig Torras, E. Villa, G. Mickisch, T. Nguyen, R. Stec, M. Schroff, Cristina Suarez Rodriguez, S. Rottey, Boris Alekseev, O. Rick, D. Condori, W.J. Mackillop, J. Gligorov, Christopher M. Booth, A. Fontana, A.S. Ataergin, L. Capdevila, J.-F. Martini, M. Jimenez, J. Loewy, Piotr Tomczak, J. Hu, K.L. Baker-Neblett, M. Pastorek, P. Rescigno, V. Miskovska, F. Atzori, Thomas Gauler, K. Fode, Ü.E. Bagriacik, D. Nosov, Y. Kim, P.C. Lara, Frede Donskov, Michael B. Atkins, L. Géczi, V. Lorusso, Kiruthikah Thillai, F. Zhou, A.M. Aparicio, B. González, Susan Groshen, M. Aieta, R. Cathomas, E. Calvo, A. Lopez, S. Hernando, D.S. Heo, F. Goldwasser, F. Boccardo, Carlos H. Barrios, V. Damiano, Toni K. Choueiri, L.N. Pandite, F.J. Afonso, Jonathan Shamash, Fiona C Thistlethwaite, G.R. Hudes, Mellar P. Davis, D. Macedo, A. Font, Joaquim Bellmunt, S. Lundstam, Ignacio Gil-Bazo, T. Eisen, J. Qiu, Siamak Daneshmand, David I. Quinn, Ashok Panneerselvam, S. De Placido, L. Jacobasch, M. Climent, Luca Faloppi, Petri Bono, B.K. Mohanti, F. Valduga, Y. Huang, M. Zemanova, M. Fehr, E. Biasco, A. Kaprin, T. Montella, Cristian Loretelli, O. Ekinci, S. S¸en, C. Bailly, Sylvie Negrier, L. Ozkan, Beata Korytowsky, T. de Revel, A. Somers, B. Escudier, Umut Demirci, K. Stauch, Helen Boyle, A. Jirillo, C. Kim, R.A. Figlin, N. Shi, Joseph K. T. Lee, A. Jouinot, G. Abdel Metaal, R. Marconcini, C. Dubot, A. Pinto, L. Crino, T.E. Hutson, Thomas Powles, J. Mardiak, D. Cesic, Sook Ryun Park, D. Kim, S. Cetintas, Subramanian Hariharan, Alessandro Bittoni, M. Cotreau, J. Donovan, J. Obertova, Robert J. Motzer, and T. Steiner

Subjects
medicine.medical_specialty, medicine.medical_treatment, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Prostate, Internal medicine, medicine, Stomatitis, Objective response, 030304 developmental biology, 0303 health sciences, Proteinuria, Genitourinary system, business.industry, Treatment options, Hematology, medicine.disease, Nephrectomy, 3. Good health, medicine.anatomical_structure, Oncology, Tolerability, 030220 oncology & carcinogenesis, medicine.symptom, business
Abstract

Background Study results demonstrated that IFN augments BEV activity and improves median PFS in pts with mRCC. Thus, combination BEV + IFN is a standard first-line treatment option for mRCC. Combining BEV with the mTOR inhibitor EVE may be an efficacious and well-tolerated treatment option. The open-label, phase II RECORD-2 trial compared first-line EVE + BEV and IFN + BEV in mRCC. Patients and methods: Therapy-naive pts with clear cell mRCC and prior nephrectomy were randomized 1:1 to BEV 10 mg/kg IV every 2 weeks with either EVE 10 mg oral daily or IFN (9 MIU SC 3 times/week, if tolerated). Tumour assessments were every 12 weeks. Primary objective was treatment effect on progression-free survival (PFS) per central review based on an estimate of the chance of a subsequent phase III trial success (50% threshold for phase II success). Results In EVE + BEV (n = 182) and IFN + BEV (n = 183) arms, median age was 60/60 years, 76/72% of pts were men, MSKCC risk was favourable/intermediate/poor in 36/57/7% and 36/57/7% of pts, and 43/46% of pts had >2 organs involved, respectively. For EVE + BEV and IFN + BEV, median treatment duration was 8.5/8.3 months, respectively; 23/26% of pts discontinued due to AEs. In EVE + BEV and IFN + BEV arms, median PFS by central review was 9.3/10.0 months (HRIFN/EVE, 0.91; 95% CI, 0.69-1.19; P =0.485), respectively; probability of subsequent phase III success was 5.1%. Results of central and local PFS analysis were consistent. Objective response rate was 27/28% in EVE + BEV and IFN + BEV arms, respectively. Median overall survival (OS) was not reached in the EVE + BEV arm and was 25.9 months (95% CI: 21.1, 30.2) in the IFN + BEV arm. Most frequent AEs (%) were stomatitis (63), proteinuria (49), diarrhoea (39), hypertension (38), and epistaxis (35) in EVE + BEV arm and decreased appetite (45), fatigue (41), proteinuria (37), and pyrexia (35) in IFN + BEV arm. Conclusions In RECORD-2, PFS and tolerability were similar for first-line EVE + BEV and IFN + BEV. Final OS analysis will occur after 2-year follow-up. Disclosure A. Ravaud: Alain Ravaud is a member of global, European, and/or French boards on urological tumors for Pfizer, Novartis, GlaxoSmithKline, Bayer-Schering, and Dendreon, and has received institutional grant support from Pfizer, Novartis, and Roche. O. Anak: Ozlem Anak is an employee of Novartis Pharma AG. D. Pelov: Diana Pelov is an employee of Novartis Pharmaceuticals Corporation. A. Louveau: Anne-Laure Louveau is an employee of Novartis Pharma S.A.S. T. M-H: Tay M-H is a speaker for an advisory board for Novartis Pharmaceuticals Corporation. B. Melichar: Bohuslav Melichar has received honoraria from Novartis and Roche and served on an advisory board for Roche. All other authors have declared no conflicts of interest.

Published
2012

7. SEOM-GEICO clinical guideline on epithelial ovarian cancer (2023).

Author

Perez-Fidalgo JA, Gálvez-Montosa F, Guerra EM, Madariaga A, Manzano A, Martin-Lorente C, Rubio-Pérez MJ, Alarcón J, Barretina-Ginesta MP, and Gaba L

Subjects
Humans, Female, Prognosis, Medical Oncology standards, Medical Oncology methods, Carcinoma, Ovarian Epithelial therapy, Carcinoma, Ovarian Epithelial pathology, Ovarian Neoplasms therapy, Ovarian Neoplasms pathology, Ovarian Neoplasms diagnosis
Abstract

In recent years, the incorporation of new strategies to the therapeutic armamentarium has completely changed the outcomes of epithelial ovarian cancer (EOC). The identification of new predictive and prognostic biomarkers has also enabled the selection of those patients more likely to respond to targeted agents. Nevertheless, EOC is still a highly lethal disease and resistance to many of these new agents is common. The objective of this guideline is to summarize the most relevant strategies to manage EOC, to help the clinician throughout the challenging diagnostic and therapeutic processes and to provide evidence-based recommendations., (© 2024. The Author(s).)

Published
2024
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8. Cumulative incidences of hypogonadism, hypertension, and dyslipidaemia in patients with stage I seminoma treated with a risk-adapted strategy: a Spanish single-centre retrospective analysis.

Author

Tapia JC, Gavira J, Anguera G, Sanchez S, Romano A, Bosma F, Molina A, Sanz-Beltran J, Martin-Lorente C, Algaba F, and Maroto P

Subjects
Humans, Male, Retrospective Studies, Adult, Middle Aged, Incidence, Spain epidemiology, Young Adult, Neoplasm Staging, Risk Factors, Aged, Hypogonadism epidemiology, Hypogonadism complications, Dyslipidemias epidemiology, Dyslipidemias complications, Hypertension epidemiology, Hypertension complications, Testicular Neoplasms epidemiology, Testicular Neoplasms complications, Testicular Neoplasms pathology, Seminoma complications, Seminoma epidemiology, Seminoma pathology, Carboplatin administration & dosage
Abstract

Purpose: To describe the incidences of hypogonadism, hypertension, and dyslipidaemia in patients with stage 1 seminoma (S1S) testicular cancer (TC) treated with a risk-adapted strategy., Methods: A retrospective analysis from 2000 to 2020 was conducted. Active surveillance (AS), carboplatin one cycle, and carboplatin two cycles were offered according to risk factors. Cumulative incidences and relapse-free survival (RFS) were estimated., Results: Of the 145 patients, 8 (5.4%) were excluded due to bilateral TC or hypogonadism at diagnosis. Median follow-up time was 8.2 years. Eighty-four, 30, and 33 patients were treated with AS, carboplatin one cycle, and carboplatin two cycles, respectively. In the overall population, the 5-year and 10-year cumulative incidences were 1.6% and 5.3% for hypogonadism; 2.0% and 8.6% for hypertension; and 12.4% and 25.1% for dyslipidaemia. No statistically significant differences were found in the incidences among the three adjuvant strategies. Five-year and 10-year RFS were 85.9% and 83.3% for AS; 92.4% and 84.0% for carboplatin one cycle; and 96.7% at both times for carboplatin two cycles., Conclusion: There were no statistically differences in cumulative incidences of hypogonadism, hypertension, and dyslipidaemia in S1S patients treated with a risk-adapted strategy., (© 2024. The Author(s), under exclusive licence to Federación de Sociedades Españolas de Oncología (FESEO).)

Published
2024
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9. Treatment Patterns and Survival Outcomes Before and After Access to Immune Checkpoint Inhibitors for Patients With Metastatic Urothelial Carcinoma: A Single-Center Retrospective Study From 2004 to 2021.

Author

Tapia JC, Bosma F, Gavira J, Sanchez S, Molina MA, Sanz-Beltran J, Martin-Lorente C, Anguera G, and Maroto P

Subjects
Humans, Retrospective Studies, Male, Female, Aged, Middle Aged, Carcinoma, Transitional Cell drug therapy, Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell secondary, Urinary Bladder Neoplasms drug therapy, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms pathology, Treatment Outcome, Aged, 80 and over, Urologic Neoplasms drug therapy, Urologic Neoplasms mortality, Urologic Neoplasms pathology, Spain, Progression-Free Survival, Survival Rate, Follow-Up Studies, Immune Checkpoint Inhibitors therapeutic use
Abstract

Introduction: Metastatic urothelial carcinoma (mUC) is a lethal disease with limited treatment options. We aimed to compare the treatment patterns and outcomes of patients with mUC who were treated before and after the introduction of immune checkpoint inhibitors (ICIs) at a tertiary hospital in Barcelona., Methods: Single-center retrospective study from 2004 to 2021. Access to ICIs began in December 2014. We analyzed differences in clinical characteristics and survival outcomes, such as overall survival (OS), progression-free survival (PFS), and restricted mean survival time (RMST)., Results: A total of 206 patients were included. The median follow-up was 48.6 months. Ninety and 116 patients were treated during the pre-ICIs and the post-ICIs eras, respectively. We found high treatment attrition rates, with no differences in the number of patients who received second-line (48%) and third-line (26%) therapies between the two eras. In the second-line, ICIs became the predominant therapy (58%), leading to a 30% reduction in the utilisation of platinum-based ChT and non-platinum ChT. Innovative approaches including ICIs in the first-line treatment (18%) and targeted therapies in the third-line setting (34%) were observed. We found no differences in the median OS, 2-year OS, or 24-month RMST between the two periods., Conclusion: ICIs have emerged as a transformative treatment option, reshaping the treatment landscape. Nevertheless, substantial attrition rates from first-line to subsequent lines of systemic therapies might impede the potential impact of ICIs on long-term survival outcomes across the entire population., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Published
2024
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10. The impact of olaparib dose reduction and treatment interruption on treatment outcome in the SOLO2/ENGOT-ov21 platinum-sensitive recurrent ovarian cancer.

Author

Francis KE, Kim SI, Friedlander M, Gebski V, Ray-Coquard I, Clamp A, Penson RT, Oza A, Perri T, Huzarski T, Martin-Lorente C, Cecere SC, Colombo N, Ataseven B, Fujiwara K, Sonke G, Vergote I, Pujade-Lauraine E, Kim JW, and Lee CK

Subjects
Carcinoma, Ovarian Epithelial drug therapy, Female, Humans, Mutation, Neoplasm Recurrence, Local chemically induced, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local genetics, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerases, Treatment Outcome, Drug Tapering, Ovarian Neoplasms drug therapy, Ovarian Neoplasms genetics
Abstract

Background: Maintenance treatment with poly (ADP-ribose) polymerase (PARP) inhibitor is now the standard of care in patients with BRCA-mutated platinum-sensitive recurrent ovarian cancer following response to chemotherapy. In the SOLO2 trial, adverse event (AE)-associated olaparib interruption, dose reduction, and discontinuation occurred in 50%, 28%, and 17% of patients, respectively. We used data from the SOLO2 trial to evaluate the impact of dose alterations on survival outcomes and identified baseline characteristics associated with dose alteration., Patients and Methods: We computed relative dose intensity (RDI) defined as the received dose as a percentage of the standard dose (300 mg twice a day) during the first 12 weeks on treatment. Patients were categorized into RDI >98%, RDI 90%-98%, and RDI <90%. The association between RDI categories with progression-free survival (PFS) and overall survival (OS) were examined using a 12-week landmark Cox regression analysis. Logistic regression analysis was used to correlate baseline factors with RDI at 12 weeks., Results: In patients on olaparib included in the landmark analysis (n = 185), the mean 12-week RDI was 91.4%. There was no significant difference across 12-week RDI >98% (n = 110), 90%-98% (n = 29), and <90% (n = 45) categories for PFS (median, 14.2 versus 19.3 versus 34.4 months; P = 0.37) and OS (median, 49.7 versus 49.5 versus 54.1 months; P = 0.84). Risk of RDI ≤90% increased with baseline performance status 1 [odds ratio (OR): 2.54; 95% confidence interval (CI): 1.11-5.82] any nausea (OR: 3.17; 95% CI: 0.9-11.23), and with body weight ≤70 kg (OR: 1.86; 95% CI: 0.92-3.76)., Conclusions: Dose reduction and interruption for the management of olaparib-associated AEs during the first 12 weeks did not impact on PFS and OS. When counselling patients requiring dose reductions or interruptions due to AEs, the results of this study will help assure patients that their outcomes will not be adversely affected., Competing Interests: Disclosure KEF reports intuitional funding from AstraZeneca (AZ). MF reports institutional funding from AZ, Novartis, and Beigene; consulting fees from AZ, Novartis, GlaxoSimthKline (GSK), Merck Sharp & Dohme (MSD), Takeda, and Lilly; honoraria for lectures from AZ, GSK, and ACT-Genomics; travel support from AZ; and participation in a data advisory role with Australasian Gastro-Intestinal Cancer Trials Group and Independent Data and Safety Monitoring Board. IRC reports personal fees and travel support from AZ, GSK, and Clovis Oncology; and personal fees from Roche, Mersana, Deciphera, Eisai, Amgen, Bristol Myers Squibb, OncXerna, and Aravive. AC reports institutional research funding from AZ; payment from Clovis Oncology for lectures and travel support; and he participates in an advisory role to AZ. RP reports institutional funding from AZ. He participates in an advisory role to AbbVie, AZ, Care4ward (unpaid), Clovis Oncology, Curio Science, Eisai Inc., Genentech, Janssen Oncology (J&J), Merck & Co., Mersana Therapeutics, Inc., NewLink Genetics, Nexus Global Group, Pieris Pharma Inc., Roche, Inc., Sutro Biopharma, Syndax Pharmaceuticals, Tesaro Inc., Vascular Biogenics Ltd. NC reports grants, consulting fees, and personal fees from AZ; consulting fees and personal fees from GSK; and personal fees from Tesaro, Novartis, Clovis, MSD, GSK, EISAI. She participates in an advisory role with Roche, PharmaMar, AZ, Clovis Oncology, MSD, GSK, Tesaro, Pfizer, BIOCAD, ImmunoGen, Mersana, OncXerna, and Eisai. KF reports institutional research funding and honoraria for lectures from AZ. GS reports institutional research funding from AZ, MSD, Novartis, and Roche; and consulting fees paid to the institution from BioViva and Segen. IV reports receiving institutional fees from Oncoinvent AS and Genmab; grant funding from Amgen and Roche; consulting fees from Aksebio, Amgen, GmbH, AZ, Clovis Oncology, Carrick Therapeutics, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, Roche, Genmab, GSK, Immunogen Inc., Jazz Pharma, Karyopharm, Mersana, Millennium Pharmaceuticals, MSD, Novocure, Novartis, Octimet Oncology NV, Oncoinvent AS, Sotio a.s., Verastem Oncology, Zentalis; and travel expenses from Amgen, MSD, Tesaro, AZ, Roche. EPL reports medical writing assistance for the primary SOLO2 publication from AZ; institutional grants from AZ and Merck; personal payments for lectures from AZ and GSK; and participation in an advisory role with Incyte, Roche, and Pfizer. He reports other interests including as an employee of ARCAGY GINECO research group. CKL reports institutional payments from Roche, AZ, and Merck KGA; and personal payments for lectures, presentations or travel support from AZ, Amgen, Takeda, Boehringer Ingelheim, Pfizer, Yuhan, Merck KGA, Roche, and MSD. All other authors have declared no conflicts of interest., (Copyright © 2022 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.)

Published
2022
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11. Management of advanced ovarian cancer in Spain: an expert Delphi consensus.

Author

Redondo A, Oaknin A, Rubio MJ, Barretina-Ginesta MP, de Juan A, Manso L, Romero I, Martin-Lorente C, Poveda A, and Gonzalez-Martin A

Subjects
Consensus, Female, Humans, Spain, Surveys and Questionnaires, Ovarian Neoplasms therapy
Abstract

Background: To determine the state of current practice and to reach a consensus on recommendations for the management of advanced ovarian cancer using a Delphi survey with a group of Spanish gynecologists and medical oncologists specially dedicated to gynecological tumors., Methods: The questionnaire was developed by the byline authors. All questions but one were answered using a 9-item Likert-like scale with three types of answers: frequency, relevance and agreement. We performed two rounds between December 2018 and July 2019. A consensus was considered reached when at least 75% of the answers were located within three consecutive points of the Likert scale., Results: In the first round, 32 oncologists and gynecologists were invited to participate, and 31 (96.9%) completed the online questionnaire. In the second round, 27 (87.1%) completed the online questionnaire. The results for the questions on first-line management of advanced disease, treatment of patients with recurrent disease for whom platinum might be the best option, and treatment of patients with recurrent disease for whom platinum might not be the best option are presented., Conclusions: This survey shows a snapshot of current recommendations by this selected group of physicians. Although the majority of the agreements and recommendations are aligned with the recently published ESMO-ESGO consensus, there are some discrepancies that can be explained by differences in the interpretation of certain clinical trials, reimbursement or accessibility issues.

Published
2021
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12. SEOM clinical guideline in ovarian cancer (2020).

Author

Redondo A, Guerra E, Manso L, Martin-Lorente C, Martinez-Garcia J, Perez-Fidalgo JA, Varela MQ, Rubio MJ, Barretina-Ginesta MP, and Gonzalez-Martin A

Subjects
Antineoplastic Agents, Immunological therapeutic use, Bevacizumab therapeutic use, Carcinoma, Ovarian Epithelial pathology, Chemotherapy, Adjuvant methods, Clinical Trials, Phase III as Topic, Cytoreduction Surgical Procedures methods, Female, Humans, Maintenance Chemotherapy methods, Medical Oncology, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local surgery, Neoplasm Staging methods, Ovarian Neoplasms pathology, Poly(ADP-ribose) Polymerase Inhibitors therapeutic use, Randomized Controlled Trials as Topic, Societies, Medical, Spain, Carcinoma, Ovarian Epithelial diagnosis, Carcinoma, Ovarian Epithelial therapy, Ovarian Neoplasms diagnosis, Ovarian Neoplasms therapy
Abstract

Despite remarkable advances in the knowledge of molecular biology and treatment, ovarian cancer remains the leading cause of death from gynecologic cancer. In the last decade, there have been important advances both in systemic and surgical treatment. However, there is no doubt that the incorporation of PARP inhibitors as maintenance after the response to platinum-based chemotherapy, first in recurrent disease and recently also in first line, will change the natural history of the disease.The objective of this guide is to summarize the current evidence for the diagnosis, treatment, and follow-up of ovarian cancer, and to provide evidence-based recommendations for clinical practice.

Published
2021
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