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Systemic chemotherapy (CT) is the treatment of choice for advanced pancreatic ductal adenocarcinoma (PDAC). Biliary obstruction is common in this setting and may interfere with CT administration due to jaundice or cholangitis related to biliary stent malfunction. To evaluate the impact of biliary events on CT administration and survival in patients with stage III-IV PDAC. Patients enrolled in a randomized trial of nab-paclitaxel plus gemcitabine with/without capecitabine and cisplatin in advanced PDAC were included. Data on management of jaundice, biliary stents/complications and CT were prospectively collected and retrospectively analyzed. Modified overall (mOS) and progression-free (mPFS) survival were evaluated. Eighty-eight patients met the inclusion criteria (50% females; median age 65years). Seven of eight (87.5%) patients who placed plastic stents developed biliary complications versus 14/30 (46.7%) with metallic stents (p = 0.071). Patients without biliary complications completed planned CT in 64.2% versus 47.6% of cases (p = 0.207). CT completion was related to longer mOS (17 vs 12 months, p = 0.005) and mPFS (9 vs 6 months, p = 0.011). mOS was shorter when biliary complications occurred (12 vs 17 months, p = 0.937), as was mPFS (6 vs 8 months, p = 0.438). Complications related to biliary obstruction influence chemotherapy completion and survival in patients with advanced PDAC. [ABSTRACT FROM AUTHOR]

Pancreatic Ductal Adenocarcinoma (PDAC) is an aggressive disease with poor outcomes. One of the reasons for the dismal prognosis resides in its impressive ability to alter the nutritional status of patients who develop malnutrition, cachexia, anorexia, and sarcopenia in most cases. The ideal way to measure such changes in PDAC patients, in order to readily identify them and avoid complications or discontinuations of treatment is a relatively unexplored area. In addition, most PDAC patients experience pancreatic exocrine insufficiency (PEI) that contributes to the complex puzzle of malnutrition and that can be treated with Pancreatic Enzyme Replacement Therapy (PERT). We review current knowledge on the impact of nutritional status on both surgical and medical treatments for PDAC, reporting available data on the causes of malnutrition, characteristics, and advantages of different tools to investigate nutritional status and possible strategies to improve patient outcomes. All PDAC patients should receive a careful nutritional assessment at diagnosis, and this should be repeated alongside their treatment path. Screening tools and biochemical variables or scores are associated with prognosis, but bioimpedance vector analysis (BIVA) and radiological assessment of body composition seem more accurate in predicting clinical outcomes and postoperative complications. [ABSTRACT FROM AUTHOR]

By 2030 70% of newly diagnosed pancreatic ductal adenocarcinoma (PDAC) will occur in older adults. Elderly patients, defined by the World Health Organization (WHO) as people older than 65 years, represent a heterogeneous group with different biological and functional characteristics that need personalized anticancer treatments. Since older patients are under-represented in randomized phase III trials, their management is mostly extrapolated from studies performed in younger patients, without robust evidence-based recommendations. However, data from retrospective studies and case-control series show that elderly may benefit from chemotherapy in both the adjuvant and advanced disease settings. Although with discordant results, gemcitabine-based treatment and dose-adapted fluorouracil combination regimens seem to be effective and well tolerated in this subset of patients. A proper balance of potential treatment benefits and side effects represent the crucial point for managing elderly patients with PDAC. Therefore an appropriate patient selection is essential to maximize the therapeutic benefit in the older population: randomized studies aiming to better standardizing fitness parameters and implementing the routine use of comprehensive geriatric assessments are strongly warranted. In this light, the detection of molecular prognostic markers able to detect patients who may benefit more from oncological treatments should be a primary endpoint of age-focused clinical trials. Altogether, the field of geriatric oncology will expand in the next years, and the clinical management of elderly patients affected by PDAC will become a major public health issue. [ABSTRACT FROM AUTHOR]

Abstract Background The current trial assessed whether the addition of cisplatin and capecitabine to the nab-paclitaxel–gemcitabine backbone is feasible and active against borderline and locally advanced pancreatic adenocarcinoma (PDAC). Method Fifty-four chemo-naive patients, aged between 18 and 75 years, with a pathological diagnosis of locally advanced or borderline resectable PDAC were randomised to receive either nab-paclitaxel, gemcitabine, cisplatin and oral capecitabine (PAXG; arm A; N = 26) or nab-paclitaxel followed by gemcitabine (AG; arm B; N = 28). The primary end-point was the tumour resection rate. If at least four such resections were performed, the treatment was considered as active. The secondary end-points were progression-free survival (PFS), overall survival (OS), Response Evaluation Criteria in Solid Tumours response rate, Hartman's pathologic response, carbohydrate antigen 19.9 response rate and toxicity. Results Eight patients (31%) in the PAXG arm and nine (32%) in the AG arm underwent resection. PFS at 1-year was 58% in arm A and 39% in arm B. OS at 18-month was 69% in arm A and 54% in arm B. Conclusions In this phase II study, the addition of cisplatin and capecitabine to the AG backbone was feasible and yielded promising results in terms of disease control without detrimental impact on tolerability. The approach warrants further investigation in a phase III study. Trial registration NCT01730222. Highlights • No standard therapy has been yet identified in borderline/locally advanced disease. • A very limited number of randomised trials have been completed in this setting. • This current trial evaluates the activity and feasibility of cisplatin, nab-paclitaxel, capecitabine, gemcitabine (PAXG) and nab-paclitaxel, gemcitabine (AG) regimens. • Both regimens were effective in terms of disease control. • PAXG regimen appears more convenient from several perspectives than AG. [ABSTRACT FROM AUTHOR]