Publications by authors named "Filippo Merloni"

7 Publications

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Cancer patient perspective in the arena of COVID-19 pandemic.

Psychooncology 2021 Jul 27. Epub 2021 Jul 27.

Clinical Oncology, Università Politecnica delle Marche, AOU Ospedali Riuniti di Ancona, Ancona, Italy.

Objective: The coronavirus disease 2019 (COVID-19) outbreak has been declared a global pandemic of unprecedented proportions. Italy is a country which has been heavily affected. Cancer patients are at a higher risk owing to their intrinsic fragility related to their underlying disease and oncologic treatment. Against this backdrop, we conducted a survey to investigate how patients perceived their condition, clinical management and availability of information during the pandemic.

Methods: Between 15 April and 1 May 2020 a survey was submitted to cancer patients at oncology departments in the Marche region. Questions regarding the perception of personal safety, continuity of cancer care, information quality and psychological distress.

Results: Seven hundred patients participated in the survey; 59% were female and 40% were aged between 46 and 65. The majority of the participants perceived compliance with appropriate safety standards by cancer care providers and 80% were reassured about their concerns during the medical interview. 40% were worried of being at a higher risk of infection and 71% felt they were at a greater risk because of chemotherapy. 55% felt that postponing cancer treatment could reduce its efficacy, however 76% declared they did not feel abandoned at the time of treatment postponement. Patients between 46 and 65 years declared a significant reduction in sleep (p < 0.01) and in concentration (p = 0.03).

Conclusions: The emergency care offered to cancer patients has been deemed satisfactory in terms of both safety standards and care management. However, the majority of participants perceived the mutual negative influence between their oncologic disease and the risk of infection highlighting the need for special measures to ensure safe continuity of care.
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http://dx.doi.org/10.1002/pon.5774DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8420223PMC
July 2021

Prognostic Impact of Ki-67 Change in Locally Advanced and Early Breast Cancer after Neoadjuvant Chemotherapy: A Single Institution Experience.

J Oncol 2021 4;2021:5548252. Epub 2021 May 4.

Clinica Oncologica e Centro Regionale di Genetica Oncologica, Università Politecnica delle Marche, AOU Ospedali Riuniti, Ancona (AN) 60126, Marche, Italy.

Systemic neoadjuvant chemotherapy (NCT) is a standard treatment for locally advanced breast cancer (LABC) and for selected early breast cancer (EBC). In these settings, the prognostic and predictive role of Ki-67 before and after NCT is unclear. The aim of our study was to investigate the prognostic role of Ki-67 change in patients not achieving pathological complete response (pCR). We retrospectively analyzed data of patients who did not achieve pCR assessing Ki-67 expression pre- and post-NCT. We stratified three groups: high reduction (>20%), low reduction (1-20%), and no reduction in Ki-67. These groups were correlated with clinical and pathological data by 2 test. We estimated disease-free survival (DFS) and overall survival (OS) using Kaplan-Meier method, and we adopted univariate and multivariate Cox proportional hazard models. We selected 82 patients from a database of 143 patients, excluding those who were metastatic at diagnosis, achieved pCR, or lack data regarding Ki-67. Median age at diagnosis was 54 years (range 30-75); 51 patients were Luminal B, 10 human epidermal growth factor receptor 2 (HER-2) enriched, and 21 triple negative. A significant correlation between high Ki-67 reduction and luminal B HER-2-negative subtype was observed ( = 0,0035). The change in Ki-67 was significantly associated with DFS ( = 0,0596) and OS ( = 0,0120), also at multivariate analysis ( = 0,0256 for DFS; = 0,0093 for OS). In particular, as compared to patients with low/no reduction of Ki-67, those with high Ki-67 reduction (>20%) after NCT showed better survival (60% vs. 56% vs. 83% after 5 years from diagnosis, respectively; = 0.01). In conclusion, in our study, Ki-67 change showed a significant prognostic role in breast cancer patients treated with NCT who did not achieve pCR. Crucially, Ki-67 < 20% identifies a high-risk population that may be eligible for clinical trials with novel therapeutic interventions in adjuvant setting.
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http://dx.doi.org/10.1155/2021/5548252DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8112947PMC
May 2021

Scientia Potentia Est: How the Italian World of Oncology Changes in the COVID-19 Pandemic.

JCO Glob Oncol 2020 07;6:1017-1023

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Umberto I G M Lancisi G Salesi, Ancona, Italy.

Purpose: After coronavirus disease 2019 (COVID-19) was declared a pandemic by the WHO, a response from the Italian Health System to react to an unprecedented condition became necessary and sudden. The COVID-19 pandemic has required oncologists to redefine clinical organization and patient management. The purpose of our study was to document the difficulties emerging during the SARS-CoV-2 pandemic in Italian oncology.

Methods: We broadcasted an electronic survey to oncologic health care professionals. It consisted of 45 questions ranging from individual perception of pandemic management by hospital centers to physicians' and nurses' psychological distress and patient care.

Results: A total of 383 oncology health workers participated in the survey. The majority were female (71.8%) and from central Italy (46.2%). Impressively, a total of 357 (93%) participants declared the oncologic department reorganized routine clinical activity, but only 40.5% were adequately trained about the required procedures; 20% of the survey respondents think they have not received adequate and timely protective devices.

Conclusion: Our survey demonstrated the flexibility of oncologic teams. However, the emergency response quality has been heterogeneous, and several drawbacks have emerged from the first analyses investigating how the world of oncology changes in the COVID-19 pandemic. Information, protection, testing, and training of health care professionals are key words that should be kept in mind to encourage recovery after this tragedy and to be ready to face a similar emergency in the future.
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http://dx.doi.org/10.1200/GO.20.00209DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392780PMC
July 2020

Evaluation of Second-line Anti-VEGF after First-line Anti-EGFR Based Therapy in RAS Wild-Type Metastatic Colorectal Cancer: The Multicenter "SLAVE" Study.

Cancers (Basel) 2020 May 16;12(5). Epub 2020 May 16.

Medical Oncology, Policlinico Umberto I, 00161 Rome, Italy.

Background: The optimal anti-angiogenic strategy as second-line treatment in wild-type metastatic colorectal cancer (mCRC) treated with anti-EGFR (Epidermal Growth Factor Receptor) based first-line treatment is still debated.

Methods: This multicenter, real-world, retrospective study is aimed at evaluating the effectiveness of second-line Bevacizumab- and Aflibercept-based treatments after an anti-EGFR based first-line regimen. Clinical outcomes measured were: objective response rate (ORR), progression free survival (PFS), overall survival (OS) and adverse events (AEs) profiles.

Results: From February 2011 to October 2019, 277 consecutive mCRC patients received Bevacizumab-based (228, 82.3%) or Aflibercept-based (49, 17.7%) regimen. No significant difference was found regarding ORR. The median follow-up was 27.7 months (95%CI: 24.7-34.4). Aflibercept-treated group had a significantly shorter PFS compared to Bevacizumab-treated group (5.6 vs. 7.1 months, respectively) (HR = 1.34 (95%CI: 0.95-1.89); = 0.0932). The median OS of the Bevacizumab-treated group and Aflibercept-treated group was 16.2 (95%CI: 15.3-18.1) and 12.7 (95%CI: 8.8-17.5) months, respectively (HR= 1.31 (95%CI: 0.89-1.93) = 0.16). After adjusting for the key covariates (age, gender, performance status, number of metastatic sites and primary tumor side) Bevacizumab-based regimens revealed to be significantly related with a prolonged PFS (HR = 1.44 (95%CI: 1.02-2.03); = 0.0399) compared to Aflibercept-based regimens, but not with a prolonged OS (HR = 1.47 (95%CI: 0.99-2.17); = 0.0503). The incidence of G3/G4 VEGF inhibitors class-specific AEs was 7.5% and 26.5% in the Bevacizumab-treated group and the Aflibercept-treated group, respectively ( = 0.0001).

Conclusion: Our analysis seems to reveal that Bevacizumab-based regimens have a slightly better PFS and class-specific AEs profile compared to Aflibercept-based regimen as second-line treatment of wild-type mCRC patients previously treated with anti-EGFR based treatments. These results have to be taken with caution and no conclusive considerations are allowed.
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http://dx.doi.org/10.3390/cancers12051259DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7281759PMC
May 2020

Electrolyte disorders in advanced non-small cell lung cancer patients treated with immune check-point inhibitors: A systematic review and meta-analysis.

Crit Rev Oncol Hematol 2020 Jul 4;151:102974. Epub 2020 May 4.

Clinical Oncology, Polytechnic University of Marche, AOU Ospedali Riuniti, Via Conca 71, 60126, Ancona, Italy. Electronic address:

Background: Aim of this meta-analysis was to determine the relative risk (RR) of electrolyte disorders (EDs) in advanced non-small cell lung cancer (aNSCLC) patients treated with immune check-point inhibitors (ICIs).

Methods: We searched for phase II/III randomized controlled trials (RCTs) comparing ICIs (alone or combined with chemotherapy) with standard chemotherapy in aNSCLC. Summary incidence and RR were calculated.

Results: Six RCTs with data on all-grade hyponatremia were identified (n = 3257). The incidence was 8.7 % in the study group and 4.9 % in the control group (RR 1.78, 95 %CI 1.12-2.80). Looking at all-grade hypokalemia, 7 RCTs were included (n = 4119). Incidence was 10.4 % in ICIs-treated patients and 5.9 % in the control arms (RR 1.62, 95 % CI 1.30-2.02).

Conclusions: Treatment with ICIs in aNSCLC is associated with a significant increased risk of hyponatremia and hypokalemia compared to chemotherapy. Monitoring of electrolyte levels should be emphasized in this setting.
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http://dx.doi.org/10.1016/j.critrevonc.2020.102974DOI Listing
July 2020

Body Mass Index and Hormone Receptor Status Influence Recurrence Risk in HER2-Positive Early Breast Cancer Patients.

Clin Breast Cancer 2020 02 11;20(1):e89-e98. Epub 2019 Jul 11.

Clinica Oncologica, Università Politecnica delle Marche, AOU Ospedali Riuniti, Ancona, Italy. Electronic address:

Introduction: A reliable risk stratification on the basis of tumor biology and host factors of HER2-positive (HER2) early breast cancer (eBC) patients is needed. The aim of our study was to assess the prognostic role of body mass index (BMI) and hormone receptor (HR) expression in this setting.

Patients And Methods: We retrospectively evaluated 238 women with stage I to III HER2 breast cancer who completed adjuvant chemotherapy (CHT) and 1 year of treatment with trastuzumab. The end point was 3-year distant disease-free survival (3yDDFS). Survival analysis was evaluated using the Kaplan-Meier method. Multivariate analysis was performed using Cox proportional-hazards model adjusting for HR status, BMI, tumor staging, size, nodal status, and type of adjuvant CHT. Association among categorical variables was assessed using χ test.

Results: The early recurrence rate after 3 years resulted as 4.2% (40% HR patients and 60% HR patients). Neither HR status nor BMI alone showed an association with 3yDDFS in multivariate analysis. However, the hazard ratios for patients with HR tumors who had also BMI ≥25 (3yDDFS 86.9%; 95% confidence interval [CI], 75.0%-97.7%) were amplified compared with patients with HR tumors and with BMI <25 (3yDDFS 98%; 95% CI, 94.8%-100.0%) and other subgroups (P = .003). This observation was confirmed in multivariate analysis (hazard ratio, 1.79; 95% CI, 1.04-3.07; P = .03).

Conclusion: Our real-life data highlight a different risk of eBC recurrence after grouping patients according to HR status and BMI. These results might help clinicians to identify correct treatment strategies. Patients who are HR and have BMI ≥25 might benefit from escalation approaches, whereas those who are HR and have BMI <25 might be eligible for a shorter duration of adjuvant treatment with anti-HER2 agents.
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http://dx.doi.org/10.1016/j.clbc.2019.06.008DOI Listing
February 2020

Long-responders to anti-HER2 therapies: A case report and review of the literature.

Mol Clin Oncol 2018 Jan 8;8(1):147-152. Epub 2017 Nov 8.

Medical Oncology, Marche Polytechnic University, University Hospital Ospedali Riuniti Ancona, I-60126 Ancona, Italy.

Since the introduction of targeted therapies, prognosis in human epidermal growth factor receptor (HER) 2-positive metastatic breast cancer (MBC) has radically changed. The addition of Pertuzumab to Trastuzumab and standard chemotherapy has further increased patients' overall survival (OS). However, there is no agreement regarding the optimal duration of trastuzumab therapy in selected patients achieving long-term complete remission. In addition, no potential factors of long-term benefit have been identified yet. In the present study, we report the case of a MBC woman who was successfully treated with trastuzumab for over 10 years. At the time of diagnosis (February 2005), she revealed lung, nodal and bone metastases. Therefore, a first-line chemotherapy with Epirubicine and Docetaxel was administered for 6 cycles and then the patient started Trastuzumab plus hormonal therapy until reaching a sensible reduction of mammary lump and disappearance of distant metastases. Following a multidisciplinary evaluation, in November 2006, the patient underwent radical mastectomy and axillary dissection, achieving a complete remission. She continued Trastuzumab until September 2015 (for a total of 156 cycles) when a pleural diffusion was demonstrated. Long-term survival during anti-HER2 treatment remains a rare and optimal situation. Currently, no data exist to support trastuzumab interruption in this setting and collaborative efforts to better analyze the characteristics of long-responder patients are needed. Data regarding prognostic factors in this setting are relatively confusing. Our review reveals that hormonal receptor (HR)-positive disease is associated with a better prognosis, whereas the role of visceral spread differs by single or dual target anti HER2-inhibition. The introduction of Pertuzumab is raising concerns in terms of toxicity and its cost effectiveness. While waiting for novel molecular data and randomized trials, available evidence advocates continuous use of anti-HER2 therapies until disease progression or development of side effects.
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http://dx.doi.org/10.3892/mco.2017.1495DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5769304PMC
January 2018
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