bluuebunny/crossref_metadata_2025 huggingface dataset:
Incorporating patient preferences and priorities into end-of-life care.
Authors: Rackow Eric , Ofori Afua , Rodkey Wendy , Beveridge Roy A.
Published: February 2017

41

Background: Patients with advanced illness often face painful conversations and difficult decisions. A program was deployed to help patients identify, communicate, and incorporate their personal preferences and priorities into decisions about their care. The program was assessed by measuring movement along the readiness for change continuum. Methods: Patients residing in the home and participating in a chronic care program were referred by their case managers based on clinical conditions and whether the patient appeared to be in their last 12 months of life. Counseling sessions with patients or family caregiver/s were designed to move participants toward the following actions: be fully informed about their medical situation, describe their detailed quality of life priorities, articulate a self-defined medical decision making process, effectively communicate to their family and physicians, and implement and repeat the aforementioned steps. After 5 months (Sept-2014 to Feb-2015), movement along the readiness for change continuum (pre-contemplation, contemplation, preparation, action, maintenance, and advocacy) was reported. Results: Of the 427 patients referred, 33 could not be reached, 116 were ineligible, 50 declined or did not engage. Of the 228 participants, 191 (84%) moved at least one step in readiness for change continuum over the 5-month period. In Nov-2014, 13% of participants were in action, maintenance, or advocacy, which increased to 19% by Feb-2015. The largest observed movement to action, maintenance, or advocacy was in defining quality of life priorities: 2% Nov-2014 to 21% Feb-2015. The least movement to action, maintenance, or advocacy was observed in articulating a self-defined medical decision making process: 3% Nov-2014 to 16% Feb-2015. Case managers reported discomfort in referring members based on their assessment of length of life. Early surveys show high levels of satisfaction. Conclusions: A very high percentage of patients progressed in incorporating their preferences and priorities into end of life care as measured by the readiness to change continuum. This program is currently expanding and the referral process is changing from case manager to algorithm based identification referrals.
The role of the radiation oncologist in goals-of-care discussions.
Authors: Das Lauren C. , Son Christina H. , Daily Ellen Wasgatt , Levine Stacie K. , Hahn Olwen Mary , Liauw Stanley L. , Golden Daniel William
Published: February 2017

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Background: Effective goals-of-care discussions (GOCD) are essential when counseling patients with incurable malignancies. Because radiation and medical oncologists (RO; MO) often collaborate, their respective roles in GOCD can be unclear. This study aims to explore how often MO and RO initiate GOCD, barriers to GOCD, and MO opinions of RO conducting GOCD. Methods: RO and MO at NCI-designated comprehensive cancer centers were invited to participate in an anonymous electronic survey. The survey collected demographics and opinions regarding GOCD, training in conducting GOCD, and 3 case scenarios. The participants were provided with the GOCD definition: “A goals-of care discussion defines a patient's expected prognosis, elicits his or her values and preferences, and considers these preferences in formulating a recommendation for treatment and/or supportive care.” Response formats were Yes/No, Likert, or free response. Statistical analysis was performed with chi-squared and Wilcoxon rank-sum tests. Likert scores are reported as median[interquartile range]. Results: 554 RO and 1604 MO were successfully sent survey invitations. 76 (13.7%) RO and 153 (9.5%) MO responded with complete surveys. There was no difference in the gender distribution of survey respondents for RO and MO (67% vs 59% male, p = 0.26). Practice setting was academic medical center for 93% of respondents. 91% of respondents reported seeing ≤ 10 new cancer patients a week. MO were more likely to see metastatic or incurable patients. 63% of RO and 66% of MO reported having GOCD with > 50% of their patients (p = .94). MO were more comfortable conducting GOC discussions compared with RO (5[4-5] vs 4[3-5], p < .01). When asked how important it was for RO to conduct GOCD, RO ratings were higher than MO (5[4-5] vs 4[3-5], p = .02). 18% of RO and 42% of MO received formal training conducting GOCD (p < .01). The most common factors for initiating a GOCD were declining performance status (74%) and poor estimated life expectancy (69%). Conclusions: Although MO and RO conduct GOCD in similar frequency, MO report being more comfortable conducting GOCD and are more likely to have formal training. Compared to MO, RO rate the importance of RO conducting GOCD higher.
Impact of a multidisciplinary home palliative care unit in the place of death of patients diagnosed with cancer.
Authors: Lopez De San Vicente Borja , Arango Juan Fernando , Batiz Jacinto , Gomez Julio , Arrazubi Virginia , San Sebastian Kepa , Aguilo Matxalen , Perez-Hoyos Nany , Oliver Miriam , Sala Gonzalez Maria Angeles , Ruda Pilar , Galve Calvo Elena , Gandiaga Aiala , Novas Patricia , Abad Teresa , Sande Laura , Zumarraga Ane , Lopez Santillan Maria , Martínez del Prado Purificación
Published: February 2017

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Background: Home death rate is increasingly being used as a quantifiable indicator of the effectiveness of palliative care services. Intensifying home care and training of the end-of-life care practitioners, seems to be the way to improve the correlation between patient preferences and actual place of death. The objective of this study is to measure the impact of a multidisciplinary home palliative care unit (HPCU) (including medical, nursery, and psycological care, and social worker counselling) on the place of death of patients treated in a single oncology service. Methods: A retrospective case-control study was performed. HPCU patients consecutively admitted from January 2014 to June 2015 (cases) were matched with contemporary patients from the same center who could be followed by independent support services (Home Hospitalization, Psicooncologists and General Practitioners) (controls) by diagnosis, sex, age group ( < 60 years, 61-75y and > 75y) and oncologist physician. Place of death was registered. Odds ratio (ORR) and relative risk was analysed with SPSS for Windows ver.22.00. Results: Seventy four patients (p) admitted in a HPCU and their controls were included; 54% men; Average of age in cases 69.7years (y) (SD 10.8) and controls 68.5 y (SD 10.41), diagnosed of lung cancer 20p (27%), breast cancer 6p (8%), gastrointestinal noncolorectal cancer 16p (22%), colorectal cancer 10p (13.5%), head and neck cancer 5p (6.8%), genitourinary cancer 12p (16%), metastatic melanoma 2p, advanced sarcoma 2p and unknown primary cancer 1p. Place of death: home (cases 43p [59%], controls 8p [10%]); emergency service (1p [1.4%] vs 3p [4.1%]); in acute hospital in-patient-care (AH) (11p [15.1%] vs 29 p [39.2%]) and at a hospitalized palliative care unit (18p [24.7%], vs 34p [45.9%]); 1p of case group was lost during follow-up. The ORR for dying at home for HPCU patients was 11.82 (IC 95% 4.95-28.02) and a reduction in risk of die in an AH was seen (0.38, IC 95% 0.21-0.67). Conclusions: Death at home seems to be more feasible if cancer diagnosed patients have a proper follow-up by a multidisciplinary home palliative care unit, and it also reduce the possibility of dying in an acute hospital in-patient-care.
The influence of caregiver burden on bereavement outcomes of spousal and adult-child family caregivers of patients who have died of cancer.
Authors: McLean Sarah , Gomes Barbara , Calanzani Natalia , Bristowe Katherine , Koffman Jonathan , Higginson Irene J.
Published: February 2017

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Background: Family caregivers (FCs) provide unpaid care to patients, outside of a formal framework. A demographic imperative currently exists to allow patients to be cared for in their own homes. FCs are a vital part of this support. However, their needs, and the burden of caregiving, are often under-recognised. Challenges facing FCs, in particular adult-child FCs, include a need to combine paid employment and other family commitments with caregiving. Negative consequences associated with caregiving include a higher risk of complicated grief in bereavement. Aims: To describe and compare the bereavement outcomes of spousal and adult-child FCs of patients who died of cancer, and to evaluate the factors of care associated with adverse bereavement outcomes for each FC group. Methods: Secondary data analysis was performed of data regarding bereavement outcomes, as measured by the Texas Revised Inventory of Grief (TRIG) scores of participants in the QUALYCARE study – a mortality follow-back study of FCs. Results: 484 caregiver-patient dyads were included: 246 adult-child FCs and 238 spousal FCs. Spousal FCs were older (68.4 vs. 50.7 years, p < 0.001). Caregiving intensity was similar in both groups of FCs, but adult-child FCs were more likely to continue working outside the home while caregiving (χ2, p < 0.001). Patients with adult-child FCs were more likely to die in a nursing home than those with a spousal FC (p < 0.001). Grief intensity was highest in spousal FCs whose relative had died in hospital or a nursing home, and lowest in adult-child FCs whose relative had died in a nursing home (n = 31, p < 0.001). Caregiver burden predicted 11.6% of variance in grief intensity for adult-child FCs vs. 0.5% for spousal FCs. Conclusions: Caregiving burden has particular implications for adult- child FCs as compared to spousal FCs, in terms of bereavement outcomes. Role strain describes overlapping responsibilities with simultaneous family roles. The risk of complicated grief may be modifiable through ensuring the provision of practical supports, as well as psychological support for the caregiver, and the excellent management of both physical and psychological symptoms experienced by the patient.
The use of opioids in the last month of life in a tertiary cancer center in Jordan.
Authors: Shamieh Omar M. , Salmany Sewar S , Khamash Odai , Dawood Stella , Alkhreisat Mustafa , Ibrahim Mohamamd , Al-Rimawi Dalia , Hui David
Published: February 2017

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Background: The low rates of utilization of opioids is a major barrier to optimal pain control in cancer patients in developing countries. The presence of a palliative care service may improve opioid utilization. In our study we assessed opioid utilization in the last month of life for patients admitted to our tertiary care cancer center in Jordan, and compared the use of opioids with and without palliative care involvement. Methods: We conducted a retrospective chart review to examine opioid use for all adult patients who died at King Hussein Cancer Center between January 1st, 2012 until December 31st, 2012. Patient demographics, cancer diagnosis, type of opioid and total daily dose of opioids in morphine oral equivalent (OME) were collected in the last 30 days of life while admitted to the hospital. Results: Among the 297 patients included, the median age was 58 years (range, 19- 95), 134 (45%) were males, and 186 (62.6%) died under the palliative care service. The median admission length was 7 days. The average daily doses of opioids were 187mg, 214mg, 222mg (OME) in the last 24 hours, 48 hours, and 30 days of life, respectively, In the last 24 and 48 hours before death, 140 (47%) and 228 (77%) patients were on opioids, respectively. Younger age was associated with higher doses of opioids (P= 0.0001). We found no significant differences in patient characteristics between palliative and non-palliative care patients; however, patients under palliative care received significantly higher doses of opioids compared to non-palliative care patients in the last 30 days of life, the average daily dose of opioids (OME) was 249.4mg vs. 11.2mg (P< 0.001). There was no survival difference between palliative and non-palliative patients (P= 0.2244), or between patients who were on opioids or patients who were not (p= 0.57). Conclusions: A large minority of patients did not receive opioids at the end-of-life. Palliative care service was associated with higher utilization of opioids. Palliative care service may assist in pain management at the end-of-life.
Difference in strong opioid prescription among different cancer and care providers in advanced cancer patients in Taiwan: Analysis using national health insurance database.
Authors: Hsieh Ruey Kuen , Lin Yu-Lin , Tang Chao-Hsiun
Published: February 2017

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Background: Pain assessment and management had been adopted as an important criteria in hospital accreditation in Taiwan. National health insurance database may help to determine factors influencing patterns of strong opioid use in advanced cancer patients in their final 12 months of life. Methods: Cancer patients who died from cancer during 2008-2011 were included in the analysis. Data in prescription of strong opioids during their last 12 months of life were collected and analyzed using National Health Insurance Research Database (NHIRD). Patient’s characteristics, such as cancer types, birthdate and gender, as well as information on the provider’s characteristics, such as specialty, gender and age of the physician, the ownership and level of accreditation of the hospital, and the level of urbanization of the hospital where it is located, were also retrieved and included as the controlled variables in the analysis. Results: Of the 162,679 cancer deaths, 57,578 were prescribed strong opioids in their last year of life (35.4 percent). Strong opioid prescription steadily decreased with the corresponding increase in patient age. Besides there are difference in different cancer types. Association with prescription prevalence has also been noted among physician characteristics such as subspecialty, gender and age, as well among hospital characteristics, such as public vs private and accreditation level. Conclusions: There are significant difference in strong opioids prescription among different care providers for advanced cancer patients. Information from this study can guide further efforts in improving supportive care and education for advanced cancer care providers.
Radiotherapy (RT) for brain metastases (BM) near the end of life (EOL): Palliation or poor-quality care?
Authors: Ryoo Joan Joonsun , Batech Michael , Zheng Chengyi , Kim Raymond W , Gould Michael K , Kagan A. Robert , Lien Winston Wei
Published: February 2017

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Background: Patterns of care and EOL RT among BM patients (pts) are not well-described. Methods: Tumor registry of an integrated health care system identified 5,133 pts diagnosed with non-small-cell lung cancer (NSCLC) in 2007-2011. BM were determined by imaging. Clinical variables obtained by chart abstraction were tested as predictors of death within 14 and 30 days (d) of RT. Results: On NSCLC presentation, 10% had BM; 7% developed BM thereafter. Of 900 BM pts, 15% were not referred for brain RT due to pt preference or clinical judgments; median time to death was 21 d (range 0-578). Median survival for 5% not recommended RT was 48 d (range 13-764). Though survival was shorter when prescribed 5 vs 10 fractions (78 vs 179 d, p<0.01), suggesting providers’ sense of prognosis, 15.6% of pts died ≤14 d and 23.3% ≤30 d of RT. Inpt consultation and planned fractions were higher at external RT facilities, and RT more likely not to be completed (p<0.01). Independent predictors of EOL RT were older age, poor performance status, increasing metastatic sites, and RT consultation during hospital admission. Conclusions: BM incidence in this NSCLC cohort was 17%, with 85% referred for brain RT. A concerning number of pts received RT near the EOL. While RT recommendation, timing, and fractionation – especially on inpt evaluation – should be better tailored to life expectancy, benchmarks for quality measurement are needed. [Table: see text]
Perceived competency and knowledge in palliative and end-of-life care among physicians at an academic institution.
Authors: Sanchez Larysa Jessica , Duma Narjust , Jaker Michael , Wong Kristin
Published: February 2017

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Background: Given the importance of palliative and end-of-life (EOL) care in terminally ill patients (pts), it is crucial that physicians feel comfortable in leading EOL discussions and possess adequate knowledge in palliative care skills. Methods: We conducted an online survey of physicians at our institution to evaluate competency and knowledge in palliative and EOL care. The survey consisted of 39 questions in self-assessed skills and a 26-question validated knowledge test. Results: There were a total of 70 respondents across specialties: 30% internal or family medicine, 24.3% surgery, 14.3% pediatrics, 31.4% other, 5.7% medical/surgical oncology. The median (M) age was 52.5 (33-99), 64% were male. 18.6% reported caring for 1 to 2 dying pts and 35.7% for 3 to 10 or more dying pts in the previous 3 months (mos). 45.7% had 1 or more EOL discussions in the previous 3 mos. There was no association between (btw) the number of dying pts cared for and the number of EOL discussions, p < 0.89. 31.4% felt comfortable and 15.7% felt very comfortable providing palliative/EOL care, while 18.6% felt very uncomfortable or uncomfortable and the plurality, 34.3%, felt neither comfortable nor uncomfortable. Physicians who were comfortable or very comfortable were 1.63 times more likely to have 2 or more EOL discussions in the previous 3 mos, p < 0.0001. When rating competency level in various skills, 80% reported average (avg) to above avg skill in pain assessment, 58.6% below avg to avg in opioid dosing, 64.3% below avg to avg in managing opioid side effects, 65.7% avg to above avg in assessing non-pain symptoms. The M score on the knowledge test was 69.2 (46.1-88.4) % correct, with most incorrect answers in managing cancer pain. There was no correlation btw test score and overall comfort level, p < 1.567. Conclusions: In our cohort, the plurality of respondents felt neither comfortable nor uncomfortable in providing palliative and EOL care, self-assessed competency was often rated as below avg or avg, and overall comfort level did not correlate with knowledge test scores. This study highlights the need to improve continuing medical education in palliative and EOL care in order to enhance the quality of care physicians provide to pts.
Engaging patients and stakeholders in the process of designing a clinical trial and patient education platform.
Authors: Rosati Lauren M. , Douglas Sarah , Leventer Roger , Singer Sievers Laurie , Swan Randall W. , Teesdale James L. , McKnight Andrew D. , Engebretson Anitra , Elnahal Shereef , Hacker-Prietz Amy , Badri Omar , Yang Adeel , Al-Sulaihim Nasser M. , Pawlik Timothy M. , Browner Ilene S. , Laheru Dan , Erdek Michael A. , Snyder Claire F. , Smith Thomas J. , Herman Joseph M.
Published: February 2017

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Background: Patient engagement during the initiation, development, and implementation of a study has been shown to improve the ethical nature of research and the appropriateness of treatment methods, and insights into how best to partner with patients are needed. We describe our patient engagement experience in developing a clinical trial for non-metastatic pancreatic cancer (PCA). Methods: A team of patient research partners (PRPs) was consulted to design a multi-institutional study to evaluate the efficacy of chemotherapy, stereotactic body radiation therapy, and early palliative care (EPC) in patients with PCA who are typically ineligible for clinical trials due to advanced age, poor performance status, or preexisting comorbidities. PRPs included patients, caregivers, clinical researchers, patient advocacy organizations, and pharmaceutical companies. A 22-item initial survey on personal interests and a 5-item follow-up survey on study design were anonymously completed after two in-person meetings. Results: Of 15 PRPs involved, 9 completed the initial survey and 10 completed the follow-up survey. PRPs were most interested in improving quality of life (QOL, 89%), care coordination (78%), symptom management (67%), stress/anxiety (56%), and survival (56%). Confidence in the care team, hope, QOL, education and understanding, dignity, and pain management were reported to be the most important factors throughout the cancer experience. The majority (89%) requested that study participants have access to the study protocol and research publications supporting the study design. Because all PRPs suggested that a personal website be used to provide information to study participants and to disseminate the results of the study, an online patient education platform was adopted and customized for patients (and caregivers). Furthermore, integration of EPC into the treatment regimen was unanimously endorsed. Conclusions: Engaging PRPs in the process of designing a clinical trial for PCA appears to be feasible and valuable in identifying the study objectives most important to patients. PRPs conveyed that maintaining a good QOL is essential, and adoption of EPC in these patients should be considered.
Pilot study assessing distressors affecting patients with cancer using the distress screening tool.
Authors: Finianos Antoine Nafez , Aragon-Ching Jeanny B. , El Bahesh Ehab , Amdur Richard , Bires Jenifer , Guebre-Xabiher Hiwot
Published: February 2017

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Background: Distress is a non-stigmatic description of emotional, physical, spiritual or psychiatric stressors experienced by patients (pts) diagnosed with cancer. We sought to determine the prevalence of distress in different cancer population of pts seen in our cancer center as they are commencing chemotherapy. Methods: We retrospectively examined data using the Distress Thermometer (DT) based on the National Comprehensive Cancer Network (NCCN) and assessed a single encounter on 240 consecutive patients undergoing their first chemotherapy session. Univariate associations were examined between specific problems and overall distress levels with a 2-tailed between-group t-test. Problem area scores were computed for each subject by taking the mean number of problems rated positive within each area, and associations between each problem area score and distress was examined using Spearman correlations. Results: Among the 240 patients in the sample, mean age was 60 ± 14, 61% were female, and 82% had solid tumors. The overall mean distress, based on the DT reading, was 3.6 ± 3.0. Specific problems reported by the largest number of patients included worry (n = 85), nervousness (n = 79), fatigue (n = 70), sleep (n = 66), and fears (n = 57). Of these, all but fatigue were significantly associated with global distress in univariate analysis. When mean problems per area were calculated, and correlated with global distress, each problem area (practical, emotional, family, physical) had a significant univariate association with global distress, with emotional problems having the highest correlation (r = .52, p < .0001). The only predictors with significant independent associations to predict global distress in the general linear model were emotional problems (p = .0001) and family problems (p = .0062), independent of age, sex and tumor types. Conclusions: In cancer patients undergoing distress screening as they receive their first chemotherapy, emotional and family problems appear to have the highest correlation with distress. Improvement of supportive care services geared towards the betterment of these symptoms is of paramount importance in improving outcomes.
From PRO screening to improved wellness: A nurse-led intervention.
Authors: Morris Alison , Tribett Erika L , Tun Sandy , Winget Marcy , Blayney Douglas W. , Ramchandran Kavitha
Published: February 2017

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Background: Emotional and physical distress in cancer patients is underreported and undertreated. In effort to address this, the Quality Oncology Practice Initiative (QOPI) requires patients to be screened for emotional well-being and pain by their second oncology visit. This project details one cancer center’s quality improvement initiative to: (1) utilize patient reported outcomes (PRO) screening to identify patient distress, (2) develop adaptive nurse-led algorithms to assess and intervene for unmet needs. Methods: In June 2015, we launched electronic collection of PROs using the Patient Reported Outcome Measurement Instrument System (PROMIS) global screen. Screening is completed via EMR patient portal prior to first return visit and 30-day intervals thereafter. A nurse-led algorithm categorizing distress was developed with evidence-based clinical pathways for care. Pathways optimize primary palliative care and referrals to specialist palliative services when appropriate. In August 2015, we will randomize four nurse navigators in gynecologic oncology to test the algorithm and make adaptations for scaling cancer center wide. We will assess the percent of patients screening positive for distress and the rate of primary palliative care interventions (e.g., symptom management and psychosocial support). We will also assess rate of referral to specialist palliative teams. Finally, we will interview a subset of patients to compare self-reported need, clinical management of needs, and whether needs were managed to the patient’s satisfaction. Results: We expect to report on adoption and adaptation of the algorithm for disease-specific groups. We will also report rates of primary palliative care interventions, referrals to specialist palliative care and PROs. Conclusions: Standard screening using PROs and clinical care pathways may foster early identification and management of patient’s psychosocial and physical needs. Support for oncology nurses to lead assessment and connect patients with resources is an opportunity to incorporate primary palliative care into oncology practice. The use of structured, adaptive, novel algorithms is a promising approach to meet patient needs and improve access to supportive resources.
Health plan, physician, and medical care ratings among end-of-life (EOL) cancer survivors.
Authors: Halpern Michael T. , Urato Matthew , Schwartz Margot , Kent Erin E.
Published: February 2017

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Background: High-quality EOL care is critical for patients and families. However, little is known about factors influencing patient satisfaction with their healthcare near EOL. This study’s objective is to assess the role of characteristics of individuals with cancer near EOL on their ratings for medical care, health plans, and physicians. Methods: Retrospective analyses of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Medicare Survey linked to NCI’s Surveillance, Epidemiology, and End Results (SEER) Program. CAHPS collected Medicare beneficiaries’ ratings for overall care, physicians, health plans, and 5 composite scores of aspects of care; SEER provided data on cancer diagnosis and characteristics. The study included 5,102 Medicare beneficiaries diagnosed with cancer in SEER regions 1997-2011 who completed CAHPS following diagnosis and within one year before death. Logistic regression was used to examine associations of EOL patient characteristics with their ratings. Results: Self-reported very good or excellent (vs. poor) general health significantly (p < 0.05) predicted greater likelihood of higher ratings for all measures (ORs ranged 1.5 to 2.2). Very good/excellent mental health also predicted increased likelihood of higher ratings for all except one category (ORs 1.8 to 2.7). Other patient factors were significantly associated with a subset of ratings. For example, Hispanics (vs. Whites) were more likely to provide higher ratings for health plans (OR 1.5) and specialist physicians (OR 1.7) but lower ratings for getting needed care (OR 0.62). Fee-for-service (vs. Medicare Advantage) beneficiaries were more likely to provide higher ratings for health plans, getting needed care, and getting care quickly (ORs 1.4, 1.3, 1.6). Patient age, cancer site, and time since diagnosis had few or no significant associations with any measure. Conclusions: Among cancer patients near EOL, better self-reported general and mental health consistently predicted higher ratings. Fee-for-service Medicare patients provided higher ratings for several important categories. These results may help guide future research on interventions to improve the EOL experience among Medicare beneficiaries.
Patient and caregiver well-being: Observation of changing dyad over time.
Authors: Sannes Timothy S , Mikulich-Gilbertson Susan K , Simoneau Teresa L , Laudenslager Mark L
Published: February 2017

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Background: Allogeneic hematopoietic stem cell transplant (Allo-HSCT) is a particularly stressful time for patient and caregivers alike. As such, well-being within patient-caregivers dyads is highly correlated in previous studies. It is less clear how this dyadic relationship changes over the course of treatment and recovery. Methods: In these secondary analyses of a randomized clinical trial of psychoeducational support (5 time points across 12 months), partial correlations, adjusting for group assignment and age, tested the relationship between individual mental and physical summary scores of patients and caregivers. 117 Allo-HSCT patient and caregivers provided baseline data, with available data used at each subsequent timepoint. Quality of life was measured with the Short-Form Health Survey; divided into mental (MCS) and physical summary (PCS) scores. Results: Patients were primarily men (69.6% male; Mage=49.36; SD=13.04); caregivers were primarily female (78%;Mage=53.26;SD=12.34). Patient and caregivers’ MCS were significantly correlated at baseline (r=.23;p<.05) and 4 weeks after consenting to study participation, (r=.26;p<.01), whereas patients’ PCS scores were significantly correlated with caregivers’ MCS at 3 months (r=.26;p<.05). At 6 months, the relationship between patient PCS and caregiver MCS was no longer significant (p=.51), whereas the relationship between patient and caregiver MCS re-emerged at 6 months (r=.32; p<.05). In evaluating 6 month completers (N=84), the trend between patient-caregivers well-being displayed the same significant pattern at each timepoint. Conclusions: These data replicate significant relationships of mental well-being within patient-caregiver dyads in Allo-HSCT. This relationship shifts over time, in which caregiver mental well-being becomes related to patients’ physical functioning. These data underscore the importance of this dyadic relationship and deserve follow-up statistical approaches (e.g., covariation). Extending these relationships to clinical endpoints remains an area for future investigation. Funding: NIHCA126971(MLL); T32AG044296(TS): DA034604(SMG) and PCORI CE-1304-6208(MLL). Clinical trial information: NCT00833898.
An updated overall survival analysis with correction for protocol-planned crossover of the international, phase III, randomized, placebo-controlled trial of regorafenib in advanced gastrointestinal stromal tumors after failure of imatinib and sunitinib (GRID).
Authors: Demetri George D. , Reichardt Peter , Kang Yoon-Koo , Blay Jean-Yves , Joensuu Heikki , Schaefer Klaus Bernd , Kuss Iris , Kappeler Christian , Casali Paolo Giovanni
Published: February 2017

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Background: The GRID study showed that regorafenib improves progression-free survival compared with placebo in patients with advanced GIST after failure of at least imatinib and sunitinib (HR 0.27; 1-sided p<0.0001; Demetri 2013). At the time of the primary analysis, no significant difference in the secondary endpoint of overall survival (OS) was observed (HR 0.77; p=0.199), but this result may have been confounded by the high rate of crossover to regorafenib (85%) of placebo patients at progression. We conducted exploratory analyses of updated OS data to assess the effect of correcting for this protocol-planned crossover. Methods: The data cut-off for this updated OS analysis was 31 January 2014 (2 years after the primary analysis). OS was corrected using two randomization-based methods: rank preserving structural failure time (RPSFT) and iterative parameter estimation (IPE); both methods are considered as best choice among all correction analytics. Hazard ratios and 95% CI were derived using the Cox model. Results: A total of 139 deaths had occurred at the time of data cut-off: 91 events (68.4% of patients) in the regorafenib group and 48 (72.7%) in the placebo group. A total of 22 patients remained on regorafenib treatment (median duration 2.1 years, range 0.9–2.4). The updated hazard ratio for OS favored regorafenib (0.85, 95% CI: 0.60 - 1.21; p=0.18). Median OS was estimated as 17.4 months in both groups, with crossover from placebo. The corrected HRs for OS are less than the uncorrected HR (Table). Conclusions: The updated analysis of OS in the GRID trial is consistent with the primary analysis. An exploratory analysis correcting for the impact of cross-over on OS suggests a survival benefit for regorafenib in GIST. Clinical trial information: NCT01271712. [Table: see text]
Optimal extent of lymphadenectomy in gastric adenocarcinoma: A seven-institution study of the U.S. Gastric Cancer Collaborative.
Authors: Randle Reese W. , Swords Doug S. , Levine Edward Allen , Fitzgerald Nora , Squires Malcolm Hart , Poultsides George A. , Fields Ryan C. , Bloomston Mark , Weber Sharon M. , Pawlik Timothy M. , Jin Linda X. , Spolverato Gaya , Winslow Emily , Schmidt Carl Richard , Kooby David A. , Worhunsky David J. , Saunders Neil , Cho Clifford Suhyun , Maithel Shishir Kumar , Votanopoulos Konstantinos Ioannis
Published: February 2017

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Background: The optimal extent of lymphadenectomy in the treatment of gastric adenocarcinoma continues to be a subject of intense debate. We aimed to compare gastrectomy outcomes following limited (D1) or extended (D2) lymphadenectomy. Methods: Using the multi-institutional U.S. Gastric Cancer Collaborative database, we reviewed the morbidity, mortality, recurrence, and overall survival (OS) of 727 patients receiving D1 or D2 lymphadenectomies. Patients with stage IV disease, prior gastrectomy, and age 85 or greater were excluded. Multivariate analyses included variables with p values less than 0.1. Results: Between 2000 and 2014, 266 (36.6%) and 461 (63.4%) patients received a D1 and D2 lymphadenectomy, respectively. ASA class, mean number of comorbidities, grade, stage, and signet ring cell subtypes were similar between groups. Neoadjuvant and adjuvant chemotherapy was more common in the D2 group (p<0.001). The mean number of lymph nodes recovered was significantly higher in patients receiving a D2 lymphadenectomy (21.5 for D2 vs. 17.1 for D1, p<0.001). Median follow up was 1.3 years. While Clavien III/IV major morbidity was similar (15.0% for D1 vs. 14.5% for D2, p=0.85), mortality was worse for those receiving a D1 lymphadenectomy (4.9% vs. 1.3%, p=0.004). Recurrence rates for patients receiving D1 and D2 lymphadenectomies were 25.8% and 27.0%, respectively (p=0.74). D2 lymphadenectomy was associated with improved median OS in stage I (4.7 years for D1 vs. not reached for D2, p=0.003) stage II (3.6 years for D1 vs. 6.3 for D2, p=0.42), and stage III patients (1.3 years for D1 vs. 2.1 for D2, p=0.01). After adjusting for significant predictors of OS which included ASA, stage, grade, neoadjuvant chemotherapy, and adjuvant radiation, D2 lymphadenectomy remained a significant predictor of improved survival when compared with D1 lymphadenectomy (HR 1.5, 95% CI 1.1-2.0, p=0.008). Conclusions: D2 lymphadenectomy is associated with improved survival that is more prominent in early stages of disease. It can be performed safely without increased risk of morbidity and perioperative mortality and should be the preferred lymphadenectomy technique for the treatment of gastric adenocarcinoma.
Impact of radiotherapy duration on outcomes in patients with esophageal cancer treated with definitive concurrent radiotherapy and chemotherapy on RTOG trials 8501 and 9405.
Authors: Hallemeier Christopher Leigh , Moughan Jennifer , Haddock Michael G. , Herskovic Arnold M. , Minsky Bruce D. , Kim Harold , Major Pierre , Gore Elizabeth , Schnall Mitchell D. , Zeitzer Kenneth Lee , Komaki Ritsuko , Bush David , Jacob Rojymon , Garg Madhur , Crane Christopher H.
Published: February 2017

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Background: Radiotherapy (RT) interruptions have a negative impact on outcomes in many epithelial malignancies treated with definitive RT. The purpose of this study was to analyze the impact of RT duration on outcomes in patients (pts) with esophageal cancer treated with definitive chemoradiotherapy (CRT). Methods: Pts treated with definitive CRT on RTOG trials 8501 and 9405 were included. Separate analyses were performed in pts receiving standard dose (SD-CRT; 50 Gy + 5FU + cisplatin) and high dose (HD-CRT; 64.8 Gy + 5FU + cisplatin) CRT. Local (LF) and regional (RF) failure were estimated by the cumulative incidence method. Disease-free (DFS) and overall (OS) survival were estimated by the Kaplan-Meier method. Univariate (UVA) and multivariate (MVA) Cox proportional hazards models were utilized to examine for correlation between RT duration (< vs. ≥ median) with LF, RF, DFS and OS. Results: In the SD-CRT cohort (n=235), 96 pts (41%) had ≥ 1 RT interruption for a median of 3 (IQR 1-6) days. The median RT duration was 39 (IQR 37-43) days. In UVA and MVA, RT duration was not associated with LF, RF, DFS, or OS. Estimated outcome rates are in the table. In the HD-CRT cohort (n=107), 64 pts (60%) had ≥ 1 RT interruption for a median of 3.5 (IQR 2-7.5) days. The median RT duration was 52 (IQR 50-57) days. In UVA, RT duration ≥ 52 days was associated with a 33% reduction in risk of DFS failure (HR=0.66, 95% CI [0.44-0.98], p=0.039) and a 29% reduction in risk of death (HR=0.71, 95% CI [0.48-1.06], p=0.09). When excluding the 25 pts with RT dose < 64.8 Gy, RT duration was not associated with DFS or OS. Conclusions: In pts with esophageal cancer receiving definitive SD-CRT, an association between RT duration and outcomes was not observed. In pts receiving HD-CRT, longer RT duration was associated with improved DFS, which may have been due to a significant number of deaths at RT dose < 64.8 Gy. Supported by NCI U10 grants CA21661, CA180868, CA180822, CA37422. Clinical trial information: NCT00002631. [Table: see text]
Preoperative imatinib for locally advanced gastrointestinal stromal tumors (GIST): CONVERT trial.
Authors: Vilhena Pereira Bruno Dos Santos
Published: February 2017

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Background: Primary GISTs are frequently diagnosed as large masses requiring wide resections. Our primary objective is to evaluate response rate of imatinib through RECIST and Choi criteria in these patients. Secondary endpoints were downstaging, resectability, safety and tolerability. Methods: This phase II Brazilian study was conducted in 7 centers between 2008 and 2012. To standardize elegibility, inclusion criteria took into account the primary site, size and multi-visceral resection need per surgeon evaluation. Thirty-nine non-metastatic GIST patients with measurable disease and no previous systemic or local treatment were assigned to daily imatinib 400mg for 16 weeks followed by surgery or until medical decision, progressive disease or toxicity. Imatinib could be continued whether adjuvant or palliative according to risk stratification and residual disease. Clinicaltrials.gov NCT01483014. Results: The objective response rate was 32,1% (IC95% 17,9% - 50,7%) on RECIST and 78,6% (IC95% 60,5% - 89.8%) on Choi. One patient (3,8%) had progressive disease, six patients (20%) had serious adverse events with two (6,7%) deaths, not related to the study drug. Treatment discontinuation due to intolerance was observed in 10% of patients caused by extremities pain, nausea, neutropenia, constipation and thrombocytopenia. Surgery was performed on 23 patients (82.1%), with 83,3% being R0. Median tumor size was 9,4cm (1,2 to 22,0cm) and 72,7% had <5 mitosis/50HPF. Conclusions: Imatinib is active and safe in the preoperative setting. Although Choi criteria evaluates responses earlier, a longer course of imatinib, from 6 to 12 months, should be studied to evaluate if longer courses can increase tumor shrinkage and improve this strategy’s usefulness. Clinical trial information: NCT01483014.
Comparison of adjuvant chemoradiation to perioperative chemotherapy for the treatment of resected gastric and gastroesophageal junction adenocarincoma.
Authors: Lim Howard John , Kim Hae Rin , Schellenberg Devin , Kollmannsberger Christian K. , Cheung Winson Y.
Published: February 2017

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Background: There are several accepted peri-operative treatment modalities for resected gastric (GC) and gastroesophageal junction (GEJ) adenocarcinoma. In 2008, peri-operative chemotherapy (CT) using the MAGIC protocol was adopted as the preferred approach over adjuvant chemoradiation with the MacDonald protocol (cXRT) in British Columbia. An era to era comparison was performed to determine if there were differences in outcomes. Methods: Data from pharmacy records of patients (pts) referred to 1 of 5 cancer treatment centres in BC were analyzed from Jan 2001-July 2010. Pts that underwent curative resection for GC or GEJ were included. The cXRT cohort was defined as those treated from Jan 2001-Dec 2007, prior to the introduction of CT. The CT cohort included those treated from Jan 2008-July 2010. Descriptive statistics were used to compare the groups. Survival analysis was performed using Kaplan Meier methods. Results: Table 1 summarizes the patient characteristics. In the CT arm, there were more males, fewer pts with a LN ratio >0.2, and shorter median follow-up. 92.1% completed pre-operative chemotherapy and 44.7% completed post-operative chemotherapy whereas 73.3% of pts completed cXRT (p<0.05). Median survival was 37.5 and 36.9 months in the CT and cXRT arms, respectively. Conclusions: Delivery of CT was consistent with the MAGIC trial whereas more patients completed cXRT than in the MacDonald trial (73.3% vs. 64%). Outcomes of CT compared to cXRT appear to be similar in this comparative analysis with similar relapse and survival rates. Pre-operative CT results in fewer pts with a LN ratio > 0.2. Either modality can be considered in the peri-operative management of GC or GEJ adenocarcinoma. [Table: see text]
Salvage endoscopic submucosal dissection for the treatment of esophageal squamous cell carcinoma after local treatment failure with chemotherapy, radiotherapy, or chemoradiotherapy.
Authors: Iizuka Toshiro , Kikuchi Daisuke , Hoteya Shu , Yamada Akihiro , Kaise Mitsuru
Published: February 2017

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Background: Chemotherapy (CT), radiotherapy (RT), and chemoradiotherapy (CRT) are efficacious treatment options for esophageal squamous cell carcinoma (ESCC). However, local treatment failure remains a major problem. In this study, we applied endoscopic submucosal dissection (ESD) for the treatment of ESCC after local treatment failure with CT, RT, or CRT. The efficacy, safety, and feasibility of salvage ESD were assessed. Methods: Between 2008 and 2014, 611 patients underwent ESD for superficial ESCC in our hospital. Of them, 14 required salvage ESD: 7 for local treatment failure after CT, 4 after CRT, and 3 after RT. Each patient was treated with CT using 5-fluorouracil + cisplatin or RT, which consisted of >50 Gy of irradiation with or without concurrent CT. The following clinical findings were confirmed in all patients: no evidence of lymph node or distant metastasis after treatment, and an endoscopically resectable lesion. Results: The male to female ratio was 11:3 and the mean age was 64.9 (44-81) years. Clinical stages before treatment were T1b/T2/T3/T4 in 10/1/2/1, N0/1 in 7/7, and M0/1 in 13/1, respectively. The mean tumor size was 18.6 mm, and the mean procedure time was 45.7 min. En bloc resection was achieved in 100% of cases, and the R0 resection rate was 78.6%. Histopathological assessment of specimens taken at salvage ESD revealed that 6 lesions (42.9%) had invaded the submucosal layer and had been resected noncuratively because of a positive vertical margin (n = 2) or positive lymphovascular invasion (n = 5). No immediate or delayed complications, including major bleeding or perforation, and no ESD-related deaths occurred. At a mean follow-up period of 26.5 (range, 5–55) months, local recurrence had developed at the treatment site in 2 patient. Overall, 10 patients were still alive. The remaining 4 had developed lymph node metastasis, 2 of whom had died from it. Conclusions: Salvage ESD is an option for ESCC patients with local treatment failure after CT, RT, or CRT.
The feasibility and safety conversion surgery in stage IV gastric cancer.
Authors: Sato Tsutomu , Nishimura Ken , Nakayama Norisuke , Motohashi Osamu , Segami Kenki , Hayashi Shigeya , Kawabe Taiichi , Aoyama Toru , Hayashi Tsutomu , Yamada Takanobu , Oshima Takashi , Rino Yasushi , Ogata Takashi , Cho Haruhiko , Yoshikawa Takaki
Published: February 2017

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Background: Conversion surgery could be an option for stage IV gastric cancer when distant metastasis (M1) is disappeared by palliative chemotherapy, however, feasibility, safety and efficacy of surgery after long-term chemotherapy remains unclear. Methods: This retrospective study examined 21 gastric cancer patients who underwent curative conversion surgery between 2001 and 2013. Postoperative complications were evaluated according to the Clavien-Dindo classification. Overall survival (OS) was estimated by Kaplan-Meier method. Results: Median follow-up period (range) was 43.9 months (7.2-72.1 months). The number of M1 factors was one in 17 patients and two in 4, including metastases to non-regional lymph node in 11, peritoneum in 11, and liver in 3. The regimen of chemotherapy was S-1/CDDP in 11 patients, S-1/docetaxel/CDDP in 5, S-1/docetaxel in 2, 5FU/leucovorin/paclitaxel in 1, CPT/CDDP in 1, and S-1 monotherapy in 1. The median duration from initiation of chemotherapy to disappearance of M1 factor was 3.5 months and the median duration from initiation of chemotherapy to the operation was 7.5 months. A total of 19 patients (90.4%) underwent over D2 lymphadenectomy including modified D2 in 2 patients, D2 in 16, and D2 plus para-aortic nodal dissection in 3. M1 tumor was not resected except para-aortic nodal dissection in 3 patients. The median operation time and bleeding were 205 minutes and 228 ml, respectively. Grade 2/3/4 morbidities were observed in 5 patients (23.8%); 2 pancreatic fistula (grade 2), 2 abdominal abscess (grade 2 and 3), and 1 anastomotic leakage (grade 3). No mortality was observed. Pathological response of the primary tumor, defined as disappearance of more than two third of the tumor cells, was 66.7% including 19.0% of complete response. The overall survival (OS) after initiation of chemotherapy was 90.5% at 1-year, 85.7% at 2-year, and 75.9% at 3-year with median survival time (MST) of 52.9 months, while OS after surgery was 90.5% at 1 year, 76.2% at 2-year, and 64.5% at 3-year with MST of 40.9 months. Conclusions: Curative conversion gastrectomy for stage IV gastric cancer was feasible and safe. Considering excellent survival, conversion surgery has a value to be evaluated in prospective studies.