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https://www.readbyqxmd.com/read/29044496/ncctg-n0879-alliance-a-randomized-phase-2-cooperative-group-trial-of-carboplatin-paclitaxel-and-bevacizumab%C3%A2-%C3%A2-%C3%A2-everolimus-for-metastatic-melanoma
#1
Robert R McWilliams, Jacob B Allred, Jessica A Slostad, Rajini Katipamula, Roxana S Dronca, Kandelaria M Rumilla, Lori A Erickson, Alan H Bryce, Richard W Joseph, Lisa A Kottschade, David M King, John M Leitch, Svetomir N Markovic
BACKGROUND: Despite the success of immune checkpoint and targeted therapy, many patients with melanoma ultimately require further treatment. The combination of carboplatin, paclitaxel, and bevacizumab (CPB) has demonstrated promising activity in a single-arm study. In the current study, the authors performed a randomized phase 2 study to confirm efficacy and to determine whether adding everolimus would increase the activity of the combination. METHODS: Through the North Central Cancer Treatment Group, a total of 149 patients with unresectable AJCC 6th edition stage IV melanoma were randomized from May 2010 to May 2014 to either CPB or CPB with everolimus (CPBE)...
October 17, 2017: Cancer
https://www.readbyqxmd.com/read/28983557/role-of-deficient-dna-mismatch-repair-status-in-patients-with-stage-iii-colon-cancer-treated-with-folfox-adjuvant-chemotherapy-a-pooled-analysis-from-2-randomized-clinical-trials
#2
Aziz Zaanan, Qian Shi, Julien Taieb, Steven R Alberts, Jeffrey P Meyers, Thomas C Smyrk, Catherine Julie, Ayman Zawadi, Josep Tabernero, Enrico Mini, Richard M Goldberg, Gunnar Folprecht, Jean Luc Van Laethem, Karine Le Malicot, Daniel J Sargent, Pierre Laurent-Puig, Frank A Sinicrope
Importance: The prognostic impact of DNA mismatch repair (MMR) status in stage III colon cancer patients receiving FOLFOX (folinic acid, fluorouracil, and oxaliplatin) adjuvant chemotherapy remains controversial. Objective: To determine the association of MMR status with disease-free survival (DFS) in patients with stage III colon cancer treated with FOLFOX. Design, Setting, and Participants: The evaluated biomarkers for MMR status were determined from prospectively collected tumor blocks from patients treated with FOLFOX in 2 open-label, phase 3 randomized clinical trials: NCCTG N0147 and PETACC8...
October 5, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28921241/evaluating-the-efficacy-of-vaginal-dehydroepiandosterone-for-vaginal-symptoms-in-postmenopausal-cancer-survivors-ncctg-n10c1-alliance
#3
Debra L Barton, Jeff A Sloan, Lynne T Shuster, Paula Gill, Patricia Griffin, Kathleen Flynn, Shelby A Terstriep, Fauzia N Rana, Travis Dockter, Pamela J Atherton, Michaela Tsai, Keren Sturtz, Jacqueline M Lafky, Mike Riepl, Jacqueline Thielen, Charles L Loprinzi
BACKGROUND: Women with estrogen deficiencies can suffer from vaginal symptoms that negatively impact sexual health. This study evaluated vaginal dehydroepiandrosterone (DHEA) for alleviation of vaginal symptoms. METHODS: This three-arm randomized, controlled trial evaluated DHEA 3.25 mg and DHEA 6.5 mg, each compared to a plain moisturizer (PM) over 12 weeks, to improve the severity of vaginal dryness or dyspareunia, measured with an ordinal scale, and overall sexual health using the Female Sexual Function Index (FSFI)...
September 18, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28917648/challenges-of-conducting-a-prospective-clinical-trial-for-older-patients-lessons-learned-from-ncctg-n0949-alliance
#4
Nadine J McCleary, Joleen Hubbard, Michelle R Mahoney, Jeffrey A Meyerhardt, Daniel Sargent, Alan Venook, Axel Grothey
OBJECTIVES: While the risk of developing colorectal cancer increases with age, there are limited prospective data regarding best treatment in the older adult population. We launched a phase III trial to evaluate difference in treatment outcome for older adults (aged ≥70years) with advanced colorectal cancer. Here we review the challenges faced and reasons for poor accrual to N0949. MATERIALS AND METHODS: We describe the conceptualization, development and limited results of N0949, a randomized phase III study of fluoropyrimidine/bevacizumab with or without oxaliplatin (mFOLFOX7 or XELOX) as first line chemotherapy for metastatic colorectal cancer...
September 13, 2017: Journal of Geriatric Oncology
https://www.readbyqxmd.com/read/28763429/genome-wide-association-study-of-cardiotoxicity-in-the-ncctg-n9831-alliance-adjuvant-trastuzumab-trial
#5
Daniel J Serie, Julia E Crook, Brian M Necela, Travis J Dockter, Xue Wang, Yan W Asmann, DeLisa Fairweather, Katelyn A Bruno, Gerardo Colon-Otero, Edith A Perez, E Aubrey Thompson, Nadine Norton
OBJECTIVES: The major clinical side effect of the ERBB2-targeted breast cancer therapy, trastuzumab, is a decline in the left ventricular ejection fraction (LVEF). Improved markers are needed to better identify patients susceptible to cardiotoxicity. METHODS: The NCCTG N9831 trial compared adjuvant doxorubicin and cyclophosphamide followed by either weekly paclitaxel (arm A); paclitaxel then trastuzumab (arm B); or concurrent paclitaxel and trastuzumab (arm C) in patients with HER2-positive breast cancer...
October 2017: Pharmacogenetics and Genomics
https://www.readbyqxmd.com/read/28700816/comparative-nocebo-effects-in-older-patients-enrolled-in-cancer-therapeutic-trials-observations-from-a-446-patient-cohort
#6
Jared C Foster, Jennifer G Le-Rademacher, Josephine L Feliciano, Ajeet Gajra, Drew K Seisler, Ronald DeMatteo, Jacqueline M Lafky, Arti Hurria, Hyman B Muss, Harvey J Cohen, Aminah Jatoi
BACKGROUND: A nocebo is an inert substance associated with adverse events. Although previous studies have examined the positive (placebo) effects of such inert substances, few have examined negative (nocebo) adverse event profiles, particularly in older patients who have higher morbidity and can experience frequent and severe adverse events from cancer therapy. METHODS: This study focused on placebo/nocebo-exposed patients who participated in 2 double-blind, placebo-controlled, cancer therapeutic studies, namely, North Central Cancer Therapy Group trial NCCTG 97-24-51 and American College of Surgeons Oncology Group trial Z9001, with the goal of reporting the comparative, age-based adverse event rates, as reported during the conduct of these trials...
November 1, 2017: Cancer
https://www.readbyqxmd.com/read/28687377/postoperative-stereotactic-radiosurgery-compared-with-whole-brain-radiotherapy-for-resected-metastatic-brain-disease-ncctg-n107c-cec%C3%A2-3-a-multicentre-randomised-controlled-phase-3-trial
#7
RANDOMIZED CONTROLLED TRIAL
Paul D Brown, Karla V Ballman, Jane H Cerhan, S Keith Anderson, Xiomara W Carrero, Anthony C Whitton, Jeffrey Greenspoon, Ian F Parney, Nadia N I Laack, Jonathan B Ashman, Jean-Paul Bahary, Costas G Hadjipanayis, James J Urbanic, Fred G Barker, Elana Farace, Deepak Khuntia, Caterina Giannini, Jan C Buckner, Evanthia Galanis, David Roberge
BACKGROUND: Whole brain radiotherapy (WBRT) is the standard of care to improve intracranial control following resection of brain metastasis. However, stereotactic radiosurgery (SRS) to the surgical cavity is widely used in an attempt to reduce cognitive toxicity, despite the absence of high-level comparative data substantiating efficacy in the postoperative setting. We aimed to establish the effect of SRS on survival and cognitive outcomes compared with WBRT in patients with resected brain metastasis...
August 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28649983/high-rate-of-event-free-survival-at-24-months-with-everolimus-rchop-for-untreated-diffuse-large-b-cell-lymphoma-updated-results-from-ncctg-n1085-alliance
#8
T E Witzig, B LaPlant, T M Habermann, E McPhail, D J Inwards, I N Micallef, J P Colgan, G S Nowakowski, S M Ansell, P B Johnston
No abstract text is available yet for this article.
June 23, 2017: Blood Cancer Journal
https://www.readbyqxmd.com/read/28634656/patient-reported-eortc-qlq-cipn20-versus-physician-reported-ctcae-quantification-of-oxaliplatin-and-paclitaxel-carboplatin-induced-peripheral-neuropathy-in-ncctg-alliance-clinical-trials
#9
Jennifer Le-Rademacher, Rahul Kanwar, Drew Seisler, Deirdre R Pachman, Rui Qin, Alexej Abyzov, Kathryn J Ruddy, Michaela S Banck, Ellen M Lavoie Smith, Susan G Dorsey, Neil K Aaronson, Jeff Sloan, Charles L Loprinzi, Andreas S Beutler
PURPOSE: Clinical practice guidelines on chemotherapy-induced peripheral neuropathy (CIPN) use the NCI Common Terminology Criteria for Adverse Events (CTCAE), while recent clinical trials employ a potentially superior measure, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20), a patient-reported outcome (PRO). Practitioners and researchers lack guidance, regarding how QLQ-CIPN20 results relate to the traditional CTCAE during the serial assessment of patients undergoing chemotherapy...
June 20, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28624696/superimposable-outcomes-for-sequential-and-concomitant-administration-of-adjuvant-trastuzumab-in%C3%A2-her2-positive-breast-cancer-results-from-the-signal-phare-prospective-cohort
#10
RANDOMIZED CONTROLLED TRIAL
Xavier Pivot, Pierre Fumoleau, Jean-Yves Pierga, Suzette Delaloge, Hervé Bonnefoi, Thomas Bachelot, Christelle Jouannaud, Hugues Bourgeois, Maria Rios, Patrick Soulié, Jean-Philippe Jacquin, Sandrine Lavau-Denes, Pierre Kerbrat, David Cox, Céline Faure-Mercier, Iris Pauporte, Joseph Gligorov, Elsa Curtit, Julie Henriques, Sophie Paget-Bailly, Gilles Romieu
AIM: Adjuvant clinical trials in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer have assessed either sequential or concomitant incorporation of trastuzumab with chemotherapy; only the North Central Cancer Treatment Group (NCCTG)-N9831 trial prospectively compared both modalities. In routine trastuzumab has been incorporated into a concurrent regimen with taxane chemotherapy instead of sequential modality on the basis of a positive risk-benefit ratio. This present study assessed sequential versus concomitant administration of adjuvant trastuzumab...
August 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28552517/cost-effectiveness-analysis-of-stereotactic-radiosurgery-alone-versus-stereotactic-radiosurgery-with-upfront-whole-brain-radiation-therapy-for-brain-metastases
#11
H Kim, M S Rajagopalan, S Beriwal, K J Smith
AIMS: Stereotactic radiosurgery (SRS) alone or upfront whole brain radiation therapy (WBRT) plus SRS are the most commonly used treatment options for one to three brain oligometastases. The most recent randomised clinical trial result comparing SRS alone with upfront WBRT plus SRS (NCCTG N0574) has favoured SRS alone for neurocognitive function, whereas treatment options remain controversial in terms of cognitive decline and local control. The aim of this study was to conduct a cost-effectiveness analysis of these two competing treatments...
May 25, 2017: Clinical Oncology: a Journal of the Royal College of Radiologists
https://www.readbyqxmd.com/read/28376219/intrinsic-subtype-and-therapeutic-response-among-her2-positive-breast-tumors-from-the-ncctg-alliance-n9831-trial
#12
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 1, 2017: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/28280603/family-history-of-colorectal-cancer-and-its-impact-on-survival-in-patients-with-resected-stage-iii-colon-cancer-results-from-ncctg-trial-n0147-alliance
#13
Claire L Jansson-Knodell, Nathan R Foster, Daniel J Sargent, Paul J Limburg, Stephen N Thibodeau, Thomas C Smyrk, Frank A Sinicrope, Balkrishna Jahagirdar, Richard M Goldberg, Steven R Alberts
BACKGROUND: Family history of colon cancer often portends increased risk of disease development; however, the prognostic significance of family history related to disease and survival outcomes is unclear. METHODS: To investigate the relationship between family history of colorectal cancer and survival outcomes in stage III colon cancer patients, a prospective cohort of 1,935 patients with resected stage III colon cancer enrolled in a randomized controlled trial (N0147), comparing the standard of care FOLFOX to FOLFOX with cetuximab, was studied...
February 2017: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28089762/long-term-results-of-a-trial-of-concurrent-chemotherapy-and-escalating-doses-of-radiation-for-unresectable-non-small-cell-lung-cancer-ncctg-n0028-alliance
#14
Steven E Schild, Shauna L Hillman, Angelina D Tan, Helen J Ross, William L McGinnis, Yolanda A Garces, David L Graham, Alex A Adjei, James R Jett
INTRODUCTION: This phase I/II trial was designed to determine the maximally tolerated dose of thoracic radiotherapy as part of a combined modality approach. This report includes the long-term outcomes of patients treated on this study. The phase II portion was never completed, as RTOG-0617 opened before it was concluded. METHODS: In this study, the maximally tolerated dose was defined as 74 Gy of radiation in 37 fractions. Twenty-five patients with unresectable NSCLC were treated with 2-Gy daily fractions and concurrent weekly carboplatin and paclitaxel...
April 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27794124/intrinsic-subtype-and-therapeutic-response-among-her2-positive-breaty-st-tumors-from-the-ncctg-alliance-n9831-trial
#15
RANDOMIZED CONTROLLED TRIAL
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
#16
MULTICENTER STUDY
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
#17
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
#18
RANDOMIZED CONTROLLED TRIAL
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
#19
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
#20
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
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