Alliance for Clinical Trials in Oncology

Chicago, IL, United States

Alliance for Clinical Trials in Oncology

Chicago, IL, United States
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SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for REVLIMID (lenalidomide) 10 mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant (auto-HSCT). The expanded indication makes REVLIMID the first and only treatment to receive FDA approval for maintenance use following auto-HSCT. “Autologous stem cell transplant after induction therapy is part of the continuum of care for transplant-eligible multiple myeloma patients. However, most patients will still see their disease recur or progress after this treatment,” said Philip McCarthy, M.D., Director, Blood and Marrow Transplant Center, Department of Medicine at Roswell Park Cancer Institute. “Lenalidomide maintenance therapy, which has been shown to increase progression-free survival following autologous stem cell transplant in clinical trials can be considered a standard of care for these patients.” The approval was based on two large studies including more than 1,000 patients comparing REVLIMID maintenance therapy given until disease progression or unacceptable toxicity after auto-HSCT versus no maintenance. In both studies, the primary efficacy endpoint was progression-free survival (PFS) defined from randomization to the date of progression or death, whichever occurred first. In the most current PFS analysis, Study 1 (U.S.-based NCI sponsored cooperative group study CALGB 100104) demonstrated a median PFS of 5.7 years (95% CI: 4.4-not estimable) versus 1.9 years (95% CI: 1.6-2.5) for no maintenance, a difference of 3.8 years (HR 0.38 [95% CI: 0.28-0.50]). Study 2 (European-based study IFM 2005-02) also showed a benefit with a median PFS of 3.9 years (95% CI: 3.3-4.7) versus 2 years (95% CI: 1.8-2.3) for no maintenance, a difference of 1.9 years (HR 0.53 [95% CI: 0.44-0.64]). Individual studies were not powered for an overall survival endpoint. A descriptive analysis showed the median overall survival in Study 1 was 9.3 years (95% CI: 8.5-not estimable) for patients who received REVLIMID versus 7 years (95% CI: 5.9-8.6) for no maintenance (HR 0.59 [95% CI: 0.44-0.78]). In Study 2, median overall survival was 8.8 years (95% CI: 7.4-not estimable) for patients who received REVLIMID versus 7.3 years (95% CI: 6.7-9.0) for no maintenance (HR 0.90 [95% CI: 0.72-1.13]). “In newly-diagnosed multiple myeloma, auto-HSCT remains a viable option for many patients and often provides a strong response against the disease,” said Michael Pehl, President, Global Hematology and Oncology for Celgene. “By expanding the approval for REVLIMID to include post-transplant maintenance, patients have the potential to maintain those responses and, importantly, delay progression of the disease.” As described in the prescribing information, REVLIMID can cause fetal harm and is contraindicated in females who are pregnant. REVLIMID is only available through a restricted distribution program, Revlimid REMS®. Deep vein thrombosis, pulmonary embolism, myocardial infarction and stroke occur in patients with MM treatment with REVLIMID and thromboprophylaxis is recommended. See additional Important Safety Information below. The most frequently reported adverse reactions in ≥20% (REVLIMID arm) across both maintenance studies (Study 1, Study 2 respectively) were neutropenia (79%, 61%), thrombocytopenia (72%, 24%), leukopenia (23%, 32%), anemia (21%, 9%), upper respiratory tract infection (27%, 11%), bronchitis (5%, 47%), nasopharyngitis (2%, 35%), cough (10%, 27%), gastroenteritis (0%, 23%), diarrhea (55%, 39%), rash (32%, 8%), fatigue (23%, 11%), asthenia (0%, 30%), muscle spasm (0%, 33%) and pyrexia (8%, 21%). The most frequently reported Grade 3 or 4 reactions (more than 20% in the REVLIMID arm) included neutropenia, thrombocytopenia, and leukopenia. The frequencies of onset of adverse reactions were generally highest in the first six months of treatment and then the frequencies decreased over time or remained stable throughout treatment. In patients receiving REVLIMID maintenance therapy, hematologic second primary malignancies (SPM) occurred in 7.5% of patients compared to 3.3% in patients receiving placebo. The incidence of hematologic plus solid tumor (excluding squamous cell carcinoma and basal cell carcinoma) SPM was 14.9%, compared to 8.8% in patients receiving placebo with a median follow-up of 91.5 months. Non-melanoma skin cancer SPM, including squamous cell carcinoma and basal cell carcinoma, occurred in 3.9% of patients receiving REVLIMID maintenance, compared to 2.6% in the placebo arm. Patients should be monitored for the development of second primary malignancies. Take into account both the potential benefit of REVLIMID and the risk of second primary malignancies when considering treatment with REVLIMID. REVLIMID in combination with dexamethasone was previously approved in June 2006 for use in patients with multiple myeloma who have received at least one prior therapy, and the indication expanded in February 2015 to include patients newly diagnosed with multiple myeloma. In June 2016, an application was submitted to the European Medicines Agency (EMA) for the review of REVLIMID as maintenance treatment in NDMM patients after receiving an autologous stem cell transplant. In January 2017, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the use of REVLIMID as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation. CALGB 100104 was a phase III, randomized, controlled, double-blind, multi-center study conducted in 47 centers by the CALGB, which is now part of the Alliance for Clinical Trials in Oncology, a US national oncology cooperative group. 460 newly diagnosed multiple myeloma patients – aged between 18 and 70 years (CLcr ≥ 30 mL/min) – who had undergone induction therapy within 12 months of diagnosis and achieved at least stable disease (SD) or better 90-100 days following autologous stem cell transplant (ASCT), were randomized to receive either REVLIMID maintenance or placebo. The REVLIMID maintenance dose was 10 mg/day (after 3 months increased to 15 mg/day if tolerated) until disease progression, intolerable side effects, patient withdrawal for another reason, or death. The dose was reduced, or treatment was temporarily interrupted or stopped, as needed to manage toxicity. A dose increase to 15 mg once daily occurred in 135 patients (58%). IFM 2005-02 was a phase III, controlled, double-blind, multi-center study conducted by the University Hospital of Toulouse in concert with the IFM, an independent French myeloma cooperative group, at 78 centers in France, Belgium, and Switzerland. 614 newly diagnosed multiple myeloma patients younger than 65 years (CLcr ≥ 30 mL/min) who had undergone induction therapy and did not present with signs of disease progression within 6 months of undergoing ASCT. Patients were then randomized to receive a two-month consolidation regimen of REVLIMID monotherapy 25 mg per day on 21/28 days, followed by either REVLIMID maintenance or placebo. The REVLIMID dose was 10 mg/day (after 3 months increased to15 mg/day if tolerated) until disease progression, intolerable side effects, patient withdrawal for another reason or death. The dose was reduced, or treatment was temporarily interrupted or stopped, as needed to manage toxicity. A dose increase to 15 mg once daily occurred in 185 patients (60%). REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM) REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT) REVLIMID® is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus Allergic Reactions: REVLIMID is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide REVLIMID REMS® Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex or REVLIMID maintenance therapy should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or dose reduction. Please see the Black Box WARNINGS for further information. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on patient’s underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision Increased Mortality in Patients with CLL: In a clinical trial in the first-line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered Allergic Reactions: Angioedema and serious dermatologic reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected and should not be resumed following discontinuation for these reactions. REVLIMID capsules contain lactose; risk-benefit of treatment should be evaluated in patients with lactose intolerance Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to ≤ Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physician’s discretion Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of REVLIMID treatment and during therapy Periodic monitoring of digoxin plasma levels is recommended due to increased C and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube. This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission. All registered trademarks are owned by Celgene Corporation.


News Article | March 1, 2017
Site: www.prweb.com

Breast Surgeon, Dr. Dennis Holmes of 90210 Surgery Medical Center will review minimally invasive cryoablation for the treatment of early stage breast cancer and where it fits in the treatment paradigm at Susan G. Komen San Diego’s Annual Dinner Symposium, “Screens, Genes & The Choices We Make.” The event brings together leading cancer and wellness experts to share the latest innovations in breast cancer research, treatment and holistic well-being. The symposium will take place on Thursday, March 16, 2017 at the San Diego Del Mar Marriott. Dr. Holmes is an internationally renowned breast surgeon and cancer researcher currently serving as Interim Director of the Margie Petersen Breast Center at Providence St. John’s Health Center and Interim Director, John Wayne Cancer Institute Breast Surgery Fellowship Program. Formerly, Dr. Holmes held the positions of Chief Breast Surgeon and Medical Director of the Los Angeles Center for Women’s Health, and Chief Breast Cancer Surgeon, and Breast Cancer Research Committee Co-Chair at the University of Southern California Kenneth Norris Comprehensive Cancer Center. Dr. Holmes has been a pioneer in the field of minimally invasive breast surgery, including intraoperative radiotherapy, lymph node-sparing surgery and cryoablation “I am thrilled to partner with Komen San Diego, as we share similar goals - to save lives and pursue the best breast cancer treatments,” said Dr. Holmes. Currently, the standard of care for early stage breast cancer is surgery (e.g. lumpectomy, mastectomy) and sentinel node biopsy followed by breast radiotherapy and adjuvant endocrine and/or chemotherapy. Although surgery offers tumor removal and margin verification, a major drawback of surgery is the cosmetic and functional impairment of the breast resulting from volume changes, scar formation, nipple displacement, sensation changes, skin/scar retraction, and re-excision rate. Dr. Holmes was an investigator in the National Cancer Institute Z1072 Clinical Trial sponsored by the Alliance for Clinical Trials in Oncology. The trial examined cryoablation for the treatment of early stage breast cancer. In a 5-year multicenter study, cryoablation was shown to be 92% effective for complete ablation of invasive breast tumors ≤2 cm and 100% effective for complete ablation of invasive ductal breast cancer tumors <1.0 cm. Results from this breast cancer study (ACOSOG Z1072), which included a 5-year follow-up, were published in the Annals of Surgical Oncology. The Visica® 2 Treatment System developed by Sanarus Technologies, was the exclusive device used in the Z1072 study. “Cryoablation is a very promising alternative to traditional surgery for early stage breast cancer. Cryoablation minimizes changes in breast volume and nipple position, and avoids prominent scars,” explained Dr. Holmes. “The outstanding results of Z0172 inspired me to start the FROST Clinical Study, for which I now serve as Principal Investigator.” The FROST Clinical Study is the evolution of data from Z1072, which examines the rate of successful tumor ablation in patients treated with cryoablation of the primary tumor instead of surgical removal of early stage breast cancer. The FROST Clinical Study is currently enrolling women age 50 and older with core needle biopsy proven clinical stage I, T1, (≤1.5 cm) clinically node negative (N0), unifocal, hormone receptor positive and HER2/neu-negative invasive ductal carcinoma. Cryoablation with the Visica 2 Treatment System is a nonsurgical option for patients that have been diagnosed with early stage breast cancer, is visible on sonogram, and has been confirmed with a biopsy. This procedure has many benefits including: under 30-minutes, local anesthesia, in-office, excellent cosmesis, cost efficient, and quick patient recovery. Cryoablation is a viable option to surgery that results in complete early stage tumor ablation. About Dr. Holmes Dr. Holmes serves in the leadership of several national surgical societies and is a frequent lecturer at national conferences. He is a member of the education committee of the American Society of Breast Surgeons. Dr. Holmes is a Fellow of the American College of Surgeons and was also recently selected as Board Chair and President of the TARGIT Collaborative Group, a national research and education organization. Widely respected by colleagues for his innovative approach to breast cancer care, Dr. Holmes has gained worldwide acclaim for his pioneering research in targeted intraoperative radiotherapy. Dr. Holmes believes wholeheartedly that, with proper treatment, most women diagnosed with breast cancer will live a long, fulfilling life—a life both richer and more meaningful than they could have ever imagined. Find out more at http://www.drholmesmd.com About Sanarus Technologies In 2001, the Visica® 2 Treatment System was the first device available for cryoablation of fibroadenomas. Since then, our system has been used to successfully treat thousands of patients. The Visica 2 Treatment System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we develop innovative solutions for the nonsurgical treatment of breast tumors. We are headquartered in Pleasanton, CA, and all our products are manufactured in the USA. Find out more at http://www.sanarus.com ABOUT SUSAN G. KOMEN SAN DIEGO®: Since its inception in 1995, Komen San Diego has granted more than $18 million to research and local non-profits who provide everything from free diagnostic mammograms, meal delivery, temporary financial aid, transportation and more. Seventy-five percent of every dollar raised in San Diego stays in San Diego County to fund breast health services for uninsured and underinsured women and their families. The remaining 25 percent funds international breast cancer research. In fact, next to the U.S. government, Susan G. Komen® is the largest funder of breast cancer research in the world. For more information, please visit http://www.komensandiego.org. Connect with us on Facebook and Twitter and Instagram.


News Article | November 3, 2016
Site: www.prweb.com

Cancer Surgery of Mobile announced today that it has acquired the Visica® 2 Treatment System, a cryoablation device that uses extreme cold (cryo) to destroy tissue (ablation). Developed by Sanarus Technologies, the Visica 2 Treatment System destroys the tumor by freezing it with liquid nitrogen and damaging the adjacent vasculature that fuels tumor growth. Dr. Patterson is the first breast surgeon in Alabama to use this advanced technology for the treatment of certain breast cancers as an alternative to lumpectomy. Sharla Gayle Patterson, M.D., FACS is fellowship-trained in breast surgery oncology and specializes in oncoplastic surgery. She is certified by the American Society of Breast Surgeons and was the first surgeon in the area to receive certification in Hidden Scar Breast Cancer Surgery. Cryoablation—also referred to as tumor freezing—is a minimally invasive procedure done under ultrasound guidance in the doctors’ office or radiology suite. After injection of local anesthesia, a thin probe is inserted through the skin directly into the tumor. Liquid nitrogen is pumped into the probe to form an “ice ball” around the lesion. Freezing destroys the tumor cells, which are then reabsorbed by the body over time. The procedure can be done in under an hour with most patients reporting minimal discomfort and a resumption of normal activity right away. Little, if any, visible scarring occurs. Because no breast tissue is removed during the procedure, the natural shape of the breast is maintained. “At Cancer Surgery of Mobile, we take a proactive approach to women’s health and well-being. Our patients are encouraged to understand their options and make informed treatment decisions. Cryoablation is a great addition to the practice because we see positive outcomes from a virtually painless in-office procedure,” said Dr. Patterson. “It’s a safe and effective treatment that increases patient satisfaction and underscores our commitment to providing the highest level of patient care.” In a 5-year multicenter study funded by the National Cancer Institute and sponsored by the Alliance for Clinical Trials in Oncology, cryoablation with the Visica 2 Treatment System was shown to be 100% effective for complete ablation of invasive ductal breast cancer tumors <1.0 cm. The Visica 2 Treatment System was the exclusive device used in the Z1072 study and showed cryoablation effective in 92% of the targeted lesions. Results from this phase II trial (ACOSOG Z1072) and an introduction to the current FROST Trial for early stage breast cancer will be presented at the Synergy 2016 annual symposium, Friday November 4 at the Eden Roc, Miami Beach. The panel discussion, "Minimally Invasive Cryoablation For Early Stage Breast Cancer," features insights from Dennis R. Holmes, MD, FACS, Kamilia Kozlowski, MD and Bing Han, MD, PhD. “The breast is an ideal location for ablative therapy because there are no organs between it and the skin to get in the way of tumor access,” said Dr. Patterson. “With cryoablation, I’m able to effectively treat the target lesion and offer the patient an excellent cosmetic result.” Cryoablation with the Visica 2 Treatment System is an option for patients whose breast tumor is less than 4 cm in diameter, visible on sonogram and has been confirmed with a biopsy. About Cancer Surgery of Mobile Cancer Surgery of Mobile is a multi-specialty group consisting of surgical oncologist Dr. Lee Thompson; general surgeon Dr. Gerhard Boehm; breast surgeon Dr. Sharla Patterson; and orthopedic oncologist Dr. Zhiqing Xing. Cancer Surgery of Mobile was the first in the area to implement a High Risk Breast Cancer Clinic. Patients at the clinic receive a risk assessment, breast exam and evaluation by Dr. Patterson with recommendations for genetic testing and counseling, if needed. Consultations with a dietician, an exercise physiologist and a breast cancer nurse navigator are also available. Dr. Patterson is accepting new patients for all services, including cryoablation with the Visica 2 Treatment System. Learn more about Cancer Surgery of Mobile by visiting our website or call 251.433.5557. About Sanarus Technologies In 2001, the Visica 2 Treatment System was the first system available for cryoablation of fibroadenomas. Since then, our system has been used to successfully treat thousands of patients. The System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we develop innovative solutions for the nonsurgical treatment of breast tumors. We are headquartered in Pleasanton, CA, and all of our products are manufactured in the USA. Find out more at sanarus.com.


News Article | November 3, 2016
Site: www.eurekalert.org

PORTLAND, OR - For the second year, SWOG, the cancer clinical trials network, and its charity, The Hope Foundation, are providing $125,000 to five U.S. Department of Veterans Affairs medical centers to expand access to cancer clinical trials. Under the VA Integration Support Program, medical centers receive $25,000 in seed funding to help them enroll veterans in trials run by SWOG and other members of the National Cancer Institute's National Clinical Trials Network (NCTN). This means more veterans can enroll in research studies featuring cutting-edge medicines. The publicly funded NCTN offers well over 200 open trials at any given time, trials testing prevention and treatment strategies for a variety of cancers, including lung, prostate, and colorectal cancers - the most common forms in veterans. Clinical trials are an important option for any cancer patient managing their disease. Trials test new treatments, and are sometimes the only way to access immunotherapies or precision medicines. For many reasons, most stemming from a lack of time and money, veterans' ability to join trials sponsored by the National Cancer Institute and other groups has decreased dramatically. SWOG and The Hope Foundation are working to turn that trend around, and their efforts are paying off. Winners of the 2015 VA Integration Support Program grants have expanded the hours of current research staff or hired new staff to process paperwork, screen patients, or collect tissue or other biological samples needed to take part in trials. As a result, 13 NCTN trials are now open to veterans at these sites, including the landmark Lung-MAP precision medicine trial testing new drugs for squamous cell lung cancer. Soon, the NCI-MATCH trial will also be available at some sites. Veterans are responding to the increasing access. About 50 have been screened for trial participation, and 12 have enrolled. One is Jerry Valentino, a lung cancer patient who joined SWOG's Lung-MAP trial through the VA Connecticut Healthcare System. Valentino, a 70-year-old Vietnam War veteran, has experienced no side effects from his trial drug and is responding well to treatment. Scans show his cancer is gone - and hasn't returned. "Trials are the only way we know if drugs work or they don't," Valentino said. "It feels good to be part of the system that is moving medicine forward. This program is really helping veterans - and by all means they deserve it." Dr. Charles Blanke, SWOG group chair, agrees. Blanke created the VA Integration Support Program to help veterans and support the NCTN. Groups in the NCTN - SWOG, Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, and Children's Oncology Group - are a major part of the nation's cancer research infrastructure and enroll tens of thousands of patients each year. All five groups are funded by the National Cancer Institute, and constitute the oldest and largest cancer research network in the nation. "I am pleased with our progress and impact one year into this new program," Blanke said. "We are doing what we'd hoped to do - make great cancer trials available to veterans. Consideration of a clinical trial is a hallmark of excellent cancer care, and our veterans deserve the very best." For information on the VA Integration Support Program, contact Morgan Cox at The Hope Foundation at (734) 998-6887 or morgan@thehopefoundation.org. SWOG is part of the National Cancer Institute's National Clinical Trials Network, the nation's oldest and largest cancer research network, and is a major part of the cancer research infrastructure in the U.S. and the world. SWOG has over 12,000 members in 46 states and six foreign countries who design and conduct cancer clinical trials to improve the lives of people with cancer. Founded in 1956, SWOG's 1,300 trials have led to the approval of 14 cancer drugs, changed more than 100 standards of cancer care, and saved more than 2 million years of human life. Learn more at swog.org. The Hope Foundation is a public charity that supports SWOG's work by providing funds for research grants and fellowships, physician education, clinical trial support, and patient advocacy.


News Article | December 6, 2016
Site: www.eurekalert.org

(San Diego, December 6, 2016) - Trial results being presented today during the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego suggest two therapies that are often added to standard therapy in patients with multiple myeloma do not improve rates of progression-free survival compared with the current standard course of treatment alone. The study is the largest randomized controlled trial of post-transplant therapy for multiple myeloma ever conducted in the United States. Multiple myeloma, a cancer of the plasma cells - cells that exist in the bone marrow that help fight infection - that is diagnosed in about 30,000 people per year in the United States. For physically fit individuals below age 70, standard care consists of three components: 1) A course of initial therapy with combinations of proteasome inhibitors, thalidomide analogues, corticosteroids and alkylating agents, then high doses of the chemotherapy drug melphalan to kill cancer cells, 2) transplantation of the patient's own hematopoietic stem cells (autoHCT) to help rebuild the immune system, and 3) ongoing treatment with the chemotherapy drug lenalidomide to prevent cancer from returning. Over the past decade, many doctors have added to this regimen either by incorporating an additional intensive three-drug course of chemotherapy after autoHCT (including the drugs dexamethasone and bortezomib in addition to lenalidomide), or by adding a second round of autoHCT. "These results are very important because they answer a question that has been ongoing and has not been compared head-to-head: 'Does the addition of these interventions result in a true advantage for these patients?'" said lead study author Edward A. Stadtmauer, MD, of the Abramson Cancer Center, University of Pennsylvania in Philadelphia. "The conclusion of this study, so far, is that the other interventions are not superior to initial melphalan therapy followed by a single autoHCT followed by lenalidomide maintenance." The researchers, participating in a national collaborative effort of 54 centers, enrolled 758 patients and randomly assigned them to receive either standard care, standard care plus additional chemotherapy, or standard care plus a second round of autoHCT. With almost all patients nearing the end of follow-up, the study's Data and Safety Monitoring Board released the current results. The results showed no difference among the three groups in terms of the study's primary endpoint--38-month survival without disease progression, as indicated by intent-to-treat--with progression-free survival observed in 52 percent, 57 percent, and 56 percent of patients in each of the three treatment arms, respectively. The final analysis and the analysis of secondary outcomes including quality of life indicators, the degree of disease response, and evidence of toxicity will be available after all patients have completed 38 months of follow-up. "Despite remarkable advances in the therapy and outlook for patients with multiple myeloma over the last decade, ultimately many patients will have their disease progress. So, there's always room for improvement," said Dr. Stadtmauer. "New therapies and interventions need to be actively investigated to see how much they further benefit the early treatment of patients with myeloma; I believe that the results of this study suggest it would be reasonable to compare any new treatments to the standard therapy of melphalan followed by a single autoHCT followed by lenalidomide maintenance." The researchers will track patients in a follow-up study to assess long-term trends and outcomes. The study was funded by the Blood and Marrow Transplant Clinical Trials Network which is supported by the National Heart, Lung and Blood Institute and National Cancer Institute of the United States National Institutes of Health under Grant No. U01-HL069294. Additional funding was provided by Celgene and Takeda Oncology, makers of lenalidomide and bortezomib, respectively. Patients were enrolled by centers participating in the BMT CTN as well as through the NCI funded National Clinical Trials Network (NCTN) including ECOG-ACRIN Cancer Research Group, SWOG and the Alliance for Clinical Trials in Oncology. Edward A. Stadtmauer, MD, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pa. will present this study, titled "Comparison of Autologous Hematopoietic Cell Transplant (autoHCT), Bortezomib, Lenalidomide (Len) and Dexamethasone (RVD) Consolidation with Len Maintenance (ACM), Tandem AutoHCT with Len Maintenance (TAM) and AutoHCT with Len Maintenance (AM) for up-Front Treatment of Patients with Multiple Myeloma (MM): Primary Results from the Randomized Phase III Trial of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 0702 - StaMINA Trial)," (LBA-1) during the late-breaking abstracts session on Tuesday, December 6 at 7:30 a.m. PST in Hall AB. For the complete annual meeting program and abstracts, visit http://www. . Follow @ASH_hematology and #ASH16 on Twitter and like ASH on Facebook for the most up-to-date information about the 2016 ASH Annual Meeting. The American Society of Hematology (ASH) (http://www. ) is the world's largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 50 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. The official journal of ASH is Blood (http://www. ), the most cited peer-reviewed publication in the field, as well as the newly launched, online, open-access journal, Blood Advances (http://www. ).


News Article | December 22, 2016
Site: www.eurekalert.org

Portland, Oregon, Dec. 21, 2016 - The addition of bortezomib to a standard two-drug regimen for multiple myeloma patients significantly lengthened the time before their cancer returned, and significantly lengthened their lives, according to clinical trial results in The Lancet. Investigators from SWOG, the international cancer clinical trials network funded by the National Cancer Institute (NCI), compared the effectiveness of two drug regimens in newly diagnosed patients undergoing their first round of treatment for multiple myeloma, a type of bone marrow cancer. One regimen used in the study was lenalidomide with dexamethasone, a standard first-line treatment. The other drug regimen also included bortezomib, a second-line drug typically given to myeloma patients whose cancer progresses after initial therapy. SWOG researchers found that the addition of bortezomib made a significant difference for myeloma patients, giving them about another year of remission and another year of life. Patients receiving bortezomib, along with lenalidomide and dexamethasone, in their first six months of treatment had a median remission time of 43 months compared to a median remission of 30 months for patients who received lenalidomide and dexamethasone alone. Researchers also found that patients who received bortezomib lived a median of 75 months, or about six years, after their initial treatment. Patients who received the standard two-drug treatment lived a median of 64 months, or about five years, after initial treatment. "There's a lot of excitement about these research findings and this treatment option, which helps myeloma patients stay healthier longer and gives them more time to spend with people they love," said SWOG study principal investigator Brian G.M. Durie, M.D., a physician at Cedars-Sinai Outpatient Cancer Center in Los Angeles and chairman of the board at the International Myeloma Foundation. "Because the research was so solid, and the findings so strong, we're looking at a potential new standard of care." Results of the SWOG study, S0777, first gained attention in December 2015 at the 57th Annual Meeting of the American Society of Hematology (ASH) held in Orlando, Florida. Myeloma is the second most common blood cancer in the world. According to NCI statistics, in 2016 an estimated 30,330 new cases of myeloma will be diagnosed and 12,650 people will die of the disease in the U.S. In recent years, new drugs have brought new hope, and life expectancy for people diagnosed with multiple myeloma is slowly rising. SWOG researchers enrolled 471 eligible and consented adult patients in S0777 between February 2008 and February 2012 at 139 institutions throughout the National Cancer Trials Network (NCTN), the nation's oldest and largest publicly funded cancer research network. The NCTN includes SWOG, the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, and NRG Oncology, which all enrolled patients to S0777, as well as the Children's Oncology Group, which focuses on pediatric cancers. S0777 patients ranged in age from 28 to 87, had active myeloma, and had not had a stem-cell transplant or any prior treatment for their disease. Patients were randomized into two groups. One group received the standard two-drug treatment for six cycles over six months. That includes lenalidomide, an immunomodulating therapy marketed as Revlimid by Celegene Corporation. The other group received a three-drug combination that included bortezomib, a proteasome inhibitor marketed as Velcade by Millennium Pharmaceuticals. These patients received the triple combination therapy for eight cycles over six months. Despite the increased remission and longevity, the three-drug combination did have a drawback: Patients who received bortezomib were much more likely to experience sensory neuropathy, or tingling, pain, numbness or weakness in their hands and feet. The NCI provided primary grant funding for S0777 and was the sponsor of the study. Millennium Pharmaceuticals, Inc., The Takeda Oncology Company, and Celgene Corporation provided the study drugs under their respective Cooperative Research and Development Agreements with the NCI. A national team of SWOG researchers led S0777. Along with Durie, they include: Antje Hoering, Ph.D, of Cancer Research And Biostatistics; S. Vincent Rajkumar, M.D., of Mayo Clinic; Muneer H. Abidi, M.D., of Spectrum Health and Michigan State University; Joshua Epstein, DS.c, of University of Arkansas for Medical Sciences; Stephen P. Kahanic, M.D., of Souixland Regional Cancer Center; Mohan C. Thakuri, M.D., of Southeast Clinical Oncology Research Consortium NCORP; Frederic J. Reu, M.D., of Cleveland Clinic; Christopher M. Reynolds, M.D., of Michigan Cancer Research Consortium NCORP; Rachael Sexton, M.S., of Cancer Research And Biostatistics; Robert Z. Orlowski, M.D., Ph.D, of MD Anderson Cancer Center; Bart Barlogie, M.D., Ph.D, of University of Arkansas for Medical Sciences; and Angela Dispenzieri, M.D., of Mayo Clinic. SWOG is a global network of researchers that design and conduct cancer clinical trials, and, as part of the Nation Cancer Institute's National Clinical Trials Network, is a major part of the cancer research infrastructure in the U.S. and the world. The group's goal is to change medical practice so it improves the lives of people with cancer. Founded in 1956, SWOG's 1,300 trials have led to the approval of 14 cancer drugs, changed the standard of cancer care more than 100 times, and saved more than 2 million years of human life. Learn more at swog.org.


News Article | February 15, 2017
Site: www.prweb.com

Global Breast Health & Wellness Center, founded by Dr. April Speed, announced it has expanded its cryoablation treatment of fibroadenoma to include early stage breast cancer with the Visica® 2 Treatment System. Developed by Sanarus Technologies, the Visica 2 Treatment System is a cryoablation device that uses extreme cold liquid nitrogen (cryo) to destroy tissue (ablation). The device destroys the tumor by freezing and damaging the adjacent vasculature that fuels tumor growth. Dr. April L. Speed is board-certified by the American College of Surgeons and is a member of the American Society of Breast Surgeons, the Society of Surgical Oncology and the American Society of Clinical Oncology (ASCO). Dr. Speed was recognized by her peers and awarded the ASCO National Diversity in Oncology Award in 2009. Cryoablation—also referred to as tumor freezing—is a minimally invasive procedure done under ultrasound guidance in the doctor’s office or radiology suite. After injection of local anesthesia, a thin probe is inserted through the skin directly into the tumor. Liquid nitrogen is pumped into the probe to form an “ice ball” around the lesion. Freezing destroys the tumor cells, which are then reabsorbed by the body over time. The procedure can be done in less than an hour with most patients reporting minimal discomfort and a resumption of normal activity right away. Little, if any, visible scarring occurs. Because no breast tissue is removed during the procedure, the natural shape of the breast is maintained. ”I’ve been providing cryoablation for the treatment of fibroadenomas since 2015 and have obtained very good results” said Dr. Speed. “Those results coupled with the publication of the National Cancer Institute Z1072 Trial have truly encouraged me to expand my practice to offer cryoablation for early stage breast cancer tumors.” In a 5-year multicenter study funded by the National Cancer Institute and sponsored by the Alliance for Clinical Trials in Oncology, cryoablation with the Visica 2 Treatment System was shown to be 100% effective for complete ablation of invasive ductal breast cancer tumors <1.0 cm. The Visica 2 Treatment System was the exclusive device used in the Z1072 study and showed cryoablation to be effective in 92% of the targeted lesions. Results from this breast cancer study (ACOSOG Z1072), which included a 5-year follow-up, were published in the Annals of Surgical Oncology. Dr. Speed further explained that “In November 2016, I opened my new state of the art facility located in Buckhead to provide Greater Atlanta with a comprehensive, 100% dedicated, breast surgery practice. Cryoablation is one of our primary treatment options for our patients because it provides an opportunity for women to have cutting edge therapy with dignity and detail performed in a serene, patient-centered environment. It also gives women the benefit of a minimally invasive procedure with little to no scarring, downtime, or discomfort.” Dr. Speed recently discussed cryoablation and other breast cancer related topics on Atlanta Business RadioX. She discussed the technology of cryoablation, who would qualify as a patient, and why she has chosen to offer cryoablation for the treatment of early stage breast cancer lesions. She has also been featured on CentricTV. Cryoablation with the Visica 2 Treatment System is a nonsurgical option for patients that have been diagnosed early stage breast tumor that is less than 4 cm in diameter, is visible on sonogram and has been confirmed with a biopsy. About Global Breast Health & Wellness Center Dr. Speed serves on several boards, the Susan G. Komen for the Cure Greater Atlanta Affiliate, and the Georgia Perimeter College. She's a highly sought-after speaker, author, consultant and lecturer on breast cancer and breast health. Dr. Speed has recently embarked upon an exciting venture of private practice in two convenient locations, Buckhead and Conyers, and welcomes all of her previous patients and new patients alike to continue to be a part of this amazing journey of transformation from your Breast Health to your Best Health℠. Let's treat it, beat it, move on!℠ To contact Dr. Speed go http://www.draprilspeed.com or call 678.210.2846 About Sanarus Technologies In 2001, the Visica® 2 Treatment System was the first available for cryoablation of fibroadenomas. Since then, our system has been used to successfully treat thousands of patients. The Visica 2 Treatment System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we develop innovative solutions for the nonsurgical treatment of breast tumors. We are headquartered in Pleasanton, CA, and all of our products are manufactured in the USA. Find out more at http://www.sanarus.com


News Article | February 15, 2017
Site: www.prweb.com

Diagnostic Center for Women has announced that Dr. Michael J. Plaza expands use of cryoablation treatment of fibroadenoma to include early stage breast cancer with the Visica® 2 Treatment System. Developed by Sanarus Technologies, the Visica 2 Treatment System is a cryoablation device that uses extreme cold (cryo) to destroy tissue (ablation). The device destroys the tumor by freezing and damaging the adjacent vasculature that fuels tumor growth. Dr. Michael J. Plaza is board-certified by the American Board of Radiology in Diagnostic Radiology. He completed his residency at University of Miami/Jackson Memorial Hospital and breast imaging fellowship at Memorial Sloan-Kettering Cancer Center. Dr. Plaza has become the first radiologist in Miami to provide cryoablation for early stage breast cancer with the Visica 2 Treatment System. Cryoablation—also referred to as tumor freezing—is a minimally invasive procedure done under ultrasound guidance in the doctor’s office or radiology suite. After injection of local anesthesia, a thin probe is inserted through the skin directly into the tumor. Liquid nitrogen is pumped into the probe to form an “ice ball” around the lesion. Freezing destroys the tumor cells, which are then reabsorbed by the body over time. The procedure can be done in less than an hour with most patients reporting minimal discomfort and a resumption of normal activity right away. Little, if any, visible scarring occurs. Because no breast tissue is removed during the procedure, the natural shape of the breast is maintained. Dr. Plaza began using cryoablation for fibroadenoma in February 2016, and expanded to treating early stage breast cancer in October 2016. “We saw great results in treating benign breast tumors, and with the growing evidence in the medical literature, especially the National Cancer Institute Z1072 Trial we decided to expand our practice to include cryoablation of early stage breast cancer,” said Dr. Plaza. In a 5-year multicenter study funded by the National Cancer Institute and sponsored by the Alliance for Clinical Trials in Oncology, cryoablation with the Visica 2 Treatment System was shown to be 100% effective for complete ablation of invasive ductal breast cancer tumors <1.0 cm. The Visica 2 Treatment System was the exclusive device used in the Z1072 study and showed cryoablation to be effective in 92% of the targeted lesions. Results from this breast cancer study (ACOSOG Z1072), which included a 5-year follow-up, were published in the Annals of Surgical Oncology. “Cryoablation is an evolution in the treatment of early stage breast cancer. Unlike surgery, it is a minimally invasive procedure that preserves the shape of the breast and can be performed in the office under 30 minutes while the patient is awake” Dr. Plaza explains. “Patients can typically return to work the next day. I am excited to bring this modality to the patients in Miami.” Cryoablation with the Visica 2 Treatment System is a nonsurgical option for patients that have been diagnosed with early stage breast cancer, is visible on sonogram and has been confirmed with a biopsy. About Diagnostic Center for Women The Diagnostic Center For Women is a premier imaging facility focused on fostering female wellness. Established in 1999, they are committed to providing the most reliable and comprehensive testing available. Their facility is accredited in mammography, breast and body MRI and obstetric and gynecologic ultrasound by the following organizations: American College of Radiology (ACR), Mammography, Intersocietal Accreditation Commission (IAC), Breast MRI, Body MRI, and American Institute of Ultrasound Medicine (AIUM), Obstetric and Gynecologic Ultrasound. “At the Diagnostic Center for Women, we understand your unique health needs.” Find out more at http://www.dxforwomen.com About Sanarus Technologies In 2001, the Visica® 2 Treatment System was the first available for cryoablation of fibroadenomas. Since then, our system has been used to successfully treat thousands of patients. The Visica 2 Treatment System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we develop innovative solutions for the nonsurgical treatment of breast tumors. We are headquartered in Pleasanton, CA, and all of our products are manufactured in the USA. Find out more at http://www.sanarus.com


News Article | November 16, 2016
Site: www.prweb.com

Knoxville Comprehensive Breast Center announced today that it has acquired the Visica® 2 Treatment System, a cryoablation device that uses extreme cold (cryo) to destroy tissue (ablation). Developed by Sanarus Technologies, the Visica 2 Treatment System destroys the tumor by freezing it with liquid nitrogen and damaging the adjacent vasculature that fuels tumor growth. Dr. Kozlowski is the first clinical breast radiologist in Tennessee to use the Visica 2 Treatment System to treat patients with early stage breast cancer. Kamilia Kozlowski, M.D. is a board-certified radiologist who has devoted her professional career to the field of breast imaging. She started the first breast center in Knoxville over 30 years ago with a mission to save lives and streamline the delivery of quality breast health care for women in the region. Since its inception, the Knoxville Comprehensive Breast Center has been at the forefront of independent breast centers nationwide. Clinical Breast Radiology, a specialty developed by Dr. Kozlowski, differs from traditional radiology in that clinical breast radiologists manage both the diagnostic and clinical aspects of care. Patients are not burdened with visits to multiple specialists, as clinical breast radiologists can diagnose and direct treatment in one setting. “It’s so rewarding to offer this advanced technology to our patients with early stage breast cancer, when appropriate. Cryoablation is a targeted, precision treatment that can obviate the need for surgery in many cases,” said Dr. Kozlowski. “Comprehensive breast care involves identifying an abnormality early and treating it before it has a chance to become problematic. There’s nothing better than seeing patients walk out of the office after the procedure, content in knowing that their early stage lesion has been taken care of without surgery or a change in the shape of their breast.” Cryoablation—also referred to as tumor freezing—is a minimally invasive procedure done under ultrasound guidance in the doctors’ office or radiology suite. After injection of local anesthesia, a thin probe is inserted through the skin directly into the tumor. Liquid nitrogen is pumped into the probe to form an “ice ball” around the lesion. Freezing destroys the tumor cells, which are then reabsorbed by the body over time. The procedure can be done in under an hour with most patients reporting minimal discomfort and a resumption of normal activity right away. Little, if any, visible scarring occurs. Because no breast tissue is removed during the procedure, the natural shape of the breast is maintained. Dr. Kozlowski recently presented data at Synergy 2016 – an annual multidisciplinary interventional oncology conference held in Miami, Florida. Results from her study of cryoablation in eight early estrogen-positive breast cancer patients indicate that another benefit to cryoablation is an increase in the humoral response, i.e., the formation of antibodies to the tumor that help prevent the spread of distant disease. Dr. Kozlowski also reported on the potential for significant cost savings to patients, insurance companies and government, were more early stage breast cancers treated with cryoablation. “Breast cancer is still the number one cancer affecting women that continues to increase in incidence as women age. Because the average breast cancer doubles in size every year, I encourage women to be diligent about annual screening,” said Dr. Kozlowski. “Ideally, we’ll continue to find more breast cancers early and treat them in-office with this innovative and effective procedure.” In a 5-year multicenter study funded by the National Cancer Institute and sponsored by the Alliance for Clinical Trials in Oncology, cryoablation with the Visica 2 Treatment System was shown to be 100% effective for complete ablation of invasive ductal breast cancer tumors <1.0cm. Results from this breast cancer study (ACOSOG Z1072), which included a 5-year follow-up, were published in the Annals of Surgical Oncology. The Visica 2 Treatment System was the exclusive device used in the Z1072 study and showed cryoablation effective in 92% of the targeted lesions. Cryoablation with the Visica 2 Treatment System is a safe and effective option for patients whose breast tumor is less than 4cm in diameter, visible on sonogram and has been confirmed with a biopsy. About Knoxville Comprehensive Breast Center Founded in 1983 by Kamilia F. Kozlowski, M.D., KCBC was the first independent breast center of its kind in Tennessee and remains one of only a few nationwide. The multidisciplinary practice delivers streamlined, cost-effective care in a woman-friendly setting. Specialists include clinical breast radiologists, a dedicated breast surgeon, medical oncologists, radiation oncologists, a breast pathologist, plastic and reconstructive surgeon and lymphedema specialist. Find out more by visiting http://www.knoxvillebreastcenter.com. About Sanarus Technologies In 2001, the Visica 2 Treatment System was the first system available for cryoablation of fibroadenomas. Since then, our system has been used to successfully treat thousands of patients. The System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we pride ourselves in developing innovative solutions for the nonsurgical treatment of breast tumors. We are headquartered in Pleasanton, CA and all of our products are manufactured in the USA. Find out more at http://www.sanarus.com.


News Article | October 26, 2016
Site: www.eurekalert.org

Satellite meetings for interested investigators will occur Nov. 28 and 30 at the Radiological Society of North America annual meeting in Chicago The Tomosynthesis Mammography Imaging Screening Trial (TMIST), the first large-scale breast cancer screening trial in nearly 25 years, is approved for funding by the National Cancer Institute (NCI). The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), leading the trial, is now recruiting medical facilities as it prepares to open the trial in mid-2017. TMIST will enroll 165,000 asymptomatic women in the US and Canada, between the ages of 45 and 74, to compare the incidence of advanced cancers in those screened for four years with digital breast tomosynthesis vs. standard digital mammography. The study aims to provide a modern basis for the continued use of mammography for breast cancer screening. Interested medical imaging providers can attend one of two TMIST informational sessions while at the upcoming Radiological Society of North America (RSNA) annual meeting in Chicago: No pre-registration is required to attend. To participate in TMIST, a medical facility must be (1) located in the US or Canada, (2) able to provide both imaging methods in the same location, and (3) a member of a research group in the NCI National Clinical Trials Network (NCTN), either directly or through the NCI Community Oncology Research Program (NCORP). TMIST will require nearly 100 sites, estimating that each will enroll about four to five women per day to reach the accrual goal in about three years. Available for interviews are the following spokespersons for TMIST: lead investigator Etta D. Pisano, MD at Beth Israel Deaconess Medical Center and Harvard Medical School; lead statistician Constantine A. Gatsonis, PhD at the ECOG-ACRIN Biostatistics and Data Management Center located at the Brown University Center for Statistical Sciences; and ECOG-ACRIN group co-chair Mitchell D. Schnall, MD, PhD at the University of Pennsylvania. TMIST image acquisition, storage, and sharing will be carried out at the ACR Center for Research and Innovation. Dr. Gatsonis will lead the TMIST statistical analysis. The NTCN research groups are the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG. Imaging providers can submit email inquiries at http://www. to check on their NCTN status or ask questions about the trial. The ECOG-ACRIN Cancer Research Group is a membership-based scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer. ECOG-ACRIN comprises nearly 1100 member institutions in the United States and around the world. Approximately 12,000 physicians, translational scientists, and associated research professionals from the member institutions are involved in Group research, which is organized into three scientific programs: Cancer Control and Outcomes, Therapeutic Studies, and Biomarker Sciences. ECOG-ACRIN is supported primarily through National Cancer Institute research grant funding, but also receives funding from private sector organizations through philanthropy and collaborations. It is headquartered in Philadelphia, Pa. For more information, visit http://www. or call 215.789.3631.

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