bluuebunny/crossref_metadata_2025_split huggingface dataset:
Emotional concerns in cancer survivors not treated with chemotherapy.
Authors: Nikoomanesh Tina , Goldfarb Melanie 
Published: February 2017

233 Background: Emotional concerns can impact quality of life in all cancer (CA) survivors, regardless of receipt of chemotherapy. Methods: Surgically treated CA survivors that were not treated with chemotherapy were identified in the 2010 LiveStrong Survey. Only patients that responded to all 9 categories of emotional concern questions were included (energy/fatigue, depression and mood, identity and grief/guilt, faith and spirituality, fear of recurrence, social anxiety, shame, concern for family, insecurity). A total emotional concern score was calculated (0-9) and independent t-tests or ANOVA identified factors that impacted the total score. After stratification by CA type, linear regression determined which factors, if any, were important predictors of having more emotional concerns. Results: Of 649 CA survivors, most were white (91.0%), insured (97.8%), employed/student (79.3%), married/domestic partner (76.2%), and had survived at least 5 years (69.8%); many were > 40 years old (62.8%). The median number of reported emotional concerns was 4 (mean 4.3, SD 2.0) with 3.1% of patients reporting no concerns. Patients with brain or head/neck CAs had the highest scores (5.3, SD 1.5-1.7), whereas those with other endocrine tumors or melanoma had the lowest scores (3.9, SD 2.0-2.1), (p = 0.001). Additionally, age < 40 at diagnosis, female gender, being employed, uninsured, having less education, and having received radiation (RT), hormone (HT), or other additional therapy all increased the emotional concern score (p < 0.05); race/ethnicity, marital status, and income did not impact the score. After stratification by CA type, only the following increased emotional concerns: receipt of HT for breast CA (B = 0.30), being employed (B = 0.82) or retired (B = 0.41) for thyroid CA, female gender (B = 0.51) or receiving RT (B = 0.38) for bone/soft tissue CA, age < 40 (B = 0.37) and receipt of other/HT (B = 0.31) for melanoma, and female gender for (B = 0.76) for other endocrine tumors. Conclusions: Significant emotional concerns are reported by surgically treated cancer survivors not treated with chemotherapy. These concerns are most influenced by cancer type and treatment, but not race/ethnicity, marital status, or income.
Incidental renal tumors in cancer survivors: Minimally invasive management by image-guided thermal ablation.
Authors: Abdelsalam Mohamed E. , Sabir Sharjeel H , Kusin Samuel B. , Matin Surena F. , Wood Christopher G. , Karam Jose A. , Ahrar Kamran 
Published: February 2017

258 Background: To investigate presentation, management and outcome of renal tumors in patients with prior or current history of cancer. Methods: A retrospective review of a database for patients undergoing ablation of renal tumors between January 2012 and June 2014 was performed. For each patient , the following was recorded: Prior or current history of cancer (other than renal cell carcinoma), histology of primary tumor, status of primary cancer (remission or under therapy), size of the renal tumor, thermal ablation technology , complications of ablation, development of metastases from renal tumor, deceased or alive , cause of death and the length of follow up. Results: Ninety five renal ablation procedures were performed in 91 patients between January 2012 and June 2014. Of this subset, 37 patients (27 male and 10 females) with average age 63 years (Age range 53-85 Years) had prior or current history of malignancy (6 patients had more than one primary cancer) other than renal tumor including Prostate(6), colorectal (4), Breast (4) lymphoma (3) and others (20). All renal tumors were discovered incidentally, none of the patients had symptoms related to renal tumors. Twenty four patients were in remission and 13 patients were undergoing therapy for their primary malignancy at the time of ablation. Ablation was performed using radiofrequency (n = 30) or cryoablation (n = 9) for 39 renal lesions with average size of 2.4cm (Range 1.1 to 4 cm). After average of 20 months (range 5-35 months) of observation 34 patients (92%) were still alive. Three patients died of their primary cancer. None of the patients developed complication from the procedure, 1 patient had recurrence after 6 month; for which renal ablation was performed. None of the patients developed metastatic disease from or died of renal cell carcinoma. Conclusions: Staging workup and surveillance imaging studies in cancer patients can lead to incidental detection of primary renal tumors. Minimally invasive therapy with image guided radiofrequency ablation or cryotherapy is feasible, safe and effective. Image guided ablation has no discernable impact on the course of therapy for the primary tumor. Furthermore, it has minimal to no morbidity for patients in remission.
A randomized controlled study for the long term follow-up of breast cancer survivors: A primary care physician (PCP) coordinated care delivery model.
Authors: Wang Yong Alison , Chen Shih-Ping , Horng Chen-Fang , Hsieh Ling-Ling , Hsu Kai-Hsin , Chu Chen-Shin , Tsai Shu-Yi , Chan Yu-Hui , Shih Shih-Ming , Cheng Chun-Chiu 
Published: February 2017

36 Background: Generalist involvement in cancer survivorship care is becoming a global trend, however, significant barriers exist. As a major cancer center in Taiwan, KF-SYSCC is implementing an academic institution-based comprehensive survivorship program, a PCP-coordinated care delivery model. Our goal is to promote health, manage chronic diseases, attend to psychosocial needs, and optimize health care resources without compromising cancer-related clinical outcome or patient satisfaction. Methods: We designed a randomized study with staggered transition of stage 0-3 breast cancer patients from oncologist care to the PCP-coordinated program at one or two years after cancer surgery. The outcomes for comparing the two care models include late effects of breast cancer treatment, anxiety and depression, health-related quality of life, recurrence-related clinical outcome, preventive care, chronic disease management, patient satisfaction, and health services utilization. Questionnaires were given every 6 months from 6 to 30 months after surgery. Results: Within six months, 270 eligible individuals were approached with an enrollment rate of 58% (target sample 1,200). The barriers for non-enrollment include: having established relationship with oncologist, transfer time too soon, lack of trust for non-oncologist, unwilling to change care provider, treatment not yet completed. The 113 non-participants did not differ from the 157 participants in age or cancer characteristics. Between the 1-year and 2-year transfer groups, there were no significant differences in demographics, tumor characteristics and treatment modalities. The initial BCPT and SF-36 questionnaires showed poorer performance in the areas of hot flashes, pain, cognition, weight, role physical, energy, and health perception, as compared with areas of bladder, vaginal, arm problems, physical and social functioning, mental health, and role emotional. Conclusions: We have started a randomized study to evaluate a generalist care model to survivorship care. Baseline patient characteristics were defined. Several barriers to the transition of the new care delivery model were identified.
Impact of sarcopenia on short- and long-term outcomes in patients with gastric cancer.
Authors: Hirata Fumiko , Kawamura Taiichi , Nishiwaki Noriyuki , Fujiya Keiichi , Omori Hayato , Takagi Wataru , Tatsubayashi Taichi , Honda Shinsaku , Hikage Makoto , Makuuchi Rie , Tokunaga Masanori , Tanizawa Yutaka , Bando Etsuro , Kinugasa Yusuke , Sugiura Teiichi , Uesaka Katsuhiko , Terashima Masanori 
Published: February 2017

19 Background: Depletion of skeletal muscle in aged people (sarcopenia) regarded as a poor prognostic factor in various cancers. The aim of this study was to assess the impact of preoperative sarcopenia on postoperative short- and long-term outcomes in patients with gastric cancer underwent curative resection. Methods: A total of 881 patients who underwent R0 resection for gastric cancer aged 65 or older between June 2003 and March 2011 were included in this study. Muscle mass was assessed by measuring percentage of arm muscle area (%AMA). Preoperative sarcopenia was defined as aged 65 or older, %AMA <80%, and decline in grip strength ( <25kg in men, <20kg in women), according to algorithm suggested by European Working Group on Sarcopenia in Older People (EWGSOP) with slight modification. Relationship between sarcopenia and short- and long-term outcomes were evaluated using uni- and multi-variate analysis. Results: Of 881 patients, sarcopenia was diagnosed in 62 patients (7.0%). Incidence of sarcopenia was significantly higher in patients with aged (75 or older), female, low BMI (18.5 or less) and poor PS (2). There was no significant difference of operation time or blood loss between sarcopenic and non-sarcopenic patients. Postoperative complications (Clavien–Dindo classification grade III or higher) was observed in 124 patients (14.1%). Multivariate analysis revealed that T stage and intraoperative blood loss were significant independent risk factors for postoperative complications. The incidence of postoperative complication was similar regardless of the sarcopenia status. The 5-year survival rate was tended to be worse in the sarcopenic patients (67.7%) than in the non-sarcopenic patients (78.4%) (p = 0.058). Multivariate analysis demonstrated that age (75 or older), male, total gastrectomy, D2 lymph node dissection, and sarcopenia were selected as independent prognostic factors for gastric cancer. Conclusions: Preoperative sarcopenia determined by %AMA seems not to be a risk for postoperative morbidity. However, sarcopenia appears to be a significant prognostic factor in patients with gastric cancer underwent curative resection.
Stromal characterization of small bowel adenocarcinomas.
Authors: Pedersen Katrina , Smyrk Thomas C. , McWilliams Robert R. 
Published: February 2017

288 Background: Programmed-death 1 (PD-1) receptor and its corresponding ligand, PD-L1, have been found to be clinically relevant in maintaining immune tolerance to malignant cells in an increasing number of tumor types. We have previously shown that nearly half of 48 randomly selected, resected small bowel adenocarcinomas at any stage exhibit positive PD-L1 expression. Furthermore, a larger quantity of tumor infiltrating lymphocytes (TILs) within the tumor stroma or microsatellite instability (MSI-H) have been associated with improved likelihood of response to PD-1 and PD-L1 inhibitors. We have descriptively characterized the stromal components of small bowel adenocarcinomas to determine if similar tumor/stromal features to drug-responsive tumors can be seen. Methods: 30 tumors were immunohistochemically stained for CD8 (T-lymphocytes), CD68 (macrophages), and e-cadherin. They were morphologically screened for MSI-H status with light microscopy. PD-L1 staining was previously performed and reported. Results: Of the 30 tumors, there was no correlation between the density of macrophages and T-lymphocytes, nor was there a correlation with the burden of immune cells with e-cadherin expression. 14/30 (47%) tumors had 3+/4+ expression of CD8+ lymphocytes. 7/14 (50%) of these tumors were morphologically MSI-H. No tumors with low CD8+ cells (1+/2+) were MSI-H. PD-L1 expression colocalized exclusively with macrophages and not with lymphocytes. Conclusions: There appears to be no association between the proportions of immune cells and basement membrane integrity. MSI-H tumors are more likely to have a greater quantity of CD8+ lymphocytes in the stroma; however, PD-L1 stromal expression appears to colocalize with macrophages. Further pathologic characterization is needed in patients treated with PD-1 and other immune checkpoint inhibitors to determine the clinical significance of these observations.
Comparative effectiveness of combination TACE/ablation vs. monotherapy in hepatocellular carcinoma.
Authors: Winer Arthur , Rosen Yohei , Lu Frederick , Berman Russell S. , Melis Marcovalerio , Miller George , Pachter H. Leon , Newman Elliot , Hatzaras Ioannis 
Published: February 2017

350 Background: Hepatocellular Carcinoma (HCC) is a leading cause of cancer-related death worldwide. Loco-regional treatment modalities for HCC include Trans-Arterial Chemoembolization (TACE) and Radiofrequency/Microwave Ablation (RFA/MWA). Studies have shown that dual therapy with both TACE and ablation is beneficial, though data is limited. We retrospectively studied all HCC patients treated with either TACE, ablation, or dual therapy at a tertiary referral public hospital to determine differences in survival. Methods: Following IRB approval, all patients diagnosed with HCC (1998-2013) at our institution were retrospectively analyzed for date of diagnosis, treatment-type, length of follow-up, and survival. Patients were excluded if they did not undergo TACE or RFA/MWA, or underwent other treatments, such as surgery. The primary outcome was all-cause mortality 5 years after diagnosis. Kaplan Meier curves were created and statistics with Log-rank testing and hazard ratios (HR) were performed. Results: Of 509 patients diagnosed with HCC, 109 (21.4%) met inclusion criteria. 60 were treated with TACE alone, 30 with ablation alone, and 19 were treated with both, either concomitantly or in sequence. Median follow-up and overall median survival was 15.5, 19, and 52 months for TACE, ablation, and dual therapy, respectively. Survival at 5 years was 11.9%, 13.3% and 42.1% for TACE, ablation, and combination groups respectively. Kaplan Meier analysis revealed a significant increase in survival in the combination therapy group vs. RFA or TACE alone at 5 years (p = 0.0006). However, there was no significant difference in survival when comparing TACE vs. RFA/MWA at 5 years (HR = 1.18, p = 0.48). Conclusions: Our study suggests a greater survival benefit for patients treated with TACE and RFA/MWA versus either modality alone.
A phase Ib/IIa study of combination therapy with gemcitabine and Atu027 in patients with locally advanced or metastatic pancreatic adenocarcinoma.
Authors: Schultheis Beate , Strumberg Dirk , Kuhlmann Jan , Wolf Martin , Link Karin , Seufferlein Thomas , Kaufmann Joerg , Gebhardt Frank , Bruyniks Nico , Pelzer Uwe 
Published: February 2017

385 Background: Atu027 is a liposomally formulated short interfering RNA with anti-metastatic activity, which silences expression of protein kinase N3 (PKN3) in the vascular endothelium. PKN3 acts as a Rho effector downstream of PI3K. This trial was designed to assess safety, pharmacokinetics and efficacy of Atu027 in combination with gemcitabine in advanced pancreatic carcinoma (APC). Methods: 23 patients (pts) with APC stage 3 or 4 were enrolled and randomly assigned to different Atu027 dosing schedules (arm 1: 0.253mg/kg once weekly, n = 11; arm 2: 0.253mg/kg twice-weekly, n = 12) but identical gemcitabine regimen. Response was evaluated according to RECIST 1.1. Quality of life was assessed with EORTC questionnaire QLQ-C30. Results: Combination therapy with Atu027 and gemcitabine was given up to 7.8 months until progression. Grade 3 adverse events (AEs) were reported by 9/11 pts (82%) in arm 1 and 11/12 pts (92%) in arm 2. Grade 4 AEs were reported by two pts in each arm. Interestingly, there was a difference in median progression free survival (mPFS) between the two treatment arms. Arm 1 showed an mPFS of 1.8 [95%CI: 0.4-5.5] months vs. 5.3 [95%CI: 1.5-6.0] months in arm 2, p= 0.399. In a post-hoc analysis of metastatic disease only, the difference in mPFS between the two arms reached statistical significance (1.6 [95%CI:0.4-2.1] vs 2.9 [95%CI:1.0-7.3] months, n = 9 vs 10, p= 0.025). Disease control during treatment was achieved in 4/11 (36%) pts in arm 1 and in 7/12 (58%) pts in arm 2. New lesions occurred in all (6/6) pts in arm 1 who had at least one RECIST re-evaluation but only 5/10 pts (50%) in arm 2. In quality of life analysis, pts in the once-weekly arm showed a stable global health status while pts in the twice-weekly arm reported an improvement (0-100 score change from baseline: -2.3 vs +21.6 after one cycle, N = 7 vs 7). Conclusions: Combination of Atu027 with gemcitabine for the treatment of APC is safe and was well tolerated. Despite the small patient number, there is a clear signal that twice-weekly Atu027 dosing might be superior to the once-weekly regimen. These results suggest efficacy of Atu027 and warrant further investigation with Atu027 added to standard of care in APC. Clinical trial information: NCT01808638.
Phase Ib study of cancer stem cell (CSC) pathway inhibitor BBI-608 administered in combination with FOLFIRI with and without bevacizumab (Bev) in patients (pts) with advanced colorectal cancer (CRC).
Authors: Hubbard Joleen Marie , O'Neil Bert H. , Jonker Derek J. , Halfdanarson Thorvardur Ragnar , Starodub Alexander , Grothey Axel , Borodyansky Laura , Li Chiang 
Published: February 2017

569 Background: BBI-608 is an oral first-in-class cancer stemness inhibitor that blocks STAT3-mediated transcription of cancer stemness genes. Potent anti-CSC activity was observed in vitro and in vivo,in mono and combination therapy. In phase I studies, BBI-608 was generally well tolerated with encouraging signs of anti-tumor activity. Methods: A phase Ib open label, multi-center study in pts with advanced CRC was undertaken to confirm the RP2D of BBI-608 in combination with FOLFIRI with or without BEV. BBI-608 was administered at 240 mg BID in combination with FOLFIRI (5-FU 400 mg/m2 bolus with 2400 mg/m2, irinotecan 180 mg/m2, and leucovorin 400 mg/m2infusion) with or without BEV 5 mg/kg, administered bi-weekly until progression of disease, unacceptable toxicity, or other discontinuation criterion was met. Results: 18 heavily pretreated pts with an average of > 3 prior lines of therapy of which 10 pts (56%) previously progressed on FOLFIRI were enrolled. Of the 17 pts evaluable for response, 8 pts received FOLFIRI and 9 pts received FOLFIRI with BEV in combination with BBI-608. Most common adverse events included grade 1 and 2 diarrhea, abdominal pain, nausea, vomiting and anorexia. No dose limiting toxicity or new adverse events were seen, and the safety profile was similar to that of each regimen as monotherapy. Grade 3 events related to protocol therapy included diarrhea occurring in 3 pts, fatigue in 2 pts and dehydration in 1 pt. All events resolved after dose reduction and/or start of anti-diarrheal medications. No significant pharmacokinetic interactions were observed. Disease control (PR+SD) was observed in 16 of 17 evaluable pts (94%) with 2 PR (per RECIST 1.1 criteria: 44% and 33% regression) and 14 SD (of which 13 (93%) had tumor regression < 25%). In the evaluable pts, median progression free survival was 5.54 months. Of 17 pts, 7 (41%) had prolonged SD of > 6 months. Conclusions: This phase Ib study confirmed that BBI-608 at 240 mg bid can be safely combined with FOLFIRI with and without BEV, and shows encouraging anti-tumor activity in heavily pretreated CRC pts, even in pts with prior progression on FOLFIRI-based therapy. Clinical trial information: NCT02024607.
Prognostic impact of primary tumor site location in metastatic colorectal cancer (mCRC).
Authors: Matos Ignacio , Ortiz Carolina , Elez Elena , Argiles Guillem , Grasselli Julieta , Macarulla Teresa , Capdevila Jaume , Alsina Maria , Sauri Tamara , Hierro Cinta , Verdaguer Helena , Sanz-Garcia Enrique , Martinez Ana Maria , Espin Eloy , Dopazo Cristina , Landolfi Stefania , Nuciforo Paolo , Vivancos Ana , Dienstmann Rodrigo , Tabernero Josep 
Published: February 2017

578 Background: CRC site is associated with differences in key molecular features that may impact survival in the metastatic (met) setting. We assessed the magnitude of outcome differences in a non-clinical trial scenario and explored how rectum cancer (RC) compares with right- and left-sided (RS and LS) colon tumors. Methods: Retrospective analysis of clinicopathological and molecular data from all mCRC patients (pts) treated at VHIO from January 2010 to June 2015. Targeted mutation (mut) profiling of driver oncogenes was performed by mass spectrometry (MassARRAY, Sequenom) or with next generation sequencing (Amplicon MiSeq, Illumina). Survival after relapse (SAR) was defined as time from diagnosis of met disease to death. Tumor site was categorized as RS (cecum, ascending, hepatic flexure, and transverse), LS (splenic flexure, descending, and sigmoid) or RC. We performed Cox proportional hazards models and adjusted for covariates including number and location of met sites, surgical resection of met lesions, and KRAS, BRAF and PIK3CA mut. Results: From 686 pts analyzed, primary site was RS/LS/RC in 29.4%/43.4%/27.2%, respectively. Pts with LS tumors were less likely to have ≥ 2 met sites (32%/20%/29%; p = 0.01). Lung metastases were more common in RC pts (20%/15%/36%; p < 0.001), peritoneal metastasis in pts with RS tumors (28%/14%/5%, p < 0.001). Surgical resection of any met disease was performed less frequently in pts with RS tumors (28%/46%/41%; p < 0.001). KRAS mut (59%/45%/44%), BRAF V600E mut (9%/5%/3%) and PIK3CAmut (25%/14%/11%) were more prevalent in RS tumors. In the overall population with survival data (n = 606, 424 events), SAR was significantly lower in pts with RS tumors (31/46/46 months; RS vs. LS HR = 1.54 [1.2-2.0], p < 0.001; rectum vs. left HR = 1.0 [0.7-1.3], p = 0.83). For comparison, worse SAR was also seen in the subset of pts (n = 337; 276 events) not eligible for surgical resection of met disease (26/31/35 months; right vs. left HR = 1.60 [1.2-2.2], p = 0.004; rectum vs. left HR = 0.9 [0.6-1.2], p = 0.42). Conclusions: The worse SAR of pts diagnosed with right-sided CRC tumors cannot be explained only by their distinctive met pattern or mutation profile of common oncogenes. Left-sided and rectum tumors have similar outcomes.
The usefulness of clinical pathways (CP) in managing quality and cost in oncology networks.
Authors: Ellis Peter G. , O'Neil Bert H. , Earle Martin F. , McCutcheon Stephanie , Benson Hans 
Published: February 2017

715 Background: UPMC CancerCenter (UPMC) and Indiana University Health (IUH) utilize Via Pathways (VP) for their CP initiative. VP are developed and maintained by disease committees that evaluate therapies on merit of efficacy, then toxicity, and finally cost (if efficacy and toxicity are comparable) to provide a recommendation for specific patient presentations. Recent data from key studies regarding the use of panitumumab (PAN) or cetuximab (CET) in the setting of metastatic colo-rectal cancer by the colo-rectal committee led to the determination that both treatments were equally effective with no significant difference in toxicity (Price et al., 2014; Peeters et al., 2014). A subsequent cost comparison utilizing CMS average sales prices demonstrated an approximate 14% monthly cost advantage for PAN. A substitution of PAN for CET across all metastatic lines of therapy in the pathway was initiated as of August 2014. This analysis was undertaken to understand the impact of this change. Methods: We reviewed the UPMC and IUH data within the VP database to compare new treatment starts of CET and PAN before and after this change was put in place. Results: There was rapid change in the selection behavior between the two drugs as demonstrated in the table. Conclusions: The results in this simple example of substituting equivalent drugs based on cost exemplify the power of CP to rapidly change prescribing habits across two large cancer networks. CP serve as an invaluable tool to allow oncology practices to quickly respond to the changing treatment norms of oncology care. [Table: see text]