Search

PURPOSE This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430 ). METHODS We assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m2) + gemcitabine (1,000 mg/m2) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety. RESULTS Two hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 ( nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P = .18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82; 95% CI, 0.694 to 0.965; P = .02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82; 95% CI, 0.680 to 0.996; P = .045). At a 16-month follow-up (cutoff, April 3, 2020; median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events; 81% mature) was 41.8 ( nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR, 0.82; 95% CI, 0.687 to 0.973; P = .0232). At the 5-year follow-up (cutoff, April 9, 2021; median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80; 95% CI, 0.678 to 0.947; P = .0091). Eighty-six percent ( nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events. CONCLUSION The primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.

Spain’s national agency for library coordination (Dirección General del Libro, Archivos y Bibliotecas, SubdirecciónGeneral de Coordinación Bibliotecaria) has launched a series of initiatives to disseminate and preserve thenational bibliographic heritage. The digitization of collections and their internet distribution (using well-known standardssuch as DC, OAI-PMH,OAIS, Premis, SRU/SW) is their most recent project. In addition to all the benefits this brings, theirefforts to build consensus for the project is especially appreciated. Of particular significance, they have secured the cooperationof Spain’s autonomous communities (i. e., regional governments), all of their initiatives incorporate technologyand procedures compliant with the action Digital Libraries of the EU’s VII Framework Programme.

Global access to knowledge is one of the most interesting challenges for librarians at the moment. Network cooperation at the local, regional, national and international level is essential to achieve this goal. The Ministry of Culture’s library policy in recent years has allowed for the creation of the needed cooperation structures so that all administrations and all types of libraries can collaborate together in projects and initiatives targeted at the joint development of their networks and systems, which provides for the acknowledgement of libraries as key democratic institutions in education, cultural, social and research and development policies.

Peptide receptor radionuclide therapy (PRRT) is an established treatment in advanced neuroendocrine tumors (NETs), which overexpressed somatostatin receptors. However, after progression there are a limited number of available treatments. We want to share a case report about a patient with a NET re-treated with 177Lu-DOTATATE and a literature review about salvage treatment with PRRT. We present a 26-year-old man who started with pelvic pain and after a biopsy of a retro-rectal mass observed in a magnetic resonance was diagnosed with an advanced neuroendocrine tumour. After progression to lanreotide, everolimus and sunitinib, treatment with 177Lu-DOTATATE was initiated, achieving an excellent response with a progression free survival (PFS) of 38 months. At the time of progression, re-treatment with 177Lu-DOTATATE was decided, showing a new partial response, which is currently stable after 15 months. The patient had not presented significant treatment-related toxicity. Although there are no randomized phase III trials or a consensus about the number or dose of cycles, there is evidence about the efficacy and low toxicity of salvage treatment with 177Lu-DOTATATE in NETs. Median progression-free survival ranges from 6 to 22 months. Toxicity is mostly hematologic (anemia and neutropenia), 4-7% grade 3/4.

Background: Some studies have suggested a higher risk of respiratory complications related to COVID-19 (C-19) in cancer patients (pts), but there is a lack of knowledge concerning the outcomes and prognostic factors We evaluated whether various factors can predict a more serious C-19 infection Methods: We conducted a retrospective study including 51 pts diagnosed of C-19 between March 10 and April 7, 2020 All pts present tumor disease at diagnosis of C-19: advanced disease, neoadjuvant treatment (ttm) or maintenance ttm after definitive chemoradiotherapy It has been evaluated whether certain factors may present an increased risk for the development of a SCE, defined as death, the need of high oxygen flow (FiO2≥50%), non-invasive or invasive mechanical ventilation or Intensive Care Unit admission These factors have been age, ECOG, ttm line, type of ttm, time from last ttm to C-19 diagnosis, smoke, hypertension, diabetes mellitus, chronic obstructive pulmonary disease, cardiopathy, body mass index, fever, cough, dyspnea, myalgia, gastrointestinal symptoms, infiltrates in chest radiography, CURB65 ≥1, creatine phosphokinase, lactate dehydrogenase and D-Dimer elevated, lymphopenia and PaO2/FiO2

Aims To prove if there is clinical inertia in the identification and treatment of episodes of breakthrough cancer pain (BTcP), comparing actual results from clinical practice with clinical oncologists’ prior perception. Design Observational and descriptive study, using information collected by practising medical oncologists, at three moments: (a) questionnaire regarding their professional judgement of the handling of patients with BTcP in their practice, (b) cross-sectional clinical screening, to detect possible existing cases of BTcP in a representative sample of their patients, (c) retrospective self-audit of clinical case histories of patients diagnosed with BTcP to find out about how it has been handled. Participants and study period A random sample on a state level of 108 specialists in medical oncology. 540 patients who suffer some type of cancer pain on the designated study date for each specialist (July–December 2016). Results The global prevalence of BTcP in the study sample covered 91.3% of the patients who were suffering some type of cancer pain. Barely 2% of the doctors surveyed suspected figures around this mark. 40.9% of the cases had not been previously detected as BTcP by their doctors. Although 90% of the patients who had previously been diagnosed with BTcP received a specific analgesic treatment for the symptoms, 42% of those patients with known BTcP were not able to control their episodes of pain. Conclusions Clinical inertia is a serious problem in the handling of BTcP in medical oncology services, where it is the subject of a significantly low level of detection and treatment, despite the contrasting perception of specialists. pre-print 339 KB

[Purpose]: Breakthrough cancer pain (BTcP) has been shown to be a prevalent and poor prognostic factor for oncologic patients, which remain under diagnosed and undertreated. In 2012, the Spanish Society of Medical Oncology (SEOM) published a clinical practice guideline (CPG) for the treatment of cancer pain which specifically addressed the management of BTcP., [Methods]: Fundación ECO designed a qualitative study using an Internet-based survey to investigate the attitudes toward, compliance with, and use of SEOM Guideline., [Results]: A total of 83 oncologists with a mean experience of 13 years responded. Overall, 82% were aware of different guidelines to manage BTcP. Notably, attitudes toward guidelines were highly positive and there was nearly unanimous agreement that CPG provided the best scientific evidence available (99%), on the minimum information to be gathered for the medical history (100%), on the need for a specific treatment for BTcP (100%), and fentanyl as the first-choice drug (99%). Interestingly, there were discrepancies between what oncologists agreed with and what they do in clinical practice. In fact, 87.6% declare full compliance with SEOM guideline, although adherence to registration of BTcP data in medical records ranged from 30.1 to 91.6% (mean 64.5%); therapeutic management compliance was higher ranging from 75.9 to 91.6%. Main barriers identified were time pressure together with vague statements and limited dissemination of the guidelines., [Conclusion]: Despite oncologist’s clinical practice is increasingly guided by GPC, it suffers from limited compliance, at least in part due to suboptimal statements. Improved dissemination and education are needed to enhance guideline implementation., This study was funded by Kyowa Kirin Farmacéutica S. L.U. through Fundación ECO.

Background In 2017, the ECO Foundation (Excellence and Quality in Oncology) completed the EIO-50 project to learn about the diagnostic and treatment criteria of opioid-induced constipation (OIC) in cancer patients. The EIO-Praxis project was designed as a continuation of EIO-50, to learn about the current clinical practice of oncology professionals for the management of patients with OIC (process, follow-up and results). Methods 77 health care professionals (HCP) from oncology units participated in the study. Each investigator collected information from 10 medical records of cancer patients who received OIC treatment, with a total of 770 records. In each center, 6 indicators of its structure were collected and the completion of a questionnaire with 15 questions regarding patient’s follow-up and treatment process was conducted. Results According to healthcare professionals (HCP), an average proportion of 47.5% of cancer patients received treatment with opioids. From these, an average of 44.9% developed OIC. 51.9% of the investigators didn’t follow any guidelines for the management of patients with OIC. The mean age of the patients of the study was 61.6 years old. The mean duration of opioid treatment was 4.9 months, with an average time of 16.5 days from the start of opioid treatment to the appearance of the first symptoms of OIC. Only in 55.1% of the patients, the presence of functional constipation before starting opioid treatment was assessed. Patients of the study presented the following Rome IV criteria symptoms: 82.6% reduced bowel frequency, 52.9% fewer than three spontaneous bowel movements per week, 54.4% development or worsening of straining and stool consistency (54.2%). The majority of the patients were treated with laxatives (76.0%). Oral Peripherally Active µ-Opioid Receptor Antagonist (PAMORA) was also used in 54.8% of the patients. Conclusions Despite new guidelines for the management of constipation in cancer patients were published in 2018, the management of OIC is still insufficient. After laxative failures, the use of PAMORA drugs should be taken into consideration for the management of OIC. Legal entity responsible for the study ECO Foundation. Funding Kyowa Kirin. Disclosure E. Aranda Aguilar: Advisory / Consultancy: Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Merck; Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi. J. Garcia Foncillas: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Research grant / Funding (institution): Merck. E. Diaz Rubio: Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Genomica; Advisory / Consultancy, Speaker Bureau / Expert testimony: Servier; Advisory / Consultancy, Research grant / Funding (institution): Merck Serono; Speaker Bureau / Expert testimony: MSD; Research grant / Funding (institution): Roche; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Sysmex. R. Lopez: Shareholder / Stockholder / Stock options, Licensing / Royalties: Nasasbiotech; Shareholder / Stockholder / Stock options: Mtrap Inc; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: MSD; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Novartis; Advisory / Consultancy: Janssen; Advisory / Consultancy: Lilly; Advisory / Consultancy: Pfizer; Travel / Accommodation / Expenses: PharmaMar; Travel / Accommodation / Expenses: Pierre Fabre. All other authors have declared no conflicts of interest.

Background Malignant bowel obstruction can occur in 18% of cases. SEMS can be an alternative to surgery. BV has been associated with bowel perforation but data on the safety of SEMS for occlusive colon cancer during BV-containing regimens are lacking. Methods Retrospective analysis of 136 patients with malignant bowel obstruction who underwent placement of SEMS between 2012 and 2017 in two hospitals. Chemotherapy and BV-containing regimens, stent-related complications and outcomes were recorded. Results 58 (42.6%) SEMS were placed as a bridge to surgery and 78 (57.4%) as a palliative intent for stage IV disease. 129 patients (94.9%) had a left-sided obstruction. Technical success was achieved in 133 of 136 (98%). Overall, major stent-related complications after two-weeks of insertion were observed in 36 patients (26.5%): Re-obstruction in 18 patients (50%), 11 perforations (30.5%), 5 bleeding (14%) and 2 migrations (5.5%). Complications in the metastatic group (n = 78) 14 (18%) had re-obstructions, 7 (9%) perforations, 4 (5%) minor bleeding and 2 (2.5%) migrations. Multivariate analysis identified stage IV and chemotherapy as significant risk factors for stent-related complications. Patients who received systemic therapy are more likely to develop complications (OR 1.84; CI95% 1.29-6.22, p = 0.0007). 16 patients received BV, 2 (12.5%) had a perforation. Univariate analysis did not show that BV was more likely to develop perforations, although the incidence was higher in this subset of patients. No differences were observed between chemotherapy alone and BV in overall complications. Kaplan-Meier analysis showed significant longer OS for patients treated with systemic therapy (27 vs. 11 months, p = Conclusions Placement of SEMS is effective and relatively safe but, with an overall complication rate of 26%. The major early risk is perforation that can increase up to 12% during BV treatment. In patients with obstructing advanced colorectal cancer that would benefit from SEMS, we should consider the risks associated with systemic therapies, taking into account the improvement in survival with BV. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.