bluuebunny/crossref_metadata_2025 huggingface dataset:
The effects of dexamethasone and placebo on symptom clusters in advanced cancer patients: A preliminary report.
Authors: Yennu Sriram , Williams Janet L. , Chisholm Gary B. , Bruera Eduardo
Published: February 2017

187

Background: Advanced cancer patients frequently experience debilitating symptoms that occur in clusters, but few pharmacological studies have targeted symptom clusters. Our objective was to examine the effects of dexamethasone on symptom clusters. Methods: Secondary analysis of a recent RCT of dexamethasone (DEX) vs placebo (PL) on cancer symptoms as assessed by FACIT-F-Fatigue; FAACT-Anorexia-Cachexia; BPI - Pain; HADS- Anxiety-Depression; ESAS: Sleep, Drowsiness, Dyspnea. Symptom clusters were identified based on baseline symptoms [ESAS] using principal component analysis. Cluster scores were computed by adding each scale divided by the maximum value for the scale: Fatigue- Anorexia-Depression = (Fatigue /52 + Anorexia/48+ HADS-Depression/21); Sleep-Anxiety-Drowsiness = (Sleep/10+HADS-Anxiety/21+Drowsiness /10); Pain-Dyspnea = (BPI/10 +Dyspnea /10). Higher number indicates better QOL. Correlations and change in the severity of symptom clusters were analyzed. Results: In 114 evaluable patients, 3 clusters accounted for 63% of the total variance at baseline: Fatigue-anorexia/cachexia-depression cluster (FAD); sleep-anxiety-drowsiness cluster (SAD) and Pain-Dyspnea cluster (PD). Median (IQR) improvement in the FAD cluster at Day 15 and Day 8 was significantly higher in the DEX than in the PL group [0.22 (-0.04, 0.45) vs. 0.06 (-.30, .20), P = 0.016)] and [0.15 (-0.84, 0.35) vs-0.095 (-0.35, 0.16), p = 0.017] respectively. There was no significant change observed in SAD and PD after DEX. Median (IQR) scores for FAD and PD of the DEX group at baseline, day 8, and day 15 were 1.42(1.1,1.7),1.71(1.3,2.1),1.78(1.4,2.2); [1.1(0.8,1.4); 1.38(.04,1.6); 1.43(1.3,1.7) respectively and significantly correlated over time at Day 8 (r = 0.76; p < 0.001) Day 15 (r = 0.55;p < 0.001) [FAD]; Day 8 (r = 0.36; p < 0.001) Day 15 (r = 0.45; p < 0.001) [PD]. Conclusions: FAD cluster showed improvement with dexamethasone and consistent correlation overtime, as compared to SAD and PD cluster. These findings suggest that fatigue-anorexia/cachexia- and depression share a common a common pathophysiologic basis. Further studies are needed to investigate this cluster and target anti-inflammatory therapies. Clinical trial information: NCT00489307.
Impact of opioid use on survival in patients with newly diagnosed stage IV non-hematologic malignancies.
Authors: Zylla Dylan Michael , Richter Sara , Shapiro Alice C. , Gupta Pankaj
Published: February 2017

188

Background: Pain is a challenging problem in patients with advanced cancers. Opioids are commonly required to treat cancer-related pain, but may be associated with tumor progression and shorter survival. We recently reported that high opioid use during the first 90 days after diagnosis is associated with shorter survival in patients with advanced lung cancer. Methods: We identified 1386 newly diagnosed stage IV non-hematologic malignancies from 2005-2013 and gathered pain and opioid utilization within 90 days of treatment using data from electronic medical records and the tumor registry. Opioid utilization was stratified into low opioid exposure (LOE; no opioid prescriptions or one prescription for a short-acting opioid) and high opioid exposure (HOE; any long-acting opioid prescription or 2 or more short-acting opioid prescriptions). Pain was analyzed by the proportion of time patients reported levels of moderate-severe pain (i.e., pain level ≥ 4). The effects of opioid exposure, prognosis of tumor type ( < 1 year vs ≥ 1 year), and gender on overall survival were analyzed in univariable and multivariable models. Results: Patients in the HOE (n = 887) and LOE (n = 499) groups were well matched for age, gender, and tumor type. Moderate-severe pain was higher in the HOE group compared to the LOE group (29.3% vs 14.0%). HOE was associated with shorter median survival compared to LOE (7.2 vs 13.2 months, p-value < 0.0001). On multivariable analysis, HOE was associated with shorter overall survival after adjusting for age, gender and tumor prognosis (HR 1.4, 95% CI 1.2- 1.6) (Table). Conclusions: Results support prior studies of advanced prostate and lung cancers, and show early utilization of opioids is a strong prognostic factor for survival. Further prospective investigation on the role of opioid receptors and opioid utilization is urgently needed. [Table: see text]
Outcomes of hypofractionated palliative radiotherapy for choroidal metastases.
Authors: Hahn Ezra , Velazquez-Martin Juan Pablo , Somani Sohel , Salazar Pedro , Domville Daniela , Payne David , Xu Wei , Su Jie , Pavlin Charles , Simpson Rand , Laperriere Normand , Krema Hatem , Waldron John N. , Chung Caroline
Published: February 2017

194

Background: External beam radiotherapy (RT) is an effective palliative treatment for choroidal metastases aimed at preserving vision and obtaining local tumor control. Delivery of 30-40 Gy in 2 Gy daily fractions is a standard approach in many centers. At our center, a shorter, more convenient schedule of 20 Gy in 5 fractions has been used in this palliative setting. This study reports the efficacy and toxicity of this hypofractionated RT approach. Methods: We conducted a retrospective review of patients treated in the Ocular Oncology clinic at Princess Margaret Cancer Center who received RT (20 Gy in 5 fractions) for choroidal metastases between January 1, 1999 and November 30, 2012. Primary outcome measures were change in visual acuity and tumor response. Secondary outcomes included toxicities of RT, tumor control, and overall survival from the date of choroidal metastases diagnosis. Results: A total of 55 patients with 71 involved eyes were included. Decreased vision was the presenting symptom in 43 eyes (61%). Visual acuity improved from a median of 20/70 to 20/40 between baseline assessment and last follow-up, and remained stable or improved in 56 eyes (80%). On ultrasound, tumor regression was observed in 64 eyes (91%) with complete response in 47 eyes (67%). Metastases progressed in 4 eyes (6%) despite RT with 1 eye requiring enucleation. Median survival after diagnosis of choroidal metastases was 13 months with estimated overall survival at 1, 2, and 3 years to be 50% (36-62), 23% (12-35), and 8% (3-18), respectively. Forty-nine patients (89%) did not experience any acute complications. Mild acute toxicities included transitory dryness in 5 patients and episcleritis in 1 patient. Cataracts developed in 4 eyes (6%), retinopathy in 1 eye, optic neuropathy in 7 eyes (10%), pigmentary maculopathy in 5 eyes (7%), and neovascular glaucoma in 1 eye. Conclusions: A short fractionation schedule of 20 Gy in 5 fractions is a well-tolerated treatment that effectively preserves vision and gains local tumor control for many patients with choroidal metastases. This hypofractionated approach would help reduce the burden of a longer treatment course in this palliative patient population.
Anticipating the needs of the neuro-oncology caregiver.
Authors: Page Margaretta S , Molina Idonah , Patt Judy , Chang Susan M
Published: February 2017

228

Background: It is well documented that CGs of neuro-oncology patients have complex needs that vary across the disease trajectory. It has also been suggested that needs vary by individual and further work to better understand the expectations of support, as well as the timing and nature of support is needed. Methods: In September 2013, the UCSF Neuro-Oncology Division launched a program to specifically provide care to CGs. We focused initial efforts on the needs of CGs of patients with newly diagnosed glioblastoma (NDGBM) who were offered services over the first 4 months of the illness. For high risk (HR) patients characterized either at the time of progression or transition to hospice, CGs were offered services as much as needed after referral. The needs assessment spanned several domains. We report on the first 18 months of providing care to these two groups of CGs. Results: Of 65 CGs of NDGBM patients, 21% identified no needs, and of those that did, 52% had more than one need. 82% of 144 CGs of HR patients had multiple needs. Both groups had highest needs around emotional support and advocacy, with the HR CGs expressing significant higher need for emotional support at 80%. HR CGs had higher percentage of needs when compared to the NDGBM CGs around obtaining caregiver resources ( 42% vs. 28%), family relations (30% vs. 11 %), health care navigation and obtaining psychological services (26% vs. 6 %), and health information (21% vs. 8%). Conclusions: CGs express the need for increasingly complex support as the illness progresses with a differential demand compared to the time of initial diagnosis. This suggests that developing specific modules of care for high demand needs throughout the trajectory of the illness will improve the QOL of CGs of neuro-oncology patients.
Value of help from someone who's been there.
Authors: Schultz Debbie McCally , French Susan Penn
Published: February 2017

241

Background: Cancer patients want to speak with someone who has their diagnosis, treatment or experience; but speaking with someone before an ostomy surgery, pelvic extenteration or the Whipple procedure, etc. can be particularly helpful due to the increased anxiety related to these and other serious procedures. A custom peer mentoring program by the cancer center for diagnosis or serious treatment purposes is optimal. Clinicians and patients want the service and attest to the importance of a one-on-one support connection. Methods: Steps were taken to partner with clinicians feeling peer support would be important to their patient. They want to make the best connection possible in a timely manner. Clinicians worked with the psychosocial program offering support to customize the connection so it would match the patient’s next treatment step. Peer mentors were recruited and trained to deliver a motivational interview style of approach in speaking with others who have the same cancer treatment experience. Mentors share resiliency tips they have developed or have found helpful. Results: MD Anderson Cancer Center’s Volunteer Services department offers a One-on-One support program of trained survivor volunteers available to support other survivors. The program has become a valued psychosocial offering by the MD Anderson. The clinicians and Volunteer Services staff team together to create a specific type of peer mentoring for a serious treatment or procedure or diagnosis. The volunteer staff department administers the One-on-One support program by recruiting, training and making available the connections when requested by clinician or patient. Currently, there are 1912 active survivor volunteers in the One-on-One support database. 2370 connections were made in FY14 and 1596 connections to date in FY15. Conclusions: Patients get support from survivors who have had the same experience at a time when their anxiety may be highest. Survivors who have lived through the same serious treatment and are hopeful and resilient after the procedures make the patient feel less isolated, frightened and supported by others. Caregivers, who often have more anxiety than the patient, welcome the support for their loved one.
Racial differences in suicide deaths after cancer diagnosis: A SEER-based analysis of 2,336,949 patients.
Authors: Chen Yu-Wei , Wu Chao-Ping , Chiu Yu-Han , Chang Angela Y. , Chen Chen-Hao , Feng Yen-Chen , Lin Sheng-Hsuan , Sheu Yi-Han , Lin Yen-Feng
Published: February 2017

244

Background: Risk of suicide is increased after cancer diagnosis. Our study aims to investigate the racial differences on risk of suicide after cancer diagnosis in a nationwide cohort of U.S. patients. Methods: Patients ≥ 18 years and diagnosed with breast (n = 616,099; 26.4%), lung (n = 585,978; 25.0%), colorectal (n = 429,060; 18.4%), or prostate cancer (n = 705,812; 30.2%) from 1988-2010 in Surveillance, Epidemiology and End Results Program (SEER) were identified. A Cox-proportional hazard model was used to compare the suicide mortality of the races (Hispanic white, African American, Asian/Pacific Islander, American Indian/Alaska Native) to non-Hispanic white patients adjusting for age, sex, marital status, household income, education level and cancer sites. Results: A total of 2,336,949 patients were identified, and there were 3,406 suicide death events. Fifty percent of suicide deaths were within 32 months after cancer diagnosis (interquartile range: 66 months). After a median follow-up of 49 months, the suicide mortality was lower in African American (HR: 0.29, 95% CI: 0.25-0.35, p value <.0001), Hispanic white (HR: 0.49, 95% CI: 0.41-0.58, p value <.0001), Asian/Pacific Islander (HR: 0.67, 95% CI: 0.57-0.79, p value<.0001). The suicide mortality was the same comparing American Indian/Alaska Native to non-Hispanic white patients (HR: 1.01, 95% CI: 0.62-1.65, p value: 0.97). Conclusions: After adjusting for sociodemographic factors, non-Hispanic white cancer patients still had higher risk of suicide death after cancer diagnosis. Future studies should address the racial differences of psychological stress after cancer diagnosis. [Table: see text]
Empowering bereaved parents in the development of a comprehensive bereavement program.
Authors: Snaman Jennifer Malia , Phillips Charlene , Levine Deena R. , Baker Justin N.
Published: February 2017

47

Background: The death of a child poses special challenges to both bereaved families and staff. Each individual's grief journey is unique and ongoing; however, common themes and support systems help to define successful bereavement services. Bereaved parents who have experienced the loss of a child have special insight and can help to identify the key components necessary for the development and implementation of a comprehensive bereavement program. Methods: The bereavement program at St. Jude Children’s Research Hospital is multifactorial and involves both supportive services and useful resources that have been developed by parents who have lost a child to cancer at our institution. Results: The program begins with anticipatory bereavement services prior to death by the bereavement coordinator and Palliative Care team. Following the child’s death, a bereaved parent mentor is offered and available. These mentors have been trained how to identity and triage abnormal or concerning behaviors and how to obtain additional psychosocial support for at risk families. The materials include a parent-created a resource manual with parent and sibling with recommended books, websites, and other helpful references. Parents developed a booklet containing reflective pieces and several videos describing difficult moments in their grief journey to provide a support to other parents, siblings, and staff. Finally, they designed and illustrated communication cards to be sent to all bereaved families at key time points during the first two years following a child’s death. Conclusions: The innovative nature of this program with multiple components of the parent-driven comprehensive bereavement program can serve as a paradigm for the development of others programs and for the field of hospice and palliative medicine as a whole.
Family caregiver grief and depression outcomes from the ENABLE III randomized controlled trial.
Authors: Dionne-Odom J Nicholas , Azuero Andres , Lyons Kathleen , Hull Jay , Tosteson Tor , Li Zhongze , Bakitas Marie
Published: February 2017

48

Background: Little is known whether early palliative care (PC) support for family caregivers (FCGs) impacts grief and depression after care recipients die. We conducted a randomized controlled trial (RCT) of a nurse-led, phone-based concurrent PC intervention for FCGs delivered at the time of care recipients’ advanced cancer diagnosis (early group) or 12 weeks later (delayed group). We hypothesized that grief and depression scores would be lower for early compared to delayed group FCGs. Methods: Early vs. delayed RCT (10/2010-9/2013) of 123 FCGs of community dwelling persons with advanced cancer in a rural, New Hampshire NCI-designated comprehensive cancer center and affiliated outreach clinics and a Vermont VA medical center receiving a multicomponent intervention (ENABLE [Educate, Nurture, Advise, Before Life Ends]) consisting of 3 weekly sessions, monthly follow-up, and a bereavement call. FCGs of persons dying during the study period completed the Center for Epidemiological Study-Depression scale (CESD) and the Prigerson Inventory of Complicated Grief-Short Form (PG13) 8-12 weeks after care recipients’ deaths. Generalized estimating equations were used to compute group means, standard deviations, and between-group effect size differences. Results: For care recipients who died (n = 70), 44 FCGs (early: n = 19; delayed: n = 25) completed after-death questionnaires. Mean depression scores (CESD) for the early group was 14.6 (SD = 10.7) and for the delayed group was 17.6 (SD = 11.8). Mean grief scores (PG13) for the early group was 22.7 (SD = 4.9) and for the delayed group was 24.9 (SD = 6.9). Between-group effect size differences were not statistically significant (CESD: d = -.27, p = .38; PG13: d = -.36, p = .24). Conclusions: Though statistically insignificant, the magnitude of the observed between-group differences for depression was small and for grief was medium. Considering the small sample size and the delayed group’s mean depression score surpassing the clinical cutoff (CESD score > 16), the clinical relevance of these findings cannot be ruled out. Future upstream FCG PC interventions initiated long before end of life should continue to examine intervention effects on FCG after-death outcomes. Clinical trial information: NCT01245621.
Differences in palliative care needs among cancer survivors in an inner city academic facility versus a suburban community facility.
Authors: Lutz Alison , Regn Rachel , Robinson William , Robinson William R.
Published: February 2017

61

Background: To determine differences in palliative care (PC) needs in newly diagnosed cancer patients from an inner-city academic facility compared to a suburban, community facility. Also, to identify ways to improve PC for cancer patients in these locations. Methods: 270 subjects with cancer were prospectively identified, 85 from an inner city academic facility (Site A), and 185 from a suburban community facility in the same metropolitan area. (Site B) All patients received treatment from board-certified oncologists. Master’s level Social Workers asked all subjects to complete a standardized, validated questionnaire to determine their palliative care needs prior to treatment. Completed questionnaires were collected and data was depersonalized and analyzed by the authors. Statistical differences were assessed using standard methods. Results: Site A patients were younger (56.3 vs 61.5years) less likely to be caucasian (35/85, 41.2% vs 114/185, 61.6%) and less likely to have private insurance (28/85, 32.9% vs 187/185, 47%). Site B patients were more likely to express a fear of pain, (112/185, 60.5% vs 28/85,32.9%) dying, (112/185, 60.5% vs 18/85, 21.2%) being alone, (112/185(60.5% vs 15/85, 17.7%) or nausea (117/185, 63.2% vs 10/85, 11.8%). Site A patients were more likely to express fear of not having transportation, (35/85, 41.2% vs 42/185, 22.1%) inability to pay for prescriptions, (28/85, 32.9% vs 40/185, 21.6%) or child care (13/85, 15.3% vs 9/185, 4.9%). All differences were significant at a p < 0.05. Conclusions: There are major differences in the PC needs of patients presenting to an inner-city academic vs suburban community facility. To be most effective, PC programs must be tailored to the community. Interventions proposed for the suburban community facility include early access to: 1) grief counseling, 2) support groups, 3) Nurse-Navigators. Interventions proposed for the inner city academic facility include early access to: 1) Medication cost assistance programs (local philanthropies, facility-based pharmacy discounts) 2) travel services (cab vouchers, coordination with public transportation schedules) 3) on-site child care facilities.
An international collaborative design of clinical nursing practice guidelines for patients with cholangiocarcinoma.
Authors: Acquisto Susan , Iyer Renuka V. , Driskill Karen M , Pinheiro Natasha , Weatherly Jacqueline , Musto Kaitlyn R , Lowitzer Heidi , McCallum Lynne , Drapek Lorraine
Published: February 2017

65

Background: Cholangiocarcinoma (CC) accounts for approximately 3% of all gastrointestinal cancers and have a poor incident to mortality rate. The incidence in the United States (US) is 2,000-3,000 cases annually, with this rate steadily increasing during the last twenty years; this trend is not solely observed in US but also seen in Europe, Australia and Japan. The highest incidence is seen in Southeast Asia due to parasitic infection. CC presents many challenges to healthcare professionals due to the anatomic nature of CC (Lowe et al, 2015). The worldwide increase in incidence of CC is indication for the essential development of nursing practice guidelines underpinned by expert evidence and knowledge and regarding the key aspects of care. Methods: A collaboration of nursing professionals representing major cancer research institutions from around the country and the United Kingdom worked together to identify key aspects of care, the aim being to develop Clinical Nursing Practice Guidelines. The process included an exhaustive literature review using Pubmed, Uptodate, Medline, and CINAHL databases; submission of respective institutional practices; group consensus on guideline content, evidence-based scoring assignment and approval by the Cholangiocarcinoma Medical Advisory Board. Results: The guidelines developed include the care of the patient: (1) with external biliary drains and internal bile duct stents, (2) with intractable nausea and vomiting resulting from disease process, (3) with fatigue resulting from disease process, (4) undergoing chemotherapy, (5) undergoing photon radiation, (6) undergoing radiation on a clinical trial, and (7) preparing for liver transplantation. The purpose of the guidelines are to advance the scientific knowledge of the symptoms experienced, quality of life of patients with CCA, establish standards in patient care, and improve quality of care and satisfaction for patients diagnosed with CC. Conclusions: Creation of evidence-based guidelines will provide a springboard for expanded competent knowledge and a model to test for improvement in the care and quality of life of the patient with CC.
A randomized controlled trial of a cardiopulmonary resuscitation (CPR) video decision support tool for seriously ill hospitalized patients with advanced cancer.
Authors: El-Jawahri Areej , Temel Jennifer S. , Ramchandran Kavitha , Jackson Vicki A. , Chang Yuchiao , Walker-Corkery Elizabeth , Mann Eileen , Volandes Angelo E.
Published: February 2017

7

Background: Discussing CPR preferences with patients with advanced cancer who are hospitalized is a critical component of end-of-life decision making. However, these discussions are challenging and often avoided by clinicians. We examined the impact of a CPR video decision tool on patients’ choices and knowledge about CPR, and their comfort with watching the video. Methods: We conducted a multi-center randomized controlled trial of 116 patients with advanced cancer hospitalized at two academic oncology centers. We randomized patients to either a 3-minute video describing CPR (n = 52) or standard-oncology care (n = 64). The primary outcome was participants’ preferences for CPR (immediately after viewing the video in the intervention arm). Secondary outcomes included patients’ knowledge (using 5-item questionnaire with higher score reflects greater knowledge), and intervention participants’ comfort with watching the video. Results: The mean age was 66 years (SD = 12); 50% were women, 84% were white, and 48% had lung or gastrointestinal cancer. Only 47% of study participants reported having a discussion about their CPR preferences at the time of admission to the hospital. At baseline, there were no differences in patients’ preferences for not wanting CPR between the intervention and control arms (63% vs. 58%, P = 0.79). After the intervention, participants randomized to the video were more likely not to want CPR (81% vs. 58%, P = 0.03) and were more knowledgeable (mean knowledge score 4.3 vs. 3.2, P < 0.0001) versus control participants. In the intervention arm, 81% of participants found the video helpful, and 94% felt comfortable watching it and would recommend it to others. Conclusions: Seriously ill hospitalized patients with advanced cancer who watched a CPR video decision support tool were more likely not to want CPR and were better informed about their options. Participants reported feeling comfortable watching the video and would recommend it to others facing similar decisions. Video decision support tools can facilitate end-of-life decision-making for hospitalized patients with advanced cancer. Clinical trial information: NCT01527331.
Validation of the Spanish version of the QODD questionnaire (QODDq-ESP) in a home-based cancer palliative care program and development of the QODDq-ESP-12.
Authors: Perez-Cruz Pedro Emilio , Padilla Pérez Oslando , Bonati Pilar , Thomsen Parisi Oliva , Tupper Satt Laura , Gonzalez Otaiza Marcela , Ceballos Yanez Diego , Maldonado Morgado Armando
Published: February 2017

70

Background: Improving quality of death (QOD) is a key goal in palliative care. No instruments to measure QOD have been validated in Spanish. The goal of this study was to validate the Spanish version of the quality of death and dying questionnaire (QODD) and to develop a shortened version of this instrument suitable to be completed by phone interview. Methods: Translation/back-translation and adaptation of the QODD was performed following established standards. One question was removed due to cultural inadequacy. We enrolled caregivers (CGs) of consecutive deceased cancer patients from a single palliative care clinic in Santiago, Chile. CGs were contacted by phone between 4 and 12 weeks after patients’ death. Participating CGs completed the adapted QODD (QODD-ESP) by phone interview. A global rating question assessing quality of life (QOL) during the last week of life was included. A shortened version of the QODD (QODD-ESP-12) based on the model by Downey et al. (J Pain Sympt Manage 2010;39) was created. Measures of reliability (Cronbach-alpha), convergent validity (correlation with global rating question) and construct validity (factorial analysis [FA]) were estimated for both versions of the instrument. Results: 150 (50%) out of 302 CGs completed the QODD-ESP. Patients mean (standard deviation [SD]) age was 67 (14), 71 (47%) female and 131 (87%) died at home. CGs mean (SD) age was 51 (13), 128 (85%) female. Mean QODD-ESP score was 69 (range 35-96) with an alpha = .829. Correlation with last week QOL was .434 (p < .01). Kaiser-Meyer-Olkin measure of sampling adequacy was .585, not supporting the existence of a unique underlying construct. Mean QODD-ESP-12 score was 69 (range 31-97) with a alpha = .728. Correlation with last week QOL was .306 (p < .01). Confirmatory FA of QODD-ESP-12 showed that data fitted well Downey’s model (Chi2 4.85 (60), p = .311 Comparative Fit ndex = .98; Tuker-Lewis Index = .977 and root mean square error of approximation (RMSEA) = .023 (CI: 0-.056). Conclusions: QODD-ESP-12 is a reliable and valid instrument with good psychometric properties and can be used to assess QOD in a Spanish speaking cancer palliative care population by phone interview.
Patient-reported distress symptoms in patients undergoing palliative radiotherapy.
Authors: Single Megan , Hollant Laeticia , Gaines Katherine , Smart Bridget , Habboush Jacob , Biers Heather , Day Atiya , Miller Robert Clell , Vallow Laura , Tzou Katherine S.
Published: February 2017

75

Background: The focus of palliative radiotherapy (RT) is on improving quality of life (QOL) for patients with serious illnesses by eliminating or decreasing physical symptoms. The importance of assessing distress levels in palliative care patients is recognized due to the relevance of QOL, as treatment is given to provide symptom-relief rather than curative results. We sought to identify the most common causes of patient reported distress during palliative RT. Methods: Retrospective review was performed for patients who received palliative RT from 11/1/2012 to 6/4/2015 for various types of metastatic cancer at our institution. All patients completed a Patient Reported Distress (PRD) questionnaire with 30 specific questions and an overall distress thermometer prior to beginning treatment. The PRD survey quantified 30 areas of current concern ranging in patient-reported values from 1 to 5 in addition to a linear analog measure from 0 to 10 of overall reported distress in the last month. Results: Completed PRD surveys were available for a total of 297 patients, 149 (50.2%) female and 148 (49.8%) male. All patients were undergoing external beam radiation therapy for treatment of metastatic disease. 49 (16%) received chemotherapy and 46 (9%) underwent surgery. Overall distress ranged from 0 to 10, with a median of 5.0. The mean distress scores for the top five concerns ranged from 1.4 to 2.7. Top distresses were “Fatigue” (2.7), “Pain that affects daily functioning” (2.6), “How will I feel during treatment” (2.5), “Sleep difficulties” (2.4), and “Out of pocket medical costs” (2.3). Least troubling symptoms were “Transportation” (1.4), “A loved one relying on me for their physical care” (1.5), “My job” (1.5), “Housing during treatment” (1.5), “Spirituality” (1.5), and “Anger” (1.5). Conclusions: Patients demonstrated concern for distress related to interruption of activities of normal life, such as tiredness and insomnia, pain, and overall burdens from treatment. Medical costs were also a major concern. Importantly, housing and transportation were not issues in the current study but could be of concern in other regions. Providers should be aware that patients’ primary concerns may not be directly related to the symptom being palliated.
Patients’ perception of long-term, low-molecular weight heparins for cancer-associated thrombosis (CAT): Treatment expectations, convenience, and satisfaction related to patient profile.
Authors: Cajfinger Francis , Farge-Bancel Dominique , Falvo Nicolas , Sevestre Marie-Antoinette , Lamblin Anne ,   On behalf of TROPIQUE investigators
Published: February 2017

88

Background: In the TROPIQUE study CAT pts had high expectations for anticoagulant treatment & long-term LMWH was perceived as convenient with high degree of treatment satisfaction. In this study, using the Perception of Anti-Coagulant Treatment Questionnaires (PACT-Q), we assessed the inpact of patient profile on treatment expectations, convenience and satisfaction. Methods: PACT-Q (1&2) were proposed on a voluntarily basis to cancer pts recently diagnosed with symptomatic venous thromboembolism; the global mean scores±SD was correlated to pts characteristics. Results: 269 PACT-Q1 & 139 PACT-Q2 were analysed &135 pts done both of them. In all pts, the highest mean scores were for expectations of symptom relief (4.22±0.9), confidence in preventing clots (3.98±1.04) & importance of simplicity of use (3.94±0.75). For clot prevention men were more confident (4.06±0.81) vs women (3.85±0.88). Expectations of symptom relief was higher in women (4.07±0.98) vs men (3.89±1.09). Importance of ease of use was higher in treated pts (4.27±0.89) vs no therapy (4.00±0.99) & pts with age ≥ 49 (4.46±0.59) vs < 49 years (3.98±1.07). At the end of the study, PACT-Q2 answers showed, an Anticoagulant Treatment Satisfaction scores of 62.9±16.7. 67.2% of pts felt strongly reassured & 48.5% were satisfied with symptom decrease. 69.1% of pts were satisfied / very satisfied with their anticoagulant treatment. Treatment-related side effects were as expected (41.7%), better/much better than expected (45.5%). 80.6% of pts reported higher ease with tinzaparin and 76.2% with other LMWH. According to pts characteristics, satisfaction was higher in men (64.4±17.7) vs women (61.0±15.0), in non-metastatic (64.6±16.9) vs metastatic (61.1±16.2). ECOG (3-4) pts reported lower treatment convenience with higher satisfaction vs ECOG (0-1); 80.0% of ECOG (3-4) pts were satisfied/very satisfied with anticoagulant treatment. 70.0% of ECOG (1-0) patients stated symptom decrease & 80.0 % a feeling of reassurance. Conclusions: pt’s profile influenced positively the perception of long-term LMWH treatment but not the convenience & treatment satisfaction.
Starving for attention: Malnutrition screening in a community cancer center.
Authors: Sivendran Shanthi , Roda Patti I. , Sporay Jennifer , Guittar Ronald , Cox Christine , Newport Kristina Braine
Published: February 2017

96

Background: It is estimated that 50% of cancer patients are at risk for malnutrition, causing physical and emotional distress that interferes with cancer treatment. Early detection and intervention may prevent severe malnutrition. Assessment and management of malnutrition are included in National Comprehensive Cancer Network (NCCN) guidelines but no specific recommendation regarding screening tool selection is provided. The Malnutrition Screening Tool (MST) is a short, easily administered screening tool, validated for identification of malnutrition in cancer patients. In this study, we describe the results of MST administration in a large community cancer institute. Methods: The MST was administered during all patient visits to our cancer institute in 2015. Patients scoring 2 or higher were identified as ‘at risk’ for malnutrition, resulting in electronic dietitian referral prompts. We retrospectively reviewed MST results from April through June 2015 and compared to dietitian referrals during the same period in 2014. At that time, dietitian consults were prompted by physician referral, patient request, or triggered by NCCN distress thermometer screen. Results: The MST identified 84% more patients in need of dietitian referral in 2015 compared to usual care in 2014. From April through June 2015, the MST was administered during 4082 discrete patient encounters. 6.7% of these visits resulted in MST score of 2 or greater for a total of 193 ‘at risk’ patients in need of referral to dietitian. Weight loss of 2 pounds or greater was reported by patients in 16% of encounters. Eating poorly because of a decreased appetite was reported by patients in 13% of the encounters. From April through June 2014, 105 patients were referred for dietitian consult, indicating the MST identified 88 more ‘at risk’ patients. Conclusions: The MST is a simple, valid tool for malnutrition screening in cancer patients that resulted in an 84% increase in identification of ‘at risk’ patients. This tool should be considered for standard malnutrition screening of cancer patients, to prompt referral for dietitian intervention.
Clinical activity of AMG 337, an oral MET kinase inhibitor, in adult patients (pts) with MET-amplified gastroesophageal junction (GEJ), gastric (G), or esophageal (E) cancer.
Authors: Kwak Eunice Lee , LoRusso Patricia , Hamid Omid , Janku Filip , Kittaneh Muaiad , Catenacci Daniel Virgil Thomas , Chan Emily , Bekaii-Saab Tanios S. , Amore Benny , Hwang Yuying C. , Tang Rui , Ngarmchamnanrith Gataree , Hong David S.
Published: February 2017

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Background: Dysregulation of the MET pathway can promote tumor growth and metastasis. AMG 337 is an investigational, oral MET kinase inhibitor that is being evaluated in a first-in-human study. Here we describe the clinical activity, safety, and tolerability of AMG 337 in ptswith MET-amplified GEJ, G, and E cancers. Methods: Key eligibility criteria: age ≥ 18 years, advanced solid tumors, measurable disease, ECOG ≤ 2, adequate organ function. AMG 337 was administered QD or BID. Starting dose was 25 mg, with planned dose escalation of 50–500 mg QD and 100–200 mg BID. Ptswith MET overexpression/amplification/mutation could enroll to the highest dose deemed safe at any time. Results: As of April 2014, 80 pts had received ≥ 1 dose of AMG 337. Median (range) age, 58 (19–79) years; men, 61%; ECOG ≤ 1, 96%. Of the 51 pts with pre- and post-central read data, 10 pts had MET-amplified GI cancers (all of which were GEJ, G, or E cancers). Responses in these pts are shown in the table. One pt had a complete response (duration 100 wks) and 4 pts had partial responses (durations up to 52 wks). The most common treatment-emergent AEs (in > 20% of all pts) were headache, nausea, fatigue, vomiting, and constipation. AEs and dose-limiting toxicities were reported previously (Hong et al., ASCO 2014). The AE profile of pts with GI cancers was comparable to that of all ptsenrolled in the study. QD maximum tolerated dose (MTD) is 300 mg; BID MTD has not been reached. Conclusions: Responses to AMG 337 were observed in a subset of pts with MET-amplified GI tumors. A dose-expansion phase will enroll up to 50 ptswith MET-amplified tumors at the MTD. Clinical trial information: NCT01253707. [Table: see text]
Long-term survival results of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: A multicenter phase II trial (JCOG 0703).
Authors: Nakamori Mikihito , Katai Hitoshi , Mizusawa Junki , Nakamura Kenichi , Hiki Naoki , Yoshikawa Takaki , Kojima Kazuyuki , Imamoto Haruhiko , Ninomiya Motoki , Kitano Seigo , Sasako Mitsuru ,   JCOG Stomach Cancer Study Group
Published: February 2017

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Background: Laparoscopic gastrectomy has been a common tool for gastric cancer patients in eastern Asian countries. A large-scale prospective study with a sample size sufficient to investigate the benefit of laparoscopy-assisted distal gastrectomy (LADG) has never been reported. We conducted a multi-center phase II trial (JCOG0703) to evaluate the safety of LADG with nodal dissection for clinical stage I gastric cancer patients. A short-term outcome including postoperative complications of LADG as a result of this study was already reported and a following multi-center phase III trials (JCOG0912) to confirm the non-inferiority of LADG compared with open gastrectomy in terms of overall survival (OS) was already started. Long-term outcomes as the secondary endpoints of this study are reported here after 5-year follow up period. Methods: The subjects of this study comprised patients with clinical stage I gastric cancer that were able to undergo a distal gastrectomy. LADG with D1 plus suprapancreatic lymph node dissection was performed by credentialed gastric surgeons who experienced >=30 LADG and >=30 open gasterctomy. The primary endpoint was the proportion of patients who developed either anastomotic leakage or a pancreatic fistula. The secondary endpoints included surgical morbidity, short-term clinical outcome, OS, and relapse free survival (RFS). Results: Between November 2007 and September 2008, 176 eligible patients were enrolled. 140/23/9/4 patients had pStage IA/IB/II/IIIA disease respectively. No patients had recurrence. 3 patients died without recurrence. 5-year OS was 98.2% (95%CI, 94.7% to 99.4%). 5-year RFS was 98.2% (95%CI, 94.4% to 99.4%). Conclusions: The long-term outcome of LADG for Stage I gastric cancer patients seem comparable to those of open procedures. However, this result should be confirmed by a randomized control trial. We have just finished an accrual of 921 patients for a multi-center phase III trial (JCOG0912) to confirm the non-inferiority of LADG compared with open gastrectomy in terms of OS. Clinical trial information: UMIN000000874.
A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer who relapsed after S-1 adjuvant therapy, XP after TS-1 adjuvant failure (XParTS).
Authors: Takahashi Masazumi , Tsuburaya Akira , Nishikawa Kazuhiro , Tanabe Kazuaki , Yamaguchi Kensei , Yoshino Shigefumi , Namikawa Tsutomu , Yoshikawa Takaki , Rino Yasushi , Kawada Junji , Tsuji Akihito , Taira Koichi , Kawabata Ryohei , Kodera Yasuhiro , Hirashima Yoshinori , Yabusaki Hiroshi , Hirabayashi Naoki , Fujitani Kazumasa , Morita Satoshi , Sakamoto Junichi
Published: February 2017

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Background: For gastric cancer, standard regimens including S-1 for adjuvant and first-line chemotherapy have been established in Japan, while for early relapse after adjuvant therapy there is no standard treatment. In our retrospective analysis, relapse-free interval of less than 6 months was associated with poor progression-free survival (PFS) and overall survival (OS). To evaluate the efficacy and safety of capecitabine plus cisplatin (XP) treatment, for patients with advanced gastric cancer who relapsed within 6 months after S-1 adjuvant therapy, we conducted a multicenter phase II trial in Japan (NCT Identifier: NCT01412294). Methods: Patients who had received adjuvant chemotherapy for gastric cancer including S-1 for more than 12 weeks, thereafter relapsed within 6 months, 20–74 years of age and HER2- negative, were assigned to receive capecitabine 1000 mg/m2 bid for 14 days plus cisplatin 80 mg/m2 (day 1) every 3-week. The primary endpoint was PFS and the secondary endpoints were OS, time to treatment failure, overall response rate (ORR) and safety. Planned sample size was 40 according to median PFS threshold of 2 months. Results: From June 2011 to April 2014, 40 patients were assigned. Median age was 64, 32 males (80%); adjuvant chemotherapy: regimen, S-1 monotherapy (n=34, 85%), and median number of course was 7.0 (3-18). In 40 patients median PFS was 20 weeks (95%CI, 17-24), which was longer than protocol-specified threshold of 2 months. Median OS was 77 weeks (95%CI, 34-NE), ORR was 8/40 (22% including 12 NE cases; 95%CI, 44-74). Most common grade ≥3 adverse events (AEs) were neutropenia (23%), anemia (18%), hypercreatinine (18%), fatigue (13%), diarrhea (7.5%), and anorexia (7.5%). Conclusions: XP was safe and effective for those patients with relatively poor prognosis after S-1 adjuvant failure. Since profile of S-1 and capecitabine was different, XP can be recommended rather than S-1 plus cisplatin, Japanese standard first- line regimen. Clinical trial information: NCT01412294.
A prospective study of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104).
Authors: Takahashi Ikuo , Shimokawa Mototugu , Emi Yasunori , Tanioka Hiroaki , Shiraishi Takeshi , Oki Eiji , Saeki Hiroshi , Tsuji Akihito , Ishigami Sumiya , Kakeji Yoshihiro , Baba Hideo , Natsugoe Shoji , Maehara Yoshihiko ,   Kyushu Study Group of Clinical Cancer (KSCC)
Published: February 2017

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Background: Capecitabine plus cisplatin (XP) is one of the standard therapies for metastatic gastric cancer (mGC). However there is no clinical practice date in Japan, and results from the ToGA and AVAGAST study suggested dose of cisplatin should be lower in Japanese. This study was designed to evaluate the efficacy and safety of mXP in the clinical practice in Japanese mGC patients (pts) including the elderly. Methods: The study design was multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated mGC; presence of measurable lesions; age 20 years; ECOG performance status (PS) 0–2; and adequate organ function. Pts received mXP (cisplatin 60 mg/m2 d1 plus capecitabine 1,000 mg/m2 bid d1-14) q3w. This schedule was repeated until unacceptable toxicity or disease progression occurred. The primary endpoint was RECIST-confirmed objective response rate (ORR). A sample size of 40 was planned for a threshold ORR of 30% and expected value of 50%, with one-sided alpha of 0.05 and beta of approximately 0.2. Results: Of the 42 pts (male/female, 34/8; median age, 63.5 years (range 50-81); PS 0/1/2, 34/8/0) enrolled from Nov 2011 to Oct 2013. One patient did not fulfill the eligibility criteria. Forty one pts were assessed for response; CR 2 pts, PR 16 pts, SD 14 pts, PD 8 pts, and NE 1 pts. The confirmed ORR was 43.9% (90% CI; 31.2-56.7%, 95% CI; 28.7-59.1%). Median PFS and mOS were 4.5 months (95% CI; 3.9 – 6.5M) and 11.4 months (95% CI; 7.7 – not reached). The most common grade 3/4 adverse events were anorexia 24.4%, neutropenia 36.6%, fatigue 9.8%, hand-foot syndrome 7.3%. Grade 3/4 peripheral neuropathy did not occur. Conclusions: First-line chemotherapy for HER2-negative patient of mXP showed a promising response rate and an acceptable tolerability profile in the clinical practice in Japanese mGC pts including the elderly. Clinical trial information: UMIN:000006668.
Characteristics and prognosis of gastric cancer according to Helicobacter pylori.
Authors: Seo Ji Yeon , Jin Eun Hyo , Yoon Hyuk , Jo Hyun Jin , Shin Cheol Min , Park Young Soo , Kim Nayoung , Jung Hyun Chae , Lee Dong Ho
Published: February 2017

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Background: Different features of gastric cancer according to Helicobacter pylori(Hp) infection is still under debate. The aim of this study was to compare clinical, pathologic characteristics and prognosis of gastric cancer between Hp-positive (HpP) and Hp-negative (HpN) gastric cancer. Methods: Patients diagnosed as gastric cancer in Seoul National University Bundang hospital from June 2003 to December 2010 were reviewed. Status of Hp was evaluated by histology and rapid urease test (RUT). Patients who had positive histology and/or positive RUT were classified as HpP. Patients who had atrophic gastritis and/or intestinal metaplasia from histology were also classified as HpP. Patients who had both negative histology and RUT were defined as HpN. Results: The number of patients with HpP and HpN were 852 (62.6%) and 509 (37.4%), respectively. Antral location was more common in gastric cancer with HpP than in those with HpN (51.8% vs 44.9%, P = 0.003). Stage of gastric cancer was higher in patients with HpN than in patients with HpP (stage IV 17.9% vs 9.6%, P < 0.001). Age, sex of patients and Lauren classification of gastric cancer was not different according to Hp status. Recurrence and mortality was significantly higher in patients with HpN gastric cancer than those in HpP gastric cancer (P = 0.002 and P= 0.001). Conclusions: Gastric cancers have different clinical and pathologic features according to the Hp status. Patients with HpN gastric cancers have poorer prognosis than those with HpC or HpP gastric cancers.