bluuebunny/crossref_metadata_2025 huggingface dataset:
Comparison of physical function and falls among women with persistent symptoms of chemotherapy-induced peripheral neuropathy.
Authors: Winters-Stone Kerri M , Hilton Coleman , Luoh Shiuh-Wen , Jacobs Peter , Faithfull Sarah , Horak Fay B
Published: February 2017

130

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a side effect of cancer treatment that may persist and impact physical function. Studies that quantify functional consequences associated with CIPN in post-treatment cancer survivors are rare, based on self-report, or use small samples. The purpose of this study was to compare objective and self-report measures of physical function, gait patterns, and falls between women cancer survivors with or without symptoms of CIPN. Methods: Baseline assessments from 678 women cancer survivors enrolled in exercise trials were available for analysis. Women who self-reported symptoms of CIPN (CIPN+) were compared to asymptomatic women (CIPN-) on the following: maximal leg press strength (LPmax); timed chair stand (CS), physical performance battery (PPB), gait patterns (speed (SP), step number (SN), stride length (SL), base of support (BOS), % time in double support (%DS)), self-report physical function (PF) and disability (DIS), and falls in the past year (% fallers). Group comparisons were made using analysis of covariance, adjusting for time since diagnosis and cancer site (breast or other). Results: After excluding women who had diabetes, were premenopausal at cancer diagnosis or had not received chemotherapy, 462 cases were analyzed (age: 62±6yrs; time since diagnosis: 5.8±4.1yrs). CIPN+ (N = 210) and CIPN- (N = 252) groups significantly differed on all measures (*p < 0.05; **p < 0.01), except maximal leg strength and base of support during a usual walk, with worse performance for CIPN+. Conclusions: In our sample of women cancer survivors, 45% had symptoms of CIPN an average of 6 years post treatment and significantly worse physical function, altered gait patterns and more falls than asymptomatic women. CIPN should be addressed early in treatment and strategies to improve function and mobility and prevent falls need to be tested. [Table: see text]
Grading financial toxicity based upon its impact on health-related quality of life (HRQol).
Authors: De Souza Jonas A. , Aschebrook-Kilfoy Brisa , Grogan Raymon , Yap Bonnie J. , Daugherty Christopher , Cella David
Published: February 2017

16

Background: Financial toxicity (FTox) is an important symptom. We hypothesized that FTox can be graded based on statistically significant and clinically meaningful changes in HRQoL. Methods: FTox was assessed by the COST (COmprehensive Score for financial Toxicity) in 2 sets of cancer patients (pts). Set 1(S1): pts with Stage IV cancers on chemotherapy. Gradations of FTox were determined by ROC analyses based on conventions for clinically meaningful small (0.2), medium (0.5) and large (0.8) effect sizes (e.s.) for the FACT-G HRQoL instrument. Demographics, income, mood disorders (POMS), and symptoms (EORTC QLQ-C30) were collected. We computed η2 (Eta squared) to estimate the magnitude of the variability in HRQoL explained by specific symptoms. Set 2 (S2): pts and survivors with thyroid cancer within 3 years of diagnosis. In S2, HRQoL was assessed by the thyroid-specific City of Hope HRQoL measure. Results: A total of 600 cancer pts were assessed (233 in the S1 and 367 in the S2). S1: the median COST value was 23 (range 0-44). ROC curve analyses produced 4 COST grades (G): G0 ≥ 26 (99 pts, 42%); G1: ≥ 14-26 (71 pts, 31%); G2: > 0-14 (58 pts, 25%); and G3: = 0 (5 pts, 2%). Pts with G0 had no impact of FTox on their HRQoL. Absolute e.s. decreases in FACT-G by grade compared to G0 were: G1, 0.59 (95% CI: 0.27 – 0.90); G2, 0.92 (CI: 0.59 – 1.26); G3, 1.77 (CI: 0.83 – 2.70). In multivariate analyses, mood explained 22% (CI 13-31%) of the variability in FACT-G; FTox, 7.6% (CI 2.2-15%); fatigue, 5.6% (CI 1.1-12%); pain, 3.6% (CI 0.3-9.6%); and loss of appetite, 3.4%(CI 0.3-9.3%). VS: applying the COST thresholds to S2, we had: G0: 154 pts (42%); G1: 126 (34%); G2: 84 (23%); and G3: 3(1%). The decreases in HRQoL measured in e.s. were: G1: 0.84 (CI: 0.68 – 1.00); G2: 1.88 (CI: 1.67 – 2.09); G3: 2.99 (CI: 2.29 – 3.68). The association between HRQoL and FTox was significant in multivariate models in both sets (p < 0.001). Conclusions: We developed and validated a FTox grading system in 2 different set of patients. This grading was anchored on independent and clinically meaningful changes in HRQoL attributable to FTox. FTox is a meaningful event that can be objectively measured, and should be included in the assessment of patient-centered outcomes.
Determinants of adherence to physical activity guidelines among overweight and obese African American breast cancer survivors: Implications for intervention approach.
Authors: Smith Selina , Yoo Wonsuk , Ansa Benjamin E. , Coughlin Steven S. , Whitehead Mary S.
Published: February 2017

178

Background: Public health agencies encourage breast cancer survivors (BCSs) to follow their physical activity guidelines (PAGs). However, adherence to these guidelines is low. African American (AA) BCSs are more often overweight or obese and less likely than women of other races to report adherence to physical activity (PA) recommendations. To address the research question, “what prevents AA BCSs from following PAGs,” we examined socioeconomic, clinical, and psychosocial correlates with PA levels. Methods: AA women diagnosed and treated for breast cancer participating in a breast cancer support group (n = 191) completed a lifestyle assessment tool (LAT) capturing demographic characteristics; breast cancer diagnosis and treatment history; health-related quality of life (HR-QoL); weight history, including body mass index and post-diagnosis weight gain; and physical activity. Logistic regression and analysis of variance were used to determine whether these covariates were associated with meeting ( > 17.5 MET h/wk); partially meeting (8.75-17.5 MET h/wk); or not meeting ( < 8.75 MET h/wk) PAGs. Results: Preliminary results indicate that 44.44% of AA BCSs met PAGs. This percent is below the national average for AA women (56.5%) and white women (67.5%). Conclusions: Identifying factors that influence adherence to physical activity behaviors is important in developing effective interventions. These findings may help generate hypotheses for future research to undergird efforts to increase PA among AA BCSs.
Post-traumatic stress disorder in young breast cancer survivors.
Authors: Vazquez Danny A. , Rosenberg Shoshana M. , Gelber Shari I. , Ruddy Kathryn Jean , Morgan Evan , Recklitis Christopher J. , Come Steven E. , Schapira Lidia , Partridge Ann H.
Published: February 2017

202

Background: Posttraumatic stress disorder (PTSD) is associated with morbidity and mortality in affected populations. Cancer survivors experience PTSD at a rate higher than the general population, with young age and female gender identified as risk factors. While young women with breast cancer experience greater psychosocial distress in general following diagnosis (dx), little is known about PTSD in this population. Methods: Women dx’d with Stage I-III breast cancer at age ≤ 40 were surveyed as a part of a multi-site cohort study. Demographic, treatment, psychosocial characteristics (including self-reported psychiatric conditions and use of psychiatric medications prior to dx), anxiety and depression (Hospital Anxiety and Depression Scale), fear of recurrence (Lasry Scale), and social support (Medical Outcomes Study) were assessed within 1 year after dx. PTSD was measured at 30 months post-dx using the PTSD Checklist – Civilian Version; a score ≥ 50 was considered positive for PTSD. Univariable and stepwise multivariable logistic regression were used to evaluate factors associated with PTSD. Results: 572 women were eligible for this analysis; median age at dx was 37 (range: 17-40); 87% had Stage I or II cancer. 37/572 women (6.5%) met criteria for PTSD at 30 months. Lower educational attainment, less financial comfort, less social support, stage 2 (vs. 1) disease, receipt of chemotherapy, fear of recurrence, anxiety and depression, and psychiatric comorbidities were associated (p ≤ 0.05) with PTSD in univariable analyses. Chemotherapy (OR = 3.48, 95% CI = 1.09-11.06), anxiety by HADS (OR = 20.29, 95% CI = 7.83-52.53), and psychiatric comorbidities (OR = 4.22, 95% CI = 1.40-12.74) were associated with increased likelihood of PTSD, whereas college education (OR = 0.25, 95% CI = 0.10-0.59) and greater social support (OR = 0.41, 95% CI = 0.17-0.99) appeared to be protective in multivariable analyses. Conclusions: PTSD affects a minority of young breast cancer survivors, with the prevalence in our cohort similar to that seen in other breast cancer populations. Early identification of those at risk for developing PTSD is essential for the adequate treatment of affected women and for the improvement of health outcomes and quality of life in cancer survivors.
Sexual function of long-term rectal cancer survivors.
Authors: McMullen Carmit K. , Grant Marcia , Wendel Christopher , Bulkley Joanna E , Sun Virginia , Herrinton Lisa J. , Hornbrook Mark C. , Krouse Robert S.
Published: February 2017

209

Background: Many rectal cancer survivors report problems with intimacy and sexual function after surgery. The extent of these problems is not well known. Methods: Long-term rectal cancer survivors (5+ years post-diagnosis) who were members of Kaiser Permanente with permanent ostomy (n = 183) or sphincter-sparing surgery (N = 394) completed a mailed survey. Participants were identified through tumor registries and health plan data. Items from the City of Hope Quality of Life Colorectal Cancer scale assessed disruption to intimate relationships due to the surgery on a scale of 0-10, with 10 indicating the least disruption. Other items assessed current experiences of and satisfaction with sexual function as well as comfort being undressed in front of a partner. Results: Survey response rate was 60.5% (N = 577). Respondents’ average age was 73 years, 41% were female, 63% were married or partnered at the time of survey, and 30% reported being sexually active. Fifteen percent of those who were not sexually active feared resuming sexual activity. Thirty-five percent of all respondents found their sexual activity unsatisfying. Of the 236 female respondents, 24% reported current problems with vaginal dryness, 12% with vaginal stricture, and 9% with vaginal pain. Of the 341 male respondents, 64% reported current problems getting an erection and 65% with maintaining one. Survivors with ostomy vs. sphincter-sparing surgery reported more interference with personal relationships (6.4 vs. 8.3, p < .001) and less ability to be intimate (5.1 vs. 7.0, p < .0001). A higher percentage with ostomy also reported discomfort being undressed in front of their partner (40.6% vs. 10.6%, p < .001). Conclusions: Many rectal cancer survivors were unsatisfied with their sexual activity. One in ten women reported vaginal stricture, which can be mitigated by early intervention. Nearly 1/4 reported problems (dryness, pain) that can be addressed at any phase of survivorship. Two thirds of men reported trouble with getting an erection and with maintaining one, indicating a significant opportunity for intervention in this cohort. Sexual function did not differ significantly between surgery groups. In line with previous reports, survivors with ostomy had more intimacy and body image problems.
Patient-reported outcomes (PROs), unmet need, and psychosocial adaptation among recent breast cancer (BC) survivors.
Authors: Palmer Steven C , DeMichele Angela , Schapira Marilyn M. , Glanz Karen , Blauch Abigail , Pucci Donna A. , Jacobs Linda A.
Published: February 2017

212

Background: BC survivors have physical and psychosocial symptoms which, if unaddressed, result in unmet need. Unmet need has been examined primarily in long term survivors, and understanding the characteristics associated with unmet need is under-studied among recent patients. Methods: Eligibility included non-metastatic BC treated < 1 year prior. Participants completed a PRO symptom measure and reported unmet need for assistance for symptoms. Concerns about recurrence risk, late effects, health maintenance, family needs, and hereditary risks were assessed. Anxiety and depressive symptoms were assessed using the HADS; quality of life (QoL),using the SF-12. Results: Participants (N = 137) were primarily white (72%), middle-aged (M = 55 yrs), and treated for Stage I (47%) or II (38%) BC. Participants reported an average of 10.7 symptoms (R = 0-18), while unmet need was less common (M = 2.6, R = 0-15). Physical and mental health QoL were similar to norm values (M = 48.0; M = 53.5). 13% and 29% met “caseness” (i.e., criteria for significant elevation) for depression or anxiety on the HADS, respectively. Unmet need was trichotomized into no (0), low (1-3), and elevated (4-15) groups. Level of unmet need was not predicted by demographic variables, time from end of treatment, treatment exposure, staging, or physical QoL. Groups differed significantly with respect to level of patient concern, mental health QoL, anxiety and depression, and meeting caseness for depression on the HADS (all p < 0.03) with elevated needs being associated with worse outcomes. In multivariate analysis, overall unmet need was independently predicted by depression and level of survivorship concerns (R2 = .28, p < .001). Conclusions: In the year after treatment, patient reported symptoms are common, but unmet need is less common. QoL is similar to national norms. Higher unmet need is associated with worse psychosocial adaptation, including QoL, patient concerns, anxiety, and depression. In particular, depression and survivorship concerns independently predict unmet need. Addressing unmet needs among recent BC survivors may be one means of improving the psychological functioning of these survivors.
Patient-reported outcome driven case management system for hematology and oncology patients.
Authors: Warsame Rahma M. , Dispenzieri Angela , Croghan Katrina , Hubbard Joleen Marie , Thompson Carrie A. , Sloan Jeffrey
Published: February 2017

229

Background: Modern clinical practice places time restrictions on the amount of information and processing that can be done in a typical office visit. Meeting patient needs within the healthcare system is often inefficient and ineffective, contributing to patient and clinician dissatisfaction and suboptimal outcomes. We developed a point-of-care case management system for oncology clinical practices adapted from an algorithm initially designed for patients with diabetes. The system’s goal is to obtain patient-reported quality of life (QOL) outcomes and provide clinicians with information regarding QOL issues to address. Methods: Literature review and focus groups of oncology patients were used to identify key patient concerns. The program was adapted for cancer patients to collect the identified patient concern including QOL, fatigue, pain and other cancer-specific issues scored on a scale of 0-10. Suggested actions and available resources were identified for the patient/clinician based on the issue selected. We performed a pilot study involving 20 cancer patients to assess feasibility, and administered a “was it worth it survey” (WIWI). Results: The resultant hematology/oncology electronic system includes a set of eight primary “buttons”: Personal Relationships, Emotional health, Physical healthy, Cancer diagnosis and treatment, Health behaviors, Money, Care planning and Something else. Every “button” was selected, most commonly Cancer diagnosis and treatment 6/20 (30%). The median (range) reported QOL, fatigue and pain were 7 (1-10), 4 (0-8), 2 (0-8), respectively. The average completion of the tool took 4 minutes. One hundred percent of patients who took the survey thought it was worth it, would participate again and recommend it to others. Conclusions: The system was quick and easy to utilize in a small pilot of patients. All of the identified categories were chosen and relevant to our patient population. This tool has the potential to improve patient well-being and clinical outcomes, reduce the burden on clinicians and distribute case management activities to the most appropriate providers. Next steps include initiating a larger prospective protocol to assess if this tool improves QOL over time.
Emerging from the haze: A psycho-educational series to combat cognitive complaints after cancer treatment.
Authors: Bailey Charlotte , Asher Arash , Jo Mi-Yeoung
Published: February 2017

230

Background: Cognitive dysfunction after cancer treatment can be distressing and may profoundly impact quality of life, feasibility of returning to work, and social reintegration. Meaningful, evidence-based options for cancer-related cognitive changes are limited and urgently needed. A standardized rehabilitation program targeting common cognitive problems faced by cancer survivors may represent a safe, low-cost, effective treatment that can be easily disseminated. Emerging from the Haze (Haze) is a 6 week multi-disciplinary clinical program that provides a psycho-educational series to patients who are experiencing changes in cognition or having difficult adjustment after cancer diagnosis or treatment. The Haze course covers topics including: mood and stress management, mindfulness meditation, countering negative automatic thoughts, compensatory strategies for attention, memory, and executive functioning/problem solving, pacing and balance in addition to wellness issues related to cognition such as sleep hygiene, nutrition, social isolation, and exercise. The purpose of this research was to assess changes in the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog) scores immediately after the intervention and at regular intervals until the 1 year mark. Methods: Patients were given questionnaires including the FACT-Cog on the first day of the Haze series. The FACT-Cog includes the following domains: Perceived Cognitive Impairment (PCI), Perceived Cognitive Abilities (PCA), and Impact on Quality of Life (QOL). The survey battery was repeated on the last day of the series, 3 months, 6 months and 1 year after the series. Results: Based on the first 110 patients with various cancer types that have completed Haze, highly statistically significant improvements have been found in PCI (p < 0.001; Mean Δ = 8.71), QOL (p < 0.001; Mean Δ = 2.09), and PCA ( p < 0.001; Mean Δ= 2.83) based on a before and after comparison of the FACT-Cog. Conclusions: It appears that a multi-disciplinary psycho-educational clinical program to address cognitive changes and adjustment difficulties after treatment can have a positive effect on patients’ perceived cognitive functioning as measured by FACT-Cog.
Impact of yoga on quality of life for young adult noncurative cancer patients: A pilot study.
Authors: Keats Melanie , Woodside Hillary , Culos-Reed S. Nicole
Published: February 2017

249

Background: A growing body of evidence is emerging to suggest that the practice of yoga can improve disease and treatment-related side effects in the non-curative cancer patient by addressing their physical, psychological, and spiritual needs. Regrettably, the literature regarding the positive benefits of yoga for the young adult (YA) non-curative cancer patient is limited. Accordingly, the purpose of this ongoing exploratory study is to examine the feasibility and safety of a 7-week home/hospice based instructive Hatha yoga intervention (Yoga Thrive - available on DVD) in non-curative, YA cancer patients. Secondary outcomes include the examination of the efficacy of yoga in mitigating cancer and treatment-related side effects through ratings of self-reported quality of life (QOL). Methods: A single-arm, non-randomized, pre and post-test, pilot investigation of a 7-week instructive home/hospice-based Hatha yoga program is currently ongoing. Pre/post program data include measures of QOL, specific to palliative disease and spiritual domains as well as open-ended measures of perceived program value. Feasibility data (e.g., recruitment, adherence, safety) are also collected. Results: To date, four YA non-curative cancer patients have participated in the 7-week yoga program. Preliminary data show a significant difference in both functional well-being (p= .047, ηp2= 0.78) and spirituality (FACIT-Sp) scores (p= 0.04, ηp2= 0.77). Although not statistically significant, a large effect in physical well-being (ηp2= 0.38); general cancer outcomes (FACT-G) (ηp2= 0.42); and palliative specific scores (ηp2= 0.62) have also emerged. Early responses to the post-program exit questions suggest that participants find the program as an opportunity for self-care, separate from traditional cancer therapies. Subjective improvements in flexibility and mindfulness (e.g., body awareness, relaxation, and calmness) have also been reported. Additionally, participants have complemented the program for its ease and flexibility of use. Conclusions: Early findings of this study provide support for the feasibility and efficacy of a home/hospice-based yoga program for YA non-curative cancer patients.
Systematic development of a a breast cancer survivorship program at a small independent oncology practice.
Authors: Rogers Cynthia , Satpute Shailesh R.
Published: February 2017

52

Background: It is widely accepted that providing survivorship care plans leads to improvements in outcomes for cancer survivors. Treatment summaries are now part of ASCO and NCCN survivorship guidelines. We faced a unique challenge of implementing the survivorship care plan at the Jones Clinic as a small independent practice. The Jones Clinic consists of three full time physicians and two full time nurse practitioners. We see approximately 850 new patients per year. Methods: As a part of ASCO’s quality training program, we focused on the stage I – III (early stage) breast cancer patients who completed their initial therapy. We formed a team, identified the barriers, created a flow diagram of the process, assigned roles for each individual member and finally implemented the process. Results: The major issues identified were lack of provision in the electronic medical record (EMR) system for survivorship and lack of standardized data entry process. We created a system in the EMR for survivorship data entry and extraction of such data in a document. Since July 2015, one hundred percent of breast cancer patients completing adjuvant therapy at the Jones Clinic have received a survivorship treatment summary and a plan of care. The care plan is also shared with their primary care provider. Importantly, creating a survivorship document required less than 10 minutes of the provider’s time. Conclusions: We are now able to provide our patients with a survivorship care plan and address survivorship issues within thirty days of completion of therapy. Creating the care plan requires minimal time from the providers. Our new process meets ASCO guidelines for survivorship care plans and no additional staffing was needed. We now plan to provide a survivorship care plan to all oncology patients treated with curative intent.
Disease-free survival of women 70 years or older with stage I-II BC treated with BCS and RT.
Authors: Gopi Mounika , Hager Steven Jeffrey , Kimball Beth , Monson Jedidiah Mercer
Published: February 2017

e268

Background: Breast RT is the standard of care for women undergoing BCS. Recent trends suggest omitting RT for women > 70 years of age. Our retrospective study evaluated the DFS and failure pattern of women > 70 treated with BCS and RT compared with their younger cohorts. Methods: Between 2009-2011, 101 women with Stage I-II BC were treated with BCS and RT at a physician-owned, community-based cancer center. Clinical, pathologic and treatment characteristics were extracted from patients’ medical records. Results: Of the 101 patients, 71 comprised the < 70 cohort and 30 comprised the > 70 cohort. Patients in the older cohort were more likely to have Stage I tumors (80% vs 64%), but the cohorts were otherwise balanced in terms of T-size, grade, ER/PR and Her2 status. RT was typically delivered in a first course of 50.4 Gy to the whole breast followed by a 10 Gy boost. Median DFS for the older cohort was 36 months (range, 1-66) and 41 months for the younger cohort (range, 1-74). There was only one event in the older cohort, a patient who developed DM at 40 months. In the younger cohort one patient developed LR at 54 months, and 4 developed DM at 18, 33, 51 and 54 months. Conclusions: In our community-based study, women > 70 who received BCS and RT experienced excellent DFS and local control. The three-year median DFS observed in the older women in our study suggests that a long-term view should be taken when treating older patients and that biological age rather than chronological age is a better determinant of when cancer therapies should be withheld.
Prognostic factors affecting severity of radiation-induced fibrosis.
Authors: Maklad Ahmed M , Assaf Hanan Abdel-Rady , Nada Essameldin Abdelaziz , Elyamany Ashraf , Badran Asmaa A
Published: February 2017

e280

Background: Evaluation of prognostic factors affecting Radiation Induced Fibrosis (RIF) to help for decreasing its incidence and to improve quality of life for cancer survivors. Methods: Thirty patients were included in this study .It was carried out at faculty of medicine, Sohag University Hospital, Egypt during the period between July 2012 and July 2013 after approval of university ethical committee. We included all patients with (RIF) which is persistent or appeared after 6 months of completion of radiation therapy. Detailed medical history and clinical examination were done for all patients included in the study. We categorized the patients according to severity of RIF into four grades according RTO 2010. Assessment of pain was done according to 0–10 Numeric Pain Rating Scale. Results: Thirty patients with RIF were included in the study. The age of the studied patients ranged from 21- 65 years with a Mean 48,33 ± SD of 10,88. 56.7% of the cases were more than 50 years old. Female patients were 73.3%. BMI of the studied patients ranged from 19-40 kg/cm2 with a Mean 28.03 ± SD of 6.98. 26.7%patients were smokers.43.3% patientshadprevious history of acute radio dermatitis.60% had breast tumor. Chest was affected in 19 (60%) patients, back in 3 (10%) patients, neck in 4 (13%) patients, lower limbs in 2 (7%) patients, and face in 2 (7%) patients.T1 represented in 30%, T2 in 36.7%, T3 in 13.3% while T4 in 20% of the included patients. Twenty four (80%) patientsreceived chemotherapy before radiation. We documented a significant relation between BMI and severity of RIF (p = 0.007).Severity of RIF was significantly associated with higher BMI (p = 0.007), higher radiation doses (p = 0.02), higher number of radiotherapy treatment fraction (p = 0.03), higher radiation field sizes (p = 0.003), and patients with duration of more than one year of RIF (p < 0.001). Patients from rural areas documented higher degree of RIF (p = 0.03). Conclusions: It is important to give more attention to RIF as a one of late toxicity of radiation therapy. It can be minimized by avoiding its predisposing factors to improve quality of life of cancer survivors.
Statistical analysis on the behavior and recurrence of breast phyllodes tumors.
Authors: Ye John Shangming
Published: February 2017

e294

Background: Statistical analysis on the behavior, diagnosis accuracy, treatment, and recurrence of breast phyllodes tumors. Methods: Thousands of phyllodes tumor cases have been analyzed by mathematical statistics in order to assess the behavior, diagnosis, classification, treatment, recurrence, and five-year survival rates. Results: The age of breast phyllodes tumor patients generally ranges from ten years old to over eighty years old, and the disease most frequently occurs between ages of forty and fifty among various ethnicities. For clinic-pathological features, over 70% of the patients' tumors may be classified as benign, about 20% borderline, and less than 10% malignant. Patients who had ages over 40, larger tumor sizes, permeative borders, atypia, high stromal hypercellularity, and especially high mitotic activity were observed to develop borderline and malignant phyllodes tumor more frequently. Recurrences were noted in about 13% for all patients, but the ratio of recurrence rate of benign : borderline : malignant tumor is approximately 1: 1.5 : 3. A five-year survival rate was observed in almost 100% of patients with benign tumors, 98% with borderline, and about 88% with malignant. Accurate diagnosis at an early stage plays a vital role for effective treatment. Conclusions: Early stage accurate diagnosis, post-excision pathology analysis on the fibroepithelial tumor tissue for confirming the clinicopathological features, and wide excision (with negative margins) may reduce the risk of tumor recurrence and improve the respective survival rates of the breast phyllodes tumor patients.
Prospective randomized phase II study of FOLFIRI versus FOLFOX7 in advanced gastric adenocarcinoma: A Chinese Western Cooperative Gastrointestinal Oncology Group study.
Authors: Bi Feng , Li Qiu , Wen Feng , Zhou Chengya , Qiu Meng , Liu Jiyan , Chen Jing , Yi Cheng , Li Zhiping , Luo Deyun , Xu Feng , Cai Xiaohong ,   Chinese Western Cooperative Gastrointestinal Oncology Group
Published: February 2017

1

Background: The purpose was to compare mFOLFIRI (arm A) with mFOLFOX7 (arm B) as first-line treatments in patients (pts) with locally advanced gastric adenocarcinoma in an open, randomized, phase II study. Methods: Previously untreated metastatic or recurrent gastric adenocarcinoma pts with measurable disease received mFOLFIRI (arm A) or mFOLFOX7 (arm B) every 2 weeks. The second-line treatment was mFOLFOX7 for arm A and mFOLFIRI for arm B. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), disease control rate (DCR) and toxicity. Results: In total, 200 pts were included. The evaluable population consisted of 128 pts (54 in arm A; 74 in arm B). The median PFS of arm A was 2.9 months (m) (1.9 to 4.1 m) versus 4.1 m (3.2 to 4.8 m) for arm B(p0.109). The median OS was 9.9 months (6.0 to 13.5 m) for arm A versus 12.0 m for arm B (10.3 to 13.7m; p= 0.431). The DCRs for arm A and arm B were 59.3% and 66.3%, respectively (p = 0.850). In subgroup analysis of the pts who completed both treatment lines per protocol, the median OS was 11.0 m (5.1 to 16.9 m) for the mFOLFIRI/mFOLFOX7 group and 20.2 m (13.4 to 26.6 m) for the mFOLFOX7/mFOLFIRI group ( p= 0.030). Both regimens were well-tolerated with acceptable and manageable toxicities. Grade ¾ adverse events were 53.2% and 55.4% in arm A and arm B, respectively. Conclusions: There was no significant difference in the PFS or DCR. However, mFOLFOX7 followed by mFOLFIRI might have a better OS. Clinical trial information: ChiCTR-TRC-08000167. [Table: see text]
On-trial radiotherapy quality assurance in NeoSCOPE: A randomised phase II trial of chemoradiotherapy in oesophageal cancer.
Authors: Evans Elin , Jones Gareth , Radhakrishna Ganesh , Hawkins Maria A , Mukherjee Somnath , Maggs Rhydian , Ray Ruby , Crosby Tom David Lewis , Gwynne Sarah
Published: February 2017

119

Background: Failure to adhere to trial protocols for target volume delineation (TVD) within radiotherapy (RT) trials may have an adverse effect on, and potentially invalidate trial outcomes. NeoSCOPE, a UK phase II study RCT of two neo-adjuvant CRT regimens in oesophageal cancer, undertook prospective individual case-reviews (ICR) to identify and correct such variations. Methods: All participating centres had passed a pre-accrual outlining benchmark case with detailed feedback provided. Prospective ICR was undertaken for all patients. Real time review (feedback to centres within 3 working days) was performed on the first 20 patients recruited and the first case submitted from each participating centre. Subsequent cases were subject to ‘timely retrospective review’, with review within 2 weeks of the start of RT. Target volumes (including organ at risk), along with diagnostic information, were submitted in DICOM format to the RTQA centre. Each case was reviewed by an upper gastrointestinal radiation oncologist, against pre-determined acceptable and unacceptable variations, using a standardised proforma. Unacceptable variation required re-submission. The outlining reviews were complimented by prospective review of planning. Results: 83 cases were reviewed in total, 39 (47%) of which were real-time and 44 (53%) timely- retrospective. 9(11%) cases required re-submission, of which 6 were real-time reviews and 3 timely-retrospective. Delineation of the tumour (GTV) and elective nodal areas (CTVB) were the most common unacceptable variations. 29 (74%) of real time reviews were returned within 3 working days and 100% of retrospective returned by 3rdfraction. The review process did not result in any delay in starting treatment. Conclusions: Prospective review of outlining in the NeoSCOPE trial has enabled identification and correction of unacceptable variations from the protocol without introducing treatment delays. The reduction in the re-submission rate for timely-retrospective review cases suggests an educational benefit from the pre-trial RTQA and the real-time review process. Clinical trial information: NCT01843829.
Feasibility of the combination chemotherapy with 5-fluorouracil and oxaliplatin in metastatic gastric or colorectal cancer patients more than age of 80.
Authors: Lim Kyu-Hyoung , Lee Hui-Young , Park Sung Bae , Song Seo-Young
Published: February 2017

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Background: The combination chemotherapy of 5-fluorouracil (5-FU) and Oxaliplatin is usually used in gastric cancer (GC) and colorectal cancer (CRC). The safety and efficacy of the combination chemotherapy in patients over 80-years old has not been established yet. The purpose of this study was to assess the clinical outcomes and tolerability in the combination with 5-FU, leucovorin and oxaliplatin as first-line treatment in extremely elderly patients with GC or CRC. Methods: Eligibility included: 1) more than 80-years old, 2) metastatic gastric or colorectal cancer 3) chemotherapy-naive, 4) ECOG PS 0-1, 5) adequate organ function. Patients received the combination chemotherapy of 5-FU, leucovorin and oxaliplatin. Response evaluation was done every 8 weeks with RECIST criteria and toxicity was evaluated with NCI-CTCAE. Results: Between Sep 2008 and Nov 2014, 28 patients were reviewed and composed of equal numbers of GC and CRC. The median age was 82.2 years (80.0-85.6yrs) in GC and 81.1 years (80.0-89.3) in CRC, respectively. Total administrated cycles were 89 with median cycles of 5 in GC and 112 with median cycles of 11 in CRC. The median progression-free survival (PFS) and overall survival (OS) in GC were 5.4 months and 6.6 months, as compared with 7.3 months and 8.1 months, respectively. There were no significant difference in PFS (p = 0.94) and OS (p = 0.28) between GC and CRC. Overall survival rates at 1 year were 35.7% and 42.9%, respectively. After disease progression, salvage chemotherapy in GC and CRC was administrated in 1 and 7 patients, respectively. Common grade 3/4 hematology toxicities in both group were neutropenia, anemia. Frequent non-hematological toxicities were anorexia (60%), neuropathy (40%) and mucositis (25%), which were grade 1/2. Conclusions: The combination chemotherapy of 5-fluorouracil (5-FU) and Oxaliplatin has limited effect on improvement of OS in metastatic gastric or colorectal cancer patients more than age of 80. Further studies on the role of chemotherapy in these extremely elderly patients are needed.
FPA144-001: A first in human study of FPA 144, an ADCC-enhanced, FGFR2b isoform-selective monoclonal antibody in patients with advanced solid tumors.
Authors: Bendell Johanna C. , Rogers Seema , Xiang Hong , Pierce Kristen L. , Krishnan Kartik , Sikorski Robert S. , Hambleton Julie , Rasco Drew W.
Published: February 2017

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Background: FPA144 is a humanized monoclonal IgG1 antibody directed against the 2b Isoform of thefibroblast growth factor receptor (FGFR2b) that has been glycoengineered to enhance ADCC. Amplification of FGFR2 is found in a number of tumors, including 3 – 9% of gastric cancer, and is associated with poor prognosis. FPA144-001 is a phase 1 study in two parts: Part 1 will evaluate the safety and pharmacokinetics (PK) of FPA144 in patients with solid tumors; Part 2 will evaluate efficacy in gastric cancer patients whose tumors overexpress FGFR2b, as determined by a proprietary test. Here we present early safety and PK results from solid tumor patients treated with FPA144. Methods: A standard 3+3 design was used to assess safety, tolerability and PK of escalating doses of FPA144 in patients with advanced solid tumors (Part 1A) or recurrent/metastatic gastric cancer (Part 1B). Tumor testing for FGFR2gene amplification or FGFR2b overexpression was conducted centrally by a proprietary assay consisting of both FISH and IHC. Results: At the time of data analysis, enrollment of FPA144-001 through the 6mg/kg q2w cohort had been completed. In Part 1A, 13 patients with 8 different tumor types have been enrolled. Patients have been treated for an average of 4 cycles (range 1 – 10, median 2) or 101 days (range 28 – 287, median 43). Nine patients have discontinued the study for progressive disease or lack of clinical benefit; all others continue on study treatment. No dose-limiting toxicities have been observed, and no patients have withdrawn due to an adverse drug reaction. Upper respiratory infection, alopecia and fatigue are the AEs reported in more than one patient; one SAE of dyspnea and pyrexia not related to drug has been reported. PK analysis demonstrates non-linear clearance in doses up to 3mg/kg, likely due to receptor-mediated clearance. Conclusions: FPA144 is a glycoengineered monoclonal antibody directed against FGFR2b that is being developed for the treatment of patients with tumors that overexpress FGFR2b. FPA144 has been safely administered at doses up to 6mg/kg q2w; dose escalation continues. Updated safety, PK and anti-tumor activity will be presented. Clinical trial information: NCT02318329.
Bone loss and vitamin D deficiency post gastrectomy for gastro-esophageal malignancy.
Authors: Virik Kiran , Wilson Robert
Published: February 2017

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Background: Metabolic bone disease is a known but incompletely understood consequence of gastrectomy. Post gastrectomy osteoporosis (OP) is multifactorial. Evidence suggests that patients who undergo this surgery require long term bone health assessment and nutritional support. Methods: 30 post gastrectomy patients (2000-2008) from a single centre in Australia were evaluated re bone health post surgery and post nutritional supplementation. Exploratory analysis included: age, gender, pathology, type of surgery, 25 OH-vitamin D, calcium, parathyroid hormone (PTH), bone mineral density (BMD), vertebral XRs, urinary calcium and N telopeptides of type I collagen. Other risk factors evaluated were: smoking, corticosteroid use, alcohol intake, hyperthyroidism, menopausal status, hyperparathyroidism (hPTH), pre-existing bone disease. Results: The median age of the cohort was 67.5 (range 53-83) of whom 22 (73%) were male. Histology showed 16 (53%) gastric adenocarcinoma, 6 (20%) esophageal adenocarcinoma, 2 (7%) GISTs, 5 (17%) gastric/duodenal lymphoma and 1 other category. Similar numbers of patients underwent total (12) and partial/distal gastrectomy (12), with 6 having a subtotal gastrectomy. 22 (73%) had a Roux-en-Y or BR II reconstruction and 8 had a BRI/other. Median time from surgery to first BMD was 54.5 months (range 12-360) with median correlative calcium level 2.24 (range 1.97-2.49), median vitamin D level 43 (range 11-82) and median PTH 6.4 (range 1.8-13.8). Osteoporosis was diagnosed in 14 (47%) of patients, osteopenia in 14 and 2 (7%) patients had a normal BMD. Low vitamin D was seen in 23 (77%) patients, low calcium levels in 5 (17%) and secondary hPTH in 12 (41%). Post nutritional supplementation preliminary results showed 2/23 (9%) had a low vitamin D level, 3/11 (27%) had secondary hPTH, 5/19 (26%) had osteoporosis, 12/19 (63%) had osteopenia and 2/19 had a normal BMD. Analysis of other risk factors is to follow. Conclusions: Poor bone health and vitamin D deficiency is a clinically significant problem post gastrectomy. Patients should undergo long term nutritional and bone health surveillance in addition to their oncological follow up post resection.
Safety, PD-L1 expression, and clinical activity of avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with advanced gastric or gastroesophageal junction cancer.
Authors: Chung Hyun Cheol , Arkenau Hendrik-Tobias , Wyrwicz Lucjan , Oh Do-Youn , Lee Keun-Wook , Infante Jeffrey R. , Chin Kevin M. , von Heydebreck Anja , Kang Yoon-Koo , Safran Howard
Published: February 2017

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Background: The programmed death-1 receptor (PD-1) and its ligand (PD-L1) are key therapeutic targets in the reactivation of the immune response against cancer. Avelumab* (MSB0010718C) is a fully human anti-PD-L1 IgG1 antibody being investigated in clinical trials. We report safety and clinical activity of avelumab in patients (pts) with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) based on level of PD-L1 expression. This phase Ib JAVELIN study (NCT01772004) enrolled pts who had progressed on prior therapy ( ≥ 2L) and pts who had received 1L chemotherapy but had not yet progressed (switch-maintenance [Mn]) Methods: Pts received avelumab 10 mg/kg Q2W until confirmed progression, unacceptable toxicity, or withdrawal. Tumours were assessed every 6 wks (RECIST 1.1). Best overall response and progression-free survival (PFS) were evaluated. Adverse events (AEs) were graded by NCI-CTCAE v4.0. PD-L1 expression was assessed by immunohistochemistry using various cutoff criteria Results: As of Feb 13, 2015, 75 pts with GC/GEJ were treated with avelumab (20 pts, 2L; 55 pts, Mn). Treatment-related treatment-emergent AEs (TR-TEAEs) of any grade occurred in 47 pts (62.7%); the most common ( > 10%) was infusion-related reaction (12 [16.0%], all grade 1/2). Nine pts (12.0%) reported a grade ≥ 3 TR-TEAE, including fatigue (2), thrombocytopenia (2), and anemia (2; each 2.7%). There was 1 treatment-related death (hepatic failure/autoimmune hepatitis). Responses were observed in 7 pts (3/20 2L, all PRs; 4/55 Mn, 1 CR, 3 PRs). PD-L1 expression was evaluable in 55 pts (12/20 2L, 43/55 Mn), including in 3 pts with a response. Median PFS in 2L group was 36.0 wks (95% CI: 6.0, 36.0) for PD-L1+ and 11.6 wks (2.1, 21.9) for PD-L1− ( ≥ 1% cutoff). In Mn group, median PFS for PD-L1+ and PD-L1− status was 17.6 wks (5.9, 18.0) and 11.6 wks (5.7, 17.7), respectively ( ≥ 1% cutoff). Conclusions: Single agent avelumab showed an acceptable safety profile and clinical activity in GC/GEJ pts. Objective responses and disease stabilization were observed in both groups. Median PFS was longer in PD-L1+ pts. Phase III trials in 1L and 3L GC/GEJ are underway.*Proposed INN Clinical trial information: NCT01772004.
Phase III randomized study of sorafenib plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC): CALGB 80802 (Alliance).
Authors: Abou-Alfa Ghassan K. , Niedzwieski Donna , Knox Jennifer J. , Kaubisch Andreas , Posey James , Tan Benjamin R. , Kavan Petr , Goel Rakesh , Murray John J. , Bekaii-Saab Tanios S. , Tam Vincent Channing , Rajdev Lakshmi , Kelley Robin Kate , Siegel Abby , Balletti Jennifer , Harding James J. , Schwartz Lawrence HOWARD , Goldberg Richard M. , Bertagnolli Monica M. , Venook Alan P.
Published: February 2017

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Background: An exploratory analysis of a randomized phase II study in HCC comparing doxorubicin (D) alone to doxorubicin plus sorafenib (D+S) showed a significant improvement in overall survival favoring D+S (JAMA, 2011). The results appeared promising compared to the historic outcomes seen in the pivotal sorafenib (S) trials. CALGB 80802 was designed to determine if D+S improved survival compared to S alone. Methods: Patients with histologically proven advanced HCC, no prior systemic therapy and Child-Pugh A were randomized to receive D 60 mg/m2 every 21 days plus S 400 mg PO twice daily (D+S) or S alone. For bilirubin ≥ 1.3x normal, D and S doses were halved. D was maxed out at 360 mg/m2. The study was stratified by extent of disease (locally advanced; metastatic), the primary endpoint was overall survival (OS); and secondary endpoint progression-free survival (PFS). The final analysis was to occur when 364 events were observed among 480 total patients, with 90% power to detect a 37% increase in median OS (10.7 to 14.7 months; 1-sided α = 0.05). Results: The Alliance DSMB halted the study after accrual of 346 patients (173 on each of D+S and S) when a futility boundary was crossed at a planned interim analysis. With 107 events in each arm, median OS was 9.3 months (95%CI 7.1-12.9) for D+S, and 10.5 months (95% CI 7.4-14.3) for S with a hazard ratio (HR) 1.06 (95% CI 0.8-1.4) for D+S vs. S. Median PFS was 3.6 (95% CI 2.8-4.6) and 3.2 months (95% CI 2.3-4.1), respectively (HR = 0.90, 95% CI 0.72-1.2). There were 38 deaths on treatment: 18 on D+S and 20 on S. Among these 8 [sepsis (1), dysphagia (1), pneumonia (1), cardiac (2), hepatic failure (2), and not otherwise specified (1)] on D+S, and 3 [fatigue (1), hepatic failure (1), and a secondary malignancy (1)] on S, were at least possibly related to treatment. A maximum grade 3 or 4 only hematologic adverse events (AE) occurred in 37.8% of patients on D+S and 8.1% of patients on S. Non-hematologic AEs were comparable, in 63.6% and 61.5% of patients, respectively. Conclusions: The addition of D to S resulted in higher toxicity and did not improve OS or PFS. The S median OS of about 10 months is consistent with previous reports. NCI Grant U10CA180821 Clinical trial information: NCT01015833.
Auranofin to prevent progression of pancreatic ductal adenocarcinoma.
Authors: Rios Perez Mayrim V. , Roife David , Dai Bing Bing , Kang Ya'an , Li Xinqun , Pratt Michael , Fleming Jason B.
Published: February 2017

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Background: Auranofin, an FDA anti-rheumatic agent shown to have anticancer properties for lung and ovarian cancer has never been studied for pancreatic cancer. We hypothesize that Auranofin may prevent pancreatic ductal adenocarcinoma (PDAC) progression by induction of apoptosis. Methods: We performed in vitro and in vivo studies using human PDAC cell lines and patient-derived xenografts (PDX) to assess Auranofin anticancer activity. Sensitivity to the compound was determined based on IC50s. Western blot assay was used to interrogate mechanisms of apoptosis, autophagy, and resistance. Two PDAC orthotopic mouse models were designed to determine optimal dose (survival), and antitumor effect (non-survival). Results: We found more than half of PDAC cell lines (10/18) to be sensitive to Auranofin based on IC50s below 5µM. Ex vivo tissue growth inhibition greater than 44% was observed for 13 PDX tissue cases treated with 10 µM Auranofin. Treatment with low-dose Auranofin (0.5-1µM) was found to induce PARP cleavage and LC3B expression among sensitive cell lines when compared to control (0.1% DMSO). High Txnrd1 and low Nrf2 expression was observed for resistant cell lines. Survival study using MiaPaCa-2 Luc+ showed 15mg/kg IP as the optimal dose due to absence of gross solid organ metastasis up to 13 weeks post-treatment (median survival 8 and 12, respectively; p = 0.0953). Non-survival study using MDA-Patc53 Luc+ showed a decreased tumor bioluminescence (p = 0.1097) and a 9-fold decrease in mean tumor progression from baseline (p = 0.1640) 3 weeks post-treatment. Conclusions: We have demonstrated that Auranofin prevents PDAC progression using two animal models. In vitro studies suggest apoptosis and autophagy as possible mechanisms of action, and Txnrd1 as a biomarker of resistance. This study altogether demonstrates both primary and metastatic antitumor effect of Auranofin for PDAC, which could represent an advantageous therapeutic approach for a broad selection of patients in both neoadjuvant and adjuvant settings.