News Article | May 1, 2017
Although Journal of the American College of Surgeons study shows better care at high-volume surgical centers for patients with pancreatic or thyroid cancer, few patients travel for their cancer operations CHICAGO (May 1, 2017): New study findings link traveling to an academic medical center for surgical removal of pancreatic or thyroid cancer with higher quality surgical care for both cancers, and longer survival for patients with pancreatic cancer compared with patients who receive treatment at a hospital closer to home. Despite the advantages, few patients with these cancers travel within the United States for their cancer operations, according to the authors of the study, which is published online as an "article in press" on the Journal of the American College of Surgeons website in advance of print publication. "Little was known about whether traveling to receive surgical cancer care results in differences in perioperative outcomes and overall survival," said senior investigator Raymon H. Grogan, MD, FACS, assistant professor of surgery at the University of Chicago Medicine. "Yet, there is a well-established relationship between a surgeon's high volume of operations and patients' improved outcomes for pancreatic and thyroid cancer, and most high-volume surgeons in the United States practice in metropolitan settings and academic referral medical centers. "We wanted to know: if you live in a rural area, does it benefit you to travel to a high-volume academic medical center for your cancer operation?" To understand the effect of travel on the overall survival rate and quality of care, Dr. Grogan and co-investigators focused on two types of cancer with different chances for cure. One, papillary thyroid cancer, is the most frequent type of thyroid cancer and is usually slow growing and its treatments are associated with a low complication rate. The other, the most common form of cancer of the pancreas, pancreatic ductal adenocarcinoma, tends to be aggressive with a much worse survival rate. Using patient records entered into the National Cancer Database (NCDB), the authors analyzed data for 105,677 patients with papillary thyroid cancer and 22,983 patients with pancreatic ductal adenocarcinoma. This database is cosponsored by the American College of Surgeons and the American Cancer Society and includes information on approximately 75 percent of all newly diagnosed cancer cases in the United States. In this proof-of-concept study, the investigators employed a new method of defining travel using data available in the NCDB and the U.S. Census Bureau. They determined the average area of a county in square miles, for metropolitan, urban, and rural areas (from largest to smallest population) in each of the nine national regions described by the Census Bureau.* The researchers considered patients to have traveled for cancer care if the shortest distance from home to treatment center was greater than either the square root of the area of their county if they lived in metropolitan areas or metropolitan-adjacent counties or twice the square root of area of their county if they lived in a county that was not adjacent to a metropolitan area. The minimum distance for patients who traveled ranged from 20 to 84 miles, the investigators found. Patients residing in the Pacific and Mountain Regions were excluded from analysis because of discordant travel lengths compared with other regions, according to the article. Travel correlated with receiving care at an academic (university-affiliated) medical center, said Michael G. White, MD, the study's lead author and a general surgery resident physician at the University of Chicago Medicine. Among patients with pancreatic cancer, those living in rural and urban areas who traveled to an academic medical center for their care had longer overall survival compared with patients who underwent cancer operations near their home communities, the researchers reported. Overall survival is a measure of the length of time from a person's cancer diagnosis to the time of his or her death, regardless of the cause of death.. Patients with this aggressive pancreatic cancer lived two months longer on average if they traveled for care, Dr. Grogan reported. Additionally, patients who traveled for care were more likely to have lymph node dissection, which is removal of selected lymph nodes for examination for cancer. This surgical approach is the standard of care for pancreatic cancer that can be removed surgically, Dr. White said. Patients who traveled also had better rates of clear margins--no microscopic evidence of cancer remaining in the tissues around the removed tumor. As expected, the researchers found no survival differences by travel in patients with thyroid cancer, which Dr. Grogan said has an average five-year survival rate of 97 percent. Importantly, however, patients who traveled were more likely to receive care that followed cancer treatment guidelines from the American Thyroid Association and the National Comprehensive Cancer Network, an indicator of quality of care, he stated. "Our data do not necessarily show that patients who don't travel for cancer care receive suboptimal care," Dr. Grogan stressed. "Rather, patients who travel more often receive the gold standard care - care that more often conforms with evidence-based recommendations." Yet, only 9 percent of patients with thyroid cancer and approximately 25 percent of pancreatic cancer patients traveled for their surgical care, the data showed. Dr. Grogan said, "Although we found that travel is associated with better outcomes, the vast majority of these cancer patients are not traveling for their care." From the data, he said they cannot conclude why most patients opt to not travel for their cancer operations or what impact the local physicians' referral patterns have on patients' decision making. In the case of why more pancreatic cancer patients travel then thyroid cancer patients, Dr. White speculated, "Poorer survival rates for pancreatic cancer may drive the choice to travel to a medical center that performs a higher volume of these operations." Noting that lengthy travel to a cancer treatment center may have disadvantages as well as the observed advantages, Dr. Grogan said their study gives patients with cancer more information to decide what is important to them. Whether patients travel for surgical cancer care or not, he recommended that they ask their surgeon two important questions: "How many of these operations do you perform each year? What is your complication rate when performing this operation?" Other co-authors were Edwin L. Kaplan, MD, FACS; Peter Angelos, MD, PhD, FACS; and Dezheng Huo, MD, PhD, from the University of Chicago and Megan K. Applewhite, MD, of Albany Medical College, Albany, N.Y. "FACS" designates that a surgeon is a Fellow of the American College of Surgeons. This study received funding from the National Institutes of Health's National Cancer Institute (K12CA139160 to Raymon H Grogan). The study was presented in November 2016 at the Western Surgical Association 124th Scientific Session in Coronado, Calif. Citation: A Tale of Two Cancers: Traveling to Treat Pancreatic and Thyroid Cancer. Journal of the American College of Surgeons. DOI: http://dx. . * US Census Bureau. Census regions and divisions of the United States. Available at: https:/ . Accessed April 12, 2017. About the American College of Surgeons The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 80,000 members and is the largest organization of surgeons in the world. For more information, visit http://www. .
News Article | May 2, 2017
Researchers in Texas have released a new report summarizing the growing body of encouraging studies on anti-angiogenesis drugs like bevacizumab in the treatment of malignant mesothelioma. Surviving Mesothelioma has just published an article on the report. Click here to read the details. A pair of doctors from the University of Texas Southwestern Medical Center summarized the findings of multiple studies on bevacizumab and other drugs that inhibit the formation of blood vessels in mesothelioma tumors. Writing in the journal OncoTargets and Therapy, they conclude that these drugs not only help fight pleural mesothelioma tumors by choking off their blood supply, but that they may fight the asbestos cancer in another way, as well. “Emerging evidence also suggests that VEGF may suppress T-cell-mediated immune response, and therefore, anti-VEGF therapies may augment the effect of immunotherapy in cancer,” write Pavel Levin, MD, PhD, and Jonathan Dowell, MD, of the University of Texas Southwestern Medical Center, authors of the new report. “We have been watching the news on Avastin closely, especially since the National Comprehensive Cancer Network guidelines added it as a possible first-line mesothelioma treatment last year, along with pemetrexed and cisplatin,” says Alex Strauss, Managing Editor for Surviving Mesothelioma. To learn more about how bevacizumab works and why it is not an appropriate treatment choice for every mesothelioma patient, see VEGF-Inhibitor Looks Promising for Malignant Mesothelioma, now available on the Surviving Mesothelioma website. Levin, PA, and Dowell, JE, “Spotlight on bevacizumab and its potential in the treatment of malignant pleural mesothelioma: the evidence to date”, April 7, 2017, OncoTargets and Therapy, 2057-2066, https://www.dovepress.com/spotlight-on-bevacizumab-and-its-potential-in-the-treatment-of-maligna-peer-reviewed-fulltext-article-OTT For more than a decade, Surviving Mesothelioma has brought readers the most important and ground-breaking news on the causes, diagnosis and treatment of mesothelioma. All Surviving Mesothelioma news is gathered and reported directly from the peer-reviewed medical literature. Written for patients and their loved ones, Surviving Mesothelioma news helps families make more informed decisions.
News Article | April 17, 2017
Hypertension, or high blood pressure, may come with a plus side, at least for a subset of women with ovarian cancer. New research from epidemiologists at Roswell Park Cancer Institute, published in the journal Cancer Causes & Control, provides evidence that hypertension and diabetes and the use of medications to treat these common conditions may influence the survival of ovarian cancer patients — sometimes in a detrimental way, but in the case of hypertension medications, perhaps as a benefit. Using pooled data from 15 studies that were part of the Ovarian Cancer Association Consortium, an international team of collaborators led by Kirsten Moysich, PhD, MS, and Albina Minlikeeva, PhD, MPH, retroactively examined the associations between survival among patients diagnosed with invasive epithelial ovarian cancer and those patients’ history of hypertension, heart disease, diabetes, and medications taken for those conditions. They found that while a history of diabetes was associated with a 112% higher risk of mortality across more than 7,600 cases, no significant mortality associations were observed for hypertension or heart disease. In fact, the authors report, among women with endometrioid ovarian cancer, a subtype of epithelial ovarian cancer typically associated with better outcomes, hypertension — a condition that applied to nearly 26% of women in the pooled analysis — was associated with 46% lower risk of ovarian cancer progression. “This is a coincidental and unintended consequence of hypertension and its treatment, but it’s a silver lining to a serious but largely manageable medical condition that has reached epidemic prevalence in the U.S. and many other countries worldwide,” says Dr. Moysich, Distinguished Professor of Oncology in the departments of Cancer Prevention and Control and Immunology at the Buffalo cancer center. This study is the first to highlight the role of comorbidities in relation to ovarian cancer survival by histological subtype, and confirmed previous findings linking a history of diabetes to increased risk of death among ovarian cancer patients. It’s possible that commonly prescribed antihypertensive medications, including beta blockers, may influence the growth of ovarian tumors. But the team also documented a higher overall risk of death for patients who had ever taken beta blockers, and notes that further study is needed to better understand these processes and interactions. “Our results suggest that it is important to investigate factors that explain the difference in cancer outcomes among women with different types of ovarian cancer. Most studies only consider clinical characteristics at diagnosis, such as stage and histology in relation to ovarian cancer prognosis,” adds Dr. Minlikeeva, a postdoctoral Research Affiliate with Roswell Park’s Department of Cancer Prevention and Control. “Our findings emphasize the importance of understanding the full clinical profile for women with ovarian cancer in order to predict ovarian cancer outcomes.” Approximately 22,300 new cases of ovarian cancer are diagnosed each year in the U.S., with an estimated 14,200 women dying from the disease each year. Endometrioid carcinoma accounts for about 20% of all epithelial ovarian cancers. The study, “History of hypertension, heart disease, and diabetes and ovarian cancer patient survival: evidence from the ovarian cancer association consortium,” is available at link.springer.com. This work was funded in part by grants and contracts from the National Cancer Institute (project nos. K07CA080668, K07CA095666, K22CA138563, N01CN55424 P30CA072720, P50CA105009, P50CA159981, R01CA074850, R01CA080742, R01CA095023, R01CA112523, R01CA126841, R01CA188900, R01CA54419, R01CA58598, R01CA61107, R01CA76016, R01CA87538, R25CA113951 and T32CA108456), National Library of Medicine (project no. K01LM012100), Division of Cancer Control and Population Sciences (project no. N01PC67001) and Roswell Park Alliance Foundation. A full list of funders is available in the Acknowledgments section at that link. For an online version of this release, please visit: https://www.roswellpark.org/media/news/epidemiological-analysis-shows-unexpected-benefit-related-high-blood-pressure-many The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci(at)roswellpark(dot)org. Follow Roswell Park on Facebook and Twitter.
News Article | April 17, 2017
New research led by a radiation oncologist at Roswell Park Cancer Institute indicates that less may be more when it comes to some forms of radiation therapy for cancer. In a presentation highlighted in a plenary session today at the Multidisciplinary Thoracic Cancers Symposium in San Francisco, California, Anurag Singh, MD, shared updated evidence that patients receiving stereotactic body radiation therapy (SBRT) as treatment for non-small cell lung cancer (NSCLC) benefit as much from a single fraction, or dose, of radiation as they would from the standard three-dose treatment schedule — and with significant advantages in terms of convenience for patients and caregivers. Used as an alternative to surgery for some patients with solid-tumor cancers, SBRT allows oncologists to deliver radiation therapy, or radiotherapy, in briefer, higher-intensity doses and with more precise targeting of the tumor compared to standard radiotherapy. Dr. Singh is first author on the presentation of updated results from a randomized phase II clinical study conducted in collaboration with researchers from the Cleveland Clinic and SUNY Upstate Medical University. The study involved 98 patients treated for locally controlled peripheral NSCLC, or tumors located along the outside edges of the lung, between 2008 and 2015. While findings from this work were first presented at the American Society for Radiation Oncology 2016 Annual Meeting in September, this latest analysis reports data based on a longer follow-up interval (two years). The research team found that overall survival at two years was 72% for patients treated with a single dose of 30 grays (Gy) of radiation compared to 59% for those who received 60 Gy total delivered through three 20-Gy doses. Incidence and severity of adverse events was similar for the two groups of patients, with 14 (29%) of patients treated on the one-dose 30-Gy schedule experiencing side effects of grade 3 or higher, compared to 17 (35%) of those receiving three 20-Gy doses. “Our study is the first to show that one fraction of SBRT, a ‘one and done’ treatment approach, is as good as three fractions for early-stage lung cancer in terms of survival and toxicity,” notes Dr. Singh. “We’ve shown that we can cut patients’ total radiation exposure in half without any reduction in efficacy or impact, but with notable benefits in terms of convenience for patients because their treatment was consolidated into a single visit.” Funding for this research was provided by the Roswell Park Alliance Foundation, the Cleveland Clinic and Upstate Medical University. Jointly sponsored by the American Society for Radiation Oncology, American Society of Clinical Oncology and The Society of Thoracic Surgeons, the Multidisciplinary Thoracic Cancers Symposium is an annual gathering of oncology specialists focused on research and treatment in lung cancer and other thoracic cancers. The meeting started today and continues through March 18. For an online version of this release, please visit: https://www.roswellpark.org/media/news/updated-data-sbrt-radiation-nsclc-lung-cancer-confirm-benefits-one-and-done-approach Editor’s note: See a video interview with Dr. Anurag Singh, lead author on this research, at https://www.youtube.com/watch?v=Upswp7pEySU The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci(at)roswellpark(dot)org. Follow Roswell Park on Facebook and Twitter.
News Article | March 1, 2017
FORT WASHINGTON, Pennsylvania, 1. März 2017 /PRNewswire/ -- Das National Comprehensive Cancer Network® (NCCN®) hat mithilfe von Finanzierung durch die NCCN Foundation® und die Kidney Cancer Association die deutsche Übersetzung der NCCN Guidelines for Patients®: Nierenkrebs veröffentlicht. Die NCCN Guidelines for Patients® [NCCN Leitlinien für Patienten] sind patientenfreundliche Anpassungen der NCCN Leitlinien für die klinische Praxis, die von Gesundheitsexperten in der ganzen Welt für die Bestimmung der besten Behandlungsmöglichkeiten von Krebspatienten verwendet werden. Sie enthalten unvoreingenommene fachkundige Anleitungen von Krebszentren in den USA, die Menschen dabei unterstützen sollen, mit ihren Ärzten über die besten Optionen für die Behandlung ihrer Krankheit zu sprechen. „Wir sind stolz, nun auch die deutsche Übersetzung der NCCN Guidelines for Patients®: Nierenkrebs vorstellen zu können. Der Zugriff auf leicht verständliche Behandlungsinformationen erlaubt es Patienten mit Nierenkrebs, informierte Entscheidungen über ihre Behandlung zu treffen", sagte Marcie R. Reeder, MPH, Executive Director der NCCN Foundation. Die NCCN Guidelines for Patients sind in leicht verständlicher Sprache verfasst und schließen patientenfreundliche Elemente ein, wie z. B. Fragen, die man seinem Arzt stellen sollte, ein Begriffsglossar und medizinische Illustrationen. Die deutsche Übersetzung der NCCN Guidelines for Patients®: Nierenkrebs kann von NCCN.org/patients und mit der mobilen App NCCN Patient Guides for Cancer heruntergeladen werden. Informationen über die Druckversion finden Sie unter NCCN.org/patients. Über NCCN Das National Comprehensive Cancer Network® (NCCN®) ist eine gemeinnützige Vereinigung von 27 weltweit führenden Krebszentren, die sich der Patientenbetreuung, Forschung und Bildung widmen. Es arbeitet an der Verbesserung der Qualität, Wirksamkeit und Effizienz der Krebsbetreuung, damit Patienten ein besseres Leben führen können. Unter der Leitung und mithilfe des Fachwissens von Klinikexperten der Mitgliederinstitutionen des NCCN entwickelt die NCCN Ressourcen, die den zahlreichen Stakeholdern in den Gesundheitsversorgungssystemen wertvolle Informationen bereitstellen. Als Vermittler bei hochqualitativer Krebsbetreuung unterstützt das NCCN die Bedeutung laufender Qualitätsverbesserung und ist sich der Bedeutung der Schaffung von Leitlinien für die klinische Praxis bewusst, die für die Verwendung durch Patienten, Kliniker und andere Entscheidungsträger im Gesundheitswesen angebracht sind. NCCN.org. Über die NCCN Foundation Die NCCN Foundation® wurde vom NCCN gegründet, um Menschen mit Krebs zu befähigen und fortschrittliche Innovation in der Onkologie zu fördern. Die NCCN Foundation unterstützt Menschen mit Krebs und ihre Betreuer während aller Phasen der Behandlung. NCCNFoundation.org Über die Kidney Cancer Association Die Kidney Cancer Association [Nierenkrebsvereinigung] ist eine wohltätige, nationale Organisation, die sich aus Patienten, Familienmitgliedern, Ärzten, Forschern und anderen Gesundheitsexperten zusammensetzt. Sie bietet ein breites Spektrum von Dienstleistungen an, darunter Patientenvertretung, Unterstützung sowohl öffentlicher als auch privater Forschung, Informationen und Bildung. KidneyCancer.org
News Article | February 15, 2017
LONDON--(BUSINESS WIRE)--Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) and AstraZeneca PLC (“AstraZeneca”) will present data from the ongoing Phase II clinical trial of savolitinib in patients with papillary renal cell carcinoma (“PRCC”) at the 2017 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology (“ASCO-GU”), to be held in Orlando, Florida from February 16 to 18, 2017. Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, has shown early clinical benefit in multiple Phase I and II studies in a number of cancers. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity. PRCC, the second most common histologic subtype of renal cell carcinoma (“RCC”), is associated with alterations in the c-Met gene (e.g. mutations, amplifications, and/or chromosomal changes). Therapies that are currently available for RCC patients have demonstrated only modest benefit in PRCC and there are no therapies specifically approved for the treatment of c-Met-driven PRCC. National Comprehensive Cancer Network guidelines recommend enrolling patients in clinical trials for first-line systemic therapy. “There is a clear unmet medical need in PRCC,” said Toni Choueiri, Director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. “The dataset from this Phase II study is compelling, with a very clear efficacy signal in MET-driven patients and an encouraging long duration of response, while remaining very well tolerated.” He added, “These results support the initiation of the pivotal Phase III trial in a selected population of MET-driven PRCC. This innovative patient selection approach would be the first ever molecularly selected trial in renal cell carcinoma.” “We are delighted to report this highly encouraging progression-free survival data in Met-driven papillary renal cell carcinoma, a disease with no approved treatment options,” said Christian Hogg, Chief Executive Officer of Chi-Med. “With development of the companion diagnostic assay to screen Met-driven disease now also complete we are preparing for the initiation of our global Phase III study, the first global registration trial for savolitinib.” The current Phase II trial is the largest prospective clinical study ever conducted in PRCC patients. It is a global single arm study of savolitinib in 109 patients with locally advanced or metastatic PRCC and was initiated in May 2014. It is being conducted in 22 clinical centers in the US, Canada, UK, and Spain, and completed enrollment in October 2015. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02127710. The most recent results of the study will be presented in detail as follows: Once presented, the presentation will be available at www.chi-med.com/news. Further information about ASCO-GU is available at gucasym.org. Chi-Med and AstraZeneca are currently initiating a global pivotal Phase III trial, the first pivotal study ever conducted in c-Met-driven PRCC and the first molecularly selected trial in RCC. Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-Met alterations and patient outcomes, including any predictive biomarkers. A single-arm biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer (PRCC) 1Dana-Farber Cancer Institute, Boston, US 2Fox Chase Cancer Center, Philadelphia, US 3Sarah Cannon Research Institute, London, UK 4MD Anderson Cancer Centre, Houston, US 5Tom Baker Cancer Center, Calgary, Canada 6Barts Cancer Institute, London, UK 7AstraZeneca, Waltham, US, 8AstraZeneca, Cambridge, UK 9Institute Gustave Roussy, Paris, France 10City of Hope, Duarte, US Background: Savolitinib (HMPL-504/Volitinib, AZD6094) is a potent, selective mesenchymal epithelial transition (“MET”) inhibitor (IC of 4 nM). MET and its ligand, hepatocyte growth factor (“HGF”), are known to play an important role in the molecular events underlying oncogenesis in PRCC, a disease without a clear standard of care and marked by alterations of chromosome 7 (containing both MET and HGF genes) in a majority of patients as well as gene amplification or MET kinase domain mutations (Albiges et al 2014, Linehan et al, 2015). Methods: This study evaluates savolitinib in PRCC patients dosed at 600 mg daily until disease progression. Objective Response Rate (“ORR”) is the primary endpoint. Progression-Free Survival (“PFS”) & Duration of Response are secondary endpoints. Patient Reported Outcome (“PRO”) and Health-Related Quality of Life (“HRQoL”) questionnaires are exploratory endpoints. Eligibility includes naïve and previously treated metastatic PRCC, ECOG PS 0 or 1. Archival tumor was used to centrally confirm PRCC pathology post hoc and to determine MET status using Next Generation Sequencing (Foundation Medicine Inc, US). Results: As of 27 June 2016, 109 patients were dosed. Best response was PR n=8, SD n=43, PD n=48 & 10 patients were not evaluable for response. 44 patients are MET-driven (MET/HGF gene copy number gain or kinase domain mutations), 46 patients were MET-negative, 19 patients are status unknown. MET-driven pts included Papillary Type I & II histologies. All 8 responders were in the MET-driven group, 18% ORR in this subset. Median PFS in the MET-driven group was 6.2 months (95% CI: 4.1–7.0) vs. 1.4 months (95% CI: 1.4–2.7) in the MET-negative group (p=0.002). Overall 10/109 patients had adverse events (“AEs”) leading to discontinuation. 23/109 patients had ≥ Grade 3 toxicity related to savolitinib. The most common AEs (all grades) includes: nausea (39%), fatigue (27%), edema (18%) and abnormal liver function tests (LFTs) (17%). One death from hepatic encephalopathy was considered related to savolitinib. PRO & HRQoL data was not statistically analyzed, descriptive data support main efficacy findings. Conclusions: In the largest biomarker-profiled trial dedicated to PRCC, savolitinib was generally well tolerated with anti-tumor activity in MET-driven patients. These findings warrant further clinical investigation of savolitinib in MET-driven PRCC. About the Unmet Medical Need in c-Met-Driven PRCC Patients Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually, and the total market for kidney cancer treatments is expected to reach US$4.5 billion in 2020, according to Frost & Sullivan. RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics. Among these histologic variants of RCC, clear cell RCC (“ccRCC”) is the most common, accounting for 75-80% of RCC. PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC. The proportion of PRCC patients whose tumors are c-Met-driven has historically been estimated at 40-70%. In the largest study to date, presented at the annual meeting of the American Association for Cancer Research 2014, analysis of 220 frozen tumor samples catalogued in the French RCC Network indicated that 55-60% of PRCC patients showed gains in Chromosome 7 (i.e. c-Met amplification). The biology and molecular characteristics of PRCC are different from those of ccRCC. This results in significantly worse prognosis and treatment outcomes for patients with PRCC when compared to patients with ccRCC. Highlighting the unmet need is the fact that, although there are several drugs approved for use in RCC (the latest being approved in April 2016), these approvals were generally on the basis of studies conducted with a preponderance of ccRCC patients. The need for different agents and more specific data tailored to the PRCC disease setting has been identified as a critical gap in the care of these patients. Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare-related consumer products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China. Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com. AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology. By harnessing the power of four scientific platforms – Immuno-Oncology, the genetic drivers of cancer and resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death. AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib in PRCC, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate savolitinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of savolitinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the US Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
News Article | March 1, 2017
SAINT-GENIS-POUILLY, France, March 01, 2017 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or the “Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that its product NETSPOT® (gallium Ga 68 dotatate) has been included in the National Comprehensive Cancer Network® (“NCCN”) Clinical Practice Guidelines in Oncology version 1.2017 update for the evaluation of neuroendocrine tumors (“NETs”). NCCN® is a not-for-profit alliance of leading cancer centers in the U.S. that produces authoritative guidelines for oncology physicians for the treatment of all major malignancies, and for their detection, prevention, risk reduction and associated supportive care. Eric Liu, MD, FACS, neuroendocrine tumor surgeon and Co-Director, The Neuroendocrine Institute at Rocky Mountain Cancer Center and HealthOne, stated, “As a physician that sees more than 400 patients with NETs per year, I am very grateful to have NETSPOT® available and included in the NCCN Guidelines®. This advance in imaging capability provides treating physicians with enormous insights, enabling better directed surgeries and enhanced decision making regarding different therapeutic options. Ultimately, I believe the use of NETSPOT® will lead to improved outcomes for patients.” Lale Kostakoglu, MD, MPH, Chief, Nuclear Medicine and Molecular Imaging, at the Icahn School of Medicine at Mount Sinai, stated, “We, as molecular imagers, are very pleased to see this valuable imaging modality be finally integrated into a national management algorithm for neuroendocrine tumors. The ability to image these patients with this compound is crucial to the success of any molecular imaging program. I believe this technology will lead to significant changes in patient management and will guide decisions for targeted therapies.” Stefano Buono, Chief Executive Officer of AAA said, “We are pleased to see NETSPOT® acknowledged by NCCN® as a clinically relevant tool for the evaluation of patients with NETs. The inclusion of NETSPOT® in the NCCN Guidelines® for NETs should facilitate coverage from private payors and increase access for many patients. The NET community has been very supportive of the innovation NETSPOT® brings and it is our goal to make it available in as many markets as possible.” NETSPOT® was approved by the US Food and Drug Administration (“FDA”) on June 1, 2016, 23 months from the first pre-Investigational New Drug meeting with the Agency. AAA and its radiopharmacy partners around the U.S. are now delivering 400 doses of NETSPOT® per month. The company is seeking to grow its network of radiopharmacy partners from 20 sites to more than 40 sites over the first half of 2017. In December 2016, the Centers for Medicare & Medicaid Services (“CMS”) granted NETSPOT® Transitional Pass-Through status under an “A-code” (A9587) for drug reimbursement, effective January 1, 2017. Additionally, the same Healthcare Common Procedure Coding System (“HCPCS”) “A Code” will be used on claims to private payers. NETSPOT®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. There are no Contraindications for use. Warnings and Precautions include Ga 68 dotatate contributing to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. The safety of Ga 68 dotatate was evaluated in three single center studies and in a survey of the scientific literature. No serious adverse reactions were identified. NETSPOT® is available in two forms: As a drug kit for reconstitution using a Ga 68 generator, and as a ready-to-use injection delivered from local radiopharmacies in select metropolitan areas. The kit has been designated as an orphan drug by the EMA and the FDA. For full prescribing information for NETSPOT® please refer to: http://go.usa.gov/cSywA. Advanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. AAA’s lead investigational therapeutic candidate, Lutetium Lu 177 Dotatate (Lutathera®), is a novel MNM compound that AAA is currently developing for the treatment of Neuroendocrine Tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 22 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has 500 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, U.S. and Canada). AAA reported sales of €88.6 million in 2015 (+27% vs. 2014) and sales of €81.3 million for the first 9 months of 2016 (+23% vs. 9 months 2015). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com. This press release may contain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for Lutetium Lu 177 Dotatate and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of Lutetium Lu 177 Dotatate and our other products or product candidates; our estimates regarding the market opportunity for Lutetium Lu 177 Dotatate, our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the U.S.; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory actions or litigations; and general economic, political, demographic and business conditions in Europe, the U.S. and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
News Article | February 28, 2017
Specific dairy foods may influence breast cancer risk in women, although risk varies by the source of the dairy product, according to a study published online ahead of print in the journal Current Developments in Nutrition. Researchers at Roswell Park Cancer Institute report that while high overall consumption of dairy products, and in particular of yogurt, is linked to a lower risk for breast cancer, high intake of American, cheddar and cream cheeses was associated with a slightly increased risk for breast cancer. The case-control study examined the association between the types and quantity of dairy foods consumed among 1,941 women diagnosed with breast cancer and 1,237 control participants in the Roswell Park Data Bank and BioRepository between 2003 and 2014. Participants’ usual intake of dairy foods was identified using a self-administered food frequency questionnaire and grouped into monthly intakes of total dairy, milk, yogurt, low-fat cheese, other cheese and sweet dairy products. The study adjusted for age, race, body-mass index, menopausal status, energy intake, type of milk usually consumed, cigarette smoking status and family history of breast cancer. “Dairy foods are complex mixtures of nutrients and non-nutrient substances that could be negatively as well as positively associated with breast cancer risk. Future studies are needed to confirm the protective potential of yogurt in this type of cancer,” says the lead author of the study, Susan McCann, PhD, RD, Professor of Oncology in the Department of Cancer Prevention and Control at Roswell Park. “This study of the differences among women and their consumption of dairy products offers significant new understanding into the potential risk factors associated with breast cancer,” says senior author Christine Ambrosone, PhD, Senior Vice President for Population Sciences and Chair of the Department of Cancer Prevention and Control. “While diet is thought to be responsible for 30% of all cancers, we hope that further research will help us to more fully understand which food products are most valuable in terms of reducing risk for this disease.” This research was supported, in part, by a grant from the National Cancer Institute (award no. P30CA016056). The study, “Usual consumption of specific dairy foods is associated with breast cancer in the Roswell Park Cancer Institute Data Bank and BioRespository,” is available at cdn.nutrition.org. For an online version of this release, please visit: https://www.roswellpark.org/media/news/dairy-intake-may-impact-risk-breast-cancer-reports-roswell-park-team The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci(at)roswellpark(dot)org. Follow Roswell Park on Facebook and Twitter.
News Article | March 2, 2017
Not intended for UK- or US-based media Merck, a leading science and technology company, announced today that the UK National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Determination (FAD) recommending the routine National Health Service (NHS) use of Erbitux® (cetuximab) in combination with either FOLFIRI or FOLFOX as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer (mCRC). Erbitux has long been established and reimbursed as a first-line standard-of-care treatment option in most European countries and many other countries worldwide. "The NICE decision is great news for patients and their families in England, as it now means they will have access to this effective first-line treatment," said Maya Martinez-Davis, Global Head of Oncology Franchise for Merck's biopharma business. "Our efforts in working with NICE to reach this important milestone are part of our relentless commitment to bringing tailored, effective therapies to patients worldwide." This decision expands the previous NICE recommendation, which endorsed the use of Erbitux in combination with either FOLFOX or FOLFIRI solely for patients whose cancer had spread only to the liver (liver-limited disease). It is based on robust data from Phase III clinical studies having demonstrated that Erbitux in combination with either FOLFIRI,, or FOLFOX,,, as a first-line treatment for patients with RAS wild-type mCRC, confers significant benefit in patient outcomes. "Patients with metastatic colorectal cancer in the UK have very limited access to effective first-line treatments," said Jola Gore-Booth, Founder/CEO of the colorectal cancer patient advocacy group, EuropaColon. "We are therefore delighted with NICE's decision, as it means there is now more choice for patients in England regarding treatment options that they can benefit from." Both the European Society for Medical Oncology and the US National Comprehensive Cancer Network clinical guidelines also recommend first-line treatment with Erbitux, in combination with either FOLFOX or FOLFIRI, for patients with RAS wild-type mCRC., Erbitux has obtained marketing authorization in over 90 countries worldwide. To date, more than 480,000 patients with mCRC have been treated with Erbitux. For further information and press materials please visit http://www.merckgroup.com/media-center-oncology. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. By publishing a Final Appraisal Determination (FAD), the National Institute for Health and Care Excellence (NICE) has made final recommendations on how Erbitux with FOLFOX/FOLFIRI should be used in the NHS. If there are no successful appeals, the final recommendations will be issued as NICE guidance. Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors. Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux® (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.- Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually. An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer. Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women. Erbitux® is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe. Erbitux has already obtained market authorization in over 90 countries world-wide for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of Euro12.85 billion in 66 countries. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
News Article | March 2, 2017
HOUSTON--(BUSINESS WIRE)--Radiologists from Synergy Radiology Associates (SRA) are now treating Houston-area patients with colon cancer that has spread to the liver, using an advanced treatment for inoperable liver tumors. Originally indicated for inoperable liver cancer, new national cancer guidelines allow for the use of Selective Internal Radiation Therapy (SIRT) in patients with liver dominant, chemotherapy resistant colorectal disease. “This treatment offers new hope to patients suffering from this difficult disease,” said SRA interventional radiologist Michael Richter, M.D. “For radiologists, this updated guideline means we have another tool in our arsenal for treating a very challenging cancer diagnosis.” SIRT is an interventional radiology procedure that delivers millions of tiny, radioactive SIR-Spheres® microspheres through blood vessels directly to the tumor site. Developed by Sirtex Medical Limited (ASX: SRX), SIR-Spheres is now included as a Category 2A recommended treatment in the latest National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for colon cancer and rectal cancer. “SIRT is an important part of a multidisciplinary approach to liver cancer that can help improve quality of life with fewer side effects, and we’re excited to make it available to area patients,” said SRA President Walid Adham, M.D. “We will continue to look at new treatments that provide advantages over current treatments that can benefit our referring physicians and their patients.” SIR-Spheres microspheres are the only fully FDA-approved microspheres for colorectal cancer that has metastasized to the liver. The NCCN Category 2A designation means there is uniform consensus among the NCCN panel that SIRT with yttrium-90 (Y-90) microspheres is an appropriate option in chemotherapy resistant patients whose colorectal disease has spread to the liver. The recommendation also places SIR-Spheres on par with recommended metastatic colon cancer chemotherapy treatments. SRA radiologists are now performing the procedure at Memorial Hermann The Woodlands Hospital, Memorial Hermann Southwest Hospital, and Memorial Hermann Southeast Hospital. Most patients are usually able to go home four to six hours after the procedure, and the reported side effects are few. Patients experience mild, flu-like symptoms for a period of one to two weeks after the procedure. SIRT can be used for primary liver cancers as well as metastatic disease in the liver, including colorectal and breast cancer. For more information on SIRT and other minimally invasive procedures, visit our Y-90 informational page. Physician practices interested in learning more about Y-90 radioembolization should contact the Synergy Radiology interventional team at 713-897-5853. Formed in 2011 through the convergence of Houston’s top three radiology groups, Synergy Radiology Associates is the largest private radiology practice in the Houston metropolitan area. The SRA team of more than 80 board certified radiologists, highly skilled clinical staff and support professionals serve eleven area hospitals and several outpatient imaging centers with a broad range of subspecialties, including neuroradiology, body imaging, musculoskeletal, breast imaging, thoracic, cardiovascular, pediatric and interventional. SRA is committed to providing our patients and the medical communities we serve with the highest caliber of radiology services available. For more information, visit www.synergyrad.org, call (713) 621-7436 or connect with us on Facebook, LinkedIn or Pinterest.