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Academic & Community Cancer Research United (ACCRU) Scientific Achievements Completed ACCRU Studies 2006-2011* • Number of studies: 29 • Tumor types: • • • • • • • • • Breast – 8 Cancer control - 5 CRC – 4 Ovarian – 3 Lung – 3 Lymphoma – 2 Melanoma – 2 Gastroesoph – 1 Pancreas – 1 Studies Breast CRC Ovarian Lung Lymphoma Melanoma Gastroesoph Pancreas Cancer control *Includes research conducted by Mayo Clinic Cancer Research Consortium (MCCRC) Accrual • Total accrual: 1698 patients • Tumor types: • • • • • • • • • Cancer control - 943 CRC – 295 Breast – 202 Lymphoma – 72 Lung – 71 Ovarian – 39 Gastroesoph – 33 Pancreas – 27 Melanoma – 15 Highlights Breast cancer Study design Results AVF3694g A Multicenter, Phase III, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Untreated Metastatic Breast Cancer (RIBBON I) Robert et al., JCO 2011 AVF3693g AVF3693g A Phase III, Multicenter, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Treated Metastatic Breast Cancer (RIBBON II) Brufsky et al., JCO 2011 Highlights Breast cancer Study design Results RC0639 Phase II Study of Cardiac Safety and Tolerability of an Adjuvant Chemotherapy plus Trastuzumab with Lapatinib in Patients with Resected HER2+ Breast Cancer Palmieri et al., AACR 2009 Johnson et al., AACR 2009 Highlights Colorectal cancer Study design Results 14387 (CORRECT) A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus Best Supportive Care in Patients with Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy Grothey et al., Lancet 2012 L_9444 (CONcePT) A Phase IV, Randomized, Prospective, Multicenter Comparison of an Intermittent Schedule of Oxaliplatin (IO) Combined with 5-Fluorouracil, Leucovorin (FOLFOX) Bevacizumab versus the Conventional (CO) Mode of Administration of FOLFOX/Bevacizumab Plus Neuro-prophylaxis with Calcium/Magnesium for the Optimization of First-Line Therapy of Metastatic Colorectal Cancer Grothey et al., ASCO 2008 Manuscript submitted as Hochster et al. Highlights Colorectal cancer Study design Results RC0948 The Oncotype DX Colon Cancer Assay for Stage II Colon Carcinoma: does it impact on physician adjuvant treatment decision making and patient satisfaction? Data to be presented at ASCO GI Symposium 2013 Alberts et al. Highlights Ovarian cancer Study design Results B9E-US-S302 Phase III Randomized Trial of Induction Chemotherapy with Gemcitabine and Carboplatin Followed by Elective Paclitaxel Consolidation versus Paclitaxel and Carboplatin Followed by Elective Paclitaxel Consolidation in Patients with Primary Epithelial Ovarian, Primary Peritoneal Cancer or Fallopian Tube Carcinoma Gordon et al., Gynecol Oncol 2011 RC0661 LAPTOP-OC: A Phase II Trial of Lapatinib in Combination with Weekly Topotecan in Patients with PlatinumRefractory/Resistant Ovarian and Primary Peritoneal Carcinoma Weroha et al., Gynecol Oncol 2011 Highlights Melanoma Study design Results AVF4096g (BEAM) A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients with Metastatic Melanoma Kim et al., JCO 2012 Highlights Lymphoma Study design Results MC0485 (ROAD) A Phase II Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone with Rituxan (ROAD) in Patients with Relapsed CD20+ B-Cell NonHodgkin's Lymphoma Johnston et al., ASCO 2009 Highlights Cancer control Study design Results MC04CC Phase III, randomized study of the effects of parenteral iron, oral iron, or no iron supplementation on the erythropoietic response to darbepoetin alfa for patients with chemotherapy-associated anemia. Blood 2009 Nov 20; 114(22):261; Zoledronic acid for treatment of osteopenia and osteoporosis in women with primary breast cancer undergoing adjuvant aromatase inhibitor therapy. Breast. 2010 Apr; 19(2):926. MC05C8 J Clin Oncol. 2011 Jan 1; 29(1):97-105. Contact Information • Dr. Axel Grothey, Professor of Oncology • ACCRU Chair • [email protected] • 507-284-5352 • Ms. Aimee Tillman, • ACCRU Program Manager-Operations • [email protected] • 507-266-4636 • Main Research Coordinating Center • [email protected] • 507-538-7448 ©2011 MFMER | slide-12