tbuckley/cabot-search huggingface dataset:
Quality of life in breast cancer patients receiving sentinel-node (SN) biopsy alone or with axillary dissection (AD): Results from NSABP Protocol B-32
Authors: S. R. Land, J. A. Kopec, M. Lee, S. R. Haile, M. W. Ritter, D. Krag, S. J. Anderson, P. A. Ganz, N. Wolmark
Journal: Journal of Clinical Oncology (2008)

9533 Background: NSABP B-32, a phase III randomized trial of SN resection vs SN resection followed by AD (SNAD) in early stage breast cancer, provided a unique opportunity to compare patient-reported outcomes (PROs) arm function, symptoms, and quality of life (QOL). We report the final treatment (TX) comparison of PROs. Methods: Women with operable invasive breast cancer were eligible for B-32; those whose SNs were negative were eligible for the PRO questionnaire sub-study. Symptoms, arm-related disabilities, and QOL were assessed at baseline, 1 week after surgery (post-op), 2–3 weeks post-op, and 6, 12, 18, 24, 30, 36 months (mos). The primary endpoint, a multi- item ipsilateral surgery symptom scale, was compared between TX at 6 and 12 mos using two-sided, two-sample t-tests, with Bonferroni correction. An anticipated accrual of 819 patients (pts) was calculated to yield 87% power for the primary comparisons. We compared each PRO item by TX with repeated measures analysis. We analyzed separately pts who received lumpectomy vs mastectomy, and accounted for breast reconstruction and dominant hand. Results: 749 pts enrolled in the PRO sub-study before B-32 completed accrual (358 SNAD, 391 SN). Arm symptoms were greater for SNAD pts (effect size 0.4, p<0.0001 at 6 mos; effect size 0.25, p=0.006 at 12 mos). Over the complete time on study, SNAD pts had more difficulty pushing large objects, lifting objects, reaching, and conducting social and work activity (p<0.001). They were more likely to avoid arm use and to experience symptoms (p=0.002 breast tenderness; p<0.001 all other items). The treatment difference persisted over time for avoidance of arm use; arm or breast tenderness or swelling; and breast pain, numbness, skin sensitivity, or tightness. Overall QOL was better among SN pts (p<0.001) and improved over time (p<0.001). In both groups, treatment was well tolerated by 6 mos: only 10% of pts reported restriction of social/recreational activity, and overall QOL averaged 8 (scale 0–10). Conclusions: SN pts experienced significantly fewer symptoms and activity limitations. However, long-term levels of symptoms and limitations were low, and QOL was high, for both groups. No significant financial relationships to disclose.
High- versus standard-dose megestrol acetate in women with advanced breast cancer: a phase III trial of the Piedmont Oncology Association.
Authors: H B Muss, L D Case, R L Capizzi, M R Cooper, J Cruz, D Jackson, F Richards, B L Powell, C L Spurr, D White
Journal: Journal of Clinical Oncology (1990)

One hundred seventy-two patients with advanced breast cancer were randomized to receive oral standard-dose megestrol acetate (MA), 160 mg/d or high-dose MA, 800 mg/d. All but two patients had one prior trial of tamoxifen therapy for either metastatic disease (74%) or as adjuvant treatment (26%). Pretreatment characteristics were similar for both arms. High-dose MA resulted in a superior complete plus partial response rate (27% v 10%, P = .005), time to treatment failure (median, 8.0 v 3.2 months, P = .019), and survival (median, 22.4 v 16.5 months, P = .04) when compared with standard-dose therapy. These differences remained significant after adjustment for other covariates. Thirty-four patients were given high-dose MA after failure of standard-dose MA treatment, and none responded. Weight gain was the most distressing side effect, with 13% of standard-dose and 43% of high-dose patients gaining more than 20 lbs. Four major cardiovascular events occurred in patients receiving high-dose treatment and one in patients given standard doses. Other toxicity was modest. High-dose MA may represent a significant improvement in secondary endocrine therapy for advanced breast cancer patients refractory to initial endocrine treatment, but its use on a regular basis should be reserved until these results are confirmed by other clinical trials.
Abstract MP060: Effect of Low Carbohydrate Diets versus Low Fat Diets on Cardiovascular Risk Factors: A Meta-Analysis of Randomized Controlled Trials
Authors: Tian Hu, Katherine Mills, Lu Yao, Kathryn Demanelis, Mohamed Eloustaz, Tanika Kelly, Jiang He, Lydia Bazzano
Journal: Circulation (2012)

Obesity is a major public health problem in the US population. Low carbohydrate diets are popular as a means of weight loss; however, there is concern for adverse effects on cardiovascular (CV) risk factors. We conducted a meta-analysis of randomized controlled trials comparing the effect of low carbohydrate diets (≤45% of energy from carbohydrates) versus low fat diets (≤30% of energy from fat) on CV risk factors, including systolic and diastolic blood pressure, total cholesterol, high-density-lipoprotein (HDL) cholesterol, low-density-lipoprotein (LDL) cholesterol, triglycerides, body mass index, waist circumference, fasting blood glucose and serum insulin. We searched MEDLINE, EMBASE, Web of Science and the Cochrane Database of Systematic Reviews, and manually examined references in selected articles and relevant literature reviews. Information on participant characteristics, trial design and duration, dietary composition, and CV risk factors were extracted using a standardized protocol. Random effects models were used to pool mean differences between CV risk factors on the two diets. From 785 potentially relevant publications, 23 randomized controlled trials compared low carbohydrate diets with low fat diets with intervention duration ≥ 6 months and reported CV risk factors as primary outcomes. These studies included data from 2,961 participants in total. The average percent of energy from carbohydrate intake was 20.7% on low carbohydrate diets and the average percent of energy from fats was 25.9% on low fat diets. Compared to participants on low fat diets, those on low carbohydrate diets showed favorable changes in HDL cholesterol, triglycerides and body mass index, with pooled net changes (95% CI) of 3.2 mg/dL (1.9, 4.5), -13.0 mg/dL (-17.3, -7.8) and -0.4 kg/m2 (-0.7, -0.1), respectively. After removing studies without intention-to-treat analysis, the change in body mass index was no longer significant (N=16). Changes in total and LDL cholesterol favored low fat diets, but after accounting for publication bias, results were no longer significant for total, LDL and HDL cholesterol. In conclusion, our findings show that low carbohydrate diets were at least as effective as low fat diets for weight loss, and did not have significant adverse effects on other CV risk factors. In fact, low carbohydrate diets had a significant and favorable impact on triglycerides. These findings suggest that low carbohydrate diets can be recommended to obese persons with CV risk factors for the purpose of weight loss.
ROUTINE CINE-CMR FOR PROSTHESIS ASSOCIATED MITRAL REGURGITATION: A MULTICENTER COMPARISON TO ECHOCARDIOGRAPHY
Authors: Lauren A. Simprini, Anika Afroz, Igor Klem, Christoph Jensen, Raymond Kim, John Heitner, Michael Sood, Elizabeth Chandy, Dipan Shah, Juan Lopez-Mattei, Robert Biederman, Monvadi B. Srichai, John Grizzard, Anthony Fuisz, Kambiz Ghafourian, Afshin Farzaneh-Far, Jonathan Weinsaft
Journal: Journal of the American College of Cardiology (2013)
Hyperbaric oxygen as a radiation sensitizer for locally advanced squamous cell carcinoma of the head and neck: A phase I dose-escalation study.
Authors: R. E. Clarke, T. H. Davis, R. L. Foote, P. L. Claus, J. C. Buckey, S. H. Okuno, A. K. Fariss, S. Pohar, J. R. Hussey
Journal: Journal of Clinical Oncology (2010)

e16002 Background: The effectiveness of radiotherapy (RT) depends on tumor oxygenation. Hyperbaric oxygen (HBO) markedly elevates tumor oxygen tensions both in vitro and in vivo, with persistence of tissue oxygen concentration long enough to permit conventional RT delivery. This multicenter study was designed to determine feasibility and tolerability of adding HBO to concurrent chemoradiation in the treatment of locally-advanced squamous cell carcinoma of the head and neck (SCCHN). Methods: Study population: histologically confirmed SCCHN of any site, stage III-IV (M0), life expectancy > 6 months, KPS ≥ 70. Chemoradiation: intensity modulated RT (IMRT) 70 Gy at 2 Gy/day, 5 days/week, over seven weeks, with cisplatin 30 mg/m2 once per week. HBO: 100% oxygen at 2.4 atmospheres pressure for 30 minutes; RT to be given within 15 minutes of completing HBO. HBO was dose-escalated in cohorts of 3 subjects (cohort 1: HBO 2 times per week; cohort 2: HBO 3 times per week; cohort 3: HBO 5 times per week) if not more than 1 grade 4 toxicity observed per cohort. Results: Ten of 12 subjects were able to complete study treatment. Two left the trial due to a non-HBO related serious adverse event (1) and non- compliance (1). One other was diagnosed with bone and liver metastases during follow-up. There was no dose-limiting toxicity from HBO. Significant adverse events were similar to conventional concurrent chemoradiation. Three patients (25%) required myringotomy tubes. Average time between HBO and RT: 10.2 minutes. Clinical complete response was seen in all 100%. No recurrences have been seen at a median follow-up of 19 months. Conclusions: DeliveringHBO immediately prior to IMRT with conventional clinical equipment is both feasible and well tolerated. HBO did not appear to increase the acute toxicity of chemoradiation. There have been no recurrences during the follow-up period. The 5 treatments per week HBO regimen is recommended for subsequent phase II and phase III studies. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration National Baromedical Services Sechrist Industries
Abstract 027: Effectiveness of a 2-phase Color-coded Food and Beverage Intervention among Minority and Low-income Employees
Authors: Douglas E Levy, Jason Riis, Lillian Sonnenberg, Susan Barraclough, Anne N Thorndike
Journal: Circulation (2012)

Background: Effective strategies are needed to address obesity, particularly among minority and low-income individuals. Simple point-of-purchase interventions have the potential to improve nutrition choices of a diverse population. Methods: We tested the effectiveness of a 2-phase food labeling and choice architecture intervention among different racial and socioeconomic groups in 4,642 employees who were regular patrons at a large hospital cafeteria in Boston, MA. After collecting baseline sales data for 3 months, we implemented Phase 1 to label all items green (healthy), yellow (less healthy), or red (unhealthy). In Phase 2, we manipulated “choice architecture,” making green-labeled items more accessible and red-labeled items less accessible. We calculated the proportion of items purchased by an employee labeled green or red during each 3-month period (baseline, Phase 1, Phase 2) and assessed person-level changes. We linked employee cash register data to human resources files to determine demographics, including race/ethnicity (self-reported) and job type (measure of socioeconomic status). We tested the interaction between intervention phase and race or job type to determine differences in intervention effects across subgroups. We calculated average calories and price per beverage during each phase. Results: Employees were white (73%), black (10%), Latino (7%), and Asian (10%). At baseline, black and Latino employees purchased higher proportions of red items compared to white employees (33%, 28%, and 18%, respectively, p&lt;0.001) and lower proportions of green (33%, 38%, and 48%, p&lt;0.001). Purchases by Asian employees did not differ from white employees. Adjusting for demographics, labeling decreased all employees’ purchases of red items (-11.2%, 95% CI -13.6% to -8.9%) and increased green purchases (6.6%, 95% CI 5.2% to 7.9%). The greatest effect was for red beverages (-23.8%, 95% CI -28.1 to -19.6). Choice architecture further decreased red purchases after labeling. Intervention effects were similar across all race and job types (p&gt;0.05 for tests of interaction between race or job type and intervention phase). At baseline, average calories per beverage purchased by black and Latino employees was higher than for white employees (126, 113, and 87 calories, respectively, p&lt;0.001). During the 2-phase intervention, mean calories per beverage decreased similarly for all racial groups and job types (-15 calories, 95% CI -18 to -13), but the mean cost per beverage did not change. Conclusions: Despite racial and socioeconomic differences in purchasing of healthy foods at baseline, a simple color-coded labeling and choice architecture intervention improved food and beverage choices among employees from all backgrounds.
A multicenter U.S. trial of neoadjuvant pemetrexed plus cisplatin (PC) followed by extrapleural pneumonectomy (EPP) and hemithoracic radiation (RT) for stage I-III malignant pleural mesothelioma (MPM)
Authors: L. M. Krug, H. Pass, V. W. Rusch, H. L. Kindler, D. Sugarbaker, K. Rosenzweig, J. S. Friedberg, K. Pisters, C. K. Obasaju, N. J. Vogelzang
Journal: Journal of Clinical Oncology (2007)

7561 Background: The optimal management for fit patients with early stage MPM remains controversial. One approach involves neoadjuvant chemotherapy followed by EPP and hemithoracic RT and prior trials using gemcitabine and cisplatin have been reported (Weder JCO 2004, Flores JTO 2006). We administered PC, followed by EPP and RT to further assess feasibility and survival of trimodality therapy in a larger, multicenter study. Methods: Eligibility criteria: Stage T1–3 N0–2, no prior surgical resection, adequate organ function (including predicted post-op FEV1 &gt;35%) and PS 0–1. Pts received pemetrexed 500 mg/m 2 plus cisplatin 75 mg/m 2 with vitamin supplementation for 4 cycles. Pts without disease progression underwent EPP followed by RT (54 Gy). The primary endpoint was pathologic complete response (pCR) rate. Enrollment was completed in March, 2006. Results: 77 patients were enrolled and 72 are evaluable. Median age 63.5 (range 34–78), M:F = 51:21, Clinical stage I:II:III:IV = 5:31:33:1, epithelial:nonepithelial = 58:15, ECOG PS 0:1:2 = 28:42:2. 83% of patients completed all four cycles of PC. Grade 3/4 events related to chemotherapy included: neutropenia (4%), febrile neutropenia (3%), nausea (1%), vomiting (3%), pneumonia (6%), pulmonary embolism (1%), and chest pain (3%). Of 73 pts assessed for radiologic response, 3 CRs, 21 PRs, 36 SDs, 3 PDs, and 10 were unevaluable; (RR= 33% [95% CI, 0.22, 0.45]). Of 54 pts who underwent surgery, EPP completion rate was 87% (47/54); that is 47/77 (61%) by ITT. Pathologic stage I:II:III:IV:NE = 4:12:24:3:11. One pCR was confirmed. 35/39 completed RT. Preliminary TTP =13.1 mo (95% CI=9.6, 15.9; 48% censored) and median survival=16.6 mo (95% CI=13.9, 19.3; 55% censored;1-yr survival = 68%). Conclusions: This multicenter trial testing trimodality therapy in MPM showed that it is feasible with a high rate of chemotherapy delivery. One pCR was observed. Preliminary survival is below that reported by single institutions for patients undergoing EPP but with a high censorship rate at this early time point. Further analyses are necessary to identify a cohort of patients most likely to benefit. This study was sponsored by Eli Lilly &amp; Company. No significant financial relationships to disclose.
<i>Notes from the Field</i>: Ongoing Cholera Outbreak — Kenya, 2014–2016
Authors: Githuka George, Jacob Rotich, Hudson Kigen, Kiama Catherine, Bonface Waweru, Waqo Boru, Tura Galgalo, Jane Githuku, Mark Obonyo, Kathryn Curran, Rupa Narra, Samuel J. Crowe, Ciara E. O’Reilly, Daniel Macharia, Joel Montgomery, John Neatherlin, Kevin M. De Cock, Sara Lowther, Zeinab Gura, Daniel Langat, Ian Njeru, Jackson Kioko, Nicholas Muraguri
Journal: MMWR Morbidity and Mortality Weekly Report (2016)

On January 6, 2015, a man aged 40 years was admitted to Kenyatta National Hospital in Nairobi, Kenya, with acute watery diarrhea. The patient was found to be infected with toxigenic Vibrio cholerae serogroup O1, serotype Inaba. A subsequent review of surveillance reports identified four patients in Nairobi County during the preceding month who met either of the Kenya Ministry of Health suspected cholera case definitions: 1) severe dehydration or death from acute watery diarrhea (more than four episodes in 12 hours) in a patient aged ≥5 years, or 2) acute watery diarrhea in a patient aged ≥2 years in an area where there was an outbreak of cholera. An outbreak investigation was immediately initiated. A confirmed cholera case was defined as isolation of V. cholerae O1 or O139 from the stool of a patient with suspected cholera or a suspected cholera case that was epidemiologically linked to a confirmed case. By January 15, 2016, a total of 11,033 suspected or confirmed cases had been reported from 22 of Kenya's 47 counties (Table). The outbreak is ongoing.
Hyperplastic Foci in Precancerous Rat Liver: Light Microscopic and Electron Microscopic Study
Authors: Alan H. Timme
Journal: JNCI Journal of the National Cancer Institute (1978)

4-Dimethylaminoazobenzene was fed to Wistar-derived, male, albino rats after hepatic siderosis had been induced by including ferric citrate in the diet. Iron-free foci of hepatocytes developed and this characteristic enabled them to be recognized macroscopically in the brown parenchyma. Five such lesions, each 1 mm or less in diameter, were studied by light and electron microscopy. The cells in the foci were larger than those surrounding the foci and had a granular and moderately basophilic cytoplasm. Ultrastructurally, the cells closely resembled normal hepatocytes. They possessed well-developed rough endoplasmic reticulum, numerous free ribosomes, peroxisomes, bile canaliculi, and cytoplasmic junctional complexes, but only small stores of glycogen were observed. Occasional ferritin-laden lysosomes persisted in some cells. These foci were regarded as hyperplastic. Possibly, they evolved into hyperplastic nodules either of the basophilic or vacuolated type. These foci should be clearly distinguished from hyperbasophilic foci that consisted of very poorly differentiated cells.
Induction of Tumors in Rats With Procarbazine Hydrochloride
Authors: Margaret G. Kelly, Roger W. O'Gara, Sidney T. Yancey, Constance Botkin
Journal: JNCI Journal of the National Cancer Institute (1968)

Single and repeated administration of procarbazine hydrochloride [N-isopropyl-α-2-(methylhydrazino)-p-toluamide, hydrochloride] by oral or intraperitoneal route induced tumors in Osborne-Mendel and Fischer rats. All the rats were less than 1 year old at death. In Osborne-Mendel rats, 90–100% of females and 70% of males developed mammary adenocarcinomas in a median latent period of 13–19 and 27 weeks, respectively, 40% of males developed hemangioendotheliomas and hemangiomas of the spleen, and several rats developed pulmonary tumors. Carcinoma of the duodenum and the jejunum, hemangioendothelioma of the kidney, uterus, and liver, leukemia, fibrosarcoma of the oral submucosa, and subcutaneous rhabdomyosarcoma each were found in one animal only. In Fischer rats, 20–60% of the females and none of the males developed mammary tumors (median latent period in females, 34–43 weeks), 40% of the females and 30% of the males developed tumors of the kidney, 10% of the females developed tumors of the uterus, 15% of the females and 30% of the males developed squamous cell carcinoma of the ceruminous and of the sebaceous glands, and a few animals developed pulmonary tumors. Leiomyosarcoma of the jejunum, ganglioneuroma of the adrenal gland, lymphosarcoma, reticulum cell sarcoma of lymph node, retroperitoneal rhabdomyosarcoma, and a subcutaneous fibrosarcoma each were found in one rat.
Systolic and diastolic dysfunction in childhood cancer survivors
Authors: C. A. Brouwer, A. Postma, M. P. van den Berg, M. T. Bink-Boelkens, W. A. Kamps, A. J. Smit, J. M. Vonk, E. G. de Vries, N. Zwart, J. A. Gietema
Journal: Journal of Clinical Oncology (2008)

10032 Background: In childhood cancer survivors (CCS), cardiac dysfunction has been mainly characterized by systolic dysfunction (SysDfx). However, both SysDfx and diastolic dysfunction (DiasDfx) are considered to be risk factors (RF) in development of clinical heart failure. Therefore, we aimed to assess the prevalence and treatment-related RF of SysDfx and DiasDfx after potential cardiovascular-toxic childhood cancer treatment (CCT). Methods: A cross-sectional single centre cardiovascular cohort study was performed in 277 CCS treated between 1976–1999 with anthracyclines (A, N=199; median (range) dose 183 (50–600) mg/m2), platinum (N=22) and/or radiotherapy (RT, N=175; chestRT, N=69; neckRT, N=67). Median age at diagnosis was 9 (0–20)-y, current age 28 (18–48)-y and follow-up (FU) 18 (5–31)-y post-treatment. Cardiac assessment included echocardiography and assessment of N-terminal pro-brain natriuretic peptide (NTproBNP). Results were compared with those of 130 age- and sex-matched sibling controls. By multivariate logistic regression, we studied the influence of CCT on the main outcome measures SysDfx (wall motion score index >1.00) and DiasDfx (E/A-ratio <1.00 and/or mean Tissue Velocity Imaging of early diastole <8.00cm/s). We adjusted for age at diagnosis, sex, current age, hypertension and BMI. Results: Clinical heart failure was found in 15 (5%) CCS. Compared with controls, CCS had a higher prevalence of SysDfx (13% vs. 2%; p<0.001) and DiasDfx (15% vs. 2%; p<0.001). In 26/40 (65%) CCS with DiasDfx no SysDfx was found. Overall, 68 (25%) CCS vs. 4 (3%) controls (p<0.001) had SysDfx and/or DiasDfx and CCS had a higher NTproBNP (47 (11–4758) vs. 34 (11–257) ng/L; p<0.001). SysDfx was associated with A-dose (by 100mg/m2; OR (95%CI) 1.4 (1.1–1.8)), not with chestRT (OR 1.1 (0.5- 2.6)). DiasDfx was associated with hypertension (OR 6.1 (2.4–15.7)), A-dose (by 100mg/m2; OR 1.4 (1.1–1.8)), chestRT (OR 3.5 (1.3–9.0)) and neckRT (OR 2.7 (1.1–7.1)). Conclusion: At median 18-y FU, 25% of CCS treated with potential cardiovascular-toxic CCT had evidence of SysDfx and/or DiasDfx. For DiasDfx, anthracycline-dose and chest-/neckRT were identified as RF. DiasDfx may be of prognostic significance in development of clinical heart failure and needs to be explored as potential intervention target. No significant financial relationships to disclose.
<i>The Doctor Henri Vaquez (1860-1936), Cardiologist</i>
Authors: Jeanette M. Smith
Journal: JAMA (2016)

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