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1. MITO END-3: efficacy of avelumab immunotherapy according to molecular profiling in first-line endometrial cancer therapy

Author

Pignata, S., Califano, D., Lorusso, D., Arenare, L., Bartoletti, M., De Giorgi, U., Andreetta, C., Pisano, C., Scambia, G., Lombardi, D., Farolfi, A., Cinieri, S., Passarelli, A., Salutari, V., De Angelis, C., Mignogna, C., Priolo, D., Capoluongo, E.D., Tamberi, S., Scaglione, G.L., Arcangeli, V., De Cecio, R., Scognamiglio, G., Greco, F., Spina, A., Turinetto, M., Russo, D., Carbone, V., Casartelli, C., Schettino, C., and Perrone, F.

Published
2024
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2. 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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3. Atezolizumab and chemotherapy for advanced or recurrent endometrial cancer (AtTEnd): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Colombo, N, Biagioli, E, Harano, K, Galli, F, Hudson, E, Antill, Y, Choi, C, Rabaglio, M, Marmé, F, Marth, C, Parma, G, Fariñas-Madrid, L, Nishio, S, Allan, K, Lee, Y, Piovano, E, Pardo, B, Nakagawa, S, Mcqueen, J, Zamagni, C, Manso, L, Takehara, K, Tasca, G, Ferrero, A, Tognon, G, Lissoni, A, Petrella, M, Laudani, M, Rulli, E, Uggeri, S, Barretina Ginesta, M, Zola, P, Casanova, C, Arcangeli, V, Antonuzzo, L, Gadducci, A, Cosio, S, Clamp, A, Persic, M, Mcneish, I, Tookman, L, Redondo Sanchez, A, Baldini, E, Palaia, I, Benedetti Panici, P, Takahashi, N, Lombard, J, Ardizzoia, A, Bologna, A, Herrero Ibáñez, A, Musolino, A, Márquez Vázquez, R, Pietzner, K, Braicu, E, Heinzelmann-Schwarz, V, Powell, M, Yokoyama, Y, Baron-Hay, S, Abeni, C, Martin Lorente, C, Cueva, J, Trillsch, F, Heitz, F, Ataseven, B, Petru, E, Heubner, M, Sadozye, A, Dubey, S, Tazbirkova, A, Tiley, S, Chrystal, K, Kim, S, Fehr, M, Scatchard, K, Anand, A, Taylor, A, Watary, H, Enomoto, T, Yoshihara, K, Selva-Nayagam, S, Karki, B, Harrison, M, Wilkinson, K, Goh, J, Glasgow, A, Chantrill, L, Lee, C, Bertolini, A, Narducci, F, Bellotti, G, Fusco, V, Aebi, S, Del Grande, M, Colombo, I, Tokunaga, H, Shigeta, S, Goss, G, Siow, Z, Steer, C, Lin, H, Colombo N., Biagioli E., Harano K., Galli F., Hudson E., Antill Y., Choi C. H., Rabaglio M., Marmé F., Marth C., Parma G., Fariñas-Madrid L., Nishio S., Allan K., Lee Y. C., Piovano E., Pardo B., Nakagawa S., McQueen J., Zamagni C., Manso L., Takehara K., Tasca G., Ferrero A., Tognon G., Lissoni A. A., Petrella M., Laudani M. E., Rulli E., Uggeri S., Barretina Ginesta M. P., Zola P., Casanova C., Arcangeli V., Antonuzzo L., Gadducci A., Cosio S., Clamp A., Persic M., McNeish I., Tookman L., Redondo Sanchez A., Baldini E., Palaia I., Benedetti Panici P., Takahashi N., Lombard J., Ardizzoia A., Bologna A., Herrero Ibáñez A. M., Musolino A., Márquez Vázquez R., Pietzner K., Braicu E., Heinzelmann-Schwarz V. A., Powell M., Yokoyama Y., Baron-Hay S., Abeni C., Martin Lorente C., Cueva J. F., Trillsch F., Heitz F., Ataseven B., Petru E., Heubner M. L., Sadozye A. H., Dubey S., Tazbirkova A., Tiley S., Chrystal K., Kim S. W., Fehr M., Scatchard K., Anand A., Taylor A., Watary H., Enomoto T., Yoshihara K., Selva-Nayagam S., Karki B., Harrison M., Wilkinson K., Goh J., Glasgow A., Chantrill L., Lee C., Bertolini A., Narducci F., Bellotti G., Fusco V., Aebi S., Del Grande M., Colombo I., Tokunaga H., Shigeta S., Goss G., Siow Z. R., Steer C., Lin H., Colombo, N, Biagioli, E, Harano, K, Galli, F, Hudson, E, Antill, Y, Choi, C, Rabaglio, M, Marmé, F, Marth, C, Parma, G, Fariñas-Madrid, L, Nishio, S, Allan, K, Lee, Y, Piovano, E, Pardo, B, Nakagawa, S, Mcqueen, J, Zamagni, C, Manso, L, Takehara, K, Tasca, G, Ferrero, A, Tognon, G, Lissoni, A, Petrella, M, Laudani, M, Rulli, E, Uggeri, S, Barretina Ginesta, M, Zola, P, Casanova, C, Arcangeli, V, Antonuzzo, L, Gadducci, A, Cosio, S, Clamp, A, Persic, M, Mcneish, I, Tookman, L, Redondo Sanchez, A, Baldini, E, Palaia, I, Benedetti Panici, P, Takahashi, N, Lombard, J, Ardizzoia, A, Bologna, A, Herrero Ibáñez, A, Musolino, A, Márquez Vázquez, R, Pietzner, K, Braicu, E, Heinzelmann-Schwarz, V, Powell, M, Yokoyama, Y, Baron-Hay, S, Abeni, C, Martin Lorente, C, Cueva, J, Trillsch, F, Heitz, F, Ataseven, B, Petru, E, Heubner, M, Sadozye, A, Dubey, S, Tazbirkova, A, Tiley, S, Chrystal, K, Kim, S, Fehr, M, Scatchard, K, Anand, A, Taylor, A, Watary, H, Enomoto, T, Yoshihara, K, Selva-Nayagam, S, Karki, B, Harrison, M, Wilkinson, K, Goh, J, Glasgow, A, Chantrill, L, Lee, C, Bertolini, A, Narducci, F, Bellotti, G, Fusco, V, Aebi, S, Del Grande, M, Colombo, I, Tokunaga, H, Shigeta, S, Goss, G, Siow, Z, Steer, C, Lin, H, Colombo N., Biagioli E., Harano K., Galli F., Hudson E., Antill Y., Choi C. H., Rabaglio M., Marmé F., Marth C., Parma G., Fariñas-Madrid L., Nishio S., Allan K., Lee Y. C., Piovano E., Pardo B., Nakagawa S., McQueen J., Zamagni C., Manso L., Takehara K., Tasca G., Ferrero A., Tognon G., Lissoni A. A., Petrella M., Laudani M. E., Rulli E., Uggeri S., Barretina Ginesta M. P., Zola P., Casanova C., Arcangeli V., Antonuzzo L., Gadducci A., Cosio S., Clamp A., Persic M., McNeish I., Tookman L., Redondo Sanchez A., Baldini E., Palaia I., Benedetti Panici P., Takahashi N., Lombard J., Ardizzoia A., Bologna A., Herrero Ibáñez A. M., Musolino A., Márquez Vázquez R., Pietzner K., Braicu E., Heinzelmann-Schwarz V. A., Powell M., Yokoyama Y., Baron-Hay S., Abeni C., Martin Lorente C., Cueva J. F., Trillsch F., Heitz F., Ataseven B., Petru E., Heubner M. L., Sadozye A. H., Dubey S., Tazbirkova A., Tiley S., Chrystal K., Kim S. W., Fehr M., Scatchard K., Anand A., Taylor A., Watary H., Enomoto T., Yoshihara K., Selva-Nayagam S., Karki B., Harrison M., Wilkinson K., Goh J., Glasgow A., Chantrill L., Lee C., Bertolini A., Narducci F., Bellotti G., Fusco V., Aebi S., Del Grande M., Colombo I., Tokunaga H., Shigeta S., Goss G., Siow Z. R., Steer C., and Lin H.

Abstract

Background: At the time of AtTEnd trial design, standard treatment for advanced or recurrent endometrial cancer included carboplatin and paclitaxel chemotherapy. This trial assessed whether combining atezolizumab with chemotherapy might improve outcomes in this population. Methods: AtTEnd was a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial done in 89 hospitals in 11 countries across Europe, Australia, New Zealand, and Asia. Enrolled patients were aged 18 years or older, and had advanced or recurrent endometrial carcinoma or carcinosarcoma, an Eastern Cooperative Oncology Group performance status of 0–2, and received no previous systemic chemotherapy for recurrence. Patients were randomly assigned (2:1) using an interactive web response system (block size of six) to either atezolizumab 1200 mg or placebo given intravenously with chemotherapy (carboplatin at area under the curve of 5 or 6 and paclitaxel 175 mg/m2 intravenously on day 1 every 21 days) for 6–8 cycles, then continued until progression. Stratification factors were country, histological subtype, advanced or recurrent status, and mismatch repair (MMR) status. Participants and treating clinicians were masked to group allocation. The hierarchically tested co-primary endpoints were progression-free survival (in patients with MMR-deficient [dMMR] tumours, and in the overall population) and overall survival (in the overall population). Primary analyses were done in the intention-to-treat population, defined as all randomly assigned patients who gave their full consent to participation in the study and data processing. Safety was assessed in all patients included in the intention-to-treat population who received at least one dose of study treatment. Here, we report the primary progression-free survival and the interim overall survival results. This study is ongoing and is registered with ClinicalTrials.gov, NCT03603184. Findings: Between Oct 3, 2018, and Jan 7, 2022, 551 patients were r

Published
2024

4. Intracranial complications of sinogenic and otogenic infections in children:an ESPN survey on their occurrence in the pre-COVID and post-COVID era

Author

Massimi, L., Cinalli, G., Frassanito, P., Arcangeli, V., Auer, C., Baro, V., Bartoli, A., Bianchi, F., Dietvorst, S., Di Rocco, F., Gallo, P., Giordano, F., Hinojosa, J., Iglesias, S., Jecko, V., Kahilogullari, G., Knerlich-Lukoschus, F., Laera, R., Locatelli, D., Luglietto, D., Luzi, M., Messing-Jünger, M., Mura, R., Ragazzi, P., Riffaud, L., Roth, J., Sagarribay, A., Pinheiro, M. Santos, Spazzapan, P., Spennato, P., Syrmos, N., Talamonti, G., Valentini, L., Van Veelen, M. L., Zucchelli, M., Tamburrini, G., Massimi, L., Cinalli, G., Frassanito, P., Arcangeli, V., Auer, C., Baro, V., Bartoli, A., Bianchi, F., Dietvorst, S., Di Rocco, F., Gallo, P., Giordano, F., Hinojosa, J., Iglesias, S., Jecko, V., Kahilogullari, G., Knerlich-Lukoschus, F., Laera, R., Locatelli, D., Luglietto, D., Luzi, M., Messing-Jünger, M., Mura, R., Ragazzi, P., Riffaud, L., Roth, J., Sagarribay, A., Pinheiro, M. Santos, Spazzapan, P., Spennato, P., Syrmos, N., Talamonti, G., Valentini, L., Van Veelen, M. L., Zucchelli, M., and Tamburrini, G.

Abstract

Background: COVID-19 pandemic is thought to have changed the epidemiology of some pediatric neurosurgical disease: among them are the intracranial complications of sinusitis and otitis (ICSO). According to some studies on a limited number of cases, both streptococci-related sinusitis and ICSO would have increased immediately after the pandemic, although the reason is not clear yet (seasonal changes versus pandemic-related effects). The goal of the present survey of the European Society for Pediatric Neurosurgery (ESPN) was to collect a large number of cases from different European countries encompassing the pre-COVID (2017–2019), COVID (2020–2021), and post-COVID period (2022–June 2023) looking for possible epidemiological and/or clinical changes. Material and methods: An English language questionnaire was sent to ESPN members about year of the event, patient’s age and gender, presence of immune-deficit or other favoring risk factors, COVID infection, signs and symptoms at onset, site of primary infection, type of intracranial complication, identified germ, type and number of surgical operations, type and duration of medical treatment, clinical and radiological outcome, duration of the follow-up. Results: Two hundred fifty-four cases were collected by 30 centers coming from 14 different European countries. There was a statistically significant difference between the post-COVID period (129 children, 86 cases/year, 50.7% of the whole series) and the COVID (40 children, 20 cases/year, 15.7%) or the pre-COVID period (85 children, 28.3 cases/year, 33.5%). Other significant differences concerned the presence of predisposing factors/concurrent diseases (higher in the pre-COVID period) and previous COVID infection (higher in the post-COVID period). No relevant differences occurred as far as demographic, microbiological, clinical, radiological, outcome, morbidity, and mortality data were concerned. Paranasal sinuses

Published
2024

5. 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

6. Specific Learning Disorders (SLD) and behavior impairment: Comorbidity or specific profile?

Author

Chieffo, Daniela Pia Rosaria, Arcangeli, Valentina, Moriconi, F., Marfoli, A., Lino, F., Vannuccini, S., Marconi, Elisa, Turrini, Ida, Brogna, Claudia, Veredice, Chiara, Antonietti, Alessandro, Sani, Gabriele, Mercuri, Eugenio Maria, Chieffo D. P. R., Arcangeli V., Marconi E., Turrini I., Brogna C., Veredice C., Antonietti A. (ORCID:0000-0002-7212-8076), Sani G. (ORCID:0000-0002-9767-8752), Mercuri E. M. (ORCID:0000-0002-9851-5365), Chieffo, Daniela Pia Rosaria, Arcangeli, Valentina, Moriconi, F., Marfoli, A., Lino, F., Vannuccini, S., Marconi, Elisa, Turrini, Ida, Brogna, Claudia, Veredice, Chiara, Antonietti, Alessandro, Sani, Gabriele, Mercuri, Eugenio Maria, Chieffo D. P. R., Arcangeli V., Marconi E., Turrini I., Brogna C., Veredice C., Antonietti A. (ORCID:0000-0002-7212-8076), Sani G. (ORCID:0000-0002-9767-8752), and Mercuri E. M. (ORCID:0000-0002-9851-5365)

Abstract

Specific Learning Disorder (SLD) is a neurodevelopmental disorder characterized by difficulties in perceiving and processing verbal and non-verbal information. It is usually accompanied by impaired academic skills leading to school dropout and emotional disturbances, resulting in significant distress and behavioral problems. Methods: A cognitive, academic, and emotional-behavioral assessment was performed at T0 and T1 in children and adolescents with SLD. Participants received psychotherapy and speech therapy treatment from T0 to T1. Results: In SLD,the most compromised cognitive functions were working memory and writing skills. An impact on academic abilities was found. Children and adolescents with SLD experience greater anxiety and depression levels compared to their control peers. Conclusions: SLD may adversely influence psychological well-being. To counteract such a consequence, more specific cognitive and academic skill-oriented strategies should be taken into consideration.

Published
2023

7. 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

9. 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

10. Posterior Fossa Tumor Rehabilitation: An Up-to-Date Overview

Author

Chieffo, Daniela Pia Rosaria, Lino, F., Arcangeli, Valentina, Moriconi, F., Frassanito, Paolo, Massimi, Luca, Tamburrini, Gianpiero, Chieffo D. P. R., Arcangeli V., Frassanito P., Massimi L., Tamburrini G. (ORCID:0000-0002-7139-5711), Chieffo, Daniela Pia Rosaria, Lino, F., Arcangeli, Valentina, Moriconi, F., Frassanito, Paolo, Massimi, Luca, Tamburrini, Gianpiero, Chieffo D. P. R., Arcangeli V., Frassanito P., Massimi L., and Tamburrini G. (ORCID:0000-0002-7139-5711)

Abstract

This narrative review highlights the latest achievements in the field of post-surgical rehabilitation of posterior fossa tumors. Studies investigating the effects of cognitive rehabilitation programs have been considered, following a comprehensive literature search in the scientific electronic databases: Pubmed, Scopus, Plos One, and ScienceDirect. This review investigates the effects of cognitive remediation, with specific highlights for single cognitive domains. The results revealed that in spite of the increasing number of children who survive into adulthood, very few studies investigated the effects of rehabilitation programs in this specific population. This study details new, promising therapeutic opportunities for children after brain surgery. More research in this filed is needed to identify the most effective protocols for clinical use.

Published
2022

13. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study

Author

Cicchiello, F., Riva, F., Cazzaniga, M. E., Pedani, F., Nicolini, Matteo, Butti, C., Liscia, N., Pogliani, C., Capri, Giorgia, Alu', Matteo, Febbraro, A., Petrucelli, L., D'Onofrio, L., De Laurentiis, M., Pellegrini, D., Mentuccia, L., Cocciolone, V., Miraglio, E., Bajardi, E., Dester, M., Paternò, Enrico, Guaitoli, G., Ferrarini, I., Gervasi, Elisea, Licata, L., Benedetto, C., Andreis, D., Bordin, E., Ancona, C., Pizzuti, L., Fotia, V., Berardi, R., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G. V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M. C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, Anna, Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M. R., Vici, P., Zambelli, Ruggero Astolfo, Clivio, L., Torri, V., Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cazzaniga, M. E, Bianchi, G. V, Cursano, M. C, Valerio, M. R, Torri, V., De Laurentiis, Michelino, Cicchiello, F., Riva, F., Cazzaniga, M. E., Pedani, F., Nicolini, M., Butti, C., Liscia, N., Pogliani, C., Capri, G., Alù, M., Febbraro, A., Petrucelli, L., D'Onofrio, L., De Laurentiis, M., Pellegrini, D., Mentuccia, L., Cocciolone, V., Miraglio, E., Bajardi, E., Dester, M., Paternò, E., Guaitoli, G., Ferrarini, I., Gervasi, E., Licata, L., Benedetto, C., Andreis, D., Bordin, E., Ancona, C., Pizzuti, L., Fotia, V., Berardi, R., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G. V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M. C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, A., Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M. R., Vici, P., Zambelli, A., Clivio, L., Cazzaniga, M., Ala, M., ARRIVAS BAJARDI, E., Paternã², E., Bianchi, G., Cursano, M., and Valerio, M.

Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, chemistry.chemical_compound, ErbB-2, 0302 clinical medicine, Dose-intensity, Exemestane, 80 and over, Neoplasm Metastasis, Fulvestrant, Aged, 80 and over, education.field_of_study, Advanced breast cancer, Dose-intensity, Everolimus, Fulvestrant, Hormone-receptor positive, Advanced breast cancer, Everolimus, Hormone-receptor positive, Adult, Aged, Androstadienes, Breast Neoplasms, Female, Follow-Up Studies, Humans, Middle Aged, Neoplasm Staging, Surgery, General Medicine, Everolimu, 030220 oncology & carcinogenesis, Receptor, medicine.drug, medicine.medical_specialty, Population, Socio-culturale, 03 medical and health sciences, Breast cancer, Internal medicine, medicine, Adverse effect, education, Gynecology, business.industry, fungi, Cancer, medicine.disease, Clinical trial, 030104 developmental biology, chemistry, business
Abstract

Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Results From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33–83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1–7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4–58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). Conclusions The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.

Published
2017

14. Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study

Author

Cazzaniga, M., Verusio, C., Ciccarese, M., Fumagalli, A., Sartori, D., Ancona, C., Airoldi, M., Moretti, G., Ficorella, C., Arcangeli, V., Diodati, L., Zambelli, A., Febbraro, A., Generali, D., Pistelli, M., Garrone, O., Musolino, A., Vici, P., Maur, M., Mentuccia, L., La Verde, N., Bianchi, G., Artale, S., Blasi, L., Piezzo, M., Atzori, F., Turletti, A., Benedetto, C., Cursano, M. C., Fabi, A., Gebbia, V., Schirone, A., Palumbo, R., Ferzi, A., Frassoldati, A., Scavelli, C., Clivio, L., Torri, V., On behalf of The EVA Study Group, Cazzaniga, Marina, Verusio, Claudio, Ciccarese, Mariangela, Fumagalli, Alberto, Sartori, Donata, D'Ancona, Cristina, Airoldi, Mario, Moretti, Gabriella, Ficorella, Corrado, Arcangeli, Valentina, Diodati, Lucrezia, Zambelli, Alberto, Febbraro, Antonio, Generali, Daniele, Pistelli, Mirco, Garrone, Ornella, Musolino, Antonino, Vici, Patrizia, Maur, Michela, Mentuccia, Lucia, La Verde, Nicla, Bianchi, Giulia, Artale, Salvatore, Blasi, Livio, Piezzo, Matilde, Atzori, Francesco, Turletti, Anna, Benedetto, Chiara, Cursano, Maria Concetta, Fabi, Alessandra, Gebbia, Vittorio, Schirone, Antonio, Palumbo, Raffaella, Ferzi, Antonella, Frassoldati, Antonio, Scavelli, Claudio, Clivio, Luca, Torri, Valter, Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio MR., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M.C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., and On behalf of The EVA Study Group

Subjects
medicine.medical_specialty, Socio-culturale, Hormone-receptor positive, Exemestane, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Breast cancer, Elderly, Weight loss, Internal medicine, Advanced breast cancer, Everolimus, Oncology, medicine, 030212 general & internal medicine, Stomatitis, Pneumonitis, business.industry, Cancer, medicine.disease, Rash, Everolimu, chemistry, 030220 oncology & carcinogenesis, MED/06 - ONCOLOGIA MEDICA, medicine.symptom, business, Research Paper, medicine.drug
Abstract

BACKGROUND: The present analysis focuses on real-world data of Everolimus- Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and [greater than or equal to] 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel- Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged [greater than or equal to] 65 years, of whom 87 were [greater than or equal to] 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged [greater than or equal to] 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (> 7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged [greater than or equal to] 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.

Published
2018

15. Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study

Author

Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Ancona C., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., On behalf of The EVA Study Group, Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Ancona C., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., and On behalf of The EVA Study Group

Abstract

BACKGROUND: The present analysis focuses on real-world data of Everolimus- Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and [greater than or equal to] 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel- Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged [greater than or equal to] 65 years, of whom 87 were [greater than or equal to] 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged [greater than or equal to] 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (> 7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged [greater than or equal to] 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.

Published
2018

16. Correction: Everolimus (Eve) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study (Oncotarget (2018) 9:77 (34639-34640) DOI: 10.18632/oncotarget.25874)

Author

Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., and Torri V.

Abstract

This article has been corrected: The correct author names are given below: Chiara Ancona and Michela Piezzo.

Published
2018

17. Erratum: Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study (Oncotarget (2018) 9 (31877-31887) DOI: 10.18632/oncotarget.25874)

Author

Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., and Torri V.

Abstract

This article has been corrected: The correct author name is given below:.

Published
2018

18. Single-suture craniosynostosis: is there a correlation between preoperative ophthalmological, neuroradiological, and neurocognitive findings?

Author

Chieffo, Daniela Pia Rosaria, Arcangeli, Valentina, Bianchi, Federico, Salerni, Annabella, Massimi, Luca, Frassanito, Paolo, Tamburrini, Gianpiero, Chieffo, D P R, Arcangeli, V, Bianchi, F, Salerni, A, Massimi, L, Frassanito, P, Tamburrini, G (ORCID:0000-0002-7139-5711), Chieffo, Daniela Pia Rosaria, Arcangeli, Valentina, Bianchi, Federico, Salerni, Annabella, Massimi, Luca, Frassanito, Paolo, Tamburrini, Gianpiero, Chieffo, D P R, Arcangeli, V, Bianchi, F, Salerni, A, Massimi, L, Frassanito, P, and Tamburrini, G (ORCID:0000-0002-7139-5711)

Abstract

Background In spite of literature data stating that children with single-suture craniosynostosis have an increased risk for neuropsychological deficits, no data are present clarifying the potential risk factors. Methods All children with non-syndromic single-suture craniosynostosis operated on from January 2014 to January 2017 were enrolled. A comprehensive neurocognitive and neuro-ophthalmological evaluation was performed before surgery and 6 months after surgery. A further neurocognitive evaluation was performed 12 months after surgery. All children had a preoperative CT/MR study. Results One hundred forty-two patients were enrolled; 87 are affected by sagittal craniosynostosis, 38 by trigonocephaly, and 17 by plagiocephaly. A global neurocognitive impairment was documented in 22/87 children with scaphocephaly, 5/38 children with trigonocephaly, and 6/17 children with anterior plagiocephaly. There was a significant relationship between results of the ophthalmological evaluation, global IQ, and CT findings at diagnosis (r = 0.296, p < 0.001; r =0.187, p 0.05). Though a significant recovery was documented after surgery, a persistence of eye coordination deficits was present at 6 months in 1 out of 3 children with abnormal preoperative exams. A significant correlation was found between pathological CT findings and persistence of below average neuro-ophthalmological and neurocognitive findings 6 months after surgery, as well as between CT findings and neurocognitive scores at the 1 year follow-up (r = 0.411; p < 0.01). Conclusion The presence of neuroradiological abnormalities appears to be related to both ophthalmological and neurocognitive deficits at diagnosis. This relationship is maintained in spite of the surgical treatment in children who show the persistence of ophthalmological and neurocognitive deficits during the follow-up.

Published
2020

19. 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

20. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study

Author

Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cicchiello F., Riva F., Cazzaniga M. E., Pedani F., Nicolini M., Butti C., Liscia N., Pogliani C., Capri G., Alu M., Febbraro A., Petrucelli L., D'Onofrio L., De Laurentiis M., Pellegrini D., Mentuccia L., Cocciolone V., Miraglio E., Bajardi E., Dester M., Paterno E., Guaitoli G., Ferrarini I., Gervasi E., Licata L., Benedetto C., Andreis D., Bordin E., Ancona C., Pizzuti L., Fotia V., Berardi R., Airoldi M., Arcangeli V., Artale S., Atzori F., Ballerio A., Bianchi G. V., Blasi L., Campidoglio S., Ciccarese M., Cursano M. C., Piezzo M., Fabi A., Ferrari L., Ferzi A., Ficorella C., Frassoldati A., Fumagalli A., Garrone O., Gebbia V., Generali D., La Verde N., Maur M., Michelotti A., Moretti G., Musolino A., Palumbo R., Pistelli M., Porpiglia M., Sartori D., Scavelli C., Schirone A., Turletti A., Valerio M. R., Vici P., Zambelli A., Clivio L., Torri V., Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cicchiello F., Riva F., Cazzaniga M. E., Pedani F., Nicolini M., Butti C., Liscia N., Pogliani C., Capri G., Alu M., Febbraro A., Petrucelli L., D'Onofrio L., De Laurentiis M., Pellegrini D., Mentuccia L., Cocciolone V., Miraglio E., Bajardi E., Dester M., Paterno E., Guaitoli G., Ferrarini I., Gervasi E., Licata L., Benedetto C., Andreis D., Bordin E., Ancona C., Pizzuti L., Fotia V., Berardi R., Airoldi M., Arcangeli V., Artale S., Atzori F., Ballerio A., Bianchi G. V., Blasi L., Campidoglio S., Ciccarese M., Cursano M. C., Piezzo M., Fabi A., Ferrari L., Ferzi A., Ficorella C., Frassoldati A., Fumagalli A., Garrone O., Gebbia V., Generali D., La Verde N., Maur M., Michelotti A., Moretti G., Musolino A., Palumbo R., Pistelli M., Porpiglia M., Sartori D., Scavelli C., Schirone A., Turletti A., Valerio M. R., Vici P., Zambelli A., Clivio L., and Torri V.

Abstract

Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Results From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33–83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1–7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4–58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). Conclusions The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.

Published
2017

23. Metronomic chemotherapy (mCHT) in HER2-ve advanced breast cancer (ABC) patients (pts): old drugs, new results. The multicenter VICTOR-6 study

Author

Cazzaniga, M., primary, Orlando, L., additional, Melegari, E., additional, Arcangeli, V., additional, Butera, A., additional, Pinotti, G., additional, Vallini, I., additional, Mocerino, C., additional, Giovanardi, F., additional, Cretella, E., additional, Gambaro, A., additional, Pistelli, M., additional, Donati, S., additional, Pizzuti, L., additional, Spagnuolo, A., additional, Putzu, C., additional, Leonardi, V., additional, De Angelis, C., additional, Pedroli, S., additional, and Torri, V., additional

Published
2017
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24. Everolimus-exemestane (EE) vs palbociclib-letrozole (PL) or palbociclib-fulvestrant (PF) in the treatment of metastatic HR+, HER2- breast cancer. Indirect comparisons with network meta-analysis for daily clinical practice

Author

Stocchi, L., primary, Gianni, L., additional, Nicolini, M., additional, Santelmo, C., additional, Carminati, O., additional, Arcangeli, V., additional, Papi, M., additional, Cherubini, C., additional, Polselli, A., additional, and Tassinari, D., additional

Published
2017
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25. Everolimus-exemestane (EE) vs palbociclib-letrozole (PL) or palbociclib-fulvestrant (PF) in the treatment of metastatic HR+, HER2- breast cancer. An indirect comparison with network meta-analysis

Author

Cherubini, C., primary, Gianni, L., additional, Stocchi, L., additional, Arcangeli, V., additional, Carminati, O., additional, Papi, M., additional, Pasini, G., additional, Fantini, M., additional, Nicoletti, S.V.L., additional, and Tassinari, D., additional

Published
2017
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26. Preoperative neurocognitive evaluation as a predictor of brain tumor grading in pediatric patients with supratentorial hemispheric tumors

Author

Chieffo, Daniela Pia Rosaria, Tamburrini, Gianpiero, Frassanito, P., Arcangeli, V., Caldarelli, Massimo, Di Rocco, C., Chieffo, D., Tamburrini, Gianpiero (ORCID:0000-0002-7139-5711), Caldarelli, M. (ORCID:0000-0002-2111-3800), Chieffo, Daniela Pia Rosaria, Tamburrini, Gianpiero, Frassanito, P., Arcangeli, V., Caldarelli, Massimo, Di Rocco, C., Chieffo, D., Tamburrini, Gianpiero (ORCID:0000-0002-7139-5711), and Caldarelli, M. (ORCID:0000-0002-2111-3800)

Abstract

Objective: The objective of the present study was to retrospectively evaluate the relationship between tumor grading and a selective evaluation of neurocognitive and behavioral functions in children with supratentorial hemispheric brain tumors. Methods: Children admitted with a diagnosis of supratentorial hemispheric tumors involving the cerebral hemispheres or the thalamus at the Pediatric Neurosurgery Unit of the Catholic University of Rome between January 2008 and January 2014 were considered for the present study. Exclusion criteria were represented by age less than 2 years, severe neurological deficits, seizures, and a metastatic disease. A selective neurocognitive and behavioral workout was used for children aged less and more than 5 years. Results: Global cognitive functions as well as selective neurocognitive and behavioral profiles were found to be significantly worse in children with low-grade tumors, compared with those affected by higher-grades histotypes. Frontal locations for cortical tumors and thalamic lesions were significantly related with worse results, with a clear contribution of dominant vs. nondominant hemisphere involvement and an age higher than 5 years. Conclusions: Preoperative global and selective neurocognitive evaluation might contribute to the prediction of the tumor aggressiveness. Due to a longer clinical history, more benign tumors more frequently arrive to the diagnosis with a neurocognitive compromise in spite of an apparently mild presence of neurological symptoms and signs.

Published
2016

28. Toxicity of targeted therapy in elderly patients

Author

Stocchi, L., primary, Famtini, M., additional, Drudi, G., additional, Barzotti, E., additional, Ridolfi, C., additional, Nicoletti, S., additional, Arcangeli, V., additional, Drudi, F., additional, Nicolini, M., additional, Polselli, A., additional, Santelmo, C., additional, Tamburini, E., additional, Gianni, L., additional, and Tassinari, D., additional

Published
2016
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29. Pazopanib plus weekly paclitaxel versus weekly paclitaxel alone for platinum-resistant or platinum-refractory advanced ovarian cancer (MITO 11): a randomised, open-label, phase 2 trial

Author

Pignata, S, Lorusso, D, Scambia, Giovanni, Sambataro, D, Tamberi, S, Cinieri, S, Mosconi, Am, Orditura, M, Brandes, Aa, Arcangeli, V, Panici, Pb, Pisano, C, Cecere, Sc, Di Napoli, M, Raspagliesi, F, Maltese, G, Salutari, V, Ricci, C, Daniele, G, Piccirillo, Mc, Di Maio, M, Gallo, C, Perrone, F., Scambia, Giovanni (ORCID:0000-0003-2758-1063), Pignata, S, Lorusso, D, Scambia, Giovanni, Sambataro, D, Tamberi, S, Cinieri, S, Mosconi, Am, Orditura, M, Brandes, Aa, Arcangeli, V, Panici, Pb, Pisano, C, Cecere, Sc, Di Napoli, M, Raspagliesi, F, Maltese, G, Salutari, V, Ricci, C, Daniele, G, Piccirillo, Mc, Di Maio, M, Gallo, C, Perrone, F., and Scambia, Giovanni (ORCID:0000-0003-2758-1063)

Abstract

BACKGROUND: Inhibition of angiogenesis is a valuable treatment strategy for ovarian cancer. Pazopanib is an anti-angiogenic drug active in ovarian cancer. We assessed the effect of adding pazopanib to paclitaxel for patients with platinum-resistant or platinum-refractory advanced ovarian cancer. METHODS: We did this open-label, randomised phase 2 trial at 11 hospitals in Italy. We included patients with platinum-resistant or platinum-refractory ovarian cancer previously treated with a maximum of two lines of chemotherapy, Eastern Cooperative Oncology Group performance status 0-1, and no residual peripheral neurotoxicity. Patients were randomly assigned (1:1) to receive weekly paclitaxel 80 mg/m(2) with or without pazopanib 800 mg daily, and stratified by centre, number of previous lines of chemotherapy, and platinum-free interval status. The primary endpoint was progression-free survival, assessed in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01644825. This report is the final analysis; the trial is completed. FINDINGS: Between Dec 15, 2010, and Feb 8, 2013, we enrolled 74 patients: 37 were randomly assigned to receive paclitaxel and pazopanib and 37 were randomly assigned to receive paclitaxel only. One patient, in the paclitaxel only group, withdrew from the study and was excluded from analyses. Median follow-up was 16·1 months (IQR 12·5-20·8). Progression-free survival was significantly longer in the pazopanib plus paclitaxel group than in the paclitaxel only group (median 6·35 months [95% CI 5·36-11·02] vs 3·49 months [2·01-5·66]; hazard ratio 0·42 [95% CI 0·25-0·69]; p=0·0002). We recorded no unexpected toxic effects or deaths from toxic effects. Adverse events were more common in the pazopanib and paclitaxel group than in the paclitaxel only group. The most common grade 3-4 adverse events were neutropenia (11 [30%] in the pazopanib group vs one [3%] in the paclitaxel group), fatigue (four [11%] vs tw

Published
2015

35. Genetic and Epigenetic Alterations of CDH1 Regulatory Regions in Hereditary and Sporadic Gastric Cancer

Author

Celina São José, Francesca Rebuzzi, Chiara Molinari, Matteo Canale, Daniele Calistri, Elisa Ferracci, Paola Ulivi, Ana André, Gianluca Tedaldi, Paolo Morgagni, Valentina Arcangeli, Sara Pignatta, Luca Saragoni, Rita Barbosa-Matos, Carla Oliveira, Guglielmina Nadia Ranzani, Mila Ravegnani, Rita Danesi, Giovanni Martinelli, Tedaldi G., Molinari C., Jose C.S., Barbosa-Matos R., Andre A., Danesi R., Arcangeli V., Ravegnani M., Saragoni L., Morgagni P., Rebuzzi F., Canale M., Pignatta S., Ferracci E., Martinelli G., Ranzani G.N., Oliveira C., Calistri D., and Ulivi P.

Subjects
Next-Generation Sequencing, Pharmaceutical Science, Biology, Pharmacy and materia medica, Drug Discovery, Genetic predisposition, medicine, Epigenetics, Gene, CDH1 gene, Regulation of gene expression, Genetics, DNA methylation, gastric cancer, Methylation, medicine.disease, RS1-441, Regulatory sequence, Molecular Medicine, Medicine, Hereditary diffuse gastric cancer, regulatory regions, genetic predisposition
Abstract

E-cadherin is a key player in gastric cancer (GC) and germline alterations of CDH1, its encoding gene, are responsible for Hereditary Diffuse Gastric Cancer (HDGC) syndrome. This study aimed at elucidating the role of genetic variants and DNA methylation of CDH1 promoter and enhancers in the regulation of gene expression. For this purpose, we analyzed genetic variants of the CDH1 gene through Next-Generation Sequencing (NGS) in a series of GC cell lines (NCI-N87, KATO-III, SNU-1, SNU-5, GK2, AKG, KKP) and the corresponding CDH1 expression levels. By bisulfite genomic sequencing, we analyzed the methylation status of CDH1 regulatory regions in 8 GC cell lines, in a series of 13 sporadic GC tissues and in a group of 20 HDGC CDH1-negative patients and 6 healthy controls. The NGS analysis on CDH1 coding and regulatory regions detected genetic alterations in 3 out of 5 GC cell lines lacking functional E-cadherin. CDH1 regulatory regions showed different methylation patterns in patients and controls, GC cell lines and GC tissues, expressing different E-cadherin levels. Our results showed that alterations in terms of genetic variants and DNA methylation patterns of both promoter and enhancers are associated with CDH1 expression levels and have a role in its regulation.

Published
2021
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36. Prophylactic risk-reducing salpingo-oophorectomy in BRCA mutation carriers: what is going on in a region of northern Italy?

Author

M. Stefanetti, Fabio Facchinetti, Giovanni Grandi, Roberto Berretta, Laura Cortesi, Ruby Martinello, Angela Toss, P. De Iaco, A. Perrone, R. De Domenico, Andrea Amadori, Lorenzo Aguzzoli, Vincenzo Dario Mandato, Stefano Friso, C. Merisio, G Comerci, Pantaleo Greco, Gennaro Scutiero, Anna Myriam Perrone, F. Rosati, M. D. Nuzzo, V. Arcangeli, Margaret Sammarini, Grandi G., Perrone A.M., Perrone A., Mandato V.D., Comerci G., Sammarini M., Merisio C., Amadori A., Stefanetti M., Martinello R., Facchinetti F., De Iaco P., Aguzzoli L., Arcangeli V., Berretta R., Cortesi L., De Domenico R., Nuzzo M.D., Friso S., Greco P., Rosati F., Scutiero G., and Toss A.

Subjects
endocrine system diseases, medicine.medical_treatment, BRCA, 0302 clinical medicine, Medicine, 030212 general & internal medicine, Young adult, skin and connective tissue diseases, Ovarian Neoplasms, 030219 obstetrics & reproductive medicine, Obstetrics, BRCA1 Protein, Obstetrics and Gynecology, Middle Aged, female genital diseases and pregnancy complications, Risk-reducing salpingo-oophorectomy, Serous fluid, Italy, Female, Breast cancer survivor, Hysterectomy, Ovarian cancer, Prophylactic, pathology, Adult, Aged, BRCA2 Protein, Breast Neoplasms, Humans, Mutation, Risk, Young Adult, Salpingo-oophorectomy, Breast Neoplasm, Human, medicine.medical_specialty, Prophylactic, General Biochemistry, Genetics and Molecular Biology, NO, 03 medical and health sciences, Breast cancer, business.industry, Ovarian Neoplasm, BRCA mutation, Cancer, medicine.disease, Concomitant, pathology, business
Abstract

Background BRCA1 mutation carriers are recommended to undergo prophylactic risk-reducing salpingo-oophorectomy (RRSO) between the ages of 35 and 40 or when child bearing is complete, with a possible delay until age 40–45 for BRCA2 mutation carriers. Study Question Primary outcome was the rate of unsuspected cancer findings during RRSO in a region of northern Italy (Emilia Romagna) and secondary outcomes were details of RRSO: age at surgical intervention, the venue of the procedures in relation to the surgical/pathological quality and the rate/role of concomitant opportunistic hysterectomies. Study Design Multicentre data collection by invitation to report current RRSO practices. Results A total of 222 RRSOs (54.5 % BRCA1, 34.7 % BRCA2, 1.8 % BRCA1 and BRCA2 combined, 5.8 % BRCA-VUS and 3.2 % BRCA not better specified) were reported from 9 different centres, half in non-university hospitals and the remainder in university hospitals. Breast cancer survivors (56.3 %) underwent the RRSO at a younger age (47.8 vs 50.6 years, p = 0.02). The mean and median ages at surgical intervention (49.0 and 48.0, respectively) were similar for BRCA1 and BRCA2 mutation carriers, as was the temporal trend in age distribution, and proportions treated in university and non-university hospitals. A diagnosis of ovarian invasive cancer was reported in 3.5 % of subjects, all BRCA1 or BRCA-combined subjects, at a median and mean age of 57 years (range 42–68). Abnormal tubal findings, such as serous tubal intraepithelial lesions (STIL) (100 %), secretory cell outgrowth (SCOUT) (100 %) and STIC (71.4 %), were mainly reported by pathologists in university hospitals. Of the 222 procedures, 15 (6.7 %) included hysterectomies: in none of these cases was a primitive uterine endometrioid or serous cancer found. Conclusions The results from this multicentre regional study should guide future preventive health policies for RRSO in BRCA mutation carriers.

Published
2021

37. Pazopanib plus weekly paclitaxel versus weekly paclitaxel alone for platinum-resistant or platinum-refractory advanced ovarian cancer (MITO 11): a randomised, open-label, phase 2 trial

Author

Saverio Cinieri, Daniela Sambataro, Vanda Salutari, Stefano Tamberi, Anna Maria Mosconi, Francesco Raspagliesi, Francesco Perrone, Sandro Pignata, Giovanni Scambia, Maria Carmela Piccirillo, Valentina Arcangeli, Giuseppa Maltese, Carmela Pisano, Gennaro Daniele, Marilena Di Napoli, Massimo Di Maio, Alba A. Brandes, Caterina Ricci, Sabrina Chiara Cecere, Pierluigi Beneditti Panici, Domenica Lorusso, Ciro Gallo, Michele Orditura, Pignata, S, Lorusso, D, Scambia, G, Sambataro, D, Tamberi, S, Cinieri, S, Mosconi, Am, Orditura, M, Brandes, Aa, Arcangeli, V, Panici, Pb, Pisano, C, Cecere, Sc, Di Napoli, M, Raspagliesi, F, Maltese, G, Salutari, V, Ricci, C, Daniele, G, Piccirillo, Mc, Di Maio, M, Gallo, C, and Perrone, F

Subjects
medicine.medical_specialty, Indazoles, Paclitaxel, medicine.medical_treatment, Population, Drug Resistance, Phases of clinical research, Aged, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Drug Resistance, Neoplasm, Female, Humans, Italy, Middle Aged, Neoplasm Recurrence, Local, Ovarian Neoplasms, Platinum, Pyrimidines, Sulfonamides, Treatment Outcome, Oncology, Neutropenia, Gastroenterology, Pazopanib, chemistry.chemical_compound, Internal medicine, pazopanib, medicine, Clinical endpoint, education, Chemotherapy, education.field_of_study, business.industry, medicine.disease, Surgery, Neoplasm Recurrence, ovarian cancer, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Local, chemistry, Neoplasm, Ovarian cancer, business, medicine.drug
Abstract

BACKGROUND: Inhibition of angiogenesis is a valuable treatment strategy for ovarian cancer. Pazopanib is an anti-angiogenic drug active in ovarian cancer. We assessed the effect of adding pazopanib to paclitaxel for patients with platinum-resistant or platinum-refractory advanced ovarian cancer. METHODS: We did this open-label, randomised phase 2 trial at 11 hospitals in Italy. We included patients with platinum-resistant or platinum-refractory ovarian cancer previously treated with a maximum of two lines of chemotherapy, Eastern Cooperative Oncology Group performance status 0-1, and no residual peripheral neurotoxicity. Patients were randomly assigned (1:1) to receive weekly paclitaxel 80 mg/m(2) with or without pazopanib 800 mg daily, and stratified by centre, number of previous lines of chemotherapy, and platinum-free interval status. The primary endpoint was progression-free survival, assessed in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01644825. This report is the final analysis; the trial is completed. FINDINGS: Between Dec 15, 2010, and Feb 8, 2013, we enrolled 74 patients: 37 were randomly assigned to receive paclitaxel and pazopanib and 37 were randomly assigned to receive paclitaxel only. One patient, in the paclitaxel only group, withdrew from the study and was excluded from analyses. Median follow-up was 16·1 months (IQR 12·5-20·8). Progression-free survival was significantly longer in the pazopanib plus paclitaxel group than in the paclitaxel only group (median 6·35 months [95% CI 5·36-11·02] vs 3·49 months [2·01-5·66]; hazard ratio 0·42 [95% CI 0·25-0·69]; p=0·0002). We recorded no unexpected toxic effects or deaths from toxic effects. Adverse events were more common in the pazopanib and paclitaxel group than in the paclitaxel only group. The most common grade 3-4 adverse events were neutropenia (11 [30%] in the pazopanib group vs one [3%] in the paclitaxel group), fatigue (four [11%] vs two [6%]), leucopenia (four [11%] vs one [3%]), hypertension (three [8%] vs none [0%]), raised aspartate aminotransferase or alanine aminotransferase (three [8%] vs none), and anaemia (two [5%] vs five [14%]). One patient in the pazopanib group had ileal perforation. INTERPRETATION: Our findings suggest that a phase 3 study of the combination of weekly paclitaxel plus pazopanib for patients with platinum-resistant or platinum-refractory advanced ovarian cancer is warranted. FUNDING: National Cancer Institute of Napoli and GlaxoSmithKline. Copyright © 2015 Elsevier Ltd. All rights reserved. Comment in Targeting the microenvironment in ovarian cancer. [Lancet Oncol. 2015]

Published
2015

38. Psychological Sequelae of Dog Bites in Children: A Review.

Author

Monti L, Kotzalidis GD, Arcangeli V, Brozzi C, Iacovino R, Giansanti C, Belella D, Marconi E, Pulitanò SM, Mazza M, Marano G, Conti G, Janiri D, Sani G, and Chieffo DPR

Abstract

Background/objectives: Although rare in the Western world, dog bites may be lethal or lead to physically severe outcomes. However, little attention is given to their psychological consequences. We aimed to review their psychological consequences in children 1-14 years of age, focusing on the prevalence and nature of psychological disorders, evaluating the impact on future mental health of children and their families, and assessing the effectiveness of preventive interventions and measures., Methods: On 23 May 2024, we investigated the PubMed, CINAHL, and PsycINFO/PsycARTICLES databases using ("dog bite" OR animal-induced OR animal-caused) AND (psychol* OR mental OR psychiatr* OR anxiety OR anxious OR depress* OR obsess* OR trauma* OR psychosis OR psychotic OR schizophren* OR schizoaffect*) filtered for ages 0-18 years. This resulted in 311 records, of which 50 were eligible. These included original research, case reports, patient surveys, and reviews/meta-analyses., Results: Findings indicate that younger children are particularly vulnerable, often suffering head/neck bites, leading to severe injuries and psychological distress, with post-traumatic stress disorder (PTSD) being a common outcome. Symptoms such as nightmares, flashbacks, anxiety, and social withdrawal were frequently reported. Positive parental support and timely psychological interventions were found to mitigate these effects., Conclusions: Interdisciplinary approaches integrating education, cognitive restructuring, and behaviour modification are needed to effectively prevent and address the psychological impacts of dog bites. Summarising, dog bites in children result in substantial psychological sequelae, necessitating robust prevention and intervention strategies to improve their quality of life and reduce the risk of chronic mental conditions.

Published
2024
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39. Evaluation of an Italian Population-Based Programme for Risk Assessment and Genetic Counselling and Testing for BRCA1/2-Related Hereditary Breast and Ovarian Cancer after 10 Years of Operation: An Observational Study Protocol.

Author

Ferretti S, Sassoli de Bianchi P, Canuti D, Campari C, Cortesi L, Arcangeli V, Barbieri E, D'Aloia C, Danesi R, De Iaco P, De Lillo M, Lombardo L, Moretti G, Musolino A, Palli D, Palmonari C, Ravegnani M, Tafà A, Tononi A, Turchetti D, Zamagni C, Zampiga V, Bucchi L, and The Hboc Study Group

Abstract

Hereditary breast/ovarian cancer (HBOC) syndrome is caused by the inheritance of monoallelic germline BRCA1/2 gene mutations. If BRCA1/2 mutation carriers are identified before the disease develops, effective actions against HBOC can be taken, including intensive screening, risk-reducing mastectomy and salpingo-oophorectomy, and risk-reducing medications. The Italian National Prevention Plan mandates the creation of regional BRCA genetic testing programmes. So far, however, only informal data have been reported on their implementation. We have designed a study aimed at evaluating the results of a population-based programme for risk assessment and genetic counselling and testing for BRCA1/2-related HBOC that is underway in the Emilia-Romagna region (northern Italy). The programme-which is entirely free-includes basic screening with an estimate of the likelihood of carrying a BRCA1/2 mutation using a familial risk assessment tool, a closer examination of women with suspected risk increase, an assessment of the need for further genetic counselling and, if needed, genetic testing and risk-reducing interventions. In this paper, the design of the programme and the protocol of the study are presented. The study has an observational, historical cohort design. Eligible are the women found to be at an increased risk of HBOC (profile 3 women). The main objectives are (i) to determine the precision of the programme in measuring the level of risk of HBOC for profile 3 women; (ii) to determine the characteristics of profile 3 women and their association with the risk management strategy chosen; (iii) to compare the age at onset, histologic type, tumour stage, molecular subtype, and prognosis of breast/ovarian cancers observed in the cohort of profile 3 women with the features of sporadic cancers observed in the general female population; (iv) to determine the level and the determinants of adherence to recommendations; and (v) to determine the appropriateness and timing of risk-reducing surgery and medications. Investigating the quality and results of the programme is necessary because the best practices in risk assessment and genetic counselling and testing for BRCA1/2-related cancer and the challenges they encounter should be identified and shared. The study has the potential to provide sound empirical evidence for the factors affecting the effectiveness of this type of service.

Published
2024
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40. Atypical cancer risk profile in carriers of Italian founder BRCA1 variant p.His1673del: Implications for classification and clinical management.

Author

Innella G, Fortuno C, Caleca L, Feng BJ, Carroll C, Parsons MT, Miccoli S, Montagna M, Calistri D, Cortesi L, Pasini B, Manoukian S, Giachino D, Matricardi L, Foti MC, Zampiga V, Piombino C, Barbieri E, Lutati FV, Azzolini J, Danesi R, Arcangeli V, Caputo SM, Boutry-Kryza N, Goussot V, Hiraki S, Richardson M, Ferrari S, Radice P, Spurdle AB, and Turchetti D

Subjects
Humans, Female, Italy epidemiology, Middle Aged, Adult, Pedigree, Breast Neoplasms genetics, Breast Neoplasms epidemiology, Aged, Heterozygote, Founder Effect, Risk Factors, Carrier Proteins, BRCA1 Protein genetics, Genetic Predisposition to Disease, Penetrance, Ovarian Neoplasms genetics
Abstract

Background: BRCA1:c.5017&#95;5019del (p.His1673del) is a founder variant relatively frequent in Northern Italy. Despite previous suggestion of pathogenicity, variant classification in public databases is still conflicting, needing additional evidence., Methods: Maximum likelihood penetrance of breast/ovarian and other cancer types was estimated using full pedigree data from 53 informative Italian families. The effect of the variant on BRCA1-ABRAXAS1 interaction was assessed using a GFP-fragment reassembly-based PPI assay. Results were combined with additional data from multiple sources to classify the variant according to ACMG/AMP classification rules specified for BRCA1/2., Results: Variant-carriers displayed increased risk for ovarian cancer (HR = 33.0, 95% CI = 7.0-155.0; cumulative risk at age 70 = 27.6%, 95% CI = 12.6-40.0%) but not for breast cancer (HR = 0.7, 95% CI = 0.2-2.2). An increased risk of uterine cancer (HR = 8.0, 95% CI = 1.03-61.6) emerged, warranting further evaluation. Likelihood-ratio in favor of pathogenicity was 98898642.82 under assumption of standard BRCA1 breast and ovarian penetrance, and 104240832.84 after excluding breast cancer diagnoses (based on penetrance results). Functional analysis demonstrated that the variant abrogates the BRCA1-ABRAXAS1 binding, supporting the PS3 code assignment within the ACMG/AMP rule-based model. Collectively, these findings allowed to classify the variant as pathogenic., Conclusion: Pathogenicity of BRCA1:c.5017&#95;5019del(p.His1673del) has been confirmed; however, breast cancer risk in Italian families is not increased, unlike in families from other countries and in carriers of most BRCA1 pathogenic variants. The knowledge of atypical risk profiles for this and other variants will pave the way for personalized management based on specific genotype., (© 2024 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.)

Published
2024
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41. The Relationship between Language and Technology: How Screen Time Affects Language Development in Early Life-A Systematic Review.

Author

Massaroni V, Delle Donne V, Marra C, Arcangeli V, and Chieffo DPR

Abstract

Screen time refers to the amount of time a child is exposed to a screen, that is, television, computer, smartphone, or any other digital medium. Prolonged screen time in the first years of life may affect a child's cognitive abilities, especially language acquisition. A systematic review was conducted, following the PRISMA-P guidelines, with the aim to explore the available literature relating to the impact of screen time on children's language development. This review identified 18 articles. The articles reviewed showed that prolonged screen time and exposure to screens in the first 2 years of life can negatively affect language development and communication skills, in terms of comprehension and vocabulary range. In addition, overexposure to screens in the early years can affect overall cognitive development, especially attention to environmental stimuli, social experiences, problem solving, and communication with others, e.g., the alternance of rhythms and roles in a conversation. In conclusion, our systematic review supports the idea that preschool screen time has negative effects on children's cognitive and language development. Television seems to be the medium most detrimental to children's skills, as it is used in a passive manner and is often characterised by language and content that do not suit the child's processing mode. Future studies should increasingly focus on the digital media that children possess at an early age, such as mobile phones and tablets, and on how children relate to the online world, such as social networks.

Published
2023
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42. Impact of the time interval between primary or interval surgery and adjuvant chemotherapy in ovarian cancer patients.

Author

Farolfi A, Petracci E, Gurioli G, Tedaldi G, Casanova C, Arcangeli V, Amadori A, Rosati M, Stefanetti M, Burgio SL, Cursano MC, Lolli C, Zampiga V, Cangini I, Schepisi G, and De Giorgi U

Abstract

Introduction: Primary debulking surgery (PDS), interval debulking surgery (IDS), and platinum-based chemotherapy are the current standard treatments for advanced ovarian cancer (OC). The time to initiation of adjuvant chemotherapy (TTC) could influence patient outcomes., Methods: We conducted a multicenter retrospective cohort study of advanced (International Federation of Gynecology and Obstetrics (FIGO) stage III or IV) OC treated between 2014 and 2018 to assess progression-free survival (PFS) and overall survival (OS) in relation to TTC. All patients underwent a germline multigene panel for BRCA1/2 evaluation., Results: Among the 83 patients who underwent PDS, a TTC ≥ 60 days was associated with a shorter PFS (hazard ratio (HR) 2.02, 95% confidence interval (CI) 1.04-3.93, p = 0.038), although this association lost statistical significance when adjusting for residual disease (HR 1.52, 95% CI 0.75-3.06, p = 0.244, for TTC and HR 2.73, 95% CI 1.50-4.96, p = 0.001, for residual disease). Among 52 IDS patients, we found no evidence of an association between TTC and clinical outcomes. Ascites, type of chemotherapy, or germline BRCA1/2 mutational status did not influence TTC and were not associated with clinical outcomes in PDS or IDS patients., Discussion: In conclusion, longer TTC seems to negatively affect prognosis in patients undergoing PDS, especially those with residual disease., Competing Interests: UG has received advisory board or consultancy fees from Merck Sharp & Dohme, Bristol Myers Squibb, Janssen, Astellas, Sanofi, Bayer, Pfizer, Ipsen, Novartis, and Pharmamar and institutional research grants from AstraZeneca, Sanofi, and Roche. AF has received personal honoraria for lectures from AstraZeneca, GSK-Tesaro, and Clovis and is on the advisory board of Janssen, AstraZeneca, and GSK-Tesaro. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Farolfi, Petracci, Gurioli, Tedaldi, Casanova, Arcangeli, Amadori, Rosati, Stefanetti, Burgio, Cursano, Lolli, Zampiga, Cangini, Schepisi and Giorgi.)

Published
2023
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43. Specific Learning Disorders (SLD) and Behavior Impairment: Comorbidity or Specific Profile?

Author

Chieffo DPR, Arcangeli V, Moriconi F, Marfoli A, Lino F, Vannuccini S, Marconi E, Turrini I, Brogna C, Veredice C, Antonietti A, Sani G, and Mercuri EM

Abstract

Introduction: Specific Learning Disorder (SLD) is a neurodevelopmental disorder characterized by difficulties in perceiving and processing verbal and non-verbal information. It is usually accompanied by impaired academic skills leading to school dropout and emotional disturbances, resulting in significant distress and behavioral problems., Methods: A cognitive, academic, and emotional-behavioral assessment was performed at T0 and T1 in children and adolescents with SLD. Participants received psychotherapy and speech therapy treatment from T0 to T1., Results: In SLD, the most compromised cognitive functions were working memory and writing skills. An impact on academic abilities was found. Children and adolescents with SLD experience greater anxiety and depression levels compared to their control peers., Conclusions: SLD may adversely influence psychological well-being. To counteract such a consequence, more specific cognitive and academic skill-oriented strategies should be taken into consideration.

Published
2023
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44. A Novel FLCN Variant in a Suspected Birt-Hogg-Dubè Syndrome Patient.

Author

Bandini E, Zampiga V, Cangini I, Ravegnani M, Arcangeli V, Rossi T, Mammi I, Schiavi F, Zovato S, Falcini F, Calistri D, and Danesi R

Subjects
Humans, Proto-Oncogene Proteins genetics, Tumor Suppressor Proteins genetics, Birt-Hogg-Dube Syndrome genetics, Birt-Hogg-Dube Syndrome pathology, Carcinoma, Renal Cell genetics, Neoplastic Syndromes, Hereditary, Kidney Neoplasms genetics, Kidney Neoplasms pathology
Abstract

Subjects with pathogenic (PV) and likely pathogenic (LPV) FLCN variants have an increased risk of manifesting benign and malignant disorders that are related to Birt-Hogg-Dubé syndrome (BHDS): an autosomal dominantly inherited disorder whose severity can vary significantly. Renal cell carcinoma (RCC) development in BHD (Birt-Hogg-Dubé) patients has a very high incidence; thus, identifying this rare syndrome at early stages and preventing metastatic spread is crucial. Over the last decade, the advancement of Next Generation Sequencing (NGS) and the implementation of multigene panels for hereditary cancer syndromes (HCS) have led to a subsequent focus on additional genes and variants, including those of uncertain significance (VUS). Here, we describe a novel FLCN variant observed in a subject manifesting disorders that were suspected to be related to BHDS and with a family history of multiple cancers.

Published
2023
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45. Case report: Post-COVID new-onset neurocognitive decline with bilateral mesial-temporal hypometabolism in two previously healthy sisters.

Author

Cocciolillo F, Chieffo DPR, Giordano A, Arcangeli V, Lazzareschi I, Morello R, Zampino G, Valentini P, and Buonsenso D

Abstract

Background: Long coronavirus disease (COVID) is increasingly recognized in adults and children; however, it is still poorly characterized from a clinical and diagnostic perspective, particularly in the younger populations., Case Presentation: We described the story of two sisters-with high social and academic performance before their severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-who reported severe neurocognitive problems, initially classified as psychologic pandemic distress and eventually found to have significant brain hypometabolism., Conclusions: We provided a detailed clinical presentation of neurocognitive symptoms in two sisters with long COVID associated with brain hypometabolism documented in both sisters. We believe that the evidence of objective findings in these children further supports the hypothesis that organic events cause persisting symptoms in a cohort of children after SARS-CoV-2 infection. Such findings highlight the importance of discovering diagnostics and therapeutics., Competing Interests: DB has received grants from Roche Italia and Pfizer to study long COVID in children and has participated in a peer-to-peer program on long COVID sponsored by Pfizer. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Cocciolillo, Chieffo, Giordano, Arcangeli, Lazzareschi, Morello, Zampino, Valentini and Buonsenso.)

Published
2023
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46. Prevalence of a BRCA2 Pathogenic Variant in Hereditary-Breast-and-Ovarian-Cancer-Syndrome Families with Increased Risk of Pancreatic Cancer in a Restricted Italian Area.

Author

Zampiga V, Cangini I, Bandini E, Azzali I, Ravegnani M, Ravaioli A, Mancini S, Tebaldi M, Tedaldi G, Pirini F, Veneroni L, Frassineti GL, Falcini F, Danesi R, Calistri D, and Arcangeli V

Abstract

PVs and LPVs in BRCA1/2 genes are correlated to a high risk of developing breast cancer and/or ovarian cancer (Hereditary Breast and Ovarian Cancer syndrome, HBOC); additionally, in recent years, an increasing number of BRCA 1/2 variants have been identified and associated with pancreatic cancer. Epidemiologic studies have highlighted that inherited factors are involved in 10% to 20% of PCs, mainly through deleterious variants of BRCA2 . The frequency of BRCA1/2 germline alterations fluctuates quite a lot among different ethnic groups, and the estimated rate of PVs/LPVs variants in Italian HBOC families is not very accurate, according to different reports. The aim of our study is to describe the prevalence of a BRCA2 PV observed in a selected cohort of HBOC patients and their relatives, whose common origin is the eastern coast of Emilia Romagna, a region of Italy. This study provides insight into the frequency of the variant detected in this area and provides evidence of an increased risk of pancreatic and breast cancer, useful for genetic counseling and surveillance programs., Competing Interests: The authors declare no conflict of interest.

Published
2023
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47. Eye Movement Desensitization and Reprocessing (EMDR) as a Possible Evidence-Based Rehabilitation Treatment Option for a Patient with ADHD and History of Adverse Childhood Experiences: A Case Report Study.

Author

Guidetti C, Brogna P, Chieffo DPR, Turrini I, Arcangeli V, Rausa A, Bianchetti M, Rolleri E, Santomassimo C, Di Cesare G, Ducci G, Romeo DM, and Brogna C

Abstract

Background: Children with Attention Deficit Hyperactivity Disorder (ADHD) having a history of adverse childhood experiences (ACEs) could be very difficult to treat with standard psychotherapeutic approaches. Some children diagnosed with ADHD may have Post-Traumatic Stress Disorder (PTSD) or have had experienced a significant traumatic event. Trauma and PTSD could exacerbate ADHD core symptoms and be a risk factor of poor outcome response., Objective: to report for the first time the history of a patient with ADHD and ACE successfully treated with an EMDR approach., Conclusion: EMDR could be a promising treatment for ADHD children with a history of traumatic experiences in addition to pharmacological treatments.

Published
2023
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48. Clinical Impact of Next-Generation Sequencing Multi-Gene Panel Highlighting the Landscape of Germline Alterations in Ovarian Cancer Patients.

Author

Gurioli G, Tedaldi G, Farolfi A, Petracci E, Casanova C, Comerci G, Danesi R, Arcangeli V, Ravegnani M, Calistri D, Zampiga V, Cangini I, Fonzi E, Virga A, Tassinari D, Rosati M, Ulivi P, and De Giorgi U

Subjects
Humans, Female, Genetic Predisposition to Disease, BRCA1 Protein genetics, Mutation, Genes, BRCA2, Germ-Line Mutation, High-Throughput Nucleotide Sequencing, Ovarian Neoplasms drug therapy, Breast Neoplasms genetics
Abstract

BRCA1 and BRCA2 are the most frequently mutated genes in ovarian cancer (OC) crucial both for the identification of cancer predisposition and therapeutic choices. However, germline variants in other genes could be involved in OC susceptibility. We characterized OC patients to detect mutations in genes other than BRCA1/2 that could be associated with a high risk of developing OC and permit patients to enter the most appropriate treatment and surveillance program. Next-generation sequencing analysis with a 94-gene panel was performed on germline DNA of 219 OC patients. We identified 34 pathogenic/likely pathogenic variants in BRCA1/2 and 38 in other 21 genes. The patients with pathogenic/likely pathogenic variants in the non-BRCA1/2 genes mainly developed OC alone compared to the other groups that also developed breast cancer or other tumors (p = 0.001). Clinical correlation analysis showed that the low-risk patients were significantly associated with platinum sensitivity (p < 0.001). Regarding PARP inhibitors (PARPi) response, the patients with pathogenic mutations in the non-BRCA1/2 genes had worse PFS and OS. Moreover, a statistically significantly worse PFS was found for every increase of one thousand platelets before PARPi treatment. To conclude, knowledge about molecular alterations in genes beyond BRCA1/2 in OC could allow for more personalized diagnostic, predictive, prognostic, and therapeutic strategies for OC patients.

Published
2022
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49. Developmental Coordination Disorder and Joint Hypermobility in Childhood: A Narrative Review.

Author

Romeo DM, Venezia I, De Biase M, Ascione F, Lala MR, Arcangeli V, Mercuri E, and Brogna C

Abstract

Children with developmental coordination disorder (DCD) and joint hypermobility could present an overlap of symptoms and motor functional difficulties. The link between these two clinical conditions has not yet been clarified. Recent studies reported a high incidence (30-50%) of motor delay in children who are referred to hypermobility and of enhanced joint hypermobility in children with DCD. The aim of this study was to provide a critical review of the literature outlining the association between DCD or limited motor performance and joint hypermobility. Studies were eligible for inclusion if they were written in English and human-based. All the studies were first selected, looking for the presence of a clinical association between developmental coordination disorder or motor performance and hyperlaxity and reporting details of outcome. After a review of the full texts, 16 articles for a total of 1898 children met the inclusion criteria. In general, there was evidence of a higher incidence of motor delay or DCD in children who are referred to hypermobility and of enhanced joint hypermobility in children with DCD with similar range of functional difficulties. These results could influence the way to support children with rehabilitation and the type of intervention according to the prevalence of one of the two conditions.

Published
2022
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50. Posterior Fossa Tumor Rehabilitation: An Up-to-Date Overview.

Author

Chieffo DPR, Lino F, Arcangeli V, Moriconi F, Frassanito P, Massimi L, and Tamburrini G

Abstract

This narrative review highlights the latest achievements in the field of post-surgical rehabilitation of posterior fossa tumors. Studies investigating the effects of cognitive rehabilitation programs have been considered, following a comprehensive literature search in the scientific electronic databases: Pubmed, Scopus, Plos One, and ScienceDirect. This review investigates the effects of cognitive remediation, with specific highlights for single cognitive domains. The results revealed that in spite of the increasing number of children who survive into adulthood, very few studies investigated the effects of rehabilitation programs in this specific population. This study details new, promising therapeutic opportunities for children after brain surgery. More research in this filed is needed to identify the most effective protocols for clinical use.

Published
2022
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