tbuckley/cabot-search huggingface dataset:
iMETx (Individualized Metabolic Rx): Pilot study of an environmental intervention to increase energy expenditure among breast cancer survivors.
Authors: Tarah Jean Ballinger, Emily Nelson, Timothy Olsen, Kathy Miller, Jeffrey Sledge
Journal: Journal of Clinical Oncology (2018)

TPS10125 Background: Physical activity (PA) is associated with improved quality of life and outcomes in breast cancer survivors. However, many are inactive at diagnosis and activity levels worsen following treatment. PA interventions in breast cancer survivors have suffered from low acceptability and sustainability. The motives, capability, and environment affecting each individual vary, and an effective PA intervention will need to account for these differences. Designed to address this need, this study pilots an individualized, dynamic intervention (iMETx) to increase energy expenditure in breast cancer survivors. Methods: Patients with history of stage 0-III breast cancer who have completed primary treatment are recruited from Indiana University Simon Cancer Center. Those with comorbidities precluding use of a stationary bicycle are excluded. Energetic capacity (power generation) is assessed at baseline using a stationary bicycle protocol designed to be accurate over a range of physical capabilities and feasible in a clinic setting. Patients wear a GPS/accelerometer activity monitor for 3 weeks to collect baseline energy expenditure. During the subsequent 12 week intervention, patients receive tailored “prescriptions” every 1-3 days from the iMETx web application. Prescriptions are based on individual power ability and environment, and are dynamic, adjusted to achieve pre-determined energy endpoints. Following the intervention, power generation is re-assessed. Patients are monitored for 12 additional weeks to estimate sustainability. Each assessment point also includes DEXA to determine body composition, serum for markers of inflammation and metabolism, and questionnaires assessing quality of life and psychosocial factors. Throughout the study, patients interact with the web application to provide continuous feedback and actively engage in the research process. Feasibility will be assessed by compliance with study procedures, and preliminary effect of the intervention will be determined by changes in energetic capacity, energy expenditure, body composition, and quality of life. Sixteen patients have accrued out of a planned 60. Clinical trial information: NCT03158519.
Long-term (LT) disease-free survival (DFS) of melanoma (MM) and renal cell cancer (RCC) patients following high-dose interleukin-2 (HD IL2).
Authors: Joseph Clark, Brendan D. Curti, Elizabeth J. Davis, Howard Kaufman, Asim Amin, Ajjai Shivaram Alva, Douglas Buckner Johnson, Richard L. White, Peter H. Wiernik, Janice P. Dutcher
Journal: Journal of Clinical Oncology (2017)

e21005 Background: HD IL2 treatment (Tx) produces durable complete responses (CRs) and surgical CRs. Patients (pts) achieving partial response (PR) and stable disease (SD) demonstrate improved survival compared with pts who progress. Methods: 7 HD IL2 Tx centers identified pts with survival &gt; 5 years (yrs) after HD IL2. DFS was from end of IL2 to January 2017. Tx courses generally consisted of 2 1-week cycles of HD IL2, 600,000-720,000 U/kg IV every 8 hours. We collected data on pts Tx with HD IL2 alone, or HD IL2 plus local Tx (surgery or radiation (SRS) leading to CR) with survival &gt; 5 yrs after HD IL2 Tx. Results: 72 pts are reported: 29 RCC (male 22, female 7) and 43 mm (male 26, female 17). Median age at Tx of RCC is 54 yrs (range, 47-67 yrs) and of mm is 50 yrs (range, 24-72 yrs). Sites of metastatic disease for 26 mm pts were lymph nodes (LN) -18, lungs-12, bone-6, liver-9, brain-3, other organs-10 and for 22 RCC pts were lung-17, LN-5, adrenal-4, bone-3, other organs-8. Number of IL2 courses received: 1-10 pts, 1.5-4 pts, 2-28 pts, 2.5-5 pts, 3-24 pts, 4-one pt. Among the 29 RCC pts, there are 24 CRs, 3 surgical CRs and 2 PRs with no further Tx. Among 43 mm pts, there are 34 CRs, 2 near CRs, and 7 Surgical/SRS CRs. DFS in these pts after HD IL2 Tx ranges from 5+ yrs to 30+ yrs, median 10.5+ yrs. 10 RCC and 16 mm are alive &gt; 5 - &lt; 10 yrs after IL2, and 19 RCC and 27 mm are alive &gt; 10 yrs after IL2. LT toxicity among these 72 pts includes hypothyroidism-5 pts, arthralgias/arthritis-5 pts, vitiligo-3 pts, and 1 pt each: neuropathy, PVCs, and normal pressure hydrocephalus. Additional pts may be added as records become available. Conclusions: We document LT DFS ( &gt; 5 yrs) after CR or PR from HD IL2 alone. Surgical or SRS conversion of PR to CR can produce durable CRs. LT DFS was observed in pts with visceral and bone metastases, not only those with LN or lung sites. Neither age, sex, nor number of courses of IL2 predicted LT DFS. Chronic toxicity due to IL2 is uncommon in LT survivors.
Dynamic change of PD-L1 expression on circulating tumor cells in advanced gastrointestinal tumor patients undergoing PD-1 blockade therapy.
Authors: Chunyan Yue, Yu-Bo Jiang, Ping Li, Yue-hua Wang, Da Li, Yan-lian Yang, Zhi-yuan Hu, Jian-Ming Xu
Journal: Journal of Clinical Oncology (2018)

12033 Background: Tumor PD-L1 levels have predictive value in PD-1/PD-L1 checkpoint blockade therapies, yet biopsies can only provide baseline information. Whether PD-L1 expression on circulating tumor cells (CTCs) could serve as an alternative biomarker is of great interest. Methods: We established an immunofluorescence assay for semi-quantitative assessment of the PD-L1 expression levels on CTCs with four categories (PD-L1negative, PD-L1low, PD-L1medium and PD-L1high). 35 patients with advanced gastrointestinal tumors were enrolled in a phase 1 trial of a PD-1 inhibitor, IBI308. The CTC numeration and the PD-L1 expression levels were analyzed prior the treatment and at the time of therapeutic evaluation. Results: Prior the treatment of PD-1 inhibitor, 97% (34/35) patients had CTCs, ranging from1 to 70 (median 7). 74% (26/35) had PD-L1positive CTCs, and 60% (21/35) had at least one PD-L1high CTCs. The disease control (DC) rate in PD-L1high patients (48%) is much higher than the others (14%). The group with at least 20% abundance of PD-L1high CTCs had even higher DC rate of 64% (9/14), with only 14% DC rate for the rest (3/21). We also observed that the count changes of total CTC, PD-L1postive CTC and PD-L1high CTC correlate quite well with disease outcome (P < 0.001, P = 0.002 and 0.007, respectively). In addition, the abundance of PD-L1high CTCs at baseline had predicative significance for progression free survival (PFS). Conclusions: We revealed that the abundance of PD-L1high CTCs at baseline might serve as a predictor to screen patients for PD-1/PD-L1 blockade therapies and measuring the dynamic changes of CTC could indicate the therapeutic response at early time. Clinical trial information: NCT02937116.
Nutritional risk as predictor for short-term outcomes in a prospective cohort of elderly patients with cancer.
Authors: Jose Iran Costa, Jurema Telles O Lima, Anke Bergmann, Maria Julia Gonçalves Mello, Mirella Rebello Bezerra, Zilda Cavalcanti, Letícia telles Sales, Luiz Claudio Santos Thuler
Journal: Journal of Clinical Oncology (2017)

e21533 Background: To determine if the nutritional risk according Mini Nutritional Assessment Short-Form (MNA®-SF) is an independent factor for short-term outcomes (infection, un programmed hospitalization and premature death) within the first six months after study entry. Methods:Prospective cohort study of elderly patients (≥ 60 years) with a recent diagnosis of cancer admitted to an outpatient oncology unit. At baseline sociodemographic and clinical variables were determined and comprehensive geriatric assessment (CGA) was conducted including MNA-SF. The outcomes were first Healthcare-associated Infection, un programmed hospitalization and death. Data were analyzed using multivariate Cox proportional hazards models; overall survival was estimated using the Kaplan–Meier method and survival curves were compared using the Log rank test. Results:The cohort consisted of 608 elderly patients followed for 180 days or until the censured data. Mean age was 71.9 years (range: 60‒96), 305 (50.2%) participants were at risk of malnutrition. During this period, 216 (35.5%) participants were hospitalized, 179 (29.4%) HAI and 100 (16.4%) died. After adjustment for age, site of cancer and cancer stage the multivariate regression Cox model showed that being undernourished was an independent predictor of infection (HR = 1.88, 95%CI 1.32-2.67, p &lt; 0.001) hospitalization (HR = 1.5, 95% CI:1.10- 2.06, p = 0.012) and death (HR = 3.12, 95% CI: 1.74‒ 5.78, p &lt; 0.001) Conclusions:Nutritional risk at admission was identified as a significant predictor of risk for premature death, infection, and need for hospitalization in elderly cancer patients. The use of MNA-SF should be incorporated into regular geriatric assessment of older patients with cancer
Utility of a novel smartphone application for breast cancer survivors.
Authors: Malcolm R. Kell, Mitchell Barry
Journal: Journal of Clinical Oncology (2017)

e21577 Background: Breast cancer survivorship aims to improve quality of life and reduce the risk of relapse after diagnosis and treatment. Smartphone applications are now widely used and facilitate many daily activities. Excercise and diet are key components of survivorship and modification of both can improve longterm breast cancer outcome. We have developed a smartphone application focused on enhancing excercise and diet following breast cancer diagnosis; Breast Cancer Survivor. Methods: A Smartphone application was developed with Portable Medical Technology, Ireland (https://itunes.apple.com/ie/app/breast-cancer-survivor/id1043485265?mt = 8). We focused on improving excercise and caloric balance to reduce body mass index. The appliction measured excercise, intensity and distance, to calculate individual energy expenditure and set a target aimed at reducing BMI by 10% over 8 weeks. In additon to excercise we gave dietry advice to focus on caloric intake. We have examined both national and international usage of the application after it was realeased free of charge, for the initial 6 months after release. Results: 770 users donwloaded and used Breast Cancer Survivor in the initial 6 months. Majority of users were in Ireland (38% n = 534), United Kingdom (24.6% n = 339) and United States of America ( 10.7% n = 147). 1376 session of use were recorded and off these 44.2% (n = 608) were return users. BCS app was used for an average of 2.2 minutes per session.Following initial release and local media coverage usage peaked at 401 sessions and then plateaued at 118 sessions after 6 months with only social media coverage. Conclusions: Smartphone application is an effective lifestyle modification, targeting breast cancer survivors. Breast Cancer Survivor has been widely used with only limited promotion. Breast cancer survivorship can be promoted with a smartphone application.
The relative effectiveness of cancer awareness months: A Google trends analysis of the United States from 2004 to 2017.
Authors: Nyle Hamidi, Adeel Khan
Journal: Journal of Clinical Oncology (2018)

e13544 Background: Internet search traffic provides a proxy measure into patients’ information-seeking behaviors. As the largest search engine in the world, Google’s data provided via Google Trends has become the largest provider of this category of data as it is publicly-viewable, passively-collected, and expansive. We sought here to examine cancer awareness months’ impacts on people’s internet search habits, focusing on the four malignancies with highest incidence in the US: breast, prostate, colorectal, and lung. Methods: Google Trends was utilized to obtain relative search engine traffic values (defined as search volume indices, SVIs) in the United States from January 2004 to December 2017. The terms queried were BREAST CANCER, COLORECTAL CANCER + COLON CANCER + RECTAL CANCER, PROSTATE CANCER, and LUNG CANCER with Boolean operators. Mean SVIs from each cancer’s awareness month were compared to mean SVIs for the remainder of the year using two-tailed two-independent sample t-tests. All analyses were conducted in R (V3.1.1) in accordance with previously published Google Trends investigations. Results: For breast cancer, mean SVI for its awareness month October was 79.1 vs. 34.5 for the rest of the year, t (166) = 18.6, p < 0.001. For colorectal cancer, mean SVI for its awareness month March was 79.4 vs. 67.3 for the rest of the year t (166) = 5.5, p < 0.001, while for prostate cancer, mean SVI for its awareness month September was 66.6 vs. 67.2 for the rest of the year, t (152) = 0.2, p = 0.86. Finally for lung cancer, mean SVI for its awareness month November was 42.9 vs. 45.3 for the rest of the year t (166) = 0.8, p = 0.37. Conclusions: Google search volume for terms related to breast cancer were significantly higher in its awareness month compared to the rest of the year. This was similarly true for colorectal cancer, suggesting that these respective awareness months are successful in increasing attention. However for both prostate and lung cancers, search volume did not significantly differ in their respective awareness months. These data suggest that different awareness campaigns have varying success in promoting their diseases and furthermore provide information on which malignancies may need further attention.
Intra-tumor heterogeneity of T cell receptor repertoire in lung cancers and its association with tumor genomic profile.
Authors: Jianjun Zhang, Junya Fujimoto, Erik Yusko, Jianhua Zhang, Marissa Vignali, Xingzhi Song, Jaime Rodriguez-Canales, Edwin Roger Parra Cuentas, Carmen Behrens, Sharon Benzeno, Harlan Robins, Don Lynn Gibbons, Stephen Swisher, John Heymach, Andrew Futreal, Ignacio Ivan Wistuba
Journal: Journal of Clinical Oncology (2016)

8539 Background: Immune checkpoint blockade has shown unprecedented durable clinical benefit in lung cancer patients, however, the response rate is modest. PD-L1 is the only available biomarker for immune checkpoint blockade therapy for non-small cell lung cancers (NSCLC), but the presence of robust responses in patients with low PD-L1 argues against the value of PD-L1 as an exclusionary predictive biomarker. One explanation is the significant intratumor heterogeneity (ITH) of PD-L1 observed in NSCLC tumors. T cell receptor repertoire (TCR) has been reported to be associated with response to immune checkpoint blockade in melanoma patients and was proposed as a potential predictive biomarker. However, the ITH of TCR has not been well studied. In addition, the relationship between TCR repertoire and tumor genomic profile in NSCLC is largely unknown. Methods: Multiregion TCR repertoire profiling by ImmunoSEQ was applied to 45 tumor regions (2-5 regions per tumor) and 11 normal lung tissues from 11 patients with lung adenocarcinoma. T cell density, TCR clonality and diversity were calculated using ImmunoSeq Analyzer. Morisita overlap index (MOI) was used to assess the heterogeneity of TCR repertoire between each pair of samples. Genomic profiling derived from whole exome sequencing of the same multiregion tumor samples was analyzed for the association with TCR repertoire. Results: Different patients demonstrated distinct TCR repertoire: MOI is close to 0 between samples of different patients. The infiltrating T cell density (quantity) did not differ between tumors and normal lung tissues (p = 0.7 by Wilcox signed-rank test). However, TCR repertoire (quality) in tumors is significantly different from matched normal lung tissues: mean MOI is 0.46 between tumor regions versus 0.08 between normal lung tissues and tumors (p < 0.0001, by t-test). TCR repertoire ITH was observed in all patients but the complexity of TCR ITH varies: mean MOI ranges from 0.05 to 1.0 in different patients. T cell clonality is correlated with mutation burden (R = 0.73, p = 0.01 by Pearson product-moment correlation). Conclusions: TCR ITH is common in NSCLC and therefore should be taken into account when assessing TCR as a biomarker.
Prospective erythrocyte mass tranfusion-induced iron overload observation in pediatric oncoheamatalogical patients.
Authors: Rugile Cesaite, Jelen Rascon
Journal: Journal of Clinical Oncology (2018)

e22518 Background: i) evaluate the frequency of iron overload in children with oncohaematological diseases after multiple erythrocyte mass (EM) transfusions during chemotherapy; ii) assess the value of serum iron parameters in predicting iron overload during chemotherapy. Methods: we prospectively investigated an association between the amount of the transfused EM and the levels of serum ferritin, serum iron and unsaturated iron binding capacity (UIBC) in pediatric oncohaematalogical patients before and during chemotherapy between 2015 and 2017. Iron overload was defined by serum ferritin levels ≥ 1000 μmol/L. Results: Sixty five patients were enrolled into the study, among them there were 33 (51%) males and 32 (49%) females. The median age of patients at diagnosis was 6 years (range 0-17 years). Repetitive transfusions were performed in 54 (83%) of the enrolled patients. The median total volume of transfused EM was 1883 ml (range 130-17164 ml). Iron overload, defined by high ferritin level (≥ 1000 μmol/L) was observed in 30% of patients who received multiple EM transfusions during chemotherapy. There was no correlation between post-treatment serum ferritin level and either the amount of the transfused EM (Pearson correlation coefficient r = 0.21), or the number of performed EM transfusions (r = 0.18). There was also no significant difference between the mean levels of serum iron (21.8 μmol/L versus 22.1 μmol/L, p = 0.94) before and after treatment. However we found a significant inverse correlation between the post-treatment UIBC level and both the amount of transfused EM (r = -0.54, p < 0.05), and the number of performed transfusions (r = -0.53, p < 0.05). In addition, there was a statistically significant, albeit weak, inverse correlation between the post-treatment serum ferritin level and UIBC (r = -0.38, p < 0.05). Conclusions: i) iron overload was detected in 30% of pediatric oncohaematological patients who received multiple erythrocyte mass transfusions during chemotherapy; ii) treatment-associated iron overload is better represented by serum UIBC.
TCT-423 Incidence and prognostic impact of the calcified nodule in coronary artery disease patients on hemodialysis
Authors: Akihiko Okamura, Hiroyuki Okura, Atsushi Kyodo, Saki Iwai, Ayaka Keshi, Koshiro Kanaoka, Atsushi Kyodo, Azusa Sakagami, Daisuke Kamon, Yukihiro Hashimoto, Yukihiro Hashimoto, Tomoya Ueda, Tsunenari Soeda, Makoto Watanabe, Yoshihiko Saito
Journal: Journal of the American College of Cardiology (2018)
Nimotuzumab as a single agent palliative therapy in performance score 3 and above in EGFR expressing tumors.
Authors: Suresh VS Attili, Dilip Pawar, Chinnababu Sunkavalli
Journal: Journal of Clinical Oncology (2017)

e21635 Background: Nimotuzumab is a humanized IgG1 monoclonal antibody against the EGFR extracellular domain that has been evaluated in solid tumors as a single agent or in combination with chemotherapy and radiation. However when used without radiation, its always used in adjunct to chemotherapy. With encouraging results of other EGFR monoclonal antibodies as single agent therapies, we explored the possibility of using Nimotuzumab as single agent by which we could avoid chemo related side effects. In view of the limited options availability for subjects with PS 3 and more we thought of choosing this population for analysis of Nimotuzumab as single agent palliative therapy in PS 3 and above EGFR expressing tumors for safety and efficacy Methods: Details of the 38 subjects with pre-treated advanced refractory or progressive solid tumors having PS of more than 2 were evaluated. Nimotuzumab was administered weekly at 200 mg/m2 as single agent for 4 weeks (induction phase) and patients were stratified into those with improved PS and those without. The subjects without PS improvement were continued on the single agent and those with improvement were offered additional chemotherapy . Nimotuzumab could be continued beyond disease progression. Results: Out of 38 patients, 18 had improvement in the PS and were offered chemotherapy later. 16 patients had stable PS and disease. 3 subjects were lost to follow up and 1 patient did not continued. The median number of nimotuzumab applications was 6 (2–11) in the induction phase and the median chemotherapy cycles were 3 (1-6). No toxicity occurred during induction phases (single agent nimotuzumab) and during chemotherapy the Grade II/IV toxicities were observed in 6 (33%) cases predominantly cytopeneas, neuropathy and diarrhea. The median PFS was 142 days (95% CI, 84 to 182), and the median improvement in QOL was 6 points on a scale of 30. Conclusions: Nimotuzumab is well tolerated and may have a role in the treatment of advanced cancers as a single agent in patients with poor performance status. 47% of the patients who are otherwise not eligible for chemo became eligible and had better QOL and longer PFS [compared to historical controls]
Gemcitabine, dexamethasone, and cisplatin (GDP) as an effective therapy as salvage and mobilization regimen in patients with relapsed or refractory Hodgkin lymphoma.
Authors: Ayla Gokmen, Ender Soydan, Zafer Gokgoz, Mevlude Kurdal, Ibrahim Tek, Osman Ilhan, Onder Arslan, Muhit Ozcan
Journal: Journal of Clinical Oncology (2018)

e19517 Background: The best combination chemotherapy as a salvage and mobilization regimen in patients with relapsed or refractory Hodgkin lymphoma ( HL) remains unknown. We retrospectively analysed the efficacy and safety of gemcitabine, dexamethasone and cisplatin (GDP) combination chemotherapy in patients with relapsed and refractory HL. Methods: 30 patients (18 male and 12 female patients) with relapsed or refractory HL who were treated with GDP as salvage and mobilization regimen before autologous stem cell transplantation bettween 2013-2017 in our center were included. Median age was 30 ( ranges 15-63). Eight patients had refractory (previous treatment cyles: 2-6), 22 patients had relapsed disease before treatment with GDP. All patients received at least 2 cyles of salvage chemotherapy. GDP regimen consisted of gemcitabine 1000 mg/ m2 /day on days 1 and 8, cisplatin 75 mg/ m2 /day on day 1 and dexamethasone 40 mg/ d on day 1-4. Results: Neither febrile neutropenic episode nor any other toxicities that necessitated treatment delay was observed. Overall response rate (ORR) was 73 %. Eleven ( 36.6%) patients achieved complete remission ( CR), 11 (36.6%) partial remission (PR) and 8 (26.6%) patients had stable disease. Stem cell mobilization was started after the second cyle of GDP with G-CSF 10 mcg/kg. Stem cell collection was achieved in all patients (%100) with a median 13.4x106 /kgCD 34 + cells ( ranges 3.0-59.0). All patients underwent autologous stem cell transplantation successfully with expected engraftment kinetics. We did not observed febrile neutropenic episode or any other dose limiting toxicities. Conclusions: GDP is an effective and safe outpatient salvage regimen in in patients with relapsed or refractory HL. The treatment can be given as an outpatient basis which may takes huge advantage in this setting.