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Phase 3 oncology

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https://www.readbyqxmd.com/read/29675772/phase-i-ii-study-of-radiofrequency-ablation-for-painful-bone-metastases-japan-interventional-radiology-in-oncology-study-group-0208
#1
Noboru Tanigawa, Yasuaki Arai, Koichiro Yamakado, Takeshi Aramaki, Yoshitaka Inaba, Susumu Kanazawa, Osamu Matsui, Masaya Miyazaki, Yoshihisa Kodama, Hiroshi Anai, Akihiro Hamanaka
PURPOSE: A prospective multicenter phase I/II trial was performed to evaluate the clinical safety and efficacy of radiofrequency ablation (RFA) for metastatic bone tumors. MATERIALS AND METHODS: Thirty-three patients (27 men, 6 women, mean age 61 years) with metastatic bone tumors were enrolled. In phase I, nine patients were enrolled, and the safety of RFA was evaluated. In phase II, 23 patients were included, and an intent-to-treat analysis was performed. The primary endpoint was to evaluate the treatment's safety...
April 12, 2018: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/29669701/crizotinib-in-patients-with-advanced-inoperable-inflammatory-myofibroblastic-tumours-with-and-without-anaplastic-lymphoma-kinase-gene-alterations-european-organisation-for-research-and-treatment-of-cancer-90101-create-a-multicentre-single-drug-prospective-non
#2
Patrick Schöffski, Jozef Sufliarsky, Hans Gelderblom, Jean-Yves Blay, Sandra J Strauss, Silvia Stacchiotti, Piotr Rutkowski, Lars H Lindner, Michael G Leahy, Antoine Italiano, Nicolas Isambert, Maria Debiec-Rychter, Raf Sciot, Thomas Van Cann, Sandrine Marréaud, Axelle Nzokirantevye, Sandra Collette, Agnieszka Wozniak
BACKGROUND: An inflammatory myofibroblastic tumour (IMFT) is a rare mesenchymal neoplasm characterised by anaplastic lymphoma kinase (ALK) gene rearrangements. We assessed the activity and safety of crizotinib, a tyrosine kinase inhibitor, targeting ALK in patients with advanced IMFT either with or without ALK alterations. METHODS: We did a multicentre, biomarker-driven, single-drug, non-randomised, open-label, two-stage phase 2 trial (European Organisation for Research and Treatment of Cancer 90101 CREATE) at 13 study sites (five university hospitals and eight specialty clinics) in eight European countries (Belgium, France, Germany, Italy, Netherlands, Poland, Slovakia, and the UK)...
April 12, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29669181/racial-disparity-in-oncologic-and-quality-of-life-outcomes-in-patients-with-locally-advanced-head-and-neck-squamous-cell-carcinomas-enrolled-in-a-randomized-phase-2-trial
#3
Margaret K Guerriero, Mary W Redman, Kelsey K Baker, Renato G Martins, Keith Eaton, Laura Q Chow, Rafael Santana-Davila, Christina Baik, Bernardo H Goulart, Sylvia Lee, Cristina P Rodriguez
BACKGROUND: To better understand patient-reported quality of life (PRQOL) for patients with head and neck cancer, PRQOL scores were collected in a clinical trial. METHODS: Patients were randomized to arm A (70 Gy of radiation with cisplatin) or arm B (70 Gy of radiation with cisplatin plus erlotinib at 150 mg daily). PRQOL scores were measured on days -7 (arm B only), 0, 30, and 180 with the University of Washington Quality of Life Questionnaire. Associations with clinical factors and outcomes were explored with linear mixed, logistic, and Cox regression models...
April 18, 2018: Cancer
https://www.readbyqxmd.com/read/29666296/phase-ii-study-to-evaluate-the-efficacy-and-safety-of-rilotumumab-and-bevacizumab-in-subjects-with-recurrent-malignant-glioma
#4
Mary Lou Affronti, Jennifer Gamboa Jackman, Frances McSherry, James E Herndon, Elwood C Massey, Eric Lipp, Annick Desjardins, Henry S Friedman, Gordana Vlahovic, James Vredenburgh, Katherine B Peters
LESSONS LEARNED: Due to evolving imaging criteria in brain tumors and variation in magnetic resonance imaging evaluation, it is not ideal to use response rate as a primary objective. Future studies involving antiangiogenic agents should use overall survival.Disease-expected toxicities should be considered when defining the clinical significance of an adverse event. For example, vascular thromboembolic events are common in brain tumor patients and should not be attributed to the study drug in the safety analysis...
April 17, 2018: Oncologist
https://www.readbyqxmd.com/read/29661497/postoperative-chemotherapy-for-node-positive-cervical-cancer-results-of-a-multicenter-phase-ii-trial-jgog1067
#5
Maki Matoda, Nobuhiro Takeshima, Hirofumi Michimae, Takashi Iwata, Harushige Yokota, Yutaka Torii, Yorito Yamamoto, Kazuhiro Takehara, Shin Nishio, Hirokuni Takano, Mika Mizuno, Yoshiyuki Takahashi, Yuji Takei, Tetsuya Hasegawa, Mikio Mikami, Takayuki Enomoto, Daisuke Aoki, Toru Sugiyama
OBJECTIVE: This multicenter phase II Japanese Gynecologic Oncology Group study (JGOG1067) was designed to evaluate the efficacy and safety of postoperative chemotherapy in patients with node-positive cervical cancer. METHODS: Patients with stage IB-IIA squamous cervical cancer who underwent radical hysterectomy and were confirmed to have pelvic lymph node metastasis were eligible for this study. The patients postoperatively received irinotecan (CPT-11; 60mg/m2 intravenously on days 1 and 8) and nedaplatin (NDP; 80mg/m2 intravenously on day 1)...
April 13, 2018: Gynecologic Oncology
https://www.readbyqxmd.com/read/29661495/narcotics-reduction-quality-and-safety-in-gynecologic-oncology-surgery-in-the-first-year-of-enhanced-recovery-after-surgery-protocol-implementation
#6
Jennifer E Bergstrom, Marla E Scott, Yewande Alimi, Ting-Tai Yen, Deborah Hobson, Karime K Machado, Edward J Tanner, Amanda N Fader, Sarah M Temkin, Stephanie Wethington, Kimberly Levinson, Sam Sokolinsky, Brandyn Lau, Rebecca L Stone
OBJECTIVES: Enhanced Recovery After Surgery (ERAS) programs are mechanisms for achieving value-based improvements in surgery. This report provides a detailed analysis of the impact of an ERAS program on patient outcomes as well as quality and safety measures during implementation on a gynecologic oncology service at a major academic medical center. METHODS: A retrospective review of gynecologic oncology patients undergoing elective laparotomy during the implementation phase of an ERAS program (January 2016 through December 2016) was performed...
April 13, 2018: Gynecologic Oncology
https://www.readbyqxmd.com/read/29650362/tazemetostat-an-ezh2-inhibitor-in-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-and-advanced-solid-tumours-a-first-in-human-open-label-phase-1-study
#7
Antoine Italiano, Jean-Charles Soria, Maud Toulmonde, Jean-Marie Michot, Carlo Lucchesi, Andrea Varga, Jean-Michel Coindre, Stephen J Blakemore, Alicia Clawson, Benjamin Suttle, Alice A McDonald, Mark Woodruff, Scott Ribich, Eric Hedrick, Heike Keilhack, Blythe Thomson, Takashi Owa, Robert A Copeland, Peter T C Ho, Vincent Ribrag
BACKGROUND: Activating enhancer of zeste homolog 2 (EZH2) mutations or aberrations of the switch/sucrose non-fermentable (SWI/SNF) complex (eg, mutations or deletions of the subunits INI1 or SMARCA4) can lead to aberrant histone methylation, oncogenic transformation, and a proliferative dependency on EZH2 activity. In this first-in-human study, we aimed to investigate the safety, clinical activity, pharmacokinetics, and pharmacodynamics of tazemetostat, a first-in-class selective inhibitor of EZH2...
April 9, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29650280/evaluation-of-the-quality-of-the-reporting-of-phase-ii-clinical-trials-in-oncology-a-systematic-review
#8
REVIEW
Romain Rivoirard, Julien Langrand-Escure, Mathieu Oriol, Fabien Tinquaut, Franck Chauvin, Chloé Rancoule, Nicolas Magné, Aurélie Bourmaud
OBJECTIVE: To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. METHODS: databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. RESULTS: Thirteen publications were retained...
May 2018: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/29628465/-pharmacological-characteristics-and-clinical-study-results-of-the-oral-proteasome-inhibitor-ixazomib-ninlaro-%C3%A2-capsules-2-3-mg-3-mg-and-4-mg
#9
Michiko Machida, Shinichi Fukunaga, Takahito Hara
Ixazomib (Ninlaro® capsule) is an oral small molecule 20S proteasome inhibitor created by Millennium Pharmaceuticals, Inc (Takeda Oncology Company). Ubiquitin proteasome system is a major regulatory system for maintaining protein homeostasis, and an important mechanism for degrading proteins, such as those involved in proliferation regulation, cell cycle regulation and apoptosis, in cells. Ixazomib selectively and reversibly binds to the β5 subunit of the 20S proteasome, inhibits its chymotrypsin-like activity, and thereby accumulates ubiquitinated proteins...
2018: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
https://www.readbyqxmd.com/read/29628312/alt-803-an-il-15-superagonist-in-combination-with-nivolumab-in-patients-with-metastatic-non-small-cell-lung-cancer-a-non-randomised-open-label-phase-1b-trial
#10
John M Wrangle, Vamsidhar Velcheti, Manish R Patel, Elizabeth Garrett-Mayer, Elizabeth G Hill, James G Ravenel, Jeffrey S Miller, Mohammad Farhad, Kate Anderton, Kathryn Lindsey, Michele Taffaro-Neskey, Carol Sherman, Samantha Suriano, Marzena Swiderska-Syn, Amy Sion, Joni Harris, Andie R Edwards, Julie A Rytlewski, Catherine M Sanders, Erik C Yusko, Mark D Robinson, Carsten Krieg, William L Redmond, Jack O Egan, Peter R Rhode, Emily K Jeng, Amy D Rock, Hing C Wong, Mark P Rubinstein
BACKGROUND: Immunotherapy with PD-1 or PD-L1 blockade fails to induce a response in about 80% of patients with unselected non-small cell lung cancer (NSCLC), and many of those who do initially respond then develop resistance to treatment. Agonists that target the shared interleukin-2 (IL-2) and IL-15Rβγ pathway have induced complete and durable responses in some cancers, but no studies have been done to assess the safety or efficacy of these agonists in combination with anti-PD-1 immunotherapy...
April 5, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29625879/tivantinib-for-second-line-treatment-of-met-high-advanced-hepatocellular-carcinoma-metiv-hcc-a-final-analysis-of-a-phase-3-randomised-placebo-controlled-study
#11
Lorenza Rimassa, Eric Assenat, Markus Peck-Radosavljevic, Marc Pracht, Vittorina Zagonel, Philippe Mathurin, Elena Rota Caremoli, Camillo Porta, Bruno Daniele, Luigi Bolondi, Vincenzo Mazzaferro, William Harris, Nevena Damjanov, Davide Pastorelli, María Reig, Jennifer Knox, Francesca Negri, Jörg Trojan, Carlos López López, Nicola Personeni, Thomas Decaens, Marie Dupuy, Wolfgang Sieghart, Giovanni Abbadessa, Brian Schwartz, Maria Lamar, Terri Goldberg, Dale Shuster, Armando Santoro, Jordi Bruix
BACKGROUND: Tivantinib (ARQ 197), a selective, oral MET inhibitor, improved overall survival and progression-free survival compared with placebo in a randomised phase 2 study in patients with high MET expression (MET-high) hepatocellular carcinoma previously treated with sorafenib. The aim of this phase 3 study was to confirm the results of the phase 2 trial. METHODS: We did a phase 3, randomised, double-blind, placebo-controlled study in 90 centres in Australia, the Americas, Europe, and New Zealand...
April 3, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29625408/nutritional-intervention-in-head-and-neck-cancer-patients-during-chemo-radiotherapy
#12
Serena Della Valle, Silvia Colatruglio, Vanessa La Vela, Elena Tagliabue, Luigi Mariani, Cecilia Gavazzi
OBJECTIVE: Head and neck cancer patients experience unintentional weight loss and malnutrition at diagnosis, during oncologic treatment, and after the end of therapy because of reduction of eating ability. The aim of the present study was to assess nutrition intervention efficacy in maintaining basal nutritional conditions. METHODS: Head and neck cancer patient candidates for chemoradiotherapy and requiring enteral nutrition (EN) support through gastrostomy, according to international guidelines, were included in the study...
February 5, 2018: Nutrition
https://www.readbyqxmd.com/read/29624549/phase-ii-clinical-trial-to-evaluate-the-efficacy-of-transanal-endoscopic-total-mesorectal-excision-for-rectal-cancer
#13
Sung Chan Park, Dae Kyung Sohn, Min Jung Kim, Hee Jin Chang, Kyung Su Han, Jong Hee Hyun, Jungnam Joo, Jae Hwan Oh
BACKGROUND: Total mesorectal excision has become the standard treatment for rectal cancer, and several investigators have shown that a transanal approach is a feasible option. OBJECTIVE: This study aimed to evaluate the efficacy of transanal endoscopic total mesorectal excision in patients with rectal cancer. DESIGN: This study was a prospective, single-arm phase II trial. It was registered on clinicaltrials.gov under identifier NCT02406118...
May 2018: Diseases of the Colon and Rectum
https://www.readbyqxmd.com/read/29614991/influence-of-complete-administration-of-adjuvant-chemotherapy-cycles-on-overall-and-disease-free-survival-in-locally-advanced-rectal-cancer-post-hoc-analysis-of-a-randomized-multicenter-non-inferiority-phase-3-trial
#14
Flavius Sandra-Petrescu, Florian Herrle, Iris Burkholder, Peter Kienle, Ralf-Dieter Hofheinz
BACKGROUND: A randomized trial demonstrated that capecitabine is at least as effective as fluorouracil in the adjuvant treatment of patients with locally advanced rectal cancer. However, not all patients receive all planned cycles of chemotherapy. Therefore it is of interest how complete or partial administration of chemotherapy influences oncological outcome. METHODS: A post hoc analysis of a trial with 401 randomized patients, nine being excluded because of missing data, was performed...
April 3, 2018: BMC Cancer
https://www.readbyqxmd.com/read/29614381/phytosome-complex-of-curcumin-as-complementary-therapy-of-advanced-pancreatic-cancer-improves-safety-and-efficacy-of-gemcitabine-results-of-a-prospective-phase-ii-trial
#15
Davide Pastorelli, Aline S C Fabricio, Petros Giovanis, Simona D'Ippolito, Pasquale Fiduccia, Caterina Soldà, Andrea Buda, Cosimo Sperti, Romeo Bardini, Gianfranco Da Dalt, Giulia Rainato, Massimo Gion, Fulvio Ursini
A large body of biomedical evidence indicates that activation of Nrf2 by curcumin increases the nucleophilic tone and damps inflammation cumulatively supporting the malignant phenotype. Conversely, genetic analyses suggested a possible oncogenic nature of constitutive Nrf2 activation since an increased nucleophilic tone is alleged increasing chemoresistance of cancer cells. Aiming to contribute to solve this paradox, this study addressed the issue of safety and efficacy of curcumin as complementary therapy of Gemcitabin on pancreatic cancer...
March 31, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29606586/larotrectinib-for-paediatric-solid-tumours-harbouring-ntrk-gene-fusions-phase-1-results-from-a-multicentre-open-label-phase-1-2-study
#16
Theodore W Laetsch, Steven G DuBois, Leo Mascarenhas, Brian Turpin, Noah Federman, Catherine M Albert, Ramamoorthy Nagasubramanian, Jessica L Davis, Erin Rudzinski, Angela M Feraco, Brian B Tuch, Kevin T Ebata, Mark Reynolds, Steven Smith, Scott Cruickshank, Michael C Cox, Alberto S Pappo, Douglas S Hawkins
BACKGROUND: Gene fusions involving NTRK1, NTRK2, or NTRK3 (TRK fusions) are found in a broad range of paediatric and adult malignancies. Larotrectinib, a highly selective small-molecule inhibitor of the TRK kinases, had shown activity in preclinical models and in adults with tumours harbouring TRK fusions. This study aimed to assess the safety of larotrectinib in paediatric patients. METHODS: This multicentre, open-label, phase 1/2 study was done at eight sites in the USA and enrolled infants, children, and adolescents aged 1 month to 21 years with locally advanced or metastatic solid tumours or CNS tumours that had relapsed, progressed, or were non-responsive to available therapies regardless of TRK fusion status; had a Karnofsky (≥16 years of age) or Lansky (<16 years of age) performance status score of 50 or more, adequate organ function, and full recovery from the acute toxic effects of all previous anticancer therapy...
March 29, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29573941/encorafenib-plus-binimetinib-versus-vemurafenib-or-encorafenib-in-patients-with-braf-mutant-melanoma-columbus-a-multicentre-open-label-randomised-phase-3-trial
#17
Reinhard Dummer, Paolo A Ascierto, Helen J Gogas, Ana Arance, Mario Mandala, Gabriella Liszkay, Claus Garbe, Dirk Schadendorf, Ivana Krajsova, Ralf Gutzmer, Vanna Chiarion-Sileni, Caroline Dutriaux, Jan Willem B de Groot, Naoya Yamazaki, Carmen Loquai, Laure A Moutouh-de Parseval, Michael D Pickard, Victor Sandor, Caroline Robert, Keith T Flaherty
BACKGROUND: Combined BRAF-MEK inhibitor therapy is the standard of care for BRAFV600 -mutant advanced melanoma. We investigated encorafenib, a BRAF inhibitor with unique target-binding properties, alone or in combination with the MEK inhibitor binimetinib, versus vemurafenib in patients with advanced BRAFV600 -mutant melanoma. METHODS: COLUMBUS was conducted as a two-part, randomised, open-label phase 3 study at 162 hospitals in 28 countries. Eligible patients were aged 18 years or older and had histologically confirmed locally advanced (American Joint Committee on Cancer [AJCC] stage IIIB, IIIC, or IV), unresectable or metastatic cutaneous melanoma, or unknown primary melanoma; a BRAFV600E or BRAFV600K mutation; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; and were treatment naive or had progressed on or after previous first-line immunotherapy...
March 21, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29565650/recent-advances-in-theranostics-and-challenges-for-the-future
#18
J Harvey Turner
Theranostic nuclear oncology is on the cusp of adoption into routine clinical management of neuroendocrine tumours (NETs) following publication of the Phase 3 randomized controlled trial, NETTER-1. For the first time, level 1b evidence of efficacy and safety of 68-gallium/177 lutetium-DOTA-octreotatepeptide receptor radionuclide therapy (PRRT), of midgut NETs was established. Multicentre Phase 2 studies of 68-gallium/177 lutetium-PSMA theranostic approaches to management of end-stage metastatic castrate-resistant prostate cancer (mCRPC), are also very encouraging...
March 22, 2018: British Journal of Radiology
https://www.readbyqxmd.com/read/29558830/naturopathic-oncology-care-for-thoracic-cancers-a-practice-survey
#19
Dugald Seely, Julie K Ennis, Ellen McDonell, Linlu Zhao
BACKGROUND AND OBJECTIVES: There is a lack of information on therapies recommended by naturopathic doctors (NDs) for lung and gastroesophageal cancer care. Study objectives were to: (1) identify the most common interventions considered for use by NDs; (2) identify interventions NDs recommend to support key therapeutic goals; and (3) identify potential contraindications between integrative and conventional therapies. METHODS: Oncology Association of Naturopathic Physicians (OncANP) members (n = 351) were invited to complete an electronic survey...
March 1, 2018: Integrative Cancer Therapies
https://www.readbyqxmd.com/read/29557060/jcog0911-integra-study-a-randomized-screening-phase-ii-trial-of-interferon%C3%AE-plus-temozolomide-in-comparison-with-temozolomide-alone-for-newly-diagnosed-glioblastoma
#20
Toshihiko Wakabayashi, Atsushi Natsume, Junki Mizusawa, Hiroshi Katayama, Haruhiko Fukuda, Minako Sumi, Ryo Nishikawa, Yoshitaka Narita, Yoshihiro Muragaki, Takashi Maruyama, Tamio Ito, Takaaki Beppu, Hideo Nakamura, Takamasa Kayama, Shinya Sato, Motoo Nagane, Kazuhiko Mishima, Yoko Nakasu, Kaoru Kurisu, Fumiyuki Yamasaki, Kazuhiko Sugiyama, Takanori Onishi, Yasuo Iwadate, Mizuhiko Terasaki, Hiroyuki Kobayashi, Akira Matsumura, Eiichi Ishikawa, Hikaru Sasaki, Akitake Mukasa, Takayuki Matsuo, Hirofumi Hirano, Toshihiro Kumabe, Nobusada Shinoura, Naoya Hashimoto, Tomokazu Aoki, Akio Asai, Tatsuya Abe, Atsuo Yoshino, Yoshiki Arakawa, Kenichiro Asano, Koji Yoshimoto, Soichiro Shibui
PURPOSE: This study explored the superiority of temozolomide (TMZ) + interferonβ (IFNβ) to standard TMZ as treatment for newly diagnosed glioblastoma (GBM) via randomized phase II screening design. EXPERIMENTAL DESIGN: Eligibility criteria included histologically proven GBM, with 50% of the tumor located in supratentorial areas, without involvement of the optic, olfactory nerves, and pituitary gland and without multiple lesions and dissemination. Patients in the TMZ + radiotherapy (RT) arm received RT (2...
March 20, 2018: Journal of Neuro-oncology
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