bluuebunny/crossref_metadata_2025 huggingface dataset:
Evaluation of psycho-social distress in patients treated in a community-based oncology group practice in Germany
Authors: Mergenthaler U. , Heymanns J. , Köppler H. , Thomalla J. , van Roye C. , Weide R.
Published: August 2020

e20577

Background: Systematic evaluation of psycho-social distress in oncology outpatients is an important issue. Therefore we assessed feasibility and benefit of standardized routine screening using the Distress Thermometer (DT) and the Problem List (PL) in daily practice. Methods: All patients attending the practice between July and September 2008 were administered the DT and the PL. Patients were classified into the disease groups solid tumors, hematological neoplasms, benign hematological diseases and other non-malignant diseases. The individual treatment phase was evaluated additionally. Participants in a mammography screening programme were assessed as a control group. 500 randomly selected patients were sent a feedback-form to describe how they experienced the DT's influence on the doctor-patient-communication. Results: The 1,446 patients reported an average distress level of 4.7 with 37% indicating a distress level > 5. Patients with other non-malignant diseases (81% autoimmune diseases or hereditary hemochromatosis) showed the highest average distress level of 5.2. Regarding the treatment phases, the most distressed patients were patients who just learned about their diagnosis of relapsed or metastatic disease (6.4), patients receiving Best Supportive Care (5.4) and patients receiving adjuvant anti-hormonal therapy (5.4). The most frequently indicated problems causing distress were exhaustion/fatigue (49%), pain (44%), impaired mobility (41%) and sleep disorders (39%) respectively. Breast cancer patients stated a distress level of 5.2. The average distress level in 474 mammography screening participants was 3.3. 37% of 190 patients who returned the feedback-form indicated that the DT and PL were useful tools to speak to their doctor about their distress more precisely. 38% felt better than usual after this conversation. Conclusions: The study shows that cancer patients do not necessarily show higher distress than patients with severe non-malignant diseases. The problems patients most frequently indicate as distressing are somatic disorders. DT and PL are applicable for routine screening in an outpatient setting. Physicians as well as patients stated that the use of the DT improved the quality of their communication.

No significant financial relationships to disclose.
Hypofractionated radiotherapy and hormonal therapy in elderly breast cancer patients
Authors: Minea L. N. , Anghel R. , Isacu I. , Bacinschi X. , Tarlea A. , Georgescu T. , Georgescu T.
Published: August 2020

e20584

Background: Life expectancy increased in female population and we are facing higher incidence of breast cancer in patients over 80 years old. Considering age related comorbidities they are usually frail population which often can not receive chemotherapy or radical surgery. We evaluated once-a-week hypofractionated radiotherapy together with hormonal therapy for these patients in terms of local control, side effects and progression-free survival. Methods: Between January 2002 - December 2006 in the Oncological Institute of Bucharest Radiotherapy Department 59 patients with the age over 80 have been treated with once weekly hypofractionated radiotherapy associated with hormonal therapy. The clinical stage distribution was: stage I 9 patients, stage II 28 patients, stage III 22 patients. Radiation therapy was delivered once a week, dose=6.5 Gy, to a total dose of 32.5 Gy in 5 fractions for tumor site and lymph nodes. All patients received post irradiation hormonal therapy: Tamoxifen intended for 5 years. Results: 45 patients supporting the entire treatment (77%). 8 patients received less than 32.5 Gy (13%). 6 patients received less than 2 years hormonal therapy (10%). Radiotherapy led to: CR in 13 patients, PR in 31 patients, SD in 10 patients and PD in 5 patients. Toxicities after radiation therapy have been: grade 1–2 nausea in 6 patients, radiodermitis in 43 patients (grade 1–2 - 36 patients and grade 3–4 - 7 patients) and grade 1–2 leucopenia in 18 patients. Late toxicities of all grade occurred in 49.15% of patients: skin reaction - 19 patients, lung fibrosis - 8 patients (2 symptomatic and 6 asymptomatic) and cardiac failure - 2 patients. After one year 12 patients were free of disease and 38 patients were free of progression. 9 patients progressed; 4 of them died, 2 from their cancer. After two years 10 patients were free of disease and 35 free of progression. 14 patients dead and 4 death were cancer-related. Progression-free survival rate at 2 years was 76.27%. Conclusions: Definitive hypofractionated radiotherapy allows a good local control with acceptable toxicity and good progression free survival rate. This schedule associated with hormonal therapy is a good alternative to conventional multimodality treatment and to standard fractionation for patients over 80 years old.

No significant financial relationships to disclose.
Life-threatening dermatologic toxicities to cancer drug therapy: An assessment of the published peer-reviewed literature
Authors: Sorrell J. , West D. P. , Bennett C. L. , Raisch D. W. , Lacouture M. E.
Published: August 2020

e20592

Background: Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) lie on opposite ends of a clinical spectrum characterized by skin detachment, mucosal involvement and bullous skin lesions. Currently, reporting is in the range of 1–7 cases of SJS and 0.4–1.2 of TEN/million persons/year, with mortality as high as 35%. The association of cancer drug therapy with SJS/TEN has been uncommonly addressed. Methods: We searched Ovid (incl.1950 through Nov 2008), PubMed (incl.1948 to present) and Litt's Drug Eruption Reference Manual (incl.1980 through Oct 2007) using search terms and combination of terms relevant for SJS/TEN and cancer drug therapy. Only primary case reports were included. Histology reporting was not required for inclusion. Results: Of 448 results, there were 20 reports of SJS associated with 12 FDA-approved drugs and 22 reports of TEN associated with 16 FDA-approved drugs. In addition, all cases (cancer therapy and non-cancer therapy) were obtained from Medwatch (through Mar 2008). ( Table ) Conclusions: Whereas mild-moderate dermatologic toxicities including alopecia, nail abnormalities or rashes are frequent with cancer drug therapies, it is essential for the oncologist to be familiar with life-threatening dermatologic toxicities such as SJS and TEN, and the agents that have been associated with such reactions.

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Effect of PHY906 on capecitabine (CAP)-induced diarrhea in patients with GI malignancies
Authors: Hoimes C. J. , Lamb L. , Lok W. , Elligers K. , Carbone R. , Keley K. , Lansigan F. , Liu S. H. , Cheng Y. C. , Saif M. W.
Published: August 2020

e20595

Background: 15.4% of pts with GI cancers treated with CAP alone at 1250mg/m2 BID D1–14 q 3 wks (14/7) develop G3/4 diarrhea (Hoff et al. JCO, 2001). PHY906 composed of 4 herbs, Scutellaria baicalensis Georgi, Glycyrrhiza uralensis Fisch., Ziziphus jujuba Mill., and Paeonia lactiflora Palla, has been used to treat diarrhea since approximately 300AD. Preliminary studies showed synergistic activity of PHY906 with chemotherapeutics and reduction of chemotherapy-induced GI toxicities, especially chemotherapy-induced diarrhea (CID). Methods: We prospectively evaluated 44 pts treated on a clinical study with CAP plus PHY906 for diarrhea (experimental arm) and compared to historical data by Hoff et al., CAP 14/7 alone arm (control arm). Experimental arm consisted of pts with refractory solid tumors in phase I and gemcitabine-refractory advanced pancreatic cancer (APC) in phase II. Ph I pts received PHY906 800mg BID D1–4 with escalating doses of CAP (1000mg/m2→1250mg/m2→1500 mg/m2→1750mg/m2 BID) D1 -7 q 2 wks (7/7), until MTD. Ph II treated pts with APC at 1500 mg/m2 and PHY906 800mg BID D1–4. Toxicity was assessed per NCI-CTCAE-v3.0. In addition, correlative chemokine (IL-2, IL-4, IL-5, etc) levels will be quantified by cytometric bead array. Results: 44 pts (30M/14F; median 64yr) received 209 cycles (median:3, r:<1–14) of PHY906 in the four CAP-7/7 escalation cohorts in Phase I (19 pts), then at the MTD of 1500mg/m2 BID in Phase II (25 pts). Phase I pts had GI malignancies; 15 (63%) had APC and 6 (25%) colorectal. Of all phase I and phase II pts, G3/4 diarrhea was observed in 5 (11.4%) pts, without G3/4 constipation. One pt with APC who received 3 cycles at the 1500mg/m2 dose level was diarrhea-free until he was removed from the study; he continued on single-agent CAP at 1000mg/m2 BID and developed G3 diarrhea. Conclusions: In this study, G3/4 diarrhea was reduced by 19.5% in pts treated with PHY906 (experimental arm) when combined with CAP 7/7 compared to historical controls (control arm). As an underlying mechanism of CID may include cytokine activation, evalation of cytokines is ongoing.

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Budget impact analysis of sargramostim use in patients with chemotherapy-induced neutropenia
Authors: Duh M. , Toy E. L. , Porter C. L. , Books P. L. , Vekeman F. , Barghout V. , Skarin A. T.
Published: August 2020

e20596

Background: Myeloid growth factors are used to treat and prevent chemotherapy-induced neutropenia (CIN). Filgrastim and its long-acting version pegfilgrastim are granulocyte colony-stimulating factors (G-CSF), whereas sargramostim is a dual granulocyte- macrophage colony-stimulating factor (GM-CSF). This study analyzed the budget impact of substituting GM-CSF for G-CSF in the management of CIN from the perspective of a US health plan. Methods: A spreadsheet model was developed to compute annual and per-member-per-month (PMPM) costs associated with CSFs. Inputs included cancer prevalence, the proportion of patients receiving chemotherapy and G/GM-CSFs, incidence and cost of relevant adverse events (e.g., bone pain), and G/GM-CSF drug acquisition and administration costs. Incidence and cost of infection- and febrile neutropenia-related hospitalizations, based on recent analysis of medical insurance claims data, were also used. Cost savings (2006 USD) were assessed for utilization share switches from G-CSF to GM-CSF. Results: For a health plan with 1 million members, an estimated 976 patients received G/GM-CSF annually. Increasing baseline utilization shares for pegfilgrastim, filgrastim, and sargramostim of 70/30/0%, respectively, to alternative shares of 50/25/25% yielded substantial cost savings (see Table ), primarily related to G/GM-CSF acquisition and administration costs. Savings for patients switching from pegfilgrastim were greater than for patients switching from filgrastim. Results were sensitive to assumptions for drug cost and frequency of administration, but cost savings were observed for most scenarios. Conclusions: This study suggests that health plans can realize substantial cost savings by substituting sargramostim for filgrastim and pegfilgrastim in CIN patients. With 25% of sargramostim substitution, the cost saving could reach ≈$2 million for a health plan with 1 million members, or a saving of 16 cents per member per month.

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Classification procedure of the German version of the Cancer Fatigue Scale (CFS-D)
Authors: Reif M. , Kröz M. , Schad F. , von Laue H. , Feder G. , Matthes H. , Girke M.
Published: August 2020

e20608

Background: Fatigue severely reduces quality of life in many cancer patients. Cancer related fatigue (CRF) occurs with anaemia, during and after chemo- or radiotherapy and in advanced tumour states. The Cancer Fatigue Scale (CFS) is a well validated 15-item, 3-dimensional inventory (physical, cognitive, affective). Our classification procedure of its German version aimed at best separation of fatigue in cancer patients from healthy controls. Methods: CFS-D study data was combined from two studies that included CSF-D evaluations: a) 21 breast cancer (BC) and 7 colorectal cancer (CRC) patients (from a group of 57 cancer patients) and all 57 matched-pairs healthy controls (C); b) 41 BC and 25 CRC patients with chemotherapy. Analysing repeated ratings, four groups were found to significantly differ in global CFS-D (N female/male): C 65/27, CRC with (+) viscum album (VA) 27/34, BC + VA 110/0, BC without (-) VA 30/0. In cut-off analyses of sum- and subscales we iteratively categorized the data using moving thresholds and calculated their chi-square (X2) statistics when crossed with the study groups. CFS-D values were chosen as cut-off thresholds that yielded maximum X2 values when tested in 2x2-, 3x4-, and 4x4-tables. We plotted ROC curves to check for congruency of cut-off and ROC values. Results: Global CFS-D median (min.-max.) were: C 18 (2–38), CRC 22 (1–46), BC + VA 27 (0–54), and BC - VA 29.5 (7–48). For global CFS-D, cut-off and ROC analyses indicated ‘unclear’ CRF starting at 23 and ‘probable’ at 30. Subscale results were less definite; maybe with categories ‘unclear’/‘probable’ for dimensions ‘physical’: 9/15, ‘cognitive’: 9/11, ‘affective’: 6/8. Conclusions: The CFS-D is a highly reliable and valid global CRF questionnaire indicating categories ‘probable’ >= 30, ‘unclear’ at 23–29 and ‘none’ < 23. Thresholds for CFS-D subscales are less clear-cut and can not simply be calculated as proportional fractions of the total scale.

No significant financial relationships to disclose.
Zoledronic acid for the prevention of bone loss in patients with previously untreated lymphoma undergoing chemotherapy
Authors: Cataldo V. D. , Thompson M. A. , Toth B. B. , Sanjorjo P. , Bourgeois S. J. , Bekele B. N. , Jimenez C. , Murphy W. A. , Byfield S. A. , Hagemeister F. B.
Published: August 2020

e20611

Background: Treatment of lymphoma with alkylating agents and steroids causes bone loss and increased fracture risk. In addition, over half of all untreated lymphoma patients are osteopenic or osteoporotic at diagnosis. Pamidronate reduces bone loss and risk of vertebral fractures in lymphoma patients undergoing chemotherapy (CT). However, the effects of the more potent bisphosphonate (BP) zoledronic acid (ZA) in this setting are unknown. Therefore, we report on a phase III trial evaluating the effect of ZA on bone mineral density (B) in patients with newly-diagnosed lymphoma undergoing CT. Methods: In total, 72 patients will be randomized to either the control arm [calcium carbonate (1,200 mg orally/day) plus vitamin D (400 IU orally/day)], or the BP arm [calcium carbonate and vitamin D as in the control arm plus ZA (4 mg IV at baseline and at 6 months)]. The primary endpoint is the absolute change in B of the lumbar spine (LS) and femoral neck (FN) at baseline and 12 months. Results: Thus far, 112 patients have been screened for enrollment. Twenty-seven patients (24.1%) failed screening due to periodontal disease, a predetermined exclusion criterion of the study. To date, 14 patients in the control arm and 9 patients in the BP arm have completed the one-year follow up period including baseline and one-year B evaluations. Comparing patients in the control arm to those in the BP arm, the average absolute change in B at the LS was -0.048 g/cm2 vs. 0.0093 g/cm2 (p=0.005), at the left FN was -0.039 g/cm2 vs. 0.0074 g/cm2 (p=0.01), and at the right FN was -0.043 g/cm2 vs. 0.0211 g/cm2 (p<0.001), respectively. There have been no therapy-related serious adverse events or skeletal fractures in either arm. Conclusions: ZA in combination with calcium carbonate and vitamin D improves the B of patients with lymphoma undergoing CT. Given the incidence of below-average pre-treatment B and the known deleterious effects of lymphoma therapy on bone density, baseline B evaluation is warranted in all lymphoma patients. The high rate of periodontal disease in this patient population emphasizes the need for careful dental evaluation prior to BP therapy given the well-described, albeit rare, risk of osteonecrosis of the jaw from ZA.

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Determining issues of importance for patients with breast cancer: Results of a web-based study in 1,072 patients to enhance the content validity for the development of a new health-related quality of life (QL) instrument, the Breast Cancer Symptom Scale (BCSS)
Authors: Horigan J. L. , Gralla R. J. , Davis B. J. , Hollen P. J. , Petersen J. A. , Burg K. , Belland A. , Carleton J.
Published: August 2020

e20615

Background: Identifying key issues for patients with malignancy is central to assessing QL and patient reported outcomes during all points of the illness trajectory. The involvement of patients in establishing content validity is crucial for instrument development. The conceptual model for the BCSS focuses on areas of importance for patients (Hollen, Supp Care Ca 1994). Methods: We used the established patient base of the web-based NexCura information resource to survey registered patients with breast cancer. Demographic stratifications included disease stage, age, menopausal status, time since diagnosis, prior/current treatment with surgery, RT, chemotherapy, hormonal, targeted, and CAM approaches. 1072 patients (median age 53, 65% stage I, 43% > 2 years since diagnosis) completed the anonymous web-conducted survey. Patients ranked 21 issues on a 5-point scale, assessing the importance of each item. Issues included general, physical, functional, psychosocial and summative items. Results: The 9 highest ranked items are seen below. Results are described by the percent of patients choosing the top category (very important) and the top 2 importance categories. The five lowest ranked items dealt with appetite, breast-specific issues, hot flashes and sexuality. Ratings by breast cancer subsets (newly diagnosed, on treatment, NED, hormonal or non-hormonal treatment, metastatic disease, survivors) showed some differences compared with the whole group. Conclusions: These results represent one of the largest surveys of concerns expressed by patients with breast cancer and support using computer-assisted technology to assess such information for rapid input of large patient samples. This study gives strong support for content validity for the BCSS and provides data on which to base separate QL instruments for specific breast cancer settings.

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Vitamins B6 and B12 supplementation to prevent chemotherapy-induced neuropathy (CiN): Interim analysis of the taxane cohort
Authors: Verschraegen C. F. , Royce M. , Lee S. J. , Movva S. , Susan L. , Michael G.
Published: August 2020

e20621

Background: Chemotherapy-induced neuropathy (CiN) is common with heavy metals, taxanes, and vinca alcaloids. Pyridoxine (Vit B6) is used for diabetic neuropathy and cyanocobalamine (Vit B12) is required for synthesis of myelin and maintenance of the integrity of neuronal tissue. We hypothesized that supplementing patients (pts) with these 2 vitamins will prevent CiN. There were 3 pt cohorts depending on the chemotherapy regimen. Pts receiving any taxane enrolled in the taxane cohort (N=46), pts receiving vincristine or vinblastine enrolled in the vinca cohort (N=7), and all other pts receiving a platinum enrolled in the heavy metal cohort (N=25). The taxane cohort is reported here. Methods: Pts starting treatment with a taxane were randomized to a 1/6 of 100% of the daily recommended dose of a multivitamin/day (placebo) versus the same plus Vit B6, 50 mg tid, and Vit B12, 1 mg q 3–4 weeks (MV+Vit), during 4 cycles of chemotherapy. No other supplements were allowed. Taxane Fact G and a formal neurologic examination were performed prior to, and after 2 & 4 cycles of chemotherapy. Statistical methods were based on least squared means with ANCOVA and t-test (Cella, JCO, 2008). Results: To date, 46 pts treated with taxanes were randomized; 22 to placebo and 24 to MV+Vit. 13 and 16 pts completed 2 cycles and 8 and 6 pts completed 4 cycles, respectively. On the neuro examination, the only significant difference between placebo and MV+Vit was in the cold sensation (p=0.0097). The physical well being and the neuro modules of the Taxane Fact G significantly worsened after 4 cycles of chemotherapy in the placebo group (p=0.0289 and 0.0173, respectively), but this significant trend was not observed in the MV+Vit group (p=0.8318 and p=0.0866). The study will accrue 76 pts per cohort. Conclusions: The preliminary trends in this study suggest that vitamin supplementation with Vit B6 and B12 may reduce CiN during taxane-based chemotherapy.

No significant financial relationships to disclose.
Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan
Authors: Vishnu P. , Jasti P. , Ding L. , Heilbrun L. K. , Venkatramanamoorthy R. , LoRusso P. M. , Heath E. I.
Published: August 2020

e20626

Background: It is important to increase our understanding of recruitment barriers in the elderly population to improve their participation in clinical trials. The primary objective of this study was to describe the demographics, treatment, toxicity, and overall survival (OS) of all patients ≥ 65 years who presented to the Phase I clinical trials service at KCI between 1995–2005. Methods: Patient demographics, co-morbidities, tumor type, reason not enrolled on a Phase 1 clinical trial, toxicities, and OS were obtained by retrospective chart reviews. The patients were divided into 3 mutually exclusive groups: patients considered but not enrolled (PC), enrolled but not treated (PE), and treated (PT). OS was compared across these three groups. Results: 216 patients met the study criteria. Of these, there were 114 PC, 7 PE, and 95 PT. Lack of enrollment was due to ineligibility (30%), loss to follow-up (12%), refusal (8%), or no trial available (2%). Median age was 71 years, 63% were males and 87% were Caucasian. 59% had performance status (PS) 1; 16% had PS 2. 66% of patients had a history of cardiovascular disease but renal, liver, hematological diseases were found in less than 7% of patients at baseline. Colorectal (27%), lung (15%) and prostate (8%) were the 3 most common cancers. 54% received a cytotoxic agent, 62% a biologic agent, and 17% combination therapy. The 3 most common Grade 3–4 toxicities were: 15% leucopenia, 11% electrolyte abnormalities, and 4% anemia. The median OS for PC, PE, and PT was 3.9 mos, 2.2 mos, and 8.4 mos, respectively (p < 0.001 between any pair). However, PS 0–1 patients comprised 47%, 75%, and 73% of those 3 patient subgroups, respectively. Conclusions: More than half of the elderly patients initially considered for Phase 1 clinical trials at KCI were not enrolled due to ineligibility, refusal, or lost to follow up. Phase I chemotherapy appears feasible in patients age ≥ 65 years old. OS was significantly longer for patients treated on Phase I trials compared to those who were not, although that may be confounded by PS differences. More detailed OS comparisons will be presented.

No significant financial relationships to disclose.
Epidermal growth factor receptor (EGFR) inhibitor–related skin toxicity: Review of interim data from a phase II study (20060314) of panitumumab (pmab) with FOLFIRI in the first-line treatment of metastatic colorectal cancer (mCRC)
Authors: Karthaus M. , Hofheinz R. , Mineur L. , Letocha H. , Greil R. , Thaler J. , Gamelin E. , Wright L. , Köhne C. ,   20060314 Study Group and Cancer Center Munich South, Study Team Klinikum Neuperlach
Published: August 2020

e20634

Background: Skin toxicity that can impact quality of life as well as treatment adherence is commonly associated with EGFR therapy. Despite their particular importance in terms of making decisions regarding supportive care, time to onset and maximum grade of skin toxicity are seldom reported. Pmab is a fully human monoclonal antibody directed against the EGFR with demonstrated monotherapy activity in patients (pts) with wild-type KRAS expressing, chemotherapy refractory, mCRC. Methods: In this single-arm study, first-line pts with histologically confirmed mCRC were enrolled to receive pmab (6mg/kg) and FOLFIRI every 2 weeks. This trial is ongoing to evaluate the primary endpoint of objective response rate and secondary endpoints including disease control rate, duration of response, time to response, progression-free survival, time to progression and other safety aspects. The focus of this abstract is skin toxicity. Results: Cutoff for the initial interim analysis was 27 June 2008. Of the 154 pts enrolled, 68% are male; median age is 64 years (range 21–84) and 95% of pts had ECOG PS 0–1. A total of 97% of pts had experienced at least one adverse event (any grade) and 55% of pts had experienced a grade 3/4 event. Grade 3/4 skin and subcutaneous toxicities were observed in 20% of pts ( Table ). Median time to first cutaneous toxicity and median time to most severe toxicity were 9 (95%CI, 7–13) and 14 (95%CI, 13–16) days, respectively. The most severe toxicity was grade 4 in one pt. Conclusions: Combining pmab with FOLFIRI in the first-line setting is a well-tolerated regimen. Skin toxicity was observed in 92% of patients; onset, incidence, and severity of which appears to be comparable to published data. Management of skin toxicities will be presented.

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Sudden onset fatigue (SOF) in patients with breast cancer: Characteristics and symptomatology
Authors: Nahleh Z. A. , Wu H. , Galvin E. , Leedy D.
Published: August 2020

e20637

Background: Cancer-related fatigue is underrecognized and poorly managed. Unpredictability and rapid onset in fatigue is stressed by cancer patients but seldom addressed by health care professionals. Although sudden onset of cancer-related fatigue is anecdotally documented across qualitative studies, the symptom has never been systematically investigated. Our purpose is to describe the symptom and clinical characteristics of SOF in breast cancer patients receiving chemotherapy. Methods: This is a cross-sectional descriptive study enrolling female breast cancer outpatients undergoing chemotherapy in an urban cancer center. A brief questionnaire assessing the symptom characteristics of SOF was completed by subjects. Comprehensive metabolic panel and complete blood counts, were obtained. Descriptive statistics described the symptom characteristics of SOF. Mann-Whitney tests examined the differences between those who did and did not experience SOF. Results: Thirty patients have been enrolled. Median age 53 years (31 to 65; SD=7.7), 60% were Black. 80% (n=24) experienced SOF in the past 7 days with a median of 4 days a week and 2.5 episodes per day. SOF was most likely (75%) to occur in the afternoon while patients were engaging in activities. Levels of fatigue before, during, and after a specific episode of SOF were 5, 9, and 5, respectively, on 0–10 (highest) rating scale. Weakness, sweating, or pain sometimes accompanied SOF. When SOF occurred, individuals immediately needed to stop activities to rest until it went away. Those who experienced SOF had significantly lower levels of calcium (Median=8.9 vs. 9.4), albumin (Median=3.7 vs. 7.1), and hematocrit (Median=32.1 vs. 36) (p<0.05). Those who experienced SOF also had higher levels of GPT (Median=25.5 vs. 17), lower levels of total protein (Median=6.7 vs. 7.1), WBC (Median=4.9 vs. 8.9), RBC (Median=3.4 vs. 3.9), and hemoglobin (Median=10.7 vs. 11.4). Conclusions: Our ongoing study is one of the first to identify the characteristics of patients at high risk of SOF. SOF needs to be recognized and managed when patients undergo chemotherapy. Associated conditions should be identified and addressed. The ultimate goal is to minimize the distress and improve the quality of life of patients receiving chemotherapy.

No significant financial relationships to disclose.
Effect of nutritional status and support on survival in esophageal cancer patients undergoing combined modality therapy
Authors: Plastaras J. P. , Haynes J. C. , Mick R. , Hertan L. M. , Urdaneta A. I. , Metz J. M.
Published: August 2020

e20641

Background: Baseline nutritional status is associated with clinical outcomes in esophageal cancer. Moreover, nutritional support during chemoradiation has been shown to improve outcomes in other disease sites. This retrospective study evaluated the impact of nutritional interventions and baseline nutritional status on outcomes in patients (pts) with locally advanced esophageal cancer. Methods: A retrospective review was performed of 132 pts treated with curative intent using radiation (RT) between 1986 and 2007 at the Hospital of the University of Pennsylvania. The median age of the population was 60 years (range: 33–86). Esophagectomy was performed in 70%, with adjuvant RT in 60% and neoadjuvant RT in 40%. Concurrent chemotherapy was given to 85% of the group. Nutritional counseling was provided to 83% of pts. During RT, oral or enteral nutritional supplements were provided to 77% of pts and intravenous fluids (IVF) were given to 38%. Median follow-up was 14.1 months. Results: Median survival from end of radiation was 1.5 yrs. Median absolute and percentage weight loss during RT were 6.2 lbs and 3.8%, respectively. Median percentage decrease in hemoglobin and albumin were 5.7% and 9.1%, respectively. Univariable Cox regression analysis demonstrated a statistically significant association between weight loss of ≥5 lbs during RT and worse survival (HR 1.74, 95% CI 1.09 - 2.79, p=0.02). Decrease in hemoglobin of 5% or more (HR 1.22, 95% CI 0.59 - 2.54) and decrease in albumin of 10% or more (HR 1.09, 95% CI 0.48 - 2.48) were not associated with survival. Patients who received only nutritional supplements during RT survived significantly longer (p=0.03) than pts who received IVF regardless of nutritional supplementation (HR 2.12, 95% CI 1.12 - 4.01) or pts who received neither nutritional supplements nor IVF (HR 1.8, 95% CI 1.03 - 3.14). Conclusions: Weight loss during RT predicted for worse survival. Nutritional factors before and during RT may be important in outcomes in patients with esophageal cancer and may be modifiable. The use of IVF may be a potential indicator of worse prognosis. Future prospective studies should consider these factors in trial design.

No significant financial relationships to disclose.
CNTO328 (Anti-IL-6 mAb) treatment and hemoglobin (Hb) levels in renal cell cancer
Authors: Schipperus M. , Cornfeld M. , Rijnbeek B. , Berns B. , Rossi J.
Published: August 2020

e20648

Background: CNTO328 is a chimeric monoclonal antibody against the inflammatory cytokine, IL-6, which is currently being studied in hematologic and solid malignancies. IL-6 is a potent inducer of hepatic production of hepcidin, which is the key regulator of iron homeostasis and causes anemia by blocking iron export from enterocytes and macrophages. Hepcidin is an important factor in the pathogenesis of ‘anemia of chronic disease‘. CNTO328 treatment has previously been shown to produce profound Hb increases in Castleman's disease, a disorder caused by deregulated IL-6 production. We subsequently conducted this retrospective review to assess whether CNTO328 treatment is associated with an increase in Hb level in renal cell cancer patients (pts). Methods: All laboratory results for pts with metastatic renal cell carcinoma in this open label phase 2 study were reviewed. Pts were treated with CNTO328 (6 mg/kg) IV infusions Q2 weeks and were evaluated for tumor response and markers of pharmacodynamic effect. The difference in Hb levels from baseline to end of study was calculated. Results: Twenty pts (19 males) with a median age of 62 yrs (range 50–77) were studied. The median number of infusions was 6 (1–13). Of 18 pts evaluable for tumor response, 11 (61%) had SD and 7 (39%) had PD. The median baseline Hb was 13.6 g/dL (10.8–17.1). Nineteen pts were evaluable for Hb response. No pts received ESAs or transfusions. Treatment with CNTO328 resulted in a sustained Hb increase in 16 of the 19 pts (84%), with 13 (68%) achieving a max Hb increase of ≥ 1 g/dL (median 1.9; range 1.0–3.5). Hb responses were early (by day 8) and independent of tumor response. No Hb overshoot or thromboembolic events were observed. A trend toward decreased platelet and neutrophil counts was observed. Conclusions: Though pts were not anemic at baseline, our results suggest that CNTO328 leads to sustained increase in Hb levels, not correlated with tumor response. This increase in Hb is presumably due to the reduction of hepcidin via IL-6 blockade and targeting the hepcidin pathway may lead to new therapies for anemia of cancer. This hypothesis warrants further evaluation with prospective mechanistic studies.

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The importance of fertility preservation in women with early breast cancer
Authors: Agbarya A. , Linn S.
Published: August 2020

e20663

Background: Young women with breast cancer often seek advice regarding treatment effects on their fertility. The purpose of this study was to gain a better understanding of women's attitudes to fertility and how these concerns affect decision-making. Methods: A survey on fertility issues was developed for young women with a history of early-stage breast cancer. The survey was completed by direct interviews with the patients. Results: Eighty-four eligible respondents completed the survey. Mean age at breast cancer diagnosis was 34.7 years. Fifty-seven percent of the women were Jewish and 43% were Arabic; 71% were married; 75% had more than 12 years of education. Stages at diagnosis were: I - 51%; II - 38%; III - 11%. Seventy-seven percent of the women were within six months of diagnosis and 49% reported substantial concern about becoming infertile with treatment. In multivariate logistic regression, a greater concern about infertility was associated with a wish for children (p=0.0008), number of children less than three (p=0.001), more than 12 years of education (p=0.004), and a moderate or high level of fear of treatment (p=0.004). Seventy-nine percent of patients reported discussing fertility concerns with their doctors, and 14% underwent a medical procedure for fertility preservation. Only five patients stated that infertility concerns influenced their treatment decisions. Conclusions: 1. Fertility after treatment is a major concern for young breast cancer patients undergoing chemotherapy. 2. This statement was not affected by ethnicity. 3. There is a need to communicate with and educate young patients regarding fertility issues and large scale future research directed at preserving fertility for young breast cancer survivors is warranted.

No significant financial relationships to disclose.
Ovarian function after high-dose chemotherapy in childhood: Risk factors for developing partial ovarian failure and how to identify them early
Authors: Frey M. , Brugières L. , Bougnères P. , Bouvattier C. , Thomas-Teinturier C. , Calmanti S. , Goma G. , Oberlin O. , Hartmann O.
Published: August 2020

e20665

Background: During the last 30 years, polychemotherapies, surgery and radiotherapy have been established as standard therapies for treating pediatric cancers thus leading to a significant improvement in terms of 5-year-overall-survival which is now around 70% among children and adolescents. On the other hand, these treatments cause severe sequelae such as ovarian failure (OF) in young girls leading to a premature menopause and infertility. Methods: 29 patients treated at the Institute Gustave Roussy (Villejuif, France) have been investigated in an attempt to find biological and/or clinical markers, and imaging predictive of a partial ovarian insufficiency leading to an early menopause. Eligibility criteria: age >12 years at time of analysis; peripheral stem cell graft between 2–20 years; high dose chemotherapy. Results: 23/29 were eligible for this analysis (6 withdrawn due to oral contraception). 13/23 patients (56.5%) show no clinical evidence of ovarian treatment-related toxicity with a 13 years median time to transplant. 10/23 (43.5%) have complete ovarian insufficiency, among whom the majority have already received substitution hormone therapy (SHT). Out of 75% of pre-pubescent patients at transplant, only 2 have OF. All patients grafted at puberty (15.3 years) have high-dose chemotherapy-related immediate or definitive OF. Thiotepa >900mg/mq is castrating (odds ratio-10.1; p-0.04). Dosages of anti-müllerian hormone (AMH) collapses in patients with IO (p=0.002). Mensed patients have lower AMH dosages compared to normal population (p=2.10-e9) as for antral follicule count (>2mm). Conclusions: 1) 13/23 patients show no evidence of OF. 2) Main risk factors of OF: age ≥ 12 years; post pubertal status; thiotepa >900 mg/m2 (OR=10.1 and p=0.04). 3) Despite normal menses, many women who underwent high dose chemotherapy exhibit low AMH and Inhibine B levels and low count of follicles at a young age. These are possible markers of ovarian depletion. Cryopreservation of the ovarian cortex should be proposed to patients grafted due to a cancer independently of the age at which they have undergone high-dose chemotherapy.

No significant financial relationships to disclose.
Efficacy of orally available selective melanocortin-4 receptor antagonists in a murine model of cancer cachexia
Authors: Dallmann R. , Weyermann P. , Magyar J. P. , Anklin C. , Hufschmid M. , Nordhoff S. , Henneböhle M. , Dubach- Powell J. , Courdier-Fruh I. , Mondadori C.
Published: August 2020

e20668

Background: Cachexia is among the most debilitating and life-threatening aspects of cancer. It represents a metabolic syndrome affecting essential functional circuits involved in the regulation of homeostasis, and includes anorexia, fat and muscle tissue wasting. The anorexigenic peptide alpha-MSH is believed to be crucially involved in the normal and pathologic regulation of food intake. It was speculated that blockade of its central physiological target, the melanocortin (MC)-4 receptor, might provide a promising anti-cachexia treatment strategy. This idea is supported by the fact that in animal studies, agouti-related protein (AgRP), the endogenous inverse agonist at the MC-4 receptor, was found to affect two hallmark features of cachexia, i.e. to increase food intake and to reduce energy expenditure. Methods: Two recently discovered, non peptidic, chemically unrelated, orally active MC-4 receptor antagonists penetrating the blood brain barrier were studied. Specifically, the influence on food intake in healthy mice, and effects in the murine C26 cancer-cachexia model were investigated. Results: Both compounds were found to distinctly increase food intake in healthy mice. Moreover, in mice subcutaneously implanted with C26 adenocarcinoma cells, repeated oral administration (starting the day after tumor implantation) of each of the two compounds almost completely prevented tumor induced weight loss, and diminished loss of lean body mass and fat mass. Conclusions: In contrast to the previously reported peptidic and small molecule MC-4 antagonists, the compounds described here work by the oral administration route. In the light of patient care, orally active compounds might offer a considerable advantage for the treatment of cancer cachexia.

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The efficacy of percutaneous vertebroplasty for palliation of pain in vertebral metastases associated with solid malignancies
Authors: Lee B. , Franklin I. , Coombes C. , Leonard R. , Gishen P. , Stebbing J.
Published: August 2020

e20670

Background: Painful vertebral metastases are a debilitating and common complication of a number of solid malignancies. Percutaneous vertebroplasty appears beneficial for patients with acute compression fractures of multiple aetiologies including myeloma, and osteoporosis. There are few reports on its use in the setting of metastatic solid malignancy. Methods: We identified all individuals who had undergone percutaneous vertebroplasty at our institution since 2004 and focused on those with metastatic solid malignancies. Their clinical characteristics and outcomes were investigated. Results: From 136 cases that underwent percutaneous vertebroplasties, 19 were performed mainly in breast, prostate, lung, and renal cancers. Of these 19 cases, ten patients (53%) were treated for solitary lesions, 3 (16%) were injected at two levels and the remaining 6 cases (31%) underwent cement injection at three levels. The majority of patients (84%) reported short (within 48 hours) and longer term symptomatic improvements. At a median follow up of one year, 6 patients have died. Conclusions: This study illustrates that percutaneous vertebroplasty can be a safe and beneficial palliative procedure for patients with pain related to metastatic vertebral disease. Up to three vertebral levels maybe injected at one sitting with good results. Its use can be successfully combined with other treatment modalities (radiotherapy and chemotherapy). For optimal results its use before radiotherapy has been recommended. Although it does not improve the survival outcome, palliation is a reasonable goal when life expectancy is short. Cost benefits from this procedure will come from reduced analgesic requirements and avoided complications of long-term bed rest, with significant potential savings from reduced in-patient admissions for pain control, home care costs, community nursing, and out-of ours access to clinical services.

No significant financial relationships to disclose.
Comorbidity and survival in advanced non-small cell lung cancer (NSCLC) veteran patients
Authors: Chang V. T. , Hoover D. R. , Cogswell J. , Cholankeril M. , Badin S. , Yang W. , Yan H. , Gonzalez M. L. , Einhorn J. , Kasimis B. S.
Published: August 2020

e20675

Background: Prognostic value of comorbidity at diagnosis has received increasing attention. We studied whether the Charlson Comorbidity Index (CMI), Cumulative Illness Rating Scale (CIRS), Kaplan Feinstein Index (KFI), and/or VA Comorbidity Scale (VA) independently predicted survival for NSCLC patients Methods: In an IRB approved protocol, the charts of 101 patients with Stage IIIA, IIIB or IV Non small cell lung cancer seen from 2004 through 2006 at a VA medical center were reviewed of whom 94 have already died. Comorbidity scores ECOG performance status (PS), stage, number of treatments, serum LDH, and albumin levels were obtained or coded from medical records. Survival analyses were performed using proportional hazards models. Results: Median (M) patient age was 69 years (range 51–88), the M ECOG PS was 1 (range 0–4); 13 (13%) had stage IIIA, 27 (26%) IIB and 62 (61%) IV. The M number of treatments was 1 (range 0–6). Histologies were adenocarcinoma in 48 (48%) pts, squamous cell in 37 (37%) pts, and other 17 (15%) pts. The M survival was 207 days (range 4–1785 days). The Median (and ranges) were: 4.2 (1.2–12.8) for CMI, 3 (0–6) for CIRS15, 5(0–11) for CIRS16, 1.8 (0–4) for CIRS17, 0(0–1) for CIRS18, 2 (0–3) for KFI, and 4 (0–8) for VA. The M albumin was 3.7 (range 1.9–5.3) and LDH 201 (range 104–1036). In univariate survival analyses, the stage (p<0.001), ECOG PS (p<0.001), albumin (p<0.003), and the CIRS 17 (p <0.052) were predictive of survival; when, however, bisected by median values, the VA scale (p<0.027), ECOG PS (p<0.052) and albumin (p<.0017) were significantly related to survival but age, LDH, CMI, KFI and subscales of the CIRS (CIRS 16, CIRS 17, CIRS18) were not related to survival. In multivariate proportional hazards analyses that included stage and a comorbidity index, the CIRS16 (p<.032) was an independent predictor of survival; the combinations of stage (p<0.008), ECOG PS (p<.004), stage (p<.006) and albumin (p<.002) were independent predictors of survival. Conclusions: In this small sample, current comorbidity indices did not add to determinations of survival of veterans with advanced NSCLC. Further research is needed in a larger sample. Supported in part by the New Jersey Commission for Cancer Research 09–1133-CCR-EO and VA HSRD IIR 02–103.

No significant financial relationships to disclose.
Therapy of palmar-plantar erythrodysesthesia after continual fluoropyrimidin administration with 10% uridin ointment
Authors: Netikova I. , Sedlackova E. , Konopasek B. , Petruzelka L.
Published: August 2020

e20690

Background: Palmar-plantar erythrodysesthesia, so called hand -foot syndrom (HFS), is a common side effect and in many cases the limiting factor of chemotherapy with continual fluoropyrimidine administration. The exact mechanism of keratinocyte damage by fluoropyrimidins is as yet unknown, as well as effective therapy. Uridin was one of several chemicals that could influence cell metabolism of pyrimidins and is effective in case of HFS skin toxicity. The detailed pharmacological explanation of selective effect of uridin rescue has been missing. The local skin administration of uridin is proved to be efficient in patients with HFS; however, it works well only after 5-FU or capecitabine administration, but not as a prevention. This phenomenon is so far explained by displacing 5-FU from intracellular metabolic pathways due to the increased offer of uridine. Usage of an uridin ointment in spite of encouraging practical experiences has not been so far supported by any prospective randomized study. In many countries, including the Czech Republic, uridin is not registered for routine medical treatment. Methods: During the 2 years period 84 patients were treated with a fluoropyrimidin based chemotherapy (mainly capecitabin) with the 10% uridin ointment, 2–3 times daily and were followed. Number of chemotherapy cycles, a grade of HFS and it´s site, time of uridin local administration and a grade of HFS after treatment, were evaluted. Results: 16 patients have finished uridin treatment after first unit pack (100g). The reason was a change of therapy after tumor progresion or change of hospital. Next we evaluated a group of 68 patients. In 23 patients (34 %) we havent´t seen any effect. In 45 patients (66 %) decreasing of HFS intensity after 2 - 4 weeks of local administration about 1- 2 grades.1 pacient with alergic anamneses has developed atypical small white skin papulas. Other local or systemic allergic reactions were not observed. Conclusions: The 10% uridin ointment seems to be suitable as a supportive treatment for HFS.

No significant financial relationships to disclose.
The frequency of febrile neutropenia in oncology patients receiving chemotherapy
Authors: Chohan K. , Lai D. , McNamara M. , Grogan L. , Breathnach O. S.
Published: August 2020

e20691

Background:Febrile neutropenia (F/N) is a relatively common and serious side effect for oncology patients undergoing chemotherapy. Due to varying dosages and frequency of cytotoxic agents administered to oncology patients, the incidence and grade of neutropenia varies. The purpose of this study was to establish the frequency of febrile neutropenia in different chemotherapy regimens. Methods: Data was collected on 343 patients who underwent chemotherapy over a 9 month period. Regimens that caused at least one episode of febrile neutropenia in patients within that period were assessed in the study. A list of the patients on identified chemotherapy regimens during the time period was generated by the pharmacy department. Data on patients who had febrile neutropenia was obtained from their clinical notes. Clinical data was then obtained on all those patients. This information was then used to compare the frequency of febrile neutropenia in the included chemotherapy regimens. Results: 343 patients were included in this study. Of those, 41 patients developed febrile neutropenia within the 9 month period (11%); there were 49 cases of febrile neutropenia (14%) in total as some patients had more than one episode. Conclusions: Febrile neutropenia (FN) is a known potential side-effect from treatment with chemotherapy. This study highlights the rates of FN in patients treated within one centre. In patients being treated with specific chemotherapy regimens this study may guide the increased use of G-CSF and better outline the risk profile of such therapy to patients.

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No significant financial relationships to disclose.