bluuebunny/crossref_metadata_2025 huggingface dataset:
A phase II study of loratidine (L) and naproxen (N) to prevent pegfilgrastim-induced pain (PIP).
Authors: Kirshner Jeffrey J. , Heckler Charles E , Reichel Carol , Morrow Gary R.
Published: March 2020

e19510

Background: We have previously demonstrated the efficacy of N in terms of preventing the incidence, severity and duration of PIP (ASCO 2010; JCO, in press). Last year at ASCO, we reported the results of a pilot study of L, using similar methodology. The present pilot study was designed to determine the safety and efficacy of the combination of N + L , used to prevent PIP. Methods: Using identical eligibility criteria to the aforementioned studies, 41 pts were treated with N 500 mg po bid and L 10 mg po qd beginning on the morning of their initial dose of P and continuing for 5-8 days. Pain at any time was recorded by pts in diaries using a 0-10 scale. Unexpected adverse events were promptly reported. Similar methodology and statistical analyses were used, with the primary endpoint being AUC for the severity and duration of pain. Results: Six pts either did not take the pills or return questionnaires. 35 evaluable pts were treated (27F;8M). Cancers included 24 breast, 7 lung and 4 others. AUC was 7.10. At any time during the 5 days after administration of P, 10 pts experienced no pain, 17 had some mild pain and 8 had some severe pain. No unexpected adverse events were reported. Comparison to our prior studies is tabulated (see table below). Conclusions: The combination of N + L does not appear to be unsafe when used to prevent PIP, but in these small pilot studies, the regimen does not appear to be any more efficacious than either drug when used alone. A larger study is needed to specifically evaluate efficacy and toxicity. [Table: see text]
ASCO's international cancer corps: Oncology nursing education in Honduras.
Authors: Sheldon Lisa Kennedy , Carlson Julie R. , Sanchez Jose Angel
Published: March 2020

e19515

Background: Developing countries face a heavy cancer burden. Nurses in oncology care are challenged by lack of resources and training to care for these patients. Volunteer nurses from other nations have been used as clinician/educators on service trips organized by ASCO’s International Cancer Corps and Health Volunteers Overseas. In 2011, a team of four oncology providers, two gynecologic oncologists and two oncology nurses, traveled to Tegucigalpa, Honduras, to improve cancer care through education/training and professional development. Methods: The team explored cancer care and oncology nursing in outpatient and inpatient settings, provided training to residents and medical students, and presented the first ever cancer nursing conference in this country. The two-day conference, with over 100 participants from different cities and insitutions, included cancer registry data, treatments such as chemotherapy, radiotherapy and surgery, symptom management, palliative care and psychosocial concerns. It concluded with a roundtable discussion for future directions. A survey was piloted with conference participants to assess needs for continuing education and professional development. Data were collected from 61 nurses (age, gender, education/training, years in oncology, work settings, access to educational resources, and educational needs). Results: The majority of the nurses (59.7%) learned about cancer care during patient care with <4% having formal training/coursework. The most common cancers were leukemias, breast, cervical, and stomach. The nurses wanted more education about chemotherapy (medications, administration, management of side effects), pain management, palliative care and emotional support. Conclusions: Volunteer oncology providers can improve cancer care in developing countries. Meeting the educational needs requires site-specific exploration of training and resources, and the goals of providers, hospitals, and healthcare organizations in the host country. The survey could be replicated prior to travel to assess the needs of oncology nurses in other developing countries and plan appropriate training programs.
Assessment of cancer patients of the local patient’s support organizations and the available sources of the patient’s health education: Local perspectives from Saudi Arabia.
Authors: Kandasamy Ravichandran , Al-Dalee Abdelmuniem , Aljubran Ali Husain
Published: March 2020

e19526

Background: Few Local patients’ support organizations are available for cancer patients in Saudi Arabia. These non governmental organizations NGOs were recently founded to provide social, financial, logistic and educational support to cancer patients. Their role and participation to the cancer patient’s care is not well estimated. On the other hand, Health education is imperative. However, there is yet no clear estimation of the adequacy and quality of the available local sources for cancer health education. This study was intended to show the cancer patient’s assessment of the available resources of support and health education to cancer patients. Methods: The subjects were adult cancer patients who attended the outpatient clinics at King Faisal cancer center in Riyadh, Saudi Arabia. They completed a validated questionnaire of six sections. In this abstract, we only present the data of the fifth and sixth sections. The fifth is regarding patient’s impression about the support provided by the family and society. The sixth is about the patient’s sources of information and education about their diseases. Results: 234 patients participated. Age range: 15-86, median: 40.5 y. Males: 61.5%. 12.4% from suburban areas. 41.5% had higher than high school education, and 76% had annual income <$32,000. 90% of the participating patients evaluated the family support as full support. However, 92% did not receive any support from the NGOs, and 54% were not aware that such organizations exist. Only 20% of those who suffered psychological/ psychiatric changes actually did ask for help. Regarding the patient’s use of the available sources of health education, 77% received education other than that provided directly by physicians. 45% had more information about their conditions from educational brochures and health magazines and only 33% sought more information from the internet. Conclusions: The cancer patient’s assessment of the role and participation of the NGOs is generally poor. Majority of patients were able to have more information about their conditions through different means. The use of internet is relatively inadequate.
Level of scientific evidence underlying palliative care recommendations arising from the National Comprehensive Cancer Network (NCCN) clinical practice guidelines.
Authors: Cruz Felipe Melo , Prearo Fernando Mauro Lima , Cubero Daniel Iracema , Del Giglio Auro
Published: March 2020

e19537

Background: The palliative care NCCN recommendations are classified according to the level of scientific evidence in four groups: category I, high level of evidence with uniform consensus; category IIA, lower level of evidence with uniform consensus; category IIB, lower level of evidence without a uniform consensus but with no major disagreement; and category III, any level of evidence but with major disagreement. Palliative care guidelines have not yet been judged as to the relative content of each of the aforementioned types of recommendations. Methods: We analyzed the distribution of categories of evidence cited in the 10 supportive care NCCN guidelines, version 2.2011. Results: Of the 2,537 recommendations found in the 10 guidelines, the proportion of category I, IIA and IIB recommendations were 2.9%, 95.7%, 1.4%, respectively. There wasn’t any category III recommendation (table 1). The fields with a higher rate of category I recommendations were fatigue (14.3%) and chemotherapy induced nausea and vomiting (12.7%). No category I recommendations were found on Senior Adult Oncology, Cancer and Chemotherapy induced Anemia and Adult Cancer Pain. Conclusions: : Palliative care NCCN recommendations are largely based on lower level of evidence, but with uniform expert opinion. This data show the urgent need to expand palliative care research in oncology. [Table: see text]
Review of practice patterns of primary granulocyte-colony stimulating factor prophylaxis and impact on febrile neutropenia rate and chemotherapy delivery in patients with early breast cancer treated with modern adjuvant chemotherapy.
Authors: Mates Mihaela , Hopman Wilma , Altwairgi Abdullah Khalaf
Published: March 2020

e19541

Background: Febrile neutropenia (FN) is a major complication of chemotherapy and is associated with substantial morbidity and mortality. Primary prophylaxis with granulocyte colony-stimulating factors (PP-G-CSF) is recommended for regimens with FN risk above 20%. We undertook a review of practice patterns of PP-G-CSF and impact on febrile neutropenia rate and chemotherapy delivery in patients with early breast cancer (EBC) treated with modern adjuvant chemotherapy (ACT) at the Cancer Centre of Southeastern Ontario. Methods: Women with EBC receiving at least one cycle of modern ACT (taxane containing regimens with or without anthracyclines) between January 2009 and December 2011 were included in our review. We collected demographic, disease-related, treatment-related, and outcome variables for each patient. Results: 239 women were treated with modern ACT during the specified period and were included in our analysis. Median age was 55 (32-80); 197 (82%) were <65 years and 148 (62%) were postmenopausal. 212 (89%) patients were treated with an anthracycline-taxane (A-T) regimen and 27 (11%) with a taxane (T) regimen. 145 patients (61%) received PP-G-CSF: 47 (32%) with filgrastim (F) and 98 (68%) with pegfilgrastim (PF). Of all patients 50 (21%) developed at least one FN episode. PP-G-CSF led to lower FN rate (15% vs 31%; p=0.002), reduced dose delay (17% vs 27%; p=0.060) and dose reduction (19% vs 25%; p=0.28) of planned ACT. In women receiving PP-G-CSF higher rate of FN was associated with age ≥ 65 years (27% vs 12% if < 65 years; OR 2.8, p=0.053); T regimen (30% vs 12% for A-T; OR 3.1, p=0.041) and F use (28% [n=13] vs 8% [n=8] with PF; OR 4.3, p=0.003). Conclusions: In this single-centre retrospective cohort study patients with EBC treated with modern ACT had a high rate of FN (31%) without PP-G-CSF. More than half (61%) of the patients received PP-G-CSF which led to fewer FN episodes and increased delivery of planned ACT; however, the risk of FN remained high at 15%. Factors linked to higher rate of FN despite PP-G-CSF were older age, taxane-based chemotherapy and use of filgrastim.
Treatment patterns and outcomes of acneiform skin eruptions from anti-epidermal growth factor receptor (EGFR) therapies for metastatic colorectal cancer (mCRC).
Authors: Dascalu Bogdan , Kennecke Hagen F. , Lim Howard John , Cheung Winson Y.
Published: March 2020

e19547

Background: Use of anti-EGFR therapies, such as cetuximab (Cmab) and panitumumab (Pmab), is associated with acneiform eruptions. Because research suggests a correlation between rash severity and outcomes in unselected patients, concerns remain that prophylactic treatment of rash may interfere with anti-tumor activities of these drugs. Our aims were to 1) characterize the treatment patterns for rash due to Cmab and Pmab and 2) evaluate if a prophylactic vs reactive approach to rash management modifies outcomes. Methods: All patients diagnosed with wild-type K-ras mCRC from July 2009 to June 2011 in British Columbia, Canada and prescribed either Cmab or Pmab were reviewed to describe patterns of prophylactic (before rash) and reactive (after rash) use of antibiotics and steroid creams. Using Cox regression, the relationship between rash management and overall survival was characterized. Results: In total, 119 patients were analyzed: median age at diagnosis was 63 years, 61% were men, 34% received Cmab and 66% Pmab, and median number of anti-EGFR treatment was 9 cycles. Rash occurred in over 90% of patients. Among them, reactive was favored over prophylactic treatment (66 vs 34%). Older patients (60+ years) and those with ECOG 0/1 were more likely to receive prophylactic creams (44 vs 20%, p=0.01) and antibiotics (62 vs 12%, p=0.01), respectively. There were no further differences in rash management based on other patient or tumor characteristics (all p>0.05). Median OS was 7.0 months. The number of treatment cycles and overall survival were similar in both prophylactic and reactive groups (both p>0.05). In Cox regression, ECOG 2+ correlated with worse survival than ECOG 0/1 (HR for death 5.25 95% CI 2.01- 9.23, p<0.01). However, survival outcomes were statistically similar between patients prescribed antibiotics prophylactically vs. reactively (HR=1.10, 95% CI 0.43-2.80, p=0.85) and between patients given steroid creams prophylactically vs. reactively (HR=2.00, 95% CI 0.58-6.92, p=0.27). Conclusions: Prophylactic treatment of anti-EGFR related rash is associated with similar outcomes as compared to reactive rash treatment in mCRC patients.
Variations in serum vitamin D status during cancer chemotherapy.
Authors: Koczwara Bogda , Woodman Richard John , Teleni Laisa Vicki , Kimlin Michael , Walpole Euan Thomas , Jain Kunal , Karapetis Christos Stelios , Smith Emma-Louise , Davidson Wendy Louise , Ferguson Maree , Sukumaran Shawgi , Kichenadasse Ganessan , Isenring Elizabeth
Published: March 2020

e19550

Background: Low serum vitamin D in cancer patients has been associated with inferior cancer outcomes and bone loss. The impact of chemotherapy on vitamin D levels is not known. We examined serum vitamin D levels during chemotherapy to identify magnitude and predictors of change. Methods: A prospective study of chemotherapy naïve patients commencing chemotherapy in two different sun exposure areas. Vitamin D (25(OH)D) deficiency was defined as ≤25 nmol/L and insufficiency 26-50 nmol/L. Demographic data, nutrition, sun exposure, season and biochemical parameters were collected at baseline 6 weeks (6W) and 12 weeks (12W) since commencement of treatment. The effects were assessed using a multivariate multilevel linear regression model that also included age, gender and BMI. Results: 82 Caucasian and 3 indigenous patients were enrolled. Median age was 57 (21-85) years. Forty-nine (58%) were female; 54 (65%) were treated with curative intent. Tumours included 29 (34%) breast,12 (14%) colorectal, 9 (11%) lymphomas, 7 (8%) leukemias, 7 (8%) lung, 5 (6%) ovarian, 3 (4%) testis, 3 (4%) unknown primary and 10 (11%) others. Median weight was 75 kg (50-151) and median BMI was 26.9 kg/m2 (17.7- 44.5). Seventy-six (89%) and 55 (65%) patients were receiving chemotherapy treatment at 6W and 12W respectively. Mean (±SD) serum 25(OH)D at baseline was 49.2±22.3 nmol/L. Ten (12%) patients were vitamin D deficient at baseline and a further 33 (41%) had insufficient levels. Mean serum 25(OH)D status was higher in higher sun exposure locations (61.9±22.1 nmol/L vs 42.2±19.2 nmol/L, p<0.001), varied according to season (spring=46.9±20.3 nmol/L, summer=50.8±18.2 nmol/L, fall=76.4±25.2 nmol/L, winter=36.5±15.7 nmol/L, p<0.001) and changed with treatment period (baseline=49.2±22.3 nmol/L, 6W=40.9±19.0 nmol/L, 12W=45.9±19.7 nmol/L, p=0.002). There was no association between 25(OH)D status and age, gender, BMI or nutritional status. Conclusions: Chemotherapy is associated with a fall in serum 25(OH)D. Further research is needed to determine the underlying mechanism, the impact of low serum 25(OH)D on patient outcomes and the potential role for screening and vitamin D supplementation in this group.
Thromboembolic events and bleeding in patients with metastatic carcinoma treated with chemotherapy and bevacizumab.
Authors: Ferrer Ana Isabel , Sanchez Jose Luis , Rodriguez Maria Carmen , Soriano Carmen , Aliaga Luis Alberto , Garcia Nieto Sandra , Alonso Maria Carmen , Fernandez Antonio
Published: March 2020

e19576

Background: An increased risk of thromboembolic events (TE) and bleeding (Bl) has been observed in some trials among cancer patients (CP) treated with bevacizumab (B) and chemotherapy (QT). Our aim is to assess specific risk of TE and Bl in unselected CP treated with QT and B in general clinical practice. Methods: Retrospectively, we collected data of all metastatic CP treated with QT and B in our 3rd level hospital, since April 2007 to December 2011. Clinical histories were review to collect any TE or bleeding occurred during or immediately after the treatment. We compare risk of TE/bleeding with 94 control CP treated with QT during the same period. Results: A total of 143 CP were treated with B and QT. Of them, 105 patients (73,4%) due to metastatic colorectal cancer, 19 patients (13,3%) due to metastatic breast cancer and 12 patients (8,4%) due to metastatic non-small cell lung cancer. Median duration of B treatment was 175 days (range 18-1079). During the treatment, 9 patients (6,3%)had a venous TE, 1 patient (0,7%) had and artherial TE, and 5 patients (3,5%) had severe bleeding. Among the 94 control patients, 8 had a venous TE (8,5%), 2 had an artherial TE (2,1%) and 1 had a severe bleeding (1,1%) Risk of TE was not statistically different between groups, (OR 1.58, IC 95% 0.63-3.96) Neither for venous TE (OR 1.38, IC95% 0.51-3.72) nor for artherial events (OR 3.08, IC95% 0.27-34.5) No differences in bleeding risk was found (OR 0,29, IC 95% 0.03-2.58). Conclusions: B added to QT treatment does not appear to increase risk of TE or bleeding in general metastasic population. Although a larger number of patients would evaluate better this risk, we could assess that if patients are selected by other clinical risk factors, bevacizumab does not confer an increased risk of TE or haemorrhage.
Effect of anamorelin/ONO-7643, a selective ghrelin receptor agonist, on tumor growth in a lung cancer mouse xenograft model.
Authors: Northrup Robert , Kuroda Ken , Manning Duus Elizabeth , Routt Barnes Sheri , Wiley Tim , Pietra Claudio
Published: March 2020

e19577

Background: Anamorelin/ONO-7643 is an orally-active ghrelin receptor agonist in development for non-small cell lung cancer (NSCLC)-related cachexia/anorexia. It displays both anabolic and orexigenic properties via its ghrelin and growth hormone (GH) secretagogue activity. However, increasing GH and insulin-like growth factor-1 (IGF-1) in cancer patients raises potential concerns of stimulating tumor growth. In this study, we investigated the effect of ghrelin and Anamorelin/ONO-7643 on tumor growth in a NSCLC xenograft model. Methods: On Day 1 (D1), 21 days after implanting A549 tumors, female nude mice were sorted into six groups (n=15/group) and administered ghrelin (2 mg/kg i.p.), Anamorelin/ONO-7643 (3, 10, or 30 mg/kg p.o.) or vehicles (saline i.p. or de-ionized water p.o.) for 28 days, starting on D3. Tumor growth, body weight, and food consumption were monitored. Mice used to assess plasma levels of murine GH (mGH) and IGF-1 (mIGF-1) were sorted into three groups (n=21/group) and treated for 28 days with ghrelin, the high dose of Anamorelin/ONO-7643 or vehicle (de-ionized water p.o.). Results: After 28 days of treatment, there was no difference in median tumor volumes (D30 values: 1008, 936, 1080, 666 and 847 mm3 for vehicle, ghrelin and Anamorelin/ONO-7643 at 3, 10 and 30 mg/kg, respectively). Ghrelin significantly increased mGH compared to controls, while Anamorelin/ONO-7643 modestly increased mGH. Peak mIGF-1 levels were slightly higher in animals given ghrelin or Anamorelin/ONO-7643 compared to vehicle, although not significantly. Anamorelin/ONO-7643 at 10 and 30 mg/kg/day showed a statistically significant (p<0.01) increase in body weight from D1 to D30 compared to control animals, with no change in food consumption. Ghrelin treatment had no effect on body weight or food consumption. Conclusions: Anamorelin/ONO-7643 or ghrelin treatment for 28 days had no effect on tumor growth in A549 tumor-bearing nude mice, despite increased mGH and a trend of increased mIGF-1. Anamorelin/ONO-7643 also significantly increased body weight at 10 and 30 mg/kg/day. These results support using ghrelin receptor agonist-based treatments in managing NSCLC-related cachexia/anorexia.
Long-term use of sustained-release cytarabine for symptomatic management and treatment of meningeosis neoplastica.
Authors: Jahn Franziska , Behlendorf Timo , Globig Cordula , Jordan Berit , Wolf Hans-Heinrich , Jordan Karin , Schmoll Hans-Joachim
Published: March 2020

e19579

Background: Treatment of meningeosis neoplastica remains challenging due to advanced systematic disease and limited treatment options including a high treatment burden. Liposomal Cytarabine (DepoCyte) is a slow-release formulation of cytarabine that maintains cytotoxic concentrations in the Cerebrospinal fluid (CSF) for >14 days following a single injection. This two week interval has potential benefit due to reduced interventions especially in palliative settings. Methods: We reviewed all patients at our institution treated with liposomal cytarabine (LC) between 3/2004 and 9/2011.The data included tumor type, ICF-cell-count, neurologic disorders due to meningeal affection and time interval from intrathecal therapy to progression and to death of the patient.Assessment for meningeosis neoplastica included neurological examination, CSF assessment and brain MR imaging. LC was administered intralumbar at 50 mg every 2-weeks until progression or appearance of severe side effects. Results: To date 51 adult patients eligible for safety evaluation (48 pts. for efficacy evaluation) (median age 61 y [range 23 - 81 y]) were treated with LC. 72.5% of the included patients had lymphoma, 5.9% breast cancer and 21.6% other solid malignancies. Concurrent systemic chemotherapy was given in 82% of the patients. A total of 160 doses were administered (mean 2.9, range 1- 13). The most frequent side effects were mucositis (21.6%), elevated body temperature (15.7%), backpain (9.8%) and nausea/vomiting (7.8/5.9%). In two lymphoma patients with long term use of LC (13/ 4 applications) cauda equina syndroms appeared. In 61.9% of patients a reduction of neurological symptoms could be achieved; 53% of the patients attained a cytological response in CSF. Median overall survival was 20 months. Conclusions: The obtained results are comparable to those previously reported for methotrexate given 3 times a week. Thus our trial indicates that the 14-day dosing interval is on one hand effective to decrease neurological symptoms caused by meningeosis neoplastica with a favourable safety profile and on the other hand is less burdensome for the patients due to reduced manipulation and treatment burden respectively.
Observational study of ifosfamide (Ifos) neurotoxicity (N): The prospective use of a nursing assessment tool.
Authors: Held-Warmkessel Jeanne , Davey Monica , Litwin Samuel , Lee John , Smith Mitchell Reed , Millenson Michael M , Cohen Adam D. , Somaiah Neeta , Hudes Gary R. , Plimack Elizabeth R. , Wong Yu-Ning , Kim Sharon , vonMehren Margaret
Published: March 2020

e19580

Background: Ifos chemotherapy is known to cause central nervous system toxicity. Risk factors have not been well identified in the literature, with limited information on the onset, duration, and severity of this toxicity. No clinical tools are available to assess and document N. Methods: We developed a clinical nursing assessment tool based upon review of the literature. Patients initiating inpatient Ifos chemotherapy, after informed consent was obtained under an IRB approved protocol, were prospectively monitored for signs and symptoms of N during 1 cycle of therapy. A full neurologic nursing assessment of 24 signs and symptoms including a hand writing sample was done at baseline and a basic assessment evaluating alertness, orientation, sense of well being and a hand writing sample was repeated every 12 hours. In the event N was identified, a full assessment was repeated; observed N was graded using the NCI CTC, version 3. Other variables collected were demographic traits, dose per day, hydration, and potential risk factors for N: renal function, albumin, largest pelvic tumor dimension, prior Ifos or cisplatin, use of other medications with potential for N, and alcohol use history. Individual factors were analyzed using Fisher’s exact test or the Wilcoxon two-sample test. Results: Eighty patients were accrued from 5/09-1/12. Median age was 54.5 (range: 21-85), 51% were males, PS 0 in 26.3%, 1 in 65%, 2 in 6.3% and 3 or 4 in 1.3% each. Diagnosis was sarcoma in 73.75%, lymphoma 22.5%, or germ cell tumor 3.75%. N was observed in 47.5% of patients. Toxicities in >15% of patients were sleepiness (25%), lethargy and restlessness (16.25% for each), and dizziness (15%). The majority were grade 1-2 (89.6%). Factors associated with N included generic versus brand formulation of Ifos (p=0.041) and prior history of a drug related neurotoxicity (p=0.047). BSA, performance status, gender, age, dose per m2, total planned dose, pretreatment Cr, and pretreatment albumin were not associated. Conclusions: The incidence of Ifos N is common using this nursing assessment tool, although usually low grade. We identified the formulation of Ifos and a prior history of drug related N as statistically correlated with developing N.
Surveillance after primary breast cancer treatment: What motivates ASCO experts?
Authors: Mogal Harveshp D. , Allam Emad S. , Margenthaler Julie A. , Chen Ling , Virgo Katherine S. , Johnson Frank E.
Published: March 2020

e19593

Background: Breast carcinoma is the most common cancer among American women except for skin cancer. Over 200,000 patients are diagnosed with breast cancer annually in the U.S. Most receive curative-intent treatment. About 2.5 million women with a history of breast cancer are now alive and eligible for surveillance. ASCO has published evidence-based guidelines for surveillance after primary breast cancer treatment but dramatic variation in the actual practice patterns of ASCO clinicians has been shown. We sought to evaluate potential factors that motivate expert clinicians as they design their own surveillance strategies. Methods: A custom-designed survey instrument with 11 questions about putative motivating factors was e-mailed to the 3,245 ASCO members who had indicated that breast cancer was a major focus of their clinical practice. Responses were submitted on a 10-level Likert-type scale. The percentage of responses for each point on the scale for each of the potential motivating factors was tabulated. We ranked the factors in accordance with the percentage responses on the scale. Results: 1,013 responses (31%) were submitted; 734 (73%) were evaluable. “Potential detection of a second primary breast cancer” was the strongest motivating factor (53% with a score of "strongly agree"). Conclusions: We believe this is the first empirical evidence about factors that may motivate expert clinicians in selecting surveillance strategies. Understanding these factors may be useful in devising methods to decrease the present variation in these strategies. [Table: see text]
Frequency, indications, outcomes, and factors associated with successful opioid rotation in cancer patients presenting to an outpatient supportive care center.
Authors: Reddy Akhila Sunkepally , Yennurajalingam Sriram , Pulivarthi Kalyan , Kwon Jung Hye , Frisbee-Hume Susan , Bruera Eduardo
Published: March 2020

e19599

Background: Opioids are first line medications for cancer pain. Opioid rotation (OR) is recommended for uncontrolled cancer pain (UCP) and opioid induced neurotoxicity (OIN). Limited data exist on frequency, indications and outcomes of OR in ambulatory cancer patients in outpatient setting. Methods: We reviewed consecutive outpatient visits to the Supportive Care Center in 2008 for OR. Data regarding demographics, Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale, pain characteristics, opioid use, indication for OR, outcomes, morphine equivalent daily dose (MEDD) and supportive counseling was collected in all patient visits who followed up within 5 weeks of OR. Successful OR was defined as a 2 point or 30% reduction in ESAS symptom score, resolved symptoms of OIN and continuation of new opioid at follow up. Stepwise logistic regression analysis was performed to determine factors associated with successful OR. Results: 244/2471(10%) patient visits had OR and 142 (58%) were followed up within 5 weeks. 40% (57/142) were consult visits. 74% (105/142) were white, 60% (85/142) male. Median age and performance status were 55 and 1. GI (24%) and lung (22%) were the most common cancer types with 77% (110/142) advanced cancer. Median time (Q1-Q3) between OR and follow up was 14 (7-21) days. Most common indications for OR were UCP 82% and OIN 13%. 34% had partial OR and 16% had more than one reason for OR. Pain characteristics were 49% nociceptive, 21% mixed and 11% neuropathic. Median (Q1-Q3) pain and symptom distress score improved: -2 (-4-0, P=.003) and -5 (-14-7, P=.004). Median MEDD (Q1-Q3) decreased from 162 (90-287) to 156 (90-280, P=.82). 66% (94/142) had successful OR. Fentanyl (34%) before and Methadone (55%) after OR were most common opioids. 17% (24/142) had another OR at follow up visit. High MEDD (P=.05) prior to OR was associated with successful OR. Conclusions: 10% of outpatient visits had OR with a 66% success rate in treating UCP and OIN. Further research is needed to determine predictors of successful OR.
Patient-reported KPS and other measures as predictors of survival in patients with advanced cancer.
Authors: Chang Victor T , Scott Charles B. , Gonzalez Melanie L. , Yan Houling , Einhorn Jan , Crump Barbara , Kasimis Basil
Published: March 2020

e19606

Background: Understanding determinants of survival remains a challenge in patients(pts) with advanced cancer. Prognostic factors of interest include pts rating of their own performance status, and patient responses from the EQ-5D. Methods: This prospective study was approved by the VA New Jersey HCS IRB. Pts with metastatic cancer whose cancer had already been treated with standard or experimental chemotherapy with KPS < 80%, or who did not wish to receive systemic chemotherapy, were recruited in a specified manner. At entry, Karnofsky performance status (KPS) was estimated, pts rated their own KPS, and answered a modified version of the EQ-5D. Cox regression survival analyses were performed. Results: Of 242 pts enrolled, 237 pts were analyzable. Median (M) age was 67 years (range 44-88), with 56% white, 41% black and 3% other; lung (26%) and prostate (18%) were the 2 most common primary sites and M KPS was 60% (range 30-100%). The majority (97%) of pts have died, with M survival of 95 days, range 4-2032 days. Higher KPS is associated with decreased risk of death (p<.0001). Both patient KPS (p<0.0319) and physician rated KPS were predictive of survival (p<0.004). Discrepancy between physician and pt KPS was noted, with upstaging by pts 48%, same for 27%, and downstaging in 25%, with no effect on survival. Physician KPS was a better predictor than pt KPS at each level. The EQ-5D pain item showed an increased risk of death with increasing pain (p<0.0001). The pain item was associated with KPS: pts with no pain had average KPS 75; moderate pain average KPS 63; extreme pain average KPS 48. The patient’s EQ-5D health rating was positively correlated with survival (p=0.0054), and with KPS (r=0.36). The other items in the EQ-5D did not predict survival. When all the factors (physician KPS, pt KPS, pain, health) were incorporated into a Cox model, only physician KPS was statistically significant (p=0.0033). Conclusions: Pts ratings of health and pain are significantly associated with KPS. Pts have a more positive outlook on their performance status. Physician KPS may be a better predictor because physicians have a wider frame of reference. Physician KPS can contribute to determination of hospice eligibility. Supported by VA HSRD IIR 2-103
Neutropenic complications with carboplatin AUC 5 and paclitaxel 175 mg/m2 (CP) regimen in Indian patients: A community-based single center experience.
Authors: Bharthuar Anubha , Chopra Shamit
Published: March 2020

e19607

Background: In most oncology clinical trials, the majority of patients are of Caucasian ethnicity. It is often difficult to apply the same chemotherapy with equal dose intensity in Indian patients due to increased risk of complications. The exact incidence of complications & whether the difference in chemotherapy tolerability is due to genetic or environmental factors remain unclear. We provide a community-based single center experience with the commonly used CP regimen in Indian patients. Methods: A retrospective study of all patients who received CP regimen (Cockroft Gault formula for CrCl) from September 2010 to December 2011 was undertaken. Incidence of neutropenic complications, G-CSF utilization & pRBC transfusion was determined. Results: Fifty six patients received 194 cycles of CP (range 1-8 cycles, median 3 cycles, mean paclitaxel dose 256mg, mean carboplatin dose 431mg, average BSA 1.56). Clinical characteristics : male 16, female 40; age range 34 - 82 yrs, median 55 yrs; site - breast 6, ovary 19, cervix/uterus 11, esophagus 8, others 12; stage – I/II/III 7, IV 42; histology – SCC 21, Adenoca 34. After the 1st cycle, there were 8 neutropenic complications (14%)- 4 patients (7%) with neutropenia (ANC<1500 cells/mm3) and 4 patients (7%) with neutropenic fever. Forty-two patients received the 2nd cycle, & in total 12 patients required G-CSF support (28%). There were 3 deaths, 2 due to neutropenic fever & sepsis. Average baseline hemoglobin was 11.5gm/dl with 5 episodes of pRBC transfusion. Conclusions: Although the incidence of neutropenia in Indian patients receiving CP is not higher than previous reports (20-25%), there is a much higher incidence of neutropenic fever (over the reported 1-2%) & death, resulting in high G-CSF utilization. This raises several issues such as the role of prophylactic antibiotics, impact of environmental & socio-economic factors (compromised nutritional status & hygiene, lack of disease insight & lack of access to urgent health care). We will need to implement additional measures, increase patient & family awareness by frequent education & counseling so as to reduce complications & improve clinical outcomes in Indian patients.
Predictors of palliative care (PC) referral for advanced cancer patients.
Authors: Tanco Kimberson , Hui David , Kim Sun Hyun , Kwon Jung Hye , Zhang Tao , Kang Jung Hun , Rhondali Wadih , Chisholm Gary B. , De la Cruz Maxine , Karuturi Meghan Sri , Bruera Eduardo
Published: March 2020

e19613

Background: We previously examined factors associated with delayed PC referral. Little is known about the actual proportion of patients referred to PC. We determined the proportion of patients who had a PC consultation at our cancer center and the predictors of referral. Methods: All adult patients in the Houston area who died of advanced cancer between 9/1/2009 and 2/28/2010 while under the care of our institution were included. We collected baseline demographics and data on PC referral. Multivariate logistic regression was used to examine factors associated with PC referral. Results: 386/912 (42%) decedents had a PC referral, and 179 (46%) were seen initially as outpatients. In multivariate analysis, PC referral was associated with younger age (odds ratio (OR) 0.98 per year; 95% confidence interval (CI) 0.97-0.99; P<0.001), married status (OR 1.5; 1.1-2.0; P=0.005), and gynecologic cancer (OR 1.9, 1.1-3.5, P=0.02 relative to lung). Among patients with a PC referral, outpatient consultation was more likely among patients with head and neck cancer (OR=5.5, 1.7-17.6, P=0.004 relative to lung). In contrast, hematologic malignancy was associated with decreased PC referral (OR=0.59, 0.36-0.97, P=0.04), fewer outpatient PC consultations (OR=0.3, 0.1-0.7, P=0.01) and less time from referral to death (Table). Conclusions: Younger, married patients and those with gynecologic cancer were more like to be referred to palliative care. Head and neck cancer patients were more often seen as PC outpatients. Patients with hematologic malignancies had fewer PC referrals and often late in the disease trajectory compared to patients with solid tumors. [Table: see text]
Use of high white blood cell (WBC) count to predict poor survival outcome in gastrointestinal (GI) cancer with thrombotic event.
Authors: Lee Myung Ah , Lee Guk Jin , Hong Ji Hyung , Lee Hee Yeon , Roh Sang Young
Published: March 2020

e19614

Background: There are some known risk factors for deep vein thrombosis in cancer patients, such as primary site of cancer, white blood cell count (WBC), hemoglobin (Hb), platelet count (PLT). We investigated the association between these factors and the overall survival as prognostic factor in gastrointestinal (GI) cancer patients. Methods: All the patients with gastrointestinal cancer, who developed deep vein thrombosis or pulmonary thromboembolism through the clinical course, were retrospectively reviewed between January 2009 and June 2011 at Seoul St. Mary’s Hospital. According to treatment, patients were classified into two groups; the chemotherapy group and the supportive care group. Results: Of the fifty-six patients, median age was sixty three year-old. Stomach cancer was most common 35% , pancreatic cancer 31%, colorectal cancer 19%, and biliary cancer was 15%. There were three pattern of thrombosis: 19 (34%) deep vein thrombosis (DVT) only, 12 (21%) pulmonary thromboembolism (PTE) only, 25 (45%) combined DVT with PTE. WBC count above 11,000/µ° showed the poor overall survival than other group (median survival 3.4 months vs. 1.7 months, respectively, p=0.015) However, other risk factor did not show any significant association (Hb: p=0.521, PLT: p=0.295) In chemotherapy group, twelve (55%) patients had progressive disease and ten (45%) patients had stable disease at the time of thrombotic event. There was no statistically significant association between thrombosis and tumor response. The chemotherapy group had tendency of better survival outcome than the supportive care group without statistical significance (median survival 2.4 months vs. 5.3months, p=0.07). Conclusions: In GI cancer patients, elevated white blood cell count above 11,000/µ° can be important prognostic and risk factor for thrombosis with poor survival outcome. And the response of chemotherapy seemed to have no influence on thrombotic event during chemotherapy. This is very limited study due to small sample size and retrospective analysis, and heterogenous type of cancer. Further large study should be warranted to define the thrombotic risk factor as prognostic marker.
Rate of pathologic fractures associated with zoledronic acid treatment in both breast and prostate cancer patients with bone metastases: Findings from real-world clinical practice.
Authors: Regan David H. , Wollschleger Dennis J , Harwin William N. , Szabo Stephen , DiBenedetto Joseph , Namjoshi Madhav
Published: March 2020

e19615

Background: Recent papers by Stopeck et al (J Clin Oncol, 2010), and by Fizazi et al (Lancet, 2011) evaluated rates of pathologic fractures (PF) in breast cancer (BC) and prostate cancer (PC) patients with bone metastases, and concluded that 23% and 15% of the patients on zoledronic acid (ZOL) respectively had a PF. Since these results were obtained within a randomized controlled trial environment, it is very important to compare these rates to those observed in actual practice. The objective of this study was therefore to determine the rate of PF among both BC and PC patients with bone metastases treated with ZOL in clinical practice. Methods: A patient chart review was conducted in two institutions, Florida Cancer Specialists (FCS) and Georgia Cancer Specialists (GCS) to determine the rate of PF in BC and PC patients with bone metastases initiating ZOL. BC and PC patients with confirmed diagnoses who initiated ZOL treatment from 2005 thru 2007 were included in the study. The patients were required to have been on ZOL for a minimum of 18 months following initiation of treatment. Demographic information, baseline clinical characteristics, and outcomes related to the treatment of bone metastases were assessed. Results: A total of 207 BC patients and 178 PC patients were included in the sample. Median age in the BC group was 65, and in the PC group was 74. In the BC cohort, of the 207 patients, only 17 (8.2%) patients had a PF. In the PC cohort, of the 178 patients, only 8 (4.5%) patients had a pathological fracture. When evaluated by institution, only 5 (4.7%) BC patients, and 4 (4%) PC patients from FCS had a pathological fracture; and only 12 (12%) BC and 4 (5.2%) PC patients from GCS had a pathological fracture. Conclusions: The findings from this study indicate that the rate of pathological fractures associated with ZOL treatment in clinical practice is very different from that observed in a randomized controlled trial setting. Physicians, payers and policy makers should carefully consider these findings in both clinical pathway decisions and formulary inclusion.
Prospective study on the association of depression and anxiety on quality of life, treatment adherence and prognosis in patients with advanced non small cell lung cancer.
Authors: Nunez-Valencia Carolina , Angulo Patricia , Macedo Omar , Dorantes Yuzmiren , De la Mata Dolores , Onate-Ocana Luis F. , Arrieta Oscar
Published: March 2020

e19618

Background: Symptoms of depression and anxiety are common in patients with lung cancer and could produce impact on health-related quality of life (HRQL) and survival. The aim of the present study is to evaluate the association of depression and anxiety on HRQL, treatment adherence and prognosis in patients with non-small cell lung cancer (NSCLC). Methods: This is a prospective study of consecutive patients with stages IIIB-IV NSCLC. Depression and anxiety were measured with the Hospital Anxiety and Depression Scale (HADS) and the International Psychiatric Interview (MINI), and HRQL with the EORTC QLQ-C30 and QLQ-LC13 questionnaires.All instruments were applied before treatment; at three and six months. Lack of adherence to treatment was considered in patients who stopped attending consultation. Overall survival (OS) was calculated with the Kaplan-Meier and Cox methods. Results: Eighty-two patients were included, mean age 58.9 years. Depression and anxiety were found in 32.9 and 34.1% - respectively - at the initial evaluation. Factors associated with depression were: female gender (p=0.034) and poor performance status (p=0.048). Depression showed association to HRQL; particularly Global health status/QoL and functional scales (i.e: Physical, Role, Emotional, cognitive and Social); Anxiety also showed association to HRQL; particularly Global health status/QoL and functional scales (all p≤0.05).Patients with depression presented a median OS of 6.8 months (95% CI 2.4-11.1) whilst non-depressed patients: 14 (10.3-17.6). Anxiety was not associated to OS. By multivariate analysis, depression has a hazard ratio of 1.9 (95% CI 1.03-3.7, p=0.042). Forty-four percent of the patients with depression had poor treatment adherence versus 14% of the non-depressed (p<0.05). Conclusions: One third of patients with advanced NSCLC presented depression and anxiety. Both were associated to decreased HRQL functional scales of QLQ-C30 and treatment adherence. Depression was independently associated to poor prognosis.
Rash to mTOR inhibitor everolimus: Systematic review and meta-analysis.
Authors: Ramirez-Fort Marigdalia K. , Case Emily Christine , Rosen Alyx C. , Wu Shenhong , Lacouture Mario E.
Published: March 2020

e19624

Background: Everolimus is an mTOR inhibitor approved for treatment of renal cell carcinoma, subependymal giant cell astrocytoma, and progressive neuroendocrine tumors of pancreatic origin. Its use may be hindered due to adverse events, including rash. The reported incidence and risk of rash to everolimus varies widely and has not been closely investigated. Therefore, we conducted a systematic review and meta-analysis of the literature to determine the incidence and risk of developing rash. Methods: We searched PubMed and Web of Science databases and abstracts presented at the American Society of Clinical Oncology from 1998 to July 2011 using the keyword “everolimus” to identify relevant clinical trials. Eligible studies included prospective phase II and phase III clinical trials of cancer patients on 10 mg of everolimus daily with available data on incidence of rash. The summary incidence and relative risk (RR) of rash were calculated using either the random-effects or fixed-effects model, depending on the heterogeneity of the constituent studies. Results: A total of 2,242 patients with various malignancies from 13 clinical trials were included in the analysis. The summary incidences of all-grade and high-grade rash in patients on everolimus were28.6% (95% CI: 20.8 – 38.0) and 1.0% (95% CI: 0.6 – 1.7), respectively. Everolimus was associated with a statistically significant increased risk of all-grade rash (RR=3.853, 95% CI: 2.470 – 6.013, p=0.000), but the RR for high-grade rash (RR= 2.997, 95% CI: 0.633 – 14.185) was not statistically significant, with a p value of 0.166. Conclusions: Everolimus is associated with a significant risk of developing rash. Management of rash to everolimus is critical to prevent dose modifications and decreased quality of life, both of which can negatively affect clinical outcomes.
A pilot study of direct care nurse (DCN) education to improve adherence and knowledge of erlotinib in patients with non-small cell lung cancer.
Authors: Lucca Joan Vern , Hooper Catherine L. , Boucher Jean , Pedulla Lillian Vitale , Berry Donna Lynn , Marcoux J Paul
Published: March 2020

e19637

Background: Adherence for oral anticancer agents is a major concern for patients in the ambulatory setting. Adherence rates for oral medication regimens are associated with proper knowledge and monitoring for adverse side effects including symptom management. To improve patient-reported adherence we studied feasibility of a DCN educational intervention to enhance participant knowledge and adherence to erlotinib while monitoring for side effects. Methods: A prospective, pilot study with 30 NSCLC patients was conducted. The study included a DCN structured education session utilizing an adapted educational tool (MOATT) from the Multinational Association of Supportive Care in Cancer (MASCC); followed within 72 hours by a DCN phone call to assess patient learning, adherence, and adverse side effects. Primary endpoints included participant-reported Knowledge Rating Scale (KRS) scores and adherence behaviors measured by the Morisky Medication Adherence Scale (MMAS-8). Adverse side effects and feasibility data were analyzed for each DCN/patient encounter. Results: MMAS-8 adherence scores indicated medium (n=11) to high (n=14) adherence rates and high KRS scores (mean 8.9, range of 7.5-10). Mean age of patients was 67 years (range 45-84 years), majority were female (81%), with race/ethnicity as Caucasian 80%, Asian 10%, and Black 10%. Mean number of erlotinib adverse events was 2.48 per patient and 22% reported 4 or more side effects. Patients contacted DCN 60 times between start and end of protocol. Feasibility included 90% (n=27/30) completing the protocol, mean time 30 minutes to administer educational session and 14 minutes for DCN 72-hour follow-up phone call. Documentation of visits indicated nurse education and follow-up, including monitoring side effects, provided valued supportive care. Conclusions: Data supports the need for and feasibilty of a nurse-led structured protocol to enhance adherence, knowledge, and symptom management. Further study of this education/monitoring intervention for patients initiating oral anticancer agents in the ambulatory setting is recommended.