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https://www.readbyqxmd.com/read/27794124/intrinsic-subtype-and-therapeutic-response-among-her2-positive-breaty-st-tumors-from-the-ncctg-alliance-n9831-trial
#1
Edith A Perez, Karla V Ballman, Afshin Mashadi-Hossein, Kathleen S Tenner, Jennifer M Kachergus, Nadine Norton, Brian M Necela, Jennifer M Carr, Sean Ferree, Charles M Perou, Frederick Baehner, Maggie Chon U Cheang, E Aubrey Thompson
BACKGROUND: Genomic data from human epidermal growth factor receptor 2-positive (HER2+) tumors were analyzed to assess the association between intrinsic subtype and clinical outcome in a large, well-annotated patient cohort. METHODS: Samples from the NCCTG (Alliance) N9831 trial were analyzed using the Prosigna algorithm on the NanoString platform to define intrinsic subtype, risk of recurrence scores, and risk categories for 1392 HER2+ tumors. Subtypes were evaluated for recurrence-free survival (RFS) using Kaplan-Meier and Cox model analysis following adjuvant chemotherapy (n = 484) or chemotherapy plus trastuzumab (n = 908)...
February 2017: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/27374464/everolimus-combined-with-r-chop-21-for-new-untreated-diffuse-large-b-cell-lymphoma-ncctg-1085-alliance-safety-and-efficacy-results-of-a-phase-1-and-feasibility-trial
#2
Patrick B Johnston, Betsy LaPlant, Ellen McPhail, Thomas M Habermann, David J Inwards, Ivana N Micallef, Joseph P Colgan, Grzegorz S Nowakowski, Stephen M Ansell, Thomas E Witzig
BACKGROUND: The PI3K-mTORC pathway is upregulated in diffuse large B-cell lymphoma (DLBCL) and can be targeted with the mTOR complex 1 (mTORC1) inhibitor everolimus. Everolimus has activity in relapsed DLBCL. These data provide the rationale to combine everolimus with standard treatment for DLBCL of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone delivered in a 21-day cycle (R-CHOP-21) for six cycles. METHODS: We did a phase 1 and feasibility study (NCCTG 1085) of oral everolimus 10 mg/day plus R-CHOP-21 in patients aged at least 18 years with new, untreated, CD20-positive DLBCL (stages II-IV) in the NCCTG (Alliance) National Cancer Institute Cooperative Group (USA)...
July 2016: Lancet Haematology
https://www.readbyqxmd.com/read/27368067/results-of-ncctg-n0275-alliance-a-phase-ii-trial-evaluating-resection-followed-by-adjuvant-radiation-therapy-for-patients-with-desmoplastic-melanoma
#3
William G Rule, Jacob B Allred, Barbara A Pockaj, Svetomir N Markovic, David J DiCaudo, Lori A Erickson, Richard L Deming, Steven E Schild
To examine, in a prospective fashion, the utilization and efficacy of adjuvant radiation therapy (RT) in patients with resected desmoplastic melanoma (DM). Adult patients with resected, margin-negative, and nonmetastatic DM were eligible for this single-arm prospective phase II study. Patients were to receive postoperative RT, 30 Gy in five fractions, to the operative bed with 2- to 3-cm margins (depending on the tumor location). Nodal basin RT was not allowed. The primary study endpoint was the 2-year local recurrence rate (LRR)...
August 2016: Cancer Medicine
https://www.readbyqxmd.com/read/27197192/improved-survival-of-her2-breast-cancer-patients-treated-with-trastuzumab-and-chemotherapy-is-associated-with-host-antibody-immunity-against-the-her2-intracellular-domain
#4
Keith L Knutson, Raphael Clynes, Barath Shreeder, Patrick Yeramian, Kathleen P Kemp, Karla Ballman, Kathleen S Tenner, Courtney L Erskine, Nadine Norton, Donald Northfelt, Winston Tan, Carmen Calfa, Mark Pegram, Elizabeth A Mittendorf, Edith A Perez
The addition of trastuzumab to chemotherapy extends survival among patients with HER2(+) breast cancer. Prior work showed that trastuzumab and chemotherapy augments HER2 extracellular domain (ECD)-specific antibodies. The current study investigated whether combination therapy induced immune responses beyond HER2-ECD and, importantly, whether those immune responses were associated with survival. Pretreatment and posttreatment sera were obtained from 48 women with metastatic HER2(+) breast cancer on NCCTG (now Alliance for Clinical Trials in Oncology) studies, N0337 and N983252...
July 1, 2016: Cancer Research
https://www.readbyqxmd.com/read/27083333/longitudinal-adverse-event-assessment-in-oncology-clinical-trials-the-toxicity-over-time-toxt-analysis-of-alliance-trials-ncctg-n9741-and-979254
#5
Gita Thanarajasingam, Pamela J Atherton, Paul J Novotny, Charles L Loprinzi, Jeff A Sloan, Axel Grothey
BACKGROUND: Traditional methods of reporting adverse events in clinical trials are inadequate for modern cancer treatments with chronic administration. Conventional analysis and display of maximum grade adverse events do not capture toxicity profiles that evolve over time or longer lasting, lower grade toxic effects; we aimed to address this shortcoming in this study. METHODS: We developed an analytic approach and standardised, comprehensive format, the Toxicity over Time (ToxT) approach, which combines graphs and adverse event tabular displays with multiple longitudinal statistical techniques into a readily applicable method to study toxic effects...
May 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27047721/survival-in-patients-with-non-metastatic-breast-cancer-treated-with-adjuvant-trastuzumab-in-clinical-practice
#6
Christopher M Gallagher, Kenneth More, Anthony Masaquel, Tripthi Kamath, Annie Guerin, Raluca Ionescu-Ittu, Roy Nitulescu, Marjolaine Gauthier-Loiselle, Nicholas Sicignano, Elizabeth Butts, Eric Q Wu, Brian Barnett
PURPOSE: The NSABP Trial B-31 and NCCTG Trial N9831 (B-31/N9831 trials, Romond et al. in N Engl J Med 353:1673-84, 2005. doi:10.1056/NEJMoa052122; Perez et al. in J Clin Oncol 32:3744-52, 2014. doi:10.1200/JCO.2014.55.5730) established the efficacy of adjuvant trastuzumab for patients with HER2-positive early stage breast cancer. We aimed to estimate the overall survival (OS) and relapse-free survival (RFS) of HER2-positive non-metastatic breast cancer patients treated with adjuvant trastuzumab in a clinical practice setting in the United States...
2016: SpringerPlus
https://www.readbyqxmd.com/read/26795391/-cardiotoxicity-of-trastuzumab-in-the-adjuvant-treatment-of-breast-cancer-patients-results-of-the-ncctg-n9831-trial
#7
RANDOMIZED CONTROLLED TRIAL
David Krug
No abstract text is available yet for this article.
March 2016: Strahlentherapie und Onkologie: Organ der Deutschen Röntgengesellschaft ... [et Al]
https://www.readbyqxmd.com/read/26763541/testing-of-candidate-single-nucleotide-variants-associated-with-paclitaxel-neuropathy-in-the-trial-ncctg-n08c1-alliance
#8
Ganesh K Boora, Rahul Kanwar, Amit A Kulkarni, Alexej Abyzov, Jeff Sloan, Kathryn J Ruddy, Michaela S Banck, Charles L Loprinzi, Andreas S Beutler
Paclitaxel-induced peripheral neuropathy (PIPN) cannot be predicted from clinical parameters and might have a pharmacogenomic basis. Previous studies identified single nucleotide variants (SNV) associated with PIPN. However, only a subset of findings has been confirmed to date in more than one study, suggesting a need for further re-testing and validation in additional clinical cohorts. Candidate PIPN-associated SNVs were identified from the literature. SNVs were retested in 119 patients selected by extreme phenotyping from 269 in NCCTG N08C1 (Alliance) as previously reported...
April 2016: Cancer Medicine
https://www.readbyqxmd.com/read/26658227/association-between-dpyd-c-1129-5923-c-g-hapb3-and-severe-toxicity-to-5-fluorouracil-based-chemotherapy-in-stage-iii-colon-cancer-patients-ncctg-n0147-alliance
#9
RANDOMIZED CONTROLLED TRIAL
Adam M Lee, Qian Shi, Steven R Alberts, Daniel J Sargent, Frank A Sinicrope, Jeffrey L Berenberg, Axel Grothey, Blase Polite, Emily Chan, Sharlene Gill, Morton S Kahlenberg, Suresh G Nair, Anthony F Shields, Richard M Goldberg, Robert B Diasio
Severe (grade≥3) adverse events (AEs) to 5-fluorouracil (5-FU)-based chemotherapy regimens can result in treatment delays or cessation, and, in extreme cases, life-threatening complications. Current genetic biomarkers for 5-FU toxicity prediction, however, account for only a small proportion of toxic cases. In the current study, we assessed DPYD variants suggested to correlate with 5-FU toxicity, a deep intronic variant (c.1129-5923 C>G), and four variants within a haplotype (hapB3) in 1953 stage III colon cancer patients who received adjuvant FOLFOX±cetuximab...
March 2016: Pharmacogenetics and Genomics
https://www.readbyqxmd.com/read/26640699/adult-patients-with-supratentorial-pilocytic-astrocytoma-long-term-follow-up-of-prospective-multicenter-clinical-trial-ncctg-867251-alliance
#10
Paul D Brown, S Keith Anderson, Xiomara W Carrero, Brian P O'Neill, Caterina Giannini, Eva Galanis, Sunjay A Shah, Ross A Abrams, Walter J Curran, Jan C Buckner, Edward G Shaw
BACKGROUND: Pilocytic astrocytoma is a rare tumor in adults. This report is of a prospective clinical trial with long-term follow-up. METHODS: Between 1986 and 1994, 20 eligible adults with supratentorial pilocytic astrocytomas were enrolled in a prospective intergroup trial of radiotherapy (RT) after biopsy (3 patients) or observation after gross (11 patients) or subtotal (6 patients) resection. RESULTS: At the time of analysis (median follow-up, 20...
December 2015: Neuro-oncology Practice
https://www.readbyqxmd.com/read/26578722/gene-expression-profiling-identifies-responsive-patients-with-cancer-of-unknown-primary-treated-with-carboplatin-paclitaxel-and-everolimus-ncctg-n0871-alliance
#11
MULTICENTER STUDY
H H Yoon, N R Foster, J P Meyers, P D Steen, D W Visscher, R Pillai, D M Prow, C M Reynolds, B T Marchello, R B Mowat, B I Mattar, C Erlichman, M P Goetz
BACKGROUND: Carboplatin (C) and paclitaxel (P) are standard treatments for carcinoma of unknown primary (CUP). Everolimus, an mTOR inhibitor, exhibits activity in diverse cancer types. We did a phase II trial combining everolimus with CP for CUP. We also evaluated whether a gene expression profiling (GEP) test that predicts tissue of origin (TOO) could identify responsive patients. PATIENTS AND METHODS: A tumor biopsy was required for central confirmation of CUP and GEP...
February 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/26530743/a-randomized-phase-2-study-comparing-2-stereotactic-body-radiation-therapy-schedules-for-medically-inoperable-patients-with-stage-i-peripheral-non-small-cell-lung-cancer-nrg-oncology-rtog-0915-ncctg-n0927
#12
RANDOMIZED CONTROLLED TRIAL
Gregory M M Videtic, Chen Hu, Anurag K Singh, Joe Y Chang, William Parker, Kenneth R Olivier, Steven E Schild, Ritsuko Komaki, James J Urbanic, Robert D Timmerman, Hak Choy
PURPOSE: To compare 2 stereotactic body radiation therapy (SBRT) schedules for medically inoperable early-stage lung cancer to determine which produces the lowest rate of grade ≥3 protocol-specified adverse events (psAEs) at 1 year. METHODS AND MATERIALS: Patients with biopsy-proven peripheral (≥2 cm from the central bronchial tree) T1 or T2, N0 (clinically node negative by positron emission tomography), M0 tumors were eligible. Patients were randomized to receive either 34 Gy in 1 fraction (arm 1) or 48 Gy in 4 consecutive daily fractions (arm 2)...
November 15, 2015: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/26526218/comparing-and-validating-simple-measures-of-patient-reported-peripheral-neuropathy-for-oncology-clinical-trials-ncctg-n0897-alliance-a-pooled-analysis-of-2440-patients
#13
Heshan Liu, Angelina D Tan, Rui Qin, Daniel J Sargent, Axel Grothey, Jan C Buckner, Paul L Schaefer, Jeff A Sloan
INTRODUCTION: Current standard evaluation of Peripheral Neuropathy (PN) is based on an investigator-reported classification system that is commonly unable to correctly reflect the subjective symptoms for patients. Thus more reliable methods to assess PN are needed. This study assessed alternative methods of assessing patient-reported PN in 5 North Central Cancer Treatment Group (NCCTG) clinical trials. METHOD: Two single-item assessments relating to numbness and tingling were used to measure PN...
2015: SOJ Anesthesiology & Pain Management
https://www.readbyqxmd.com/read/26187617/analysis-of-molecular-markers-by-anatomic-tumor-site-in-stage-iii-colon-carcinomas-from-adjuvant-chemotherapy-trial-ncctg-n0147-alliance
#14
Frank A Sinicrope, Michelle R Mahoney, Harry H Yoon, Thomas C Smyrk, Stephen N Thibodeau, Richard M Goldberg, Garth D Nelson, Daniel J Sargent, Steven R Alberts
PURPOSE: To determine the frequency and prognostic association of molecular markers by anatomic tumor site in patients with stage III colon carcinomas. EXPERIMENTAL DESIGN: In a randomized trial of adjuvant FOLFOX ± cetuximab, BRAF(V600E) and KRAS (exon 2) mutations and DNA mismatch repair (MMR) proteins were analyzed in tumors (N = 3,018) in relationship to tumor location, including subsite. Cox models were used to assess clinical outcome, including overall survival (OS)...
December 1, 2015: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/26143528/association-of-the-charcot-marie-tooth-disease-gene-arhgef10-with-paclitaxel-induced-peripheral-neuropathy-in-ncctg-n08ca-alliance
#15
Ganesh K Boora, Amit A Kulkarni, Rahul Kanwar, Peter Beyerlein, Rui Qin, Michaela S Banck, Kathryn J Ruddy, Josef Pleticha, Cynthia A Lynch, Robert J Behrens, Stephan Züchner, Charles L Loprinzi, Andreas S Beutler
The predisposition of patients to develop polyneuropathy in response to toxic exposure may have a genetic basis. The previous study Alliance N08C1 found an association of the Charcot-Marie-Tooth disease (CMT) gene ARHGEF10 with paclitaxel chemotherapy induced peripheral neuropathy (CIPN) related to the three non-synonymous, recurrent single nucleotide variants (SNV), whereby rs9657362 had the strongest effect, and rs2294039 and rs17683288 contributed only weakly. In the present report, Alliance N08CA was chosen to attempt to replicate the above finding...
October 15, 2015: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/26056183/randomized-phase-iii-trial-of-paclitaxel-once-per-week-compared-with-nanoparticle-albumin-bound-nab-paclitaxel-once-per-week-or-ixabepilone-with-bevacizumab-as-first-line-chemotherapy-for-locally-recurrent-or-metastatic-breast-cancer-calgb-40502-ncctg-n063h
#16
RANDOMIZED CONTROLLED TRIAL
Hope S Rugo, William T Barry, Alvaro Moreno-Aspitia, Alan P Lyss, Constance Cirrincione, Eleanor Leung, Erica L Mayer, Michael Naughton, Deborah Toppmeyer, Lisa A Carey, Edith A Perez, Clifford Hudis, Eric P Winer
PURPOSE: We compared nab-paclitaxel or ixabepilone once per week to paclitaxel with bevacizumab as first-line therapy for patients with advanced breast cancer (BC) to evaluate progression-free survival (PFS) for nab-paclitaxel or ixabepilone versus paclitaxel. PATIENTS AND METHODS: Eligible patients were age ≥ 18 years with chemotherapy-naive advanced BC. Patients were randomly assigned to bevacizumab with paclitaxel 90 mg/m(2) (arm A), nab-paclitaxel 150 mg/m(2) (arm B), or ixabepilone 16 mg/m(2) (arm C), once per week for 3 of 4 weeks...
July 20, 2015: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/26031708/the-complementary-nature-of-patient-reported-outcomes-and-adverse-event-reporting-in-cooperative-group-oncology-clinical-trials-a-pooled-analysis-ncctg-n0591
#17
MULTICENTER STUDY
Pamela J Atherton, Deborah W Watkins-Bruner, Carolyn Gotay, Carol M Moinpour, Daniel V Satele, Kathryn A Winter, Paul L Schaefer, Benjamin Movsas, Jeff A Sloan
CONTEXT: Clinical trials use clinician-graded adverse events (AEs) and patient-reported outcomes (PROs) to describe symptoms. OBJECTIVES: The aim of the study was to examine the agreement between PROs and AEs in the clinical trial setting. METHODS: Patient-level data were pooled from seven North Central Cancer Treatment Group, two Southwest Oncology Group, and three Radiation Therapy Oncology Group lung studies that included both PROs and AE data...
October 2015: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/25605861/genomic-analysis-reveals-that-immune-function-genes-are-strongly-linked-to-clinical-outcome-in-the-north-central-cancer-treatment-group-n9831-adjuvant-trastuzumab-trial
#18
RANDOMIZED CONTROLLED TRIAL
Edith A Perez, E Aubrey Thompson, Karla V Ballman, S Keith Anderson, Yan W Asmann, Krishna R Kalari, Jeanette E Eckel-Passow, Amylou C Dueck, Kathleen S Tenner, Jin Jen, Jian-Bing Fan, Xochiquetzal J Geiger, Ann E McCullough, Beiyun Chen, Robert B Jenkins, George W Sledge, Eric P Winer, Julie R Gralow, Monica M Reinholz
PURPOSE: To develop a genomic signature that predicts benefit from trastuzumab in human epidermal growth factor receptor 2-positive breast cancer. PATIENTS AND METHODS: DASL technology was used to quantify mRNA in samples from 1,282 patients enrolled onto the Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer (North Central Cancer Treatment Group N9831 [NCCTG-N9831]) adjuvant trastuzumab trial. Cox proportional hazard ratios (HRs), adjusted for significant clinicopathologic risk factors, were used to determine the association of each gene with relapse-free survival (RFS) for 433 patients who received chemotherapy alone (arm A) and 849 patients who received chemotherapy plus trastuzumab (arms B and C)...
March 1, 2015: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/25526733/a-phase-ii-trial-of-everolimus-temozolomide-and-radiotherapy-in-patients-with-newly-diagnosed-glioblastoma-ncctg-n057k
#19
MULTICENTER STUDY
Daniel J Ma, Evanthia Galanis, S Keith Anderson, David Schiff, Timothy J Kaufmann, Patrick J Peller, Caterina Giannini, Paul D Brown, Joon H Uhm, Steven McGraw, Kurt A Jaeckle, Patrick J Flynn, Keith L Ligon, Jan C Buckner, Jann N Sarkaria
BACKGROUND: The mammalian target of rapamycin (mTOR) functions within the phosphatidylinositol-3 kinase (PI3K)/Akt pathway as a critical modulator of cell survival. This clinical trial evaluated the combination of the mTOR inhibitor everolimus with conventional temozolomide (TMZ)-based chemoradiotherapy. METHODS: Newly diagnosed patients with glioblastoma multiforme were eligible for this single arm, phase II study. Everolimus (70 mg/wk) was started 1 week prior to radiation and TMZ, followed by adjuvant TMZ, and continued until disease progression...
September 2015: Neuro-oncology
https://www.readbyqxmd.com/read/25490892/loss-of-heterozygosity-at-the-cyp2d6-locus-in-breast-cancer-implications-for-germline-pharmacogenetic-studies
#20
Matthew P Goetz, James X Sun, Vera J Suman, Grace O Silva, Charles M Perou, Yusuke Nakamura, Nancy J Cox, Philip J Stephens, Vincent A Miller, Jeffrey S Ross, David Chen, Stephanie L Safgren, Mary J Kuffel, Matthew M Ames, Krishna R Kalari, Henry L Gomez, Ana M Gonzalez-Angulo, Octavio Burgues, Hiltrud B Brauch, James N Ingle, Mark J Ratain, Roman Yelensky
BACKGROUND: Controversy exists regarding the impact of CYP2D6 genotype on tamoxifen responsiveness. We examined loss of heterozygosity (LOH) at the CYP2D6 locus and determined its impact on genotyping error when tumor tissue is used as a DNA source. METHODS: Genomic tumor data from the adjuvant and metastatic settings (The Cancer Genome Atlas [TCGA] and Foundation Medicine [FM]) were analyzed to characterize the impact of CYP2D6 copy number alterations (CNAs) and LOH on Hardy Weinberg equilibrium (HWE)...
December 8, 2014: Journal of the National Cancer Institute
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