bluuebunny/crossref_metadata_2025_split huggingface dataset:
Role of epoetins in beta-thalassemia minor patients with solid tumors undergoing chemotherapy: Results of a retrospective analysis
Authors: Soto Parra H. J. , Medula E. , Latteri F. , Lavenia G. , Amadio P. , Cordio S. , Magnano C. 
Published: March 2020

19600 Background: β-Thalassemia minor (β-Tm) is the most common hereditary disorder in the Mediterranean region with a prevalence of 6% in Sicily. β-Tm is characterised by mild anemia (A). Therefore, we performed a retrospective analysis to evaluate the course of A in β-Tm pts with solid tumors (ST) undergoing chemotherapy (CT). Methods: β-Tm pts with ST were identified from our clinical record database [history and/or hemoglobin (Hb) A2 level > 3.3%]. Inclusion criteria were first-line or second-line CT after a CT-free interval of 6 mos. Exclusion criteria:concomitant radiotherapy (RT) , or previous RT to pelvic region, or active bleeding. Results: From July 2004 until the present day, 26 β-Tm pts with ST have been observed, and 23 fulfil the criteria of this analysis. The pt demography was as follows: median age, 56 years (range, 38–76 years); Males: 9 pts; PS 0/1: 19/4; stage IV: 10; types of cancers: breast 7, gastrointestinal 7, others 9; platinum containing regimen: 7. A was evaluated during first and second-line treatments in 19 and 4 pts, respectively. The mean values of Hb and the incidence of pts (%) with mild (from ≥10 and <12 gr/dl) or moderate (<10 gr/dl) A during CT, were as follows. No paradoxical effect of CT on the Hb level was observed. One pt received transfusions (Hb level, 7.8 gr/dl). Nine pts were treated with epoetin (darbepoetin alfa, 7 pts) and iron supplements due to worsening A (mean Hb value = 9 gr/dl ± 0.6): five pts experienced a ≥2 gr/dl increase in the Hb level at 8 weeks, one had >1 gr/dl, one had stable values = 9 gr/dl, and two pts had decreased values, i.e. < 8 gr/dl, and required transfusions. Conclusion: This analysis demonstrates that 70% of β-Tm pts with ST have mild or moderate A prior to CT. The A of β-Tm patients is worsened by CT and results in moderate A in 55% of the pts. Epoetins, particularly effectively ameliorate A when administered to pts with Hb levels of <10 gr/dl. This data suggests that epoetin treatment during CT may benefit β-Tm pts; however, prospective trials are required. No significant financial relationships to disclose. [Table: see text]
Feasibility of group follow-up visit for breast cancer survivors
Authors: Ruud C. O. , Francis K. , Stephens C. , Rajab M. H. 
Published: March 2020

19603 Background: The ASCO 2006 guidelines specify that regularly scheduled follow-up care of breast cancer survivors should be the standard. Follow up care is a “teachable moment” to train survivors in positive habits. A group visit model at the Cleveland Clinic proved feasible and improved patient satisfaction for other diseases. Our objectives include assessing the feasibility of an adapted group follow-up visit for the care of breast cancer patients and patient satisfaction. Methods: A feasibility study targeting breast cancer patients who completed primary therapy and were scheduled for a routine appointment. We mailed letters inviting patients to a follow-up group visit. Patients were divided into 3 groups, each scheduled for a separate (90–120 minute). During the first half of the visit, participants were divided into three groups; 5-minute physician exam, nurse review of medications and vital signs, and instruction by a social worker. Groups were rotated. During the second half the doctor, nurse, and social worker met with all participants in one room starting with an educational presentation about fatigue and exercise. Each participant was subsequently interviewed by the physician in the presence of their peers. Shared complaints were investigated first. Patients rated their satisfaction with the different parts of the visit on a scale of 1–5. Participants were surveyed pre- and post- education session and asked if they would participate again. Participants were allowed to bring a family member or friend. Results: 29 (29.6 %) out of 98 consented and 22 (22.5%) attended;10 in first visit, 5 in second visit and 7 in last visit. Average age 61±8, ranged from 46–72 years. Most participants were satisfied with all parts of the group visit, except two in the first group were less satisfied with the check in process and moving between rooms. Comparing the pre- vs. post- educational session surveys showed an improved understanding of the importance of fatigue or exercise. 17 (77%) out of 22 participants agreed to participate in another group visit. Conclusion: Group visit format is feasible and provides patient satisfaction. No significant financial relationships to disclose.
Pilot study of dronabinol for adult patients with primary malignant gliomas
Authors: Vredenburgh J. J. , Bohlin C. H. , Reardon D. A. , Desjardins A. , Quinn J. A. , Rich J. N. , Bota D. A. , Goli K. J. , Friedman H. S. , Allen D. H. 
Published: March 2020

19607 Background: Chemotherapy-induced nausea and vomiting (CINV) are common adverse effects from chemotherapy. While most treatments administered in patients with primary gliomas are not highly emetogenic, up to 50% of neuro-oncology patients report CINV despite 5HT3 or steroid therapies. Adjuvant benzodiazepines frequently alter mental status. Dronabinol may provide a safe alternative option without compromise of neurological status. his study seeks to describe toxicities (TOX) associated with dronabinol administration in neuro-oncology patients. A secondary aim is to describe the impact that dronabinol has on their quality of life (QOL). Methods: This is an exploratory study of adult patients with WHO Grade III/IV primary gliomas on adjuvant chemotherapy. Power analysis determined a sample size of 34 subjects for 0.80 effect size. Enrollment is ongoing with 18/34 adult patients accrued. Patients take dronabinol 5 mg BID 24 hours prior to, during, and 48 hours after completion of oral/IV chemotherapy. Patients continue their established antiemetic regimen. Between chemotherapy doses, dronabinol is reduced to 2.5 mg daily. Intolerance of dronabinol is defined as 2 or more Grade 3 or greater non-hematologic TOX according to the CTC v.3 definition handbook. Modified Functional Living Index-Emesis (FLIE), Functional Assessment of Cancer Therapy-Brain Tumor (FACT-Br), Mini Mental Status Exam (MMSE), and CINV visual analog scales are collected at specific points for 2 cycles for TOX and QOL data. Results: Subjects are predominately male (n=10); mean age of 45.2 years. Four withdrew due to Grade 3 neurologic TOX of cognitive changes (n=3) despite decreasing dosages; Grade 3 persistent CINV (n=1) despite increasing dronabinol dosage. Increased dosages were required in 4 subjects to better manage CINV. Two required decreased doses for Grade 2 neurologic TOX. Most subjects (n=14) reported stable or improved QOL by FACT-Br and FLIE while the 4 withdrawn subjects reported worsening QOL related to TOX. Conclusions: Dronabinol is safe and effective for administration as an adjunct to standard antiemetic therapy during treatment for primary glioma. The dose may be titrated with minimal toxicities and improvement in QOL. No significant financial relationships to disclose.
Defining the pathophysiology of the paclitaxel-acute pain syndrome
Authors: Wolf S. L. , Loprinzi C. L. , Maddocks-Christianson K. , Rao R. D. , Dyck P. B. , Mantyh P. , Dyck P. J. 
Published: March 2020

19613 Background: Paclitaxel therapy often results in a unique sub-acute pain syndrome, whose pathophysiology is unknown. While this syndrome is often termed as a ‘myalgia’ or ‘arthralgia’, it has not been demonstrated to be associated with any structural injury of muscles or joints. Identifying the pathophysiology mechanisms that result in the paclitaxel-acute pain syndrome might be a positive step in the development of effective prevention and/or treatment strategies. With the hypothesis that the paclitaxel-acute pain syndrome occurs as a result of nerve injury, an observational study to clarify the clinical characteristics of this syndrome was initiated. Methods: Oncology patients who were treated with at least one dose of paclitaxel and reported developing sub-acute pain were questioned using a detailed structured interview. Various aspects of the pain, including the time of onset, duration, location, severity, and exacerbating factors were evaluated. Data were tabulated descriptively. Results: Eighteen patients were interviewed. The onset of pain typically occurred 1–2 days after therapy and lasted for a median of 4–5 days. Pain was most commonly located in the back, hips, shoulders, thighs, legs and feet, with the most common descriptors used being ‘aching’ or ‘deep pain’. Commonly used adjectives to describe the pain were: ‘radiating’, ‘shooting’, ‘aching’, ‘stabbing’ and ‘pulsating’. Some patients described increased pain with weight bearing or walking. Fifteen of 18 patients specifically denied localization of pain to either joints or muscles. Conclusions: The nature of the pain, i.e. , generalized, deep aching pain, the notation of increased sensitivity with weight bearing (mechanical hyperalgesia) and the lack of localization to joints or muscles, support the hypothesis that the paclitaxel-acute pain syndrome results from a hyperalgesic dysfunction of nociceptive receptors, their fibers, or the spinothalamic system. These clinical conclusions are supported by the recent findings that markers of cellular injury can be identified in peripheral nerve tissues shortly following paclitaxel administration in an animal model (Peters CM, et al., Exp Neurol. 2007 Jan;203(1):42- 54). No significant financial relationships to disclose.
Anemia management with erythropoietic stimulating therapies (ESTs) in patients (pts) with gastrointestinal (GI) malignancies: Results from a prospective observational study
Authors: Chen E. , Larholt K. , Wang Q. , Bookhart B. , McKenzie R. , Tak Piech C. 
Published: March 2020

19614 Background: Chemotherapy-induced anemia is a common problem for pts with GI malignancies. To assess dosing patterns and outcomes in GI malignancy pts treated with ESTs (epoetin alfa (EPO) and darbepoetin alfa (DARB), a subset analysis of an ongoing registry was conducted. Methods: Data drawn between1/04 and 10/06 from 41 U.S. oncology clinics from the Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (D.O.S.E.) registry were assessed. Pts were included in this analysis if they were diagnosed with a GI malignancy (colon, rectal, gastric, esophageal, or pancreatic), = 18 years, and received = 2 doses of either EPO or DARB. Outcomes assessed included mean baseline (BL) characteristics, transfusion utilization, hemoglobin (Hb) at Weeks 4, 8, and 12 after initiation of EPO or DARB, and cumulative EST doses with associated cost (based on 9/2006 wholesale acquisition cost). Results: 186 pts (82 EPO, 104 DARB) were identified. BL characteristics were similar between treatment groups: age 64 years, 45% women, and Hb 10.5g/dL. Both groups had a similar treatment duration (7 weeks) and number of Hb determinations (7.6); however, the DARB group had significantly more office visits (EPO 7, DARB 9.8, p=.0006). The proportion of pts transfused from Week 5 to end of study and number of units transfused/pt were similar between both groups. Hb values were similar at Weeks 4 (11.1 g/dL), 8 (11.1 g/dL), and 12 (11.0 g/dL). The mean administered dose per injection was 42,143 Units for EPO and 225 mcg for DARB. Mean cumulative administered dose during the treatment episode was 296,476 Units for EPO and 1,131 mcg for DARB, resulting in a dose ratio of 262:1 (Units EPO:mcg DARB). Overall EST cost was significantly lower in the EPO group compared to the DARB group (EPO $3,608, DARB $5,028, p=.0024). Conclusions: Similar hematological outcomes for EPO- and DARB-treated pts with GI malignancies were observed. Based on observed dosing patterns and cumulative EST utilization from this prospective observational study, EST costs were 28% lower in the EPO group than the DARB group. The observed dose ratio is consistent with previously reported clinical studies. No significant financial relationships to disclose.
Risk factors for neutropenic fever in lymphoma patients receiving chemotherapy
Authors: Teegala S. R. , Zhou X. , Huen A. , Ji Y. , Fayad L. E. , Romaguera J. E. , Vadhan-Raj S. 
Published: March 2020

19616 Background: Neutropenic fever (NF) can be a serious complication of chemotherapy (CT) in lymphoma patients (pts), however the exact incidence with the current regimens and risk factors for NF are not well known. Methods: A retrospective cohort study was conducted to determine the incidence of NF, and logistic regression analysis were performed to identify the clinical and laboratory features correlated with NF in lymphoma. Medical records of all newly referred lymphoma pts (n=1046) in 2003 were reviewed. Results: 425 pts who received ≥ 1 cycle of treatment at MDACC were included in the analysis. Median age was 57 (range 17–87) with 262 (62%) newly diagnosed. Most common first regimens were (± rituxan) CHOP (29%), Hyper-CVAD ± Ara-c-MTX (23%), and ABVD (8%), with the total number of cycles were 1638 (median 3, range, 1–10). NF was observed in 23 % (97/425) of pts and 8 % (123/1638) of cycles, with the highest number in cycle 1 (49/123). The NF incidence among most common regimens were (± rituxan) Hyper-CVAD/ Ara-c/MTX 53% (31/58), Hyper-CVAD 24% (9/37), CHOP 22% (27/125), and ABVD 6% (2/34), and most common subtypes were MCL (33%), LCL (23%), HD (16%), and FL (13%). In the univariate regression analysis, CT, Hb, Ca, LDH, lymphocyte (ALC) and neutrophil (ANC) counts, were significantly associated with the NF. Using multivariate logistic regression, baseline ALC count (=1000 vs. >1000/μL: OR=2.251, 95% CI, 1.194 to 4.244, p=0.0121), Hb (<12 g/dL vs. ≥ 12g/dL: OR=2.117, 95% CI, 1.122 to 3.996, p=0.0207), age (>60 vs. ≤60: OR=2.035, 95% CI, 1.066 to 3.884, p=0.0312), CT (high vs. low risk: OR=2.913, 95% CI, 1.520 to 5.583, p=0.0013) were the most important baseline risk factors for NF in cycle-1. Conclusions: The incidence of NF in this population is high in cycle 1. Baseline pt characteristics including old age, high risk CT, low ALC and Hb were found to be significant risk factors predictive for NF in cycle-1. These findings could be useful to identify high risk pts for consideration of treatment approaches for prevention of NF. No significant financial relationships to disclose.
Mucositis in cancer patients: Prototypic semi-mechanistic kinetic model
Authors: Peterson D. E. , Lalla R. V. , Srivastava R. , Loew L. M. 
Published: March 2020

19617 Background: Recent research advances have helped (i) define pathobiology of alimentary tract mucosal injury secondary to cancer therapy and (ii) link molecular mechanisms with clinically important outcomes. Recently-developed computational biology modeling may further enhance these advances. Semi-mechanistic (SM) modeling allows one to approach quantitative analysis of a biochemical system that is incompletely determined. In this study, data from sequential oral mucosal biopsies in 3 patients developing oral mucositis secondary to hematopoietic stem cell transplantation (HSCT) conditioning were utilized to establish a prototypic computational model for this toxicity. Methods: Plasma and oral mucosal biopsy specimens were obtained from 3 autologous HSCT patients before and after administration of conditioning chemotherapy: Day -10, +10, +28 and +100; Day 0 was day of transplant. Full-thickness tissue samples were measured by RT- PCR for COX-1, COX-2, IL-1β and TNF-a. Plasma samples were measured by ELISA for PGE2 and PGI2, markers of COX-2 activity. The SM model was implemented as a system of 6 ordinary differential equations with 15 parameters. Parameter estimation and simulations were conducted based on experimental results, using a combination of Mathematica, Berkeley Madonna and Virtual Cell software packages. Results: The SM model captured the behavior of COX-1, IL-1β and PGE2 dynamics, predicting an exponential decay for each of these species. Half-lives relative to average steady-state values were found to be 9.7 days, 8.7 days and 9.3 days for COX-1, IL-1β and PGE2 respectively. Correlation ratios for each of these species were calculated to be 0.62, 0.61 and 0.90 respectively. Conclusions: This prototypic model provides a basis for development of a detailed mathematical model for quantifying relevant components of the mucositis pathway. This combination of modeling and experiment could also identify gaps in the pathway that would be important targets for new hypotheses, including possible feedback mechanisms relative to inflammatory cytokines. No significant financial relationships to disclose.
Treatment profiles in patients with cancer aged 80 years or more
Authors: Noonan A. M. , Horgan A. M. , Grogan L. , Breathnach O. S. 
Published: March 2020

19620 Background: There is much criticism about the omission of very elderly patients (>80 years old) from clinical trials. The question is raised as to whether results of clinical trials performed with younger pts (usually <75 years) can be extrapolated to the very elderly population. The most recent Irish census predicts that those aged =80 yrs is set to rise dramatically from the 2001 level of 98,000 to a projected 323,000 in 2036. Accordingly oncologists will have to plan carefully to appropriately treat these pts. Methods: A retrospective review of all new pts referrals aged =80 years was performed for the period Sept. 2005 to Sept. 2006. Pts records were analysed for age, cancer diagnosis, co-morbidities, treatment plan and complications. Results: A total of 52 referrals were identified but records were available for only 49 pts. The average age was 83.7 years (80–93yrs). The M:F ratio was 1.04:1. The 4 most common cancers were Colorectal (20%), lung (18%), oesophageal (12%) and breast (10%). The mean number of co-morbidities was 5. 13 pts (26%) had a previous unrelated cancer diagnosis. 19 patients (38.8%) received cancer treatment (see table ). Three other pts were offered chemotherapy but declined citing age and fear of side effects as their reasons. 68% of patients receiving cancer treatment had a performance status (PS) of ECOG =1. The main reasons cited for not giving cancer treatment were poor PS (21), comorbidities (13), or patient preference (3). 75% of patients receiving chemotherapy were on schedule with no delays. Only 25% (2) of patients experienced delays due to toxicity. Conclusion: In this diverse group of very elderly cancer pts, those that received cancer treatment tolerated it reasonably well. However, 55% of pts were deemed unfit for cancer treatment at presentation due to poor performance status or compromising co-morbidities. This fact must be taken into account when setting recruitment targets for this age group when planning oncology clinical trials. No significant financial relationships to disclose. [Table: see text]
Changes in iron parameters in patients (pts) with chemotherapy-induced anemia (CIA) receiving darbepoetin alfa (DA) every 3 weeks with and without intravenous iron supplementation
Authors: Suto T. , Vansteenkiste J. F. , Mossman T. , Pinter T. 
Published: March 2020

19621 Background: There is growing interest in the use of intravenous (IV) iron supplementation in pts receiving erythropoiesis- stimulating agents (ESAs). We present an exploratory analysis of iron parameters in pts with CIA enrolled in a phase IIIb, randomized, open- label, study of DA administered with either IV iron or oral/no iron. Methods: Eligible pts had a non-myeloid malignancy and CIA (baseline Hb < 11g/dL). Pts received DA 500 mcg every 3 weeks (Q3W) using the Aranesp (darbepoetin alfa) prefilled SureClick autoinjector. Pts were randomly allocated (1:1) to receive either DA + 200 mg IV iron (200 mg Q3W with DA Q3W or two 100 mg doses within 3 weeks) or DA + oral/no iron. Randomization was stratified by tumor type and baseline Hb (< or = 10 g/dL). The primary endpoint was % pts achieving a hematopoietic response (Hb = 12 g/dL or increase = 2 g/dL). Results: 396 randomized pts received 1 dose of DA (IV-iron arm = 200; oral/no-iron arm = 196). Mean (SD) age was 61.0 (11.5) yrs; 61% (n = 240) were women; 28% (n = 111) had lung/gynecological tumors. Pt demographics were similar between arms. 44 (11%) pts had baseline iron deficiency (TSAT < 15%; serum ferritin < 100 μg/L); 5 (2%) in the IV iron arm and 23 (12%) in the oral/no-iron arm developed it. 141 (36%) pts had baseline functional iron deficiency (serum iron < 60 μg/dL; serum ferritin > 20 μg/L; TSAT < 20%); 54 (27%) in the IV arm and 67 (35%) in the oral/no-iron arm developed it. See table for iron parameters. Improved Hb-based responses in the IV-iron arm will be presented. Conclusions: Pts who received DA Q3W + IV iron appeared less likely to develop iron deficiency; iron deficiency may reduce responsiveness to ESAs. These pts also appeared to have a larger increase in mean serum ferritin levels. In contrast, mean serum iron, %TSAT, total iron binding capacity, and reticulocytes appeared to be similar in the 2 arms for most of the study period, suggesting that these iron parameters are not influenced by IV iron. No significant financial relationships to disclose. [Table: see text]
Pharmacokinetic effect of aprepitant on irinotecan in patients with colorectal cancer
Authors: Nieva J. J. , Webb W. , Siuzdak G. 
Published: March 2020

19622 Background: Alterations in the activity of cytochrome P450 enzymes can affect the clearance of chemotherapeutic drugs. Aprepitant, a moderate inhibitor and inducer of cytochrome P450 3A4, is now increasingly used for the prevention of chemotherapy induced nausea and vomiting as an adjuct to irinotecan-containing chemotherapy. There is little published data on the potential interaction between these agents. We sought to determine if aprepitant impacts the clinical pharmacokinetics of irinotecan. Methods: Patients with colorectal cancer receiving FOLFIRI chemotherapy were eligible for enrollment. Each patient received 2 cycles of FOLFIRI chemotherapy with, and 2 cycles without, aprepitant as part of the anti-emetic regimen. Plasma was obtained for each chemotherapy cycle at: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 and 48 hours. Irinotecan and its active metabolite SN-38 plasma levels were measured in duplicate by LC-FLD. Differences between groups were evaluated using a paired students t-test. Results: We administered 8 cycles of FOLFIRI chemotherapy for treatment of colorectal cancer to 2 patients. Median Cmax of irinotecan and SN-38 was 1,628 ± 1,565 ng/mL and 18.8 ± 9.7 ng/mL for aprepitant treated chemotherapy cycles compared with 1376 ± 1536 ng/mL and 23.5 ± 8.5 ng/mL for conventionally pre-medicated cycles. Median area under the concentration versus time curve (AUC) for irinotecan was 583.9 ± 317.6 μg/ml·min in aprepitant treated cycles and 682.6 ±266.5 μg/ml·min during conventionally treated cycles. Median AUC for SN-38 was 15.0 ± 7.5 μg/ml·min and 18.0 ± 9.0 μg/ml·min in aprepitant and conventionally premedicated chemotherapy cycles respectively. Conclusions: In this pilot study, aprepitant, as it is typically administered, did not have any significant effect on irinotecan pharmacokinetics in patients with colorectal cancer. No significant financial relationships to disclose.