bluuebunny/crossref_metadata_2025_split huggingface dataset:
Oncologists practice with opioids in cancer pain
Authors: El-Foudeh M. , Alsirafy S. A. , Hassan A. , Hidayetullah M. 
Published: April 2020

18602 Background: The majority of cancer patients are mostly under the care of their primary oncologists for both active and symptom management. Pain is the most feared symptom in cancer patients. In general, it is highly prevalent and under treated. Barriers to adequate pain management still exist even among specialized care givers. Improper opioid utilization is one of main factors within those impediments. The pattern of opioid prescription among oncologists in a specialized hospital was examined on referral to a palliative care unit within the same institution. Methods: Over a period of six months (between Dec. 2003 and June 2004) 290 cancer patients were referred to the section of palliative medicine from different medical specialties within the same institution. The medical records of 233 (80%) were analyzed, 116(50%) were referred from oncology specialists (radiation, medical & hematology oncology), 76 referred patients fulfilled the study criteria. On referral; all eligible patients had to be on opioids for pain. The pattern of opioid prescription by oncologists in this group of patients with reference to the currently available guidelines was examined. Results: The following results were found: Pain was inadequately controlled in 71% patients. Although, the majority of the patients 92% were able to utilize the oral route, it was only used in 36% of patients. The first strong regular opioid was the standard morphine in only 46% of patients. Breakthrough opioid was prescribed to most patients (91%). However, dose and interval were outside the general guidelines in 44% & 81% respectively. Laxatives were not prescribed in half of the patients Conclusions: Opioids are the principal effective, relatively simple and practical drugs in pain relief. Yet, within specialized care providers as shown in this study, opioid utilization was unsatisfactory. More understanding of pain assessment, better opioid utilization and more knowledge of opioid pharmacology still warranted. No significant financial relationships to disclose.
Analysis of factors influencing outcome in patients with in transit malignant melanoma (MM) undergoing isolated limb perfusion (ILP) using standardized operative parameters with melphalan and biological agents
Authors: Soriano P. A. , Libutti S. K. , Pingpank J. F. , Beresenev T. , Steinberg S. M. , Bartlett D. L. , Fraker D. L. , Helsabeck C. , Alexander H. R. 
Published: April 2020

8006 Background: In transit disease afflicts about 10% of MM patients and no single systemic or regional treatment has been widely accepted as most effective or appropriate. Previously, the impact of ILP on the natural history of MM patients has been difficult to gauge. We report long-term outcomes in MM patients undergoing hyperthermic ILP in an era of increasingly accurate staging, uniform operative and treatment conditions, and regular follow-up. Methods: Between 5/1992 to 2/2005, 90 patients (median age: 57 y [range: 24–84]; F: 49, M: 41) with Stage IIIA or IIIAB MM underwent a 90 min hyperthermic (mean calf T: 39.3° C) ILP (melphalan: 10–13 mg/L limb volume, TNF: 3–6 mg [n=44], or IFN: 200 μg [n=38]) using uniform operative technique including intra-operative leak monitoring. There was 1 operative mortality (1/91, 1.1%). Patients were prospectively followed for response, in-field progression free (PFS), and overall survival (OS). Parameters associated with in-field PFS and OS were analyzed by the Kaplan-Meier method with log rank tests, as well as by Cox proportional hazards models. Results: There were 61 complete responses (68%) and 23 partial responses (26%). At a median follow-up of 47 months, median in-field PFS was 12.4 months, and median OS was 47.4 months; 5 and 10-year actuarial OS were 43 and 34%, respectively. Female gender and low tumor burden (< 20 tumors) were associated with prolonged in-field PFS (M:F hazard ratio (HR): 2.07, CI:1.27–3.38; 21+ vs. ≤20 tumors HR: 2.29, CI: 1.21- 4.34; p<0.011 for both) in a Cox model, whereas TNF, IFN, perfusion pressure, and tumor stage were not. Female gender was associated with improved OS (p=0.027, M:F HR=1.82, 95% CI 1.07–3.09) and Stage IIIA marginally so, in univariate analysis, (p=0.065). Conclusions: ILP for MM patients is associated with noteworthy in-field PFS and prolonged OS. Neither use of TNF nor tumor stage were significantly associated with in-field PFS in Cox models, while female gender was associated with better outcomes. In appropriately selected patients using standardized technique, ILP has clinical benefit in this setting. No significant financial relationships to disclose.
Estimating survival probability in stage III melanoma: A multivariable individualized patient risk assessment nomogram
Authors: Coit D. G. , Qin Zhou C. , Patel A. , Panageas K. 
Published: April 2020

8020 Background: Recent revisions in the AJCC staging system have increased its complexity without comparable improvement in prognostic accuracy for patients with Stage III melanoma. Furthermore, there remains significant prognostic heterogeneity, even within Stages IIIA, IIIB, and IIIC. The current study was undertaken to develop a model for individual patient risk assessment, both to facilitate patient care, and to help define prognostically homogeneous patient populations for entry into clinical trials. Methods: Patients with AJCC Stage III melanoma were identified from a prospective single institution database. Overall survival was calculated from the date of Stage III to last followup. A multivariate Cox model of independent prognostic factors was developed, and a multivariable individualized patient risk assessment nomogram was built from that model. Results: Among 1,064 patients with Stage III melanoma, 535 have died, at a median followup of 44 months. Independent predictors of overall survival are shown in the table. Individual patient three and five year survival was predicted by incorporating all eight variables into a prognostic nomogram. The nomogram was superior to the AJCC Staging system in predicting outcome in Stage III melanoma patients. Conclusions: Individual patient risk assessment is more accurate than traditional AJCC staging in predicting outcome in Stage III melanoma. This approach, which can be easily incorporated into a handheld computing environment, offers potential advantages for both patient care and clinical research, and should be explored in the next iteration of the AJCC staging system. [Table: see text] No significant financial relationships to disclose.
Gene expression profiling of primary cutaneous melanoma: Expression of replication origins firing genes predicts clinical outcome
Authors: Spatz A. , Winnepenninckx V. , Lazar V. , Michiels S. , Dessen P. , Stas M. , Eggermont A. M. , Sarasin A. , Tursz T. , Van Den Oord J. 
Published: April 2020

8024 Background: Gene-expression profiling in human cutaneous melanomas is impaired by the difficulty in getting access to a retrospective collection of frozen tumors. Thus, compared to other tumors, gene expression profiling data on human cutaneous melanomas are scarce, and data with prognostic implication are entirely lacking. In order to better understand the progression of this tumor and to identify key genes involved in melanoma prognosis, we correlated gene-expression profiles with clinical outcome in a cohort of 83 patients with primary melanoma. Methods: A class comparison and class prediction analysis was performed to identify genes able to predict 4-years. distant metastasis free-survival in 58 primary melanomas with at least 4-years follow-up or intercurrent distant metastasis or death. Results were also validated at the protein level in an independent population of 176 primary melanomas with a median clinical follow-up of 8.5 years. Results: We identified a set of sequences discriminating between primary melanomas associated with good and poor prognosis. Some of these sequences correspond to key-genes in the regulation of replication origins firing, such as mini-chromosome maintenance genes and geminin. The prognostic value of overexpression of replication origins firing genes is independent from thickness, ulceration, age and sex. Conclusions: This study has identified key-genes associated with in vivo metastatic dissemination of cutaneous melanomas. Some of our data provide new diagnostic tools for the accurate diagnosis of melanoma and shed new light on the molecular mechanisms underlying poor prognosis in melanoma patients. As some of these molecules are currently under study as targets for therapy, our data can have significant impact on the development of new melanoma therapies. No significant financial relationships to disclose.
Dose and schedule selection for the anti-CTLA4 monoclonal antibody ticilimumab in patients (pts) with metastatic melanoma
Authors: Gomez-Navarro J. , Sharma A. , Bozon V. , Bulanhagui C. , Pavlov D. , Eck S. , Ribas A. , Camacho L. H. 
Published: April 2020

8032 Background: Ticilimumab therapy has demonstrated anti-tumor activity in pts with metastatic melanoma. Its indirect, immune-mediated antitumor effects pose unique challenges for dose/regimen selection. Methods: It was our original intention to select the clinical dose/regimen of ticilimumab based on (1) clinical safety and tolerability and (2) attainment of target plasma concentrations derived from pre-clinical work using an ex vivo assay of ticilimumab-induced enhancement of cytotoxic T-cell function. Because numerous pts with metastatic melanoma experienced clinical benefit (i.e., durable objective responses [OR] and/or long-term survival) in early clinical trials of ticilimumab, we are using (1) safety and tolerability and (2) clinical benefit to guide dose/regimen selection. Data for evaluating these criteria come from a single-dose Phase 1 trial (0.01, 0.1, 1, 3, 6, 10 and 15 mg/kg) and an ongoing multiple-dose Phase 1/2 trial in pts with melanoma (Phase 1 portion: 3, 6 and 10 mg/kg Q1M; Phase 2 portion: 10 mg/kg Q1M and 15 mg/kg Q3M). Results: In the single-dose Phase 1 trial, 10 mg/kg was the Protocol-defined MTD but a high rate of clinical benefit was seen in the 15 mg/kg dose cohort (6/6 pts). Because the DLTs seen at 15 mg/kg (Gr 3 diarrhea, Gr 3 rash) were moderate and resolved completely within 3 months of dosing, 15 mg/kg Q3M was proposed as a safe and tolerable dose and is being studied in the Phase 2 portion of the multiple-dose Phase 1/2 trial. The Phase 1 portion of the multiple-dose Phase 1/2 trial revealed that 10 mg/kg is safe and tolerable with monthly dosing so 10 mg/kg Q1M is also being studied in the Phase 2 portion of the trial. At the end of the Simon Optimum-defined Stage 1 of the Phase 2 portion of the ongoing trial, the OR rate (3/18 pts) is the same for both dosing regimens. However, with 15 mg/kg Q3M, Gr 3/4 adverse events were less frequent (6% versus 34%). Conclusions: 15 mg/kg Q3M is proposed as the clinical dose/regimen for ticilimumab in metastatic melanoma. This dose/regimen appears to have anti-tumor activity approximately equal to 10 mg/kg Q1M but it appears to have a superior safety profile. [Table: see text]
Chemotherapy-naïve cancer patients’ expectations of developing treatment-related side effects: A URCC CCOP study of 670 patients from community practices
Authors: Hofman M. , Morrow G. R. , Ranson S. L. , Jean-Pierre P. , Dakhil S. R. , Moore T. , Atkins J. 
Published: April 2020

8509 Background: Adequate management of cancer related side effects is important for patients yet challenging for clinical staff. Cancer treatment side effects have been characterized reasonably well in the literature; however, less is known about the relationships among response expectancies, personal characteristics, and side effects development of chemotherapy-naïve patients undergoing doxorubicin treatments. Methods: The present sample included 701 cancer patients from 14 CCOP institutions affiliated with the URCC CCOP research base. Of the total sample, 670 patients provided evaluable data to an item that assessed expectations that they will develop side effects such as nausea, vomiting, fatigue, and hair loss. Patients indicated their expectations on a 5-point scale (from 1 = “I am certain I will NOT have this” to 5 = “I am certain I WILL have this”). Results: The median number of symptoms expected (any value other than 1) was 4. Hair loss was most expected (98%) and vomiting the least (87%). Older patients (> 53-years, N = 316, ) were less confident they would get nausea (Mold = 2.96, SE = 0.064; Myoung = 3.23, SE = 0.057, p < 0.01) and hair loss (Mold = 4.22, SD = 0.063; Myoung = 4.39, SE = 0.051, p < 0.05). Females (n = 633) were more confident they would get hair loss than males (Mfemale = 4.34, SE = 0.041; Mmale = 3.89, SE = 0.172, p < 0.05). Patients who had some college (n = 397) thought it was more likely they would get hair loss than patients with less education (Mcollege = 4.38, SE = 0.048; Mnocollege = 4.21, SE = 0.069, p < 0.05). Conclusions: Chemotherapy-naïve patients scheduled to take doxorubicin clearly exhibit expectations about treatment side effects, which are influenced by age, gender and education. The findings show that knowledge of patients’ response expectancies and personal characteristics should be considered and integrated into interventions to control treatment side effects. Supported, in part, by a supplement from the Division of Cancer Control and Population Sciences, NCI, to Public Health Service grant U10 CA37420 and by grant RSG-01-071-PBP from the ACS [Table: see text] No significant financial relationships to disclose.
Perceptions and beliefs related to cancer care among African-American and Caucasian patients
Authors: Matsuyama R. K. , Lyckholm L. J. , Grange C. , Utsey S. , Smith T. J. 
Published: April 2020

8518 Background: Without a clear understanding of belief systems and cultures it is not possible to provide optimal care to ethnic minority individuals. This study examined perceptions and beliefs of African-Americans and Caucasians related to cancer care. Methods: Eleven focus groups were conducted with 39 African-American and Caucasian cancer patients recruited from a university-affiliated cancer clinic, using established qualitative methodology. Data analysis included whole group analysis with a team of 4 researchers. Atlas Ti software was used to validate the coding and establish Intra-rater and inter-rater reliability. Results: There were consistent themes across both ethnicities that related to reactions to diagnosis, wanting certain types of information, wanting to stay positive, coping, and social connectivity. Cultural differences were also apparent (Table). Differences based on ethnicity Conclusions: African-American participants described increased religiosity and faith after diagnosis and were more likely than Caucasian participants to seek information about cancer issues from friends, family, and community. There also were differences in perceptions of how health care providers demonstrate care for patients. Findings have implications for training professionals regarding ways patients seek information, the role of spirituality and religion in care and behaviors that patients perceive as indicative of caring. [Table: see text] No significant financial relationships to disclose.
Polysomnographic measures of sleep moderate the relationship between depression and pain
Authors: Parker K. P. , Bliwise D. L. , Dalton J. , Harris W. , Jain S. , Kohles-Baker M. , Ribeiro M. , Vena C. , Viswanathan B. 
Published: April 2020

8526 Background: We explored the effects of polysomnographic measures of nocturnal sleep on depression and pain in advanced cancer patients taking opioids. Methods: The sample included 72 subjects (solid tumor, Stages III/IV) with a mean age of 55.9 (9.1); 39 were male. All were taking opioids. Subjects underwent ambulatory polysomnography for 48 hours in their homes. Nocturnal sleep parameters included total sleep time (minutes); sleep efficiency (SE; %); sleep latency (SL; minutes); rapid-eye-movement sleep latency (REML; minutes); the percentages (%) of non-rapid eye movement (NREM) Stages 1, 2, and slow wave sleep (SWS, 3 & 4), and REM sleep; and the number of awakenings > 60 seconds. Subjects kept an opioid diary, data from which were converted into a mean hourly morphine equivalent dose (HMED). Subjects also completed the Brief Pain Inventory (BPI) and the Beck Depression Inventory (BDI). Descriptive, correlation, and regression procedures were used for data analysis. Results: Subjects had a mean nocturnal sleep period of 400.1 ± 97.4 minutes. The SL was normal at 26.5 ± 42.6 minutes but the SE was low (77.5 ± 13.2%). Most sleep was light NREM Stages 1 and 2 with decreased amounts of deep SWS (0.3 ± 2.7%) and REM sleep (14.4 ± 8.5%). The REML was prolonged at 149.1 ± 105.1 minutes. The mean BPI scores for pain intensity and interference were 4.4 ± 1.4 and 5.0 ± 2.1, respectively. The mean BDI score was 13.7 ± 7.9. The average HMED was .59 ± .1. Controlling for age and gender, regression analyses revealed that SWS and REM sleep moderated the relationship between depression and pain. Those with more SWS had lower depression levels in spite of higher pain intensity (t = -2.8, p = .007) while those with more REM sleep had lower depression levels despite higher pain interference (t = -2.0, p = .045). Controlling for pain intensity and interference, HMED was positively associated with Stage 1 % (r = .36, p = .001) and the number of nocturnal awakenings > 60 seconds (r = .28, p = .019). Conclusions: Opioids may lighten and disrupt sleep altering sleep cycle progression. The resulting decrements in SWS and REM sleep may lead to increased depression and enhanced pain. Consideration of the timing and dosing of opioids in relationship to nocturnal sleep may decrease depression and subsequently optimize pain management. No significant financial relationships to disclose.
Can preoperative assessment of cancer in the elderly (PACE) predict 30-days postoperative outcomes?
Authors: Audisio R. A. , Ramesh H. S. , Gennari R. , Corsini G. , Maffezzini M. , Hoekstra H. J. , Mobarak D. , Bozzetti F. , Colledan M. , Wildiers H. , Pope D. P. 
Published: April 2020

8537 Background: Surgery is the treatment of choice for solid cancers. Frequent functional impairment/comorbidities in the elderly enhances the risk of treatment related complications. Inability to forecast short term outcomes after cancer surgery in elderly affects clinical practice, denying optimal treatment. No validated instrument is available to help make informed decision; a compilation of validated questionnaires (PACE) is established to preoperatively inform on the health condition of elderly cancer pts. This international multicentre study investigates how components of PACE preoperatively assessed are associated with postoperative outcomes. Methods: A prospective series of consenting elderly cancer pts (≥70 yrs) receiving elective surgery (moderate-major+) were recruited from 8 hospitals (UK, Netherlands, Italy, Japan, Belgium) (07/2003–12/2005) and assessed using PACE (Comorbidities, IADL, ADL, GDS, BFI, PS, MMS, ASA). 30day morbidity, hospital stay and mortality were recorded. Results: 448 pts [breast (48%), GI (30%), GU (16%), miscellaneous (6%)] were recruited and followed postoperatively. Observed morbidity was 36% (161 pts), mortality 4% (16 pts) and median hospital stay was 5 days (range 2 -10). All components of PACE but ASA were associated with morbidity (p<0.05) and hospital stay (p<0.05) on univariate analysis. Operative deaths were too few to look for associations. Forward stepwise logistic regression models (multivariate analysis) identified 3 components of PACE as best describing the occurrence of post-surgical morbidity: BFI (OR (upper quartile)= 2.4; 95% CI=1.2–4.9); PS (OR=1.9; 95% CI=1.1–3.4); IADL (OR=1.7; 95% CI=1.0–3.0). The same components were also selected into the model as best describing hospital stay beyond average: BFI (OR (upper quartile)=18.1; 95% CI=7.2–45.3), PS (OR=2.2; 95%=1.2–4.4) and IADL (OR=2.7; 95% CI=1.4–5.1). Of those pts exposed to all 3 factors entered into the regression models 61% experienced complications and >80% had a longer hospital stay. Conclusions: BFI, PS and IADL appear to be the most relevant prognosticators of short term surgical outcomes. A holistic appraisal of elderly pts undergoing surgery is warmly recommended when consenting the patient and during the decision making process. No significant financial relationships to disclose.
Effect of zoledronic acid (Z) treatment based on serum parathyroid hormone (PTH) levels in patients (pts) with malignant bone disease
Authors: Berruti A. , Dogliotti L. , Tampellini M. , Lipton A. , Hirsh V. , Saad F. , Liati P. , Shirina N. , Cook R. , Hei Y. L. 
Published: April 2020

8610 Background: Z prevents skeletal-related events (SREs) in pts with bone metastases or multiple myeloma. However, secondary hyperparathyroidism and increased PTH may stimulate osteoclast activity and tumor growth, thus potentially limiting the efficacy of Z. Methods: Serum PTH was assessed at baseline and every 3 months in 1,068 pts enrolled in 3 randomized trials: 547 received Z, and 521 received placebo or pamidronate. Results: 213 (20%) pts had elevated PTH at baseline, and 105 of 547 (19%) pts had elevated PTH during Z treatment. In patients with normal baseline PTH, Z significantly reduced the incidence of SREs and delayed time to first SRE compared with control, whereas the risk of SREs was not reduced in patients with elevated baseline PTH. In prostate cancer patients, Z significantly decreased the risk of death compared with placebo in pts with normal baseline PTH (relative risk [RR] = 0.72; 95% confidence interval [CI]: 0.55, 0.94; P = .015). No survival advantage was observed in this subpopulation among pts with lung cancer or other solid tumors. In the small subset of pts with elevated PTH during Z treatment, there was an increased risk of death (for breast cancer pts, RR = 1.68 [95% CI: 1.10, 2.56]; P = .016; for prostate cancer pts, RR = 2.92 [95% CI: 1.83, 4.67]; P < .001). Additionally, elevated PTH during Z treatment in prostate cancer pts also significantly correlated with an increased risk of bone lesion progression (RR = 1.54 [95% CI: 1.09, 2.17]; P = .015). Elevated PTH during treatment did not affect the incidence or time to onset of SREs. Among pts with lung cancer or other solid tumors, elevated PTH during Z treatment did not provide any predictive or prognostic information. Conclusions: PTH levels either at baseline or during Z treatment appear to correlate with disease progression and the clinical benefit of Z in pts with bone metastases from certain types of cancer. This retrospective analysis suggests the importance of PTH status in patients undergoing Z treatment. Normalization of PTH levels may increase the benefit of Z. [Table: see text]