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Phase 3 oncology

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https://www.readbyqxmd.com/read/28440953/immunotherapy-with-single-agent-nivolumab-for-advanced-leiomyosarcoma-of-the-uterus-results-of-a-phase-2-study
#1
Eytan Ben-Ami, Constance M Barysauskas, Sarah Solomon, Kadija Tahlil, Rita Malley, Melissa Hohos, Kathleen Polson, Margaret Loucks, Mariano Severgnini, Tara Patel, Amy Cunningham, Scott J Rodig, F Stephen Hodi, Jeffrey A Morgan, Priscilla Merriam, Andrew J Wagner, Geoffrey Shapiro, Suzanne George
BACKGROUND: Immunotherapy has changed the therapeutic landscape in oncology. Advanced uterine leiomyosarcoma (ULMS) remains an incurable disease in most cases, and despite new drug approvals, improvements in overall survival have been modest at best. The goal of this study was to evaluate programmed-death 1 (PD-1) inhibition with nivolumab in this patient population. METHODS: This single-center phase 2 trial completed enrollment between May and October 2015. Patients received 3 mg/kg of intravenous nivolumab on day 1 of each 2-week cycle until disease progression or unacceptable toxicity...
April 25, 2017: Cancer
https://www.readbyqxmd.com/read/28439738/prospective-open-uncontrolled-phase-i-study-to-define-a-well-tolerated-dose-of-oral-artesunate-as-add-on-therapy-in-patients-with-metastatic-breast-cancer-artic-m33-2
#2
Cornelia von Hagens, Ingeborg Walter-Sack, Maren Goeckenjan, Julia Osburg, Brigitte Storch-Hagenlocher, Serkan Sertel, Michael Elsässer, Bjoern Andrew Remppis, Lutz Edler, Judith Munzinger, Thomas Efferth, Andreas Schneeweiss, Thomas Strowitzki
PURPOSE: The antimalarial drug artesunate (ART) is a promising candidate for cancer treatment as it displays anticancer effects in various models. While in short-term treatment of malaria, an excellent safety profile has been found for ART, the potential long-term treatment of cancer patients demands a phase I dose-finding clinical trial determining the daily ART dose which would be well tolerated as add-on therapy. METHODS: Patients with metastatic breast cancer were to receive either 100 or 150 or 200 mg oral ART daily as add-on to their guideline-based oncological therapy for a study period of four weeks with frequent clinical and laboratory monitoring until 4-8 weeks thereafter...
April 24, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28438473/bevacizumab-and-paclitaxel-carboplatin-chemotherapy-and-secondary-cytoreduction-in-recurrent-platinum-sensitive-ovarian-cancer-nrg-oncology-gynecologic-oncology-group-study-gog-0213-a-multicentre-open-label-randomised-phase-3-trial
#3
Robert L Coleman, Mark F Brady, Thomas J Herzog, Paul Sabbatini, Deborah K Armstrong, Joan L Walker, Byoung-Gie Kim, Keiichi Fujiwara, Krishnansu S Tewari, David M O'Malley, Susan A Davidson, Stephen C Rubin, Paul DiSilvestro, Karen Basen-Engquist, Helen Huang, John K Chan, Nick M Spirtos, Raheela Ashfaq, Robert S Mannel
BACKGROUND: Platinum-based chemotherapy doublets are a standard of care for women with ovarian cancer recurring 6 months after completion of initial therapy. In this study, we aimed to explore the roles of secondary surgical cytoreduction and bevacizumab in this population, and report the results of the bevacizumab component here. METHODS: The multicentre, open-label, randomised phase 3 GOG-0213 trial was done in 67 predominantly academic centres in the USA (65 centres), Japan (one centre), and South Korea (one centre)...
April 21, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28436593/results-for-patients-with-sarcoma-not-otherwise-specified-and-other-diagnoses-than-ewing-sarcoma-treated-according-to-the-euro-ewing-99-trial
#4
Judith Amalie Frank, Andreas Ranft, Michael Paulussen, Heribert Juergens, Jarmila Kruseova, Sebastian Bauer, Felix Niggli, Peter Reichardt, Uta Dirksen
BACKGROUND: Euro-EWING 99 trial of the European Ewing tumor Working Initiative of National Groups (EE99) was an international phase III study in patients with Ewing sarcoma. The German Society of Pediatric Oncology and Hematology (GPOH) data center registered and followed patients with other diagnoses than Ewing sarcoma who were treated according to the EE99 protocol in an additional non-Ewing database. PROCEDURE: Data of 27 patients with other diagnoses than Ewing sarcoma treated according to the EE99 protocol were analyzed...
April 24, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28434648/nivolumab-in-patients-with-advanced-hepatocellular-carcinoma-checkmate-040-an-open-label-non-comparative-phase-1-2-dose-escalation-and-expansion-trial
#5
Anthony B El-Khoueiry, Bruno Sangro, Thomas Yau, Todd S Crocenzi, Masatoshi Kudo, Chiun Hsu, Tae-You Kim, Su-Pin Choo, Jörg Trojan, Theodore H Welling, Tim Meyer, Yoon-Koo Kang, Winnie Yeo, Akhil Chopra, Jeffrey Anderson, Christine Dela Cruz, Lixin Lang, Jaclyn Neely, Hao Tang, Homa B Dastani, Ignacio Melero
BACKGROUND: For patients with advanced hepatocellular carcinoma, sorafenib is the only approved drug worldwide, and outcomes remain poor. We aimed to assess the safety and efficacy of nivolumab, a programmed cell death protein-1 (PD-1) immune checkpoint inhibitor, in patients with advanced hepatocellular carcinoma with or without chronic viral hepatitis. METHODS: We did a phase 1/2, open-label, non-comparative, dose escalation and expansion trial (CheckMate 040) of nivolumab in adults (≥18 years) with histologically confirmed advanced hepatocellular carcinoma with or without hepatitis C or B (HCV or HBV) infection...
April 20, 2017: Lancet
https://www.readbyqxmd.com/read/28426538/five-phases-of-recovery-and-rehabilitation-after-allogeneic-stem-cell-transplantation-a-qualitative-study
#6
Mariska C M van der Lans, Frederika E Witkamp, Wendy H Oldenmenger, Annoek E C Broers
BACKGROUND: For patients with a hematological malignancy, allogeneic stem cell transplantation (alloSCT) is a treatment modality that may cause a wide range of problems. Little is known about the process of recovery and rehabilitation and the problems that alloSCT patients are confronted with during the first-year posttransplant. OBJECTIVE: This study explored the problems of patients during the first year after alloSCT, to better understand the process of recovery and rehabilitation...
April 20, 2017: Cancer Nursing
https://www.readbyqxmd.com/read/28423741/lenalidomide-and-the-risk-of-serious-infection-in-patients-with-multiple-myeloma-a-systematic-review-and-meta-analysis
#7
Li Ying, Tong YinHui, Zheng Yunliang, Haozhen Sun
The immunomodulatory drug lenalidomide is highly effective against newly diagnosed and relapsed/refractory multiple myeloma (MM), but serious and even fatal infections have been associated with its use. In this meta-analysis, we assessed the overall risk of infection to MM patients treated with lenalidomide. Eleven phase II or III clinical trials, comprising 3,210 subjects, were selected from the Embase, Pubmed, and Cochrane Library databases, from the Clinical Trial Registration website, and from meeting abstracts and virtual presentations at the American Society of Clinical Oncology...
March 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/28419431/moving-beyond-maximum-tolerated-dose-for-targeted-oncology-drugs-use-of-clinical-utility-index-to-optimize-venetoclax-dosage-in-multiple-myeloma-patients
#8
Kevin J Freise, Aksana K Jones, Maria E Verdugo, Rajeev M Menon, Paulo C Maciag, Ahmed Hamed Salem
Exposure-response analyses of venetoclax in combination with bortezomib and dexamethasone in previously treated patients with multiple myeloma (MM) were performed on a Phase 1b venetoclax dose-ranging study. Logistic regression models were utilized to determine relationships, identify sub-populations with different responses and optimize the venetoclax dosage that balanced both efficacy and safety. Bortezomib refractory status and number of prior treatments were identified to impact the efficacy response to venetoclax treatment...
April 17, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28416603/high-throughput-immunogenetics-for-clinical-and-research-applications-in-immunohematology-potential-and-challenges
#9
Anton W Langerak, Monika Brüggemann, Frédéric Davi, Nikos Darzentas, Jacques J M van Dongen, David Gonzalez, Gianni Cazzaniga, Véronique Giudicelli, Marie-Paule Lefranc, Mathieu Giraud, Elizabeth A Macintyre, Michael Hummel, Christiane Pott, Patricia J T A Groenen, Kostas Stamatopoulos
Analysis and interpretation of Ig and TCR gene rearrangements in the conventional, low-throughput way have their limitations in terms of resolution, coverage, and biases. With the advent of high-throughput, next-generation sequencing (NGS) technologies, a deeper analysis of Ig and/or TCR (IG/TR) gene rearrangements is now within reach, which impacts on all main applications of IG/TR immunogenetic analysis. To bridge the generation gap from low- to high-throughput analysis, the EuroClonality-NGS Consortium has been formed, with the main objectives to develop, standardize, and validate the entire workflow of IG/TR NGS assays for 1) clonality assessment, 2) minimal residual disease detection, and 3) repertoire analysis...
April 17, 2017: Journal of Immunology: Official Journal of the American Association of Immunologists
https://www.readbyqxmd.com/read/28410911/comprehensive-analysis-of-survival-outcomes-in-non-clear-cell-renal-cell-carcinoma-patients-treated-in-clinical-trials
#10
Guillermo de Velasco, Rana R McKay, Xun Lin, Raphel B Moreira, Ronit Simantov, Toni K Choueiri
BACKGROUND: Clinical data from patients with non-clear cell renal cell carcinoma (nccRCC) receiving targeted therapy are limited, and many clinical trials have excluded these patients from study entry. We sought to investigate the outcomes of patients with nccRCC treated in clinical trials in the modern era compared with the outcomes of patients with clear cell RCC (ccRCC). PATIENTS AND METHODS: We conducted a retrospective study of patients with metastatic RCC who had received targeted therapy in Pfizer-sponsored phase II and III clinical trials from 2003 to 2013...
March 21, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28410182/parent-and-health-care-provider-perceptions-for-development-of-a-web-based-weight-management-program-for-survivors-of-pediatric-acute-lymphoblastic-leukemia-a-mixed-methods-study
#11
Sara Folta, Winnie Chang, Rachel Hill, Michael Kelly, Susan Meagher, W Paul Bowman, Fang Fang Zhang
BACKGROUND: Survivors of pediatric acute lymphoblastic leukemia (ALL) may experience unhealthy weight gain during treatment, which has been associated with higher risk for chronic health issues. OBJECTIVE: The purpose of this study was to obtain feedback on weight management in pediatric ALL survivors and on the content and implementation of a Web-based weight management program. METHODS: Study participants included 54 parent survey respondents and 19 pediatric oncology professionals in 4 focus groups...
February 9, 2017: JMIR Cancer
https://www.readbyqxmd.com/read/28409853/a-phase-1-study-of-the-cxcr4-antagonist-plerixafor-in-combination-with-high-dose-cytarabine-and-etoposide-in-children-with-relapsed-or-refractory-acute-leukemias-or-myelodysplastic-syndrome-a-pediatric-oncology-experimental-therapeutics-investigators-consortium
#12
Todd M Cooper, Edward Allan Racela Sison, Sharyn D Baker, Lie Li, Amina Ahmed, Tanya Trippett, Lia Gore, Margaret E Macy, Aru Narendran, Keith August, Michael J Absalon, Jessica Boklan, Jessica Pollard, Daniel Magoon, Patrick A Brown
BACKGROUND: Plerixafor, a reversible CXCR4 antagonist, inhibits interactions between leukemic blasts and the bone marrow stromal microenvironment and may enhance chemosensitivity. A phase 1 trial of plerixafor in combination with intensive chemotherapy in children and young adults with relapsed or refractory acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS) was performed to determine a tolerable and biologically active dose. PROCEDURE: Plerixafor was administered daily for 5 days at four dose levels (6, 9, 12, and 15 mg/m(2) /dose) followed 4 hr later by high-dose cytarabine (every 12 hr) and etoposide (daily)...
April 14, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28408243/erlotinib-and-bevacizumab-in-patients-with-advanced-non-small-cell-lung-cancer-and-activating-egfr-mutations-belief-an-international-multicentre-single-arm-phase-2-trial
#13
Rafael Rosell, Urania Dafni, Enriqueta Felip, Alessandra Curioni-Fontecedro, Oliver Gautschi, Solange Peters, Bartomeu Massutí, Ramon Palmero, Santiago Ponce Aix, Enric Carcereny, Martin Früh, Miklos Pless, Sanjay Popat, Athanasios Kotsakis, Sinead Cuffe, Paolo Bidoli, Adolfo Favaretto, Patrizia Froesch, Noemí Reguart, Javier Puente, Linda Coate, Fabrice Barlesi, Daniel Rauch, Michael Thomas, Carlos Camps, Jose Gómez-Codina, Margarita Majem, Rut Porta, Riyaz Shah, Emer Hanrahan, Roswitha Kammler, Barbara Ruepp, Manuela Rabaglio, Marie Kassapian, Niki Karachaliou, Rachel Tam, David S Shames, Miguel A Molina-Vila, Rolf A Stahel
BACKGROUND: The tyrosine kinase inhibitor erlotinib improves the outcomes of patients with advanced non-small-cell lung carcinoma (NSCLC) harbouring epidermal growth factor receptor (EGFR) mutations. The coexistence of the T790M resistance mutation with another EGFR mutation in treatment-naive patients has been associated with a shorter progression-free survival to EGFR inhibition than in the absence of the T790M mutation. To test this hypothesis clinically, we developed a proof-of-concept study, in which patients with EGFR-mutant NSCLC were treated with the combination of erlotinib and bevacizumab, stratified by the presence of the pretreatment T790M mutation...
April 10, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28404157/nab-paclitaxel-versus-solvent-based-paclitaxel-in-patients-with-previously-treated-advanced-gastric-cancer-absolute-an-open-label-randomised-non-inferiority-phase-3-trial
#14
Kohei Shitara, Atsuo Takashima, Kazumasa Fujitani, Keisuke Koeda, Hiroki Hara, Norisuke Nakayama, Shuichi Hironaka, Kazuhiro Nishikawa, Yoichi Makari, Kenji Amagai, Shinya Ueda, Kazuhiro Yoshida, Hideki Shimodaira, Tomohiro Nishina, Masahiro Tsuda, Yukinori Kurokawa, Takao Tamura, Yasutsuna Sasaki, Satoshi Morita, Wasaburo Koizumi
BACKGROUND: Weekly administration of solvent-based paclitaxel is one of the standard second-line chemotherapy regimens for advanced gastric cancer. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) was developed to improve the solubility of paclitaxel and does not need premedication to avoid infusion-related reactions associated with solvent-based paclitaxel. Additionally, higher doses of nab-paclitaxel can be administered over a shorter infusion time and at higher drug concentrations compared with solvent-based paclitaxel...
April 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28404155/survival-outcomes-following-laparoscopic-versus-open-d3-dissection-for-stage-ii-or-iii-colon-cancer-jcog0404-a-phase-3-randomised-controlled-trial
#15
Seigo Kitano, Masafumi Inomata, Junki Mizusawa, Hiroshi Katayama, Masahiko Watanabe, Seiichiro Yamamoto, Masaaki Ito, Shuji Saito, Shoichi Fujii, Fumio Konishi, Yoshihisa Saida, Hirotoshi Hasegawa, Tomonori Akagi, Kenichi Sugihara, Takashi Yamaguchi, Tadahiko Masaki, Yosuke Fukunaga, Kohei Murata, Masazumi Okajima, Yoshihiro Moriya, Yasuhiro Shimada
BACKGROUND: Although benefits of laparoscopic surgery compared with open surgery have been suggested, the long-term survival of patients undergoing laparoscopic surgery for colon cancer requiring Japanese D3 dissection remains unclear. We did a randomised controlled trial to establish non-inferiority of laparoscopic surgery to open surgery. METHODS: We did an open-label, multi-institutional, randomised, two-arm phase 3 trial in 30 hospitals in Japan. Patients aged 20-75 years who had histologically proven colon cancer; tumours located in the caecum or ascending, sigmoid, or rectosigmoid colon; T3 or deeper lesions without involvement of other organs, node stages N0-2, and metastasis stage M0; and tumour size of 8 cm or smaller were included...
April 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28403082/metronomic-oral-cyclosphosphamide-as-third-line-systemic-treatment-or-beyond-in-patients-with-inoperable-locoregionally-advanced-recurrent-or-metastatic-nasopharyngeal-carcinoma
#16
Victor H F Lee, Dora L W Kwong, Ka-On Lam, Yu-Ching Lai, Yun Li, Chi-Chung Tong, Patty P Y Ho, Wing-Lok Chan, Lai-San Wong, Dennis K C Leung, Sum-Yin Chan, Fong-Ting Chan, To-Wai Leung, Anne W M Lee
There is no standard third-line or further systemic treatment for patients with inoperable locoregionally advanced recurrent or metastatic nasopharyngeal carcinoma (NPC). Metronomic oral cyclophosphamide provides an acceptable and cheap option for these heavily pretreated patients who had limited choices. We conducted a prospective phase II single-arm open-label study of metronomic oral cyclophosphamide. Patients with locoregionally advanced recurrent inoperable (rT3/T4, rN2-N3b) or metastatic (rM1) NPC who had Eastern Cooperative Oncology Group (ECOG) performance status (PS) (0-2) and had progressed after at least 2 lines of palliative systemic chemotherapy were eligible...
April 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28398845/potentially-curable-pancreatic-cancer-american-society-of-clinical-oncology-clinical-practice-guideline-update
#17
Alok A Khorana, Pamela B Mangu, Jordan Berlin, Anitra Engebretson, Theodore S Hong, Anirban Maitra, Supriya G Mohile, Matthew Mumber, Richard Schulick, Marc Shapiro, Susan Urba, Herbert J Zeh, Matthew H G Katz
Purpose To update the Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline published on May 31, 2016. The October 2016 update focuses solely on new evidence that pertains to clinical question 4 of the guideline: What is the appropriate adjuvant regimen for patients with pancreatic cancer who have undergone an R0 or R1 resection of their primary tumor? Methods The recently published results of a randomized phase III study prompted an update of this guideline...
April 11, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28397697/nab-paclitaxel-plus-either-gemcitabine-or-simplified-leucovorin-and-fluorouracil-as-first-line-therapy-for-metastatic-pancreatic-adenocarcinoma-afugem-gercor-a-non-comparative-multicentre-open-label-randomised-phase-2-trial
#18
Jean-Baptiste Bachet, Pascal Hammel, Jérôme Desramé, Aurélia Meurisse, Benoist Chibaudel, Thierry André, Philippe Debourdeau, Jérome Dauba, Thierry Lecomte, Jean-François Seitz, Christophe Tournigand, Thomas Aparicio, Véronique Guerin Meyer, Julien Taieb, Julien Volet, Amandine Monier, Franck Bonnetain, Christophe Louvet
BACKGROUND: Nab-paclitaxel plus gemcitabine has become a standard treatment regimen in patients with metastatic pancreatic adenocarcinoma; however, retrospective data suggest that gemcitabine might be inefficient in 50-60% of patients and thus not an optimum regimen in combination with nab-paclitaxel. We did a phase 2 trial to assess the activity and safety of a new regimen of nab-paclitaxel plus simplified leucovorin and fluorouracil. METHODS: We did a non-comparative, multicentre, open-label, randomised phase 2 trial in 15 hospitals and institutions in France...
May 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28395880/treatment-of-metastatic-uveal-melanoma-with-adoptive-transfer-of-tumour-infiltrating-lymphocytes-a-single-centre-two-stage-single-arm-phase-2-study
#19
Smita S Chandran, Robert P T Somerville, James C Yang, Richard M Sherry, Christopher A Klebanoff, Stephanie L Goff, John R Wunderlich, David N Danforth, Daniel Zlott, Biman C Paria, Arvind C Sabesan, Abhishek K Srivastava, Liqiang Xi, Trinh H Pham, Mark Raffeld, Donald E White, Mary Ann Toomey, Steven A Rosenberg, Udai S Kammula
BACKGROUND: Uveal melanoma is a rare tumour with no established treatments once metastases develop. Although a variety of immune-based therapies have shown efficacy in metastatic cutaneous melanoma, their use in ocular variants has been disappointing. Recently, adoptive T-cell therapy has shown salvage responses in multiple refractory solid tumours. Thus, we sought to determine if adoptive transfer of autologous tumour-infiltrating lymphocytes (TILs) could mediate regression of metastatic uveal melanoma...
April 7, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28389316/maintenance-therapy-with-vinflunine-plus-best-supportive-care-versus-best-supportive-care-alone-in-patients-with-advanced-urothelial-carcinoma-with-a-response-after-first-line-chemotherapy-maja-sogug-2011-02-a-multicentre-randomised-controlled-open-label-phase
#20
Jesus García-Donas, Albert Font, Begoña Pérez-Valderrama, José Antonio Virizuela, Miquel Ángel Climent, Susana Hernando-Polo, José Ángel Arranz, Maria Del Mar Llorente, Nuria Lainez, José Carlos Villa-Guzmán, Begoña Mellado, Aránzazu González Del Alba, Daniel Castellano, Enrique Gallardo, Urbano Anido, Xavier García Del Muro, Montserrat Domènech, Javier Puente, Rafael Morales-Barrera, Jose Luis Pérez-Gracia, Joaquim Bellmunt
BACKGROUND: Maintenance therapy improves outcomes in various tumour types, but cumulative toxic effects limit the choice of drugs. We investigated whether maintenance therapy with vinflunine would delay disease progression in patients with advanced urothelial carcinoma who had achieved disease control with first-line chemotherapy. METHODS: We did a randomised, controlled, open-label, phase 2 trial in 21 Spanish hospitals. Eligible patients had locally advanced, surgically unresectable, or metastatic transitional-cell carcinoma of the urothelial tract, adequate organ function, and disease control after four to six cycles of cisplatin and gemcitabine (carboplatin allowed after cycle four)...
April 4, 2017: Lancet Oncology
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