bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-term use of fentanyl pectin nasal spray in patients with breakthrough pain in cancer.
Authors: Taylor Donald , Radbruch Lukas , Revnic Julia , Torres Luis M. , Ellershaw John E , Perelman Michael Sidney 
Published: March 2020

9563 Background: Given that patients with cancer are living longer, there is a need to ensure that treatments used for palliative care are well tolerated and effective during long-term use. The objective of this study was to investigate the use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients taking regular opioid therapy. Methods: A total of 401 adult patients, taking at least 60 mg/day oral morphine or equivalent, with an average of 1 to 4 episodes of BTPc per day, who were either newly enrolled or had completed a randomized controlled trial with FPNS, entered into an open-label assessment study (NCT00458510). Of these, 171 patients, continued into an extension period. Up to 4 episodes of BTPc per day were treated with FPNS at titrated doses between 100 µg and 800 µg. Patients returned to the clinic at 4-week intervals for assessment and reporting of any adverse events (AEs). Results: There were 163 patients with documented FPNS use. The mean duration of use was 325 days; 46 patients used FPNS for more than 1 year, while the maximum duration was 3 years and 8 months. In total, 2% of patients withdrew from the study due to lack of efficacy. Seventy-four percent of patients did not change their FPNS dose. The most common AEs, aside from disease progression, were: insomnia, 9.9%; nausea, 9.4%; vomiting, 9.4%; and peripheral edema, 9.4%. The overall incidence of treatment-related AEs was 11.1%, the most common being constipation (4.1%), with no apparent dose relationship. Ten patients (5.8%) experienced treatment-related nasal AEs, which, with the exception of 1 severe event, were all mild or moderate. Conclusions: FPNS appeared to provide a sustained benefit and was well tolerated during the long-term treatment of BTPc. Clinical trial information: NCT00458510.
Attitudes regarding privacy of genomic information in personalized cancer therapy.
Authors: Rogith Deevakar , Yusuf Rafeek Adeyemi , Hovick Shelly Renee Anstey , Peterson Susan K. , Burton-Chase Allison Michelle , Li Yisheng , Meric-Bernstam Funda , Bernstam Elmer Victor 
Published: March 2020

9576 Background: Cancer therapy is increasingly personalized to the molecular characteristics of a particular patient and his/her tumor. Patients and providers express interest in personalized therapy yet concerns regarding the privacy of genomic data have been raised, particularly in the context of research. We evaluated patients’ attitudes regarding privacy of genomic data. Methods: Newly registered female breast cancer patients at MD Anderson Cancer Center were invited to participate. Of 308 consecutive patients approached, 100 completed a survey assessing attitudes regarding association of personal identifying information with genomic data, risks for potential insurance and employment discrimination based on genomic information, and willingness to share genomic data (32% response rate). Results: Most patients (83%) indicated that genomic data should be protected. However, only 13% endorsed concern regarding genomic data privacy, measured using a composite scale (α= 0.92). Patients expressed more concern about insurance discrimination than employment discrimination (43% vs. 28%, p<0.001), and these two variables were highly correlated (χ2=32.7, p<0.001). Patients expressed greater trust in research institutions like MD Anderson to protect the security of their molecular data compared with government agencies or drug companies (80% vs. 63% vs. 56%; p < 0.001). Most did not endorse concern regarding association of their genomic data with their name and identities (51%), billing and insurance (56%), or clinical data (73%). Patients were more willing to share de-identified data than identified data with researchers other than their treating physicians (p<0.001). 36% of patients were willing to share identified data with any MD Anderson researcher and 14% with any cancer researcher. Conclusions: Patients generally expressed low levels of concern regarding privacy of genomic data. Cancer patients may recognize the clinical and research value of genomic testing and a significant proportion are willing to share their genomic data with researchers.
Correlations of patient-reported measures (PRM) for health, quality of life (QOL), functional status, and social supports with survival in early-stage colon cancer.
Authors: Chen Annie , Hsu Tina , Kennecke Hagen F. , Lai Anky , Chen Leo , Speers Caroline , Woods Ryan , Cheung Winson Y. 
Published: March 2020

9577 Background: PRM can enhance our understanding of patients’ needs and facilitate cancer treatment decision making. Few studies have explored the relationships between brief PRM and outcomes in early stage colon cancer. Our aims were 1) to determine the effects of prospectively collected PRM on cancer-specific (CSS) and overall survival (OS) and 2) to examine if this association is modified in the elderly. Methods: Patients diagnosed with stage 1 to 3 colon cancer in 2008, evaluated at 1 of 5 regional cancer centers in British Columbia, and provided baseline PRM were included. PRM consisting of a series of short, self-administered scales that described patient-reported health, QOL, functional status and social supports were collected at baseline and correlated with CSS and OS using regression models that controlled for known prognostic factors such as tumor and nodal stage. We subsequently assessed for effect modification by age, stratifying the cohort into younger (YP; <70 years) and elderly patients (EP; >/=70 years). Results: In total, 223 patients were included: 94 (42%) were EP, 111 (49%) were women, and 152 (68%) were white. Compared to YP, EP were more frequently widowed (27 vs 9%, p=0.0005) and reported having children (92 vs 81%, p=0.03), but they were less likely to receive chemotherapy (57 vs 90%, p<0.0001). There were no significant differences in PRM based on age, with the majority indicating they had regular contact with family and friends (92%) and many describing good overall health, QOL, and functional status (48, 61, and 69%, respectively). However, a significant proportion wished for more emotional support (54%). In regression models, self-reported poor functional status was associated with worse OS (HR 2.69, 95%CI 1.09-6.65), but not CSS (HR 1.74, 95%CI 0.61-4.94). This did not differ significantly between YP and EP (p interaction >0.05). No other PRM correlated with OS or CSS (all p>0.05). Conclusions: For early stage colon cancer, self-reported functional status was independently associated with OS. Additional PRM failed to enhance prognostication, suggesting that more comprehensive tools may be required to improve patient assessments.
Role of religiosity in medical decision making among patients with colorectal cancer.
Authors: Surati Mosmi , Davis Rachel , Hawley Sarah T. , Abrahamse Paul , Ward Kevin C. , Kato Ikuko , Morris Arden M. 
Published: March 2020

9579 Background: Physician-based medical decision making (DM) has declined in favor of more patient-centered approaches. Most studies indicate that patients want to be involved; however, the level of desired involvement varies between patients wanting to make their own decisions and those preferring to leave decisions to physicians. Little is known of the factors associated with DM preferences. Given data demonstrating the influence of religion among cancer patients, we explored religiosity and decision making preferences in colorectal cancer (CRC) patients. Methods: We surveyed a population-based cohort of Stage III CRC patients from the Detroit and Georgia SEER registries. Patients were queried about desired level of involvement in DM, trust in physicians, religiosity, receipt of adjuvant chemotherapy, and demographics. Religiosity was assessed using the Holland System of Belief Inventory. Physician trust was assessed using the Wake Forest Physician Trust scale. Responses were collected along a Likert scale and results were dichotomized. Surveys were analyzed using univariate and bivariate methods. Results: Thus far, 430 CRC patients have responded (56% response rate). The median participant age is 61 years, 45% are female, and 19% are black. 54% indicated a preference for shared DM, 35% prefer “doctors to make [their] decisions”, and 11% prefer to “make [their] own decisions”. The distribution did not differ by age, gender, race, income, or level of education. Higher religiosity was associated with higher trust in the surgeon (p=0.007) but not the oncologist (p=0.3). Patients with higher religiosity scores and higher physician trust were more likely to prefer that their doctors make the decisions (p= 0.023, p<0.001). Preference for physician DM was associated with higher receipt of adjuvant chemotherapy (p=0.002). Conclusions: Patients who were more religious preferred to leave medical DM to physicians. Those who relied on physician DM were more likely to receive chemotherapy. This association may be mediated through higher trust. Understanding the influence of religiosity may be a tool to help providers get their patients appropriate cancer care.
Risk and predictors of suicide in colorectal cancer patients: A SEER analysis.
Authors: Samawi Haider , Shaheen Abdel Aziz , Tang Patricia , Heng Daniel Yick Chin , Cheung Winson Y. , Vickers Michael M. 
Published: March 2020

9596 Background: Colorectal cancer (CRC) patients have a higher risk of suicide as compared with the general population. Due to differences in the sites/morbidity of recurrences as well as ostomy rates, we sought to evaluate the distribution and predictors of suicide among patients with colon and rectal cancer. Methods: A retrospective analysis was undertaken using the Surveillance, Epidemiology, and End Results (SEER) database from 1973-2009. Patients included were >18yrs and had confirmed adenocarcinoma of the colon or rectum. Results: Included in this analysis were 187,996 rectal cancer and 443,368 colon cancer patients. Colon cancer patients were older (median age 71 vs. 67 yrs, p <0.001) and included more females (51 vs. 43%, p <0.001) as compared to rectal cancer patients. Suicide rates were similar (611 [0.14%] vs. 337 [0.18%], p <0.001), as was the median time to suicide for colon vs. rectal cancer patients respectively (37 vs.32 months, p = 0.13). On univariate analysis, having rectal cancer was a predictor of suicide (HR 1.26; 95% CI: 1.10-1.43). However after adjustment for age, sex, race, marital, primary site surgery, stage and one primary, rectal cancer was not a predictor of suicide (HR 1.05; CI: 0.83- 1.33). In the combined CRC cohort, independent predictors of suicide included age >70 (HR 1.55; CI: 1.23-1.94), male gender (HR 7.56; CI: 5.34-10.70), being single (HR 1.56; CI: 1.14- 2.13), distant metastases at diagnosis (HR 1.58; CI: 1.13- 2.21), and white race (HR 3.21; CI: 1.75- 5.88). Also, lack of resection of primary tumor was associated with increased risk of suicide (HR 2.83; CI: 1.97- 4.05). Among colon cancer cohort, older age, male gender, and white race as well as lack of primary resection were independent predictors of suicide. Similarly, the aforementioned predictors as well as metastatic disease on presentation were the independent predictors of suicide in the rectal cohort. Conclusions: The suicide risk in CRC patients is low (< 0.2%) and no difference was found based on location of primary tumor. Gender, age, distant spread of disease, intact primary tumour and race are the main predictors of suicide among colorectal patients. Future studies and interventions are needed to target these high risk groups.
Racial and ethnic variation in employment and financial experiences of breast cancer survivors.
Authors: Jagsi Reshma , Pottow John A.E. , Griffith Kent A. , Hamilton Ann S. , Graff John , Katz Steven J. , Hawley Sarah T. 
Published: March 2020

9601 Background: Concerns exist regarding the employment and financial experiences of cancer survivors and whether they differ by race/ethnicity. Methods: In a longitudinal survey of women reported to the Los Angeles and Detroit SEER registries for nonmetastatic breast cancer, we compared experiences of 4-year survivors by race/ethnicity. Results: Overall, 31% of 1,536 respondents (68% response rate) felt their financial status was worse since diagnosis (63% attributed this to breast cancer). This varied by race/ethnicity: 41% of Spanish-speaking Latinas (SSL), 33% English-speaking Latinas (ESL), 23% blacks (B), and 29% whites (W), p<0.001. The median respondent had spent ≤$2000 on breast cancer medical expenses; 16% had spent >$5000. 12% had medical debt 4 yrs post-diagnosis: 17% of ESL, 14% B, 10% SSL, and 9% W (p=0.01). Minority respondents were more likely to report foregoing medical care due to cost and other privations due to their medical expenses (Table). Overall, 14% felt their employment status was worse since diagnosis, and 61% of these attributed this to breast cancer. 755 worked for pay some time after diagnosis, of whom 56% said it was at least somewhat important to work to keep health insurance (55% of SSL, 65% ESL, 65% B, 50% W, p=0.03); 24% would look for a new job if assured of comparable benefits (45% of SSL, 29% ESL, 22% B, 17% W, p<0.001); 7% had increased work hours to cover cancer-related expenses; 27% had decreased work hours due to cancer-related health issues; and 7% believed they had been denied job opportunities because of cancer. Conclusions: In this population-based sample of breast cancer survivors, job lock was common, and many women perceived being worse off with respect to finances and employment as a result of their breast cancer. Medical debt and privation varied significantly by race/ethnicity. [Table: see text]
Pain sensitivity and aromatase inhibitor (AI)-associated arthralgias (AIAA).
Authors: Henry Norah Lynn , Harte Steven , Conlon Anna S.C. , Griffith Kent A. , Ramirez Gabriela , Hayden Jill , Smerage Jeffrey B. , Schott Anne F. , Hayes Daniel F. , Williams David A. , Clauw Daniel A 
Published: March 2020

9615 Background: AIAA affect up to half of AI-treated women with early stage breast cancer, and can lead to treatment discontinuation in 20-30%. The etiology is thought to be related to estrogen deprivation although the mechanism is unknown. In premenopausal women, lower estrogen levels have been associated with increased pain. Impaired descending pain inhibitory pathways, which may be a risk factor for developing chronic pain, have also been associated with lower estrogen levels. We prospectively tested whether AI-induced estrogen deprivation alters pain sensitivity, thereby increasing the risk of developing AIAA. Methods: Fifty postmenopausal women with early stage breast cancer initiating AI therapy were enrolled to the study. Subjects underwent experimental pressure pain testing and conditioned pain modulation (CPM) assessment and completed symptom questionnaires prior to AI initiation and after 3 months. Positive CPM values (>0) signify impaired descending pain inhibition. Serum estradiol concentrations were determined using an ultrasensitive assay. T-tests, Fisher’s exact test, and linear regression models were used to assess associations among baseline (BL) experimental pain measures, patient-reported pain, and clinical factors. P values <0.05 were considered statistically significant. Results: All subjects had decreased serum estradiol concentrations with AI therapy. No statistically significant change in pressure pain threshold or CPM with AI therapy was detected. In addition, no association between change in patient-reported pain with AI therapy and change in pain threshold or CPM was identified. Patients demonstrated impaired CPM at baseline (mean 8.0, SD 14.9), and this impairment was greater in patients previously treated with chemotherapy 14.4 vs 2.0, p=0.006), with non-significant trends towards this being more pronounced in those with more severe pain. Conclusions: AI therapy did not impact pressure pain threshold or CPM, suggesting that AIAA is not likely due to pain amplification from estrogen depletion. Studies examining chemotherapy-induced changes in pain processing are needed to better understand how these alterations might contribute to the pain that these patients often develop.
Randomized double-blind placebo-controlled trial of celecoxib for radiation-induced oral mucositis.
Authors: Lalla Rajesh V. , Choquette Linda E. , Curley Kathleen F. , Dowsett Robert J. , Feinn Richard S. , Hegde Upendra P. , Pilbeam Carol C. , Salner Andrew L. , Sonis Stephen T. , Peterson Douglas E. 
Published: March 2020

9620 Background: Oral mucositis (OM) is a painful complication of radiation therapy (RT) for head and neck (H&N) cancer. OM can compromise nutrition, require opioid analgesics and hospitalization for pain control, and lead to treatment interruptions. Due to the role of inflammatory pathways in the pathogenesis of OM, this study investigated the effect of inhibition of cyclooxygenase-2 (COX-2) on severity and morbidity of OM. Methods: In this randomized double-blind placebo-controlled trial,40 H&N cancer patients were randomized to daily use of 200 mg celecoxib or matched placebo, for the duration of RT. Eligibility criteria included planned RT dose of ≥ 5000 cGy to 2+ areas of the mouth and no contraindication for celecoxib use. The planned sample size of 20 per arm provided 80% power to detect a 1 point difference in mean Oral Mucositis Assessment Scale (OMAS) score (range 0-5) at 5000 cGy RT (primary endpoint), applying a two-tailed, two-sample t-test at the 5% level of significance. Clinical OM, normalcy of diet, pain scores and analgesic use were assessed 2-3 times a week by blinded investigators during the 6-7 week period of RT, using validated scales. Results: Twenty subjects were randomized to each arm, which were similar with respect to tumor location, radiation dose, and concomitant chemotherapy. In both arms, mucositis and pain scores increased over the course of RT. Intent-to-treat analyses demonstrated no significant difference in mean (SD) OMAS scores at 5000 cGy [celecoxib 1.32 (0.71), placebo 1.27 (0.86), p = 0.83, two sample t-test]. There was also no difference between the celecoxib and placebo arms respectively, in mean OMAS scores over the period of RT (SD) [0.98(0.77) & 0.97 (0.86), p = 0.84], mean worst pain scores [3.38 (3.07) & 3.31 (3.32), p = 0.83], mean normalcy of diet scores [5.43 (3.86) & 5.11(3.94), p = 0.65], or mean daily opioid medication use in IV morphine equivalents [19.08 (16.57) & 20.48 (19.07), p = 0.48], all by linear mixed model fixed effects regression analysis. There were no SAEs attributed to celecoxib use. Conclusions: Daily use of a selective COX-2 inhibitor, during the period of RT for H&N cancer, did not reduce the severity of clinical OM, pain, dietary compromise or use of opioid analgesics. Clinical trial information: NCT00698204.
A genetic variant of 5-hydroxytryptamine receptor 3C (HTR3C): A novel link to chemotherapy-induced side effects.
Authors: Rubinek Tami , Pud Dorit , Har-Zahav Gil , Symon Zvi , Laitman Yael , Wolf Ido 
Published: March 2020

9630 Background: Symptom clusters are defined as three or more concurrent symptoms that are related to each other. Clusters may stem from common physiological mechanisms and may better represent adverse effects to chemotherapy compared to individual symptoms. We aimed to identify association between the experience of symptom clusters and specific genetic alterations. Methods: Study population consisted of 108 breast cancer patients who received over two cycles of adjuvant doxorubicin and cyclophosphamide (AC) treatment at the oncology institute of the Sheba Medical Center. Participants completed the Memorial Symptom Assessment Scale, the Lee Fatigue Scale and the Center for Epidemiological Studies Depression Scale. Hierarchical cluster analysis was used to identify patients' subgroups based on their symptom experience. For the genetic analyses, DNA was extracted from peripheral blood and single nucleotide polymorphisms (SNPs) of candidate genes were tested using restriction endonuclease assays. Results: Two distinct subgroups were identified based on severity of fatigue, depression, nausea, and change in food tastes: "all high" (n=79) and "all low" (n=29) level of all symptoms. As patients did not have active cancer, symptoms were attributed solely to chemotherapy. A genetic variant of HTR3C (rs6766410) results in a substitution of asparagine to lysine (N163K) may be associated with nausea and vomiting. We tested the association between this variant and symptom score. 51 of 75 (68%) patients with high symptom score harbored the variant allele, compared to 13 of 28 (46%) of those with low symptom score (p=0.038). Conclusions: Analysis of genetic background of clusters, rather than for individual symptoms, represents a novel approach for the study of chemotherapy-induced side effects. This approach enabled the identification of HTR3C variant as a possible mediator of side effects following treatment with AC. Discovering the genetic basis of symptom clusters may lead to the development of novel diagnostic and therapeutic modalities able to improve symptom management. This may translate to improved outcome among chemotherapy-treated cancer patients.
Treatment of depressive symptoms in breast cancer patients undergoing adjuvant therapy.
Authors: Navari Rudolph M. 
Published: March 2020

9631 Background: Studies have shown a high prevalence of depression in patients with cancer. Women with breast cancer may have a high risk of depression particularly in a post-menopausal or estrogen deficient state and may develop a high level of depressive symptoms at the time of initial diagnosis. Newly diagnosed early stage breast cancer patients were screened for depressive symptoms prior to the initiation of adjuvant therapy. The oral antidepressant fluoxetine was studied to determine if its use affected depressive symptoms, completion of adjuvant treatment, quality of life, and survival. Methods: Patients with newly diagnosed early stage breast cancer were screened for depressive symptoms prior to the initiation of adjuvant therapy. Patients with depressive symptoms were randomized in a double blind fashion to daily oral fluoxetine (20 mg) or placebo. Patients were then followed for 6 months and evaluated for quality of life, completion of adjuvant treatment, and depressive symptoms. Patients with stage I disease at the time of initial diagnosis were subsequently assessed for disease recurrence and survival at five years. Results: Two hundred three of 357 screened patients with newly diagnosed early stage breast cancer were found to have depressive symptoms prior to the initiation of adjuvant therapy. One hundred ninety-three patients were randomized to fluoxetine or placebo. The use of fluoxetine for 6 months resulted in a significantly (p<0.01) higher number of patients with an improvement in quality of life, a higher completion of adjuvant treatment (chemotherapy, hormonal therapy, chemotherapy plus hormonal therapy) and a reduction in depressive symptoms compared to patients who received placebo. At five years, there was a significant (p<0.01) improvement in survival for patients with Stage I disease who received fluoxetine, possibly related to a higher completion of adjuvant treatment. Conclusions: An antidepressant should be considered for early stage breast cancer patients with depressive symptoms who are receiving adjuvant treatment.