bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized comparison of darbepoetin alfa every three weeks with epoetin thrice weekly for chemotherapy induced anemia in nonhematological cancer patients
Authors: Kotsori A. A. , Vaslamatzis M. M. , Alexopoulos C. G. 
Published: March 2020

19625 Background: A strong tendency exists nowadays in clinical practice to move from thrice weekly (TIW) to weekly (QW) and even every 3 weeks (Q3W) administration of erythropoetic therapy for chemotherapy induced anemia. Although head to head comparison of QW Darbepoetin with TIW Epoetin showed similar effectiveness between the two, such a study for Q3W Darbepoetin has not been published so far. Methods: We randomly compared Q3W Darbepoetin (500mcg, Group B) with TIW Epoetin, 10.000 U (20.000 U in nonresponders after 6 weeks, Group A) in 100 patients with chemotherapy induced anemia (Hb = 11gr). Evaluation was performed on week 6 and 12 including QOL assessment using FACT-An scale Results: At present, all patients have completed first evaluation and 94 second evaluation. All will have completed second evaluation by the end of January 2007. In group A, Hb increased from 10.31±0.81 at baseline to 11.5±1.8 at 6 weeks (p=.000) and to 12±2.27 at 12 weeks (p=0.000). No significant (p=.13) increase was observed between week 6 and 12. In group B, a non significant (p=.068) increase of Hb was observed from baseline (10.27±.78) to week 6 (10.68±.24) but Hb increased significantly (p=.005) to 11.12±1.7 at 12 weeks. It also increased between week 6 and 12 (p=.009). In all 100 patients, Hb increased from 10.30±.79 at baseline to 11.09±1.74 at 6 weeks (p= .000) and to 11.58±2.05 at 12 weeks (p=.000). It also increased between week 6 and 12 (p=.005). Seven of 31 (22%) responders in group A had to double Epoetin dose. Eight patients in group A required transfusions compared with 7 in group B (p=NS). On an intent to treat analysis, RR at 6 weeks was 52% for Epoetin versus 30% for Darbepoetin (p=.078) and 62% versus 46%, respectively at 12 weeks. QOL analysis will be presented. Conclusions: Q3W Darbepoetin is a very convenient scheme with comparable effectiveness with TIW Epoetin. No significant financial relationships to disclose.
Octreotide for the treatment of symptoms of bowel obstruction in advanced cancer
Authors: Imamura S. , Maehara S. 
Published: March 2020

19626 Background: Symptom of bowel obstruction are common and serious complications in terminal advanced cancer patients. Mechanisms of bowel obstructions include intraabdominal carcinomatosis, drug-induced intestinal immobility and intraluminal obstruction. Octreotide inhibits the release of the several gastrointestinal hormones thereby reducing GI tract secretion, and increase the GI tract absorption by slowing down intestinal mobility and decreasing the splanchnic blood flow. Methods: Objectives of this study evaluated efficacy of octreotide in terminal cancer patients with bowel obstruction. We treated all patients with recurrent or advanced cancer admitted to our palliative unit in last 2 years, who had continuous nausea and vomiting related to no surgically bowel obstruction. Octreotide started at a dose of 150 mcg/day in subcutaneous infusion or continuous intravenous infusion, and increase to a dose of 300 mcg/day depending on the symptom. Results: 52 patients with terminal cancer were included in this study. Primary tumor were 13 colon-rectum 13, gastric 8, pancreas 8, biliary tract 4, esophagus 2, gynecological 3 and others 12. The mean age of patients is 71 years of age. All patient have died from tumor progression. The mean dose is 232 mcg/day and the mean duration of treatment is 24 days. 23 patients (45%) were remarkably improved and can take a meal. 15 patients (29%) were improved and diminished vomiting. But 13 patients (25%) remained continuous vomiting. The patient with markedly efficacy lived 2 times longer than other groups. No serious side effects were present. Conclusions: Octreotide shows good efficacy in the management of symptom of malignant obstruction and can be used safely in this population. No significant financial relationships to disclose.
Safety of transdermal fentanyl (TF) in front-line approach to severe cancer pain. Meta-analysis of randomized clinical trials
Authors: Maltoni M. , Scarpi E. , Poggi B. , Tassinari D. 
Published: March 2020

19627 Background: To assess the safety of TF when compared with Slow Releasing Oral Morphine (SROM) in the front-line approach to severe cancer pain. Methods: A systematic review of literature in the MEDLINE and EMBASE data bases from 1966 to October 2006, using “Administration, Cutaneous” [MeSH term], “Administration, Oral” [MeSH term], “Analgesic, Opioid/*administration & dosage/adverse effects” [MeSH term], “Delayed-Action Preparations” [MeSH term], “Fentanyl/*administration & dosage/adverse effects” [MeSH term], “Cancer Pain/*drug therapy” [MeSH term], “Morphine/*administration & dosage/adverse effects” [MeSH term] as search terms was performed independently by two authors (DT and MM). All the randomized phase III trials comparing TF and SROM were considered eligible and included into the analysis. The overall side effects odds ratio (OR) was the primary end point of the analysis; overall gastrointestinal side effects, constipation, nausea, somnolence, the patient's preference and the trial withdrawal pooled ORs the secondary ones. Heterogeneity between the trials was analysed using the Mantel-Haenszel test, and the outcome analysis was performed using a fixed effects model and an alpha error lower than 5%. Results: 3 trials met the selection criteria and were included into the analysis. The safety of TF and SROM was analysed in 373 patients (188 and 185 respectively treated with TF and SROM). A significant difference in favour of TF was observed for constipation (OR=0.42, p=0.002), somnolence (OR=0.559, p=0.018) and the preference of the patient (OR=0.39, p<0.001): no significant differences were observed for overall side effects (OR=0.82, p=0.51), overall gastrointestinal side effects (OR=0.87, p=0.6), nausea (OR=1.2, p=0.446) and trial withdrawal (OR=0.62, p=0.59). No heterogeneity was documented between the trials. Conclusion: Although no differences exist between TF and SROM in efficacy (with equianalgesic doses) and safety (when assessed as overall safety profile) on the whole, the differences in the peculiar safety profile of the two opiates seems to favour TF in patient's preference in the choice of front-line treatment of severe cancer pain. No significant financial relationships to disclose.
The academic oncology hospitalist—a model for improved teaching and patient care
Authors: Denes A. E. , DiPersio J. F. , Ellis M. J. 
Published: March 2020

19630 Background: The care of hospitalized cancer patients in academic institutions is usually assigned to residents and fellows with supervision by a “rotating” attending oncologist. This approach ensures that, at a minimum, each patient’s care is reviewed and supervised by an attending physician. This model, however, has several shortcomings including: 1) lack of continuity of care 2) limited time for teaching 3) limited knowledge of diseases outside of the research or clinical interests of the attending 4) lack of consistent clinical leadership and 5) communication problems when the attending physician is in clinic, meetings, or research activities. Methods: We felt that a model in which a senior medical oncologist with an interest in patient care, teaching, and clinical research serves as the full time director of the inpatient oncology service would address these challenges. The organizational chart for this model will be presented. In this model, the attending oncologist meets with the “post call” intern/resident team, fellow, and hospitalist each morning to review and discuss all patients admitted to the service in the prior 24 hrs. The afternoons are spent visiting patients, reviewing the status of all patients on the service, and evaluating high acuity new admissions. An oncology core curriculum lecture series was developed with daily lectures. The trainees are encouraged to attend additional conferences as time permits. Results: The program was initiated in November 2005 and has been a universal success. Patient satisfaction has improved significantly and the number of graduating residents pursuing fellowships in oncology has increased from 3–4 to 7–8 per year. The attending physicians are able to continue their clinic schedules and research activities without interruption. We are planning to review this experience to evaluate additional changes in patient outcome such as length of stay, efficacy of symptom control, and readmission rates. Conclusions: Our model of inpatient oncology care has improved patient satisfaction, teaching, and faculty utilization. It lends itself to develop clinical trials of inpatient cancer care. We suggest it be considered in academic cancer centers to achieve similar goals. No significant financial relationships to disclose.
RESPOND - Raising awareness of anemia in oncology centers through computer algorithm driven guidelines: Assessment of intraclass correlation metrics for the accuracy of algorithmic definitions
Authors: Foubert J. , Aapro M. , Soubeyran P. , Bokemeyer C. , Van Erps J. , Muenzberg M. , Turner M. , MacDonald K. , Abraham I. 
Published: March 2020

19633 Background: Publication of evidence-based (EB) practice guidelines (EBPGs) does not assure their application in patient care. Computerized clinical decision support systems (CDSSs) incorporating EBPGs may promote EB decision-making about individual patients. Most CDSSs are knowledge-, not evidence-based. Effective CDSSs are those integrated into workflow, providing point of care guidance, and offering actionable recommendations. Few are validated in terms of algorithmic operationalization. RESPOND is a CDSS based on the 2006 update of the European Organisation for Research and Treatment of Cancer (EORTC) EBPGs for erythropoietic proteins in cancer-related anemia. Method: Descriptive study. Panel of five experts (three physicians, two nurses) rated the 27 algorithms derived from the EORTC EBPGs in terms of accuracy (binary: yes/no). If not judged accurate, experts were asked to explain and propose correction. Objective was to attain intraclass correlation coefficient (ICC) >0.90 for each operationalization in a maximum of three iterations. Table 1 . Example of operationalization of guideline Hb, hemoglobin Results: In iteration 1, three experts agreed with all 27 sets; one disagreed with one set and one with four sets; therefore ICC = 1.00 for 22 sets; ≤0.90 for five sets. Three sets concerned additional output to be generated, and one a substantive inaccuracy; all were corrected. One set concerned a suggestion not supported by evidence, hence not incorporated. In iteration 2, all five experts agreed with all sets, thus ICC = 1.00 for 27 sets. Conclusions: The RESPOND CDSS being developed and validated is based on algorithms that accurately specify, in the form of conditional dependency rules, the EORTC EBPGs for erythropoietic proteins. [Table: see text] [Table: see text]
A post-treatment individualized prescriptive exercise and recreation therapy intervention for breast cancer patients
Authors: Groff D. G. , Battaglini C. L. , Peppercorn J. 
Published: March 2020

19637 Background: The number of breast cancer survivors is increasing due to early detection and advancements in treatment leading to increased concern with long term side effects and quality of life after therapy for early stage breast cancer. The Get REAL & HEEL Breast Cancer Program addresses the physiological and psychological declines experienced by breast cancer survivors post-treatment through combined exercise (EX) and recreation therapy (RT) to strengthen the body and mind of survivors and improve overall QOL. Methods: Women with early stage breast cancer within 6 months from completion of initial therapy were recruited to participate in a combined EX and RT intervention. The EX consisted of cardiovascular endurance (VO2 Max), muscular endurance (ME) and flexibility (FL) training. The RT included activities such as leisure counseling, bio-feedback, heart-math, crafts, and a ropes course. Each participant engaged in an individually prescribed intervention for 8 weeks, 3 times per week, for approximately 1.5 hour per therapy session. A battery of fitness and psychological assessments including, VO2 Max, body composition (BC), ME, FL, fatigue (F), depression (D), QOL were used to assess baseline parameters and outcomes. Descriptive statistics presenting the results of baseline and final assessments were used to evaluate program outcomes. Results: Fifteen subjects, age 30 to 75, volunteered for the program. At initial analysis, clinically relevant changes in physiological and psychological parameters were observed. Improvements in VO2 Max, BC, and ME were observed for all subjects. Positive changes in psychological parameters were also observed in all of subjects including decreased F and D accompanied by increased QOL. Conclusions: The results of this pilot program are promising and suggest that further evaluation of this novel combination of EX and RT to improve physical and emotional functioning, and overall QOL after breast cancer treatment are warranted. No significant financial relationships to disclose.
Comprehensive geriatric assessment (CGA) in elderly women with early breast cancer
Authors: Girones R. S. , Torregrosa D. M. , Torró J. , Aguiló J. , Maestu I. , Diaz Beveridge R. 
Published: March 2020

19641 Background: Advancing age is a major risk factor for breast cancer. Long-term follow up is recommended after diagnosis and treatment of early breast cancer. With older age, the risk of comorbid conditions and functional impairment is increased. A useful tool in the management and follow-up of these elderly patients could be a CGA Methods: Purpose of the study: Descriptive, transversal study of the prevalence of other comorbidities and of the functional impairment in elderly patients on follow-up after curative treatment of early breast cancer. Patients: Women aged ≥ 70 years at time of diagnosis, with removed early breast cancer. Attended in a outpatient unit from January 2005 to June 2006. No disease recurrences were allowed. Methods: CGA was conducted in an oncology unit. The assessment used usual screening instruments (ADL, IADL, POMA, GDS, MMSE, MNA) as well as the performance status (PS). Co-morbidity was classified using the Charlson score. Results: 91 pts underwent CGA. Mean age at surgery of primary tumour: 76 (70–92). Mean age at time of CGA: 80 (71–95). > 75% of patients had more than 84 years at time of GCA: Median follow up: 5 years (1–12). 47% PS 0. 9% PS 2. 83% were fully independent for ADL and 71% for IADL. IADL most affected was the ability to drive/use public transport. Median Charlson Score was 2 (1–6). ≥ 75% of patients had score ≥4. Most frequent comorbidity: cardiovascular disease (hypertension). Cognitive deterioration: 15%, depression: 16%. Only 28% were thin (BMI< 22). 75% were polymedicated (> 6 drugs). 28% had geriatric syndromes. 23% were “frail” (at least one of the following items): ADL < 80; ≥ 3 comorbidities, performance status < 60, ≥ 1 geriatric syndrome. Conclusions: Our results are better than reports from other geriatric teams using CGA, in terms on functional status and frailty. A high prevalence of comorbidity in our study, similar to other reports. A selection bias cannot be excluded, as the fitter patients are those that usually keep on with the follow-up. While those frail patients that do not due to their functional impairment are usually lost. Older patients with early breast cancer on follow-up have a high prevalence of comorbidity. However, in our serie, function and independence is maintained. No significant financial relationships to disclose.
BCIRG 006: Docetaxel and trastuzumab-based regimens improve DFS and OS over AC-T in node positive and high risk node negative HER2 positive early breast cancer patients: Quality of life (QOL) at 36 months follow-up
Authors: Robert N. J. , Eiermann W. , Pienkowski T. , Crown J. , Martin M. , Pawlicki M. , Chan A. , Bee V. , Slamon D. , Au H. 
Published: March 2020

19647 Background: The primary objective of the BCIRG 006 trial was to determine if the use of trastuzumab in early high-risk HER2-positive breast cancer significantly improved clinical outcomes. A secondary objective was to evaluate the QOL of patients receiving the 2 treatments. Methods: The BCIRG 006 trial compared adjuvant standard AC (doxorubicin/cyclophosphamide x 4 cycles) followed by docetaxel x 4 [AC-T] or 2 trastuzumab-containing regimens, AC followed by T with trastuzumab x 1 year [AC-TH] or TCarbo x 6 with trastuzumab x 1 year [TCH] in patients with node positive or high-risk node negative HER2-positive early breast cancer (n=3222). Results: The 2nd planned interim analysis, median follow-up at 36 months, showed that both AC-TH and TCH significantly improved the DFS and OS over the control (relative reduction risk of relapse 39% (P<0.0001) and 33% (P=0.0003) respectively, for AC-TH and TCH vs control). Relative reduction in the risk of death was 41% (P=0.0041) and 34% (P =0.017) respectively, for AC-TH and TCH vs control. Congestive heart failure occurred in 0.4% of patients in AC-T and TCH vs 1.9% of patients in AC-TH. Global safety profile was acceptable in all 3 arms and more favourable in TCH than AC-TH. QOL, a secondary endpoint of this trial, was assessed using the EORTC QLQC-30, BR-23, and EQ5D. We will present the primary QOL endpoints comparing Physical Function, Global Health Status, Future Perspectives, and Systemic Treatment Effects change scores from baseline to mid-chemotherapy, end of chemotherapy, and 12 months follow-up (with a 10% change considered clinically important). The proportion of patients with improved/stable/worsened QOL scores will be compared with chi-square tests. Other QOL exploratory analyses will be presented. [Table: see text]
Quality of life and survival in patients receiving chemotherapy for advanced non-small cell lung cancer (NSCLC)
Authors: St-Pierre D. M. , Kreisman H. , Kasymjanova G. , Agulnik J. S. , Swanson T. , Pepe C. , Lajeunesse L. , Gagne S. , Dajczman E. , Pereira L. , Small D. 
Published: March 2020

19649 Background: Quality of life (QoL) is an important endpoint measure in clinical cancer trials. We evaluated prospectively the effects of two cycles of chemotherapy (CT) on QoL and the relationship between QoL and survival in advanced NSCLC patients (pts). Methods: The short-form of the SF36 was completed prior to and after 2 cycles of chemotherapy. An ITT analysis was used; a score of 0 was assigned to those who died and the last observation was carried forward for those with missing data. Results: Fifty-nine pts consented to participate and pre-chemo evaluation was available for 58 pts. Of these 58, only 40 pts completed the study (4 died, 14 did not complete the post evaluation). There were 26M: 32F with a median age of 61±11 years. Fifty pts (86%) were stage 3B (pl. eff)/4 and 50pts (86%) were PS 0–1. Overall QoL decreased significantly from 100±19 to 91±36 after two cycles of chemotherapy (p=0.03). This decline was attributed to a significant decrease in the physical health subscale (p=0.001), with 36% of pts reporting a clinically significant decline of =2. No change in the mental health subscale was observed. The symptoms that had the most profound negative impact on the physical health subscale were: ‘easily get sick’ (54%), ‘increased pain’ (30%) and ‘decreased activities’ (27%). SD+PR occurred in 36 (62%) pts, whereas 22 (38%) pts had PD after two cycles of chemotherapy. No correlation was found between response to chemo and change in QoL. The median survival (15±6.8mo), of pts whose QoL score remained stable or improved (n=36) was significantly better than those (n=22) whose QoL decreased (9±3.2 mo) (p=0.01). Conclusions: QoL decreased following chemotherapy due to a decrease in the physical health subscale. Further studies are required to determine if training can improve physical health and thus QoL and survival. No significant financial relationships to disclose.
Measurement of DKK1 and FRP in breast and prostate cancer patients with bone metastases: Impact of zoledronic acid (ZA)
Authors: Helsten T. , Corr M. , Mortimer J. E. 
Published: March 2020

19659 Background: Bone metastases produce an imbalance in osteoblast and osteoclast activity. While metastases from prostate cancer are osteoblastic, metastases from breast cancer may be osteolytic, osteoblastic or mixed. The wnt/frizzled pathway is involved in maturation of osteoblasts and in adult bone homeostasis. We explored the wnt antagonists dickkopf (DKK1) and frizzled related protein (FRP) as potential biomarkers in bone metastasis after ZA treatment. Methods: This is a pilot cohort study in bisphosphonate naive breast and prostate cancer patients with bone metastases. Cancer therapy was not specified. Patients received 2 monthly doses of ZA 4 mg IV. Pre- and post-treatment (day 60) sera were collected for measurement of FRP and DKK1, along with IL-6, calcium, creatinine and bone-specific alkaline phosphatase (BAP, a marker of osteoblast activity). Primary endpoint: mean change in FRP and DKK1; Secondary endpoints: correlation of biomarkers with each other and comparison of breast vs. prostate cancer patients. Biomarkers were measured using standard ELISA assays. Statistics: comparison of means = student t-test, correlation coefficients = Pearson. Results: Mature data from 14 patients are reported here, 9 with breast and 5 with prostate cancer. Mean age = 61 years (range 42–89). Two breast cancer patients were premenopausal. One prostate and 3 breast cancer patients received chemotherapy; all others were treated hormonally. After ZA, calcium decreased in all patients (p = 0.09). BAP decreased in all but 1 breast and 1 prostate cancer patient (mean decrease 20.0, p = 0.16). IL-6 was undetectable in most patients. FRP decreased in all but 4 patients (mean decrease 6.2, p = 0.13). There was no discernable pattern for DKK1. Pre-treatment DKK1 correlated with FRP (p = 0.01, r2 = 0.39), but there was no correlation post-treatment. Post-treatment DKK1 correlated with both serum calcium (p = 0.04, r2 = 0.49) and BAP (p = 0.005, r2 = 0.65). There was no difference between breast and prostate cancer patients. Conclusions: It is feasible to measure DKK1 and FRP in patients with malignant bone disease. Treatment with ZA has measurable effects upon these and other serum markers. Further studies with more patients are needed to evaluate their potential as biomarkers. No significant financial relationships to disclose.