bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and safety of a two drug-combination regimen for cancer-related cachexia in the clinical practice.
Authors: Madeddu Clelia , Dessi Mariele , Orgiano Laura , Antoni Giorgia , Serpe Roberto , Omoto Itaru , Cau Maria Chiara , Macciò Antonio , Mantovani Giovanni 
Published: March 2020

e20556 Background: To test the safety and efficacy of a combination treatment (including nutraceuticals, i.e. quercetin, alpha lipoic acid and curcumin) with carnitine + celecoxib for the treatment of cancer-related anorexia/cachexia syndrome (CACS) in the clinical practice. Primary endpoints: safety, increase of lean body mass (LBM) and improvement of quality of life. Secondary endpoints: increase of physical performance (tested by grip strength and 6-min walk test, 6MWT) and decrease of inflammation (assessed by serum levels of IL-6 and Glasgow prognostic score, GPS). Methods: Outpatients with advanced cancer at different sites with CACS (i.e. loss of body weight >5% of the pre-illness or ideal weight in the previous 3 months) were eligible to receive: L-carnitine 4 g/day + Celecoxib 300 mg/day. All patients received as basic treatment polyphenols 300 mg/day, lipoic acid 300 mg/day, carbocysteine 2.7 g/day, Vitamin E, A, C, all orally. Treatment duration was 4 months. Results: From June 2011 to April 2012, 75 patients with advanced cancer (all stage IV) at different sites were enrolled: 40 completed the treatment and were evaluable (mean age 65 ± 9.6, range 32-82 years). Results showed a significant increase of LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) from baseline as well as physical performance assessed by 6MWT. Quality of life (assessed by EORTC-QLQ-C30) as well as fatigue (assessed by MFSI-SF) also improved significantly. ECOG PS and GPS decreased significantly. The treatment was safe, no grade 3–4 toxicities occurred and no patient had to discontinue the treatment due to severe adverse events. Conclusions: The results of the present study confirm the efficacy and safety of the two-drug combination regimen previously shown in a randomized clinical trial (Madeddu et al, Clinical Nutrition 31:176-182,2012). Therefore, this simple, feasible, effective, safe, with favorable cost-benefit profile, two-drug approach could be suggested in the clinical practice as a treatment for CACS.
Intra-arterial infusion of irinotecan loaded microparticles (IAIRIM) for symptomatic and unresectable colorectal cancer (UCRC): Preliminary report.
Authors: Comelli Simone , Bini Roberto , Gallo Giacomo , Savio Daniele , Viora Tiziana , Vaudano Giacomo Paolo , Leli Renzo 
Published: March 2020

e20562 Background: We evaluated feasibility, safety and efficacy of IAIRIM on a compassionate use basisto treat locally UCRC and investigated a volume reduction of the target lesion. Methods: We considered patients with UCRC not eligible for any conventional treatment presenting severe anemia from rectal bleeding, colon obstruction and severe pain. A multidisciplinary evaluation was performed by surgeon, radiologist and oncologist. Patients underwent abdominal quadriphasic CT scan, in order to obtain a preliminary arterial mapping of the tumour; colostomy was performed in all patients. Angiography of superior and inferior mesenteric arteries was obtained to define the lesion vascularization and perform IAIRIM. A month later a new CT scan evaluation was performed to evaluate the volume of the target on Aw Volume share 2 (slice thickness 5mm). We defined the results adopting MASS, RECIST and mChoi response criteria. QoL was reported adopting Edmonton scale and EORTC QLQ-C30. Results: Ten patients were enrolled, IAIRIM was successfully performed in all without major complications. Ten patients experienced a clinical improvement with disappearance of bleeding and reduction of pain in a week. Fever lasting 36 hours (24-48) and minimal discomfort procedure related in were observed in all . Reduced but persisting muchorrea and tenesm were reported in 4 patient. After four months all patients were alive without pain or bleeding. 8/10 patients experienced mass reduction ( -39%; range -96% / +7%) and 2/10 no evidence of progression. QoL: Edmonton scale (considering only pain, fatigue, well-being and depression items) was around 7 in 8/10 patients before treatment and 6 in 2/10 patients. After treatment 6/10 patients reported mean score 3; 3/10 reported 4, 1/10 reported 2. Using EORTC QLQ-C30, mean score decreased from 3 to 2. Conclusions: IAIRIM seems feasible, with low side effects in patients bearing UCRC considered out of usual approaches. A reduction of symptomatic treatments and an increase of QoL (Edmonton and EORT QLQ-C30 scale) has been recorded in all patients. Volume reduction of the tumour has been observed in nine patients. Further experiences are warranted.
Automatic inpatient palliative care consultation (PCC): Too little, too late to impact quality of life for advanced cancer patients?
Authors: Rocque Gabrielle Betty , Campbell Toby Christopher , Barnett Anne Elizabeth , Quale Renae M , Eickhoff Jens C. , Bailey Howard Harry , Burkard Mark E. , Cleary James F. 
Published: March 2020

e20565 Background: Patients with advanced cancer who are hospitalized have high symptom burden and a short life expectancy, which may warrant PCC. Methods: Using sequential cohorts, we prospectively assessed implementation of automatic PCC for hospitalized cancer patients. The primary outcome was hospice utilization. Secondary outcomes included evaluation of changes in quality of life (FACIT-PAL), symptoms (ESAS), satisfaction (FAMCARE), and anxiety and depression (HADS). Surveys were administered at baseline, 2 weeks and 3 months post-hospitalization. Chart abstraction was utilized to assess demographics, resource use, and survival information. Results: Patients were evaluated consecutively (65 in the control group, 70 in the intervention). At admission, 91% reported uncontrolled symptoms: 52% pain; 15% dyspnea. 60% of intervention patients received PCC during their first admission. 54 patients completed surveys (29 control group, 25 PCC group), 64 patients declined or were unable to complete surveys, 16 patients were excluded due to language barriers, physician preference, or not receiving surveys. Using an intent-to-treat analysis, there was no difference between patients in the control and the intervention group in FACIT-PAL (119 ± 29 vs 123 ± 30, p = 0.68 ), ESAS (28 ± 14 vs 26 ± 15, p = 0.74) HADS (13 ± 6.6 vs. 12.± 4.7, p = 0.58), or FAMCARE (58 ± 9.1 vs 59 ± 8.6, p = 0.61). In both groups, patients had modest worsening of symptoms and quality of life over the course of the study. Survival and Health Services data analysis, including hospice referral, is proceeding. Conclusions: Automatic PPC had little impact on patient-reported symptoms and quality of life. Limitations included: small patient population; high rate of incomplete surveys, likely due to illness burden; penetration of the PCC was limited to 60% by patient or provider preference and consultant availability. Our primary outcome analysis (hospice utilization) is forthcoming, as are data on survival and Health Services outcomes.
Long-term cancer survivorship care: On the radar screen?
Authors: Mehta Rutika , Jain Rohit , Rhodes Lori , Abraham Joseph , Miller Kenneth David 
Published: March 2020

e20567 Background: Long-term cancer survivors require comprehensive care. The purpose of this study was to describe how survivorship care fits into oncologists’ clinical time, and characterize long-term cancer survivors’ problems and oncology follow-up care. Methods: We abstracted 18,882 medical records of unique cancer patient visits during 2010 at a major NCI-designated cancer center and then evaluated survivor care for one week in April, 2010 to characterize how oncologists spend their clinical time. Finally, we selected three subgroups from the survivor population (n≈100 each) of survivors at 1-5 years, 6-10 years, and >10 years after diagnosis. We collected demographic data, purpose of visit, cancer-specific information, late and long-term effects, and type of care delivered, including surveillance for recurrence, intervention, prevention, and coordination of care. Results: In the larger group of 18,882, only 14% of survivors were more than 10 years post-diagnosis. Approximately two-thirds of the survivors were women. Breast cancer survivors comprised 38%, and survivors of hematologic malignancies accounted for 21% of the population. During the one week studied, the majority of oncologists' patients (74%) were actively receiving treatment; only 5% of their patients were 5 or more years post-diagnosis. Second or secondary malignancies were noted in 8% of patients. Late and long-term effects were uncommon. Approximately 25% of survivors beyond five years were observed to have late effects due to cancer treatment, most common being fatigue, neurological endocrine, and cardiac. Of the 300 selected survivors, sixty-two percent received only surveillance care during their visit. Only 3% of these patients received an entire array of survivorship care that included surveillance, intervention, co-ordination and prevention. Conclusions: A small proportion of oncologists’ visits were with long-term cancer survivors (5-14%) of whom only 25% had late or long-term effects of cancer treatment so overall very few of office visits were with long-term survivors who had late and long-term complications. All visits involved surveillance for cancer recurrence but there was little focus on prevention, intervention, and coordination of care for cancer survivors.
Fertility counseling in young adult patients with cancer.
Authors: Reichert Sonia Evelyn , Sanchez Sadie , Kolb Jen , Steinberg Amir S. , Holcombe Randall F. , Garland Elizabeth , Gabrilove Janice Lynn 
Published: March 2020

e20570 Background: In 2008, 450,000 US cancer survivors were of reproductive age (18-45 years). Currently, oncologists receive little training about fertility preservation and counseling for patients. In 2006, the American Society of Clinical Oncology (ASCO) recommended oncologists “discuss the possibility of infertility during their reproductive years prior to chemotherapy.” This study aimed to evaluate adherence to these guidelines and determine if a chemotherapy consent form increased compliance. Methods: At a tertiary care center in New York on April 23, 2012, a specialized chemotherapy consent form, including a fertility risk statement and checkbox, was implemented. A retrospective chart review was conducted 250 days before April 23, 2012 (pre group) and 250 days after April 23, 2012 (post group). This study included patients 18-45 years old with a new malignant diagnosis who received fertility altering therapy. Patients with a prognosis less than 12 months were excludedfrom the study. Data collected included demographics, documentation of fertility discussions, presence of a signed chemotherapy consent form and the use of a fertility risk checkbox prior to initiation of treatment. Results: Of 645 new patient visits, 80 in the pre-group and 53 in the post-group met the inclusion criteria. The mean age (SD) for the pre and post groups was 35.6 (±6.7) and 36.8 (±6.7) respectively. Thirty-five (43.8%) patients had documented fertility counseling in the pre group compared to 16 (30.1%) in the post group. A Cochran–Mantel–Haenszel test determined that these 2 groups were not statistically different (p = 0.250). In the post group, 5 (12.8%) patients had both documented fertility counseling and a consent form; and only 3 (7.6%) patients had evidence of documented counseling, a consent form and the fertility risk box checked. Conclusions: Fertility counseling was documented in less than half of cancer patients for whom this procedure is recommended. The introduction of a specialized chemotherapy consent form did not improve the rates of documented fertility counseling. Further exploration is needed to identify the barriers to fertility counseling and identify the best resources and tools for providers to ensure compliance with ASCO guidelines.
Dose reduction (DR) due to chemotherapy induced peripheral neuropathy (CIPN) in breast cancer (BC) patients (pts) in the neoadjuvant/adjuvant settings.
Authors: Bhatnagar Bhavana , Gilmore Steven , Goloubeva Olga G. , Wang Lulu , Medeiros Michelle , Chumsri Saranya , Tkaczuk Katherine Hanna , Edelman Martin J. , Bao Ting 
Published: March 2020

e20574 Background: CIPN is a common and potentially dose-limiting complication of many effective cytotoxic agents. Taxanes are the cornerstone of treatment in BC. Limited data are available regarding the prevalence and severity of DR due to CIPN following taxane use. Methods: Charts of 123 consecutive newly diagnosed BC pts treated with a taxane as part of standard neoadjuvant/adjuvant chemotherapy at the University of Maryland Greenebaum Cancer Center between 01/01/2008 and 12/31/2011 were reviewed. Treating physicians followed standard recommendations for DR. Results: Median age at diagnosis was 53 years (range, 32-78), 120 female/3 male, 48 Caucasian (C), 70 African-American (AA), 5 had a history of alcohol abuse, and 20 had a diagnosis of diabetes mellitus (DM). Seventy pts received docetaxel, 46 paclitaxel, 7 received both or nab-paclitaxel. Fifty (40%) pts required DR, with 21 (17%) due to CIPN and 29 (23%) due to other causes. The median relative dose intensity (received dose/planned dose) for the 21 CIPN-induced dose reduction pts was 88% (range, 62%-97%). A multivariable logistic regression model was used to compare pts who did and did not require DR based on the following possible risk factors: taxane received, DM, alcohol use, and race. Based on the effects estimated by statistical model, there was no difference between pts who did and did not undergo DR with regard to factors listed. However, diabetic pts were over twice as likely to require DR (OR = 2.4, 95% CI: 0.6-10.2, p=0.06). The univariable logistic regression model for 50 pts who had undergone DR revealed possible differences in developing CIPN between C and AA patients. The chances of DR due to CIPN are higher in AA pts (OR=4.3, 95% CI: 1.1-16.7, p=0.03). Pts who received paclitaxel are more likely to require DR due to CIPN than those treated with docetaxel (OR=10.4, 95% CI: 2.7-39.6, p=0.001). Conclusions: 1. CIPN-induced dose-reduction occurred in 17% of our study population. 2. The median relative dose intensity was 88%. 3. DM may increase the overall risk of dose reduction, and AA, paclitaxel therapy may confer a higher risk of CIPN-induced dose reduction.
A pilot study exploring issues around decision making in older women with primary operable breast cancer.
Authors: Parks Ruth M. , Hall Louise , Tang Siau-Wei , Lakshmanan Radhika , Howard Penny , Winterbottom Linda , Morgan David A. L. , Porock Davina , Cox Karen , Cheung Kwok-Leung 
Published: March 2020

e20588 Background: Decision making process related to cancer treatment is complex, influenced by tumour factors, patients and clinicians, and may affect outcomes eg quality of life (QOL). Studies are scarce in exploring this subject in the older population. This pilot study aimed to investigate this in older (≥70 years) women newly diagnosed with clinically T0-2N0-1M0 breast cancer. Methods: Patients as described were invited to participate. Actual treatment planning was made by the clinical team and was not part of the study. Semi-structured interviews were conducted within 6 weeks and at 6 months, alongside Comprehensive Geriatric Assessment (CGA) and QOL assessment using EORTC QLQ-C30. Interview recordings were transcribed (intelligent verbatim) and then analysed by (i) identifying themes; and (ii) comparing them with CGA and QOL measures. Results: Forty-one patients took part at the time of analysis. The following themes emerged in different patient combinations, at both time points. 1) Symptoms - The majority presented symptomatically (87%, 21/31). At 6 months, 45% (18/40) reported a negative feeling, but 81% (22/27) said they would choose the same treatment again. 2) Knowledge - Most patients (80%, 28/35) knew someone with a cancer diagnosis, but did not know much about breast cancer or treatment (87%, 18/24). 3) Reactions - At diagnosis, only 48% (10/23) felt ‘shocked’ or ‘surprised,’ while the remainder had ‘no reaction’ or ‘were prepared’. The majority (91%, 29/32) felt that they had received enough information about treatment options or that they did not have an option. 4) QOL - Most patients (88%, 15/17) thought they had made the right treatment choice. The majority (86%, 6/7) were not worried about the future and 91% (10/11) reported no change in QOL. No relationship was seen between these interview findings and the treatment modalities received. These findings were consistent with the results of CGA and QOL assessment. Conclusions: These preliminary findings suggest that these patients were generally happy with the decision made for their treatments and had a fairly good QOL and future outlook. The study has now entered into a second stage where more in-depth interviews are being conducted.
Efficacy and safety of BCD-017, a novel pegylated filgrastim: Results of open-label controlled phase II study in patients with breast cancer receiving myelosuppressive chemotherapy.
Authors: Salafet Olga V. , Chernovskaya Tatiana V. , Sheveleva Ludmila P. , Khorinko Andrey V. , Prokopenko Tatiana I. , Nechaeva Marina P. , Burdaeva Olga N. , Matrosova Marina P. , Kovalenko Nadezhda V. , Ovchinnikova Elena G. , Koroleva Irina , Ivanov Roman A. 
Published: March 2020

e20593 Background: Pegfilgrastim (conjugate of filgrastim and 20 kDa polyethylene glycol (PEG) is approved for treatment of chemotherapy-associated neutropenia. BCD-017 (empegfilgrastim) is a covalent conjugate of filgrastim with 30 kDa PEG. Increased molecular weight of PEG molecule may provide additional benefits compared to pegfilgrastim. Methods: To compare efficacy and safety of filgrastim and BCD-017 at 3 mg and 6 mg doses an open-label, randomized, active-comparator, non-inferiority trial was conducted. 60 patients with histologically or cytologically confirmed breast cancer were randomly assigned to receive either subcutaneous (s.c.) injection of 3 mg BCD-017 (n=21), 6 mg BCD-017 (n = 20), or 5 mg/kg s.c. injections of filgrastim (n=19) administered daily until ANC ≥ 10x109 cells/L (maximum of 14 days) after chemotherapy (doxorubicin 60 mg/m2 and docetaxel 75 mg/m2) with stratification for weight and prior chemotherapy exposure. The primary efficacy endpoint was the incidence of severe neutropenia (ANC < 1.0x109 cells/L) during the first cycle of chemotherapy. Results: Incidence of severe neutropenia during the first chemotherapy cycle was 85,7%, 65,0% and 61,1% in BCD-017 3 mg, BCD-017 6 mg and filgrastim groups, respectively. Differences between BCD-017 groups and filgrastim group were not significant. Mean duration of grade 4 neutropenia in cycle 1 was 0,43, 0,40 and 0,33 days, accordingly (95% CI for difference between BCD-017 3 mg and filgrastim groups -0.22 to 0.41; 95% CI for difference between BCD-017 6 mg and filgrastim groups -0.25 to 0.38). Febrile neutropenia was observed only in BCD-017 3 mg and BCD-017 6 mg groups (one case in each group). A single administration of BCD-017 at the doses of 3 mg and 6 mg was as safe and well tolerated as standard daily filgrastim administration. There were no unexpected adverse events in all groups. Conclusions: The results of this study support comparable efficacy of single s.c. injection of 6 mg BCD-017 versus daily 5 mg/kg s.c. injections of filgrastim. Further phase III study of BCD-017 for treatment and prophylaxis of neutropenia in patients receiving chemotherapy is necessary. Clinical trial information: NCT01569087.
Integrating patients’ values into decisions to enroll in phase I trials: A feasibility study.
Authors: Hendershot Kristopher A , Dossul Tehseen , Wall Louise , Owonikoko Taofeek Kunle , Harvey R Donald , Thomas Cheryl B , McCormick Jennifer B , Khuri Fadlo Raja , Pentz Rebecca D. 
Published: March 2020

e20608 Background: The American Society of Clinical Oncology recommends that physicians (MDs) assess the treatment goals and preferences of patients (pts) with advanced stage cancer. Available data, however, shows that pts’ values are not always well prioritized when making a treatment plan. Therefore, we iteratively developed a values tool containing 16 belief domains to inform MDs during conversations with their pts about the pts’ current priorities as they plan the next step in care. The purpose of this study was to determine the feasibility of using this values tool (defined as half of the tools having at least one value checked and half of the MDs discussing at least one value) in a phase I clinic setting. Methods: We audio-taped initial MD-pt conversations about potential enrollment in a phase I clinical trial at two academic medical centers (Emory and Mayo). The pts completed the values tool by selecting the 4 most important considerations for their next stage of care and were instructed to give the completed tool to the MD. The MDs were informed through the consent process but not specifically coached on use of the tool. The recorded conversations were coded using standard qualitative methodology to determine if a value from the tool was discussed. Results: There were 23 recorded encounters. All of the completed tools had at least one value checked and 19 of 23 (83%) completed tools were delivered to the MDs by the pts, as instructed. Of those who received the tool, 12 (63%) MDs discussed one or more of the values. The average satisfaction scores on a 5-point Likert scale were 3.9, 4.0, and 4.0, respectively, for tool clarity, ease of understanding, and benefit for pts who are offered a phase 1 trial (22/23 pts completed the evaluation). Average satisfaction scores from the 19 MDs who completed evaluations were 4.2 and 4.6, respectively, for influence of the tool on their treatment recommendation and accurate reflection of pts’ desires. Conclusions: The study met the predefined feasibility threshold and provides a strong rationale for future efficacy testing, including coaching of MDs. The tool was well accepted by both MDs and pts, and failure to deliver the completed tool by the pt was identified as a potential barrier to its effectiveness.
Survival effects of erythropoiesis-stimulating agents (ESAs) in patients with breast cancer: A meta-analysis.
Authors: Leyland-Jones Brian , Aapro Matti S. , Moebus Volker , Nitz Ulrike , O'Shaughnessy Joyce , Pronzato Paolo , Untch Michael , Tomita Dianne , Bohac Gerry C. 
Published: March 2020

e20616 Background: New data are available from two trials of ESA use in patients with breast cancer receiving chemotherapy. We conducted a meta-analysis of trials of ESA use in this population. Methods: A literature search identified reports from 1997-2012 that included mortality data from controlled ESA trials (epoetin alfa, epoetin beta, darbepoetin alfa, biosimilars) in patients with breast cancer receiving chemotherapy. We used data from company databases for Amgen Inc. or Janssen Products LP studies and published data for other studies. Random-effects odds ratios (OR) were calculated to compare results for patients randomized to ESA to patients randomized to control. Analyses were stratified by metastatic stage; mixed stage or treatment; and adjuvant/neoadjuvant treatment. Results: We analyzed 9 studies (N = 4713; ESA n = 2346, control n = 2367) (Table).The overall stratified random-effects OR for death was 1.17 (95% confidence interval, 0.99-1.39). Details are presented in the Table. Conclusions: Overall survival OR remains consistent with prior data after including recent results. [Table: see text]