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Article: Development and Validation of the PaP Score Nomogram for Terminally Ill Cancer Patients.

Scarpi, Emanuela / Nanni, Oriana / Maltoni, Marco

2022 Volume 14, Issue 10

Abstract: The validated Palliative Prognostic (PaP) score predicts survival in terminally ill cancer patients, assigning patients to three different risk groups according to a 30-day survival probability: group A, >70%; group B, 30−70%; and group C, <30%. We aimed ...

Abstract	The validated Palliative Prognostic (PaP) score predicts survival in terminally ill cancer patients, assigning patients to three different risk groups according to a 30-day survival probability: group A, >70%; group B, 30−70%; and group C, <30%. We aimed to develop and validate a PaP nomogram to provide individualized prediction of survival at 15, 30 and 60 days. Three cohorts of consecutive terminally ill cancer patients were used: one (n = 519) for nomogram development and internal validation, and a second (n = 451) and third (n = 549) for external validation. Multivariate analyses included dyspnea, anorexia, Karnofsky performance status, clinical prediction of survival, total white blood count and lymphocyte percentage. The predictive accuracy of the nomogram was determined by Harrell’s concordance index (95% CI), and calibration plots were generated. The nomogram had a concordance index of 0.74 (0.72−0.75) and showed good calibration. The internal validation showed no departures from ideal prediction. The accuracy of the nomogram at 15, 30 and 60 days was 74% (70−77), 89% (85−92) and 72% (68−76) in the external validation cohorts, respectively. The PaP nomogram predicts the individualized estimate of survival and could greatly facilitate clinical care decision-making at the end of life.
Language	English
Publishing date	2022-05-19
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers14102510
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Article ; Online: Radiotherapy at the End of Life: From Retrospective Analysis to Strategies to Improve Outcomes.

Rossi, Romina / Cravero, Paola / Pallotti, Maria Caterina / Valenti, Vanessa / Massa, Ilaria / Foca, Flavia / Nanni, Oriana / Pieri, Martina / Romeo, Antonino / Tontini, Luca / Donati, Costanza Maria / Morganti, Alessio Giuseppe / Maltoni, Marco

Journal of pain and symptom management

2024

Language	English
Publishing date	2024-03-10
Publishing country	United States
Document type	Letter
ZDB-ID	639142-4
ISSN	1873-6513 ; 0885-3924
ISSN (online)	1873-6513
ISSN	0885-3924
DOI	10.1016/j.jpainsymman.2024.03.001
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Article ; Online: Use of Sequential Multiple Assignment Randomized Trials (SMARTs) in oncology: systematic review of published studies.

Lorenzoni, Giulia / Petracci, Elisabetta / Scarpi, Emanuela / Baldi, Ileana / Gregori, Dario / Nanni, Oriana

British journal of cancer

2022 Volume 128, Issue 7, Page(s) 1177–1188

Abstract: Sequential multiple assignments randomized trials (SMARTs) are a type of experimental design where patients may be randomised multiple times according to pre-specified decision rules. The present work investigates the state-of-the-art of SMART designs in ...

Abstract	Sequential multiple assignments randomized trials (SMARTs) are a type of experimental design where patients may be randomised multiple times according to pre-specified decision rules. The present work investigates the state-of-the-art of SMART designs in oncology, focusing on the discrepancy between the available methodological approaches in the statistical literature and the procedures applied within cancer clinical trials. A systematic review was conducted, searching PubMed, Embase and CENTRAL for protocols or reports of results of SMART designs and registrations of SMART designs in clinical trial registries applied to solid tumour research. After title/abstract and full-text screening, 33 records were included. Fifteen were reports of trials' results, four were trials' protocols and fourteen were trials' registrations. The study design was defined as SMART by only one out of fifteen trial reports. Conversely, 13 of 18 study protocols and trial registrations defined the study design SMART. Furthermore, most of the records considered each stage separately in the analysis, without considering treatment regimens embedded in the trial. SMART designs in oncology are still limited. Study powering and analysis is mainly based on statistical approaches traditionally used in single-stage parallel trial designs. Formal reporting guidelines for SMART designs are needed.
MeSH term(s)	Humans ; Randomized Controlled Trials as Topic ; Research Design ; Medical Oncology
Language	English
Publishing date	2022-12-26
Publishing country	England
Document type	Systematic Review ; Journal Article ; Review
ZDB-ID	80075-2
ISSN	1532-1827 ; 0007-0920
ISSN (online)	1532-1827
ISSN	0007-0920
DOI	10.1038/s41416-022-02110-z
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Article: The role of clinical trials in the sustainability of the Italian national health service cancer drug expenditure.

Gasperoni, Lorenzo / Cafaro, Alessandro / Ferretti, Eleonora / Di Iorio, Valentina / Nanni, Oriana / Masini, Carla

European journal of hospital pharmacy : science and practice

2022 Volume 30, Issue 2, Page(s) 96–100

Abstract: Objective: Clinical trials offer new and potentially more effective therapeutic options for cancer patients and a potential cost-saving opportunity, especially considering that trial drugs are provided free-of-charge. The aim of this study was to ... ...

Abstract	Objective: Clinical trials offer new and potentially more effective therapeutic options for cancer patients and a potential cost-saving opportunity, especially considering that trial drugs are provided free-of-charge. The aim of this study was to analyse drug-related cost savings in clinical trials in a cancer institute over a 3 year period. The cost savings relate to the pharmaceutical expenditure of our centre, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori". Methods: We conducted a retrospective analysis of patients taking part in interventional clinical cancer trials approved by a local independent Ethics Committee between 1 January 2018 and 31 December 2020. The standard of care (SOC) was identified as the standard treatment that would have been offered to a patient if he/she had not been enrolled in the study. The sum of SOC costs of all patients represents the potential cost avoidance during the study period. Results were stratified by year, trial promoter, trial phase and tumour type. The same approach was used to perform a secondary analysis of compassionate use programmes. Result: In the 3 year analysis, 1,257 patients were treated with experimental therapies in 244 clinical trials, of which 157 were profit and 87 academic. Results showed an overall cost savings of €13,266,518, more than 50% of which (€7,035,009) was related to phase III studies. Profit clinical trials generated €9,069,764 (68.4%) of the drug cost savings compared with €4,196,754 (31.6%) of academic studies. The stratification for tumour type was €3,552,592 (26.8%) genitourinary cancer, €3,268,074 (24.6%) melanoma, €2,574,127 (19.4%) haematological malignancies, €2,330,791 (17.6%) lung cancer, €728,149 (5.5%) gastrointestinal cancer, €557,608 (4.2%) rare tumours and €255,178 (1.9%) breast cancer. The secondary analysis on compassionate use included 122 patients involved in 28 different access programmes and revealed cost savings of €1,649,550. Conclusion: The results of our analysis point to the benefits of participating in and planning clinical trials for the public healthcare sector.
MeSH term(s)	Female ; Humans ; State Medicine ; Health Expenditures ; Retrospective Studies ; Antineoplastic Agents/therapeutic use ; Breast Neoplasms
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2022-05-16
Publishing country	England
Document type	Journal Article
ZDB-ID	2650179-X
ISSN	2047-9964 ; 2047-9956
ISSN (online)	2047-9964
ISSN	2047-9956
DOI	10.1136/ejhpharm-2022-003297
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Article ; Online: Baseline and Longitudinal Neutrophil-to-Lymphocyte Ratio as Prognostic Factor for Metastatic Colorectal Cancer: A Secondary Analysis of the ITACa Randomized Trial.

Petracci, Elisabetta / Passardi, Alessandro / Biggeri, Annibale / Valgiusti, Martina / Monti, Manlio / Frassineti, Giovanni Luca / Nanni, Oriana / Scarpi, Emanuela

JCO precision oncology

2023 Volume 8, Page(s) e2300256

Abstract: Purpose: We aimed to investigate the prognostic role of baseline and longitudinal levels of neutrophil-to-lymphocyte ratio (NLR) in patients with metastatic colorectal cancer (mCRC) treated with chemotherapy + bevacizumab (CT + B) or chemotherapy only. ... ...

Abstract	Purpose: We aimed to investigate the prognostic role of baseline and longitudinal levels of neutrophil-to-lymphocyte ratio (NLR) in patients with metastatic colorectal cancer (mCRC) treated with chemotherapy + bevacizumab (CT + B) or chemotherapy only. Additionally, we investigated whether treatment outcomes were mediated by the longitudinal biomarker. Methods: Data from an Italian randomized phase III trial were used. The main end point was progression-free survival (PFS). To address research questions, a series of joint models of longitudinal and survival data were specified, and the direct and indirect treatment effects were quantified. Results: Data for 239 patients, 113 (47.3%) treated with CT + B and 126 (52.7%) with CT only, were included in the analyses. The effect of NLR seemed to be mediated by the longitudinal trajectory of the biomarker. Only in the patient subgroup treated with CT + B, the baseline NLR retained a direct effect on PFS. Regarding the effect of treatment on PFS, two scenarios were observed. In the subgroup of patients with low baseline, NLR bevacizumab showed a direct protective effect only (hazard ratio [HR], 0.66 [95% CI, 0.45 to 0.98]), whereas in the subgroup with high baseline NLR, there was evidence for an adverse direct effect (HR, 1.63 [95% CI, 1.03 to 2.57]) and a protective indirect-which is mediated by the longitudinal biomarker-effect (HR, 0.71 [95% CI, 0.55 to 0.90]). Conclusion: In our study, inflammatory indexes collected longitudinally showed a significant adverse prognostic role, thus suggesting the collection and use of such data for better clinical decision making. In the specific setting, we considered this is particularly important as the treatment effect seemed to be modified by both the baseline and longitudinal inflammation statuses. However, further research is needed to understand the possible factors underlying these results.
MeSH term(s)	Humans ; Bevacizumab/therapeutic use ; Biomarkers ; Colonic Neoplasms ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/pathology ; Lymphocytes/pathology ; Neutrophils/pathology ; Prognosis ; Rectal Neoplasms ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase III as Topic
Chemical Substances	Bevacizumab (2S9ZZM9Q9V) ; Biomarkers
Language	English
Publishing date	2023-12-12
Publishing country	United States
Document type	Journal Article
ISSN	2473-4284
ISSN (online)	2473-4284
DOI	10.1200/PO.23.00256
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Article ; Online: CDK4/6-Inhibitors Versus Chemotherapy in Advanced HR+/HER2-Negative Breast Cancer: Results and Correlative Biomarker Analyses of the KENDO Randomized Phase II Trial.

Schettini, Francesco / Palleschi, Michela / Mannozzi, Francesca / Brasó-Maristany, Fara / Cecconetto, Lorenzo / Galván, Patricia / Mariotti, Marita / Ferrari, Alessia / Scarpi, Emanuela / Miserocchi, Anna / Nanni, Oriana / Sanfeliu, Esther / Prat, Aleix / Rocca, Andrea / De Giorgi, Ugo

The oncologist

2024 Volume 29, Issue 5, Page(s) e622–e634

Abstract: Background: The optimal treatment approach for hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2-negative MBC) with aggressive characteristics remains controversial, with lack of randomized trials comparing cyclin-dependent ... ...

Abstract	Background: The optimal treatment approach for hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2-negative MBC) with aggressive characteristics remains controversial, with lack of randomized trials comparing cyclin-dependent kinase (CDK)4/6-inhibitors (CDK4/6i) + endocrine therapy (ET) with chemotherapy + ET. Materials and methods: We conducted an open-label randomized phase II trial (NCT03227328) to investigate whether chemotherapy + ET is superior to CDK4/6i + ET for HR+/HER2-negative MBC with aggressive features. PAM50 intrinsic subtypes (IS), immunological features, and gene expression were assessed on baseline samples. Results: Among 49 randomized patients (median follow-up: 35.2 months), median progression-free survival (mPFS) with chemotherapy + ET (11.2 months, 95% confidence interval [CI]: 7.7-15.4) was numerically shorter than mPFS (19.9 months, 95% CI: 9.0-30.6) with CDK4/6i + ET (hazard ratio: 1.41, 95% CI: 0.75-2.64). Basal-like tumors under CDK4/6i + ET exhibited worse PFS (mPFS: 11.4 months, 95% CI: 3.00-not reached [NR]) and overall survival (OS; mOS: 18.8 months, 95% CI: 18.8-NR) compared to other subtypes (mPFS: 20.7 months, 95% CI: 9.00-33.4; mOS: NR, 95% CI: 24.4-NR). In the chemotherapy arm, luminal A tumors showed poorer PFS (mPFS: 5.1 months, 95% CI: 2.7-NR) than other IS (mPFS: 13.2 months, 95% CI: 10.6-28.1). Genes/pathways involved in BC cell survival and proliferation were associated with worse outcomes, as opposite to most immune-related genes/signatures, especially in the CDK4/6i arm. CD24 was the only gene significantly associated with worse PFS in both arms. Tertiary lymphoid structures and higher tumor-infiltrating lymphocytes also showed favorable survival trends in the CDK4/6i arm. Conclusions: The KENDO trial, although closed prematurely, adds further evidence supporting CDK4/6i + ET use in aggressive HR+/HER2-negative MBC instead of chemotherapy. PAM50 IS, genomic, and immunological features are promising biomarkers to personalize therapeutic choices.
MeSH term(s)	Humans ; Female ; Breast Neoplasms/drug therapy ; Breast Neoplasms/pathology ; Cyclin-Dependent Kinase 4/antagonists & inhibitors ; Middle Aged ; Cyclin-Dependent Kinase 6/antagonists & inhibitors ; Biomarkers, Tumor/metabolism ; Receptor, ErbB-2/metabolism ; Aged ; Adult ; Protein Kinase Inhibitors/therapeutic use ; Protein Kinase Inhibitors/pharmacology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Receptors, Estrogen/metabolism ; Receptors, Progesterone/metabolism
Chemical Substances	Cyclin-Dependent Kinase 4 (EC 2.7.11.22) ; Cyclin-Dependent Kinase 6 (EC 2.7.11.22) ; Biomarkers, Tumor ; Receptor, ErbB-2 (EC 2.7.10.1) ; Protein Kinase Inhibitors ; CDK4 protein, human (EC 2.7.11.22) ; CDK6 protein, human (EC 2.7.11.22) ; ERBB2 protein, human (EC 2.7.10.1) ; Receptors, Estrogen ; Receptors, Progesterone
Language	English
Publishing date	2024-01-03
Publishing country	England
Document type	Journal Article ; Clinical Trial, Phase II ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1093/oncolo/oyad337
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Zs.A 4845: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Fall predictors in hospitalized patients living with cancer: a case-control study.

Zeneli, Anita / Montalti, Sandra / Masciangelo, Itria / Manieri, Gloria / Golinucci, Monica / Nanni, Oriana / Montella, Maria Teresa / Martinelli, Giovanni / Petracci, Elisabetta

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

2022 Volume 30, Issue 10, Page(s) 7835–7843

Abstract: Purpose: To identify fall predictors and develop an assessment tool to be used for screening hospitalized cancer patients at risk for fall.: Methods: A retrospective case-control study was conducted in 2018 at a cancer center in Northern Italy. The ... ...

Abstract	Purpose: To identify fall predictors and develop an assessment tool to be used for screening hospitalized cancer patients at risk for fall. Methods: A retrospective case-control study was conducted in 2018 at a cancer center in Northern Italy. The study participants were 448 adult cancer patients admitted to the oncology ward from 2009 to 2013. The case group consisted of 112 patients presenting at least one fall, while controls were randomly chosen by matching each case for age, sex, and admission period with three patients who did not fall. Data for the fall predictors were extracted from the electronic medical records. Conditional logistic regression was used to evaluate the association between patient's characteristics and fall risk. Results: The overall prevalence of patients having at least one candidate fall predictor was high (98%). Seven of the studied variables showed an independent association with fall risk at multivariate analysis. These were tumor site, the presence of neurologic diseases, gait imbalance disorders, fatigue, and the assumption of certain medications such as diuretics, hypnotics, and opioids (odds ratios and 95% confidence intervals in brackets were 3.78 (1.78-8.13), 2.26 (1.08-4.77), 4.22 (1.87-9.52), 2.76 (1.45-5.26), 2.66 (1.52-4.66), 2.41 (1.20-4.85), and 3.03 (1.68-5.45), respectively). Conclusions: In this study, we identified falling risk factors in an Italian population of hospitalized cancer patients and developed a new risk assessment tool. An external validation is necessary before implementing our screening tool in clinical practice.
MeSH term(s)	Adult ; Case-Control Studies ; Diuretics ; Humans ; Inpatients ; Neoplasms/epidemiology ; Retrospective Studies ; Risk Assessment ; Risk Factors
Chemical Substances	Diuretics
Language	English
Publishing date	2022-06-16
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1134446-5
ISSN	1433-7339 ; 0941-4355
ISSN (online)	1433-7339
ISSN	0941-4355
DOI	10.1007/s00520-022-07208-x
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Article ; Online: Correction: Elevated levels of eEF1A2 protein expression in triple negative breast cancer relate with poor prognosis.

Giudici, Fabiola / Petracci, Elisabetta / Nanni, Oriana / Bottin, Cristina / Pinamonti, Maurizio / Zanconati, Fabrizio / Scaggiante, Bruna

PloS one

2019 Volume 14, Issue 12, Page(s) e0227068

Abstract: This corrects the article DOI: 10.1371/journal.pone.0218030.]. ...

Abstract	[This corrects the article DOI: 10.1371/journal.pone.0218030.].
Language	English
Publishing date	2019-12-19
Publishing country	United States
Document type	Published Erratum
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0227068
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Article ; Online: Diagnostic effectiveness of [

Bottoni, Gianluca / Fiz, Francesco / Puntoni, Matteo / Matteucci, Federica / Monti, Manuela / DeCensi, Andrea / Nanni, Oriana / Brain, Etienne / Alberini, Jean Louis / Dib, Bassam / Sacchetti, Gianmauro / Trimboli, Pierpaolo / Treglia, Giorgio / Harbeck, Nadia / Sola, Simona / Gennari, Alessandra / Piccardo, Arnoldo

European journal of nuclear medicine and molecular imaging

2023 Volume 50, Issue 8, Page(s) 2477–2485

Abstract: Introduction: [: Materials and methods: From a multicentre database, we enrolled all patients with metastatic BC who had undergone both [: Results: 92 patients, bearing a total of 2678 metastases, were enrolled. On PBA, the DR of [: Conclusions!# ...

Abstract	Introduction: [ Materials and methods: From a multicentre database, we enrolled all patients with metastatic BC who had undergone both [ Results: 92 patients, bearing a total of 2678 metastases, were enrolled. On PBA, the DR of [ Conclusions: The overall DR of [
MeSH term(s)	Humans ; Female ; Breast Neoplasms/diagnostic imaging ; Breast Neoplasms/pathology ; Positron Emission Tomography Computed Tomography/methods ; Receptors, Estrogen ; Prospective Studies ; Fluorodeoxyglucose F18 ; Estradiol
Chemical Substances	Receptors, Estrogen ; Fluorodeoxyglucose F18 (0Z5B2CJX4D) ; Estradiol (4TI98Z838E)
Language	English
Publishing date	2023-03-07
Publishing country	Germany
Document type	Multicenter Study ; Journal Article ; Comment
ZDB-ID	8236-3
ISSN	1619-7089 ; 0340-6997 ; 1619-7070
ISSN (online)	1619-7089
ISSN	0340-6997 ; 1619-7070
DOI	10.1007/s00259-023-06173-9
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Article: A real-world retrospective, observational study of first-line pembrolizumab plus chemotherapy for metastatic non-squamous non-small cell lung cancer with PD-L1 tumor proportion score < 50% (PEMBROREAL).

Cafaro, Alessandro / Foca, Flavia / Nanni, Oriana / Chiumente, Marco / Coppola, Marina / Baldo, Paolo / Orzetti, Sabrina / Enrico, Fiorenza / Ladisa, Vito / Lerose, Rosa / Nardulli, Patrizia / Maiolino, Piera / Gradellini, Federica / Gasbarro, Anna Rita / Carrucciu, Gisella / Provasi, Riccardo / Cappelletto, Paola Cristina / Pasqualini, Alessandra / Vecchia, Stefano /

Veraldi, Marianna / De Francesco, Adele Emanuela / Crinò, Lucio / Delmonte, Angelo / Masini, Carla

Frontiers in oncology

2024 Volume 14, Page(s) 1351995

Abstract: Introduction: The phase III Keynote-189 trial established a first-line treatment combining pembrolizumab with pemetrexed and platinum as a standard treatment for patients with stage IV non-small cell lung cancer (NSCLC) without known : Methods: ... ...

Abstract	Introduction: The phase III Keynote-189 trial established a first-line treatment combining pembrolizumab with pemetrexed and platinum as a standard treatment for patients with stage IV non-small cell lung cancer (NSCLC) without known Methods: PEMBROREAL is a retrospective, observational study on patients with NSCLC who started pembrolizumab combined with pemetrexed and platinum within the reimbursability time window, considered as December 2019 to December 2020. The primary endpoints were to assess progression-free survival (PFS) and overall survival (OS; using the Kaplan-Meier method), response to therapy, and tolerability. Results: Until February 2022, 279 patients (median follow-up: 19.7 months) have been observed. The median PFS was 8.0 months (95% confidence interval: 6.5-9.2). OS was not reached, but we can estimate a 12- to 24-month survival rate for the combined treatment: 66.1% and 52.5%, respectively. PD-L1 expression and Eastern Cooperative Group (ECOG) Performance Status were both associated with PFS and OS. Overall, only 44.4% of patients reported an adverse event, whereas toxicity led to a 5.4% discontinuation rate. Conclusion: The results of the PEMBROREAL study have shown that the combined treatment of pembrolizumab with pemetrexed and platinum is effective for metastatic non-squamous NSCLC, even for patients with PD-L1 levels below 50%, despite the differences in patient demographics and pathological features compared to the Keynote-189 study. The adverse events reported during the study were more typical of chemotherapy treatment rather than immunotherapy, and physicians were able to manage them easily.
Language	English
Publishing date	2024-03-27
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2024.1351995
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