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2. Clinical characteristics and survival outcome of early-stage, high-grade, serous tubo-ovarian carcinoma according to BRCA mutational status

Author

Marchetti, C, Ataseven, B, Perrone, A, Cassani, C, Fruscio, R, Sassu, C, Apostol, A, Harter, P, De Iaco, P, Camnasio, C, Moubarak, M, Giannarelli, D, Scambia, G, Fagotti, A, Marchetti C., Ataseven B., Perrone A. M., Cassani C., Fruscio R., Sassu C. M., Apostol A. I., Harter P., De Iaco P., Camnasio C. A., Moubarak M., Giannarelli D., Scambia G., Fagotti A., Marchetti, C, Ataseven, B, Perrone, A, Cassani, C, Fruscio, R, Sassu, C, Apostol, A, Harter, P, De Iaco, P, Camnasio, C, Moubarak, M, Giannarelli, D, Scambia, G, Fagotti, A, Marchetti C., Ataseven B., Perrone A. M., Cassani C., Fruscio R., Sassu C. M., Apostol A. I., Harter P., De Iaco P., Camnasio C. A., Moubarak M., Giannarelli D., Scambia G., and Fagotti A.

Abstract

Objective: To investigate the role of BRCA1/2 mutations in early ovarian cancer (eOC) (International Federation of Gynecology and Obstetrics FIGO 2014 stage I-II), and its impact on prognosis after relapse. Methods: In this multicenter retrospective study, clinical and survival data from high-grade serous (HGS)-eOC patients at presentation and recurrence were compared according to BRCA status: BRCA-mutated (BRCAmut) vs. BRCA wild-type (BRCAwt). Results: Among 191 HGS-eOC patients, 89 were BRCAmut and 102 BRCAwt. There was no significant difference according to the BRCA status in terms of Progression-Free Survival (PFS). A longer Overall Survival (OS) was found in BRCAmut patients. Stage I patients had significantly improved PFS vs stage II, regardless of BRCA status. At multivariate analysis, stage at diagnosis was the only variable with a significant effect on PFS. No factors were significantly relevant on OS, albeit younger age and BRCA mutation showed a slight impact. Post-Recurrence Survival (PRS) in the BRCAmut population was significantly improved compared with BRCAwt. At multivariate analysis, Secondary Cytoreductive Surgery was the strongest predictor for longer PRS, followed by PARPi maintenance at recurrence. Conclusions: BRCA-status is not a prognostic factor in early ovarian cancer regarding PFS. However, our data suggest a better prognosis after relapse in BRCAm population.

Published
2024

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

5. Lymph node staging in grade 1–2 endometrioid ovarian carcinoma apparently confined to the ovary: Is it worth?

Author

Bizzarri, N, Imterat, M, Fruscio, R, Giannarelli, D, Perrone, A, Mancari, R, Traut, A, Rosati, A, du Bois, A, Ferrari, D, De Iaco, P, Ergasti, R, Ataseven, B, Bianchi, T, Di Stanislao, M, Perri, M, Heitz, F, Concin, N, Fanfani, F, Vizza, E, Scambia, G, Harter, P, Fagotti, A, Bizzarri N., Imterat M., Fruscio R., Giannarelli D., Perrone A. M., Mancari R., Traut A., Rosati A., du Bois A., Ferrari D., De Iaco P., Ergasti R., Ataseven B., Bianchi T., Di Stanislao M., Perri M. T., Heitz F., Concin N., Fanfani F., Vizza E., Scambia G., Harter P., Fagotti A., Bizzarri, N, Imterat, M, Fruscio, R, Giannarelli, D, Perrone, A, Mancari, R, Traut, A, Rosati, A, du Bois, A, Ferrari, D, De Iaco, P, Ergasti, R, Ataseven, B, Bianchi, T, Di Stanislao, M, Perri, M, Heitz, F, Concin, N, Fanfani, F, Vizza, E, Scambia, G, Harter, P, Fagotti, A, Bizzarri N., Imterat M., Fruscio R., Giannarelli D., Perrone A. M., Mancari R., Traut A., Rosati A., du Bois A., Ferrari D., De Iaco P., Ergasti R., Ataseven B., Bianchi T., Di Stanislao M., Perri M. T., Heitz F., Concin N., Fanfani F., Vizza E., Scambia G., Harter P., and Fagotti A.

Abstract

Objective: The aim of this study was to assess the disease-free survival (DFS) and overall survival (OS) of patients with grade 1–2 endometrioid ovarian carcinoma apparently confined to the ovary, according to surgical staging. Methods: Multicenter, retrospective, observational cohort study. Patients with endometrioid ovarian carcinoma, surgical procedure performed between May 1985 and December 2019, stage pT1 N0/N1/Nx, grade 1–2 were included. Patients were stratified according to lymphadenectomy (defined as removal of any lymph node versus no lymph node assessment), and subgroup analyses according to tumor grade were performed. Kaplan-Meier curves and cox regression analyses were used to perform survival analyses. Results: 298 patients were included. 199 (66.8 %) patients underwent lymph node assessment. Of these, 166 (83.4 %) had unilateral/bilateral pelvic and para-aortic/caval lymphadenectomy. Eleven (5.5 %) patients of those who underwent lymph node assessment showed pathologic metastatic lymph nodes (FIGO stage IIIA1). Twenty-seven patients (9.1 %) had synchronous endometrioid endometrial cancer. After a median follow up of 45 months (95 %CI:37.5–52.5), 5-year DFS and OS of the entire cohort were 89.8 % and 96.2 %, respectively. Age ≤ 51 years (HR=0.24, 95 %CI:0.06–0.91; p = 0.036) and performance of lymphadenectomy (HR=0.25, 95 %CI: 0.07–0.82; p = 0.022) represented independent protective factors toward risk of death. Patients undergoing lymphadenectomy had better 5-year DFS and OS compared to those not receiving lymphadenectomy, 92.0 % versus 85.6 % (p = 0.016) and 97.7 % versus 92.8 % (p = 0.013), respectively. This result was confirmed after exclusion of node-positive patients. When stratifying according to tumor grade (node-positive excluded), patients with grade 2 who underwent lymphadenectomy had better 5-year DFS and OS than those without lymphadenectomy (93.0 % versus 83.1 %, p = 0.040 % and 96.5 % versus 90.6 %, p = 0.037, respectively). Conclusion

Published
2023

6. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Koroveshi, Dhurata, Bouzid, Kamel, Casalnuovo, Monica, Cascallar, Diana, Korbenfeld, Ernesto Pablo, Bastick, Patricia, Beith, Jane, Colosimo, Maree, Friedlander, Michael, Ganju, Vinod, Green, Michael, Patterson, Kevin, Redfern, Andrew, Richardson, Gary, Ceric, Timur, Gordana, Kecman, Beato, Carlos Augusto, Ferrari, Marcela, Hegg, Roberto, Helena, Vanessa, Ismael, Gustavo Fernando, Lessa, Alvaro Edson, Mano, Max, Morelle, Alessandra, Nogueira, Jose Alberto, Timcheva, Konstanta, Tomova, Antoaneta, Tsakova, Maya, Zlatareva-Petrova, Ani, Asselah, Jamil, Assi, Hazem, Brezden-Masley, Christine, Chia, Stephen, Freedman, Ori, Harb, Mohammed, Joy, Anil Abraham, Kulkarni, Swati, Prady, Catherine, Gaete, Alejandro Andres Acevedo, Matamala, Luis, Torres, Roberto, Yanez, Eduardo, Franco, Sandra, Urrego, Marcela, Gugić, Damir, Vrbanec, Damir, Melichar, Bohuslav, Prausová, Jana, Vyzula, Rostislav, Pilarte, Rafael Gutierrez, León, María Isabel, Muñoz, Rene, Ramos, Glenda, Azeem, Hamdy Abdel, Aziz, Amr Abdel, El Zawahry, Heba, Osegueda, Finlander Rosales, Alexandre, Jerome, Artignan, Xavier, Barletta, Hugues, Beguier, Emmanuel, Berdah, Jean-François, Marty, Chantal Bernard, Bollet, Marc, Bourgeois, Hugues, Bressac, Claude, Burki, Franck, Campone, Mario, Coeffic, David, Cojocarasu, Oana Zveltlana, Dagada, Corinne, Dalenc, Florence, Del Piano, Francesco, Desauw, Christophe, Desmoulins, Isabelle, Dohollou, Nadine, Egreteau, Joelle, Ferrero, Jean-Marc, Foa, Cyril, Garidi, Reda, Gasnault, Laurent, Gligorov, Joseph, Guardiola, Emmanuel, Hamizi, Salima, Jarcau, Rosana, Jacquin, Jean-Philippe, Jaubert, Dominique, Jolimoy, Geneviève, Mineur, Hortense Laharie, Largillier, Remy, Leduc, Bernard, Martin, Philippe, Melis, Adrien, Monge, Jeremy, Moullet, Isabelle, Mousseau, Mireille, Nguyen, Suzanne, Orfeuvre, Hubert, Petit, Thierry, Pivot, Xavier, Priou, Frank, Bach, Isabelle Sillet, Simon, Helene, Stefani, Laetitia, Uwer, Lionel, Youssef, Ali, Aktas, Bahriye, von der Assen, Albert, Augustin, Doris, Balser, Christina, Bauer, Lelia-Eveline, Bechtner, Christina, Beyer, Greta, Brucker, Cosima, Bückner, Ute, Busch, Steffi, Christensen, Bernd, Deryal, Mustafa, Farrokh, Andre, Faust, Elke, Friedrichs, Kay, Graf, Heiko, Griesshammer, Martin, Grischke, Eva-Maria, Hänle, Claudia, Heider, Andrea, Henschen, Stephan, Hesse, Tobias, Jackisch, Christian, Kisro, Jens, Köhler, Andreas, Kuemmel, Sherko, Lampe, Dieter, Lantzsch, Tilmann, Latos, Kunibert, Lex, Benno, Liedtke, Cornelia, Luedders, Doerte, Maintz, Christoph, Müller, Volkmar, Overkamp, Friedrich, Park-Simon, Tjoung-won, Paul, Marion, Prechtl, Anita, Ringsdorf, Uta, Runnebaum, Ingo, Ruth, Sylvia, Salat, Christoph, Scheffen, Iris, Schilling, Jörg, Schmatloch, Sabine, Schmidt, Marcus, Schneeweiss, Andreas, Schrader, Iris, Seipelt, Gernot, Simon, Elke, Stefek, Andrea, Stickeler, Elmar, Thill, Marc, Tio, Joke, Tuczek, Anna, Warm, Mathias, Weigel, Michael, Wischnik, Arthur, Wojcinski, Sebastian, Ziegler-Löhr, Katja, Aravantinos, Gerasimos, Ardavanis, Alexandros, Fountzilas, George, Gogas, Helen, Kakolyris, Stylianos, Mavroudis, Dimitris, Papadimitriou, Christos, Papandreou, Christos, Papazisis, Konstantinos, Castro, Hugo, Hernandez-Monroy, Cesar Estuardo, Ngan, Roger, Yeo, Winnie, Bittner, Nora, Boer, Katalin, Csejtei, Andras, Horvath, Zsolt, Kocsis, Judit, Mangel, László Csaba, Mezei, Klara, Nagy, Zsuzsanna, Szanto, Janos, Atmakusuma, Djumhana, Fadjari, Heri, Kurnianda, Djohan, Prayogo, Nugroho, Tanggo, Eddie Herman, Coate, Linda, Hennessy, Bryan, Kelly, Cathy, Martin, Michael, Nasim, Saira, O'Connor, Miriam, Aieta, Michele, Allegrini, Giacomo, Amadori, Dino, Bidoli, Paolo, Biti, Giampaolo, Bordonaro, Roberto, Bottini, Alberto, Carterni, Giacomo, Cavanna, Luigi, Cazzaniga, Marina, Cognetti, Francesco, Contu, Antonio, Cruciani, Giorgio, Donadio, Michela, Falcone, Alfredo, Farci, Daniele, Forcignanò, R. Chiara, Frassoldati, Antonio, Gaion, Fernando, Gamucci, Teresa, Giotta, Francesco, de Laurentiis, Michele, Livi, Lorenzo, Lorusso, Vito, Maiello, Evaristo, Marchetti, Paolo, Mariani, Gabriella, Mion, Marta, Moscetti, Luca, Musolino, Antonino, Pazzola, Antonio, Pedrazzoli, Paolo, Pigi, Andrea, de Placido, Sabino, Caremoli, Elena Rota, Santoro, Armando, Tienghi, Amelia, Ahn, Jin-Seok, Jung, Kyung Hae, Lee, Keun Seok, Lee, Soo Hyeon, Seo, Jae Hong, Sohn, Joo-Hyuk, Cesas, Alvydas, Juozaityte, Elona, Cheah, Nellie Lay Chin, Chong, Flora Li Tze, Devi, Beena C.R., Phua, Vincent, Teoh, Darren, Ching, Lee Wei, Yusof, Mastura, Corona, Jorge, Dominguez, Adriana, Mendoza, René Lazaro González, Hernandez, Carlos Alberto, Ramiro, Alejandro Juarez, Santos, Juan Matos, Espinosa, Paola Morales, Villarreal Garza, Cynthia Mayte, Errihani, Hassan, Bakker, Sandra, van den Berkmortel, Franchette, Blaisse, R.J.B., Huinink, Daan ten Bokkel, van den Bosch, J., Braun, J.J., Dercksen, M.W., Droogendijk, Helga, Erdkamp, Frans, Haringhuizen, Annebeth, de Jongh, F.E., Kok, T.C., Los, Maartje, Madretsma, Stanley, Terwogt, Jetske M. Meerum, van der Padt, Annemieke, van Rossum-Schornagel, Quirine Clementine, Smilde, T.J., de Valk, Bart, van der Velden, Annette, van Warmerdam, Laurence, van de Wouw, A.J., North, Richard, Kersten, Christian, Mjaaland, Ingvild, Wist, Erik, Aziz, Zeba, Masood, Nehal, Rashid, Kamran, Shah, Mazhar, Alcedo, Juan Carlos, Aleman, Diana, Neciosup, Silvia, Reategui, Rocio, Valdiviezo, Natalia, Vera, Luis, Fernando, Gracieux, Roque, Fernando, Strebel, Heinrik Martin, Krzemieniecki, Krzysztof, Litwiniuk, Maria, Mruk, Andrzej, Pienkowski, Tadeusz, Sawrycki, Piotr, Slomian, Grzegorz, Tomczak, Piotr, Afonso, Noemia, Cardoso, Fátima, Damasceno, Margarida, Nave, Monica, Badulescu, Florinel, Ciule, Larisa, Curescu, Stefan, Eniu, Alexandru, Filip, Dumitru, Grecea, Daniela, Jinga, Dan-Corneliu, Lungulescu, Dan, Oprean, Cristina Marinela, Stanculeanu, Dana Lucia, Turdean, Maria, Dvornichenko, Viktoria, Emelyanov, Sergey, Lichinitser, Mikhail, Manikhas, Alexey, Sakaeva, Dina, Shirinkin, Vadim, Stroyakovskiy, Daniil, Abulkhair, Omalkhair, Zekri, Jamal, Filipovic, Sladjana, Kovcin, Vladimir, Nedovic, Jasmina, Pesic, Jasna, Vasovic, Suzana, Ng, Raymond, Bystricky, Branislav, Leskova, Jaroslava, Mardiak, Jozef, Mišurová, Etela, Wagnerova, Maria, Takač, Iztok, Demetriou, Georgia Savva, Dreosti, Lydia, Govender, Poovandren, Jordaan, Johannes Petrus, Veersamy, Petrosian, Romero, Jose Luis Alonso, Lopez, Norberto Batista, Arias, Carmen Cañabate, Chacon, Jose, Aramburo, Antonio Fernandez, Morales, Luis Antonio Fernandez, Garcia, Mirta, Estevez, Laura Garcia, Garcia-Palomo Perez, Andres, Garcia Saenz, Jose Angel, Garcia Sanchis, Laura, Cubells, Laia Garrigos, Cortijo, Lucia Gonzalez, Santiago, Santiago Gonzalez, De Aranguiz, Blanca Hernando Fernandez, Mañas, José Juan Illarramendi, Gallego, Pedro Jimenez, Cussac, Antonio Llombart, Ferrandiz, Cristina Llorca, Garrido, Maria Lomas, Alvarez, Pilar Lopez, Vega, Jose Manuel Lopez, Del Prado, Purificacion Martinez, Jañez, Noelia Martinez, Murillo, Serafin Morales, Rosales, Adolfo Murias, Jaso, Laura Murillo, Fernandez, Ignacio Pelaez, Martorell, Antonia Perello, Carrion, Ramon Perez, Simon, Sonia Pernas, Alcibar, Arrate Plazaola, Lorenzo, Jose Ponce, Garcia, Vanesa Quiroga, Asensio, Teresa Ramon y Cajal, Maicas, Maria Dolores Torregrosa, Villanueva Silva, Maria Jose, Killander, Fredrika, Svensson, Jan Henry, Fehr, Mathias, Hauser, Nik, Müller, Andreas, Pagani, Olivia, Passmann-Kegel, Heike, Popescu, Razvan, Rabaglio, Manuela, Rauch, Daniel, Schlatter, Christina, Zaman, Khalil, Chang, Tsai-Wang, Huang, Chiun-Sheng, Wang, Hwei-Chung, Yu, Jyh-Cherng, Bandidwattanawong, Chanyoot, Maneechavakajorn, Jedzada, Seetalarom, Kasan, Dejthevaporn, Thitiya (Sirisinha), Somwangprasert, Areewan, Vongsaisuwon, Mawin, Akbulut, Hakan, Altundag, Kadri, Arican, Ali, Bozcuk, Hakan, Eralp, Yesim, Idris, Mohamed, Isikdogan, Abdurrahman, Senol, Coskun Hasan, Sevinc, Alper, Uygun, Kazim, Yucel, Eftal, Yucel, Idris, Yumuk, Fulden, Shparyk, Yaroslav, Voitko, Nataliia, Jaloudi, Mohammed, Adams, Jocelyn, Agrawal, Rajiv, Ahmed, Samreen, Alhasso, Abdulla, Allerton, Rozenn, Anwar, Suhail, Archer, Caroline, Ashford, Richard, Barraclough, Lisa, Bertelli, Gianfilippo, Bishop, Jill, Branson, Tony, Butt, Mohammed, Chakrabarti, Amit, Chakraborti, Prabir, Churn, Mark, Crowley, Clare, Davis, Ruth, Dhadda, Amandeep, Eldeeb, Hany, Fraser, Judith, Hall, Julia, Hickish, Tamas, Hogg, Martin, Howe, Theresa, Joffe, Jonathan, Kelleher, Muireann, Kelly, Stephen, Kendall, Anne, Kristeleit, Hartmut, Lumsden, Graeme, Macmillan, Craig, MacPherson, Iain, Malik, Zafar, Mithal, Natasha, Neal, Anthony, Panwar, Udaiveer, Proctor, Andrew, Proctor, Steven John, Raj, Sanjay, Rehman, Shazza, Sandri, Ines, Scatchard, Kate, Sherwin, Elizabeth, Sims, Eliot, Singer, Julian, Smith, Sarah, Tahir, Saad, Taylor, Wendy, Tsalic, Medy, Verrill, Mark, Wardley, Andrew, Waters, Simon, Wheatley, Duncan, Wright, Kathryn, Yuille, Frances, Alonso, Isabel, Artagaveytia, Nora, Rodriguez, Robinson, Arbona, Esther, Garcia, Yuraima, Lion, Lorena, Marcano, Dalila, Van Thuan, Tran, Gligorov, J., Ataseven, B., Verrill, M., De Laurentiis, M., Jung, K.H., Azim, H.A., Al-Sakaff, N., Lauer, S., Shing, M., and Pivot, X.

Published
2017
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7. The impact of olaparib dose reduction and treatment interruption on treatment outcome in the SOLO2/ENGOT-ov21 platinum-sensitive recurrent ovarian cancer

Author

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

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 affecte

Published
2022

8. Efficacy and safety of olaparib according to age in BRCA1/2-mutated patients with recurrent platinum-sensitive ovarian cancer: Analysis of the phase III SOLO2/ENGOT-Ov21 study

Author

Trillsch, F, Mahner, S, Ataseven, B, Asher, R, Aryal, N, Dubot, C, Clamp, A, Penson, R, Oza, A, Amit, A, Huzarski, T, Casado, A, Scambia, G, Friedlander, M, Colombo, N, Fujiwara, K, Sonke, G, Denys, H, Lowe, E, Lee, C, Pujade-Lauraine, E, Trillsch F., Mahner S., Ataseven B., Asher R., Aryal N., Dubot C., Clamp A., Penson R. T., Oza A., Amit A., Huzarski T., Casado A., Scambia G., Friedlander M., Colombo N., Fujiwara K., Sonke G. S., Denys H., Lowe E. S., Lee C. K., Pujade-Lauraine E., Trillsch, F, Mahner, S, Ataseven, B, Asher, R, Aryal, N, Dubot, C, Clamp, A, Penson, R, Oza, A, Amit, A, Huzarski, T, Casado, A, Scambia, G, Friedlander, M, Colombo, N, Fujiwara, K, Sonke, G, Denys, H, Lowe, E, Lee, C, Pujade-Lauraine, E, Trillsch F., Mahner S., Ataseven B., Asher R., Aryal N., Dubot C., Clamp A., Penson R. T., Oza A., Amit A., Huzarski T., Casado A., Scambia G., Friedlander M., Colombo N., Fujiwara K., Sonke G. S., Denys H., Lowe E. S., Lee C. K., and Pujade-Lauraine E.

Abstract

Background: Olaparib has significantly improved outcome and patient-centered endpoints in BRCA1/2-mutated patients with recurrent platinum-sensitive ovarian cancer (PSOC). Specific information on efficacy and safety of olaparib for older patients appears of special interest. Methods: 295 patients from the SOLO2 trial randomly assigned to olaparib or placebo were categorized according to age-cutoff at 65 years. Efficacy, tolerability, and quality of life (QoL) of olaparib relative to placebo within in each age group was analyzed. Results: Baseline characteristics were similar in patients ≥65 years (N = 62;21.0%) compared to patients <65 years (N = 233;78.9%). No significant difference in the magnitude of progression-free survival (PFS) benefit from olaparib for older patients (N = 40, hazard ratio [HR]≥65 0.43, 95%-confidence interval [CI] 0.24–0.81) as compared with younger patients (N = 155, HR<65 0.31 (95%-CI 0.22–0.43) was seen (interaction P = 0.33). The overall survival (OS)benefit seen in younger patients in the olaparib arm was not observed in older patients. Older and younger patients had comparable safety profiles and QoL scores although higher discontinuation rates for toxicity, and higher frequency of AML/MDS were noted in the older subset. TWiST analysis revealed clinically meaningful duration of good QoL on olaparib for both age groups (≥65: 13.5 vs <65: 18.4 months, P = 0.05). Conclusions: Results of this large phase III cohort of BRCA1/2-mutated PSOC patients treated with olaparib underline impressive efficacy of olaparib maintenance irrespective of age. Although toxicity and tolerability did not raise significant concerns, some caution, close monitoring, and follow-up needs to be exercised for older patients given higher discontinuation rates, frequency of AML/MDS, and no clear effects on OS.

Published
2022

9. 167P Deep learning-based whole slide image analysis to predict sentinel node status in the INSEMA cohort

Author

Marmé, F., primary, Krieghoff-Henning, E., additional, Gerber, B., additional, Schmitt, M., additional, Zahm, D-M., additional, Bauerschlag, D., additional, Forstbauer, H., additional, Hildebrandt, G., additional, Ataseven, B., additional, Brodkorb, T., additional, Denkert, C., additional, Stachs, A., additional, Krug, D., additional, Heil, J., additional, Golatta, M., additional, Kuehn, T., additional, Nekljudova, V., additional, Loibl, S., additional, Reimer, T., additional, and Brinker, T., additional

Published
2023
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10. CCNE1 and survival of patients with tubo-ovarian high-grade serous carcinoma: An Ovarian Tumor Tissue Analysis consortium study

Author

Kang, E-Y, Weir, A, Meagher, NS, Farrington, K, Nelson, GS, Ghatage, P, Lee, C-H, Riggan, MJ, Bolithon, A, Popovic, G, Leung, B, Tang, K, Lambie, N, Millstein, J, Alsop, J, Anglesio, MS, Ataseven, B, Barlow, E, Beckmann, MW, Berger, J, Bisinotto, C, Boesmueller, H, Boros, J, Brand, AH, Brooks-Wilson, A, Brucker, SY, Carney, ME, Casablanca, Y, Cazorla-Jimenez, A, Cohen, PA, Conrads, TP, Cook, LS, Coulson, P, Courtney-Brooks, M, Cramer, DW, Crowe, P, Cunningham, JM, Cybulski, C, Darcy, KM, El-Bahrawy, MA, Elishaev, E, Erber, R, Farrell, R, Fereday, S, Fischer, A, Garcia, MJ, Gayther, SA, Gentry-Maharaj, A, Gilks, CB, Grube, M, Harnett, PR, Harrington, SP, Harter, P, Hartmann, A, Hecht, JL, Heikaus, S, Hein, A, Heitz, F, Hendley, J, Hernandez, BY, Hernando Polo, S, Heublein, S, Hirasawa, A, Hogdall, E, Hogdall, CK, Horlings, HM, Huntsman, DG, Huzarski, T, Jewell, A, Jimenez-Linan, M, Jones, ME, Kaufmann, SH, Kennedy, CJ, Khabele, D, Kommoss, FKF, Kruitwagen, RFPM, Lambrechts, D, Le, ND, Lener, M, Lester, J, Leung, Y, Linder, A, Loverix, L, Lubinski, J, Madan, R, Maxwell, GL, Modugno, F, Neuhausen, SL, Olawaiye, A, Olbrecht, S, Orsulic, S, Palacios, J, Pearce, CL, Pike, MC, Quinn, CM, Mohan, GR, Rodriguez-Antona, C, Ruebner, M, Ryan, A, Salfinger, SG, Sasamoto, N, Schildkraut, JM, Schoemaker, MJ, Shah, M, Sharma, R, Shvetsov, YB, Singh, N, Sonke, GS, Steele, L, Stewart, CJR, Sundfeldt, K, Swerdlow, AJ, Talhouk, A, Tan, A, Taylor, SE, Terry, KL, Toloczko, A, Traficante, N, Van de Vijver, KK, van der Aa, MA, Van Gorp, T, Van Nieuwenhuysen, E, Van-Wagensveld, L, Vergote, I, Vierkant, RA, Wang, C, Wilkens, LR, Winham, SJ, Wu, AH, Benitez, J, Berchuck, A, Candido Dos Reis, FJ, DeFazio, A, Fasching, PA, Goode, EL, Goodman, MT, Gronwald, J, Karlan, BY, Kommoss, S, Menon, U, Sinn, H-P, Staebler, A, Brenton, JD, Bowtell, DD, Pharoah, PDP, Ramus, SJ, Kobel, M, Kang, E-Y, Weir, A, Meagher, NS, Farrington, K, Nelson, GS, Ghatage, P, Lee, C-H, Riggan, MJ, Bolithon, A, Popovic, G, Leung, B, Tang, K, Lambie, N, Millstein, J, Alsop, J, Anglesio, MS, Ataseven, B, Barlow, E, Beckmann, MW, Berger, J, Bisinotto, C, Boesmueller, H, Boros, J, Brand, AH, Brooks-Wilson, A, Brucker, SY, Carney, ME, Casablanca, Y, Cazorla-Jimenez, A, Cohen, PA, Conrads, TP, Cook, LS, Coulson, P, Courtney-Brooks, M, Cramer, DW, Crowe, P, Cunningham, JM, Cybulski, C, Darcy, KM, El-Bahrawy, MA, Elishaev, E, Erber, R, Farrell, R, Fereday, S, Fischer, A, Garcia, MJ, Gayther, SA, Gentry-Maharaj, A, Gilks, CB, Grube, M, Harnett, PR, Harrington, SP, Harter, P, Hartmann, A, Hecht, JL, Heikaus, S, Hein, A, Heitz, F, Hendley, J, Hernandez, BY, Hernando Polo, S, Heublein, S, Hirasawa, A, Hogdall, E, Hogdall, CK, Horlings, HM, Huntsman, DG, Huzarski, T, Jewell, A, Jimenez-Linan, M, Jones, ME, Kaufmann, SH, Kennedy, CJ, Khabele, D, Kommoss, FKF, Kruitwagen, RFPM, Lambrechts, D, Le, ND, Lener, M, Lester, J, Leung, Y, Linder, A, Loverix, L, Lubinski, J, Madan, R, Maxwell, GL, Modugno, F, Neuhausen, SL, Olawaiye, A, Olbrecht, S, Orsulic, S, Palacios, J, Pearce, CL, Pike, MC, Quinn, CM, Mohan, GR, Rodriguez-Antona, C, Ruebner, M, Ryan, A, Salfinger, SG, Sasamoto, N, Schildkraut, JM, Schoemaker, MJ, Shah, M, Sharma, R, Shvetsov, YB, Singh, N, Sonke, GS, Steele, L, Stewart, CJR, Sundfeldt, K, Swerdlow, AJ, Talhouk, A, Tan, A, Taylor, SE, Terry, KL, Toloczko, A, Traficante, N, Van de Vijver, KK, van der Aa, MA, Van Gorp, T, Van Nieuwenhuysen, E, Van-Wagensveld, L, Vergote, I, Vierkant, RA, Wang, C, Wilkens, LR, Winham, SJ, Wu, AH, Benitez, J, Berchuck, A, Candido Dos Reis, FJ, DeFazio, A, Fasching, PA, Goode, EL, Goodman, MT, Gronwald, J, Karlan, BY, Kommoss, S, Menon, U, Sinn, H-P, Staebler, A, Brenton, JD, Bowtell, DD, Pharoah, PDP, Ramus, SJ, and Kobel, M

Abstract

BACKGROUND: Cyclin E1 (CCNE1) is a potential predictive marker and therapeutic target in tubo-ovarian high-grade serous carcinoma (HGSC). Smaller studies have revealed unfavorable associations for CCNE1 amplification and CCNE1 overexpression with survival, but to date no large-scale, histotype-specific validation has been performed. The hypothesis was that high-level amplification of CCNE1 and CCNE1 overexpression, as well as a combination of the two, are linked to shorter overall survival in HGSC. METHODS: Within the Ovarian Tumor Tissue Analysis consortium, amplification status and protein level in 3029 HGSC cases and mRNA expression in 2419 samples were investigated. RESULTS: High-level amplification (>8 copies by chromogenic in situ hybridization) was found in 8.6% of HGSC and overexpression (>60% with at least 5% demonstrating strong intensity by immunohistochemistry) was found in 22.4%. CCNE1 high-level amplification and overexpression both were linked to shorter overall survival in multivariate survival analysis adjusted for age and stage, with hazard stratification by study (hazard ratio [HR], 1.26; 95% CI, 1.08-1.47, p = .034, and HR, 1.18; 95% CI, 1.05-1.32, p = .015, respectively). This was also true for cases with combined high-level amplification/overexpression (HR, 1.26; 95% CI, 1.09-1.47, p = .033). CCNE1 mRNA expression was not associated with overall survival (HR, 1.00 per 1-SD increase; 95% CI, 0.94-1.06; p = .58). CCNE1 high-level amplification is mutually exclusive with the presence of germline BRCA1/2 pathogenic variants and shows an inverse association to RB1 loss. CONCLUSION: This study provides large-scale validation that CCNE1 high-level amplification is associated with shorter survival, supporting its utility as a prognostic biomarker in HGSC.

Published
2023

11. Adult ovarian granulosa cell tumors: analysis of outcomes and risk factors for recurrence

Author

Plett, H, Ricciardi, E, Vacaru, V, Ramspott, J, Colombo, N, Sehouli, J, du Bois, A, Garbi, A, Richter, R, Ataseven, B, Aletti, G, Braicu, E, Heitz, F, Portuesi, R, Muallem, M, Dagres, T, Parma, G, Roser, E, Traut, A, Multinu, F, Harter, P, Plett, Helmut, Ricciardi, Enzo, Vacaru, Vlad, Ramspott, Jan Phillip, Colombo, Nicoletta, Sehouli, Jalid, du Bois, Andreas, Garbi, Annalisa, Richter, Rolf, Ataseven, Beyhan, Aletti, Giovanni, Braicu, Elena, Heitz, Florian, Portuesi, Rosalba, Muallem, Mustafa-Zelal, Dagres, Timoleon, Parma, Gabriella, Roser, Eva, Traut, Alexander, Multinu, Francesco, Harter, Philipp, Plett, H, Ricciardi, E, Vacaru, V, Ramspott, J, Colombo, N, Sehouli, J, du Bois, A, Garbi, A, Richter, R, Ataseven, B, Aletti, G, Braicu, E, Heitz, F, Portuesi, R, Muallem, M, Dagres, T, Parma, G, Roser, E, Traut, A, Multinu, F, Harter, P, Plett, Helmut, Ricciardi, Enzo, Vacaru, Vlad, Ramspott, Jan Phillip, Colombo, Nicoletta, Sehouli, Jalid, du Bois, Andreas, Garbi, Annalisa, Richter, Rolf, Ataseven, Beyhan, Aletti, Giovanni, Braicu, Elena, Heitz, Florian, Portuesi, Rosalba, Muallem, Mustafa-Zelal, Dagres, Timoleon, Parma, Gabriella, Roser, Eva, Traut, Alexander, Multinu, Francesco, and Harter, Philipp

Abstract

Objective: Adult granulosa cell tumors represent less than 5% of all ovarian malignancies. The aim of this study was to analyze the clinicopathological parameters and their impact on progression-free and overall survival. Methods: Patients with primary adult granulosa cell tumors treated in three international referral centers between July 1999 and December 2018 were included. The following data were anonymously exported from the prospective database: age at diagnosis, International Federation of Gynecology and Obstetrics (FIGO) stage, adjuvant therapy, surgical procedures, progression-free survival, and overall survival. Descriptive statistical analysis regarding tumor and treatment characteristics was performed. Survival analyses included Kaplan-Meier functions and Cox proportional hazard ratios (HR). Results: A total of 168 patients with primary adult granulosa cell tumors were included. Median age was 50 years (range 13-82). With regard to stage distribution, 54.2% (n=91) of patients were FIGO stage IA, 1.2% (n=2) were stage IB, 26.8% (n=45) were stage IC, and 17.9% (n=30) were FIGO stage II-IV. 66.7% (n=112) of patients underwent surgical restaging, of whom 17.9% (n=20) were moved to a higher stage. In addition, 36 (21.4%) patients underwent fertility-sparing surgery. After a median follow-up of 61 months (range 0-209), 10.7% of patients (n=18) had recurrent disease and 4.8% (n=8) died of disease. Five-year progression-free survival was 86.1% and estimated overall survival was 95.7%. Five-year progression-free survival was worse for patients with advanced stages (FIGO stage IA/B vs IC: HR 5.09 (95% CI 1.53 to 16.9); FIGO stage IA/B vs II-IV: HR 5.62 (95% CI 1.58 to 19.9)). Nineteen patients receiving adjuvant chemotherapy had lower estimated 5-year progression-free survival compared with patients not receiving chemotherapy (49.7% vs 91.1%, p<0.001; HR 9.15 (95% CI 3.62 to 23.1)). Conclusion: The prognosis of patients with primary adult granulosa cell tumors

Published
2023

12. Impact of substage and histologic type in stage I ovarian carcinoma survival: a multicenter retrospective observational study

Author

Imterat, M, Bizzarri, N, Fruscio, R, Perrone, A, Traut, A, du Bois, A, Rosati, A, Ferrari, D, De Iaco, P, Ataseven, B, Ergasti, R, Volontè, S, Tesei, M, Heitz, F, Perri, M, Concin, N, Fanfani, F, Scambia, G, Fagotti, A, Harter, P, Imterat, Majdi, Bizzarri, Nicolò, Fruscio, Robert, Perrone, Anna Myriam, Traut, Alexander, du Bois, Andreas, Rosati, Andrea, Ferrari, Debora, De Iaco, Pierandrea, Ataseven, Beyhan, Ergasti, Raffaella, Volontè, Silvia, Tesei, Marco, Heitz, Florian, Perri, Maria Teresa, Concin, Nicole, Fanfani, Francesco, Scambia, Giovanni, Fagotti, Anna, Harter, Philipp, Imterat, M, Bizzarri, N, Fruscio, R, Perrone, A, Traut, A, du Bois, A, Rosati, A, Ferrari, D, De Iaco, P, Ataseven, B, Ergasti, R, Volontè, S, Tesei, M, Heitz, F, Perri, M, Concin, N, Fanfani, F, Scambia, G, Fagotti, A, Harter, P, Imterat, Majdi, Bizzarri, Nicolò, Fruscio, Robert, Perrone, Anna Myriam, Traut, Alexander, du Bois, Andreas, Rosati, Andrea, Ferrari, Debora, De Iaco, Pierandrea, Ataseven, Beyhan, Ergasti, Raffaella, Volontè, Silvia, Tesei, Marco, Heitz, Florian, Perri, Maria Teresa, Concin, Nicole, Fanfani, Francesco, Scambia, Giovanni, Fagotti, Anna, and Harter, Philipp

Abstract

Objective: This international study aimed to investigate the impact of substage, histological type and other prognostic factors on long-term survival for stage I ovarian carcinoma. Methods: Our study was a retrospective multicenter cohort study that included patients with the International Federation of Gynecology and Obstetrics (FIGO) stage I (IA-IC3) ovarian carcinoma treated at four European referral centers in Germany and Italy. Using Kaplan-Meier survival curves we compared overall and disease-free survival between the different stage I groups. Results: A total of 1115 patients were included. Of these, 48.4% (n=540) were in stage IA, 6.6% (n=73) stage IB, and 45% (n=502) stage IC, of the latter substage IC1, 54% (n=271), substage IC2, 31.5% (n=158), and substage IC3, 14.5% (n=73). Five-year overall and disease-free survival rates for the entire cohort were 94% and 86%, respectively, with no difference between stage IA and IB. However, there was a significantly better overall and disease-free survival for stage IA as compared with stage IC (p=0.007 and p<0.001, respectively). Multivariate analysis revealed incomplete/fertility-sparing staging (HR 1.95; 95% CI 1.27 to 2.99, and HR 3.54; 95% CI 1.83 to 6.86, respectively), and stage IC (HR 2.47; 95% CI 1.63 to 3.75) as independent risk factors for inferior disease-free survival, while low-grade endometrioid (HR 0.42; 95% CI 0.25 to 0.72) and low-grade mucinous (HR 0.17; 95% CI 0.06 to 0.44) histology had superior disease-free survival. Considering overall survival, stage IC (HR 2.41; 95% CI 1.45 to 4.01) and older age (HR 2.41; 95% CI 1.46 to 3.95) were independent risk factors. Conclusion: Although stage I ovarian carcinoma exhibited excellent outcomes, the prognosis of patients with stage IA differs significantly compared with stage IC. Sub-optimal staging as an indicator for quality of care, and tumor biology defined by histology (low-grade endometrioid/mucinous) independently impact disease-free survival.

Published
2023

13. Lymph node staging in grade 1–2 endometrioid ovarian carcinoma apparently confined to the ovary: Is it worth?

Author

Bizzarri, Nicolo', Imterat, M., Fruscio, R., Giannarelli, Diana, Perrone, A. M., Mancari, R., Traut, A., Rosati, A., du Bois, A., Ferrari, D., De Iaco, P., Ergasti, R., Ataseven, B., Bianchi, T., Di Stanislao, M., Perri, M. T., Heitz, F., Concin, N., Fanfani, Francesco, Vizza, E., Scambia, Giovanni, Harter, P., Fagotti, Anna, Bizzarri N., Giannarelli D., Fanfani F. (ORCID:0000-0003-1991-7284), Scambia G. (ORCID:0000-0003-2758-1063), Fagotti A. (ORCID:0000-0001-5579-335X), Bizzarri, Nicolo', Imterat, M., Fruscio, R., Giannarelli, Diana, Perrone, A. M., Mancari, R., Traut, A., Rosati, A., du Bois, A., Ferrari, D., De Iaco, P., Ergasti, R., Ataseven, B., Bianchi, T., Di Stanislao, M., Perri, M. T., Heitz, F., Concin, N., Fanfani, Francesco, Vizza, E., Scambia, Giovanni, Harter, P., Fagotti, Anna, Bizzarri N., Giannarelli D., Fanfani F. (ORCID:0000-0003-1991-7284), Scambia G. (ORCID:0000-0003-2758-1063), and Fagotti A. (ORCID:0000-0001-5579-335X)

Abstract

Objective: The aim of this study was to assess the disease-free survival (DFS) and overall survival (OS) of patients with grade 1–2 endometrioid ovarian carcinoma apparently confined to the ovary, according to surgical staging. Methods: Multicenter, retrospective, observational cohort study. Patients with endometrioid ovarian carcinoma, surgical procedure performed between May 1985 and December 2019, stage pT1 N0/N1/Nx, grade 1–2 were included. Patients were stratified according to lymphadenectomy (defined as removal of any lymph node versus no lymph node assessment), and subgroup analyses according to tumor grade were performed. Kaplan-Meier curves and cox regression analyses were used to perform survival analyses. Results: 298 patients were included. 199 (66.8 %) patients underwent lymph node assessment. Of these, 166 (83.4 %) had unilateral/bilateral pelvic and para-aortic/caval lymphadenectomy. Eleven (5.5 %) patients of those who underwent lymph node assessment showed pathologic metastatic lymph nodes (FIGO stage IIIA1). Twenty-seven patients (9.1 %) had synchronous endometrioid endometrial cancer. After a median follow up of 45 months (95 %CI:37.5–52.5), 5-year DFS and OS of the entire cohort were 89.8 % and 96.2 %, respectively. Age ≤ 51 years (HR=0.24, 95 %CI:0.06–0.91; p = 0.036) and performance of lymphadenectomy (HR=0.25, 95 %CI: 0.07–0.82; p = 0.022) represented independent protective factors toward risk of death. Patients undergoing lymphadenectomy had better 5-year DFS and OS compared to those not receiving lymphadenectomy, 92.0 % versus 85.6 % (p = 0.016) and 97.7 % versus 92.8 % (p = 0.013), respectively. This result was confirmed after exclusion of node-positive patients. When stratifying according to tumor grade (node-positive excluded), patients with grade 2 who underwent lymphadenectomy had better 5-year DFS and OS than those without lymphadenectomy (93.0 % versus 83.1 %, p = 0.040 % and 96.5 % versus 90.6 %, p = 0.037, respectively). Conclusion

Published
2023

15. Dilution of molecular-pathologic gene signatures (MPG) by parameter unrelated to tumor biology (UTB) may prevent prediction of the resection status after debulking surgery in patients with advanced ovarian cancer

Author

Heitz, F, Kommoss, S, Tourani, R, Grandelis, A, Uppendahl, L, Aliferis, C, Burges, A, Wang, C, Canzler, U, Wang, J, Belau, A, Prader, S, Hanker, L, Ma, S, Ataseven, B, Hilpert, F, Schneider, S, Sehouli, J, Kimmig, R, Kurzeder, C, Schmalfeldt, B, Braicu, I, Harter, P, Dowdy, S C, Winterhoff, B JN, Pfisterer, J, and du Bois, A

Published
2019
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18. Sarkome

Author

Eiermann, W., Ataseven, B., Gaß, O., Kaufmann, Manfred, editor, Costa, Serban D., editor, and Scharl, Anton, editor

Published
2013
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19. Role of substage and histologic subtype in stage I epithelial ovarian cancer survival: a multicenter retrospective observational study

Author

Imterat, M, additional, Bizzarri, N, additional, Fruscio, R, additional, Perrone, AM, additional, Traut, A, additional, du Bois, A, additional, Rosati, A, additional, Ferrari, D, additional, De Iaco, P, additional, Ataseven, B, additional, Ergasti, R, additional, Volontè, S, additional, Tesei, M, additional, Heitz, F, additional, Perri, MT, additional, Concin, N, additional, Fanfani, F, additional, Scambia, G, additional, Fagotti, A, additional, and Harter, P, additional

Published
2022
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20. Rolle der Fertilitätserhaltenden Therapie bei Patientinnen mit Borderline-Tumoren des Ovars

Author

Westermann, T, additional, Heitz, F, additional, Ataseven, B, additional, Pauly, N, additional, Moubarak, M, additional, Strojna, A, additional, Kaiser, S, additional, Welz, J, additional, Imterat, M, additional, Concin, N, additional, Dagres, T, additional, Vrentas, V, additional, Traut, A, additional, Plett, H, additional, du Bois, A, additional, and Harter, P, additional

Published
2022
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21. Einfluss der Diagnose des Erstrezidivs auf die gesundheitsbezogene Lebensqualität von Patientinnen mit fortgeschrittenem Ovarialkarzinom (AGO-OVAR 19/II)

Author

Czogalla, B, additional, Ataseven, B, additional, Kommoss, S, additional, Reuß, A, additional, Sehouli, J, additional, Lampe, B, additional, Schmalfeldt, B, additional, Wimberger, P, additional, Witteler, R, additional, Buderath, P, additional, Herwig, U, additional, Bronger, H, additional, Emons, G, additional, Klar, M, additional, Hasenburg, A, additional, de Gregorio, N, additional, Hilpert, F, additional, du Bois, A, additional, Mahner, S, additional, and Harter, P, additional

Published
2022
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24. Stellenwert der Rezidivoperation beim adulten Granulosazelltumor des Ovars

Author

Kaiser, S, additional, Harter, P, additional, Heitz, F, additional, Westermann, T, additional, Welz, J, additional, Schwameis, R, additional, Concin, N, additional, Imetrat, M, additional, Strojna, A, additional, Dagres, T, additional, Vrentas, V, additional, Hinrichs, J, additional, Boland, S, additional, Pauly, N, additional, Heikaus, S, additional, Moubarak, M, additional, Traut, A, additional, and Ataseven, B, additional

Published
2022
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32. Is there any therapeutic role of pelvic and para-aortic lymphadenectomy in apparent early stage epithelial ovarian cancer?

Author

Bizzarri, N, du Bois, A, Fruscio, R, De Felice, F, De Iaco, P, Casarin, J, Vizza, E, Chiantera, V, Corrado, G, Cianci, S, Magni, S, Ferrari, D, Giuliani, D, Harter, P, Ataseven, B, Bommert, M, Perrone, A, Scambia, G, Fagotti, A, Bizzarri N., du Bois A., Fruscio R., De Felice F., De Iaco P., Casarin J., Vizza E., Chiantera V., Corrado G., Cianci S., Magni S., Ferrari D., Giuliani D., Harter P., Ataseven B., Bommert M., Perrone A. M., Scambia G., Fagotti A., Bizzarri, N, du Bois, A, Fruscio, R, De Felice, F, De Iaco, P, Casarin, J, Vizza, E, Chiantera, V, Corrado, G, Cianci, S, Magni, S, Ferrari, D, Giuliani, D, Harter, P, Ataseven, B, Bommert, M, Perrone, A, Scambia, G, Fagotti, A, Bizzarri N., du Bois A., Fruscio R., De Felice F., De Iaco P., Casarin J., Vizza E., Chiantera V., Corrado G., Cianci S., Magni S., Ferrari D., Giuliani D., Harter P., Ataseven B., Bommert M., Perrone A. M., Scambia G., and Fagotti A.

Abstract

Objective: The therapeutic role of pelvic and para-aortic lymphadenectomy in surgical staging of apparent early-stage epithelial ovarian cancer (eEOC) is still under debate. The aim of this study was to evaluate the potential therapeutic role of systematic lymphadenectomy in patients with eEOC. Methods: Multi-center retrospective cohort study, comparing women with apparent eEOC who underwent comprehensive bilateral pelvic and para-aortic lymphadenectomy (defined as ≥20 lymph nodes) versus patients receiving no lymphadenectomy or lymph node sampling, from 05/1985 to 12/2016. Patients with bulky nodes at CT-scan and those without complete intra-peritoneal surgical staging were excluded. Only patients who received at least 3 cycles of platinum-based adjuvant chemotherapy were included. Results: Out of 2559 patients with FIGO stage IA-IIIA1 ovarian cancer, 639 (25.0%) met inclusion criteria. 360 (56.3%) underwent comprehensive lymphadenectomy, 150 (23.5%) lymph node sampling and 129 (20.2%) no lymphadenectomy. Patients who underwent comprehensive lymphadenectomy were younger (p < 0.001), experienced a higher number of severe post-operative complications (p = 0.008) and had a longer time to start chemotherapy (p = 0.034). There was no difference in intra-operative complications. Median follow-up was 63 months (range, 5–342). The 5-year disease-free survival (DFS) was 79.7% vs. 76.5% vs. 68.3% (p = 0.006), and 5-year overall survival (OS) was 92.3% vs. 94.5% vs. 89.8% (p = 0.165) in women who received comprehensive lymphadenectomy vs. lymph node sampling vs. no lymphadenectomy, respectively. Lymphadenectomy represented an independent factor for DFS improvement, HR 0.52 (95%CI 0.37–0.73) (p < 0.001). Conclusion: Pelvic and para-aortic lymphadenectomy in surgical staging of eEOC improves DFS for the price of increasing post-operative complications and time to chemotherapy but does not affect OS. Better understanding of tumor biology may help to identify those patients

Published
2021

39. Efficacy and safety of olaparib according to age in BRCA1/2-mutated patients with recurrent platinum-sensitive ovarian cancer: Analysis of the phase III SOLO2/ENGOT-Ov21 study

Author

Trillsch, F., Mahner, S., Ataseven, B., Asher, R., Aryal, N., Dubot, C., Clamp, A., Penson, R. T., Oza, A., Amit, A., Huzarski, T., Casado, A., Scambia, Giovanni, Friedlander, M., Colombo, N., Fujiwara, K., Sonke, G. S., Denys, H., Lowe, E. S., Lee, C. K., Pujade-Lauraine, E., Scambia G. (ORCID:0000-0003-2758-1063), Trillsch, F., Mahner, S., Ataseven, B., Asher, R., Aryal, N., Dubot, C., Clamp, A., Penson, R. T., Oza, A., Amit, A., Huzarski, T., Casado, A., Scambia, Giovanni, Friedlander, M., Colombo, N., Fujiwara, K., Sonke, G. S., Denys, H., Lowe, E. S., Lee, C. K., Pujade-Lauraine, E., and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Background: Olaparib has significantly improved outcome and patient-centered endpoints in BRCA1/2-mutated patients with recurrent platinum-sensitive ovarian cancer (PSOC). Specific information on efficacy and safety of olaparib for older patients appears of special interest. Methods: 295 patients from the SOLO2 trial randomly assigned to olaparib or placebo were categorized according to age-cutoff at 65 years. Efficacy, tolerability, and quality of life (QoL) of olaparib relative to placebo within in each age group was analyzed. Results: Baseline characteristics were similar in patients ≥65 years (N = 62;21.0%) compared to patients <65 years (N = 233;78.9%). No significant difference in the magnitude of progression-free survival (PFS) benefit from olaparib for older patients (N = 40, hazard ratio [HR]≥65 0.43, 95%-confidence interval [CI] 0.24–0.81) as compared with younger patients (N = 155, HR<65 0.31 (95%-CI 0.22–0.43) was seen (interaction P = 0.33). The overall survival (OS)benefit seen in younger patients in the olaparib arm was not observed in older patients. Older and younger patients had comparable safety profiles and QoL scores although higher discontinuation rates for toxicity, and higher frequency of AML/MDS were noted in the older subset. TWiST analysis revealed clinically meaningful duration of good QoL on olaparib for both age groups (≥65: 13.5 vs <65: 18.4 months, P = 0.05). Conclusions: Results of this large phase III cohort of BRCA1/2-mutated PSOC patients treated with olaparib underline impressive efficacy of olaparib maintenance irrespective of age. Although toxicity and tolerability did not raise significant concerns, some caution, close monitoring, and follow-up needs to be exercised for older patients given higher discontinuation rates, frequency of AML/MDS, and no clear effects on OS.

Published
2022

43. 382 Molecular classification of endometrial carcinoma substantially changing risk-assessment: Results from a european multicentre initiative

Author

Kommoss, S, primary, Grube, M, additional, Knoll, K, additional, Lum, A, additional, Brambs, C, additional, Pauly, N, additional, Kommoss, F, additional, Heublein, S, additional, Battista, M, additional, Mittelstadt, S, additional, Rohner, A, additional, Preaetorius, T, additional, Hasenburg, A, additional, Ataseven, B, additional, Talhouk, A, additional, Diebold, J, additional, Zeimet, AG, additional, Staebler, A, additional, and Mcalpine, J, additional

Published
2021
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45. 930 Comparison of clinicopathological characteristics and survival outcomes of patients with grade III endometrioid adenocarcinoma and carcinosarcoma

Author

Güngördük, K, primary, Plett, H, additional, Gülseren, V, additional, Meydanli, MM, additional, Boyraz, G, additional, Ozdemir, IA, additional, Şahin, H, additional, Şenol, T, additional, Yildirim, N, additional, Turan, T, additional, Oge, T, additional, Gokcu, M, additional, Taşkın, S, additional, Ayhan, A, additional, and Ataseven, B, additional

Published
2021
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46. 1196 A randomised phase II study of combination chemotherapy with nintedanib/placebo in advanced/recurrent endometrial cancer. FANDANGO/ENGOT-EN1/FANDANGO

Author

Mirza, M, primary, Berton, D, additional, Vergote, I, additional, Depont Christensen, R, additional, Floquet, A, additional, Maenpaa, J, additional, Braicu, I, additional, Altintas, S, additional, Follana, P, additional, Ør Knudsen, A, additional, Ataseven, B, additional, Selle, F, additional, Lundgren, C, additional, Huober, J, additional, Fabbro, M, additional, Denys, H, additional, Heudel, P, additional, Magnusson, M, additional, Lindemann, K, additional, and Sehouli, J, additional

Published
2021
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49. Impact of BRCA1/2 Germline Status on intraperitoneal Tumor Distribution, Operability, and Incidence of postoperative Complications in Patients with epithelial Ovarian Cancer

Author

Ataseven, B., Tripon, D., Schwameis, R., Harter, P., Rhiem, K., Schneider, S., Heikaus, S., Baert, T., Alesina, P., Heitz, F., Traut, A., Groeben, H. T., Schmutzler, R., du Bois, A., Ataseven, B., Tripon, D., Schwameis, R., Harter, P., Rhiem, K., Schneider, S., Heikaus, S., Baert, T., Alesina, P., Heitz, F., Traut, A., Groeben, H. T., Schmutzler, R., and du Bois, A.

Published
2021

50. European Society of Gynaecological Oncology quality indicators for the surgical treatment of endometrial carcinoma

Author

Concin, N., Planchamp, F., Abu-Rustum, N. R., Ataseven, B., Cibula, D., Fagotti, Anna, Fotopoulou, C., Knapp, P., Marth, C., Morice, P., Querleu, D., Sehouli, J., Stepanyan, A., Taskiran, C., Vergote, I., Wimberger, P., Zapardiel, I., Persson, J., Fagotti A. (ORCID:0000-0001-5579-335X), Concin, N., Planchamp, F., Abu-Rustum, N. R., Ataseven, B., Cibula, D., Fagotti, Anna, Fotopoulou, C., Knapp, P., Marth, C., Morice, P., Querleu, D., Sehouli, J., Stepanyan, A., Taskiran, C., Vergote, I., Wimberger, P., Zapardiel, I., Persson, J., and Fagotti A. (ORCID:0000-0001-5579-335X)

Abstract

BACKGROUND: Quality of surgical care as a crucial component of a comprehensive multi-disciplinary management improves outcomes in patients with endometrial carcinoma, notably helping to avoid suboptimal surgical treatment. Quality indicators (QIs) enable healthcare professionals to measure their clinical management with regard to ideal standards of care. OBJECTIVE: In order to complete its set of QIs for the surgical management of gynecological cancers, the European Society of Gynaecological Oncology (ESGO) initiated the development of QIs for the surgical treatment of endometrial carcinoma. METHODS: QIs were based on scientific evidence and/or expert consensus. The development process included a systematic literature search for the identification of potential QIs and documentation of the scientific evidence, two consensus meetings of a group of international experts, an internal validation process, and external review by a large international panel of clinicians and patient representatives. QIs were defined using a structured format comprising metrics specifications, and targets. A scoring system was then developed to ensure applicability and feasibility of a future ESGO accreditation process based on these QIs for endometrial carcinoma surgery and support any institutional or governmental quality assurance programs. RESULTS: Twenty-nine structural, process and outcome indicators were defined. QIs 1-5 are general indicators related to center case load, training, experience of the surgeon, structured multi-disciplinarity of the team and active participation in clinical research. QIs 6 and 7 are related to the adequate pre-operative investigations. QIs 8-22 are related to peri-operative standards of care. QI 23 is related to molecular markers for endometrial carcinoma diagnosis and as determinants for treatment decisions. QI 24 addresses the compliance of management of patients after primary surgical treatment with the standards of care. QIs 25-29 highlight the need

Published
2021

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