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Mehra Golshan, Constance T Cirrincione, William M Sikov, Lisa A Carey, Donald A Berry, Beth Overmoyer, Nora L Henry, George Somlo, Elisa Port, Harold J Burstein, Clifford Hudis, Eric Winer, David W Ollila
OBJECTIVE: It had been previously shown that patients who receive neoadjuvant systemic therapy (NST) are more likely to undergo breast-conserving therapy (BCT) than those who have primary surgery. However, the frequency with which patients who are not BCT-eligible prior to NST convert to BCT-eligible with treatment is unknown. To document this conversion rate in a subset of patients expected to have a high clinical response rate to NST, we studied surgical assessment and management of patients enrolled on a randomized neoadjuvant trial for stage II-III HER2-positive breast cancer (HER2 + BC)(CALGB 40601)...
November 2016: Breast Cancer Research and Treatment
W Blum, B L Sanford, R Klisovic, D J DeAngelo, G Uy, B L Powell, W Stock, M R Baer, J E Kolitz, E S Wang, E Hoke, K Mrózek, J Kohlschmidt, C D Bloomfield, S Geyer, G Marcucci, R M Stone, R A Larson
In this prospective phase 2 clinical trial conducted by Cancer and Leukemia Group B (CALGB, now the Alliance), we studied decitabine as maintenance therapy for younger adults with acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive induction and consolidation. Given that decitabine is clinically active in AML and with hypomethylating activity distinct from cytotoxic chemotherapy, we hypothesized that 1 year of maintenance therapy would improve disease-free survival (DFS) for AML patients <60 years, who did not receive allogeneic stem cell transplantation in CR1...
October 7, 2016: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
Alberto Sandri, Francesco Guerrera, Matteo Roffinella, Stefania Olivetti, Lorena Costardi, Alberto Oliaro, Pier Luigi Filosso, Paolo Olivo Lausi, Enrico Ruffini
BACKGROUND: To assess the trend of our surgical patients affected by malignant pleural mesothelioma (MPM) and submitted to diagnostic/palliative or curative surgical procedures and to validate the European Organisation for Research and Treatment of Cancer (EORTC) prognostic score in our patient population. METHODS: This is a cohort study of patients submitted to surgery for MPM from January 2007 to December 2013. Primary outcome was overall survival (OS). Univariate and multivariate-adjusted comparisons by EORTC prognostic score for OS were accomplished using Cox method...
August 2016: Journal of Thoracic Disease
Christian Niederwieser, Deedra Nicolet, Andrew J Carroll, Jonathan E Kolitz, Bayard L Powell, Jessica Kohlschmidt, Richard M Stone, John C Byrd, Krzysztof Mrózek, Clara D Bloomfield
Achievement of complete remission is essential for long-term survival of acute myeloid leukemia patients. We evaluated the prognostic significance of cytogenetics at complete remission in 258 adults with de novo acute myeloid leukemia and abnormal pretreatment karyotypes, treated on Cancer and Leukemia Group B front-line studies, with cytogenetic data at onset of morphologic complete remission. Thirty-two patients had abnormal karyotypes at time of initial complete remission (28 had ≥1 abnormalities seen pretreatment, and four acute myeloid leukemia-related abnormalities not detected pretreatment); 226 patients had normal remission karyotypes...
July 28, 2016: Haematologica
Ace J Hatch, Alexander B Sibley, Mark D Starr, J Chris Brady, Chen Jiang, Jingquan Jia, Daniel L Bowers, Herbert Pang, Kouros Owzar, Donna Niedzwiecki, Federico Innocenti, Alan P Venook, Herbert I Hurwitz, Andrew B Nixon
Circulating protein markers were assessed in patients with colorectal cancer (CRC) treated with cetuximab in CALGB 80203 to identify prognostic and predictive biomarkers. Patients with locally advanced or metastatic CRC received FOLFOX or FOLFIRI chemotherapy (chemo) or chemo in combination with cetuximab. Baseline plasma samples from 152 patients were analyzed for six candidate markers [epidermal growth factor (EGF), heparin-binding EGF (HBEGF), epidermal growth factor receptor (EGFR), HER2, HER3, and CD73]...
September 2016: Cancer Medicine
Erica T Warner, Karla V Ballman, Carrie Strand, Judy C Boughey, Aman U Buzdar, Lisa A Carey, William M Sikov, Ann H Partridge
Previous studies demonstrated poor response to neoadjuvant systemic therapy (NST) for breast cancer among black women and women who are overweight or obese, but this may be due to chemotherapy underdosing. We assessed associations of race, ethnicity, and body mass index (BMI) with pathologic complete response (pCR) in clinical trial populations. 1797 women enrolled in four NST trials (CALGB 40601, 40603; ACOSOG Z1041, Z1071) were included. Tumor subtypes were defined by estrogen receptor (ER) and HER2 status...
August 2016: Breast Cancer Research and Treatment
Jeanne S Mandelblatt, Jonathan D Clapp, Gheorghe Luta, Leigh Anne Faul, Michelle D Tallarico, Trina D McClendon, Jessica A Whitley, Ling Cai, Tim A Ahles, Robert A Stern, Paul B Jacobsen, Brent J Small, Brandelyn N Pitcher, Estrella Dura-Fernandis, Hyman B Muss, Arti Hurria, Harvey J Cohen, Claudine Isaacs
BACKGROUND: The number of survivors of breast cancer aged ≥65 years ("older") is growing, but to the authors' knowledge, little is known regarding the cognitive outcomes of these individuals. METHODS: A cohort of cognitively intact older survivors with nonmetastatic, invasive breast cancer was recruited from 78 sites from 2004 through 2011; approximately 83.7% of the survivors (1280 survivors) completed baseline assessments. Follow-up data were collected at 6 months and annually for up to 7 years (median, 4...
July 22, 2016: Cancer
Jing Zhou, Rongce Zhao, Feng Wen, Pengfei Zhang, Ruilei Tang, Hongdou Chen, Jian Zhang, Qiu Li
Cetuximab (Cetux)/Bevacizumab (Bev) treatments have shown considerably survival benefits for patients with metastatic colorectal cancer (mCRC) in the last decade. But they are costly. Currently, no data is available on the health economic implications of testing for extended RAS wild-type (wt) prior to Cetux/Bev treatments of patients with mCRC. This paper aimed to evaluate the cost-effectiveness of predictive testing for extended RAS-wt status in mCRC in the context of targeting the use of Cetux/Bev.Markov model 1 was conducted to provide evidence evaluating the cost-effectiveness of predictive testing for KRAS-wt or extended RAS-wt status based on treatments of chemotherapy plus Cetux/Bev...
July 2016: Medicine (Baltimore)
Peter C Enzinger, Barbara Ann Burtness, Donna Niedzwiecki, Xing Ye, Kathe Douglas, David H Ilson, Victoria Meucci Villaflor, Steven J Cohen, Robert J Mayer, Alan Venook, Al Bowen Benson, Richard M Goldberg
PURPOSE: To determine the optimal chemotherapy backbone for testing in future US cooperative group studies for metastatic esophageal and gastroesophageal junction cancers. Cetuximab was added to each treatment arm based on promising preclinical data. PATIENTS AND METHODS: Patients with previously untreated metastatic esophageal or gastroesophageal junction cancer were randomly assigned at a one-to-one-to-one ratio to epirubicin, cisplatin, and continuous-infusion fluorouracil (ECF), irinotecan plus cisplatin (IC), or FOLFOX (oxaliplatin, leucovorin, and bolus and infusional fluorouracil)...
August 10, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Daniel L Hertz, Kouros Owzar, Sherrie Lessans, Claudia Wing, Chen Jiang, William K Kelly, Jai N Patel, Susan Halabi, Yoichi Furukawa, Heather E Wheeler, Alexander Sibley, Cameron Lassiter, Lois S Weisman, Dorothy Watson, Stefanie D Krens, Flora Mulkey, Cynthia L Renn, Eric J Small, Philip G Febbo, Ivo Shterev, Deanna Kroetz, Paula N Friedman, John F Mahoney, Michael A Carducci, Michael J Kelley, Yusuke Nakamura, Michiaki Kubo, Susan G Dorsey, M Eileen Dolan, Michael J Morris, Mark J Ratain, Howard L McLeod
PURPOSE: Discovery of single nucleotide polymorphisms (SNPs) that predict a patient's risk of docetaxel-induced neuropathy would enable treatment individualization to maximize efficacy and avoid unnecessary toxicity. The objectives of this analysis were to discover SNPs associated with docetaxel-induced neuropathy and mechanistically validate these associations in preclinical models of drug-induced neuropathy. EXPERIMENTAL DESIGN: A genome-wide association study was conducted in metastatic castrate-resistant prostate cancer patients treated with docetaxel, prednisone and randomized to bevacizumab or placebo on CALGB 90401...
May 3, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Maura N Dickler, William T Barry, Constance T Cirrincione, Matthew J Ellis, Mary Ellen Moynahan, Federico Innocenti, Arti Hurria, Hope S Rugo, Diana E Lake, Olwen Hahn, Bryan P Schneider, Debasish Tripathy, Lisa A Carey, Eric P Winer, Clifford A Hudis
PURPOSE: To investigate whether anti-vascular endothelial growth factor therapy with bevacizumab prolongs progression-free survival (PFS) when added to first-line letrozole as treatment of hormone receptor-positive metastatic breast cancer (MBC). PATIENTS AND METHODS: Women with hormone receptor-positive MBC were randomly assigned 1:1 in a multicenter, open-label, phase III trial of letrozole (2.5 mg orally per day) with or without bevacizumab (15 mg/kg intravenously once every 3 weeks) within strata defined by measurable disease and disease-free interval...
August 1, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
H Alachkar, N Fulton, B Sanford, G Malnassy, M Mutonga, R A Larson, C D Bloomfield, G Marcucci, Y Nakamura, W Stock
Asparaginase, which depletes asparagine and glutamine, activates amino-acid stress response. Oxidative stress mediated by excessive reactive oxygen species (ROS) causes enhanced mitochondrial permeabilization and subsequent cell apoptosis and is considered as a plausible mechanism for drug-induced hepatotoxicity, a common toxicity of asparaginase in adults with acute lymphoblastic leukemia (ALL). Studies investigating the pharmacogenetics of asparaginase in ALL are limited and focused on asparaginase-induced allergic reaction common in pediatric patients...
March 29, 2016: Pharmacogenomics Journal
Eugene J Pietzak, James A Eastham
Multimodal strategies combining local and systemic therapy offer the greatest chance of cure for many with men with high-risk prostate cancer who may harbor occult metastatic disease. However, no systemic therapy combined with radical prostatectomy has proven beneficial. This was in part due to a lack of effective systemic agents; however, there have been several advancements in the metastatic and castrate-resistant prostate cancer that might prove beneficial if given earlier in the natural history of the disease...
May 2016: Current Urology Reports
Massimo Di Maio, Paolo Bironzo, Giorgio Vittorio Scagliotti
With the advent of targeted agents, randomized phase II trials designed with explicit comparative intent, to allow a better interpretation of the results obtained with experimental treatment, have become a common approach for anti-cancer drug development. In the Cancer and Leukemia Group B (CALGB) 30504 randomized phase II trial, patients with extensive-stage small-cell lung cancer (SCLC), without progression after four to six cycles of standard chemotherapy with cisplatin or carboplatin plus etoposide, were randomized to sunitinib or placebo, until disease progression...
February 2016: Translational Lung Cancer Research
Linda W Martin, Jonathan D'Cunha, Xiaofei Wang, Debra Herzan, Lin Gu, Naif Abraham, Todd L Demmy, Frank C Detterbeck, Shawn S Groth, David H Harpole, Mark J Krasna, Kemp Kernstine, Leslie J Kohman, G Alexander Patterson, David J Sugarbaker, Robin T Vollmer, Michael A Maddaus, Robert A Kratzke
PURPOSE: Outcomes after resection of stage I non-small-cell lung cancer (NSCLC) are variable, potentially due to undetected occult micrometastases (OM). Cancer and Leukemia Group B 9761 was a prospectively designed study aimed at determining the prognostic significance of OM. MATERIALS AND METHODS: Between 1997 and 2002, 502 patients with suspected clinical stage I (T1-2N0M0) NSCLC were prospectively enrolled at 11 institutions. Primary tumor and lymph nodes (LNs) were collected and sent to a central site for molecular analysis...
May 1, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Xiaoli Ma, Gwénaël Le Teuff, Benjamin Lacas, Ming Sound Tsao, Stephen Graziano, Jean-Pierre Pignon, Jean-Yves Douillard, Thierry Le Chevalier, Lesley Seymour, Martin Filipits, Robert Pirker, Pasi A Jänne, Frances A Shepherd, Elisabeth Brambilla, Jean-Charles Soria, Pierre Hainaut
INTRODUCTION: Tumor protein p53 gene (TP53) mutations are common in stage I through III non-small cell lung cancer, but clinical trials have shown inconsistent results regarding their relationship to the effects of adjuvant therapy. The objective is to clarify their putative prognostic and predictive effects. METHODS: A pooled analysis of TP53 mutations (exons 5-8) was conducted in four randomized trials (the International Adjuvant Lung Cancer Trial, J BRonchus 10, Cancer and Leukemia Group B-9633, and Adjuvant Navelbine International Trialist Association trial) of platinum-based adjuvant chemotherapy (ACT) versus observation (OBS)...
June 2016: Journal of Thoracic Oncology
Rebecca DeBoer, Gregory Koval, Flora Mulkey, Meir Wetzler, Steven Devine, Guido Marcucci, Richard M Stone, Richard A Larson, Clara D Bloomfield, Susan Geyer, Charles G Mullighan, Wendy Stock
Recent studies have identified oncogenic lesions in Philadelphia chromosome-positive (Ph+)  acute lymphoblastic leukemia (ALL) and ABL1 kinase mutations that confer resistance to tyrosine kinase inhibitors. We sought to determine the prevalence and clinical impact of these lesions in patients on CALGB 10001, a previously reported Phase II study of imatinib, chemotherapy, and hematopoietic cell transplant in adult Ph + ALL. Of the 58 enrolled, 22 relapsed. By direct sequencing, an ABL1 kinase mutation known to induce imatinib resistance was present at relapse in 13 of 20...
October 2016: Leukemia & Lymphoma
Hyung L Kim, Susan Halabi, Ping Li, Greg Mayhew, Jeff Simko, Andrew B Nixon, Eric J Small, Brian Rini, Michael J Morris, Mary-Ellen Taplin, Daniel George
BACKGROUND: Prognosis associated with metastatic renal cell carcinoma (mRCC) can vary widely. METHODS: This study used pretreatment nephrectomy specimens from a randomized phase III trial. Expression levels of candidate genes were determined from archival tumors using the OpenArray® platform for TaqMan® RT-qPCR. The dataset was randomly divided at 2:1 ratio into training (n = 221) and testing (n = 103) sets to develop a multigene prognostic signature. FINDINGS: Gene expressions were measured in 324 patients...
November 2015: EBioMedicine
Nataniel H Lester-Coll, Charles E Rutter, Suzanne B Evans
BACKGROUND AND PURPOSE: Breast radiotherapy (RT) for elderly women with estrogen receptor positive early stage breast cancer (ER+ESBC) improves local recurrence (LR) rates without benefitting overall survival. Breast boost is a common practice, although the absolute benefit decreases with age. Consequently, an analysis of its cost-effectiveness in the elderly ESBC populations is warranted. MATERIAL AND METHODS: A Markov model was used to compare cost-effectiveness of RT with or without a boost in elderly ER+ESBC patients...
April 2016: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
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