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Wang M.,University of Houston | Popplewell L.L.,City of Hope National Medical Center | Collins R.H.,University of Texas Southwestern Medical Center | Winter J.N.,Northwestern University | And 15 more authors.
British Journal of Haematology

The multicentre, open-label, two-stage, single-arm, phase 2, PILLAR (PIvotaL Lymphoma triAls of RAD001)-1 study (NCT00702052) assessed the efficacy and safety of everolimus 10 mg/d in adults with confirmed mantle cell lymphoma (MCL) refractory to or intolerant of bortezomib who received ≥1 other antineoplastic agent, either separately or in combination with bortezomib. Primary endpoint was overall response rate (ORR) per investigator review according to the response criteria for malignant lymphoma. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. Fifty-eight patients were enrolled from August 2008-January 2011. Five partial responses were observed (ORR 8·6%; 90% confidence interval [CI] 3·5-17·3%); the study did not meet the prespecified objective of ≥8 objective responses among 57 patients. Median PFS and OS were 4·4 months (95% CI 3·5-6·1) and 16·9 months (95% CI 14·4-29·9), respectively. Grade 3/4 non-haematological toxicities occurred in 70·7% of patients. Based on laboratory values, grade 3/4 thrombocytopenia, neutropenia and anaemia occurred in 13·8%, 13·8% and 8·6% of patients, respectively. Everolimus demonstrated modest activity and acceptable tolerability in heavily pretreated patients with MCL refractory to or intolerant of bortezomib. Future studies evaluating everolimus in a less refractory population or in combination with other targeted therapies in refractory MCL are warranted. © 2014 John Wiley & Sons Ltd. Source

Page B.R.,Medical Center Blvd | Shaw E.G.,Medical Center Blvd | Shaw E.G.,Wake forest University | Grisell D.,Greenville Health System Cancer Institute | And 5 more authors.

Background Common acute-term side effects of brain radiotherapy (RT) include fatigue, drowsiness, decreased physical functioning, and decreased quality of life (QOL). We hypothesized that armodafinil (a wakefulness-promoting drug known to reduce fatigue and increase cognitive function in breast cancer patients receiving chemotherapy) would result in reduced fatigue and sleepiness for patients receiving brain RT. Methods A phase II, multi-institutional, placebo-controlled randomized trial assessed feasibility of armodafinil 150 mg/day in participants receiving brain RT, from whom we obtained estimates of variability for fatigue, sleepiness, QOL, cognitive function, and treatment effect. Results From September 20, 2010, to October 20, 2012, 54 participants enrolled with 80% retention and 94% self-reported compliance. There were no grade 4-5 toxicities, and the incidence of grade 2-3 toxicities was similar between treatment arms, the most common of which were anxiety and nausea (15%), headaches (19%), and insomnia (20%). There were no statistically significant differences in end-RT or 4 week post-RT outcomes between armodafinil and placebo in any outcomes (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue, Brief Fatigue Inventory, Epworth Sleepiness Scale, FACT-Brain, and FACIT-cognitive function). However, in participants with more baseline fatigue, those treated with armodafinil did better than those who received the placebo on the end-RT assessments for several outcomes. Conclusion Armodafinil 150 mg/day was well tolerated in primary brain tumor patients undergoing RT with good compliance. While there was no overall significant effect on fatigue, those with greater baseline fatigue experienced improved QOL and reduced fatigue when using armodafinil. These data suggest that a prospective, phase III randomized trial is warranted for patients with greater baseline fatigue. © 2015 The Author(s). Source

Brown C.,East Carolina University | Ben-Or S.,Greenville Health System Cancer Institute | Walker P.,Leo nkins Cancer Center | Bowling M.,East Carolina University
JNCCN Journal of the National Comprehensive Cancer Network

Background: The Leo W. Jenkins Cancer Clinic has adopted a programmatic, multidisciplinary approach to thoracic tumors, which has involved the implementation of new therapeutic and diagnostic approaches. In 2012 we began using electromagnetic navigational bronchoscopy (ENB) as a new diagnostic tool. ENB uses a guidance system that combines CT imaging with magnetic field-guided spatial information to allow tissue sampling or placement of fiducial markers to guide radiation therapy. Methods: The numbers of early-stage (I and II) and late-stage (III and IV) lung cancers were compared before and after the introduction of ENB. We also examined the number of cases of fiducial marker placement using bronchoscopy versus interventional radiology before and after ENB was introduced. Fisher's exact test was used to compare the early-versus late-stage lung cancers found at diagnosis pre-and post-ENB introduction, fiducial marker placements using interventional radiology versus bronchoscopy pre-and post-ENB introduction, and pneumothorax rates. Results: More early-stage cancers were diagnosed after ENB introduction (67 of 286 cases vs 116 of 290; P<.0001). Bronchoscopy was also used more frequently to place fiducial markers post-ENB (53 of 86 pre-ENB vs 105 of 117 post-ENB; P<.0001) and had a lower pneumothorax rate (4% vs 22%) than fiducial placement in interventional radiology (P<.001). Conclusions: The addition of ENB to a multidisciplinary thoracic oncology program may permit the diagnosis of lung cancer at an earlier stage and offers the ability to safely place fiducial markers for therapeutic purposes, such as radiation therapy, within the same procedure, potentially improving safety and decreasing time to treatment. © 2016 JNCCN-Journal of the National Comprehensive Cancer Network. Source

Rappaport M.J.,University of South Carolina | Showell D.L.,University of South Carolina | Edenfield W.J.,University of South Carolina | Edenfield W.J.,Greenville Health System Cancer Institute
Rare Tumors

Ghost cell odontogenic carcinoma (GCOC) is an exceedingly rare malignant tumor on the spectrum of already uncommon odontogenic or dentinogenic tumors. We describe here the case of metastatic GCOC in a patient with a history of recurrent dentinogenic ghost cell tumor of the mandible, now presenting with bilateral pleural effusions. We will discuss typical histopathologic and histochemical features of GCOC, along with results of genomic testing and their role in directing therapy. © 2015 M.J. Rappaport et al. Source

Sterba K.R.,Medical University of South Carolina | Armeson K.,Medical University of South Carolina | Franco R.,Greenville Health System Cancer Institute | Harper J.,Medical University of South Carolina | And 4 more authors.
Cancer Nursing

Background: Interventions addressing cancer survivors' posttreatment concerns can be time-intensive and require specialized staff. Research is needed to identify feasible minimal intervention strategies to improve survivors' quality of life after treatment. Objectives: The objective of this study was to evaluate the feasibility and short-term impact of a minimal clinic intervention on breast cancer survivors' quality of life, unmet needs, distress, and cancer worry. Interventions/Methods: In this randomized controlled pilot trial, we enrolled breast cancer survivors at the end of treatment and administered baseline surveys. Participants were randomized to study arm (4-week video plus educational booklet intervention group and usual care group) and completed follow-up surveys at 10 weeks. Linear regression was used to examine intervention effects on quality of life outcomes controlling for clinical and demographic factors. Open-ended questions were used to examine program satisfaction and obtain feedback to improve the intervention. Results: We enrolled 92 survivors in the trial. Participants rated the intervention highly and reported feeling less isolated and having more realistic expectations about their recovery after completing the program. Despite positive qualitative findings, no significant intervention effects were observed for quality of life, unmet needs, distress, or cancer worry in unadjusted or adjusted analyses. Conclusions: Future research is needed to define optimal intervention elements to prepare breast cancer survivors for the posttreatment period. Implications for Practice: Effective survivorship interventions may require more intensive components such as clinical input and longer follow-up periods. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. Source

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