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phase III carcinoma

Sandro Virgilio Porceddu, Mathias Bressel, Michael Geoffrey Poulsen, Adam Stoneley, Michael John Veness, Lizbeth Moira Kenny, Chris Wratten, June Corry, Stephen Cooper, Gerald Blaise Fogarty, Marnie Collins, Michael Kevin Collins, Andrew Martin John Macann, Christopher Gerard Milross, Michael Gordon Penniment, Howard Yu-Hao Liu, Madeleine Trudy King, Benedict James Panizza, Danny Rischin
Purpose To report the results of the Trans Tasman Radiation Oncology Group randomized phase III trial designed to determine whether the addition of concurrent chemotherapy to postoperative radiotherapy (CRT) improved locoregional control in patients with high-risk cutaneous squamous cell carcinoma of the head and neck. Patients and Methods The primary objective was to determine whether there was a difference in freedom from locoregional relapse (FFLRR) between 60 or 66 Gy (6 to 6.5 weeks) with or without weekly carboplatin (area under the curve 2) after resection of gross disease...
March 14, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Eduardo Méndez, Cristina P Rodriguez, Micheal Kao, Sharat C Raju, Ahmed Diab, Richard A Harbison, Eric Q Konnick, Ganesh Mugundu, Rafael Santana-Davila, Renato Martins, Neal D Futran, Laura Q M Chow
PURPOSE: The WEE1 tyrosine kinase regulates G2/M transition and maintains genomic stability, particularly in p53-deficient tumors which require DNA repair after genotoxic therapy. There is a need to exploit the role of WEE1 inhibition in head and neck squamous cell carcinoma (HNSCC) mostly driven by tumor-suppressor loss. This completed phase I clinical trial represents the first published clinical experience using the WEE1 inhibitor, AZD1775, with cisplatin and docetaxel. EXPERIMENTAL DESIGN: We implemented an open-label phase I clinical trial using a 3+3 dose-escalation design for patients with Stage III/IVB HNSCC with borderline-resectable or unresectable disease, who were candidates for definitive chemoradiation...
March 13, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Jean-Charles Nault, Peter R Galle, Jens U Marquardt
Hepatocellular carcinomas (HCC) are characterized by considerable phenotypic and molecular heterogeneity. Treatment and design of clinical trials are particularly challenging due a co-existing liver disease present in the majority of patients which limits aggressive therapeutic options. Despite positive results in recent phase III clinical trials, that confirmed the high value of antiangiogenic therapies for HCC in both first (sorafenib and lenvatinib) and second line (regorafenib and cabozantinib) treatment modalities, failure of several large randomized controlled clinical trials over the last 10 years underlines the necessity for innovative treatment strategies and implementation of findings from translational studies to overcome this unmet clinical need...
March 2, 2018: Journal of Hepatology
Makoto Sonobe, Masatsugu Hamaji, Hideki Motoyama, Toshi Menju, Akihiro Aoyama, Toyofumi F Chen-Yoshikawa, Toshihiko Sato, Hiroshi Date
PURPOSE: We reported previously a phase II study of adjuvant chemotherapy consisting of four cycles of vinorelbine (25 mg/m2 ) and cisplatin (40 mg/m2 ), given on days 1 and 8, every 4 weeks, to Japanese patients with completely resected stage II or III non-small cell lung cancer (NSCLC; UMIN 000005055). However, the follow-up was too short for us to evaluate a definitive 5-year overall survival rate and after-effects. METHODS: Between December 2006 and January 2011, 60 patients were enrolled in this study...
March 3, 2018: Surgery Today
Pierce K H Chow, Mihir Gandhi, Say-Beng Tan, Maung Win Khin, Ariunaa Khasbazar, Janus Ong, Su Pin Choo, Peng Chung Cheow, Chanisa Chotipanich, Kieron Lim, Laurentius A Lesmana, Tjakra W Manuaba, Boon Koon Yoong, Aloysius Raj, Chiong Soon Law, Ian H Y Cua, Rolley R Lobo, Catherine S C Teh, Yun Hwan Kim, Yun Won Jong, Ho-Seong Han, Si-Hyun Bae, Hyun-Ki Yoon, Rheun-Chuan Lee, Chien-Fu Hung, Cheng-Yuan Peng, Po-Chin Liang, Adam Bartlett, Kenneth Y Y Kok, Choon-Hua Thng, Albert Su-Chong Low, Anthony S W Goh, Kiang Hiong Tay, Richard H G Lo, Brian K P Goh, David C E Ng, Ganesh Lekurwale, Wei Ming Liew, Val Gebski, Kenneth S W Mak, Khee Chee Soo
Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (90 Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment...
March 2, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Giovanni Schinzari, Ernesto Rossi, Francesco Pierconti, Giovanna Garufi, Santa Monterisi, Antonia Strippoli, Ettore D'Argento, Alessandra Cassano, Carlo Barone
Vinflunine is the only cytotoxic agent tested as a second line therapy in transitional cell carcinoma of the urothelium in a phase III trial. It is not largely employed in clinical practice because of the high incidence of grade 3-4 toxicity. We evaluated efficacy and safety of Vinflunine at the dose of 280 mg/m2 every 3 weeks associated with primary prophylaxis with granulocyte growth factors and laxatives for patients progressed after platinum + Gemcitabine. Overall survival was 8.5 months, progression-free survival 4...
February 2, 2018: Oncotarget
Uwe Wollina, Georgi Tchernev, Torello Lotti
BACKGROUND: Non-melanoma skin cancer (NMSC) is the most common malignancy in humans. Targeted therapy with monoclonal antibody cetuximab is an option in case of advanced tumor or metastasis. AIM: We present and update of the use of cetuximab in NMSC searching PUBMED 2011-2017. METHODS: The monoclonal antibody cetuximab against epidermal growth factor receptor (EGFR) has been investigated for its use in NMSC during the years 2011 to 2017 by a PUBMED research using the following items: "Non-melanoma skin cancer AND cetuximab," "cutaneous squamous cell carcinoma AND cetuximab," and "basal cell carcinoma AND cetuximab", and "cetuximab AND skin toxicity"...
January 25, 2018: Open Access Macedonian Journal of Medical Sciences
(no author information available yet)
The phase III IMmotion151 trial found that the combination of atezolizumab and bevacizumab boosts progression-free survival compared with sunitinib in patients with advanced or metastatic renal cell carcinoma. The increase was 2.8 months in all patients and 3.5 months in patients with PD-L1-positive tumors.
February 26, 2018: Cancer Discovery
Michele Maio, Karl Lewis, Lev Demidov, Mario Mandalà, Igor Bondarenko, Paolo A Ascierto, Christopher Herbert, Andrzej Mackiewicz, Piotr Rutkowski, Alexander Guminski, Grant R Goodman, Brian Simmons, Chenglin Ye, Yibing Yan, Dirk Schadendorf
BACKGROUND: Systemic adjuvant treatment might mitigate the high risk of disease recurrence in patients with resected stage IIC-III melanoma. The BRIM8 study evaluated adjuvant vemurafenib monotherapy in patients with resected, BRAFV600 mutation-positive melanoma. METHODS: BRIM8 was a phase 3, international, double-blind, randomised, placebo-controlled study that enrolled 498 adults (aged ≥18 years) with histologically confirmed stage IIC-IIIA-IIIB (cohort 1) or stage IIIC (cohort 2) BRAFV600 mutation-positive melanoma that was fully resected...
February 21, 2018: Lancet Oncology
Cesar E Ochoa, Richard W Joseph
Targeted agents form the backbone of most therapeutic strategies in advanced renal cell carcinoma (aRCC) but ultimately resistance develops and toxicity often leads to discontinuation of treatment, limiting the clinical benefits of these treatments. Nivolumab, a fully human IgG4 anti-PD-1 antibody, selectively blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2 and provides a novel therapy option for patients with aRCC. In 2015, the pivotal phase III study CheckMate 025 led to the Food and Drug Administration approval of nivolumab in patients with aRCC who had received prior anti-angiogenic therapy, and in 2017, the phase III study CheckMate 214 showed that combined immunotherapy with nivolumab plus ipilimumab resulted in greater objective response rate and prolonged progression-free survival when compared with sunitinib in intermediate- and poor-risk patients with previously untreated aRCC...
2018: Journal of Kidney Cancer and VHL
Omar Abdel-Rahman
BACKGROUND: The current study aims to investigate the impact of baseline characteristics on the outcomes of sorafenib-treated advanced Hepatocellular carcinoma (HCC) patients in the setting of a clinical trial. METHODS: This is a secondary analysis of the comparator arm (sorafenib arm) of the NCT00699374 study which is a phase III multicenter study conducted between 2008 and 2010. The univariate probability of overall and progression-free survival was assessed among different patient subsets through Kaplan-Meier analysis and log-rank testing...
February 17, 2018: Journal of Cancer Research and Clinical Oncology
Kuai-Le Zhao, Yi Xia, Yun-Hai Li, Yun Chen, Qi Liu, Jun-Hua Zhang, Jia-Ying Deng, Ta-Shan Ai, Han-Ting Zhu, Harun Badakhshi
BACKGROUND: This study was performed to assess the efficacy and feasibility of definitive chemoradiotherapy consisting of weekly doses of combined paclitaxel and carboplatin concurrent with radiation therapy, followed by 2 cycles of consolidation chemotherapy for advanced esophageal carcinoma. METHODS: Eligibility criteria included local, advanced, newly diagnosed and postoperative local regional lymph node metastasis; Eastern Cooperative Oncology Group (ECOG) score ≤ 2; and adequate organ function...
February 12, 2018: International Journal of Clinical Oncology
Arduino A Mangoni, Ganessan Kichenadasse, Andrew Rowland, Michael J Sorich
Background: There is inconsistency in the criteria used to define anti-vascular endothelial growth factor (VEGF) drug-induced hypertension (AVEGF-HT) in published studies. It is unknown whether specific patient characteristics similarly predict AVEGF-HT using different criteria. Methods: We assessed the associations between clinical and demographic factors (n = 22) and AVEGF-HT, using six criteria based on predefined on-treatment blood pressure (BP) thresholds or absolute BP elevations versus baseline, in a post hoc analysis of a phase III trial of 1102 patients with renal cell carcinoma (RCC) randomized to pazopanib or sunitinib (COMPARZ study)...
2018: Therapeutic Advances in Medical Oncology
Monica Khunger, Prantesh Jain, Sagar Rakshit, Vinay Pasupuleti, Adrian V Hernandez, James Stevenson, Nathan A Pennell, Vamsidhar Velcheti
INTRODUCTION: Programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors show significant clinical activity in non-small-cell lung carcinoma (NSCLC). However, there is a relative lack of data on comparative efficacy of these drugs in the first-line setting versus chemotherapy-treated patients. We compared the efficacy and toxicity of these drugs in these 2 distinct groups of patients. MATERIALS AND METHODS: Electronic databases (PubMed-Medline, EMBASE, Scopus) and major conference proceedings were systematically searched for all phase I to III clinical trials in NSCLC using PD-1/PD-L1 inhibitors...
January 10, 2018: Clinical Lung Cancer
C A Morton, R Dominicus, P Radny, T Dirschka, A Hauschild, U Reinhold, R Aschoff, M Ulrich, S Keohane, S Ekanayake-Bohlig, S Ibbotson, R Ostendorf, C Berking, D Gröne, H J Schulze, H M Ockenfels, V Jasnoch, H Kurzen, M Sebastian, H Stege, P Staubach-Renz, G Gupta, F Hübinger, I Ziabreva, B Schmitz, A Gertzmann, H Lübbert, R-M Szeimies
BACKGROUND: Basal cell carcinoma (BCC) represents the most common non-melanoma skin cancer worldwide affecting mainly adult, fair-skinned individuals. The WHO distinguishes aggressive and non-aggressive forms of which prototypical variants of the latter are primary nodular and superficial BCC. OBJECTIVES: To demonstrate non-inferiority of BF-200 ALA (a nanoemulsion gel containing 5-aminolaevulinic acid) compared to MAL (a cream containing methyl-aminolevulinate) in the treatment of non-aggressive BCC with photodynamic therapy (PDT)...
February 12, 2018: British Journal of Dermatology
Mickaël Burgy, Julie Leblanc, Christian Borel
The issue of induction chemotherapy (ICT) interest in locoregionally advanced squamous cell cancer of the head and neck is a real epic that has been carried out over four phase III studies: PARADIGM, DECIDE, NCT01086826 and lastly the conclusive GORTEC 2007-02. With no significant benefit in overall survival of ICT, followed by concurrent chemoradiation over the standard chemoradiotherapy alone, in three of these studies, and a significant number of treatment-related deaths with the standard regimen docetaxel, cisplatin, and fluorouracil, ICT is no longer a hot topic...
February 7, 2018: Anti-cancer Drugs
Shadia A Galal, Muhammad Khattab, Samia A Shouman, Raghda Ramadan, Omaima M Kandil, Omnia M Kandil, Ashraf Tabll, Yasmine S El Abd, Reem El-Shenawy, Yasmin M Attia, Ahmed A El-Rashedy, Hoda I El Diwani
Recently a dramatic development of the cancer drug discovery has been shown in the field of targeted cancer therapy. Checkpoint kinase 2 (Chk2) inhibitors offer a promising approach to enhance the effectiveness of cancer chemotherapy. Accordingly, in this study many pyrimidine-benzimidazole conjugates were designed and twelve feasible derivatives were selected to be synthesized to investigate their activity against Chk2 and subjected to study their antitumor activity alone and in combination with the genotoxic anticancer drugs cisplatin and doxorubicin on breast carcinoma, (ER+) cell line (MCF-7)...
February 2, 2018: European Journal of Medicinal Chemistry
Paul M Barr, Hongli Li, W Richard Burack, Michael LeBlanc, Sonali M Smith, Ajay K Gopal, Justin D Floyd, Daniel O Persky, Oliver W Press, Richard I Fisher, Jonathan W Friedberg
BACKGROUND: Despite an abundance of therapeutic options, advanced-stage follicular lymphoma remains incurable. Furthermore, the ideal sequence and absolute benefit of post-induction therapy is unclear. We designed SWOG S0801 to assess the efficacy and safety of consolidative radioimmunotherapy and sequential maintenance rituximab following chemoimmunotherapy. METHODS: For this single-arm, phase 2, multicentre study, we enrolled patients aged 18 years and older with a diagnosis of stage III, IV, or bulky stage II follicular lymphoma, grades 1, 2, or 3a, who had not received previous therapy, from from 20 institutions within the United States National Cancer Institute Clinical Trials Network...
March 2018: Lancet Haematology
T Berghmans, B Grigoriu, J P Sculier, A P Meert
INTRODUCTION: Classical therapeutic strategy for advanced and metastatic non-small cell lung cancer, without activable oncogenic driver mutation, has been based mainly on cytotoxic chemotherapy with modest benefits in terms of increased survival. BACKGROUND: A better understanding of the mechanisms involved in the regulation of the immune system led to the development of antibodies directed against immune checkpoints such as PD-L1. The first encouraging clinical data from phase I studies assessing anti-PD1 and anti-PD-L1 antibodies have been confirmed in randomised phase III trials...
January 27, 2018: Revue des Maladies Respiratoires
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