Randomized trial of sucrosomial iron supplementation in patients with chemotherapy-related anemia treated with ESA.

BACKGROUND: Iron supplementation improves the erythropoiesis-stimulating agents' (ESAs) response in chemotherapy-related anemia. The primary aim of our study is to assess the efficacy of sucrosomial iron, a new oral iron formulation, in cancer patients with chemotherapy-induced anemia treated with ESAs. The secondary objectives included the efficacy into two subgroups of patients (iron replete and functional iron deficiency) between the two study arms, safety and the effect on transfusion need. METHODS: In this randomized, multicentre, open-label, phase III clinical trial, 60 cancer patients were enrolled. Each patient was randomly assigned (1:1) to receive 12 weeks of oral sucrosomial iron at the dose of 30 mg daily in combination with ESAs or no supplementation to ESA treatment. The endpoint considered for efficacy was the proportion of patients achieving complete hematological response at 12 weeks (increase in Hb > 2 g/dL from baseline, without RBC transfusions in the previous 28 days or achieving Hb ≥ 12 g/dL). RESULTS: There was a statistically significant association between oral sucrosomial iron supplementation in combination with ESAs and the achievement of a complete hematological response. This response was achieved within 12 weeks by 31% of patients in the control group and by 52% of patients supplemented with oral sucrosomial iron. A trend of greater response in sucrosomial iron arm was found in both subgroups. No difference was observed about safety and transfusion need. CONCLUSIONS: Sucrosomial iron is well tolerated and its combination with ESAs improves the hematological response in cancer patients with chemotherapy-related anemia. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: This study has been reviewed by the Institutional Ethics Committee of the IRCCS Policlinico San Matteo Foundation, Pavia, Italy (28/04/2015; prot. N. 20,150,002,059), and by the Institutional Ethics Committee of the other Italian oncological centers involved in this study.

Correction to: Which elderly newly diagnosed glioblastoma patients can benefit from radiotherapy and temozolomide? A PERNO prospective study.

The members of the PERNO Study Group were not individually captured in the metadata of the original publication. They are included in the metadata of this publication.

Can early palliative care with anticancer treatment improve overall survival and patient-related outcomes in advanced lung cancer patients? A review of the literature.

PURPOSE: Metastatic non-small-cell lung cancer (NSCLC), the leading cause of death from cancer worldwide, is a debilitating disease that results in a high burden of symptoms and poor quality of life; the estimated prognosis after the diagnosis has been established was less than 1 year until some years ago. At the present, the new targeted therapies and immunotherapy are changing the course of the disease. However, advanced NSCLC remains an incurable disease, with a poor prognosis for the majority of the affected patients, so that quality of life and relief from symptoms are primary objectives of treatment. Some evidences suggest that early palliative care (EPC) for these patients can improve quality of life and even survival. DESIGN: A systematic review of the studies evaluating the impact on objective and on patient-reported outcomes of the introduction of EPC in opposition to standard care (SC), for advanced lung cancer patients, was performed. Because of the small number of studies conducted in this area, retrospective studies were also considered for the review. RESULTS: Five studies were included because they matched the inclusion criteria previously defined as relevant for the study. The review found that both survival and quality of life were better for patients included in EPC groups. CONCLUSIONS: While results of the studies included in this review are not always comparable because different methods and scales have been used, there is enough evidence for clinical oncologists to implement the use of EPC in clinical practice for advanced lung cancer patients.

Which elderly newly diagnosed glioblastoma patients can benefit from radiotherapy and temozolomide? A PERNO prospective study.

The role of temozolomide concurrent with and adjuvant to radiotherapy (RT/TMZ) in elderly patients with glioblastoma (GBM) remains unclear. We evaluated the outcome of patients >70 years in the context of the Project of Emilia-Romagna Region in Neuro-Oncology (PERNO), the first Italian prospective observational population-based study in neuro-oncology. For this analysis the criteria for selecting patients enrolled in the PERNO study were: age >70 years; PS 0-3; histologically confirmed GBM; postoperative radiotherapy (RT) after surgery with or without concomitant temozolomide (TMZ) or postsurgical TMZ alone. Between January 2009 and December 2010, 76 GBM elderly patients were identified in the prospective PERNO study. Twenty-three patients did not receive any treatment after surgery, and 53 patients received postsurgical treatments (25 patients received RT alone and 28 patients RT/TMZ). Median survival was 11.1 months (95 % CI 8.8-13.5), adding temozolomide concomitant and adjuvant to radiotherapy it was 11.6 months (95 % CI 8.6-14.6), and 9.3 months (95 % CI 8.1-10.6) in patients treated with RT alone (P = 0.164). However, patients with MGMT methylated treated with RT/TMZ obtained a better survival (17.2 months, 95 % CI 11.5-22.9) (P = 0.042). No difference in terms of survival were observed if patients with MGMT unmethylated tumor received RT alone, or RT/TMZ or, in MGMT methylated tumor, if patients received radiotherapy alone. In elderly patients RT/TMZ represent a widely used approach but it is effective with methylated MGMT tumors only.

Distance as a Barrier to Cancer Diagnosis and Treatment: Review of the Literature.

The burden of travel from a patient's residence to health care providers is an important issue that can influence access to diagnosis and treatment of cancer. Although several studies have shown that the travel burden can result in delays in diagnosis and treatment of many common cancers, its role appears underestimated in the treatment of patients in clinical practice. Therefore, we performed a review of the published data on the role of travel burden influencing four items: delay of diagnosis, adequate treatment of cancer, outcome, and quality of life of cancer patients. Forty-seven studies published up to December 2014 were initially identified. Twenty studies were excluded because they did not regard specifically the four items of our review. Twenty-seven studies formed the basis of our study and involved 716,153 patients. The associations between travel burden and (a) cancer stage at diagnosis (12 studies), (b) appropriate treatment (8 studies), (c) outcome (4 studies), and (d) quality of life (1 study) are reported. In addition, in two studies, the relation between travel burden and compliance with treatment was examined. The results of our review show that increasing travel requirements are associated with more advanced disease at diagnosis, inappropriate treatment, a worse prognosis, and a worse quality of life. These results suggest that clinical oncologists should remember the specific travel burden problem for cancer patients, who often need health care services every week or every month for many years.

Ultrasound guidance reduces pneumothorax rate and improves safety of thoracentesis in malignant pleural effusion: report on 445 consecutive patients with advanced cancer.

BACKGROUND: Malignant pleural effusion (MPE) is an extremely common problem affecting cancer patients, and thoracentesis is an essential procedure in an attempt to delineate the etiology of the fluid collections and to relieve symptoms in affected patients. One of the most common complications of thoracentesis is pneumothorax, which has been reported to occur in 20% to 39% of thoracenteses, with 15% to 50% of patients with pneumothorax requiring tube thoracostomy.The present study was carried out to assess whether thoracenteses in cancer patients performed with ultrasound (US) guidance are associated with a lower rates of pneumothorax and tube thoracostomy than those performed without US guidance. METHODS: A total of 445 patients were recruited in this retrospective study. The medical records of 445 consecutive patients with cancer and MPE evaluable for this study, undergoing thoracentesis at the Oncology-Hematology and Internal Medicine Departments, Piacenza Hospital (Italy) were reviewed. RESULTS: From January 2005 to December 2011, in 310 patients (69.66%) thoracentesis was performed with US guidance and in 135 (30.34%) without it. On post-thoracentesis imaging performed in all these cases, 15 pneumothoraces (3.37%) were found; three of them (20%) required tube thoracostomy. Pneumothorax occurred in three out of 310 procedures (0.97%) performed with US guidance and in 12 of 135 procedures (8.89%) performed without it (P<0.0001). It must be emphasized that in all three patients with pneumothorax requiring tube thoracostomy, thoracentesis was performed without US guidance. CONCLUSIONS: The routine use of US guidance during thoracentesis drastically reduces the rate of pneumothorax and tube thoracostomy in oncological patients, thus improving safety as demonstrated in this study.

Humoral Response and Safety after a Fourth Dose of the SARS-CoV-2 BNT162b2 Vaccine in Cancer Patients Undergoing Active Treatment-Results of a Prospective Observational Study.

Only a few studies have been carried out on the efficacy and safety of a fourth dose of the COVID-19 vaccine in patients with cancer. In this prospective observational study, we aimed to assess the serological response and safety of the fourth booster shot of the BNT162b2 vaccine in 79 cancer patients, vaccinated between 1 March and 25 August 2022, under systemic anticancer therapy. The primary endpoint was to assess the increase in the anti-SARS-CoV-2 antibodies; secondary endpoints were the vaccine safety and side effects. Consequently, 40 patients (50.63%) revealed the maximum detection values in their IgG titers before the fourth dose of the vaccine, while 39 patients (49.37%) did not. Primary endpoint: Of 39 patients, 36 (92.31%) showed a significant increase in the anti-SARS-CoV-2 IgG titers, and 32 of them (82.05%) reached the maximum titration values. Secondary endpoints: The most common adverse events were mild in severity and included injection site pain, erythema and tiredness. The majority of the adverse reactions reported were grade 1 and no grade 3 and 4 reactions were detected. Our data provide evidence that a fourth dose of the BNT162b2 anti-SARS-CoV-2 vaccine is effective and safe in patients with solid tumors in active anticancer treatment.

Intense antiextracellular adaptive immune response to human cytomegalovirus in very old subjects with impaired health and cognitive and functional status.

Human aging is characterized by expanded and altered adaptive immune responses to human CMV (HCMV). It is unclear whether this expansion has its origins in age-related homeostatic disturbances or viral reactivation, whether anti-CMV immune surveillance may still be effective, and what are the consequences of this expanded immune response for health and longevity. We conducted an observational cross-sectional study in groups of HCMV-seropositive subjects aged >or=65 y of variable health status to compare the intensity of Ab responses against HCMV with those against EBV and with CD4(+) and CD8(+) T cell proinflammatory effector responses directed to HCMV-derived pp65 and immediate-early protein 1 synthetic peptides. Ab responses to HCMV, but not to EBV, and anti-HCMV CD4(+), but not CD8(+), T cell responses were more intense in elderly subjects aged >or=85 y in poor health and were inversely correlated with markers of functional activity and cognitive function. Therefore, humoral and CD4(+) T cell anti-HCMV responses were specifically intensified in advanced aging associated with comorbidity and cognitive and functional impairments. Such a distinctive pattern of adaptive immunity indicates that immune responses targeting the extracellular phase of HCMV are increased in these elderly subjects and could represent an indirect effect of localized and undetectable HCMV reactivation. This study demonstrates that the oldest subjects in poor health with physical and mental impairment express intense functional immune responses to extracellular HCMV and suggests that they may be at risk for direct pathogenic effects by HCMV reactivation as well as indirect pathogenic effects linked to proinflammatory anti-HCMV effector responses.

Bedside Peripheral Ultrasound-Guided Vascular Access in 253 Patients Hospitalized With COVID-19 Pneumonia: A Retrospective Italian Study.

Background Several studies have recommended the use of vascular access in the treatment of COVID-19 patients. However, little is known about the utility and safety of using a peripheral ultrasound-guided vascular access device (UGVAD) at the bedside of hospitalized COVID-19 patients. To examine this, a retrospective monocenter study was carried out at the oncology-hematology department of Azienda Sanitaria di Piacenza, Italy. Methods We retrospectively analyzed data from three general hospitals in a district in North Italy on the positioning of UGVADs used with hospitalized COVID-19 patients. The positioning of the VAD was performed by a dedicated team using ultrasound guidance. The primary endpoint was the duration of VAD until the patient's recovery or death. The secondary endpoints were complications of the use of VADs, which included vein thrombosis, infections, device malfunction, and viral contamination of the operators. Results Between February 21, 2020, and April 30, 2020, 253 consecutive hospitalized patients with COVID-19 pneumonia underwent UGVAD positioning. A midline was inserted in 88.53% of the patients, while peripheral central venous catheters and femoral central catheters were inserted in 9.88% and 1.59% of the patients, respectively. The mean lifespan of the VADs was 10.36±9.96 days (range: 1-73). Primary endpoint: The use of the VAD allowed the planned treatment in 92.88% of the patients; in the remaining 7.12%, the VAD was repositioned. Secondary endpoints: Complications of VAD were registered in 15.02% of the patients (dislocation, 9.49%; infection, 1.98%; thrombosis, 1.58%; occlusion, 1.19%; and malfunction, 0.79%). No contamination of the operators was registered. Discussion and conclusion With the limitation of being a retrospective study, our report suggests that ultrasound-guided positioning of VAD may allow the safe clinical management (drug infusion, hydration, parenteral nutrition, and phlebotomy) of hospitalized COVID-19 patients. The observance of recommended procedures protected all operators from infection.

[Home care: home venous access device insertion during covid-19 pandemic in not autonomous patients. From an emergency activity to a daily work practice.] / Cure a casa: posizionamento di dispositivo venoso a domicilio per pazienti non autonomi durante la pandemia covid-19. Da attività in emergenza a pratica routinaria.

INTRODUCTION: Reliable venous access is essential in providing effective care for many patients. Various vascular access devices (VAD) are available, and are placed by a specialized team using ultrasound guidance in a dedicated room of the hospital; however, during the pandemic covid-19 many not autonomous or bedridden patients were unable to reach the hospital for VAD insertion, because the unavailability of ambulance for the transport. For this reason the specialized team organized a modality for positioning the VAD at bedside at home. METHODS: In 2012 a VAD-team was established by the health authority in the oncology-hematology Department at the hospital of Piacenza. This team was dedicated in positioning ultrasound-guided vascular access. During the covid-19 pandemic the VAD-team modified its organization to reach patients at home to position VAD, initially for oncologic people unable to go to the hospital; this procedure was subsequently extended to other bedridden patients with non-oncologic disease. The positioning of the VAD was performed under ultrasound guidance, according to the same modalities used in hospital. The primary endpoin was the suitability of the VAD to allow the planned treatment. The secondary endpoint was complications of the use of VADs. RESULTS: Between March 2020 to December 2020 and January 2021 to December 2021, VAD were positioned in 118 and 134 patients respectively. The VAD utilized were midlines for each patient. The mean age of the patients was 88 years, the majority were female (>60%). The majority of the patients had neurodegenerative disease (>60%) or advanced cancers (>25%). The VAD allowed the planned treatment in 94% of the patients. The complications were infrequent: VAD dislocation (<1%), thrombosis (<2%). No infection was registered. DISCUSSION AND CONCLUSION: During covid-19 pandemic, the VAD-team demonstrated the feasibility of VADs home positioning, for patients that need to be transported by ambulance to the hospital for a venous catheter insertion. This procedure allows saving of economic and human resources both for patients and caregivers, in addiction can leave the ambulance free for other use. Due to this study, this procedure has become routine practice in our health district for patients bedridden or not autonomous.

Mediterranean Diet Affects Blood Circulating Lipid-Soluble Micronutrients and Inflammatory Biomarkers in a Cohort of Breast Cancer Survivors: Results from the SETA Study.

Breast cancer (BC) is a major public health concern and substantial research has shown that adhering to a healthy dietary pattern, such as the Mediterranean Diet (MD), may prevent the onset of cancer and BC relapses. This study aims at specifically investigating the association of MD with circulating dietary-related biomarkers in a cohort of BC survivors. Eighty patients (mean age of 54.9 ± 10.6) with a histologically confirmed diagnosis of BC who had not received any pharmacological or radiotherapy treatment for at least two months were enrolled. Fasting serum lipid-soluble vitamins (retinol, tocopherol), plant pigments (ß-carotene, lutein + zeaxanthin, cryptoxanthin, lycopene), inflammatory and oxidative stress markers (ceruloplasmin; haptoglobin; paraoxonases; reactive oxygen molecule; thiol groups, Ferric reducing antioxidant power), and cardiometabolic parameters (body mass index (BMI); glucose; insulin; HOMA-IR; total cholesterol; LDL-cholesterol; HDL-cholesterol; triglycerides) were analyzed. Adherence to the MD was assessed through the Mediterranean Diet Score (MDS) questionnaire. Fasting blood samples were collected for the evaluation of selected biomarkers. MDS resulted positively correlated with ß-carotene (r 0.331; p < 0.01) and lycopene (r 0.274; p < 0.05) and negatively with retinol (r -0.346; p < 0.05). Among the investigated inflammatory biomarkers, MDS was only correlated with antioxidant capacity (r 0.256; p < 0.05), while none of the investigated cardiometabolic parameters were significantly correlated with this index. The strong significant correlation between ß-carotene and MDS encourages us to consider this pro-vitamin as a putative biomarker to take into account for evaluating the adherence to the MD.

Prevalence of COVID-19 Infection in Asymptomatic Cancer Patients in a District With High Prevalence of SARS-CoV-2 in Italy.

Background Cancer patients are presumed a frail group at high risk to contract coronavirus disease (COVID-19). The aim of this study was to investigate the prevalence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection in asymptomatic cancer patients attending the outpatient clinic of a general hospital in a region with a high prevalence of SARS-CoV-2 infection (North Italy, first wave). Methods We retrospectively analyzed data of consecutive cancer patients attending the outpatient clinic of the oncology unit, General Hospital of Piacenza. All the patients having underlying cancer, without clinical suspicion of COVID-19, attending the outpatient clinic underwent nasopharyngeal swabs, from April 3, 2020 to June 3, 2020 and were included in this study. Results In a two-month period, 260 consecutive, asymptomatic (for COVID-19) cancer patients were tested for COVID-19. There were 160 women and 100 men; 218 patients were under active anticancer treatment, 32 in the diagnostic/staging phase waiting for treatment, and 10 treated with supportive care only. Ten of the 260 patients (3.85%) showed COVID-19 positivity. All but one (treated with hormone therapy) of the COVID-19 positive patients delayed anticancer treatment. The mean delay of anticancer treatment was 45.86±27.66 days (range 21-87 days), and the mean time for viral clearance was 25.7±22.68 days (range 7-79 days). All the 10 patients with COVID-19 and cancer overcame the infection, and treated patients could restart anticancer treatment. Conclusion Our data indicate a high prevalence of COVID-19 in cancer patients in an area with a high prevalence of SARS-CoV-2 infection. Routine COVID-19 testing of cancer patients when asymptomatic allowed an early detection, isolation, and treatment, avoiding viral spread among other frail patients and among medical/nurse staff.

COVID-19 vaccines in adult cancer patients with solid tumours undergoing active treatment: Seropositivity and safety. A prospective observational study in Italy.

INTRODUCTION: Patients with cancer are presumed a frail group at high risk of contracting coronavirus disease (COVID-19), and vaccination represents a cornerstone in addressing the COVID-19 pandemic. However, data on COVID-19 vaccination in cancer patients are fragmentary and poor. METHODS: An observational study was conducted to evaluate the seropositivity rate and safety of a two-dose regimen of the BNT162b2 or messenger RNA-1273 vaccine in adult patients with solid cancer undergoing active anticancer treatment or whose treatment had been terminated within 6 months of the start of the study. The control group was composed of healthy volunteers. Serum samples were evaluated for SARS-COV-2 antibodies before vaccinations and 2-6 weeks after the administration of the second vaccine dose. Primary end-point: seropositivity rate. Secondary end-points: safety, factors influencing seroconversion, IgG titers of patients versus healthy volunteers, COVID-19 infection. RESULTS: Between 20th March 2021 and 12th June 2021, 293 consecutive patients with cancer-solid tumours underwent a program of COVID-19 vaccinations; of these, 2 patients refused vaccination, 13 patients did not receive the second dose of the vaccine because of cancer progression, and 21 patients had COVID-19 antibodies at baseline and were excluded. The 257 evaluable patients had a median age of 65 years (range 28-86), 66.15% with metastatic disease. Primary end-point: seropositivity rate in patients was 75.88% versus 100% in the control group. Secondary end-points: no Grade 3-4 side-effects, no COVID-19 infections were reported. Patients median IgG titer was significantly lower than in the control group; male sex and active anticancer therapy influenced negative seroconversion. BNT162b2 or messenger RNA-1273 vaccines were immunogenic in cancer patients, showing good safety profile.

Ultrasound-guided central venous catheterization in cancer patients improves the success rate of cannulation and reduces mechanical complications: a prospective observational study of 1,978 consecutive catheterizations.

BACKGROUND: A central venous catheter (CVC) currently represents the most frequently adopted intravenous line for patients undergoing infusional chemotherapy and/or high-dose chemotherapy with hematopoietic stem-cell transplantation and parenteral nutrition. CVC insertion represents a risk for pneumothorax, nerve or arterial punctures. The aim of this prospective observational study was to explore the safety and efficacy of CVC insertion under ultrasound (US) guidance and to confirm its utility in clinical practice in cancer patients. METHODS: Consecutive adult patients attending the oncology-hematology department were eligible if they had solid or hematologic malignancies and required CVC insertion. Four types of possible complication were defined a priore: mechanical, thrombotic, infection and malfunctioning. The patient was placed in Trendelenburg's position, a 7.5 MHZ puncturing US probe was placed in the supraclavicular site and a 16-gauge needle was advanced under real-time US guidance into the last portion of internal jugular vein. The Seldinger technique was used to place the catheter, which was advanced into the superior vena cava until insertion into right atrium. Within two hours after each procedure, an upright chest X-ray and ultrasound scanning were carried out to confirm the CVC position and to rule out a pneumotorax. CVC-related infections, symptomatic vein thrombosis and malfunctioning were recorded. RESULTS: From December 2000 to January 2009, 1,978 CVC insertional procedures were applied to 1,660 consecutive patients. The procedure was performed 580 times in patients with hematologic malignancies and 1,398 times those with solid tumors. A single-needle puncture of the vein was performed on 1,948 of 1,978 procedures (98.48%); only eighteen attempts among 1,978 failed (0.9%). No pneumotorax, no major bleeding, and no nerve puncture were reported; four cases (0.2%) showed self-limiting hematomas. The mean lifespan of CVC was 189.7 +/- 18.6 days (range 7-701). Symptomatic deep-vein thrombosis of the upper limbs developed in 48 patients (2.42%). Catheter-related infections occurred in 197 (9.96%) of the catheters inserted. They were successfully treated with antibiotics and only in 48 (2.9%) patients definitive CVC removal was required for infection and/or thrombosis or malfunctioning. CONCLUSIONS: This study represents the largest published series of consecutive patients with cancer undergoing CVC insertion under US guidance; this procedure allowed the completion of the therapeutic program for 1,930/1,978 (97.6%) of the catheters inserted. The absence of pneumotorax and other major complications indicates that US guidance should be mandatory for CVC insertion in patients with cancer.

Cancer patients with COVID-19: a retrospective study of 51 patients in the district of Piacenza, Northern Italy.

BACKGROUND: Cancer patients are considered a highly fragile group in the current coronavirus disease 2019 (COVID-19) pandemic. MATERIAL & METHODS: In this study, patients with COVID-19 and cancer, hospitalized in Piacenza, Italy, from 4 April to 4 May 2020 were included. Risk factors for death were analyzed. RESULTS: Fifty-one COVID-19 cancer patients were included, of which the median age was 71.02 years (range: 51-86) and 70.59% were male. Cancer types included gastrointestinal (25.49%), genitourinary (25.49%) and lung (23.53%). Forty-five (88.24%) patients received hydroxychloroquine-based therapy. In addition, 25 of 51 patients died (49%): 12 of 51 (23.53%) owing to cancer and 13 of 51 (25.49%) owing to COVID-19. CONCLUSION: The risks for death were related to later onset of treatment for COVID-19, severe/critical COVID-19, age, elevated basal CRP and elevated lactate dehydrogenase.

Elderly cancer patients' preferences regarding the disclosure of cancer diagnosis. Experience of a single institution in Italy.

The disclosure of a diagnosis of cancer is complex, particularly in older patients for reasons related to the wishes of the family, fear of discouraging the patient, or the patient's inability to understand the information. So our insight into older people's perspectives regarding the disclosure of their cancer diagnosis is fragmentary and inadequate. To examine the views of older adults regarding this issue, we performed a prospective observational study in an inpatient oncology clinic. From January 2006 to June 2006, a sample of 132 consecutive cancer patients aged over 70 years with a variety of solid tumors, recently diagnosed and mainly at an advanced stage, agreed to take part in a survey about the disclosure of the diagnosis of their disease. Of the 132 patients who verbally agreed to participate and were given questionnaires, 106 returned data. The majority of patients (64.1%) in this study wanted to be informed about the diagnosis of their disease also if it was cancer, and 58.5% were in fact informed about the exact nature of their disease. Male patients were more keen to know the diagnosis than female patients (P = 0.002) and they were in fact more informed about their diagnosis than female patients (P = 0.005). Patients with more formal education were more informed than patients with less formal education (P = 0.035). This study demonstrates that the preferences of older patients regarding cancer diagnosis disclosure are highly similar to those of younger people. Male patients and patients with more formal education were more informed than female patients and patients with less formal education.

The Prognostic Roles of Gender and O6-Methylguanine-DNA Methyltransferase Methylation Status in Glioblastoma Patients: The Female Power.

BACKGROUND: Clinical and molecular factors are essential to define the prognosis in patients with glioblastoma (GBM). O6-methylguanine-DNA methyltransferase (MGMT) methylation status, age, Karnofsky Performance Status (KPS), and extent of surgical resection are the most relevant prognostic factors. Our investigation of the role of gender in predicting prognosis shows a slight survival advantage for female patients. METHODS: We performed a prospective evaluation of the Project of Emilia Romagna on Neuro-Oncology (PERNO) registry to identify prognostic factors in patients with GBM who received standard treatment. RESULTS: A total of 169 patients (99 males [58.6%] and 70 females [41.4%]) were evaluated prospectively. MGMT methylation was evaluable in 140 patients. Among the male patients, 36 were MGMT methylated (25.7%) and 47 were unmethylated (33.6%); among the female patients, 32 were methylated (22.9%) and 25 were unmethylated (17.9%). Survival was longer in the methylated females compared with the methylated males (P = 0.028) but was not significantly different between the unmethylated females and the unmethylated males (P = 0.395). In multivariate analysis, gender and MGMT methylation status considered together (methylated females vs. methylated males; hazard ratio [HR], 0.459; 95% confidence interval [CI], 0.242-0.827; P = 0.017), age (HR, 1.025; 95% CI, 1.002-1.049; P = 0.032), and KPS (HR, 0.965; 95% CI, 0.948-0.982; P < 0.001) were significantly correlated with survival. CONCLUSIONS: Survival was consistently longer among MGMT methylated females compared with males. Gender can be considered as a further prognostic factor.

Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life.

AIM: Early palliative care (EPC) in oncology has shown sparse evidence of a positive impact on patient outcomes, quality of care outcomes and costs. PATIENTS AND METHODS: Data for this secondary analysis were taken from a trial of 207 outpatients with metastatic pancreatic cancer randomly assigned to receive standard cancer care plus on-demand EPC (standard arm) or standard cancer care plus systematic EPC (interventional arm). After 20 months' follow-up, 149 (80%) had died. Outcome measures were frequency, type and timing of chemotherapy administration, use of resources, place of death and overall survival. RESULTS: Some indices of end-of-life (EoL) aggressiveness had a favourable impact from systematic EPC. Interventional arm patients showed higher use of hospice services: a significantly longer median and mean period of hospice care (P = 0.025 for both indexes) and a significantly higher median and mean number of hospice admissions (both P < 0.010). In the experimental arm, chemotherapy was performed in the last 30 days of life in a significantly inferior rate with respect to control arm: 18.7% versus 27.8% (adjusted P = 0.036). Other non-significant differences were seen in favour of experimental arm. CONCLUSIONS: Systematic EPC showed a significant impact on some indicators of EoL treatment aggressiveness. These data, reinforced by multiple non-significant differences in most of the other items, suggest that quality of care is improved by this approach. This study is registered on ClinicalTrials.gov (NCT01996540).