bluuebunny/crossref_metadata_2025 huggingface dataset:
A retrospective analysis of elderly population with metastatic colorectal cancer treated with raltitrexed in the target therapy era.
Authors: Ugidos Lisardo , Rodriguez-Pascual Jesus , Alvarez-Gallego Rafael , Munoz Cesar , Sanz Enrique , Ceniceros Lucia , Cubillo Antonio
Published: May 2019

e23022

Background: Raltitrexed is a antifolate chemotherapy agent with activity against metastatic colorectal cancer (mCRC). Most clinical trials with raltitrexed were performed before approval of anti-EGFR and anti-VEGF therapies. Its toxity profile suggests that might be a useful drug to treat elder patients, but there are no specific data in this population group. Methods: A retrospective review of elderly patients (70 years or older) with mCRC treated with raltitrexed monotherapy in our hospital between 2008 and 2017 was conducted. All of them had received previously oxaliplatin, irinotecan, fluoropyrimidines, and bevacizumab as standard therapy. All RAS native patients had received also anti-EGFR drugs. Results: Eighteen elder patients were reviewed, 11 (61%) male. Age ranged 70-85 years (median 78). All patients had ECOG PS 0 or 1. Locations were rectum (4), right colon (8), and left colon (6). Number of treatment lines ranged 2-5 (median 3). Three pts (16%) had received regorafenib previously. KRAS and BRAF were mutated in 61% and 5% respectively. Median number of cycles was 3 (1-13). Response rate was 11% (2 partial responses). Stable disease was achieved in 33%. Median progression-free and global survival were 2.8 (95% CI 1.2-10) and 5.9 (95% CI 1.6-18) months respectively. Grade 3-4 hematologic and non-hematologic toxicities were present in 22% and 5.5% respectively. Dose reduction was needed only in 11%. Sex, location, RAS status were not related to response or survival. Conclusions: Raltitrexed is a well tolerated option por elderly patients after standard treatment of mCRC.
The comprehensive geriatric assessment in malignancies and prognostic factors: Description of a prospective cohort of 889 Brazilian elderly cancer patients.
Authors: Telles O Lima Jurema , Viana Raissa , Rebello Mirella , Mello Maria Julia Gonçalves , Sales Letícia telles , Bergmann Anke , Cavalcanti Zilda , Thuler Luiz Claudio Santos
Published: May 2019

e23035

Background: According to the World Health Organization (WHO), the definition of "elderly" varies according to the degree of development of the country. In Low and Medium Development Countries (LMDC), a person aged 60 or older is considered elder, opposed to developed countries (65 or older). It is in LMDC that is occurring the largest relative increase in the incidence of cancer, specially those related to aging. The Comprehensive Geriatric Assessment (CGA) is still underutilized in oncological clinical practice, especially in LMDC. Objectives: To determine predictive factors for the occurrence of early death (in the first six months of surveillance) and to perform the development and temporal validation of a practical prognostic score based on the CGA to predict early death (up to 180 days) in elderly cancer patients. Methods: A prospective cohort enrolled elderly patients ≥ 60 years with a recent cancer diagnosis admitted between 2015-2017. The CGA performed at the time of admission included the following instruments: CCI; KPS; MMSE; TUG test; IPAQ; ADL; MNA; MNA-SF; GDS15; PPS and Polypharmacy. The studied outcome was early death, defined as the one that occurred within the first six months after the diagnosis. Survival analysis (Kaplan-Meier) and Cox proportional hazard regression was performed. Results: 889 patients were included in the study, performed at a referral center in cancer of a teaching hospital in Northeastern Brazil. The independent risk factors for death identified by CGA were: Mini exam of mental state (MMSE) as a continuous variable (HR 1.04 95% CI 1.00-1.07), Geriatric depression scale (GDS-15) ≥ 10 (HR 1 , 50 IC95% 1.10-2.07), Karnofsky Functional Performance Scale (KPS) < 50 (HR 1.57 IC95% 1.02-2.42), Katz Index ≤4 (HR 2.58 IC95% 1.68-3.97) and the Mininutrition assessment (MAN-SF) < 12 (HR 2.96 IC95% 2.00-4.39), with higher risk for early death amongst patients with abnormalities detected by the scales performed at admission (log rank < 0.001). Conclusions: Comprehensive geriatric assessment is an important tool to identify fragility in elderly cancer patients. Some of its scales should be incorporated into clinical practice, as they are simple and significant prognostic markers and identify patients with a higher risk of death in the first twelve months.
Chemotherapy and trastuzumab-induced cardiotoxicity in geriatric breast cancer patients.
Authors: Agbisit Christian , Johnson Alexander , Robinson Kathy , Delfino Kristin , Desai Meghna R.
Published: May 2019

e23043

Background: Cardiotoxicity is a known side effect of anthracyclines & trastuzumab. Dilated cardiomyopathy is the most common form of cardiotoxicity associated with this treatment. Cardiovascular disease & cancer are common conditions in the geriatric populations. These comorbidities complicate the treatment of geriatric breast cancer patients. The purpose of this study was to determine the cardiotoxic effects of chemotherapy & trastuzumab in a geriatric population of breast cancer patients. Methods: An institutional database of a total of 269 patients with histologically confirmed invasive or in-situ breast cancer with age 65 years or older at the time of diagnosis was reviewed in an IRB approved fashion. Patients were divided in groups depending on the therapy (AC/TAC, CMF, TC and Trastuzumab) they received. Fisher’s exact test was used to calculate overall survival (OS). Results: Of the 269 patients, 72 (26.8%) were offered chemotherapy & 197 (73.2%) were not. Of the patients offered chemotherapy, 58 (21.6%) accepted treatment & 14 (5.2%) declined. 17 (6.7%) had an early termination, AC n = 11,( 4.1%), TAC n = 13, (4.8%), CMF n = 0, (0%), Trastuzumab n = 12, (4.5%), TC n = 11, (4.1%). Cardiovascular risk factors taken into consideration were, CAD n = 30, (13.8%), HLD n = 23, (10.6%), HTN n = 98, (45.2%), HTN/HLD n = 66, (30.4%), DM (N = 45, (16.7%), Smoking n = 121, (46.4%) & BMI > 30, n = 116,( 48.1%). Patients completing chemotherapy had higher OS than patients who had early termination (P = 0.017). Of the 24 patients who received Anthracycline containing regimen, 1 experienced cardiotoxicity. There was no statistically significant difference in OS between AC, TAC & Trastuzumab (P = 0.570, P = 0.547, P = 0.614). A decrease in OS was seen for patient who received TC (P = 0.002). Of the 12 who received trastuzumab, 1 experienced cardiotoxicity. There was a significant association between patients with a high BMI ( > 30) & increased cardiovascular comorbidities (P = 0.0009) but had no impact early on termination of chemotherapy or OS, NS (P = 0.7). Conclusions: The cardiotoxic effect of anthracyclines and trastuzumab are well known, however in our study, only 2 elderly breast cancer patients who received chemotherapy experienced cardiotoxicity. As would be expected, those who completed chemotherapy had improved OS. There were no difference in OS between AC, TAC and Trastuzumab, however TC treatment was associated with a decrease in OS.BMI had an impact on cardiovascular comorbidities but not on early termination of chemotherapy or OS.
Lactate response during acute exercise in cancer survivors undergoing exercise rehabilitation.
Authors: Harman Nicholas , Ramani Arjun , George Benjamin Jacob , Hayward Reid
Published: May 2019

e23047

Background: Cancerous cells express a markedly different metabolic profile characterized by lactate production even when oxygen is plentiful. Lactate accumulation is a common marker for energy production and utilization, yet it is currently unclear how blood lactate responds during acute exercise to volitional fatigue in individuals with cancer and how this response is modified with exercise-based rehabilitation. The purpose of the current study is to assess the effect of an acute exercise bout to volitional fatigue on lactate accumulation before and after an exercise-based rehabilitation program for cancer survivors. Methods: 33 cancer survivors (female, n = 18; male, n = 15) were recruited to participate in a 12-week exercise-based rehabilitation program. All participants performed an initial assessment of physiological parameters, including blood lactate accumulation (LA) during a progressive treadmill protocol to volitional fatigue. LA was quantified every 2 minutes during treadmill testing via finger stick. The exercise intervention consisted of one hour sessions, three days per week, and included cardiovascular endurance, muscular strength, balance, and flexibility exercises. After 12 weeks of rehabilitation, participants completed a follow-up evaluation of physiological parameters. Results: There was a significant increase in LA at volitional fatigue after 12 weeks of training (Initial: 6.17 ± 2.61 mM, Post 12 Weeks: 7.26 ± 2.10 mM; p = 0.04), with no significant difference in resting blood lactate. The workload at which anaerobic lactate threshold presented was significantly increased after 12 weeks (Initial: 5.87 ± 1.59 METs, Post 12 weeks: 7.35 ± 1.85 METs; p = 0.02). Conclusions: Cancer survivors respond to acute exercise to volitional fatigue in a manner similar to healthy controls. Furthermore, similar to the response observed in healthy populations, cancer survivors exhibited an increase in lactate threshold and an increase in peak lactate accumulation at volitional fatigue after completing an exercise-based rehabilitation program. Thus, although many cancerous cells have a unique glycolytic profile, this does not appear to influence training-induced adaptations in blood lactate.
Mobile text messaging to improve adjuvant hormone therapy and side effect management among breast cancer patients: A pilot RCT.
Authors: Wen Kuang-Yi , Goldstein Lori J. , Smith Rita , Miller Suzanne M.
Published: May 2019

e23061

Background: Substantial evidence reports that adjuvant hormone therapy (AHT) decrease breast cancer (BCa) recurrence and mortality, however, many patients are nonadherent due to troublesome side effects. The goal of this pilot study is to test a novel mobile text messaging-based intervention ( TXT2Adhere) that delivers adherence-promoting and side effect coping tips messages. Methods: 58 BCa patients who were within 1 month of AHT initiation were randomized into the TXT2Adhere group (n = 29) or usual care control group (UC, n = 29). Intervention participants received a daily reminder prompt for medication uptake and two messages addressing the importance of AHT adherence and management for potential side effects for 3 months. Assessments were conducted at baseline, 1-month, 2-month, and 3-month. Results: Participants in the TXT2Adhere group reported higher AHT adherence at 2 months (93% vs. 54%, p < 0.05) but this difference between groups disappeared at 3-month as adherence rate in the TXT2Adhere group greatly declined at month 3. Increase in symptom distress at 3-month was found substantially smaller in the TXT2Adhere group than the UC group, although this difference was not statistically significant. Conclusions: Daily text messages promoting adherence and side-effect management demonstrated feasibility with better short-term adherence. Potential intervention improvement to facilitate greater participant engagement and adherence behaviors as the onset of symptoms (e.g. during month 3) needs to be considered.
Patient-reported outcomes for dental health, shoulder-neck dysfunction, and overall quality of life after treatment with radiation for head and neck cancer.
Authors: Verma Neha , Tan Xianming , Knowles Mary , Bernard Stephen A. , Chera Bhishamjit S.
Published: May 2019

e23064

Background: The current exploratory cross-sectional study was designed to better characterize survivorship issues among patients treated with radiation for head and neck cancer with regard to dental health, shoulder-neck dysfunction, and overall quality of life. Methods: Patients (n = 58) being seen for follow-up at a radiation oncology clinic at least one year beyond the end of treatment completed three survey questionnaires: the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30), the EORTC Head and Neck module (EORTC QLQ-H&N35), and an original 18-item Dental Health and Shoulder Function questionnaire. The questionnaires were scored and univariate analyses were performed using the variables of age, radiation dosage, definitive radiation + neck dissection vs. definitive surgery + postoperative radiation, and chemotherapy. Results: Median follow-up was 2.5 years. Of patients surveyed, 35% reported having more problems with their general dental health as compared to before treatment and 38% reported having pain at night in the neck and shoulder; 79% of patients reported being counseled about their dental health prior to treatment while 31% reported being counseled about possible shoulder-neck dysfunction. Patients younger than 65, patients receiving higher doses of radiation, and patients undergoing definitive surgery + postoperative radiation reported a higher burden of functional and symptomatic issues. Conclusions: Patients treated with radiation for head and neck cancer face a number of survivorship issues, including problems with dental health and shoulder-neck dysfunction, and many do not feel that they are adequately counseled about these issues prior to treatment. Subsets of patients who may experience a higher burden of functional and symptomatic issues include patients younger than 65, patients receiving higher doses of radiation, and patients undergoing definitive surgery + postoperative radiation. Increasing pre-treatment counseling for all patients and placing a particular emphasis on supportive care for these subsets of patients may allow us to better support this growing population of cancer survivors.
Implementation of a brief screening tool to identify needs of cancer survivors.
Authors: McDonough Allison L. , Lei Yvonne Y. , Haggett Dana , Jimenez Rachel , Johnston Katherine T. , Moy Beverly , Spring Laura , Peppercorn Jeffrey M.
Published: May 2019

e23075

Background: Innovation in health care delivery is needed to improve care for cancer survivors. We report a pragmatic study intended to evaluate our experience with adopting screening guidelines from the National Comprehensive Cancer Network (NCCN) to the routine care of breast cancer survivors in primary care and oncology follow up. Methods: We adapted the NCCN recommended screening questions into a plain language self-administered 1 page intake questionnaire. The tool was administered to a convenience sample of female breast cancer survivors in routine follow-up at an oncology or primary care clinic from September through December 2018. Domains included symptoms, lifestyle concerns, and financial issues. Frequency of concerns was assessed as “never”, “rarely”, “sometimes”, “very frequently” and “always”. We dichotomized results and evaluated feasibility of administration, prevalence of reported symptoms and qualitative assessment of burden as well as utility of the tool among participating clinicians. Results: 165 out of 169 patients offered the questionnaire participated (98%). Office staff provided the questionnaire at routine visits without notable impact on clinic flow. Most commonly endorsed concerns (sometimes or more) were: desire to improve fitness or nutrition (80%), worry about cancer recurrence (72%), and problems with sleep (57%). A majority also reported feeling nervous or worried (55%) and aches or pains in limbs or joints (55%). Several issues known to be underreported in clinic visits were endorsed including lack of satisfaction with sexual function (30% sometimes or more, 12% very often or always) and difficulty remembering things (47% sometimes or more, 13% very often or always). Among 7 participating clinicians, the tool was deemed useful and not burdensome. Several noted that it led to discussing issues that may not otherwise have been addressed. Suggestions included systematically identifying resources and strategies to address common issues and incorporating the tool into the electronic health record to increase utility. Conclusions: Screening for individual needs among survivors is feasible and efficient and may identify prevalent issues that otherwise can be missed in routine survivorship care.
Effect of temozolomide on neurogenesis and anxiety in the adult mouse brain.
Authors: Hussaini Syed , Jang Mihyeon
Published: May 2019

e23082

Background: The hippocampus is one of two regions in the adult brain where new neurons are generated well into adulthood. Newborn neurons develop from neural stem cells, and are consequently integrated into the hippocampal circuitry to function in learning and memory. Temozolomide (TMZ) is a commonly used alkylating agent for treatment of malignant gliomas. In this study, we examine the effects of TMZ on adult neurogenesis and cognitive function in the murine model. Methods: Adult male mice (8-week-old) were injected daily with TMZ (25 mg/kg, i.p.) for 2, 2.5 and 3.5 weeks to estimate progenitor proliferation, neuronal maturation and animal behavior respectively. For progenitor proliferation, a single dose of BrdU (50mg/kg, i.p.) was injected at 2 weeks and the mice sacrificed 2 hours later. For maturation analysis, five separate doses of EdU (41.1 mg/kg, i.p.) were injected over five days starting at 2 weeks. Three weeks after first EdU injection mice were sacrificed. Both BrdU and EdU are novel thymidine analogues that label dividing cells. Immunostaining was performed on hippocampal brain slices to label progenitors at different stages of development. For behavioral analysis, daily tests measuring anxiety, memory and motor activity were started at 2 weeks into TMZ administration. Results: TMZ significantly reduced the resident radial glia-like and non-radial glia-like population (MCM2+Nestin+), as well as the overall proliferating progenitor pool (n = 2, p < 0.05). In addition, it significantly reduced the population of Type-3 neuroblasts (EdU+DCX+NeuN-) (n = 4, p < 0.05). During neuronal maturation, immature new neurons (EdU+DCX+NeuN+) and mature new neurons (EdU+DCX-NeuN+) were also reduced by TMZ (n = 4, p < 0.05). These effects of TMZ coincided with specific behavioral deficits. While TMZ had no effect on working memory and locomotor activity, mice that underwent TMZ administration showed significantly increased anxiety on the open field test (n = 7, p < 0.05). Conclusions: Our findings demonstrate TMZ significantly impairs cellular proliferation of neural stem cells and fate-committed neuroblasts, and increases anxiety with sparing of non-hippocampal-dependent memory. TMZ may thus be associated with specific deficits in hippocampal function in the adult brain, providing mechanistic insight into adverse effects that may be observed with TMZ treatment.
Development of a comprehensive prognostic model of lymphedema risk for breast cancer survivors.
Authors: Kwan Jennifer , Famiyeh Petra , Su Jie , Xu Wei , Yip Kenneth , Liu Fei Fei
Published: May 2019

e23083

Background: Lymphedema is a side-effect of cancer treatment affecting up to 1 in 5 cancer survivors. It is associated with life-threatening medical complications and higher medical costs. To facilitate early detection and treatment of lymphedema in high-risk patients, improved prognostic modeling is required. Methods: The study cohort comprised of female breast cancer survivors at the Princess Margaret Cancer Centre during 2016-18. Using lymphedema diagnosis as the end-point, the Cox proportional-hazards model was applied to patient, disease, and treatment-related parameters to assess performance of established and putative novel prognostic factors for lymphedema. Concordance index (C-index) and Kaplan-Meier analyses were used to evaluate prognostic performance. Results: A total of 176 breast cancer survivors were included in the preliminary analysis. On univariable analysis, traditional treatment-related risk factors for lymphedema (e.g. axillary lymph node dissection, number of lymph nodes dissected, use of radiotherapy) were significant (p < 0.05). Additionally, other treatment-related factors (e.g. radiation boost, supraclavicular radiation), disease factors (e.g. tumor size, number of positive lymph nodes, cancer stage), and patient/biological factors (e.g. developing a surgical seroma) were significant (p < 0.05). Multivariable analysis revealed one traditional treatment-related factor (i.e. number of lymph nodes dissected) and other treatment details (e.g. radiation boost, axillary/supraclavicular radiation) to be the most significant factors. Combining radiation treatment details with traditional treatment-related lymphedema risk factors improved the C-index from 0.609 to 0.710 and separated patients into high- and low-risk groups with 2-year lymphedema-free survivals of 26% (15-44%) and 85% (74-97%) respectively (p < 0.001). Conclusions: Prognostication of lymphedema risk can be improved by considering radiation treatment details, including use of radiation boost and site of radiotherapy. Biological factors, such as developing a surgical seroma, may reveal predisposition towards edema. Validation on an independent data set is being completed. Prospective validation is also required.
Long-term neurotoxicity in women with breast cancer.
Authors: Faruqi Fahad Ahmed , Loprinzi Charles L. , Ruddy Kathryn Jean , Couch Fergus , Staff Nathan , Olson Janet E.
Published: May 2019

e23089

Background: Taxanes (paclitaxel and docetaxel) are commonly administered as part of chemotherapy for breast cancer, but long-term data on chemotherapy-induced peripheral neuropathy (CIPN) are limited in this population. We aimed to assess CIPN approximately three years after an initial exposure to paclitaxel or docetaxel. Methods: In a cross-sectional observation study, which surveyed consented enrollees annually after receipt of care at Mayo Clinic for a new breast cancer diagnosis over age 18, we collected patient-reported EORTC CIPN20 data by mailed questionnaire at baseline and three years after a breast cancer diagnosis. We then confirmed patient-reported chemotherapy data by chart abstraction and only included those who had received a standard course of docetaxel-based or paclitaxel-based chemotherapy, but had not had other neurotoxic treatment for cancer. CIPN20 overall and sensory scale raw scores were converted to a 0-100 linear scale with lower scores indicating more severe symptoms. Results: 84 women who received a taxane for breast cancer completed the survey. 82 were treated in the adjuvant or neo-adjuvant setting, while 2 received a taxane for metastatic breast cancer. 67 women received paclitaxel, while 17 received docetaxel. The median age at diagnosis was 51.5 years (range 31-86). 37 had estrogen receptor (ER) and/or progesterone receptor (PR) positive and human epidermal growth factor receptor-2 (Her2) negative, 31 Her2 positive, and 16 triple negative breast cancer. The median CIPN20 score was 92.98 (range 33.33-100). The median sensory CIPN score was 92.59 (range 25.94-100). 81% of women had an overall CIPN20 score of less than 100, and 68% had a sensory score of less than 100. Conclusions: The majority of women who received a taxane based chemotherapy regimen for breast cancer reported at least mild neuropathic symptoms three years out from treatment. Additional research is needed to help tailor chemotherapy decisions to toxicity risks and to reduce the likelihood of long-term CIPN, which can impair quality of life.
Pilot study investigating an oncofertility program in adults with breast or sarcoma cancers.
Authors: Bhave Manali A. , Fang Fang , Kidwell Kelley M. , Smith Gloria Lola , Chugh Rashmi , Burness Monika Leigh
Published: May 2019

e23096

Background: Cancer survival is at an all-time high; however, patients often face long-term consequences including infertility. Loss of fertility can be devastating and lead to long-lasting emotional distress. Despite consensus guidelines encouraging providers to discuss infertility risk and refer for fertility preservation (FP) consultations, fertility counseling and FP occur in only 10-29% of patients of childbearing age. A few identified barriers include lack of provider knowledge on FP, constraints on time and lack of available resources. Methods: This is a prospective pilot study evaluating the efficacy of an oncofertility program in increasing discussions on infertility risk and FP between providers and patients. The oncofertility program includes medical provider education, an electronic medical record (EMR)-based best practice alert with smart order set, patient education pamphlets and a patient navigator through Reproductive Endocrinology and Infertility (REI). Our primary objective was to increase documentation on fertility in the EMR, while our secondary objective was to increase referrals to REI for females and orders for semen cryopreservation for males. Provider and patient-reported outcomes were also obtained. Results: 19 patients with a new diagnosis of breast or sarcoma (7 pre-intervention and 12 post-intervention) were enrolled and 17 providers participated in the study at the University of Michigan. There was no change in documentation on fertility in the EMR and no increase in fertility referrals placed. However, patients reported a statistically significant change in amount of information provided on infertility risk and FP from "too little" to "the right amount." Providers also reported increased confidence in initiating a conversation about FP and a trend towards increased comfort documenting their conversations on FP in the EMR. Conclusions: With an increase in cancers diagnosed in young adults, there is a need to improve counseling on the risk of infertility with cancer treatment and FP options. Through an easily implemented oncofertility program, we were able to improve medical provider confidence in initiating this important conversation, provide patients with education on infertility risk and FP and streamline the process for FP referrals utilizing the EMR.
Medical cannabis in cancer patients: Prevalence, efficacy, and safety.
Authors: Macari David , Gbadamosi, MD. Bolanle , Ezekwudo Daniel , Khoury John , Jaiyesimi Ishmael A. , Gaikazian Susanna S.
Published: May 2019

e23099

Background: Cancer patients are using medical cannabis (MC) to address symptoms, however, little data exists to guide clinicians when counseling patients regarding use. We seek to define the patterns of MC use among oncology patients as well as efficacy and safety of MC. Methods: Cancer patients attending oncology office visits at Beaumont Hospital, Michigan from July – Dec 2018 were anonymously surveyed. The survey included data regarding demographics, diagnosis, treatment, symptom burden, and MC use. Patients who reported MC since their cancer diagnosis completed a section on patterns of use, efficacy, and safety. Results: Response rate was 188 of 327 (57.1%). Ages ranged from 18 to > 71, 59% were 61 or older. Early stage solid malignancy was 38%, metastatic was 41%, and hematologic malignancy was 21%. Cancer treatment was active in 80%. MC use was reported in 46 of 188 (24.5%). Median composite baseline symptom score ranging from 8 (best) to 32 (worst) was higher in patients using MC vs non-users; 17.5 vs 14.4 (p < 0.001). Pain was the symptom with the highest frequency of improvement 34/42 (81%), followed by appetite 34/44 (77%), and anxiety 32/44 (73%). MC improved ability to tolerate treatment in 24/44 (54%). The most frequent adverse effects were cloudy thinking 7/42 (17%), and decreased energy 4/41 (10%) Use of cannabis prior to cancer had no impact on median composite efficacy score (p = 0.43). Age > 61 was not associated with higher toxicity (p = 0.077). Conclusions: This data confirms MC is being utilized by a significant portion of cancer patients, across age, diagnosis, stage, and treatment. Patients with a higher severity of baseline symptoms are more likely to use MC, and report a favorable efficacy profile of MC with no increased risk of adverse effects in older population and similar efficacy in novel MC users. Minimal toxicity was reported in this cohort. Prospective studies are needed to define the efficacy and safety of MC. [Table: see text]
Randomized phase II study comparing mannitol with furosemide for the prevention of cisplatin-induced renal toxicity in advanced non-small cell lung cancer: The OLCSG1406 trial.
Authors: Makimoto Go , Hotta Katsuyuki , Oze Isao , Ninomiya Kiichiro , Ninomiya Takashi , Kubo Toshio , Ohashi Kadoaki , Ichihara Eiki , Rai Kammei , Tabata Masahiro , Maeda Yoshinobu , Kiura Katsuyuki
Published: May 2019

e23105

Background: Although cisplatin-based chemotherapy has been the mainstay in the treatment of advanced non-small cell lung cancer (NSCLC), it is still controversial as to whether furosemide (FUR) or mannitol (MAN) is better as a forced diuresis for avoiding cisplatin-induced nephrotoxicity. We conducted a randomized phase II trial to clarify this issue in candidates. Methods: Those with advanced NSCLC, suitable for receiving cisplatin-based chemotherapy with an adequate renal function were randomly assigned either to the FUR arm or the MAN arm. Either of forced diuretics was administered with an appropriate hydration in cisplatin administration. The primary endpoint of the study was a proportion of ≥ grade 1 serum Creatinine (Cr) elevation in the first cycle, defined by the CTCAE v4.0. Results: The trial was terminated early with 44 (FUR arm; 22 and MAN arm; 22) of the planned 66 patients because of slow accrual. The patient demographics are listed in Table1. In the first cycle, 2 (9%) and 4 patients (18%) developed grade 1 Cr elevation, respectively (P = 0.33), despite no ≥ grade 2 toxicity. The median time to develop the worst Cr score was 29 (range: 26-31) and 12 (range: 8-28) days, respectively. All patients recovered within 3 to 330 days, respectively. Cisplatin induced grade 3 emesis was observed in 3 patients (14%) in MAN arm, whilst none developed in FUR arm. No treatment related deaths were observed. Conclusions: In this setting, the preventive effect of the two types of forced diuretics on cisplatin-induced renal toxicity was not significantly different. Clinical trial information: UMIN000015293. [Table: see text]
Impact of high-dose vitamin d supplementation on short physical performance battery and bioelectrical impedance analysis in older patients with prostate cancer on ADT.
Authors: Inglis Julia Ellen , Culakova Eva , Dunne Richard Francis , Janelsins Michelle Christine , Lin Po-Ju , Mustian Karen Michelle , Peppone Luke Joseph
Published: May 2019

e23106

Background: Androgen deprivation therapy (ADT) is standard treatment for prostate cancer but may cause changes in body composition that lead to decreased physical function. Low vitamin D status is also associated with decreased functionality. The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating functionality. The bioelectrical impedance analysis (BIA) is a portable tool for assessing lean mass and phase angle, a measure of nutrition status and frailty in chronic disease. Methods: This was a secondary analysis of a randomized controlled trial to assess the impact of high dose vitamin D in older patients (≥60 yrs) with prostate cancer on ADT. Patients with prostate cancer (N = 59, age 67.6 ± 5.4) with vitamin D insufficiency ( < 32 ng/ml) were randomized to high-dose vitamin D (n = 29, 600 IU/daily plus 50,000 IU/weekly) or low-dose vitamin D (n = 30, 600 IU/daily plus placebo weekly) for 24 weeks. SPPB tests and BIA were assessed at baseline, 12 weeks and 24 weeks. Phase angle values were calculated using atan(reactance/resistance) x (180°/π). A phase angle value < 5.7° is a valid cutoff for frailty in older men. Results: Serum analyses showed compliance with vitamin D intake (25-OH vitamin D change: high vitamin D = +32.0 ng/ml vs low dose RDA vitamin D = +4.3 ng/ml; p < .01). There were no difference at all three assessments for SPPB or lean mass between arms. The high-dose vitamin D group had wider phase angle values at 12 weeks (5.81º vs. 5.32º; p = .018) and 24 weeks (5.89º vs. 5.40º; p = .030). The low-dose group had phase angle values < 5.7º over the course of the study. At baseline, over 18% of patients had phase angle values below the 10th percentile of the general population matched on age and BMI. As vitamin D levels increased throughout the study, fewer patients fell below the 10th percentile. Conclusions: The high-dose vitamin D group maintained wider phase angle values over 24 weeks, while phase angle for the low-dose group decreased from baseline. High-dose vitamin D supplementation may impact factors related to phase angle and frailty in patients receiving ADT. Funding: NCI UGCA189961, R21CA175793, K07CA168911, and GR501293.
Ondansetron versus palonosetron as a marker of non-adherence to antiemetic prophylaxis guidelines in highly emetogenic chemotherapy.
Authors: Roeland Eric , Ruddy Kathryn Jean , LeBlanc Thomas William , Clark-Snow Rebecca Anne , Wickham Rita S. , Binder Gary , Sebastiani Silvia , Potluri Ravi C. , Papademetriou Eros , Schmerold Luke M. , Navari Rudolph M.
Published: May 2019

e23108

Background: ASCO antiemetic guidelines recommend upfront triple prophylaxis (NK1 receptor antagonist (RA) + 5HT3 RA + dexamethasone) for patients receiving highly emetogenic chemotherapy (HEC). Physicians exhibit high variation in HEC guideline adherence, principally involving inclusion of NK1 RA. Whether adherence is associated with selection of the specific 5HT3 RA agent remains inadequately studied. Methods: In the IBM Explorys electronic health record database, we used procedure and diagnosis codes to identify HEC courses and related nausea/vomiting (NV) from 2012 to 2018. We defined HEC guideline adherence as triple prophylaxis at chemotherapy initiation. We assigned HEC courses for ≥ 7 day cycles of cisplatin or anthracycline + cyclophosphamide (AC), or carboplatin (≥ 14 day cycles as a proxy for AUC ≥ 4) to prescribing oncologists based on encounter frequency. We categorized 5HT3 RA use of each physician treating ≥ 5 HEC courses based on their most commonly used 5HT3 and performed descriptive statistics. Results: Of 12,262 HEC courses, 57% involved physicians having greater use of ondansetron (OND) (mean OND to palonosetron (PALO) ratio of 3.9:1). These courses had lower guideline adherence (due to NK1 RA omission) and higher rates of NV for combined HEC, AC, and carboplatin. NV rates for cisplatin did not vary by 5HT3 agent used. Courses involving physicians with greater PALO use (mean OND:PALO ratio of 0.2:1) had superior adherence and NV rates, despite involving a slightly higher risk population (younger and/or female). Conclusions: According to HEC antiemetic guidelines, NK1 RA use should occur independent of 5HT3 RA agent selection. However, we observed less NK1 RA use where OND was preferred, which may have caused the observed higher rates of NV with OND. Further evaluation should assess whether pharmacy cost minimization is a driver of both OND preference and NK1 omission in HEC. [Table: see text]
Knowledge, attitude and practices regarding use of medical cannabis: A national survey among israeli oncologists.
Authors: Mirelman Dan , Waissengrin Barliz , Goldway Noam , Wolf Ido
Published: May 2019

e23110

Background: Despite lack of clinical trials reporting on beneficial effects of the cannabis plant for cancer-associated symptoms, its use is increasing worldwide. Approximately 10,000 Israeli cancer patients receive permits for the use of medical cannabis, making cannabis one of the most commonly prescribed oncology treatments in Israel and making the Israeli oncologists highly experienced with its use. The experience gained by the Israeli oncologists is therefore highly valuable. Materials and Methods: We conducted a web-based survey among all 238 Israeli oncologists, addressing personal experience; knowledge and attitudes toward the use of cannabis in oncology. Results: Response rate was 54% (n = 126), with the vast majority (87%) regularly prescribing cannabis to their patients. Anorexia, pain and nausea were the most common indications for cannabis use. While 90% of responders stated lack of sufficient knowledge regarding cannabis, its use was perceived as effective and safe. Interestingly, while most oncologists stated that opioids should be used as a first line treatment for cancer pain, most would prefer cannabis for pain relief if needed by a close relative. Oncologists who support cannabis legalization were more likely to prescribe it. Conclusions: Our findings indicate extensive use and perception of efficacy despite lack of knowledge, and indicate unique role for moral attitudes affecting clinical decisions. These data call for the implementation of an educational program and practical guidelines enabling more consistent and rational approach toward cannabis role in oncology.
Use of remote symptom monitoring with breast cancer survivors using patient-reported outcome (PRO) measures in MyChart.
Authors: Terstriep Shelby A. , Wacker James , Quinlan Charissa , Pochardt Kiara , Basch Ethan M.
Published: May 2019

e23125

Background: Electronic patient-reported outcome monitoring has been found to improve quality of life and overall survival when used with metastatic cancer patients during treatment (Basch, et al., 2017). There has been limited data on using PROs to enhance clinical outcomes in cancer survivorship. This pilot study of breast cancer survivors assessed utilization and satisfaction of electronic proactive symptom and adherence monitoring. Methods: Eighty breast cancer survivors who had completed surgery, chemotherapy, and/or radiation and had received their survivorship care plan were randomized to either usual care or to the PRO monitoring group. The PRO group received questions from the NIH PROMIS toolkit through their patient portal (EPIC) monthly for 6 months. The triage nurse received an alert if the survivor reported on the questionnaire that they had moderate to severe symptoms, had not taken their medication, or would like to speak to a nurse. Participants in the control arm were assessed for sadness, anxiety and satisfaction with provider communication at their usual follow-up visits. Results: Response rates for surveys ranged from 47to 75%. Patients in the PRO monitoring group exhibited no difference in satisfaction at 3 months but had significantly higher scores at 6 months for communication (P=0.005) and monitoring (P= 0.002). Anxiety scores were not significantly different among the usual care group versus the frequent remote monitoring group. Conclusions: Electronic PROs monitoring between clinic visits improved satisfaction with communication and follow-up without increasing anxiety in breast cancer survivors. The pilot data indicate continued development of efficient PROs monitoring can be an important tool to transform the survivorship care plan from a document to an active process of proactively monitoring symptoms and adherence. Support: UG1CA189823. Reference: Basch, E., Deal, A. M., Dueck, A.C., et al. (2017). Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. Jama, 318 (2), 197. Study Number: A23_Pilot2
Assessing quality of life (QoL) of patients and their caregivers on phase I clinical trials.
Authors: Chan Gloria HJ , Fransiska Diana , Chee Cheng Ean
Published: May 2019

e23130

Background: Patients on Phase I trials help advance science through their participation but there is a paucity of data regarding QoL of patients and their caregivers. Methods: Phase I trial patients from a single Asian centre were assessed at baseline and at 3 time intervals after treatment initiation with EORTC-core (QLQ-C30) and Comprehensive Score for Financial Toxicity (COST) questionnaires. Caregivers’ QoL were assessed with Zarit-Burden Interview (ZBI). Paired-sample t-tests were used to test for QoL differences at different time intervals. Results: 35 patients have been recruited with 70 individual visits so far. 60% of patients were female, 74% were Chinese. The most common cancer types were gastrointestinal (51.5%) and gynaecological (25.7%). Patients had a median of 3 lines of prior treatment (range: 0-9). QLQ-C30 scores range from 0 to 100, higher scores represent a high level of QoL/functioning. At baseline, the mean global QoL score was 51.9 (range: 16.7-100). The mean physical, role, cognitive, emotional and social functioning scores (FS) were 74.1 64.7, 86.6, 78.8 and 69.5 respectively. Patients were most bothered by fatigue and pain. 65.7% experienced grade 1 or 2 financial toxicities based on COST. There were significant improvements in physical (14.5 +/- 16.7, p < 0.001), cognitive (18.1 +/- 25.0, p = 0.002) and emotional (10.5 +/- 18.4, p = 0.012) FS at baseline and 1-month post treatment. Patients experienced a reduction in fatigue, but no change in pain or financial concerns. Only 28.6% of patients were referred to palliative care medicine. Of 19 caregivers surveyed with ZBI, 10 experienced little/no burden, 8 had mild-moderate levels of burden and 1 reported severe burden. Conclusions: This is the first Asian study reporting QoL of cancer patients and their caregivers in Phase I clinical trials. In this group of heavily pre-treated patients, Phase I options can result in QoL improvement. Two-thirds of caregivers had minimal burden. Identifying QoL issues of patients and their caregivers will improve supportive care rendered to them.
Predictors of anxiety and depression risk among individuals with lung cancer.
Authors: Stein Kevin , McManus Shauna , Gardan Pierre M. , Olson Julie S. , Miller Melissa F. , Clark Kelly , House Linda S. , Zaleta Alexandra Katherine
Published: May 2019

e23136

Background: Lung cancer (LC) patients can face long-term symptom burden, quality of life concerns, and enduring distress. This study explored predictors of psychosocial distress among a community-based sample of LC survivors. Methods: 208 individuals with LC enrolled in Cancer Support Community’s Cancer Experience Registry, provided demographic/clinical background, and reported cancer-related distress using CancerSupportSource, a 25-item tool measuring level of concern ( 0-4) over 5 domains: emotional well-being (including 2-item depression and 2-item anxiety risk screening subscales), symptom burden and impact, body image and healthy lifestyle, health care team communication (HCTC), and relationships and intimacy. Using logistic regression, we estimate which domains influence anxiety and depression risk, controlling for significant demographic/clinical variables. Results: Participants were 68% female, 83% non-Hispanic White; mean ( SD) age = 61 (11) years; mean ( SD) years since diagnosis = 3.1 (4.5); 86% non-small cell lung cancer (NSCLC); 43% ever diagnosed as metastatic. 52% underwent surgery; 76% received chemotherapy, 65% radiation. 53% were at risk for clinically significant anxiety; 42% for clinically significant depression. Concerns about relationships and intimacy were associated with greater odds of anxiety risk ( OR= 1.70; p< .01); a positive interaction suggested that anxiety risk among individuals with NSCLC varied by HCTC concerns, with greater concerns being associated with higher risk ( p< .05). Concerns about symptom burden and impact ( OR= 1.21; p< .01) and HCTC ( OR= 1.57; p< .05) were significantly associated with greater odds of depression risk; these associations did not vary by LC type. Conclusions: Concerns around health care team communication, relationships and intimacy, and symptom burden and impact are important considerations in understanding risk for anxiety and depression among lung cancer patients and survivors. Additionally, type of lung cancer (NSCLC) can moderate the degree to which concerns about HCTC are associated with risk. Findings highlight the need for constructive patient-provider communication, particularly around relationships and intimacy and symptom burden. Clinical trial information: NCT02333604.
The ESCAPADE Study: Early supportive care for advanced cancer patients, assessing care delivery and provider engagement.
Authors: Levine Oren Hannun , Bainbridge Daryl , Pond Gregory Russell , Slaven Marissa , Dhesy-Thind Sukhbinder K. , Sussman Jonathan , Meyer Ralph M.
Published: May 2019

e23142

Background: Advanced cancer patients benefit from early integration of palliative care (EIPC) with usual care. A proposed model of EIPC reserves specialized palliative care (SPC) for complex patients, while primary care providers (PCP) and oncologists oversee basic palliative care (PC). We studied the attitudes among patients and their healthcare providers regarding delivery of EIPC. Methods: A cross-sectional study at a tertiary cancer centre in Ontario. Patients with newly diagnosed incurable gastrointestinal (GI) cancer were surveyed using a study specific instrument for the outcomes of interest: importance of and preferences for accessing support across 8 domains of PC (disease management, physical, psychological, social, spiritual, practical, end of life care, loss and grief). Healthcare providers within the circle of care completed a parallel survey for each recruited patient. Primary analysis involved use of descriptive statistics to summarize survey results and concordance between patient and provider responses. Results: From Oct 2017 - Nov 2018, 67 patients were surveyed (median age 69, 34% female). 90% had an identified medical oncologist, and 19% had SPC. 97% had a PCP, but only 42% listed a PCP as part of the care team. Median time from first oncology assessment for advanced cancer to patient survey completion was 52.5 days. 85 providers responded (oncologist = 59, PCP = 20, SPC = 6; response rate 92%; 1-3 physician responses per patient). Disease management and physical concerns were most important to patients. In these domains, 67% and 81% of patients endorsed receiving care from the preferred provider, but concordance between patient and physician responses regarding most responsible provider was only 58% and 38%. For all other domains, 87 – 100% of patients attributed primary responsibility to self or family rather than any healthcare provider. Conclusions: Respondents did not assign responsibility to physicians early in the disease trajectory for many domains of PC. Our findings suggest that incorporating patient activation and empowerment into EIPC requires further study. PCPs appeared to have limited involvement in PC for newly diagnosed advanced GI cancer patients.