bluuebunny/crossref_metadata_2025_split huggingface dataset:
Multicentric ipilimumab experience in Turkish patients with metastatic melanoma: MIPI-TURK.
Authors: Sevinc Alper , Turna Hande , Ozdogan Mustafa , Buyukberber Suleyman , Demir Gokhan , Gokmen Erhan , Mandel Nil Molinas , Paydas Semra , Akbulut Hakan , Celik Ismail 
Published: March 2020

e19024 Background: Ipilimumab, an anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen) monoclonal antibody has been shown to enhance immune responses and induce durable clinical responses in patients with metastatic melanoma. The authors report retrospectively on metastatic melanoma patients treated under Expanded Access Program in Turkey among 13 centers. Methods: Patients with metastatic melanoma were treated with ipilimumab 3 mg/kg for 4 doses on weeks 1, 4, 7, 10 as induction. Response evaluation was done on week 12. Patients with complete response (CR), partial response (PR) and stable disease (SD) at week 12 were eligible for re-induction. Results: A total of 75 patients enrolled with 70 evaluable. Ipilumumab treatment was given as 2nd, 3rd and 4th line in 20.0%, 64.3% and 15.7% of patients respectively. The numbers of patients receiving ipilimumab for 1, 2, 3 and 4 doses were 9, 12, 13 and 36, respectively. Seven of 70 patients were eligible for re-induction. G1/2 adverse events were reported in 32.8% (23/70) of patients whereas G3/4 was 14.3% (10/70). The most common G1/2 immune related adverse event was skin rash (14.3%) followed by muscle weakness (10.0%) and gastrointestinal side effects (8.6%). There were seven G3 side effects (diarrhea in 4, muscle weakness in 1, hypothyroidism in 1 and GI bleeding in 1 patient). There was one reversible G4 thrompocytopenia and two deaths were associated with hepatic AEs. Thirty-six of 70 patients (51.4%) completed 4 doses ipilimumab treatment were available for response evaluation. There was no CR. The disease control rate (DCR) was 36.1% (PR: 8.3% and SD 27.8%). Median time to progression (TTP) was 2.7 months (95% CI, 2.1-4.2 months). Median overall survival was not reached with 61.3% of patients surviving within 12 months of follow up period. Conclusions: As a conclusion, ipilimumab treatment resulted in favorable clinical benefit for metastatic melanoma patients. Data generated by our 13 centers revealed an efficacy and safety profile consistent with the currently avaliable knowledge.
Prognostic significance of metastatic cascade in melanoma.
Authors: Kidner Travis Brad , Yoon Jeong Lim , Faries Mark B. , Morton Donald L. 
Published: March 2020

e19029 Background: The ability of metastases to spawn subsequent generations of metastatic lesions is controversial, and its prognostic significance is unknown. We hypothesize that melanoma metastases that have spread to draining lymph nodes will have a worse prognosis than those that have not. Methods: One hundred consecutive patients who had undergone pulmonary resection for metastatic melanoma and who had concomitant hilar and/or mediastinal lymph node evaluation available were identified. Patient demographics, tumor characteristics, mediastinal lymph node status, and overall survival were analyzed. Results: 100 patients (71%) were male and the mean age at metastasectomy was 55 years (mean age at diagnosis 47 years.) The average Breslow thickness was 2.43mm (range 0.46 – 20.55). Twenty-one (21%) of the patients had evidence of metastatic disease present in regional lymph nodes during pulmonary resection. The 5-year overall survival for patients with positive mediastinal lymph nodes was 16% versus 36% with node negative disease (p=0.0005). On multivariate analysis, age at pulmonary resection (HR 1.018, 95% CI 1.002-1.035) and regional lymph nodes status (HR 3.203, 95% CI 1.774-5.781) were found to be independent prognostic indicators of 5-year overall survival. Conclusions: Regional lymph node status is an important prognostic factor in patients with pulmonary metastatic melanoma, and regional nodal assessment should be considered during metastasectomy. The metastatic cascade appears to be a strong prognostic factor in melanoma.
Neuropsychiatric side effects of high-dose IL-2 on patient with advanced melanoma or renal cell carcinoma.
Authors: Ray Vani , Guan Ran , Treisman Jonathan S , Nilakantan Vani , Chen Han Yang , Sinha Ishan , Offutt Julie 
Published: March 2020

e19030 Background: Treatment of patients with end stage renal cell carcinoma (RCC) or melanoma remains difficult. Immunotherapy with high-dose bolus interleukin (IL-2) is the first biological product clinically approved for the treatment of these cancers. Although effective in 15-20% of patients, high-dose IL-2 treatment has significant neuropsychiatric side effects that mandate treatment cessation. Currently, there is little information available on patients who are prone to these neuro-psychiatric side effects. The main objective was to investigate whether occult brain metastases predispose the patient to developing neuro-psychiatric side effects. Methods: We performed retrospective medical chart reviews of patients who had either RCC or malignant melanoma. Variables considered include patient demographics, cancer type, IL-2 treatment, response to treatment, location of metastasis, prior surgery, prior psychiatric history, and substance abuse. We conducted multivariable log-binomial regression analyses to examine the association between risk factors and neuro-psychiatric side effects. Results: Our study population included 261 cancer patients, among them 54% had melanoma (N=141) and 31% had post neuro-psychiatric disorders (N=81). We found that nicotine abstinence in past smokers (remission) was significantly associated with increased neuro psychiatric side-effects (RR=1.88, P=.015) among melanoma patients, but not RCC patients. The multivariable regression analysis showed that having pre-existing psychiatric disorders was the only factor significantly associated with neuropsychiatric effects (aRR=1.92, P<0.0001), after adjusting for potential confounders. Having brain metastasis, however, was not significantly associated with neuropsychiatric effects (aRR=1.10, P=0.627). Conclusions: Contrary to our original hypothesis, prior psychiatric history was the only significant factor predisposing patients to develop neuro-psychiatric side effects during IL-2 treatment and not occult brain metastases. Future studies with larger patient numbers and longitudinal design will help to refine the findings from this research.
Systemic therapy in advanced cutaneous squamous cell carcinoma (CSCC): The Roswell Park experience.
Authors: Jarkowski Anthony , Hare Ryan B , Loud Peter , Skitzki Jospeh J. , Kane John Michael , Salerno May Kilian , Zeitouni Nathalie , Nestico Jill , Vona Karen L , Groman Adrienne E. , Khushalani Nikhil I. 
Published: March 2020

e19041 Background: Treatment of locally advanced unresectable (LAU) or metastaticCSCC (mCSCC) is sub-optimal with a paucity of robust data on systemic therapy. Platinum or fluorouracil-based chemotherapy is commonly used. This retrospective study aimed to evaluate the efficacy and outcomes of patients (pts) with LAU or mCSCC treated with systemic therapy. Methods: Records ofpts with CSCC treated with systemic therapy from Jan ‘01 – Jan ‘11 were reviewed. Response was assessed using WHO criteria. Descriptive results were assessed using Wilcoxon Rank Sum test for ordinal responses and Pearson Chi-square test for categorical responses. Survival was calculated by the Kaplan-Meier method. Results: Of 28 pts identified, 25 pts (M:F – 18:7), median age 66 yrs (39, 85) had required data for final analysis. 11 pts (44%) had facial primary tumors (including 7 of the external ear). 19 pts (76%) had LAU and 6 pts had mCSCC. 17 pts (68%) received multi-agent 1st-line chemotherapy (CT). 72%, 76% and 48% pts received platinum, taxane or cetuximab respectively as part of their regimens. 14 pts got 2nd line therapy and 4 pts received concurrent radiation therapy. Partial response (PR) was 44% and 24% pts had stable disease (SD) for a disease control rate of 68%. With a median follow-up of 42.8m, the median progression-free (PFS) and overall survival (OS) were 5.5m (2.3, 13.2) and 10.9m (5.3, 21.3) respectively; 3-yr OS was 22%. Pts with WHO response had improved PFS (20.8m; 4.4, NR; p<.0001) and OS (37.5m; 10.3, NR; p=.0003) compared to pts with SD/PD (PFS 2.7m; OS 5.9m). Use of platinum-based therapy significantly improved PFS and OS, while taxanes and cetuximab had no impact in this small cohort. 91% (n=10) of pts who had a PR received a platinum drug. There was no difference in PFS or OS between face and non-face primary site CSCC and multi-agent versus single agent therapy. Conclusions: Platinum-based therapy remains a standard option in advanced CSCC management. Agents to improve response rates are needed and future trials should address the role of other therapies in CSCC, including novel targeted and CT combinations.
DTIC and GM-CSF in the treatment of patients with metastatic melanoma.
Authors: Barber Beth , Zhao Zhongyun , Wang Song , Wagner Volker Jean 
Published: March 2020

e19045 Background: To describe patients with metastatic melanoma being treated with mono-therapy, dacarbazine (DTIC) or granulocyte-macrophage colony-stimulating factor (GM-CSF). Methods: Using a large U.S. medical claims database, patients were identified between 2005 and 2010 using ≥2 melanoma diagnoses (ICD-9-CM: 172.xx, V10.82) and ≥2 diagnoses for metastasis (ICD-9-CM: 197.xx, 198.xx). Patients who received mono-therapy with DTIC or GM-CSF as the first documented drug therapy after metastatic diagnosis were identified. Patient demographic and clinical characteristics and treatment duration were compared between patients treated with DTIC and those who received GM-CSF. Furthermore, comparisons were also made between the two treatment groups after 1-to-1 matching on age, gender, and baseline comorbidities. Results: A total of 81 patients with metastatic melanoma receiving first-line DTIC and 24 patients with metastatic melanoma receiving first-line GM-CSF were included in this analysis. On average, DTIC patients were 8.5 years older (p = 0.009) and had higher baseline Charlson Comorbidity Index scores (D0.43, p = 0.005) than GM-CSF patients. The mean duration of first line treatment was 94 days on DTIC and 135 days on GM-CSF. The mean length of follow-up from the start of first line was 257 days on DTIC and 451 days on GM-CSF. After each GM-CSF patient was matched with a DTIC patient on age, gender, and baseline Charlson Comorbidity Index score, the mean duration of first line treatment was 79 days on matched DTIC and 135 days on GM-CSF, and the mean length of follow-up from the start of first line was 317 days on matched DTIC and 451 days on GM-CSF. Conclusions: Patients with metastatic melanoma who received DTIC treatment were older and had higher comorbidity index scores but shorter treatment duration than those who received GM-CSF; the difference in treatment duration remained after DTIC patients were matched with GM-CSF patients on age, gender and comorbidity index scores.
Immune monitoring of phase II trial of hu14.18-IL2 for patients with metastatic melanoma.
Authors: Albertini Mark R. , Hank Jacquelyn A , Gadbaw Brian Christopher , Kostlevy Jordan , Haldeman Jennifer , Gan Jacek , Kim KyungMann , Eickhoff Jens C. , Gillies Stephen , Sondel Paul M. 
Published: March 2020

e19047 Background: Phase I testing of the hu14.18-IL2 immunocytokine (IC) in patients (pts) with melanoma showed immune activation, reversible toxicities, and a maximal tolerated dose (MTD) of 7.5 mg/m2/day. Methods: In this phase II study, 14 metastatic melanoma pts were scheduled to receive hu14.18-IL2 at 6 mg/m2/day as 4-hour intravenous infusions on days 1, 2 and 3 of each 28 day cycle. Pts with stable disease (SD) or regression following cycle 2 could receive 2 additional treatment cycles. The primary objective was to evaluate anti-tumor activity and response duration. Secondary objectives evaluated adverse events and immunologic activation. Results: All pts received 2 cycles of treatment. One pt had a partial response (PR) [1 PR of 14 pts = response rate of 7.1%; confidence interval 0.2%-33.9%] and 4 pts had SD and received cycles 3 and 4. The PR and SD responses lasted 3-4 months. All toxicities were reversible. Analysis of serum IC for all pts showed a mean value of 1.42 ug/ml on C1D1 and 1.38 ug/ml on C1D3. Pts had a peripheral blood lymphocytosis on day 8 and increased C-reactive protein (CRP). A significant increase in sIL2R levels was seen in all courses from baseline to day 3 (p<0.001 for both courses 1 and 2). Infusion of the IC into these pts enabled their serum to mediate antibody dependent cell-mediated cytotoxicity using the circulating IC. Eight pts developed a “positive” anti-idiotype antibody against hu14.18-IL2 based on a bridging assay, and 13 developed a detectible anti-idiotypic antibody based on a binding inhibition assay. There was no significant effect of this anti-idiotypic antibody response on the in vivo level of hu14.18-IL2. While one PR in 14 pts met protocol criteria to proceed to stage 2 and enter 16 additional pts, we suspended stage 2 due to limited availability of hu14.18-IL2 at that time and the brief duration of PR and SD. Conclusions: We conclude that subsequent testing of hu14.18-IL2 should involve melanoma pts with minimal residual disease based on compelling preclinical data as well as the confirmed immune activation with some antitumor activity in this study. In addition, the demonstrated immunological activation of hu14.18-IL2 with manageable toxicities suggests the potential for combination treatments.
Evaluation of mobile gamma camera imaging in sentinel lymph node biopsy for melanoma independent of pre-operative lymphscintigraphy.
Authors: Judge Joshua Marshall , Slingluff Craig L. , Dengel Lynn Thacher , Williams Mark , Popovic Kosta 
Published: March 2020

e19062 Background: Sentinel lymph node biopsy (SLNB) is the standard method for staging cutaneous melanoma and involves identifying the first node(s) draining a tumor, by detecting an intradermally-injected radioactive colloid tracer. Intra-operatively the sentinel node(s) are identified with a hand-held gamma probe. Pre-operative lymphoscintigraphy is obtained to identify draining lymph node basins, but requires coordinating schedules between nuclear medicine and the operating room. A pilot study utilizing Mobile Gamma Camera (MGC) devices in conjunction with conventional lymphoscintigraphy for intraoperative sentinel node localization provided clinical benefit in 20% of patients. However, utilizing MGC devices to localize lymph node basins at the time of surgery independent of conventional lymphoscintigraphy with a fixed gamma camera (FGC) has not been adequately studied. Here, we present the results of a clinical trial utilizing MGC devices to localize lymph node basins in a manner blinded to the FGC images in order to compare the modalities directly. Methods: In 2011-12 18 patients underwent Tc99 sulfur colloid lymphoscintigraphy, and MGC survey immediately pre-operative by the study surgeon. The study surgeon established an operative plan using the MGC survey, while blinded to lymphoscintigraphy results. SLNB was then performed with use of a gamma probe and intra-operative MGC imaging. Results: 22 lymph node basins were detected in 18 imaged patients by lymphoscintigraphy. All of these basins were identified by the study surgeon using the MGC device in the pre-operative setting prior to un-blinding. In every case the operative plan established based on pre-operative MGC imaging was confirmed by the FGC images. In two cases, additional information from the MGC images aided surgical decision-making. 5 of 22 lymph node basins were positive for metastasis. All of these basins were identified by pre-operative MGC imaging, and all individual positive nodes were identified by intra-operative MGC imaging. Conclusions: Pre-operative MGC imaging in sentinel lymph node biopsy can provide comparable information for operative planning, compared to standard FGC imaging.
Ambulatory serial drainage of ascitis or pleural effusion by a multiperforated catheter port system.
Authors: Polycarpe Emmanuel Mohandas , Meunier Katy Luce 
Published: March 2020

e19500 Background: Symptomatic pleural effusion or recurrent ascitis effusions are frequent in end-stage malignancies, induce serial drainage and impair quality of live. Methods: We report our experience with a multiperforated 10 Fr silicone catheter totally implanted in pleural or peritoneal cavities, by Seldinger access, connected to a subcutaneous port system surgically implanted, with local anaesthesia. To avoid tumour seeding along the catheter , it is used a purse string technique to water-tight the entry point of catheter. Patient on demand serial drainage of serosal effusion by percutaneous access to the port can be performed in outpatient department. To reduce risk of device obstruction, we rinse with saline serum under pressure to generate a turbulent outflow to flush any deposit after drainage. Results: Between January 2008 and April 2010, 28 patients underwent implants of 12 peritoneal and 18 pleural (2 bilateral) implantable multiperforated catheter port systems with a prospective follow up. There were 10 men and 18 women with a mean age of 64 years (range: 39-84 years). Primary malignancies were breast (9), pancreas (4), ovarian (4), stomach (2), endometrial (2), kidney (2), skin melanoma (2), prostate (1), peritoneum (1), and lymphoma with cardiac insufficiency (1). Twenty-seven patients obtained partial or complete relief of their symptoms. The number of aspirations performed was between 2 and 25 over a period of 8 to 454 days for 2,560 days of catheter implantation. Eight patients died within 3 weeks after placement of the system and 6 survived more than 6 months. One case of pneumothorax has been diagnosed after early symptoms recurrence and successfully aspirated throw the port. One case of infection of pleural fluid had been detected by systematic bacteriological sampling without clinical manifestation. One case of port infection was du to a previous asymptomatic infection of ascitis with multiple fluid collections and requires port removal. No case of tumour seeding or port system obstruction was observed. Conclusions: This outpatient management palliative technique is an easy option with high rate of efficacy, safety and comfort to control symptoms induced by pleural or ascitis recurrent effusion.
Distress screening and follow-up: Multidisciplinary routine toward a personalized approach.
Authors: Bergerot Cristiane Decat , Buso Marco Murilo 
Published: March 2020

e19504 Background: Cancer care still fails to address psychosocial problems, which can compromise the effectiveness of health care and thereby adversely affect cancer patients. The present retrospective study explores a routine of distress screening, followed by a multidisciplinary discussion, in order to devise strategies for intervention and treatment. Methods: Over two years, 328 patients from a private cancer center, located in Brasilia, the capital of Brazil, participated in a longitudinal study. They were evaluated three times over a 6-month period using the Distress Thermometer and the Hospital Anxiety and Depression Scale. The data of each evaluation were discussed between oncologist assistant and psychologist, establishing appropriate intervention. Descriptive statistics, Pearson’s correlation and a logistic regression were employed to analyze the data. Results: There was a prevalence of female patients (64%). They were between 18 - 86 years (M = 54.7, SD = 15.8). Gastrointestinal (28%), breast (23.8%) and hematologic cancer (22.6%) were the main diagnosis, being 29% with early disease stage and 59.1% with late stage. The distress level progressively decreased along the evaluations: first day (55.8%), middle (27%) and last day of chemotherapy (13.4%). The same decrease occurred in anxiety and depression scale. There was a significant association (p < .001) between distress vs. anxiety and distress vs. depression over phases of evaluation: first day (r = 0.8, t(328) = 21.6; r = 0.8, t(328) = 16.2; R2 = 0.85), middle (r = 0.8, t(285) = 18.4; r = 0.8, t(285) = 20.9; R2 = 0.86) and last day of chemotherapy (r = 0.8, t(261) = 14.7; r = 0.8, t(261) = 20.8; R2 = 0.82). The incidence of distress shows to be related to anxiety, depression, gender, emotional and physical problems. Conclusions: Preliminary results suggest that distress, anxiety and depression scores tends to reduce during the 6-months period of evaluation. This results support the multidisciplinary discussion in order to propose the best intervention and treatment tailored to each case, being more assertive. In our experience we note the importance of distress screening and the health team integration to understand patient's experiences and to improve cancer care.
Retrospective study of febrile neutropenia.
Authors: Martinez Lago Nieves , Vieito Maria , Anido Urbano , Candamio Sonia , Lopez Rafael , Barón Francisco J. , Vidal Yolanda , Aguin Losada Santiago , Campos Marta Carmona , Rodriguez Lopez Carmela , Leon Luis , Varela Ponte Rafael 
Published: March 2020

e19505 Background: Although its mortality has decreased in the last years, neutropenic fever is still one of the most important oncological emergencies. Methods: We have assessed the epidemiological data on patients admitted or evaluated for neutropenic sepsis in a third level cancer center from January 2009 to December 2010. Results: We have found 68 patients who had at least one episode of febrile neutropenia, of them 66% were male and 34% female, and the mean age was 59 years. The performance status was 0 and 1 in 80% of patients and only 19% percent had serious comorbilities such as renal dysfunction, cirrhosis, diabetes mellitus or chronic pulmonary disease. 36% of our patients had a high risk neutropenic fever per MASCC criteria. The majority of patients were lung cancer (31%) breast cancer (22%); and gastrointestinal cancer (28%) and 53% where treated with palliative intention. The episodes of febrile neutropenia were more frequent in patients in first line of treatment (72%) and first cycle of any treatment (42%). 8% of patients were treated with chemorradiation and 35% of the patients were receiving prophylaxis with GCSF. There was no found the source of the infection in 45% of patients. 25% had positive cultures. The porcetaje of infections with gram-positive and-negative was very similar. Patients were treated with a combination of amikacine and ceftacidime in 63% of times, further addition of vancomicine or antifungical therapies were only needed in minority of patients, 88% percent of patients received granulocyte stimulating factors. The mean duration of the neutropenia was of 2 days. Following chemotherapy treatment doses were reduced in 44% of patients and delayed in 26%. Thirteen percent of patients received secondary prophylaxis with GCSF, treatment regimen changed was changed in only 2% of patients and 29% received no further treatment. Conclusions: The mortality rate was of 3%, and the time of hospitalization was short (mean of 7 days). Febrile neutropenia remains a serious complication that we have to decrease.