tbuckley/cabot-search huggingface dataset:
Induction chemotherapy (IC) followed by radiochemotherapy (RCT) versus radiochemotherapy alone as treatment in advanced laryngeal (LC)/hypopharyngeal cancer (HC): Phase IIb.
Authors: Rainald Knecht
Journal: Journal of Clinical Oncology (2014)

6015 Background: Recently published long term results of the RTOG 91-11(J Clin Oncol 31:845-852) have shown that locoregional control and larynx preservation is in favour to concomitant radiochemotherapy(RCT).However there have been no differences in survival between IC, RCT and RT. RTOG 91-11 didn’t use novel IC regimens like the standard IC Protocol of TPF (Tax324,Lancet Oncol 2011;12:153-59).The aim of the study was therefore to answer the question(a) if the addition of the standard IC TPF protocol to the standard RCT of the 91-11 is able to enhance the treatment efficacy(b)if TuVol and molecular markers are able to predict the outcome. Methods: 278 UICC Stage III/IV patients have been treated according the RTOG 91-11 protocol (concomitant arm) +/- IC TPF Tax323 induction protocol.Objective response and adverse events were assessed trough the RECIST criteria and the NCI CTCAE v2.0.Tumor assessment(endoscopy,biopsy,MRI)and EORTC QLQ C30 HN35 survey were carried out at the end of ICT and CRT and during fixed intervals after therapy. Primary endpoint was TTF assuming a 15% difference in favour of IC . Results: 5year Results:TPF IC+RCT vs.RCT:Completion of therapy 75%/82%; ORR 94%/87%; local 77%/64%,regional 72%/60% control(p<0.05);larynx preservation 87%/79%;distant control 94%/81%(p<0.05);OS 61%/55%(n.s);DFS 46%/37%,significant in HC(p=0.03).TTF difference in favour of IC was accepted(p=0.048).No significant differences in Grade 3-4 toxicities with the exception of neutropenia.CR after IC and IC+RCT was associated with better survival with only IC being highly significant in multivariate analysis(p<0.001).TuVol correlated with response rate(p=0.003)as well as Ki67+ and vascular density in the tumor(p<0.05). Conclusions: The addition of the Tax 324 TPF IC protocol to the 91-11 RCT protocol may be an appropriate approach for advanced risk for local and distant failure.The dose of cisplatin during RCT should be limted to 200mg/m2.
Phase II study of <i>pseudomonas aeruginosa</i>-mannose-sensitive hemagglutinin in combination with capecitabine for HER2-negative metastatic breast cancer pretreated with anthracycline and taxane.
Authors: Fangfang Lv, Jun Cao, Zhebin Liu, Zhong Hua Wang, Jian Zhang, Sheng Zhang, Leiping Wang, Xinmin Zhao, Shao Zhimin, Biyun Wang, Xi-Chun Hu
Journal: Journal of Clinical Oncology (2014)

1053 Background: Metastatic breast cancer (MBC) remains an incurable disease despite major therapeutic advances. Pseudomonas aeruginosa–mannose-sensitive hemagglutinin (PA-MSHA) has been established to have anti-proliferative effects against breast cancer cells in preclinical experiments, and is indicated for treatment of cancer in China. We performed a phase II trial combining PA-MSHA with capecitabine in patients with heavily pretreated MBC. Methods: Eligibility criteria included human epidermal growth factor receptor 2–negative MBC, prior therapy with anthracyclines and taxanes, at least one prior chemotherapy regimen for metastatic disease or early relapse after a taxane plus anthracycline adjuvant regimen, and adequate organ function and performance status. PA-MSHA 1 mg was administered subcutaneously every other day and capecitabine 2000 mg/m2orally twice a day for 2 weeks on, 1 week off. The primary end point was progression-free survival. The trial was registered at www.ClinicalTrials.gov (ID NCT01380808). Results: A total of 97 patients were enrolled. Median progression-free survival (PFS) was 4.0 months [95 % confidence interval (CI) 3.0–4.9), which was not significantly different from that in historical controls. However, median PFS was significantly longer (8.2 months; 95 % CI 6.7–9.7) in 24 patients with moderate immune-related adverse events (irAEs) such as fever or skin induration at the injection site than in those with no or mild irAEs (3.1 months, 95 % CI 2.5–3.6; p = 0.003). Overall survival was also improved in these patients (25.4 vs. 16.4 months; p = 0.044). PA-MSHA has a good safety profile, with only 6 patients (6.2 %) discontinuing treatment. PA-MSHA did not increase capecitabine-related toxicities such as hand-foot syndrome, nausea, and vomiting. Conclusions: Adding PA-MSHA to capecitabine has a good safety profile in patients with heavily pre-treated MBC, although benefit from this regimen might occur only in patients with moderate PA-MSHA–related adverse events. Clinical trial information: NCT01380808.
Role of nonselective beta blockers in hepatocellular carcinoma prevention: A retrospective analysis in patients with cirrhosis.
Authors: Abhishek Kumar, Hiren Patel, Hamid Shaaban, Michael Maroules
Journal: Journal of Clinical Oncology (2014)

e15141 Background: Hepatocellular carcinoma (HCC) is the sixth most common cancer. Viral eradication in hepatitis B (Hep B) reduces the risk of HCC. In Hepatitis C patients Interferon α2b doesn’t reduce HCC. Gut-derived inflammation and neo-angiogenesis are important in hepatic carcinogenesis; Non-selective beta-blocker (NSBB) can potentially reduce the development and growth of HCC. Methods: We retrospectively enrolled 200 patients from medical records diagnosed with cirrhosis and portal hypertension between January 2001 and December 2013. Eighteen patients were excluded (taking selective beta-blocker and/or unavailable medical records). The etiology of cirrhosis, use of NSBB, demographics and presence of HCC was collected. Results: There were 139 (75.8%) males. The mean age for portal hypertension with cirrhosis 55.6 ± 11.7 & HCC was 62.6 ± 9.7 years. The distribution of race was 96 (52.7%) Hispanic & 40 (22%) Caucasian. Causes of cirrhosis were alcohol 92 (50.5%), followed by Hep C 78 (42.9%). One hundred (Propranolol=97, Nadolol=3) patients were on NSBB. Forty-two patients (M=34, F=8) had a diagnosis of HCC. Use of NSBB was associated with lower odds of developing HCC [OR 0.123, CI 95% (0.053, 0.286) p<0.0001]. In males, odds were lower in NSBB [OR 0.112, CI 95% (0.042, 0.295) p<0.0001]. Significantly lower odds were also found in Hep C [OR 0.17, CI 95% (0.056, 0.513) p<0.0001], alcohol [OR 0.039, CI 95% (0.005, 0.309) p<0.0001], Hispanic [OR 0.146, CI 95% (0.044, 0.479) p=0.0008] and AA [OR 0.062, CI 95% (0.01, 0.386) p=0.001]. Statistical significance was not reached in females [OR 0.174, p= 0.051], Hep B subgroup [p=1] and Caucasian subgroup [p=0.2]. Conclusions: We demonstrated that use of NSBB in patients with all-cause cirrhosis results in lower odds of developing HCC. Possible mechanisms includes preventing lipid peroxidation membranes, reducing intracellular calcium, attenuating mitochondrial dysfunction, inhibiting Bax-mediated cytochrome C release, NADPH oxidase and protein kinase C activity, decreasing vascular endothelial growth factor (VEGF)/basic fibroblast growth factor gene expression.
Clinical course and prognostic factors for patients with brain metastasis in non-small cell lung cancer.
Authors: Yoshihito Kogure, Chiyoe Kitagawa, Masahide Oki, Hideo Saka
Journal: Journal of Clinical Oncology (2014)

e19131 Background: Prognosis of non-small cell lung cancer (NSCLC) patients with brain metastasis (BM) has been reported to be poor even in those patients treated with systemic chemotherapy. Development of imaging technology, radiation therapy and chemotherapy might improve survival time. The aim of this study was to evaluate survival in NSCLC patients with BM and eligible for systemic chemotherapy. Methods: Clinical information was retrospectively assembled for NSCLC patients with BM who received first-line systemic therapy at our institution between January 1, 2004 and December 31, 2012. Overall survival (OS) was compared using log-rank test, and Cox regression analysis was performed to identify independent prognostic factors. Results: Sixty-one consecutively treated patients were collected at our institution. Patient characteristics were: median age, 66 years (range: 52-84); male/female, 36/25; Adeno/Squamous/others, 53/4/4; ECOG performance status (PS) 0/1/2, 8/45/8; and epidermal growth factor receptor (EGFR) mutation +/-/unknown, 24/16/21. Brain metastatic status: number ≤5/6-10/ ≥11, 47/6/8; median maximal size, 10 mm (range: 3-38); edema +/-, 28/33; and symptoms +/-, 20/41. Among these patients, 10 received local therapy (5, neurosurgery and 5, radiation therapy) and 26 patients underwent chemotherapy for initial therapy. EGFR-tyrosine kinase inhibitor (TKI) was treated in 29 patients. Median progression-free survival was 7.2 months (range: 4.77-9.64) and median OS was 14.5 months (range: 11.3-17.7). In the Cox model including sex, age, PS, histology, treatment of EGFR-TKI and brain metastatic status as covariates, we found that poor PS (hazard ratio (HR) 3.89, 95% confidence interval (CI): 1.31-11.49, P=0.014), brain edema (HR 4.82, 95% CI: 1.44-16.08, P=0.011), and no treatment with EGFR-TKI (HR 2.24, 95% CI: 1.12-4.47, P=0.023) were independent worse prognostic factors. Conclusions: Median OS of NSCLC patients with BM at 14.5 months was longer than reported before. Brain edema was a significantly worse prognostic factor, whereas the number of BM and clinical neurological symptoms were not prognostic factors for this population.
Outcome and prognostic factors of salivary gland carcinoma arising in minor, submandibular, or sublingual glands: A retrospective multicenter study of the Japan Oral Oncology Group.
Authors: Hiroshi Kurita, Takahiro Kamata, Michihiro Ueda, Tetsuro Yamashita, Yoshihide Ota, Mitsunobu Otsuru, Tadaaki Kirita, Nobuhiro Yamakawa, Masaya Okura, Tomonao Aikawa, Masahiro Umeda, Souichi Yanamoto, Takahide Komori, Takashi Shigeta, Kiyoshi Harada, Yasuyuki Michi
Journal: Journal of Clinical Oncology (2014)

e17038 Background: Carcinomas of the salivary glands may arise either from major or minor glands. Surgery represents the mainstay of treatment of salivary gland carcinomas. The complete excision of tumor with an adequate margin can be easily achieved in case of minor, submandibular, or sublingual salivary glands, even though in many cases flaps are required to repair the defect. The purpose of this study is to describe outcome and prognostic factors of these surgically treated salivary gland carcinoma. Methods: 294 consecutive patients who underwent planned radical resection of salivary gland cancer from 1990 to 2010 were analyzed. Univariate and multivariate analyses were carried out to analyze clinical and pathological factors (primary site, T- and N-classification, histologic grade, state of an excision margin, radiotherapy, and chemotherapy) that influence prognosis of the salivary gland cancer. Results: The median follow-up time was 176 months. Overall survival, local control, and distant metastasis rate after 5 and 10 years were 84%, 83%, 20% and 71%, 75%, 28%, respectively. In the multivariate analysis, primary site (hazard ratio [HR] = 2.52; minor vs. sublingual gland), T-classification (HR = 1.61), histologic grade (HR = 1.95), and number of metastatic lymph node (HR = 1.25) were all independent prognostic factors for overall survival. Local control depended on T-stage, and status of surgical margin. The relative risk of local recurrence with surgery alone, compared with surgery plus postoperative radiotherapy, was 0.56, although it was not statistically significant (p = 0.07). Distant metastases were independently correlated with primary site, T-stage, status of surgical margin, and number of metastatic lymph node. Conclusions: The results of this study suggested that primary site, T-classification, histologic grade, status of surgical margin, and number of metastatic lymph node are important prognosis factor in the treatment of salivary gland cancer arising in minor, submandibular, or sublingual glands. It is also suggested that postoperative radiotherapy will show a possibility of improving prognosis.
Comparison of Mortality and Comorbidity Rates Between Holocaust Survivors and Individuals in the General Population in Israel
Authors: Naama Fund, Nachman Ash, Avi Porath, Varda Shalev, Gideon Koren
Journal: JAMA Network Open (2019)

Previous studies have suggested that Holocaust survivors may experience different chronic comorbidities more often than the general population. However, the mortality hazard among these individuals has not been addressed.To assess the overall mortality rate and comorbidities of a cohort of Holocaust survivors compared with an age-matched control group.This cross-sectional study included all Holocaust survivors insured by Maccabi Healthcare Services in Israel who were born between 1911 and 1945 in Europe and control individuals born in Israel during the same years and insured by the same service. Data were collected from January 1, 1998, through December 31, 2017.Rates of morbidities and mortality rates adjusted for sex, socioeconomic status, and body mass index using logistic regression, Cox regression, and Kaplan-Meier analysis.The 38 597 Holocaust survivors included 22 627 women (58.6%) and had a mean (SD) age of 81.7 (5.4) years, and the 34 931 individuals in the control group included 18 615 women (53.3%) and had a mean (SD) age of 77.7 (5.3) years. The Holocaust survivors had higher rates than control individuals of reported hypertension (32 038 [83.0%] vs 23 285 [66.7]), obesity (12 838 [33.3%] vs 9254 [26.5]), chronic kidney disease (11 929 [30.9%] vs 6927 [19.8]), cancer (11 369 [29.5%] vs 9721 [27.8]), dementia (6389 [16.6%] vs 3355 [9.6]), ischemic heart disease, nonmyocardial infarction (5729 [14.8%] vs 4135 [11.8]), myocardial infarction (3641 [9.4%] vs 2723 [7.8]), and osteoporotic fractures among women (6429 [28.4%] vs 4120 [22.1]). In contrast, the overall mortality rate was lower among Holocaust survivors (25.3%) compared with the control group (41.1%). After adjustment for confounders, mean age at death was significantly higher in the survivor group compared with the control group.The findings showed higher rates of comorbidities and lower mortality among Holocaust survivors, which may be associated with a combination of improved health literacy and unique resilience characteristics among Holocaust survivors. More research is needed to explore the biologic and psychosocial basis for these results.
Abstract P283: Changes in Sugar-sweetened and Diet Soda Consumption in Relation to Weight and Waist Circumference Change in a Cohort of Mexican Women
Authors: Dalia Stern, Nicole Middaugh, Megan Rice, Ruy López-Ridaura, Walter Willett, Martin Lajous
Journal: Circulation (2017)

Introduction: Obesity is associated with an increased risk of many NCDs, including cardiovascular diseases. Consumption of soda has been linked to weight gain. Mexico is the second largest consumer of soda in the world and close to 70% of Mexican women are overweight or obese. Hypothesis: We hypothesize that increase consumption of sugar-sweetened soda willbe associated with increases in weight and weight circumference. Methods: We evaluated changes in soda consumption and short-term weight and waist circumference gain in the Mexican Techers Cohort. A subsample of 11,218 participants reported reproductive history, lifestyle factors, and medical conditions and responded to a 137-item semi-quantitative food-frequency questionnaire (FFQ) at baseline in 2006 and at follow-up in 2008. Participants self-reported height and weight and were provided a measuring tape and instructions to assess their waist circumference. We used multivariable linear regression to estimate the impact of 2-year change in sugar-sweetened and diet soda consumption on change in weight and waist circumference, adjusting for potential confounders. Results: In multivariable analyses, each additional sugar-sweetened soda serving/day was associated with 0.95 kg (95% CI 0.71, 1.20) increase in weight and 0.94 cm (95% CI 0.48, 1.39) increase in waist circumference over the two-year study period. Changes in diet soda consumption were not associated with changes in weight or waist circumference. Conclusions: An increase in sugar-sweetened soda consumption was associated to short-term weight gain in Mexican women. Accumulated over time, even modest weight gain may have important health implications. Our results underscore the urgent need to rapidly reduce sugar-sweetened beverage consumption in this population.
Local cell-mediated immunity in stage III and IV colon cancer.
Authors: Oleg Ivanovich Kit, Elena Alekseevna Nikipelova, Elena Yurievna Zlatnik, Alexander Vasilievich Shaposhnikov, Inna Arnoldovna Novikova, Roman Evgenievich Tolmakh
Journal: Journal of Clinical Oncology (2014)

e22097 Background: A comparative analysis of lymphocyte subpopulation content in tissues of different areas of the large intestine in patients with stage III and IV colon cancer was made. Methods: Subpopulation content of T-lymphocytes (T-general – CD3+, helpers/inductors – CD3+CD4+, cytotoxic - CD3+CD8) and B-lymphocytes (CD19+), natural killers NK (CD16+CD56+) and T-lymphocytes with TCRαβ and TCRγδ in tumor tissue, peritumoral zone (1-3 cm from the tumor) and along the resection line (7-10 cm from the tumor border), taken during surgical procedures, was determined in 73 patients with stage III colon cancer (T3-4N1-2M0) and in 40 patients with stage IV colon cancer (T3-4N1-2M1). Immunophenotyping of lymphocytes from colon tissue samples was performed with the method of flow cytometry. Results: The study of lymphocytes quantity in the samples showed low content of cytotoxic T-lymphocytes (CD4+CD8+) in stage IV colon cancer compared to stage III both along the resection line (28,2±2,7% against 36,1±2,5%) and in peritumoral zone (19,8±2,8% against 29,1±2,1%) by 22% and 32% respectively, as well as high content of B-cells in all tissues studied: by 44% along the resection line (34,1±2,7% against 23,7±2,4%), by 34% in peritumoral zone (43,5±3,4% against 32,4±2,9%) and by 41% in the tumor (26,2±2,4% against 18,6±1,99%) (p<0,05). Low level of T-lymphocytes (41,1±3,2% against 52,5±2,0%) (p<0,05) in stage IV in peritumoral zone was registered. Changes were found in T-lymphocytes with TCRγδ. Thus, quantity of T-lymphocytes with TCRγδ in stage IV in peritumoral zone (5,5±1,3%) and in the tumor (6,1±1,2%) decreased by 39,0% and 44,0% respectively compared to the same zones in primary colon cancer (9,0±0,98% and 10,9±1,5% respectively) (p<0,05). Conclusions: Thus, in stage IV colon cancer complicated disorders of local cell-mediated antitumor immunity on account of considerable decrease of quantity of effector cytotoxic CD3+CD8+-cells and tissue T-lymphocytes with TCRγδ receptors were found, and high content of B-cells under this pathology suggests participating of some of that lymphocyte clones in tumor growth, which needs further studying.
Association of sunitinib exposure with toxicity outcome in a real-life population of elderly patients with cancer.
Authors: Pascaline Boudou-Rouquette, Audrey Thomas-Schoemann, Olivier Huillard, Anatole Cessot, Anne Chahwakilian, Galdric Orvoen, Julie Giroux, Jean-Philippe Durand, Michel Vidal, Benoit Blanchet, Francois Goldwasser
Journal: Journal of Clinical Oncology (2014)

e20523 Background: Elderly people represent a growing population susceptible to be treated with sunitinib (SU). The aim of this retrospective study was to explore the relationship between SU exposure and the occurrence of dose-limiting toxicities (DLT) in a real-life population of elderly patients. Methods: Elderly patients(>70 years old) received sunitinib at a starting dose of 50 mg per day (4 weeks on/2 weeks off) (standard regimen, SR) or a continuous daily dose of 25 or 37.5 mg (adapted regimen, AR) after a multidisciplinary risk assessment. DLT during the first cycle (6 weeks) were assessed every 14 days, and SU and SU 12662 (active metabolite) plasma concentrations were measured by liquid chromatography. SU, SU 12662 and composite (SU+SU12662) exposure (AUC) were estimated from a bayesian approach. Results: Twenty-five patients, median age 75 years [25th-75th percentile 72-82 ], 13 (52%) men, 64% mRCC, median ECOG-PS=1 (0-3), median active comorbidities of 2 (0-4) and 15 (60%) pts with polypharmacy (> 3 drugs) were included. Eleven pts were included in the SR group, and 14 in AR group (7 pts with 37.5 mg and 7 pts with 25 mg). DLT occurred in 6/11 (54%) in SR group and 9/14 (64%) in AR group, resulting in either dose reductions (36% and 36%, respectively) or definitive SU discontinuation (9% and 21%, respectively). The most frequent grade 3-4 AE in SR and AR groups was hypertension (36% and 29%, respectively). Median composite AUC (n=19) on day 14 after treatment initiation was 1865 ng/mL.h (25th-75th percentile 1287-2253). In SR group, pts with DLT exhibited a greater composite exposure than pts without DLT (3086 ± 982 vs 1621 ± 395 ng/mL.h, respectively p=0.0148). In contrast, in AR group, there was no significant difference in composite AUC between patients with DLT and those without (1542 ± 708 vs 1345 ± 745 ng/mL.h, p=0.70). Conclusions: This retrospective study shows a same frequency of DLTs in pts receiving SR compared to those with AR, and a lack of relation between composite exposure and DLT occurrence in patients under AR. This suggests that SR associated with drug monitoring would be a better option than an initial dose reduction in a real-life population of elderly cancer patients under sunitinib.
Respiratory Isolation Based on Rapid Molecular Testing in an Intermediate Tuberculosis-Burden Country
Authors: Ja Young Kim, Min Jee Hong, Sung-Han Kim
Journal: JAMA Internal Medicine (2019)

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