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Lesser G.J.,Section on Hematology and Oncology | Stark N.,Section on Hematology and Oncology | Williford S.,Southeast Cancer Control Consortium | Astrid Garino L.,Metro Minnesota CCOP
Journal of Supportive Oncology | Year: 2013

Background: Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits. Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10's effects on self-reported fatigue, depression, and quality of life (QOL). Methods: Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8, 16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time. Results: Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age (range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 μg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 μg/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States-Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy-Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy-Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies-Depression scale (11.6 vs 12.3, P = .632). Conclusions: Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment. © 2013 Frontline Medical Communications.


Kozloff M.F.,University of Chicago | Berlin J.,Vanderbilt Ingram Cancer Center | Flynn P.J.,Metro Minnesota CCOP | Kabbinavar F.,University of California at Los Angeles | And 4 more authors.
Oncology | Year: 2010

Background: Elderly patients are underrepresented in clinical trials and frequently undertreated with standard therapy. The BRiTE observational cohort study assessed the safety and effectiveness of bevacizumab-based first-line therapy for metastatic colorectal cancer among a large cohort of elderly patients (896 patients ≥65 years, among 1,953 total patients). Methods: Treatment patterns, safety, progression-free survival (PFS), overall survival (OS) and survival beyond first progression (SBP) were analyzed by age cohorts. OS and SBP were further analyzed using Cox proportional hazards regression. Results: Median PFS (months) was similar across age cohorts (<65 years, 9.8; 65 to <75, 9.6; 75 to <80, 10.0; ≥80, 8.6). Median OS (months) decreased with age (<65 years, 26.0; 65 to <75, 21.1; 75 to <80, 20.3; ≥80, 16.2). SBP declined with age; however, a Cox model adjusting for baseline and postbaseline covariates that were imbalanced among age cohorts showed a reduced independent effect of age on SBP (months) (<65 years, 12.0; 65 to <75, 11.4; 75 to <80, 11.3; ≥80, 10.0) compared with unadjusted analyses. Use of bevacizumab in subsequent postprogression regimens decreased with age. Incidence of targeted adverse events did not increase with age, except for arterial thromboembolic events (ATEs), for which Eastern Cooperative Oncology Group performance status, anticoagulation and arterial disease history were stronger prognostic factors than age. Conclusions: Elderly patients receiving bevacizumab with first-line chemotherapy showed treatment benefit, although there was reduced median survival with increasing age. There was no increased toxicity among elderly patients, except for risk of ATEs. Copyright © 2010 S. Karger AG, Basel.


Kirshner J.J.,Hematology Oncology Associates of Central New York | Heckler C.E.,University of Rochester | Janelsins M.C.,University of Rochester | Dakhil S.R.,Wichita CCOP | And 3 more authors.
Journal of Clinical Oncology | Year: 2012

Purpose: Pegfilgrastim-induced bone pain is a significant clinical problem that may result in discontinuation of pegfilgrastim and lead to less effective chemotherapy dosing. Interventions for pegfilgrastim-induced bone pain are needed. Patients and Methods: The University of Rochester Cancer Center Clinical Community Oncology Program Research Base randomly assigned 510 patients at 17 sites to receive either naproxen (500 mg two times per day) or placebo on the day of pegfilgrastim administration, continuing for 5 to 8 days after pegfilgrastim. Patients recorded pain severity (using a scale of 0 to 10) and duration in daily diaries. The primary outcome measure was the area under the curve (AUC) for pain for days 1 through 5. Secondary outcome measures included the identification of risk factors for the development of pain and response to naproxen. Results Patients' mean age was 55.6 years and 86% were female. Sixty-eight percent of patients had breast cancer and 10% had lung cancer. Pain reached its peak at 3 days for both groups. The mean AUC for pain was 7.71 for the placebo group and 6.04 for the naproxen group (P = .037). Naproxen reduced maximum pain from 3.40 to 2.59 (P = .005). Naproxen also reduced overall pain incidence from 71.3% to 61.1% (P = .020) and duration from 2.40 to 1.92 days (P = .009). The reduction in severe pain (> 5 on a scale of 1 to 10) from 27.0% to 19.2% was also significant (P = .048). Risk factors could not be identified to predict incidence, severity, or ability to prevent pegfilgrastiminduced bone pain. Conclusion: Our phase III randomized placebo-controlled clinical trial demonstrated that naproxen at a dose of 500 mg twice per day is effective in reducing the incidence and severity of pegfilgrastim-induced bone pain. © 2012 by American Society of Clinical Oncology.


Gewandter J.S.,University of Rochester | Mohile S.G.,University of Rochester | Heckler C.E.,University of Rochester | Ryan J.L.,University of Rochester | And 4 more authors.
Supportive Care in Cancer | Year: 2014

Purpose: Chemotherapy-induced peripheral neuropathy (CIPN) occurs in as high as 70 % of patients receiving certain types of chemotherapy agents. The FDA has yet to approve a therapy for CIPN. The aim of this multicenter, phase III, randomized, double-blind, placebo-controlled trial was to investigate the efficacy of 2 % ketamine plus 4 % amitriptyline (KA) cream for reducing CIPN. Methods: Cancer survivors who completed chemotherapy at least 1 month prior and had CIPN (>4 out of 10) were enrolled (N=462). CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average "pain, numbness, or tingling in [their] hands and feet over the past 24 h" on an 11-point numeric rating scale at baseline and 6 weeks post intervention. ANCOVA was used to measure differences in 6-week CIPN with effects including baseline CIPN, KA treatment arm, and previous taxane therapy (Y/N). Results: The KA treatment showed no effect on 6-week CIPN scores (adjusted mean difference=-0.17, p=0.363). Conclusions: This study suggests that KA cream does not decrease CIPN symptoms in cancer survivors. © 2014 Springer-Verlag.


News Article | December 9, 2016
Site: www.eurekalert.org

Portland, Oregon - A drug typically used to treat depression and anxiety can significantly reduce joint pain in postmenopausal women being treated for early stage breast cancer, according to new SWOG research to be presented Friday at a special plenary presentation at the San Antonio Breast Cancer Symposium. Investigators from SWOG, the international cancer clinical trials network funded by the National Cancer Institute (NCI), conducted a randomized, placebo-controlled trial to test whether duloxetine, a depression and anxiety drug, could alleviate pain caused by aromatase inhibitors, a common breast cancer treatment that's particularly effective with postmenopausal women. Dr. N. Lynn Henry led the clinical trial, called S1202. A SWOG investigator from Huntsman Cancer Institute at the University of Utah and co-chair of SWOG's symptom control and quality of life committee, Henry wanted to conduct the study because it addressed a common problem for women with breast cancer. Tens of thousands of postmenopausal women each year are treated with aromatase inhibitors (AIs), pills that stop the production of estrogen and essentially starve hormone receptor-positive breast cancer cells. Many women - as many as 50 percent -- experience joint pain and stiffness as a side effect of AI therapy. About 20 percent experience significant pain. This can affect knees, hips, hands, and wrists, and make it difficult for women to walk, climb stairs, do simple tasks like type, or sit for an extended period of time. Henry said some women stop taking their medication to get relief. The pain is so common it has a name: AI-Associated Musculoskeletal Syndrome (AIMSS). "A lot of 60-year-old women report feeling like they're 80," Henry said. "The pain can really interfere with daily life. And this is a big problem. The length of treatment with AIs can be five to 10 years, so we're asking a lot of women to manage significant discomfort for a very long period of time." While clinical trials have shown that acupuncture and exercise can reduce symptoms of AIMSS, there is no evidence for an effective solution for all women. Henry and her team chose to test duloxetine, a drug commonly sold as Cymbalta by original maker Eli Lilly and Company. Duloxetine is primarily used to treat depression and anxiety, and also fibromyalgia and nerve pain caused by diabetes. SWOG researchers enrolled 299 adult patients to S1202 at 43 institutions throughout the NCI's National Cancer Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP). Those 299 patients were randomly assigned to either receive duloxetine or a placebo for 12 weeks. They filled out a questionnaire upon enrolling, and again at two, six, 12 and 24 weeks into the study. Questions focused on pain, rated on a 0-10 scale, and also on depression and quality of life. Results showed that patients taking duloxetine saw their average pain drop on the scale from 5.5 to about 3. Improvement was rapid, and relief persisted through the end of the 12-week trial. Improvement in pain was also seen in the placebo arm of the trial, suggesting a robust placebo effect. Henry will present her findings at one of six plenary sessions at the San Antonio Breast Cancer Symposium, a leading cancer research conference with an international audience. "We've shown that this treatment is a potential option for women," Dr. Henry said. "Taking this drug may help them tolerate their breast cancer treatment. And it's important for their health that they stick with their treatment." Her work was supported in part by NCI grants CA189974, CA37429, CA189821, CA189816, CA189823, CA180868, CA189867, CA15488, CA21115, CA180820; Damon Runyon Cancer Research Foundation; and Eli Lilly and Company, which provided the study drug and matching placebo. A national team of SWOG researchers took part in S1202. Along with Dr. Henry, they include: Joe Unger, Ph.D, of Fred Hutchinson Cancer Research Center; Anne Schott, M.D. of University of Michigan Comprehensive Cancer Center; Louis Fehrenbacher, M.D. of Kaiser Permanente, Northern California; Patrick J. Flynn, M.D., Metro Minnesota CCOP/Minnesota Oncology; Debra Prow, M.D., McFarland Clinic; Carl W. Sharer, D.O., Phoenixville Cancer Center; Danika L. Lew, M.A., Fred Hutchinson Cancer Research Center; Anna Moseley, M.S., Fred Hutchinson Cancer Research Center; Michael J. Fisch, M.D., AIM Specialty Health; Carol Moinpour, Ph.D., Fred Hutchinson Cancer Research Center; Dawn L. Hershman, M.D., Columbia University Medical Center; James L. Wade, III, M.D., Cancer Care Specialists of Illinois/Heartland NCORP. SWOG is a global network of researchers that design and conduct cancer clinical trials, and, as part of the Nation Cancer Institute's National Clinical Trials Network, is a major part of the cancer research infrastructure in the U.S. and the world. The group's goal is to change medical practice so it improves the lives of people with cancer. Founded in 1956, SWOG's over 1,300 trials have led to the approval of 14 cancer drugs, changed the standard of cancer care more than 100 times, and saved more than 2 million years of human life. Learn more at swog.org.


Quon H.,University of Pennsylvania | Leong T.,Emory University | Haselow R.,Metro Minnesota CCOP | Leipzig B.,University of Arkansas for Medical Sciences | And 2 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2011

Purpose: The Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma. Methods and Materials: Eligible patients were randomized to RT (70 Gy at 1.8-2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m 2. Failure-free survival (FFS) and overall survival (OS) curves were estimated with the Kaplan-Meier method and compared with the log rank test. Results: Between 1982 and 1987, 371 patients were accrued, and 308 patients were found eligible for analysis. Median follow-up was 62 months. The median FFS was 6.5 and 7.2 months for the RT and RT + cisplatin groups, respectively (p = 0.30). The p value for the treatment difference was p = 0.096 in multivariate modeling of FFS (compared to a p = 0.30 in univariate analysis). Expected acute toxicities were significantly increased with the addition of cisplatin except for in-field RT toxicities. Late toxicities were not significantly different except for significantly more esophageal (9% vs. 3%, p = 0.03) and laryngeal (11% vs. 4%, p = 0.05) late toxicities in the RT + cisplatin group. Conclusion: The addition of concurrent weekly cisplatin at 20 mg/m 2 to daily radiation did not improve survival, although there was evidence of activity. Low-dose weekly cisplatin seems to have modest tumor radiosensitization but can increase the risk of late swallowing complications. © 2011 Elsevier Inc.


Knox J.J.,University of Toronto | Qin R.,Mayo Medical School | Strosberg J.R.,H. Lee Moffitt Cancer Center and Research Institute | Tan B.,University of Washington | And 6 more authors.
Investigational New Drugs | Year: 2015

Background There is strong rationale to combine temsirolimus (TEM) with Bevacizumab (BEV) for patients with advanced HCC. Methods A modified two-stage Simon phase II trial was performed with plans to advance to stage 2 if more than 2 patients had confirmed PR or >18 patients were progression free at 6 months out of 25 in stage 1. Toxicity, PFS and overall survival were secondary endpoints. Eligible pts had advanced HCC, Child Pugh A liver status and no prior systemic therapy involving the VEGF or m-TOR targeted agents. Patients were treated with temsirolimus 25 mg IV on Days 1, 8, 15, and 22 of a 28 day cycle and bevacizumab 10 mg/kg IV on Days 1 and 15 of the cycle. Results Twenty-eight eligible patients were enrolled, 26 evaluable receiving a median of 6.5 cycles (range 1-18). Drug related toxicities were common including cytopenias, fatigue, mucositis, diarrhea and mild bleeds. Dose reductions or discontinuation of TEM were common. Accrual closed for presumed futility after interim analysis of the first 25 evaluable patients showed only one PR and 16/25 were progression-free at 6 months. However, the final data update in March 2013 demonstrated 4 confirmed PRs, a 5th unconfirmed PR and 16 /26 progression-free at 6 months. Median PFS and OS were 7 and 14 months respectively. Conclusion This first-line HCC trial evaluating the BEV/TEM doublet reports an ORR of 19 % and OS of 14 months which is favorable but requires further study at a more optimized dose and schedule. © 2014 Springer Science+Business Media New York.


PubMed | Johns Hopkins Kimmel Cancer Center, University of Wisconsin - Madison, Dana-Farber Cancer Institute, Lehigh Valley Hospital Cedar Crest and 2 more.
Type: Clinical Trial, Phase II | Journal: Clinical genitourinary cancer | Year: 2015

Atrasentan, an oral endothelin receptor A antagonist, demonstrated phase 1 activity in patients with renal cell carcinoma (RCC). A phase 2 study was undertaken in patients with measurable or bone-only metastatic RCC in the pre-VEGF/TKI era.Patients were stratified by disease status and prior immunotherapy. Eligible patients had no prior chemotherapy, 0 to 1 prior immunotherapies, and an Eastern Cooperative Oncology Group performance status of 0 to 2. Patients received atrasentan 10 mg per day until progression. The primary end point was progression-free (PF) rate at 6 months. Rates of 25% among patients treated with prior immunotherapy and 45% among patients with no prior immunotherapy were considered promising. A 2-stage design was used for cohorts without prior immunotherapy.From 2003 to 2005, 98 patients were registered. Median treatment duration was 9.9 weeks (range, 0.3-107 weeks). Toxicities were mild; 71% of patients reported no grade 3 or higher treatment-related events. Grade 4 events included neutropenia (n = 3), dyspnea (n = 2), thrombosis (n = 1), and arrhythmia (n = 1). Two grade 5 events (dyspnea and constitutional) were possibly treatment related. Six-month PF rates (90% confidence interval) were 14% (6-25), 0% (0-39), 8% (1-23), and 22% (8-44), respectively, for patients with prior immunotherapy/measurable disease (n = 44), prior immunotherapy/bone metastases (n = 6), no prior immunotherapy/measurable disease (n = 25), and no prior immunotherapy/bone metastases (n = 18). Median PF survival was 2.3 months (95% confidence interval, 2.0-3.5 months).Although well tolerated, atrasentan did not yield 6-month PF rates supporting its use as first-line monotherapy in patients with advanced RCC.


Ryan J.L.,University of Rochester | Heckler C.E.,University of Rochester | Roscoe J.A.,University of Rochester | Dakhil S.R.,Witchita CCOP | And 4 more authors.
Supportive Care in Cancer | Year: 2012

Purpose Despite the widespread use of antiemetics, nausea continues to be reported by over 70% of patients receiving chemotherapy. Methods In this double blind, multicenter trial, we randomly assigned 744 cancer patients to four arms: 1) placebo, 2) 0.5 g ginger, 3) 1.0 g ginger, or 4) 1.5 g ginger. Nausea occurrence and severity were assessed at a baseline cycle and the two following cycles during which patients were taking their assigned study medication. All patients received a 5-HT3 receptor antagonist antiemetic on Day 1 of all cycles. Patients took three capsules of ginger (250 mg) or placebo twice daily for 6 days starting 3 days before the first day of chemotherapy. Patients reported the severity of nausea on a 7-point rating scale ("1"="Not at all Nauseated" and "7"="Extremely Nauseated") for Days 1-4 of each cycle. The primary outcomes were to determine the dose and efficacy of ginger at reducing the severity of chemotherapy-induced nausea on Day 1 of chemotherapy. Results A total of 576 patients were included in final analysis (91% female, mean age = 53). Mixed model analyses demonstrated that all doses of ginger significantly reduced acute nausea severity compared to placebo on Day 1 of chemotherapy (p=0.003). The largest reduction in nausea intensity occurred with 0.5 g and 1.0 g of ginger (p=0.017 and p=0.036, respectively). Anticipatory nausea was a key factor in acute chemotherapy-induced nausea (p<0.0001). Conclusions Ginger supplementation at a daily dose of 0.5 g-1.0 g significantly aids in reduction of the severity of acute chemotherapy-induced nausea in adult cancer patients. © 2011 Springer-Verlag.


Tan W.W.,Mayo Medical School | Dueck A.C.,Mayo Medical School | Flynn P.,Metro Minnesota CCOP | Steen P.,Sanford Medical Center | And 4 more authors.
Annals of Oncology | Year: 2013

Background: Based on preclinical studies, the vascular endothelial pathway is an important mechanism for estrogen receptor resistance. We conducted a phase II study of fulvestrant and bevacizumab in patients with aromatase inhibitor pretreated metastatic breast cancer. Patients and methods: A single-stage phase II study was conducted with these objectives: 6-month progression-free survival (PFS), tumor response, toxic effect, and overall survival. Regimen: 250 mg fulvestrant days 1 and 15 (cycle 1) then day 1 (cycle 2 and beyond) and 10 mg/kg bevacizumab days 1 and 15 of each 4-week cycle. Results: At interim analysis, 20 eligible patients initiated treatment, 11 were progression free and on treatment at 3 months, not meeting the protocol-specified efficacy requirements (at least 12 of 20). Accrual remained open during interim analysis with 36 patients enrolling before final study closure. Among the 33 eligible patients, the median PFS was 6.2 months [95% confidence interval (CI) 3.6-10.1 months]. Of the 18 with measurable disease, 4 (22%) patients (95% CI 6% to 48%) had a confirmed tumor response (1 complete, 3 partial). The most common grade 3/4 adverse events were hypertension 3 (9%) and headache 3 (9%). Conclusions: The fulvestrant/bevacizumab combination is safe and tolerable; however, it did not meet its statistical end point. © The Author 2013.

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