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Article ; Online: Bridging gaps in cancer cachexia Care: Current insights and future perspectives.

Bianchini, Carlotta / Bonomo, Pierluigi / Bossi, Paolo / Caccialanza, Riccardo / Fabi, Alessandra

2024 Volume 125, Page(s) 102717

Abstract: Cachexia is characterized by severe weight loss and skeletal muscle depletion, and is a threat to cancer patients by worsening their prognosis. International guidelines set indications for the screening and diagnosis of cancer cachexia and suggest ... ...

Abstract	Cachexia is characterized by severe weight loss and skeletal muscle depletion, and is a threat to cancer patients by worsening their prognosis. International guidelines set indications for the screening and diagnosis of cancer cachexia and suggest interventions (nutritional support, physical exercise, and pharmacological treatments). Nevertheless, real-life experience not always aligns with such indications. We aimed to review the current state of the field and the main advancements, with a focus on real-life clinical practice from the perspectives of oncologists, nutrition professionals, and radiologists. Pragmatic solutions are proposed to improve the current management of the disease, emphasizing the importance of increasing awareness of clinical nutrition's benefits, fostering multidisciplinary collaboration, promoting early identification of at-risk patients, and leveraging available resources. Given the distinct needs of patients who are receiving oncologic anti-cancer treatments and those in the follow-up phase, the use of tailored approaches is encouraged. The pivotal role of healthcare professionals in managing patients in active treatment is highlighted, while patient and caregiver empowerment should be strengthened in the follow-up phase. Telemedicine and web-based applications represent valuable tools for continuous monitoring of patients, facilitating timely and personalized intervention through effective communication between patients and healthcare providers. These actions can potentially improve the outcomes, well-being, and survival of cancer patients with cachexia.
MeSH term(s)	Humans ; Cachexia/diagnosis ; Cachexia/etiology ; Cachexia/therapy ; Neoplasms/complications ; Neoplasms/therapy ; Prognosis
Language	English
Publishing date	2024-03-13
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	125102-8
ISSN	1532-1967 ; 0305-7372
ISSN (online)	1532-1967
ISSN	0305-7372
DOI	10.1016/j.ctrv.2024.102717
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Article ; Online: Lobular Carcinoma of the Breast and Utility of Oncotype Dx®: a Retrospective Decision Impact Analysis.

Barni, Sandro / Fabi, Alessandra / Petrelli, Fausto

Clinical breast cancer

2022 Volume 23, Issue 3, Page(s) e173–e174

Abstract: Purpose: It is still relatively questioned if the benefit of Recurrent Score (RS) extends to invasive lobular carcinoma (ILC), which represents 10-15% of all invasive Breast Cancer (BC). We present the results of the lobular carcinoma subgroup of the ... ...

Abstract	Purpose: It is still relatively questioned if the benefit of Recurrent Score (RS) extends to invasive lobular carcinoma (ILC), which represents 10-15% of all invasive Breast Cancer (BC). We present the results of the lobular carcinoma subgroup of the PONDx Italy study[1]. that collected data on real-life use of the Oncotype DX® test in Italian oncological community clinical practice. Methods: We present the results of the lobular carcinoma subgroup of the PONDx Italy study that collected data on real-life use of the Oncotype DX® test in Italian oncological community clinical practice. The study primarily evaluated the impact of the Oncotype DX assay results on physicians' treatment decisions. In the primary analysis, data from 1724 BC patients who underwent Oncotype DX testing were available from 27 reference centers located in 6 regions of Italy (Lombardia, Lazio, Emilia Romagna, Campania, Abruzzo, and Marche). Results: Among patients with data available, 214 had ILC. In this cohort, 100 (47%) of patients with ILC had treatment recommendations for CT + HT before the availability of their RS result. After the availability of the RS result, recommendations for CT+HT decreased to 47 cases (22%). Conclusion: the decision to opt for the Oncotype Dx test should not be based on the histology subgroup only because a small population of ER+ ILC BC patients may still attain important information from testing. Despite this information, its predictive value needs more dedicated trials to be confirmed.
MeSH term(s)	Humans ; Female ; Carcinoma, Lobular/genetics ; Carcinoma, Lobular/therapy ; Carcinoma, Lobular/pathology ; Breast Neoplasms/diagnosis ; Breast Neoplasms/genetics ; Breast Neoplasms/therapy ; Retrospective Studies ; Neoplasm Recurrence, Local/diagnosis ; Neoplasm Recurrence, Local/genetics ; Neoplasm Recurrence, Local/pathology ; Gene Expression Profiling/methods
Language	English
Publishing date	2022-12-14
Publishing country	United States
Document type	Editorial
ZDB-ID	2106734-X
ISSN	1938-0666 ; 1526-8209
ISSN (online)	1938-0666
ISSN	1526-8209
DOI	10.1016/j.clbc.2022.12.005
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Article ; Online: Molecular Profile and Matched Targeted Therapy for Advanced Breast Cancer Patients.

Falcone, Rosa / Lombardi, Pasquale / Filetti, Marco / Fabi, Alessandra / Altamura, Valeria / Scambia, Giovanni / Daniele, Gennaro

Current oncology (Toronto, Ont.)

2023 Volume 30, Issue 2, Page(s) 2501–2509

Abstract: 1) Background: Precision oncology is opening new treatment opportunities for patients suffering from solid tumors. In the last two decades, the advent of CDK4/6 inhibitors, immunotherapy, and antibody-drug conjugates (ADC) improved survival outcomes for ...

Abstract	(1) Background: Precision oncology is opening new treatment opportunities for patients suffering from solid tumors. In the last two decades, the advent of CDK4/6 inhibitors, immunotherapy, and antibody-drug conjugates (ADC) improved survival outcomes for advanced or metastatic breast cancers (BC). Nevertheless, some patients progress to approved therapies and still maintain good clinical conditions. (2) Methods: With the aim to estimate the accrual rate to experimental precision oncology treatments, we collected molecular and clinical characteristics of BC patients evaluated at Phase 1 Unit of Fondazione Policlinico Gemelli. Clinical data were retrieved from hospital records. Molecular analysis was performed using Next-Generation Sequencing (NGS) FoundationOne CDx on tissue or blood. (3) Results: Among the 38 BC patients referred to our unit, 35 completed the genomic analysis. All patients were female with advanced (mean number of metastatic sites: 3, range 1-6) BC. Median age at our evaluation was 52 (IQR, 48-59). ECOG PS was good in 97% of the study population, although heavily pre-treated (median number of systemic treatments: 5, IQR 3-7). Half of referred patients were HR
MeSH term(s)	Humans ; Female ; Male ; Triple Negative Breast Neoplasms/genetics ; Precision Medicine ; Mutation ; Genomics ; Molecular Targeted Therapy
Language	English
Publishing date	2023-02-18
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	1236972-x
ISSN	1718-7729 ; 1198-0052
ISSN (online)	1718-7729
ISSN	1198-0052
DOI	10.3390/curroncol30020191
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Article ; Online: Gli analoghi LHRH: l’attuale ruolo nel trattamento del carcinoma mammario nella fase di malattia precoce e avanzata.

Fabi, Alessandra / Catania, Giovanna

Recenti progressi in medicina

2019 Volume 110, Issue 7, Page(s) 347–355

Abstract: LHRH analogues (LHRHa) are used in the treatment of breast cancer that occurs in young women. Amenorrhoea induced by chemotherapy correlates with a reduced risk of recurrence disease. In premenopausal women, analogous LHRHs are used to suppress ovarian ... ...

Title translation	LHRH analogs: current role in early and advanced breast cancer treatment of premenopausal patients.
Abstract	LHRH analogues (LHRHa) are used in the treatment of breast cancer that occurs in young women. Amenorrhoea induced by chemotherapy correlates with a reduced risk of recurrence disease. In premenopausal women, analogous LHRHs are used to suppress ovarian estrogen production, raising estrogen hormone levels to post-menopausal values and improving patient outcomes. Two large clinical studies have investigated the role of complete estrogen blockage in adjuvant hormonal treatment of premenopausal patients. Both studies showed the clinical benefit of ovarian suppression treatment, mainly associated with non-steroidal aromatase inhibitor exemestane in high-risk patients. In the recent years, hormonal treatments made available in clinical practice have considerably prolonged the median survival of patients suffering from endocrine-responsive metastatic breast cancer. Even in the premenopausal setting, CDK4/6 inhibitors in association with endocrine therapy have shown a marked improvement in patient outcomes. The safety and efficacy of this new class of drugs demonstrated in the MONALEESA-7 study in premenopausal women and in the premenopausal subgroups of the PALOMA-3 and MONARCH 2 studies support the use of hormone therapy and analogous LHRH combined with CDK 4/6 inhibitor in patients in premenopausal. Finally, LHRH analogues have been extensively studied in strategies for maintaining ovarian function and fertility preservation during adjuvant chemotherapy in younger patients.
MeSH term(s)	Antineoplastic Agents, Hormonal/administration & dosage ; Antineoplastic Agents, Hormonal/adverse effects ; Antineoplastic Agents, Hormonal/pharmacology ; Aromatase Inhibitors/administration & dosage ; Aromatase Inhibitors/adverse effects ; Aromatase Inhibitors/pharmacology ; Breast Neoplasms/drug therapy ; Breast Neoplasms/pathology ; Chemotherapy, Adjuvant/methods ; Female ; Fertility Preservation ; Gonadotropin-Releasing Hormone/analogs & derivatives ; Humans ; Premenopause
Chemical Substances	Antineoplastic Agents, Hormonal ; Aromatase Inhibitors ; Gonadotropin-Releasing Hormone (33515-09-2)
Language	Italian
Publishing date	2019-08-04
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	138266-4
ISSN	2038-1840 ; 0034-1193
ISSN (online)	2038-1840
ISSN	0034-1193
DOI	10.1701/3197.31747
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Article: Impact of epilepsy and its treatment on brain metastasis from solid tumors: A retrospective study.

Maschio, Marta / Maialetti, Andrea / Giannarelli, Diana / Koudriavtseva, Tatiana / Galiè, Edvina / Fabi, Alessandra

Frontiers in neurology

2022 Volume 13, Page(s) 967946

Abstract: Introduction: Retrospective observational study on medical records of patients with epilepsy related brain metastases (BM) to evaluate efficacy, safety and possible interaction with cancer treatment of different anti-seizure medications (ASMs) and the ... ...

Abstract	Introduction: Retrospective observational study on medical records of patients with epilepsy related brain metastases (BM) to evaluate efficacy, safety and possible interaction with cancer treatment of different anti-seizure medications (ASMs) and the risk of seizures. Materials and methods: We consecutively reviewed all medical records of epilepsy-related BM patients from 2010 to 2020 who were followed for at least one month at the Brain Tumour-related Epilepsy Center of the IRCCS Regina Elena National Cancer Institute Rome, Italy. Results: We selected 111 cancer patients. Of these, only 42 had at least undergone a second neurological examination. In the whole population, 95 (85.2%) had seizures and 16 patients had no seizures (14.4%). The most frequently first ASM prescribed was LEV (40.5%). We observed a significant correlation between tumor site and probability of having seizures, but not between seizure type and age (>65 or <65 years). Among 42 patients, 26 were administered levetiracetam, followed by oxcarbazepine. Until the last follow-up, 19 never changed the first ASM, maintained the same dosage and remained seizure free. After a median of 7 months, 16 (38.1%) required changes in therapeutic treatment due to inefficacy. At the last follow-up, 24 patients (57.1%) were seizure free. Eighteen patients (42.8%) never achieved freedom from seizures despite had at least 2 therapy changes. Two patients changed ASM due to adverse events and 1 to phenobarbital owing to the interaction with cancer treatment. The mean daily dose of first ASM in all 42 patients was very close to the Defined Daily Dose (DDD). Conclusion: In BM patients seizure incidence could be underestimated; a team evaluation performed by oncologist and neurologist together, could guarantee an accurate taking care of both oncological illness and epilepsy, in this fragile patient population. More than 50% of our patients respond to monotherapy with new generation ASMs. Furthermore we deemed in patients receiving chemotherapy the choice of ASM should consider possible interactions with antitumor therapies, for this reason newer generation ASMs should be the preferred choice. It is necessary to get close to the DDD before considering an ASM ineffective in seizure control.
Language	English
Publishing date	2022-10-21
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2564214-5
ISSN	1664-2295
ISSN	1664-2295
DOI	10.3389/fneur.2022.967946
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Article: Ribociclib Plus Letrozole in Italian Male Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Case Studies of Phase 3b CompLEEment-1 Trial.

Caputo, Roberta / Fabi, Alessandra / Romagnoli, Emanuela / Baldini, Editta / Grasso, Donatella / Fenderico, Nicola / Michelotti, Andrea

Breast cancer (Dove Medical Press)

2022 Volume 14, Page(s) 351–362

Abstract: Abstract: Male breast cancer (BC) is rare, globally constituting only 0.5-1% of all patients with BC. In Italy, more than 2000 new male BC cases were registered between 2000 and 2014. The survival rate was lower in males than in females. Delayed ... ...

Abstract	Abstract: Male breast cancer (BC) is rare, globally constituting only 0.5-1% of all patients with BC. In Italy, more than 2000 new male BC cases were registered between 2000 and 2014. The survival rate was lower in males than in females. Delayed diagnosis may be the reason for poorer outcome observed in male BC patients compared with female patients. Due to lack of substantial evidence and low availability of published data on male BC, the current treatment recommendations are based on evidence derived from trials on female patients. In Italy, most of the male BC patients are estrogen and progesterone receptor-positive. Targeted therapy in combination with endocrine therapy provides a clinically meaningful outcome in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) advanced BC. CompLEEment-1 is a single-arm, open-label, multicenter, phase 3b trial investigating the safety and efficacy of a CDK4/6 inhibitor, ribociclib, in combination with letrozole in men and women. Herein, we report the results from a retrospective analysis of five Italian male patients who completed the core phase. In this case series, the combination of ribociclib and letrozole was well tolerated and appeared to be effective in the male cohort with HR-positive, HER2-negative advanced BC in Italy. CompLEEment-1 trial representative of a real-world setting would add value by supporting the existing efficacy and safety profile of ribociclib in combination with letrozole in male patients with HR-positive, HER2-negative advanced BC. Clinicaltrialsgov registration number: NCT02941926.
Language	English
Publishing date	2022-10-18
Publishing country	New Zealand
Document type	Case Reports
ZDB-ID	2520722-2
ISSN	1179-1314
ISSN	1179-1314
DOI	10.2147/BCTT.S376902
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Article ; Online: The likelihood of being helped or harmed as a patient-centred tool to assess cyclin dependent kinase 4/6 inhibitors clinical impact and safety in metastatic breast cancer: a systematic review and sensitivity-analysis.

Mastrantoni, Luca / Orlandi, Armando / Palazzo, Antonella / Garufi, Giovanna / Fabi, Alessandra / Daniele, Gennaro / Giannarelli, Diana / Tortora, Giampaolo / Bria, Emilio

EClinicalMedicine

2023 Volume 56, Page(s) 101824

Abstract: Background: In hormone-receptor positive/HER2-negative metastatic breast cancer (mBC) no randomized comparisons are available between CDK4/6 inhibitors. We undertook this systematic review and meta-analysis to assess the reliability of the likelihood of ...

Abstract	Background: In hormone-receptor positive/HER2-negative metastatic breast cancer (mBC) no randomized comparisons are available between CDK4/6 inhibitors. We undertook this systematic review and meta-analysis to assess the reliability of the likelihood of being helped or harmed (LHH). Methods: PubMed, CENTRAL, Embase and oncological meetings websites were searched to September 13th, 2022. We included phase III randomized controlled trials (RCTs) investigating palbociclib, ribociclib and abemaciclib in addition to endocrine therapy (ET) compared to placebo in hormone-receptor positive/HER2-negative advanced or mBC. Outcomes were progression-free survival (PFS), overall survival (OS), adverse events (AEs), dose reductions and discontinuations. Hazard ratios (HRs) and risk differences were computed with a random effect model to estimate the number needed to treat/harm (NNT/NNH). LHH was computed as (1/NNT)/(1/NNH). PROSPERO registration number: CRD42022362417. Findings: 2204 records were screened and seven RCTs (4415 patients) were included. A significant PFS benefit was observed in patients treated with a CDK4/6 inhibitor compared to placebo (HR 0.549; 0.508-0.594, Interpretation: Palbociclib and ribociclib showed lower LHHs for haematological toxicities and abemaciclib for diarrhea. Palbociclib confirmed to be a manageable drug. The LHH appears to be a reliable synthesis tool for balancing risks and benefits of experimental drugs when head-to-head comparisons are missing. Funding: None.
Language	English
Publishing date	2023-01-20
Publishing country	England
Document type	Journal Article
ISSN	2589-5370
ISSN (online)	2589-5370
DOI	10.1016/j.eclinm.2023.101824
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Article: Unusual phylogenetic tree and circulating actionable ESR1 mutations in an aggressive luminal/HER2-low breast cancer: Case report.

Allegretti, Matteo / Barberi, Vittoria / Ercolani, Cristiana / Vidiri, Antonello / Giordani, Elena / Ciliberto, Gennaro / Giacomini, Patrizio / Fabi, Alessandra

Frontiers in oncology

2023 Volume 12, Page(s) 1050452

Abstract: Under therapeutic pressure aggressive tumors evolve rapidly. Herein, a luminal B/HER2-low breast cancer was tracked for >3 years during a total of 6 largely unsuccessful therapy lines, from adjuvant to advanced settings. Targeted next generation ... ...

Abstract	Under therapeutic pressure aggressive tumors evolve rapidly. Herein, a luminal B/HER2-low breast cancer was tracked for >3 years during a total of 6 largely unsuccessful therapy lines, from adjuvant to advanced settings. Targeted next generation sequencing (NGS) of the primary lesion, two metastases and 14 blood drawings suggested a striking, unprecedented coexistence of three evolution modes: punctuated, branched and convergent. Punctuated evolution of the trunk was supported by
Language	English
Publishing date	2023-01-11
Publishing country	Switzerland
Document type	Case Reports
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2022.1050452
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Article: Defining the endpoints: how to measure the efficacy of drugs that are active against central nervous system metastases.

Fabi, Alessandra / Vidiri, Antonello

Translational lung cancer research

2017 Volume 5, Issue 6, Page(s) 637–646

Abstract: Brain metastases (BMs) are the most common cause of malignant central nervous system (CNS) tumors in adults. In the recent past, patients with BMs were excluded from clinical trials, but now, with the advent of new biological and immunological drugs, ... ...

Abstract	Brain metastases (BMs) are the most common cause of malignant central nervous system (CNS) tumors in adults. In the recent past, patients with BMs were excluded from clinical trials, but now, with the advent of new biological and immunological drugs, their inclusion is more common. In the last era response and progression criteria used across clinical trials have defined the importance to consider not only measurement changes of brain lesions but also the modification of parameters related to the metastases such as metabolism of tissue and its pathological features. Magnetic resonance imaging (MRI) represents the first choice in the evaluation of BMs; the computed tomography (CT) scan will be made only in case of MRI's contraindication. CT, MRI and positron emission tomography (PET-CT), may be used to monitor response to treatment as part of clinical and radiological follow up. In the evaluation of response to treatment, MRI shows superior accuracy in comparison to CT; PET-CT is useful in particularly in cases of BMs underwent to locoregional therapies in the differential diagnosis between recurrence or radionecrosis. Now is possible to use functional imaging as CT-perfusion, dynamic susceptibility contrast (DSC) MR imaging, dynamic contrast-enhanced (DCE) MR imaging, diffusion-weighted MR imaging and MR-Spectroscopy in the evaluation of treatment response; these imaging techniques can provide qualitative and quantitative imaging parameters that allow pathophysiologic correlation. In the evaluation of the response to immunotherapy treatments, the immune-related response criteria (irRC) are considered as the gold standard. The irRC utilizes bidimensional measurements, quantifying the tumor dimension using a product of the longest diameter and the longest perpendicular diameter. We analyze clinical and radiological criteria to better define outcome of drugs for BMs from solid tumors in the new era of biological and immunological therapies.
Language	English
Publishing date	2017-01-28
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	10.21037/tlcr.2016.11.02
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Article: Economic Evaluation for Palbociclib Plus Fulvestrant vs Ribociclib Plus Fulvestrant and Abemaciclib Plus Fulvestrant in Endocrine-Resistant Advanced or Metastatic Breast Cancer in Italy.

Colombo, Giorgio Lorenzo / Valentino, Maria Chiara / Fabi, Alessandra / Dieci, Maria Vittoria / Caruggi, Mauro / Bruno, Giacomo Matteo / Lombardi, Gloria / Di Matteo, Sergio

Therapeutics and clinical risk management

2023 Volume 19, Page(s) 301–312

Abstract: Background: To date, no study evaluated the cost-effectiveness of palbociclib (PAL) plus fulvestrant (FUL) vs ribociclib (RIB) plus FUL and abemaciclib (ABM) plus FUL in Italy. Cost-effectiveness analysis comparing the three cyclin-dependent 4/6 kinase ... ...

Abstract	Background: To date, no study evaluated the cost-effectiveness of palbociclib (PAL) plus fulvestrant (FUL) vs ribociclib (RIB) plus FUL and abemaciclib (ABM) plus FUL in Italy. Cost-effectiveness analysis comparing the three cyclin-dependent 4/6 kinase inhibitors in combination with endocrine therapies for the management of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer in Italy was developed. Material and methods: To assess the cost-effectiveness of PAL plus FUL vs RIB plus FUL and ABM plus FUL, a cost-minimization has been carried out with a conservative scenario considering three CDK4/6 inhibitors with equal effectiveness in terms of overall survival (OS) (MAIC, Rugo et al 2021). Adverse events (AEs) associated with all therapies were obtained from clinical trials. Ad-hoc analysis was performed to estimate the cost-effectiveness considering the quality-of-life (QoL) data (Lloyd et al 2006). Results: Cost-minimization inputs were drugs, visits and exams, AE monitoring and best supportive care (BSC) before the progression state, active and BSC in the progression and terminal phase of the last two weeks of life. Given the comparability of PAL, RIB and ABM in terms of efficacy, this analysis demonstrated slight economic savings over a lifetime for PAL. Results showed saving per patient of €305 (lifetime) when PAL is compared with RIB; for PAL vs ABM a saving of €243 (lifetime) in a conservative scenario. Results of a budget impact analysis showed a potential savings of €319,563 for PAL vs RIB and €297,544 for PAL vs ABM. When QoL data were considered, results may favor PAL due to the lower impact of AE with savings and improvement in the QoL related to fewer AE. Conclusion: From the Italian perspective, a cost-saving profile associated with the use of PAL+FUL for the management of advanced/metastatic HR+/HER2- breast cancer compared to RIB+FUL and ABM+FUL emerged.
Language	English
Publishing date	2023-03-28
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2186560-7
ISSN	1178-203X ; 1176-6336
ISSN (online)	1178-203X
ISSN	1176-6336
DOI	10.2147/TCRM.S391769
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