Medical Oncology Unit Research Articles

A cross-sectional, comparative, syndromic description of oncological mixed pain in Medical Oncology units in Spain.

The reason cancer pain remains prevalent and hard to classify may be partially explained by the failure to identify neuropathic mechanisms. The objective of this research was to identify the syndromes of cancer pain that may be particularly hard to manage due to their mixed pathophysiology. A series of 384 patients who had cancer of any type, at any stage, and suffered from chronic pain (symptom onset > 3months) were assessed during a routine return visit in Spain. Medical oncologists indicated the presence and pathophysiology of 33 predefined pain syndromes on a per-patient basis. This information was then measured against clinical, psychosocial, and health care-related data to determine which syndromes pose particular challenges. The mean (standard deviation) age of patients was 61.6 (12.6)years, 49.7% were women. Most (82%) had advanced metastatic disease, 68.7% were on second-line or palliative therapies. The worst syndrome was nociceptive, pure neuropathic, and mixed in 34.6, 26.9, and 38.6% of patients, respectively. Any syndrome could be of mixed pathophysiology. Only 10 syndromes were common (≥ 5% of patients). Syndromes related to malignant bone pain and involvement of chest wall structures were the most frequent. Certain syndromes (including tumor-related bone pain, chemotherapy-induced peripheral neuropathies, paraneoplastic pain syndromes, and malignant neuralgias or injury to cranial nerves) can be particularly challenging when they have a mixed pathophysiology, because the neuropathic component is rarely or unevenly considered. Virtually all cancer pain syndromes can present mixed pathophysiology. Certain syndromes can include neuropathic components that are frequently overlooked.

Patients' understanding of clinical research: An Italian cancer patient survey.

Patients' awareness of clinical research and their involvement in clinical trials is of great importance, but it is difficult to estimate the extent of knowledge on the research being undertaken. We evaluated the level of knowledge about clinical research using a self-reporting survey distributed to 967 adult patients with cancer attending the Departments of Medical Oncology and Onco-Haematology Units of IRST IRCCS and 4 hospitals in the region of Emilia-Romagna, Italy. The questionnaire was composed of 10 specific items on research knowledge. Patients responding correctly to at least 8 of the 10 items were considered to have a good understanding of clinical research. The questionnaire was completed by 769 patients (response rate 79.5%). Only 19% of patients were found to have a good understanding of clinical research. Patients with higher education and those who had previous clinical trial experience showed a significantly better understanding. Fifty-three percent of patients said that they would be willing to participate in a trial studying a new drug and 75% expressed an interest in taking part in informative meetings/events about clinical studies. Our results show that patients' understanding of clinical research is limited and highlight an interest in learning more.

Experience with pazopanib in the treatment of metastatic renal cell carcinoma: a monocentric experience.

The aim of the study was to assess the activity and the safety of pazopanib as first-line therapy in patients with metastatic renal cell carcinoma. Between September 2011 and April 2014, 15 patients (8 females and 7 males) with metastatic renal cell carcinoma, referred to the Medical Oncology Unit of Policlinico-Bari, were treated with pazopanib, administered orally at the dose of 800 mg daily. Patients were assessed for activity every three months by computed tomography. The primary endpoint was response rate evaluated by RECIST criteria and progression-free survival. To date, 15 patients have been evaluated for response: 11 (73.4%) achieved a partial response after 3 months of therapy with a median duration of 11.6 months (range, 5-31); 3 (20%) had stable disease with a median of 6 months (range, 4-7). No complete response has been observed. One patient progressed, and the median time to disease progression was 11 months. At a median time of 21 months, 14 patients are continuing therapy with pazopanib, and the benefit achieved has remained unchanged in all of them. The median progression-free survival was 10.52 months. Grade 3-4 toxicity was hypertension in 2 patients. The data confirm other experiences showing the efficacy of pazopanib as first-line therapy in metastatic renal cell carcinoma. The overall clinical benefit rate (partial response + stable disease) was particularly high (>90). There is strong evidence of a long-lasting disease control both for patients achieving partial response and for those with stable disease.

Abstract OT1-03-03: Phase II, open label, randomized, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with operable or locally advanced/Inflammatory HER2-positive breast cancer. ImmunHER trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

Abstract Background: Tumor-infiltrating lymphocytes (TILs) have been reported to be associated with increased therapeutic efficacy of trastuzumab in the (neo)adjuvant setting for HER2-positive breast cancer (BC). Subcutaneous (SC) trastuzumab has been observed to act at different immunologic levels than IV trastuzumab. Therefore, by modifying the modality of administration of trastuzumab, it could be possible to interfere with different pathways of the immune system and exert a favorable immunomodulation in HER2-positive BC. Trial design: In this non-comparative, phase II, neoadjuvant, randomized study, patients will be treated with FEC chemotherapy (fluorouracil 500 mg/m2; epirubicin 75 mg/m2; cyclophosphamide 500 mg/m2) q21 for 3 cycles. Then, they will be randomly assigned in a 1:1 ratio to receive: docetaxel (75 mg/m2) plus pertuzumab (840 mg loading dose, then 420 mg) plus IV trastuzumab (8 mg/kg loading dose, then 6 mg/kg) q21 for 4 cycles (Group A) or, docetaxel plus pertuzumab plus SC trastuzumab (fixed dose of 600 mg) q21 for 4 cycles (Group B). After surgery, study patients will receive trastuzumab q21 x 14 cycles using the same formulation (SC or IV) of the preoperative phase. Eligibility criteria: Patients must have previously untreated, T2-4d primary HER2-positive BC with no metastatic disease. Other inclusion criteria are: age 18 or older; ECOG performance status 0-1; availability of tumor tissue from diagnostic biopsy; normal left ventricular ejection fraction; normal organ and marrow function. Specific aims: The main objective of this trial is to evaluate variations of host immune response parameters to either trastuzumab SC or trastuzumab IV given in combination with pertuzumab and chemotherapy as neoadjuvant treatment of patients with HER2-positive BC. Tumor samples obtained at diagnosis and at definitive surgery will be centrally analyzed for TILs. Blood samples will be also collected during study treatment for tumor-specific lymphocyte cell activity (TLA) analysis. Feasibility, efficacy, safety and health-related quality of life will be also evaluated. Statistical methods: The primary endpoint is post-surgery pathologic TIL rate on residual disease. The threshold for classifying subjects with high TILs, or not, is defined as equal to 15%, according to the median TIL rate observed in primary HER2-positive tumors. Because this is a phase II study with 2 non-comparative arms, Simon's optimal 2-stage design will be used for each of the 2 study groups. For each arm we assume: p1 = 0.4, expected rate of subjects with high TILs on residual disease, p0 = 0.1, lowest limit of the subject rate (alpha= 0.05; beta= 0.20). Present accrual and target accrual: A total of 60 patients (first stage: 16 patients) will be enrolled from multiple institutions. From November 29, 2016 to June 11, 2017, 34 patients have been recruited. Contact information:Dr. Antonino Musolino, MD, MSc, PhD; Medical Oncology Unit, University Hospital of Parma; Tel: +390521702316; Fax: +390521995448; e-mail: amusolino@ao.pr.it. Clinical Trials.gov: NCT03144947. Citation Format: Musolino A, Gori S, Cavanna L, Graiff C, Frassoldati A, Bria E, Bisagni G, Zambelli A, Partesotti G, Brandes A, Bonetti A, Moscetti L, Zamagni C, Rocca A, Generali D, Montemurro F, Gianni L, Tognetto M, Maglietta G, Todeschini R. Phase II, open label, randomized, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with operable or locally advanced/Inflammatory HER2-positive breast cancer. ImmunHER trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC) [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT1-03-03.

Platinum doublets as first-line treatment for elderly patients with advanced non-small cell lung cancer.

More than 50% of patients with advanced non-small cell lung cancer are diagnosed in the elderly. Few prospective clinical data with cisplatin-based chemotherapy are available, and some authors have suggested that a non-platinum single agent should be the preferred form of cure in these patients. The aim of the study was to evaluate the efficacy and safety of first-line chemotherapy based on platinums (carboplatin or cisplatin) plus a third generation compound (vinorelbine or gemcitabine) in elderly patients with advanced non-small cell lung cancer in daily clinical practice. A retrospective analysis of consecutive elderly (≥70 years of age) patients with advanced non-small cell lung cancer treated at our Medical Oncology Unit from February 2005 to September 2011 was performed. A total of 249 cycles of chemotherapy was administered to 62 patients (median age, 72 years; range, 70-81) presenting a median Charlson comorbidity index of 1 and a good ECOG PS (0-1, 52 patients; 2, 10 patients). The median number of cycles/patient was 4, and all 62 patients received a platinum-based doublet as first-line chemotherapy: 57 with carboplatin (92%) and 5 with cisplatin (8%). As best response to the treatment, 19 (31%) partial responses and 20 (32%) stable diseases were observed. Median overall survival was 9.8 months. Toxicity was mild; grade III-IV neutropenia was the most frequently observed side effect in 19 administered cycles (8%). Advanced non-small cell lung cancer in elderly patients can be safely treated with a platinum-based doublet. Observed toxicity is manageable, and overall survival is in keeping with data from the literature.

Outcomes and Prognostic Factors of Small Cell Lung Cancer: A Retrospective Study

Background: Small cell lung cancer (SCLC) is a high grade neuroendocrine tumor, and has aggressive nature, so the majority of cases are presented with extensive disease. SCLC was staged into 2 categories: limited-stage disease (LS-SCLC) and extensive disease (ES-SCLC). Despite SCLC is sensitive to ra-diotherapy and chemotherapy, SCLC has high tendency for rapid dissemina-tion to regional and distant sites. Median survival time ranged from 2 - 4 months in patients with untreated SCLC. Multiagent chemotherapy was the primary treatment for SCLC. Aim of the work: This retrospective study was conducted to evaluate and analyze clinical features, treatment outcome, sur-vival and prognostic factors affecting survival in patients with SCLC presented to Clinical Oncology and Nuclear Medicine department, Chest department and Medical oncology unit in Mansoura Oncology Centre during the period from 2000-2015. Methods: Data of patients were collected from their files. The information obtained included demographic features, treatment received; its toxicity and outcome, survival and its prognostic factors. Demographic data were: age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), smoking status, stage of disease. Data also included disease presentation and metastatic sites. Several factors affecting survival were analysed as age, sex, stage, PS, smoking status and LDH. Results: Sixty-three patients were enrolled in this study. Median age was 56.2 ± 6. Strong male predominance (92.1%) was observed; 84.1% of them were smoker. Thirty six patients (57.2%) were of ECOG-PS of 0 - 1. ES-SCLC was reported in 65% of cases and LDH was high (>1.5 xN) in 47.6%. The most common symptom was chest pain (38.1%) followed by cough (31.8%), weight loss (30%). Fifteen patients had single metastatic site (23.8%) and bone was the most common site of metastasis (reported in 8 patients) followed by brain, lung and liver. 2-year overall survival rate was 35% with median survival time of 14 months. On multivariate analysis, there were significantly higher survival in patients aged < 65 years (P = 0.03), female gender (P = 0.04), LD-SCLC (P = 0.03), good performance status (P = 0.04), low LDH level (P = 0.02) and non-smoker (P = 0.04). Conclusion: This clinico-epidemiologic study provides multiple prognostic factors that have important impact on survival as age, sex, LDH level, stage, smoking and performance status. Larger number of patients and prospective studies are needed to clarify more prognostic factor.

Sustainability of Eribulin Treatment for Patients with Metastatic Breast Cancer: is the Cost of the Drug Related to the Benefit Produced (Effectiveness and Safety)? a Single Center Experience

Objective:To report the clinical outcomes and health care costs of Metastatic Breast Cancer patients treated with Eribulin, in the Medical Oncology Unit of the Messina University. Method:We retrospectively analyzed the costs associated with eribulin treatment in 15 MBC patients from January 2014 to December 2016 at Messina University Hospital. The PFS , ORR , DCR and the average cost of patient therapy were calculated. Result:15 patients were included in this analysis. They had received a median of 4 lines of therapy previously (including adjuvant treatment) and had significant visceral involvement (median 3 organs). A median of 4 cycles of eribulin was delivered. There were partial responses in 20% patients , stable disease status in 14% , and progressive disease in 66% . The median progression-free survival was 15 weeks (3.5 months), ORR was 20%, DCR was 33% . The most frequent treatment-related adverse events were neutropenia (26%), and febrile neutropenia (20%). Therapy for these patients resulted in a cost of euros 158.244,76. Assessing the repayment by the pharmaceutical company equals to euros 20.238,37 for non –responders patients , there is a net cost of euros 138.006,39. Conclusion: Our results have shown that treatment with eribulin applied to patients pretreated in III / IV metastatic line and beyond, so the high percentage of non-responders is determined because of the already expired general conditions at the beginning of treatment. Despite this ,eribulin was shown to be an effective and safe therapeutic option in heavily pretreated patients with MBC. The costs associated with eribulin therapy have shown that payment by result contributes to making the cost of therapy more sustainable by the National Health Service

Pilot study of digital tools to support multimodal hand hygiene in a clinical setting

Digital tools for hand hygiene do not share data, limiting their potential to support multimodal programs. The Christie NHS Foundation Trust, United Kingdom, worked with GOJO (in the United States), MEG (in Ireland), and SureWash (in Ireland) to integrate their systems and pilot their combined use in a clinical setting. A 28-bed medical oncology unit piloted the system for 5 weeks. Live data from the tools were combined to create a novel combined risk status metric that was displayed publicly and via a management Web site. The combined risk status reduced over the pilot period. However, larger and longer duration studies are required to reach statistical significance. Staff and especially patient reaction was positive in that 70% of the hand hygiene training events were by patients. The digital tools did not negatively impact clinical workflow and received positive engagement from staff and patients. The combined risk status did not change significantly over the short pilot period because there was also no specific hand hygiene improvement campaign underway at the time of the pilot study. The results indicate that integrated digital tools can provide both rich data and novel tools that both measure impact and provide feedback to support the implementation of multimodal hand hygiene campaigns, reducing the need for significant additional personnel resources.

Oncology nurse perspectives on the nature and meaning of their positive relationships with seriously ill patients.

42 Background: Inpatient oncology nurses regularly care for patients at or near the end of life. Given increasing attention to risk of compassion fatigue in this setting, we conducted a qualitative study to explore nurses’ perspectives on the nature and meaning of their positive relationships with patients who were seriously ill or dying. Methods: We conducted in-depth interviews with 24 registered nurses (RN)s working on an inpatient medical oncology unit at an academic medical center. We used a semi-structured interview guide to elicit RNs’ descriptions of ‘good’ relationships they had with patients/families with attention to aspects that made these relationships meaningful. Using a framework approach, including an iterative coding process, two team members independently coded all interview data (Kappa = .80) and worked with a multidisciplinary team to identify themes. Results: RNs (95.8% female; 95.8% non-Hispanic white, M age = 32.7 yrs [SD = 10.8 yrs], median yrs as RN = 4.0 [range: 1.5-35.0 yrs]) described specific cases in which they felt they had developed ‘good’ relationships with patients and families. RN descriptions centered on highly intimate and transformative moments in patient/family care. These unique moments occurred in the context of longitudinal nurse-patient relationships in which RNs felt able to 1) facilitate patient/family processing of emotions and disclosure of treatment preferences that they otherwise were not able to process or disclose to other loved ones or clinicians; 2) provide highly-skilled patient-centered care to reduce patient suffering; and/or 3) facilitate patient/family prognostic understanding and peace at the end of life. RNs felt privileged to serve these roles. Memorable transformative moments enriched RNs’ professional identities and inspired their continued work. Conclusions: Inpatient oncology nurse-patient relationships serve distinctive functions for both patient-centered care and RN well being. Results underscore the importance of assisting RNs in managing patient symptoms, forming longitudinal relationships with patients/families, and coping with factors that impede ‘good’ relationships.

Cancer care for migrant patients: the value of a dedicated service

Background: In developed countries, including Italy, the immigrant population with cancer is growing and wide disparities in cancer prevention and treatment have been demonstrated between migrants and native populations. Here we report preliminary data of a project aimed to create a dedicated service for immigrants affected by cancer in order to reduce health disparities in this subgroup of patients (pts) by implementing the right and access to healthcare as an opportunity for integration and social inclusion. Patients and methods: In September 2016, a specific service for migrant oncology pts consisting of a dedicated outpatient clinic was started at our Medical Oncology Unit. From then, any foreign born accessing our hospital with a suspicion or with a diagnosis of cancer was referred to our dedicated clinic. This project is supported by AIOM. Results: From September 1st 2016 to April 30th 2017 a total of 72 pts (20 male and 52 female) accessed our dedicated service. Most pts (66 pts) were from Less Developed Countries (Eastern Europe, Africa, Asia, Central/Southern America), whereas a minority of them (6 pts) was from Developed Countries (United Kingdom, France, Australia, Japan). 52 pts were managed in the outpatient clinic whereas 20 needed hospitalization. The most common diagnosis was breast cancer (36 pts), followed by gastrointestinal (9 pts), genitourinary (8 pts), gynecologic (8 pts), lung (6 pts), head and neck (3 pts), skin (1 pt), and hematologic cancer (1 pt). 53 pts underwent curative surgery, 37 received radiotherapy, (29 in adjuvant/neo-adjuvant setting, 3 with curative intent, 5 in palliative setting), 46 received chemotherapy (27 in adjuvant/neo-adjuvant setting, 3 with curative intent, 16 in metastatic setting) 24 received endocrine therapy (20 in adjuvant setting, 4 in metastatic setting), 10 received best supportive care. Most patients reported that financial, social, and logistical support would help them to comply with the diagnostic-therapeutic pathway. Conclusions: These preliminary results showing high attendance of migrant cancer pts at our clinic suggest that a dedicated service could provide migrants greater access to cancer care. Further multidisciplinary interventions directed to psychologic and social needs of these pts should be implemented, in order to ensure that each migrant have a full access to high-quality health care, without discrimination on the basis of nationality, religion, gender or race.

EMERALD: Emergency visit audit of patients treated under medical oncology in a tertiary cancer center: Logical steps to decrease the burden.

Background:We are a tertiary care cancer center and have approximately 1000–1500 emergency visits by cancer patients undergoing treatment under the adult medical oncology unit each month. However, due to the lack of a systematic audit, we are unable to plan steps toward the improvement in quality of emergency services, and hence the audit was planned.Methods:All emergency visits under the adult medical oncology department in the month of July 2015 were audited. The cause of visit, the demographic details, cancer details, and chemotherapy status were obtained from the electronic medical records. The emergency visits were classified as avoidable or unavoidable. Descriptive statistics were performed. Reasons for avoidable emergency visits were sought.Results:Out of 1199 visits, 1168 visits were classifiable. Six hundred and ninety-six visits were classified as unavoidable (59.6%, 95% CI: 56.7–62.4), 386 visits were classified as probably avoidable visit (33.0%, 95% CI: 30.4–35.8) whereas the remaining 86 (7.4%, 95% CI: 6.0–9.01) were classified as absolutely avoidable. Two hundred and ninety-seven visits happened on weekends (25.6%) and 138 visits converted into an inpatient admission (11.9%). The factors associated with avoidable visits were curative intention of treatment (odds ratio - 2.49), discontinued chemotherapy status (risk ratio [RR] - 8.28), and private category file status (RR – 1.89).Conclusion:A proportion of visits to emergency services can be curtailed. Approximately one-fourth of patients are seen on weekends, and only about one-tenth of patients get admitted.

Survival of patients with Kaposi's sarcoma in the South African antiretroviral treatment era: A retrospective cohort study.

When South Africa (SA) implemented its antiretroviral therapy (ART) programme in 2004, the model for treating HIV-positive Kaposi's sarcoma (KS) patients shifted from symptomatic palliation to potential cure. To evaluate survival and changes over time in AIDS-KS patients treated at a tertiary academic hospital oncology unit (the Steve Biko Academic Hospital medical oncology unit) in Pretoria, SA, in the context of ART availability in SA. We conducted a retrospective review of electronic and paper records of KS patients who accessed cancer care between May 2004 and September 2012. We used Kaplan-Meier survival functions to estimate 1- and 2-year survival, and Cox regression models to identify changes over time and prognostic factors. Our study included 357 AIDS-KS patients, almost all of whom were black Africans (n=353, 98.9%); 224 (62.7%) were men. The median age at cancer diagnosis was 37 (interquartile range (IQR) 30 - 43) years, and the median baseline CD4+ count was 242 (IQR 130 - 403)cells/µL. Most patients received ART (n=332, 93.0%) before or after KS diagnosis; 169 (47.3%) were treated with chemotherapy and 209 (58.6%) with radiation therapy. Mortality was 62.7% lower (adjusted hazard ratio (HR) 0.37, 95% confidence interval (CI) 0.19 - 0.73) in the late (2009 - 2012) than in the early (2004 - 2008) ART period. Receiving chemotherapy (adjusted HR 0.3, 95% CI 0.15 - 0.61) and poor-risk AIDS Clinical Trials Group KS stage (adjusted HR 2.88, 95% CI 1.36 - 6.09) predicted mortality. Our results show that large national ART roll-out programmes can successfully reduce KS-related mortality at the individual patient level. If ART coverage is extended, KS-associated morbidity and mortality are likely to drop.

Abstract 4232: Gastrointestinal stromal tumor: Retrospective analysis of 44 cases of center of reference in eastern Algeria

Abstract Aim: To analyze the clinicopathologic characteristics, prognostic factors, and treatment of gastrointestinal stromal tumors (GISTs). Methods: We conducted a retrospective analysis of all cases of GISTs treated in the Medical Oncology Unit from 2010 through 2015. Results: We analyzed 44 patients with a median age of 49.43 years (17-76 years) with sex ratio 1:1. The main symptom was abdominal pain. Thirty patients had limited-stage disease and 14 patients had metastatic disease. We observed 90% of the immunohistochemistry exams were positive for CD117 (c-Kit+). The most frequent location was in the stomach (45%), the high-risk group was predominant (50%) and the average tumor size is 12.84 cm. Surgery was considered R0 (extensive) in 75% of the cases and the main sites of metastases were liver and peritoneum.25 patients received imatinib 400 mg qDay in adjuvant setting,5 patients in neoadjuvant, 13 patients in palliative and 1 patient had best supportive care. A total of 44 patients were followed up for 1 to 78 months.6 patients (13 %) developed recurrence or metastasis during or after adjuvant treatment. Two patients had surgery after neoadjuvant treatment(40%). 4 patients treated in second line with imatinib 800 mg qDay, 5 patients with sunitinib and 2 patients rechallenged in third line with imatinib 800 mg qDay. Conclusion: Our patients presented mainly in the form of high-risk disease, Surgery is the mainstay treatment when GISTs are localized, Adjuvant therapy is used depending their risk of relapse. In the advanced disease, tyrosine kinase inhibitors have substantially improved the prognosis of GISTs. Note: This abstract was not presented at the meeting. Citation Format: Soufyane Ali Boukhalfa, Tah Filali. Gastrointestinal stromal tumor: Retrospective analysis of 44 cases of center of reference in eastern Algeria [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4232. doi:10.1158/1538-7445.AM2017-4232

How to measure faculty clinical activity in a comprenhesive cancer center.

e18202 Background: The faculty clinical activity in a comprehensive Cancer Center is difficult to measure. Time clinical units is the most common procedure worldwide. In our group we have developed a new system based on the daily real activity of each medical oncologist of our team. Methods: We collected the daily activity from january to december 2016 of each doctor considering different values( from 1 to 4)depending on the complexity of the activity. Follow up visit of a patient (1), treatment visit (2). Clinical trial visit or Inpatient visit (3) and New Patient First visit (4). Then we added all the daily values of each medical oncologist. Results: 2016 Clinical activity growth measured by traditional time methods was consider 31,5%. When we applicated our new method it was 33,4%. The clinical activity of each Oncology Unit changed clearly when we applied our method. For example , breast cancer unit change from 25% to 20 % of the global activity, GI Unit from 47% to 50%, Lung Unit from 13% to 15% . In Genitourinary and Gynecological cancer and Prostate tumor units there are no change. This changes draw the different complexity of each Oncology Unit. It was clearly usefull to get a better information of the real clinical activity of each team and cancer center. Conclusions: This tool can be useful to unifique and compare the different complexity in the clinical activity of Medical Oncology Teams, units and hospitals allocating resources based on this new system.

Retrospective analysis of patients (pts) with metastatic melanoma (MM) showing long-term response (LTR) to vemurafenib (Vb).

e21001 Background: Efficacy of Vb in the treatment of mm has been established. We aimed to analyze characteristics of pts achieving LTR to Vb in order to identify potential predictive factors of prolonged benefit. Methods: We collected information about pts affected by BRAF V600 mutated mm treated with Vb at Medical Oncology Unit of Istituto Nazionale dei Tumori, Milan, Italy, from 09/2010 to 08/2014. LTR was defined as clinical or radiological benefit longer than 14 months (mos). Biological data about circulating lymphocyte subpopulations and CCL2 levels were also determined. Results: 46 pts (26 men, 20 women) were identified. Median age was 58 years. ECOG performance status was 0 in 44 pts. Disease stage was M1a in 14 pts, M1c in 20 pts. 8 pts had high serum LDH levels and 5 brain metastases at baseline. 41 pts harbored BRAF V600E mutation, 5 V600K. Median follow up was 47 mos. 5 pts had received adjuvant interferon; 9 pts had been treated with up to 3 lines for metastatic disease (either chemotx or ipilimumab). According to RECIST 1.1, 22% of pts showed complete response (CR), 50% partial response and 22% stable disease. Notably, all CRs were maintained for more than 2 years. 26 pts progressed, mostly (38%) with brain metastases; 16 of them continued tx beyond progression. Median duration of response was 33 mos, being significantly longer in M1a than in M1c (44 versus 28 mos). Median PFS was 32.5 mos; median OS was not reached. All pts experienced at least 1 adverse event (AE); the AEs were moderate or severe in 22% of cases. 19 pts underwent dose reduction, but no discontinuation due to AEs was observed. After 6 mos of tx, pts with LTRs had less myeloid derived suppressor cells (CD11b+ CD14+) and more memory Th1 cells (CD8+ CXCR3+) if compared with pts not bearing LTRs. The same pts after 1 mo of tx showed lower plasma levels of CCL2, a marker of acquired resistance to Vb. Conclusions: Vb can induce LTRs in a subset of pts with mm also in presence of unfavorable prognostic factors, though M1a pts are more likely to obtain prolonged benefit. Toxicity is frequent, but manageable with limited dose reductions. Exploratory biological analyses suggest an immunomodulatory effect of Vb and the existence of circulating biomarkers of LTR.

Managing pazopanib toxicity in the treatment of advanced soft tissue sarcoma

Background Pazopanib is a multikinase inhibitor registered for the treatment of advanced renal clear cell carcinoma (RCC) and as second or further-line therapy in advanced non-adipocytic soft tissue sarcoma (STS). It is a relatively well-tolerated compound, but, as with many other tyrosine kinase inhibitors (TKI), chronic toxicity may become a challenge that both patient and physician need to take into account when starting treatment. This retrospective study investigated toxicities and their management in STS patients treated with pazopanib in routine clinical practice in Italy. Materials and Methods Data were collected between January 2013 and May 2016 at Candiolo Cancer Institute and Prato Medical Oncology Unit. The primary objective was to describe observed toxicities in a real-life setting, and use this information to inform strategies for adverse event management. Results A total of 43 patients with advanced STS who received treatment with pazopanib were included. Median progression-free survival was 4 months and median overall survival was 18 months. The most common toxicities were fatigue (74.4%), hypertension (72%), hair hypopigmentation (74.4%) and diarrhea (60.5%). Liver toxicities occurred in less than one-third of patients. Severe adverse events, requiring drug interruption, were relatively rare. Conclusions This study confirms the safety and efficacy of pazopanib in pretreated unresectable or metastatic soft tissue sarcoma, and highlights the importance of close follow-up and patient support to improve compliance and treatment duration.

The Symbolic Functions of Nurses' Cognitive Artifacts on a Medical Oncology Unit.

Acute care nurses continue to rely on personally created paper-based tools-their "paper brains"-to support work during a shift, although standardized handoff tools are recommended. This interpretive descriptive study examines the functions these paper brains serve beyond handoff in the medical oncology unit at a cancer specialty hospital. Thirteen medical oncology nurses were each shadowed for a single shift and interviewed afterward using a semistructured technique. Field notes, transcribed interviews, images of nurses' paper brains, and analytic memos were inductively coded, and analysis revealed paper brains are symbols of patient and nurse identity. Caution is necessary when attempting to standardize nurses' paper brains as nurses may be resistant to such changes due to their pride in constructing personal artifacts to support themselves and their patients.

1358P - Evaluation of burnout syndrome and personalized intervention in the medical oncology unit of the Second University of Naples (SUN)

1358P - Evaluation of burnout syndrome and personalized intervention in the medical oncology unit of the Second University of Naples (SUN)

Neutrophil/lymphocyte ratio helps select metastatic pancreatic cancer patients benefitting from oxaliplatin.

High Neutrophil/Lymphocyte ratio (NLR), as a measure of enhanced inflammatory response, has been negatively associated with prognosis in patients with localized pancreatic ductal adenocarcinoma (PDA). In the present study, we aimed at investigating the prognostic value of NLR in two homogeneous groups of chemotherapy-naïve metastatic PDA patients. Patients were treated with either gemcitabine (GEM) or gemcitabine/oxaliplatin (GEMOXA). We also assessed whether NLR could identify patients benefiting from the use of oxaliplatin. Consecutive PDA patients treated at the Medical Oncology Unit of Tor Vergata University Hospital of Rome with either GEM or GEMOXA were included (n= 103). NLR was assessed before and during chemotherapy and correlated with outcome together with common clinical and biochemical variables. Among 17 analyzed variables NLR, Karhofsky Perfomance Status (KPS), d-dimer and erythrocyte sedimentation rate were found to be significantly associated with median Overall Survival (mOS) at the univariate analysis. Only NLR and KPS were independent prognosticator at multivariate analysis, with NLR displaying the highest statistical significance. NLR was also predictive of oxaliplatin activity, as only patients with NLR > 2.5 (cutoff determined upon ROC analysis) derived benefit from GEMOXA over GEM. NLR is both an independent prognostic and predictive factor in metastatic PDA, since only patients with high NLR seem to benefit from the addition of oxaliplatin. NLR may help select patients for whom a particularly poor prognosis might justify more intensive, yet less tolerable, combination regimens.

R09 - Systematic pain evaluation in hospitalized cancer patients in a Medical Oncology Unit: feasibility and utility of pain monitoring by Numeric Rating Scale in cancer pain management

R09 - Systematic pain evaluation in hospitalized cancer patients in a Medical Oncology Unit: feasibility and utility of pain monitoring by Numeric Rating Scale in cancer pain management