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randomized controlled trial toxicity

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https://www.readbyqxmd.com/read/29048238/superiority-of-a-vitamin-b12-containing-emollient-compared-to-a-standard-emollient-in-the-maintenance-treatment-of-mild-to-moderate-plaque-psoriasis
#1
Ester Del Duca, Francesca Farnetani, Nathalie De Carvalho, Ugo Bottoni, Giovanni Pellacani, Steven P Nisticò
Psoriasis is a chronic inflammatory skin disease affecting 2%-3% of the population. The wide range of drugs currently available for its treatment could be associated, in the long term, with organ toxicity and adverse events, thus, clinical monitoring throughout treatment is required. This investigator-initiated trial (IIT) evaluated the efficacy and the safety of a vitamin B12-containing ointment in comparison with glycerol-petrolatum-based emollient cream used twice a day to treat mild-to-moderate plaque psoriasis for a period over 12 weeks followed by a wash-out observation period of 4 weeks...
October 1, 2017: International Journal of Immunopathology and Pharmacology
https://www.readbyqxmd.com/read/29045659/bevacizumab-chemotherapy-versus-chemotherapy-alone-in-elderly-patients-with-untreated-metastatic-colorectal-cancer-a-randomized-phase-ii-trial-prodige-20-study-results
#2
T Aparicio, O Bouché, J Taieb, E Maillard, S Kirscher, P-L Etienne, R Faroux, F Akouz Khemissa, F El Hajbi, C Locher, Y Rinaldi, T Lecomte, S Lavau-Denes, M Baconnier, A Oden-Gangloff, D Genet, E Paillaud, F Retornaz, E François, L Bedenne
BACKGROUND: Metastatic colorectal cancer frequently occurs in elderly patients. Bevacizumab in combination with front line chemotherapy is a standard treatment but some concern raised about tolerance of bevacizumab for these patients. The purpose of PRODIGE 20 was to evaluate tolerance and efficacy of bevacizumab according to specific endpoints in this population. PATIENTS AND METHODS: Patients aged 75 and over were randomly assigned to bevacizumab + chemotherapy (BEV) versus chemotherapy (CT)...
September 28, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29045516/navigating-the-highlights-of-phase-iii-trials-a-watchful-eye-on-evidence-based-radiotherapy
#3
J C Trone, S Espenel, A Rehailia-Blanchard, E Guillaume, N Vial, C Rancoule, C Rodriguez-Lafrasse, M Ben Mrad, A El Meddeb Hamrouni, E Ollier, C Chargari, E Deutsch, A Vallard, N Magné
Background: Phase III randomized controlled trials (RCTs) are the cornerstone of evidence-based oncology. However, there is no exhaustive review describing the radiotherapy RTCs characteristics. The objective of the present study was to describe features of all phase III RCTs including at least a radiation therapy. Methods and materials: Requests were performed in the Medline database (via PubMed). The latest update was performed in April 2016, using the following MESH terms: 'clinical trials: phase III as topic', 'radiotherapy', 'brachytherapy', as keywords...
July 12, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29040974/an-intergroup-randomized-phase-ii-study-of-bevacizumab-or-cetuximab-in-combination-with-gemcitabine-and-in-combination-with-chemoradiation-in-patients-with-resected-pancreatic-carcinoma-a-trial-of-the-ecog-acrin-cancer-research-group-e2204
#4
Jordan D Berlin, Yang Feng, Paul Catalano, James L Abbruzzese, Philip A Philip, Robert R McWilliams, Andrew M Lowy, Al B Benson Iii, A William Blackstock
OBJECTIVES: Evaluate toxicity of two treatment arms, A (cetuximab) and B (bevacizumab), when combined with gemcitabine, and chemoradiation in patients with completely resected pancreatic carcinoma. Secondary objectives included overall survival (OS) and disease-free survival (DFS). METHODS: Patients with R0/R1 resection were randomized 1:1 to cetuximab or bevacizumab administered in combination with gemcitabine for two treatment cycles. Next three cycles included concurrent cetuximab/bevacizumab plus chemoradiation, followed by one cycle of cetuximab/bevacizumab...
October 18, 2017: Oncology
https://www.readbyqxmd.com/read/29037481/surgical-outcomes-among-elderly-women-with-endometrial-cancer-treated-by-laparoscopic-hysterectomy-a-nrg-gynecologic-oncology-group-study
#5
Erin A Bishop, James J Java, Kathleen N Moore, Nick M Spirtos, Michael L Pearl, Oliver Zivanovic, David M Kushner, Floor Backes, Chad A Hamilton, Melissa A Geller, Jean Hurteau, Cara Mathews, Robert M Wenham, Pedro T Ramirez, Susan Zweizig, Joan L Walker
OBJECTIVE: Tolerance of and complications due to minimally invasive hysterectomy and staging in the older endometrial cancer population is largely unknown despite the fact that this is the most rapidly growing age group in the United States. The objective of this retrospective review is to compare operative morbidity by age in patients on the Gynecologic Oncology Group (GOG) LAP2 trial. METHODS: This is a retrospective analysis of patients from GOG LAP2, a trial that included clinically early stage uterine cancer patients randomized to laparotomy vs...
October 13, 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/29037071/evidence-based-review-of-biobran-mgn-3-arabinoxylan-compound-as-a-complementary-therapy-for-conventional-cancer-treatment
#6
Soo Liang Ooi, Debbie McMullen, Terry Golombick, Dipl Nut, Sok Cheon Pak
INTRODUCTION: Conventional cancer treatment, including surgery, chemotherapy, and radiotherapy, may not be sufficient to eradicate all malignant cells and prevent recurrence. Intensive treatment often leads to a depressed immune system, drug resistance, and toxicity, hampering the treatment outcomes. BioBran/MGN-3 Arabinoxylan is a standardized arabinoxylan concentrate which has been proposed as a plant-based immunomodulator that can restore the tumor-induced disturbance of the natural immune system, including natural killer cell activity to fight cancer, complementing conventional therapies...
October 1, 2017: Integrative Cancer Therapies
https://www.readbyqxmd.com/read/29037017/preoperative-chemoradiotherapy-versus-postoperative-chemoradiotherapy-for-stage-ii-iii-resectable-rectal-cancer-a-meta-analysis-of-randomized-controlled-trials
#7
Jin Ho Song, Jae Uk Jeong, Jong Hoon Lee, Sung Hwan Kim, Hyeon Min Cho, Jun Won Um, Hong Seok Jang
PURPOSE: Whether preoperative chemoradiotherapy (CRT) is better than postoperative CRT in oncologic outcome and toxicity is contentious in prospective randomized clinical trials. We systematically analyze and compare the treatment result, toxicity, and sphincter preservation rate between preoperative CRT and postoperative CRT in stage II-III rectal cancer. MATERIALS AND METHODS: We searched Medline, Embase, and Cochrane Library from 1990 to 2014 for relevant trials...
September 2017: Radiation Oncology Journal
https://www.readbyqxmd.com/read/29033099/custirsen-ogx-011-combined-with-cabazitaxel-and-prednisone-versus-cabazitaxel-and-prednisone-alone-in-patients-with-metastatic-castration-resistant-prostate-cancer-previously-treated-with-docetaxel-affinity-a-randomised-open-label-international-phase-3-trial
#8
Tomasz M Beer, Sebastien J Hotte, Fred Saad, Boris Alekseev, Vsevolod Matveev, Aude Fléchon, Gwenaelle Gravis, Florence Joly, Kim N Chi, Zafar Malik, Brent Blumenstein, Patricia S Stewart, Cindy A Jacobs, Karim Fizazi
BACKGROUND: Docetaxel and cabazitaxel improve overall survival compared with mitoxantrone in patients with metastatic castration-resistant prostate cancer. Custirsen (OGX011) is a second generation highly specific antisense oligonucleotide that inhibits the production of clusterin, an antiapoptotic protein that is upregulated in response to chemotherapy and that confers treatment resistance. We aimed to assess whether custirsen in combination with cabazitaxel and prednisone increases overall survival in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel...
October 9, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29017493/enzalutamide-versus-abiraterone-as-a-first-line-endocrine-therapy-for-castration-resistant-prostate-cancer-enable-study-for-pca-a-study-protocol-for-a-multicenter-randomized-phase-iii-trial
#9
Kouji Izumi, Atsushi Mizokami, Mikio Namiki, Shogo Inoue, Nobumichi Tanaka, Yuko Yoshio, Kei Ishibashi, Manabu Kamiyama, Noriyasu Kawai, Hideki Enokida, Takashi Shima, Shizuko Takahara
BACKGROUND: Both enzalutamide and abiraterone have demonstrated improved radiographic progression-free and overall survival for castration-resistant prostate cancer (CRPC) compared with placebo controls before docetaxel treatment in phase III studies. These oral agents target androgen and androgen receptor signaling and are thought to be less toxic than chemotherapy. Cross-resistance to these agents was recently reported because of their similar mechanism of action, and it is important to assess which agent is more effective to use initially for CRPC...
October 10, 2017: BMC Cancer
https://www.readbyqxmd.com/read/29016694/efficacy-of-azole-therapy-for-tegumentary-leishmaniasis-a-systematic-review-and-meta-analysis
#10
Endi Lanza Galvão, Ana Rabello, Gláucia Fernandes Cota
BACKGROUND: Several controlled and uncontrolled studies addressing azole antifungal drugs for cutaneous and mucosal leishmaniasis have been published with inconclusive results. We conducted a systematic literature review of studies evaluating the efficacy and toxicity associated with azole therapy for tegumentary leishmaniasis. METHODOLOGY: PRISMA guidelines for systematic reviews and the Cochrane manual were followed, and the review methodology was registered (PROSPERO; CRD42016048668)...
2017: PloS One
https://www.readbyqxmd.com/read/29016225/asco-value-framework-highlights-the-relative-value-of-treatment-options-in-ovarian-cancer
#11
Jonathan Foote, Angeles Alvarez Secord, Margaret Liang, David E Cohn, Elizabeth Jewell, Laura J Havrilesky
PURPOSE: The ASCO value framework allows physicians and patients to compare the relative value of novel treatments. Our aim was to assess the value of three frontline ovarian cancer therapies by using this framework. METHODS: From phase III, randomized controlled clinical trial (RCT) data, the net health benefits (NHBs) for three frontline ovarian cancer treatment options-dose-dense paclitaxel (Japanese Gynecologic Oncology Group study JGOG 3016), intraperitoneal (IP)/intravenous (IV) chemotherapy (Gynecologic Oncology Group [GOG] study GOG 172), and concurrent plus maintenance bevacizumab (GOG 218 and the Seventh International Collaborative Ovarian Neoplasm study [ICON7])-were calculated...
October 10, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28993052/nivolumab-in-patients-with-advanced-gastric-or-gastro-oesophageal-junction-cancer-refractory-to-or-intolerant-of-at-least-two-previous-chemotherapy-regimens-ono-4538-12-attraction-2-a-randomised-double-blind-placebo-controlled-phase-3-trial
#12
Yoon-Koo Kang, Narikazu Boku, Taroh Satoh, Min-Hee Ryu, Yee Chao, Ken Kato, Hyun Cheol Chung, Jen-Shi Chen, Kei Muro, Won Ki Kang, Kun-Huei Yeh, Takaki Yoshikawa, Sang Cheul Oh, Li-Yuan Bai, Takao Tamura, Keun-Wook Lee, Yasuo Hamamoto, Jong Gwang Kim, Keisho Chin, Do-Youn Oh, Keiko Minashi, Jae Yong Cho, Masahiro Tsuda, Li-Tzong Chen
BACKGROUND: Patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, two or more previous regimens of chemotherapy have a poor prognosis, and current guidelines do not recommend any specific treatments for these patients. We assessed the efficacy and safety of nivolumab, a fully human IgG4 monoclonal antibody inhibitor of programmed death-1 (PD-1), in patients with advanced gastric or gastro-oesophageal junction cancer who had been previously been treated with two or more chemotherapy regimens...
October 5, 2017: Lancet
https://www.readbyqxmd.com/read/28978174/comparison-of-outcomes-between-trimodal-therapy-and-radical-cystectomy-in-muscle-invasive-bladder-cancer-a-propensity-score-matching-analysis
#13
Yeon Joo Kim, Sang Jun Byun, Hanjong Ahn, Choung-Soo Kim, Beom-Sik Hong, Sangjun Yoo, Jae-Lyun Lee, Young Seok Kim
Although radical cystectomy (RC) is considered as the standard therapy for muscle-invasive bladder cancer (MIBC), trimodal therapy (TMT) combining transurethral resection of the tumor with radiotherapy and chemotherapy is increasingly recommended as an alternative approach for bladder preservation. In the absence of randomized trials, we compared the clinical outcomes between RC and TMT using propensity score matching with 50 patients in the RC arm and 29 patients in the TMT arm. With respective median follow-up periods of 23 and 32 months for the RC and TMT groups, 5-year distant metastasis-free survival (58% vs...
September 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/28975831/stereotactic-body-radiation-therapy-for-hepatocellular-carcinoma-and-intrahepatic-cholangiocarcinoma
#14
Puja S Venkat, Sarah E Hoffe, Jessica M Frakes
The role of external beam radiation therapy for primary liver malignancies has historically been limited due to the risk of radiation-induced liver disease. However, with the advent of stereotactic body radiotherapy (SBRT), we are able to dose escalate while safely sparing critical nearby structures. This review explores the evidence surrounding the use of SBRT for the treatment of primary liver malignancies. A review of the literature was performed. This article discusses the challenges, efficacy, and safety of SBRT for primary liver malignancies in order to conceptualize its role within a multidisciplinary framework...
July 2017: Cancer Control: Journal of the Moffitt Cancer Center
https://www.readbyqxmd.com/read/28975081/radiotherapy-for-oligometastatic-lung-cancer
#15
REVIEW
Derek P Bergsma, Joseph K Salama, Deepinder P Singh, Steven J Chmura, Michael T Milano
Non-small cell lung cancer (NSCLC) typically presents at an advanced stage, which is often felt to be incurable, and such patients are usually treated with a palliative approach. Accumulating retrospective and prospective clinical evidence, including a recently completed randomized trial, support the existence of an oligometastatic disease state wherein select individuals with advanced NSCLC may experience historically unprecedented prolonged survival with aggressive local treatments, consisting of radiotherapy and/or surgery, to limited sites of metastatic disease...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/28973074/consolidative-radiotherapy-for-limited-metastatic-non-small-cell-lung-cancer-a-phase-2-randomized-clinical-trial
#16
Puneeth Iyengar, Zabi Wardak, David E Gerber, Vasu Tumati, Chul Ahn, Randall S Hughes, Jonathan E Dowell, Naga Cheedella, Lucien Nedzi, Kenneth D Westover, Suprabha Pulipparacharuvil, Hak Choy, Robert D Timmerman
Importance: Patterns-of-failure studies suggest that in metastatic non-small-cell lung cancer (NSCLC) sites of gross disease at presentation are the first to progress when treated with chemotherapy. This knowledge has led to increased adoption of local ablative radiation therapy in patients with stage IV NSCLC, though prospective randomized evidence is limited. Objective: To determine if intervening with noninvasive stereotactic ablative radiotherapy (SAbR) prior to maintenance chemotherapy in patients with non-progressive limited metastatic NSCLC after induction therapy led to significant improvements in progression-free survival (PFS)...
September 24, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28969086/efficacy-and-safety-of-apatinib-in-stage-iv-sarcomas-experience-of-a-major-sarcoma-center-in-china
#17
Feng Li, Zhichao Liao, Jun Zhao, Gang Zhao, Xubin Li, Xiaoling Du, Yun Yang, Jilong Yang
PURPOSE: This study was conducted to review the efficacy and safety of Apatinib in stage IV sarcoma patients who failed previous chemotherapy. MATERIALS AND METHODS: The clinical information on 16 patients with stage IV sarcomas who failed in prior chemotherapy and subsequently received Apatinib treatment was collected. Apatinib was given 500mg/daily and 4 weeks as a cycle. All patients had at least one measurable extracranial tumor according to Response Evaluation Criteria In Solid Tumors 1...
September 8, 2017: Oncotarget
https://www.readbyqxmd.com/read/28961845/borealis-1-a-randomized-first-line-placebo-controlled-phase-ii-study-evaluating-apatorsen-and-chemotherapy-for-patients-with-advanced-urothelial-cancer
#18
J Bellmunt, B J Eigl, E Senkus, Y Loriot, P Twardowski, D Castellano, N Blais, S S Sridhar, C N Sternberg, M Retz, S Pal, B Blumenstein, C Jacobs, P S Stewart, D P Petrylak
Background: Five-year survival of patients with inoperable, advanced urothelial carcinoma treated with the first-line chemotherapy is 5%-15%. We assessed whether the Hsp27 inhibitor apatorsen combined with gemcitabine plus cisplatin (GC) could improve overall survival (OS) in these patients. Patients and methods: This placebo-controlled, double-blind, phase II trial randomized 183 untreated urothelial carcinoma patients (North America and Europe) to receive GC plus either placebo (N = 62), 600 mg apatorsen (N = 60), or 1000 mg apatorsen (N = 61)...
October 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28961836/late-toxicities-and-clinical-outcome-at-5%C3%A2-years-of-the-accord-12-0405-prodige-02-trial-comparing-two-neoadjuvant-chemoradiotherapy-regimens-for-intermediate-risk-rectal-cancer
#19
D Azria, J Doyen, M Jarlier, I Martel-Lafay, C Hennequin, P Etienne, V Vendrely, E François, G de La Roche, O Bouché, X Mirabel, B Denis, L Mineur, J Berdah, M Mahé, Y Bécouarn, O Dupuis, G Lledo, J Seitz, L Bedenne, S Gourgou-Bourgade, B Juzyna, T Conroy, J Gérard
Background: Outcome of intermediate risk rectal cancer may be improved by the addition of oxaliplatin during 5-fluoruracil concomitant neoadjuvant chemoradiotherapy. The purpose of this study is to analyze the main clinical results of the ACCORD12 trial (NCT00227747) in rectal cancer after 5 years of follow-up. Patients and methods: Inclusion criteria were as follows: rectal adenocarcinoma accessible to digital examination staged T3-T4 Nx M0 (or T2 Nx distal anterior rectum)...
October 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28958469/lenalidomide-maintenance-therapy-in-previously-treated-chronic-lymphocytic-leukaemia-continuum-a-randomised-double-blind-placebo-controlled-phase-3-trial
#20
Asher A Chanan-Khan, Andrey Zaritskey, Miklos Egyed, Samuel Vokurka, Sergey Semochkin, Anna Schuh, Jeannine Kassis, David Simpson, Jennie Zhang, Brendan Purse, Robin Foà
BACKGROUND: The efficacy and safety of lenalidomide as maintenance therapy after chemotherapy-based second-line therapy in patients with chronic lymphocytic leukaemia is unknown. Although kinase inhibitors can improve outcomes for some patients with relapsed and refractory disease, not all patients have access to these novel drugs. In this study, we aimed to assess the efficacy and safety of lenalidomide as maintenance therapy in patients with previously treated chronic lymphocytic leukaemia...
September 25, 2017: Lancet Haematology
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