An inflammatory pseudotumor of the liver is a rare tumor-like lesion composed of polymorphous inflammatory cell infiltrates and variable amounts of fibrosis that can often mimic a malignant liver neoplasm. The etiology of inflammatory pseudotumors of the liver is unknown; symptoms are faint and imaging non-specific. Thus, it is often hard to make a diagnosis preoperatively and it is not so rare to over-treat patients with this disease or vice versa. Thus, more profound knowledge is necessary to plan appropriate disease management. We reported our two cases and systematically searched the literature regarding IPTL. We selected articles published in English from four databases, PubMed, Scopus, Web of Science and Google Scholar, and we included only articles with consistent data. Twenty nine papers fulfilling criteria for the review were selected. The analysis of 69 cases published from 1953 confirmed that the risk factors are unclear, the imaging data is not specific, and biopsy is crucial but not so widely used in clinical practice due to the procedure’s related risks, and relatively low effectiveness and improvement in imaging analysis. Regarding treatment, surgeons have moved towards a more conservative attitude over the years due to better imaging quality and patient surveillance. However, surgery remains the modality of choice for most cases with an indeterminate diagnosis. Even if an inflammatory pseudotumor of the liver is a benign tumor with a good prognosis, not requiring any treatment in most cases, sometimes it remains challenging to differentiate it from ICC; therefore, there is a solid recommendation to manage this condition with a multidisciplinary team.

EOX (epirubicin, oxaliplatin, and capecitabine) is one of the standard regimens for metastatic or locally advanced gastric cancer (GC). A new combination based on fractional docetaxel (low-TOX) has been developed in an attempt to increase the efficacy of EOX and reduce the heavy toxicity of classical docetaxel regimens. Overall, 169 previously untreated GC patients were randomized between EOX (arm A) and low-TOX (arm B). The primary endpoint was progression-free survival (PFS), while secondary ones were overall survival (OS), overall response rate (ORR), disease control rate (DCR), and tolerability. The study was designed to detect a 35% (80% power at a two-sided 5% significance level) PFS increase with low-TOX and an interim analysis for futility was planned after the first 127 events. At the cut-off date of interim analysis, median PFS was 6.3 months [95% confidence interval (CI) 5.0–8.1] in arm A vs 6.3 months (95% CI 5.0–7.8) in arm B, without statistical difference. OS was comparable in the two arms: 12.4 in arm A (95% CI 9.1–19.2) vs 11.5 months in arm B (95% CI 8.6–15.0). ORR was 33% and 24%, while DCR was 68% and 67%, respectively. Treatment modification (91% vs 78%, P = 0.017) and number of patients with CTC grade ≥ 3 adverse events (42 vs 35) were higher in arm B. A triplet regimen based on the fractional dose of docetaxel achieves no improvement over EOX which remains a potential standard treatment in many patients with inoperable, locally advanced or metastatic GC.

Chemoradiotherapy as an alternative to surgery can be offered to patients affected by loco-regionally advanced head and neck cancer (HNC). Induction chemotherapy is a valid option, supported by few positive trials, but its real efficacy is still a matter of debate. The standard regimen for induction chemotherapy in Europe is a combination of docetaxel (75 mg/m2) and reduced dose doses of cisplatin (75 mg/m2) and 5-fluorouracil (750 mg/m2 day, for five consecutive days) (TPF). It is less toxic and more effective than the historical therapy PF (cisplatin 100 mg/m2 and fluorouracil 1,000 mg/m2/day for five consecutive days). However, in some studies treatment-related mortality has been reported to be as high as 6%. Therefore, some less toxic combinations, such as a modified TPF regimen and the combination of carboplatin plus paclitaxel have been studied. These regimens are showing promising results but deserve further validation in comparative trials. Furthermore, several trials are underway in order to enhance TPF with immune checkpoints inhibitors. Compared to chemoradiotherapy, induction chemotherapy followed by chemoradiation was shown to be non-inferior, and it could decrease the distant metastatic progression, especially in high-risk populations. For selected patients, induction chemotherapy could be a strong option. The chemoselective process that leads to immediate surgery for non-responders, the high response rate (complete responses are sometimes observed), and the survival data, are all arguments in favor of induction chemotherapy, if performed in experienced centers involving health professionals in the context of a skilled multidisciplinary team.

Background: In the last decade, a series of analyses failed to identify predictive biomarkers of resistance/susceptibility for anti-angiogenic drugs in metastatic colorectal cancer (mCRC). We conducted an exploratory preplanned analysis of serum pro-angiogenic factors (SErum aNgiogenesis-cenTRAL) in 72 mCRC patients enrolled in the phase II CENTRAL (ColorEctalavastiNTRiAlLdh) trial, with the aim to identify potential predictive factors for sensitivity/resistance to first line folinic acid-fluorouracil-irinotecan regimen (FOLFIRI) plus bevacizumab. Methods: First-line FOLFIRI/bevacizumab patients were prospectively assessed for the following circulating pro-angiogenic factors, evaluated with ELISA (enzyme-linked immunosorbent assay)-based technique at baseline and at every cycle: Vascular endothelial growth factor A (VEGF-A), hepatocyte growth factor (HGF), stromal derived factor-1 (SDF-1), placental derived growth factor (PlGF), fibroblast growth factor-2 (FGF-2), monocyte chemotactic protein-3 (MCP-3), interleukin-8 (IL-8). Results: Changes in circulating FGF-2 levels among different blood samples seemed to correlate with clinical outcome. Patients who experienced an increase in FGF-2 levels at the second cycle of chemotherapy compared to baseline, had a median Progression Free Survival (mPFS) of 12.85 vs. 7.57 months (Hazard Ratio—HR: 0.73, 95% Confidence Interval—CI: 0.43-1.27, p = 0.23). Similar results were seen when comparing FGF-2 concentrations between baseline and eight-week time point (mPFS 12.98 vs. 8.00 months, HR: 0.78, 95% CI: 0.46–1.33, p = 0.35). Conclusions: Our pre-planned, prospective analysis suggests that circulating FGF-2 levels’ early increase could be used as a marker to identify patients who are more likely to gain benefit from FOLFIRI/bevacizumab first-line therapy.

INTRODUCTION:Head and neck cancer represents a variety of tumors involving different organs in the cervical district, burdened by poor prognosis when diagnosed in an advanced stage. Immunotherapy with both anti-PD-1 nivolumab and pembrolizumab has the aim of increasing overall survival for patients with this malignancy. We report the first case of immune-related encephalitis caused by nivolumab in this setting of disease and present a brief review of the literature.CASE DESCRIPTION:A 60-year-old woman had been treated with concomitant chemoradiotherapy for a locally advanced human papillomavirus-negative squamous cell carcinoma of the tonsil. After local recurrence, she was treated with platinum-based first-line chemotherapy, followed by nivolumab at further progression within 6 months. Nivolumab was administered for 19 weeks, then discontinued due to the occurrence of immune-related hypothyroidism and grade 2 diarrhea. A month after the onset of the endocrinopathy, the patient also developed steroid-responsive encephalitis, considered as a consequence of anti-PD-1 therapy. One year after discontinuation of immunotherapy, toxicities have resolved and the patient is maintaining a complete radiologic response.CONCLUSIONS:Immunotherapy is a relatively new and promising therapy in the field of oncology. Its mechanism of action, which aims to stimulate the immune system against cancer cells, is not comparable to systemic and cytotoxic chemotherapy, which directly attacks and destroys malignant cells. Despite these differences, immunotherapy is not to be considered free from side effects, sometimes life-threatening.

Chemoradiotherapy as an alternative to surgery can be offered to patients affected by loco-regionally advanced head and neck cancer (HNC). Induction chemotherapy is a valid option, supported by few positive trials, but its real efficacy is still a matter of debate. The standard regimen for induction chemotherapy in Europe is a combination of docetaxel (75 mg/m(2)) and reduced dose doses of cisplatin (75 mg/m(2)) and 5-fluorouracil (750 mg/m(2) day, for five consecutive days) (TPF). It is less toxic and more effective than the historical therapy PF (cisplatin 100 mg/m(2) and fluorouracil 1,000 mg/m(2)/day for five consecutive days). However, in some studies treatment-related mortality has been reported to be as high as 6%. Therefore, some less toxic combinations, such as a modified TPF regimen and the combination of carboplatin plus paclitaxel have been studied. These regimens are showing promising results but deserve further validation in comparative trials. Furthermore, several trials are underway in order to enhance TPF with immune checkpoints inhibitors. Compared to chemoradiotherapy, induction chemotherapy followed by chemoradiation was shown to be non-inferior, and it could decrease the distant metastatic progression, especially in high-risk populations. For selected patients, induction chemotherapy could be a strong option. The chemoselective process that leads to immediate surgery for non-responders, the high response rate (complete responses are sometimes observed), and the survival data, are all arguments in favor of induction chemotherapy, if performed in experienced centers involving health professionals in the context of a skilled multidisciplinary team.

The original version of this article unfortunately contained a mistake. All the authors first name and second name has been inadvertently interchanged. Now the authors name are corrected.

Early and loco-regionally advanced oral tongue squamous cell carcinoma (OTSCC) can be treated by surgery alone or followed by adjuvant radiotherapy or chemoradiotherapy. Nevertheless, up to 40% of patients develop tumour relapse. The aim of our study is to investigate the clinical and pathological features associated with reduced disease-free survival (DFS) in a cohort of surgically-resected OTSCC patients. One hundred and six patients surgically resected for OTSCC were retrospectively identified from clinical records. DFS was calculated according to the Kaplan-Meier method and differences between variables were assessed with Log-Rank test. A multivariable Cox regression model was used to analyse the impact of different prognostic factors on DFS. After a median of follow-up of 8.9 years, 22 events, including 11 deaths, were observed. Overall, the 5-year DFS-rate was 87.4%. The presence of extra-nodal extension (p = 0.023) and perineural invasion (p = 0.003) were significantly correlated with shorter DFS (in univariate analysis). In multivariable analysis, extra-nodal extension and perineural invasion confirmed their role as independent prognostic factors associated with an increased risk of disease recurrence [hazard ratio (HR) 2.87, 95% CI 1.11 - 7.42, p = 0.03; HR 3.85, 95% CI 1.49 - 9.96, p = 0.006, respectively]. p16 and p53 expressions in tumour cells were detected in 12% (n = 9) and 46% (n = 40) of cases, respectively. No differences in DFS were observed between p16+ and p16- (p = 0.125) and between p53+ and p53- tumours (p = 0.213). In conclusion, radical surgery, eventually followed by adjuvant radiotherapy or chemo-radiotherapy, can achieve high cure rates in OTSCC. After long-term follow-up, perineural invasion and extra-nodal extension confirmed their role as prognostic factors associated with reduced DFS in OTSCC patients.

Aim: The aims of the study are to evaluate the clinical outcomes of first-line treatment with platinum-based chemotherapy and cetuximab in patients with relapsing/metastatic head and neck cancer (RM HNC) and to identify predictors of treatment response. Methods: This is a retrospective, observational, longitudinal, real-world study involving 6 oncology centres in Italy. All consecutive patients with RM HNC treated between January 2007 and December 2016 with a first-line therapy consisting of a platinum-based chemotherapy regimen plus cetuximab were included. The primary objective of the study was to assess overall survival (OS) and progression-free survival (PFS). Secondary objectives included the identification of predictors of treatment response. Results: Overall, 297 patients were identified. Median OS was 10.8 months (95% confidence interval [CI] 9.3-12.2), whereas median PFS was 4.8 months (95% CI 4.3-5.5). On multivariable analysis, independent unfavourable prognostic factors for OS were performance status (PS) Eastern Cooperative Oncology Group (ECOG) > 0, presence of residual tumour at primary site, platinum resistance and lack of objective response. Unfavourable predictors for PFS included cancer primary site (paranasal sinuses, hypopharynx), PS ECOG > 0, presence of residual tumour at primary site, platinum resistance and lack of objective response. Independent unfavourable predictors of objective response were tumour site (oral cavity, larynx-hypopharynx), residual tumour at primary site and prior chemotherapy. Conclusions: The availability of new treatment modalities and epidemiological changes make the periodic reassessment of prognostic factors of great relevance to guide clinical practice and the design of future randomised clinical trials. (C) 2019 Elsevier Ltd. All rights reserved.

BACKGROUND:Bendamustine, used for the treatment of indolent B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia, is known to cause prolonged myelosuppression and lymphocytopenia and has been associated with the risk of developing serious and fatal infections. While reports of localized CMV infections in asymptomatic patients exist, disseminated CMV disease has not been described.CASE PRESENTATION:We report the first case of disseminated CMV infection in a 75-year-old male diagnosed with lymphoplasmacytic lymphoma/Waldenström macroglobulinemia with massive bone marrow infiltration. Despite 6-cycle R-bendamustine chemotherapy resulted in a good partial response, the patient developed persistent fever and severe weight loss. Analysis of cerebrospinal fluid and peripheral blood revealed the presence of CMV-DNA, while the fundus oculi examination revealed bilateral CMV retinitis. Treatment with induction and maintenance drugs was complicated by neutropenia and deterioration of renal function with electrolyte imbalance. From an immunological standpoint, we observed a profound imbalances in phenotype and function of B- and T-cell subsets, with a high proportion of circulating total, activated CD69+ and CD80+ B-cells, a low γ/δ T-cell frequency with a high proportion of CD69- and CD38-expressing cells, and hyperactivated/exhausted CD4+ and CD8+ T-cell phenotypes unable to face CMV challenge.CONCLUSIONS:We hereby describe a severe form of disseminated CMV disease after R-bendamustine treatment. Our observations strongly support the careful clinical monitoring of CMV reactivation/infection in oncologic patients undergoing this therapeutic regimen.

Background: There is limited information about prognostic factors in RM HNC pts receiving first-line platinum-based chemotherapy and cetuximab. Moreover, we lack survival data in a real-world population, without the selection bias affecting pts enrolled in clinical trials. Methods: We evaluated all consecutive pts treated from 1/2007 to 12/2016 in 6 Italian Centres. The following baseline prognostic factors were investigated: sex, age, site of disease, tumor grading, HPV status for oropharyngeal cancer, performance status (PS), weight loss in the previous 3 months (less/more than 5%), comorbidities (according to ACE-27), residual tumor at primary site, previous chemotherapy or cetuximab in curative setting, previous radiotherapy, platinum type (cisplatin/carboplatin, CBDCA), chemotherapy schedule (weekly/3-weekly), platinum and cetuximab doublet or with a third drug (i.e. 5FU or paclitaxel). For each potential predictor variable, Kaplan-Meier curves for OS and PFS were estimated, and a Log-rank test was used to compare survivorship in different levels of the variable. A Cox proportional hazard model was run including only predictors characterized by a significant (p < 0.05) Log-rank test. Results: We analyzed 340 pts, with a median PFS/OS of 5.0/10.6 months. The 1-year and 3-year OS rate for all pts was 44.2% (CI: 39.1-50.0) and 7.8% (CI: 5.1-12.0). Only one out of two pts received a second-line therapy. In univariate analysis lower OS was associated with PS > 0 (p < 0.001), residual tumor at primary site (p < 0.001) and CBDCA use (p = 0.012) while lower PFS was associated with paranasal sinus site (p = 0.008), PS > 0 (p = 0.001), CBDCA use (p = 0.035) and residual tumor at primary site (p < 0.001). All these predictors except for platinum type remained significant at multivariate analysis. Pts with clinical response to treatment carried a more favorable prognosis, while progressive disease as best response had a dismal median OS of 5.8 months. Conclusions: In non-selected RM HNC pts, we obtained a median PFS and OS of 5.0 and 10.6 months, very similar to 5.6 and 10.1 months reported in Extreme trial (Vermorken et al. 2008). At baseline, PS and residual tumor at primary site could be used to define pt prognosis. Legal entity responsible for the study: Paolo Bossi. Funding: Has not received any funding. Disclosure: P. Bossi, D. Ferrari, R. Depenni, G. Azzarello: Advisory board: Merck Serono. L.F. Licitra: Advisory board and research support: Merck Serono. All other authors have declared no conflicts of interest.

Head and neck cancer (HNC) is a fatal malignancy with an overall long-term survival of about 50% for all stages. The diagnosis is not rarely delayed, and the majority of patients present with loco-regionally advanced disease. The rate of second primary tumors after a diagnosis of HNC is about 3–7% per year, the highest rate among solid tumors. Currently, a single-modality or a combination of surgery, radiotherapy and chemotherapy (CHT), is the standard treatment for stage III–IV HNC. For the recurrent/metastatic setting, in the last 40 years great efforts have been made in order to develop a more effective CHT regimen, from the use of methotrexate alone, to the combination of cisplatin (CDDP) and 5-fluorouracile (5FU) or paclitaxel. Recently, the introduction of cetuximab, an anti-EGFR monoclonal antibody, to the CDDP–5FU doublet (EXTREME regimen) has improved the overall response rate, the progression-free survival and the overall survival (OS) compared to CHT alone. Nowadays, the EXTREME regimen is the standard of care for the first-line treatment of recurrent/metastatic head and neck carcinoma (RMHNC). In the last years, new promising therapies for RMHNC such as immune checkpoint inhibitors (ICIs), which have demonstrated favorable results in second-line clinical trials, gained special interest. Nivolumab and pembrolizumab are the first two ICIs able to prolong OS in the second-, later-line and platinum-refractory setting, with tolerable toxicities. This review summarizes the current state of the art in RMHNC treatment options.

Background: Previous findings suggested that bevacizumab might be able to improve response rate (RR) in colorectal cancer patients with high lactic dehydrogenase (LDH) basal levels. Methods: We conducted a phase II trial to prospectively ascertain whether bevacizumab in combination with FOLFIRI could have an improved clinical activity in patients with high LDH serum levels. Primary end point of the study was RR; secondary end points were median overall survival and median progression-free survival (mPFS). Results: A total of 81 patients were enrolled. No difference in terms of ORR (39% vs 31% for low vs high LDH level stratum, P = 0.78) and mPFS (14.16 vs 10.29 months, HR: 1.07, 95% CI: 0.51-2.24, P = 0.83) between the strata was observed, whereas overall survival (OS) was significantly longer for patients with low LDH (24.85 vs 15.14 months, HR: 4.08, 95% CI: 1.14-14.61, P = 0.0004). In a not-pre-planned exploratory analysis using different cut-off ranges for LDH, we observed RR up to 70%, with no improvement in progression-free survival or OS. Conclusions: The CENTRAL trial failed to demonstrate that high LDH levels were related to a significantly improved RR in patients receiving first-line FOLFIRI and bevacizumab. The LDH serum levels should then no further be investigated as a predictive factor in this setting.

Background:Previous findings suggested that bevacizumab might be able to improve response rate (RR) in colorectal cancer patients with high lactic dehydrogenase (LDH) basal levels.Methods:We conducted a phase II trial to prospectively ascertain whether bevacizumab in combination with FOLFIRI could have an improved clinical activity in patients with high LDH serum levels. Primary end point of the study was RR; secondary end points were median overall survival and median progression-free survival (mPFS).Results:A total of 81 patients were enrolled. No difference in terms of ORR (39% vs 31% for low vs high LDH level stratum, P= 0.78) and mPFS (14.16 vs 10.29 months, HR: 1.07, 95% CI: 0.51–2.24, P= 0.83) between the strata was observed, whereas overall survival (OS) was significantly longer for patients with low LDH (24.85 vs 15.14 months, HR: 4.08, 95% CI: 1.14–14.61, P= 0.0004). In a not-pre …

The publisher regrets that the collaborators for this paper were not listed as such within the author details of the published paper. The collaborators were published in the Acknowledgements and are as follows: Alberto Farolfi, Silvia Ruscelli, Martina Valgiusti, Sara Pini, Marina Faedi, Department of Medical Oncology, IRST IRCCS, Meldola; Angela Ragazzini, Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola; Cristina Pittureri and Elena Amaducci, Palliative Care and Hospice Unit, AUSL Romagna, Cesena; Irene Guglieri, Psychooncology Service, Veneto Institute of Oncology IOV – IRCCS, Padua; Francesca Bergamo, Sara Lonardi, Department of Clinical and Experimental Oncology, Medical Oncology 1, Veneto Institute of Oncology IOV – IRCCS, Padua; Camilla Di Nunzio, Medical Oncology Unit, Oncology–Hematology Department, Guglielmo da Saliceto Hospital, Piacenza; Monica Bosco, Palliative Care Unit, Oncology–Hematology Department, Guglielmo da Saliceto Hospital, Piacenza; Barbara Bocci, Medical Oncology Unit, San Paolo Hospital, Milan; Alfina Bramanti and Chiara Gandini, Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia; Angela Buonadonna, Medical Oncology Unit, Aviano National Cancer Institute, Aviano; Alessandro Comandone, Medical Oncology Unit, Presidio Humanitas Gradenigo, Turin; Sonia Zoccali, Coordinamento Cure Palliative (supported by F.I.L.E., Leniterapia Italian Foundatio), Florence; Maria Simona Pino, Medical Oncology Unit, Oncology Department, S. Maria Annunziata Hospital, Florence; Davide Dalu, Palliative Care Unit, Oncology Department, L. Sacco Hospital, Milan; Pietro Sozzi, Oncology Unit, Ospedale degli Infermi, Ponderano; Alberto Gozza, Medical Oncology, Department of Medicine, E.O. Galliera Hospitals, Genoa; Monica Giordano and Carla Longhi, Oncology Unit, Sant'Anna Hospital, Como; Cristina Autelitano, Palliative Care Unit, Arcispedale S. Maria Nuova – IRCCS, Reggio Emilia; Teresa Gamucci, Oncology Unit, SS Trinità Hospital Sora, ASL Frosinone, Frosinone; Cataldo Mastromauro, Oncology Unit, ULSS 12 Veneziana, Venice; Rodolfo Scognamiglio, Hospice Nazareth, Mestre; Daniela Degiovanni, Palliative Care Unit, Casale Monferrato, ASL Alessandria; Federica Negri, Medical Oncology Unit, Istituti Ospitalieri, Cremona; Augusto Caraceni, Palliative Care, Pain Therapy and Rehabilitation Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan; and Luigi Montanari, Palliative Care Unit Ravenna, AUSL Romagna, Italy. The publisher would like to apologise for any inconvenience caused. Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of lifeEuropean Journal of CancerVol. 69PreviewEarly palliative care (EPC) in oncology has shown sparse evidence of a positive impact on patient outcomes, quality of care outcomes and costs. Full-Text PDF

BackgroundPlatinum-based chemoradiation (CCRT) is the standard treatment for Locally Advanced Head and Neck Squamous-Cell Carcinoma (LAHNSCC). Cetuximab/RT (CET/RT) is an alternative treatment option to CCRT. The efficacy of induction chemotherapy (IC) followed by chemoradiation compared to chemoradiation alone has not been demonstrated in randomized clinical trials. The goals of this phase II-III trial were to assess: (i) the overall survival (OS) of IC versus no-induction (no-IC) and (ii) the Grade 3-4 in-field mucosal toxicity of CCRT versus CET/RT. The present paper focuses on the analysis of efficacy.Materials and methodsPatients with LAHNSCC were randomized to receive concomitant treatment alone [CCRT (Arm A1) or CET/RT (Arm A2)], or three cycles of induction docetaxel/cisplatin/5 fluorouracil (TPF) followed by CCRT (Arm B1) or followed by CET/RT (Arm B2). The superiority hypothesis of OS comparison of IC versus no-IC (Arms B1 + B2 versus A1 + A2) required 204 deaths to detect an absolute 3-year OS difference of 12% (HR 0.675, with 80% power at two-sided 5% significance level).Results414 out of 421 patients were finally analyzed: 206 in the IC and 208 in the no-IC arm. Six patients were excluded because of major violation and one because of metastatic disease at diagnosis. With a median follow-up of 44.8 months, OS was significantly higher in the IC arm (HR 0.74; 95% CI 0.56-0.97; P = 0.031). Complete Responses (P = 0.0028), Progression Free Survival (P = 0.013) and the Loco-regional Control (P = 0.036) were also significantly higher in the IC arm. Compliance to concomitant treatments was not affected by induction TPF.ConclusionsIC followed by concomitant treatment improved the outcome of patients with LAHNSCC without compromising compliance to the concomitant treatments. The degree of the benefit of IC could be different according to the type of the subsequent concomitant strategy.Clinical Trial NumberNCT01086826, www.clinicaltrials.gov.

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 nonsignificant 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. (C) 2016 Elsevier Ltd. All rights reserved.