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3. When one size does not fit all: Reconsidering PCOS etiology, diagnosis, clinical subgroups, and subgroup-specific treatments

Author

Unfer, V., Kandaraki, E., Pkhaladze, L., Roseff, S., Vazquez-Levin, M.H., Laganà, A.S., Shiao-Yng, C., Yap-Garcia, M.I.M., Greene, N.D.E., Soulage, C.O., Bevilacqua, A., Benvenga, S., Barbaro, D., Pintaudi, B., Wdowiak, A., Aragona, C., Kamenov, Z., Appetecchia, M., Porcaro, G., Hernandez Marin, I., Facchinetti, F., Chiu, T., Pustotina, O., Papalou, O., Nordio, M., Cantelmi, T., Cavalli, P., Vucenik, I., D'Anna, R., Unfer, V.R., Dinicola, S., Salehpour, S., Stringaro, A., Montaninno Oliva, M., Tugushev, M., Prapas, N., Bizzarri, M., Espinola, M.S.B., Di Lorenzo, C., Ozay, A.C., and Nestler, J.

Published
2024
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4. Contraception During Perimenopause: Practical Guidance

Author

Grandi G, Di Vinci P, Sgandurra A, Feliciello L, Monari F, and Facchinetti F

Subjects
contraception, perimenopause, sarcs, larcs, oral contraceptives, combined oral contraceptives, vaginal rings, patch, intrauterine devices, implants, forties, metabolism., Gynecology and obstetrics, RG1-991
Abstract

Giovanni Grandi,1 Pierluigi Di Vinci,2 Alice Sgandurra,1 Lia Feliciello,1 Francesca Monari,1 Fabio Facchinetti1 1Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Modena, 41124, Italy; 2International Doctorate School in Clinical and Experimental Medicine, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, 41124, ItalyCorrespondence: Giovanni Grandi, Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Via del Pozzo 71, Modena, 41124, Italy, Tel +39 059 422 2665, Email giovanni.grandi@unimore.itAbstract: Climacteric is by no means in itself a contraindication to safe contraception. On the contrary, there are several conditions related to the perimenopause that could benefit from the use of modern contraceptives, mainly hormonal, with the goals of avoiding unintended pregnancies and giving further possible benefits beyond contraception (menstrual cycle control, a reduction of vasomotor symptoms and menstrual migraines, a protection against bone loss, a positive oncological risk/benefit balance). This narrative review aims to provide practical guidance on their possible use in this particular life stage, both short- and long-acting reversible contraceptives, and to assist clinicians for women transitioning from contraception to their menopausal years, including the possible initiation of postmenopausal hormone therapy. Comprehensive contraceptive counselling is an essential aspect of the overall health and wellbeing of women and should be addressed with each such patient irrespective of age.Keywords: contraception, perimenopause, SARCs, LARCs, oral contraceptives, combined oral contraceptives, vaginal rings, patch, intrauterine devices, implants, forties, metabolism

Published
2022

6. Meningeal “Lazarus Response” to Lorlatinib in a ROS1-Positive NSCLC Patient Progressing to Entrectinib

Author

Facchinetti F, Levy A, Ammari S, Naltet C, Lavaud P, Aldea M, Vasseur D, Planchard D, and Besse B

Subjects
tyrosine kinase inhibitors (tki), central nervous system (cns), brain, lung cancer, radiotherapy., Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Francesco Facchinetti,1,2 Antonin Levy,3,4 Samy Ammari,5 Charles Naltet,6 Pernelle Lavaud,6 Mihaela Aldea,6 Damien Vasseur,7 David Planchard,6 Benjamin Besse2,6 1Predictive Biomarkers and Novel Therapeutic Strategies in Oncology, Inserm U981, Gustave Roussy Cancer Center, Villejuif, France; 2Université Paris-Saclay, Faculté de Médecine, Le Kremlin-Bicêtre, France; 3Department of Radiation Oncology, Institut d’Oncologie Thoracique (IOT), Gustave Roussy Cancer Center, Villejuif, France; 4INSERM U1030, Molecular Radiotherapy, Gustave Roussy, Université Paris-Saclay, Villejuif, France; 5Department of Radiology, Gustave Roussy Cancer Center, Villejuif, France; 6Department of Medical Oncology, Institut d’Oncologie Thoracique (IOT), Gustave Roussy Cancer Center, Villejuif, France; 7Department of Medical Biology and Pathology, Gustave Roussy Cancer Center, Villejuif, FranceCorrespondence: Benjamin BesseDepartment of Medical Oncology, Institut d’Oncologie Thoracique (IOT), Gustave Roussy Cancer Center, Villejuif, FranceEmail benjamin.besse@gustaveroussy.frBackground: ROS1 tyrosine kinase inhibitors (TKIs) have showed activity and efficacy in ROS1-rearranged non-small cell lung cancer (NSCLC). In the clinical practice, besides the utilization of crizotinib, less is known about the best treatment strategies involving additional, new-generation TKIs for the sequential treatment of ROS1-positive NSCLC patients.Case Presentation: A patient suffering from a ROS1-rearranged lung adenocarcinoma, after receiving cisplatin-pemetrexed chemotherapy, was treated with entrectinib, a new-generation ALK/ROS1/NTRK inhibitor. After 16 months, central nervous system (CNS) metastases appeared, without extra-cerebral disease progression. Stereotactic brain radiotherapy was performed and entrectinib was maintained, due to the global systemic disease control. Approximately one month after radiotherapy, thoracic and meningeal progressions were detected, the latter highly symptomatic with neurocognitive disorders, visual hallucinations and worsening of psycho-motor impairment. A lumbar puncture was positive for tumor cells and for an EZR-ROS1 fusion. The administration of lorlatinib (a third-generation ALK/ROS1 inhibitor) prompted an extremely rapid improvement of clinical conditions, anticipating the positive results observed at radiologic evaluation that confirmed the disease response still ongoing after nine months since treatment start.Discussion: With the expanding availability of targeted agents with differential activity on resistance mechanism and on CNS disease, choosing wisely the best treatment strategies is pivotal to assure the best clinical outcomes in oncogene-addicted NSCLC patients. Here we have reported lorlatinib reverted an almost fatal meningeal carcinomatosis developing during entrectinib in a ROS1-positive NSCLC patient.Keywords: tyrosine kinase inhibitors, TKI, central nervous system, CNS, brain, lung cancer, radiotherapy

Published
2021

11. Profile of entrectinib and its potential in the treatment of ROS1-positive NSCLC: evidence to date

Author

Facchinetti F and Friboulet L

Subjects
Lung cancer, ROS1, Tyrosine kinase inhibitors, Entrectinib., Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Francesco Facchinetti, Luc Friboulet INSERM U981, Gustave Roussy Cancer Campus, Université Paris Saclay, Villejuif, FranceCorrespondence: Francesco FacchinettiINSERM U981, Gustave Roussy Cancer Campus, 114 Rue Edouard, Villejuif 94800, FranceTel + 33 14 211 5662Email Francesco.Facchinetti@gustaveroussy.frAbstract: ROS1 inhibition provides impressive survival benefits in ROS1-rearranged non-small cell lung cancer (NSCLC) patients. Crizotinib is the only tyrosine kinase inhibitor (TKI) approved by both FDA and EMA for the treatment of ROS1-positive lung cancer. In addition, several TKI have been tested with preliminary proofs of success in this oncogene-driven disease, either in the post-crizotinib setting or as first-line targeted agents. Here we present the evidence concerning entrectinib, an ALK/ROS1/NTRK inhibitor developed across different tumor types harboring rearrangements in these genes, in the context of ROS1-driven NSCLC. Of interest, in August 2019 entrectinib was granted by FDA accelerated approval for the treatment of ROS1-rearranged NSCLC, as well as of NTRK-driven solid tumors.Keywords: lung cancer, ROS1, tyrosine kinase inhibitors, entrectinib

Published
2019

13. Profile of atezolizumab in the treatment of metastatic non-small-cell lung cancer: patient selection and perspectives

Author

Facchinetti F, Bordi P, Leonetti A, Buti S, and Tiseo M

Subjects
Non-small cell lung cancer (NSCLC), Immune checkpoint blockers (ICB), PD-1, PD-L1, Atezolizumab development, Biomarkers., Therapeutics. Pharmacology, RM1-950
Abstract

Francesco Facchinetti, Paola Bordi, Alessandro Leonetti, Sebastiano Buti, Marcello Tiseo Medical Oncology Unit, University Hospital of Parma, Parma, Italy Abstract: Programed cell death-1/programed death ligand-1 (PD-1/PD-L1) blockade represents an affirmed reality in the treatment of advanced non-small-cell lung cancer (NSCLC) patients. Atezolizumab, an anti-PD-L1 agent, figures among the drugs that provide previously unenvisaged outcomes in the pretreated setting of metastatic NSCLC. Increasing evidence vouches for the early administration of PD-1/PD-L1 blockers in untreated patients, encompassing atezolizumab combinations with chemotherapy and the anti-angiogenic agent bevacizumab. Moreover, the development of atezolizumab allowed to derive several hints regarding clinical and immunological factors predictive of its activity and efficacy, some of them exclusive among this class of drugs. This review provides an overview of atezolizumab development throughout clinical trials toward its applicability in the routine practice, with a particular focus on patient selection based on clinical and immune-related factors. Keywords: non-small cell lung cancer, NSCLC, immune checkpoint blockers, ICB, PD-1, PD-L1, atezolizumab development, biomarkers

Published
2018

14. Host immune-inflammatory markers to unravel the heterogeneous outcome and assessment of patients with PD-L1 ≥50% metastatic non-small cell lung cancer and poor performance status receiving first-line immunotherapy

Author

Banna, G, Tiseo, M, Cortinovis, D, Facchinetti, F, Aerts, J, Baldessari, C, Giusti, R, Bria, E, Grossi, F, Berardi, R, Morabito, A, Catino, A, Genova, C, Mazzoni, F, Gelibter, A, Rastelli, F, Macerelli, M, Chiari, R, Gori, S, Mansueto, G, Citarella, F, Cantini, L, Rijavec, E, Bertolini, F, Cappuzzo, F, De Toma, A, Friedlaender, A, Metro, G, Pensieri, M, Porzio, G, Ficorella, C, Pinato, D, Cortellini, A, Addeo, A, Banna GL, Tiseo M, Cortinovis D, Facchinetti F, Aerts JGJV, Baldessari C, Giusti R, Bria E, Grossi F, Berardi R, Morabito A, Catino A, Genova C, Mazzoni F, Gelibter A, Rastelli F, Macerelli M, Chiari R, Gori S, Mansueto G, Citarella F, Cantini L, Rijavec E, Bertolini F, Cappuzzo F, De Toma A, Friedlaender A, Metro G, Pensieri MV, Porzio G, Ficorella C, Pinato DJ, Cortellini A, Addeo A, Banna, G, Tiseo, M, Cortinovis, D, Facchinetti, F, Aerts, J, Baldessari, C, Giusti, R, Bria, E, Grossi, F, Berardi, R, Morabito, A, Catino, A, Genova, C, Mazzoni, F, Gelibter, A, Rastelli, F, Macerelli, M, Chiari, R, Gori, S, Mansueto, G, Citarella, F, Cantini, L, Rijavec, E, Bertolini, F, Cappuzzo, F, De Toma, A, Friedlaender, A, Metro, G, Pensieri, M, Porzio, G, Ficorella, C, Pinato, D, Cortellini, A, Addeo, A, Banna GL, Tiseo M, Cortinovis D, Facchinetti F, Aerts JGJV, Baldessari C, Giusti R, Bria E, Grossi F, Berardi R, Morabito A, Catino A, Genova C, Mazzoni F, Gelibter A, Rastelli F, Macerelli M, Chiari R, Gori S, Mansueto G, Citarella F, Cantini L, Rijavec E, Bertolini F, Cappuzzo F, De Toma A, Friedlaender A, Metro G, Pensieri MV, Porzio G, Ficorella C, Pinato DJ, Cortellini A, and Addeo A

Abstract

Background: Patients with programmed cell death-ligand 1 (PD-L1) ≥50% metastatic non-small cell lung cancer (mNSCLC) and ECOG performance status (PS) of 2 treated with first-line immunotherapy have heterogeneous clinical assessment and outcomes. Methods: To explore the role of immune-inflammatory surrogates by the validated lung immuno-oncology prognostic score (LIPS) score, including the neutrophil-to-lymphocyte ratio (NLR) and the pretreatment use of steroids, alongside other prognostic variables. A retrospective analysis of 128 patients with PS2 and PD-L1 ≥50% mNSCLC treated between April 2018 and September 2019 with first-line pembrolizumab in a real-world setting was performed. Results: With a median follow-up of 15.3 months, the 1-year overall survival (OS) and median progression-free survival (PFS) were 32.3% (95% CI: 30.9–33.9) and 3.3 months (95% CI: 1.8–4.7), respectively. The NLR, lactate dehydrogenase (LDH) and pretreatment steroids results were the only significant prognostic factors on the univariate analysis and independent prognostic factors by the multivariate analysis on both OS and PFS. The LIPS score, including the NLR and pretreatment steroids, identified 29 (23%) favourable-risk patients, with 0 factors, 1-year OS of 67.6% and median PFS of 8.2 months; 57 (45%) intermediate-risk patients, with 1 factor, 1-year OS 32.1% and median PFS 2.7 months; 42 (33%) poor-risk patients, with both factors, 1-year OS of 10.7% and median PFS of 1.2 months. Conclusions: The assessment of pre-existing imbalance of the host immune response by combined blood and clinical immune-inflammatory markers may represent a way to unravel the heterogeneous outcome and assessment of patients with mNSCLC and poor PS in the immune-oncology setting.

Published
2022

15. External validation of prognostic models to predict stillbirth using International Prediction of Pregnancy Complications (IPPIC) Network database: individual participant data meta-analysis

Author

Allotey, J, Whittle, R, Snell, K, Smuk, M, Townsend, R, von Dadelszen, P, Heazell, A, Magee, L, Smith, G, Sandall, J, Thilaganathan, B, Zamora, J, Riley, R, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, A, Salvesen, K, Bhattacharya, S, Uiterwaal, C, Staff, A, Andersen, L, Olive, E, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramirez, J, Masse, J, Audibert, F, Magnus, P, Jenum, A, Baschat, A, Ohkuchi, A, Mcauliffe, F, West, J, Askie, L, Mone, F, Farrar, D, Zimmerman, P, Smits, L, Riddell, C, Kingdom, J, van de Post, J, Illanes, S, Holzman, C, van Kuijk, S, Carbillon, L, Villa, P, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, van Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, C, Nagata, C, Brown, M, Vollebregt, K, Takeda, S, Langenveld, J, Widmer, M, Saito, S, Haavaldsen, C, Carroli, G, Olsen, J, Wolf, H, Zavaleta, N, Eisensee, I, Vergani, P, Lumbiganon, P, Makrides, M, Facchinetti, F, Sequeira, E, Gibson, R, Ferrazzani, S, Frusca, T, Norman, J, Figueiro, E, Lapaire, O, Laivuori, H, Lykke, J, Conde-Agudelo, A, Galindo, A, Mbah, A, Betran, A, Herraiz, I, Trogstad, L, Steegers, E, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, W, Browne, J, Allen, R, Costa, F, Klipstein-Grobusch Browne, K, Crowther, C, Jorgensen, J, Forest, J, Rumbold, A, Mol, B, Giguere, Y, Kenny, L, Ganzevoort, W, Odibo, A, Myers, J, Yeo, S, Goffinet, F, Mccowan, L, Pajkrt, E, Teede, H, Haddad, B, Dekker, G, Kleinrouweler, E, Lecarpentier, E, Roberts, C, Groen, H, Skrastad, R, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, J, Monterio, I, Pillalis, A, Souza, R, Hawkins, L, Gabbay-Benziv, R, Crovetto, F, Figuera, F, Jorgensen, L, Dodds, J, Patel, M, Aviram, A, Papageorghiou, A, Khan, K, Allotey J., Whittle R., Snell K. I. E., Smuk M., Townsend R., von Dadelszen P., Heazell A. E. P., Magee L., Smith G. C. S., Sandall J., Thilaganathan B., Zamora J., Riley R. D., Khalil A., Thangaratinam S., Coomarasamy A., Kwong A., Savitri A. I., Salvesen K. A., Bhattacharya S., Uiterwaal C. S. P. M., Staff A. C., Andersen L. B., Olive E. L., Redman C., Sletner L., Daskalakis G., Macleod M., Abdollahain M., Ramirez J. A., Masse J., Audibert F., Magnus P. M., Jenum A. K., Baschat A., Ohkuchi A., McAuliffe F. M., West J., Askie L. M., Mone F., Farrar D., Zimmerman P. A., Smits L. J. M., Riddell C., Kingdom J. C., van de Post J., Illanes S. E., Holzman C., van Kuijk S. M. J., Carbillon L., Villa P. M., Eskild A., Chappell L., Prefumo F., Velauthar L., Seed P., van Oostwaard M., Verlohren S., Poston L., Ferrazzi E., Vinter C. A., Nagata C., Brown M., Vollebregt K. C., Takeda S., Langenveld J., Widmer M., Saito S., Haavaldsen C., Carroli G., Olsen J., Wolf H., Zavaleta N., Eisensee I., Vergani P., Lumbiganon P., Makrides M., Facchinetti F., Sequeira E., Gibson R., Ferrazzani S., Frusca T., Norman J. E., Figueiro E. A., Lapaire O., Laivuori H., Lykke J. A., Conde-Agudelo A., Galindo A., Mbah A., Betran A. P., Herraiz I., Trogstad L., Smith G. G. S., Steegers E. A. P., Salim R., Huang T., Adank A., Zhang J., Meschino W. S., Browne J. L., Allen R. E., Costa F. D. S., Klipstein-Grobusch Browne K., Crowther C. A., Jorgensen J. S., Forest J. -C., Rumbold A. R., Mol B. W., Giguere Y., Kenny L. C., Ganzevoort W., Odibo A. O., Myers J., Yeo S. A., Goffinet F., McCowan L., Pajkrt E., Teede H. J., Haddad B. G., Dekker G., Kleinrouweler E. C., LeCarpentier E., Roberts C. T., Groen H., Skrastad R. B., Heinonen S., Eero K., Anggraini D., Souka A., Cecatti J. G., Monterio I., Pillalis A., Souza R., Hawkins L. A., Gabbay-Benziv R., Crovetto F., Figuera F., Jorgensen L., Dodds J., Patel M., Aviram A., Papageorghiou A., Khan K., Allotey, J, Whittle, R, Snell, K, Smuk, M, Townsend, R, von Dadelszen, P, Heazell, A, Magee, L, Smith, G, Sandall, J, Thilaganathan, B, Zamora, J, Riley, R, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, A, Salvesen, K, Bhattacharya, S, Uiterwaal, C, Staff, A, Andersen, L, Olive, E, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramirez, J, Masse, J, Audibert, F, Magnus, P, Jenum, A, Baschat, A, Ohkuchi, A, Mcauliffe, F, West, J, Askie, L, Mone, F, Farrar, D, Zimmerman, P, Smits, L, Riddell, C, Kingdom, J, van de Post, J, Illanes, S, Holzman, C, van Kuijk, S, Carbillon, L, Villa, P, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, van Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, C, Nagata, C, Brown, M, Vollebregt, K, Takeda, S, Langenveld, J, Widmer, M, Saito, S, Haavaldsen, C, Carroli, G, Olsen, J, Wolf, H, Zavaleta, N, Eisensee, I, Vergani, P, Lumbiganon, P, Makrides, M, Facchinetti, F, Sequeira, E, Gibson, R, Ferrazzani, S, Frusca, T, Norman, J, Figueiro, E, Lapaire, O, Laivuori, H, Lykke, J, Conde-Agudelo, A, Galindo, A, Mbah, A, Betran, A, Herraiz, I, Trogstad, L, Steegers, E, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, W, Browne, J, Allen, R, Costa, F, Klipstein-Grobusch Browne, K, Crowther, C, Jorgensen, J, Forest, J, Rumbold, A, Mol, B, Giguere, Y, Kenny, L, Ganzevoort, W, Odibo, A, Myers, J, Yeo, S, Goffinet, F, Mccowan, L, Pajkrt, E, Teede, H, Haddad, B, Dekker, G, Kleinrouweler, E, Lecarpentier, E, Roberts, C, Groen, H, Skrastad, R, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, J, Monterio, I, Pillalis, A, Souza, R, Hawkins, L, Gabbay-Benziv, R, Crovetto, F, Figuera, F, Jorgensen, L, Dodds, J, Patel, M, Aviram, A, Papageorghiou, A, Khan, K, Allotey J., Whittle R., Snell K. I. E., Smuk M., Townsend R., von Dadelszen P., Heazell A. E. P., Magee L., Smith G. C. S., Sandall J., Thilaganathan B., Zamora J., Riley R. D., Khalil A., Thangaratinam S., Coomarasamy A., Kwong A., Savitri A. I., Salvesen K. A., Bhattacharya S., Uiterwaal C. S. P. M., Staff A. C., Andersen L. B., Olive E. L., Redman C., Sletner L., Daskalakis G., Macleod M., Abdollahain M., Ramirez J. A., Masse J., Audibert F., Magnus P. M., Jenum A. K., Baschat A., Ohkuchi A., McAuliffe F. M., West J., Askie L. M., Mone F., Farrar D., Zimmerman P. A., Smits L. J. M., Riddell C., Kingdom J. C., van de Post J., Illanes S. E., Holzman C., van Kuijk S. M. J., Carbillon L., Villa P. M., Eskild A., Chappell L., Prefumo F., Velauthar L., Seed P., van Oostwaard M., Verlohren S., Poston L., Ferrazzi E., Vinter C. A., Nagata C., Brown M., Vollebregt K. C., Takeda S., Langenveld J., Widmer M., Saito S., Haavaldsen C., Carroli G., Olsen J., Wolf H., Zavaleta N., Eisensee I., Vergani P., Lumbiganon P., Makrides M., Facchinetti F., Sequeira E., Gibson R., Ferrazzani S., Frusca T., Norman J. E., Figueiro E. A., Lapaire O., Laivuori H., Lykke J. A., Conde-Agudelo A., Galindo A., Mbah A., Betran A. P., Herraiz I., Trogstad L., Smith G. G. S., Steegers E. A. P., Salim R., Huang T., Adank A., Zhang J., Meschino W. S., Browne J. L., Allen R. E., Costa F. D. S., Klipstein-Grobusch Browne K., Crowther C. A., Jorgensen J. S., Forest J. -C., Rumbold A. R., Mol B. W., Giguere Y., Kenny L. C., Ganzevoort W., Odibo A. O., Myers J., Yeo S. A., Goffinet F., McCowan L., Pajkrt E., Teede H. J., Haddad B. G., Dekker G., Kleinrouweler E. C., LeCarpentier E., Roberts C. T., Groen H., Skrastad R. B., Heinonen S., Eero K., Anggraini D., Souka A., Cecatti J. G., Monterio I., Pillalis A., Souza R., Hawkins L. A., Gabbay-Benziv R., Crovetto F., Figuera F., Jorgensen L., Dodds J., Patel M., Aviram A., Papageorghiou A., and Khan K.

Abstract

Objective: Stillbirth is a potentially preventable complication of pregnancy. Identifying women at high risk of stillbirth can guide decisions on the need for closer surveillance and timing of delivery in order to prevent fetal death. Prognostic models have been developed to predict the risk of stillbirth, but none has yet been validated externally. In this study, we externally validated published prediction models for stillbirth using individual participant data (IPD) meta-analysis to assess their predictive performance. Methods: MEDLINE, EMBASE, DH-DATA and AMED databases were searched from inception to December 2020 to identify studies reporting stillbirth prediction models. Studies that developed or updated prediction models for stillbirth for use at any time during pregnancy were included. IPD from cohorts within the International Prediction of Pregnancy Complications (IPPIC) Network were used to validate externally the identified prediction models whose individual variables were available in the IPD. The risk of bias of the models and cohorts was assessed using the Prediction study Risk Of Bias ASsessment Tool (PROBAST). The discriminative performance of the models was evaluated using the C-statistic, and calibration was assessed using calibration plots, calibration slope and calibration-in-the-large. Performance measures were estimated separately in each cohort, as well as summarized across cohorts using random-effects meta-analysis. Clinical utility was assessed using net benefit. Results: Seventeen studies reporting the development of 40 prognostic models for stillbirth were identified. None of the models had been previously validated externally, and the full model equation was reported for only one-fifth (20%, 8/40) of the models. External validation was possible for three of these models, using IPD from 19 cohorts (491 201 pregnant women) within the IPPIC Network database. Based on evaluation of the model development studies, all three models had an overa

Published
2022

16. Detection of ROS1 rearrangement in non-small cell lung cancer: current and future perspectives

Author

Rossi G, Jocollé G, Conti A, Tiseo M, Zito Marino F, Donati G, Franco R, Bono F, Barbisan F, and Facchinetti F

Subjects
lung, adenocarcinoma, ROS1, FISH, immunohistochemistry, NGS, rearrangement, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Giulio Rossi,1 Genny Jocollé,2 Antonia Conti,3 Marcello Tiseo,4 Federica Zito Marino,5,6 Giovanni Donati,7 Renato Franco,5,6 Francesca Bono,8 Francesca Barbisan,9 Francesco Facchinetti4,10 1Pathology Unit, 2Oncology Unit, Azienda USL Valle d’Aosta, Regional Hospital “Parini”, Aosta, 3Medical Illustrator, Riccione, 4Medical Oncology Unit, University Hospital of Parma, Parma, 5Pathology Unit, Istituto Nazionale Tumori Fondazione G. Pascale, 6Pathology Unit, Luigi Vanvitelli University of Campania, Naples, 7Unit of Thoracic and Senology Surgery, Azienda USL Valle d’Aosta, Regional Hospital “Parini”, Aosta, 8Unit of Pathologic Anatomy, San Gerardo Hospital, IRCCS, Monza, 9Pathology Unit, University Hospital, Azienda Ospedali Riuniti, Ancona, Italy; 10INSERM, U981, Gustave Roussy Cancer Campus, Villejuif, France Abstract: ROS1 rearrangement characterizes a small subset (1%–2%) of non-small cell lung cancer and is associated with slight/never smoking patients and adenocarcinoma histology. Identification of ROS1 rearrangement is mandatory to permit targeted therapy with specific inhibitors, demonstrating a significantly better survival when compared with conventional chemotherapy. Detection of ROS1 rearrangement is based on in situ (immunohistochemistry, fluorescence in situ hybridization) and extractive non-in situ assays. While fluorescence in situ hybridization still represents the gold standard in clinical trials, this technique may fail to recognize rearrangements of ROS1 with some gene fusion partner. On the other hand, immunohistochemistry is the most cost-effective screening technique, but it seems to be characterized by low specificity. Extractive molecular assays are expensive and laborious methods, but they specifically recognize almost all ROS1 fusions using a limited amount of mRNA even from formalin-fixed, paraffin-embedded tumor tissues. This review is a discussion on the present and futuristic diagnostic scenario of ROS1 identification in lung cancer. Keywords: lung, adenocarcinoma, ROS1, FISH, immunohistochemistry, NGS, rearrangement

Published
2017

26. Neonatal outcomes in an expectantly managed prospective cohort of late preterm prelabor rupture of membranes

Author

Benuzzi, M., primary, Tramontano, A.L., additional, Menichini, D., additional, Semprini, M., additional, Del Villano, N., additional, Zinani, I., additional, Berardi, A., additional, Rigoli, F., additional, Costa, P., additional, Consonni, S., additional, Di Tommaso, M., additional, Orlandi, G., additional, Strambi, N., additional, Facchinetti, F., additional, Locatelli, A., additional, Chiossi, G., additional, and Monari, F., additional

Published
2023
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32. The clinical landscape of cell-free DNA alterations in 1671 patients with advanced biliary tract cancer

Author

Berchuck, J.E., primary, Facchinetti, F., additional, DiToro, D.F., additional, Baiev, I., additional, Majeed, U., additional, Reyes, S., additional, Chen, C., additional, Zhang, K., additional, Sharman, R., additional, Uson Junior, P.L.S., additional, Maurer, J., additional, Shroff, R.T., additional, Pritchard, C.C., additional, Wu, M.-J., additional, Catenacci, D.V.T., additional, Javle, M., additional, Friboulet, L., additional, Hollebecque, A., additional, Bardeesy, N., additional, Zhu, A.X., additional, Lennerz, J.K., additional, Tan, B., additional, Borad, M., additional, Parikh, A.R., additional, Kiedrowski, L.A., additional, Kelley, R.K., additional, Mody, K., additional, Juric, D., additional, and Goyal, L., additional

Published
2022
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34. 1349P A prospective study on clinicians' attitudes and survival outcomes for patients with NSCLC and poor performance status in the immunotherapy era: PICASO study (GOIRC-04-2020).

Author

Facchinetti, F., Camerini, A., Bennati, C., Bordi, P., De Carlo, E., Mazzoni, F., Metro, G., Bertolini, F., Longo, L., Ricciardi, S., Pilotto, S., Bria, E., Giardina, D., Passiglia, F., Cortinovis, D.L., Scotti, V., Novello, S., Tognetto, M., Di Maio, M., and Tiseo, M.

Subjects
*SURVIVAL rate, *MEDICAL personnel, *LONGITUDINAL method, *IMMUNOTHERAPY, *NON-small-cell lung carcinoma
Published
2024
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35. Maternal dietary adherence during pregnancy to recommendations: a cross-sectional study in Modena

Author

De Pasquale, L, Palandri, L, Casalucci, Ma, Azzalini, D, Lucaccioni, L, Passini, E, Facchinetti, F, and Righi, E

Subjects
pregnancy, compliance, diet recommendations, diet recommendations, Public Health, Environmental and Occupational Health, pregnancy, compliance
Abstract

Background Unbalanced nutrients intake and incorrect weight gain can lead to immediate and future adverse health consequences for both mother and child. The Italian Society of Gynaecology and Obstetrics (SIGO), has drawn up a series of nutritional recommendations with the aim of promoting a correct food intake for future mothers. The purpose of our study was to assess adherence to good dietary indications during pregnancy and to evaluate if voluptuary habits could play a role. Methods This cross-sectional study investigated dietary habits during the last trimester of pregnancy. We evaluated the adherence to dietary SIGO recommendations of a sample of pregnant women representative of physiologic full-term pregnancies (n = 572, mean age 33.4±5.2) living in Modena (Italy), recruited between 2016 and 2020. Maternal diet during pregnancy was assessed by a self-administered questionnaire fill in at the hospital after childbirth, evaluating lifestyle habits and usual food intake. Descriptive statistics and bivariate associations (Chi-square tests) were performed. Results More than 50% of women did not comply with SIGO dietary recommendations. Overall, adherence was very low, ranging between 8.4% (sweets) and 38.8% (seafood), for all food categories, excluding coffee and tea (89%), alcohol (76.2%), red wine (99.1%) and seasoning (olive oil 93.4%). Preliminary results suggest that several factors and behaviours, including BMI before pregnancy, age, smoking habits, education, are associated with levels of adherence to different food categories. Conclusions Poor adherence to a proper dietary regimen during pregnancy is a missed opportunity for prevention and demonstrates the importance of promoting public health interventions to improve dietary recommendations adherence. Several initiatives, such as courses, information campaigns, use of social media and counselling can be useful for a nutrition education in pregnancy, raising awareness of the related benefits for both mother and child. Key messages • Nowadays pregnant women’s compliance to diet recommendations is still low. • There is still a lot to do in terms of education and awareness of future mothers.

Published
2022

36. Exposure to phthalates, potential endocrine disruptors, in an infant cohort in Modena, Italy

Author

Lugli, C, Palandri, L, Ferrari, A, Barbieri, R, Trevisani, V, Passini, E, Lucaccioni, L, Facchinetti, F, and Righi, E

Subjects
phthalates, biomonitoring, Public Health, Environmental and Occupational Health, phthalates, urine, early life exposure, biomonitoring, early life exposure, urine
Abstract

Phthalates are pollutants ubiquitous in the environment. Human exposure to phthalates and their endocrine disrupting effects have been widely studied. Therefore, the European Union forbids phthalates in toys, cosmetic and kitchenware manufacturing. However, phthalate metabolites can still be found in human biological matrices. The purpose of this study is to investigate phthalate exposure over time in a group of Italian healthy newborns. In a prospective cohort study, we enlisted 187 women who gave birth in the University Hospital of Modena, Italy, between January 2019 and May 2020. Urine samples from women after delivery and from their infants at birth, 3 and 6 months were collected and 8 metabolites of 6 phthalates were analysed. Descriptive statistics were calculated and preliminary correlation coefficients tests were performed. Monoethylphthalate (MEP) was always detectable in urine samples. MEP, monomethylphthalate and diethylhexylphthalate metabolites showed an increasing trend over time, while monobutylphthalate and monobenzylphthalate showed decreasing levels over time. Associations between levels of phthalates metabolites in mother and infant pairs at birth were found for a few metabolites, while metabolites in infant samples at 3 and 6 months appeared often significantly associated. Infants’ phthalate exposure in Modena is still high and prolonged over time, even to those more toxic and strictly regulated. As phthalates presence in indoor environment can be a risk factor especially for the most fragile groups of population, such as children, public Health campaigns addressing childbearing age women should stress about the risk posed by these substances and how to avoid their exposure. Moreover, regulatory actions and a stricter legislation should be considered. Key messages • In Italy infant exposure to phthalates, including those strictly forbidden, appears still high and continuous over time. • Public heath intervention and stricter regulatory actions should be considered.

Published
2022

38. 34P Gustave Roussy Match-R study: A descriptive analysis of the molecular target population

Author

Florez Arango, J.D., primary, Rodriguez, J.E., additional, Facchinetti, F., additional, Guaitoli, G., additional, Benitez Montanez, J.C., additional, Baldini, C., additional, Scoazec, J-Y., additional, Lacroix, L., additional, Vasseur, D., additional, Soria, J-C., additional, Loriot, Y., additional, André, F., additional, Friboulet, L., additional, Besse, B., additional, and Ponce, S., additional

Published
2022
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39. 109P Characteristics of clonal hematopoiesis-related mutations identified in liquid biopsies from patients with metastatic solid tumors

Author

Vasseur, D., primary, Arbab, A., additional, Giudici, F., additional, Marzac, C., additional, Michiels, S., additional, Tagliamento, M., additional, Bayle, A., additional, Aldea, M., additional, Fievet, A., additional, Auger, N., additional, Friboulet, L., additional, Facchinetti, F., additional, Géraud, A., additional, Ponce, S., additional, Hollebecque, A., additional, Besse, B., additional, Baptiste Micol, J., additional, Italiano, A., additional, Lacroix, L., additional, and Rouleau, E., additional

Published
2022
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41. The PDE4 inhibitor tanimilast shows distinct immunomodulatory properties associated with a type 2 endotype and CD141 upregulation

Author

Nguyen, H O, primary, Salvi, V, additional, Tiberio, L, additional, Govoni, M, additional, Villetti, G, additional, Civelli, M, additional, Barbazza, I, additional, Gaudenzi, C, additional, Passari, M, additional, Schioppa, T, additional, Sozio, F, additional, Dal Prete, A, additional, Sozzani, S, additional, Bosisio, D, additional, and Facchinetti, F, additional

Published
2022
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44. MA07.06 Eradicating Drug Tolerant Persisters (DTPs) In EGFR-Mutated Non Small Cell Lung Cancer (NSCLC) By Targeting TROP2

Author

Baldacci, S., Brea, E.J., Facchinetti, F., Malhotra, S., Tolstorukov, M., Booker, M., Li, Z., Chakravarti, S., Lococo, F., D’Agnelli, S., Gnetti, L., Leonetti, A., Feng, W.W., Tsai, J.A., Hartley, A.-V., Locquet, M.-A., Alessi, J.V., Awad, M.M., Lau, C., Saldanha, A., Chopade, P., Kivlehan, S., Ngo, K., Lizotte, P., Ivanova, E., Gokhale, P., Paweletz, C., Smith, E.L., Jänne, P.A., and Barbie, D.A.

Published
2024
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45. MA07.03 Systematic Engineering of TROP2 CAR T Cell Therapy to Overcome Resistance Pathways in EGFRmutant NSCLC

Author

Brea, E.J., Baldacci, S., Chakravarti, S., Mottram, A.P., Facchinetti, F., Ramasubramanian, A., Savage, N., Ngo, K., Vo, H.V., Leeper, B.A., Ivanova, E.V., Saldanha, A., Locquet, M.-A., Salamah, A., Stornante, C., Campisi, M., Mahadevan, N.R., Thai, T.C., Haggerty, T.J., Nie, C., Deng, C., Wang, X., Liu, L.L., Gokhale, P.C., Paweletz, C.P., Jänne, P.A., Barbie, D.A., and Smith, E.L.

Published
2024
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47. Ultrasound for antenatal diagnosis of placenta accreta spectrum in women with placenta previa: results from ADoPAD study

Author

Fratelli, N., Prefumo, F., Maggi, C., Cavalli, C., Sciarrone, A., Garofalo, A., Viora, E., Vergani, P., Ornaghi, S., Betti, M., Vaglio Tessitore, I., Cavaliere, A. F., Buongiorno, S., Vidiri, A., Fabbri, E., Ferrazzi, E., Maggi, V., Cetin, I., Frusca, T., Ghi, T., Kaihura, C., Di Pasquo, E., Stampalija, T., Belcaro, C., Quadrifoglio, M., Veneziano, M., Mecacci, F., Simeone, S., Locatelli, A., Consonni, S., Chianchiano, N., Labate, F., Cromi, A., Bertucci, E., Facchinetti, F., Fichera, A., Granata, D., Antonio, F. D( extquotesingle)., Foti, F., Avagliano, L., Bulfamante, G. P., Cal(`(i)) and, G., Fratelli, N, Prefumo, F, Maggi, C, Cavalli, C, Sciarrone, A, Garofalo, A, Viora, E, Vergani, P, Ornaghi, S, Betti, M, Tessitore, I Vaglio, Cavaliere, A F, Buongiorno, S, Vidiri, A, Fabbri, E, Ferrazzi, E, Maggi, V, Cetin, I, Frusca, T, Ghi, T, Kaihura, C, Di Pasquo, E, Stampalija, T, Belcaro, C, Quadrifoglio, M, Veneziano, M, Mecacci, F, Simeone, S, Locatelli, A, Consonni, S, Chianchiano, N, Labate, F, Cromi, A, Bertucci, E, Facchinetti, F, Fichera, A, Granata, D, Antonio, F D', Foti, F, Avagliano, L, Bulfamante, G P, and Calì, G

Subjects
diagnosi, placenta accreta spectrum, cesarean section, diagnosis, low-lying placenta, ultrasound, placenta previa
Abstract

To evaluate the diagnostic performance of third trimester ultrasound for the diagnosis of clinically significant Placenta accreta spectrum disorder (PAS) in women with a low-lying placenta (less than 20 mm from the internal cervical os) or placenta praevia (covering the os) METHODS: Pregnant women with a low-lying placenta or placenta praevia, age ≥ 18 years and gestational age at ultrasound ≥ 26+0/7 weeks of gestation were prospectively included in the study. Ultrasound suspicion of PAS was raised in the presence of at least one of these signs: (1) obliteration of the hypoechoic space between the uterus and the placenta; (2) interruption of the hyperechoic interface between the uterine serosa and the bladder wall; (3) abnormal placental lacunae. In order to assess the ability of ultrasound to detect clinically significant PAS, a composite outcome comprehensive of both active management at delivery and histopathological confirmation of PAS was considered as the reference standard. PAS was considered of clinical significance if, in addition to histological confirmation, at least one of these procedures was carried out after delivery: use of hemostatic intrauterine balloon, compressive uterine suture, peripartum hysterectomy, uterine/hypogastric artery ligation, uterine artery embolization.

Published
2022

48. External validation of prognostic models to predict stillbirth using International Prediction of Pregnancy Complications (IPPIC) Network database: individual participant data meta-analysis

Author

Allotey, J., Whittle, R., Snell, K. I. E., Smuk, M., Townsend, R., von Dadelszen, P., Heazell, A. E. P., Magee, L., Smith, G. C. S., Sandall, J., Thilaganathan, B., Zamora, J., Riley, R. D., Khalil, A., Thangaratinam, S., Coomarasamy, A., Kwong, A., Savitri, A. I., Salvesen, K. A., Bhattacharya, S., Uiterwaal, C. S. P. M., Staff, A. C., Andersen, L. B., Olive, E. L., Redman, C., Sletner, L., Daskalakis, G., Macleod, M., Abdollahain, M., Ramirez, J. A., Masse, J., Audibert, F., Magnus, P. M., Jenum, A. K., Baschat, A., Ohkuchi, A., Mcauliffe, F. M., West, J., Askie, L. M., Mone, F., Farrar, D., Zimmerman, P. A., Smits, L. J. M., Riddell, C., Kingdom, J. C., van de Post, J., Illanes, S. E., Holzman, C., van Kuijk, S. M. J., Carbillon, L., Villa, P. M., Eskild, A., Chappell, L., Prefumo, F., Velauthar, L., Seed, P., van Oostwaard, M., Verlohren, S., Poston, L., Ferrazzi, E., Vinter, C. A., Nagata, C., Brown, M., Vollebregt, K. C., Takeda, S., Langenveld, J., Widmer, M., Saito, S., Haavaldsen, C., Carroli, G., Olsen, J., Wolf, H., Zavaleta, N., Eisensee, I., Vergani, P., Lumbiganon, P., Makrides, M., Facchinetti, F., Sequeira, E., Gibson, R., Ferrazzani, S., Frusca, T., Norman, J. E., Figueiro, E. A., Lapaire, O., Laivuori, H., Lykke, J. A., Conde-Agudelo, A., Galindo, A., Mbah, A., Betran, A. P., Herraiz, I., Trogstad, L., Smith, G. G. S., Steegers, E. A. P., Salim, R., Huang, T., Adank, A., Zhang, J., Meschino, W. S., Browne, J. L., Allen, R. E., Costa, F. D. S., Klipstein-Grobusch Browne, K., Crowther, C. A., Jorgensen, J. S., Forest, J. -C., Rumbold, A. R., Mol, B. W., Giguere, Y., Kenny, L. C., Ganzevoort, W., Odibo, A. O., Myers, J., Yeo, S. A., Goffinet, F., Mccowan, L., Pajkrt, E., Teede, H. J., Haddad, B. G., Dekker, G., Kleinrouweler, E. C., Lecarpentier, E., Roberts, C. T., Groen, H., Skrastad, R. B., Heinonen, S., Eero, K., Anggraini, D., Souka, A., Cecatti, J. G., Monterio, I., Pillalis, A., Souza, R., Hawkins, L. A., Gabbay-Benziv, R., Crovetto, F., Figuera, F., Jorgensen, L., Dodds, J., Patel, M., Aviram, A., Papageorghiou, A., Khan, K., Clinicum, HUS Gynecology and Obstetrics, Department of Obstetrics and Gynecology, HUS Children and Adolescents, Lastentautien yksikkö, Children's Hospital, Allotey, J, Whittle, R, Snell, K, Smuk, M, Townsend, R, von Dadelszen, P, Heazell, A, Magee, L, Smith, G, Sandall, J, Thilaganathan, B, Zamora, J, Riley, R, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, A, Salvesen, K, Bhattacharya, S, Uiterwaal, C, Staff, A, Andersen, L, Olive, E, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramirez, J, Masse, J, Audibert, F, Magnus, P, Jenum, A, Baschat, A, Ohkuchi, A, Mcauliffe, F, West, J, Askie, L, Mone, F, Farrar, D, Zimmerman, P, Smits, L, Riddell, C, Kingdom, J, van de Post, J, Illanes, S, Holzman, C, van Kuijk, S, Carbillon, L, Villa, P, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, van Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, C, Nagata, C, Brown, M, Vollebregt, K, Takeda, S, Langenveld, J, Widmer, M, Saito, S, Haavaldsen, C, Carroli, G, Olsen, J, Wolf, H, Zavaleta, N, Eisensee, I, Vergani, P, Lumbiganon, P, Makrides, M, Facchinetti, F, Sequeira, E, Gibson, R, Ferrazzani, S, Frusca, T, Norman, J, Figueiro, E, Lapaire, O, Laivuori, H, Lykke, J, Conde-Agudelo, A, Galindo, A, Mbah, A, Betran, A, Herraiz, I, Trogstad, L, Steegers, E, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, W, Browne, J, Allen, R, Costa, F, Klipstein-Grobusch Browne, K, Crowther, C, Jorgensen, J, Forest, J, Rumbold, A, Mol, B, Giguere, Y, Kenny, L, Ganzevoort, W, Odibo, A, Myers, J, Yeo, S, Goffinet, F, Mccowan, L, Pajkrt, E, Teede, H, Haddad, B, Dekker, G, Kleinrouweler, E, Lecarpentier, E, Roberts, C, Groen, H, Skrastad, R, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, J, Monterio, I, Pillalis, A, Souza, R, Hawkins, L, Gabbay-Benziv, R, Crovetto, F, Figuera, F, Jorgensen, L, Dodds, J, Patel, M, Aviram, A, Papageorghiou, A, Khan, K, Tampere University, Obstetrics and Gynaecology, APH - Quality of Care, Amsterdam Reproduction & Development (AR&D), APH - Personalized Medicine, APH - Digital Health, and Obstetrics and gynaecology

Subjects
Calibration (statistics), Perinatal Death, Overfitting, Cohort Studies, Fetal Development, 0302 clinical medicine, Discriminative model, 3123 Gynaecology and paediatrics, Models, Pregnancy, GROWTH RESTRICTION, Statistics, Medicine, Prenatal, 030212 general & internal medicine, Ultrasonography, RISK, 030219 obstetrics & reproductive medicine, PRETERM, Radiological and Ultrasound Technology, LOW-DOSE ASPIRIN, DIAGNOSIS TRIPOD, Obstetrics and Gynecology, General Medicine, Statistical, Stillbirth, Prognosis, Pregnancy Complication, external validation, individual participant data, intrauterine death, prediction model, stillbirth, Female, Humans, Infant, Newborn, Models, Statistical, Pregnancy Complications, Regression Analysis, Risk Assessment, Ultrasonography, Prenatal, 3. Good health, PREECLAMPSIA, Meta-analysis, Human, Cohort study, Prognosi, MEDLINE, Regression Analysi, WEEKS GESTATION, 03 medical and health sciences, VELOCIMETRY, Radiology, Nuclear Medicine and imaging, RECURRENCE, business.industry, Infant, Newborn, R1, HYPERTENSIVE DISORDERS, Reproductive Medicine, Sample size determination, Cohort Studie, RG, business, RA, Predictive modelling
Abstract

Objective Stillbirth is a potentially preventable complication of pregnancy. Identifying women at high risk of stillbirth can guide decisions on the need for closer surveillance and timing of delivery in order to prevent fetal death. Prognostic models have been developed to predict the risk of stillbirth, but none has yet been validated externally. In this study, we externally validated published prediction models for stillbirth using individual participant data (IPD) meta-analysis to assess their predictive performance. Methods MEDLINE, EMBASE, DH-DATA and AMED databases were searched from inception to December 2020 to identify studies reporting stillbirth prediction models. Studies that developed or updated prediction models for stillbirth for use at any time during pregnancy were included. IPD from cohorts within the International Prediction of Pregnancy Complications (IPPIC) Network were used to validate externally the identified prediction models whose individual variables were available in the IPD. The risk of bias of the models and cohorts was assessed using the Prediction study Risk Of Bias ASsessment Tool (PROBAST). The discriminative performance of the models was evaluated using the C-statistic, and calibration was assessed using calibration plots, calibration slope and calibration-in-the-large. Performance measures were estimated separately in each cohort, as well as summarized across cohorts using random-effects meta-analysis. Clinical utility was assessed using net benefit. Results Seventeen studies reporting the development of 40 prognostic models for stillbirth were identified. None of the models had been previously validated externally, and the full model equation was reported for only one-fifth (20%, 8/40) of the models. External validation was possible for three of these models, using IPD from 19 cohorts (491 201 pregnant women) within the IPPIC Network database. Based on evaluation of the model development studies, all three models had an overall high risk of bias, according to PROBAST. In the IPD meta-analysis, the models had summary C-statistics ranging from 0.53 to 0.65 and summary calibration slopes ranging from 0.40 to 0.88, with risk predictions that were generally too extreme compared with the observed risks. The models had little to no clinical utility, as assessed by net benefit. However, there remained uncertainty in the performance of some models due to small available sample sizes. Conclusions The three validated stillbirth prediction models showed generally poor and uncertain predictive performance in new data, with limited evidence to support their clinical application. The findings suggest methodological shortcomings in their development, including overfitting. Further research is needed to further validate these and other models, identify stronger prognostic factors and develop more robust prediction models. (c) 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Published
2022

49. Mode of birth in women with low-lying placenta: protocol for a prospective multicentre 1:3 matched case-control study in Italy (the MODEL-PLACENTA study)

Author

Ornaghi, S, Colciago, E, Vaglio Tessitore, I, Abbamondi, A, Antolini, L, Locatelli, A, Inversetti, A, Pintucci, A, Cetin, I, Bracco, B, Fabbri, E, Sala, V, Meroni, M, Volpe, G, Benedetti, S, Bulfoni, C, Marconi, A, Lagrasta, F, Paolini, C, Mazza, E, Candiani, M, Valsecchi, L, Smid, M, Pasi, F, Pozzoni, M, Castoldi, M, Vignali, M, Dal Molin, G, Guarano, A, Pellegrino, A, Callegari, C, Betti, M, Lazzarin, S, Prefumo, F, Zanardini, C, Parolin, V, Catalano, A, Barbolini, E, Antonazzo, P, Pignatti, L, Tintoni, M, Spelzini, F, Martinelli, A, Facchinetti, F, Chiossi, G, Vergani, P, Ornaghi S., Colciago E., Vaglio Tessitore I., Abbamondi A., Antolini L., Locatelli A., Inversetti A., Pintucci A., Cetin I., Bracco B., Fabbri E., Sala V., Meroni M., Volpe G., Benedetti S., Bulfoni C., Marconi A., Lagrasta F., Paolini C. L., Mazza E., Candiani M., Valsecchi L., Smid M., Pasi F., Pozzoni M., Castoldi M., Vignali M., Dal Molin G., Guarano A., Pellegrino A., Callegari C., Betti M., Lazzarin S., Prefumo F., Zanardini C., Parolin V., Catalano A., Barbolini E., Antonazzo P., Pignatti L., Tintoni M., Spelzini F., Martinelli A., Facchinetti F., Chiossi G., Vergani P., Ornaghi, S, Colciago, E, Vaglio Tessitore, I, Abbamondi, A, Antolini, L, Locatelli, A, Inversetti, A, Pintucci, A, Cetin, I, Bracco, B, Fabbri, E, Sala, V, Meroni, M, Volpe, G, Benedetti, S, Bulfoni, C, Marconi, A, Lagrasta, F, Paolini, C, Mazza, E, Candiani, M, Valsecchi, L, Smid, M, Pasi, F, Pozzoni, M, Castoldi, M, Vignali, M, Dal Molin, G, Guarano, A, Pellegrino, A, Callegari, C, Betti, M, Lazzarin, S, Prefumo, F, Zanardini, C, Parolin, V, Catalano, A, Barbolini, E, Antonazzo, P, Pignatti, L, Tintoni, M, Spelzini, F, Martinelli, A, Facchinetti, F, Chiossi, G, Vergani, P, Ornaghi S., Colciago E., Vaglio Tessitore I., Abbamondi A., Antolini L., Locatelli A., Inversetti A., Pintucci A., Cetin I., Bracco B., Fabbri E., Sala V., Meroni M., Volpe G., Benedetti S., Bulfoni C., Marconi A., Lagrasta F., Paolini C. L., Mazza E., Candiani M., Valsecchi L., Smid M., Pasi F., Pozzoni M., Castoldi M., Vignali M., Dal Molin G., Guarano A., Pellegrino A., Callegari C., Betti M., Lazzarin S., Prefumo F., Zanardini C., Parolin V., Catalano A., Barbolini E., Antonazzo P., Pignatti L., Tintoni M., Spelzini F., Martinelli A., Facchinetti F., Chiossi G., and Vergani P.

Abstract

Introduction The term placenta praevia defines a placenta that lies over the internal os, whereas the term low-lying placenta identifies a placenta that is partially implanted in the lower uterine segment with the inferior placental edge located at 1-20 mm from the internal cervical os (internal-os-distance). The most appropriate mode of birth in women with low-lying placenta is still controversial, with the majority of them undergoing caesarean section. The current project aims to evaluate the rate of vaginal birth and caesarean section in labour due to bleeding by offering a trial of labour to all women with an internal-os-distance >5 mm as assessed by transvaginal sonography in the late third trimester. Methods and analysis The MODEL-PLACENTA is a prospective, multicentre, 1:3 matched case-control study involving 17 Maternity Units across Lombardy and Emilia-Romagna regions, Italy. The study includes women with a placenta located in the lower uterine segment at the second trimester scan. Women with a normally located placenta will be enrolled as controls. A sample size of 30 women with an internal-os-distance >5 mm at the late third trimester scan is needed at each participating Unit. Since the incidence of low-lying placenta decreases from 2% in the second trimester to 0.4% at the end of pregnancy, 150 women should be recruited at each centre at the second trimester scan. A vaginal birth rate ≥60% in women with an internal-os-distance >5 mm will be considered appropriate to start routinely admitting to labour these women. Ethics and dissemination Ethical approval for the study was given by the Brianza Ethics Committee (No 3157, 2019). Written informed consent will be obtained from study participants. Results will be disseminated by publication in peer-reviewed journals and presentation in international conferences. Trial registration number NCT04827433 (pre-results stage)

Published
2021

50. Neonatal outcomes and risk of neonatal sepsis in an expectantly managed cohort of late preterm prelabor rupture of membranes

Author

Chiossi, G, Di Tommaso, M, Monari, F, Consonni, S, Strambi, N, Zoccoli, S, Seravalli, V, Comerio, C, Betti, M, Cappello, A, Vergani, P, Facchinetti, F, Locatelli, A, Chiossi G., Di Tommaso M., Monari F., Consonni S., Strambi N., Zoccoli S. G., Seravalli V., Comerio C., Betti M., Cappello A., Vergani P., Facchinetti F., Locatelli A., Chiossi, G, Di Tommaso, M, Monari, F, Consonni, S, Strambi, N, Zoccoli, S, Seravalli, V, Comerio, C, Betti, M, Cappello, A, Vergani, P, Facchinetti, F, Locatelli, A, Chiossi G., Di Tommaso M., Monari F., Consonni S., Strambi N., Zoccoli S. G., Seravalli V., Comerio C., Betti M., Cappello A., Vergani P., Facchinetti F., and Locatelli A.

Abstract

Objective: Expectant management in patients with prelabor preterm rupture of membranes between between 340/7 and 36 6/7 weeks (late preterm pPROM or LpPROM) has been shown to decrease the burden of prematurity, when compared to immediate delivery. As the severity of prematurity depends on gestational age (GA) at PROM, and PROM to delivery interval, we first investigated how such variables affect neonatal outcomes (NO). Second, we assessed the risk of neonatal sepsis. Study design: retrospective cohort study on neonatal morbidity among singleton infants born to expectantly managed mothers with LpPROM in five hospitals affiliated with three Italian academic institutions. The primary NO was a composite of neonatal death, non-invasive (cPAP) or invasive (mechanical ventilation) respiratory support, hypoglycemia (< 44 mg/dl needing therapy), newborn sepsis, confirmed seizures, stroke, intraventricular hemorrhage (IVH), basal nuclei anomalies, cardiopulmonary resuscitation, umbilical-cord-blood arterial pH < 7.0 or base excess < -12.5, and prolonged hospitalization (≥ 5 days). Univariate analysis described differences in the population according to GA at delivery. Multivariate logistic regression was then used to investigate the effects of GA at PROM, and PROM to delivery interval on the NO. Results: 258/606 (42.6 %) women with LpPROM were expectantly managed, as they did not deliver within the first 24 h. The median latency duration was 2 (95 %CI 1−3) days, having no effect on neonatal morbidity on multivariate analysis. Multivariate analysis also showed increased risks of adverse NO among PROM at 34 (OR 2.3 95 %CI 1.03−5.1) but not at 35 weeks when compared to 36 weeks, and among women receiving antenatal corticosteroids (OR 3.6 95 %CI 1.3−9.7), while antibiotic treatment showed a non-significant protective effect (OR 0.2 95 %CI 0.04−1.02). Prevalence of neonatal sepsis was 0.8 % (2/258) Conclusion: Expectant management of LpPROM should be encouraged especially

Published
2021

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