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317 results on '"Tognon, G."'

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

Author: Colombo, N., Gadducci, A., Sehouli, J., Rulli, E., Mäenpää, J., Sessa, C., Montes, A., Ottevanger, N. B., Berger, R., Vergote, I., D’Incalci, M., Churruca Galaz, C., Chekerov, R., Nyvang, G. B., Riniker, S., Herbertson, R., Fossati, R., Barretina-Ginesta, M. P., Deryal, M., Mirza, M. R., Biagioli, E., Iglesias, M., Funari, G., Romeo, M., Tasca, G., Pardo, B., Tognon, G., Rubio-Pérez, M. J., DeCensi, A., De Giorgi, U., Zola, P., Benedetti Panici, P., Aglietta, M., Arcangeli, V., Zamagni, C., Bologna, A., Westermann, A., Heinzelmann-Schwarz, V., Tsibulak, I., Wimberger, P., and Poveda, A.
Published: 2023
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2. Diagnosis and management of isolated serous tubal intraepithelial carcinoma: A qualitative focus group study

Author: Negri, S, Fisch, C, de Hullu, J, van Bommel, M, Simons, M, Bogaerts, J, Apperloo, M, Baiocchi, G, Bakker, J, Bart, J, van Beekhuizen, H, Bernardini, M, Boere, I, Bulten, J, Chen, L, Chrzan, A, Dorum, A, Ewing-Graham, P, Ferrero, A, Floter Radestad, A, Fruscio, R, Gaarenstroom, K, Garcia, C, Harter, P, Hoogstad-van Evert, J, de Iaco, P, Klooster, A, Kooreman, L, Jacobsen, M, Kruse, A, Kwon, J, Lawson, B, Lax, S, van Lonkhuijzen, L, Lu, K, Manchanda, R, Marchetti, C, Mccluggage, W, Mcnally, O, Mourits, M, Nicum, S, Norquist, B, Perrone, A, Piek, J, Polastro, L, Polee, M, Rabban, J, Reesink, N, de los Reyes Oliver Perez, M, Roes, E, Rychlik, A, Shih, I, Soong, T, Speiser, P, Stone, R, Tamussino, K, Tognon, G, Tuninetti, V, Valabrega, G, Vos, M, Welz, J, Zizioli, V, Hermens, R, Steenbeek, M, Negri S., Fisch C., de Hullu J. A., van Bommel M., Simons M., Bogaerts J., Apperloo M. J. A., Baiocchi G., Bakker J. L., Bart J., van Beekhuizen H. J., Bernardini M. Q., Boere I., Bulten J., Chen L. -M., Chrzan A., Dorum A., Ewing-Graham P. C., Ferrero A., Floter Radestad A., Fruscio R., Gaarenstroom K. N., Garcia C., Harter P., Hoogstad-van Evert J. S., de Iaco P., Klooster A., Kooreman L. F. S., Jacobsen M., Kruse A. -J., Kwon J. S., Lawson B. C., Lax S. F., van Lonkhuijzen L. R. C. W., Lu K. H., Manchanda R., Marchetti C., McCluggage W. G., McNally O. M., Mourits M. J. E., Nicum S., Norquist B. M., Perrone A. M., Piek J. M. J., Polastro L., Polee M. B., Rabban J. T., Reesink N., de los Reyes Oliver Perez M., Roes E. -M., Rychlik A., Shih I. -M., Soong T. R., Speiser P., Stone R. L., Tamussino K., Tognon G., Tuninetti V., Valabrega G., Vos M. C., Welz J., Zizioli V., Hermens R. P. M. G., Steenbeek M. P., Negri, S, Fisch, C, de Hullu, J, van Bommel, M, Simons, M, Bogaerts, J, Apperloo, M, Baiocchi, G, Bakker, J, Bart, J, van Beekhuizen, H, Bernardini, M, Boere, I, Bulten, J, Chen, L, Chrzan, A, Dorum, A, Ewing-Graham, P, Ferrero, A, Floter Radestad, A, Fruscio, R, Gaarenstroom, K, Garcia, C, Harter, P, Hoogstad-van Evert, J, de Iaco, P, Klooster, A, Kooreman, L, Jacobsen, M, Kruse, A, Kwon, J, Lawson, B, Lax, S, van Lonkhuijzen, L, Lu, K, Manchanda, R, Marchetti, C, Mccluggage, W, Mcnally, O, Mourits, M, Nicum, S, Norquist, B, Perrone, A, Piek, J, Polastro, L, Polee, M, Rabban, J, Reesink, N, de los Reyes Oliver Perez, M, Roes, E, Rychlik, A, Shih, I, Soong, T, Speiser, P, Stone, R, Tamussino, K, Tognon, G, Tuninetti, V, Valabrega, G, Vos, M, Welz, J, Zizioli, V, Hermens, R, Steenbeek, M, Negri S., Fisch C., de Hullu J. A., van Bommel M., Simons M., Bogaerts J., Apperloo M. J. A., Baiocchi G., Bakker J. L., Bart J., van Beekhuizen H. J., Bernardini M. Q., Boere I., Bulten J., Chen L. -M., Chrzan A., Dorum A., Ewing-Graham P. C., Ferrero A., Floter Radestad A., Fruscio R., Gaarenstroom K. N., Garcia C., Harter P., Hoogstad-van Evert J. S., de Iaco P., Klooster A., Kooreman L. F. S., Jacobsen M., Kruse A. -J., Kwon J. S., Lawson B. C., Lax S. F., van Lonkhuijzen L. R. C. W., Lu K. H., Manchanda R., Marchetti C., McCluggage W. G., McNally O. M., Mourits M. J. E., Nicum S., Norquist B. M., Perrone A. M., Piek J. M. J., Polastro L., Polee M. B., Rabban J. T., Reesink N., de los Reyes Oliver Perez M., Roes E. -M., Rychlik A., Shih I. -M., Soong T. R., Speiser P., Stone R. L., Tamussino K., Tognon G., Tuninetti V., Valabrega G., Vos M. C., Welz J., Zizioli V., Hermens R. P. M. G., and Steenbeek M. P.
Abstract: Objective: A Serous Tubal Intraepithelial Carcinoma (STIC) without concomitant invasive carcinoma is occasionally identified and associated with a high risk of subsequent peritoneal carcinomatosis. Management needs optimisation. This study explores professionals' opinions and clinical practices regarding the diagnosis, counselling, treatment and follow-up of isolated STIC to facilitate clinical decision making and optimise the direction of future research. A secondary aim is to assess international clinical guidelines. Design: Focus group study. Setting: Four online sessions. Population: International panel (n = 12 countries) of gynaecologists, gynaecologic oncologists, pathologists and medical oncologists (n = 49). Methods: A semi-structured interview guide was used. Two independent researchers analysed transcripts by open and axial coding. Results were organised in domains. Relevant (inter)national guidelines were screened for recommendations regarding isolated STIC. Main Outcome Measures: Professionals' opinions and clinical practices regarding isolated STIC management. Results: Regarding pathology, most professionals identified the SEE-FIM protocol as standard of care for high-risk patients, whereas variation exists in the histopathological examination of fallopian tubes in the general population. Confirmation of STIC diagnosis by a specialised pathologist was recommended. Regarding work-up and follow-up after STIC diagnosis, there was variety and discordance. Data on outcomes is limited. As for treatment, chemotherapy and PARP inhibitors were not recommended by most. Eleven guidelines provided limited recommendations. Conclusions: We identified recommendations and highlighted knowledge gaps in the diagnosis and management of isolated STIC. Moreover, recommendations in clinical guidelines are limited. There is an agreed need for international collaboration for the prospective registration of isolated STIC.
Published: 2024

3. Single-Agent Trabectedin Versus Physician's Choice Chemotherapy in Patients With Recurrent Ovarian Cancer With BRCA -Mutated and/or BRCAness Phenotype: A Randomized Phase III Trial

Author: Lorusso, D, Raspagliesi, F, Ronzulli, D, Valabrega, G, Colombo, N, Pisano, C, Cassani, C, Tognon, G, Tamberi, S, Mangili, G, Mammoliti, S, De Giorgi, U, Greco, F, Mosconi, A, Breda, E, Artioli, G, Andreetta, C, Casanova, C, Ceccherini, R, Frassoldati, A, Salutari, V, Giolitto, S, Scambia, G, Lorusso D., Raspagliesi F., Ronzulli D., Valabrega G., Colombo N., Pisano C., Cassani C., Tognon G., Tamberi S., Mangili G., Mammoliti S., De Giorgi U., Greco F., Mosconi A. M., Breda E., Artioli G., Andreetta C., Casanova C., Ceccherini R., Frassoldati A., Salutari V., Giolitto S., Scambia G., Lorusso, D, Raspagliesi, F, Ronzulli, D, Valabrega, G, Colombo, N, Pisano, C, Cassani, C, Tognon, G, Tamberi, S, Mangili, G, Mammoliti, S, De Giorgi, U, Greco, F, Mosconi, A, Breda, E, Artioli, G, Andreetta, C, Casanova, C, Ceccherini, R, Frassoldati, A, Salutari, V, Giolitto, S, Scambia, G, Lorusso D., Raspagliesi F., Ronzulli D., Valabrega G., Colombo N., Pisano C., Cassani C., Tognon G., Tamberi S., Mangili G., Mammoliti S., De Giorgi U., Greco F., Mosconi A. M., Breda E., Artioli G., Andreetta C., Casanova C., Ceccherini R., Frassoldati A., Salutari V., Giolitto S., and Scambia G.
Abstract: PURPOSELiterature evidence suggests that trabectedin monotherapy is effective in patients with recurrent ovarian cancer (OC) presenting BRCA mutation and/or BRCAness phenotype.METHODSA prospective, open-label, randomized phase III MITO-23 trial evaluated the activity and safety of trabectedin 1.3 mg/m2 given once every 3 weeks (arm A) in BRCA 1/2 mutation carriers or patients with BRCAness phenotype (ie, patients who responded to ≥two previous platinum-based treatments) with recurrent OC, primary peritoneal carcinoma, or fallopian tube cancer in comparison with physician's choice chemotherapy in the control arm (arm B; pegylated liposomal doxorubicin, topotecan, gemcitabine, once-weekly paclitaxel, or carboplatin). The primary end point was overall survival (OS) evaluated in the intention-to-treat population.RESULTSOverall, 244 patients from 21 MITO centers were randomly assigned (arm A = 122/arm B = 122). More than 70% of patients received ≥three previous chemotherapy lines and 35.7% had received a poly (ADP-ribose) polymerase inhibitor (PARPi) before enrollment. Median OS was not significantly different between the arms: arm A: 15.8 versus arm B: 17.9 months (P =.304). Median progression-free survival was 4.9 months in arm A versus 4.4 months in arm B (P =.897). Among 208 patients evaluable for efficacy, the objective response rate was 17.1% in arm A and 21.4% in arm B, with comparable median duration of response (5.62 v 5.66 months, respectively). No superior effect was observed for trabectedin in the prespecified subgroup analyses according to BRCA mutational status, chemotherapy type, and pretreatment with a PARPi and/or platinum-free interval. Trabectedin showed a higher frequency of grade ≥3 adverse events (AEs), serious AEs, and serious adverse drug reactions compared with control chemotherapy.CONCLUSIONTrabectedin did not improve median OS and showed a worse safety profile in comparison with physician's choice control chemotherapy.
Published: 2024

4. 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. 37P Estrogen-mimetic effects of mitotane in patients with adrenocortical carcinoma: Focus on this neglected toxicity

Author: Turla, A., primary, Laganà, M., additional, Cremaschi, V., additional, Trevisan, B., additional, Abate, A., additional, Tamburello, M., additional, Sigala, S., additional, Bettini, D.L., additional, Grisanti, S., additional, Gambino, A., additional, Tognon, G., additional, Cosentini, D., additional, and Berruti, A., additional
Published: 2024
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6. Development of lumped-parameters models for the thermal evaluation and air quality in aircrafts

Author: Tognon, G, primary, Biasibetti, P, additional, and Zarrella, A, additional
Published: 2024
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7. ESMO–ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease

Author: Baert, T., Banerjee, S., Belaroussi, I., Blecharz, P., Bruchim, I., Cibula, D., Colombo, N., Concin, N., Davidson, B., Dashora, A., Devouassoux-Shisheboran, M., du Bois, A., Ferrero, A., Glasspool, R., González-Martin, A., Heinzelmann-Schwarz, V., Joly, F., Kim, J.W., Kridelka, F., Ledermann, J., Lorusso, D., Mahner, S., McCluggage, W.G., McNeish, I., Mikami, M., Mirza, M.R., Morice, P., Nicum, S., Olbrecht, S., O’Donnell, D.M., Pautier, P., Planchamp, F., Pignata, S., Querleu, D., Ray-Coquard, I., Rodolakis, A., Sehouli, J., Selcukbiricik, F., Sessa, C., Singh, N., Tan, D.S.P., Timmerman, D., Tognon, G., van der Velden, J., Vergote, I., Witteveen, P.O., and Zeimet, A.G.
Published: 2019
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8. Planning engagement with web resources to improve health habits among home-working employees

Author: Tognon, G, primary, Holfored, D, additional, Gladwell, V, additional, Murray, K, additional, Nicoll, M, additional, Knox, A, additional, McCloy, R, additional, and Loaiza, V, additional
Published: 2023
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9. Comparison of the Choices criteria with national logo criteria in Sweden and Singapore

Author: Tognon, G, primary, Lee, C, additional, Chan, W K, additional, Ingman, A, additional, Wasserman, M, additional, Hunsberger, M, additional, Lissner, L, additional, Middelham, J, additional, Roodenburg, AJC, additional, and Smorenburg, H, additional
Published: 2023
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10. SIMBIO-SYS: Scientific Cameras and Spectrometer for the BepiColombo Mission

Author: Cremonese, G., Capaccioni, F., Capria, M. T., Doressoundiram, A., Palumbo, P., Vincendon, M., Massironi, M., Debei, S., Zusi, M., Altieri, F., Amoroso, M., Aroldi, G., Baroni, M., Barucci, A., Bellucci, G., Benkhoff, J., Besse, S., Bettanini, C., Blecka, M., Borrelli, D., Brucato, J. R., Carli, C., Carlier, V., Cerroni, P., Cicchetti, A., Colangeli, L., Dami, M., Da Deppo, V., Della Corte, V., De Sanctis, M. C., Erard, S., Esposito, F., Fantinel, D., Ferranti, L., Ferri, F., Ficai Veltroni, I., Filacchione, G., Flamini, E., Forlani, G., Fornasier, S., Forni, O., Fulchignoni, M., Galluzzi, V., Gwinner, K., Ip, W., Jorda, L., Langevin, Y., Lara, L., Leblanc, F., Leyrat, C., Li, Y., Marchi, S., Marinangeli, L., Marzari, F., Mazzotta Epifani, E., Mendillo, M., Mennella, V., Mugnuolo, R., Muinonen, K., Naletto, G., Noschese, R., Palomba, E., Paolinetti, R., Perna, D., Piccioni, G., Politi, R., Poulet, F., Ragazzoni, R., Re, C., Rossi, M., Rotundi, A., Salemi, G., Sgavetti, M., Simioni, E., Thomas, N., Tommasi, L., Turella, A., Van Hoolst, T., Wilson, L., Zambon, F., Aboudan, A., Barraud, O., Bott, N., Borin, P., Colombatti, G., El Yazidi, M., Ferrari, S., Flahaut, J., Giacomini, L., Guzzetta, L., Lucchetti, A., Martellato, E., Pajola, M., Slemer, A., Tognon, G., and Turrini, D.
Published: 2020
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11. INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

Author: INOVATYON study group, Colombo, N., Gadducci, A., Sehouli, J., Rulli, E., Mäenpää, J., Sessa, C., Montes, A., Ottevanger, N. B., Berger, R., Vergote, I., D'Incalci, M., Churruca Galaz, C., Chekerov, R., Nyvang, G. B., Riniker, S., Herbertson, R., Fossati, R., Barretina-Ginesta, M. P., Deryal, M., Mirza, M. R., Biagioli, E., Iglesias, M., Funari, G., Romeo, M., Tasca, G., Pardo, B., Tognon, G., Rubio-Pérez, M. J., DeCensi, A., De Giorgi, U., Zola, P., Benedetti Panici, P., Aglietta, M., Arcangeli, V., Zamagni, C., Bologna, A., Westermann, A., Heinzelmann-Schwarz, V., Tsibulak, I., Wimberger, P., Poveda, A., Tampere University, Clinical Medicine, Department of Gynaecology and Obstetrics, Colombo, N, Gadducci, A, Sehouli, J, Rulli, E, Mäenpää, J, Sessa, C, Montes, A, Ottevanger, N, Berger, R, Vergote, I, D'Incalci, M, Churruca Galaz, C, Chekerov, R, Nyvang, G, Riniker, S, Herbertson, R, Fossati, R, Barretina-Ginesta, M, Deryal, M, Mirza, M, Biagioli, E, Iglesias, M, Funari, G, Romeo, M, Tasca, G, Pardo, B, Tognon, G, Rubio-Pérez, M, Decensi, A, De Giorgi, U, Zola, P, Benedetti Panici, P, Aglietta, M, Arcangeli, V, Zamagni, C, Bologna, A, Westermann, A, Heinzelmann-Schwarz, V, Tsibulak, I, Wimberger, P, and Poveda, A
Subjects: Cancer Research, All institutes and research themes of the Radboud University Medical Center, Oncology, 3123 Gynaecology and paediatrics, 3122 Cancers, platinum-free interval, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
Abstract: Background This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC). Methods Patients with OC (up to two previous platinum-based lines), with a TFIp of 6–12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75). Results The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94–1.35; p = 0.197). Grade 3–5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP). Conclusions This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6–12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities. Clinical trial registration ClinicalTrials.gov, number NCT01379989.
Published: 2023

12. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer

Author: Colombo, N, Tomao, F, Benedetti Panici, P, Nicoletto, M, Tognon, G, Bologna, A, Lissoni, A, Decensi, A, Lapresa, M, Mancari, R, Palaia, I, Tasca, G, Tettamanzi, F, Alvisi, M, Rulli, E, Poli, D, Carlucci, L, Torri, V, Fossati, R, Biagioli, E, Colombo N., Tomao F., Benedetti Panici P., Nicoletto M. O., Tognon G., Bologna A., Lissoni A. A., DeCensi A., Lapresa M., Mancari R., Palaia I., Tasca G., Tettamanzi F., Alvisi M. F., Rulli E., Poli D., Carlucci L., Torri V., Fossati R., Biagioli E., Colombo, N, Tomao, F, Benedetti Panici, P, Nicoletto, M, Tognon, G, Bologna, A, Lissoni, A, Decensi, A, Lapresa, M, Mancari, R, Palaia, I, Tasca, G, Tettamanzi, F, Alvisi, M, Rulli, E, Poli, D, Carlucci, L, Torri, V, Fossati, R, Biagioli, E, Colombo N., Tomao F., Benedetti Panici P., Nicoletto M. O., Tognon G., Bologna A., Lissoni A. A., DeCensi A., Lapresa M., Mancari R., Palaia I., Tasca G., Tettamanzi F., Alvisi M. F., Rulli E., Poli D., Carlucci L., Torri V., Fossati R., and Biagioli E.
Abstract: Background: Previous findings showed that cediranib-olaparib increased PFS in women with recurrent platinum-sensitive ovarian cancer compared to olaparib alone. Methods: BAROCCO trial randomized 123 patients: 80 mg/m2 paclitaxel weekly up to 24 weeks (control), olaparib 300 mg tablets twice daily together with 20 mg cediranib daily (continuous schedule) or with 20 mg cediranib 5 days/week (intermittent schedule) until progression. The primary objective was the PFS comparison between each experimental arm and the control (alpha one-sided 5%; power 80%; HR 0.5). Results: The median platinum-free interval was 1.9 months, 60% of patients had been pretreated with 3 or more chemotherapy lines. Median PFS for paclitaxel, the continuous, and the intermittent schedules were 3.1, 5.6, and 3.8 months. The HR for PFS in the continuous arm vs control was 0.76 (90% CI: 0.50–1.14, p = 0.265). The HR for PFS in the intermittent arm vs control was 1.03 (90% CI: 0.68–1.55, p = 0.904). Treatment was discontinued due to adverse events in 15%, 20%, and 5% of patients in the control, continuous and intermittent arms. Grade ≥ 3 anemia and diarrhea and hypertension of any grade occurred only in the experimental arms, and peripheral neuropathies and alopecia only in the control arm. Five serious adverse drug reactions occurred and two were fatal: one in the control and one in the continuous arm. Conclusions: The combination of cediranib-olaparib was not superior to chemotherapy in terms of PFS in heavily pretreated platinum-resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population. Clinical trial identification: IRFMN-OVA-7289, EudraCT: 2016–003964-38, NCT03314740.
Published: 2022

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

Author: Colombo, N, Gadducci, A, Sehouli, J, Rulli, E, Mäenpää, J, Sessa, C, Montes, A, Ottevanger, N, Berger, R, Vergote, I, D'Incalci, M, Churruca Galaz, C, Chekerov, R, Nyvang, G, Riniker, S, Herbertson, R, Fossati, R, Barretina-Ginesta, M, Deryal, M, Mirza, M, Biagioli, E, Iglesias, M, Funari, G, Romeo, M, Tasca, G, Pardo, B, Tognon, G, Rubio-Pérez, M, Decensi, A, De Giorgi, U, Zola, P, Benedetti Panici, P, Aglietta, M, Arcangeli, V, Zamagni, C, Bologna, A, Westermann, A, Heinzelmann-Schwarz, V, Tsibulak, I, Wimberger, P, Poveda, A, Ottevanger, N B, Nyvang, G B, Barretina-Ginesta, M P, Mirza, M R, Rubio-Pérez, M J, DeCensi, A, Colombo, N, Gadducci, A, Sehouli, J, Rulli, E, Mäenpää, J, Sessa, C, Montes, A, Ottevanger, N, Berger, R, Vergote, I, D'Incalci, M, Churruca Galaz, C, Chekerov, R, Nyvang, G, Riniker, S, Herbertson, R, Fossati, R, Barretina-Ginesta, M, Deryal, M, Mirza, M, Biagioli, E, Iglesias, M, Funari, G, Romeo, M, Tasca, G, Pardo, B, Tognon, G, Rubio-Pérez, M, Decensi, A, De Giorgi, U, Zola, P, Benedetti Panici, P, Aglietta, M, Arcangeli, V, Zamagni, C, Bologna, A, Westermann, A, Heinzelmann-Schwarz, V, Tsibulak, I, Wimberger, P, Poveda, A, Ottevanger, N B, Nyvang, G B, Barretina-Ginesta, M P, Mirza, M R, Rubio-Pérez, M J, and DeCensi, A
Abstract: BACKGROUND: This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC). METHODS: Patients with OC (up to two previous platinum-based lines), with a TFIp of 6-12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75). RESULTS: The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94-1.35; p = 0.197). Grade 3-5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP). CONCLUSIONS: This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6-12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT01379989.
Published: 2023

14. A prognostic regulatory pathway in stage I epithelial ovarian cancer: new hints for the poor prognosis assessment

Author: Calura, E., Paracchini, L., Fruscio, R., DiFeo, A., Ravaggi, A., Peronne, J., Martini, P., Sales, G., Beltrame, L., Bignotti, E., Tognon, G., Milani, R., Clivio, L., Dell'Anna, T., Cattoretti, G., Katsaros, D., Sartori, E., Mangioni, C., Ardighieri, L., D'Incalci, M., Marchini, S., and Romualdi, C.
Published: 2016
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15. INTEGRATED PATHWAY ANALYSIS IDENTIFIES A 3-GENE SIGNATURE PREDICTING PLATINUM RESPONSE AND OUTCOME OF HIGH GRADE SEROUS OVARIAN CARCINOMA PATIENTS: EP1116

Author: Bignotti, E, Benvenuto, G, Paracchini, L, Zanotti, L, Romani, C, Tognon, G, Calura, E, Vicini, D, Adorni, M, Paderno, M C, Bianchi, T, Odicino, F, Sartori, E, Ravaggi, A, DʼIncalci, M, Marchini, S, Todeschini, P, and Romualdi, C
Published: 2019
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16. Development of lumped-parameters models for the thermal evaluation and air quality in aircrafts.

Author: Tognon, G, Biasibetti, P, and Zarrella, A
Published: 2023
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17. Geo-spectral map of the lunar far side Tsiolkovskiy crater

Author: Tognon, G., Zambon, F., Carli, C., Massironi, M., Fonte, S., Giacomini, L., Pozzobon, R., Rinaldi, G., Salari, G., and Tosi, F.
Published: 2023

18. Mechanical, natural and hybrid ventilation systems in different building types: Energy and indoor air quality analysis

Author: Tognon, G., Marigo, M., De Carli, M., and Zarrella, A.
Subjects: Building simulations, Infection risk, Natural ventilation, Air conditioning systems, Building simulations, Hybrid ventilation, Infection risk, Natural ventilation, Air conditioning systems, Hybrid ventilation
Published: 2023

19. Geological mapping and preliminary spectral analysis of Mare Ingenii basin

Author: Tognon, G., Salari, G., Zambon, F., Giacomini, L., Combe, J-Ph., Massironi, M., Tosi, F., Pozzobon, R., Rinaldi, G., and Fonte, S
Published: 2023

20. Body composition by dual-energy X-ray spectrometry and bioelectrical impedance spectroscopy in a healthy population at age 75 and 80

Author: Mehlig, K., Freyer, E., Tognon, G., Malmros, V., Lissner, L., and Bosaeus, I.
Published: 2014
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21. Thromboembolic events and antithrombotic prophylaxis in advanced ovarian cancer patients treated with bevacizumab: secondary analysis of the phase IV MITO-16A/MaNGO-OV2A trial

Author: Di Liello, R, Arenare, L, Raspagliesi, F, Scambia, G, Pisano, C, Colombo, N, Frezzini, S, Tognon, G, Artioli, G, Gadducci, A, Lauria, R, Ferrero, A, Cinieri, S, De Censi, A, Breda, E, Scollo, P, De Giorgi, U, Lissoni, A, Katsaros, D, Lorusso, D, Salutari, V, Cecere, S, Lapresa, M, Nardin, M, Bogani, G, Distefano, M, Greggi, S, Gargiulo, P, Schettino, C, Gallo, C, Daniele, G, Califano, D, Perrone, F, Pignata, S, Piccirillo, M, Di Liello R., Arenare L., Raspagliesi F., Scambia G., Pisano C., Colombo N., Frezzini S., Tognon G., Artioli G., Gadducci A., Lauria R., Ferrero A., Cinieri S., De Censi A., Breda E., Scollo P., De Giorgi U., Lissoni A. A., Katsaros D., Lorusso D., Salutari V., Cecere S. C., Lapresa M., Nardin M., Bogani G., Distefano M., Greggi S., Gargiulo P., Schettino C., Gallo C., Daniele G., Califano D., Perrone F., Pignata S., Piccirillo M. C., Di Liello, R, Arenare, L, Raspagliesi, F, Scambia, G, Pisano, C, Colombo, N, Frezzini, S, Tognon, G, Artioli, G, Gadducci, A, Lauria, R, Ferrero, A, Cinieri, S, De Censi, A, Breda, E, Scollo, P, De Giorgi, U, Lissoni, A, Katsaros, D, Lorusso, D, Salutari, V, Cecere, S, Lapresa, M, Nardin, M, Bogani, G, Distefano, M, Greggi, S, Gargiulo, P, Schettino, C, Gallo, C, Daniele, G, Califano, D, Perrone, F, Pignata, S, Piccirillo, M, Di Liello R., Arenare L., Raspagliesi F., Scambia G., Pisano C., Colombo N., Frezzini S., Tognon G., Artioli G., Gadducci A., Lauria R., Ferrero A., Cinieri S., De Censi A., Breda E., Scollo P., De Giorgi U., Lissoni A. A., Katsaros D., Lorusso D., Salutari V., Cecere S. C., Lapresa M., Nardin M., Bogani G., Distefano M., Greggi S., Gargiulo P., Schettino C., Gallo C., Daniele G., Califano D., Perrone F., Pignata S., and Piccirillo M. C.
Abstract: INTRODUCTION: The use of routine antithrombotic prophylaxis is not recommended for advanced cancer patients receiving chemotherapy. The effect of bevacizumab-containing therapy on the risk of thromboembolic events remains controversial in ovarian cancer patients. We report on the incidence of thromboembolic events and the prevalence of antithrombotic therapy in patients enrolled in the single arm, phase IV, MITO-16A/MaNGO-OV2A trial. METHODS: In this trial, potential prognostic factors for patients with previously untreated ovarian cancer receiving a combination of platinum-based chemotherapy and bevacizumab were explored and the final analysis has already been reported. In this secondary analysis, the occurrence of thromboembolic events and the use of antithrombotic therapy were described according to the clinical characteristics of the patients. The prognostic role of thromboembolic events for progression-free and overall survival were also evaluated. RESULTS: From October 2012 to November 2014, 398 eligible patients were enrolled. 76 patients (19.1%) were receiving some type of anticoagulant or anti-aggregant treatment at baseline. Overall, 24 thromboembolic events were reported (cumulative incidence of 6.0%). The occurrence of thromboembolic events was not associated with baseline patient characteristics and was not modified by the use of antithrombotic prophylaxis (HR 0.60, 95% CI 0.18 to 2.0). Occurrence of thromboembolic events was not associated with progression-free survival (HR 1.34, 95% CI 0.83 to 2.15) or overall survival (HR 0.78, 95% CI 0.37 to 1.61). CONCLUSIONS: In our study, a 6.0% rate of thromboembolic events was reported during treatment with bevacizumab plus chemotherapy. Thromboembolic events were not associated with the clinical characteristics of the patients or with the use of antithrombotic prophylaxis, nor did they significantly affect the long-term prognosis. TRIAL REGISTRATION NUMBER: NCT01706120.
Published: 2021

22. Evaluation of angiogenesis-related genes as prognostic biomarkers of bevacizumab treated ovarian cancer patients: Results from the phase iv mito16a/mango ov-2 translational study

Author: Califano, D, Gallo, D, Vinciguerra, G, De Cecio, R, Arenare, L, Signoriello, S, Russo, D, Ferrandina, G, Citron, F, Losito, N, Gargiulo, P, Simeon, V, Scambia, G, Cecere, S, Montella, M, Colombo, N, Tognon, G, Bignotti, E, Zannoni, G, Canzonieri, V, Ciucci, A, Spina, A, Scognamiglio, G, Del Sesto, M, Schettino, C, Piccirillo, M, Perrone, F, Chiodini, P, Pignata, S, Baldassarre, G, Califano D., Gallo D., Vinciguerra G. L. R., De Cecio R., Arenare L., Signoriello S., Russo D., Ferrandina G., Citron F., Losito N. S., Gargiulo P., Simeon V., Scambia G., Cecere S. C., Montella M., Colombo N., Tognon G., Bignotti E., Zannoni G. F., Canzonieri V., Ciucci A., Spina A., Scognamiglio G., Del Sesto M., Schettino C., Piccirillo M. C., Perrone F., Chiodini P., Pignata S., Baldassarre G., Califano, D, Gallo, D, Vinciguerra, G, De Cecio, R, Arenare, L, Signoriello, S, Russo, D, Ferrandina, G, Citron, F, Losito, N, Gargiulo, P, Simeon, V, Scambia, G, Cecere, S, Montella, M, Colombo, N, Tognon, G, Bignotti, E, Zannoni, G, Canzonieri, V, Ciucci, A, Spina, A, Scognamiglio, G, Del Sesto, M, Schettino, C, Piccirillo, M, Perrone, F, Chiodini, P, Pignata, S, Baldassarre, G, Califano D., Gallo D., Vinciguerra G. L. R., De Cecio R., Arenare L., Signoriello S., Russo D., Ferrandina G., Citron F., Losito N. S., Gargiulo P., Simeon V., Scambia G., Cecere S. C., Montella M., Colombo N., Tognon G., Bignotti E., Zannoni G. F., Canzonieri V., Ciucci A., Spina A., Scognamiglio G., Del Sesto M., Schettino C., Piccirillo M. C., Perrone F., Chiodini P., Pignata S., and Baldassarre G.
Abstract: Background. Epithelial ovarian cancer (EOC) is a rare, highly lethal disease. In a subset of high grade EOC patients, maintenance therapy with the antiangiogenic drug Bevacizumab (BEV) is a valuable option. To date, no validated predictive or prognostic biomarkers exist for selecting EOC patients that might benefit from BEV treatment. Methods. Immunohistochemistry and RT-qPCR evaluated the expression of seven angiogenesis-related proteins and of a twelve microRNAs angio-signature in EOC patients, treated in first line with chemotherapy plus BEV (MITO16A/ManGO OV-2 phase IV trial). Centralized statistical analyses assessed the associations between each biomarker, clinical prognostic factors and survival outcomes. Results. High miR-484 expression was associated with longer progression-free and overall survival. Notably, the combined expression of miR-484 and its target VEGFB identified a subset of patients that might mostly benefit from BEV treatment. No other significant correlations were found between the other analyzed biomarkers and patients’ survival. The application of a shrinkage procedure to adjust for over-fitting hazard ratio estimates reduced the association significance. Conclusions. The analysis of angiogenesis related biomarkers in EOC patients homogenously treated with BEV in first line provides novel insight in their prognostic value and suggests that some of them might merit to be tested as predictive markers of drug activity in dedicated randomized trials.
Published: 2021

23. Sharing real-world experiences to optimize the management of olaparib toxicities: a practical guidance from an Italian expert panel

Author: Lorusso, D, Bologna, A, Cecere, S, De Matteis, E, Scandurra, G, Zamagni, C, Arcangeli, V, Artioli, F, Bella, M, Blanco, G, Cardalesi, C, Casartelli, C, De Vivo, R, Di Napoli, M, Gisone, E, Lauria, R, Lissoni, A, Loizzi, V, Maccaroni, E, Mangili, G, Marchetti, C, Martella, F, Naglieri, E, Parolin, V, Ricciardi, G, Ronzino, G, Salutari, V, Scarfone, G, Secondino, S, Spagnoletti, I, Tasca, G, Tognon, G, Guarneri, V, Lorusso D., Bologna A., Cecere S. C., De Matteis E., Scandurra G., Zamagni C., Arcangeli V., Artioli F., Bella M., Blanco G., Cardalesi C., Casartelli C., De Vivo R., Di Napoli M., Gisone E. B., Lauria R., Lissoni A. A., Loizzi V., Maccaroni E., Mangili G., Marchetti C., Martella F., Naglieri E., Parolin V., Ricciardi G., Ronzino G., Salutari V., Scarfone G., Secondino S., Spagnoletti I., Tasca G., Tognon G., Guarneri V., Lorusso, D, Bologna, A, Cecere, S, De Matteis, E, Scandurra, G, Zamagni, C, Arcangeli, V, Artioli, F, Bella, M, Blanco, G, Cardalesi, C, Casartelli, C, De Vivo, R, Di Napoli, M, Gisone, E, Lauria, R, Lissoni, A, Loizzi, V, Maccaroni, E, Mangili, G, Marchetti, C, Martella, F, Naglieri, E, Parolin, V, Ricciardi, G, Ronzino, G, Salutari, V, Scarfone, G, Secondino, S, Spagnoletti, I, Tasca, G, Tognon, G, Guarneri, V, Lorusso D., Bologna A., Cecere S. C., De Matteis E., Scandurra G., Zamagni C., Arcangeli V., Artioli F., Bella M., Blanco G., Cardalesi C., Casartelli C., De Vivo R., Di Napoli M., Gisone E. B., Lauria R., Lissoni A. A., Loizzi V., Maccaroni E., Mangili G., Marchetti C., Martella F., Naglieri E., Parolin V., Ricciardi G., Ronzino G., Salutari V., Scarfone G., Secondino S., Spagnoletti I., Tasca G., Tognon G., and Guarneri V.
Abstract: Olaparib is the first poly(ADP-ribose) polymerase inhibitor approved as maintenance therapy of recurrent ovarian cancer (OC) patients with a BRCA mutation. To achieve the maximum clinical benefit, adherence to olaparib must be persistent. However, in clinical practice, this is challenged by the frequent suboptimal management of toxicities. In view of the expanding use of olaparib also in Italy, physicians must learn how to adequately and promptly manage drug toxicities not to unnecessarily interrupt or reduce the dose. The experts agreed that nausea,vomiting, anemia, and fatigue are the most frequent events experienced by OC patients on olaparib, and that these toxicities usually develop early during treatment, are mainly of grade 1–2 and transient and can be managed with simple non-pharmacological interventions. By sharing their real-world experiences, the panel prepared, for each toxicity, an algorithm organized by grade and besides the procedures indicated in the local label, included supportive care interventions based also on nutritional and lifestyle modifications and psycho-oncology consultation. Moreover, in view of the tablet entry into the Italian market, the full and reduced dosages of capsules and tablets were compared. This practical guidance is intended to be a tool to support especially less-experienced physicians in the management of these complex patients, with the aim to help preventing the worsening of patients’ conditions and the unnecessary interruption/reduction of olaparib dosage, which may jeopardize treatment efficacy.
Published: 2020

24. 751P Safety and tolerability of durvalumab (D) + carboplatin/paclitaxel (CP) + bevacizumab (B) followed by D, B + olaparib (O) maintenance (mtx) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumour BRCA1/BRCA2 mutation (non-tBRCAm) in the phase III DUO-O trial

Author: Aghajanian, C., Schmalfeldt, B., Okamoto, A., Reuss, A., Kim, J-W., Marquina Ospina, G., Ayhan, A., Salutari, V., Lebreton, C., Labudovic, D., Tognon, G., Chudecka-Glaz, A.M., Berger, R., Lheureux, S., Henry, S., Burges, A., Wenham, R.M., Nishio, S., Marshall, L., and Harter, P.
Published: 2024
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25. L1CAM expression as a predictor of platinum response in high-risk endometrial carcinoma

Author: Romani, C., Capoferri, D., Reijnen, C., Lonardi, S., Ravaggi, A., Ratti, M., Bugatti, M., Zanotti, L., Tognon, G., Sartori, E., Odicino, F., Calza, S., Pijnenborg, J.M.A., Bignotti, E., Romani, C., Capoferri, D., Reijnen, C., Lonardi, S., Ravaggi, A., Ratti, M., Bugatti, M., Zanotti, L., Tognon, G., Sartori, E., Odicino, F., Calza, S., Pijnenborg, J.M.A., and Bignotti, E.
Abstract: Item does not contain fulltext, For high-risk endometrial cancer (EC) patients, adjuvant chemotherapy is recommended to improve outcome. Yet, predictive biomarkers for response to platinum-based chemotherapy (Pt-aCT) are currently lacking. We tested expression of L1 cell-adhesion molecule (L1CAM), a well-recognised marker of poor prognosis in EC, in tumour samples from high-risk EC patients, to explore its role as a predictive marker of Pt-aCT response. L1CAM expression was determined using RT-qPCR and immunohistochemistry in a cohort of high-risk EC patients treated with Pt-aCT and validated in a multicentric independent cohort. The association between L1CAM and clinicopathologic features and L1CAM additive value in predicting platinum response were determined. The effect of L1CAM gene silencing on response to carboplatin was functionally tested on primary L1CAM-expressing cells. Increased L1CAM expression at both genetic and protein level correlated with high-grade, non-endometrioid histology and poor response to platinum treatment. A predictive model adding L1CAM to prognostic clinical variables significantly improved platinum response prediction (C-index 78.1%, P = .012). In multivariate survival analysis, L1CAM expression was significantly associated with poor outcome (HR: 2.03, P = .019), potentially through an indirect effect, mediated by its influence on response to chemotherapy. In vitro, inhibition of L1CAM significantly increased cell sensitivity to carboplatin, supporting a mechanistic link between L1CAM expression and response to platinum in EC cells. In conclusion, we have demonstrated the role of L1CAM in the prediction of response to Pt-aCT in two independent cohorts of high-risk EC patients. L1CAM is a promising candidate biomarker to optimise decision making in high-risk patients who are eligible for Pt-aCT.
Published: 2022

26. Integrated Biomarker Analysis Reveals L1CAM as a Potential Stratification Marker for No Specific Molecular Profile High-Risk Endometrial Carcinoma

Author: Ravaggi, A., Capoferri, D., Ardighieri, L., Ghini, I., Ferrari, F., Romani, C., Bugatti, M., Zanotti, L., Vrede, S.W., Tognon, G., Pijnenborg, J.M.A., Sartori, E., Calza, S., Bignotti, E., Odicino, F., Ravaggi, A., Capoferri, D., Ardighieri, L., Ghini, I., Ferrari, F., Romani, C., Bugatti, M., Zanotti, L., Vrede, S.W., Tognon, G., Pijnenborg, J.M.A., Sartori, E., Calza, S., Bignotti, E., and Odicino, F.
Abstract: Item does not contain fulltext, Histopathologic assessment of high-risk endometrial cancer (EC) suffers from intersubject variability and poor reproducibility. The pragmatic classification in four molecular subgroups helps to overcome these limits, showing a significant prognostic value. The "no specific molecular profile" (NSMP) is the most heterogeneous EC subgroup, requiring further characterization to better guide its clinical management. DNA sequencing of POLE exonuclease domain and immunohistochemistry for PMS2, MSH6, and p53 were performed in order to stratify a cohort of 94 high-risk EC patients in the four molecular subgroups. Moreover, a panel of seven additional biomarkers was tested. Patients were found to be 16% POLE-mutated, 36% mismatch repair-deficient, 27% p53-abnormal, and 21% NSMP. In the multivariable model, molecular groups confirmed their significant association with disease-specific survival and progression-free survival, with p53-abnormal and NSMP endometrial cancer characterized by poor outcomes. Among the additional evaluated biomarkers, L1CAM was the only one with a significant prognostic value within the NSMP subgroup. NSMP/L1CAM-positive patients experienced the worst outcome and were "early-relapsing" after platinum-based chemotherapy, with a significantly shorter platinum-free interval compared to L1CAM-negative patients. L1CAM appears to be a promising candidate as a prognostic and predictive biomarker in the high-risk NSMP subgroup, which is actually known to lack specific molecular markers.
Published: 2022

27. Associations between energy intake, daily food intake and energy density of foods and BMI z-score in 2–9-year-old European children

Author: Hebestreit, A., Börnhorst, C., Barba, G., Siani, A., Huybrechts, I., Tognon, G., Eiben, G., Moreno, L. A., Fernández Alvira, J. M., Loit, H. M., Kovacs, E., Tornaritis, M., and Krogh, V.
Published: 2014
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28. List of contributors

Author: Baker, J.L., primary, Baranowski, J., additional, Baranowski, T., additional, Bes-Rastrollo, M., additional, Boylan, S., additional, Bray, G.A., additional, Clifton, P., additional, Diep, C.S., additional, Economos, C.D., additional, Fogelholm, M., additional, Fong, M., additional, Fuller, N.R., additional, Gill, T.P., additional, Grace, C., additional, Hatfield, D.P., additional, Herman, C.P., additional, Hu, F., additional, Hunsberger, M., additional, Jackson-Leach, R., additional, James, W.P.T., additional, Keller, K., additional, Kelly, B., additional, King, L., additional, Lau, N.S., additional, Lissner, L., additional, Luscombe-Marsh, N.D., additional, Martinez-Gonzalez, M.A., additional, Poelman, M.P., additional, Polivy, J., additional, Pomeranz, L., additional, Popkin, B.M., additional, Proietto, J., additional, Rayner, M., additional, Roberto, C.A., additional, Rolls, B.J., additional, Soo, J., additional, Stanton, R., additional, Steenhuis, I.H.M., additional, Stubbs, R.J., additional, Sumithran, P., additional, Thow, A.M., additional, Tognon, G., additional, Vermeer, W.M., additional, and Williams, R., additional
Published: 2015
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29. Low-fat diets in obesity management and weight control

Author: Hunsberger, M., primary, Tognon, G., additional, and Lissner, L., additional
Published: 2015
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30. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer

Author: Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Lorusso D., Hilpert F., Gonzalez Martin A., Rau J., Ottevanger P., Greimel E., Luck H. -J., Selle F., Colombo N., Kroep J. R., Mirza M. R., Berger R., Pardo B., Grischke E. -M., Berton-Rigaud D., Martinez-Garcia J., Vergote I., Redondo A., Cardona A., Bastiere-Truchot L., Du Bois A., Kurzeder C., Del Campo J. M., Bover I., Barretina-Ginesta P., Ortega E., Garcia Y., Romero I., Poveda A., Herrero A., Vidal L., Rubio M. J., Romeo M., Mendiola C., Arranz J. A., Santaballa A., Gomez De Liano A., Marme F., Mahner S., Canzler U., Zorr A., Gropp-Meier M., Cayir P., Schmalfeldt B., Rautenberg B., Meier W., Belau A., Gerber B., Rein D., Jackisch C., Janni W., Heubner M., Pautier P., Fabbro M., Floquet A., You B., Favier L., Joly F., Weber B., Hardy-Bessard A. -C., Gadducci A., Tognon G., DeCensi A., Savarese A., PISANO, CARLO MARIA, Sonke G., Reyners A., Kristensen G., Bjurberg M., Rosenberg P., Marth C., Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Lorusso D., Hilpert F., Gonzalez Martin A., Rau J., Ottevanger P., Greimel E., Luck H. -J., Selle F., Colombo N., Kroep J. R., Mirza M. R., Berger R., Pardo B., Grischke E. -M., Berton-Rigaud D., Martinez-Garcia J., Vergote I., Redondo A., Cardona A., Bastiere-Truchot L., Du Bois A., Kurzeder C., Del Campo J. M., Bover I., Barretina-Ginesta P., Ortega E., Garcia Y., Romero I., Poveda A., Herrero A., Vidal L., Rubio M. J., Romeo M., Mendiola C., Arranz J. A., Santaballa A., Gomez De Liano A., Marme F., Mahner S., Canzler U., Zorr A., Gropp-Meier M., Cayir P., Schmalfeldt B., Rautenberg B., Meier W., Belau A., Gerber B., Rein D., Jackisch C., Janni W., Heubner M., Pautier P., Fabbro M., Floquet A., You B., Favier L., Joly F., Weber B., Hardy-Bessard A. -C., Gadducci A., Tognon G., DeCensi A., Savarese A., PISANO, CARLO MARIA, Sonke G., Reyners A., Kristensen G., Bjurberg M., Rosenberg P., and Marth C.
Abstract: Introduction The PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes. Patients and methods Eligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression. Results At database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms. Discussion Consistent with
Published: 2019

31. Detailed age determinations for Tsiolkovskiy crater

Author: Tognon G., Ferrari S., Pozzobon R., Massironi M.
Published: 2021
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32. From morpho-stratigraphic to geo(spectro)-stratigraphic units: the PLANMAP contribution

Author: Massironi, M., Rossi, A. P., Wright, J., Zambon, F., Poehler, C., Giacomini, L., Carli, C., Ferrari, S., Semenzato, A., Luzzi, E., Pozzobon, R., Tognon, G., Rothery, D. A., van der Bogert, C., Galluzzi, V., and Altieri, F.
Published: 2021

33. European quadrangle mapping of Mercury: status report

Author: Galluzzi, Valentina, Rothery, D. A., Giacomini, L., Guzzetta, L., El Yazidi, M., Ferranti, L., Lennox, A. R., Malliband, C., Man, B., Massironi, M., Palumbo, P., Pegg, D. L., Tognon, G., and Wright, J.
Published: 2021

34. Evaluation of angiogenesis-related genes as prognostic biomarkers of bevacizumab treated ovarian cancer patients: Results from the phase iv mito16a/mango ov-2 translational study

Author: Califano, D., Gallo, D., Vinciguerra, G. L. R., De Cecio, R., Arenare, L., Signoriello, S., Russo, D., Ferrandina, Maria Gabriella, Citron, F., Losito, N. S., Gargiulo, P., Simeon, V., Scambia, Giovanni, Cecere, S. C., Montella, M., Colombo, N., Tognon, G., Bignotti, E., Zannoni, Gian Franco, Canzonieri, V., Ciucci, A., Spina, A., Scognamiglio, G., Del Sesto, M., Schettino, C., Piccirillo, M. C., Perrone, F., Chiodini, Paola Maddalena, Pignata, S., Baldassarre, Gaetano, Ferrandina G. (ORCID:0000-0003-4672-4197), Scambia G. (ORCID:0000-0003-2758-1063), Zannoni G. F. (ORCID:0000-0003-1809-129X), Chiodini P., Baldassarre G., Califano, D., Gallo, D., Vinciguerra, G. L. R., De Cecio, R., Arenare, L., Signoriello, S., Russo, D., Ferrandina, Maria Gabriella, Citron, F., Losito, N. S., Gargiulo, P., Simeon, V., Scambia, Giovanni, Cecere, S. C., Montella, M., Colombo, N., Tognon, G., Bignotti, E., Zannoni, Gian Franco, Canzonieri, V., Ciucci, A., Spina, A., Scognamiglio, G., Del Sesto, M., Schettino, C., Piccirillo, M. C., Perrone, F., Chiodini, Paola Maddalena, Pignata, S., Baldassarre, Gaetano, Ferrandina G. (ORCID:0000-0003-4672-4197), Scambia G. (ORCID:0000-0003-2758-1063), Zannoni G. F. (ORCID:0000-0003-1809-129X), Chiodini P., and Baldassarre G.
Abstract: Background. Epithelial ovarian cancer (EOC) is a rare, highly lethal disease. In a subset of high grade EOC patients, maintenance therapy with the antiangiogenic drug Bevacizumab (BEV) is a valuable option. To date, no validated predictive or prognostic biomarkers exist for selecting EOC patients that might benefit from BEV treatment. Methods. Immunohistochemistry and RT-qPCR evaluated the expression of seven angiogenesis-related proteins and of a twelve microRNAs angio-signature in EOC patients, treated in first line with chemotherapy plus BEV (MITO16A/ManGO OV-2 phase IV trial). Centralized statistical analyses assessed the associations between each biomarker, clinical prognostic factors and survival outcomes. Results. High miR-484 expression was associated with longer progression-free and overall survival. Notably, the combined expression of miR-484 and its target VEGFB identified a subset of patients that might mostly benefit from BEV treatment. No other significant correlations were found between the other analyzed biomarkers and patients’ survival. The application of a shrinkage procedure to adjust for over-fitting hazard ratio estimates reduced the association significance. Conclusions. The analysis of angiogenesis related biomarkers in EOC patients homogenously treated with BEV in first line provides novel insight in their prognostic value and suggests that some of them might merit to be tested as predictive markers of drug activity in dedicated randomized trials.
Published: 2021

35. Adherence to a Mediterranean-like dietary pattern in children from eight European countries. The IDEFICS study

Author: Tognon, G, Moreno, L A, Mouratidou, T, Veidebaum, T, Molnár, D, Russo, P, Siani, A, Akhandaf, Y, Krogh, V, Tornaritis, M, Börnhorst, C, Hebestreit, A, Pigeot, I, and Lissner, L
Published: 2014
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36. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer

Author: Lorusso, D., Hilpert, F., Martin, A.G., Rau, J., Ottevanger, P., Greimel, E., Luck, H.J., Selle, F., Colombo, N., Kroep, J.R., Mirza, M.R., Berger, R., Pardo, B., Grischke, E.M., Berton-Rigaud, D., Martinez-Garcia, J., Vergote, I., Redondo, A., Cardona, A., Bastiere-Truchot, L., Bois, A. du, Kurzeder, C., Campo, J.M. del, Bover, I., Barretina-Ginesta, P., Ortega, E., Garcia, Y., Romero, I., Poveda, A., Herrero, A., Vidal, L., Rubio, M.J., Romeo, M., Mendiola, C., Arranz, J.A., Santaballa, A., Liano, A.G. de, Marme, F., Mahner, S., Canzler, U., Zorr, A., Gropp-Meier, M., Cayir, P., Schmalfeldt, B., Rautenberg, B., Meier, W., Belau, A., Gerber, B., Rein, D., Jackisch, C., Janni, W., Heubner, M., Pautier, P., Fabbro, M., Floquet, A., You, B., Favier, L., Joly, F., Weber, B., Hardy-Bessard, A.C., Gadducci, A., Tognon, G., DeCensi, A., Savarese, A., Pisano, C., Sonke, G., Reyners, A., Kristensen, G., Bjurberg, M., Rosenberg, P., Marth, C., PENELOPE Trial Investigators, Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Targeted Gynaecologic Oncology (TARGON), and Guided Treatment in Optimal Selected Cancer Patients (GUTS)
Subjects: Oncology, Receptor, ErbB-3, medicine.medical_treatment, Carcinoma, Ovarian Epithelial, Deoxycytidine, 0302 clinical medicine, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Aged, 80 and over, Ovarian Neoplasms, 0303 health sciences, education.field_of_study, Obstetrics and Gynecology, Middle Aged, Progression-Free Survival, ovarian cancer, patient-reported outcomes, 030220 oncology & carcinogenesis, Female, Pertuzumab, medicine.drug, Adult, medicine.medical_specialty, Paclitaxel, overall survival, Population, Placebo, patient-reported outcome, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Double-Blind Method, HER3, pertuzumab, Internal medicine, medicine, Humans, Patient Reported Outcome Measures, RNA, Messenger, education, 030304 developmental biology, Aged, Chemotherapy, business.industry, medicine.disease, Gemcitabine, Drug Resistance, Neoplasm, Topotecan, business, Ovarian cancer
Abstract: IntroductionThe PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes.Patients and methodsEligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression.ResultsAt database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms.DiscussionConsistent with the primary results, adding pertuzumab to chemotherapy for low tumor HER3 mRNA-expressing platinum-resistant ovarian cancer did not improve overall survival, but showed trends in some cohorts. Except for increased diarrhea symptoms, pertuzumab had no impact on patient-reported outcomes.ClinicalTrials.gov:ClinicalTrials.gov:NCT01684878.
Published: 2019

37. Potential application of electronic nose in processed animal proteins (PAP) detection in feedstuffs

Author: Dell'Orto V., Baldi A., Cheli F., Tognon G., Pinotti L., and Campagnoli A.
Subjects: PAP determination, electronic nose, Biotechnology, TP248.13-248.65, Environmental sciences, GE1-350
Abstract: Electronic nose and olfactometry techniques represent a modern analytical approach in food industry since they could potentially improve quality and safety of food processing. The aim of this study was to evaluate possible application of electronic nose in PA P detection and recognition in feed. For this purpose 6 reference feedstuffs (CRA-W / UE STRAT F E E D Project) were used. The basis of the test samples was a compound feed for bovine fortified with processed animal proteins ( PAP) consisting of meat and bone meal (MBM) and/or fish meal at different concentrations. Each feed sample was tested in glass vials and the odour profile was determined by the ten MOS (metal oxide semi-conductor) sensors of the electronic nose. Ten different descriptors, representing each ten sensors of electronic nose, were used to characterise the odour of each sample. In the present study, electronic nose was able to discriminate the blank sample from all other samples containing PA P ( M B M , fish meal or both). Samples containing either 0.5% of MBM or 5% of fish meal were identified, while samples containing a high fish meal content (5%) associated with a low MBM content (0.5%) were not discriminated from samples containing solely fish meal at that same high level (5%). This latter indicates that probably the high fish meal level, in samples containing both MBM and fish meal, tended to mask MBM odour. It was also evident that two odour descriptors were enough to explain 72.12% of total variability in odour pattern. In view of these results, it could be suggested that electronic nose and olfactometry techniques can provide an interesting approach for screening raw materials in feed industry, even though further studies using a wider set of samples are needed.
Published: 2004

38. Microscopic method in processed animal proteins identification in feed: applications of image analysis

Author: Savoini G, Dell'Orto V., Cheli F., Tognon G., Campagnoli A., and Pinotti L.
Subjects: Processed animal proteins (PAP), official microscopic method, image analysis, Biotechnology, TP248.13-248.65, Environmental sciences, GE1-350
Abstract: Processed animal proteins (PAP) detection and identification in feedstuffs can be difficult in distinguishing among land animals, i.e. poultry and mammals. Thus, the aim of this study was to evaluate the potential application of image analysis in PAP identification. For this purpose four reference samples containing poultry meals and four reference samples containing mammalian meat and bone meals were used. Each sample was analyzed using the microscopic method (98/88/EC). Bone fragments are characterized by similar morphological features (colours, shape, lacunae shape, lacunae distribution, etc.) that make it diff i c u l t to distinguish between poultry and mammals. Through a digital camera and an image analysis software a total of 30 bone fragment lacunae images at X400 were obtained. For each image 29 geometric parameters related to the lacunae and 3 geometric parameters related to the canaliculae of lacunae, were measured using the image analysis software obtaining 960 observations. Of the 32 descriptors used two, the area of the lacunae and their perimeter, were able to explain 96.15% of the total variability of the data, even though their contribution was different (83.97% vs. 12.18%, respectively). Through these two descriptors it was possible to distinguish between mammalian and poultry lacunae, except in two cases (6.6%), in which poultry lacunae were wrongly classified as mammalian. This latter can be related with higher variability in the lacunae area recorded for mammals compared to poultry. On the basis of the present study, it can be concluded that image analysis represents a promising potential tool in PAP identification, that may provide accurate and reliable results in feedstuffs characterisation, analysis and control.
Published: 2004

39. INOVATYON study: Randomized phase III international study comparing trabectedin/PLD followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

Author: Colombo, N., Gadducci, A., Sehouli, J., Biagioli, E., Nyvang, G-B., Riniker, S., Montes, A., Ottevanger, N., Zeimet, A. G. G., Vergote, I. B., Funari, G., Baldoni, A., Tognon, G., De Censi, A., Churruca Galaz, C., Chekerov, R., Maenpaa, J., Rulli, E., Fossati, R., and Poveda, A.
Published: 2020
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40. Geological characterization of Tsiolkovskiy crater as a possible landing site

Author: Tognon, G., Pozzobon, R., and Massironi, M.
Published: 2020

41. SIMBIO-SYS:Scientific Cameras and Spectrometer for the BepiColombo Mission

Author: Cremonese, G., Capaccioni, F., Capria, M.T., Doressoundiram, A., Palumbo, P., Vincendon, M., Massironi, M., Debei, S., Zusi, M., Altieri, F., Amoroso, M., Aroldi, G., Baroni, M., Barucci, A., Bellucci, G., Benkhoff, J., Besse, S., Bettanini, C., Blecka, M., Borrelli, D., Brucato, J.R., Carli, C., Carlier, V., Cerroni, P., Cicchetti, A., Colangeli, L., Dami, M., Da Deppo, V., Della Corte, V., De Sanctis, M.C., Erard, S., Esposito, F., Fantinel, D., Ferranti, L., Ferri, F., Ficai Veltroni, I., Filacchione, G., Flamini, E., Forlani, G., Fornasier, S., Forni, O., Fulchignoni, M., Galluzzi, V., Gwinner, K., Ip, W., Jorda, L., Langevin, Y., Lara, L., Leblanc, F., Leyrat, C., Li, Y., Marchi, S., Marinangeli, L., Marzari, F., Mazzotta Epifani, E., Mendillo, M., Mennella, V., Mugnuolo, R., Muinonen, K., Naletto, G., Noschese, R., Palomba, E., Paolinetti, R., Perna, D., Piccioni, G., Politi, R., Poulet, F., Ragazzoni, R., Re, C., Rossi, M., Rotundi, A., Salemi, G., Sgavetti, M., Simioni, E., Thomas, N., Tommasi, L., Turella, A., Van Hoolst, T., Wilson, L., Zambon, F., Aboudan, A., Barraud, O., Bott, N., Borin, P., Colombatti, G., El Yazidi, M., Ferrari, S., Flahaut, J., Giacomini, L., Guzzetta, L., Lucchetti, A., Martellato, E., Pajola, M., Slemer, A., Tognon, G., Turrini, D., Cremonese, G., Capaccioni, F., Capria, M.T., Doressoundiram, A., Palumbo, P., Vincendon, M., Massironi, M., Debei, S., Zusi, M., Altieri, F., Amoroso, M., Aroldi, G., Baroni, M., Barucci, A., Bellucci, G., Benkhoff, J., Besse, S., Bettanini, C., Blecka, M., Borrelli, D., Brucato, J.R., Carli, C., Carlier, V., Cerroni, P., Cicchetti, A., Colangeli, L., Dami, M., Da Deppo, V., Della Corte, V., De Sanctis, M.C., Erard, S., Esposito, F., Fantinel, D., Ferranti, L., Ferri, F., Ficai Veltroni, I., Filacchione, G., Flamini, E., Forlani, G., Fornasier, S., Forni, O., Fulchignoni, M., Galluzzi, V., Gwinner, K., Ip, W., Jorda, L., Langevin, Y., Lara, L., Leblanc, F., Leyrat, C., Li, Y., Marchi, S., Marinangeli, L., Marzari, F., Mazzotta Epifani, E., Mendillo, M., Mennella, V., Mugnuolo, R., Muinonen, K., Naletto, G., Noschese, R., Palomba, E., Paolinetti, R., Perna, D., Piccioni, G., Politi, R., Poulet, F., Ragazzoni, R., Re, C., Rossi, M., Rotundi, A., Salemi, G., Sgavetti, M., Simioni, E., Thomas, N., Tommasi, L., Turella, A., Van Hoolst, T., Wilson, L., Zambon, F., Aboudan, A., Barraud, O., Bott, N., Borin, P., Colombatti, G., El Yazidi, M., Ferrari, S., Flahaut, J., Giacomini, L., Guzzetta, L., Lucchetti, A., Martellato, E., Pajola, M., Slemer, A., Tognon, G., and Turrini, D.
Abstract: The SIMBIO-SYS (Spectrometer and Imaging for MPO BepiColombo Integrated Observatory SYStem) is a complex instrument suite part of the scientific payload of the Mercury Planetary Orbiter for the BepiColombo mission, the last of the cornerstone missions of the European Space Agency (ESA) Horizon + science program. The SIMBIO-SYS instrument will provide all the science imaging capability of the BepiColombo MPO spacecraft. It consists of three channels: the STereo imaging Channel (STC), with a broad spectral band in the 400-950 nm range and medium spatial resolution (at best 58 m/px), that will provide Digital Terrain Model of the entire surface of the planet with an accuracy better than 80 m; the High Resolution Imaging Channel (HRIC), with broad spectral bands in the 400-900 nm range and high spatial resolution (at best 6 m/px), that will provide high-resolution images of about 20% of the surface, and the Visible and near-Infrared Hyperspectral Imaging channel (VIHI), with high spectral resolution (6 nm at finest) in the 400-2000 nm range and spatial resolution reaching 120 m/px, it will provide global coverage at 480 m/px with the spectral information, assuming the first orbit around Mercury with periherm at 480 km from the surface. SIMBIO-SYS will provide high-resolution images, the Digital Terrain Model of the entire surface, and the surface composition using a wide spectral range, as for instance detecting sulphides or material derived by sulphur and carbon oxidation, at resolutions and coverage higher than the MESSENGER mission with a full co-alignment of the three channels. All the data that will be acquired will allow to cover a wide range of scientific objectives, from the surface processes and cartography up to the internal structure, contributing to the libration experiment, and the surface-exosphere interaction. The global 3D and spectral mapping will allow to study the morphology and the composition of any surface feature. In this work, we describe the on
Published: 2020

42. Sharing real-world experiences to optimize the management of olaparib toxicities: a practical guidance from an Italian expert panel

Author: Lorusso, Domenica, Bologna, A., Cecere, S. C., De Matteis, E., Scandurra, G., Zamagni, C., Arcangeli, V., Artioli, F., Bella, M., Blanco, G., Cardalesi, C., Casartelli, C., De Vivo, R., Di Napoli, M., Gisone, E. B., Lauria, R., Lissoni, A. A., Loizzi, V., Maccaroni, E., Mangili, G., Marchetti, Claudia, Martella, F., Naglieri, E., Parolin, V., Ricciardi, G., Ronzino, G., Salutari, Vanda, Scarfone, G., Secondino, S., Spagnoletti, I., Tasca, G., Tognon, G., Guarneri, V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), Salutari V., Lorusso, Domenica, Bologna, A., Cecere, S. C., De Matteis, E., Scandurra, G., Zamagni, C., Arcangeli, V., Artioli, F., Bella, M., Blanco, G., Cardalesi, C., Casartelli, C., De Vivo, R., Di Napoli, M., Gisone, E. B., Lauria, R., Lissoni, A. A., Loizzi, V., Maccaroni, E., Mangili, G., Marchetti, Claudia, Martella, F., Naglieri, E., Parolin, V., Ricciardi, G., Ronzino, G., Salutari, Vanda, Scarfone, G., Secondino, S., Spagnoletti, I., Tasca, G., Tognon, G., Guarneri, V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), and Salutari V.
Abstract: Olaparib is the first poly(ADP-ribose) polymerase inhibitor approved as maintenance therapy of recurrent ovarian cancer (OC) patients with a BRCA mutation. To achieve the maximum clinical benefit, adherence to olaparib must be persistent. However, in clinical practice, this is challenged by the frequent suboptimal management of toxicities. In view of the expanding use of olaparib also in Italy, physicians must learn how to adequately and promptly manage drug toxicities not to unnecessarily interrupt or reduce the dose. The experts agreed that nausea,vomiting, anemia, and fatigue are the most frequent events experienced by OC patients on olaparib, and that these toxicities usually develop early during treatment, are mainly of grade 1–2 and transient and can be managed with simple non-pharmacological interventions. By sharing their real-world experiences, the panel prepared, for each toxicity, an algorithm organized by grade and besides the procedures indicated in the local label, included supportive care interventions based also on nutritional and lifestyle modifications and psycho-oncology consultation. Moreover, in view of the tablet entry into the Italian market, the full and reduced dosages of capsules and tablets were compared. This practical guidance is intended to be a tool to support especially less-experienced physicians in the management of these complex patients, with the aim to help preventing the worsening of patients’ conditions and the unnecessary interruption/reduction of olaparib dosage, which may jeopardize treatment efficacy.
Published: 2020

43. Expression profiles of PRKG1, SDF2L1 and PPP1R12A are predictive and prognostic factors for therapy response and survival in high-grade serous ovarian cancer

Author: Benvenuto, G, Todeschini, P, Paracchini, L, Calura, E, Fruscio, R, Romani, C, Beltrame, L, Martini, P, Ravaggi, A, Ceppi, L, Sales, G, Donati, F, Perego, P, Zanotti, L, Ballabio, S, Grassi, T, Marchette, M, Tognon, G, Sartori, E, Adorni, M, Odicino, F, D'Incalci, M, Bignotti, E, Romualdi, C, Marchini, S, Benvenuto, Giuseppe, Todeschini, Paola, Paracchini, Lara, Calura, Enrica, Fruscio, Robert, Romani, Chiara, Beltrame, Luca, Martini, Paolo, Ravaggi, Antonella, Ceppi, Lorenzo, Sales, Gabriele, Donati, Federica, Perego, Patrizia, Zanotti, Laura, Ballabio, Sara, Grassi, Tommaso, Marchette, Martina Delle, Tognon, Germana, Sartori, Enrico, Adorni, Marco, Odicino, Franco, D'Incalci, Maurizio, Bignotti, Eliana, Romualdi, Chiara, Marchini, Sergio, Benvenuto, G, Todeschini, P, Paracchini, L, Calura, E, Fruscio, R, Romani, C, Beltrame, L, Martini, P, Ravaggi, A, Ceppi, L, Sales, G, Donati, F, Perego, P, Zanotti, L, Ballabio, S, Grassi, T, Marchette, M, Tognon, G, Sartori, E, Adorni, M, Odicino, F, D'Incalci, M, Bignotti, E, Romualdi, C, Marchini, S, Benvenuto, Giuseppe, Todeschini, Paola, Paracchini, Lara, Calura, Enrica, Fruscio, Robert, Romani, Chiara, Beltrame, Luca, Martini, Paolo, Ravaggi, Antonella, Ceppi, Lorenzo, Sales, Gabriele, Donati, Federica, Perego, Patrizia, Zanotti, Laura, Ballabio, Sara, Grassi, Tommaso, Marchette, Martina Delle, Tognon, Germana, Sartori, Enrico, Adorni, Marco, Odicino, Franco, D'Incalci, Maurizio, Bignotti, Eliana, Romualdi, Chiara, and Marchini, Sergio
Abstract: High-grade serous ovarian cancer (HGS-EOCs) is generally sensitive to front-line platinum (Pt)-based chemotherapy although most patients at an advanced stage relapse with progressive resistant disease. Clinical or molecular data to identify primary resistant cases at diagnosis are not yet available. HGS-EOC biopsies from 105 Pt-sensitive (Pt-s) and 89 Pt-resistant (Pt-r) patients were retrospectively selected from two independent tumor tissue collections. Pathway analysis was done integrating miRNA and mRNA expression profiles. Signatures were further validated in silico on a cohort of 838 HGS-EOC cases from a published dataset. In all, 131 mRNAs and 5 miRNAs belonging to different functionally related molecular pathways distinguish Pt-s from Pt-r cases. Then, 17 out of 23 selected elements were validated by orthogonal approaches (SI signature). As resistance to Pt is associated with a short progression-free survival (PFS) and overall survival (OS), the prognostic role of the SI signature was assessed, and 14 genes associated with PFS and OS, in multivariate analyses (SII signature). The prognostic value of the SII signature was validated in a third extensive cohort. The expression profiles of SDF2L1, PPP1R12A and PRKG1 genes (SIII signature) served as independent prognostic biomarkers of Pt-response and survival. The study identified a prognostic molecular signature based on the combined expression profile of three genes which had never been associated with the clinical outcome of HGS-EOC. This may lead to early identification, at the time of diagnosis, of patients who would not greatly benefit from standard chemotherapy and are thus eligible for novel investigational approaches.
Published: 2020

44. Aluminum-triggered structural modifications and aggregation of β-amyloids

Author: Ricchelli, F., Drago, D., Filippi, B., Tognon, G., and Zatta, P.
Published: 2005
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45. The association between plasma homocysteine and coronary heart disease is modified by the MTHFR 677C>T polymorphism

Author: Mehlig, K, Leander, K, de Faire, U, Nyberg, F, Berg, C, Rosengren, A, Björck, L, Zetterberg, H, Blennow, K, Tognon, G, Torén, K, Strandhagen, E, Lissner, L, and Thelle, D
Published: 2013
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46. Intake of total, animal and plant protein and subsequent changes in weight or waist circumference in European men and women: the Diogenes project

Author: Halkjær, J, Olsen, A, Overvad, K, Jakobsen, M U, Boeing, H, Buijsse, B, Palli, D, Tognon, G, Du, H, van der A, D L, Forouhi, N G, Wareham, N J, Feskens, E JM, Srensen, T IA, and Tjnneland, A
Published: 2011
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47. LBA30 INOVATYON study: Randomized phase III international study comparing trabectedin/PLD followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

Author: Colombo, N., primary, Gadducci, A., additional, Sehouli, J., additional, Biagioli, E., additional, Nyvang, G-B., additional, Riniker, S., additional, Montes, A., additional, Ottevanger, N., additional, Zeimet, A.G.G., additional, Vergote, I.B., additional, Funari, G., additional, Baldoni, A., additional, Tognon, G., additional, De Censi, A., additional, Galaz, C. Churruca, additional, Chekerov, R., additional, Maenpaa, J., additional, Rulli, E., additional, Fossati, R., additional, and Poveda, A., additional
Published: 2020
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48. Mechanisms involved in the photosensitized inactivation of Acanthamoeba palestinensis trophozoites

Author: Ferro, S., Guidolin, L., Tognon, G., Jori, G., and Coppellotti, O.
Published: 2009
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49. Dietary Glycemic Index in Relation to Long-term Changes of Weight and Waist Circumference in a European Population: the DiOGenes study

Author: Du, H., van der A, D. L., Saris, W. H.M., van Bakel, M. E., Halkjær, J., Tjønneland, A., Forouhi, N. G., Wareham, N. J., Boeing, H., Schulze, M. B., Masala, G., Tognon, G., Overvad, K., Slimani, N., Sørensen, T. I.A., and Feskens, E. J.M.
Published: 2008

50. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial

Author: Vergote, I. Scambia, G. O'Malley, D.M. Van Calster, B. Park, S.-Y. del Campo, J.M. Meier, W. Bamias, A. Colombo, N. Wenham, R.M. Covens, A. Marth, C. Raza Mirza, M. Kroep, J.R. Ma, H. Pickett, C.A. Monk, B.J. Park, S.Y. Song, Y.S. Makarova, Y. Trinidad, J. Ngan, H.Y.S. Aravantinos, G. Nam, J.-H. Gorbunova, V. Krikunova, L. Bae, D.-S. Arija, J.A.A. Mirza, M.R. Zamagni, C. Papandreou, C. Raspagliesi, F. Lisyanskaya, A. Benzaquen, A.O. Tognon, G. Ortega, E. Herraez, A.C. Buscema, J. Green, A. Burger, R. Sakaeva, D. Sanchez, A.R. Ghamande, S. King, L. Petru, E. Peen, U. Takeuchi, S. Ushijima, K. Martin, A.G. Kamelle, S. Carney, M. Forget, F. Bentley, J. Sehouli, J. Zola, P. Kato, H. Fadeeva, N. Gotovkin, E. Vladimirov, V. Marin, M.R. Alia, E.G. Shahin, M. Bhoola, S. Tewari, K. Anderson, D. Honhon, B. Pelgrims, J.G. Oza, A. Jimenez, J.G.-D. Hansen, V. Benjamin, I. Renard, V. Van den Bulck, H. Haenle, C. Koumakis, G. Yokota, H. Popov, V. Bradley, W. Wenham, R. Reid, R. McNamara, D. Friedman, R. Barlin, J. Spirtos, N. Chapman, J. Sevelda, P. Huizing, M. Lamot, C. Goffin, F. Hondt, L.D. Covens, A. Spadafora, S. Rautenberg, B. Reimer, T. Möbus, V. Hilpert, F. Gropp-Meier, M. Savarese, A. Pignata, S. Verderame, F. Mizuno, M. Takano, H. Ottevanger, P. Velasco, A.P. Palacio-Vazquez, I. Law, A. McIntyre, K. Teneriello, M. Fields, A. Lentz, S. Street, D. Schwartz, B. Mannel, R. Lim, P. Pulaski, H. Janni, W. Zorr, A. Karck, U. Cheng, A.C.K. Sorio, R. Gridelli, C. Aoki, D. Oishi, T. Hirashima, Y. Boere, I. Ferrer, E.F. Braly, P. Wilks, S. Lee, C. Schilder, J. Veljovich, D. Secord, A. Davis, K. Rojas-Espaillat, L. Lele, S. DePasquale, S. Squatrito, R. Schauer, C. Dirix, L. Vuylsteke, P. Joosens, E. Provencher, D. Lueck, H.-J. Hein, A. Burges, A. Canzler, U. Park-Simon, T.-W. Griesinger, F. Gadducci, A. Alabiso, O. Okamoto, A. Sawasaki, T. Saito, T. Ibañez, A.H. Calomeni, C. Spillman, M. Choksi, J. Taylor, N. Muller, C. Moore, D. DiSilvestro, P. Cunningham, M. Rose, P. Oppelt, P. Verhoeven, D. Graas, M.-P. Ghatage, P. Tonkin, K. Kurzeder, C. Schnappauf, B. Müller, V. Schmalzrie, H. Kalofonos, H. Bruzzone, M. Kroep, J. Diaz, C.C. Garcia, J.M. Polo, S.H. Garrison, M. Rocconi, R. Andrews, S. Bristow, R. McHale, M. Basil, J. Houck III, W. Bell, M. Cosin, J. Modesitt, S. Kendrick, J. Wade III, J. Wong, C. Evans, A. Buekers, T. Vanderkwaak, T. Ferriss, J. Darus, C. DAndre, S. Higgins, R. Monk, B. Bakkum-Gamez, J. DeMars, L. Van Le, L. Puls, L. Trehan, S. LaPolla, J. Michelson, E.D. Merchant, J. Peterson, C. Reid, G. Seago, D. Zweizig, S. Gajewski, W. Panwalkar, A. Leikermoser, R. Bogner, G. Debruyne, P. D'hondt, R. Berteloot, P. Kerger, J. Biagi, J. Castonguay, V. Welch, S. Muhic, A. Heubner, M. Grischke, E.-M. Rack, B. Fleisch, M. Lordick, F. Pectasides, D. Ho, W.M. Selvaggi, L. Vasquez, F.M. Villanueva, W.O.B. Alavez, A.M. Kessels, L. Bertran, A.S. Fernandez, C.M. Fabregat, M.B. Del Prete, S. Elkas, J. Cecchi, G. Kumar, P. Huh, W. Messing, M. Karimi, M. Kelley, A. Edraki, B. Mutch, D. Leiserowitz, G. Anderson, J. Lentz, S. Chambers, S. Morris, R. Waggoner, S. Gordon, A. Method, M. Johnson, P. Lord, R. Drake, J. Sivarajan, K. Midathada, M. Rice, K. Wadsworth, T. Pavelka, J. Edwards, R. Miller, D.S. Ford, P.L. Hurteau, J. Bender, D. Schimp, V. Creasman, W. Lerner, R. Chamberlain, D. Kueck, A. McDonald, J. Malad, S. Robinson-Bennett, B. Davidson, S. Krivak, T. Lestingi, T. Arango, H. Berard, P. Finkelstein, K. Gaur, R. Krasner, C. Ueland, F. Talmage, L. Yamada, S. Sutton, G. Potkul, R. Prasad-Hayes, M. Osborne, J. Celano, P. Thigpen, J. Sharma, S. Schilder, R. Tammela, J. Kemeny, M. Brown, A. Eisenhauer, E. Williams, J. Rowland, K. Nahum, K. Burke, J. Dar, Z. Fleming, N. Gibb, R. Guirguis, A. Herzog, T. John, V. Kumar, S. Kamat, A. Kassar, M. Leitao, M. Levine, L. Mendez, L. Patel, D. Berry, E. Warshal, D. Wolf, J. Zarwan, C. Collins, Y. Spitzer, G. Miller, B. Einstein, M. TRINOVA-3/ENGOT-ov2/GOG-3001 investigators
Abstract: Background: Angiopoietin 1 and 2 regulate angiogenesis and vascular remodelling by interacting with the tyrosine kinase receptor Tie2, and inhibition of angiogenesis has shown promise in the treatment of ovarian cancer. We aimed to assess whether trebananib, a peptibody that inhibits binding of angiopoietin 1 and 2 to Tie2, improved progression-free survival when added to carboplatin and paclitaxel as first-line therapy in advanced epithelial ovarian, primary fallopian tube, or peritoneal cancer in a phase 3 clinical trial. Methods: TRINOVA-3, a multicentre, multinational, phase 3, double-blind study, was done at 206 investigational sites (hospitals and cancer centres)in 14 countries. Eligible patients were aged 18 years or older with biopsy-confirmed International Federation of Gynecology and Obstetrics (FIGO)stage III to IV epithelial ovarian, primary peritoneal, or fallopian tube cancers, and an ECOG performance status of 0 or 1. Eligible patients were randomly assigned (2:1)using a permuted block method (block size of six patients)to receive six cycles of paclitaxel (175 mg/m2)and carboplatin (area under the serum concentration-time curve 5 or 6)every 3 weeks, plus weekly intravenous trebananib 15 mg/kg or placebo. Maintenance therapy with trebananib or placebo continued for up to 18 additional months. The primary endpoint was progression-free survival, as assessed by the investigators, in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01493505, and is complete. Findings: Between Jan 30, 2012, and Feb 25, 2014, 1164 patients were screened and 1015 eligible patients were randomly allocated to treatment (678 to trebananib and 337 to placebo). After a median follow-up of 27·4 months (IQR 17·7–34·2), 626 patients had progression-free survival events (405 [60%]of 678 in the trebananib group and 221 [66%]of 337 in the placebo group). Median progression-free survival did not differ between the trebananib group (15·9 months [15·0–17·6])and the placebo group (15·0 months [12·6–16·1])groups (hazard ratio 0·93 [95% CI 0·79–1·09]; p=0·36). 512 (76%)of 675 patients in the trebananib group and 237 (71%)of 336 in the placebo group had grade 3 or worse treatment-emergent adverse events; of which the most common events were neutropenia (trebananib 238 [35%]vs placebo 126 [38%])anaemia (76 [11%]vs 40 [12%]), and leucopenia (81 [12%]vs 35 [10%]). 269 (40%)patients in the trebananib group and 104 (31%)in the placebo group had serious adverse events. Two fatal adverse events in the trebananib group were considered related to trebananib, paclitaxel, and carboplatin (lung infection and neutropenic colitis); two were considered to be related to paclitaxel and carboplatin (general physical health deterioration and platelet count decreased). No treatment-related fatal adverse events occurred in the placebo group. Interpretation: Trebananib plus carboplatin and paclitaxel did not improve progression-free survival as first-line treatment for advanced ovarian cancer. The combination of trebananib plus carboplatin and paclitaxel did not produce new safety signals. These results show that trebananib in combination with carboplatin and paclitaxel is minimally effective in this patient population. Funding: Amgen. © 2019 Elsevier Ltd
Published: 2019

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