bluuebunny/crossref_metadata_2025 huggingface dataset:
Actigraphy measured sleep disruption as a predictor of survival in advanced breast cancer.
Authors: Palesh Oxana , Gerry Arianna Aldridge , Zeitzer Jamie M. , Koopman Cheryl , Jo Booil , Neri Eric , Nouriani Bita , Spiegel David
Published: March 2020

9532

Background: Sleep disruption, prevalent in cancer patients and survivors, is associated with disrupted hormonal circadian rhythms and poor quality of life. Previous studies in cancer patients and survivors have pointed out the association between poor sleep and faster disease progression. However, until now these studies have been limited by their retrospective or correlational design, providing little resolution of the question of whether sleep disruption accelerates disease progression or whether disease progression dysregulates sleep, or whether a third factor might underlie the association between sleep dysregulation and disease progression. This study aimed to clarify this relationship by using a longitudinal research design to examine whether sleep disruption assessed at baseline predicts survival in women with metastatic breast cancer. Methods: We examined sleep quality and duration in 97 women diagnosed with metastatic breast cancer (mean age=54.6, SD=9.8) via wrist-worn actigraphy for 3 days and sleep diaries. Sleep quality was operationalized as poor sleep efficiency (the ratio of total asleep time to total time in bed * 100%). Results: As hypothesized, poor sleep efficiency was found to predict shorter survival (Hazard Ratio (HR), 0.96, 95% CI, 0.93 to 0.98, p<0.001) over 6 years. This relationship remained significant (HR, 0.94, CI, 0.91 to 0.97, p<.001) even after controlling for other known prognostic factors (age, ER status, cancer treatment, metastatic spread, cortisol levels, and depression). Conclusions: Our findings show that sleep dysregulation is a clear and significant independent prognostic factor for disease progression in metastatic breast cancer. Further research is needed to determine whether treating sleep disruption with cognitive behavioral therapy or medication can improve survival in metastatic breast cancer. Funded by P01AG018784, R01CA118867, K07CA132916.
The role of social exposure to smoking on smoking cessation in adult cancer survivors.
Authors: Eng Lawson , Pringle Dan , Qiu Xin , Shen Xiaowei , Niu Chongya , Mahler Mary , Halytskyy Oleksandr , Charow Rebecca , Lam Christine , Shani Ravi M. , Villeneuve Jodie , Tiessen Kyoko , Brown M Catherine , Alibhai Shabbir M.H. , Jones Jennifer M. , Howell Doris , Goldstein David P. , Xu Wei , Selby Peter , Liu Geoffrey
Published: March 2020

9536

Background: We previously described a strong inverse relationship between social smoking exposures (at home, spousal and with peers) and smoking cessation in lung cancer, with adjusted odds ratios (aOR) of 3-8 (Eng et al, ASCO 2012, abst 9032). In the current analysis, we evaluated whether these associations hold true in adult cancers in general, particularly cancers not traditionally known to have smoking as a risk factor. Methods: 616 cancer survivors across multiple cancer sites were surveyed on their smoking, alcohol, and physical activity habits before and at various times after cancer diagnosis. Social smoking exposures were documented. Multivariate logistic regression models evaluated the association of each variable with change in each habit after diagnosis adjusted for significant socio-demographic and clinico-pathological covariates. Results: Median follow-up after diagnosis was 26 months. 15% had breast cancers; 15% gastrointestinal; 20% genitourinary-gynecological; 24% haematological; 36% other. Among current smokers at diagnosis, 56% quit after diagnosis; no ex- or never-smoker restarted. Patients without secondary home smoking exposure were significantly more likely to quit smoking than those with home exposures (aOR=9.5, 95% CI [2.4-37.8]). Similar results were seen in patients with non-smoking spouses versus smoking spouses (aOR=3.7 [1.0-13.4]), and with lack of peer smoke exposure (aOR=3.7 [1.3-10.7]). 63% patients who quit did so in the 1 year period surrounding the diagnosis date (6-months pre or post diagnosis). In comparison, first and second-hand smoking exposures did not affect other modifiable behaviours such as alcohol or physical activity. Patient awareness of quality of life and survival benefits of smoking cessation and receiving smoking cessation counselling were not associated with improved smoking cessation. Conclusions: Secondary smoking exposures are associated with lack of smoking cessation in adult cancer survivors, even in cancers not traditionally linked to smoking. Being diagnosed with cancer may be an important `teachable moment` to help patients quit, but results are strongly influenced by the surrounding social exposure to smoking. PS and GL contributed equally.
Factors related to end-of-life (EOL) chemotherapy in solid tumor (ST) patients.
Authors: Rodriguez Maria Alma , DeJesus Yvette A , Cheng Lee , Buzdar Aman , Burke Thomas W.
Published: March 2020

9538

Background: Oncologists will be required to report quality measures for cancer care, including use of chemotherapy in the last two-weeks of life. In this study, we evaluated how use of chemotherapy in ST patients (pts) within 14 days of EOL may be influenced by clinical factors. Methods: Adult pts (≥18 years) treated for ST at our institution, deceased December 01, 2010 through May 31, 2012, were retrospectively studied. Data on demographics, chemotherapy (excluded: hormones) within 14 days EOL, comorbidities, and cancer diagnoses were from tumor registry and administrative databases. Logistic regression analysis was performed for association of EOL chemotherapy with age, gender, ethnicity, comorbidities , cancer types, and metastatic status. Results: 5,607 pts met study criteria: median age 64 years; 48% female; 76% metastatic disease. EOL chemotherapy frequency was 3.9% overall, 4.6% in metastatic disease versus 1.7% in non-metastatic disease (p<0.01). In 23 patients with non-metastatic disease who received chemotherapy, the diagnoses were: brain/other nerve system (34.8%, 8/23) and lung/bronchus (21.7%, 5/23).The top 10 frequencies in chemotherapy use by tumour sites were: melanoma (6.7%), female breast (5.5%), lung & bronchus (4.9%), pancreas (4.2%), brain/other never system (3.9%), head & neck (3.8%), female genital system, excluding ovary (3.4%), ovary (3.2%), liver/intrahepatic bile duct (3.0%), colon & rectum (2.6%). By regression analysis, the factor statistically significantly associated with receiving chemotherapy was metastatic disease (odds ratio [OR], 3.29; 95% CI,1.96-5.54), while factors associated with significantly less treatment were age ≥ 65 (OR, 0.66; 95% CI, 0.49-0.90); and any co-morbid conditions (≥1 versus 0) (OR, 0.58; 95% CI, 0.38-0.89). Conclusions: A small portion of ST patients who died received EOL chemotherapy (3.9%). However, metastatic disease and diagnosis category influenced treatment. Melanoma and breast cancer patients had higher frequency of EOL treatment. Older age and comorbidities were associated with less treatment. Variation in EOL treatment of ST patients is thus influenced by several clinical factors, but did not seem influenced by gender or ethnicity factors.
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.
Impact of fosaprepitant use on dermal and vascular adverse events in anthracycline-based regimens administered through peripheral lines.
Authors: Fujii Takeo , Nishimura Naoki , Kanai Hisako , Ishimaru Hiromasa , Kawano Junko , Takahashi Osamu , Yamauchi Hideko , Yamauchi Teruo
Published: March 2020

9629

Background: Fosaprepitant is effective in the prevention of chemotherapy-induced nausea and vomiting. In January 2012, we started using fosaprepitant in anthracycline- and cisplatin-based regimens and observed a tendency for an increase in dermal and vascular adverse events (AEs) at local infusion sites, particularly in the anthracycline group. In this study, we tested the hypothesis that fosaprepitant use is associated with dermal and vascular AEs differentially between anthracycline- and cisplatin-based regimens. Methods: We conducted a retrospective cohort study consisting of all patients who were administered anthracycline- or cisplatin- based regimens in 2011 and 2012 at St. Luke’s International Hospital, Tokyo. Aprepitant was used in 2011 and fosaprepitant was used in 2012. All other factors including pre- and post-hydration, premedication, and injection schedule were the same. Dermal and vascular AEs was defined as any grade pain or skin changes at local infusion sites or infusion veins. Factors we considered include fosaprepitant use, chemotherapy regimen, age, number of prior regimens, and body mass index. Interaction analysis using multivariate logistic regression was used to evaluate the association between treatment regimen, fosaprepitant, and risk of AEs. Results: A total of 268 patients (aged 54.3±12.3) were included, of which 120 (44.8%) used fosaprepitant. Among fosaprepitant users, 50 patients (41.7%) developed dermal and vascular AEs, whereas only 16 patients (10.8%) experienced AEs among non-users (P< .001). When stratified by regimen, fosaprepitant was associated with a statistically significant increased risk of AEs (OR 12.10; 95% CI 5.45-26.93) in the anthracycline group. In contrast, no association was observed in the cisplatin group (OR 1.04; 95% CI 0.29-3.75). Statistically significant evidence of interaction was found (P< .001) between regimen and fosaprepitant in the risk of AEs. Conclusions: Our results support the finding that using fosaprepitant in anthracycline-based regimens increases dermal and vascular AEs. In response, we discourage the use of fosaprepitant in anthracycline-based regimens through peripheral lines.
A randomized, double-blind study of “Scrambler” therapy versus sham for painful chemotherapy-induced peripheral neuropathy (CIPN).
Authors: Campbell Toby Christopher , Nimunkar Amit J , Retseck Janet , Eickhoff Jens C. , Backonja Miroslav , Cleary James F. , Kwekkeboom Kristine L , Yen Thomas Y
Published: March 2020

9635

Background: CIPN is a debilitating, dose-limiting toxicity. The MC5A is a non-invasive electro-analgesia device delivering “Scrambler Therapy,” which has shown benefit for painful CIPN in uncontrolled studies. No sham-controlled trials of MC5A have been performed. Methods: Eligible patients included adults with neuropathic pain (NP) for > 6 months, pain scores ≥4/10 numerical rating scale (NRS), and no history of diabetes or other peripheral neuropathies. Patients received up to 10 daily sessions of 50 minutes with either MC5A or a novel active sham device constructed to deliver a just perceptible electrical sensation. Sham output is neither a TENS nor MC5A and is designed to be nontherapeutic. Active and sham treatments were applied to the affected limbs. 14 patients were randomized with no baseline differences. Patients and evaluators were blinded to study arm. Pain was measured before, daily during, after and 3 months post-treatment (verbal NRS). The primary endpoint was change in pain. Secondary endpoints included quantitative neurosensory testing (QST), validated patient-report measures, and cytokines. Results: There were 7 patients in each arm. The table shows changes in pain scores pre- and post-treatment by day and group. There was no difference between arms and no arm x day interaction. There was no significant day or arm effect for the function sub scales. Conclusions: In a small pilot study, MC5A was not significantly different from sham therapy for the primary outcome. The sham is feasible and provides a mechanism for future controlled studies with MC5A. Secondary endpoints, e.g. QST are forthcoming. Clinical trial information: NCT01261780. [Table: see text]
Patterns of palliative radiation near the end of life: A single-institution retrospective analysis.
Authors: Alcorn Sara R. , Smith Thomas J. , McNutt Todd R. , Cheng M. Jennifer , Dy Sydney Morss , Hales Russell K. , DeWeese Theodore L. , Ellsworth Susannah G.
Published: March 2020

9636

Background: The care of patients who receive radiation therapy (RT) at the end of life (EOL) is under scrutiny to ensure effectiveness and value, with many patients not completing RT (Gripp, 2010; Toole, 2012). This retrospective analysis seeks to describe patterns of utilization of palliative RT, including rates of completion of RT offered at the EOL and the use of single fraction RT for bone metastases. Methods: Electronic medical records were used to create a database of 3,383 RT plans for brain, bone, lung, and other metastatic sites in patients treated at Johns Hopkins Hospital from 9/1/2007-7/15/2012. RT plans without palliative intent were excluded. T-tests and logistic regression compared patient and treatment characteristics between patients who died > 1 month versus ≤ 1 month after their last RT fraction. Results: A total of 983 patients were treated to 1,524 sites, with an average of 1.7 RT sites (SD 1.3) per patient. Of these, 872 (89%) patients had complete records and were included in analysis. At the time of analysis, 85% had died. The mean age of 62.1 years (SD 3.4) did not differ statistically based on time from RT to death. Death ≤ 1 month after RT was documented in 215 (24.7%) patients. Compared to patients living > 1 month after RT, patients receiving RT within the last month of life were more likely to be lung (17% versus 9%), less likely to be brain (34% versus 44%), and equally likely to be bone (45% versus 43%) sites. Patients who died ≤ 1 month after completing RT spent on average 5 days (16.6%) of the last month of life receiving RT, with no significant difference by disease site. Conclusions: Most patients receiving palliative RT finish therapy, with 25% dying ≤ 1 month after RT. Single fraction bone RT was relatively uncommon, with no significant difference in the rates of single fraction RT based on time from RT to death. These data provide a framework to match treatment patterns with national guidelines. Additionally, they provide context to model risk of death shortly after RT, which can aid in clinical decision-making. [Table: see text]
Efficacy of rebamipide-gargle for chemotherapy-induced oral mucositis.
Authors: Nakamura Masato , Shinohara Akiyoshi , Onikubo Toshihide , Nakamura Kumi , Kamikawa Harumi , Oda Kyota , Tauchi Katsunori
Published: March 2020

9637

Background: Chemotherapy-induced oral mucositis (CIOM) is a severe adverse event resulting from cancer chemotherapy, and causes severe pain which impacts eating, nutrition, infection and overall quality of life. CIOM can result in unplanned treatment interruptions including dose reduction or treatment delay. Toxic free radicals and several pro-inflammatory cytokines produced by anti-cancer drugs have been reported to correlate with CIOM. Rebamipid, an endogenous inducer of prostaglandins, is widely used for gastric ulcers and gastritis in Asia. It has been shown to increase gastric endogenous prostaglandin E2 and I2, to promote gastric epithelial mucin, to behave as an oxygen–free radical scavenger, and to have other anti-inflammatory actions. In this study, we made a rebamipide gargle using rebamipide and ultrahydrogel, which is added for mucosal protection and to sustain the rebamipide on oral mucosa for a long time. Methods: The objective of this study is to evaluate the efficacy of the rebamipide gargle in relieving CIOM. Each 300ml of rebamipide gargle is made by combining rebamipide 600mg, high molecular weight polyethylene oxide 3g, carrageenin 1.2g, pineapple flavor and water. Patients were instructed to use the rebamipide gargle 5-6 times a day. The severity of CIOM was assessed according to the National Cancer Institute Common TerminologyCriteria for Adverse Events (CTCAE version 4.0). Results: From November 2009 to December 2012, 175 patients with CIOM were enrolled in this study (colorectal cancer 95 patients, breast cancer 32, gastric cancer 22, lung cancer 14, and other cancers 12). The patients’ CTCAE grades (3/2/1/0) changed from (n=13/64/98/0) to (0/10/103/62) respectively after initiation of rebamipide gargle (p<.01; paired t test). A decrease in CTCAE was observed in 142 patients (81.1%) including 62 patients (35.4%) achieving grade 0. The mean duration to best response was 14 days (range: 1-49), and rebamipide gargle was continued 42 days (range: 5-970).There were no unexpected safety events. Conclusions: Rebamipide gargle was well tolerated and demonstrated significant therapeutic response for CIOM.
Oral HPV infection in HPV-positive oropharyngeal cancer cases and their spouses.
Authors: D'Souza Gypsyamber , Gross Neil D. , Pai Sara I , Haddad Robert I. , Gillison Maura L. , Posner Marshall R.
Published: March 2020

CRA6031

The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Saturday, June, 1, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.
Serum CEA and CA 15-3 levels according to breast cancer subtypes.
Authors: Dede Isa , Utkan Gungor , Akbulut Hakan , Urun Yuksel , Mizrak Dilsa , Icli Fikri
Published: March 2020

e11511

Background: Carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 15-3 are frequently elevated in patients with metastatic breast cancer (MBC). In this study we aimed to correlate levels according to breast cancersubtypes with MBC. Methods: From January 2008 to December 2012, ninety-eight patients with MBC who were treated at Ankara University School Of Medicine, Department of Medical Onkology were included in this study.Serum levels of CEA and CA 15-3were measured and compared according to tumor estrogen receptor (ER), progesteron receptor (PR), and human epidermal growth factor receptor 2 (HER2) status. Results: In this cohort, overall ER,PR and HER2 positivity rates were 65 %,68%,and 58%, retrospectively. Positivite ER status was associated with elevated levels of CA 15-3 and cea. Of these, CA 15-3 levels elevated in 40.5% of ER positivite and 24.1 % of ER negativite patients (p=0.027). Similarly, 46.8 % of ER positivite and 18.2% of ER negativite patients had elevated levels of CEA (P=0.022). no association between PR and HER2 status and tumor markers was observed. Conclusions: The breast cancer subtypes are correlated with serum levels of tumor markers in patients with MBC. Tumor markers elevation may be associated with biological background of breast cancer subtypes. Further validation is needed to determine the role of these markers in diffrent tumor types for monitoring patients with MBC.
Adherence to adjuvant hormone therapy (AHT) in early breast cancer (BC).
Authors: Lohmann Ana , Al Barrak Jasem , Peixoto Renata D'Alpino , Chen Leo , Cheung Winson Y.
Published: March 2020

e11522

Background: Randomized controlled trials of early BC consistently demonstrate a survival benefit from AHT. Some studies show that adherence to AHT is suboptimal, but data are conflicting. There are concerns that poor adherence can negatively impact survival. We conducted a systematic review to evaluate adherence to AHT in early BC and clinical factors associated with non-adherence. Methods: Using search terms such as 'adherence', ‘adjuvant treatment’ and ‘breast cancer’, we identified a total of 843 articles published between 1990 and 2012 of which 43 met our eligibility criteria (7 prospective and 36 retrospective). Pooled estimates of adherence and non-adherence were derived by random effects models. Heterogeneity was assessed by the Cochran's Q and I-squared statistics. To detect for potential publication bias, Egger’s test was conducted. Results: The median rates of adherence, compliance, continuation and persistence to AHT were 77%, 79%, 69% and 81%, respectively. Compared to individuals aged <60 years, patients aged >/=60 years had a significantly higher likelihood of non-adherence (RR 1.59, 95% CI 1.27-2.00, p<0.001). Likewise, non-white patients were more likely to poorly adhere to AHT when compared to their white counterparts (RR 1.39, 95% CI 1.00-1.94, p=0.05). Additionally, prior or concurrent receipt of chemotherapy (RR 1.41, 95% CI 1.06-1.88, p=0.018) and radiation (RR 1.79, 95% CI 1.14-2.81, p=0.011) were independently associated with worse adherence. Interestingly, those with more than a moderate income level defined as >$30,000 per annum had a greater likelihood of poor adherence to AHT when compared to low income earners (RR 1.12, 95% CI 1.01-1.24, p<0.024). There was moderate to high heterogeneity across studies, but there was no evidence of publication bias. Conclusions: In this systematic review, adherence rates to AHT for early BC were suboptimal, underscoring the importance of increased vigilance and need for strategies that promote compliance with proven therapies. Poor adherence patterns were observed in specific patient subsets, but these were not limited to only marginalized populations. Prospective trials of adherence interventions that stratify by these patient subgroups are warranted.
Clinical benefit of fulvestrant in postmenopausal women with advanced breast cancer according to prior therapy.
Authors: De Angelis Carmine , Cerillo Ivana , Ruocco Raffaella , Bruzzese Dario , Forestieri Valeria , Lauria Rossella , Stanzione Brigida , Paciolla Immacolata , De Laurentiis Michelino , De Placido Sabino , Arpino Grazia
Published: March 2020

e11528

Background: Hormone therapy (HT) is limited by the onset of resistance. Preclinical studies suggest that complete blockade of the estrogen receptor (ER) with the ER antagonist Fulvestrant (F) can overcome this resistance. The aim of this study was to evaluate the efficacy and tolerability of F in postmenopausal women with hormone-responsive (HR) metastatic breast cancer (MBC) previously treated with Tamoxifen (T) or Aromatase Inhibitors (AI). Methods: From May 2006 to July 2008 83 patients with HR MBC progressing after T or AI for adjuvant or metastatic disease receiving F 250 mg/month were identified. Median time to progression (TTP), overall survival (OS), clinical benefit rate (CBR) defined as the proportion of partial or complete responses (CR, PR) or stable disease (SD) lasting ‡6 months were analyzed. Results: Six, 32, 33 and 12 patients received F as 1st, 2nd, 3rd and 4thline of HT for MBC, respectively. Fulvestrant resulted in an overall CBR of 38.6% (32/83) with 0% CR, 9% PR, 30%SD, 56% PD. Disease was not evaluable in 4.8% of cases. Median TTP to F was 4.9 months (4 - 5.8; 95% C.I.) and OS was 20.1 months (15.8 - 24.4; 95% C.I.). Patients with visceral metastases and with more advanced lines of overall therapy had worse outcome (OR 3.13, 1.17-8.37, 95% C.I.; p 0.023 and OR 0.72, 0.54-0.96, 95% C.I.; p 0.025, respectively). However, Fulvestrant showed activity up to the fourth line of endocrine therapy regardless of number of metastatic sites and previous AI or T therapy. Overall treatment was well tolerated. Arthralgia, swelling, and myalgia were the most common adverse all were grade 1 or 2. No injection-related adverse events were reported. Conclusions: Fulvestrant is an active treatment in HR MBC previously challenged with HT. Safety profile is optimal and it may be a suitable option in extensively pre-treated patients. Further exploration of its use in this patient population is warranted.