tbuckley/cabot-search huggingface dataset:
Neoadjuvant bevacizumab, capecitabine, and radiotherapy in locally advanced rectal cancer: Interim results of a phase II CRAB trial.
Authors: V. Velenik, J. Ocvirk, M. Omejc, M. Music, F. Anderluh, I. Oblak, I. Edhemovic, E. Brecelj, M. Kropivnik
Journal: Journal of Clinical Oncology (2010)

e14006 Background: Preoperative capecitabine-based chemoradiation (CRT) is a standard treatment for locally advanced rectal cancer. The radiosensitizing effect of bevacizumab (Bev), an inhibitor of the angiogenesis pathways, may further enchance tumor regression. This prospective, nonrandomized phase II study evaluated the efficacy and safety of Bev combined with capecitabine and concurrent RT for locally advanced rectal cancer. Methods: Patients (pts) with stage II or III rectal cancer confirmed by MRI were treated with an infusion of Bev (5 mg/kg) 2 weeks prior to neoadjuvant CRT, followed by Bev 5 mg/m2 on week 3, 5, 7 and capecitabine 825 mg/m2 bid including weekends during RT. RT was administered at 50.4 Gy (25×1.8 Gy with boost 3×1.8 Gy, 3D conformal technique), starting on week 3. Total mesorectal excision was scheduled 6-8 weeks after completion of CRT. Tumor regression grades (TRG) were evaluated on surgical specimens according to Dworak. The primary endpoint was complete pathologic response (pCR). Results: Twenty-six of 39 pts enrolled so far were eligible for safety and efficacy analyses. Median age was 57 (range: 31–74) years, 65% of pts were male. Six pts (23%) had T3N0 tumors, 6 pt (23%) T3N1, 2 pt (8%) T2N2, 9 pts (35%) T3N2, and 3 pts (11%) T4N2. In 11 pts (43%) tumor invaded the mesorectal fascia. The median tumor distance from anal verge was 5 (range: 1–11) cm. All pts received 50.4 Gy RT and 4 Bev infusions. Temporary capecitabine intake interruption was necessary for 1 (3.8%) due to leucopenia grade 2. Grade 3 toxicities included dermatitis (n = 5, 19.2%), diarrhea (n = 1, 3.8%) and proteinuria (n = 2, 7.7%). Nineteen patients (73%) had sphincter preserving surgery and in 1 pt exploration only was performed because of carcinosis of peritoneum. TRG 4 (pCR) was recorded in 4/25 pts (16%) and TRG 3 in 4 pts (16%). T-, N- and overall downstaging rates were 56%, 68% and 76%, respectively. Conclusions: Preoperative CRT with bevacizumab and capecitabine is safe and feasible. The high pathologic downstaging rate is promising, although so far, the pCR rate appeared to be lower than previously reported by some investigators. No significant financial relationships to disclose.
The Human CD38 Monoclonal Antibody Daratumumab Improves the Anti-Myeloma Effect of Lenalidomide with Dexamethasone in Vitro
Authors: Michel de Weers, Michael van der Veer, Berris van Kessel, Joost M Bakker, Shulamiet Wittebol, Paul WHI Parren, Henk M. Lokhorst, Tuna Mutis
Journal: Blood (2011)
Effect of Body Mass Index (BMI) At Diagnosis On Survival Patterns of Multiple Myeloma (MM) Patients in the Veterans Health Administration (VHA).
Authors: Kristen M. Sanfilippo, Tracey Beason, Su-Hsin Chang, Suhong Luo, Graham A Colditz, Ravi Vij, Michael H. Tomasson, Arun Ganti, Kenneth R. Carson
Journal: Blood (2012)
Impact of flaxseed supplementation and dietary fat restriction on prostate cancer proliferation and other biomarkers: Results of a Phase II randomized controlled trial (RCT) using a presurgical model
Authors: S. L. George, T. J. Polascik, D. M. Albala, P. J. Walther, J. Moul, J. F. Madden, D. C. Snyder, V. Hars, B. R. Switzer, R. T. Vollmer, W. Demark-Wahnefried
Journal: Journal of Clinical Oncology (2007)

1510 Background: Diet may play a key role in the etiology of prostate cancer (PC). Dietary fat restriction (DFR) and flaxseed supplementation (FS) may reduce risk, though results are mixed. We undertook an RCT to test the comparative effects of these dietary regimens on the biology of the prostate and other biomarkers. Methods: PC patients (N=161) scheduled ≥ 21 days prior to prostatectomy were block randomized on race (black vs non-black) and biopsy Gleason sum (&lt;7 vs 7+) to these diets: 1) control; 2) FS (30 g/day); 2) DFR (&lt;20% total energy); or 4) FS+DFR. Blood was drawn upon accrual and prior to surgery and analyzed for prostate specific antigen (PSA), sex hormone binding globulin (SHBG), total testosterone (T), insulin-like growth factor 1 (IGF1), IGF binding protein 3 (IGFBP3), c- reactive protein (CRP), and total and low density lipoprotein cholesterol (TC &amp; LDL-C). Proliferation (MIB-1) and apoptosis (TUNEL) was assessed in the malignant and benign prostate. Results: Complete data were collected on 93% of the sample; mean length on protocol was 30 days. Median MIB-1 positive (+) cells/total nuclei ratios were: 1=2.38;2=1.71;3=2.93;4=1.58. Primary analyses suggest a significant protective effect (p=0.016) of FS. Secondary analyses of MIB-1 + nuclei (controlling for total cell counts) show increased proliferation with DFR (p=.017), and a significant interaction with FS and DFR (p&lt;.0001). No differences were observed between groups with regard to PC apoptosis, and histology of benign tissue. No differences were observed between arms for PSA, SHBG, T, IGF1, IGFBP3 or CRP. Significant differences were observed between arms for changes in serum lipids and body weight [ΔTC = +9/-26/-46/-37 mg/dL; ΔLDLC = -14/-17/-29/-21 mg/dL and Δ weight = +0.3/-1.3/-1.7/-1.1 kg (p’s&lt;.05)]; effects were attributed to DFR and not FS. Side effects did not differ between arms Conclusions: Preliminary findings suggest that FS is safe and exerts a protective effect (main effect or via interaction with DFR) on PC. Data also provide further support of DFR for cardiovascular disease, though its role in PC is less clear. Further controlled analyses and additional studies are needed to confirm findings. No significant financial relationships to disclose.
Prosigna (PAM50) to predict response to neoadjuvant chemotherapy (NAC) in HR+/HER2- early breast cancer (EBC) patients.
Authors: Begona Jimenez Rodriguez, Ana Isabel Lavado Fernandez, Nuria Ribelles, Pedro Sanchez-Rovira, Luis Vicioso, Martina Alvarez, Vanessa de Luque, Cesar Ramirez Tortosa, Wesley Buckingham, Carl Schaper, Arthur Jeiranian, Naeem Dowidar, Sean Ferree, Ester Villar, Irene Zarcos, Alfonso Sanchez-Muñoz, Carlos Gonzalez-Hermoso, Casilda Llacer Perez, Aleix Prat, Emilio Alba
Journal: Journal of Clinical Oncology (2015)

11049 Background: Prosigna has been clinically validated in 2 large randomized studies to predict the risk of distant and late recurrence in HR+/HER2- patients treated with endocrine therapy.NAC efficacy is evaluated through pathological surrogates such as residual cancer burden(RCB) and pathologic complete response(pCR), and this response has been correlated to improved survival.HR+/HER2- tumors typically have low rates of pathologic response, however,genomic tests may be able to differentiate between patients who would or would not respond to NAC. We evaluate the correlation between ProsignaROR score and response to NAC. Methods: Retrospective analysis was performed on FFPE HR+/HER2- breast tumors from EBC patients who were treated with a contemporary NAC regimen (anthracyclines+taxanes)in a multi-center Spanish cohort. The Prosigna assay was performed on the NanoString nCounter Dx Analysis System at HU Virgende la Victoria de Málaga/CIMES-UMA. Univariate analysis was used to evaluate the correlation of ProsignaROR score and intrinsic subtype to pathologic response. RCB was determined centrally and used as the primary endpoint. Results: 95.8% (207/216) ofcore biopsy samplesyielded passing results of which 180 had anRCB classification. Medianage was48y.o.(27-75), initial mammographic tumor size was 3.4cm(1-10), and 27% of patients had G3 tumors. The overall rate of RCB-0/Iwas 18.9%. Prosigna subtypes observed: LuminalA n = 54; LuminalB n = 105; Basal-liken = 14;Her2En = 7. Rate of response RCB-0/I(%) according to PAM50 subtypes was LumA = 9.3%, Her2E = 14.2%, LumB = 20%, Basal = 50%. Prosigna ROR was a significant predictor of response to NAC (p = 0.047).Luminal A tumors were unresponsive to NAC relative to the other intrinsic subtypes (Odds RatioLumA vs. non-LumA = 0.341, p = 0.037). Conclusions: Prosigna ROR reliably predicted response to NAC in this HR+/HER2- population. High-risk tumors were significantly more likely to respond to NAC than lower-risk tumors. The intrinsic subtypes were also predictive of chemo-sensitivity with Luminal A tumors being resistant to NAC,supporting the current St. Gallen consensus guideline where intrinsic subtype determines chemotherapy use.
Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Authors: Arend von Stackelberg, Franco Locatelli, Gerhard Zugmaier, Rupert Handgretinger, Tanya M. Trippett, Carmelo Rizzari, Peter Bader, Maureen M. O’Brien, Benoît Brethon, Deepa Bhojwani, Paul Gerhardt Schlegel, Arndt Borkhardt, Susan R. Rheingold, Todd Michael Cooper, Christian M. Zwaan, Phillip Barnette, Chiara Messina, Gérard Michel, Steven G. DuBois, Kuolung Hu, Min Zhu, James A. Whitlock, Lia Gore
Journal: Journal of Clinical Oncology (2016)

Purpose Blinatumomab is a bispecific T-cell engager antibody construct targeting CD19 on B-cell lymphoblasts. We evaluated the safety, pharmacokinetics, recommended dosage, and potential for efficacy of blinatumomab in children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL). Methods This open-label study enrolled children < 18 years old with relapsed/refractory BCP-ALL in a phase I dosage-escalation part and a phase II part, using 6-week treatment cycles. Primary end points were maximum-tolerated dosage (phase I) and complete remission rate within the first two cycles (phase II). Results We treated 49 patients in phase I and 44 patients in phase II. Four patients had dose-limiting toxicities in cycle 1 (phase I). Three experienced grade 4 cytokine-release syndrome (one attributed to grade 5 cardiac failure); one had fatal respiratory failure. The maximum-tolerated dosage was 15 µg/m2/d. Blinatumomab pharmacokinetics was linear across dosage levels and consistent among age groups. On the basis of the phase I data, the recommended blinatumomab dosage for children with relapsed/refractory ALL was 5 µg/m2/d for the first 7 days, followed by 15 µg/m2/d thereafter. Among the 70 patients who received the recommended dosage, 27 (39%; 95% CI, 27% to 51%) achieved complete remission within the first two cycles, 14 (52%) of whom achieved complete minimal residual disease response. The most frequent grade ≥ 3 adverse events were anemia (36%), thrombocytopenia (21%), and hypokalemia (17%). Three patients (4%) and one patient (1%) had cytokine-release syndrome of grade 3 and 4, respectively. Two patients (3%) interrupted treatment after grade 2 seizures. Conclusion This trial, which to the best of our knowledge was the first such trial in pediatrics, demonstrated antileukemic activity of single-agent blinatumomab with complete minimal residual disease response in children with relapsed/refractory BCP-ALL. Blinatumomab may represent an important new treatment option in this setting, requiring further investigation in curative indications.
Alternation of Cellular Morphology and Proliferation Induced by microRNA in Human Leukemia Cell Line, UT-7/EPO.
Authors: Nobuyoshi Kosaka, Yusuke Yamamoto, Nami Nogawa, Keiichi Sugiura, Hiroshi Miyazaki, Norio Komatsu, Takahiro Ochiya, Takashi Kato
Journal: Blood (2006)
Adjuvant Therapy for Resected Gallbladder Cancer: Analysis of the National Cancer Data Base
Authors: Kalyan C. Mantripragada, Fatima Hamid, Hammad Shafqat, Adam J. Olszewski
Journal: JNCI Journal of the National Cancer Institute (2016)

Management of resected gallbladder cancer relies on single-arm trials and retrospective observations. Our objective was to evaluate adjuvant therapy in a nationwide data set using causal inference methods to address sources of bias. We studied patients with T2-3 or node-positive, nonmetastatic gallbladder cancer, resected with grossly negative margins and reported to the National Cancer Data Base between 2004 and 2011. We defined adjuvant therapy as any chemotherapy within 90 days of surgery, and upfront concurrent chemoradiation as radiation within 14 days of first chemotherapy. After adjusting for missing data and guarantee-time bias, and using propensity score analysis to minimize indication bias, we compared overall survival of patients receiving adjuvant therapies with untreated case subjects. Adjuvant chemotherapy was administered to 28.8% of 4775 patients, and upfront chemoradiation to 13.5%. Treatment was less frequent among patients who were older, patients with comorbidities, and among white Hispanic women. T3 or node-positive disease, microscopically positive margins, or extended resection increased the likelihood of adjuvant therapy. Overall survival at three years was 39.9% (95% confidence interval [CI] = 38.4% to 41.4%) and was unaffected by adjuvant therapy after adjusting for multiple confounders (hazard ratio = 1.01, 95% CI = 0.92 to 1.10). Patients with T3 or node-positive tumors treated with upfront adjuvant chemoradiation had a modest early survival advantage (absolute difference at two years = 6.8%, 95% CI = 1.1% to 12.6%), but survival curves converged after five years of follow-up. The curative potential of current adjuvant therapy in gallbladder cancer is questionable, justifying placebo-controlled investigation of novel chemotherapy combinations or alternative approaches. Chemoradiation may provide a short-term benefit in locally advanced tumors.
Cyclic-AMP Responsive Element Binding Protein 1 (CREB) As a New Potential Druggable Target in Pediatric Acute Lymphoblastic Leukemia
Authors: Naomi E van der Sligte, Arja ter Elst, Kim R Kampen, Frank JG Scherpen, Hendrik Mulder, Sander H Diks, Frank N. van Leeuwen, Evelina S. De Bont
Journal: Blood (2011)
Anti-Obese Hormone Adiponectin Regulates Emergency Hematopoiesis and Antibacterial Response Through Downregulation Of Socs3 In Hematopoietic Progenitor Cells
Authors: Yosuke Masamoto, Shunya Arai, Tomohiko Sato, Akihide Yoshimi, Iseki Takamoto, Naoto Kubota, Takashi Kadowaki, Mineo Kurokawa
Journal: Blood (2013)
Sixty seconds on . . . posing
Authors: Nigel Hawkes
Journal: BMJ (2016)

I’m a social psychologist.

Our whole profession is under assault from critics who say that it is little more than “tabloid fodder,” full of glamorous and widely publicised but irreproducible claims reached by underpowered studies and “p-hacking” (mining data to find significant patterns without first having a specific hypothesis). It’s very wounding.

Some big claims have lost a bit of their swagger, certainly. One of the …
Zika Getting on Your Nerves? The Association with the Guillain–Barré Syndrome
Authors: Jennifer A. Frontera, Ivan R.F. da Silva
Journal: New England Journal of Medicine (2016)

Parra and colleagues1 report in the Journal the results of a prospective study of 68 Colombian patients who had a syndrome consistent with the Guillain–Barre syndrome, 66 of whom had previously had symptoms of Zika virus (ZIKV) infection. Major strengths of this study include the documentation of a temporal relationship between the Guillain–Barre syndrome and ZIKV infection (marked by a substantial increase in the incidence of the Guillain–Barre syndrome after the introduction of ZIKV, from 20 to 90 cases per month throughout Colombia), the criteria applied for the diagnosis of the Guillain–Barre syndrome, and the molecular and serologic flavivirus data . . .
Reference-based phasing using the Haplotype Reference Consortium panel
Authors: Po-Ru Loh, Petr Danecek, Pier Francesco Palamara, Christian Fuchsberger, Yakir A Reshef, Hilary K Finucane, Sebastian Schoenherr, Lukas Forer, Shane McCarthy, Goncalo R Abecasis, Richard Durbin, Alkes L Price
Journal: Nature Genetics (2016)
Phase Ib/II study of LEE011, everolimus, and exemestane in postmenopausal women with ER+/HER2-metastatic breast cancer.
Authors: Aditya Bardia, Shanu Modi, Mariana Chavez-Mac Gregor, Muaiad Kittaneh, Alyssa J. Marino, Alessandro Matano, Suraj Bhansali, Becker Hewes, Javier Cortes
Journal: Journal of Clinical Oncology (2014)

535 Background: Aromatase inhibitors (AIs) are the recommended first-line endocrine therapy for postmenopausal (PM) patients (pts) with ER+/HER2– advanced/metastatic breast cancer (aBC). However, resistance develops over time. Activation of the PI3K/AKT/mTOR pathway and downstream cyclin D–cyclin-dependent kinase (CDK4/6) has been implicated in endocrine-therapy resistance. Combination of the mTOR inhibitor everolimus (EVE) with exemestane (EXE) significantly improved PFS of pts with ER+/HER2– aBC (BOLERO-2), and preclinical data suggest that combination of EXE, EVE, and the CDK4/6 inhibitor LEE011 may be even more effective in endocrine-resistant ER+/HER2– BC. Methods: During Phase (Ph) Ib, PM pts with ER+/HER2– aBC are being treated with escalating doses of LEE011 (3 wks on/1 wk off), EVE (continuous), and a fixed daily dose of EXE (25 mg/d; continuous; arm 1); or with a safety run-in of LEE011 (600 mg/d; 3 wks on/1 wk off) and EXE (25 mg/d; continuous; arm 2) to confirm the recommended Ph II dose (RP2D). The primary objective of the Ph Ib part of the study is to determine the maximum tolerated dose and/or RP2D in arm 1. Safety, tolerability, and PK will also be assessed. Dose escalation is guided by a Bayesian Logistic Regression Model (BLRM) with overdose control principle. Results: As of Dec 12, 2013, 6 pts have been treated in arm 1 with 200 mg/d LEE011, 2.5 mg/d EVE, and EXE, and among the 5 pts evaluable for dose determination, no DLTs were observed. AEs observed to date have been mainly hematologic (as expected with a CDK 4/6 inhibitor) and mild to moderate.Preliminary PK suggest that LEE011 exposure in the presence of EVE is similar to that of single agent, while for EVE there was a 2-fold increase in exposure at steady state.Pts are currently being treated in arm 1 cohort 2 (300 mg/d LEE011, 2.5 mg/d EVE, and EXE) and in arm 2. Conclusions: To the best of our knowledge, this is the first trial evaluating an AI in combination with an mTOR and a CDK4/6 inhibitor. Preliminary data suggest that the triple combination of LEE011 + EVE + EXE is feasible. The exposure of EVE is slightly increased. In Ph II of the study, pts will be randomized to receive LEE011 + EVE + EXE, LEE011 + EXE, or EVE + EXE, and safety and efficacy compared. Clinical trial information: NCT01857193.
Blockade of PDGF receptor beta by CDP860, a humanized, PEGylated di-Fab', leads to fluid accumulation and increased tumor vascularised volume
Authors: GC Jayson, Gjm Parker, S Mullamitha, JW Valle, M Saunders, L Broughton, J Lawrance, B Carrington, C Roberts, B Issa, DL Buckley, S Cheung, K Davies, Y Watson, K Zinkewich-Péotti, L Rolfe, A Jackson
Journal: Journal of Clinical Oncology (2005)
Quantitative Detection of DNMT3A R882H Mutation in Course of Treatment of Acute Myeloid Leukemia Patients
Authors: Olga Blau, Rimma Berenstein, Claudia Baldus, Nikola Suckert, Kathrin Rieger, Axel Nogai, Antonio Pezzutto, Bernd Doerken, Igor Wolfgang Blau
Journal: Blood (2015)
Application of all-trans retinoic and regulates the activity of the lysyl oxidase family of crosslinking enzymes in photoaged skin
Authors: A K Langton, M J Sherratt, C E M Griffiths, R E B Watson
Journal: British Journal of Dermatology (2014)

Times Cited: 0 Annual Meeting of the British-Society-of-Investigative-Dermatology Annual Meeting of the British-Society-for-Investigative-Dermatology APR 07-09, 2014 Newcastle, ENGLAND Newcastle Upon Tyne, ENGLAND British Soc Investigat Dermatol 0
The Future of High-Quality Care Depends on Better Assessment of Physician Performance
Authors: Daniel J. Schumacher, Cees P. M. van der Vleuten, Carol L. Carraccio
Journal: JAMA Pediatrics (2016)

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Phase I/II trial of doranidazole (PR-350) and concurrent thoracic radiotherapy (TRT) in patients (pts) with locally advanced (LA) non-small cell lung cancer (NSCLC)
Authors: K. Takeda, S. Negoro, K. Nakagawa, Y. Segawa, Y. Nishimura, M. Fukuoka, Y. Ariyoshi
Journal: Journal of Clinical Oncology (2006)

17064 Background: PR-350 was a nitoroimidazole derivative as a hypoxic cell radiosensitizer with low toxixity, developed by POLA Chemical Industries Inc.(Yokohama, Japan). We undertook this phase I/II trial to characterize the safety, pharmacokinetics (PK), and antitumor activity of the combination chemotherapy of platinum agent and paclitaxel followed by PR-350 and concurrent TRT in pts with LANSCLC. This trial was conducted by West Japan Thoracic Oncology Group (WJTOG). Methods: Major eligibility included 20–74 years old, histologically or cytologically proven NSCLC, surgically unresectable stage IIIA and IIIB, no prior therapy, ECOG performance status of 0 to 1, and adequate organ functions. All pts received two cycles of cisplatin of 80 mg/m 2 and paclitaxel of 180 mg/m 2 before radiotherapy with PR-350. The radiation dose was 60 Gy in 30 fractions of 2 Gy over 6 weeks. PR-350 dose of 2000 mg/m 2 was administered as a 25 minutes intravenously prior to irradiation daily. The starting consecutive days were 10 times with daily TRT, and the times were escalated in increments of 10 times for successive groups of 6 new pts. PK studies of PR-350 were performed on the first day and the end. Induction chemotherapy of carboplatin (AUC = 6) and paclitaxel (200mg/m 2 ) was also permitted in phase II portion. Results: 37 pts were enrolled into this trial. Major severe toxicity was radiation pneumonitis, which developed 2 treatment related deaths (TRD). Grade 3 or more esophagitis was not developed in this trial. PR-350 was able to administered 30 consecutive days with concurrent TRT. Overall response rate was 67.6% (95% CI: 50.2–82.0%). Median survival time was 16.8 months (95% CI: 12.1–21.9 months), and 1 and 2 year survival rate were 64% and 21%, respectively. No cumulative effect was demonstrated among 3 dose levels by PK studies. Conclusions: Induction chemotherapy followed by TRT with 30 times of PR-350 was well tolerated and promising for the treatment of LANSCLC. [Table: see text] No significant financial relationships to disclose.
A BMT Model Mice for Myelodysplastic Syndromes (MDS) and Transformation to AML.
Authors: Naoko Watanabe-Okochi, Jiro Kitaura, Hironori Harada, Ryoichi Ono, Hideaki Nakajima, Tetsuya Nosaka, Toshiya Inaba, Toshio Kitamura
Journal: Blood (2006)
Suppression by TFR cells leads to durable and selective inhibition of B cell effector function
Authors: Peter T Sage, Noga Ron-Harel, Vikram R Juneja, Debattama R Sen, Seth Maleri, Waradon Sungnak, Vijay K Kuchroo, W Nicholas Haining, Nicolas Chevrier, Marcia Haigis, Arlene H Sharpe
Journal: Nature Immunology (2016)