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https://www.readbyqxmd.com/read/28214977/braf-mutated-colorectal-cancer-what-is-the-optimal-strategy-for-treatment
#1
REVIEW
Romain Cohen, Pascale Cervera, Magali Svrcek, Anna Pellat, Chantal Dreyer, Aimery de Gramont, Thierry André
The BRAF activating mutation, harbored by approximately 10% of colorectal cancers (CRC), confers dramatic prognosis to advanced diseases. In early-stage setting, the identification of the BRAF mutation does not impact the therapeutic decision. Yet, the BRAF mutation could be considered as a stratification factor in adjuvant trials, because of its prognostic impact after relapse. Moreover, both BRAF mutation and mismatch repair (MMR) statuses should be determined in all CRC to help identify sporadic tumors versus Lynch syndrome-related tumors...
February 2017: Current Treatment Options in Oncology
https://www.readbyqxmd.com/read/28212060/pembrolizumab-as-second-line-therapy-for-advanced-urothelial-carcinoma
#2
Joaquim Bellmunt, Ronald de Wit, David J Vaughn, Yves Fradet, Jae-Lyun Lee, Lawrence Fong, Nicholas J Vogelzang, Miguel A Climent, Daniel P Petrylak, Toni K Choueiri, Andrea Necchi, Winald Gerritsen, Howard Gurney, David I Quinn, Stéphane Culine, Cora N Sternberg, Yabing Mai, Christian H Poehlein, Rodolfo F Perini, Dean F Bajorin
Background Patients with advanced urothelial carcinoma that progresses after platinum-based chemotherapy have a poor prognosis and limited treatment options. Methods In this open-label, international, phase 3 trial, we randomly assigned 542 patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy to receive pembrolizumab (a highly selective, humanized monoclonal IgG4κ isotype antibody against programmed death 1 [PD-1]) at a dose of 200 mg every 3 weeks or the investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine...
February 17, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28209298/utidelone-plus-capecitabine-versus-capecitabine-alone-for-heavily-pretreated-metastatic-breast-cancer-refractory-to-anthracyclines-and-taxanes-a-multicentre-open-label-superiority-phase-3-randomised-controlled-trial
#3
Pin Zhang, Tao Sun, Qingyuan Zhang, Zhongyu Yuan, Zefei Jiang, Xiao Jia Wang, Shude Cui, Yuee Teng, Xi-Chun Hu, Junlan Yang, Hongming Pan, Zhongsheng Tong, Huiping Li, Qiang Yao, Yongsheng Wang, Yongmei Yin, Ping Sun, Hong Zheng, Jing Cheng, Jinsong Lu, Baochun Zhang, Cuizhi Geng, Jian Liu, Roujun Peng, Min Yan, Shaohua Zhang, Jian Huang, Li Tang, Rongguo Qiu, Binghe Xu
BACKGROUND: Utidelone, a genetically engineered epothilone analogue, has shown promise as a potential treatment for breast cancer in phase 1 and 2 trials. The aim of this phase 3 trial was to compare the efficacy and safety of utidelone plus capecitabine versus capecitabine alone in patients with metastatic breast cancer. METHODS: We did a multicentre, open-label, superiority, phase 3, randomised controlled trial in 26 hospitals in China. Eligible participants were female patients with metastatic breast cancer refractory to anthracycline and taxane chemotherapy regimens...
February 10, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28209296/best-time-to-assess-complete-clinical-response-after-chemoradiotherapy-in-squamous-cell-carcinoma-of-the-anus-act-ii-a-post-hoc-analysis-of-randomised-controlled-phase-3-trial
#4
Robert Glynne-Jones, David Sebag-Montefiore, Helen M Meadows, David Cunningham, Rubina Begum, Fawzi Adab, Kim Benstead, Robert J Harte, Jill Stewart, Sandy Beare, Allan Hackshaw, Latha Kadalayil
BACKGROUND: Guidelines for anal cancer recommend assessment of response at 6-12 weeks after starting treatment. Using data from the ACT II trial, we determined the optimum timepoint to assess clinical tumour response after chemoradiotherapy. METHODS: The previously reported ACT II trial was a phase 3 randomised trial of patients of any age with newly diagnosed, histologically confirmed, squamous cell carcinoma of the anus without metastatic disease from 59 centres in the UK...
February 10, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28207285/improvements-in-clinical-trials-information-will-improve-the-reproductive-health-and-fertility-of-cancer-patients
#5
Angela Dauti, Brigitte Gerstl, Serena Chong, Orin Chisholm, Antoinette Anazodo
There are a number of barriers that result in cancer patients not being referred for oncofertility care, which include knowledge about reproductive risks of antineoplastic agents. Without this information, clinicians do not always make recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information and recommendations that clinicians have available in clinical trial protocols regarding oncofertility management and follow-up, and the information that patients may receive in clinical trials patient information sheets or consent forms...
February 16, 2017: Journal of Adolescent and Young Adult Oncology
https://www.readbyqxmd.com/read/28199814/baricitinib-versus-placebo-or-adalimumab-in-rheumatoid-arthritis
#6
Peter C Taylor, Edward C Keystone, Désirée van der Heijde, Michael E Weinblatt, Liliana Del Carmen Morales, Jaime Reyes Gonzaga, Sergey Yakushin, Taeko Ishii, Kahaku Emoto, Scott Beattie, Vipin Arora, Carol Gaich, Terence Rooney, Douglas Schlichting, William L Macias, Stephanie de Bono, Yoshiya Tanaka
Background Baricitinib is an oral, reversible inhibitor of the Janus kinases JAK1 and JAK2 that may have therapeutic value in patients with rheumatoid arthritis. Methods We conducted a 52-week, phase 3, double-blind, placebo- and active-controlled trial in which 1307 patients with active rheumatoid arthritis who were receiving background therapy with methotrexate were randomly assigned to one of three regimens in a 3:3:2 ratio: placebo (switched to baricitinib after 24 weeks), 4 mg of baricitinib once daily, or 40 mg of adalimumab (an anti-tumor necrosis factor α monoclonal antibody) every other week...
16, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28192641/effects-of-induction-docetaxel-platinum-and-fluorouracil-chemotherapy-in-patients-with-stage-iii-or-iva-b-nasopharyngeal-cancer-treated-with-concurrent-chemoradiation-therapy-final-results-of-2-parallel-phase-2-clinical-trials
#7
Lin Kong, Youwang Zhang, Chaosu Hu, Ye Guo, Jiade J Lu
BACKGROUND: The effects of docetaxel, platinum, and fluorouracil (TPF) induction chemotherapy plus concurrent chemoradiotherapy (CCRT) on locoregionally advanced nasopharyngeal cancer (NPC) are unclear. This study examined the long-term outcomes of the addition of this regimen to CCRT for stage III and IVA/B NPC. METHODS: Two parallel, single-arm phase 2 trials were performed synchronously to evaluate the efficacy and toxicity of TPF-based induction chemotherapy in patients with stage III or IVA/B NPC...
February 13, 2017: Cancer
https://www.readbyqxmd.com/read/28190762/optimal-fractionation-of-preoperative-radiotherapy-and-timing-to-surgery-for-rectal-cancer-stockholm-iii-a-multicentre-randomised-non-blinded-phase-3-non-inferiority-trial
#8
Johan Erlandsson, Torbjörn Holm, David Pettersson, Åke Berglund, Björn Cedermark, Calin Radu, Hemming Johansson, Mikael Machado, Fredrik Hjern, Olof Hallböök, Ingvar Syk, Bengt Glimelius, Anna Martling
BACKGROUND: Radiotherapy reduces the risk of local recurrence in rectal cancer. However, the optimal radiotherapy fractionation and interval between radiotherapy and surgery is still under debate. We aimed to study recurrence in patients randomised between three different radiotherapy regimens with respect to fractionation and time to surgery. METHODS: In this multicentre, randomised, non-blinded, phase 3, non-inferiority trial (Stockholm III), all patients with a biopsy-proven adenocarcinoma of the rectum, without signs of non-resectability or distant metastases, without severe cardiovascular comorbidity, and planned for an abdominal resection from 18 Swedish hospitals were eligible...
February 9, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28163000/peri-operative-chemotherapy-with-or-without-bevacizumab-in-operable-oesophagogastric-adenocarcinoma-uk-medical-research-council-st03-primary-analysis-results-of-a-multicentre-open-label-randomised-phase-2-3-trial
#9
David Cunningham, Sally P Stenning, Elizabeth C Smyth, Alicia F Okines, William H Allum, Sam Rowley, Laura Stevenson, Heike I Grabsch, Derek Alderson, Thomas Crosby, S Michael Griffin, Wasat Mansoor, Fareeda Y Coxon, Stephen J Falk, Suzanne Darby, Kate A Sumpter, Jane M Blazeby, Ruth E Langley
BACKGROUND: Peri-operative chemotherapy and surgery is a standard of care for patients with resectable oesophagogastric adenocarcinoma. Bevacizumab, a monoclonal antibody against VEGF, improves the proportion of patients responding to treatment in advanced gastric cancer. We aimed to assess the safety and efficacy of adding bevacizumab to peri-operative chemotherapy in patients with resectable gastric, oesophagogastric junction, or lower oesophageal adenocarcinoma. METHODS: In this multicentre, randomised, open-label phase 2-3 trial, we recruited patients aged 18 years and older with histologically proven, resectable oesophagogastric adenocarcinoma from 87 UK hospitals and cancer centres...
February 2, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28156642/adherence-to-anti-emetic-guidelines-with-a-newly-approved-chemotherapy-agent-trifluridine-tipiracil-tas-102-a-single-institution-study
#10
Aminah Jatoi
: 221 Background: To our knowledge, no study has examined adherence to antiemetic guidelines with soon-to-be-approved or newly approved chemotherapy agents. In 2015, the Food and Drug Administration approved 18 cancer drugs, underscoring the timeliness of this topic. Here, we hypothesize that patients prescribed new drugs are at risk for poor guideline adherence, and we report on antiemetic prescribing practices and outcomes with TAS-102, a recently approved drug for metastatic colorectal cancer...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28156640/efficacy-of-rolapitant-for-prevention-of-chemotherapy-induced-nausea-and-vomiting-cinv-in-patients-with-gastrointestinal-and-colorectal-cancers
#11
Karin Jordan, Bernardo Leon Rapoport, Ian D Schnadig, Martin Chasen, Sujata Arora, Daniel Powers, Lee Steven Schwartzberg
: 222 Background: Rolapitant (VARUBI) is a selective, long-acting neurokinin-1 receptor antagonist (RA) for the prevention of CINV. Rolapitant effectively prevented CINV in phase 3 trials of patients (pts) receiving highly or moderately emetogenic chemotherapy (HEC, MEC). While MEC and HEC regimens are commonly used to treat pts with gastrointestinal and colorectal cancers (GI/CRC), very few studies have evaluated the effectiveness of a neurokinin-1 RA regimen in these pts. We assessed the incidence of CINV and efficacy of rolapitant in a subset of pts with GI/CRC...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28156638/rolapitant-for-control-of-chemotherapy-induced-nausea-and-vomiting-cinv-in-patients-with-gynecologic-cancer
#12
Lee Steven Schwartzberg, Sujata Arora, Daniel Powers, Karin Jordan, Rudolph M Navari
: 223 Background: Rolapitant, a long-acting neurokinin-1 receptor antagonist, protected against CINV in patients receiving highly or moderately emetogenic chemotherapy (HEC or MEC). METHODS: In 3 double-blind phase 3 studies, patients were randomized to receive oral rolapitant 180 mg or placebo before administration of HEC or MEC. All patients received a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone. In a post hoc analysis of 3 pooled studies (2 HEC and 1 MEC), we assessed the efficacy and safety of rolapitant in patients with gynecologic (ovarian, uterine, or cervical) cancer...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152547/neratinib-resistance-and-cross-resistance-to-other-her2-targeted-drugs-due-to-increased-activity-of-metabolism-enzyme-cytochrome-p4503a4
#13
Susan Breslin, Michelle C Lowry, Lorraine O'Driscoll
BACKGROUND: Neratinib is in Phase 3 clinical trials but, unfortunately, the development of resistance is inevitable. Here, we investigated the effects of acquired neratinib resistance on cellular phenotype and the potential mechanism of this resistance. METHODS: Neratinib-resistant variants of HER2-positive breast cancer cells were developed and their cross-resistance investigated using cytotoxicity assays. Similarly, sensitivity of trastuzumab-resistant and lapatinib-resistant cells to neratinib was assessed...
February 2, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28145906/safety-of-tofacitinib-in-the-treatment-of-rheumatoid-arthritis-in-latin-america-compared-with-the-rest-of-the-world-population
#14
Oswaldo M Castañeda, Felix J Romero, Ariel Salinas, Gustavo Citera, Eduardo Mysler, Oscar Rillo, Sebastiao C Radominski, Mario H Cardiel, Juan J Jaller, Carlos Alvarez-Moreno, Dario Ponce de Leon, Graciela Castelli, Erika G García, Kenneth Kwok, Ricardo Rojo
OBJECTIVE: Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint destruction. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post hoc analysis assessed the safety of tofacitinib in Latin American (LA) patients with RA versus the Rest of World (RoW) population. METHODS: Data were pooled from 14 clinical studies of tofacitinib: six Phase 2, six Phase 3 and two long-term extension studies. Incidence rates (IRs; patients with events/100 patient-years of treatment exposure) were calculated for safety events of special interest combined across tofacitinib doses...
February 1, 2017: Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases
https://www.readbyqxmd.com/read/28144693/-phase%C3%A2-iii-study-for-local-or-locally-advanced-prostate-cancer-randomized-double-blind-placebo-controlled-phase%C3%A2-3-study-of-apalutamide-in-patients-with-local-high-risk-prostate-cancer-or-locally-advanced-prostate-cancer-receiving-primary-radiotherapy-atlas
#15
https://www.readbyqxmd.com/read/28141932/an-expanded-portfolio-of-survival-metrics-for-assessing-anticancer-agents
#16
Jennifer Karweit, Srividya Kotapati, Samuel Wagner, James W Shaw, Steffan W Wolfe, Amy P Abernethy
OBJECTIVES: With the introduction of more effective anticancer agents that prolong survival, there is a need for new methods to define the clinical value of treatments. The objective of this preliminary qualitative and quantitative analysis was to assess the utility of an expanded portfolio of survival metrics to differentiate the value of anticancer agents. STUDY DESIGN: A literature review was conducted of phase 3 trial data, reported in regulatory submissions within the last 10 years of agents for 6 metastatic cancers (breast cancer, colorectal cancer [CRC], melanoma, non-small cell lung cancer [NSCLC], prostate cancer [PC], and renal cell cancer [RCC])...
January 2017: American Journal of Managed Care
https://www.readbyqxmd.com/read/28129987/comparison-of-adjuvant-gemcitabine-and-capecitabine-with-gemcitabine-monotherapy-in-patients-with-resected-pancreatic-cancer-espac-4-a-multicentre-open-label-randomised-phase-3-trial
#17
John P Neoptolemos, Daniel H Palmer, Paula Ghaneh, Eftychia E Psarelli, Juan W Valle, Christopher M Halloran, Olusola Faluyi, Derek A O'Reilly, David Cunningham, Jonathan Wadsley, Suzanne Darby, Tim Meyer, Roopinder Gillmore, Alan Anthoney, Pehr Lind, Bengt Glimelius, Stephen Falk, Jakob R Izbicki, Gary William Middleton, Sebastian Cummins, Paul J Ross, Harpreet Wasan, Alec McDonald, Tom Crosby, Yuk Ting Ma, Kinnari Patel, David Sherriff, Rubin Soomal, David Borg, Sharmila Sothi, Pascal Hammel, Thilo Hackert, Richard Jackson, Markus W Büchler
BACKGROUND: The ESPAC-3 trial showed that adjuvant gemcitabine is the standard of care based on similar survival to and less toxicity than adjuvant 5-fluorouracil/folinic acid in patients with resected pancreatic cancer. Other clinical trials have shown better survival and tumour response with gemcitabine and capecitabine than with gemcitabine alone in advanced or metastatic pancreatic cancer. We aimed to determine the efficacy and safety of gemcitabine and capecitabine compared with gemcitabine monotherapy for resected pancreatic cancer...
January 24, 2017: Lancet
https://www.readbyqxmd.com/read/28126333/first-line-ceritinib-versus-platinum-based-chemotherapy-in-advanced-alk-rearranged-non-small-cell-lung-cancer-ascend-4-a-randomised-open-label-phase-3-study
#18
Jean-Charles Soria, Daniel S W Tan, Rita Chiari, Yi-Long Wu, Luis Paz-Ares, Juergen Wolf, Sarayut L Geater, Sergey Orlov, Diego Cortinovis, Chong-Jen Yu, Maximillian Hochmair, Alexis B Cortot, Chun-Ming Tsai, Denis Moro-Sibilot, Rosario G Campelo, Tracey McCulloch, Paramita Sen, Margaret Dugan, Serafino Pantano, Fabrice Branle, Cristian Massacesi, Gilberto de Castro
BACKGROUND: The efficacy of ceritinib in patients with untreated anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer (NSCLC) is not known. We assessed the efficacy and safety of ceritinib versus platinum-based chemotherapy in these patients. METHODS: This randomised, open-label, phase 3 study in untreated patients with stage IIIB/IV ALK-rearranged non-squamous NSCLC was done in 134 centres across 28 countries. Eligible patients were assigned via interactive response technology to oral ceritinib 750 mg/day or platinum-based chemotherapy ([cisplatin 75 mg/m(2) or carboplatin AUC 5-6 plus pemetrexed 500 mg/m(2)] every 3 weeks for four cycles followed by maintenance pemetrexed); randomisation was stratified by World Health Organization performance status (0 vs 1-2), previous neoadjuvant or adjuvant chemotherapy, and presence of brain metastases as per investigator's assessment at screening...
January 23, 2017: Lancet
https://www.readbyqxmd.com/read/28125763/continued-treatment-effect-of-zoledronic-acid-dosing-every-12-vs-4-weeks-in-women-with-breast-cancer-metastatic-to-bone-the-optimize-2-randomized-clinical-trial
#19
Gabriel N Hortobagyi, Catherine Van Poznak, W Graydon Harker, William J Gradishar, Helen Chew, Shaker R Dakhil, Barbara B Haley, Nicholas Sauter, Ramon Mohanlal, Ming Zheng, Allan Lipton
Importance: Zoledronic acid, a potent bisphosphonate, is commonly administered to patients with bone metastases to reduce the risk of skeletal-related events (SREs). However, there have been concerns regarding its long-term monthly administration. Objective: To examine whether zoledronic acid every 12 weeks was noninferior to zoledronic acid every 4 weeks in patients with metastatic breast cancer that involved the bone who had previously received a standard dosing regimen of zoledronic acid and/or pamidronate disodium...
January 26, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28125369/payer-perspectives-on-patient-reported-outcomes-in-health-care-decision-making-oncology-examples
#20
Andrew P Brogan, Carla DeMuro, Amy M Barrett, Denise D'Alessio, Vasudha Bal, Susan L Hogue
BACKGROUND: Health authorities and payers increasingly recognize the importance of patient perspectives and patient-reported outcomes (PROs) in health care decision making. However, given the broad variety of PRO endpoints included in clinical programs and variations in the timing of PRO data collection and country-specific needs, the role of PRO data in reimbursement decisions requires characterization. OBJECTIVES: To (a) determine the effect of PRO data on market access and reimbursement decisions for oncology products in multiple markets and (b) assess the effect of PRO data collected after clinical progression on payer decision making...
February 2017: Journal of Managed Care & Specialty Pharmacy
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