bluuebunny/crossref_metadata_2025_split huggingface dataset:
Managing cancer and living meaningfully (CALM): A randomized controlled trial of a psychological intervention for patients with advanced cancer.
Authors: Rodin Gary , Lo Christopher , Rydall Anne , Nissim Rinat , Malfitano Carmine , Shnall Joanna , Zimmermann Camilla , Hales Sarah 
Published: September 2018

LBA10001 The full, final text of this abstract will be available at abstracts.asco.org at 2:00 PM (EDT) on Friday, June 2, 2017, and in the Annual Meeting Proceedings online supplement to the June 20, 2017, issue of the Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.
SCORAD III: Randomized noninferiority phase III trial of single-dose radiotherapy (RT) compared to multifraction RT in patients (pts) with metastatic spinal canal compression (SCC).
Authors: Hoskin Peter , Misra Vivek , Hopkins Kirsten , Holt Tanya , Brown Gillian , Arnott Seonaid , Shibu Thomas Sharon , Reczko Krystyna , Beare Sandy , Lopes Andre , Forsyth Sharon 
Published: September 2018

LBA10004 The full, final text of this abstract will be available at abstracts.asco.org at 2:00 PM (EDT) on Friday, June 2, 2017, and in the Annual Meeting Proceedings online supplement to the June 20, 2017, issue of the Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.
Temporal trends in chronic disease among survivors of childhood cancer diagnosed across three decades: A report from the Childhood Cancer Survivor Study (CCSS).
Authors: Gibson Todd M. , Mostoufi-Moab Sogol , Stratton Kayla , Barnea Dana , Chow Eric Jessen , Donaldson Sarah S. , Howell Rebecca M. , Hudson Melissa M. , Leisenring Wendy M. , Mahajan Anita , Nathan Paul C. , Ness Kirsten K. , Sklar Charles A. , Tonorezos Emily S. , Weldon Christopher Bertero , Wells Elizabeth M. , Yasui Yutaka , Armstrong Gregory T. , Robison Leslie L. , Oeffinger Kevin C. 
Published: September 2018

LBA10500 The full, final text of this abstract will be available at abstracts.asco.org at 2:00 PM (EDT) on Friday, June 2, 2017, and in the Annual Meeting Proceedings online supplement to the June 20, 2017, issue of the Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.
Adding abiraterone for men with high-risk prostate cancer (PCa) starting long-term androgen deprivation therapy (ADT): Survival results from STAMPEDE (NCT00268476).
Authors: James Nicholas D. , De Bono Johann S. , Spears Melissa Ruth , Clarke Noel , Mason Malcolm David , Dearnaley David P. , Ritchie Alastair W S , Russell J. Martin , Gilson Clare , Jones Robert J. , Gillessen Silke , Matheson David , Aung San , Birtle Alison J. , Chowdhury Simon , Gale Joanna , Malik Zafar , O'Sullivan Joe M. , Parmar Mahesh K B , Sydes Matthew Robert 
Published: September 2018

LBA5003 The full, final text of this abstract will be available at abstracts.asco.org at 7:30 AM (EDT) on Saturday, June 3, 2017, and in the Annual Meeting Proceedings online supplement to the June 20, 2017, issue of the Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.
UNICANCER: Prospective cohort study of treatment related chronic toxicities in patients with localized breast cancer (CANTO).
Authors: Luis Ines Maria Vaz Duarte , Cottu Paul H. , Mesleard Christel , Martin Anne-Laure , Dumas Agnes , Dauchy Sarah , Tredan Olivier , Levy Christelle , Adnet Johan , Rousseau-Tsangaris Marina , Andre Fabrice , Arveux Patrick 
Published: September 2018

TPS10125 Background: Corresponding with improved survival among breast cancer patients an awareness of the long term effects of cancer treatments has increased. There is now a call for better coordination of care and management of these patients to focus on their survivorship. This study will identify factors associated with the development and persistence of long term toxicities in patients treated for Stage I-III breast cancer. In addition, it will characterize their incidence as well as, psychological, social and economic impacts. Methods: This is a prospective cohort study enrolling newly diagnosed invasive cT0-cT3, cN0-3, M0 breast cancer patients of 26 French comprehensive cancer centers. All patients will be followed for a minimum of 5 years. Patients will be assessed at diagnosis, 3-6 (M0), 12 (M12), 36 (M36), 48 (M48), 60 (M60), months after treatment completion. Treatment completion is defined as completion of primary surgery, chemotherapy or radiotherapy, whichever comes last. Adjuvant trastuzumab, endocrine therapy or participation in clinical trials can be ongoing. CANTO collects an extensive list of clinical, treatment, and toxicity data including validated patient reported outcomes questionnaires ( Hospital Anxiety and Depression scale [HADS], Scheier et Carver’s Questionnaire, Life Orientation Test-Revised [LOT-R], Beck Depression Inventory [BDI-SF], European Organization for Research and Treatment-QOL questionnaire for breast cancer [EORTC QLQC30-BR23], EORTC-FA13, 12 Item Short Form Survey [SF12], Global physical activity questionnaire [GPAQ]6, impact of cancer questionnaire [IOCv2], economic and social questionnaires). Blood collection is available for all patients at diagnosis, M0, M12, M36 and M60. Genotyping will be performed in all samples. Biologic substudies are ongoing (e.g, microbiotic and cognitive substudy). CANTO aggregates a multidisciplinary team of French investigators and created a dedicated national network. Enrolment started in 2012 and by December 2016, 10030 patients were already enrolled, with a goal of 12.000 patients. Clinical trial information: NCT01993498.
Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).
Authors: Kimmick Gretchen Genevieve , Bosworth Hayden B , Keefe Francis J , Sutton Linda , Owen Lynda , Erkanli Alaattin , Reed Shelby D. , Staley Sarah A , Pak Sarah , Barrett Nadine , Huettel Scott , Shelby Rebecca A. 
Published: September 2018

TPS10128 Background: Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem, with rates of non-adherence ranging from 28% to 59%. Non-adherence to AET contributes to increased medical costs and increased mortality. Symptoms (e.g., pain, hot flashes, sleep problems, vaginal dryness) associated with AET are related to non-adherence and early discontinuation of treatment. Our goal is to test the efficacy of a novel self-management intervention (SMAET) that teaches patients skills for enhancing adherence to AET and coping with AET-related symptoms. Methods: Trial participants will be recruited from a tertiary care medical center and community clinics that are located in medically underserved areas. Target enrollment is 400 patients. Prospective participants must meet the following criteria: diagnosis of Stage I to III breast cancer; hormone receptor positive tumor; local definitive cancer treatment complete; within 12 months of beginning AET; have at least 18 months of AET recommended; and at least 21 years of age. We will test the effects of the SMAET intervention (n = 200) by comparing it to a general health education intervention (n = 200; attention control). The SMAET protocol includes 7 sessions providing systematic training in coping skills for managing symptoms that interfere with adherence and 3 maintenance calls delivered over 6 months by a nurse via the phone. The intervention also includes interactive voice messaging that is tailored based on real-time adherence data. The primary study outcome, adherence to AET, will be assessed in real-time for 18 months using wireless smart pill bottles (i.e., bottle opening and percent of pills remaining). Symptom interference will be examined as a secondary outcome and will be assessed over 18 months. If effective, the intervention may reduce the burden of AET use. Clinical trial information: NCT02707471.
Phase 1 trial of lyso-thermosensitive liposomal doxorubicin (LTLD) and magnetic resonance guided high intensity focused ultrasound (MR-HIFU) for pediatric refractory solid tumors.
Authors: Kim AeRang , Sharma Karun , Yarmolenko Pavel , Celik Haydar , Kaplan Rosandra N. , Dome Jeffrey , Musso Lauren , Borys Nicholas , Partanen Ari , Warner Lizette , Kim Peter C W 
Published: September 2018

TPS10579 Background: Prognosis for children and young adults with refractory solid tumors remains unacceptably poor. Current approaches have reached the limits of maximal dose intensification, and the acute and late side effects of therapy are substantial. MR-HIFU is an innovative therapy that uses an external applicator to focus ultrasound energy inside a tumor non-invasively and without radiation. The resulting heating is precisely controlled and accurately targeted with the aid of MR thermometry and anatomic imaging. The flexibility and control over local heating by MR-HIFU provide an ideal system to be used with LTLD, a novel formulation of liposomal doxorubicin with the unique property of rapid heat-activated release of doxorubicin, an active agent in most pediatric solid tumors. The potential synergistic effects include enhanced permeability of the tumor vasculature, enhanced extravasation of the drug and subsequent high local concentrations of doxorubicin in the targeted tumor, inhibition of DNA repair, and stimulation of immune responses. Methods: This is the first pediatric trial of LTLD with MR-HIFU in refractory solid tumors (NCT02536183). Part A is a phase 1 dose escalation study to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of LTLD combined with MR-HIFU ablation in children. Part B combines LTLD at the MTD/RP2D with MR-HIFU induced mild hyperthermia (MHT) in an expanded cohort. Patients ≤21 (Part A) and ≤30 (Part B) years of age with refractory solid tumors at sites accessible to MR-HIFU, adequate organ function including cardiac function, and prior anthracycline dose of ≤ 450 mg/m2 are eligible. LTLD is administered intravenously over 30 min followed immediately by MR-HIFU on day 1 of a 21-day cycle. Patients can receive a maximum of 6 cycles (or lifetime of 600 mg/m2 of cumulative anthracycline) provided treatment is tolerated and have at least stable disease. Secondary objectives evaluate changes in quality of life and pharmacodynamic immune markers in children treated with LTLD and MR-HIFU. Clinical trial information: NCT02536183.
A randomized, open-label, multicentre, phase IV study evaluating palbociclib plus endocrine treatment versus a chemotherapy based treatment strategy in patients with hormone receptor positive/HER2-negative metastatic breast cancer in a real world setting.
Authors: Loibl Sibylle , Barinoff Jana , Seiler Sabine , Decker Thomas , Denkert Carsten , Luebbe Kristina , Furlanetto Jenny , Mueller Volkmar , Mundhenke Christoph , Schmidt Marcus , von Minckwitz Gunter , Uhlig Mathias , Burchardi Nicole , Thill Marc 
Published: September 2018

TPS1115 Background: Although endocrine based therapy is recommended as first-line treatment in metastatic breast cancer (MBC) in patients with an HER2-/HR+ tumour up to 50% of the patients receive chemotherapy. Palbociclib (P) a CDK4/6 inhibitor improves PFS by 42% in endocrine sensitive and resistant HER2-/HR+ MBC when added to an endocrine therapy (ET). Patients included in clinical trials are often criticised not to be representative for real world breast cancer patients. Methods: Patients with first-line HER2-/HR+ MBC who are candidate for mono-chemotherapy will be eligible to be randomised 1:1 to receive either P plus ET per label or mono-chemotherapy per investigator´s choice with or without maintenance ET. In both study arms, treatment will be given until disease progression, unacceptable toxicity, withdrawal of consent of the patient or change of initial treatment plan (either planned six chemotherapy cycles followed by maintenance ET or chemotherapy until disease progression). Primary objective is to compare the time-to-treatment failure (TTF), defined as time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity and death. Secondary objectives are progression free survival, overall survival at 36 months, amongst other time to event endpoints; investigator assessed overall clinical response; toxicity and compliance; patient well-being and health care utilization by daily monitoring treatment impact. Aim: 360 patients will be accrued to show an improved TTF for P in combination with ET. Recruitment will start in QII/2017 and is planned for approximately 18 months in 100 sites in Germany, Spain, Poland, Italy, France, UK and Canada. Conclusions: The aim of the trial is to demonstrate that an endocrine based strategy consisting of ET plus P is superior to a chemotherapy based strategy as first-line therapy in women with HER2-/HR+ breast cancer in a real world setting.
CEA, CA15.3 and 18-FDG PET in the follow-up of early breast cancer (BC) patients (pts): A prospective, multicentric, randomized trial—KRONOS patient-oriented new surveillance study Italy.
Authors: Zamagni Claudio , Gion Massimo , Mariani Luigi , Stieber Petra , Rubino Daniela , Fanti Stefano , Baum Richard P. , Wirtz Ralph M , Hakim Rossella , Bernardi Alessandra , Cacciari Nicoletta , Quercia Sara , Fini Angela , Lenzi Manuela , Pizzirani Cinzia , Pagliaro Maria , Tomasini Sara , Toracchio Sonia , Carapelle Marianna , Barbieri Elena 
Published: September 2018

TPS11627 Background: Current recommendations for breast cancer (BC) surveillance in asymptomatic patients (pts) include only mammography and physical examination and arise from two trials conducted in the 80’s. Since then new findings about BC biology, treatment and the introduction of cutting-edge diagnostic technologies such as 18-FDG PET have deeply modified our clinical scenarios. The aim of this prospective randomized trial is to verify if the serial measurement of CEA and CA15-3 followed by 18-FDG PET can anticipate the diagnosis of BC recurrence compared to control arm by estimation of the difference of restricted mean survival time (RMST) between the two arms. If the end-point will be met a subsequent extension trial will investigate the impact of the earlier diagnosis of distant metastases on survival. Methods: Pts diagnosed with stage I-III BC, who underwent adequate surgery are eligible. Special histologies and low-risk cases according to St. Gallen criteria are excluded. The study includes pts at the beginning of the follow-up after the conclusion of primary treatment (cohort 1), and pts that have concluded without relapse the first 5 years of follow-up (cohort 2). Eligible pts will be randomized in a 1:1 ratio to follow-up according to local practice (control arm) or to three-monthly serial dosing of CEA and CA15-3 and subsequent 18 FDG-PET only in case of an increase of CEA and/or CA 15.3 greater than a critical difference compared to baseline (experimental arm). The following stratification factors will be used: node negative vs positive, HER2 negative vs positive, ER positive vs negative. Eight-hundred pts will be enrolled over 3 years. For such a calculation, we made the assumption of a 20% baseline 5-year incidence of relapse. The target reduction of three months in RMST implies a median time of diagnostic anticipation, conditional on having BC recurrence, of 10 months. The follow-up will continue until 10 years from surgery. Since 23rd October 2014 573 pts have been enrolled. The present trial was approved by the Ethical Committee of each participating centre and is registered on Clinical trial information: NCT02261389.
A study of rovalpituzumab tesirine in frontline treatment of patients with DLL3 expressing extensive small cell lung cancer.
Authors: Hann Christine L. , Morgensztern Daniel , Dowlati Afshin , Burns Timothy Francis , Jotte Robert M. , Pennell Nathan A. , Richey Stephen Lane , Wolf Juergen , Sebastian Martin , Overbeck Tobias R. , Socinski Mark A. , Lally Satwant , Da Costa Daniel , Yalamanchili Sreeni , Camidge D. Ross 
Published: September 2018

TPS2598 Background: Treatment and survival of SCLC patients (pts) has remained mostly unchanged over past decades with high response rates to initial therapy (cisplatin/carboplatin + etoposide), but relapse is near universal with median survival < 1 year in extensive disease. Delta-like protein 3 (DLL3) is an inhibitory ligand of the Notch receptor family identified as a novel target in high-grade neuroendocrine tumors, and is highly expressed in SCLC but not in normal tissue. Rovalpituzumab tesirine (Rova-T™) is an antibody-drug conjugate targeting DLL3. A Phase I study of Rova-T monotherapy in 2nd and 3rd line SCLC pts demonstrated encouraging antitumor activity with an ORR of 18% in all pts, and an ORR of 38% in DLL3-high pts (Rudin et al., Lancet Oncol, 2016.). Methods: This is a Phase I, open-label, multicenter study (NCT02819999; no pts enrolled as of 7 February 2017).In Phase Ia (escalation), 15-34 previously untreated DLL3-high pts will be enrolled and randomized to 1 of 4 cohorts. The primary objective of the Phase Ia portion is assessment of safety and dose-limiting toxicities (DLTs). Phase Ib (expansion) will enroll up to 2 cohorts of 30 pts each, and its primary objective is to characterize antitumor activity of the selected cohort(s). Secondary objectives (Phase Ia/b) include assessment of pharmacokinetics and anti-therapeutic antibodies against Rova-T, and characterization of antitumor activity (Phase Ia). Eligible pts: adults with histologically or cytologically confirmed extensive DLL3-high SCLC based on immunohistochemistry; ECOG 0-1; and life expectancy ≥ 12 weeks. Clinical trial information: NCT02819999. [Table: see text]
Phase IB study to evaluate the safety of selinexor in combination with multiple standard chemotherapy agents in patients with advanced malignancies.
Authors: Naing Aung , Fu Siqing , Tsimberidou Apostolia Maria , Pant Shubham , Piha-Paul Sarina Anne , Janku Filip , Hong David S. , Colen Rivka R. , Carter Brett W. , Evans Elizabeth , Tawbi Hussein Abdul-Hassan , Karp Daniel D. , Subbiah Vivek , Dev Rony , Hess Kenneth R. , Ueno Naoto T. , Simon George R. , Overman Michael J. , Coleman Robert L. , Meric-Bernstam Funda 
Published: September 2018

TPS2603 Background: Selinexor is a first-in-class, slowly reversible, Selective Inhibitor of Nuclear Export (SINE) compound that specifically blocks XPO1. Inhibition of XPO1 results in nuclear localization, accumulation, and reactivation of tumor suppressor proteins, therefore selectively inducing apoptosis in cancer cells, while largely sparing normal cells. This unique property of XPO1 inhibition has been deployed as a novel therapeutic strategy with success in several solid tumors and hematologic malignancy clinical trials. Preclinical studies have shown that SINE compounds behave synergistically to enhance cancer cell death with combined with different therapeutic agents. This Phase I trial is based on such preclinical evidence. The primary objective of the study is to establish the safety and tolerability of selinexor when given in combination with thirteen standard chemotherapy regimens. The secondary objectives are to determine disease control and progression-free survival of patients receiving selinexor administered with standard chemotherapy treatments in specific tumor subsets. Methods: Adult patients ≥ 18 years of age are eligible if they have histologically confirmed neoplasms (excluding hematological malignancies and brain tumors) that are refractory to established therapy known to provide clinical benefit for their condition. Patients are required to have either measurable disease (RECIST 1.1) or evaluable disease, and an ECOG performance status of 0-1. Enrollment is ongoing for dose escalation with the plan for dose expansion as follows: Clinical trial information: NCT02419495. [Table: see text]
GCT1021-01, a first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (HuMax-Axl-ADC) in patients with solid tumors (NCT02988817).
Authors: Lassen Ulrik Niels , Ramalingam Suresh S. , Lopez Juanita Suzanne , Harvey R Donald , Ameratunga Malaka , de Hoon Jan , Losic Nedjad , Lisby Steen , Forssmann Ulf , Vergote Ignace 
Published: September 2018

TPS2605 Background: HuMax-AXL-ADC is an antibody-drug conjugate (ADC) composed of an Axl-specific human monoclonal immunoglobulin G1 (IgG1κ) conjugated via a protease-cleavable valine-citrulline linker to the microtubule disrupting agent monomethyl auristatin E (MMAE). In vivo, HuMax-AXL-ADC demonstrated therapeutic anti-tumor efficacy in patient-derived xenograft models representing a variety of solid cancers, including pancreas, thyroid, lung, esophageal, cervical cancers and malignant melanoma. The non-clinical safety profile and pharmacokinetics (PK) of a once every 3 weeks (1Q3W) dosing schedule were established in cynomolgus monkeys. Methods: The primary objective of this trial is to determine the MTD and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors: ovarian, cervical, endometrial, thyroid cancer, NSCLC, and malignant melanoma. The trial consists of two parts, a phase I dose escalation part and a phase IIa expansion part. The dose escalation part explores two different dosing regimens: the first investigates doses from 0.3 up to 2.8 mg/kg to be administered 1Q3W. The second investigates doses in the range of 0.45 to 1.4 mg/kg to be administered weekly for 3 weeks followed by one treatment-free week (3Q4W dosing schedule). The second arm has a delayed start to inform a safe starting dose: when at least 8 patients have been evaluated for dose limiting toxicities, the 1.5 mg/kg cohort of the 1Q3W arm has been declared safe, and the predicted PK parameters of the starting dose in the 3Q4W arm are below pre-defined limits, the 3Q4W arm will be initiated. The 1Q3W arm follows a modified Bayesian Continuous Reassessment Method including escalation with overdose control in up to 41 patients on up to 7 main and 4 intermediate dose levels while the 3Q4W arm is run as a standard 3+3 trial design on up to 5-6 dose levels. In the phase IIa expansion part, further safety and biological activity data will be generated in selected indications using cohorts of 22 patients (11+11 patients in each cohort applying the Simon’s two-stage design). Clinical trial information: NCT 02988817.