tbuckley/cabot-search huggingface dataset:
Comparative efficacy of everolimus versus fulvestrant for hormone-receptor–positive (HR<sup>+</sup>) advanced breast cancer (ABC) following progression/recurrence after first-line treatment: A network meta-analysis.
Authors: Thomas Denis Bachelot, Guy Heinrich Maria Jerusalem, Maria Cikalo, Rachael McCool, Sarah King, Steven Duffy, Julie Glanville, Danielle Varley, Jie Zhang
Journal: Journal of Clinical Oncology (2013)

e11602 Background: Everolimus (EVE), an oral mammalian target of rapamycin (mTOR) inhibitor, is approved in combination with exemestane (EXE) to treat postmenopausal women (PMW) with HR + , human epidermal growth factor receptor-2–negative (HER2 – ) ABC that progressed after nonsteroidal aromatase inhibitor therapy. Fulvestrant (FUL), an estrogen receptor antagonist, is another treatment option for PMW previously treated with endocrine therapy. However, the comparative efficacy of EVE + EXE vs FUL is unknown. Methods: Six randomized, controlled trials in HR + , HER2 – ABC patients were identified by systematic literature review (Cochrane library, National Horizon Scanning Centre, and NICE Web sites) that formed a network permitting indirect comparisons of EVE + EXE or EVE + tamoxifen (TAM) vs FUL: BOLERO-2, CONFIRM, EFECT, Paridaens (2008), SoFEA, and TAMRAD. All 6 trials had EXE, TAM, or FUL 250 mg as the common comparator to form the network. Relative efficacy of EVE and FUL was obtained using a Bayesian network meta-analysis based on these 6 trials. The primary endpoint was local assessment of progression-free survival (PFS) or time to progression (TTP). The hazard ratio (HR) of EVE + EXE relative to FUL and its 95% credible intervals (CrI) were calculated. Evidence of a difference between treatments is suggested by the 95% CrI not including 1. A HR &lt;1 indicates that the hazard rate is higher in the comparator group and that the treatment is more effective. Results: EVE + EXE was found to be more efficacious for PFS/TTP than FUL 250 mg (HR = 0.47; 95% Crl, 0.38-0.58) and more efficacious than FUL 500 mg (HR = 0.59; 95% Crl, 0.45-0.77). EVE + TAM was found to be numerically better for PFS/TTP than FUL 250 mg (HR = 0.65; 95% Crl, 0.40-1.04) and numerically better than FUL 500 mg (HR = 0.81; 95% Crl, 0.49-1.33). Conclusions: The indirect evidence from this analysis suggests that EVE in combination with EXE is more efficacious than FUL 250 and 500 mg in PMW with HR + , HER2 – ABC that progresses after endocrine therapy. These data should be interpreted with caution as there is no randomized trial that directly compares EVE + EXE vs FUL.
LEFT MAIN CORONARY ARTERY EXTRINSIC COMPRESSION SECONDARY TO DILATED PULMONARY ARTERY IN A PATIENT WITH UNDERLYING ATRIAL SEPTAL DEFECT
Authors: Ping Lik Chua, Abd Malek Abdul Muizz, Arumuganathan Prem Nathan, Iynam Shargunandass, Lee Gary Chin Keong, Abdul Aziz Ahmad Fazli, Selvaraj Kamaraj, Abdullah Ramaiah Asri Ranga, Abd Ghapar Abd Kahar
Journal: Journal of the American College of Cardiology (2020)
Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma
Authors: Naim Alkhouri, Michio Imawari, Namiki Izumi, Yukio Osaki, Toshimitsu Ochiai, Takeshi Kano, Roy Bentley, Franco Trevisani
Journal: Clinical Gastroenterology and Hepatology (2020)

Patients with hepatocellular carcinoma (HCC) secondary to chronic liver disease often require invasive procedures but frequently have thrombocytopenia. Lusutrombopag is an agonist of the thrombopoietin receptor that activates platelet production.We performed an integrated analysis of data from 2 phase 3 trials (L-PLUS 1, Japan, October 2013 to May 2014, and L-PLUS 2, global, June 2015 to April 2017) that compared the efficacy and safety of lusutrombopag with placebo in patients with chronic liver disease, with and without HCC. Our analysis included patients with Eastern Cooperative Oncology Group grades of 0 or 1, Child-Pugh classes A or B, and a platelet count less than 50 × 109/L who were scheduled to undergo invasive procedures in 9 to 14 days. Patients received lusutrombopag (3 mg) or placebo daily for 7 days or fewer before an invasive procedure. Imaging studies assessed treatment-emergent adverse events, including asymptomatic portal vein thrombosis. The primary end point was no requirement for platelet transfusion before the invasive procedure and rescue therapies for bleeding 7 days or fewer after the invasive procedure.The per-protocol population included 270 patients (95 with HCC). A significantly higher proportion of patients with HCC who received lusutrombopag achieved the primary end point (68.0%) vs patients who received placebo (8.9%) (P < .0001); in patients without HCC, these proportions were 77.0% vs 21.6% (P < .0001). Lusutrombopag reduced the need for platelet transfusions, increased platelet counts for 3 weeks, and reduced the number of bleeding events in patients with and without HCC compared with placebo. Risk of thrombosis was similar to that of placebo.Patients with and without HCC receiving lusutrombopag had a reduction in the number of platelet transfusions before invasive procedures compared with patients receiving placebo, with no increase in thrombosis or bleeding. L-PLUS 1: JapicCTI-132323; L-PLUS 2: ClinicalTrials.gov number no: NCT02389621.
Validation of MSKCC nomogram for prediction of metastasis to nonsentinel lymph nodes in carcinoma breast in Indian patients.
Authors: S. P. Somashekhar, Amit Rauthan
Journal: Journal of Clinical Oncology (2013)

e11510 Background: Sentinel node biopsy has emerged as the standard of care in clinically node negative breast cancer (cT1,T2 N0). In cases where sentinel node is negative, ALND can be avoided. In nearly 30-50% cases, the sentinel lymph nodes is the only site of metastases, demonstrated in Indian population too. In ASCOG ZOO11 trial, patients who had metastases in sentinel node did not undergo ALND. Patients in the trial received radiation as part of breast conservation surgery. In Indian patients, this is not applicable as most of the patients undergo mastectomy. It would be highly beneficial to identify the subset of patients, where the sentinel node is the only site of metastasis. Various nomograms have been used to predict the risk of metastasis in non sentinel nodes. MSKCC nomogram has been validated in many studies in the USA and Netherlands. Methods: The records of 240 breast cancer patients between 2007 and 2011 who underwent SLN and / or ALND were selected. Serial hemotoxylin and eosin (HE) analysis and immunohistochemistry were routinely performed on each sentinel node. Various factors like T size, histology and grade, lymphovascular invasion, number of +ve and –ve sentinel nodes, hormonal status, multifocality were recorded. Risk of non sentinel node metastasis were calculated by nomogram. Results: 63 out of 240 patients had sentinel node positivity and underwent ALND 20 out of 63(31%) had metastasis in non sentinel nodes also. Mean predictive risk as per nomogram for SLN was 53% and non SLN mets was 68%. None of our patients had low risk of non sentinel node metastasis as per MSKCC nomogram. Conclusions: MSKCC nomogram is not validated for Indian Breast Cancer patients, in our study population as it could not differentiate between patients having metastasis in sentinel node only from those having non sentinel node metastasis based on risk stratification. Because in India, the mean Tumour (T) size is big and Grade is usually high grade and one of the reason the present MSKCC nomogram is not applicable to Indian Breast cancer patients. In Indian populations, a different nomogram is required to correctly predict the non sentinel node metastasis.
The fears of men in a prostate cancer support group: A pilot study
Authors: J. Hausdorff
Journal: Journal of Clinical Oncology (2006)

18616 Background: Little is published on prostate cancer patients’ fears and the effectiveness of interventional strategies. Methods: A 20-item questionnaire addressing various potential fears was administered to 30 men in a local prostate cancer support group: 15 had undergone curative therapy and were NED, and 15 had recurrent disease on androgen suppression. Level of fear for each question was rated from 1 to 5. At a later date, a different questionnaire was administered to 10 men with recurrent disease, addressing the predominant fear previously identified—uncontrolled symptoms at the end of life—with 10 specific questions on this subject. This was followed by the intervention: a 90 minute group discussion, led by an MD boarded in Medical Oncology and Hospice and Palliative Medicine. To assess impact, the 10 item questionnaire on end of life symptoms was readministered immediately after the discussion, and again 2 months later. Results: a) Patients with recurrent disease expressed a greater degree of fear than those free of recurrence; b) A major fear of the future is of uncontrollable symptoms at end of life, and was more of a concern than death itself; c) Of the 7 (of 10 total) items that were most significant to the patients (mean score 2.9 or higher, scale 1–5), a mean drop of 0.7 was seen in the level of fear following the intervention; d) This was inconsistently sustained 2 months later, with some concerns lessened but others not. Conclusions: In this small pilot study of men with prostate cancer, there appeared to be some measurable impact on the level of fear following the group discussion, though inconsistently sustained; questionnaires such as this are feasible to administer and appear to encourage productive discussion of difficult issues in the support group setting. No significant financial relationships to disclose.
A phase Ib study of an anti-HER2 inhibitor, lapatinib, in combination with a c-MET and VEGFR inhibitor, foretinib, in HER2-positive metastatic breast cancer (MBC): Results from NCIC CTG IND.198.
Authors: Stephen K. L. Chia, Susan Ellard, Mihaela Mates, Stephen Welch, Catalin Liviu Dragos Mihalcioiu, Wilson H. Miller, Karen A. Gelmon, Caroline A. Lohrisch, Vikaash Kumar, Sara Kristina Taylor, Linda Hagerman, Elizabeth A. Eisenhauer, Penelope Ann Bradbury
Journal: Journal of Clinical Oncology (2013)

518 Background: The mechanisms of resistance to targeted anti-HER 2 therapy are unclear. Proposed pathways include MET, VEGF and AXL. Multi-targeted pathway inhibition may delay or prevent acquired resistance to HER2 inhibition. Foretinib, an oral multi-kinase inhibitor of MET and VEGFR2, as well as PDGFRB, AXL, FLT3, TIE-2, RET and RON kinases, has pre-clinical anti-tumor activity in breast tumor models. This phase 1b study sought to establish the associated toxicities, pharmacokinetics (PK) and recommended phase II doses (RP2D) of this combination of oral tyrosine kinases inhibitors in a cohort of HER-2 positive MBC patients. Methods: Women with HER2 positive (determined locally) MBC, PS 0-2, and no limit on number of prior chemotherapies or lines of anti-HER2 therapies were enrolled. A 3+3 dose escalation design was utilized. 4 dose levels were planned with starting doses of foretinib 30 mg and lapatinib 750 mg PO OD (dose level 1) on a q 4 weekly cycle. Correlative studies from primary archival tissue are planned. Results: 19 patients were enrolled, all of whom were evaluable for toxicity assessment and 16 were evaluable for response. Median age was 60 years (34-86), 95% were PS 0-1, 53% were ER- and 95% had at least one prior anti-HER2 based regimen. A median of 2 cycles (range: 1-20) was delivered across 4 dose levels. At the 4 th dose level (foretinib 45 mg/lapatinib 1250 mg) dose limiting toxicities were documented in 4/7 patients. These included grade 3 fatigue (2 cases); grade 3 ALT elevation; grade 3 diarrhea and grade 2 joint effusion. There was only one grade 4 non-hematological toxicity (grade 4 vomiting: dose level 1) across all dose levels. One patient discontinued treatment due to toxicity with grade 3 limb edema and grade 3 proteinuria. PK of both drugs from DL1-3 did not appear to demonstrate a significant interaction. The RP2D was declared to be foretinib 45 mg and lapatinib 1000 mg PO OD. The full efficacy data and correlative studies will be presented at the meeting. Conclusions: The combination of foretinib and lapatinib can safely be delivered together, though at lower doses than either agent alone.
Randomized phase II cross-over sequential chemotherapy trial of irinotecan/cisplatin (IP) vs. gemcitabine/vinorelbine (GV) in chemo-naïve patients with stage IIIb/IV non-small cell lung cancer (NSCLC)
Authors: J. S. Lee, D. H. Lee, J. J. Lee, J. Y. Han, S. H. Park, J. E. Song, H. Y. Kim, H. T. Kim
Journal: Journal of Clinical Oncology (2006)

7134 Background: To compare the efficacy and toxicity of IP vs. non-platinum-based GV in the treatment of advanced NSCLC, we conducted a randomized phase II trial with planned cross-over to the other regimen upon disease progression (PD) after the first-line therapy. Methods: Eligibility required stage IIIb/IV NSCLC, no prior chemotherapy, measurable disease, ECOG PS 0–2, adequate organ functions, and informed consent. After stratification by gender, stage (IIIB or IV) and performance status (PS: 0–1 or 2), eligible pts were randomized to receive either IP (I 65 mg/m 2 &amp; P30 mg/m 2 on D1 &amp; 8 q 3 weeks) first then GV (G 900 mg/m 2 &amp;V25 mg/m 2 on D1 &amp; 8 q 3 weeks) upon PD (Arm A) or GV first then IP upon PD (Arm B). Results: Between 12/2003 and 06/2005, 146 pts were enrolled in either Arm A (n = 75) or Arm B (n = 71). There was no difference in gender (male: 77.3% vs. 81.7%), age (median: 58 vs. 60 yrs), PS (PS 2: 10.7% vs. 8.5%), histology (adenocarcinoma: 72.0% vs. 76.6%) and stage (IV: 88.0% vs. 87.3%). IP tended to generate more responses than GN (42.0% vs. 29.0% as first-line, 30.2% vs. 14.3% as second-line), but there was no difference in total response rate by the treatment arm (Arm A: 45.6%, B: 43.5%). During the first-line therapy, IP caused more G3+ anemia (20.0% vs. 7.1%, p = 0.048), G2/3 nausea/vomiting (41.4% vs. 12.9%, p &lt; 0.001), G2 alopecia (35.7% vs. 10.0%, p = 0.001) than GN while pneumonitis was noted only with GN (11.4%). Toxicity profile was similar after the second-line therapy. Both arms resulted in excellent survival outcome with no significant difference between the Arm A and B (median: 16.5 mo vs. 15.1 mo, p = 0.595). Conclusions: Platinum-based IP regimen seemed to be more effective in terms of response rate. Given the overall survival data and the mild toxicity profile of GV regimen, however, either treatment sequence seems to be acceptable for the treatment of advanced metastatic NSCLC. (Supported in part by NCC grants 0210140 and 0510140). No significant financial relationships to disclose.
Selumetinib in Children with Inoperable Plexiform Neurofibromas
Authors: Andrea M. Gross, Pamela L. Wolters, Eva Dombi, Andrea Baldwin, Patricia Whitcomb, Michael J. Fisher, Brian Weiss, AeRang Kim, Miriam Bornhorst, Amish C. Shah, Staci Martin, Marie C. Roderick, Dominique C. Pichard, Amanda Carbonell, Scott M. Paul, Janet Therrien, Oxana Kapustina, Kara Heisey, D. Wade Clapp, Chi Zhang, Cody J. Peer, William D. Figg, Malcolm Smith, John Glod, Jaishri O. Blakeley, Seth M. Steinberg, David J. Venzon, L. Austin Doyle, Brigitte C. Widemann
Journal: New England Journal of Medicine (2020)

No approved therapies exist for inoperable plexiform neurofibromas in patients with neurofibromatosis type 1.
Gemcitabine, oxaliplatin and weekly high-dose 5-FU as a 24-hr-infusion in chemonaive patients with advanced or metastatic carcinoma of the gallbladder: Preliminary results of a multicenter phase II-study
Authors: A. D. Wagner, P. Buechner-Steudel, H. Schmalenberg, M. Moehler, O. Kuss, R. Behrens, S. Hahnfeld, G. Kleber, A. Wein, W. E. Fleig
Journal: Journal of Clinical Oncology (2006)

4129 Background: Combinations of gemcitabine (GEM)/5-FU, GEM/oxaliplatin (LOHP) or 5-FU/LOHP work synergistically in pancreatic and/or colorectal malignancies, and have non-overlapping safety profiles. This phase II-study was designed to evaluate the efficacy and safety of the triple combination GEM/LOHP/5-FU in patients (pts) with advanced or metastatic carcinoma of the gallbladder. Methods: One-stage, multicentre phase II study. Eligibility criteria: chemonaive pts with histologically proven advanced, recurrent or metastatic gallbladder carcinoma (ECOG 0–1; expected survival &gt;3 months; measurable disease; adequate renal, hepatic and bone marrow function). According to the results of our previous phase I-study (Proc ASCO 2003, # 1298), pts were treated with GEM 900mg/m 2 as a 30-min infusion, followed by LOHP 65 mg/m 2 (2-hr infusion) after a 30 min rest and 5-FU 1500 mg/m 2 (24-hr-infusion) on d 1, 8, every 3 weeks. Planned sample size: 35 response evaluable patients. The primary endpoint was tumor response, secondary endpoints were toxicity, median survival, the one-year-survival rate, clinical benefit and quality of life. Results: At time of abstract submission, median follow-up of 35 enrolled pts is 9.8 months. Pt. characteristics: m/f: 11/24, median age 61 (range 42–81), ECOG 0/1: 24/11 (69/31%) pts, locally advanced/metastatic disease 1/32 (3/91%) pts. Analysis of tumor response is still pending. Grade III/IV (NCI-CTC) toxicities occurred in 36/3% of 191 cycles and were: leucopenia 3/1%, neutropenia 4/1%, thrombocytopenia 4/1%, anemia 2/0%, nausea 1/0%, sensory neuropathy 4/0%, asthenia 1/0%, elevated bilirubin 2/0%, AP 4/0%, or elevated SGOT/SGPT 1/0%, edema 1/0%, infection 1/0%, dyspnoe 1/1%. Median survival of all pts is 9.9 months (95% CI: 7.5–11.5), the one-year-survival-rate is 30 % (95% CI: 16–47). Conclusions: GEM/LOHP/5-FU combination therapy is tolerated well in patients with gallbladder cancer. The promising survival data has to be confirmed in a phase III study. (Supported by grants from Eli Lilly and Company, Indianapolis, IN, USA and Sanofi-Synthelabo, Paris, France). [Table: see text]
Phase II study of neoadjuvant chemotherapy (NAC) with S-1 and cisplatin (CDDP) for patients (pts) with metastatic or locally unserectable gastric cancer (MGC)
Authors: A. Nashimoto, H. Yabusaki, S. Nakagawa
Journal: Journal of Clinical Oncology (2006)

4078 Background: To improve the poor prognosis of pts with MGC, we conducted a phase II study to evaluate the feasibility and efficacy of intensive NAC to enhance surgical respectability and survival. Methods: Eligible criteria included histologically proven metastatic or locally unserectable gastric adenocarcinoma and measurable or evaluable disease, PS 0–2 and sufficient organ functions. The primary endpoint was overall survival and the secondary endpoints were overall resonse rate (ORR) and toxicities. Since Oct. 2000, chemotherapy-naïve 120 pts with MGC have received S-1 (80 mg/m 2 orally intake for 21 consecutive days) and CDDP (50 mg/m 2 intravenous drip infusion on day 8) as NAC. Treatment was repeated every 5 weeks. The median administered courses were three (range: 1–7), and median follow up periods were 13.8 months. Results: The proportion of the duration as an outpatient- therapy was 86%. 77.5% of pts (93/120) went to surgical resection; 36 had distal gastrectomy and 57 had total gastrectomy. ORR was 62.5% (CR 1, PR 74), and 61.7%, 75.7%, 28.6% and 23.8% for primary lesion, metastatic lymph nodes, liver metastases and peritoneal metastasis, respectively. Toxicity (grade 3/4): neutropenia 7.5%, thrombocytopenia 6.7%, anemia 6.7%, anorexia 5.8%, nausea 2.5%; no treatment related death. Survival: median 23 months; 1 year 79%; 4 year 31% in all pts, and 42 months; 83%; 38% in pts with gastrectomy, respectively. In univariate analyses, overall survival (OS) was predicted by the responder, limited tumor location, H0, P0, but not by age, sex, histological type, gross type, T-factor, N-factor, or performance status. In multivariate analyses, H0, P0 and responder independently predicted OS. In pts with gastrectomy, H0, curative resection, PS0 and responder predicted OS. Conclusions: NAC with S-1 and CDDP was feasible and useful for pts with MGC and resulted in a promising survival rate. No significant financial relationships to disclose.
EFFECT OF EARLY VERSUS DELAYED PERCUTANEOUS REVASCULARIZATION IN NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK
Authors: Aaqib H. Malik, Srikanth Yandrapalli, Suchith Shetty, Wilbert Aronow, Howard A. Cooper, Julio Panza
Journal: Journal of the American College of Cardiology (2020)
BRIDGING WITH ACE OF SPADE MIMICKING AS RECURRENT ACS: RECURRENT CHEST PAIN MIMICKING ACUTE CORONARY SYNDROME IN PATIENT WITH APHCM (YAMAGUCHI SYNDROME) AND MYOCARDIAL BRIDGING
Authors: Aman Patel, Daniel Jipescu, Luna Liu, Som Aftabizadeh, Karan Gupta, Giridhar Mundluru, Satish Chandraprakasam
Journal: Journal of the American College of Cardiology (2020)
ASSOCIATIONS OF VASCULAR AND LEFT VENTRICULAR FUNCTION WITH BRAIN VOLUMES AND WHITE MATTER HYPERINTENSITIES: A CROSS-SECTIONAL MAGNETIC RESONANCE IMAGING STUDY OF THE UK BIOBANK
Authors: Max Johan Pieter Van Hout, Ilona A. Dekkers, Jos J. Westenberg, Martin Schalij, Arthur Scholte, Hildo Lamb
Journal: Journal of the American College of Cardiology (2020)
Bilateral Breast Uptake of 99mTc-Pertechnetate in a Neonate With Congenital Hypothyroidism
Authors: Sonal Rakshpaul, Gaurav Malhotra, Sudha C. Rao, Raj Narwade, Alpana Utture, Ramesh V. Asopa
Journal: Clinical Nuclear Medicine (2020)

A 4-day-old female neonate with raised cord blood thyroid-stimulating hormone (127 μIU/mL) underwent Tc thyroid scan to rule out thyroid dysgenesis. The images revealed midline focus of lingual thyroid as the only functioning thyroid tissue. In addition, bilateral focal and symmetrical breast uptake was seen without clinically palpable breast nodule on either side. Transplacental transfer of maternal hormones leading to stimulation of neonatal breasts explains this unusual scan finding. One should be aware of this rare pattern of focal breast uptake in Tc-pertechnetate scan in neonates with congenital hypothyroidism to avoid scan misinterpretation.
MORTALITY &amp; PACEMAKER IMPLANTATION IN BICUSPID VERSUS TRICUSPID SEVERE AORTIC STENOSIS TREATED WITH TAVR: A SYSTEMATIC REVIEW WITH META-ANALYSIS OF SEVENTEEN STUDIES
Authors: Monil M. Majmundar, Rajkumar P. Doshi, Palak Shah, Tikal Kansara, Khush Patel, Abdullah Zoheb Azhar, Ami Patel, Ferdinand Visco, Savi Mushiyev
Journal: Journal of the American College of Cardiology (2020)
Robotics vs Laparoscopy—Are They Truly Rivals?
Authors: Natalie Liu, Jacob A. Greenberg
Journal: JAMA Surgery (2020)

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Oral Anticoagulation and Cardiovascular Outcomes in Patients With Atrial Fibrillation and End-Stage Renal Disease
Authors: Sean D. Pokorney, Eric Black-Maier, Anne S. Hellkamp, Daniel J. Friedman, Sreekanth Vemulapalli, Christopher B. Granger, Laine Thomas, Eric D. Peterson, Jonathan P. Piccini
Journal: Journal of the American College of Cardiology (2020)