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Article ; Online: Nivolumab in pretreated pleural mesothelioma: Results from an observational real-world study of patients treated within the AIFA 5% Fund.

2024 , Page(s) 3008916241229287

Abstract: Background: Pleural mesothelioma is a rare cancer with a dismal prognosis and few therapeutic options, especially in the pretreated setting. Immunotherapy with checkpoint inhibitors as single agents yielded interesting results in refractory pleural ... ...

Abstract	Background: Pleural mesothelioma is a rare cancer with a dismal prognosis and few therapeutic options, especially in the pretreated setting. Immunotherapy with checkpoint inhibitors as single agents yielded interesting results in refractory pleural mesothelioma, achieving a response rate between 10-20%, median progression-free survival of 2-5 months and median overall survival of 7-13 months. Patients and methods: A retrospective, multi-institutional study of pleural mesothelioma patients treated with nivolumab in second and further line was performed. The endpoints of the study are response rate, disease control rate, progression free survival and overall survival. Results: Sixty-five patients with pleural mesothelioma treated with nivolumab in second and further line were enrolled at seven Italian institutions. The response rate was 8%, disease control rate was 37%, median progression free survival was 5.7 months (95% CI: 2.9-9.0) and median overall survival was 11.1 (95% CI 6.2-19.9) months. A higher neutrophils and neutrophils to lymphocytes ratio at baseline were associated with worse prognosis. Conclusion: Nivolumab as a single agent is fairly active in a cohort of unselected pretreated pleural mesothelioma patients. Further investigations on clinical and translational factors are needed to define which patient might benefit most from nivolumab treatment in pleural mesothelioma.
Language	English
Publishing date	2024-02-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	280962-x
ISSN	2038-2529 ; 0300-8916
ISSN (online)	2038-2529
ISSN	0300-8916
DOI	10.1177/03008916241229287
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Article ; Online: Cetuximab for metastatic colorectal cancer.

Bria, Emilio / Cuppone, Federica / Di Maio, Massimo

The New England journal of medicine

2009 Volume 361, Issue 1, Page(s) 95–6; author reply 96–7

MeSH term(s)	Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Cetuximab ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/genetics ; Disease Progression ; Genes, ras ; Humans ; Mutation ; Prognosis
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Cetuximab (PQX0D8J21J)
Language	English
Publishing date	2009-07-02
Publishing country	United States
Document type	Comment ; Letter
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
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Article: Moving towards a customized approach for drug development: lessons from clinical trials with immune checkpoint inhibitors in lung cancer.

Pilotto, Sara / Carbognin, Luisa / Karachaliou, Niki / Garassino, Marina / Cuppone, Federica / Petraglia, Sandra / Rosell, Rafael / Tortora, Giampaolo / Bria, Emilio

Translational lung cancer research

2015 Volume 4, Issue 6, Page(s) 704–712

Abstract: Lung cancer has recently been discovered to be an immunological targetable disease, on the basis of the exciting results of the randomized trials with immune checkpoint inhibitors. Nevertheless, the survival benefit appears to not be entirely captured by ...

Abstract	Lung cancer has recently been discovered to be an immunological targetable disease, on the basis of the exciting results of the randomized trials with immune checkpoint inhibitors. Nevertheless, the survival benefit appears to not be entirely captured by the usual outcome measures, thus requiring a deep reflection about the appropriateness of the traditional statistical methodologies in this context. The intrinsic biological differences existing both in terms of mechanism of action and kinetic between immunotherapy and chemotherapy or targeted therapy, impact on patients' outcome, requiring a global revolution in the way to design clinical studies with the ideal aim to evolve towards trials carefully 'customized' on the basis of the investigational drug, the specific disease and the biological background. The exciting data recently obtained with immune checkpoint inhibitors, offer an ideal context and background to explore the major questions and future perspectives about the development of immunotherapeutic agents. In this regard, the choice of adequate endpoints, the use of modified statistical methods and the potential introduction of predictive biomarkers for immunotherapy clinical trials, will be discuss in this review in order to provide practical and rationale suggestions aimed to improve the existing model for cancer immunotherapy investigation.
Language	English
Publishing date	2015-12-01
Publishing country	China
Document type	Journal Article ; Review
ZDB-ID	2754335-3
ISSN	2226-4477 ; 2218-6751
ISSN (online)	2226-4477
ISSN	2218-6751
DOI	10.3978/j.issn.2218-6751.2015.10.08
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Article ; Online: Clinical results of randomized trials and 'real-world' data exploring the impact of Bevacizumab for breast cancer: opportunities for clinical practice and perspectives for research.

Zambonin, Valentina / De Toma, Alessandro / Carbognin, Luisa / Nortilli, Rolando / Fiorio, Elena / Parolin, Veronica / Pilotto, Sara / Cuppone, Federica / Pellini, Francesca / Lombardi, Davide / Pollini, Giovanni Paolo / Tortora, Giampaolo / Bria, Emilio

Expert opinion on biological therapy

2017 Volume 17, Issue 4, Page(s) 497–506

Abstract: Introduction: Angiogenesis plays a fundamental role in breast cancer (BC) growth, progression and metastatic spread. After the promising introduction of bevacizumab for the treatment of advanced BC, the initial enthusiasm decreased when the FDA withdrew ...

Abstract	Introduction: Angiogenesis plays a fundamental role in breast cancer (BC) growth, progression and metastatic spread. After the promising introduction of bevacizumab for the treatment of advanced BC, the initial enthusiasm decreased when the FDA withdrew its approval in 2011. Nevertheless, several clinical studies exploring the role of bevacizumab have been subsequently published. Areas covered: The aim of this study is to review the available clinical trials exploring the potential effectiveness of bevacizumab in BC, regardless of the disease setting. Expert opinion: Even if the evidence suggests that bevacizumab must be ruled out from the HER2-positive and adjuvant setting, bevacizumab's benefit remains uncertain in the neoadjuvant setting and in the advanced treatment of HER2-negative patients. In the first setting, the addition of bevacizumab to chemotherapy increased the pathological complete response (pCR) rate in most clinical trials. However, the current absence of evidence that pCR is a trial-level surrogate for survival requires waiting for long-term results. In the advanced setting, all trials showed a benefit in progression-free survival, but not in overall survival, highlighting an increase of adverse events. The lack of predictors of response represents the main unmet need in which future clinical research will undoubtedly invest.
MeSH term(s)	Angiogenesis Inhibitors/therapeutic use ; Animals ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Bevacizumab/therapeutic use ; Biomedical Research/methods ; Biomedical Research/trends ; Breast Neoplasms/diagnosis ; Breast Neoplasms/drug therapy ; Disease-Free Survival ; Female ; Humans ; Neoadjuvant Therapy/methods ; Neovascularization, Pathologic/diagnosis ; Neovascularization, Pathologic/drug therapy ; Pragmatic Clinical Trials as Topic/methods ; Randomized Controlled Trials as Topic/methods
Chemical Substances	Angiogenesis Inhibitors ; Antibodies, Monoclonal, Humanized ; Bevacizumab (2S9ZZM9Q9V)
Language	English
Publishing date	2017-04
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2052501-1
ISSN	1744-7682 ; 1471-2598
ISSN (online)	1744-7682
ISSN	1471-2598
DOI	10.1080/14712598.2017.1289171
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Article ; Online: Early recurrence risk: aromatase inhibitors versus tamoxifen.

Bria, Emilio / Carlini, Paolo / Cuppone, Federica / Vaccaro, Vanja / Milella, Michele / Cognetti, Francesco

Expert review of anticancer therapy

2010 Volume 10, Issue 8, Page(s) 1239–1253

Abstract: Aromatase inhibitors (AIs) are becoming the hormonal treatment of choice for postmenopausal women with early breast cancer. Large, well-controlled clinical studies have established the efficacy and safety of initial adjuvant therapy with letrozole or ... ...

Abstract	Aromatase inhibitors (AIs) are becoming the hormonal treatment of choice for postmenopausal women with early breast cancer. Large, well-controlled clinical studies have established the efficacy and safety of initial adjuvant therapy with letrozole or anastrozole versus the previous standard of 5 years of adjuvant tamoxifen and support using an AI (exemestane, anastrozole or letrozole) following tamoxifen for 2-3 years (early 'switch' treatment) or 5 years (extended adjuvant treatment). Reducing recurrence risk is a primary goal of adjuvant hormonal therapy. There is an early peak of recurrences 2 years after surgery; most are distant metastases rather than local or regional events. Therefore, treatment strategies such as initial therapy with AIs, which reduce early distant recurrence events, can be expected to improve long-term survival outcomes. Switching to an AI following 2-3 years of initial adjuvant tamoxifen is an effective option for patients unable to begin treatment with an AI.
MeSH term(s)	Animals ; Antineoplastic Agents, Hormonal/therapeutic use ; Aromatase Inhibitors/therapeutic use ; Breast Neoplasms/diagnosis ; Breast Neoplasms/drug therapy ; Breast Neoplasms/enzymology ; Female ; Humans ; Neoplasm Recurrence, Local/diagnosis ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/enzymology ; Risk Factors ; Tamoxifen/therapeutic use ; Time Factors
Chemical Substances	Antineoplastic Agents, Hormonal ; Aromatase Inhibitors ; Tamoxifen (094ZI81Y45)
Language	English
Publishing date	2010-08
Publishing country	England
Document type	Comparative Study ; Journal Article ; Review
ZDB-ID	2112544-2
ISSN	1744-8328 ; 1473-7140
ISSN (online)	1744-8328
ISSN	1473-7140
DOI	10.1586/era.10.54
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Article ; Online: Differential Activity of Nivolumab, Pembrolizumab and MPDL3280A according to the Tumor Expression of Programmed Death-Ligand-1 (PD-L1): Sensitivity Analysis of Trials in Melanoma, Lung and Genitourinary Cancers.

Carbognin, Luisa / Pilotto, Sara / Milella, Michele / Vaccaro, Vanja / Brunelli, Matteo / Caliò, Anna / Cuppone, Federica / Sperduti, Isabella / Giannarelli, Diana / Chilosi, Marco / Bronte, Vincenzo / Scarpa, Aldo / Bria, Emilio / Tortora, Giampaolo

PloS one

2015 Volume 10, Issue 6, Page(s) e0130142

Abstract: Background: The potential predictive role of programmed death-ligand-1 (PD-L1) expression on tumor cells in the context of solid tumor treated with checkpoint inhibitors targeting the PD-1 pathway represents an issue for clinical research.: Methods: ... ...

Abstract	Background: The potential predictive role of programmed death-ligand-1 (PD-L1) expression on tumor cells in the context of solid tumor treated with checkpoint inhibitors targeting the PD-1 pathway represents an issue for clinical research. Methods: Overall response rate (ORR) was extracted from phase I-III trials investigating nivolumab, pembrolizumab and MPDL3280A for advanced melanoma, non-small cell lung cancer (NSCLC) and genitourinary cancer, and cumulated by adopting a fixed and random-effect model with 95% confidence interval (CI). Interaction test according to tumor PD-L1 was accomplished. A sensitivity analysis according to adopted drug, tumor type, PD-L1 cut-off and treatment line was performed. Results: Twenty trials (1,475 patients) were identified. A significant interaction (p<0.0001) according to tumor PD-L1 expression was found in the overall sample with an ORR of 34.1% (95% CI 27.6-41.3%) in the PD-L1 positive and 19.9% (95% CI 15.4-25.3%) in the PD-L1 negative population. ORR was significantly higher in PD-L1 positive in comparison to PD-L1 negative patients for nivolumab and pembrolizumab, with an absolute difference of 16.4% and 19.5%, respectively. A significant difference in activity of 22.8% and 8.7% according to PD-L1 was found for melanoma and NSCLC, respectively, with no significant difference for genitourinary cancer. Conclusion: Overall, the three antibodies provide a significant differential effect in terms of activity according to PD-L1 expression on tumor cells. The predictive value of PD-L1 on tumor cells seems to be more robust for anti-PD-1 antibody (nivolumab and pembrolizumab), and in the context of advanced melanoma and NSCLC.
MeSH term(s)	Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Agents/therapeutic use ; B7-H1 Antigen/genetics ; Carcinoma, Non-Small-Cell Lung/diagnosis ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Gene Expression Regulation, Neoplastic ; Humans ; Lung/drug effects ; Lung/metabolism ; Lung/pathology ; Lung Neoplasms/diagnosis ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Melanoma/diagnosis ; Melanoma/drug therapy ; Melanoma/genetics ; Neoplasms/diagnosis ; Neoplasms/drug therapy ; Neoplasms/genetics ; Prognosis ; Treatment Outcome ; Urogenital Neoplasms/diagnosis ; Urogenital Neoplasms/drug therapy ; Urogenital Neoplasms/genetics ; Urogenital System/drug effects ; Urogenital System/metabolism ; Urogenital System/pathology
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Antineoplastic Agents ; B7-H1 Antigen ; nivolumab (31YO63LBSN) ; atezolizumab (52CMI0WC3Y) ; pembrolizumab (DPT0O3T46P)
Language	English
Publishing date	2015
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0130142
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Should subgroup analysis of randomized clinical trials have a direct impact on clinical practice?

Bria, Emilio / Di Maio, Massimo / Cuppone, Federica / Nisticò, Cecilia / Cognetti, Francesco / Giannarelli, Diana

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2007 Volume 25, Issue 5, Page(s) 605–6; author reply 606–7

MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/mortality ; Data Interpretation, Statistical ; Female ; Humans ; Male ; Practice Guidelines as Topic ; Randomized Controlled Trials as Topic/methods ; Research Design ; Sex Factors ; Survival Analysis ; Treatment Outcome
Language	English
Publishing date	2007-02-10
Publishing country	United States
Document type	Comment ; Letter
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.2006.09.0365
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Zs.A 1847: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 650: Show issues

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Article ; Online: Differential Activity of Nivolumab, Pembrolizumab and MPDL3280A according to the Tumor Expression of Programmed Death-Ligand-1 (PD-L1)

Luisa Carbognin / Sara Pilotto / Michele Milella / Vanja Vaccaro / Matteo Brunelli / Anna Caliò / Federica Cuppone / Isabella Sperduti / Diana Giannarelli / Marco Chilosi / Vincenzo Bronte / Aldo Scarpa / Emilio Bria / Giampaolo Tortora

PLoS ONE, Vol 10, Iss 6, p e

Sensitivity Analysis of Trials in Melanoma, Lung and Genitourinary Cancers.

2015 Volume 0130142

Abstract: The potential predictive role of programmed death-ligand-1 (PD-L1) expression on tumor cells in the context of solid tumor treated with checkpoint inhibitors targeting the PD-1 pathway represents an issue for clinical research.Overall response rate (ORR) ...

Abstract	The potential predictive role of programmed death-ligand-1 (PD-L1) expression on tumor cells in the context of solid tumor treated with checkpoint inhibitors targeting the PD-1 pathway represents an issue for clinical research.Overall response rate (ORR) was extracted from phase I-III trials investigating nivolumab, pembrolizumab and MPDL3280A for advanced melanoma, non-small cell lung cancer (NSCLC) and genitourinary cancer, and cumulated by adopting a fixed and random-effect model with 95% confidence interval (CI). Interaction test according to tumor PD-L1 was accomplished. A sensitivity analysis according to adopted drug, tumor type, PD-L1 cut-off and treatment line was performed.Twenty trials (1,475 patients) were identified. A significant interaction (p<0.0001) according to tumor PD-L1 expression was found in the overall sample with an ORR of 34.1% (95% CI 27.6-41.3%) in the PD-L1 positive and 19.9% (95% CI 15.4-25.3%) in the PD-L1 negative population. ORR was significantly higher in PD-L1 positive in comparison to PD-L1 negative patients for nivolumab and pembrolizumab, with an absolute difference of 16.4% and 19.5%, respectively. A significant difference in activity of 22.8% and 8.7% according to PD-L1 was found for melanoma and NSCLC, respectively, with no significant difference for genitourinary cancer.Overall, the three antibodies provide a significant differential effect in terms of activity according to PD-L1 expression on tumor cells. The predictive value of PD-L1 on tumor cells seems to be more robust for anti-PD-1 antibody (nivolumab and pembrolizumab), and in the context of advanced melanoma and NSCLC.
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2015-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Targeting targeted agents: open issues for clinical trial design.

Bria, Emilio / Di Maio, Massimo / Carlini, Paolo / Cuppone, Federica / Giannarelli, Diana / Cognetti, Francesco / Milella, Michele

Journal of experimental & clinical cancer research : CR

2009 Volume 28, Page(s) 66

Abstract: Molecularly targeted agents for the treatment of solid tumors had entered the market in the last 5 years, with a great impact upon both the scientific community and the society. Many randomized phase III trials conducted in recent years with new targeted ...

Abstract	Molecularly targeted agents for the treatment of solid tumors had entered the market in the last 5 years, with a great impact upon both the scientific community and the society. Many randomized phase III trials conducted in recent years with new targeted agents, despite previous data coming from preclinical research and from phase II trials were often promising, have produced disappointingly negative results. Some other trials have actually met their primary endpoint, demonstrating a statistically significant result favouring the experimental treatment. Unfortunately, with a few relevant exceptions, this advantage is often small, if not negligible, in absolute terms. The difference between statistical significance and clinical relevance should always be considered when translating clinical trials' results in the practice. The reason why this 'revolution' did not significantly impact on cancer treatment to displace chemotherapy from the patient' bedside is in part due to complicated, and in many cases, unknown, mechanisms of action of such drugs; indeed, the traditional way the clinical investigators were used to test the efficacy of 'older' chemotherapeutics, has become 'out of date' from the methodological perspective. As these drugs should be theoretically tailored upon featured bio-markers expressed by the patients, the clinical trial design should follow new rules based upon stronger hypotheses than those developed so far. Indeed, the early phases of basic and clinical drug development are crucial in the correct process which is able to correctly identify the target (when present). Targeted trial designs can result in easier studies, with less, better selected, and supported by stronger proofs of response evidences, patients, in order to not waste time and resources.
MeSH term(s)	Antineoplastic Agents/therapeutic use ; Clinical Trials as Topic ; Drug Design ; Humans ; Neoplasms/drug therapy
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2009-05-22
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	803138-1
ISSN	1756-9966 ; 0392-9078
ISSN (online)	1756-9966
ISSN	0392-9078
DOI	10.1186/1756-9966-28-66
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Article: Carcinoma mammario metastatic: l'aumento della sopravivvenza globale un endpoint é realistico negli studi clinici de fase III? Studi sui taxani, studio sul trastuzumab.

Bria, Emilio / Vanni, Barbara / Cuppone, Federica / Calabretta, Francesca / Campanella, Carla / Torsello, Angela / Terzoli, Edmondo

I supplementi di Tumori : official journal of Societa italiana di cancerologia ... [et al.

2004 Volume 3, Issue 4, Page(s) S65–6

Title translation	Metastatic breast cancer: is global survival increase a realistic endpoint in phase III clinical trials? Studies on taxanes; studies on trastuzumab.
MeSH term(s)	Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Breast Neoplasms/drug therapy ; Breast Neoplasms/mortality ; Breast Neoplasms/therapy ; Clinical Trials, Phase III as Topic/methods ; Combined Modality Therapy ; Endpoint Determination ; Female ; Humans ; Randomized Controlled Trials as Topic ; Survival Analysis ; Taxoids/therapeutic use ; Trastuzumab ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Taxoids ; Trastuzumab (P188ANX8CK)
Language	Italian
Publishing date	2004-07
Publishing country	Italy
Document type	Comparative Study ; Journal Article
ISSN	2283-5423
ISSN	2283-5423
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