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5. Pediatric nonrhabdomyosarcoma soft tissue sarcomas arising at visceral sites

Author

Ferrari, Andrea, Magni, Chiara, Bergamaschi, Luca, Cecchetto, Giovanni, Alaggio, Rita, Milano, Giuseppe Maria, Bertolini, Patrizia, Basso, Eleonora, Manzitti, Carla, Di Martino, Martina, Giurici, Nauga, Melchionda, Fraia, Cecinati, Valerio, Chiaravalli, Stefano, Affinita, Maria Carmen, Scagnellato, Angela, Casanova, Michela, and Bisogno, Gianni

Published
2017
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7. Clinical Phenotype and Management of Severe Neurotoxicity Observed in Patients with Neuroblastoma Treated with Dinutuximab Beta in Clinical Trials

Author

Wieczorek, Aleksandra, primary, Manzitti, Carla, additional, Garaventa, Alberto, additional, Gray, Juliet, additional, Papadakis, Vassilios, additional, Valteau-Couanet, Dominique, additional, Zachwieja, Katarzyna, additional, Poetschger, Ulrike, additional, Pribill, Ingrid, additional, Fiedler, Stefan, additional, Ladenstein, Ruth, additional, and Lode, Holger N., additional

Published
2022
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9. Phase 2 study for nonmetastatic extremity high‐grade osteosarcoma in pediatric and adolescent and young adult patients with a risk‐adapted strategy based on ABCB1/P‐glycoprotein expression: An Italian Sarcoma Group trial (ISG/OS‐2)

Author

Palmerini, Emanuela, primary, Meazza, Cristina, additional, Tamburini, Angela, additional, Bisogno, Gianni, additional, Ferraresi, Virginia, additional, Asaftei, Sebastian D., additional, Milano, Giuseppe M., additional, Coccoli, Luca, additional, Manzitti, Carla, additional, Luksch, Roberto, additional, Serra, Massimo, additional, Gambarotti, Marco, additional, Donati, Davide M., additional, Scotlandi, Katia, additional, Bertulli, Rossella, additional, Favre, Claudio, additional, Longhi, Alessandra, additional, Abate, Massimo E., additional, Perrotta, Silverio, additional, Mascarin, Maurizio, additional, D’Angelo, Paolo, additional, Cesari, Marilena, additional, Staals, Eric L., additional, Marchesi, Emanuela, additional, Carretta, Elisa, additional, Ibrahim, Toni, additional, Casali, Paolo G., additional, Picci, Piero, additional, Fagioli, Franca, additional, and Ferrari, Stefano, additional

Published
2022
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11. Role of centers with different patient volumes in the management of rhabdomyosarcoma. An analysis by the Italian Pediatric Soft Tissue Sarcoma Committee

Author

Bisogno, Gianni, primary, Congiu, Giovanna, additional, Affinita, Maria Carmen, additional, Milano, Giuseppe Maria, additional, Zanetti, Ilaria, additional, Coppadoro, Beatrice, additional, Manzitti, Carla, additional, Basso, Eleonora, additional, Tamburini, Angela, additional, Melchionda, Fraia, additional, Cellini, Monica, additional, Pericoli, Roberta, additional, D'Angelo, Paolo, additional, Cataldo, Andrea Di, additional, De Leonardis, Francesco, additional, Rabusin, Marco, additional, De Corti, Federica, additional, Zin, Angelica, additional, Alaggio, Rita, additional, Scarzello, Giovanni, additional, and Ferrari, Andrea, additional

Published
2021
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12. Front-Line Window Therapy with Temozolomide and Irinotecan in Patients with Primary Disseminated Multifocal Ewing Sarcoma: Results of the ISG/AIEOP EW-2 Study

Author

Asaftei, Sebastian Dorin, primary, Puma, Nadia, additional, Paioli, Anna, additional, Petraz, Marco, additional, Morosi, Carlo, additional, Podda, Marta, additional, Tamburini, Angela, additional, Palmerini, Emanuela, additional, Coccoli, Luca, additional, Grignani, Giovanni, additional, Manzitti, Carla, additional, Bertulli, Rossella, additional, De Leonardis, Francesco, additional, Rabusin, Marco, additional, Campello, Anna, additional, Tirtei, Elisa, additional, Picci, Piero, additional, Prete, Arcangelo, additional, Longhi, Alessandra, additional, Fagioli, Franca, additional, and Luksch, Roberto, additional

Published
2021
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13. Whole Lung Irradiation after High-Dose Busulfan/Melphalan in Ewing Sarcoma with Lung Metastases: An Italian Sarcoma Group and Associazione Italiana Ematologia Oncologia Pediatrica Joint Study

Author

Abate, Massimo E., primary, Cammelli, Silvia, additional, Ronchi, Letizia, additional, Diletto, Barbara, additional, Gandola, Lorenza, additional, Paioli, Anna, additional, Longhi, Alessandra, additional, Palmerini, Emanuela, additional, Puma, Nadia, additional, Tamburini, Angela, additional, Mascarin, Maurizio, additional, Coassin, Elisa, additional, Prete, Arcangelo, additional, Asaftei, Sebastian D., additional, Manzitti, Carla, additional, Bisogno, Gianni, additional, Pierobon, Marta, additional, Coccoli, Luca, additional, Capasso, Mariella, additional, Grignani, Giovanni, additional, Milano, Giuseppe M., additional, Kiren, Valentina, additional, Fagioli, Franca, additional, Ferrari, Stefano, additional, Picci, Piero, additional, Carretta, Elisa, additional, and Luksch, Roberto, additional

Published
2021
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14. Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance

Author

Onderzoek Beeld, Barone, Giuseppe, Barry, Ailish, Bautista, Francisco, Brichard, Bénédicte, Defachelles, Anne-Sophie, Herd, Fiona, Manzitti, Carla, Reinhardt, Dirk, Rubio, Pedro M, Wieczorek, Aleksandra, van Noesel, Max M, Onderzoek Beeld, Barone, Giuseppe, Barry, Ailish, Bautista, Francisco, Brichard, Bénédicte, Defachelles, Anne-Sophie, Herd, Fiona, Manzitti, Carla, Reinhardt, Dirk, Rubio, Pedro M, Wieczorek, Aleksandra, and van Noesel, Max M

Published
2021

15. Efficacy of dose intensification in induction therapy for localized Ewing sarcoma: Italian Sarcoma Group (ISG) and Associazione Italiana Ematologia ed Oncologia Pediatrica (AIEOP) ISG/AIEOP EW-1 study.

Author

Luksch, Roberto, primary, Milano, Giuseppe Maria, additional, Barretta, Francesco, additional, Longhi, Alessandra, additional, Palmerini, Emanuela, additional, Puma, Nadia, additional, Asaftei, Sebastian Dorin, additional, Podda, Marta Giorgia, additional, Grignani, Giovanni, additional, Bisogno, Gianni, additional, Bertulli, Rossella, additional, Coccoli, Luca, additional, Tamburini, Angela, additional, Manzitti, Carla, additional, Ferraresi, Virginia, additional, Mascarin, Maurizio, additional, Rabusin, Marco, additional, Ferrari, Stefano, additional, Picci, Piero, additional, and Fagioli, Franca, additional

Published
2021
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17. Activity of front-line window therapy with temozolomide plus irinotecan in patients with primary multifocal Ewing sarcoma: ISG/AIEOP EW-2 protocol.

Author

Sebastian, Asaftei Dorin, primary, Puma, Nadia, additional, Paioli, Anna, additional, Petraz, Marco, additional, Morosi, Carlo, additional, Podda, Marta Giorgia, additional, Tamburini, Angela, additional, Coccoli, Luca, additional, Grignani, Giovanni, additional, Manzitti, Carla, additional, Bertulli, Rossella, additional, De Leonardis, Francesco, additional, Rabusin, Marco, additional, Picci, Piero, additional, Prete, Arcangelo, additional, Longhi, Alessandra, additional, Fagioli, Franca, additional, and Luksch, Roberto, additional

Published
2020
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18. Maintenance therapy with oral cyclophosphamide plus celecoxib in patients with metastatic Ewing sarcoma: Results of the Italian Sarcoma Group/AIEOP EW-2 study.

Author

Puma, Nadia, primary, Sebastian, Asaftei Dorin, additional, Paioli, Anna, additional, Bisogno, Gianni, additional, Rabusin, Marco, additional, Coccoli, Luca, additional, Tamburini, Angela, additional, Milano, Giuseppe Maria, additional, Mascarin, Maurizio, additional, Bertulli, Rossella, additional, Grignani, Giovanni, additional, Manzitti, Carla, additional, De Leonardis, Francesco, additional, Podda, Marta Giorgia, additional, Prete, Arcangelo, additional, Picci, Piero, additional, Mura, Rosamaria, additional, Fagioli, Franca, additional, Longhi, Alessandra, additional, and Luksch, Roberto, additional

Published
2020
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22. Prognostic role of pleural effusion or ascites in localized rhabdomyosarcoma

Author

Di Carlo, Daniela, primary, Ferrari, Andrea, additional, Toffolutti, Tiziana, additional, Milano, Giuseppe Maria, additional, Manzitti, Carla, additional, Ruggiero, Antonio, additional, Dall'Igna, Patrizia, additional, Melchionda, Fraia, additional, Zanetti, Ilaria, additional, Scarzello, Giovanni, additional, and Bisogno, Gianni, additional

Published
2019
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23. Randomized use of anti-GD2 antibody dinutuximab beta (DB) long-term infusion with and without subcutaneous interleukin-2 (scIL-2) in high-risk neuroblastoma patients with relapsed and refractory disease: Results from the SIOPEN LTI-trial.

Author

Lode, Holger N., primary, Valteau-Couanet, Dominique, additional, Gray, Juliet, additional, Luksch, Roberto, additional, Wieczorek, Aleksandra, additional, Castel, Victoria, additional, Ash, Shifra, additional, Laureys, Genevieve, additional, Papadakis, Vassilios, additional, Owens, Cormac, additional, Garaventa, Alberto, additional, Manzitti, Carla, additional, Siebert, Nikolai, additional, Troschke-Meurer, Sascha, additional, Glogova, Evgenia, additional, Poetschger, Ulrike, additional, and Ladenstein, Ruth Lydia, additional

Published
2019
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24. Topotecan/carboplatin regimen for refractory/recurrent rhabdomyosarcoma in children: Report from the AIEOP Soft Tissue Sarcoma Committee

Author

Compostella, Alessia, Affinita, Maria Carmen, Casanova, Michela, Milano, Giuseppe Maria, Scagnellato, Angela, Dall'Igna, Patrizia, Chiaravalli, Stefano, Pierobon, Marta, Manzitti, Carla, Zanetti, Ilaria, Schiavetti, Amalia, Sorbara, Silvia, Mura, Rosella Maria, Ruggiero, Antonio, Ferrari, Andrea, Bisogno, Gianni, Ruggiero, Antonio (ORCID:0000-0002-6052-3511), Compostella, Alessia, Affinita, Maria Carmen, Casanova, Michela, Milano, Giuseppe Maria, Scagnellato, Angela, Dall'Igna, Patrizia, Chiaravalli, Stefano, Pierobon, Marta, Manzitti, Carla, Zanetti, Ilaria, Schiavetti, Amalia, Sorbara, Silvia, Mura, Rosella Maria, Ruggiero, Antonio, Ferrari, Andrea, Bisogno, Gianni, and Ruggiero, Antonio (ORCID:0000-0002-6052-3511)

Abstract

NTRODUCTION: From 2002 to 2011, the Italian Soft Tissue Sarcoma Committee explored a combination of topotecan and carboplatin as a second-line strategy for children with resistant or relapsing rhabdomyosarcoma. METHODS: Patients received two blocks of topotecan 2 mg/m2 on days 1, 2, and 3, and carboplatin 250 mg/m2 on days 4 and 5, followed by alternating blocks of topotecan-cyclophosphamide and carboplatin-etoposide for a total of six courses with 3-week intervals. Tumor response was assessed after two cycles, and local control was implemented when feasible. RESULTS: A total of 38 patients were included in this study: 18/38 had alveolar rhabdomyosarcoma (RMS), 10/38 had metastatic disease at diagnosis, 8/38 had tumor progression during first-line chemotherapy, 21/38 had locoregional relapses, and 9/38 had distant relapses. Thirty-two patients could be assessed for tumor response to topotecan-carboplatin, and 9 (28%) showed a complete or partial response. Twenty-four patients experienced grade IV hematologic toxicity, while transient grade 1 tubulopathy, grade 3 mucositis, transient grade 2 nephrotoxicity, and a grade 2 decline in cardiac function occurred in one patient each. The 5-year overall and progression-free survival rates were 17% and 14%, respectively. CONCLUSION: the prognosis for children with resistant or relapsing RMS remains unsatisfactory. The topotecan-carboplatin regimen was well-tolerated. Though in case of late relapse the response rate was similar to those reported for other regimes, the result achieved remains unsatisfactory. New approaches, possibly including target agents, seem more attractive for future studies.

Published
2019

26. Impact of HACA on Immunomodulation and Treatment Toxicity Following ch14.18/CHO Long-Term Infusion with Interleukin-2: Results from a SIOPEN Phase 2 Trial

Author

Siebert, Nikolai, primary, Troschke-Meurer, Sascha, additional, Marx, Madlen, additional, Zumpe, Maxi, additional, Ehlert, Karoline, additional, Gray, Juliet, additional, Garaventa, Alberto, additional, Manzitti, Carla, additional, Ash, Shifra, additional, Klingebiel, Thomas, additional, Beck, James, additional, Castel, Victoria, additional, Valteau-Couanet, Dominique, additional, Loibner, Hans, additional, Ladenstein, Ruth, additional, and Lode, Holger, additional

Published
2018
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27. Topotecan/carboplatin regimen for refractory/recurrent rhabdomyosarcoma in children: Report from the AIEOP Soft Tissue Sarcoma Committee

Author

Compostella, Alessia, primary, Affinita, Maria Carmen, additional, Casanova, Michela, additional, Milano, Giuseppe Maria, additional, Scagnellato, Angela, additional, Dall’Igna, Patrizia, additional, Chiaravalli, Stefano, additional, Pierobon, Marta, additional, Manzitti, Carla, additional, Zanetti, Ilaria, additional, Schiavetti, Amalia, additional, Sorbara, Silvia, additional, Mura, Rosella Maria, additional, Ruggiero, Antonio, additional, Ferrari, Andrea, additional, and Bisogno, Gianni, additional

Published
2018
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28. Biliary tract rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Associazione Italiana Ematologia Oncologia Pediatrica

Author

Perruccio, Katia, primary, Cecinati, Valerio, additional, Scagnellato, Angela, additional, Provenzi, Massimo, additional, Milano, Giuseppe Maria, additional, Basso, Eleonora, additional, Manzitti, Carla, additional, Cecchetto, Giovanni, additional, Alaggio, Rita, additional, Di Martino, Martina, additional, Schiavetti, Amalia, additional, Melchionda, Fraia, additional, Affinita, Maria Carmen, additional, Chiaravalli, Stefano, additional, Miglionico, Lucia, additional, Balter, Rita, additional, Tamburini, Angela, additional, Bisogno, Gianni, additional, and Ferrari, Andrea, additional

Published
2018
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30. Impact of HACA on immunomodulation and treatment toxicity following ch14.18/CHO long-term infusion with Interleukin-2 : results from a SIOPEN phase 2 trial

Author

Siebert, Nikolai, Troschke-Meurer, Sascha, Marx, Madlen, Zumpe, Maxi, Ehlert, Karoline, Gray, Juliet, Garaventa, Alberto, Manzitti, Carla, Ash, Shifra, Klingebiel, Thomas, Beck, James F., Castel, Victoria, Valteau-Couanet, Dominique, Loibner, Hans, Ladenstein, Ruth, Lode, Holger, Siebert, Nikolai, Troschke-Meurer, Sascha, Marx, Madlen, Zumpe, Maxi, Ehlert, Karoline, Gray, Juliet, Garaventa, Alberto, Manzitti, Carla, Ash, Shifra, Klingebiel, Thomas, Beck, James F., Castel, Victoria, Valteau-Couanet, Dominique, Loibner, Hans, Ladenstein, Ruth, and Lode, Holger

Abstract

GD2-directed immunotherapies improve survival of high-risk neuroblastoma (NB) patients (pts). Treatment with chimeric anti-GD2 antibodies (Ab), such as ch14.18, can induce development of human anti-chimeric Ab (HACA). Here, we report HACA effects on ch14.18/CHO pharmacokinetics, pharmacodynamics and pain intensity in pts treated by long-term infusion (LTI) of ch14.18/CHO combined with IL-2. 124 pts received up to 5 cycles of ch14.18/CHO 10 days (d) infusion (10 mg/m2/d; d8–18) combined with s.c. IL-2 (6 × 106 IU/m2/d; d1–5, d8–12). HACA, treatment toxicity, ch14.18/CHO levels, Ab-dependent cellular- (ADCC) and complement-dependent cytotoxicity (CDC) were assessed using respective validated assays. HACA-negative pts showed a steadily decreased pain in cycle 1 (74% pts without morphine by d5 of LTI) with further decrease in subsequent cycles. Ch14.18/CHO peak concentrations of 11.26 ± 0.50 µg/mL found in cycle 1 were further elevated in subsequent cycles and resulted in robust GD2-specific CDC and ADCC. Development of HACA (21% of pts) resulted in strong reduction of ch14.18/CHO levels, abrogated CDC and ADCC. Surprisingly, no difference in pain toxicity between HACA-positive and -negative pts was found. In conclusion, ch14.18/CHO LTI combined with IL-2 results in strong activation of Ab effector functions. Importantly, HACA response abrogated CDC but did not affect pain intensity indicating CDC-independent pain induction.

Published
2018

31. Salvage rates and prognostic factors after relapse in children and adolescents with malignant peripheral nerve sheath tumors

Author

Bergamaschi, Luca, Bisogno, Gianni, Manzitti, Carla, D'Angelo, Paolo, Milano, Giuseppe Maria, Scagnellato, Angela, Cappelletti, Mirko, Chiaravalli, Stefano, Dall'Igna, Patrizia, Alaggio, Rita, Ruggiero, Antonio, Di Martino, Martina, Affinita, Maria Carmen, Pierobon, Marta, Garaventa, Alberto, Casanova, Michela, Ferrari, Andrea, Ruggiero, Antonio (ORCID:0000-0002-6052-3511), Bergamaschi, Luca, Bisogno, Gianni, Manzitti, Carla, D'Angelo, Paolo, Milano, Giuseppe Maria, Scagnellato, Angela, Cappelletti, Mirko, Chiaravalli, Stefano, Dall'Igna, Patrizia, Alaggio, Rita, Ruggiero, Antonio, Di Martino, Martina, Affinita, Maria Carmen, Pierobon, Marta, Garaventa, Alberto, Casanova, Michela, Ferrari, Andrea, and Ruggiero, Antonio (ORCID:0000-0002-6052-3511)

Abstract

Background: Malignant peripheral nerve sheath tumor (MPNST) is one of the most common nonrhabdomyosarcoma soft tissue sarcomas encountered in pediatric age, and it is generally characterized by poor outcome, particularly for relapsing patients. Materials and methods: This study considered 73 patients <21 years of age with relapsing MPNST observed among 120 patients enrolled in Italian pediatric protocols from 1979 to 2004. With the aim of possibly establishing a risk-adapted stratification, patients’ outcome was examined using univariate and multivariate analysis based on clinical features at onset, first-line treatments, clinical findings at the time of first relapse, and second-line treatments. Results: The time to relapse ranged from 1 to 204 months after first diagnosis (median 7 months). The first relapse event was mainly local. At the time of our analysis, nine patients were alive in remission. The median overall survival after first relapse was 11 months, and the survival rates were 39.2% at 1 year and 15.8% at 5 years. The factors revealing the greatest impact on prognosis were as follows: initial tumor invasiveness, time of relapse, and achievement of a secondary complete remission (which was related to the feasibility of radical surgery). Conclusions: Our study confirmed the unsatisfactory prognosis for pediatric patients with relapsing MPNST and pointed to a risk-adapted stratification model for the purposes of deciding second-line treatments. For the time being, an aggressive surgical approach seems to be the only effective salvage treatment and should be recommended. New therapeutic approaches are under evaluation with a view to improving current outcomes.

Published
2018

32. Salvage rates and prognostic factors after relapse in children and adolescents with malignant peripheral nerve sheath tumors

Author

Bergamaschi, Luca, primary, Bisogno, Gianni, additional, Manzitti, Carla, additional, D'Angelo, Paolo, additional, Milano, Giuseppe Maria, additional, Scagnellato, Angela, additional, Cappelletti, Mirko, additional, Chiaravalli, Stefano, additional, Dall'Igna, Patrizia, additional, Alaggio, Rita, additional, Ruggiero, Antonio, additional, Di Martino, Martina, additional, Affinita, Maria Carmen, additional, Pierobon, Marta, additional, Garaventa, Alberto, additional, Casanova, Michela, additional, and Ferrari, Andrea, additional

Published
2017
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33. Salvage rates and prognostic factors after relapse in children and adolescents with malignant peripheral nerve sheath tumors

Author

Bergamaschi, Luca, Bisogno, Gianni, Manzitti, Carla, D'Angelo, Paolo, Milano, Giuseppe Maria, Scagnellato, Angela, Cappelletti, Mirko, Chiaravalli, Stefano, Dall'Igna, Patrizia, Alaggio, Rita, Ruggiero, Antonio, Di Martino, Martina, Affinita, Maria Carmen, Pierobon, Marta, Garaventa, Alberto, Casanova, Michela, Ferrari, Andrea, Ruggiero, Antonio (ORCID:0000-0002-6052-3511), Bergamaschi, Luca, Bisogno, Gianni, Manzitti, Carla, D'Angelo, Paolo, Milano, Giuseppe Maria, Scagnellato, Angela, Cappelletti, Mirko, Chiaravalli, Stefano, Dall'Igna, Patrizia, Alaggio, Rita, Ruggiero, Antonio, Di Martino, Martina, Affinita, Maria Carmen, Pierobon, Marta, Garaventa, Alberto, Casanova, Michela, Ferrari, Andrea, and Ruggiero, Antonio (ORCID:0000-0002-6052-3511)

Abstract

Background: Malignant peripheral nerve sheath tumor (MPNST) is one of the most common nonrhabdomyosarcoma soft tissue sarcomas encountered in pediatric age, and it is generally characterized by poor outcome, particularly for relapsing patients. Materials and methods: This study considered 73 patients <21 years of age with relapsing MPNST observed among 120 patients enrolled in Italian pediatric protocols from 1979 to 2004. With the aim of possibly establishing a risk-adapted stratification, patients' outcome was examined using univariate and multivariate analysis based on clinical features at onset, first-line treatments, clinical findings at the time of first relapse, and second-line treatments. Results: The time to relapse ranged from 1 to 204 months after first diagnosis (median 7 months). The first relapse event was mainly local. At the time of our analysis, nine patients were alive in remission. The median overall survival after first relapse was 11 months, and the survival rates were 39.2% at 1 year and 15.8% at 5 years. The factors revealing the greatest impact on prognosis were as follows: initial tumor invasiveness, time of relapse, and achievement of a secondary complete remission (which was related to the feasibility of radical surgery). Conclusions: Our study confirmed the unsatisfactory prognosis for pediatric patients with relapsing MPNST and pointed to a risk-adapted stratification model for the purposes of deciding second-line treatments. For the time being, an aggressive surgical approach seems to be the only effective salvage treatment and should be recommended. New therapeutic approaches are under evaluation with a view to improving current outcomes.

Published
2017

34. Phase 1/2 study of weekly nab-paclitaxel (nab-P) in pediatric patients (pts) with recurrent/refractory solid tumors (STs): Dose-finding and pharmacokinetics (PK).

Author

Moreno, Lucas, primary, Casanova, Michela, additional, Chisholm, Julia C., additional, Berlanga, Pablo, additional, Chastagner, Pascal B., additional, Baruchel, Sylvain, additional, Manzitti, Carla, additional, Gallego Mélcon, Soledad, additional, Gerber, Nicolas U., additional, Bisogno, Gianni, additional, Fagioli, Franca, additional, Geoerger, Birgit, additional, Glade Bender, Julia, additional, Aerts, Isabelle, additional, Bergeron, Christophe, additional, Hingorani, Pooja, additional, Elias, Ileana, additional, Simcock, Mathew, additional, Slepetis, Ruta, additional, and Vassal, Gilles, additional

Published
2016
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35. Abstract A032: Immunotherapy with ch14.18/CHO in combination with IL2 is active and effective in high-risk relapsed/refractory neuroblastoma patients

Author

Lode, Holger N., primary, Valteau-Couanet, Dominique, additional, Garaventa, Alberto, additional, Gray, Juliet, additional, Castel, Victoria, additional, Yaniv, Isaac, additional, Siebert, Nikolai, additional, Jensen, Christian, additional, Endres, Stefanie, additional, Pill, Lena, additional, Eger, Christin, additional, Seidel, Diana, additional, Jüttner, Madlen, additional, Kietz, Silke, additional, Ehlert, Karoline, additional, Janzek, Evelyne, additional, Manzitti, Carla, additional, Müller, Ina, additional, Loibner, Hans, additional, and Ladenstein, Ruth, additional

Published
2016
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36. Expression ofFOXP3,CD14, andARG1in Neuroblastoma Tumor Tissue from High-Risk Patients Predicts Event-Free and Overall Survival

Author

Stigliani, Sara, primary, Croce, Michela, additional, Morandi, Fabio, additional, Scaruffi, Paola, additional, Rigo, Valentina, additional, Carlini, Barbara, additional, Manzitti, Carla, additional, Gigliotti, Anna Rita, additional, Tonini, Gian Paolo, additional, Pistoia, Vito, additional, Ferrini, Silvano, additional, and Corrias, Maria Valeria, additional

Published
2015
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37. Ewing sarcoma of the bone in children under 6 years of age

Author

De Ioris, Maria Antonietta, Prete, Arcangelo, Cozza, Raffaele, Podda, Marta, Manzitti, Carla, Pession, Andrea, Schiavello, Elisabetta, Contoli, Benedetta, Balter, Rita, Fagioli, Franca, Bisogno, Gianni, Amoroso, Loredana, Locatelli, Franco, Luksch, Roberto, Locatelli, Franco (ORCID:0000-0002-7976-3654), De Ioris, Maria Antonietta, Prete, Arcangelo, Cozza, Raffaele, Podda, Marta, Manzitti, Carla, Pession, Andrea, Schiavello, Elisabetta, Contoli, Benedetta, Balter, Rita, Fagioli, Franca, Bisogno, Gianni, Amoroso, Loredana, Locatelli, Franco, Luksch, Roberto, and Locatelli, Franco (ORCID:0000-0002-7976-3654)

Abstract

Background: Ewing Sarcoma Family Tumours (ESFT) are rare in early childhood. The aim of this study was to report the clinical characteristics and outcome of children under 6 years of age affected by ESFT of the bone in Italy.Methods: The records of all the children diagnosed with osseous ESFT in centres members of the Associazione Italiana di Ematologia ed Oncologia Pediatrica (AIEOP) from 1990 to 2008 were reviewed. The Kaplan-Meier method was used for estimating overall and progression-free survival (OS, PFS) curves; multivariate analyses were performed using Cox proportional hazards regression model.Results: This study includes 62 patients. An axial primary localization was present in 66% of patients, with the primary site in the chest wall in 34%. Fourteen (23%) patients presented metastatic disease. The 5-year OS and PFS were 73% (95% confidence interval, CI, 58-83%) and 72% (95% CI 57-83%) for patients with localized disease and 38% (95% CI 17-60%) and 21% (95% CI 5-45%) for patients with metastatic disease. Metastatic spread, skull/pelvis/spine primary localization, progression during treatment and no surgery predicted worse survival (P < 0.01), while patients treated in the last decade had better survival (P = 0.002). In fact, the 5-year OS and PFS for patients diagnosed in the period 2000-2008 were 89% (95% CI 71-96%) and 86% (95% CI 66-94%), respectively.Conclusion: The axial localization is the most common site of ESFT in pre-scholar children. Patients treated in the most recent period have an excellent outcome.

Published
2013

38. Epithelioid Rhabdomyosarcoma

Author

Zin, Angelica, primary, Bertorelle, Roberta, additional, Dall’Igna, Patrizia, additional, Manzitti, Carla, additional, Gambini, Claudio, additional, Bisogno, Gianni, additional, Rosolen, Angelo, additional, and Alaggio, Rita, additional

Published
2014
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39. Ewing Sarcoma of the Bone in Children under 6 Years of Age

Author

De Ioris, Maria Antonietta, primary, Prete, Arcangelo, additional, Cozza, Raffaele, additional, Podda, Marta, additional, Manzitti, Carla, additional, Pession, Andrea, additional, Schiavello, Elisabetta, additional, Contoli, Benedetta, additional, Balter, Rita, additional, Fagioli, Franca, additional, Bisogno, Gianni, additional, Amoroso, Loredana, additional, Locatelli, Franco, additional, and Luksch, Roberto, additional

Published
2013
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40. Clinical benefits of granulocyte colony-stimulating factor therapy after hematopoietic stem cell transplant in children: results of a prospective randomized trial

Author

Dallorso, Sandro, Rondelli, Roberto, Messina, Chiara, Pession, Andrea, Giorgiani, Giovanna, Fagioli, Franca, Locatelli, Franco, Manzitti, Carla, Balduzzi, Adriana, Prete, Arcangelo, Cesaro, Simone, Lanino, Edoardo, Dini, Giorgio, Locatelli, Franco (ORCID:0000-0002-7976-3654), Dallorso, Sandro, Rondelli, Roberto, Messina, Chiara, Pession, Andrea, Giorgiani, Giovanna, Fagioli, Franca, Locatelli, Franco, Manzitti, Carla, Balduzzi, Adriana, Prete, Arcangelo, Cesaro, Simone, Lanino, Edoardo, Dini, Giorgio, and Locatelli, Franco (ORCID:0000-0002-7976-3654)

Abstract

Background and objectives: Hematopoietic stem cell transplantation (HSCT) is associated with profound neutropenia and significant morbidity and mortality. To evaluate the safety and efficacy of non-glycosylated recombinant human granulocyte colony-stimulating factor (rHuG-CSF) in accelerating myeloid recovery and its influence on infections, supportive therapy, and transplant-related mortality we carried out a randomized study in pediatric patients receiving HSCT. Design and methods: Two hundred and twenty-one consecutive children, recipients of an allogeneic or autologous bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplant, were randomized to either receive rHuG-CSF 10 mg/kg (n=110) or not (n=111). Results: Myeloid engraftment was faster in the treated arm (14 vs 20 days, p=0.0001). Neutrophil recovery was accelerated both in the BM subgroups (allogeneic and autologous, p=0.002) and in the PBPC group (p=0.0005). All the other evaluated variables showed an advantage in favor of rHuG-CSF treated patients that was significant for platelet transfusion independence and time to discharge (p=0.02 and p=0.04, respectively) only in the BM subgroup. Interpretation and conclusions: We conclude that faster neutrophil recovery in BM recipients receiving rHuG-CSF led to clinical benefits, while, in the PBPC subgroup, it did not translate into clinical advantages.

Published
2002

42. Expression of FOXP3, CD14, and ARG1 in Neuroblastoma Tumor Tissue from High-Risk Patients Predicts Event-Free and Overall Survival.

Author

Stigliani, Sara, Croce, Michela, Morandi, Fabio, Scaruffi, Paola, Rigo, Valentina, Carlini, Barbara, Manzitti, Carla, Gigliotti, Anna Rita, Tonini, Gian Paolo, Pistoia, Vito, Ferrini, Silvano, and Corrias, Maria Valeria

Subjects
GENE expression, NEUROBLASTOMA, RESEARCH funding, STATISTICS, SURVIVAL, DATA analysis, AT-risk people, KAPLAN-Meier estimator, LOG-rank test, MANN Whitney U Test, PROGNOSIS
Abstract

The prognosis of children with metastatic neuroblastoma (NB) > 18 months at diagnosis is dismal. Since the immune status of the tumor microenvironment could play a role in the history of disease, we evaluated the expression of CD45, CD14, ARG1, CD163, CD4, FOXP3, Perforin-1 (PRF1), Granzyme B (GRMB), and IL-10 mRNAs in primary tumors at diagnosis from children with metastatic NB and tested whether the transcript levels are significantly associated to event-free and overall survival (EFS and OS, resp.). Children with high expression of CD14, ARG1 and FOXP3 mRNA in their primary tumors had significantly better EFS. Elevated expression of CD14, and FOXP3 mRNA was significantly associated to better OS. CD14 mRNA expression levels significantly correlated to all markers, with the exception of CD4. Strong positive correlations were found between PRF1 and CD163, as well as between PFR1 and FOXP3. It is worth noting that the combination of high levels of CD14, FOXP3, and ARG1 mRNAs identified a small group of patients with excellent EFS and OS, whereas low levels of CD14 were sufficient to identify patients with dismal survival. Thus, the immune status of the primary tumors of high-risk NB patients may influence the natural history of this pediatric cancer. [ABSTRACT FROM AUTHOR]

Published
2015
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45. Intensified Induction Therapy for Newly Diagnosed, Localized Skeletal Ewing Sarcoma (ISG/AIEOP EW-1): A Randomized, Open-Label, Phase 3, Non-Inferiority Trial.

Author

Luksch R, Palmerini E, Milano GM, Paioli A, Asaftei S, Barretta F, Puma N, Cesari M, Tirtei E, Podda M, Pierobon M, Manzitti C, Ferraresi V, Tamburini A, Bertulli R, Di Pinto D, Mascarin M, Grignani G, Coccoli L, Rabusin M, De Leonardis F, Gambarotti M, Parafioriti A, Cammelli S, Vennarini S, Ferrari S, Donati DM, Bastoni S, Massimino M, Fagioli F, and Ibrahim T

Abstract

Background: Several studies have shown that the intensity of treatment in Ewing sarcoma has an impact on outcome. The present trial tested the non-inferiority of intensive, shorter, induction chemotherapy (25 weeks total treatment time) compared to the standard treatment (37 weeks) in non-metastatic Ewing sarcoma (ES) at onset., Procedure: This national, multicenter, parallel, randomized, controlled, open-label, non-inferiority, phase III trial was conducted in 14 specialized hospitals in Italy. Patients aged 2-40 years with newly diagnosed localized ES were randomized to receive four courses of induction therapy (one every 21 days) either with a standard arm (Arm A) or with an intensive arm (Arm B). For consolidation therapy, good responders (GRs) in Arm A received nine courses (37 weeks), while Arm B patients received five courses (25 weeks). Poor responders for both arms received four courses followed by high-dose busulfan/melphalan + autologous stem cell rescue. Follow-up was 5 years., Results: In the study period 2009-2018, 274 patients with ES at onset were screened, 248 were eligible, 15 refused randomization, and 233 were randomized (Arm A: 113; Arm B: 120). Median age was 14 years. Arm B was not inferior to Arm A: 5-year EFS was 77.5% and 71.6%, respectively (HR vs. Arm A: 0.74, 90% CI: 0.49-1.14). GRs were 54.9% in Arm A and 62.5% in Arm B. Hematological, gastrointestinal, and cardiovascular Grade ≥3 toxicities had higher frequencies in Arm B., Conclusions: Intensive induction therapy showed non-inferiority in 5-year EFS when compared with the standard induction therapy. Higher toxicity was reported in Arm B with similar outcome, counterbalanced in GRs with a shorter treatment plan., Clinicaltrials: gov Identifier: NCT02063022., (© 2025 The Author(s). Pediatric Blood & Cancer published by Wiley Periodicals LLC.)

Published
2025
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46. Topotecan/carboplatin regimen for refractory/recurrent rhabdomyosarcoma in children: Report from the AIEOP Soft Tissue Sarcoma Committee.

Author

Compostella A, Affinita MC, Casanova M, Milano GM, Scagnellato A, Dall'Igna P, Chiaravalli S, Pierobon M, Manzitti C, Zanetti I, Schiavetti A, Sorbara S, Mura RM, Ruggiero A, Ferrari A, and Bisogno G

Subjects
Adolescent, Child, Child, Preschool, Drug Resistance, Neoplasm drug effects, Female, Humans, Infant, Kaplan-Meier Estimate, Male, Neoplasm Recurrence, Local drug therapy, Rhabdomyosarcoma mortality, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carboplatin administration & dosage, Rhabdomyosarcoma drug therapy, Topotecan administration & dosage
Abstract

Introduction: From 2002 to 2011, the Italian Soft Tissue Sarcoma Committee explored a combination of topotecan and carboplatin as a second-line strategy for children with resistant or relapsing rhabdomyosarcoma., Methods: Patients received two blocks of topotecan 2 mg/m 2 on days 1, 2, and 3, and carboplatin 250 mg/m 2 on days 4 and 5, followed by alternating blocks of topotecan-cyclophosphamide and carboplatin-etoposide for a total of six courses with 3-week intervals. Tumor response was assessed after two cycles, and local control was implemented when feasible., Results: A total of 38 patients were included in this study: 18/38 had alveolar rhabdomyosarcoma (RMS), 10/38 had metastatic disease at diagnosis, 8/38 had tumor progression during first-line chemotherapy, 21/38 had locoregional relapses, and 9/38 had distant relapses. Thirty-two patients could be assessed for tumor response to topotecan-carboplatin, and 9 (28%) showed a complete or partial response. Twenty-four patients experienced grade IV hematologic toxicity, while transient grade 1 tubulopathy, grade 3 mucositis, transient grade 2 nephrotoxicity, and a grade 2 decline in cardiac function occurred in one patient each. The 5-year overall and progression-free survival rates were 17% and 14%, respectively., Conclusion: the prognosis for children with resistant or relapsing RMS remains unsatisfactory. The topotecan-carboplatin regimen was well-tolerated. Though in case of late relapse the response rate was similar to those reported for other regimes, the result achieved remains unsatisfactory. New approaches, possibly including target agents, seem more attractive for future studies.

Published
2019
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47. Salvage rates and prognostic factors after relapse in children and adolescents with malignant peripheral nerve sheath tumors.

Author

Bergamaschi L, Bisogno G, Manzitti C, D'Angelo P, Milano GM, Scagnellato A, Cappelletti M, Chiaravalli S, Dall'Igna P, Alaggio R, Ruggiero A, Di Martino M, Affinita MC, Pierobon M, Garaventa A, Casanova M, and Ferrari A

Subjects
Adolescent, Age Factors, Child, Child, Preschool, Female, Humans, Infant, Italy epidemiology, Male, Neoplasm Invasiveness, Neurilemmoma pathology, Prognosis, Retrospective Studies, Time Factors, Neurilemmoma diagnosis, Neurilemmoma mortality, Neurilemmoma therapy
Abstract

Background: Malignant peripheral nerve sheath tumor (MPNST) is one of the most common nonrhabdomyosarcoma soft tissue sarcomas encountered in pediatric age, and it is generally characterized by poor outcome, particularly for relapsing patients., Materials and Methods: This study considered 73 patients <21 years of age with relapsing MPNST observed among 120 patients enrolled in Italian pediatric protocols from 1979 to 2004. With the aim of possibly establishing a risk-adapted stratification, patients' outcome was examined using univariate and multivariate analysis based on clinical features at onset, first-line treatments, clinical findings at the time of first relapse, and second-line treatments., Results: The time to relapse ranged from 1 to 204 months after first diagnosis (median 7 months). The first relapse event was mainly local. At the time of our analysis, nine patients were alive in remission. The median overall survival after first relapse was 11 months, and the survival rates were 39.2% at 1 year and 15.8% at 5 years. The factors revealing the greatest impact on prognosis were as follows: initial tumor invasiveness, time of relapse, and achievement of a secondary complete remission (which was related to the feasibility of radical surgery)., Conclusions: Our study confirmed the unsatisfactory prognosis for pediatric patients with relapsing MPNST and pointed to a risk-adapted stratification model for the purposes of deciding second-line treatments. For the time being, an aggressive surgical approach seems to be the only effective salvage treatment and should be recommended. New therapeutic approaches are under evaluation with a view to improving current outcomes., (© 2017 Wiley Periodicals, Inc.)

Published
2018
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48. Epithelioid rhabdomyosarcoma: a clinicopathologic and molecular study.

Author

Zin A, Bertorelle R, Dall'Igna P, Manzitti C, Gambini C, Bisogno G, Rosolen A, and Alaggio R

Subjects
Adolescent, Age Factors, Child, Epithelioid Cells pathology, Female, Genetic Predisposition to Disease, Humans, Immunohistochemistry, Italy, Male, Phenotype, Remission Induction, Reverse Transcriptase Polymerase Chain Reaction, Rhabdomyosarcoma pathology, Rhabdomyosarcoma therapy, Treatment Outcome, Biomarkers, Tumor analysis, Biomarkers, Tumor genetics, Epithelioid Cells chemistry, Rhabdomyosarcoma chemistry, Rhabdomyosarcoma genetics
Abstract

Rhabdomyosarcoma (RMS) is the most common pediatric soft tissue sarcoma and is mostly represented by the embryonal (ERMS) and alveolar (ARMS) histotypes. Whereas ERMS shows variable genetic alterations including TP53, RB1, and RAS mutations, ARMS carries a gene fusion between PAX3 or PAX7 and FOXO1. Epithelioid RMS is a morphologic variant of RMS recently described in adults. Five cases of epithelioid RMS were identified after histologic review of 85 cases of ARMS enrolled in Italian therapeutic protocols. Immunostaining analyses (muscle-specific actin, desmin, myogenin, AP-2β, EMA, cytokeratins, INI-1) and reverse transcription polymerase chain reaction assays to detect MyoD1, myogenin, and PAX3/7-FOXO1 transcripts were performed. In 4 cases DNA sequencing of TP53 was performed; and RB1 allelic imbalance and homozygous deletion were analyzed by quantitative real-time polymerase chain reaction. Histologically, epithelioid RMS displayed sheets of large cells without rhabdomyoblastic differentiation or anaplasia in 3 and prominent rhabdoid cells in 2; necrosis was evident in 4, often with a geographic pattern. Immunostainings for INI, desmin, myogenin (scattered cells in 4, diffuse in 1) were positive in all; EMA and MNF116 were positive in 2; AP-2β was negative. PAX3/7-FOXO1 transcripts were absent. In all cases RB1 was wild type, and a TP53 mutation at R273H codon was found in 1. All patients are in complete remission, with a median follow-up of 6 years. Epithelioid RMS may occur in children and is probably related to ERMS, as suggested by lack of fusion transcripts, weak staining for myogenin, negative AP-2β, evidence of TP53 mutation (although only in 1 case), and a favorable clinical course.

Published
2014
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49. Mature B-cell renal lymphoma presenting as a single osseous mass in a child.

Author

Manzitti C, Tomà P, Rizzo A, Gambini C, and Garaventa A

Subjects
Bone Neoplasms drug therapy, Child, Humans, Humerus pathology, Kidney Neoplasms drug therapy, Kidney Neoplasms surgery, Lymphoma, B-Cell drug therapy, Lymphoma, B-Cell surgery, Male, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Bone Neoplasms secondary, Kidney Neoplasms pathology, Lymphoma, B-Cell pathology
Published
2005
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50. Clinical benefits of granulocyte colony-stimulating factor therapy after hematopoietic stem cell transplant in children: results of a prospective randomized trial.

Author

Dallorso S, Rondelli R, Messina C, Pession A, Giorgiani G, Fagioli F, Locatelli F, Manzitti C, Balduzzi A, Prete A, Cesaro S, Lanino E, and Dini G

Subjects
Adolescent, Bone Marrow Transplantation, Child, Child, Preschool, Female, Graft Survival drug effects, Humans, Infant, Male, Neutropenia prevention & control, Neutrophils cytology, Peripheral Blood Stem Cell Transplantation, Prospective Studies, Granulocyte Colony-Stimulating Factor administration & dosage, Hematopoietic Stem Cell Transplantation methods
Abstract

Background and Objectives: Hematopoietic stem cell transplantation (HSCT) is associated with profound neutropenia and significant morbidity and mortality. To evaluate the safety and efficacy of non-glycosylated recombinant human granulocyte colony-stimulating factor (rHuG-CSF) in accelerating myeloid recovery and its influence on infections, supportive therapy, and transplant-related mortality we carried out a randomized study in pediatric patients receiving HSCT., Design and Methods: Two hundred and twenty-one consecutive children, recipients of an allogeneic or autologous bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplant, were randomized to either receive rHuG-CSF 10 mg/kg (n=110) or not (n=111)., Results: Myeloid engraftment was faster in the treated arm (14 vs 20 days, p=0.0001). Neutrophil recovery was accelerated both in the BM subgroups (allogeneic and autologous, p=0.002) and in the PBPC group (p=0.0005). All the other evaluated variables showed an advantage in favor of rHuG-CSF treated patients that was significant for platelet transfusion independence and time to discharge (p=0.02 and p=0.04, respectively) only in the BM subgroup., Interpretation and Conclusions: We conclude that faster neutrophil recovery in BM recipients receiving rHuG-CSF led to clinical benefits, while, in the PBPC subgroup, it did not translate into clinical advantages.

Published
2002

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