tbuckley/cabot-search huggingface dataset:
Sentinella-GIVOM, a randomized clinical trial (RCT) on sentinel node biopsy (SNB) versus axillary lymph node dissection (ALND) in breast cancer (BC): results of first interim analysis
Authors: G. Zavagno, G. L. De Salvo, G. Scalco, F. Bozza, R. Marconato, L. Barutta, C. Racano, D. Casara, M. Lise
Journal: Journal of Clinical Oncology (2004)

559 Background: The SNB in BC has been proposed as a valid tool to stage the axilla but its therapeutic role is still unknown. In 2000, GIVOM started a RCT to evaluate whether a selective lymphadenectomy is clinically equivalent to ALND, in terms of disease free survival while contributing less morbidity. We report the interim analysis on the role of SNB as a diagnostic tool to predict the status of axillary nodes. Methods: Patients with breast cancer < 3 cm were randomized to SNB followed by ALND (group A) or SNB followed by ALND only if sentinel node (SN) was metastatic (group B). Surgeons should have performed at least 15 SNBs before randomizing patients. A surgical quality control was not planned. The day before surgery, patients received a subdermal injection of 30–50 MBq of Nanocoll into the cutaneous projection of the tumor. SN was harvested under the guidance of a γ probe. All radioactive nodes with a probe count > 10% of that of the hottest node were resected. Histological examination of the SNs was performed using haematoxylin-eosin and immunohistochemical staining. Only SNs in group B underwent frozen section examination. A pathological quality control was carried out. Results: 641 patients, enrolled in 18 clinical centers, belonging to either academic or community hospitals, were considered for analysis (326 in group A and 315 in group B). The rate of intra-operative SN identification was similar between the groups (94.8%, 95%CI=91.8–96.9 in group A and 94.9%, 95%CI=91.9–97.1 in group B). In group A, the overall accuracy of the SN status was 93.5%, the negative predictive value 91.1% (95%CI=86.7–94.5), the sensitivity 80%. Therefore, the false negative rate (FNR) was 20% (20 of 100, 95%CI=12.7–29.2). Conclusions: Within this multi-center trial, carried out in a heterogeneous setting, the SN FNR is much higher than the 5% recommended by the Philadelphia Consensus Conference. However, it could be representative of a non specialistic clinical practice setting, as reported in other studies. Therefore the SNB impact on survival must await the completion of this and other ongoing trials. No significant financial relationships to disclose.
In patients with type 2 diabetes and CV disease, empagliflozin reduced a composite of CV events at 3.1 years
Authors: Paul Shekelle
Journal: Annals of Internal Medicine (2016)

Source Citation Zinman B, Wanner C, Lachin JM, et al; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;Sep 17. [Epub ahead of print.] 26378978
Carcinogenic Effects of Diethylstilbestrol in Male Syrian Golden Hamsters and European Hamsters&lt;xref ref-type="fn" rid="FN2"&gt;2&lt;/xref&gt;
Authors: H Reznik-Schüller
Journal: JNCI Journal of the National Cancer Institute (1979)

The tumorigenic effects of sc-implanted diethylstilbestrol (DES) on male Syrian golden hamsters and European hamsters were compared. The adenohypophyses, kidneys, and testes of both species showed neoplastic responses to DES treatment. European hamsters were more sensitive than were Syrian hamsters, inasmuch as the European hamsters had a higher tumor incidence. The testicular tumors were all Leydig cell adenomas and seemed to depend on the coincident occurrence of hypophyseal neoplasms (all composed of gonadotropic cells). Of the European hamsters tested, 29% also developed liver tumors (hepatocellular adenomas, carcinomas, and cholangiocarcinomas.
Long-term survival and toxicity profile of patients with disseminated neuroendocrine tumors following multiple cycles of high activity <sup>111</sup>In pentetreotide therapy.
Authors: E. S. Delpassand, R. Sharif, J. Sims-Mourtada, I. Tworowska, L. B. Anthony
Journal: Journal of Clinical Oncology (2010)

e13545 Background: We have previously reported clinical response to multiple doses of high activity 111In pentetreotide in patients with disseminated neuroendocrine tumors. Here we report long term renal toxicity and survival following multiple 500 mCi doses of 111In-pentetreotide. Methods: In a nonrandomized trial, 83 patients (50 men, 33 women) with disseminated neuroendocrine tumor (stages III to IV) received 500mCi doses of In-111 pentetreotide therapy without co-administration of amino acid solution. Twenty-one patients received one therapy with an average dose of 489mCi/patient (390-513 mCi) and average renal dose of 330 rad (134-712 rad). Forty-one patients received two cycles of therapies with an average dose 977mCi/patient (893-1,012 mCi/patient) and cumulative renal dose of 566 rad (63-578 rad). Twenty-one patients received three therapies with an (average dose 1,464 mCi/patient (1,419-1,495mCi) and cumulative average renal dose of 665 rad (329-2,273 rad). Patients were evaluated for evidence of renal toxicity using NCI common toxicities criteria and followed for an average of 28.64 months (1.2-50.6 months). For patients with more than one therapy, data is reported after the last cycle of therapy. Kaplan Meyer survival analysis was conducted on 65 patients followed for 12 months or more. Results: Four patients had grade 1renal toxicity immediately following therapy. Of these patients 1 patient received 1 therapy, 1 patient received 2 therapies and 2 patients received 3 therapies. There were no reports of significant renal toxicity. No correlation to absorbed kidney dose was found. Average survival time was 23.4 months (1.2-50.6 months). Conclusions: Multiple 500 mCi doses of 111In-pentetreotide therapy are effective in patients with progressive disseminated neuroendocrine tumors, with minor acute renal toxicity. No long-term toxicity was observed at doses up to 1,495 mCi/ patient. The toxicity profile of this regimen suggests the opportunity for further dose escalation. No significant financial relationships to disclose.
Intensified induction and consolidation with or without maintenance chemotherapy for acute myeloid leukemia (AML): two multicenter studies of the German AML Cooperative Group.
Authors: T Büchner, D Urbanitz, W Hiddemann, H Rühl, W D Ludwig, J Fischer, H C Aul, H A Vaupel, R Kuse, G Zeile
Journal: Journal of Clinical Oncology (1985)

In two multicenter trials, a total of 576 patients with acute myeloid leukemia (AML) were treated and found to be evaluable. Two hundred forty-two patients were in a 1978 pilot study and 334 patients were in a 1982 randomized study. Ages were between 15 and 78 years (median, 48). The uniform remission induction therapy in both studies consisted of one to two courses of a 9-day combination of 6-thioguanine (TG) with cytosine arabinoside (ARA-C) and daunorubicin (DNR) [TAD9]. The timing and sequencing of TAD9 was designed according to cell kinetic effects of ARA-C. A complete remission (CR) was achieved in 65% (70% and 61%, respectively) of patients within a median of 33 days, and in 68% of responders after only one course. The CR rate in patients 60 to 78 years of age was 51% (66% and 39%, respectively). In the 1978 pilot study, different protocols of post-remission treatment were applied at the different centers: monthly 5-day maintenance, TAD9 consolidation, both consolidation and maintenance, or no further therapy. The group receiving treatment during CR showed 24% probability of remissions at 4 years v 0% probability of remissions in the untreated group. Between the different post-remission protocols, no significant differences were observed. Remission duration was not influenced by age, WBC, or morphologic cell type, but was longer in patients achieving CR within 30 days (P = .017). In the subsequent 1982 study, 145 patients in CR were randomized for TAD9 consolidation with or without monthly maintenance. The updated life-table analysis revealed a predicted rate of continuous remission at 2 1/2 years of 30% for the maintenance and 17% for the nonmaintenance arm (P = .003). These results of response and remission duration in adult patients of all ages support the validity of intensified induction therapy and of consequent myelosuppressive treatment in remission.
Hyaluronic acid levels are increased in parapneumonic pleural effusions
Authors: Theodora Zaga, Demosthenes Makris, Irene Tsilioni, Smaragda Oikonomidi, Theodoros Kyropoulos, Anastasios Damianos, Konstantinos Gourgoulianis
Journal: European Respiratory Journal (2011)

Background:  Hyaluronic acid (HA) is a component of extracellular matrix and may play a role in the pleural inflammation which is implicated in parapneumonic effusions.   Aim:  The aim of the current study was to investigate HA levels in serum and pleura in patients with parapneumonic effusions.   Methods:  We prospectively studied pleural and serum levels of HA in 58 patients with pleural effusions due to infection (complicated and uncomplicated parapneumonic effusions), carcinomatous effusions and transudative effusions due to congestive heart failure. In addition to HA, TNF-a and IL-1b levels were determined in pleural fluid and serum by ELISA.   Results:  The median±SD HA levels (pg/ml) in pleural fluid of patients with complicated effusions (39.058±11.208) were significantly increased (p  (11.230±1.969), carcinomatous effusions (10.837±4.803) or congestive heart failure (5.392±3.133). There was no correlation between pleural fluid and serum HA values. Pleural fluid TNF-a levels (146±127) and IL-1b levels (133.4±156) were significantly higher in patients with complicated parapneumonic effusions compared to patients with other types of effusion (p   Conclusion:  HA may play a significant role in the inflammatory process which characterizes exudative infectious pleuritis. Further investigation might reveal whether HA is a useful marker in the management of parapneumonic effusions.
Divergent Outcomes in Cognitive-Behavioral Therapy and Pharmacotherapy for Adult Depression
Authors: Jeffrey R. Vittengl, Robin B. Jarrett, Erica Weitz, Steven D. Hollon, Jos Twisk, Ioana Cristea, Daniel David, Robert J. DeRubeis, Sona Dimidjian, Boadie W. Dunlop, Mahbobeh Faramarzi, Ulrich Hegerl, Sidney H. Kennedy, Farzan Kheirkhah, Roland Mergl, Jeanne Miranda, David C. Mohr, A. John Rush, Zindel V. Segal, Juned Siddique, Anne D. Simons, Pim Cuijpers
Journal: American Journal of Psychiatry (2016)

Objective: Although the average depressed patient benefits moderately from cognitive-behavioral therapy (CBT) or pharmacotherapy, some experience divergent outcomes. The authors tested frequencies, predictors, and moderators of negative and unusually positive outcomes. Method: Sixteen randomized clinical trials comparing CBT and pharmacotherapy for unipolar depression in 1,700 patients provided individual pre- and posttreatment scores on the Hamilton Depression Rating Scale (HAM-D) and/or Beck Depression Inventory (BDI). The authors examined demographic and clinical predictors and treatment moderators of any deterioration (increase ≥1 HAM-D or BDI point), reliable deterioration (increase ≥8 HAM-D or ≥9 BDI points), extreme nonresponse (posttreatment HAM-D score ≥21 or BDI score ≥31), superior improvement (HAM-D or BDI decrease ≥95%), and superior response (posttreatment HAM-D or BDI score of 0) using multilevel models. Results: About 5%−7% of patients showed any deterioration, 1% reliable deterioration, 4%−5% extreme nonresponse, 6%−10% superior improvement, and 4%−5% superior response. Superior improvement on the HAM-D only (odds ratio=1.67) and attrition (odds ratio=1.67) were more frequent in pharmacotherapy than in CBT. Patients with deterioration or superior response had lower pretreatment symptom levels, whereas patients with extreme nonresponse or superior improvement had higher levels. Conclusions: Deterioration and extreme nonresponse and, similarly, superior improvement and superior response, both occur infrequently in randomized clinical trials comparing CBT and pharmacotherapy for depression. Pretreatment symptom levels help forecast negative and unusually positive outcomes but do not guide selection of CBT versus pharmacotherapy. Pharmacotherapy may produce clinician-rated superior improvement and attrition more frequently than does CBT.
Similar breast cancer cell contamination of single-day peripheral-blood progenitor-cell collections obtained after priming with hematopoietic growth factor alone or after cyclophosphamide followed by growth factor.
Authors: J L Passos-Coelho, A A Ross, D J Kahn, T J Moss, J M Davis, A M Huelskamp, S J Noga, N E Davidson, M J Kennedy
Journal: Journal of Clinical Oncology (1996)

PURPOSE To evaluate tumor-cell contamination of peripheral-blood progenitor-cell (PBPC) collections obtained after priming with granulocyte colony-stimulating factor (G-CSF). PATIENTS AND METHODS Immunocytochemical (ICC) and tumor clonogenic (TCA) assays were used to analyze tumor-cell contamination of pretreatment peripheral-blood (PB) and bone marrow (BM) samples, and of PBPC collection samples obtained after priming with G-CSF 5 micrograms/kg/d for 5 or 7 days in 38 women with advanced breast cancer undergoing high-dose chemotherapy (HDC). Results were compared with 37 historical control patients who underwent PBPC mobilization with cyclophosphamide (4 g/m2) followed by granulocyte-macrophage colony-stimulating factor (GM-CSF) 5 micrograms/kg/d for 14 days. RESULTS Before PBPC priming with G-CSF, only one of 37 (3%) PB and four of 36 (11%) BM samples had tumor cells detected by ICC. Tumor-cell contamination of PBPC collections obtained after 5 or 7 days of G-CSF priming was observed in only three of 38 patients (8%). All patients with tumor cells detected in the PBPC collection had stage IV disease. Cells with in vitro clonogenic potential were detected only in the pretreatment BM sample in one patient, and another two patients had ICC- and TCA-positive PBPC samples despite tumor-negative PB and BM before priming. These results are similar to those previously reported for PBPC primed with cyclophosphamide and GM-CSF. CONCLUSION In patients with advanced breast cancer responsive to cytotoxic chemotherapy, tumor-cell contamination is not increased in PBPC collected after 5 or 7 days priming with G-CSF and appears similar to that seen when PBPC are primed with cyclophosphamide followed by GM-CSF.
Vaccination with Irradiated Autologous Tumor Cells Mixed with Irradiated GM-K562 Cells Stimulates Antitumor Immunity and T Lymphocyte Activation in Patients with Recurrent Malignant Glioma
Authors: William T. Curry, Ramana Gorrepati, Matthias Piesche, Tetsuro Sasada, Pankaj Agarwalla, Pamela S. Jones, Elizabeth R. Gerstner, Alexandra J. Golby, Tracy T. Batchelor, Patrick Y. Wen, Martin C. Mihm, Glenn Dranoff
Journal: Clinical Cancer Research (2016)

Recurrent malignant glioma carries a dismal prognosis, and novel therapies are needed. We examined the feasibility and safety of vaccination with irradiated autologous glioma cells mixed with irradiated GM-K562 cells in patients undergoing craniotomy for recurrent malignant glioma.We initiated a phase I study examining the safety of 2 doses of GM-K562 cells mixed with autologous cells. Primary endpoints were feasibility and safety. Feasibility was defined as the ability for 60% of enrolled subjects to initiate vaccination. Dose-limiting toxicity was assessed via a 3+3 dose-escalation format, examining irradiated tumor cells mixed with 5 × 10(6) GM-K562 cells or 1 × 10(7) GM-K562 cells. Eligibility required a priori indication for resection of a recurrent high-grade glioma. We measured biological activity by measuring delayed type hypersensitivity (DTH) responses, humoral immunity against tumor-associated antigens, and T-lymphocyte activation.Eleven patients were enrolled. Sufficient numbers of autologous tumor cells were harvested in 10 patients, all of whom went on to receive vaccine. There were no dose-limiting toxicities. Vaccination strengthened DTH responses to irradiated autologous tumor cells in most patients, and vigorous humoral responses to tumor-associated angiogenic cytokines were seen as well. T-lymphocyte activation was seen with significantly increased expression of CTLA-4, PD-1, 4-1BB, and OX40 by CD4(+) cells and PD-1 and 4-1BB by CD8(+) cells. Activation was coupled with vaccine-associated increase in the frequency of regulatory CD4(+) T lymphocytes.Vaccination with irradiated autologous tumor cells mixed with GM-K562 cells is feasible, well tolerated, and active in patients with recurrent malignant glioma. Clin Cancer Res; 22(12); 2885-96. ©2016 AACR.
Efficacy of a gemcitabine based multiagent chemotherapy regimen for advanced uterine sarcomas
Authors: P. K. Singhal, S. Sharma, M. Benitez, K. Odunsi, S. Lele
Journal: Journal of Clinical Oncology (2006)

15047 Background: Advanced stage uterine sarcomas (US) have poor prognosis. Active agents in US are doxorubicin, cisplatin and ifosfamide, with response rates (RR) of 25%, 19%, and 17% respectively. Given the poor response, there remains a need for other drugs. Gemcitabine has shown activity in soft tissue sarcomas. In trials with all subtypes of sarcomas, RR observed with single and multiagent schedules are ranging from 3 to 53%. There is scarce data on the use of gemcitabine in US. Aim of our study was to determine the clinical activity of gemcitabine based regimen in patients with US. Methods: From 2002–2005, data from11 chemotherapy naïve patients diagnosed with advanced stage US was reviewed who were receiving gemcitabine/ifosfomide/platinum (GIP) combination chemotherapy regimen in an adjuvant setting after TAH and surgical staging. Ifosfomide 2gm/m 2 and Platinum 20 mg/m 2 intravenously on days 1, 2 and 3. Gemcitabine 800 mg/m 2 intravenously was administered on day 1 of a 28-day cycle. Results: Eleven pts were treated, all stages III and IV. The median age was 49 years. There were 6 carcinosarcomas, 4 LMS, and 1 ESS. Performance status was 0 (6 pts), 1 (5 pts). Four pts (36%) had undergone prior radiotherapy. The site of measurable disease in 10 pts (91%) was in the pelvis. The median number of GIP cycles received per pt was 6 (range 1–9). There were no treatment-related deaths. Hematologic toxicities of &gt; Grade 3 were seen in 82% of pts and consisted of leukopenia and anemia. 36% of pts had an episode of febrile neutropenia. Neurotoxicty (Grade 3 in 2 pts), nausea (Grade 1/2 in 6 pts), and fatigue (Grade 1/2 in 7 pts) were observed. Three (27%) complete responses were observed, four pts had a partial response (36%), for an overall RR of 63%. Four pts had progression of disease (36%). Of the 7 pts demonstrating a response, 4 had previously been irradiated and 3 had not, such that the RR in those previously irradiated was 4/4 = 100% versus 3/7 = 43% in those not previously irradiated. Conclusions: The combination of GIP is well-tolerated and seems to be active in US, yielding RR higher than seen with single agent chemotherapy agents. Pts that received previous adjuvant radiation demonstrated the best responses to this regimen. A randomized trial is needed to evaluate the true value of this regimen in advanced stage US. No significant financial relationships to disclose.
THE PLACE OF HISTAMINE IN NEUROHUMORAL TRANSMISSION
Authors: JEAN-LOUIS PARROT
Journal: Pharmacological Reviews (1954)

1. The mediator of the vasodilator fibres of the posterior roots seems to be neither histamine nor acetylcholine. 2. After irritation of the skin, histamine released by injured cells is able to stimulate peripheral endings of the vasodilator fibres and elicit a vasodilator axon reflex. 3. In the same way, histamine released from the skin by certain aggressions can stimulate the peripheral origin of certain sensory nerves and elicit painful sensations such as, possibly, burning and, very probably, itching.
Oral Nutrient Supplementation and Cognitive Function—Reply
Authors: Emily Y. Chew, Lenore Launer, Paul Bernstein
Journal: JAMA (2016)

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Randomized comparison of diaziquone and carmustine in the treatment of adults with anaplastic glioma.
Authors: S C Schold, J E Herndon, P C Burger, E C Halperin, N A Vick, J G Cairncross, D R Macdonald, E J Dropcho, R Morawetz, D D Bigner
Journal: Journal of Clinical Oncology (1993)

PURPOSE We conducted a phase III trial comparing intravenous (IV) diaziquone (AZQ) and carmustine (BCNU) as single agents in patients with cerebral anaplastic gliomas who had received surgery and radiotherapy. Its purpose was to compare the efficacy of AZQ with that of BCNU, the standard agent for brain tumor chemotherapy. PATIENTS AND METHODS Randomization between the two regimens occurred 8 weeks after completion of radiotherapy. A total of 251 patients were randomized to receive either AZQ or BCNU, and there were no significant differences between the two treatment arms in any of the known prognostic variables, including age, histologic grade, and Karnofsky performance status (KPS). RESULTS There was no significant difference in either time to tumor progression or survival between the two treatment arms. Age and histology were strong predictors of outcome, whereas KPS had relatively less effect. Three groups of patients with distinctly different outcomes could be identified: (1) older age (45+) and glioblastoma/gliosarcoma (GBM/GS) patients had a median survival of 37 weeks after randomization; (2) patients with either older age or GBM/GS had a median survival of 61 weeks; and (3) younger age (&lt; 45) and non-GBM/GS (usually anaplastic astrocytoma) patients had a median survival of 147 weeks. Toxicity was primarily hematologic, although acute gastrointestinal toxicity and chronic pulmonary toxicity were more common with BCNU. Patients randomized to AZQ who had significant hematologic toxicity that required dose reduction after the first treatment cycle had significantly longer time to tumor progression and survival than those who did not require dose reduction (P = .011 and .016, respectively). CONCLUSION There was no significant difference in efficacy between AZQ and BCNU in patients with anaplastic gliomas as tested in this study, although AZQ was somewhat better tolerated.