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https://www.readbyqxmd.com/read/29666297/phase-ii-study-of-everolimus-in-metastatic-malignant-melanoma-ncctg-n0377-alliance
#1
Jesus Vera Aguilera, Ravi D Rao, Jacob B Allred, Vera J Suman, Harold E Windschitl, Judith S Kaur, William J Maples, Val J Lowe, Edward T Creagan, Lori A Erickson, Svetomir Markovic
LESSONS LEARNED: Everolimus does not have sufficient activity to justify its use as single agent in metastatic melanoma.Patients treated with 10 mg per day dose were most likely to require dose reductions.Everolimus appeared to reduce the numbers of regulatory T cells in approximately half of the treated patients; unfortunately, these effects were not correlated with clinical outcomes. BACKGROUND: Everolimus (RAD-001) is an orally active rapamycin analogue shown in preclinical data to produce cytostatic cell inhibition, which may be potentially beneficial in treating melanoma...
April 17, 2018: Oncologist
https://www.readbyqxmd.com/read/29563133/physical-activity-and-outcomes-in-patients-with-stage-iii-colon-cancer-a-correlative-analysis-of-phase-iii-trial-ncctg-n0147-alliance
#2
Amanda I Phipps, Qian Shi, Tyler J Zemla, Efrat Dotan, Sharlene Gill, Richard M Goldberg, Sheetal Hardikar, Balkrishna Jahagirdar, Paul J Limburg, Polly A Newcomb, Anthony Shields, Frank A Sinicrope, Daniel J Sargent, Steven R Alberts
Background: Prior studies have supported an inverse association between physical activity and colon cancer risk and suggest that higher physical activity may also improve cancer survival. Among participants in a phase III adjuvant trial for stage III colon cancer, we assessed the association of physical activity around the time of cancer diagnosis with subsequent outcomes. Methods: Before treatment arm randomization (FOLFOX or FOLFOX + cetuximab), study participants completed a questionnaire including items regarding usual daily activity level and frequency of participation in recreational physical activity ( N = 1,992)...
March 21, 2018: Cancer Epidemiology, Biomarkers & Prevention
https://www.readbyqxmd.com/read/29530935/high-p95her2-her2-ratio-associated-with-poor-outcome-in-trastuzumab-treated-her2-positive-metastatic-breast-cancer-ncctg-n0337-and-ncctg-98-32-52-alliance
#3
Saranya Chumsri, Jeff Sperinde, Heshan Liu, Joseph Gligorov, Jean-Philippe Spano, Martine Antoine, Alvaro Moreno Aspitia, Winston Tan, John Winslow, Christos J Petropoulos, Ahmed Chenna, Michael Bates, Jodi Marie Weidler, Weidong Huang, Amylou Dueck, Edith A Perez
Purpose: p95HER2 is a truncated form of HER2 that confers resistance to trastuzumab in vitro , but clinical results have been conflicting to date. Given that p95HER2 levels correlate with total HER2 expression levels, which confer better outcomes, we sought to evaluate the p95HER2/HER2 ratio in the North Central Cancer Treatment Group N0337 and N98-32-52 trials. Experimental Design: The HERmark assay and VeraTag technology (Monogram Biosciences) were used to measure total HER2 and p95HER2 expression levels in 91 patient samples...
March 12, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29390054/n0332-phase-2-trial-of-weekly-irinotecan-hydrochloride-and-docetaxel-in-refractory-metastatic-breast-cancer-a-north-central-cancer-treatment-group-ncctg-trial
#4
W W Tan, D W Hillman, M Salim, D W Northfelt, D M Anderson, P J Stella, R Niedringhaus, A M Bernath, S S Gamini, F Palmieri, E A Perez
No abstract text is available yet for this article.
January 29, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29164377/systemic-and-local-effects-of-vaginal-dehydroepiandrosterone-dhea-ncctg-n10c1-alliance
#5
Debra L Barton, Lynne T Shuster, Travis Dockter, Pamela J Atherton, Jacqueline Thielen, Stephen N Birrell, Richa Sood, Patricia Griffin, Shelby A Terstriep, Bassam Mattar, Jacqueline M Lafky, Charles L Loprinzi
BACKGROUND: Dehydroepiandrosterone (DHEA) is helpful for treating vaginal symptoms. This secondary analysis evaluated the impact of vaginal DHEA on hormone concentrations, bone turnover, and vaginal cytology in women with a cancer history. METHODS: Postmenopausal women, diagnosed with breast or gynecologic cancer, were eligible if they reported at least moderate vaginal symptoms. Participants could be on tamoxifen or aromatase inhibitors (AIs). Women were randomized to 3...
April 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/29044496/ncctg-n0879-alliance-a-randomized-phase-2-cooperative-group-trial-of-carboplatin-paclitaxel-and-bevacizumab-%C3%A2-everolimus-for-metastatic-melanoma
#6
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)...
February 1, 2018: 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
#7
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...
March 1, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/28921241/evaluating-the-efficacy-of-vaginal-dehydroepiandosterone-for-vaginal-symptoms-in-postmenopausal-cancer-survivors-ncctg-n10c1-alliance
#8
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)...
February 2018: 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
#9
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
#10
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
#11
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
#12
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
#13
LETTER
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
#14
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...
November 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-her2-positive-breast-cancer-results-from-the-signal-phare-prospective-cohort
#15
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
#16
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...
October 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
#17
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
#18
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
#19
MULTICENTER STUDY
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
#20
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
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