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Article ; Online: What is the weight of expectation bias in oncology trials?

Dello Russo, Cinzia / Navarra, Pierluigi

British journal of clinical pharmacology

2023 Volume 89, Issue 4, Page(s) 1279–1281

MeSH term(s)	Humans ; Motivation ; Medical Oncology ; Neoplasms/drug therapy ; Bias
Language	English
Publishing date	2023-02-11
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15680
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Local Investigators Significantly Overestimate Overall Response Rates Compared to Blinded Independent Central Reviews in Uncontrolled Oncology Trials: A Comprehensive Review of the Literature.

Dello Russo, Cinzia / Navarra, Pierluigi

Frontiers in pharmacology

2022 Volume 13, Page(s) 858354

Abstract: Several drugs gained market authorization based on the demonstration of improved progression-free survival (PFS), adopted as a primary endpoint in Phase 3 clinical trials. In addition, an increasing number of drugs have been granted accelerated approval, ...

Abstract	Several drugs gained market authorization based on the demonstration of improved progression-free survival (PFS), adopted as a primary endpoint in Phase 3 clinical trials. In addition, an increasing number of drugs have been granted accelerated approval, and sometimes regular approval, by the main regulatory agencies based on the evaluation of the overall response rate in Phase 1 and 2 clinical trials. However, while the overall survival is an unbiased measure of drug efficacy, these outcomes rely on the assessment of radiological images and patients' categorization using standardized response criteria. The evaluation of these outcomes may be influenced by subjective factors, particularly when the analysis is performed locally. In fact, blinding of treatment is not always possible in modern oncology trials. Therefore, a blinded independent central review is often adopted to overcome the problem of expectation bias associated with local investigator assessments. In this regard, we have recently observed that local investigators tend to overestimate the overall response rate in comparison to central reviewers in Phase 2 clinical trials, whereas we did not find any significant evaluation bias between local investigators and central reviews when considering progression-free survival in both Phase 2 and 3 trials. In the present article, we have tried to understand the reasons behind this discrepancy by reviewing the available evidence in the literature. In addition, a further analysis of Phase 2 and 3 clinical trials that included the evaluation of both endpoints showed that local investigators significantly overestimate overall response rates compared to blinded independent central reviews in uncontrolled oncology trials.
Language	English
Publishing date	2022-05-16
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2022.858354
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Article: Remifentanil does not affect human microglial immune activation in response to pro-inflammatory cytokines.

Dello Russo, Cinzia / Cappoli, Natalia / Tabolacci, Elisabetta / Sollazzi, Liliana / Navarra, Pierluigi / Aceto, Paola

EXCLI journal

2023 Volume 22, Page(s) 295–309

Abstract: Remifentanil is a potent ultra-short acting μ-opioid analgesic drug, frequently used in anaesthesia due to its favorable pharmacodynamic and pharmacokinetic profile. It may be associated with the occurrence of hyperalgesia. Preclinical studies suggest a ... ...

Abstract	Remifentanil is a potent ultra-short acting μ-opioid analgesic drug, frequently used in anaesthesia due to its favorable pharmacodynamic and pharmacokinetic profile. It may be associated with the occurrence of hyperalgesia. Preclinical studies suggest a potential role of microglia, although the molecular mechanisms have not been fully elucidated. Considering the role of microglia in brain inflammation and the relevant differences among species, the effects of remifentanil were studied on the human microglial C20 cells. The drug was tested at clinically relevant concentrations under basal and inflammatory conditions
Language	English
Publishing date	2023-02-24
Publishing country	Germany
Document type	Journal Article
ISSN	1611-2156
ISSN	1611-2156
DOI	10.17179/excli2022-5667
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Article: Perioperative analgesia in the elderly.

Del Tedesco, Filippo / Sessa, Flaminio / Xhemalaj, Rikardo / Sollazzi, Liliana / Dello Russo, Cinzia / Aceto, Paola

Saudi journal of anaesthesia

2023 Volume 17, Issue 4, Page(s) 491–499

Abstract: The administration of analgesic drugs in elderly patients should take into account age-related physiological changes, loss of efficiency of homeostatic mechanisms, and pharmacological interactions with chronic therapies. Underestimation of pain in ... ...

Abstract	The administration of analgesic drugs in elderly patients should take into account age-related physiological changes, loss of efficiency of homeostatic mechanisms, and pharmacological interactions with chronic therapies. Underestimation of pain in patients with impaired cognition is often linked to difficulties in pain assessment. In the preoperative phase, it is essential to assess the physical status, cognitive reserve, and previous chronic pain conditions to plan effective analgesia. Furthermore, an accurate pharmacological history of the patient must be collected to establish any possible interaction with the whole perioperative analgesic plan. The use of analgesic drugs with different mechanisms of action for pain relief in the intraoperative phase is a crucial step to achieve adequate postoperative pain control in older adults. The combined multimodal and opioid-sparing strategy is strongly recommended to reduce side effects. The use of various adjuvants is also preferable. Moreover, the implementation of non-pharmacological approaches may lead to faster recovery. High-quality postoperative analgesia in older patients can be achieved only with a collaborative interdisciplinary team. The aim of this review is to highlight the perioperative pain management strategies in the elderly with a special focus on intraoperative pharmacological interventions.
Language	English
Publishing date	2023-08-18
Publishing country	India
Document type	Journal Article ; Review
ZDB-ID	2562174-9
ISSN	0975-3125 ; 1658-354X
ISSN (online)	0975-3125
ISSN	1658-354X
DOI	10.4103/sja.sja_643_23
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Article ; Online: LAT1, a novel pharmacological target for the treatment of glioblastoma.

Cappoli, Natalia / Jenkinson, Michael D / Dello Russo, Cinzia / Dickens, David

Biochemical pharmacology

2022 Volume 201, Page(s) 115103

Abstract: The L-Type Amino Acid transporter, LAT1 (SLC7A5), has a crucial role in mediating amino acid uptake into the cells, thus modulating cell growth and proliferation as well as other intracellular functions. Different studies have reported a central role of ... ...

Abstract	The L-Type Amino Acid transporter, LAT1 (SLC7A5), has a crucial role in mediating amino acid uptake into the cells, thus modulating cell growth and proliferation as well as other intracellular functions. Different studies have reported a central role of LAT1 in glioblastoma development and progression, suggesting that the modulation of its activity could be a novel therapeutic strategy. LAT1 also has an important role in the peripheral immune system, by regulating the activation status of several immune cells through modulation of the mechanistic target of rapamycin kinase. In glioblastoma (GBM), the blood-brain barrier is disrupted, which allows the recruitment of peripheral immune cells to the tumour site. These cells, together with resident microglia, contribute to cancer growth and progression. Currently, little is known about the function of LAT1 in the reprogramming of the immune component of the tumour microenvironment in the context of GBM. In this article, we review the available data on the role of LAT1 in the regulation of GBM biology, including its potential role in the tumour microenvironment, particularly in infiltrating-peripheral immune cells and resident microglial cells. In addition, we review the available data on the main pharmacological inhibitors of LAT1, aiming to evaluate their possible role as novel therapeutics for GBM.
MeSH term(s)	Blood-Brain Barrier/metabolism ; Cell Proliferation ; Glioblastoma/drug therapy ; Glioblastoma/pathology ; Humans ; Large Neutral Amino Acid-Transporter 1/metabolism ; Tumor Microenvironment
Chemical Substances	Large Neutral Amino Acid-Transporter 1
Language	English
Publishing date	2022-05-23
Publishing country	England
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	208787-x
ISSN	1873-2968 ; 0006-2952
ISSN (online)	1873-2968
ISSN	0006-2952
DOI	10.1016/j.bcp.2022.115103
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Article ; Online: Dimethyl fumarate induced lymphopenia in multiple sclerosis: A review of the literature.

Dello Russo, Cinzia / Scott, Kathryn Anne / Pirmohamed, Munir

Pharmacology & therapeutics

2020 Volume 219, Page(s) 107710

Abstract: Dimethyl fumarate (DMF) is a first line medication for multiple sclerosis. It has a favourable safety profile, however, there is concern regarding the occurrence of moderate-severe and sustained lymphopenia and the associated risk of progressive ... ...

Abstract	Dimethyl fumarate (DMF) is a first line medication for multiple sclerosis. It has a favourable safety profile, however, there is concern regarding the occurrence of moderate-severe and sustained lymphopenia and the associated risk of progressive multifocal leukoencephalopathy. We carried out an extensive literature review to understand the molecular mechanisms underlying this adverse reaction. Dynamic changes in certain components of the immune system are likely to be important for the therapeutic effects of DMF, including depletion of memory T cells and decrease in activated T cells together with expansion of naïve T cells. Similar modifications were reported for the B cell components. CD8
MeSH term(s)	CD8-Positive T-Lymphocytes ; Dimethyl Fumarate/adverse effects ; Humans ; Immunosuppressive Agents/adverse effects ; Lymphopenia/chemically induced ; Memory T Cells ; Multiple Sclerosis/drug therapy
Chemical Substances	Immunosuppressive Agents ; Dimethyl Fumarate (FO2303MNI2)
Language	English
Publishing date	2020-10-20
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	194735-7
ISSN	1879-016X ; 0163-7258
ISSN (online)	1879-016X
ISSN	0163-7258
DOI	10.1016/j.pharmthera.2020.107710
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Zs.A 1183: Show issues

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Article ; Online: Remifentanil does not affect human microglial immune activation in response to pro-inflammatory cytokines

Cinzia Dello Russo / Natalia Cappoli / Elisabetta Tabolacci / Liliana Sollazzi / Pierluigi Navarra / Paola Aceto

EXCLI Journal : Experimental and Clinical Sciences, Vol 22, Pp 295-

2023 Volume 309

Abstract	Remifentanil is a potent ultra-short acting μ-opioid analgesic drug, frequently used in anaesthesia due to its favorable pharmacodynamic and pharmacokinetic profile. It may be associated with the occurrence of hyperalgesia. Preclinical studies suggest a potential role of microglia, although the molecular mechanisms have not been fully elucidated. Considering the role of microglia in brain inflammation and the relevant differences among species, the effects of remifentanil were studied on the human microglial C20 cells. The drug was tested at clinically relevant concentrations under basal and inflammatory conditions. In the C20 cells, the expression and secretion of interleukin 6, interleukin 8 and the monocyte chemotactic protein 1 were rapidly induced by a mixture of pro-inflammatory cytokines. This stimulatory effect was sustained up to 24 h. Remifentanil did not exert any toxic effect nor modify the production of these inflammatory mediators, thus suggesting the lack of direct immune modulatory actions on human microglia.
Keywords	human microglia ; remifentanil ; hyperalgesia ; interleukin-6 ; interleukin-8 ; monocyte chemotactic protein 1 ; Neoplasms. Tumors. Oncology. Including cancer and carcinogens ; RC254-282 ; Biology (General) ; QH301-705.5
Subject code	610
Language	English
Publishing date	2023-02-01T00:00:00Z
Publisher	IfADo - Leibniz Research Centre for Working Environment and Human Factors, Dortmund
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A comparison between the assessments of progression-free survival by local investigators versus blinded independent central reviews in phase III oncology trials.

Dello Russo, Cinzia / Cappoli, Natalia / Navarra, Pierluigi

European journal of clinical pharmacology

2020 Volume 76, Issue 8, Page(s) 1083–1092

Abstract: Purpose: In this study, we compared the assessments of progression-free survival (PFS) carried out by the local investigator or by a blinded independent central review in the framework of phase III registration randomized controlled trials (RCT) in ... ...

Abstract	Purpose: In this study, we compared the assessments of progression-free survival (PFS) carried out by the local investigator or by a blinded independent central review in the framework of phase III registration randomized controlled trials (RCT) in oncology. Methods: We carried out a search in the clinicatrials.gov database, looking at the RCTs reporting the results of both independently assessed and investigator-assessed PFS. The hazard ratios (HRs) of investigator-assessed PFS and independently assessed PFS were recorded, and a discrepancy index was obtained by calculating the ratio of their respective HRs. Moreover, we investigated possible factors of discrepancy by analyzing the trials in different groups (by year, by tumor type, by drug type, by study design). Results: We analyzed 28 RCTs meeting the search criteria. The estimated mean discrepancy index was 0.98 (confidence interval 0.927-1.032 (n = 32)). Subgroup analysis showed that the confidence intervals in all cases included the value 1, except in the subgroup of studies started in the period 2003-2006. Conclusion: In phase III oncology trials, we found no significant differences between the hazard ratios estimated by local investigators and those estimated by blinded independent central reviews. A relatively higher variability, in terms of large CI, was found in trials with biological agents.
MeSH term(s)	Clinical Trials, Phase III as Topic ; Double-Blind Method ; Humans ; Neoplasms/mortality ; Progression-Free Survival ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2020-05-24
Publishing country	Germany
Document type	Comparative Study ; Journal Article
ZDB-ID	121960-1
ISSN	1432-1041 ; 0031-6970
ISSN (online)	1432-1041
ISSN	0031-6970
DOI	10.1007/s00228-020-02895-z
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Article ; Online: Remifentanil-induced hyperalgesia in healthy volunteers: a systematic review and meta-analysis of randomized controlled trials.

Dello Russo, Cinzia / Di Franco, Valeria / Tabolacci, Elisabetta / Cappoli, Natalia / Navarra, Pierluigi / Sollazzi, Liliana / Rapido, Francesca / Aceto, Paola

Pain

2023 Volume 165, Issue 5, Page(s) 972–982

Abstract: Abstract: Recent literature suggests that the withdrawal of remifentanil (RF) infusion can be associated with hyperalgesia in clinical and nonclinical settings. We performed a systematic review and a meta-analysis of randomized controlled trials with ... ...

Abstract	Abstract: Recent literature suggests that the withdrawal of remifentanil (RF) infusion can be associated with hyperalgesia in clinical and nonclinical settings. We performed a systematic review and a meta-analysis of randomized controlled trials with cross-over design, to assess the effect of discontinuing RF infusion on pain intensity and areas of hyperalgesia and allodynia in healthy volunteers. Nine studies were included. The intervention treatment consisted in RF infusion that was compared with placebo (saline solution). The primary outcome was pain intensity assessment at 30 ± 15 minutes after RF or placebo discontinuation, assessed by any pain scale and using any quantitative sensory testing. Moreover, postwithdrawal pain scores were compared with baseline scores in each treatment. Secondary outcomes included the areas (% of basal values) of hyperalgesia and allodynia. Subjects during RF treatment reported higher pain scores after discontinuation than during treatment with placebo [standardized mean difference (SMD): 0.50, 95% confidence interval (CI): 0.03-0.97; P = 0.04, I 2 = 71%]. A significant decrease in pain scores, compared with baseline values, was found in the placebo treatment (SMD: -0.87, 95% CI: -1.61 to -0.13; P = 0.02, I 2 = 87%), but not in the RF treatment (SMD: -0.28, 95% CI: -1.18 to 0.62; P = 0.54, I 2 = 91%). The area of hyperalgesia was larger after RF withdrawal (SMD: 0.55; 95% CI: 0.27-0.84; P = 0.001; I 2 = 0%). The area of allodynia did not vary between treatments. These findings suggest that the withdrawal of RF induces a mild but nonclinically relevant degree of hyperalgesia in HVs, likely linked to a reduced pain threshold.
MeSH term(s)	Humans ; Remifentanil/adverse effects ; Hyperalgesia/chemically induced ; Hyperalgesia/drug therapy ; Analgesics, Opioid/therapeutic use ; Piperidines/adverse effects ; Randomized Controlled Trials as Topic ; Pain/drug therapy
Chemical Substances	Remifentanil (P10582JYYK) ; Analgesics, Opioid ; Piperidines
Language	English
Publishing date	2023-11-30
Publishing country	United States
Document type	Meta-Analysis ; Systematic Review ; Journal Article
ZDB-ID	193153-2
ISSN	1872-6623 ; 0304-3959
ISSN (online)	1872-6623
ISSN	0304-3959
DOI	10.1097/j.pain.0000000000003119
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Article ; Online: The emerging role of the BDNF-TrkB signaling pathway in the modulation of pain perception.

Cappoli, Natalia / Tabolacci, Elisabetta / Aceto, Paola / Dello Russo, Cinzia

Journal of neuroimmunology

2020 Volume 349, Page(s) 577406

Abstract: The brain derived neurotrophic factor (BDNF) is a crucial neuromodulator in pain transmission both in peripheral and central nervous system (CNS). Despite evidence of a pro-nociceptive role of BDNF, recent studies have reported contrasting results, ... ...

Abstract	The brain derived neurotrophic factor (BDNF) is a crucial neuromodulator in pain transmission both in peripheral and central nervous system (CNS). Despite evidence of a pro-nociceptive role of BDNF, recent studies have reported contrasting results, including anti-nociceptive and anti-inflammatory activities. Moreover, BDNF polymorphisms can interfere with BDNF role in pain perception. In Val66Met carriers, the Met allele may have a dual role, with anti-nociceptive actions in normal condition and pro-nociceptive effects during chronic pain. In order to elucidate the main effects of BDNF in nociception, we reviewed the main characteristics of this neurotrophin, focusing on its involvement in pain.
MeSH term(s)	Animals ; Biomarkers/metabolism ; Brain-Derived Neurotrophic Factor/biosynthesis ; Brain-Derived Neurotrophic Factor/pharmacology ; Brain-Derived Neurotrophic Factor/therapeutic use ; Humans ; Membrane Glycoproteins/biosynthesis ; Pain Perception/drug effects ; Pain Perception/physiology ; Receptor, trkB/biosynthesis ; Signal Transduction/drug effects ; Signal Transduction/physiology
Chemical Substances	Biomarkers ; Brain-Derived Neurotrophic Factor ; Membrane Glycoproteins ; BDNF protein, human (7171WSG8A2) ; Receptor, trkB (EC 2.7.10.1) ; tropomyosin-related kinase-B, human (EC 2.7.10.1)
Language	English
Publishing date	2020-09-24
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	8335-5
ISSN	1872-8421 ; 0165-5728
ISSN (online)	1872-8421
ISSN	0165-5728
DOI	10.1016/j.jneuroim.2020.577406
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