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Winston-Salem, NC, United States

Benedict S.H.,University of Virginia | Yenice K.M.,University of Chicago | Followill D.,University of Houston | Galvin J.M.,Thomas Jefferson University | And 20 more authors.
Medical Physics | Year: 2010

Task Group 101 of the AAPM has prepared this report for medical physicists, clinicians, and therapists in order to outline the best practice guidelines for the external-beam radiation therapy technique referred to as stereotactic body radiation therapy (SBRT). The task group report includes a review of the literature to identify reported clinical findings and expected outcomes for this treatment modality. Information is provided for establishing a SBRT program, including protocols, equipment, resources, and QA procedures. Additionally, suggestions for developing consistent documentation for prescribing, reporting, and recording SBRT treatment delivery is provided. © 2010 American Association of Physicists in Medicine.

Anderson R.T.,Penn State College of Medicine | Kimmick G.G.,Duke University | McCoy T.P.,WFUSOM | Hopkins J.,Forsyth Regional Cancer Center | And 4 more authors.
Journal of Cancer Survivorship | Year: 2012

Objectives: This study aimed to determine the effect of a moderate, tailored exercise program on health-related quality of life, physical function, and arm volume in women receiving treatment for nonmetastatic breast cancer. Methods: Women who were within 4-12 weeks of surgery for stage I-III breast cancer were randomized to center-based exercise and lymphedema education intervention or patient education. Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B), 6-min walk, and arm volume were performed at 3-month intervals through 18 months. Repeated measures analysis of covariance was used to model the total meters walked over time, FACT-B scores, and arm volume. Models were adjusted for baseline measurement, baseline affected arm volume, number of nodes removed, age, self-reported symptoms, baseline SF-12 mental and physical component scores, visit, and treatment group. Results: Of the recruited 104 women, 82 completed all 18 months. Mean age (range) was 53.6 (32-82) years; 88% were Caucasian; 45% were employed full time; 44% were overweight; and 28% obese. Approximately, 46% had breast-conserving surgery; 79% had axillary node dissection; 59% received chemotherapy; and 64% received radiation. The intervention resulted in an average increase of 34.3 ml (SD = 12.8) versus patient education (p = 0.01). Changes in FACT-B scores and arm volumes were not significantly different. Conclusions: With this early exercise intervention after breast cancer diagnosis, a significant improvement was achieved in physical function, with no decline in health-related quality of life or detrimental effect on arm volume. Implications for cancer survivors: Starting a supervised exercise regimen that is tailored to an individual's strength and stamina within 3 months following breast cancer surgery appears safe and may hasten improvements in physical functioning. © 2011 Springer Science+Business Media, LLC.

Margolese R.G.,NRG Oncology | Margolese R.G.,McGill University | Cecchini R.S.,NRG Oncology | Cecchini R.S.,University of Pittsburgh | And 30 more authors.
The Lancet | Year: 2016

Background Ductal carcinoma in situ is currently managed with excision, radiotherapy, and adjuvant hormone therapy, usually tamoxifen. We postulated that an aromatase inhibitor would be safer and more effective. We therefore undertook this trial to compare anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy. Methods The double-blind, randomised, phase 3 National Surgical Adjuvant Breast and Bowel Project (NSABP) B-35 trial was done in 333 participating NSABP centres in the USA and Canada. Postmenopausal women with hormone-positive ductal carcinoma in situ treated by lumpectomy with clear resection margins and whole-breast irradiation were enrolled and randomly assigned (1:1) to receive either oral tamoxifen 20 mg per day (with matching placebo in place of anastrozole) or oral anastrozole 1 mg per day (with matching placebo in place of tamoxifen) for 5 years. Randomisation was stratified by age (<60 vs ≥60 years) and patients and investigators were masked to treatment allocation. The primary outcome was breast cancer-free interval, defined as time from randomisation to any breast cancer event (local, regional, or distant recurrence, or contralateral breast cancer, invasive disease, or ductal carcinoma in situ), analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00053898, and is complete. Findings Between Jan 1, 2003, and June 15, 2006, 3104 eligible patients were enrolled and randomly assigned to the two treatment groups (1552 to tamoxifen and 1552 to anastrozole). As of Feb 28, 2015, follow-up information was available for 3083 patients for overall survival and 3077 for all other disease-free endpoints, with median follow-up of 9·0 years (IQR 8·2-10·0). In total, 212 breast cancer-free interval events occurred: 122 in the tamoxifen group and 90 in the anastrozole group (HR 0·73 [95% CI 0·56-0·96], p=0·0234). A significant time-by-treatment interaction (p=0·0410) became evident later in the study. There was also a significant interaction between treatment and age group (p=0·0379), showing that anastrozole is superior only in women younger than 60 years of age. Adverse events did not differ between the groups, except for thrombosis or embolism - a known side-effect of tamoxifen - for which there were 17 grade 4 or worse events in the tamoxifen group versus four in the anastrozole group. Interpretation Compared with tamoxifen, anastrozole treatment provided a significant improvement in breast cancer-free interval, mainly in women younger than 60 years of age. This finding means that women will benefit from having a choice of effective agents for ductal carcinoma in situ. Funding US National Cancer Institute and AstraZeneca Pharmaceuticals LP. © 2016 Elsevier Ltd.

Ganz P.A.,NRG Oncology | Ganz P.A.,University of California at Los Angeles | Cecchini R.S.,NRG Oncology | Cecchini R.S.,University of Pittsburgh | And 34 more authors.
The Lancet | Year: 2016

Background The NSABP B-35 trial compared 5 years of treatment with anastrozole versus tamoxifen for reducing subsequent occurrence of breast cancer in postmenopausal patients with ductal carcinoma in situ. This report assesses the effect of these drugs on quality of life and symptoms. Methods The study was done at 333 hospitals in North America. Postmenopausal women with hormone-positive ductal carcinoma in situ treated by lumpectomy with clear resection margins and whole breast irradiation were randomly assigned to receive either tamoxifen (20 mg/day) or anastrazole (1 mg/day) for 5 years, stratified by age (<60 years vs ≥60 years). Patients and investigators were masked to treatment allocation. Patients completed questionnaires at baseline and every 6 months thereafter for 6 years. The primary outcomes were SF-12 physical and mental health component scale scores, and vasomotor symptoms (as per the BCPT symptom scale). Secondary outcomes were vaginal symptoms and sexual functioning. Exploratory outcomes were musculoskeletal pain, bladder symptoms, gynaecological symptoms, cognitive symptoms, weight problems, vitality, and depression. We did the analyses by intention to treat, including patients who completed questionnaires at baseline and at least once during follow-up. This study is registered with ClinicalTrials.gov, NCT00053898. Findings Between Jan 6, 2003, and June 15, 2006, 3104 patients were enrolled in the study, of whom 1193 were included in the quality-of-life substudy: 601 assigned to tamoxifen and 592 assigned to anastrozole. We detected no significant difference between treatment groups for: physical health scores (mean severity score 46·72 for tamoxifen vs 45·85 for anastrozole; p=0·20), mental health scores (52·38 vs 51·48; p=0·38), energy and fatigue (58·34 vs 57·54; p=0·86), or symptoms of depression (6·19 vs 6·39; p=0·46) over 5 years. Vasomotor symptoms (1·33 vs 1·17; p=0·011), difficulty with bladder control (0·96 vs 0·80; p=0·0002), and gynaecological symptoms (0·29 vs 0·18; p<0·0001) were significantly more severe in the tamoxifen group than in the anastrozole group. Musculoskeletal pain (1·50 vs 1·72; p=0·0006) and vaginal symptoms (0·76 vs 0·86; p=0·035) were significantly worse in the anastrozole group than in the tamoxifen group. Sexual functioning did not differ significantly between the two treatments (43·65 vs 45·29; p=0·56). Younger age was significantly associated with more severe vasomotor symptoms (mean severity score 1·45 for age <60 years vs 0·65 for age ≥60 years; p=0·0006), vaginal symptoms (0·98 vs 0·65; p<0·0001), weight problems (1·32 vs 1·02; p<0·0001), and gynaecological symptoms (0·26 vs 0·22; p=0·014). Interpretation Given the similar efficacy of tamoxifen and anastrozole for women older than age 60 years, decisions about treatment should be informed by the risk for serious adverse health effects and the symptoms associated with each drug. For women younger than 60 years old, treatment decisions might be driven by efficacy (favouring anastrozole); however, if the side-effects of anastrozole are intolerable, then switching to tamoxifen is a good alternative. Funding US National Cancer Institute, AstraZeneca Pharmaceuticals. © 2016 Elsevier Ltd.

Pokrzywinski R.,United Biosource Corporation | Secord A.A.,Duke University | Havrilesky L.J.,Duke University | Puls L.E.,Cancer Centers of the Carolinas | And 6 more authors.
Gynecologic Oncology | Year: 2011

Objectives: A phase II clinical trial compared docetaxel in combination with carboplatin to sequential single agent docetaxel followed by carboplatin for treatment of recurrent platinum-sensitive ovarian, peritoneal, or tubal cancer. This manuscript reports prospectively collected health-related quality of life (HRQL). Methods: Participants were randomized to either weekly docetaxel 30 mg/m 2/days 1 and 8 and carboplatin AUC 6/day 1 every 3 weeks (cDC) or docetaxel 30 mg/m 2/days 1 and 8, repeated every 3 weeks for 6 cycles followed by carboplatin AUC 6/day 1 every 3 weeks for 6 cycles or until disease progression (sDC). The primary HRQL endpoint was the trial outcome index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, and was assessed as an intent-to-treat analysis. The secondary HRQL endpoints included the FACT-O total score, the FACT-General, and several domain scores of the FACT-O instrument (physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and the ovarian cancer specific (OCS) module). The FACT-O was administered at randomization, prior to each of 6 cycles of treatment, and at study endpoint. Results: One hundred forty-eight participants were randomized to each group. Sequential docetaxel followed by carboplatin (sDC) was associated with significant improvements in the FACT-O TOI (p = 0.013), FACT-O total score (p = 0.033), and OCS (p = 0.029) compared to the combination docetaxel and carboplatin group (cDC). Conclusions: Sequential single agent docetaxel followed by carboplatin is associated with improved HRQL when compared to cDC. The improved progression-free survival observed with cDC should be weighed against lower quality of life during treatment. © 2011 Elsevier Inc. All rights reserved.

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