bluuebunny/crossref_metadata_2025_split huggingface dataset:
NESC multicenter phase II trial in the preoperative treatment of gastric adenocarcinoma with chemotherapy (docetaxel-cisplatin-5FU + lenograstim) followed by chemoradiation (RTCT) based 5FU and oxaliplatin and surgery.
Authors: Mineur Laurent , Deplanque Gael , Desseigne Francoise , Moureau-Zabotto Laurence , Boulat Olivier , Jalali Khadifa , Smith Denis Michel , Obled Stephane , Belkacemi Mohamed 
Published: March 2017

95 Background: Perioperative chemotherapy is a standard treatment. The combination of Docetaxel- cddp-5FU(DCF) is a treatment in metastatic gastric cancer with high response rate. Preoperative RTCT is expected to increase the rate of curative resections and complete histological response. We investigate the efficacy of an optimal chemotherapy with DCF + lenograstim then preoperative RTCT with oxaliplatin - 5FU in gastric adk. Methods: Between 2009 and 2014, 33 patients with gastric adenocarcinoma(adk) were included. Inclusion criteria adk of stomach, cardia, Siewert II, III, according to staging classification T2bT3T4anyNM0 optional laparoscopy. Treatment consisted of 2 cycles docetaxel 75 mg/m2 I.V. day 1, cddp 75 mg/ m2 I.V. day 1, 5-FU 750 mg/m2 continuous infusion for 120 h, every 3 weeks and lenograstim followed by RTCT delivered in 25 daily fractions of 1.8 Gy in 5 weeks with 5Fu 250mg/m2 continuous infusion per day on days 1 to 35 and oxaliplatin 85mg/m2 day 1-14-28. Surgery was performed 4-6 weeks after RTCT. The primary endpoints were pathological response rate and secondary PFS, overall survival, morbidity and post operative mortality, toxicity. Results: 33 patients were included, 1patient progressive disease(PD) after 2 cycles of DCF, 32 patients received RTCT and 2 patients PD after RTCT, 1 patient refused surgery. 29 patients were operated and 3 non resected (peritoneal metastasis). 26 patients underwent surgery after RTCT (total gastrectomy n = 12, total gastrectomy and diaphragm surgery n = 1 lewis santy n = 11, subtotal gastrectomy n = 1, Enlarged gastrectomy transverse colectomy and partial pancreatic n = 1 D1 (n = 5) and D2 (n = 21) R0 resection rate was n = 26/26. Postoperative morbidity (n = 12) and mortality (n = 2), histology mean nods examined and involved respectively 16 and 2,5. pT0pN0 23% pT1pN0 19% pTpN2N3 20% others 38%. < 10% residual tumor 27% histologic complete response 23%. Conclusions: Promising results from trials involving preoperative chemoradiation followed by surgery in gastric cancer need to be further evaluated in a Phase III and compared with perioperative CT. Clinical trial information: NCT01565109.
Phase 1 study of ZW25, a bispecific anti-HER2 antibody, in patients with advanced HER2-expressing cancers.
Authors: Hausman Diana Felice , Hamilton Erika Paige , Beeram Muralidhar , Thimmarayappa Jamuna , Ng Gordon , Meric-Bernstam Funda 
Published: March 2017

TPS215 Background: HER2 is expressed above normal levels by many cancers, including a range of gastrointestinal tumors. While HER2 can contribute to tumor growth and survival even when expressed at low levels, antibody-based HER2 targeted therapy has shown efficacy only in breast (trastuzumab [T], pertuzumab [P]) or gastric cancers (T) with the highest levels of HER2 expression or gene amplification. Therefore, there remains significant medical need, particularly for cancers with lower HER2 levels or more heterogeneous patterns of expression. ZW25 is a novel humanized bispecific antibody directed against two distinct epitopes of HER2. The unique structure of ZW25 leads to greater cell decoration and receptor internalization than T, even in the setting of low levels of HER2 expression. In preclinical models, ZW25 has demonstrated greater activity than T in both HER2 high and HER2 low-expressing cancers, including gastric cancer. This first-in-human study will evaluate the safety and preliminary anti-tumor activity of ZW25 in patients with advanced HER2-expressing cancers. Methods: This is a 2-part Phase 1 study utilizing 3+3 dose escalation (Part 1) and expansion cohorts (Part 2) to evaluate the MTD, safety, PK, and anti-tumor activity of ZW25 IV once per week in patients with locally advanced, unresectable and/or metastatic HER2-expressing cancers. Eligibility requirements include any HER2 1+, 2+, or 3+ cancer (Part1) or 2+/FISH negative breast or gastric cancer (Part 2) that has progressed after all approved therapies; ECOG PS ≤ 1; normal left ventricular function; and measurable disease per RECIST 1.1 (Part 2). Assessments include collection of adverse events and laboratory abnormalities, tumor response per RECIST 1.1 and exploratory response biomarkers as well as PET. Recruitment is ongoing at 3 centers in the United States. Clinical trial information: NCT02892123.
A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of GS-5745 combined with mFOLFOX6 as first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma.
Authors: Bendell Johanna C. , Starodub Alexander , Huang Xi , Maltzman Julia D. , Wainberg Zev A. , Shah Manish A. 
Published: March 2017

TPS217 Background: GS-5745 is a monoclonal antibody that inhibits matrix metalloproteinase 9 (MMP9), an extracellular enzyme involved in matrix remodeling, tumor growth, and metastasis. Inhibiting MMP9 is expected to block paracrine signaling and metastasis and to alter the immune microenvironment within the tumor. GS-5745 (800 mg every 2 weeks) with mFOLFOX6 was examined in a Phase 1b study in 40 patients with gastric and GEJ adenocarcinoma (GS-US-296-0101), and demonstrated encouraging activity without added toxicity. Additionally, decreased serum biomarkers suggested inhibition of MMP9 enzymatic activity by these agents. These data support the hypothesis that GS-5745 treatment inhibits MMP9 activity and that the inhibition may lead to improved clinical outcomes. Methods: This phase 3, randomized, double-blind, multicenter study investigates the efficacy and safety of GS-5745 combined with mFOLFOX6 in subjects with untreated gastric and GEJ adenocarcinoma. Total of 430 eligible subjects with advanced gastric and GEJ cancer will be randomized in a 1:1 manner to mFOLFOX6 plus GS-5745 or mFOLFOX6 plus placebo. Stratification factors include ECOG status (0 v 1), geographic region (Latin America v All other countries), and primary tumor site (gastric v GEJ). CT or MRI scans will be performed every 8 weeks to evaluate response to treatment. mFOLFOX6 will be administered on Days 1 and 15 of each 28-day treatment cycle for a total of 6 cycles followed thereafter by leucovorin (LV) and 5-fluorouracil (5-FU) dosing on Days 1 and 15 of each 28-day treatment cycle until disease progression. GS-5745/placebo 800 mg will be infused on Days 1 and Day 15 of each 28 day cycle until disease progression. Primary endpoint is OS, and secondary endpoints include PFS, ORR (RECIST 1.1), and safety. The study is designed to have an 85% power to detect clinically meaningful improvement in overall survival at the one-sided significance level of 0.025. The association of exploratory biomarkers with study drug response will also be evaluated. Enrollment opened Oct. 2015. Clinical trial information: NCT02545504.
Prospective study of early detection of malignancies in individuals at risk for developing pancreatic cancer.
Authors: Snyder Courtney Edwards , Haag Susan , Adams Domenica , Paskett Breann , Hess Jade , Borazanci Erkut Hasan 
Published: March 2017

TPS500 Background: It is estimated that by 2030 pancreatic cancer will be the second leading cause of cancer deaths in the US. Currently, only 9% of newly diagnosed pancreatic cancer is localized and 5-year survival is 7%. Due to most pancreatic cancers (PC) presenting at a later stage with poor overall survival, early detection methods must be implemented to improve treatment outcomes. Yet, effective early screening guidelines do not exist for pancreatic cancer. Our Early Detection Program (EDP) provides personalized early detection including risk assessment, screening, and genetic testing. We aim to evaluate risk assessment criteria, establish a database to delineate a pattern of characteristics, and utilize a biospecimen repository and molecular based technologies to map novel biomarkers for early detection. Methods: The EDP screens those with a family history or germline mutation consistent with potential increased risk for developing PC. Patients are eligible based on risk assessment and stratified into 3 groups based on the CAPS Consortium criteria (average, moderate, and high risk). Screenings may include genetic testing for germline mutations, blood testing including Hemoglobin A1C (HgBA1C), complete blood count (CBC), complete metabolic profile (CMP), cancer antigen 19-9 (CA 19-9), vitamin D 25-OH, lipid panel, and thyroid stimulating hormone (TSH). Serum and urine collection will be offered for banking for future studies. Patients have yearly screenings including thorough history and physical exam and cases are discussed at a multi-disciplinary pancreatic tumor board. If indicated, patients undergo MRI/MRCP abdomen, GI consult and EUS. Study participants also complete a cancer anxiety index. The EDP is still recruiting patients. Next-generation sequencing and molecular based technologies are being explored for mapping novel biomarkers for early detection. The Institute is expanding to include those at risk for breast and ovarian cancer. We are evaluating risk assessment criteria and are developing a valid and reliable EDP index (EDP-I) anxiety instrument.
Pilot skin microbiome study of patients with pancreatic cancer in comparison to patients with other malignancies as well as those without cancer.
Authors: Borazanci Erkut Hasan , Jameson Gayle S. , Hess Jade , Gelzayd Evan , Amini Sasan , Hosseini Dana , Von Hoff Daniel D. 
Published: March 2017

TPS502 Background: The microbiome is a burgeoning field involving the study of the microbial flora in humans and its effect on health. The human microbiome is altered by several environmental factors and may play a great role in inflammation and possibly in the development in several malignancies including pancreatic cancer. The purpose of this study is to characterize the skin microbiomes on the forehead and cheek of people with pancreas cancer compared to people with other forms of cancer and people without cancer by utilizing the ProdermIQ skin profiling platform. Methods: This is a prospective, open-label, pilot study. Sampling will be done as one time collection after informed consent through a skin swab on the forehead and one on the cheek. Subjects with a diagnosis of pancreatic adenocarcinoma, subjects with a diagnosis of malignancy other than pancreatic adenocarcinoma, and subjects without a diagnosis of malignancy will be enrolled for three separate arms of the study. Each study arm is composed of 25 individuals for a total of 75. Key inclusion criteria include subjects at least 18 years of age and a histologically confirmed diagnosis of pancreatic adenocarcinoma in the pancreas arm; a histological confirmed diagnosis of a malignancy other than pancreatic cancer in the other cancer arm; and individuals without cancer. Individuals with a rash or skin disorder will be excluded from the study. Once all swabs are collected they will be batch tested through next generation sequencing to characterize the skin microbiomes. A comprehensive comparison will be constructed of the profiles of each study group.
KEYNOTE-224: Phase II study of pembrolizumab in patients with previously treated advanced hepatocellular carcinoma.
Authors: Zhu Andrew X. , Knox Jennifer J. , Kudo Masatoshi , Chan Stephen L. , Finn Richard S. , Siegel Abby B. , Ma Junshui , Watson Pat , Cheng Ann-Lii 
Published: March 2017

TPS504 Background: The tyrosine kinase inhibitor sorafenib is the standard of care for first-line hepatocellular carcinoma (HCC). For patients with HCC after disease progression on sorafenib or for those with intolerance to sorafenib, no approved therapies are available. Because HCC is often driven by inflammation and is also associated with a suppressed immunoenvironment, there is a strong rationale to evaluate immunotherapy in patients with this type of cancer. The single-arm, multisite, phase 2 KEYNOTE-224 study (ClinicalTrials.gov, NCT02702414) was designed to evaluate the efficacy and safety of the anti–PD-1 antibody pembrolizumab in patients with previously treated advanced HCC. Methods: Approximately 100 patients will be enrolled. Inclusion criteria include age ≥18 years, histologically or cytologically confirmed diagnosis of HCC Barcelona Clinic Liver Cancer (BCLC) stage C disease or BCLC stage B disease not amenable to or refractory to locoregional therapy, and disease not amenable to a curative treatment approach (eg, transplantation, surgery, or ablation). Patients must also have measurable disease based on RECIST v1.1 as confirmed by central imaging vendor review, documented objective radiographic progression after stopping treatment with sorafenib or intolerance to sorafenib, Child-Pugh liver score A, ECOG performance status 0-1, and predicted life expectancy > 3 months. Patients will be allocated to receive pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles (~2 years) or until disease progression, unacceptable toxicity, patient withdrawal of consent, or investigator decision. Response will be assessed every 9 weeks per RECIST v1.1 by central imaging vendor review. Adverse events (AEs) will be assessed throughout treatment and for 30 days thereafter (90 days for serious AEs) and graded per NCI CTCAE v4.0. The primary end point is objective response rate per RECIST v1.1 by central imaging vendor review. Secondary end points are overall survival; safety and tolerability; and duration of response, disease control rate, time to progression, and progression-free survival per RECIST v1.1 by central imaging vendor review. Enrollment in KEYNOTE-224 is ongoing. Clinical trial information: NCT02702414.
A phase II trial of escalated dose proton radiotherapy with elective nodal irradiation and concomitant chemotherapy for patients with unresectable, borderline resectable, or medically inoperable pancreatic adenocarcinoma.
Authors: Nichols Romaine Charles , Morris Christopher G. , Hoppe Bradford S. , Rutenberg Michael Scott 
Published: March 2017

TPS513 Background: The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Median survival for patients with unresectable disease on the LAP-07 trial was between 15.2 and 16.4 months (Hammel P, et al. J Clin Oncol 31, 2013 [suppl; abstr LBA4003]). The absence of a survival advantage for x-ray based radiotherapy may be due to toxicity. Patients characterized as having “borderline resectable” disease fair somewhat better - although many are not converted to resectability with standard regimens. Intensified local/regional therapy for "initially unresectable" patients might 1.) Increase the share of patients undergoing curative surgery and 2.) Improve local disease control for patients who remain unresectable. A phase II study for patients with unresectable disease treated with proton therapy to a dose of 59.4 Gy (RBE) demonstrated an 18.4 month median survival without grade 2 or higher GI toxicity – suggesting the feasibility of dose intensification (Sachsman S, et al. Int J Particle Ther. 2014;1[3]:692–701.). The current protocol offers a 6% increase in radiotherapy dose with a 25% increase in dose per fraction with the goal of improving local control and extending survival. Methods: Eligibility: Biopsy proven adenocarcinoma of the pancreas that is unresectable, borderline resectable, or medically inoperable. No evidence of metastatic disease. Prior chemotherapy allowed. Treatment: 40.50 Gy (RBE) in 18 fractions to gross disease and an elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease (total dose 63 Gy [RBE] in 28 fractions) with concomitant capecitabine (1,000 mg PO BID) on radiation treatment days. Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability. Primary Objective: Improve 12 month survival from 50% to 75%. Secondary Objectives: Improve local and regional disease control Increase share of patients being converted to resectable. Compare GI toxicity with historical benchmarks. Assess quality of life. Sample Size:60 patients Clinical trial information: 02598349.
A pilot-blinded randomized feasibility trial comparing an investigational hand therapy intervention (IHT) to a traditional occupational therapy (TOT) intervention to prevent chemotherapy induced peripheral neuropathy (CIPN) of the hands in patients (pts) receiving chemotherapy (CTX).
Authors: Jameson Gayle S. , Cooper Cynthia , Borazanci Erkut Hasan , Hull Lynne , Caldwell Lana , Von Hoff Daniel D. 
Published: March 2017

TPS518 Background: CIPN is an unsolved, common problem for cancer pts. CIPN greatly affects quality of life and may impact quantity of life due to dose reductions and discontinuation of beneficial therapy. No generally accepted evidence-based prevention strategies for CIPN exist. In the discipline of hand therapy (HT), there are effective science-based interventions to treat peripheral neuropathies due to injury and disease. These interventions have not been explored in patients with CIPN. Methods: Study objective is to determine if an IHT intervention based on concepts of neuroplasticity can prevent or delay time to onset of CIPN of the hands as measured by Patient Reported Outcomes & Criteria for Adverse Events, version 4 (CTCAE 4.0), compared to a TOT intervention. Eligible pts have pancreatic cancer and receive nab-paclitaxel + gemcitabine containing combinations; have no prior evidence of peripheral neuropathy (PN) of the hands and are not taking duloxetine or gabapentin. Randomization is 1:1. Patient instructions on the blinded IHT or TOT activities are done by an Occupational Therapist prior to start of CTX, then reinforced at multiple follow-up sessions. Periodic assessments include standardized hand sensibility testing: QuickDASH, upper extremity provocative testing, TEN Test; plus pt reporting of CIPN onset, CTCAE-4, physical examination of peripheral sensory/motor neurologic assessment of the hands, Karnofsky Performance Status, and pain visual analogue scale. Participation in the study with a daily home program continues until onset of CIPN of the hands or if no CIPN then through completion of an 84 day schedule of chemotherapy. The number and proportion of patients without CIPN of the hands at the end of 84 days of CTX will be summarized for both intervention groups. For an 80% powered design with a medium effect size, 40 evaluable pts are needed (95% CI, alpha .05). Planned enrollment is up to 50 pts allowing for pt attrition. Study opened to enrollment 8/2016.
Identifying models of cancer survivorship care.
Authors: Mead Holly , Pratt-Chapman Mandi , Gianattasio Kan , Cleary Sean , Gerstein Maya 
Published: March 2017

1 Background: The growing population of cancer survivors (15.5 million in the US) face myriad health issues that require health care attention. Cancer is increasingly viewed as a chronic illness that, once treated, requires systematic and coordinated care. Little guidance, however, has been provided in terms of how programs should be organized and little research has been done to understand emerging models in the field. We aim to identify and describe the most common survivorship models of care to identify characteristics of care and provide guidance on how survivorship care should be delivered. Methods: We conducted a scan of 236 CoC-accredited cancer centers to identify characteristics that co-occur in survivorship programs and those that predict the provision of LIVESTRONG’s Essential Elements. We supplemented this approach with in-depth interviews and surveys of 32 survivorship programs to gain detailed organizational information. Results: Three models emerged from the data: The Consultative Specialized Survivorship Clinic provides a one-time onsite visit focusing on in-depth survivorship care planning and is typically led by an NP/PA. It is likely to enjoy more organizational support and to bill for services. The Longitudinal Specialized Survivorship Clinic provides ongoing care with most services delivered onsite, and is typically led by an NP/PA. It is likely to have some organizational support but less likely to bill for services. Oncology-Based Survivorship Care with Referral for Services provides ongoing survivorship care, often in tandem with treatment, but delivers most services via referral. It is typically physician-led and has no formal survivorship care planning protocol. It receives less organizational support and is less likely to bill for services. Models also differ in the numbers and types of services provided. Conclusions: These models reflect distinctive organizational and delivery system characteristics and can guide other institutions interested in providing survivorship care.
Financial impact of cancer care on survivors: Results from the 2015 LIVESTRONG survey.
Authors: Narayan Aditi 
Published: March 2017

10 Background: The cost of cancer care in the U.S. was $124.5 billion in 2010, and is projected to increase by 27% to $158 billion in 2020. With an estimated 1.7 million new cancer cases every year, it is imperative to understand the financial impact of cancer care on survivors’ decision-making and daily living. Methods: In August of 2015, LIVESTRONG conducted an online survey to learn more about the financial impact of treatment on cancer survivors and their loved ones. Two similar surveys were distributed for survivors (n = 1,704) and loved ones (n = 739). Our analyses focus on the results from the survivor survey. Results: Fifty-nine percent of survivors reported that they experienced a lot of or some financial problems as a result of cancer. Eighty-five percent of survivors reported that their provider did not discuss the costs of care with them, and 12% reported that they would have altered decisions about treatment if they had known then what they know now about the financial impact of cancer. Most survivors (59%) reported that they spent less than $10,000 on out-of-pocket costs while 27% reported that they spent between $10,000 and $24,999 on out-of-pocket costs. The majority of respondents reported that they paid out-of-pocket for doctor visit co-pays (77%), transportation (60%) and medications (51%) (Table 1). Additionally, 61% of survivors reported that they had to make financial sacrifices such as using retirement savings and spending less on day-to-day living expenses. Conclusions: With costs of cancer care expected to continue rising for the foreseeable future, there is a need for more and better communication between patients and healthcare teams related to the potential financial impact of cancer care prior to treatment. Cancer institutions should consider including financial counselors as a part of care teams to inform patients of costs based on insurance status and type, and help them make educated and well-informed decisions related to their care. [Table: see text]