bluuebunny/crossref_metadata_2025_split huggingface dataset:
Beliefs and concerns African American (AA) and white (W) patients (pts) with breast, lung, and colon cancer bring to bear on the decision to undergo chemotherapy
Authors: Smith D. , Polite B. N. , Hlubocky F. , Gehlert S. , Daugherty C. K. 
Published: March 2020

9076 Background: AA have poorer stage-specific survival for breast, colon and lung cancer than whites and are also less likely to receive therapy for these cancers. This study seeks to explore the set of beliefs and concerns patients with primarily resected breast, lung, and colon cancer bring to bear on the decision to receive chemotherapy. Methods: Semi-structured interviews were conducted and recorded by a non-physician, African-American interviewer on patients with colon, breast, and lung cancer referred to medical oncology for chemotherapy. Grounded theory methods were used to analyze and code the interview transcripts. Results: A total of 27 interviews were conducted (17AA, 10W) including pts with breast (5), colon (6) and lung cancer (16). All but 7 of the pts were referred for adjuvant therapy. Three major themes emerged: (1) Patient versus physician control in decision making; (2) Absolute trust in one's physician versus qualified trust; (3) Major role of God in the decision making process versus a partnership or minimal role of God. In terms of decision-making, roughly equal portions of AA and W (53% vs 54%) expressed a patient centered locus of control. In the area of trust, AA were less likely to express an absolute trust in their physicians (59% vs. 80%). Finally, with respect to the role of God, AA were more likely to express a major role of God for their cancer and treatment (41% vs. 7%). Very few pts viewed the opinion or advice of family or friends as important and while many expressed concerns about the side-effects of therapy, very few identified that as being an important factor in their decision to undergo therapy. Conclusions: Issues of locus of control, physician trust and the role of God were areas identified as important in the chemotherapy decision-making process and for which variability existed among the pts interviewed. Analysis of these interviews informed the incorporation of validated measures of decision-making, physician trust, and the role of God as a locus of control in an ongoing close-coded survey of a similar cancer population. No significant financial relationships to disclose.
Does quality of life improvement precede anemia correction in patients with chemotherapy-induced anemia treated with intravenous iron?
Authors: Henry D. H. , Dahl N. V. ,   G. The Ferrlecit Cancer Study Group
Published: March 2020

9082 Background: Combining intravenous (IV) iron with erythropoiesis-stimulating (ESA) therapy has been shown to increase Hgb response in treating anemia of cancer and chemotherapy. As part of a trial in anemic cancer patients on chemotherapy being treated with an ESA, we compared the effects of IV iron, oral iron, and no iron, on changes in patient-reported HRQOL. Methods: Prospective, randomized, controlled, multicenter trial. Major inclusions: pt starting chemotherapy cycle, Hb <11g/dL, ferritin >100 ng/mL or transferrin saturation >15%. Major exclusions: recent transfusion, ESA, or IV iron use, infection. All pts received epoetin alfa (40,000 U SQ/Wk for first 4 wks, then dose- adjusted per protocol). Pts were randomized to: No iron, PO FeSO4 325 mg tid, or IV ferric gluconate 125 mg IV weekly, for 8 weeks. Change in HRQOL was measured 4 weeks after start and at end of study (week 10, or last observation carried forward) using Functional Assessment of Cancer Therapy (FACT)-Anemia. Results: There were no significant between-group differences at baseline in mean Hb (10.2g/dL), TSAT (31.3%), or serum ferritin (421ng/mL) for the 129 evaluable patients, (mean age 65.3, 69% female). See Table . Hgb responses were significantly greater by end of study in evaluable pts receiving IV FG than oral iron or no iron. Only pts receiving FG reported a significant improvement in FACT-Fatigue subscale (FACT-F). This difference began at 4 weeks, while Hgb response was still similar between groups. No significant improvement in fatigue was reported by either the no iron (ESA alone) nor oral iron group. Conclusions: Combining IV iron with ESA therapy lead to an early and sustained clinically significant (=3) improvement in fatigue score, which preceded the improvement in Hgb response. [Table: see text] [Table: see text]
Racial/ethnic differences in adequacy of information and peer support for women with breast cancer
Authors: Janz N. K. , Mujahid M. , Hawley S. , Hamilton A. , Katz S. 
Published: March 2020

9085 Background: Existing disparities in quality of care for women with breast cancer suggest the need to explore the adequacy of information and care support provided to patients. This study investigated whether racial/ethnic variation existed in receipt and usefulness of cancer-related information and availability of peer support. Methods: 2,030 women diagnosed with non-metastatic breast cancer and reported to the Los Angeles County, Surveillance Epidemiologic and End Results registry between 8/05–5/06, were identified and mailed a survey shortly after initial treatment. Latina and African American (AA) women were oversampled. Outcomes included self-reported receipt and perceived usefulness of treatment-related (recovery from surgery, radiation, chemotherapy) and survivorship-related (sexual functioning, relationships, nutrition, anxiety) information and experiences with other women with breast cancer. We report results on a 50% respondent sample (N=742) that will be updated based on a final sample of 1,400 women (projected response rate, 72%). Results: More women received information and found it useful regarding treatment than survivorship issues. After adjusting for age and education, a higher percentage of Latina women, compared to white and AA women, desired more information on treatment-related issues and survivorship-related issues (p<.01). A higher percentage of Latina women also reported having no contact with other women with breast cancer, either through the health care system or a family/friend (p<.001), and reported a desire for more contact as compared to white or AA women (42%, vs. 15% and 29%, respectively). Overall, women rated the benefit of talking to other women high, particularly in helping with emotional issues and few endorsed potentially negative consequences. Conclusions: Women with breast cancer expressed the need for more useful information and care support, especially about managing survivorship concerns. Particular focus is warranted with Latina women to provide desired information and greater opportunities for peer contact. No significant financial relationships to disclose.
Results of a randomized double-blind clinical trial of Shugan-liangxue prescription for relieving hot flashes in breast cancer patients
Authors: Li P. , Sun H. 
Published: March 2020

9086 Background: Hot flashes are a common side effect for BC pts during endocrine treatment. An oral solution of TCM is prescribed for the purpose of clearing heat and cooling blood. There is no phytoestrogen in TCM compound and each herbal with luciferase activity detection. 66 patients involved in the study from October 2004 to November 2006. Methods: A placebo controlled randomized double blind clinical trial was designed. The endpoint is hot flashes relieving. The second point is improving the sleeping disturbance. Sample numbers designed by statistician. Daily average of hot flashes was recorded by pts for a week as a baseline. The age, ER and PR status, hot flashes scores were distributed approximately equal between the two groups. Hot flashes scores were evaluated according to Kupperman menopausal index (KI). TCM or placebo liquid (100ml) was administrated orally three times a day for 3 weeks by a randomized envelope method. Results: Total 66 patients were evaluated. For hot flashes in placebo group 69.7%(23/33) no change, 30.3%(10/33) relieved, no pts report symptom disappear. There are 42.4%(14/33) hot flashes no change, 42.4 % (14/33) relieved, 15.2 %(5/33) hot flashes disappearance in TCM group (P=0.006). For sleeping disturbance in placebo group is 60.6%(20/33) no change, 39.4%(13/33) sleep improvement. In TCM group is 36.4%(12/33) no change, 63.6%(21/33) sleep improvement (P=0.049). Conclusions: According to the principle of TCM treatment hot flashes and ER and/or PR positive BC endocrine treatment characteristic, the TCM prescription is effective in alleviating tamoxifen-induced hot flashes and sleep disturbance while there is no phytoestrogen. No significant financial relationships to disclose.
Understanding the choice of participating in clinical trials
Authors: Catania C. , De Pas T. M. , Goldhirsch A. , Radice D. , Adamoli L. , Medici M. , Verri E. , Marenghi C. , de Braud F. , Nolè F. 
Published: March 2020

9091 Background: The choice of whether to participate in a clinical trial by patients (pts) with cancer can be influenced, beyond trial information, by patient's own emotional and cultural properties, including past history as well as prejudices. Our hypothesis was that a better knowledge of these cultural and emotional features might be useful to improve patients-doctor dialogue, leading patients to a more conscious motivation to make the choice. Methods: We developed a 17-items, multiple-choice and open-answer questionnaire, to capture motivations for participating, or declining to take part, in clinical trials. Further information included family relationships, schooling and clinical symptoms. Patients were required to have advanced lung or breast cancer and to have never discussed participation in a clinical trial. Results: The questionnaire was answered by all the 42 pts who received it. Eighty-three percent of pts were positive about their participation. Trust in the investigator (43%) or in the Institute (21%) and hope to receive a new chance for cure (71%), both for themselves and for others, were a major motivation for a positive answer. Forty-eight percent thought participation in a clinical trial as a sign that no other “standard” treatments are available; 19% were worried of unknown side effects and 76% considered detailed information on expected toxicity to be helpful in making the decision. Sixty percent of patients were afraid of losing “precious time” by participating in a trial; 9% felt exploited as “guinea pigs” and 31% had a some degree of fear that a clinical trial is primarily motivated by economical interests. The most important reasons for accepting an oral experimental drug were its easy use (46%) and having more freedom (36%) Conclusions: Italian patients with advanced breast or lung cancer positively viewed participation in a clinical trial. Several hopes, prejudices and fears have been captured by the questionnaire, which might lead to improve the informed consent documentation and the consciousness of patients in taking their choice. Validation of the findings in a larger cohort of patients will lead to a study on the effect of a specific intervention on informing patients about clinical research. No significant financial relationships to disclose.
Quality of life and LhRH agonist therapy among prostate cancer patients who experience PSA failure
Authors: Kline K. F. , Sartor O. , Dandade N. A. , Nonzee N. J. , Vicuna B. D. , Bennett C. L. 
Published: March 2020

9093 Background: Growing numbers of prostate cancer patients survive for extended periods of time after initial diagnosis and treatment. Many experience a biochemical relapse (“PSA failure”) some time after prostatectomy or pelvic radiation. LhRH agonist therapy can reduce PSA levels, but its impact on survival time and quality of life (QOL) is unclear. We evaluated these concerns among Veterans who experienced PSA Failure. Methods: Eligibility criteria included: receipt of primary therapy for prostate cancer followed by a PSA nadir and subsequent PSA rise to at least 0.2 ng/ml. Data sources include patients (interviewer administered survey instruments on health-related QOL at baseline, 3 and 12 months) and medical records (clinical and laboratory findings). Results: 69 patients from the Jesse Brown VA Medical Center in Chicago have enrolled in the study to date. At their baseline interviews, 30 patients (43.5%) were receiving LhRH agonists (46.1% of 39 African-American patients and 48.0% of 25 White patients). LhRH agonist patients reported worse health-related QOL in domains relevant to prostate cancer than watchful waiting (WW) patients ( Table ), including increased frequency of urination, difficulty controlling urination, greater erectile dysfunction, and more limits on sexual activity. LhRH agonist and WW patients reported similar levels of sexual satisfaction. Conclusion: Of the PSA failure patients studied in this sample, those receiving LhRH agonist therapy experience more problems with urinary and sexual function than those who opted for WW. Longitudinal study will provide information about whether the LhRH therapy causes these side effects, or whether symptomatic patients are more likely to choose LhRH therapy than those with few prostate cancer symptoms. [Table: see text] No significant financial relationships to disclose.
The effect of corticorelin acetate on peritumoral brain edema: An interim report of an open-label study as part of a phase III program
Authors: Carr L. , Mechtler L. , Recht L. , Hormigo A. , Paleologos N. , Alksne J. F. , Arenson E. , Raizer J. , Shulman M. G. ,   CAPBrainEdema [Corticorelin Acetate Peritumoral Brain Edema] Study Group
Published: March 2020

9095 Background: Steroid treatment of peritumoral brain edema (PBE) in patients with malignant brain tumors (BTs) is frequently associated with debilitating steroid side effects. The investigational agent corticorelin acetate injection, a synthetic peptide identical to h-corticotropin-releasing factor (hCRF), compared favorably to dexamethasone in reducing PBE in animal models of primary or metastatic BT. Toxicology and clinical studies including a pilot study in patients with malignant BTs published in ASCO's Annual Meeting Proceedings, showed hCRF to be safe and virtually devoid of steroid side effects. Methods: Following completion of follow-up periods for one of 2 randomized, double-blind phase III trials comparing corticorelin acetate to placebo or dexamethasone, patients with primary or metastatic BTs, PBE on pre-randomized study MRIs, and Karnofsky Performance Scores =50 were enrolled in an open-label extension study in which they took 1.0 mg corticorelin acetate by subcutaneous injection bid. We tapered dexamethasone maximally as tolerated. Patients were assessed every 4 weeks. Results: Of 47 patients who received open-label corticorelin acetate for up to one year, 28 patients continue to take it. Corticorelin acetate was safe and well tolerated, with no related deaths or SAEs. Patients typically refractory to reducing steroids - including at least 5 patients >55 years of age, 7 patients with recurrent brain tumor, and 11 patients in whom prior attempt(s) to reduce dexamethasone had been unsuccessful – reduced dexamethasone with improvement or resolution of steroid side effects. We will present data in the first 30 patients to take corticorelin acetate for at least 12 weeks [the largest and longest-treated group reported to date] including changes in steroid side effects correlated with net cumulative changes in dexamethasone, and treatment-emergent AEs. Conclusions: This interim analysis supports corticorelin acetate's long-term safety, tolerability, and steroid-sparing potential. The outcome of the ongoing randomized trials may determine whether this innovative agent leads to fundamental changes in the management of PBE in patients with primary or metastatic BTs. [Table: see text]
Skin events (SE) among 1,126 patients (Pts) treated with lapatinib (L), an oral dual ErbB1/2 tyrosine kinase inhibitor (TKI)
Authors: Sweetman R. , Lacouture M. E. , Koehler M. , Laabs S. , Preston A. , Blackwell K. L. 
Published: March 2020

9102 Background: Lapatinib (L) is active as a single agent and in combination with capecitabine in pts with ErbB2+ve breast cancer. Safety profile from > 5,000 pts demonstrates infrequent Grade (G)3/4 (10%) adverse events, with drug discontinuation (disc) required in (<2%) events. SEs were commonly reported and were likely due to ErbB1 inhibition in the epidermis, as hypothesized with the other ErbB1 TKIs. However, the SE with L appear to differ clinically from other TKIs. Methods: SE in 1,126 pts reported in 8 L trials ( EGF20001 , EGF20002 , EGF20003 , EGF20004 , EGF20008 , EGF20009 , EGF20014 , + EGF100151) were pre-defined as dermatitis, drug eruption, dry skin, pruritus/urticaria, skin disorder, skin infection, nail, and hair disorder. SE were characterized based on CTC grading, and examined as to their relationship to L dose, length of L exposure, tumor type, concurrent treatment, time to onset from L initiation, and time to resolution with L dose- reduction or disc. Furthermore clinical management, skin biopsies, photos, and outcome were examined. Results: Pts were treated with L monotherapy 1,000–1,500mg daily (N=928), or in combination with capecitabine (C) (N=198). Non-L containing arms of studies EGF100151 (N=191; C alone) and EGF20001 (N=197; tamoxifen alone) served as controls. Among all L treated pts, 54% experienced SE mostly as G1/2, and 69% L+C pts experienced G1–3 SE with 50% G2. Majority of SE were deemed not specific to L and were rarely severe (no G4). Only 1% required drug disc. Most frequently reported SEs were dermatitis/drug eruption (38% all grade; 3% G3) (8% all grade, 1% G3). The frequency of SE with L at 1,500 mg QD was 57%, 1250 mg QD was 41%, and 500 BID was 63%. Most SE developed early (45% day 1–14) and persisted a median of 29 days. The majority of L pts (82%) did not require intervention (ie, dose reduction, hold, or withdraw). Conclusions: This large collection of L treated pts demonstrates that SE related to L therapy are low grade, infrequently require intervention or dose reduction, and rarely cause drug disc. Further attempts to identify pts at high risk for skin toxicity, its management, and the pathophysiology of L related SE are ongoing. No significant financial relationships to disclose.
Do most newly diagnosed advanced NSCLC patients need nutritional intervention?
Authors: Swinton N. , Kasymjanova G. , Steinberg T. , Lajeunesse L. , Dajczman E. , Kreisman H. , Small D. , Agulnik J. S. , Kawadoi J. , MacDonald N. 
Published: March 2020

9108 Background: Depletion of nutritional reserves and significant weight loss are commonly noted in patients (pts) with non-small cell lung cancer (NSCLC). The Patient Generated Subjective Global Assessment (PG-SGA) is a nutritional screening tool for cancer pts, recommended by the Oncology Network of Dietitians of Canada and the American Dietetic Association. The PG-SGA categorizes total scores into 4 ranges for nutritional triage: 0–1 requires no intervention, 2–3 requires education, 4 - 8 requires intervention by a dietitian, and =9 requires urgent symptom control and nutrition intervention. (Ottery, 2000). Methods: We determined the prevalence of malnutrition in 92 newly diagnosed advanced NSCLC pts (stages 3 / 4) in an outpatient clinic who had completed a baseline PG-SGA. We also investigated the association between CRP (an inflammatory marker which correlates with poor prognosis) and the PG-SGA. PG-SGA score was based on the sum of 4 subscales: symptoms, weight history, food intake and functional status. Results: 92 pts (M 48, F 44) aged 65 ±11 years were studied. 21 (23%) pts had a PG-SGA score of 0–3, 23 (25%) 4–8, and 48 (52%) of 9 or greater. The most common symptoms accounting for a high PG-SGA score were: no appetite 37 (40%), pain 27 (29%), constipation 26 (28%), feeling full 24 (26%), dry mouth 22 (24%) and taste changes 19 (21%). 51 (55%) pts lost 0–4.9% of their body weight in the past month, 17 (19%) had a weight loss of 5–9.9% and 24 (26%) had a weight loss =10 %. In pts with a PG-SGA score of 0–3 the median CRP was 7.0 mg/L (range: 0.7–66.0), in those with a score of 4–8 the median CRP was 41.8 mg/L (0.8–266.1) and in those with a score of =9 the median CRP was 18.5 mg/L (0.3–219.0) (p=0.02). Conclusion: At time of diagnosis, 77% of advanced NSCLC pts were in need of nutritional intervention; 52% required urgent intervention. The PG-SGA is a simple screening tool which should be incorporated into patient care in outpatient oncology clinics. No significant financial relationships to disclose.
Steroids and immunosuppressive agents potentiate the cytotoxicity of the EGFR inhibitor erlotinib (E) in human skin keratinocytes whereas Vit K3 exerts a protective effect: Implications for the management of the skin rash
Authors: Perez-Soler R. , Zou Y. , Li T. , Ling Y. 
Published: March 2020

9124 Background: Skin toxicity secondary to EGFR inhibitors is treated symptomatically with topical and systemic combinations of steroids, antibiotics, antihistamines, and immunosuppressive agents with variable and often unsatisfactory results. Vit K3 prevents EGFR inhibition induced by E and cetuximab in human A431 tumor cells, probably through an effect on the phosphatase (Perez-Soler, ASCO 2006). We studied the cytotoxic effects of different agents used to treat the EGFR inhibitor-mediated skin rash on human immortalized skin keratinocytes exposed to the EGFR inhibitor E as well as the potential protective effect of Vit K3. Methods: The cytotoxicity of E in the presence of non cytotoxic concentrations of hydrocortisone, minocycline, cyclosporine-A, diphenhydramine, and Vit K3 was assessed by MTT assay in human HaCat cells, a cell line derived from human basal epidermal cells. Results: E cytotoxicity was enhanced by 2–5 fold by cyclosporine A and hydrocortisone, not affected by minocycline and diphenhydramine, and reduced by 5-fold by Vit K3. Vit K3 25–50 μM induced EGFR activation and prevented E's inhibitory effect on EGFR. Conclusions: Steroids and immunosuppressive agents may potentiate the cytotoxic effect of anti-EGFR agents in the skin, thus providing a possible explanation for the erratic and mixed therapeutic results often observed with the use of these agents. Vit K3 was the only agent capable of abrogating the cytotoxic effect of E in this clinically relevant model of normal human skin. A topical formulation of Vit K3 is undergoing preclinical evaluation. Supported by NCI CA 91784 and 113630 and a grant from Hana Biosciences. No significant financial relationships to disclose.