bluuebunny/crossref_metadata_2025_split huggingface dataset:
Response to sunitinib in Chinese KIT-mutated metastatic mucosal melanoma
Authors: Zhu Y. , Si L. , Kong Y. , Chi Z. , Yuan X. , Cui C. , Sheng X. , Guo J. , Shen L. 
Published: August 2020

e20017 Background: To investigate the possible relationship between sunitinib response and KIT mutation as well as KIT expression. Methods: We find that a 75-year male patient with KIT-mutated metastatic mucosal (primary: nasal, metastasis: left adrenal gland, lungs and right eye) melanoma has a very good response to sunitinib 37.5mg/d consecutively. We apply IHC sp assay to detect S100, HMB-45, CD117, VEGFR, PDGFR and EGFR in the melanoma sample of this patient. DNA is also extracted from paraffin-embedded melanoma sample of this patient and PCR is carried out to amplify several exons of C-KIT (exon11,13,17,18),B-RAF(exon11, 15) and N- RAS(exon1, 2). PCR products are sent to be directly sequenced. Clinical response, PFS and OS of the patient are evaluated. Results: Strong expression of S100, HMB45, CD117, VEFGR and PDGFR is detected by IHC in the tissue sample of the patient. Furthermore, direct sequencing after PCR reveals that V559A substitution is detected in exon 11 of KIT, with mutation of T into C at 1776, leading to substitution of Valine by Alanine at 559. No mutation was detected in exon 9, 13, 17, 18 of KIT, B-RAF15, 11 or N-RAS1, 2. The patient received sunitinib 37.5mg/d from July 2008 consecutively and evaluated PR (Recist: tumors shrink 70%) lasting for 5 months with Grade II myelosuppression and stomatitis. Now the patient is still alive and received sunitinib. Conclusions: Our case report suggests that response of melanoma patients to sunitinib might be correlated to KIT mutation and expression, and large-scale clinical trial in patients with KIT mutation and over-expression might be useful to shed light on treatment of melanoma patients with individual targeted therapy. No significant financial relationships to disclose.
Metastatic melanoma in the elderly: Case series of clinical outcome and immune characteristics
Authors: Hegde U. P. , Chakraborty N. , Chhabra A. , Ray S. 
Published: August 2020

e20018 Background: Cutaneous melanoma incidence is rapidly rising in the elderly population. Imbalances of the immune system are described due to aging associated changes between CD4+, CD8+, T helper (Th) 1, Th 2 and T regulatory and T effector lymphocytes (lym). We describe clinical outcome in 10 elderly patients (pts) with cutaneous metastatic melanoma (CMM) and results of the immune studies done in a subgroup. Methods: Between October 2002 and October 2008, 10 elderly pts with treatment naïve CMM, 6 males and 4 female, median ages 76, range 57–84 years were treated at the University of Connecticut Health Center. Metastatic sites included soft tissue in 2 patients (pts), lung and/or liver with lymph node (LN) involvement (6 pts) and distant LN metastasis (2pts). Eight pts opted for treatment and received single or combination chemotherapy (5pts), high dose Interleukin 2 (2 pts), complete tumor resection followed by tumor derived heat shock protein vaccine (1 pt on clinical trial) and bio chemotherapy (1pt). One patient declined treatment (included in follow up). In vitro immune characteristics were studied in HLA-A2 positive subgroup (5pts) and included cytotoxic T lym (CTL) generation against self and non self peptides (Mart-1 27–35 and influenza MP derived peptide flu 58–66), proliferative activity of CD4+ lym in response to anti CD3 antibody under Th1 and Th2 conditions and regulatory T lym activity of CD4+CD25+ lym against CTL. Results: All patients tolerated treatments well resulting in 1 complete response, 4 partial responses, and 4 stable diseases. During 6 year follow up period, 6 patients died while 4 patients are living (one with disease). The median survival of all patients is 28.1 month (mo) while in those surviving (4pts) is 72 mo. Immune studies revealed preserved proliferative activity of CD4+ lym with stronger Th1 induction than Th2. The CTL responses to self and non self antigens were preserved while regulatory T lym showed weak activity against CTL. Conclusions: Some elderly patients with metastatic melanoma demonstrate improved outcomes and favorable immune characteristics. Further studies are needed to understand the impact of aging immune system on cutaneous melanoma. No significant financial relationships to disclose.
Use of analysis of iron metabolism with CRP-dependent ferritin index and reticulocyte hemoglobin to determine treatment strategy for chemotherapy-related anemia
Authors: Steinmetz T. , Schmitz S. , Tsamaloukas A. , Rohrberg R. , Thomas L. 
Published: August 2020

e20510 Background: Intravenous iron (IV Fe) can increase the efficacy of erythropoiesis stimulating agents (ESA). However it is still unsettled whether all patients (pts) do so. We conducted a phase II trial to analyze various parameters for the addition of IV Fe to ESA in chemotherapy treated anemic cancer pts. Methods: Pts with an indication for ESA following the EORTC guidelines and a serum ferritin (SF) level ≥20ng/ml were screened in a central laboratory. Those with a C-reactive protein (CRP)-dependent ferritin index (FI = soluble transferrin receptor (sTFR)/log ferritin ratio) above threshold (* FI ≥3.2 if CRP <5mg/l, or FI >2.0 if CRP ≥5 mg/l) were treated with iron only. Those with a sub-threshold FI received Epoetin beta (Epo) 30.000E/wk sc., and from these, those with a reticulocyte hemoglobin (Hb) content (CHr) ≤28pg/ml additionally received Fe-saccharat 200mg/wk iv up to 1g. Results: 11 centers recruited 303 pts (median age 65y, male 41%) from 10/04 to 10/06; 230 (76%) had a sub threshold FI (group Q I+IV), of whom 23 (8%, Q IV) had a CHr ≤28pg. 73 pts (24%) had an increased FI (Q II+III), indicating relative iron deficiency, of whom 27 (9%, Q III) had a CHr ≤28pg. There was no correlation between assignment to one of the groups (Q I-IV) and age, gender, body-mass-index, type or stage of tumor, endogenous Epo level, and hematokrit. In 265 pts evaluable for response Hb on d1 was 9.8 ±1.2 g/dl (mean ± SD) and 10.7 ±1.3 g/dl in 4th week. Mean increase of Hb from d1 to 8th week was 1.4 ± 1.7 g/dl. 36% pts received a transfusion within 12 weeks and 18% after the 4th week. The table shows response according to groups. Conclusions: At study onset we expected nearly all pts to receive Epo and searched for those who might have a benefit from additional IV Fe. However, we conclude in synopsis with other studies, that all pts might have a benefit from IV Fe but only 76%, those with a sub-threshold FI, have a benefit from Epo. [Table: see text] [Table: see text]
Determining the preferred dose of the serotonin antagonist (5-HT3) palonosetron: Results of an individual patient data meta-analysis (MA) of 1,947 patients in all randomized double blinded (RDB) trials
Authors: Lesser M. , Gralla R. , Napolitano B. , Raftopoulos H. , Kline M. , Bria E. , Budman D. R. 
Published: August 2020

e20512 Background: Progress in antiemetic therapy has had a major impact on the administration of cancer chemotherapy (chemo). 5-HT3 agents are among the most used drugs in oncology and are considered the primary agents in guideline-recommended combination antiemetic regimens. Randomized trials have demonstrated advantages for palonosetron (palo) when compared with other 5-HT3 drugs in single agent trials (Ann Oncol 2003, Ann Oncol 2004) and recently in a combination trial with dexamethasone (Yoshizawa, ESMO 2008). With different doses of palo in use, we undertook this MA to determine if efficacy differs for palo doses of 0.75 mg or 0.25 mg. This has an impact on clinical dosing and on guideline recommendations as to whether there should be a preferred palo dose and a preferred 5-HT3 antiemetic. Methods: After a literature search and colleague inquiry, we identified 8 RDB trials; 4 in highly emetic (HEC) and 4 in moderately emetic (MEC) chemo that included treatment arms with 0.25 mg and 0.75 mg of palo; 6 IV and 2 PO trials. Primary endpoint: Complete Response (CR - no vomiting, no rescue) over days 1–5 after chemo. Secondary endpoints: Complete Control (CC - no vomiting, days 1–5); Acute emesis (day 1); Delayed emesis (days 2 - 5); by chemo (HEC / MEC); by other prognostic factors; by side-effects. Logistic regression, stratifying for protocol and including a treatment x protocol interaction term, was first used to test for heterogeneity (Het) of odds ratios (OR). In the absence of significant Het, the protocols were “pooled” in a protocol-stratified analysis. OR>1 favors palo 0.75 mg. Results: Individual patient data were obtained for the 1947 subjects. Half were randomized to palo 0.25. No significant heterogeneity was found for CR or CC. For CR, the pooled OR = 1.00 (95% CI: 0.83–1.20); for CC, OR = 0.99 (95% CI: 0.83–1.89). Similar ORs for CR and CC were found for HEC and MEC, with no Het. Conclusions: We conclude that trials using 0.25 mg or 0.75 mg palonosetron doses yield similar efficacy for CR and CC so that reports with either dose can be used clinically or in guideline considerations. Findings are true for HEC and MEC regimens as well. [Table: see text]
In women with terminal cancer does having a family meeting affect the place of death?
Authors: Shields R. , Young W. , Bilodeau L. , Bergren W. , Dizon D. 
Published: August 2020

e20516 Background: An important objective of the patient self determination act is for patients to see their wishes fulfilled, particularly at the end of life. Studies by Tiernan et al have shown that up to 80% of patients prefer to die at home however only a small proportion of patients actually die at home. Our work on support care networks show that a large proportion of women with cancer rely on multiple persons for health care proxy roles and for primary support. Given this, we sought to determine whether conducting a formal family meeting predicts whether a patient's preferred place of death corresponds with their actual place of death. Methods: We conducted a retrospective review of 105 women seen at Women & Infants’ Hospital within the last 12 weeks of their death and stratified patients between those who had a documented family meeting and those who did not. Results: Seventy-two percent (n= 105) of the study sample had family meetings in the last 12 weeks of life. Of those who had family meetings, 61% of patients whose preference of place of death coincide with their actual place of death (p<0.0001). In the sample of patients whose wishes coincide with their family meetings (n=76), almost 60% died at home and 34% died at inpatient hospice. Of those who did not have family meetings, 89% had unknown preferences of place of death, 48% died at the nursing home, 24% died in the hospital and 24% died at home. These results reached statistical significance (p= 0.001). Conclusions: Women who had a family meeting within the last 12 weeks of life were significantly more likely to die at home or with hospice services as compared to those who did not. This highlights the importance of including a patient's support networks into any communication between those dying from cancer and their healthcare providers. A larger study is warranted to determine whether this experience is specific to women with terminal cancer or is applicable to all patients with cancer facing the end of life. No significant financial relationships to disclose.
Test of weight gain prevention intervention in stage II and III breast cancer patients receiving neoadjuvant chemotherapy
Authors: Basen-Engquist K. , Perkins H. Y. , Carmack Taylor C. L. , Hughes D. C. , Jovanovic J. L. , Arun B. K. , Murray J. L. 
Published: August 2020

e20523 Background: Weight gain is common in women with breast cancer and is worrisome, as may affect prognosis and risk of other chronic diseases. This randomized study pilot tested a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy. Methods: Breast cancer patients receiving neoadjuvant chemotherapy were randomized to a weight gain prevention intervention or a usual care control arm. The intervention used a body acceptance approach, which emphasized changes in diet (low energy density food) and exercise behavior (resistance training) rather than focusing on weight loss. It was administered in weekly sessions delivered in-person and by telephone. Assessments were done at baseline, mid-chemotherapy, pre-surgery, after surgical recovery, after a 9 week post-surgical booster intervention, and 6 months after surgery. The data on weight changes from baseline (T0) to mid-chemotherapy (T1) and presurgery (T2) is presented. Results: 33 participants were randomized the intervention (n=16) or usual care (n=17). Three control participants withdrew before assessments were done. Of the 30 remaining women, 70% had stage II and 30% had stage III breast cancer. Their mean age was 49.7 (SD=12.2), and half were premenopausal. Mean BMI was 29.3 (SD=6.1) and 70% were physically inactive. The sample was diverse with regard to self-reported ethnicity (57% white, 27% African-American, 7% Hispanic, 10% other). Change in weight from T0 to T1 was -0.9 kg in the intervention group and +1.4 kg in the usual care group (n=27, p=0.126); from T0 to T2 the change was -2.0 kg in the intervention group and +0.8 kg in the usual care group (n=20, p=0.056). When weights from a chart review were used for patients with missing assessments the T0 to T2 changes were -2.9 kg for the intervention group and 0 kg for the usual care group (n=30, p=0.065). Conclusions: Based on a preliminary analysis, there was a trend approaching statistical significance for weight loss from a diet and exercise intervention based on the body acceptance approach compared to a usual care control group. These results indicate this intervention should be tested in a larger randomized controlled trial. No significant financial relationships to disclose.
Trastuzumab in the elderly: Is it age or cardiovascular risk profile that really matters?
Authors: Serrano C. , Cortés J. , Bellet M. , Gómez P. , Saura C. , Martínez P. , Pérez J. , Atzori F. , Baselga J. , Di Cosimo S. 
Published: August 2020

e20527 Background: Elderly breast cancer (BC) patients (pts) are usually excluded from clinical trials. Nevertheless, with the increased use of trastuzumab (T) there is a need to assess and predict T-related cardiotoxicity in this population. Methods: Data were collected from women ≥70 years with BC and serial cardiac monitoring treated with T at our institution since 2005. Cardiovascular risk factors (CRF) were analysed together with left ventricular systolic function (LVEF) assessed at baseline and during T. Results: Thirty pts with early (10) or advanced (20) BC, median age 75.7 years (range 70–87), were identified. WHO performance status was 0–1 in 90% of pts. Median duration of treatment was 45 weeks (range 2–87). Basal LVEF was 63.8% (range 46.3–76). Five of 30 pts (16.6%) experienced asymptomatic cardiotoxicity defined as an absolute drop ≥10% with a final LVEF < 50% (13.3%, 4/30 pts) or any absolute drop >20% (3.3%, 1/30 pts). Four of 30 patients (13.3%) developed symptomatic cardiac heart failure. Median time to LVEF decline was 9 weeks (range 3–87). LVEF recovered to normal values in a median time of 4 weeks (range 3–48) in all but one patient. CRF are shown in Table 1 . Pts with T-related cardiotoxicity presented more often with history of cardiac disease (22.2% versus 9.5%), diabetes (22.2% versus 5%) and BMI>30 (68% versus 45%) as compared to the rest. No relevant difference was seen in terms of hyperlipemia, tobacco or hypertension. Previous or concomitant exposure to anthracyclines was not found as a risk factor either. Conclusions: Despite the limited numbers, this series shows that elderly BC pts treated with T experience reversible cardiac events similarly to those already described in younger pts. However, particular attention may be paid to cardiac history, diabetic and obese pts who appear more likely to develop T-related cardiotoxicity. [Table: see text] No significant financial relationships to disclose.
Impact of socioeconomic status on treatment outcome in patients with advanced esophagogastric cancer in Northern Ireland
Authors: Manikyam Y. , Hanna G. G. , Harte R. J. , Henry P. G. , Houston R. F. , Eatock M. M. 
Published: August 2020

e20531 Background: The survival advantage for combination chemotherapy in advanced gastroesophageal adenocarcinoma is well documented. Epirubicin and cisplatin in combination with either 5FU (ECF) or capecitabine (ECX) result in response rates of 35–46% and a median survival of around 9 months in RCT. We report the impact of socioeconomic status on the outcome of ECF and ECX treatment in advanced gastroesophageal cancer patients in Northern Ireland between 2000 and 2007. Methods: All patients with advanced esophageal (O), gastric (G), or esophagogastric junction (OGJ) adenocarcinoma, receiving palliative chemotherapy from January 2000 to August 2007, were identified from our institutional database. Baseline demographics, clinical characteristics, treatment details, and clinical outcomes were recorded. Patients receiving chemotherapy in a clinical trial were excluded. Survival was estimated using the Kaplan-Meier method. Deprivation was assessed using the patient's home address deprivation index (DPI) (Northern Ireland Multiple Deprivation Measure 2005; May 2005. Northern Ireland Statistics and Research Agency. www.nisra.gov.uk ). Results: 274 eligible patients (m=200, f=74, O=114, OGJ=19, G=141) were identified. Median age was 62 years (range 22–83). 172 (62.8%) had ECOG performance status 0 or 1. 231 patients (84.3%) had metastatic disease, 43 (15.7%) had locally advanced disease. 216 (78.8%) patients received ECF and 58 (21.2%) patients received ECX. Overall median survival was 7.3 months. Treatment response and performance status were strong predictors of survival, however disease extent did not influence survival. Median survival was significantly longer in those with DPIs in the upper two quintiles than the lower 3 quintiles (9.5 months vs. 6.8 months, p=0.032). Conclusions: Outcomes achieved with palliative ECF/ECX treatment are similar to the reference clinical trials. Socioeconomic deprivation is significantly associated with reduced survival in this group of patients and is unrelated to disease extent at presentation; however it may be related to nutritional status and comorbidity and requires further investigation. No significant financial relationships to disclose.
Longitudinal analysis of the quality of life (QoL) within a randomized phase III trial: Octreotide versus placebo for the patients having advanced hepato-cellular carcinoma (HCC)
Authors: Dumas F. , Barbare J. , Aparicio T. , Bouché O. , Lombard-Bohas C. , Faroux R. , Seitz J. , Raoul J. , Bedenne L. , Bonnetain F. 
Published: August 2020

e20537 Background: The primary objective of this ancillary study is to longitudinally compare QoL. Secondary objective was to explore definitions of time until definitive deterioration (TUDD) of QoL scores according to minimal clinically important difference cut off (MCID). Methods: Inclusion criteria were age > 18 years, diagnosis of HCC with CLIP 0 - 3 and to be ineligible for curative treatments. Patients (pts) were randomized 1:1 to receive octreotide (30 mg, every 4 weeks for 2 years or until death) or placebo (2 mL NaCl). QoL was evaluated using EORTC QLQ-C30 every 4 weeks up to 24 months. We focused analyses on the following scores: Global Health (GH), Mental Health (EF), Physical Health (PF) and Pain (P). Firstly mean differences of QoL scores between last available measurement and inclusion were compared using Wilcoxon test. Secondly TUDD were estimated using Kaplan Meier, and compared using log-rank tests. They were defined as the time interval between randomization and the first occurrence of a decrease in QLQ-C30 score of ≥ 5 points without any further improvement in QoL score of ≥ 5 points or any further available QoL data. These analyses were repeated using a 10 points MCID, and by including deaths as event. Results: Between July 2002 and October 2003 135 pts in octreotide and 137 pts in placebo arm were included. Mean differences of QoL did not differed between octreotide and placebo arm. Using a 5 points MCID, TUDD of GH score is significantly longer in the placebo group (stratified log rank p= 0.033); median was 2.3 (95% CI: 1.37–3.66) vs 4 months(2.23–5.7). Using a 10 points MCID, TUDD of GH score differed, median time was 2.5 (1.9- 3.73) for the octreotide and 4.7 months (2.73 - 5.8) for the placebo group (stratified log rank p=0.026). Including death as event for a 10 points MCID, median was 2.4 (1.83–3.17) for octreotide and 4.1 months (2.5–5) for placebo group (stratified log rank p=0.012). Conclusions: These results suggest that octreotide could have a negative effect on global QoL. We have investigated QoL analyses modalities using survival techniques dealing with binding drop out missing data and with an easier clinical interpretation of results. No significant financial relationships to disclose.
Use of advanced care directives by ambulatory chemotherapy patients with malignant disease: Likely predictors and impact of physician intervention
Authors: Hassan S. R. , Kilari D. , Politsmakher A. , Chakraborthy S. , Fogel J. , Dosik H. 
Published: August 2020

e20544 Background: Despite their poor prognosis, few cancer patients have advanced care directives (ACD). Most often, ACD is discussed in an inpatient setting, when the patient is acutely ill and often nearing the end of life. Timely and thoughtful discussion would be better accomplished for both the patient and the family before such hospitalization. Methods: Interviews were done in 108 outpatients in an ambulatory chemotherapy center. A questionnaire noted whether ACD was executed or not, demographics (including education, religion and insurance status), performance status, characteristics of their cancer, and family status. All patients without ACD were counseled on the importance of ACD. The presence of an ACD was documented at each visit. Statistical comparison of patients with and without ACD at each visit was done. Results: The following variables were significantly associated with having an ACD at the first visit. Patients living alone could not be included in the logistic regression model, as none had advanced directives. However ACD execution differed significantly in patients living alone, compared with those living with family (0/33 vs 15/75; p=0.005). An additional 42 patients executed an ACD by the third visit. At the third visit, only living with family vs living alone remained significantly associated with having ACD. [OR=3.17 95% CI: 1.34, 7.50; p=0.009]. Conclusions: The following findings are noteworthy. Only 15/108 (14%) cancer outpatients had ACD. This disturbingly low rate increased to 55/108 (51%) after physician- initiated discussion. The following characteristics predicted not having ACD before intervention: younger age, absence of metastasis, better performance status, lower education status and living alone. After several physician interventions, only living alone remained a significant barrier to ACD execution by cancer outpatients. These results provide new insights and strategies to encourage improved advanced directive execution. [Table: see text] No significant financial relationships to disclose.