Us Oncology Research

Ocala, FL, United States

Us Oncology Research

Ocala, FL, United States

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THE WOODLANDS, Texas--(BUSINESS WIRE)--McKesson Specialty Health, a division of McKesson Corporation that works together with stakeholders across the healthcare delivery system to preserve and strengthen specialty care, has played a significant role in the recent approval of ZEJULATM (niraparib). Approximately ten practices affiliated with US Oncology Research, one of the largest community-based oncology research programs in the United States supported by McKesson Specialty Health, participated in the clinical trial that led to approval by the U.S. Food and Drug Administration (FDA) on March 27, 2017. ZEJULA marks the 66th FDA approval in which US Oncology Research has contributed. ZEJULA is a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer in 2017. Historically, there have been few treatment options for women with advanced ovarian cancer. Clinical trial results demonstrated that treatment with ZEJULA reduced the risk of disease progression or death by 74% in patients with germline BRCA mutations (HR 0.26) and by 55% in patients without germline BRCA mutations (HR 0.45). “The FDA approval for ZEJULA differs from the approval of the other 2 PARP inhibitors in that it is indicated in “all comers”. A unique molecular signature is not required for use,” said Bradley J. Monk, MD, FACS, FACOG, who was part of the development process as the clinical trial study was designed, enrolled, analyzed and published. “Although biomarkers are important in predicting clinical activity, the efficacy of ZEJULA is so broad that a companion diagnostic is not mandatory. However, germline BRCA testing is still important in identifying families at risk for hereditary breast and ovarian cancer.” Dr. Monk is an oncologist with Arizona Oncology, an affiliate of The US Oncology Network and US Oncology Research. McKesson Specialty Health was also selected by TESARO as one of ZEJULA’s distributors of choice for in-office dispensing practices. Additionally, Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, was selected to be a specialty pharmacy provider in the ZEJULA distribution network. Eligible Onmark and Unity GPO members also have access to contract pricing. In-office dispensing practices looking to access ZEJULA can place orders via McKesson Specialty Health’s Customer Center or by contacting their Customer Care team at 800.482.6700. Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com. McKesson Specialty Health, a division of McKesson Corporation, works together with stakeholders across the healthcare delivery system to preserve and strengthen specialty care, passionately driven by the benefits it provides patients and the system as a whole. Through innovative provider, practice management, manufacturer and payer solutions, McKesson Specialty Health focuses on improving the financial, operational and business health of our customers and partners so they may provide the best care to patients. At McKesson Specialty Health, we believe that we are all in this together. For more information, visit www.mckessonspecialtyhealth.com. Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves 60 research sites and approximately 170 locations managing about 300 active trials at any given time. Physicians in the research network have enrolled more than 66,000 patients in over 1,500 trials since inception in 1992 and have played a role in nearly 70 FDA-approved cancer therapies, approximately one-third cancer therapies approved by the FDA to date. For more information visit https://www.usoncology.com/oncologists/us-oncology-research. To find clinical trials available through US Oncology Research visit http://trialfinder.usoncology.com Biologics, Inc. is an oncology pharmacy services company that empowers healthcare providers, payers and biopharma to optimize cancer care for the best possible outcomes – clinical, financial and emotional. Unifying fragmented healthcare services, Biologics brings efficiency and humanity to oncology care management by focusing on the patient’s best interest as the surest path to managing cost and risk. Biologics is part of McKesson Specialty Health, a division of McKesson Corporation empowering the community patient care delivery system by helping community practices advance the science, technology and quality of care. Through innovative clinical research, business and operational solutions, facilitated by integrated technology systems, we focus on improving the financial health of our customers so they may provide the best care to their patients. Our combined organization will help better support patients and expedite access to oncology therapies. For more information, visit www.mckessonspecialtyhealth.com and www.biologicsinc.com.


THE WOODLANDS, Texas--(BUSINESS WIRE)--Community oncologists affiliated with The US Oncology Network (The Network) and US Oncology Research will showcase findings from approximately 40 data presentations at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), held June 2-6, 2017 at McCormick Place in Chicago. These data presentations cover novel approaches to numerous types of cancer specialties including hematology, gastrointestinal, breast cancer and promising immunotherapy research. In addition, experts from The Network will be sharing expert perspectives during ASCO. In particular, Debra Patt, MD, MBA, MPH, will participate in an expert panel on healthcare information technology titled More Medicine, Fewer Clicks: How Informatics Can Actually Help Your Practice. Each year, more than 1.5 million people in the United States are diagnosed with cancer, and research shows that earlier detection, diagnosis, and treatment increase patients’ chances of long-term survival.1 In 2015, the Biden Moonshot Cancer program was launched to achieve 10 years of progress, in preventing, diagnosing and treating cancer, in five years. Although the healthcare landscape is changing and evolving, it’s imperative that the vitality of community cancer care is preserved, as many patients rely on resources close to their families and homes. “Inspired by the Biden Moonshot Cancer program’s commitment to developing new cancer technologies, community oncologists continue to make significant contributions in shaping the future of cancer care,” said Michael V. Seiden, MD, PhD, chief medical officer for McKesson Specialty Health and The US Oncology Network. “The US Oncology Network is comprised of more than 1,400 independent physicians dedicated to delivering value-based, integrated care for patients – close to home. Many of those practices conduct research through US Oncology Research, one of the largest community-based oncology research programs in the United States. Over the past 25 years, the organization has enrolled more than 66,000 patients into clinical trials and helped bring nearly 70 therapeutic treatments to market through participation in pivotal registration trials. These efforts underscore one way community oncologists are influencing how the war against cancer is waged.” Two US Oncology Research affiliated investigators have been selected to give oral presentations on Saturday, June 3 from 3:00 PM to 6:00 PM Central Daylight Time (CDT) in S100bc, as part of a larger session focused on Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia. “Despite recent advances in the treatment of follicular lymphoma, there remain groups of patients with this disease who have poor outcomes,” said Dr. Andorsky. “Early results from the MAGNIFY trial of rituximab plus lenalidomide in high-risk patients with follicular lymphoma found that patients with poor outcomes include those whose disease relapses early (within 2 years of initial treatment) and who are refractory to both rituximab and alkylating agents. I’m committed to helping develop novel therapies that improve the quality of care for these patients.” Dr. Sharman said, “Research is key to the treatment and cure of hematologic malignancies. We must continue to accelerate discoveries into meaningful clinical trials to improve patient outcomes. Data from the GENUINE trial show that high-risk chronic lymphocytic leukemia patients who received a combination of ublituximab (UTX) and ibrutinib (IB) demonstrated a superior response rate compared to those who received IB alone without additional clinically significant toxicity. These results are a testament to the treatment advances being made, but there is still work to be done. We must think through our patients’ journeys, from start to finish.” Affiliated oncologists are also participating in pre-conference and educational sessions by sharing insights and specialized expertise to help fellow oncologists continue to improve patient outcomes while advancing their practices. Oncology practices face complex decisions about the health technology landscape that help improve care and efficiencies. Selecting technologies that address the unique needs of an oncology practice and allow for improved identification of research and care options are essential. McKesson Specialty Health, which supports The US Oncology Network and US Oncology Research, provides coordinated resources and infrastructure that allow doctors in The Network to focus on the health of their patients, while McKesson focuses on the health of their practices. “Big data and technology are playing a large role in improving cancer care, by giving physicians access to key information on proposed treatment plans and allowing them to develop individualized care plans for their patients,” said Dr. Patt, vice president of Public Policy and Academic Affairs at Texas Oncology and chair of The US Oncology Network Pathways Taskforce for Breast Cancer. “Appropriate use of big data can enhance efficiencies, improve outcomes, advance research, and reduce healthcare costs for patients and practices.” A complete list of US Oncology Research affiliated studies and educational programs being featured at ASCO can be found here. Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves 60 research sites and approximately 170 locations managing nearly 400 active trials at any given time. Physicians in the research network have enrolled more than 66,000 patients in over 1,500 trials since inception in 1992 and have played a role in nearly 70 FDA-approved cancer therapies, approximately one-third of cancer therapies approved by the FDA to date. For more information visit https://www.usoncology.com/physicians/clinical-trials. To find clinical trials available through US Oncology Research visit http://trialfinder.usoncology.com. About The US Oncology Network Every day, The US Oncology Network (The Network) helps more than 1,400 independent physicians deliver value-based, integrated care for patients — close to home. Through The Network, these independent doctors come together to form a community of shared expertise and resources dedicated to advancing local cancer care and to delivering better patient outcomes. The Network provides doctors with access to coordinated resources, best business practices, and the experience, infrastructure and support of McKesson Specialty Health. This collaboration allows the doctors in The Network to focus on the health of their patients, while McKesson focuses on the health of their practices. Together, The Network and its affiliated physicians are committed to the success of independent practices, everywhere. For more information, visit www.usoncology.com. McKesson Specialty Health, a division of McKesson Corporation, works together with stakeholders across the healthcare delivery system to preserve and strengthen specialty care, passionately driven by the benefits it provides patients and the system as a whole. Through innovative provider, practice management, manufacturer and payer solutions, McKesson Specialty Health focuses on improving the financial, operational and business health of our customers and partners so they may provide the best care to patients. At McKesson Specialty Health, we believe that we are all in this together. For more information, visit www.mckessonspecialtyhealth.com. 1 Center for Disease Control and Prevention. Cancer – Preventing One of the Nation’s Leading Causes of Death at a Glance 2016. October 2016. Accessed May 17, 2017 at https://www.cdc.gov/chronicdisease/resources/publications/aag/dcpc.htm


THE WOODLANDS, Texas and CAMBRIDGE, Mass., Aug. 01, 2017 (GLOBE NEWSWIRE) -- Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, and US Oncology Research, one of the nation’s largest networks of independent, community-based oncology practices dedicated to advancing high-quality treatments through clinical trials, today announced a collaboration to screen and identify relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) patients with EZH2 mutations. Once identified, eligible candidates will be directed to Epizyme’s ongoing Phase 2 clinical trial of tazemetostat, the Company’s first-in-class EZH2 inhibitor, as a single-agent treatment for relapsed or refractory patients with FL or DLBCL. “Relapsed follicular lymphoma and DLBCL are difficult diseases for which there is generally poor prognosis and limited treatment options for patients,” said Michael Seiden, M.D., Ph.D. chief medical officer, US Oncology Research. “Physicians affiliated with US Oncology Research strive to provide access to the treatment strategies that are best suited to each patient. Given the encouraging clinical activity and favorable safety profile demonstrated by tazemetostat in these patient populations, US Oncology Research is pleased to work with Epizyme to offer this screening process so that appropriate patients being treated by an affiliated physician can be promptly directed to a clinical trial evaluating an investigational therapy that is targeted to their cancer.” Under the collaboration, US Oncology Research will implement a separate screening protocol in 68 locations in the U.S. to identify relapsed or refractory FL and DLBCL patients with tumors bearing EZH2 mutations who may be candidates for enrollment in Epizyme’s ongoing Phase 2 clinical trial. US Oncology Research will direct identified patients to the tazemetostat Phase 2 clinical trial for protocol screening and potential enrollment into the trial. Sites began screening patients in July 2017. “We are pleased that US Oncology Research, a program recognized for tremendous success in oncology clinical trials and for providing patients with access to novel treatments, is joining our effort to develop a targeted treatment for lymphoma patients with EZH2 mutations,” said Peter Ho, chief medical officer of Epizyme. “This collaboration significantly expands our clinical trial footprint within the United States and is expected to further enhance our enrollment of patients whose tumors harbor an EZH2 mutation for our ongoing Phase 2 study of tazemetostat. We believe that tazemetostat has the potential to play a very important role in the targeted treatment of these patients in the future.” About Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphoma (DLBCL) FL, an indolent form of non-Hodgkin lymphoma (NHL), is considered to be incurable with existing treatments and is characterized by cycles of relapse that become increasingly difficult to treat with each disease progression. Approximately 25,000 patients in the U.S. and major European countries are diagnosed with FL every year1, of which 15 to 20 percent are estimated to have an EZH2 mutation. There are no approved treatments indicated for patients with FL with an EZH2 mutation. In April 2017, the FDA granted Fast Track designation to tazemetostat for FL regardless of EZH2 mutational status. DLBCL is an aggressive form of NHL that, once diagnosed, typically requires immediate treatment. Approximately 45,000 patients are diagnosed with DLBCL in the U.S. and major European countries every year2. Among patients with germinal center DLBCL, an estimated 15 to 20 percent have an EZH2 mutation. Forty to 50 percent of patients will relapse on their first-line treatment, which is most commonly the chemotherapy regimen R-CHOP, and there are few treatment options for patients who relapse or become refractory to chemotherapy. In November 2016, the FDA granted Fast Track designation to tazemetostat for DLBCL with EZH2 mutations. About the Tazemetostat Clinical Trial Program Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for FL regardless of EZH2 mutation and for DLBCL with EZH2-activating mutations, as well as Orphan Drug designation for soft tissue sarcoma and malignant rhabdoid tumors. About US Oncology Research Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves 60 research sites and 165 locations managing about 350 active trials at any given time. Physicians in the research network have enrolled nearly 68,000 patients in over 1,500 trials since inception in 1992 and have played a role in nearly 70 FDA-approved cancer therapies, approximately one-third of all cancer therapies approved by the FDA to date. For more information visit https://www.usoncology.com/physicians/clinical-trials. About Epizyme, Inc. Epizyme, Inc. is a clinical-stage biopharmaceutical company committed to rewriting cancer treatment through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy and in relapsed and front-line disease. Using the Company's proprietary platform, Epizyme has pioneered the identification and development of small molecule inhibitors of chromatin modifying proteins (CMPs), such as tazemetostat. CMPs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of CMPs, which can allow cancer cells to grow and proliferate. By focusing on the genetic drivers of cancers, Epizyme's science seeks to match targeted medicines with the specific patients that need it. For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. (the Company) and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; whether the rate of enrollment in the Company’s trials will be increased meaningfully or at all; whether results from clinical studies will warrant meetings with regulatory authorities or submissions for regulatory approval; expectations for regulatory approvals to conduct trials or to market products; whether the Company's cash resources will be sufficient to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the "Risk Factors" section of the Company's most recent Form 10-Q filed with the SEC and in the Company's other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.


Hutson T.E.,Baylor Sammons Cancer Center | Hutson T.E.,Us Oncology Research | Al-Shukri S.,Saint Petersburg State University | Stus V.P.,Municipal Institution Dnipropetrovsk Regional Clinical Hospital Na Ii Mechnikov | And 7 more authors.
The Lancet Oncology | Year: 2013

Background: In previous clinical trials of patients with metastatic renal-cell carcinoma, patients treated with axitinib as second-line therapy had longer median progression-free survival than those treated with sorafenib. We therefore undertook a phase 3 trial comparing axitinib with sorafenib in patients with treatment-naive metastatic renal-cell carcinoma. Methods: In this randomised, open-label, phase 3 trial, patients with treatment-naive, measurable, clear-cell metastatic renal-cell carcinoma from 13 countries were stratified by Eastern Cooperative Oncology Group performance status, and then randomly assigned (2:1) by a centralised registration system to receive axitinib 5 mg twice daily, or sorafenib 400 mg twice daily. The primary endpoint was progression-free survival, assessed by masked independent review committee in the intention-to-treat population. This ongoing trial is registered at ClinicalTrials.gov, NCT00920816. Findings: Between June 14, 2010, and April 21, 2011, we randomly assigned 192 patients to receive axitinib, and 96 patients to receive sorafenib. The cutoff date for this analysis was July 27, 2012, when 171 (59%) of 288 patients died or had disease progression, as assessed by the independent review committee. There was no significant difference in median progression-free survival between patients treated with axitinib or sorafenib (10·1 months [95% CI 7·2-12·1] vs 6·5 months [4·7-8·3], respectively; stratified hazard ratio 0·77, 95% CI 0·56-1·05). Any-grade adverse events that were more common (≥10% difference) with axitinib than with sorafenib were diarrhoea (94 [50%] of 189 patients vs 38 [40%] of 96 patients), hypertension (92 [49%] vs 28 [29%]), weight decrease (69 [37%] vs 23 [24%]), decreased appetite (54 [29%] vs 18 [19%]), dysphonia (44 [23%] vs ten [10%]), hypothyroidism (39 [21%] vs seven [7%]), and upper abdominal pain (31 [16%] vs six [6%]); those more common with sorafenib than with axitinib included palmar-plantar erythrodysaesthesia (PPE; 37 [39%] of 96 patients vs 50 [26%] of 189), rash (19 [20%] vs 18 [10%]), alopecia (18 [19%] vs eight [4%]), and erythema (18 [19%] vs five [3%]). The most common grade 3 or 4 adverse events in patients treated with axitinib included hypertension (26 [14%] of 189 patients), diarrhoea (17 [9%]), asthenia (16 [8%]), weight decrease (16 [8%]), and PPE (14 [7%]); common grade 3 or 4 adverse events in patients treated with sorafenib included PPE (15 [16%] of 96 patients), diarrhoea (five [5%]), and asthenia (five [5%]). Serious adverse events were reported in 64 (34%) of 189 patients receiving axitinib, and 24 (25%) of 96 patients receiving sorafenib. Interpretation: Axitinib did not significantly increase progression-free survival in patients with treatment-naive metastatic renal-cell carcinoma compared with those treated with sorafenib, but did demonstrate clinical activity and an acceptable safety profile. Funding: Pfizer Inc. © 2013 Elsevier Ltd.


Schwartzberg L.S.,The West Clinic | Modiano M.R.,Arizona Clinical Research Center and Arizona Oncology | Chasen M.R.,The Ottawa Hospital Cancer Center | Gridelli C.,San Giuseppe Moscati Hospital | And 5 more authors.
The Lancet Oncology | Year: 2015

Background: Chemotherapy-induced nausea and vomiting is a common side-effect of many antineoplastic regimens and can occur for several days after treatment. We aimed to assess the neurokinin-1 receptor antagonist rolapitant, in combination with a serotonin (5-HT3) receptor antagonist and dexamethasone, for the prevention of chemotherapy-induced nausea and vomiting in patients with cancer after administration of moderately emetogenic chemotherapy or regimens containing an anthracycline and cyclophosphamide. Methods: We conducted a global, randomised, double-blind, active-controlled, phase 3 study at 170 cancer centres in 23 countries. We included patients with cancer aged 18 years or older, who had not received moderately or highly emetogenic chemotherapy before, with a Karnofsky performance score of 60 or higher, and a predicted life expectancy of 4 months or longer. We used an interactive web-based randomisation system to randomly allocate patients to receive either oral rolapitant (one 180 mg dose; rolapitant group) or a placebo that was identical in appearance (active control group) 1-2 h before administration of moderately emetogenic chemotherapy. Patients were stratified by sex. All patients also received granisetron (2 mg orally) and dexamethasone (20 mg orally) on day 1 (except for patients receiving taxanes as part of moderately emetogenic chemotherapy, who received dexamethasone according to the package insert) and granisetron (2 mg orally) on days 2-3. Every cycle was a minimum of 14 days. In up to five subsequent cycles, patients received the same study drug they were assigned in cycle 1, unless they chose to leave the study or were removed at the treating clinician's discretion. Efficacy analysis was done in the modified intention-to-treat population (comprising all patients who received at least one dose of study drug at a study site compliant with Good Clinical Practice [GCP]). The primary endpoint was the proportion of patients achieving a complete response (defined as no emesis or use of rescue medication) in the delayed phase (>24-120 h after initiation of chemotherapy) in cycle 1. This study is registered with ClinicalTrials.gov, number NCT01500226. The study has been completed. Findings: Between March 5, 2012, and Sept 6, 2013, 1369 patients were randomised to receive either rolapitant (n=684) or active control (n=685). 666 patients in each group received at least one dose of study drug at a GCP-compliant site and were included in the modified intention-to-treat population. A significantly greater proportion of patients receiving rolapitant had complete responses in the delayed phase than did those receiving active control (475 [71%] vs 410 [62%]; odds ratio 1·6, 95% CI 1·2-2·0; p=0·0002). The incidence of adverse events was similar in the rolapitant and control groups, with the most frequently reported treatment-related treatment-emergent adverse events being fatigue, constipation, and headache. For cycle 1, the most common grade 3-4 adverse event in the rolapitant versus active control groups was neutropenia (32 [5%] vs 23 [3%] patients). No serious adverse event was treatment-related, and no treatment-related treatment-emergent adverse event resulted in death. Interpretation: Rolapitant in combination with a 5-HT3 receptor antagonist and dexamethasone is well tolerated and shows superiority over active control for the prevention of chemotherapy-induced nausea and vomiting during the 5-day (0-120 h) at-risk period after administration of moderately emetogenic chemotherapy or regimens containing an anthracycline and cyclophosphamide. Funding: TESARO, Inc. © 2015 Elsevier Ltd.


Chasen M.R.,The Ottawa Hospital Cancer Center | Gridelli C.,San Giuseppe Moscati Hospital | Urban L.,Matrahaza Healthcare Center and University Teaching Hospital | Modiano M.R.,Arizona Clinical Research Center and Arizona Oncology | And 6 more authors.
The Lancet Oncology | Year: 2015

Background: Highly emetogenic chemotherapy induces emesis in almost all patients in the absence of prophylaxis. Guidelines recommend use of a neurokinin-1 (NK-1) receptor antagonist in conjunction with a 5-HT3 receptor antagonist and corticosteroid in patients receiving highly emetogenic chemotherapy. We aimed to assess rolapitant, an NK-1 receptor antagonist, for prevention of chemotherapy-induced nausea and vomiting in patients with cancer after administration of cisplatin-based highly emetogenic chemotherapy. Methods: We conducted two global, randomised, double-blind, active-controlled, phase 3 trials (HEC-1 and HEC-2) at 155 cancer centres (76 in HEC-1 and 79 in HEC-2) in 26 countries (17 in HEC-1 and 14 in HEC-2). We enrolled patients with cancer aged 18 years or older, who had not previously been treated with cisplatin, with a Karnofsky performance score of 60 or higher, and a predicted life expectancy of 4 months or longer. We used an interactive web-based randomisation system to randomly assign patients to treatment. Patients were stratified by sex and randomly allocated to either oral rolapitant (180 mg dose; rolapitant group) or a placebo that was identical in appearance (active control group) about 1-2 h before administration of highly emetogenic chemotherapy. All patients received granisetron (10 μg/kg intravenously) and dexamethasone (20 mg orally) on day 1, and dexamethasone (8 mg orally) twice daily on days 2-4. Every cycle was a minimum of 14 days. In up to five subsequent cycles, patients were allowed to receive the same study drug they were assigned in cycle 1, unless removed at the clinician's discretion. Patients could also choose to leave the study at any point. Efficacy analysis was done in the modified intention-to-treat population (comprising all patients who received at least one dose of study drug at a cancer centre compliant with Good Clinical Practice [GCP]). The primary endpoint was the proportion of patients achieving a complete response (no emesis or use of rescue medication) in the delayed phase (>24-120 h after initiation of chemotherapy) in cycle 1. These studies are registered with ClinicalTrials.gov, numbers NCT01499849 and NCT01500213. Both studies have been completed. Findings: Between Feb 21, 2012, and March 12, 2014, 532 patients in HEC-1 and 555 patients in HEC-2 were randomly assigned to treatment. 526 patients in HEC-1 (264 rolapitant and 262 active control) and 544 in HEC-2 (271 rolapitant and 273 active control) received at least one dose of study drug at a GCP-compliant site and were included in the modified intention-to-treat population. A significantly greater proportion of patients in the rolapitant group had complete responses in the delayed phase than did patients in the active control group (HEC-1: 192 [73%] vs 153 [58%]; odds ratio 1·9, 95% CI 1·3-2·7; p=0·0006; HEC-2: 190 [70%] vs 169 [62%]; 1·4, 1·0-2·1; p=0·0426; pooled studies: 382 [71%] vs 322 [60%]; 1·6, 1·3-2·1; p=0·0001). The incidence of adverse events was similar across treatment groups. The most commonly reported treatment-related treatment-emergent adverse events in the rolapitant versus active control groups were headache (three [<1%] vs two [<1%]), hiccups (three [<1%] vs four [<1%]), constipation (two [<1%] vs three [<1%]), and dyspepsia (two [<1%] vs three [<1%]). For cycle 1, the most common grade 3-5 adverse events in patients allocated rolapitant versus active control were neutropenia (HEC-1: nine [3%] vs 14 [5%]; HEC-2: 16 [6%] vs 14 [5%]), anaemia (HEC-1: one [<1%] vs one [<1%]; HEC-2: seven [3%] vs two [<1%]), and leucopenia (HEC-1: six [2%] vs two [<1%]; HEC-2: two [<1%] vs two [<1%]). No serious treatment-emergent adverse events were treatment related, and no treatment-related treatment-emergent adverse events resulted in death. Interpretation: Rolapitant in combination with a 5-HT3 receptor antagonist and dexamethasone is well-tolerated and shows superiority over active control for the prevention of chemotherapy-induced nausea and vomiting during the at-risk period (120 h) after administration of highly emetogenic cisplatin-based chemotherapy. Funding: TESARO, Inc. © 2015 Elsevier Ltd.


THE WOODLANDS, Texas--(BUSINESS WIRE)--US Oncology Research held its 15th Annual Science Forum earlier this fall. The annual meeting for all US Oncology Research affiliated investigators was held in Dallas and highlighted the importance of clinical trials as a treatment option for cancer patients. “A clinical trial saved my life,” said Rhonda Jenkins, breast cancer survivor, clinical trial participant and patient of Texas Oncology, an affiliate of US Oncology Research. Jenkins shared her story with the hundreds of clinical attendees, including investigators and research coordinators. “The best advice I can give to patients is to not turn down a clinical trial if one is available. I received a terminal diagnosis eleven years ago. Because of a trial, I have my life back. I no longer consider myself as having a terminal disease. Plus, participating in a trial allowed me to play a part in hopefully helping future patients fight this disease,” added Jenkins. The Annual Science Forum allows research investigators to discuss and exchange thoughts on the latest scientific approaches and novel treatment strategies. Topics of discussion included: immunotherapy; the oncology care model; early phase trials; proton therapy; genomics; precision medicine; and much more. "This Forum represents an important form of education for all of us in the cutting-edge, ongoing work in basic and clinical research against cancer,” said Daniel Von Hoff, MD, FACP, chief scientific officer, US Oncology Research. “It helps our team craft strategies for the best way to help our patients.” One strategy used by US Oncology Research is its Selected Trials for Accelerated Rollout, or STAR, method. This program quickly opens clinical trials for difficult-to-find patients. When a potential STAR trial patient has been identified, the practice is trained and the study is opened within a two-week timeframe at the location where the patient is expected to be seen. Ultimately, STAR provides the latest in clinical research to the practice where the patient has been identified. “We are truly delivering tomorrow’s treatments today,” said Michael Seiden, MD, chief medical officer, The US Oncology Network and McKesson Specialty Health. “The Annual Science Forum brings together the leadership of US Oncology Research as we both celebrate our accomplishments and look forward to building an even stronger culture of research across our national network of affiliated physicians and research staff.” During the Forum, investigators convened to hear from world renowned speakers on topics and trends in oncology research. The purpose is to continue to be at the cutting edge of research and provide patients in the community setting access to the latest treatments. Roy Herbst, MD, PhD, chief of Medical Oncology and associate director for Translational Research at Yale Cancer Center, was a keynote speaker at the Forum and spoke about novel therapies for lung cancer, including targeted and immuno-therapies. “Collaborating with research investigators across the country on the most recent trends in oncology treatment is extremely important,” said Dr. Herbst. “It is our responsibility as researchers and providers to constantly be in search for the latest and most effective treatment options to improve efficacy and decrease toxicity. It was an honor to be among such passionate and dedicated clinicians and researchers.” “This year's Annual Science Forum really put a charge into our passion for clinical research,” said David Cosgrove, MD, oncologist with Compass Oncology and associate chair of the US Oncology Research Gastrointestinal (GI) Committee. “We heard from impressive speakers involved in cutting-edge science, highlighted recent successes in our field and got great perspective regarding patient communication. The Forum highlighted some of the challenges we will face in clinical research in a community oncology setting in the years ahead, and also provided a robust framework for future success building upon the US Oncology Research model that leads the way in these endeavors. I am excited to be part of this group moving forward.” Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves approximately 60 research sites and nearly 160 locations managing about 300 active trials at any given time. Physicians in the research network have enrolled more than 64,000 patients in more than 1,500 trials since inception in 1992 and have played a role in more than 60 FDA-approved cancer therapies, nearly one-third of all cancer therapies approved by the FDA to date. For more information about US Oncology Research visit https://www.usoncology.com/oncologists/us-oncology-research. To find clinical trials available through US Oncology Research visit http://trialfinder.usoncology.com.


Galsky M.D.,Comprehensive Cancer Centers of Nevada | Galsky M.D.,Us Oncology Research | Vogelzang N.J.,Comprehensive Cancer Centers of Nevada | Vogelzang N.J.,Us Oncology Research
Annals of Oncology | Year: 2010

Background: Once castration resistance is documented and secondary hormone therapy is ineffective, standard treatment of metastatic prostate cancer is docetaxel, with bisphosphonates and radiopharmaceuticals administered to treat bone symptoms. To improve outcomes, numerous studies have evaluated docetaxel in combination with other agents. Here, results for docetaxel-based combination therapy in castration-resistant prostate cancer (CRPC) are reviewed. Materials and methods: Relevant studies were identified in databases of published literature, clinical trials, and conference abstracts using the search terms docetaxel and prostate, with additional searches carried out for identified agents. Results: Numerous classes of agents have been combined with docetaxel in phase II studies in CRPC, including tyrosine kinase inhibitors, antiangiogenic agents, bone-targeted agents, BCL-2 inhibitors, chemotherapies, immunologic agents, and vitamin D analogs. In several cases, promising rates of prostate-specific antigen response, tumor response, and survival have been reported. However, some combinations have caused increased toxicity. Phase III trials with docetaxel plus GVAX or DN-101 were terminated because of lower survival; phase III trials with docetaxel plus bevacizumab, aflibercept, dasatinib, zibotentan, atrasentan, or lenalidomide are ongoing. Conclusions: Docetaxel-based doublet therapy remains an active investigational strategy in CRPC. Further phase III data are awaited to determine whether survival can be extended compared with docetaxel alone. © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


Agarwal N.,University of Utah | Padmanabh S.,University of Utah | Vogelzang N.J.,Us Oncology Research
Clinical Genitourinary Cancer | Year: 2012

Prostate cancer is the leading cause of cancer-related morbidity and mortality in men in the Western world. Use of traditional and newer therapeutic regimens is constrained in terms of tolerance, efficacy, and cross-resistance. There is a need for newer therapies without overlapping mechanisms of action and toxicities to improve the outcome. Advances in the field of immunology and cancer biology have led to an improved understanding of the interactions between the immune system and tumors, propelling the field of cancer vaccines to the forefront of clinical investigation. Recent US Food and Drug Administration approval of sipuleucel-T, an autologous dendritic cell-based vaccine for the treatment of castration refractory prostate cancer, represents a significant advancement in the field of cancer vaccines. However, the overall survival benefits with sipuleucel-T are modest at best, and the field of cancer vaccine therapy is in a continuous state of evolution and expansion. Further improvements are expected to result from the selection of more appropriate tumor antigens, which circumvent immune tolerance, and from the development of more effective immunization strategies aimed at inducing an effective cytotoxic T-cell response. This review summarizes recent developments in the field of immunotherapy in prostate cancer with a focus on dendritic cell vaccines, virus-based vaccines, DNA-based vaccines, cell-based vaccines, peptide-based vaccine and therapies blocking immune checkpoints to break peripheral immune tolerance. © 2012 Elsevier Inc. All rights reserved.


Pal S.K.,City of Hope Comprehensive Cancer Center | Nelson R.A.,City of Hope Comprehensive Cancer Center | Vogelzang N.,Us Oncology Research
PLoS ONE | Year: 2013

Background:Recent phase III studies of targeted agents for metastatic renal cell carcinoma (mRCC) have generated median survival estimates that far exceed those observed during the cytokine era. However, substantial population-based data does not exist to confirm this trend. We sought to determine whether survival has improved for patients with mRCC diagnosed in the era of targeted therapies, as compared to the era of immunotherapy.Methods:The Surveillance, Epidemiology, and End Results (SEER) Registry was used to identify patients aged 18 and older diagnosed stage IV RCC between 1992 and 2009. Patients had documented clear cell, papillary or chromophobe histology. The Kaplan Meier method and log-rank test were used to compare disease-specific survival (DSS) for patients diagnosed from 1992-2004 (i.e., the cytokine era) and 2005-2009 (i.e., the targeted therapy era). Univariate and multivariate analyses of relevant clinicopathologic characteristics were also performed.Results:Of 5,176 patients identified using the above characteristics, 2,392 patients were diagnosed from 1992-2004 and 2,784 from 2005-2009. Median DSS was improved in those patients diagnosed from 2005-2009 (16 months vs 13 months; P<0.0001). A similar temporal trend towards improving survival was noted in patients with clear cell (P = 0.0006), but not in patients with non-clear cell disease (P = 0.32). Notable findings on multivariate analysis include an association between shorter DSS and the following characteristics: (1) diagnosis from 1992-2004, (2) advanced age (80+), and (3) absence of cytoreductive nephrectomy.Conclusions:These data reflect progress in the management of mRCC, specifically in the era of targeted therapies. Notably, it was inferred that certain treatment strategies were employed during pre-specified time periods, representing a major caveat of the current analysis. Further studies related to the influence of age and race/ethnicity are warranted, as are studies exploring the role of cytoreductive nephrectomy and novel treatments for non-clear cell disease. © 2013 Pal et al.

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