bluuebunny/crossref_metadata_2025_split huggingface dataset:
Endostatin combined with chemotherapy as first-line therapy for stage IV melanoma patients: A phase II clinical study
Authors: Cui C. , Chi Z. , Yuan X. , Si L. , Sheng X. , Shen L. , Guo J. 
Published: August 2020

e20003 Background: To observe the efficacy and safety of rh-endostatin injection (Endostar) combined with chemotherapy as first line therapy for stage IV melanoma patients. Methods: From March 2007-March 2008, 20 metastatic melanoma patients were enrolled. Endostar (15 mg d1–14) combined with dacarbazine (250 mg/m2 d1–5) or temozolomide (300 mg d 1–5) and fotemustine (100 mg/m2 d6) were given every 28days. Response, toxicity and progression free survival(PFS) were analyzed. Results: Among 20 evaluable cases, with mean cycle 2.7±0.80, four achieved partial response, six stable disease, with response rate 20.0% (4/20) and clinical benefit rate 50.0% (10/20). The median PFS reached 4.5 months (95% CI: 3.85–6.9 months), overall survival 8.5 months (95% CI: 5.62–8.54 months), with 6 months PFS rate 35% (7/20), and 6 months survival rate 65% (13/20). The Grade 3/4 toxicity was mainly myelosuppression, 40% (8/20). One patient ceased the treatment because of sinus bradycardia. Conclusions: Endostar combined with chemotherapy show its efficacy on melanoma patients and may prolong PFS. No significant financial relationships to disclose.
Correlation between prior therapeutic dendritic cell vaccination and the outcome of patients with metastatic melanoma treated with ipilimumab
Authors: Pierret L. , Wilgenhof S. , Corthals J. , Roelandt T. , Thielemans K. , Neyns B. 
Published: August 2020

e20006 Background: Ipilimumab (Ipi) is an anti-cytotoxic T lymphocyte associated antigen 4 (CTLA4) IgG1 monoclonal antibody active against metastatic melanoma. Ipi acts by reinforcement of CTL-activation trough B7/CD28 receptor stimulation. A pre- existing anti-tumor CTL repertoire, induced by dendritic cell (DC) vaccination, could influence the therapeutic effect of Ipi. The influence of prior DC-vaccination on the outcome of melanoma patients (pts) treated with Ipi at a single center was analyzed to evaluate this hypothesis. Methods: Data were obtained from the medical files of pts treated at the UZ Brussel with Ipi in protocols CA184–022, -025, and the BMS Ipi medical need program. Ipi (0.3, 3 or 10 mg/kg) was administered iv q3 wks x4 q12 wks thereafter. Results: 20 pts (10M/10F; med age 51y, range 28–72) were identified. Prior therapy: autologous DC-vaccine loaded with melanoma associated antigens (14 pts) ± IFN-a2b (9/14 pts), cytotoxic agents (17 pts). Baseline characteristics: AJCC st IV melanoma (20 pts); baseline LDH > ULN (16 pts). Ipi dose: 0.3 mg/kg (4 pts), 3 mg/kg (2 pts), 10 mg/kg (14 pts). Serial LDH measurements were available for 17 pts; 4 types of LDH-response following Ipi administration were observed: increase (11 pts), decrease (1 pt), fluctuation (4 pts), stable (1 pt). Objective response according to mWHO or irWHO: 3 PR, 1 SD, 16 PD. One pt received 0.3 mg/kg of Ipi (CA184–022) and had SD but no LDH response; at PD she received DC-vaccine and subsequently 10 mg/kg Ipi (medical need program) resulting in a fluctuating LDH-response and regression of an orbita-metastasis. Increasing LDH values following Ipi were less often observed in pts with prior DC-vaccination (5/6 pts (83%) without prior DC-vaccination had increasing LDH-values vs 6/12 pts (50%) with prior vaccination). DC- vaccination also correlated with regression of metastases and disease control (3/15 pts (20%) who were vaccinated had a PR/SD vs 1/6 (17%) PR for those who had not received prior DC-vaccinations). Conclusions: These data represent a small sample size from a single institution; however, our results suggests a potential correlation between prior therapeutic DC vaccination and outcomes in advanced melanoma patients treated with ipilimumab. [Table: see text]
Paclitaxel plus carboplatin (PC) in patients with metastatic melanoma (MM): Experience in a single institution
Authors: Diaz Romero C. , Olvera N. , Martínez H. , Mtz Cedillo J. , Cuellar M. , Morales R. , Álvarez M. , Segura B. , De la Garza J. , Aguilar P 
Published: August 2020

e20019 Background: The number of agents active in patients with metastatic melanoma is limited and cure is not an objective for treatment at this stage, so that clinical benefit in these patients is the most important. The aim of the study was to evaluate the efficacy and safety of combination regimen consisting of paclitaxel and carboplatin as second-line chemotherapy, in patients with MM. Based on reports of responses to PC, 17 patients with MM was treated at the National Cancer Institute of Mexico. Methods: We evaluated retrospectively the combination of PC in patients with MM. Data regarding patient characteristics and outcomes were abstracted from medical records of NCI of Mexico from 01/05 to 12/08. The regimen was weekly paclitaxel (at a dose of 80 mg/m2) received on days 1, 8, and 15 of a 21-day cycle and carboplatin (AUC 5) on day 1. Response evaluation was using RECIST and toxicity was according to National Cancer Institute Common Toxicity Criteria. This study was approved by the hospital ethics committee. Results: Seventeen patients with MM were treated with PC. All patients were previously treated (and failed) with dacarbazine (DTIC). Sixteen were assessable for response with three cycles of chemotherapy and seventeen for toxicity. One patient was deemed to be ineligible because they presented severe hypersensitivity reaction to paclitaxel at beginning. Objective partial response were obtained in 4 patients (25%); 8 stable disease (50%) at least four months. No patient had a complete response to therapy. Progression disease was in 4 patients (25%). In 12 (75%) we noted clinical benefit. The median time to disease progression for the entire group was 4.2 months (range, 1–11 mos), with a median overall survival of 8.1 months (range, 5.6–10.5 mos). The toxicity grade 3 reported was thrombocytopenic in 2 patients (11%) and anemia in one patient (6%). Additional patients had reversible toxicities grade 3 including alopecia, nausea and fatigue; 2 of them presented moderate hypersensitivity reactions to paclitaxel. No toxic death was noted. Conclusions: The PC combination appears to be safety and well tolerated in second line chemotherapy in MM, however we need more patients to demonstrate a true clinical benefit, we outcomes are according with other clinical reports. No significant financial relationships to disclose.
Trends in pneumonia (PNA) hospitalization among patients (pts) with chronic lymphocytic leukemia (CLL)
Authors: Jones J. A. , Flynn J. , Moran M. , Lin T. , Byrd J. 
Published: August 2020

e20500 Background: Despite recent therapeutic advances, PNA remains a significant source of morbidity and mortality among CLL pts. We determined population-level estimates for the incidence and outcome of PNA hospitalizations. We further investigated secular trends in care by comparing cohorts before (1994) and after (2004) the widespread use of multiagent chemoimmunotherapy. Methods: Using data from the U.S. Nationwide Inpatient Sample and ICD-9CM diagnosis codes, we identified all non-governmental hospitalizations of CLL pts for a primary dx of PNA in calendar years 1994 and 2004. Admissions were described by pt demographics (age, gender, race) and comorbidity (Charlson index, presence of chronic lung disease). Ten-year prevalence estimates for CLL were obtained from NCI SEER data and used as denominators in incidence calculations. Outcomes studied included need for intubation, in-hospital mortality, and length of stay (LOS). All analyses were sample weighted. Estimates and 95% confidence limits are reported. Results: PNA was the primary dx for 7316 (13.1%) and 7651 (11.2%) CLL pt admissions in 1994 and 2004, respectively. Incidence of PNA admission was similar in 1994 (140/per 1000 pts, 95%CI 130–151) and 2004 (129/per 1000 pts, 95%CI 119–138). CLL pts admitted in 2004 were older (75.7 v. 74.2 years, p<0.001) and more likely to have at least one Charlson comorbidity (67.6% v. 56.2%, p<0.001) or comorbid chronic lung disease (40.6% v. 28.3%, p<0.001) than pts in 1994. Intubation was rare in both cohorts (<1%) and did not significantly differ by year, but in-hospital mortality was significantly higher in 2004 (11.3% v. 8.2%, p=0.005). However, LOS decreased significantly between 1994 and 2004 (9.2 v. 6.4 days, p<0.001). Conclusions: PNA hospitalization rates for CLL pts have not significantly increased over the last decade despite more aggressive therapies, likely secondary to improved supportive care. However, CLL pts hospitalized for PNA are now older, increasingly likely to suffer from chronic medical illness, and significantly more likely to die while in hospital. Therapuetic strategies targeting older pts with significant comorbidities are needed. No significant financial relationships to disclose.
Can prognostic factors identify women receiving anthracycline plus cyclophosphamide-based chemotherapy (MEC) who do not require an NK1 receptor antagonist?
Authors: Warr D. , Street J. C. , Carides A. D. 
Published: August 2020

e20502 Background: Age, alcohol use, and history of sickness associated with pregnancy or motion have been identified as risk factors for chemotherapy-induced emesis. This post hoc analysis addressed two questions: 1) Can prognostic factors identify a low risk group for whom ondansetron (OND) plus dexamethasone [D] alone provide a high level of protection (≥80% no emesis)? 2) Does the NK1 receptor antagonist aprepitant improve antiemetic outcome regardless of emetic risk? Methods: The analysis was based upon outcomes in patients with breast cancer enrolled in a Phase III double-blind, placebo-controlled trial randomized to Day 1 OND 8 mg and D 20 mg before chemotherapy and OND 8 hours later and OND 8 mg bid Days 2–3 vs. Day 1 aprepitant 125 mg PO, OND 8 mg, and D 12 mg before chemotherapy and OND 8 mg 8 hours later and aprepitant 80 mg PO qd Days 2–3. Multivariate logistic regression models were used to assess the impact on emesis of the regimen with aprepitant, and previously reported risk factors, including age (<55 and ≥55 years), ethanol use (0–4 or ≥5 drinks/week), history of pregnancy-related morning sickness, and history of motion sickness, using a modified intent-to-treat approach. Results: 856 patients were assessed for efficacy. Treatment with aprepitant (p<0.0001), older age (p=0.006), ethanol use (p=0.0048), and no history of morning sickness (p=0.0007) were all significantly associated with reduced likelihood of emesis; motion sickness was not a risk factor. The Table below shows the probability of no emesis associated with the presence of 0, 1, 2, or all of these factors in the aprepitant and active control arms. Conclusions: 1) The low-risk group identified by this analysis is of questionable utility because it comprised less than 3% of patients. 2) We could not confirm that motion sickness was a significant risk factor. 3) Aprepitant improved the control of emesis irrespective of the number of risk factors for emesis. [Table: see text] [Table: see text]
Oral morphine gargles: A cost effective approach for pain relief in patients with chemoradiation induced acute oral mucositis in head and neck cancers
Authors: Haritha C. , Shankar V. 
Published: August 2020

e20504 Background: Painful oral mucositis is the most significant dose-limiting toxicity in head & neck cancer patients treated with conc. CT-RT protocol. The purpose of this study is to evaluate the efficacy of oral morphine gargles in reducing the severity of chemoradiation induced mucositis pain & thus, its impact on nutrition, quality of life & cost of supportive care, during the treatment period. Methods: 106 consecutive patients, recruited between May 2006 through Dec. 2007, with adv. head and neck cancers (54 oropharynx, 42 hypopharynx & 10 nasopharynx) were included in the study. All patients underwent treatment under conc. CT-RT (Inj.CDDP 40mg/m2 weekly, RT: 66–70gy/33–35# @200cgy/# delivered by 3D- CRT). Patients who had painful mucositis (RTOG Grade 3 or more) not controlled with magic mouthwash, Tab. Acetaminophen 500mg qds or Tab.Tramdol 50–100 mg tds were randomized into 2 groups: morphine group (MOP) -53 patients & Control group (CON) - 53 patients. Patients in both groups received adjusted doses of oral steroids based on the severity of oral mucositis. While CON group patients were given adjusted doses of tramadol, MOP group patients were assigned to 15ml of 2% morphine gargles administered every 4th hourly. Patients were instructed not to swallow the rinses and to hold the solution in the mouth for 3mins duration. All patients underwent weekly recording of (1) response to pain rated on VAS (2) weight (3) morphine systemic side-effects (4) QOL Questionnaire. Mann-Whitney test and ’T’ Test are used for statistical analysis of the data. Results: Patients in the MOP group had significant lower pain intensity scores, better QOL scores & less weight loss compared to patients in the CON group. The duration of the severe pain was atleast 1 week shorter in the MOP group. Systemic side-effects secondary (nausea, vomiting, constipation) to opiod use were significantly lower in the MOP group. The Cost of supportive care for pain management was less in the MOP group, with greater compliance for the treatment. Conclusions: Morphine gargles, in our experience, is an effective approach for pain relief in patients with CT-RT induced acute mucositis in head and neck cancers thus leading to better nutrition & compliance in the treatment. No significant financial relationships to disclose.
Chemotherapy-induced peripheral neuropathy as a predictor of neuropathic pain in breast cancer patients previously treated with paclitaxel
Authors: Reyes-Gibby C. C. , Morrow P. 
Published: August 2020

e20505 Background: Neuropathic pain (NP) remains difficult to control for a significant proportion of patients with cancer. Chemotherapy induced peripheral neuropathy (CIPN) is postulated as an initial stage to the development of NP. Among breast cancer patients, taxanes, platinum agents, and vinca alkaloids are most likely to cause NP. The purpose of this study was to assess the extent to which those who experienced CIPN (NCI toxicity criteria ≥ grade 2 sensory neuropathy) during paclitaxel chemotherapy were at risk of developing chronic NP, controlling for disease- and treatment-related variables (e.g., stage of disease, location of tumor chemotherapy and other cancer therapies, dose of chemotherapy and duration of treatment), clinical health status (e.g., comorbid conditions), and sociodemographic characteristics (e.g., age, race). Methods: We conducted a follow-up survey of breast cancer patients who previously participated in clinical trials for paclitaxel. Patients were asked if they have ever been diagnosed by the physician or healthcare provider for NP during the survey. Clinical trial data (NCI Toxicity, cummulative dose) were abstracted from a clinical database. Results: Of the 430 potential respondents, 240 responded to the survey. Mean follow-up time was 9.5 years (SD=2.1). Sixty three percent of the respondents had grade 2 or greater sensory neuropathy during their previous treatment with paclitaxel. Follow-up data showed that 18% (43/240) were subsequently diagnosed by their physician to have NP. Logistic regression analysis showed that those with CIPN during the trial were 3 times more likely to having been diagnosed with NP (OR=3; 95%CI=1.2; 7.2; p<0.001), which persisted in the multivariable model. Other variables found to be associated with NP included cummulative dose of paclitaxel, and comorbid conditions such as diabetes and osteoarthritis. Patients with NP reported twice as many visits to their health care provider (p=0.028); had taken more prescription (50% versus 19%; p=0.0001) for pain relative to those without NP. Conclusions: We provide empirical evidence on the importance CIPN as a risk factor for NP in breast cancer patients.Prospective studies with larger cohorts are needed to validate our findings. No significant financial relationships to disclose.
A randomized phase II trial of a new anticoagulant, apixaban, in metastatic cancer
Authors: Levine M. N. , Deitchman D. , Julian J. , Liebman H. , Escalante C. , O'Brien M. C. , Ramirez L. , Weise-Kelly L. , Solymoss S. 
Published: August 2020

e20514 Background: Cancer patients receiving chemotherapy, biologic, and molecular targeted therapies are at increased risk of venous thromboembolism (VTE). Currently available anticoagulants (ACs) are not well suited to prevent VTE in such patients. Vitamin K antagonist oral ACs require frequent lab monitoring and low molecular weight heparins require daily subcutaneous injection. There is concern for bleeding with ACs. Apixaban (A) is a new antithrombotic agent which inhibits activated coagulation Factor X, is taken orally, and does not require lab monitoring. Trials to prevent post-operative VTE in orthopedic surgery showed that A was effective and safe. We wanted to assess the feasibility of A in cancer. Methods: In a randomized phase II trial, patients with metastatic cancer on 1st or 2nd line chemotherapy received study drug once daily for 12 weeks; either 5, 10 or 20 mg of A, or placebo. The primary outcome measure was the proportion of patients remaining free of major bleeding (MB), clinically relevant non-major bleeding (CRNMB), VTE, and grade ≥3 adverse events considered to be probably/definitely related to study drug (AE*). After 125 patients were recruited, the sponsor eliminated further randomization to the 10 and 20 mg arms, to add experience with the 5 mg dose currently under evaluation for VTE prevention in other conditions. Data on the first 125 patients are reported. Results: The study population was 50% male; 88% had ECOG performance status 0 or 1. The most common cancers were breast, colon, pancreas, and myeloma. 23% had liver metastases. Approximately 80% of A patients completed 12 weeks of treatment. The numbers of patients with events were: Conclusions: Apixiban was well tolerated in patients with advanced cancer on chemotherapy. Major bleeding, thrombosis, and drug-related SAEs were very low. These results support further study of A in phase III trials for VTE prevention in cancer patients. [Table: see text] [Table: see text]
Acute palliative care unit in a comprehensive cancer center (CCC): Financial and clinical outcomes
Authors: Elsayem A. F. , Hui D. , Li Z. , Flores M. , Atkinson W. A. , Bruera E. 
Published: August 2020

e20518 Background: Acute palliative care units (APCU) in CCCs improves symptom control for advanced cancer patients and supports their families. However, these services are not available in the majority of cancer centers. Concerns regarding financial reimbursements represent a major barrier for establishing APCUs. The purpose of this study is to report the clinical outcomes and compare the financial outcomes of our APCU as compared to other services at our CCC. Methods: We reviewed all admissions to the APCU over the last 5 fiscal years for demographic information, length of stay, discharges, survival, hospital billings and collection of charges, and compared these to the rest of the institution. Results: 2,510 unique patients were admitted to the APCU. Median age was 59 years (19–101) and 51% were female. The median length of stay in APCU was 8 days (Q1-Q3 6–10). Median survival of patients discharged home, to health care facilities and hospice were 53, 22, and 13 days, respectively (p<0.001, log rank test), with 6 month survival of 20%, 4%, and 2%, respectively. Professional collections ranged from 42–47% of charges for APCU, vs. 32–38% for rest of the CCC and were stable over the 5 year period. Hospital collections were 47–51% of charges for APCU, vs. 55–57% for the rest of the CCC. The payer mix included commercial 1155 (46%), Medicare 755 (30%), Medicaid 126 (5%), mixed 127 (5%), indigent 198 (8%), and others 149 (6%). Conclusions: The ACPU has reimbursement outcomes consistent with the American acute care model and comparable to the rest of the CCC for last 5 years. The APCU is as viable as any other clinical programs in our institution. Further research is needed to investigate possible reasons for lack of APCU in cancer centers. No significant financial relationships to disclose.
Cognition and quality of life after chemotherapy plus radiotherapy (RT) vs. RT for pure and mixed anaplastic oligodendrogliomas: Radiation therapy oncology group trial 9402
Authors: Wang M. , Cairncross G. , Shaw E. , Jenkins R. , Scheithauer B. , Brachman D. , Buckner J. , Souhami L. , Laperriere N. , Mehta M. , Curran W. 
Published: August 2020

e20519 Background: Radiation Therapy Oncology Group 9402 compared PCV chemotherapy plus radiation therapy (PCV+RT) versus RT alone for anaplastic oligodendroglioma. Here we report 1) longitudinal changes in cognition and quality of life, 2) effects of patient factors and treatments on cognition, quality of life and survival, and 3) prognostic implications of cognition and quality of life. Methods: Cognition was assessed by Mini Mental Status Examination (MMSE) and quality of life by Brain-Quality of Life (B-QOL) by repeat assessments. Scores were analyzed for survivors and within five years of death. Shared parameter models evaluated MMSE/B-QOL with survival. Results: For survivors, MMSE and B-QOL scores were similar longitudinally and between treatments. For those dying within 5 years, MMSE scores were stable initially, while B-QOL scores decreased; both declined rapidly in the last year of life and similarly between arms. In the aggregate, scores decreased over time (P=0.0413 for MMSE; P=0.0016 for B-QOL) and were superior with age < 50 years (P<0.001 for MMSE; P=0.0554 for B-QOL) and KPS 80–100 (P<0.001). Younger age and higher KPS were associated with longer survival. After adjusting for patient factors and drop-out, survival was longer after PCV+RT (HR=0.66, 95% CI=0.49–0.9, P=0.0084; HR=0.74, 95% CI=0.54–1.01, P=0.0592) in models with MMSE and B-QOL. There were no differences in MMSE and B-QOL scores between arms (P=0.4752 and P=0.2767, respectively); higher scores predicted longer survival. Conclusions: MMSE and B-QOL scores held steady in both arms for survivors. For those who died, B-QOL scores declined slowly until the last year of life, then rapidly. Younger, fitter patients had better MMSE and B-QOL scores and longer survival. No significant financial relationships to disclose.