bluuebunny/crossref_metadata_2025_split huggingface dataset:
Variation in health-related quality of life (HRQoL) during chemotherapy for advanced non-small cell lung cancer.
Authors: Grønberg Bjørn Henning , Sørhaug Sveinung , Hjelde Harald Harris , Stene Guro Birgitte , Amundsen Tore 
Published: March 2020

9562 Background: Physicians might overestimate benefits and underestimate toxicity of cancer therapy. Thus, patient reported HRQoL is an important part of evaluating treatment effect and assessing side effects. HRQoL is commonly reported once per chemotherapy cycle and just prior to administration of the next course (day 0). Several studies have not detected differences in HRQoL despite differences in physician-observed toxicity. We hypothesized that HRQoL varies during chemotherapy cycles; that side effects are most pronounced the first week after chemotherapy administration; and that repeated assessments improve the ability to detect differences in HRQoL. Methods: Patients were randomized to receive 3 courses of either vinorelbine/carboplatin (VC) or gemcitabine/carboplatin (GC) every 3 weeks. They reported HRQoL on the EORTC QLQ C30 + LC13 on day 0, 3, 8, 11, 15 and 22 of each cycle. A difference in mean scores of > 5 points is considered clinically detectable. Results: 52 pts (VC: 25, GC: 27); median age 65; 56 % men; 85 % stage IV; 93 % performance status 0-1; 75 % completed 3 cycles; 32 % response-rate; 71 % grade 3-4 toxicity. Baseline characteristics; treatment administered and outcomes of therapy were similar between treatment arms. Completion rates of QLQs were 96-64 %. There were significant variations in mean scores during cycles for several domains (mean scores during cycle 1 for some domains are listed in the table). For several domains, there were differences of > 5 points between the treatments arms at day 3-15 that were not detectable on day 22 (day 0 of next cycle). In general, treatment related symptoms were most pronounced on day 3 in every cycle. Conclusions: Our results suggest that timing and number of assessments influence the likelihood of detecting differences in HRQoL during chemotherapy. Day 3 was the best time point for assessing reduced function and side effects of the regimens administered in our trial. [Table: see text]
Taking control of cancer: Why women are choosing mastectomy.
Authors: Covelli Andrea Marie , Baxter Nancy N. , Fitch Margaret , Wright Frances Catriona 
Published: March 2020

9571 Background: Rates of both unilateral (UM) and bilateral mastectomy (BM) for early stage breast cancer (ESBC) have been increasing since 2003. Studies suggest that this is due to women playing a more active role in their decision making, however they do not describe why women are choosing this option. Methods: We conducted a qualitative study using grounded theory to identify factors influential in women’s choice for mastectomy. Purposive sampling was used to identify women across the Greater Toronto Area (Ontario, Canada), who were suitable candidates for breast conserving surgery (BCS) but underwent UM or BM. Data were collected through semi-structured interviews. Constant comparative analysis identified key ideas and themes. Results: Data saturation was achieved after 29 in-person interviews. 12 interviewees were treated at academic cancer centres, 6 at an academic non-cancer centre and 11 at community centres. 15 women underwent UM; 14 underwent BM. Median age was 55. ‘Taking control of cancer’ was the dominant theme that emerged. There were 7 subthemes: 1.the Diagnosis of cancer was received with shock and fear; 2.during Surgical Discussion both BCS and UM were discussed; BM was discouraged by the surgeon 3.women Misperceived Risk, misunderstanding recurrence and survival rates 4.Women’s choice for UM was due to fear of recurrence and/ or radiation 5.Women’s choice for BM was due to fear of recurrence, ‘never wanting to do this again’ and/or need for cosmetic balance 6.Sources of Information varied in importance, previous cancer experience had the greatest impact 7.women were actively Controlling Outcomes, more surgery was seen as greater control. Conclusions: Women seeking UM and BM for treatment of their early stage breast cancer manage their fear of recurrence and ‘never wanting to go through this again’ by undergoing more extensive surgery. The patient’s effort to control the cancer outcome is the driving factor behind women choosing mastectomy.
Validation of the supplementary quality of life questionnaire for mouth/throat and hand/foot soreness.
Authors: Beaumont Jennifer L , Diaz Jose , Khan Sadya , Cella David 
Published: March 2020

9574 Background: PISCES is a randomized crossover trial evaluating patient preference of pazopanib versus sunitinib in advanced/ metastatic renal cell carcinoma. The Supplementary Quality of Life Questionnaire (SQLQ) was developed for this trial to assess hand/foot soreness and mouth/throat soreness (MTS). The objective of this project is to validate the SQLQ. Methods: SQLQ was administered at baseline and every two weeks thereafter. EQ-5D was administered at baseline, during the washout period, and end of second treatment period. Treatment arms were collapsed for validation. SQLQ assesses severity of MTS (1 item), limitations due to MTS (5 items), severity of hand soreness (1 item), severity of foot soreness (1 item), limitations due to foot soreness (5 items) and ability to work (1 item). Cronbach’s coefficient alpha was used to evaluate the internal consistency reliability of the multi-item subscales.T-tests compared scores between groups defined by performance status (0 versus 1) and number of metastatic sites (0/1 versus 2+) at baseline. Effect sizes (ES = mean difference / pooled standard deviation) were calculated. Results: Of 169 patients randomized, data was available on 168. Over 80% of on-study patients completed the SQLQ at each assessment. Cronbach’s coefficient alpha was ≥ 0.80 for both limitations subscales at all assessments except baseline (limitations due to MTS). Both scores differentiated between performance status groups at baseline with ES > 0.40 (p<0.05). Scores significantly differed by severity of soreness with large ES of 0.9-2.1. Moderate correlations with EQ-5D were observed for limitations scores; correlations were smaller for soreness ratings. MTS and limitations due to MTS worsened after baseline with moderate – large ES; moderate ES was observed for changes in other scores. Limitation change scores were minimal in groups with no change in soreness rating; patients with worsened soreness reported similarly worsened limitations due to soreness with moderate – large ES. Conclusions: SQLQ is a valid and responsive measure of MTS, hand/foot soreness, and limitations due to soreness. Use of the SQLQ in future clinical trials will provide further external validation.
Factors affecting perceptions of clinical trials by cancer center patients.
Authors: Korst Robert J. , Rutledge John R , Shah Neil 
Published: March 2020

9583 Background: Patient misconceptions concerning clinical trials may be barriers to accrual. We hypothesized that patients’ perceptions regarding trials may be affected by the physician specialty being visited, and positively influenced by noncompulsory exposure to an educational videotape in the waiting area prior to physician interaction. Methods: Perceptions of all new patients at a suburban cancer center regarding clinical trials were assessed over 4.5 months using an 8-item questionnaire that allowed for quantitative assessment. A 13 minute educational videotape regarding the clinical trials process was created and displayed in patient waiting areas and all subsequent new patients were identically evaluated over the following 4.5 months. Responses were tabulated and the effect of physician specialty (medical oncology, radiation oncology, breast surgery, thoracic surgery, gynecologic surgery) and videotape exposure on the frequency of positive responses was evaluated. Results: 2201 questionnaires were collected during the total study period. Prior to videotape exposure, patients who visited breast surgery were more fearful of trials than those who visited gynecologic surgery (p=0.01) and thoracic surgery (p=0.03), and were also less likely to participate in a clinical trial (p=0.001 and p=0.02). Patients who visited medical oncology and radiation oncology were less likely to participate in clinical trials than those who visited gynecologic oncology (p=0.007 and p=0.03). Exposure to the videotape positively influenced breast surgery patients regarding their understanding of randomization (p=0.001), likelihood of receiving better care in a trial (p=0.04), and likelihood of participation in a trial (p=0.02). Gynecologic surgery patients understood the concept of a placebo better after videotape exposure (p=0.02). In no group of patients did exposure to the videotape have a negative effect on their perceptions of the clinical trials process. Conclusions: Cancer center patients have different perceptions of the clinical trials process depending on the type of specialist visited. These perceptions can be positively influenced in select patients by the noncompulsory exposure to an educational videotape.
Chronic conditions and lifestyle behavior after cancer: The differences between 2,103 cancer cases and 4,185 age and gender matched controls.
Authors: Koczwara Bogda , Miller Michelle , Woodman Richard John , Coveney John , Booth Sue , Dollman James , Mackenzie Catherine , Berry Narelle 
Published: March 2020

9585 Background: Weight gain and inactivity after cancer are associated with poorer cancer outcomes and may predispose to chronic conditions but the prevalence of these among cancer survivors is not well defined. The objectives of this cross-sectional study were to determine whether those with history of cancer have a greater prevalence of chronic conditions and whether their lifestyle behaviours differ from cancer free controls. Methods: Cross-sectional self-reported data were obtained from adult telephone survey respondents between January 2010 and March 2012. Age and gender matched individuals who did not report a cancer diagnosis were randomly selected from the same data source as controls. Data reported included rates of cardiovascular disease, hypertension, hyperlipidaemia, diabetes, and osteoporosis, lifestyle behaviours (diet, physical activity and smoking), obesity, psychological distress and self-reported health. Between-group differences were assessed using McNemar’s test. Results: 2,103 cases and 4,185 controls were included in the analyses. Cancer cases had a higher prevalence than controls for all chronic conditions: cardiovascular disease 22.1% vs 18.4%, p=0.001; hypertension 53.3% vs 50%, p=0.015; hyperlipidaemia 47.8% vs 41.8%, p<0.001; diabetes 16% vs 13%, p=0.006; osteoporosis 13% vs 11%, p=0.013. There were no differences in diet, exercise or obesity. Cancer cases were more likely to report “very high” psychological distress (2.9% vs 1.7%, p=0.005) and “poor-fair” self-rated health (33.5% vs 22.9%, p<0.001). Conclusions: Despite similar diet and exercise habits and levels of obesity the prevalence of chronic conditions was significantly higher amongst those with history of cancer compared to controls. Further research is warranted to explain this increased predisposition to chronic conditions.
Tumor mutation status of Hodgkin lymphoma survivors with secondary lung adenocarcinoma.
Authors: Bond David Alan , Otterson Gregory Alan , Dunavin Neil 
Published: March 2020

9600 Background: In a multi-institutional, retrospective study of 1976 patients treated for Hodgkin's lymphoma (HL) from 1969-2007, 55 patients developed second primary lung cancers a median of 19.5 years after treatment. Of these 55 cases, 32 were identified as lung adenocarcinoma (ACA). The development of targeted therapies in recent years has made the detection of specific genomic alterations important for disease prognosis and treatment in lung ACA. The prevalence of certain genomic alterations (EGFR, ALK, and KRAS) is highly correlated with smoking history. We hypothesize that the prevalence of genomic alterations also may differ in patients with a significant exposure to radiation. Methods: This observational retrospective case series includes 6 patients treated with mediastinal radiation for HL who subsequently developed lung ACA. All patients were treated at Ohio State University Wexner Medical Center. Patients were identified by searching billing diagnosis codes in the electronic medical record and by query of the physicians in the department of thoracic oncology at our institution. IRB approval was obtained. Results: The average age at diagnosis of HL was 25 years (range 18-46) and the average age at diagnosis of lung cancer was 58 (range 52-73). All patients were treated with radiation therapy; two patients were treated additionally with chemotherapy. None of the patients received HDT-ASCT. The average time from diagnosis of HL to diagnosis of lung cancer was 33 years. Of our six cases, 2 were positive for EGFR mutations and the other four were triple negative (-EGFR, -ALK, -KRAS). Three were never smokers, one had a 1.5 pack year history, and two had 10 pack year histories. Lung cancer stages at diagnosis were 1B (n=2), 2B (n=1), 3A (n=2), 4 (n=1). Conclusions: To our knowledge, this is the first report of mutational status of second primary lung ACA following radiation therapy for Hodgkin disease. Although the number of patients is small, the higher prevalence of the EGFR mutation in this sample suggests that ACA related to radiation therapy may have a similar mutational profile to that of never smokers. Further investigation is needed to define the disease characteristics of lung ACA in HL survivors.
High-flow oxygen (HFO) and bilevel positive airway pressure (BiPAP) for refractory dyspnea in patients with advanced cancer: A randomized controlled trial.
Authors: Hui David , Morgado Margarita , Chisholm Gary B. , Withers Laura , Nguyen Quan , Finch Clarence , Frisbee-Hume Susan , Bruera Eduardo 
Published: March 2020

9611 Background: Dyspnea is one of the most common and distressing symptoms in cancer patients. Few treatments are evidence based because research in this area is difficult. The role of HFO and BiPAP in the palliation of severe refractory dyspnea has not been well characterized.We examined the changes in dyspnea, physiologic parameters and adverse effects in patients receiving HFO and BiPAP. Methods: In this phase II “pick the winner” randomized trial, we assigned hospitalized advanced cancer patients with refractory dyspnea to either HFO or BiPAP for 2 hours. We assessed dyspnea with the numeric rating scale (NRS) and modified Borg scale (MBS) before and after intervention. We also documented the vital signs, transcutaneous carbon dioxide and adverse effects. We used the sign rank test to compare before and after each intervention, and the Wilcoxon rank sum test to compare between arms with intention-to-treat analysis. Results: Thirty patients were enrolled (1:1 ratio) and 23 (77%) completed the assigned intervention. The median baseline dyspnea NRS was 7/10 (Q1-Q3 5-8), despite being on supplemental oxygen and opioids. Both HFO and BiPAP were associated with significant improvement in dyspnea after 2 h, with no differences detected between arms (Table). We observed prolonged dyspnea relief in 6 patients 1 h after completion of the study intervention. HFO improved oxygen saturation. No adverse effects were observed. Conclusions: HFO and BiPAP alleviated dyspnea, improved physiologic parameters and were safe. Our results justify larger randomized controlled trials to confirm these findings. Clinical trial information: NCT01518140. [Table: see text]
Aprepitant (AP) versus dexamethasone (D) for preventing delayed emesis induced by anthracyclines plus cyclophosphamide (A+C) chemotherapy (CT) in breast cancer patients (pts): A double-blind, multicenter, randomized study.
Authors: Roila Fausto , Ballatori Enzo , Fabi Alessandra , Fatigoni Sonia , Chiara Silvana , Ionta Maria Teresa , Aieta Michele , Clerico Mario , Palladino Maria Angela , Indelli Monica , Garrone Ornella , Bustreo Sara , Ruggeri Benedetta ,   Italian Group for Antiemetic Research
Published: March 2020

9614 Background: A combination of AP + a 5-HT3 receptor antagonist + D and AP alone is recommended, respectively, for the prophylaxis of acute and delayed emesis induced by A+C CT in breast cancer pts. In the registrative study the role of AP in delayed emesis was not defined because prophylaxis of acute emesis was different between the two arms, and the superiority of AP on delayed emesis could be the consequence of a dependent effect on the different results achieved in acute phase. Aim of this study was to compare the efficacy of AP versus D in preventing delayed emesis in pts receiving the same prophylaxis of acute emesis. Methods: A randomized double-blind study comparing AP versus D was completed in naive breast cancer pts treated with A+C. Before CT, all pts were treated with intravenous palonosetron 0.25 mg and D 8 mg, and oral AP 125 mg. On days 2 and 3 pts randomly received D 4 mg bid or AP 80 mg qd. Primary endpoint was rate of complete response (no vomiting, no rescue treatment) from days 2 - 5 after CT. Results: From September 2009 to July 2012, 580 pts were enrolled; 551 were fully evaluated, 273 in arm D and 278 in arm AP. Day 1 complete response rates were similar: 239/273 (87.6%) in D arm and 236/278 (84.9%) in AP arm. From day 2-5, complete response was the same with both antiemetic prophylaxes (79.5%), and all secondary endpoints (complete protection, total control, no vomiting, no nausea, score of FLIE) assumed similar values. During the delayed phase, incidence of insomnia (2.9% vs. 0.4%) and heartburn (8.1% vs. 3.6%) was significantly superior in D arm. Conclusions: In breast cancer pts submitted to A+C CT and receiving the same antiemetic prophylaxis for acute emesis, D and AP present similar efficacy and toxicity. Clinical trial information: NCT 00869973.
Determination of evidence-based diagnostic thresholds for upper limb lymphedema secondary to treatment for cancer.
Authors: Dylke Elizabeth S , Schembri Geoff P , Black Deborah , Ward Leigh C. , Bailey Dale L , Bailey Elizabeth A , Beith Jane McNeil , Refshauge Kathryn M. , Kilbreath Sharon 
Published: March 2020

9616 Background: Diagnosis of upper limb lymphedema (LE) secondary to treatment for cancer has been complicated by the range of diagnostic thresholds used. Traditional thresholds were arbitrarily chosen but recently normative-based cut-offs have been established. However, the diagnostic power of these thresholds has not been compared to changes identified with lymphoscintigraphy, the gold standard for diagnosis of LE. The aim of this study was to determine thresholds for commonly used clinical diagnostic tools based on lymphatic imaging outcomes. Methods: Women previously diagnosed with LE secondary to treatment for cancer (n=67), and women without LE (n=20) participated. Lymphoscintigraphy was completed and the presence and severity of dermal back flow qualitatively scored as none to mild or moderate to severe by an experienced nuclear medicine physician. On the same day, circumference measurements and segmental bioimpedance spectroscopy (BIS) for 10 cm intervals from the ulnar styloid to 40 cm proximal were recorded. The BIS inter-limb ratio for each segment and the inter-limb circumference differences were compared to diagnostic thresholds based on 2 and 3 standard deviations (SD) above the mean from normative data. Results: The number of BIS segments and circumferences measurements above a 3SD threshold correlated significantly with the dermal backflow score (Rs= 0.710 and 0.824 respectively).The number of abnormal BIS segments detected did not differ significantly between a 2SD and 3SD threshold (χ2=0.23 p=0.63). Of the 20 new abnormal segments detected, 7 were from participants with no or mild evidence of dermal backflow on lymphoscintigraphy including 3 from control participants. In contrast, 46 new abnormal inter-limb circumference differences, all from those with a LE diagnosis, were detected using a 2SD threshold (χ2= 31.785, p<0.001) Conclusions: The need for a standardized, evidenced-based approach for identification of LE is essential. We recommend diagnostic thresholds for segmental BIS be set at 3SD above the mean to minimize false positive diagnoses whereas a lower threshold of 2SD is necessary for the less sensitive inter-limb circumference difference measurements.
Population-based patterns of granulocyte colony stimulating factor (GCSF) use in breast cancer (BrCa) patients receiving myelosuppressive chemotherapy.
Authors: Lehmkuhl Michelle , Chen Leo , Cheung Winson Y. 
Published: March 2020

9625 Background: Prophylaxis with GCSF can reduce hospitalization due to neutropenic fever, but early studies show that use of GCSF is frequently suboptimal. Our aims were to 1) characterize patterns of GCSF use in a population-based cohort of BrCa patients, 2) determine the rate of neutropenia and neutropenic fever in those who received and did not receive GCSF, and 3) identify patient and physician factors associated with appropriate GCSF prophylaxis. Methods: Patients diagnosed with BrCa from January to December 2008, seen at any 1 of 5 regional cancer centers in British Columbia, Canada and treated with chemotherapy protocols that posed >20% risk of neutropenic fever were reviewed. Using regression models that adjusted for confounders, the relationship between GCSF use and 1) various patient and physician characteristics and 2) treatment outcomes, such as neutropenic fever, were analyzed. Results: A total of 525 women were included: median age was 51 years (IQR 45 to 59 years), 38% reported smoking, 50% used alcohol regularly, 62% were ECOG 0, and 26% had private health insurance. In the entire cohort, 203 (38%) patients were given GCSF. Among those treated with GCSF, 80 (39%) and 123 (61%) individuals received GCSF as primary and secondary prophylaxis, respectively. Overall, neutropenia was noted in 292 (56%) cases while neutropenic fever was experienced by 117 (22%) patients. When compared to those who did not use GCSF, patients who used GCSF experienced a lower rate of neutropenia (15 vs 49%, p<0.01) and a decreased incidence of neutropenic fever (7 vs 13%, p<0.01). In regression models, patients lacking extended medical coverage (35 vs 49%, p=0.02), poor performance status (31 vs 53%, p=0.03), and those who were evaluated at non-teaching institutions (24 vs 68% p<0.01) were less likely to receive GCSF. Patients seen at non-teaching institutions were also given primary GCSF prophylaxis less frequently (15 vs 57%, p<0.01) than those at teaching centers. Conclusions: GCSF prophylaxis was associated improved neutropenia-related outcomes. However, use of GCSF was low in this population-based cohort of BrCa patients, especially in specific marginalized subgroups.