bluuebunny/crossref_metadata_2025 huggingface dataset:
Program development in palliative care: Results from the NCI Community Cancer Centers Program (NCCCP).
Authors: Padgett Lynne Slaughter , Davis Mary Helen , Tallen Colleen , Carrigan Angela , Rowland Julia Howe
Published: February 2017

42

Background: Growing national attention to the need for metrics to document delivery of quality palliative care has resulted in a proliferation of measures and standards (e.g., Commission on Cancer, Quality Oncology Practice Initiative). While these standards offer benchmarks to strive for, there are few resources for programs to self-assess development of organizational infrastructure to achieve them. Methods: The NCCCP Cancer Palliative Care Matrix (PCM) is a performance measure and evaluation tool to aid palliative care program development in the community setting. The PCM was completed annually by 21 NCCCP sites from 2010 to 2013. Four domains related to quality measures are reported here. Proportional-odds logistic regression models were used to evaluate the relationship between year and level of response. Results: Variations in program development were seen in the quality domains of symptom assessment, palliative care services offered across the continuum of care, identification for palliative care services, and use of quality measures. In 2010, 13/21 sites reported that symptom assessment were not performed or performed inconsistently. By 2013, 13 sites reported consistent assessment with standardized tools, with 5 of these 13 able to review sequential patient assessment (p=0.002). Similar gains were seen in the domains of providing services across the continuum of cancer care and utilization of quality measures such as patient/provider satisfaction and service utilization (p=0.004, p<0.0001). Despite three years of effort, little change was seen in patient identification processes for palliative care services with only 6 of 21 sites in 2013, compared to 5 in 2010, reporting improvement in "upstream" patient identification regardless of cancer stage (p=0.065). Conclusions: Data suggest the utility of the PCM to evaluate process and quality outcomes in palliative care program development. In addition, identification of challenge and growth areas can be used to develop interventions to address quality performance in both clinical and research contexts.
Implementation of clinical triggers for palliative care consultation on a gynecologic oncology inpatient service: A pilot study.
Authors: Lefkowits Carolyn , Courtney-Brooks Madeleine , Teuteberg Winifred , Leahy Janet , Sukumvanich Paniti , Kelley Joseph L
Published: February 2017

51

Background: Our objectives were to (1) Assess the feasibility of creating clinical triggers for Palliative Care (PC) consultation on a large gynecologic oncology service and (2) Use triggers to increase PC consultation rates among trigger positive patients. Methods: Clinical triggers for PC consultation are listed below. Over a six month period, patients meeting triggers were prospectively identified and PC consultation was requested for those patients. Retrospective chart review was used to identify patients meeting triggers and gather clinical information. PC consultation rates were compared for patients meeting triggers in the 6 months pre and post trigger implementation. Statistical analysis utilized χ2 test, Fisher’s exact test and independent samples t-tests. Results: There was no difference in PC consultation rates among patients meeting triggers between the pre and post-triggers periods (see table). There was also no change in time from admission to PC consult (median time to PC consultation 1.56d vs. 2.24d, p=0.28) and no change in overall PC consultation volume (mean 17.3 new PC consults per 100 admissions/month vs. 18.5, p=0.67). Of the 38 patients in the post-triggers period who were not seen by PC, 50% (n=19) were inaccurately deemed trigger negative during their admission and 13% (n=5) were not screened at all. Conclusions: Creation of clinical triggers for PC consultation was feasible in terms of investment from relevant stakeholders. Trigger implementation was not associated with increased rates of PC consultation for those patients. High baseline rates of PC consultation and screening process issues contributed significantly to the lack of change in PC consultation rates. Use of clinical triggers may still hold promise as a strategy for standardizing PC consultation patterns and capturing subgroups of patients with high needs. Next steps include modifying our clinical triggers and screening process and expanding into the outpatient setting. [Table: see text]
Perspectives on palliative care in a multisite oncology practice.
Authors: Bishop Kenneth D. , Taber Angela Marie
Published: February 2017

52

Background: The Institute of Medicine reported that many cancer patients do not receive palliative care to manage symptoms. It is possible that practitioners do not identify palliative care as an important component of high-quality cancer care, or do not know how to most efficiently utilize available palliative care consultative services. Methods: An anonymous electronic survey was sent to physicians, nurses, nurse practitioners, physician assistants, and social workers (n=99) in our multi-site, single-institution Cancer Center. Results: Sixty-five responses were received (66% response rate). Eighty-three percent of respondents reported working primarily in the outpatient setting. Fifty-nine percent reported their patients ‘rarely use the ER for pain management’ while 16% reported their patients ‘frequently require ER visits for pain management’. Ninety-two percent considered palliative care ‘an integral part of a multidisciplinary team’ while 6% reported palliative care consultation to be ‘cumbersome to consult and coordinate with’. The most common reason for consultation was end-of-life discussions (38%) followed by chronic pain management (33%). Seventy-seven percent reported consulting between 1 and 5 times per month, 14% between 6-10 times per month, and 5% greater than 11 times per month. Thirteen percent reported that they were able to manage patient symptoms adequately themselves. The average rating for convenience of consulting palliative care was 3.8/5. Fifty-eight percent reported the most effective means of communication with palliative care consultants was through the medical record, whereas 42% reported that most effective communication took place in person. Sixty percent reported a preference for palliative care practitioners from within the division of hematology/oncology. Conclusions: Our survey suggests that the majority of oncology practitioners value palliative care consultation and are willing to incorporate palliative care services into patient management. It is possible that practitioners overestimate their utilization of palliative care services and that optimizing the convenience of consultation and communication would result in better integration of palliative care for cancer patients.
Embedding palliative care into care coordination.
Authors: Zachariah Finly , Gallo Mariela , Loscalzo Matthew , Crocitto Laura E.
Published: February 2017

62

Background: The Institute of Medicine (IOM) identified care coordination as a key strategy with potential to improve the safety and effectiveness of implemented care by deliberately organizing patient care activities and sharing information among all participants concerned. Palliative care maximizes quality of life for patient and family in serious illness and can be provided early and concurrently with curative therapies. At City of Hope National Medical Center (COH), we developed a pilot program for bladder cancer patients undergoing cystectomy to provide the benefits of care coordination and palliative care. Methods: 72 patients underwent cystectomy at COH from 2011-2013, the average case mix index was 3.51, the average length of stay (LOS) was 10.65 days, the LOS index was.92, Cost index 1.61, 30-day readmission rate 32.14%, and the most common causes for readmission were infection and dehydration. Based on comparative data, the urology service supported development of a novel pathway by a multidisciplinary team. The goals of the pathway are to facilitate navigation through the healthcare system, integrate tablet-based bio-psycho-social screening to proactively address patient and caregiver needs and goals, optimize medications to improve symptom management and recovery, empower patients with teach-back education, have anticipated interventions for likely readmission reasons, and develop effective collaboration amongst multidisciplinary providers across settings. The metrics include LOS, readmission rates, patient and family satisfaction, advanced directives on file, and cost index. Results: Hospital leadership and provider buy in was obtained, a daily rounding multidisciplinary team was created, change champions were identified, staff engagement increased, and COH and community agency staff were equipped with needed skills and support. Care model diagrams and clinical pathway orders were developed. Education materials were revised and updated. The pilot launched in April of 2014. Conclusions: We believe that a care coordination model with early integration of palliative care will improve the effectiveness of care delivered to our bladder cancer patients. A six-month retrospective review will be done to assess metric achievement.
Interdisciplinary community oncology clinic intervention to improve pain control for all patients.
Authors: Elnadry Jeanne , Duarte Tina , Yang Gregory John C. , Badari Ambuga
Published: February 2017

63

Background: In rural Yuma, AZ there are too few palliative care specialists to meet the needs of the population. This report presents a unique approach to interdisciplinary care for pain management beginning early in cancer care. To address this need a palliative care specialist collaborated with the entire clinical staff of the community cancer center, including physicians, nurses, social worker, pharmacist, and medical assistants, to initiate a new distress screening tool and develop an interdisciplinary collaborative practice model for pain management. Methods: Data was analyzed from 274 consecutive patients using a review of systems form which was modified 3/2014 to include more information regarding pain, depression/anxiety, communication about illness, spiritual needs, and educational needs, and from 55 patients admitted to home hospice. All clinical staff reviewed the data together and mapped clinical processes. A pain assessment protocol was developed for nurses and medical assistants, who gave the assessment summary to the physician seeing the patient. Further training for nurses taught an algorithm to collaborate with physicians for pain medication orders driven by the assessment findings. Results: About 1/3 of patients had significant concerns about pain. End-of-life data showed that 31% of 55 patients admitted from the cancer center to a local hospice had moderate to severe pain (pain score 4-10) at the time of hospice admission. 88% of these patients’ pain was controlled within 48 hours of admission to home hospice, with pain score 0-3. Data for 274 consecutive clinic patients showed that 30% of patients had concerns about pain, 30% about advanced care planning and communication, and 32% about anxiety, depression, and coping. Of the 162 patients who reported distress, 57% reported distress in 2 or more domains. Conclusions: Hospice data showed that nearly all cancer patients with moderate to severe pain could have pain control within 48 hours. Patients undergoing treatment should be able to have similar results, but were not. Follow-up data collection to assess effect of the collaborative practice model intervention is planned for August 2014.
Putting pediatric palliative care in prime time.
Authors: Kirch Rebecca A , Ullrich Christina K
Published: February 2017

68

Background: For patients and families at any age and stage, treating the symptoms and stress of cancer is as important as treating the disease. Palliative care has hit its stride as one of the nation’s fastest growing health care trends, with a robust evidence base, new quality standards, increasing awareness and understanding, and a related public policy agenda. This momentum positions pediatric palliative care as an essential aspect of advancing childhood cancer survivorship with high quality of life – particularly important for children given the documented symptoms, late effects and disabling conditions they experience into adulthood and across their lifetime. This oral presentation will describe pediatric palliative care’s prominent role in addressing the challenges of childhood cancer and survivorship across the continuum, providing practical clinical case study context and highlights of consumer research findings and an advocacy agenda helping address palliative care’s “identity problem” that affects access to quality care. Methods: This presentation provides practical information for integrating palliative care to benefit children and families, including lessons learned through implementation of early pediatric palliative care alongside disease-directed treatment under the Concurrent Care for Children Requirement and other initiatives. It will also identify available resources for communicating about palliative care based on consumer research from the American Cancer Society and Center to Advance Palliative Care. Results: This presentation will inform and inspire person-centered and family-focused activities to advance early integration of palliative care in research and clinical practice. It will also highlight opportunities for active involvement in the QOL national movement to improve quality cancer care. Conclusions: Audience will understand benefits of pediatric palliative care and strategies supporting its delivery through the pediatric concurrent care experience in oncology. They will also gain improved proficiency in communicating about palliative care, and will be well-positioned to engage in the QOL legislative campaign to bring palliative care everywhere as an essential element of quality care.
Disparities in hospitalized cancer patients receiving palliative care consultation.
Authors: Smith Cardinale B. , Ornstein Katherine , Stefanis Lee , Meier Diane E. , Morrison R. Sean
Published: February 2017

7

Background: Racial and ethnic disparities in healthcare have been well documented among minority groups with respect to access to care, receipt of care, and quality of care. As a result, minority populations are diagnosed with late stage cancer and have inferior outcomes likely leading to increased suffering. Little is known, however, about disparities in access to and outcomes of patients receiving specialty palliative care (PC). Methods: We used data from the Palliative Care for Cancer Patients (PC4C) study, a multisite observational study of the effect of inpatient PC on patient health outcomes and health services use among advanced cancer patients. We limited our sample to patients that received PC from established, interdisciplinary consult teams. We used univariate analyses and multiple regression analyses to compare differences in outcomes among minority (black and Hispanic) and non-minority patients receiving PC. Results: 583 (19%) patients received a PC consult. Of those, 166 (28%) were minorities and 418 (72%) non-minorities. Mean days to a palliative care consult was 4.4 vs. 3.2 in non-minorities and minorities, respectively (p=0.65). At baseline, minority patients reported a higher burden of symptoms as measured by the condensed memorial symptom assessment scale (CMSAS). Similarly, they were less likely to have talked about their wishes with their doctor (p=0.04); less likely to have completed a living will (p<0.001), or have a proxy (p<0.001); had no difference in pain but were less likely to be taking pain medications (p<0.001) or report relief from pain medicines (p=0.05). After PC consult all CMSAS symptoms improved for minority patients (except worry; p=0.03). Additionally, after PC consult there were no longer any significant differences among minorities with respect to discussing their wishes (p=0.27), DNR completion (p=0.72), proxy assignment (p=0.22) and taking pain medications (p=0.22) when compared to non-minorities. Conclusions: PC is associated with improvements in symptom control and discussions of care goals among minority patients who have worse baseline health assessments. Future efforts need to focus on increasing the availability and use of specialty PC for this at-risk population.
Performance status, quality of life, and survival in patients with advanced cancer referred to palliative care: A pilot study.
Authors: Gilbertson-White Stephanie , Weckmann Michelle , Donovan Heidi , Sherwood Paula R
Published: February 2017

77

Background: Patients with advanced cancer often need specialized palliative care (PC) for aggressive symptom management as their cancer progresses. The purpose of this study is to evaluate the feasibility of following patients with advanced cancer referred to PC for symptom management. The aims are to: 1) describe survival status at 12-wks post PC referral, and 2) compare time to PC referral, performance status, and quality-of-life (QOL) at baseline across survival status groups. Methods: Patients (N=20) with advanced cancer newly referred to PC were recruited. Date of cancer diagnosis, date of referral to PC, and survival status were abstracted from the medical record. The number of weeks was calculated from the date of cancer diagnosis to the date of PC referral. Palliative Performance Status (PPS) scale was used to measure performance status. Higher % scores indicate better performance status. SF-36 was used to measure QOL. Higher scores indicate higher perceived QOL. Results: At 12-weeks post PC referral, 6 patients were alive, 8 patients were lost to follow-up, and 6 patients had died. Missed appointments with PC or cessation of cancer treatments were primary reasons patients were lost to follow-up. Patients alive at 12-wks had the best PPS scores at baseline (mean=58%) and the shortest length of time between cancer diagnosis and PC referral (mean=81.5 wks). Patients lost to follow-up had the worst PPS scores at baseline (mean=44%) and the longest time to PC referral (mean=745 wks). No differences were found on the SF-36 subscale scores. Conclusions: Performance status was a strong predictor of survival status at 12-wks post PC referral. Patients with the longest time between diagnosis and PC referral were most likely to be lost to follow-up. All patients with advanced cancer reported significant declines in QOL. Further research is needed to understand how time to PC referral is associated with missed appointments or decisions to stop cancer treatments. Prospective research from the time of diagnosis with advanced cancer through the end-of-life is needed to better understand how PC can help maintain performance status and QOL for as long as possible.
Coping with uncertainty: A qualitative study of 33 palliative care consultations among patients with advanced cancer.
Authors: Tejani Mohamedtaki Abdulaziz , Kamen Charles Stewart , Mohile Supriya Gupta , Gramling Robert E.
Published: February 2017

92

Background: Despite scientific advances, uncertainty remains an inherent and significant issue in clinical practice. Among patients with advanced cancer, uncertainty about the future can lead to distress, loss of sense of control and lower quality of life. Helping patients manage uncertainty is a core domain of patient-centered care. Little is known about how palliative care providers work with cancer patients to accomplish this goal. Methods: We performed descriptive analysis of transcripts from audio recorded inpatient palliative care consultations among adult cancer patients referred for ‘goals of care’ or ‘end of life decision making.’ Each transcript was read as a whole and then again line by line to code verbal expressions of uncertainty. Excerpted segments dealing with uncertainty about the future were grouped and analyzed by an experienced qualitative research working group. Results: 33 consultations were analyzed: 53% men, median age 62 and median survival 3.6 weeks. Multiple expressions of uncertainty were identified – 106 by patients/families and 56 by providers. A majority (63%) were centered on the inevitable uncertainty in predicting clinical course at the end of life. Palliative care providers managed this type of uncertainty in three main ways: (a) pairing expressions of unpredictability with reiteration of what was certain/known at time of consultation (e.g. ‘we will not let you suffer’); (b) utilizing inherent uncertainty of future to promote hope and faith (e.g. ‘nobody knows how long you are going to live’) and (c) reassurance that multi-disciplinary providers would convene to provide consensus and clarity for next visit (e.g. ‘we will all put our heads together and come up with exactly which options are available.’). Conclusions: Uncertainty is highly prevalent during end of life consultations with advanced cancer patients. Palliative care providers use validating strategies to help patients acknowledge and cope with what is inherently uncertain about their future. These methods can be used to develop communication training and guidelines for use with advanced cancer patients at the end of life.
Discontinuing chronic medications: Perceptions of patients with life-limiting illness.
Authors: Kutner Jean , Ritchie Christine , Furuno Jon , Prince-Paul Maryjo , Tjia Jennifer , McPherson Mary Lynn , Sloan Jeff A. , Somers Tamara , Abernethy Amy Pickar , Blatchford Patrick Jud
Published: February 2017

97

Background: Optimal management of chronic medications is uncertain in life-limiting illness. To inform shared decision making, we assessed patient perceptions in a trial on the safety of discontinuing statins in life-limiting illness. Methods: Eligible adults (life expectancy 1–12 months, on statin for ≥ 3 months for primary/secondary prevention, recent functional decline, no active cardiovascular disease) were randomized to discontinue or continue statins and were followed monthly for up to 1 year. Cognitively intact participants were asked 9 questions regarding discontinuing statins prior to randomization. We used Pearson chi-square to compare responses between study groups and between those with and without cancer. Of 381 participants, 297 (78%) were cognitively intact (138 discontinued, 159 continued statins). Mean age was 72 years (SD 11) and mean number of medications used was 11.5 (SD 5.0); 58% (N = 173) had cancer. Results: There were no statistically significant differences between the study groups in responses to the medication perception questions. Aggregate findings are presented (Table). Patients with cancer were less likely to think that they may be able to stop other medications (28% vs. 42%, p=0.007) and that statin discontinuation means that the doctor is giving up on them (1% vs. 7%, p=0.013). Conclusions: Few participants expressed concerns about discontinuing statins; many perceived potential benefits. Cancer patients may perceive less impact from stopping statins. Clinicians should inquire about patient concerns when engaging in shared decision making about discontinuing chronic medications in the setting of advanced cancer. Clinical trial information: NCT01415934. [Table: see text]
The effect of perioperative transfusion on recurrence and survival following gastric cancer resection: A seven-institution analysis of 765 patients from the U.S. Gastric Cancer Collaborative.
Authors: Squires Malcolm Hart , Kooby David A. , Poultsides George A. , Weber Sharon M. , Bloomston Mark , Fields Ryan C. , Pawlik Timothy M. , Votanopoulos Konstantinos I. , Schmidt Carl Richard , Ejaz Aslam , Acher Alexandra W. , Worhunsky David J. , Saunders Neil , Swords Doug S. , Jin Linda X. , Cho Clifford Suhyun , Winslow Emily , Russell Maria C. , Staley Charles A. , Maithel Shishir K.
Published: February 2017

100

Background: Whether perioperative blood transfusion has a negative prognostic effect on recurrence and survival in patients undergoing resection of gastric adenocarcinoma (GAC) is unknown. Methods: All patients who underwent resection for GAC from 2000-2012 at 7 institutions were identified. The effect of transfusion on recurrence-free (RFS) and overall survival (OS) in the context of adverse clinicopathologic variables was examined by univariate (UV) and multivariate (MV) regression analyses. Results: Out of 965 pts, 765 underwent curative intent, R0 resection. Median FU for survivors was 44 mos; 30-day deaths were excluded. Median estimated blood loss (EBL) was 250cc and 166 pts (22%) received perioperative RBC transfusions. 5-yr RFS was 51% in transfused and 61% in non-transfused patients (p=0.01). Median OS was decreased in patients receiving transfusions (19 vs 50 mos, p<0.001). On MV analysis, transfusion remained an independent risk factor for decreased RFS (HR 2.8; 95% CI: 1.2-6.5; p=0.01) and decreased OS (Table), regardless of EBL or need for splenectomy. Timing (intraop vs postop) and volume (# of units) did not alter the effect of transfusion on survival. Non-transfused pts were more likely to receive adjuvant therapy (56% vs 44%; p=0.01). Conclusions: Perioperative blood transfusion is associated with decreased recurrence-free and overall survival following resection of gastric cancer, independent of adverse clinicopathologic factors. This supports the judicious use of perioperative transfusion during resection of gastric cancer. [Table: see text]
Acid-suppressive medications and risk of esophageal adenocarcinoma in patients with Barrett’s esophagus: A systematic review and meta-analysis.
Authors: Singh Preet Paul , Singh Siddharth , Garg Sushil Kumar , Iyer Prasad G. , El-Serag Hashem
Published: February 2017

11

Background: Acid-suppressive medications, particularly proton pump inhibitors (PPI), may modify risk of esophageal adenocarcinoma (EAC) in patients with Barrett’s esophagus (BE). We performed a systematic review and meta-analysis of studies evaluating the association between PPIs and histamine receptor antagonists (H2RA) and risk of EAC or high-grade dysplasia (BE-HGD) in patients with BE. Methods: Through a systematic search up to June 2013, we identified 7 observational studies (5 cohort studies and 2 case-control studies; 2,813 patients with BE, 317 cases of EAC and/or BE-HGD, 84.4% PPI users) reporting the association between PPIs or H2RA and EAC in patients with BE. Summary odds ratio (OR) with 95% confidence intervals (CI) was estimated using random effects model, and heterogeneity was measured using the inconsistency index (I2). Results: On meta-analysis, PPI use was associated with 71% reduction in EAC risk in patients with BE (adjusted OR, 0.29; 95% CI, 0.12-0.71). There was a trend toward a dose-response relationship with PPI use for >2 years protective against EAC [3 studies; PPI use >2 years vs. <2 years (as compared to no use): OR, 0.45 (0.19-1.06) vs. 1.09 (0.47-2.56)]. Considerable heterogeneity was observed in the overall analysis (I2=81%). On restricting analysis to 5 cohort studies, use of PPIs was consistently associated with a lower risk of EAC and/or BE-HGD (adjusted OR, 0.33; 95% CI, 0.19-0.58; I2=9%). H2RA use was not associated with decreased risk of EAC in patients with BE based on 2 studies (adjusted OR, 1.15; 95% CI, 0.77-1.72). Using a 67% summary risk reduction (derived from cohort studies) of EAC and/or BE-HGD with PPI use in patients with BE, and observed cumulative incidence rates of EAC and/or BE-HGD in patients with BE overall as 10.2 per 1,000 patient years, we estimate the number needed to treat with PPIs to prevent 1 case of EAC or BE-HGD in BE patients at 147. Conclusions: Based on meta-analysis of observational studies, the use of PPI, but not H2RA appears to be associated with a decreased risk of EAC and/or BE-HGD in patients with BE. PPI use should be considered in BE, and chemopreventive trials of PPIs in patients with BE are warranted.
Evaluation of the effects of postoperative oral nutrition support on body weight in gastric cancer patients by using an elemental diet: A randomized study.
Authors: Nishikawa Kazuhiro , Kishi Kentaro , Inoue Kentaro , Matsuyama Jin , Akamaru Yusuke , Kimura Yutaka , Tamura Shigeyuki , Kawabata Ryohei , Kawada Junji , Fujiwara Yoshiyuki , Kawase Tomono , Fukui Junichi , Takagi Mari , Takeno Atsushi , Shimokawa Toshio , Imamura Hiroshi
Published: February 2017

110

Background: Postoperative weight loss causes deterioration in the patient’s quality of life and influences long-term prognosis in gastric cancer patients who have undergone gastrectomy. Moreover, recent retrospective studies indicated postoperative weight loss as a risk factor for premature interruption of S-1 adjuvant chemotherapy. We conducted a prospective randomized controlled study to examine whether the early institution of nutritional support comprising an oral elemental diet (ED) prepared for post-gastrectomy patients with depressed digestive/absorptive function would help prevent postoperative weight loss. Methods: After surgery, patients were randomly assigned to the ED or control groups. The groups were divided according to the surgical methods used (total/distal gastrectomy), clinical stage (≤Ia/>Ia), and patients’ body mass index (<18.5/>18.5). In patients assigned to the ED group (Elental, 300 kcal) was provided in addition to the regular diet from the day starting soft rice diet or equivalent diet to 6–8 weeks after surgery. The primary endpoint was the percentage of body weight change from the pre-surgical body weight to that at 6–8 weeks after surgery. The secondary endpoints were ED adherence, nutrition-related blood parameter changes, and adverse effects. Results: The study included 112 patients from eight hospitals. There was a significant difference in the percentage of body weight loss (%BWL) between the ED and control groups (4.88±3.41% and 6.91±5.06%; P=0.015). Sub-group analysis showed a significant difference in the %BWL in patients who underwent total gastrectomy (5.31±3.43% and 9.11±5.57%; P=0.016). Multivariate analysis demonstrated ED treatment and surgery type as independent factors that affect body weight changes. The mean treatment compliance rate in the 58 ED-group patients was 72.9±33.1%, with a favorable median value of 90.8%. No significant differences were observed in any parameter analyzed, including hematological and non-hematological adverse events, between the two groups. Conclusions: The ED product can prevent postoperative weight loss in gastric cancer patients undergoing gastrectomy. Clinical trial information: 000008056.
Effect of a multidisciplinary cancer conference for thoracic malignancies on patient care management.
Authors: Schmidt Henner M. , Roberts John M. , Bodnar Artur M. , Kirtland Steven H. , Kunz Sonia H. , Markar Sheraz , Low Donald E.
Published: February 2017

112

Background: Treatment of thoracic cancers frequently involve multiple subspecialties thus treatment decisions are typically best facilitated in multidisciplinary tumor boards (MTB). This approach should facilitate and improve treatment decision making, standardize staging and therapeutic decisions and improve outcomes. In this study we analyze the evolution in staging and treatment decision making associated with presentation at MTB. Methods: Retrospective review of all patients with lung or esophageal cancer presented at our weekly MTB from June 1, 2010 to September 30, 2012. All providers submitting patients to tumor board recorded their current treatment plan prior to presentation. The physician’s plan was then compared to the tumor board’s final recommendation. Changes made were graded according to degree of magnitude as minor, moderate or major change. Minor changes included changes in diagnostic imaging. Moderate changes involved modifications in the type of invasive staging or biopsy procedures. Major changes were defined as changes to final therapeutic plans such as surgery, chemotherapy, or radiation therapy. Results: 435 patients with esophageal or lung cancer were discussed in the MTB. 86 patients having no prior treatment plan available were excluded. In the remaining 347 patients there were 163 patients with esophageal cancer (47%) and 184 patients with lung cancer (53%). In the esophageal cancer patients a change to the physician’s prior treatment plan was recommended in 33 cases (21%). For lung cancer patients a change in the treatment plan was recommended in 50 cases (27%). Overall a recommendation for change in treatment occurred in 83 cases (24 %). Changes were major 13%, moderate 6% and minor 5%. Follow-up in 249 patients confirmed that MTB recommendations were followed in 97% of cases. Conclusions: MTB recommendations frequently differs from the physician’s primary treatment plan. MTB reviews have previously been documented to improve patient’s outcome. The study demonstrates that in one quarter of patients MTB recommendation will be different from the primary treatment plan. Complex cancer patients should be considered for presentation at MTB whenever feasible.
Assessment and management of the risk of recurrence of resected gastrointestinal stromal tumors.
Authors: Conley Anthony Paul , Sasane Medha , Pelletier Corey L. , Guérin Annie , Macalalad Alexander R. , Huang Qing , Wu Eric Q.
Published: February 2017

119

Background: For patients with KIT+ gastrointestinal stromal tumors (GIST), several algorithms can evaluate the risk of recurrence and initiation of adjuvant therapy following primary GIST resection. With a variety of risk assessment tools and no standardized approach for assessing risk, it is unclear how physicians estimate the risk of recurrence in real-world clinical practice, and how they use the level of risk when considering adjuvant therapy. Methods: We conducted a cross-sectional survey of US oncologists on August 2013. From an existing panel of US physicians, oncologists were randomly asked to participate in an online survey of their assessment and management of GIST recurrence risk after resection of primary resectable disease. Oncologists’ feedback included rated responses by Likert scale and ranked responses by priority. Results: Of 109 participating oncologists, 69 (63%) were in private practice and 61 (56%) were in practice for >10 years. Mitotic count and primary tumor size were the most influential factors chosen for assessing risk of recurrence, followed by presence of tumor rupture during surgery, tumor location, and presence of genetic mutations. A majority of oncologists (56%) reported the revised NIH criteria as the preferred risk classification tool, mainly because it was easy to use and remember. Initial level of risk assessed after GIST resection was the key factor influencing initiation, dosage, and duration of adjuvant therapy with imatinib. 98% of physicians would treat high risk patients with adjuvant imatinib, whereas 79% would consider adjuvant treatment for intermediate risk patients, and 28% for low risk patients. The percentage who would prescribe at least 3 years of adjuvant therapy varied from 26% for low-risk patients to 52% for intermediate-risk patients and 76% for high-risk patients. Conclusions: Level of risk of recurrence is a key factor when considering adjuvant therapy after resection of resectable GIST. However, significant variability exists in the perception physicians have regarding the initiation of adjuvant therapy among intermediate to high risk patients. This may be attributed to the variability in the different risk assessment tools and criteria.
Chemoradiotherapy for highly advanced gastric cancer.
Authors: Tsutsui Mai , Takahashi Tsunehiro , Saikawa Yoshiro , Kawakubo Hirofumi , Wada Norihito , Takeuchi Hiroya , Kitagawa Yuko
Published: February 2017

121

Background: Although the prognosis of early gastric cancer is favorable, the treatment for advanced cases still have difficulty in achieving satisfactory results. Thus, more effective multimodality treatment should be established. Chemoradiotherapy has become a standard treatment for gastric cancer especially as an adjuvant therapy while radiotherapy has been expected as one of the modalities against highly advanced gastric cancer. Methods: Patients with advanced gastric cancer who were treated with chemotherapy of S-1 and cisplatin plus radiation were analyzed retrospectively. Concurrent radiation therapy (5 days/week) at 2 Gy/day was started with chemotherapy and repeated daily on days 1–5, 8–12, 15–19 and 22–26. Irradiation was planned using a computed tomography (CT) simulator for two rectangular portals with a pair of 45-degree wedge filters and was targeted at the primary tumor and surrounding lesions, including lymph nodes. Results: A total 109 patients were treated with chemoradiotherapy between 2002 and 2013 at our institute. The median age was 64 years. Histological type included 45 differentiated and undifferentiated 64 subtypes. The TNM stage before the treatment was diagnosed as IIIA: 11; IIIB: 10; IIIC: 14; IV: 74. Of the 98 evaluable patients, 69 patients had partial responses while no patients had a complete response, resulting in an overall response rate of 70%. Progressive disease (PD) occurred in 2 patients (4%). The most frequent adverse events more than grade 3 were hematologic toxicities, including leukocytopenia (47%), neutropenia (25%), and thrombocytopenia (24%). Non-hematologic toxicities such as general fatigue, renal-related events, and gastrointestinal toxicities were manageable with no treatment-related death. The median survival time was 537 days. Conclusions: While there were disadvantages of radiotherapy including the difficulty of confirming the area of irradiation due to peristaltic movement, risk of perforation and ulceration, recent technological advancement of radiation therapy has enabled pinpoint accuracy in treatment of primary gastric lesions and regional lymph nodes. There has been much anticipation that chemoradiotherapy will be a part of multidisciplinary treatment for advanced cancer.
Trastuzumab (T-mab) in combination with docetaxel/cisplatin/S-1 (DCS) for patients with HER2-positive metastatic gastric cancer: Feasibility and preliminary efficacy.
Authors: Sato Yasushi , Takayama Tetsuji , Ohnuma Hiroyuki , Hirakawa Masahiro , Osuga Takahiro , Miyamoto Hiroshi , Sagawa Tamotsu , Sato Yasuhiro , Takahashi Yasuo , Katsuki Shinich , Okuda Tokunori , Takada Kohichi , Hayashi Tsuyoshi , Sato Tsutomu , Miyanishi Koji , Takimoto Rishu , Kobune Masayoshi , Nobuoka Takayuki , Hirata Koichi , Kato Junji
Published: February 2017

124

Background: Recently the efficacy of trastuzumab (T-mab) for HER2-positive gastric cancer has been reported. We have developed a triplet-drug combination regimen consisting of docetaxel, CDDP, and S-1 (DCS) and reported that the regimen provides very high response rates (BJC 2007; CCP 2009 and 2013). To increase the efficacy of DCS in patients (pts) with HER2-positive unresectable gastric cancer, we carried out a feasibility study for the DCS-T-mab (DCS-T) regimen. Methods: Eligibility criteria included the following: age between 20 and 80 years; unresectable HER2-positive metastatic gastric cancer; normal cardiac function. Pts received oral S-1 (40 mg/m2 b.i.d.) on days 1-14, intravenous cisplatin (60 mg/m2), docetaxel (50 mg/m2) and T-mab (8 mg/kg in the first cycle and 6 mg/kg in the second cycle and thereafter) on day 8 every 3 weeks. Results: This study included 16 pts: median age, 60 years (34 – 76 years), 11 males and 5 females. PS 0/1/2, 10/4/2; differentiated/undifferentiated-type histology, 11/5; U/M/L, 7/8/1; HER2 3+, 13; HER2 2+/FISH+, 3; T3/T4a/T4b, 11/4/1; N0/N1/N2/N3, 2/0/4/10; and distant lymph nodes/liver/peritoneum/lungs/bone/ovaries, 11/7/4/2/1/1. The completion rate until the third cycle was 100%. According to the RECIST criteria, the objective response rate was 93.3%, and the median cycle to response was 1 (1–3 cycles). Adverse events of grade 3 or greater severity were: leukopenia/neutropenia, 68.8/81.3%; FN, 12.5%; anorexia, 25%; and diarrhea, 25%. All of these side effects were well controlled. Non-curative factors disappeared in 7 of 16 cases and R0 resection was carried out in 6 cases (37.5%) including 2 pts with liver metastases. A pathological response was found in 83 % of 6 resected cases. At a median follow-up of 9.8 months (2.3 – 23 months), median PFS was 12.8 months and median OS was not yet reached. Conclusions: T-mab in combination with DCS is a feasible regimen in pts with unresectable HER2-positive gastric cancer. The observed response rate is very promising and warrants further investigation. Clinical trial information: UMIN000005603.
A phase 2 study of trastuzumab in combination with S-1 and cisplatin in first-line human epidermal growth factor receptor (HER)-2-positive advanced gastric cancer.
Authors: Choo Su Pin , Chua Clarinda Wei Ling , Yamada Yasuhide , Rha Sun Young , Yong Wei Peng , Tham Chee Kian , Ng Matthew , Tai Wai Meng David , Lim Hwee Yong , Tan Iain B.
Published: February 2017

127

Background: The addition of trastuzumab to cisplatin and 5-fluorouracil or capecitabine has been shown to have superior survival benefit. In this study, the addition of trastuzumab to chemotherapy combination, S-1 (tegafur, gimeracil, oteracil potassium; TS-ONER) and cisplatin, a standard first line therapy for advanced gastric cancer in Japan, was evaluated for efficacy and safety. Methods: This was a single-arm, phase II trial recruiting patients with advanced HER-2 positive (IHC 3+ or FISH +) gastric adenocarcinoma who had not had prior systemic therapy. Patients included had measurable disease, ECOG 0-2, creatinine clearance >60ml/min, LVEF at least 50%. Patients accrued received cisplatin at 60mg/m2 on day 1 of each cycle, trastuzumab at 8mg/kg as loading dose followed by 6mg/kg on day 1 of each cycle and oral S-1 for 14 days ( dosing based on BSA), every 3 weeks. Treatment continued till progressive disease or unbearable toxicity. Primary endpoint was response rate (ORR) and secondary endpoints were PFS, OS, CBR and safety. The study was designed to distinguish a favorable ORR of 55% from a null rate of 30% at 5% significance level and 80% power. Results: A total of 30 patients were recruited. Median age was 61.9 years, 73% were males and 90% had no prior resection of primary tumor. 56.7% were Chinese, 23.3% Japanese and 20% Korean. One patient achieved complete response, 16 had partial response and 2 had stable disease >24 weeks (ORR 63%; CBR 70.4%). Three patients did not have evaluable disease. With a median follow-up of 7.2 months, the median PFS was 7.4 months with 67.7% free of disease progression at the 6-month mark. Median OS was 14.6 months. The most common AEs were anorexia (50%), fatigue (47%), diarrhea ( 47%), nausea (37%), neutropenia (33%), anemia (27%) and mucositis ( 27%). LVEF decreased <50% in 14 patients and none led to treatment discontinuation nor death. Two patients had fatal SAEs that were deemed related to study drug ( neutropenic sepsis and hypotensive shock). Correlative studies will be reported later. Conclusions: The combination of trastuzumab with S-1 and cisplatin in advanced gastric cancer is active and tolerable. Clinical trial information: NCT01736410.
Phase II study of neoadjuvant chemoradiotherapy with cisplatin plus 5-fluorouracil and elective nodal irradiation for stage II/III esophageal squamous cell carcinoma: A 2-year follow up.
Authors: Kato Ken , Hashimoto Jun , Ito Yoshinori , Nagashina Kengo , Kojima Takashi , Daiko Hiroyuki , Akimoto Tetsuo , Hamamoto Yasuo , Matsushita Hisayuki , Katano Susumu , Hara Hiroki , Tanaka Yoichi , Saito Yoshihiro , Igaki Hiroyasu
Published: February 2017

129

Background: Neoadjuvant chemotherapy with cisplatin (CDDP) plus 5-fluorouracil (5-FU) is considered the standard treatment for stage II/III esophageal squamous cell carcinoma (ESCC) in Japan. However, patient survival remains unsatisfactory and neoadjuvant chemoradiotherapy (NeoCRT) may improve the outcome of stage II/III ESCC patients. We conducted a feasibility study of NeoCRT with CDDP plus 5-FU and elective nodal irradiation in patients with stage II/III ESCC. Methods: Eligibility criteria included clinical stage II/III (UICC 6th, non-T4) ESCC, a Performance status (PS) of 0-1, and age of 20–75 years. Chemotherapy consisted of 2 courses of 5-FU infusion (1000 mg/m2, days 1–4) and a 2-h CDDP infusion (75 mg/m2, day 1), with a 4-week interval. Radiotherapy was concurrently administered to the primary tumor, metastatic lymph nodes, and regional lymph nodes (total dose of 41.4 Gy in 23 fractions. After completion of NeoCRT, transthoracic esophagectomy with extensive lymphadenectomy (>D2) was performed. The primary endpoint was the completion rate of NeoCRT with R0 resection. Results: Thirty-three patients were enrolled in this study between July 2010 and June 2011 and 2 were determined to be ineligible. Characteristics of the 31 eligible patients included, a median age of 63 years (range, 40–73 years), male/female: 28/3, PS 0/1: 19/12, and cStage IIA/IIB/III: 2/10/19. Median observation time was 30.0month. In total, 29 patients (93.5%) underwent NeoCRT with R0 resection. Among the patients who underwent surgery, there was 1 treatment-related death, and the incidence of operative morbidity was similar to that in previous studies. According to RECIST, the overall response rate was 78% (14/18) after CRT. Pathological complete response was achieved in 13 patients (42%) who underwent esophagectomy. The 2 years recurrence free survival rate 69.8%, and 2 years survival rate was77.4%, respectively. Conclusions: NeoCRT was well tolerated and found to be highly promising. A randomized controlled trial (JCOG1109) comparing with neoadjuvant chemotherapy was started. Clinical trial information: UMIN000004223.
Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma: Results of the Japan Clinical Oncology Group study JCOG 0604.
Authors: Tahara Makoto , Fuse Nozomu , Mizusawa Junki , Sato Akihiro , Nihei Keiji , Kanato Keisuke , Kato Ken , Yamazaki Kentaro , Muro Kei , Takaishi Hiromasa , Boku Narikazu , Ohtsu Atsushi
Published: February 2017

134

Background: We conducted a phase I/II trial of chemoradiotherapy (CRT) concurrent with S-1 and cisplatin to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and safety in patients with esophageal carcinoma. Methods: Eligibility criteria included histologically proven squamous cell or adeno carcinoma of the thoracic esophagus, clinical stage II/III excluded T4, PS 0-1, age 20 to 75, and no prior treatment. Chemotherapy consisted of administration of S-1 60-80 mg/m2/day on days 1-14, and cisplatin at 75 mg/m2on day 1, repeated twice every 4 weeks. Single daily radiation of 1.8 Gy in 28 fractions (total 50.4Gy) was given concurrently starting on day 1. For patients achieving an objective response after CRT, two additional cycles of chemotherapy were administered. The phase I part adopted the 3+3 cohort design. Planned sample size of 75 patients was calculated based on the weighting of threshold values of CR rate according to the registered proportion of T1-2 and T3. Results: Patient accrual was terminated early due to slow enrollment after 44 eligible patients were accrued from May 2007 to Sep 2011. Patient backgrounds were: 40 males, with median age 62 years, PS 0/1 (39/5), squamous cell carcinoma / adenocarcinoma (43/1), T1/T2/T3 (14/8/22) and N0/N1 (7/36). In the phase I part, two of six patients experienced DLTs at each level of S-1 (S-1 60 or 80 mg/m2/day). Considering treatment compliance, RD was determined as S-1 60 mg/m2/day. The CR rate, primary endpoint of phase II, was 59.5% (22/37; 90%CI, 44.6-73.1%; the weighted threshold, 57.2%; p=0.46) on central review. In the phase II part, 3-year progression-free survival was 47.3% and 3-year overall survival was 61.9%. Grade 3 or 4 toxicity in phase II part included leukopenia (57.9%) neutropenia (50%), hyponatremia (28.9%), anorexia (21.1%), anemia (18.4%), thrombocytopenia (18.4%), and febrile neutropenia (2.6%). No treatment-related deaths were observed. Conclusions: Although CRT with S-1 plus cisplatin showed acceptable toxicity and favorable 3-year survival, this study did not meet its primary endpoint. Clinical trial information: 000000710.