Fight against cancer in Italy: What patients, caregivers and healthy citizens think about care delivery from National Health System.

OBJECTIVE: This survey aimed to analyse healthy citizens (HC), cancer patients and their caregivers (CP&CG) perception about cancer care among six different Italian regions. METHODS: The survey for HC was conducted by a multinational market research institute (IPSOS) through a computer-assisted web interviewing system, using a dataset of people who had consented to be interviewed for previous studies. CP&CG were interviewed by patient advocates using paper questionnaires. RESULTS: HC completed 1831 questionnaires between May and June 2019; CP&CG filled 1779 questionnaires between May and October 2019. 55% of all interviewees felt they were adequately informed about cancer, with no disparities between regions. Overall, population was satisfied with the National Health Care System (HCS), CP&CG more than HC, probably for their personal positive experience. There were different satisfaction levels between regions regarding components of the pathway of care, but agreement about health workers' 'human component'. Forty-three per cent of the interviewed were informed about genetic tests, 47% about innovative drugs. The percentage was greater among CP&CG (51% and 61% respectively). CONCLUSIONS: Italian people were overall satisfied with HCS although with significant different perceptions between regions. Moreover, some critical issues were highlighted as low adherence at screening invitation and genetic tests. Understanding people's perception regarding HCS is crucial to support health policies and to improve the performance of HCS.

The emotional impact of the COVID-19 outbreak on cancer outpatients and their caregivers: results of a survey conducted in the midst of the Italian pandemic.

INTRODUCTION: The study investigates the emotional discomfort of cancer patients and their caregivers, who need to access the oncology day hospital to receive treatment during the COVID-19 pandemic in Italy. METHODS: This is a single-institution, prospective, cross-sectional study. From May to June 2020, the points of view of both patients and caregivers were compared through 2 different multiple-choice questionnaires, enquiring demographic characteristics, changes in emotional status, interpersonal relationships with health professionals (HCPs) and self-perception of treatment outcomes. RESULTS: Six hundred twenty-five patients and 254 caregivers were enrolled. Females were prevalent and patients were generally older than caregivers. Forty percent of patients and 25.6% of caregivers thought they were at a greater risk of contagion because lived together with a cancer patient or accessed the hospital. Both patients (86.3%) and caregivers (85.4%) considered containment measures a valid support to avoid the spread of infection. People with a lower education level were less worried about being infected with SARS-COV-2. Waiting and performing visits/treatments without caregivers had no impact on the emotional status of patients (64.4%), but generated in caregivers greater anxiety (58.8%) and fear (19.8%) of not properly managing patients at home. The majority of patients (54%) and caregivers (39.4%) thought the pandemic does not influence treatment outcomes. The relationship with HCPs was not negatively impacted for majority of patients and caregivers. CONCLUSIONS: Starting from these data, we can better understand the current psychological distress of patients and their families in order to develop potential strategies to support them in this strenuous period of crisis.

Pegylated liposomal doxorubicin as first line treatment in aids-related Kaposi's sarcoma: a real-life study.

Despite the introduction of effective combination antiretroviral therapy (cART) AIDS-related Kaposi Sarcoma (AIDS-KS) remains the most common malignancy in HIV positive patients. In advanced stage or progressive forms, chemotherapy (CT) in combination with cART is the treatment of choice. The aim of the study is to evaluate efficacy and tolerability of Pegylated Liposomal Doxorubicin (PLD) as first line CT in AIDS-KS. In this single institution retrospective study PLD (20 mg/m2 IV every 2 weeks for 6 or 12 cycles) in combination with cART was administered in poor risk and some cases of good prognosis or limited cutaneous disease. Response rate and adverse events to treatment was evaluated. We enrolled 33 patients with AIDS-KS: median age 44ys, male 90.9%, Caucasian 72.7%, cART-naïve (simultaneous diagnosis of HIV infection and KS) 84.4%, median lymphocyte CD4+ count 134cells, median HIV viral load 4.9 log10 copies/ml. 32 patients were assigned to a Poor Risk KS stage. Grade 3-4 toxicity was reported in 9 patients. No cardiovascular events or severe sepsis were described. Complete response was reported in 25 of 31 patients evaluable for efficacy. After a median follow-up of 52 months the 3-years PFS was 68.6%. PLD associated with cART is an effective, feasible and well tolerated first-line CT in advanced AIDS-KS.

Single nucleotide polymorphisms to predict taxanes toxicities and effectiveness in cancer patients.

Taxanes are used in the treatment of several solid tumours. Adverse events (AEs) might be influenced by single nucleotide polymorphisms (SNPs) in genes encoding proteins responsible for pharmacokinetic and pharmacodynamic. In this prospective, monocentric, observational study we explored the effect of SNPs in the main genes involved in taxanes metabolism and transport, on toxicity and efficacy in 125 patients (pts) treated with paclitaxel, nab-paclitaxel, or docetaxel for neoplasms. There was no statistically significant association between the investigated SNPs and AEs. The heterozygous genotype of CYP3A4*22 showed a trend of association with skin reactions in pts treated with paclitaxel and nab-paclitaxel (RR = 6.92; 95% CI 0.47, 99.8; p = 0.0766). CYP2C8*3/*4 variant carriers showed a trend of association with overall AEs in pts treated with paclitaxel and nab-paclitaxel (RR = 1.28; 95% CI 0.96, 1.67; p = 0.0898). No statistically significant relationship with treatment efficacy was found. ABCB1 3435TT showed a trend of association with a higher treatment response (RR = 0.22; 95% CI 0.03, 1.51; p = 0.0876). Despite the population was heterogeneous, CYP3A4*22 and CYP2C8 SNPs may influence paclitaxel and nab-paclitaxel toxicity and ABCB1 c.3435 may affect taxanes effectiveness, even if any statistically significant was found.

A proposal of a "ready to use" COVID-19 control strategy in an Oncology ward: Utopia or reality?

The Coronavirus Disease-2019 (COVID-19) pandemic is spreading in Italy and Lombardy is one of the most affected region. Cancer patients are higher risk of complication from COVID-19 complications; therefore they should be protected from contagion while still ensuring access to cancer care. The aim of this article is to suggest a strategy to reorganize hospital spaces and Healthcare Professionals (HCPs) staff in order to avoid COVID-19 nosocomial infection in an Oncology ward. SARS-CoV-2 is primarily transmitted through respiratory droplets and by contact. We speculated that precautions against droplet and contact transmission should be the proper way to preserve ward from COVID-19. The essence of our protocol involves: triage outside of the ward, identification of risk zones, traffic control, surveillance of all the involved subjects. Whoever attends the ward must follow the general risk prevention and mitigation measures. The application of this practical strategy can contribute to breaking the cycle of community-hospital-community transmission.

Phase II Study of Paclitaxel and Dasatinib in Metastatic Breast Cancer.

BACKGROUND: Overexpression and activation of tyrosine kinase Src has been linked to breast carcinogenesis and bone metastases. We showed the feasibility of combining the SRC inhibitor dasatinib with weekly paclitaxel in patients with metastatic breast cancer (MBC) and herein report the subsequent phase II trial. PATIENTS AND METHODS: Patients had received ≤ 2 chemotherapy regimens for measurable, HER2-negative MBC. Patients received paclitaxel and dasatinib (120 mg daily) and were assessed according to Response Evaluation Criteria in Solid Tumors for overall response rate (ORR), the primary end point. Secondary end points included progression-free survival (PFS) and overall survival (OS). A 30% ORR (n = 55) was deemed worthy of further investigation. Exploratory biomarkers included N-telopeptide (NTX) and plasma vascular epidermal growth factor (VEGF) receptor 2 as predictors of clinical benefit. RESULTS: From March 2010 to March 2014, 40 patients, including 2 men enrolled. The study was stopped early because of slow accrual. Overall, 32 patients (80%) had estrogen receptor-positive tumors and 23 (58%) had previously received taxanes. Of the 35 assessable patients, 1 (3%) had complete response and 7 (20%) partial response, resulting in an ORR of 23%. The median PFS and OS was 5.2 (95% confidence interval [CI], 2.9-9.9) and 20.6 (95% CI, 12.9-25.2) months, respectively. As expected, fatigue (75%), neuropathy (65%), and diarrhea (50%) were common side effects, but were generally low-grade. Median baseline NTX was similar in patients who had clinical benefit (8.2 nmol BCE) and no clinical benefit (10.9 nmol BCE). Similarly, median baseline VEGF levels were similar between the 2 groups; 93.0 pg/mL versus 83.0 pg/mL. CONCLUSION: This phase II study of dasatinib and paclitaxel was stopped early because of slow accrual but showed some clinical activity. Further study is not planned.

Controversies in clinicopathological characteristics and treatment strategies of male breast cancer: A review of the literature.

Male breast cancer (MaBC) is a rare disease, accounting for less than 1% of malignancies in men. For this reason, literature data on its clinicopathological characteristics are very heterogeneous and treatment strategies have mostly been extrapolated from the female counterpart. However, immunohistochemical peculiarities of MaBC have recently emerged, defining it as a distinct entity from female breast cancer (FBC), thus requiring a tailored clinical approach. MaBC appears to be more often hormone receptor positive than FBC, while data on HER2 status still remain inconclusive, indicating a possible higher incidence of HER2 alterations. Treatment strategies for MaBC have evolved and less invasive local treatments such as lumpectomy and sentinel lymph node biopsy have become part of everyday clinical practice, while there are still controversies on the indication of radiotherapy, especially after mastectomy. Similarly, differences between male and female hormonal status have raised some concerns in the use of aromatase inhibitors in male patients and the choice of best endocrine therapy is still controversial.

Aromatase inhibitors in premenopause: Great expectations fulfilled?

Tamoxifen and GnRH analogues (GnRHa) represent the mainstay of endocrine manipulations in premenopausal women. The estrogen blockade obtained by aromatase inhibitors (AIs) plus GnRHa suppresses circulating estrogens more deeply than tamoxifen plus GnRHa. Retrospective and prospective evidence confirm a substantial activity for AIs and GnRHa in locally advanced and metastatic breast cancer. In early breast cancer inconsistent evidence emerged from 2 large randomized studies with anastrozole performing as tamoxifen in terms of DFS, but significantly worse as of OS while exemestane outperformed tamoxifen as of DFS particularly in very young and high-risk women. These findings support the use of AIs plus GnRHa in advanced breast cancer while long term efficacy and safety data are expected to define the appropriate indication of AIs in early breast cancer. In addition the clinical significance of persistent circulating estrogens and long term effects of estrogen deprivation in young women need further clarification.

Attitudes on fertility issues in breast cancer patients: an Italian survey.

BACKGROUND: Fertility issues should be discussed with young women before the start of any anticancer treatment. The study is aimed to investigate the attitude on fertility among Italian oncologists and breast surgeons dealing with BCa, and to report the consensus achieved on specific statements. METHODS: One hundred and sixty-two panelists anonymously expressed an opinion through a web-based platform on 19 statements based on the Delphi method. RESULTS: Ninety-one percent of oncologists considered important to discuss with patients about fertility issues and 83% believed estrogens could stimulate the growth of hidden cancer cells in ER(+) tumors. Difficulties in accessing fertility preservation procedures were mainly due to patients' reluctance, but also to lack of coordination with the assisted reproduction specialists. No full consensus was reached on the prognostic role of pregnancy after BCa. Fifty-four percent of oncologists declared that pregnancy does not affect oncologic prognosis. Treatment with GnRHa during chemotherapy was considered the only mean for preserving ovarian function. CONCLUSIONS: Fertility preservation in BCa patients is a well-accepted practice among Italian oncologists. A poor knowledge of this specific issue emerged from the survey, even if a certain degree of agreement was observed on most fertility-related issues.

Weekly non-pegylated liposomal doxorubicin chemotherapy in heavily pre-treated patients with metastatic breast cancer.

BACKGROUND: Due to its low cardiac toxicity, non-pegylated liposomal doxorubicin (NPLD) may represent an attractive therapeutic option as salvage therapy for patients with metastatic breast cancer who have already received anthracycline-based chemotherapy. PATIENTS AND METHODS: We retrospectively reviewed 47 consecutive patients with metastatic breast cancer treated with NPLD at our Institution between 2008 and 2012. Patients received weekly NPLD at a dose of 20 mg/m(2) i.v. until disease progression or unacceptable toxicity. RESULTS: Nine patients (19.1%) achieved a partial response and 11 (23.4%) had stable disease, with a disease control rate of 42.6%; 27 patients (57.4%) had progressive disease. The median progression-free survival and overall survival were 2.7 and 11.5 months, respectively. Grade 3 and 4 adverse events did not occur. No cardiac events were observed. CONCLUSION: Weekly NPLD represents a safe and effective therapy and may be considered a new therapeutic option for heavily pre-treated patients with metastatic breast cancer.