Academic & Community Cancer Research United (ACCRU) Scientific Achievements

Completed ACCRU Studies * 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 *Includes research conducted by Mayo Clinic Cancer Research Consortium (MCCRC)

Accrual Total accrual: 1698 patients Tumor types: Cancer control CRC – 295 Breast – 202 Lymphoma – 72 Lung – 71 Ovarian – 39 Gastroesoph – 33 Pancreas – 27 Melanoma – 15

Highlights Breast cancerStudy designResults 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 cancerStudy designResults 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 cancerStudy designResults (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 cancerStudy designResults 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 cancerStudy designResults 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 Platinum- Refractory/Resistant Ovarian and Primary Peritoneal Carcinoma Weroha et al., Gynecol Oncol 2011

Highlights MelanomaStudy designResults 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 LymphomaStudy designResults MC0485 (ROAD) A Phase II Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone with Rituxan (ROAD) in Patients with Relapsed CD20+ B-Cell Non- Hodgkin's Lymphoma Johnston et al., ASCO 2009

Highlights Cancer controlStudy designResults 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; J Clin Oncol Jan 1; 29(1): MC05C8 Zoledronic acid for treatment of osteopenia and osteoporosis in women with primary breast cancer undergoing adjuvant aromatase inhibitor therapy. Breast Apr; 19(2):92- 6.

©2011 MFMER | slide-12 Contact Information Dr. Axel Grothey, Professor of Oncology ACCRU Chair Ms. Aimee Tillman, ACCRU Program Manager-Operations Main Research Coordinating Center