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Phase 3 oncology

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https://www.readbyqxmd.com/read/29223478/phase-ii-trial-of-veliparib-in-patients-with-previously-treated-brca-mutated-pancreas-ductal-adenocarcinoma
#1
Maeve A Lowery, David P Kelsen, Marinela Capanu, Sloane C Smith, Jonathan W Lee, Zsofia K Stadler, Malcolm J Moore, Hedy L Kindler, Talia Golan, Amiel Segal, Hannah Maynard, Ellen Hollywood, MaryEllen Moynahan, Erin E Salo-Mullen, Richard Kinh Gian Do, Alice P Chen, Kenneth H Yu, Laura H Tang, Eileen M O'Reilly
PURPOSE: BRCA-associated cancers have increased sensitivity to poly(ADP-ribose) polymerase inhibitors (PARPis). This single arm, non-randomised, multicentre phase II trial evaluated the response rate of veliparib in patients with previously treated BRCA1/2- or PALB2-mutant pancreatic adenocarcinoma (PDAC). METHODS: Patients with stage III/IV PDAC and known germline BRCA1/2 or PALB2 mutation, 1-2 lines of treatment, Eastern Cooperative Oncology Group 0-2, were enrolled...
December 7, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29217288/avelumab-in-metastatic-urothelial-carcinoma-after-platinum-failure-javelin-solid-tumor-pooled-results-from-two-expansion-cohorts-of-an-open-label-phase-1-trial
#2
Manish R Patel, John Ellerton, Jeffrey R Infante, Manish Agrawal, Michael Gordon, Raid Aljumaily, Carolyn D Britten, Luc Dirix, Keun-Wook Lee, Mathew Taylor, Patrick Schöffski, Ding Wang, Alain Ravaud, Arnold B Gelb, Junyuan Xiong, Galit Rosen, James L Gulley, Andrea B Apolo
BACKGROUND: The approval of anti-programmed death ligand 1 (PD-L1) and anti-programmed death 1 agents has expanded treatment options for patients with locally advanced or metastatic urothelial carcinoma. Avelumab, a human monoclonal anti-PD-L1 antibody, has shown promising antitumour activity and safety in this disease. We aimed to assess the safety profile in patients (both post-platinum therapy and cisplatin-naive) treated with avelumab and to assess antitumour activity of this drug in post-platinum patients...
December 4, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29216190/quality-of-reporting-in-oncology-phase-ii-trials-a-5-year-assessment-through-systematic-review
#3
Julien Langrand-Escure, Romain Rivoirard, Mathieu Oriol, Fabien Tinquaut, Chloé Rancoule, Frank Chauvin, Nicolas Magné, Aurélie Bourmaud
BACKGROUND: Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. DATA SOURCES: A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015)...
2017: PloS One
https://www.readbyqxmd.com/read/29209832/minimally-invasive-esophagectomy-a-propensity-score-matched-analysis-of-semiprone-versus-prone-position
#4
Maarten F J Seesing, Lucas Goense, Jelle P Ruurda, Misha D P Luyer, Grard A P Nieuwenhuijzen, Richard van Hillegersberg
BACKGROUND: The preferred surgical approach for esophageal cancer is a minimally invasive transthoracic esophagectomy with a two-field lymph node dissection. The thoracoscopic phase may be performed either in prone- or in left lateral decubitus (LLD) position. Prone positioning has been associated with better pulmonary outcomes compared to LLD positioning; however, conversion to a classic thoracotomy is more difficult. The semiprone position has been proposed as an alternative approach...
December 5, 2017: Surgical Endoscopy
https://www.readbyqxmd.com/read/29209690/prosthetic-rehabilitation-involving-the-use-of-implants-following-a-fibula-free-flap-reconstruction-in-the-treatment-of-osteosarcoma-of-the-maxilla-a-case-report
#5
E Brauner, A Quarato, F De Angelis, G Pompa, S Jamshir, V Valentini, S Di Carlo
INTRODUCTION: Osteosarcoma is an aggressive primary bone tumor composed of connective tissue cells directly producing osteoid and bone. Prosthetic rehabilitations in post-oncological patients after bone reconstruction are not substantially different than those of patients affected by severe atrophy of upper or lower jaw after bone reconstruction. The treatment for patients with a malignant neoplasia of the oral cavity requires multidisciplinary approach by a team of different specialists that follow the patient through the phases of diagnosis, therapy and oral rehabilitation...
November 2017: La Clinica Terapeutica
https://www.readbyqxmd.com/read/29202787/efficacy-and-safety-of-eribulin-in-patients-with-locally-advanced-or-metastatic-breast-cancer-not-meeting-trial-eligibility-criteria-a-retrospective-study
#6
Sakura Iizumi, Tatsunori Shimoi, Natsuko Tsushita, Seiko Bun, Akihiko Shimomura, Emi Noguchi, Makoto Kodaira, Mayu Yunokawa, Kan Yonemori, Chikako Shimizu, Yasuhiro Fujiwara, Kenji Tamura
BACKGROUND: The efficacy and safety of eribulin in patients with locally advanced or metastatic breast cancer has been demonstrated in phase III trials. However, as patients receiving eribulin in daily practice do not necessarily meet all the eligibility criteria of clinical trials, data for such patients are limited. METHODS: We identified patients with locally advanced or metastatic breast cancer, treated with eribulin monotherapy between July 2011 and December 2015 at the National Cancer Center Hospital, Tokyo, Japan...
December 4, 2017: BMC Cancer
https://www.readbyqxmd.com/read/29192364/liver-metastases-from-prostate-cancer-at-11c-choline-pet-ct-a-multicenter-retrospective-analysis
#7
Pietro Ghedini, I Bossert, L Zanoni, F Ceci, T Graziani, P Castellucci, V Ambrosini, F Massari, E Nobili, B Melotti, A Musto, S Zoboli, L Antunovic, M Kirienko, A Chiti, C Mosconi, A Ardizzoni, R Golfieri, S Fanti, C Nanni
AIM: During our daily clinical practice using 11C-Choline PET/CT for restaging patients affected by relapsing prostate cancer (rPCa) we noticed an unusual but significant occurrence of hypodense hepatic lesions with a different tracer uptake. Thus, we decided to evaluate the possible correlation between rPCa and these lesions as possible hepatic metastases. MATERIALS AND METHODS: We retrospectively enrolled 542 patients diagnosed with rPCa in biochemical relapse after a radical treatment (surgery and/or radiotherapy)...
November 30, 2017: European Journal of Nuclear Medicine and Molecular Imaging
https://www.readbyqxmd.com/read/29190182/checkpoint-inhibition-in-pediatric-hematologic-malignancies
#8
Kara L Davis, Archana M Agarwal, Anupam R Verma
Immune surveillance comprising of adaptive and innate immune systems is naturally designed to eliminate cancer development; overexpression of inhibitory receptors and their ligands prevent this check and lead to evasion and hence cancer progression and metastasis. The use of tumor-specific monoclonal antibodies (MAbs) targeting these checkpoint regulators is promising and has led to this novel field of cancer immunotherapy. The first antibody directed against cytotoxic T-lymphocyte associated protein 4 (CTLA-4), ipilimumab, showed promising results in clinical trials and was approved by the US Food and Drug Administration (FDA) for the treatment of metastatic melanoma in 2011...
November 30, 2017: Pediatric Hematology and Oncology
https://www.readbyqxmd.com/read/29189967/evaluation-of-a-specialized-oncology-nursing-supportive-care-intervention-in-newly-diagnosed-breast-and-colorectal-cancer-patients-following-surgery-a-cluster-randomized-trial
#9
Jonathan Sussman, Daryl Bainbridge, Timothy J Whelan, Kevin Brazil, Sameer Parpia, Jennifer Wiernikowski, Susan Schiff, Gary Rodin, Myles Sergeant, Doris Howell
BACKGROUND: Better coordination of supportive services during the early phases of cancer care has been proposed to improve the care experience of patients. We conducted a randomized trial to test a community-based nurse-led coordination of care intervention in cancer patients. METHODS: Surgical practices were cluster randomized to a control group involving usual care practices or a standardized nursing intervention consisting of an in-person supportive care assessment with ongoing support to meet identified needs, including linkage to community services...
November 30, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/29189588/a-randomized-phase-ii-study-of-s-1-versus-capecitabine-as-first-line-chemotherapy-in-elderly-metastatic-gastric-cancer-patients-with-or-without-poor-performance-status-clinical-and-pharmacogenetic-results
#10
Mi-Jung Kim, Sun-Young Kong, Byung-Ho Nam, Sohee Kim, Young-Iee Park, Sook Ryun Park
OBJECTIVE: This study investigated the efficacy and safety of S-1 versus capecitabine in elderly patients with metastatic gastric cancer (MGC), and examined the association between cytochrome P450 2A6 (CYP2A6) polymorphisms and treatment outcomes. MATERIALS AND METHODS: MGC patients 70-85 years old with Eastern Cooperative Oncology Group performance status 0-2 or 65-70 years old with Eastern Cooperative Oncology Group performance status 2 were randomized to receive S-1 40 mg/m, twice daily, or capecitabine 1250 mg/m, twice daily, on days 1-14 every 3 weeks...
November 17, 2017: Pharmacogenetics and Genomics
https://www.readbyqxmd.com/read/29188298/adjuvant-sandwich-chemotherapy-plus-radiotherapy-vs-adjuvant-chemotherapy-alone-for-locally-advanced-bladder-cancer-after-radical-cystectomy-a-randomized-phase-2-trial
#11
Mohamed S Zaghloul, John P Christodouleas, Andrew Smith, Ahmed Abdallah, Hany William, Hussein M Khaled, Wei-Ting Hwang, Brian C Baumann
Importance: Locoregional failure for patients with locally advanced bladder cancer (LABC) after radical cystectomy (RC) is common even with chemotherapy and is associated with high morbidity and mortality. Adjuvant radiotherapy (RT) can decrease locoregional failure but has not been studied in the chemotherapy era. Objective: To investigate if adjuvant sequential RT plus chemotherapy can improve locoregional recurrence-free survival (LRFS) compared with adjuvant chemotherapy alone...
November 29, 2017: JAMA Surgery
https://www.readbyqxmd.com/read/29183960/radium-223-safety-efficacy-and-concurrent-use-with-abiraterone-or-enzalutamide-first-u-s-experience-from-an-expanded-access-program
#12
Oliver Sartor, Nicholas J Vogelzang, Christopher Sweeney, Daniel C Fernandez, Fabio Almeida, Andrei Iagaru, Alan Brown, Matthew R Smith, Manish Agrawal, Adam P Dicker, Jorge A Garcia, Jose Lutzky, Yu-Ning Wong, Oana Petrenciuc, Jeremy Gratt, Neal D Shore, Michael J Morris
BACKGROUND: In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated radium-223 survival benefit, and before radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access radium-223 allowed life-prolonging therapies in current use. SUBJECTS, MATERIALS, AND METHODS: This phase II, open-label, single-arm, multicenter U...
November 28, 2017: Oncologist
https://www.readbyqxmd.com/read/29175149/neoadjuvant-trastuzumab-pertuzumab-and-chemotherapy-versus-trastuzumab-emtansine-plus-pertuzumab-in-patients-with-her2-positive-breast-cancer-kristine-a-randomised-open-label-multicentre-phase-3-trial
#13
Sara A Hurvitz, Miguel Martin, W Fraser Symmans, Kyung Hae Jung, Chiun-Sheng Huang, Alastair M Thompson, Nadia Harbeck, Vicente Valero, Daniil Stroyakovskiy, Hans Wildiers, Mario Campone, Jean-François Boileau, Matthias W Beckmann, Karen Afenjar, Rodrigo Fresco, Hans-Joachim Helms, Jin Xu, Yvonne G Lin, Joseph Sparano, Dennis Slamon
BACKGROUND: HER2-targeted treatments have improved outcomes in patients with HER2-positive breast cancer in the neoadjuvant, adjuvant, and metastatic settings; however, some patients remain at risk of relapse or death for many years after treatment of early-stage disease. Therefore, new strategies are needed. We did a phase 3 trial to assess a neoadjuvant regimen for HER2-positive breast cancer that replaces traditional systemic chemotherapy with targeted treatment. METHODS: We did a randomised, open-label phase 3 KRISTINE trial in 68 Translational Research In Oncology centres (hospitals and specialty cancer centres in Asia, Europe, USA, and Canada)...
November 23, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29169974/a-prospective-multicenter-phase-ii-study-of-the-efficacy-and-feasibility-of-15-minute-panitumumab-infusion-plus-irinotecan-for-oxaliplatin-and-irinotecan-refractory-kras-wild-type-metastatic-colorectal-cancer-short-infusion-of-panitumumab-trial
#14
Kohei Akiyoshi, Tetsuya Hamaguchi, Kenichi Yoshimura, Naoki Takahashi, Yoshitaka Honma, Satoru Iwasa, Atsuo Takashima, Ken Kato, Yasuhide Yamada, Hisashi Onodera, Shigeyuki Takeshita, Hisateru Yasui, Gen Sakai, Sotaro Akatsuka, Kohei Ogawa, Yosuke Horita, Yushi Nagai, Yasuhiro Shimada
BACKGROUND: In some recently updated clinical guidelines, the fully humanized monoclonal antibody panitumumab, combined with irinotecan, has been recommended as an optional third-line chemotherapy for KRAS wild-type metastatic colorectal cancer (mCRC). The present prospective, multicenter phase II study evaluated the effectiveness and safety of short 15-minute panitumumab infusions. PATIENTS AND METHODS: From January 2011 to December 2011, patients with KRAS wild-type mCRC were enrolled at 8 centers...
October 16, 2017: Clinical Colorectal Cancer
https://www.readbyqxmd.com/read/29168112/treatment-patterns-and-outcomes-in-patients-with-kras-wild-type-metastatic-colorectal-cancer-treated-in-first-line-with-bevacizumab-or-cetuximab-containing-regimens
#15
Arthur C Houts, Sarika Ogale, Nicolas Sommer, Sacha Satram-Hoang, Mark S Walker
PURPOSE: Patients with Kirsten rat sarcoma viral oncogene wild-type (KRAS WT) metastatic colorectal cancer (mCRC) treated in first line with bevacizumab (B) or cetuximab (C) plus standard chemo backbones had comparable outcomes in phase III Cancer and Leukemia Group B (CALGB) 80405. We examined comparative effectiveness of B and C regimens in real-world community settings. METHODS: This retrospective study examined progression-free survival (PFS) and OS in a US community sample of KRAS WT mCRC patients treated with first-line B (n = 254) or C (n = 146) regimens...
November 22, 2017: Journal of Gastrointestinal Cancer
https://www.readbyqxmd.com/read/29164521/funding-source-conflict-of-interest-and-positive-conclusions-in-neuro-oncology-clinical-trials
#16
Fabio Y Moraes, Lucas C Mendez, Neil K Taunk, Srinivas Raman, John H Suh, Luis Souhami, Ben Slotman, Eduardo Weltman, Daniel E Spratt, Alejandro Berlin, Gustavo N Marta
We aimed to test any association between authors' conclusions and self-reported COI or funding sources in central nervous system (CNS) studies. A review was performed for CNS malignancy clinical trials published in the last 5 years. Two investigators independently classified study conclusions according to authors' endorsement of the experimental therapy. Statistical models were used to test for associations between positive conclusions and trials characteristics. From February 2010 to February 2015, 1256 articles were retrieved; 319 were considered eligible trials...
November 21, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/29153775/weekly-paclitaxel-and-carboplatin-plus-bevacizumab-as-first-line-treatment-of-metastatic-triple-negative-breast-cancer-a%C3%A2-multicenter-phase-ii-trial-by-the-hellenic-oncology-research-group
#17
Emmanouil Saloustros, Michail Nikolaou, Konstantinos Kalbakis, Aris Polyzos, Charalampos Christofillakis, Nikolaos Kentepozidis, Nikolaos Pistamaltzian, Charalampos Kourousis, Lampros Vamvakas, Vasilios Georgoulias, Dimitris Mavroudis
BACKGROUND: Triple-negative breast cancer (TNBC) lacks a standard targeted therapeutic strategy and is treated with conventional cytotoxic agents. Because of the sensitivity of TNBC to platinum compounds and the synergistic effect of bevacizumab with paclitaxel we investigated the efficacy and toxicity of weekly paclitaxel and carboplatin in combination with bevacizumab as first-line treatment in metastatic TNBC. PATIENTS AND METHODS: This phase II study followed the Simon's 2-stage optimal design...
October 24, 2017: Clinical Breast Cancer
https://www.readbyqxmd.com/read/29151389/bevacizumab-in-recurrent-high-grade-gliomas-a-canadian-retrospective-study
#18
Mary Jane Lim Fat, Catherine Maurice, Manjula Maganti, Warren P Mason
BACKGROUND: Bevacizumab has been used in recurrent glioblastoma (rGBM) since 2010 in Canada. Given its cost, potential toxicities, and unclear efficacy, further studies are required to better define suitable candidates for therapy. METHODS: A single-center retrospective review of patients started on bevacizumab for rGBM from 2012 to 2015 was performed. Patient demographics, tumor characteristics, treatment regimen, and dates of clinical progression and death were collected...
November 20, 2017: Canadian Journal of Neurological Sciences. le Journal Canadien des Sciences Neurologiques
https://www.readbyqxmd.com/read/29149427/the-impact-of-the-national-bowel-screening-program-in-the-netherlands-on-detection-and-treatment-of-endoscopically-unresectable-benign-polyps
#19
C C M Marres, C J Buskens, E Schriever, P C M Verbeek, M W Mundt, W A Bemelman, A W H van de Ven
BACKGROUND: In January 2014, a national bowel cancer screening program started in the Netherlands. The program is being implemented in phases until 2019. Due to this program, an increase in patients referred for a colorectal resection for benign, but endoscopically unresectable polyps, is expected. So far, most resections are performed according to oncological principles despite no pre-operative histological diagnosis of malignancy. The aim of this study was to analyze the increase in referred patients during the first year of the screening program and to compare pathological results and clinical outcome of resections of patients undergoing resection for benign polyps before and after implementation of screening...
November 2017: Techniques in Coloproctology
https://www.readbyqxmd.com/read/29136453/randomized-phase-iii-trial-of-adjuvant-therapy-with-locoregional-interferon-beta-versus-surgery-alone-in-stage-ii-iii-cutaneous-melanoma-japan-clinical-oncology-group-study-jcog1309-j-feron
#20
Kenjiro Namikawa, Arata Tsutsumida, Tomonori Mizutani, Taro Shibata, Tatsuya Takenouchi, Shusuke Yoshikawa, Yoshio Kiyohara, Hiroshi Uchi, Masutaka Furue, Dai Ogata, Tetsuya Tsuchida, Naoya Yamazaki
The Dermatologic Oncology Group of Japan Clinical Oncology Group has started a randomized phase III trial to confirm the superiority of adjuvant therapy with locoregional interferon beta in overall survival over surgery alone for patients with pathological stage II/III cutaneous melanoma (JCOG1309). Patients in the interferon beta arm receive intra- or subcutaneous injections of interferon beta directly into the surgical site at a flat dose of 3 million units once per day. Treatment is repeated for 10 consecutive days every 8 weeks for a total of 3 courses during the induction phase, then 1-day injection every 4 weeks for 2...
July 1, 2017: Japanese Journal of Clinical Oncology
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