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Breast cancer-specific survival in patients with lymph node-positive hormone receptor-positive invasive breast cancer and Oncotype DX Recurrence Score results in the SEER database
Purpose
The Oncotype DX
®
Breast Recurrence Score™ (RS) assay is validated to predict breast cancer (BC) recurrence and adjuvant chemotherapy benefit in select patients with lymph node-positive (LN+), hormone receptor-positive (HR+), HER2-negative BC. We assessed 5-year BC-specific survival (BCSS) in LN+ patients with RS results in SEER databases.
Methods
In this population-based study, BC cases in SEER registries (diagnosed 2004–2013) were linked to RS results from assays performed by Genomic Health (2004–2014). The primary analysis included only patients (diagnosed 2004–2012) with LN+ (including micrometastases), HR+ (per SEER), and HER2-negative (per RT-PCR) primary invasive BC (
N
= 6768). BCSS, assessed by RS category and number of positive lymph nodes, was calculated using the actuarial method.
Results
The proportion of patients with RS results and LN+ disease (
N
= 8782) increased over time between 2004 and 2013, and decreased with increasing lymph node involvement from micrometastases to ≥4 lymph nodes. Five-year BCSS outcomes for those with RS < 18 ranged from 98.9% (95% CI 97.4–99.6) for those with micrometastases to 92.8% (95% CI 73.4–98.2) for those with ≥4 lymph nodes. Similar patterns were found for patients with RS 18–30 and RS ≥ 31. RS group was strongly predictive of BCSS among patients with micrometastases or up to three positive lymph nodes (
p
< 0.001).
Conclusions
Overall, 5-year BCSS is excellent for patients with RS < 18 and micrometastases, one or two positive lymph nodes, and worsens with additionally involved lymph nodes. Further analyses should account for treatment variables, and longitudinal updates will be important to better characterize utilization of Oncotype DX testing and long-term survival outcomes.
Journal Article
Batgirl : Stephanie Brown
\"Battling both inner and external demons, Stephanie must learn to balance school and crime-fighting or face the wrath of Barbara Gordon! With guest appearences from Batman and Robin and villains like Man-Bat and Clayface, Batgirl must step up to the mantle! Batgirl must battle the Calculator and stop his plan to unleash a nanovirus upon the citizens of Gotham City that will turn them into mindless techno-zombies, enter the FLOOD!\"-- Provided by publisher.
BOOK
Relationship Between Serum Low-Density Lipoprotein Cholesterol and In-hospital Mortality Following Acute Myocardial Infarction (The Lipid Paradox)
Lipoprotein levels are currently recognized as independent risk factors for long-term cardiovascular events after acute myocardial infarction (AMI). During the acute-phase reaction after AMI, previous studies have reported trends of decreased low-density lipoprotein cholesterol (LDL-C), increased triglycerides, and variable high-density lipoprotein cholesterol (HDL-C) levels. However, the association between LDL-C and HDL-C levels and in-hospital mortality has not been well established following AMI. The relationship between lipid levels and in-hospital all-cause mortality in 115,492 patients hospitalized for AMI (July 2002 to December 2006), registered in the National Registry of Myocardial Infarction (NRMI) 4b–5, was evaluated using multivariable-adjusted logistic regression models. Mean LDL-C was 104 ± 38, HDL-C was 41 ± 14, and triglycerides 143 ± 83 mg/dl. Compared with the lowest quartile of LDL-C (<77 mg/dl), the risk of in-hospital mortality in the second to fourth quartiles was decreased (adjusted odds ratio 0.79, 0.80, and 0.85, respectively). For HDL-C, only those in the lowest quartile (<31 mg/dl) had higher risk of in-hospital mortality (odds ratio 1.20) compared with the highest quartile (≥47 mg/dl). Results from NRMI 4b–5 suggest a lipid paradox, with lower LDL-C levels associated with increased risk of in-hospital mortality, contrary to findings outside the acute setting. Consistent with previous analyses, lowest HDL-C levels were associated with increased in-hospital mortality. In conclusion, further explorations of the relationship between very low levels of LDL-C, myocardial necrosis, and subsequent adverse cardiovascular events are warranted.
Journal Article
Orion by Walt Simonson
\"Walt Simonson's stunning, unmistakable art and storytelling are on full display here in his groundbreaking work ORION. Expanding the beloved universe originally created by Jack Kirby, Simonson's sprawling storylines and dynamic artwork elevate his titular hero, as well as the rest of the Fourth World's indispensible characters, to incredible new heights. Collected here for the first time are all twenty-five issues of Walter Simonson's ORION, as well as never-before reprinted short stories, pinups and sketch material.\"-- Provided by publisher.
BOOK
Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing
Thermal processing has gained much interest in the pharmaceutical industry, particularly for the enhancement of solubility, bioavailability, and dissolution of active pharmaceutical ingredients (APIs) with poor aqueous solubility. Formulation scientists have developed various techniques which may include physical and chemical modifications to achieve solubility enhancement. One of the most commonly used methods for solubility enhancement is through the use of amorphous solid dispersions (ASDs). Examples of commercialized ASDs include Kaletra®, Kalydeco®, and Onmel®. Various technologies produce ASDs; some of the approaches, such as spray-drying, solvent evaporation, and lyophilization, involve the use of solvents, whereas thermal approaches often do not require solvents. Processes that do not require solvents are usually preferred, as some solvents may induce toxicity due to residual solvents and are often considered to be damaging to the environment. The purpose of this review is to provide an update on recent innovations reported for using hot-melt extrusion and KinetiSol® Dispersing technologies to formulate poorly water-soluble APIs in amorphous solid dispersions. We will address development challenges for poorly water-soluble APIs and how these two processes meet these challenges.
Journal Article
Star destroyers : big ships blowing things up
\"In space, size matters. Boomers. Ships of the Line. Star Destroyers. The bigger the ship, the better the bang. From the dawn of history onward, commanding the most powerful ship around has been a dream of admirals, sultans, emperors, kings, generalissimos, and sea captains everywhere. For what the intimidation factor alone doesn't achieve, a massive barrage from super-weapons probably will. Thus it was, and ever shall be, even into the distant future. From the oceans of Earth, to beneath the ice of Europa, to the distant reaches of galactic empires, it is the great warships and their crews that sometimes keep civilization safe for the rest of us -- but sometimes become an extinction-level event in and of themselves\"--Back cover.
Book
A population-based validation study of the DCIS Score predicting recurrence risk in individuals treated by breast-conserving surgery alone
Validated biomarkers are needed to improve risk assessment and treatment decision-making for women with ductal carcinoma in situ (DCIS) of the breast. The Onco
type
DX
®
DCIS Score (DS) was shown to predict the risk of local recurrence (LR) in individuals with low-risk DCIS treated by breast-conserving surgery (BCS) alone. Our objective was to confirm these results in a larger population-based cohort of individuals. We used an established population-based cohort of individuals diagnosed with DCIS treated with BCS alone from 1994 to 2003 with validation of treatment and outcomes. Central pathology assessment excluded cases with invasive cancer, DCIS < 2 mm or positive margins. Cox model was used to determine the relationship between independent covariates, the DS (hazard ratio (HR)/50 C
p
units (U)) and LR. Tumor blocks were collected for 828 patients. Final evaluable population includes 718 cases, of whom 571 had negative margins. Median follow-up was 9.6 years. 100 cases developed LR following BCS alone (DCIS,
N
= 44; invasive,
N
= 57). In the primary pre-specified analysis, the DS was associated with any LR (DCIS or invasive) in ER+ patients (HR 2.26;
P
< 0.001) and in all patients regardless of ER status (HR 2.15;
P
< 0.001). DCIS Score provided independent information on LR risk beyond clinical and pathologic variables including size, age, grade, necrosis, multifocality, and subtype (adjusted HR 1.68;
P
= 0.02). DCIS was associated with invasive LR (HR 1.78;
P
= 0.04) and DCIS LR (HR 2.43;
P
= 0.005). The DCIS Score independently predicts and quantifies individualized recurrence risk in a population of patients with pure DCIS treated by BCS alone.
Journal Article
Expanding the Application and Formulation Space of Amorphous Solid Dispersions with KinetiSol®: a Review
Due to the high number of poorly soluble drugs in the development pipeline, novel processes for delivery of these challenging molecules are increasingly in demand. One such emerging method is KinetiSol, which utilizes high shear to produce amorphous solid dispersions. The process has been shown to be amenable to difficult to process active pharmaceutical ingredients with high melting points, poor organic solubility, or sensitivity to heat degradation. Additionally, the process enables classes of polymers not conventionally processable due to their high molecular weight and/or poor organic solubility. Beyond these advantages, the KinetiSol process shows promise with other applications, such as the production of amorphous mucoadhesive dispersions for delivery of compounds that would also benefit from permeability enhancement.
Journal Article