95 results on '"Biagioli, E."'
Search Results
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
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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.
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- 2023
3. TGFβ PATHWAY ACTIVATION IS A PREDICTOR OF PROGRESSION FREE AND OVERALL SURVIVAL IN ADVANCED HIGH-GRADE SEROUS OVARIAN CANCER ACCORDING TO THE SURGICAL AGGRESSIVENESS AND RATE OF CYTOREDUCTION OF DIFFERENT ONCOLOGIC CENTERS: EP814
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Ceppi, L, Grassi, T, Romualdi, C, Di Lorenzo, P, Palazzi, S, Biagioli, E, Garbi, A, Paracchini, L, Landoni, F, Aletti, G D, Colombo, N, Fruscio, R, Marchini, S, and DʼIncalci, M
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- 2019
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4. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer
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Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Mangano, S., Tonato, M., Zucca, E., Valsecchi, M.G., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., Dell'Oro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.
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- 2014
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5. Number needed to treat for pricing costly anticancer drugs: the example of regorafenib in metastatic colorectal cancer
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Graziano, F., Rulli, E., Biagioli, E., and Catalano, V.
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- 2016
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6. Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma
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Silvani A., De Simone I., Fregoni V., Biagioli E., Marchioni E., Caroli M., Salmaggi A., Pace A., Torri V., Gaviani P., Quaquarini E., Simonetti G., Rulli E., D'Incalci M., Poli D., Mariotti E., Caramia G., Gritti A. P., Pacchetti I., Zucchetti M., Lanza A., Basso G., Bini P., Berzero G., Diamanti L., Di Cristofori A., Manzoni A., Lanfranchi G., Ardizzoia A., Villani V., Silvani, A., De Simone, I., Fregoni, V., Biagioli, E., Marchioni, E., Caroli, M., Salmaggi, A., Pace, A., Torri, V., Gaviani, P., Quaquarini, E., Simonetti, G., Rulli, E., D'Incalci, M., Poli, D., Mariotti, E., Caramia, G., Gritti, A. P., Pacchetti, I., Zucchetti, M., Lanza, A., Basso, G., Bini, P., Berzero, G., Diamanti, L., Di Cristofori, A., Manzoni, A., Lanfranchi, G., Ardizzoia, A., Villani, V., Silvani, A, De Simone, I, Fregoni, V, Biagioli, E, Marchioni, E, Caroli, M, Salmaggi, A, Pace, A, Torri, V, Gaviani, P, Quaquarini, E, Simonetti, G, Rulli, E, D'Incalci, M, Poli, D, Mariotti, E, Caramia, G, Gritti, A, Pacchetti, I, Zucchetti, M, Lanza, A, Basso, G, Bini, P, Berzero, G, Diamanti, L, Di Cristofori, A, Manzoni, A, Lanfranchi, G, Ardizzoia, A, and Villani, V
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Oncology ,Male ,Cancer Research ,medicine.medical_treatment ,Phases of clinical research ,Antineoplastic Agent ,0302 clinical medicine ,Recurrence ,Stage (cooking) ,Leukopenia ,Brain Neoplasms ,Middle Aged ,Prognosis ,Survival Rate ,Bridged-Ring Compound ,Neurology ,030220 oncology & carcinogenesis ,Ortataxel ,Female ,Taxoids ,medicine.symptom ,Human ,medicine.drug ,Adult ,Bridged-Ring Compounds ,medicine.medical_specialty ,Prognosi ,Antineoplastic Agents ,Taxane ,Neutropenia ,Follow-Up Studie ,Brain Neoplasm ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,Progression-free survival ,Survival rate ,Aged ,Chemotherapy ,Temozolomide ,business.industry ,medicine.disease ,Neurology (clinical) ,Neoplasm Recurrence, Local ,business ,Glioblastoma ,030217 neurology & neurosurgery ,Follow-Up Studies - Abstract
Background and purpose: Glioblastoma (GBM) is the most aggressive and frequent subtype of all malignant gliomas. At the time of recurrence, therapeutic options are lacking. Ortataxel, a second-generation taxane was reported to be effective in pre-clinical and phase I clinical studies. The aim of this study was to evaluate a potential therapeutic activity of ortataxel in patients with GBM recurring after surgery and first line treatment. Methods: In this phase II study, according to a two stage design, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were considered eligible. Patients included were treated with ortataxel 75mg/m2 i.v. every 3weeks until disease progression. The primary objective of the study was to evaluate the activity of ortataxel in terms of progression free survival (PFS) at 6months after the enrollment. PFS, overall survival at 9months after the enrollment, objective response rate, compliance and safety were evaluated as secondary endpoints. Results: Between Nov 26, 2013 and Dec 12, 2015, 40 patients were recruited across six centres. The number of patients alive and free from progression at 6months after the enrollment, observed in the first stage was four (11.4%), out of 35 patients included in the analysis, below the minimum number of events (7 out of 33) required to continue the study with the second stage The most important toxicities were neutropenia and hepatotoxicity that occurred in 13.2% of patients and leukopenia that occurred in 15.8% of patients. Conclusion: Overall ortataxel treatment fail to demonstrate a significant activity in recurrent GBM patients. However in a limited number of patients the drug produced a benefit that lasted for a long time. Trial registration: This study is registered with ClinicalTrials.gov, number NCT01989884.
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- 2018
7. LBA40 Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma
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Colombo, N., Harano, K., Hudson, E., Galli, F., Antill, Y., Choi, C.H., Rabaglio, M., Marmé, F., Petru, E., Lai, C-H., Biagioli, E., Fariñas Madrid, L., Takehara, K., Allan, K., Lee, Y.C., Piovano, E., Zamagni, C., Tasca, G., Ferrero, A., and Barretina Ginesta, M.P.
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- 2023
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8. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer
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Bajetta, E., Floriani, I., Di Bartolomeo, M., Labianca, R., Falcone, A., Di Costanzo, F., Comella, G., Amadori, D., Pinto, C., Carlomagno, C., Nitti, D., Daniele, B., Mini, E., Poli, D., Santoro, A., Mosconi, S., Casaretti, R., Boni, C., Pinotti, G., Bidoli, P., Landi, L., Rosati, G., Ravaioli, A., Cantore, M., Di Fabio, F., Aitini, E., Marchet, A., Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Poli, D., Mangano, S., Tonato, M., Zucca, E., Valsecchi, MG., Floriani, I., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Bajetta, E., Di Bartolomeo, M., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., DellʼOro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Labianca, R., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Amadori, D., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Falcone, A., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Di Costanzo, F., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Pinto, C., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Daniele, B., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Nitti, D., Marchet, A., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.
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- 2014
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9. Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients: A Study Protocol
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Quaranta, L., Riva, I., Biagioli, E., Rulli, E., Poli, D., Legramandi, L., Fossarello, M., Uva, M., Carmassi, L., Gandolfi, S., Rossi, G. C., Fontana, L., Rolle, T., Tognetto, D., Mastropasqua, L., Campos, E., Nucci, C., Scuderi, G., Marchini, G., Quaranta, L., Riva, I., Biagioli, E., Rulli, E., Poli, D., Legramandi, L., Fossarello, M., Uva, M., Carmassi, L., Gandolfi, S., Rossi, G. C., Fontana, L., Rolle, T., Tognetto, D., Mastropasqua, L., Campos, E., Nucci, C., Scuderi, G., and Marchini, G.
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Male ,030213 general clinical medicine ,medicine.medical_specialty ,Open angle glaucoma ,medicine.drug_class ,Ubiquinone ,Glaucoma ,Placebo ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,law ,Settore MED/30 ,Ophthalmology ,medicine ,Humans ,Vitamin E ,Pharmacology (medical) ,Open-angle glaucoma ,Intraocular Pressure ,Aged ,Coenzyme Q10 ,business.industry ,Hazard ratio ,General Medicine ,Prostaglandin analogue ,Randomized clinical trial ,Middle Aged ,medicine.disease ,Clinical trial ,chemistry ,030220 oncology & carcinogenesis ,Female ,Ophthalmic Solutions ,Visual Fields ,business ,Glaucoma, Open-Angle - Abstract
Introduction: The CoQun® study is a multicenter, controlled trial aimed to evaluate the neuroprotective effects of Coqun®, an ophthalmic solution of Coenzyme q10 (CoQ10) and Vitamin E (VitE), in patients affected by primary open-angle glaucoma (POAG). Pre-clinical studies and small non-controlled clinical trials have previously shown a potential role of CoQ10 and VitE in glaucoma neuroprotection, both in vitro and in vivo. Methods: Randomized, parallel arm, multicenter, double-blind study. POAG patients with an IOP ranging from 17 to 21 mm Hg on monotherapy with a prostaglandin analogue (PGA) will be considered for study enrollment. Inclusion criteria will be visual field (VF) mean deviation between − 4 and − 10 dB and VF Pattern Standard Deviation between 4 and 10 dB. Eligible patients will be randomized to receive CoQun® (Arm A) or placebo (Arm B), in addition to PGA monotherapy. Planned Outcomes: Primary outcome will be time to progression, defined as the time between the baseline visit and the visit with confirmed VF progression. A total of 612 patients are planned to be enrolled, to detect a hazard ratio of 0.65, with a power of 80% and an alpha error of 0.05 (two-sided). For study power calculation, 10% non-evaluable patients are assumed. This is the first study investigating, in a randomized, double-blind and controlled fashion, the neuroprotective effects of CoQ10 and VitE in POAG patients. Trial Registration: ClinicalTrials.gov identifier, NCT03611530.
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- 2019
10. INOVATYON study: Randomized phase III international study comparing trabectedin/PLD followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line
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Colombo, N., Gadducci, A., Sehouli, J., Biagioli, E., Nyvang, G-B., Riniker, S., Montes, A., Ottevanger, N., Zeimet, A. G. G., Vergote, I. B., Funari, G., Baldoni, A., Tognon, G., De Censi, A., Churruca Galaz, C., Chekerov, R., Maenpaa, J., Rulli, E., Fossati, R., and Poveda, A.
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- 2020
11. LBA30 INOVATYON study: Randomized phase III international study comparing trabectedin/PLD followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line
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Colombo, N., primary, Gadducci, A., additional, Sehouli, J., additional, Biagioli, E., additional, Nyvang, G-B., additional, Riniker, S., additional, Montes, A., additional, Ottevanger, N., additional, Zeimet, A.G.G., additional, Vergote, I.B., additional, Funari, G., additional, Baldoni, A., additional, Tognon, G., additional, De Censi, A., additional, Galaz, C. Churruca, additional, Chekerov, R., additional, Maenpaa, J., additional, Rulli, E., additional, Fossati, R., additional, and Poveda, A., additional
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- 2020
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12. 884TiP AtTEnd/ENGOT-en7: A multicenter phase III double-blind randomized controlled trial of atezolizumab in combination with paclitaxel and carboplatin in women with advanced/recurrent endometrial cancer
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Colombo, N., primary, Antill, Y., additional, Barretina Ginesta, M.P., additional, Harano, K., additional, Hudson, E., additional, Marmé, F., additional, Marth, C., additional, Rabaglio, M., additional, Secord, A.A., additional, Fossati, R., additional, Roberto, A., additional, Tettamanzi, F., additional, and Biagioli, E., additional
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- 2020
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13. EP814 TGFβ pathway activation is a predictor of progression free and overall survival in advanced high-grade serous ovarian cancer according to the surgical aggressiveness and rate of cytoreduction of different oncologic centers
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Ceppi, L, primary, Grassi, T, additional, Romualdi, C, additional, Di Lorenzo, P, additional, Palazzi, S, additional, Biagioli, E, additional, Garbi, A, additional, Paracchini, L, additional, Landoni, F, additional, Aletti, GD, additional, Colombo, N, additional, Fruscio, R, additional, Marchini, S, additional, and D’Incalci, M, additional
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- 2019
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14. BAROCCO: A randomized phase II study of weekly paclitaxel vs cediranib-olaparib combination given with continuous or intermittent schedule in patients with recurrent platinum resistant ovarian cancer (PROC)
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Colombo, N., primary, Nicoletto, M.O., additional, Benedetti Panici, P., additional, Tognon, G., additional, Bologna, A., additional, Lissoni, A.A., additional, DeCensi, A., additional, Tomao, F., additional, Fossati, R., additional, Tettamanzi, F., additional, Rulli, E., additional, Galli, F., additional, De Luca, M., additional, Alvisi, M.F., additional, Mancari, R., additional, Ratti, M., additional, Baldoni, A., additional, Torri, V., additional, and Biagioli, E., additional
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- 2019
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15. Restoring platinum sensitivity in recurrent ovarian cancer by extending the platinum-free interval: Myth or reality?
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Tomao F., D'Incalci M., Biagioli E., Peccatori F. A., Colombo N., Tomao, F, D'Incalci, M, Biagioli, E, Peccatori, F, and Colombo, N
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Ovarian Neoplasms ,restoration ,Evidence-Based Medicine ,Time Factors ,Dose-Response Relationship, Drug ,Carcinoma, Ovarian Epithelial ,Middle Aged ,sensitivity ,Prognosis ,Disease-Free Survival ,Drug Administration Schedule ,Carboplatin ,recurrent ,Drug Resistance, Neoplasm ,Antineoplastic Combined Chemotherapy Protocols ,cancer ,ovarian ,Humans ,platinum-free-interval ,Female ,platinum ,Neoplasms, Glandular and Epithelial ,Neoplasm Recurrence, Local ,Aged - Abstract
The platinum-free interval is the most important predictive factor of a response to subsequent lines of chemotherapy and the most important prognostic factor for progression-free and overall survival in patients with recurrent epithelial ovarian cancer. A nonplatinum regimen is generally considered the most appropriate approach when the disease recurs very early after the end of chemotherapy, whereas platinum-based chemotherapy is usually adopted when the platinum-free interval exceeds 12 months. However, the therapeutic management of patients with intermediate sensitivity (ie, when the relapse occurs between 6 and 12 months) remains debatable. Preclinical and clinical data suggest that the extension of platinum-free interval (using a nonplatinum-based regimen) might restore platinum sensitivity, thus allowing survival improvement. The objective of this review was to critically analyze preclinical and clinical evidences supporting this hypothesis. Cancer 2017;123:3450-9. © 2017 American Cancer Society.
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- 2017
16. BAROCCO: A randomized phase II study of weekly paclitaxel vs cediranib-olaparib with continuous schedule vs cediranib-olaparib with intermittent schedule in advanced platinum resistant ovarian cancer
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Colombo, N., primary, Nicoletto, O., additional, Benedetti Panici, P., additional, Tognon, G., additional, Lissoni, A.A., additional, Bologna, A., additional, Tomao, F., additional, Fossati, R., additional, Tettamanzi, F., additional, Rulli, E., additional, Galli, F., additional, Alvisi, M.F., additional, Torri, V., additional, and Biagioli, E., additional
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- 2018
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17. Radiosurgery for intracranial meningioma. A systematic review and meta-analysis
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Pinzi, V, Biagioli, E, Roberto, A, Galli, F, Chiappa, F, Floriani, I., Fariselli, L, Pinzi, V, Biagioli, E, Roberto, A, Galli, F, Chiappa, F, Floriani, I, and Fariselli, L
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MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA ,neurooncology ,radiosurgery ,meningioma ,radiotherapy ,metaanalysis - Published
- 2016
18. P01.067 Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma: the experience of the Italian Association of Neuro-Oncology
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Simonetti, G, primary, Silvani, A, additional, Biagioli, E, additional, Botturi, A, additional, Caroli, M, additional, de Simone, I, additional, Fregoni, V, additional, Gaviani, P, additional, Lanza, A, additional, Marchioni, E, additional, Pace, A, additional, Quaquarini, E, additional, Salmaggi, A, additional, and D’Incalci, M, additional
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- 2018
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19. LBA58 - BAROCCO: A randomized phase II study of weekly paclitaxel vs cediranib-olaparib combination given with continuous or intermittent schedule in patients with recurrent platinum resistant ovarian cancer (PROC)
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Colombo, N., Nicoletto, M.O., Benedetti Panici, P., Tognon, G., Bologna, A., Lissoni, A.A., DeCensi, A., Tomao, F., Fossati, R., Tettamanzi, F., Rulli, E., Galli, F., De Luca, M., Alvisi, M.F., Mancari, R., Ratti, M., Baldoni, A., Torri, V., and Biagioli, E.
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- 2019
- Full Text
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20. 1002TiP - BAROCCO: A randomized phase II study of weekly paclitaxel vs cediranib-olaparib with continuous schedule vs cediranib-olaparib with intermittent schedule in advanced platinum resistant ovarian cancer
- Author
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Colombo, N., Nicoletto, O., Benedetti Panici, P., Tognon, G., Lissoni, A.A., Bologna, A., Tomao, F., Fossati, R., Tettamanzi, F., Rulli, E., Galli, F., Alvisi, M.F., Torri, V., and Biagioli, E.
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- 2018
- Full Text
- View/download PDF
21. PO-0641: Radiosurgery for intracranial meningioma. A systematic review and meta-analysis
- Author
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Pinzi, V., primary, Biagioli, E., additional, Roberto, A., additional, Galli, F., additional, Chiappa, F., additional, Floriani, I., additional, and Fariselli, L., additional
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- 2016
- Full Text
- View/download PDF
22. Diagnostic Performance of Contrast-Enhanced Ultrasound (CEUS) and Contrast-Enhanced Endoscopic Ultrasound (ECEUS) for the Differentiation of Pancreatic Lesions: A Systematic Review and Meta-Analysis
- Author
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D’Onofrio, M., additional, Biagioli, E., additional, Gerardi, C., additional, Canestrini, S., additional, Rulli, E., additional, Crosara, S., additional, De Robertis, R., additional, and Floriani, I., additional
- Published
- 2014
- Full Text
- View/download PDF
23. Peritumoral Lymphovascular Invasion Impacts the Incidence of Sentinel Lymph Node (Sln) Metastasis in Early Breast Cancer Patients (Pts) with Favorable Prognostic Features: a Retrospective Study on 345 Cases
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Verde, N.M. La, primary, Casiraghi, C., additional, Dazzani, C., additional, Floriani, I.C., additional, Biagioli, E., additional, Cordovana, A., additional, Gerardi, C., additional, Farina, G., additional, Lamera, M., additional, Di Cosimo, S., additional, Croce, A.M., additional, Lunghi, C., additional, Bianchi, F., additional, Bonavita, M., additional, and Gherardi, G., additional
- Published
- 2014
- Full Text
- View/download PDF
24. Trabectedin and Pegylated Liposomal Doxorubicin (Pld) Versus Carboplatin and Pld in Partially Platinum-Sensitive Ovarian Cancer Patients: Inovatyon Study
- Author
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Colombo, N., primary, Biagioli, E., additional, Copreni, E., additional, Floriani, I.C., additional, and Fossati, R., additional
- Published
- 2014
- Full Text
- View/download PDF
25. Diagnostic Performance of Contrast-Enhanced Ultrasound (CEUS) and Contrast-Enhanced Endoscopic Ultrasound (ECEUS) for the Differentiation of Pancreatic Lesions: A Systematic Review and Meta-Analysis.
- Author
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D'Onofrio, M., Biagioli, E., Gerardi, C., Canestrini, S., Rulli, E., Crosara, S., De Robertis, R., and Floriani, I.
- Published
- 2014
- Full Text
- View/download PDF
26. 943TiP - Trabectedin and Pegylated Liposomal Doxorubicin (Pld) Versus Carboplatin and Pld in Partially Platinum-Sensitive Ovarian Cancer Patients: Inovatyon Study
- Author
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Colombo, N., Biagioli, E., Copreni, E., Floriani, I.C., and Fossati, R.
- Published
- 2014
- Full Text
- View/download PDF
27. 274P - Peritumoral Lymphovascular Invasion Impacts the Incidence of Sentinel Lymph Node (Sln) Metastasis in Early Breast Cancer Patients (Pts) with Favorable Prognostic Features: a Retrospective Study on 345 Cases
- Author
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Verde, N.M. La, Casiraghi, C., Dazzani, C., Floriani, I.C., Biagioli, E., Cordovana, A., Gerardi, C., Farina, G., Lamera, M., Di Cosimo, S., Croce, A.M., Lunghi, C., Bianchi, F., Bonavita, M., and Gherardi, G.
- Published
- 2014
- Full Text
- View/download PDF
28. MULTICENTER, SINGLE ARM, PHASE II TRIAL ON THE EFFICACY OF ORTATAXEL IN RECURRENT GLIOBLASTOMA: THE EXPERIENCE OF THE ITALIAN ASSOCIATION OF NEUROONCOLOGY
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Simonetti, G., Silvani, A., Biagioli, E., andrea botturi, Caroli, M., Simone, I., Fregoni, V., Gaviani, P., Lanza, A., Marchioni, E., Pace, A., Quaquarini, E., Salmaggi, A., and D Incalci, M.
29. RANDOMIZED, NON-COMPARATIVE, PHASE II TRIAL OF BEVACIZUMAB AND TRABECTEDIN WITH OR WITHOUT CARBOPLATIN IN PARTIALLY PLATINUM-SENSITIVE OVARIAN CANCER (ROC) WOMEN
- Author
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Colombo, N., Nicoletto, M. O., Lissoni, A., Scambia, G., Tognon, G., Eva Negri, Galli, F., Biagioli, E., Rulli, E., Fossati, R., and D Incalci, M.
30. Met-enkephalin-like immunoreactivity (MELI) and enkephalinase activity (EKA) in cord blood and newborns in the first hours of life
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Elisabetta Baldi, Mg, Spillantini, Cosenza-Biagioli E, Mainardi G, Cianciulli D, Carbone C, and Panero C
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Time Factors ,Enkephalin, Methionine ,Endopeptidases ,Infant, Newborn ,Humans ,Neprilysin ,Fetal Blood ,Chromatography, High Pressure Liquid - Abstract
Recently, the presence and the concomitant release with catecholamines of metenkephalin and other pro-enkephalin A deriving peptides have been demonstrated in the adrenal medulla of various mammals and man. As high amounts of catecholamines are released in the newborn at delivery, probably following the stress of parturition, a similar release of met-enkephalin and other pro-enkephalin A deriving peptides from the newborn chromaffin tissue may be hypothesized. In the present study we investigate the occurrence of met-enkephalin-like immunoreactivity and enkephalinase (quite a specific enkephalin degrading enzyme) in cord and newborn plasma at different hours after birth. Our results show the presence of high met-enkephalin-like immunoreactivity levels in cord and newborn plasma with respect to normal adult values. On the contrary, cord blood enkephalinase activity was lower than in adult subjects and further decreased during the first hours of life. A positive correlation was found between the two parameters. These data seem to indicate a release of met-enkephalin-like peptides from the newborns' sympathoadrenal tissue following the stress of delivery and in the first hours of life.
31. MIRNA181A-5P EXPRESSION AS A BIOMARKER OF TGFB PATHWAY ACTIVATION ASSOCIATED WITH ONCOLOGIC OUTCOME AND TUMOR DIFFUSION IN HIGH GRADE SEROUS EPITHELIAL OVARIAN CANCER
- Author
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Ceppi, L., Palazzi, S., Romualdi, C., Dilorenzo, P., Grassi, T., Biagioli, E., Lara Paracchini, Milani, R., Buda, A., D Incalci, M., Marchini, S., and Fruscio, R.
32. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer
- Author
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Nicoletta Colombo, Federica Tomao, Pierluigi Benedetti Panici, Maria Ornella Nicoletto, Germana Tognon, Alessandra Bologna, Andrea Alberto Lissoni, Andrea DeCensi, Mariateresa Lapresa, Rosanna Mancari, Innocenza Palaia, Giulia Tasca, Francesca Tettamanzi, Maria Francesca Alvisi, Eliana Rulli, Davide Poli, Luciano Carlucci, Valter Torri, Roldano Fossati, Elena Biagioli, Colombo, N, Tomao, F, Benedetti Panici, P, Nicoletto, M, Tognon, G, Bologna, A, Lissoni, A, Decensi, A, Lapresa, M, Mancari, R, Palaia, I, Tasca, G, Tettamanzi, F, Alvisi, M, Rulli, E, Poli, D, Carlucci, L, Torri, V, Fossati, R, and Biagioli, E
- Subjects
Ovarian Neoplasms ,Paclitaxel ,Obstetrics and Gynecology ,Peripheral Nervous System Diseases ,cediranib ,olaparib ,ovarian cancer ,phase II ,randomized ,Carcinoma, Ovarian Epithelial ,Piperazines ,Oncology ,Antineoplastic Combined Chemotherapy Protocols ,Quinazolines ,Humans ,Phthalazines ,Female ,Neoplasm Recurrence, Local - Abstract
Background: Previous findings showed that cediranib-olaparib increased PFS in women with recurrent platinum-sensitive ovarian cancer compared to olaparib alone. Methods: BAROCCO trial randomized 123 patients: 80 mg/m2 paclitaxel weekly up to 24 weeks (control), olaparib 300 mg tablets twice daily together with 20 mg cediranib daily (continuous schedule) or with 20 mg cediranib 5 days/week (intermittent schedule) until progression. The primary objective was the PFS comparison between each experimental arm and the control (alpha one-sided 5%; power 80%; HR 0.5). Results: The median platinum-free interval was 1.9 months, 60% of patients had been pretreated with 3 or more chemotherapy lines. Median PFS for paclitaxel, the continuous, and the intermittent schedules were 3.1, 5.6, and 3.8 months. The HR for PFS in the continuous arm vs control was 0.76 (90% CI: 0.50–1.14, p = 0.265). The HR for PFS in the intermittent arm vs control was 1.03 (90% CI: 0.68–1.55, p = 0.904). Treatment was discontinued due to adverse events in 15%, 20%, and 5% of patients in the control, continuous and intermittent arms. Grade ≥ 3 anemia and diarrhea and hypertension of any grade occurred only in the experimental arms, and peripheral neuropathies and alopecia only in the control arm. Five serious adverse drug reactions occurred and two were fatal: one in the control and one in the continuous arm. Conclusions: The combination of cediranib-olaparib was not superior to chemotherapy in terms of PFS in heavily pretreated platinum-resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population. Clinical trial identification: IRFMN-OVA-7289, EudraCT: 2016–003964-38, NCT03314740.
- Published
- 2022
33. Assessment of proportional hazard assumption in aggregate data: a systematic review on statistical methodology in clinical trials using time-to-event endpoint
- Author
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Maurizio D'Incalci, Elena Biagioli, Eliana Rulli, Luca Porcu, Rino Bellocco, Francesca Ghilotti, Mirko Marabese, Valter Torri, Rulli, E, Ghilotti, F, Biagioli, E, Porcu, L, Marabese, M, D'Incalci, M, Bellocco, R, and Torri, V
- Subjects
Cancer Research ,Lung Neoplasms ,Article ,03 medical and health sciences ,0302 clinical medicine ,Carcinoma, Non-Small-Cell Lung ,Statistics ,Clinical endpoint ,Medicine ,Humans ,030212 general & internal medicine ,Time point ,Survival analysis ,Event (probability theory) ,Proportional Hazards Models ,Randomized Controlled Trials as Topic ,Proportional hazards model ,business.industry ,Hazard ratio ,Lung Neoplasm ,Clinical trial ,Oncology ,030220 oncology & carcinogenesis ,RMST ,Proportional Hazards Model ,Randomized controlled trials ,business ,Non-small-cell lung cancer ,Human - Abstract
Background: The evaluation of the proportional hazards (PH) assumption in survival analysis is an important issue when Hazard Ratio (HR) is chosen as summary measure. The aim is to assess the appropriateness of statistical methods based on the PH assumption in oncological trials. Methods: We selected 58 randomised controlled trials comparing at least two pharmacological treatments with a time-to-event as primary endpoint in advanced non-small-cell lung cancer. Data from Kaplan–Meier curves were used to calculate the relative hazard at each time point and the Restricted Mean Survival Time (RMST). The PH assumption was assessed with a fixed-effect meta-regression. Results: In 19% of the trials, there was evidence of non-PH. Comparison of treatments with different mechanisms of action was associated (P = 0.006) with violation of the PH assumption. In all the superiority trials where non-PH was detected, the conclusions using the RMST corresponded to that based on the Cox model, although the magnitude of the effect given by the HR was systematically greater than the one from the RMST ratio. Conclusion: As drugs with new mechanisms of action are being increasingly employed, particular attention should be paid on the statistical methods used to compare different types of agents.
- Published
- 2018
34. Parp inhibitors as maintenance treatment in platinum sensitive recurrent ovarian cancer: An updated meta-analysis of randomized clinical trials according to BRCA mutational status
- Author
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Carolina Maria Sassu, Erlisa Bardhi, Anna Di Pinto, Maria Cristina Petrella, Elena Biagioli, Pierluigi Benedetti Panici, Innocenza Palaia, Ludovico Muzii, Nicoletta Colombo, Federica Tomao, Tomao, F, Bardhi, E, Di Pinto, A, Sassu, C, Biagioli, E, Petrella, M, Palaia, I, Muzii, L, Colombo, N, and Panici, P
- Subjects
0301 basic medicine ,Oncology ,medicine.medical_specialty ,endocrine system diseases ,Population ,Genes, BRCA2 ,Genes, BRCA1 ,Gene mutation ,Maintenance therapy in ovarian cancer ,Poly(ADP-ribose) Polymerase Inhibitors ,Olaparib ,Maintenance Chemotherapy ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Maintenance therapy ,Internal medicine ,Platinum sensitive ovarian cancer ,Medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Progression-free survival ,education ,Rucaparib ,Germ-Line Mutation ,Randomized Controlled Trials as Topic ,Ovarian Neoplasms ,education.field_of_study ,business.industry ,BRCA mutation ,General Medicine ,female genital diseases and pregnancy complications ,030104 developmental biology ,PARP inhibitor ,chemistry ,030220 oncology & carcinogenesis ,Meta-analysis ,HRD ,Female ,Recurrent ovarian cancer ,Neoplasm Recurrence, Local ,business - Abstract
Objective: This meta-analysis investigated the effectiveness of PARP inhibitors (PARPis) as maintenance treatment in platinum sensitive recurrent ovarian cancer (ROC), stratifying results based on BRCA mutational status into five different categories: whole population, germ-line BRCA mutated patients, somatic BRCA mutated patients, HRD patients and wild type population. Methods: PubMed, Medline, Scopus, EMBASE and clinicaltrials.gov, as well as meeting proceedings were searched for eligible studies that described RCTs testing the efficacy of PARPis as maintenance treatment in platinum sensitive ROC. Data were extracted independently and analysed using RevMan statistical software version 5.3. Primary end-point was progression free survival (PFS). Results: The analysis confirmed the positive effect of PARPis in patients with platinum sensitive ROC in case of germinal or somatic BRCA mutations. Specifically, HR for PFS was 0.26, 95% CI 0.21–0.31, p < 0.00001 for the mutation of BRCA gene and 0.24, 95%, CI 0.12–0.48, p < 0.0001 for the somatic alteration. In addition, in the HRD population, studies that analysed the efficacy of PARPis reported a PFS improvement with HR 0.34, 95% CI 0.26–0.43, p < 0.00001. Finally, our analysis confirms the role of these drugs in prolonging PFS in the whole population with HR 0.36, 95% CI 0.32–0.42, p < 0.00001, although to a lesser extent, with a significant improvement even in wild type cancers with HR 0.49, 95%, CI 0.41–0.59, p < 0.00001). Conclusions: PARPis are effective regardless of BRCA mutational status. Future investigations are necessary to explore the use of different PARPis as monotherapy, comparing them among each other in terms of efficacy and toxicity, and exploring their potential re-use.
- Published
- 2019
35. Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer
- Author
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Simona Frezzini, Eleonora Zaccarelli, Davide Poli, Giovanni Scambia, Roldano Fossati, E. Negri, Valter Torri, Andrea Lissoni, Nicoletta Colombo, Chiara Gerardi, Francesca Galli, Alessandra Baldoni, Germana Tognon, Gabriella Farina, Eleonora Palluzzi, Elena Biagioli, Angela Pesenti Gritti, Eliana Rulli, Maurizio D'Incalci, Daniela Rubino, Annamaria Ferrero, Colombo, N, Zaccarelli, E, Baldoni, A, Frezzini, S, Scambia, G, Palluzzi, E, Tognon, G, Lissoni, A, Rubino, D, Ferrero, A, Farina, G, Negri, E, Pesenti Gritti, A, Galli, F, Biagioli, E, Rulli, E, Poli, D, Gerardi, C, Torri, V, Fossati, R, and D'Incalci, M
- Subjects
Oncology ,Cancer Research ,medicine.medical_specialty ,Bevacizumab ,Phases of clinical research ,Kaplan-Meier Estimate ,Carcinoma, Ovarian Epithelial ,Article ,Carboplatin ,Efficacy ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Ovarian cancer ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Humans ,Progression-free survival ,Survival rate ,Trabectedin ,030304 developmental biology ,Aged ,Ovarian Neoplasms ,Gynaecological cancer ,0303 health sciences ,business.industry ,Middle Aged ,Progression-Free Survival ,Clinical trial ,Survival Rate ,bevacizumab and trabectedin ,chemistry ,030220 oncology & carcinogenesis ,Female ,business ,medicine.drug - Abstract
Background Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated. Methods In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6 ≥ 30% as unacceptable. Results BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%–69%) but PFS-6 was 85% (95%CI: 62%–97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%–87%) and 16% ST-6 (95%CI 7%–30%). Conclusions BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity. Clinical Trial Registration NCT01735071 (Clinicaltrials.gov).
- Published
- 2019
36. Long-Term Clinical Benefits of Neoadjuvant Chemotherapy in Women With Locally Advanced Cervical Cancer
- Author
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Andrea Lissoni, Elena Biagioli, Mauro Signorelli, Alessandro Buda, Stefania Chiari, Costantino Mangioni, Chiara Gerardi, Rodolfo Milani, Luca Locatelli, Cristina Bonazzi, Tiziana Dell'Anna, Irene Floriani, Buda, A, Lissoni, A, Floriani, I, Biagioli, E, Gerardi, C, Bonazzi, C, Chiari, S, Locatelli, L, DELL' ANNA, T, Signorelli, M, Mangioni, C, and Milani, R
- Subjects
Oncology ,Time Factors ,medicine.medical_treatment ,Radical surgery ,Uterine Cervical Neoplasms ,Randomized-Trial ,Life ,Antineoplastic Combined Chemotherapy Protocols ,Neoadjuvant therapy ,Cervical cancer ,Optimal response ,Obstetrics and Gynecology ,Chemoradiotherapy ,Middle Aged ,Prognosis ,Neoadjuvant Therapy ,Survival Rate ,Surrogate endpoint ,Chemotherapy, Adjuvant ,Carcinoma, Squamous Cell ,Female ,Adult ,Metaanalysi ,medicine.medical_specialty ,Adolescent ,Paclitaxel ,Adenocarcinoma ,Neoadjuvant chemotherapy ,Young Adult ,Internal medicine ,medicine ,Humans ,Neoplasm Invasiveness ,Ifosfamide ,Survival rate ,Aged ,Neoplasm Staging ,Retrospective Studies ,business.industry ,Carcinoma ,Retrospective cohort study ,medicine.disease ,Doxorubicin ,Cisplatin ,business ,Biomarkers ,Progressive disease ,Follow-Up Studies - Abstract
Objective Neoadjuvant chemotherapy (NACT) is a valid treatment option for women with locally advanced cervical cancer (LACC). This study aims to evaluate the impact of sociodemographic factors, clinical factors, and NACT regimens on survival endpoints. The role of pathological response to NACT as a surrogate endpoint of survival was also assessed. Materials and Methods Retrospective analysis of consecutive sample data from women with LACC (stages Ib2-IVa) who underwent NACT followed by radical surgery was performed. Response was classified as optimal response (including complete response and optimal partial response), suboptimal partial response, stable disease, and progressive disease. Results Four hundred forty-six women who had undergone surgery from 1992 to 2011 were analyzed. The overall optimal response was 35.4%. At a median follow-up of 12.7 years, 165 women (37.0%) experienced recurrence or died. Increase in patient age at surgery, International Federation of Gynecology and Obstetrics stage III/IV versus stage Ib2, and lymph-node positivity versus negativity seemed to impact negatively on survival, whereas neoadjuvant platinum-Taxol–containing regimens (compared with platinum-based regimens) improved survival. Response to NACT could be considered a surrogate endpoint of survival. Conclusions Age, International Federation of Gynecology and Obstetrics stage III/IV, lymph-node involvement, and type of NACT administered have a significant impact on survival. Response to NACT is a good surrogate endpoint of survival in patients with LACC.
- Published
- 2015
37. A phase II randomised (calibrated design) study on the activity of the single-agent trabectedin in metastatic or locally relapsed uterine leiomyosarcoma
- Author
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Maurizio D'Incalci, Giovanni Scambia, Angela Buonadonna, Roldano Fossati, Nicoletta Colombo, E. Negri, Elena Biagioli, Francesco Raspagliesi, Francesca Galli, Eliana Rulli, Roberta Sanfilippo, Armando Santoro, Milena Bruzzone, G. Artioli, Giovanni Grignani, Paolo G. Casali, Valter Torri, Federica Grosso, Angiolo Gadducci, Domenica Lorusso, Gadducci, A, Grosso, F, Scambia, G, Raspagliesi, F, Colombo, N, Grignani, G, Casali, P, Sanfilippo, R, Buonadonna, A, Santoro, A, Bruzzone, M, Artioli, G, Lorusso, D, Biagioli, E, Fossati, R, Galli, F, Negri, E, Rulli, E, Torri, V, and D’Incalci, M
- Subjects
Adult ,Leiomyosarcoma ,Male ,0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,Anthracycline ,medicine.medical_treatment ,Phases of clinical research ,Drug development ,Docetaxel ,Deoxycytidine ,Article ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Humans ,Medicine ,Progression-free survival ,Neoplasm Metastasis ,Antineoplastic Agents, Alkylating ,Trabectedin ,Aged ,Cancer ,Chemotherapy ,Ifosfamide ,business.industry ,Middle Aged ,Survival Analysis ,Gemcitabine ,Treatment Outcome ,030104 developmental biology ,Research Design ,030220 oncology & carcinogenesis ,Uterine Neoplasms ,Disease Progression ,Female ,business ,medicine.drug - Abstract
Background: Patients with recurrent/metastatic uterine leiomyosarcoma (U-LMS) have a dismal prognosis. This phase II study aims to evaluate trabectedin efficacy and safety in advanced U-LMS. Methods: Eligible patients had received ≥ one line of chemotherapy. Gemcitabine ± docetaxel naive patients were randomised to Arm A: trabectedin 1.3 mg/m2 or calibration Arm B: gemcitabine 900 mg/m2 and docetaxel 75 mg/m2. Patients who had already received gemcitabine ± docetaxel directly entered Arm A. Primary end-point: 6-month progression-free rate (PFS-6). The null hypothesis that the true PFS-6 = 14% was tested against a one-sided alternative. This design yielded a 5% type I error rate and 90% power when the true PFS-6 is 25%. Results: Overall, 126 patients entered Arm A (45 from randomisation and 81 directly) and 42 Arm B. Arm A patients characteristics: median age = 57; ≥2 previous chemotherapy lines = 37.4%; metastatic disease = 93%. The study met the condition for trabectedin activity: PFS-6 = 35.2% (95% CI: 26.2–45). No difference in PFS by the number of previous chemotherapy lines emerged. Median OS = 20.6 months (IQR: 8–36.4). In Arm B, the PFS-6 = 51.5% (95% CI: 33.5–69.2). No toxic deaths occurred. In Arm A, only 4 patients interrupted treatment for toxicity. Conclusions: Trabectedin is active and well tolerated, retaining similar efficacy across one to three previous lines of chemotherapy.
- Published
- 2018
38. Radiosurgery for intracranial meningiomas: A systematic review and meta-analysis
- Author
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Federica Chiappa, Anna Roberto, Laura Fariselli, Irene Floriani, Valentina Pinzi, Michele Rizzi, Elena Biagioli, Francesca Galli, Greta Brenna, Pinzi, V, Biagioli, E, Roberto, A, Galli, F, Rizzi, M, Chiappa, F, Brenna, G, Fariselli, L, and Floriani, I
- Subjects
Staged radiosurgery ,Adult ,Male ,medicine.medical_specialty ,Pediatrics ,Adolescent ,medicine.medical_treatment ,Radiosurgery ,Disease-Free Survival ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Meningeal Neoplasms ,Medicine ,Effective treatment ,Humans ,Symptom control ,WHO II meningioma ,Meningeal Neoplasm ,Radiation Injurie ,Child ,Radiation Injuries ,Aged ,MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA ,Aged, 80 and over ,business.industry ,Hematology ,Middle Aged ,Disease control ,Surgery ,Treatment Outcome ,Hypo-fractionated stereotactic radiotherapy ,Oncology ,Intracranial meningioma ,030220 oncology & carcinogenesis ,Meta-analysis ,Female ,business ,Meningioma ,WHO I meningioma ,030217 neurology & neurosurgery ,Human - Abstract
Background Radiosurgery(RS), both in single and multiple sessions, have been performed for intracranial meningiomas. Different aspects are still controversial on this field. The aim of this systematic review is to summarize the current literature on long-term efficacy and safety of RS for meningiomas. Methods Online databases were searched for studies published until April 2015. The primary outcomes were disease control and progression-free-survival(PFS). The secondary outcomes were symptom control and radiation-induced toxicity. Results The estimate of disease control rate ranged from 87.0% to 100.0% at 5 years and from 67.0% to 100.0% at 10 years. The PFS rate ranged 78.0%–98.9% and 53.1%–97.2% at 5 and 10 years, respectively. The overall symptom control was 92.3%, the overall toxicity was 8.1%. Conclusions RS can be considered a safe and effective treatment. Efforts are needed in standardizing the definition of local and symptom control and toxicity in order to properly compare different treatment schedules.
- Published
- 2016
39. An OWL Ontology of Norms and Normative Judgements
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RUBINO, ROSSELLA, ROTOLO, ANTONINO, SARTOR, GIOVANNI, C. BIAGIOLI, E. FRANCESCONI, G. SARTOR, R. Rubino, A. Rotolo, and G. Sartor
- Published
- 2007
40. Legal Consolidation Formalised in Defeasible Logic and Based on Agents
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RIVERET, REGIS, PALMIRANI, MONICA, ROTOLO, ANTONINO, C. BIAGIOLI, E. FRANCESCONI, G. SARTOR, R. Riveret, M. Palmirani, and A. Rotolo
- Published
- 2007
41. Atezolizumab and chemotherapy for advanced or recurrent endometrial cancer (AtTEnd): a randomised, double-blind, placebo-controlled, phase 3 trial.
- Author
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Colombo N, Biagioli E, Harano K, Galli F, Hudson E, Antill Y, Choi CH, Rabaglio M, Marmé F, Marth C, Parma G, Fariñas-Madrid L, Nishio S, Allan K, Lee YC, Piovano E, Pardo B, Nakagawa S, McQueen J, Zamagni C, Manso L, Takehara K, Tasca G, Ferrero A, Tognon G, Lissoni AA, Petrella M, Laudani ME, Rulli E, Uggeri S, and Barretina Ginesta MP
- Subjects
- Humans, Female, Double-Blind Method, Middle Aged, Aged, Progression-Free Survival, Adult, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Endometrial Neoplasms drug therapy, Endometrial Neoplasms pathology, Endometrial Neoplasms mortality, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Paclitaxel administration & dosage, Paclitaxel adverse effects, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local pathology, Carboplatin administration & dosage
- 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/m
2 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 randomly assigned to atezolizumab (n=362) or placebo (n=189). Two patients in the atezolizumab group were excluded from all analyses due to lack of consent. Median follow-up was 28·3 months (IQR 21·2-37·6). 81 (23%) patients in the atezolizumab group and 44 (23%) patients in the placebo group had dMMR disease by central assessment. In the dMMR population, median progression-free survival was not estimable (95% CI 12·4 months-not estimable [NE]) in the atezolizumab group and 6·9 months (6·3-10·1) in the placebo group (hazard ratio [HR] 0·36, 95% CI 0·23-0·57; p=0·0005). In the overall population, median progression-free survival was 10·1 months (95% CI 9·5-12·3) in the atezolizumab group and 8·9 months (8·1-9·6) in the placebo group (HR 0·74, 95% CI 0·61-0·91; p=0·022). Median overall survival was 38·7 months (95% CI 30·6-NE) in the atezolizumab group and 30·2 months (25·0-37·2) in the placebo group (HR 0·82, 95% CI 0·63-1·07; log-rank p=0·048). The p value for the interim analysis of overall survival did not cross the stopping boundary; therefore, the trial will continue until the required number of events are recorded. The most common grade 3-4 adverse events were neutropenia (97 [27%] of 356 patients in the atezolizumab group vs 51 [28%] of 185 in the placebo group) and anaemia (49 [14%] vs 24 [13%]). Treatment-related serious adverse events occurred in 46 (13%) patients in the atezolizumab group and six (3%) patients in the placebo group. Treatment-related deaths occurred in two patients (pneumonia in one patient in each group)., Interpretation: Atezolizumab plus chemotherapy increased progression-free survival in patients with advanced or recurrent endometrial carcinoma, particularly in those with dMMR carcinomas, suggesting the addition of atezolizumab to standard chemotherapy as first-line treatment in this specific subgroup., Funding: F Hoffmann-La Roche., Competing Interests: Declaration of interests EB, FG, ER, and SU report grants from Roche to their institution to support the conduct of the study. NC reports personal fees from AstraZeneca, Clovis Oncology, Eisai, GSK, Immunogen, Mersana, MSD/Merck, Nuvation Bio, OncXerna, Pieris, Pfizer, Roche, and Novocure; and grants or research support from GSK and AstraZeneca. KH reports personal fees from AstraZeneca, Chugai, Eisai, MSD/Merck, Taiho, and Takeda; and grants or research support from MSD/Merck, Chugai, Takeda, AstraZeneca, and Daiichi Sankyo. EH reports personal fees from GSK and Clovis. FM reports personal fees from Roche, Eisai, Novartis, AstraZeneca, Pfizer, Lilly, Daiichi Sankyo, MSD/Merck, GSK, Clovis, Gilead, Myriad Genetics, Seagen, and Stemline Menarini; grants or research support from Roche; and participation on data safety monitoring or advisory boards for Immutep, Amgen, and Palleos Healthcare. CM reports personal fees from Roche, Novartis, MSD/Merck, AstraZeneca, Pfizer, PharmaMar, ImmunoGen, Daiichi Sankyo, Novocure, BioNTtech, Eisai, and GSK. LF-M reports personal fees from AstraZeneca, GSK, MSD/Merck, Eisai, and Pharma&. YCL reports personal fees from AstraZeneca, and grants or research support from BeiGene. EP reports personal fees from GSK and AstraZeneca. BP reports personal fees from AstraZeneca, GSK, MSD/Merck, and Pharma&. CZ reports personal fees from Roche, Eisai, Novartis, AstraZeneca, Pfizer, QuintilesIMS, Clovis, Eli Lilly, Istituto Gentili, Daiichi Sankyo, Seagen, MSD/Merck, GSK, and Gilead; and grants or research support from Roche, Novartis, AstraZeneca, Pfizer, Eisai, Clovis, Gilead, Seagen, Eli Lilly, Daiichi Sankyo, and MSD/Merck. KT reports personal fees from AstraZeneca, Chugai Pharma, Takeda, MSD/Merck, Nippon Kayaku, Eisai, and Sanofi; and grants or research support from Chugai Pharma. AF reports personal fees from GSK, AstraZeneca, and MSD/Merck. MP reports personal fees from AstraZeneca, Eisai, GSK, and MSD/Merck. MPBG reports personal fees from AstraZeneca, GSK, MSD/Merck, PharmaMar, Clovis Oncology, Eisai, Pharma&, and Kyowa Kirin; and a leadership role for Geico. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)- Published
- 2024
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42. Neoadjuvant chemotherapy prior to radical hysterectomy in locally advanced cervical cancer: a systematic review and meta-analysis.
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Borghi C, Biagioli E, Mauro J, Roberto A, Borghese M, and Buda A
- Subjects
- Humans, Female, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Chemotherapy, Adjuvant, Uterine Cervical Neoplasms pathology, Uterine Cervical Neoplasms drug therapy, Uterine Cervical Neoplasms surgery, Uterine Cervical Neoplasms therapy, Neoadjuvant Therapy, Hysterectomy
- Abstract
Objective: The objective of this systematic review was to evaluate the effect of different types of neoadjuvant chemotherapy regimens, in terms of optimal pathological response and oncological outcomes, in patients with locally advanced cervical cancer., Methods: A systematic search of the literature was performed. MEDLINE through PubMed and Embase databases were searched from inception to June 2023. The study was registered in PROSPERO (ID number CRD42023389806). All women with a pathological diagnosis of locally advanced cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009 classification stages IB2-IVA), any age or histology, who underwent intravenous neoadjuvant chemotherapy before radical surgery, and articles only in English language, were included. We conducted a meta-analysis for optimal pathological response after surgery and survival outcomes. The risk of bias was assessed using the Newcastle-Ottawa scale and the Risk of Bias 2 (RoB) tools. The review methods and results were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines., Results: 25 studies with a total number of 1984 patients fulfilled the eligibility criteria of our review and were included for data extraction and efficacy analysis. When compared with a two-drug regimen, the three-drug combination including cisplatin, paclitaxel, and ifosfamide or anthracyclines showed superior efficacy in terms of optimal pathological response with an odds ratio of 0.38 (95% CI 0.24 to 0.61, p<0.0001), with no difference in disease-free survival (hazard ratio (HR) 0.72, 95% CI 0.50 to 1.03, I
2 =0%, p=0.07) and higher overall survival (HR 0.63, 95% CI 0.41 to 0.97, I2 =0%, p=0.03)., Conclusions: The three-drug combination of cisplatin, paclitaxel, and ifosfamide or anthracyclines showed a higher rate of complete or optimal partial response, with the triple regimens having an advantage over the platinum-based schedules in terms of overall survival. Neoadjuvant chemotherapy followed by radical surgery should not be considered a standard of care in locally advanced cervical cancer., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)- Published
- 2024
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43. Machine Learning Application Identifies Germline Markers of Hypertension in Patients With Ovarian Cancer Treated With Carboplatin, Taxane, and Bevacizumab.
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Polano M, Bedon L, Dal Bo M, Sorio R, Bartoletti M, De Mattia E, Cecchin E, Pisano C, Lorusso D, Lissoni AA, De Censi A, Cecere SC, Scollo P, Marchini S, Arenare L, De Giorgi U, Califano D, Biagioli E, Chiodini P, Perrone F, Pignata S, and Toffoli G
- Subjects
- Humans, Female, Carboplatin adverse effects, Bevacizumab adverse effects, Taxoids adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Ovarian Neoplasms drug therapy, Ovarian Neoplasms genetics, Hypertension chemically induced, Hypertension diagnosis, Hypertension genetics
- Abstract
Pharmacogenomics studies how genes influence a person's response to treatment. When complex phenotypes are influenced by multiple genetic variations with little effect, a single piece of genetic information is often insufficient to explain this variability. The application of machine learning (ML) in pharmacogenomics holds great potential - namely, it can be used to unravel complicated genetic relationships that could explain response to therapy. In this study, ML techniques were used to investigate the relationship between genetic variations affecting more than 60 candidate genes and carboplatin-induced, taxane-induced, and bevacizumab-induced toxicities in 171 patients with ovarian cancer enrolled in the MITO-16A/MaNGO-OV2A trial. Single-nucleotide variation (SNV, formerly SNP) profiles were examined using ML to find and prioritize those associated with drug-induced toxicities, specifically hypertension, hematological toxicity, nonhematological toxicity, and proteinuria. The Boruta algorithm was used in cross-validation to determine the significance of SNVs in predicting toxicities. Important SNVs were then used to train eXtreme gradient boosting models. During cross-validation, the models achieved reliable performance with a Matthews correlation coefficient ranging from 0.375 to 0.410. A total of 43 SNVs critical for predicting toxicity were identified. For each toxicity, key SNVs were used to create a polygenic toxicity risk score that effectively divided individuals into high-risk and low-risk categories. In particular, compared with low-risk individuals, high-risk patients were 28-fold more likely to develop hypertension. The proposed method provided insightful data to improve precision medicine for patients with ovarian cancer, which may be useful for reducing toxicities and improving toxicity management., (© 2023 The Authors. Clinical Pharmacology & Therapeutics © 2023 American Society for Clinical Pharmacology and Therapeutics.)
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- 2023
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44. Observed intervention effects for mortality in randomised clinical trials: a methodological study protocol.
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Hansen ML, Jørgensen CK, Thabane L, Rulli E, Biagioli E, Chiaruttini M, Mbuagbaw L, Mathiesen O, Gluud C, and Jakobsen JC
- Subjects
- Humans, Systematic Reviews as Topic, Research Design, Critical Care, Randomized Controlled Trials as Topic, Anesthesia, Anesthesiology
- Abstract
Introduction: It is essential to choose a realistic anticipated intervention effect when calculating a sample size for a randomised clinical trial. Unfortunately, anticipated intervention effects are often inflated, when compared with the 'true' intervention effects. This is documented for mortality in critical care trials. A similar pattern might exist across different medical specialties. This study aims to estimate the range of observed intervention effects for all-cause mortality in trials included in Cochrane Reviews, within each Cochrane Review Group., Methods and Analysis: We will include randomised clinical trials assessing all-cause mortality as an outcome. Trials will be identified from Cochrane Reviews published in the Cochrane Database of Systematic Reviews. Cochrane Reviews will be clustered according to the registered Cochrane Review Group (eg, Anaesthesia, Emergency and Critical Care) and the statistical analyses will be conducted for each Cochrane Review Group and overall. The median relative risk and IQR for all-cause mortality and the proportion of trials with a relative all-cause mortality risk within seven different ranges will be reported (relative risk below 0.70, 0.70-0.79, 0.80-0.89, 0.90-1.09, 1.10-1.19, 1.20-1.30 and above 1.30). Subgroup analyses will explore the effects of original design, sample size, risk of bias, disease, intervention type, follow-up length, participating centres, funding type, information size and outcome hierarchy., Ethics and Dissemination: Since we will use summary data from trials already approved by relevant ethical committees, this study does not require ethical approval. Regardless of our findings, the results will be published in an international peer-reviewed journal., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
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45. Centre for Statistical and Methodological Excellence (CESAME): A Consortium Initiative for Improving Methodology in Randomised Clinical Trials.
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Jørgensen CK, Olsen MH, Nielsen N, Lange T, Mbuagbaw L, Thabane L, Billot L, Binder N, Garattini S, Banzi R, Demotes J, Biagioli E, Rulli E, Bertolini G, Nattino G, Mathiesen O, Torri V, Gluud C, and Jakobsen JC
- Abstract
When conducting randomised clinical trials, the choice of methodology and statistical analyses will influence the results. If the planned methodology is not of optimal quality and predefined in detail, there is a risk of biased trial results and interpretation. Even though clinical trial methodology is already at a very high standard, there are many trials that deliver biased results due to the implementation of inadequate methodology, poor data quality and erroneous or biased analyses. To increase the internal and external validity of randomised clinical trial results, several international institutions within clinical intervention research have formed The Centre for Statistical and Methodological Excellence (CESAME). Based on international consensus, the CESAME initiative will develop recommendations for the proper methodological planning, conduct and analysis of clinical intervention research. CESAME aims to increase the validity of randomised clinical trial results which will ultimately benefit patients worldwide across medical specialities. The work of CESAME will be performed within 3 closely interconnected pillars: (1) planning randomised clinical trials; (2) conducting randomised clinical trials; and (3) analysing randomised clinical trials., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)
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- 2023
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46. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer.
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Colombo N, Tomao F, Benedetti Panici P, Nicoletto MO, Tognon G, Bologna A, Lissoni AA, DeCensi A, Lapresa M, Mancari R, Palaia I, Tasca G, Tettamanzi F, Alvisi MF, Rulli E, Poli D, Carlucci L, Torri V, Fossati R, and Biagioli E
- Subjects
- Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Ovarian Epithelial drug therapy, Carcinoma, Ovarian Epithelial etiology, Female, Humans, Neoplasm Recurrence, Local drug therapy, Paclitaxel, Phthalazines, Piperazines, Quinazolines, Ovarian Neoplasms drug therapy, Ovarian Neoplasms etiology, Peripheral Nervous System Diseases
- Abstract
Background: Previous findings showed that cediranib-olaparib increased PFS in women with recurrent platinum-sensitive ovarian cancer compared to olaparib alone., Methods: BAROCCO trial randomized 123 patients: 80mg/m2 paclitaxel weekly up to 24 weeks (control), olaparib 300mg tablets twice daily together with 20mg cediranib daily (continuous schedule) or with 20mg cediranib 5 days/week (intermittent schedule) until progression. The primary objective was the PFS comparison between each experimental arm and the control (alpha one-sided 5%; power 80%; HR 0.5)., Results: The median platinum-free interval was 1.9 months, 60% of patients had been pretreated with 3 or more chemotherapy lines. Median PFS for paclitaxel, the continuous, and the intermittent schedules were 3.1, 5.6, and 3.8 months. The HR for PFS in the continuous arm vs control was 0.76 (90% CI: 0.50-1.14, p = 0.265). The HR for PFS in the intermittent arm vs control was 1.03 (90% CI: 0.68-1.55, p = 0.904). Treatment was discontinued due to adverse events in 15%, 20%, and 5% of patients in the control, continuous and intermittent arms. Grade ≥ 3 anemia and diarrhea and hypertension of any grade occurred only in the experimental arms, and peripheral neuropathies and alopecia only in the control arm. Five serious adverse drug reactions occurred and two were fatal: one in the control and one in the continuous arm., Conclusions: The combination of cediranib-olaparib was not superior to chemotherapy in terms of PFS in heavily pretreated platinum-resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population., Clinical Trial Identification: IRFMN-OVA-7289, EudraCT: 2016-003964-38, NCT03314740., (Copyright © 2022 Elsevier Inc. All rights reserved.)
- Published
- 2022
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47. The Glaucoma Italian Pediatric Study (GIPSy): The Long-term Effect of Topical Latanoprost on Central Corneal Thickness.
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Riva I, Galli F, Biagioli E, Rulli E, Longo A, Uva MG, Oddone F, Michelessi M, Weinreb RN, and Quaranta L
- Subjects
- Administration, Topical, Adolescent, Age of Onset, Antihypertensive Agents administration & dosage, Antihypertensive Agents adverse effects, Child, Child, Preschool, Cornea pathology, Female, Glaucoma congenital, Glaucoma epidemiology, Humans, Infant, Intraocular Pressure drug effects, Italy epidemiology, Long-Term Care, Male, Organ Size drug effects, Sulfonamides administration & dosage, Sulfonamides adverse effects, Thiophenes administration & dosage, Thiophenes adverse effects, Time Factors, Tonometry, Ocular, Cornea drug effects, Corneal Pachymetry, Glaucoma drug therapy, Latanoprost administration & dosage, Latanoprost adverse effects
- Abstract
Precis: Central corneal thickness (CCT) may increase over time in children affected by primary congenital glaucoma and treated with latanoprost for at least 30 months., Purpose: The purpose of this study was to investigate CCT modification over time in a population of primary pediatric glaucoma (PPG) patients prescribed a monotherapy of latanoprost., Materials and Methods: The present paper reports the results of a post hoc analysis on patients enrolled in the Glaucoma Italian Pediatric Study (GIPSy). Children affected by PPG, with a postsurgical intraocular pressure between 22 and 26 mm Hg and treated with latanoprost monotherapy for at least 30 months were eligible for the analysis. CCT variation from baseline was investigated over the follow-up using univariable and multivariable longitudinal linear mixed models. The impact of age, sex, and intraocular pressure on CCT variation were evaluated taking into account the interaction of each variable with time., Results: Twenty-seven eyes (20 patients) were included in the analysis. Mean duration of latanoprost treatment was 36.6 months (SD 2.5) and mean CCT at baseline was 551 μm (SD 37.7). A significant increase of CCT over time was revealed by multivariable analysis, taking into account the impact of age at baseline and its interaction with time (P=0.03). The interaction between age and time was significant (P=0.04), indicating that older age at baseline was associated with lower increase of CCT over time. No variation of CCT was found in univariable analysis (P=0.28)., Conclusion: In this population of PPG patients treated with latanoprost for at least 30 months, CCT significantly increased over time, when the impact of age and its interaction with time were considered.
- Published
- 2020
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48. Parp inhibitors as maintenance treatment in platinum sensitive recurrent ovarian cancer: An updated meta-analysis of randomized clinical trials according to BRCA mutational status.
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Tomao F, Bardhi E, Di Pinto A, Sassu CM, Biagioli E, Petrella MC, Palaia I, Muzii L, Colombo N, and Panici PB
- Subjects
- Female, Humans, Maintenance Chemotherapy, Randomized Controlled Trials as Topic, Genes, BRCA1, Genes, BRCA2, Germ-Line Mutation, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local genetics, Ovarian Neoplasms drug therapy, Ovarian Neoplasms genetics, Poly(ADP-ribose) Polymerase Inhibitors administration & dosage
- Abstract
Objective: This meta-analysis investigated the effectiveness of PARP inhibitors (PARPis) as maintenance treatment in platinum sensitive recurrent ovarian cancer (ROC), stratifying results based on BRCA mutational status into five different categories: whole population, germ-line BRCA mutated patients, somatic BRCA mutated patients, HRD patients and wild type population., Methods: PubMed, Medline, Scopus, EMBASE and clinicaltrials.gov, as well as meeting proceedings were searched for eligible studies that described RCTs testing the efficacy of PARPis as maintenance treatment in platinum sensitive ROC. Data were extracted independently and analysed using RevMan statistical software version 5.3. Primary end-point was progression free survival (PFS)., Results: The analysis confirmed the positive effect of PARPis in patients with platinum sensitive ROC in case of germinal or somatic BRCA mutations. Specifically, HR for PFS was 0.26, 95% CI 0.21-0.31, p < 0.00001 for the mutation of BRCA gene and 0.24, 95%, CI 0.12-0.48, p < 0.0001 for the somatic alteration. In addition, in the HRD population, studies that analysed the efficacy of PARPis reported a PFS improvement with HR 0.34, 95% CI 0.26-0.43, p < 0.00001. Finally, our analysis confirms the role of these drugs in prolonging PFS in the whole population with HR 0.36, 95% CI 0.32-0.42, p < 0.00001, although to a lesser extent, with a significant improvement even in wild type cancers with HR 0.49, 95%, CI 0.41-0.59, p < 0.00001)., Conclusions: PARPis are effective regardless of BRCA mutational status. Future investigations are necessary to explore the use of different PARPis as monotherapy, comparing them among each other in terms of efficacy and toxicity, and exploring their potential re-use., (Copyright © 2019 Elsevier Ltd. All rights reserved.)
- Published
- 2019
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49. Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer.
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Colombo N, Zaccarelli E, Baldoni A, Frezzini S, Scambia G, Palluzzi E, Tognon G, Lissoni AA, Rubino D, Ferrero A, Farina G, Negri E, Pesenti Gritti A, Galli F, Biagioli E, Rulli E, Poli D, Gerardi C, Torri V, Fossati R, and D'Incalci M
- Subjects
- Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Bevacizumab administration & dosage, Bevacizumab adverse effects, Carboplatin administration & dosage, Carboplatin adverse effects, Female, Humans, Kaplan-Meier Estimate, Middle Aged, Progression-Free Survival, Survival Rate, Trabectedin administration & dosage, Trabectedin adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Ovarian Epithelial drug therapy, Ovarian Neoplasms drug therapy
- Abstract
Background: Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated., Methods: In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6 ≥ 30% as unacceptable., Results: BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%)., Conclusions: BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity., Clinical Trial Registration: NCT01735071 (Clinicaltrials.gov).
- Published
- 2019
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50. Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients: A Study Protocol.
- Author
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Quaranta L, Riva I, Biagioli E, Rulli E, Rulli E, Poli D, and Legramandi L
- Subjects
- Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Ophthalmic Solutions therapeutic use, Ubiquinone therapeutic use, Visual Fields, Glaucoma, Open-Angle drug therapy, Intraocular Pressure drug effects, Ubiquinone analogs & derivatives, Vitamin E therapeutic use
- Abstract
Introduction: The CoQun
® study is a multicenter, controlled trial aimed to evaluate the neuroprotective effects of Coqun® , an ophthalmic solution of Coenzyme q10 (CoQ10) and Vitamin E (VitE), in patients affected by primary open-angle glaucoma (POAG). Pre-clinical studies and small non-controlled clinical trials have previously shown a potential role of CoQ10 and VitE in glaucoma neuroprotection, both in vitro and in vivo., Methods: Randomized, parallel arm, multicenter, double-blind study. POAG patients with an IOP ranging from 17 to 21 mm Hg on monotherapy with a prostaglandin analogue (PGA) will be considered for study enrollment. Inclusion criteria will be visual field (VF) mean deviation between - 4 and - 10 dB and VF Pattern Standard Deviation between 4 and 10 dB. Eligible patients will be randomized to receive CoQun® (Arm A) or placebo (Arm B), in addition to PGA monotherapy., Planned Outcomes: Primary outcome will be time to progression, defined as the time between the baseline visit and the visit with confirmed VF progression. A total of 612 patients are planned to be enrolled, to detect a hazard ratio of 0.65, with a power of 80% and an alpha error of 0.05 (two-sided). For study power calculation, 10% non-evaluable patients are assumed. This is the first study investigating, in a randomized, double-blind and controlled fashion, the neuroprotective effects of CoQ10 and VitE in POAG patients., Trial Registration: ClinicalTrials.gov identifier, NCT03611530.- Published
- 2019
- Full Text
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