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A phase Ib study of pembrolizumab plus chemotherapy in patients with advanced cancer (PembroPlus)
Background:
Pembrolizumab (P) is an anti-PD-1 antibody that blocks the interaction between programmed cell death protein 1 (PD-1) on T-cells and PD-L1 and PD-L2 on tumour cells. A phase Ib trial of P plus chemotherapy was undertaken to evaluate the safety and efficacy.
Methods:
Patients with advanced, metastatic solid tumours were enrolled onto one of six treatment arms. Pembrolizumab was given: with gemcitabine (G), G+docetaxel (D), G+nab-paclitaxel (NP), G+vinorelbine (V) or irinotecan (I) until progression or toxicity, or with liposomal doxorubicin (LD) for up to 15 cycles, progression or toxicity. Safety monitoring and response assessments were conducted.
Results:
Forty-nine patients were enrolled and treated. The most common adverse events were transaminitis, cytopenias, rash, diarrhoea, fatigue, nausea and vomiting. Arm 2 was closed due to poor accrual. The recommended phase II dose (RP2D) was determined for Arms 1, 3a, 4, 5 and 6. There were eight partial responses across multiple tumour types.
Conclusions:
Standard dose P can be safely combined with G, G+NP, G+V, I and LD. Efficacy was observed in multiple tumour types and evaluation to determine if response and duration of response are more robust than what would be expected for chemotherapy or immunotherapy alone requires further validation.
Journal Article
Quantitative credit portfolio management : practical innovations for measuring and controlling liquidity, spread, and issuer concentration risk
\"An innovative approach to post-crash credit portfolio management Credit portfolio managers traditionally rely on fundamental research for decisions on issuer selection and sector rotation. Quantitative researchers tend to use more mathematical techniques for pricing models and to quantify credit risk and relative value. The information found here bridges these two approaches. In an intuitive and readable style, this book illustrates how quantitative techniques can help address specific questions facing today's credit managers and risk analysts. A targeted volume in the area of credit, this reliable resource contains some of the most recent and original research in this field, which addresses among other things important questions raised by the credit crisis of 2008-2009. Divided into two comprehensive parts, Quantitative Credit Portfolio Management offers essential insights into understanding the risks of corporate bonds--spread, liquidity, and Treasury yield curve risk--as well as managing corporate bond portfolios. Presents comprehensive coverage of everything from duration time spread and liquidity cost scores to capturing the credit spread premium Written by the number one ranked quantitative research group for four consecutive years by Institutional Investor Provides practical answers to difficult question, including: What diversification guidelines should you adopt to protect portfolios from issuer-specific risk? Are you well-advised to sell securities downgraded below investment grade? Credit portfolio management continues to evolve, but with this book as your guide, you can gain a solid understanding of how to manage complex portfolios under dynamic events\"-- Provided by publisher.
Book
Multiscale Stochastic Volatility for Equity, Interest Rate, and Credit Derivatives
Building upon the ideas introduced in their previous book, Derivatives in Financial Markets with Stochastic Volatility, the authors study the pricing and hedging of financial derivatives under stochastic volatility in equity, interest-rate, and credit markets. They present and analyze multiscale stochastic volatility models and asymptotic approximations. These can be used in equity markets, for instance, to link the prices of path-dependent exotic instruments to market implied volatilities. The methods are also used for interest rate and credit derivatives. Other applications considered include variance-reduction techniques, portfolio optimization, forward-looking estimation of CAPM 'beta', and the Heston model and generalizations of it. 'Off-the-shelf' formulas and calibration tools are provided to ease the transition for practitioners who adopt this new method. The attention to detail and explicit presentation make this also an excellent text for a graduate course in financial and applied mathematics.
eBook
Tiotropium Bromide Step-Up Therapy for Adults with Uncontrolled Asthma
In this trial involving adults with asthma that was poorly controlled by a low-dose inhaled glucocorticoid, the addition of inhaled tiotropium was superior to a doubling of the dose of an inhaled glucocorticoid and was not inferior to the addition of inhaled salmeterol.
Many adults with asthma have inadequate control of symptoms when receiving a low-to-medium dose of an inhaled glucocorticoid.
1
,
2
Treatment options include the addition of a leukotriene modifier,
2
the addition of a long-acting beta-agonist (LABA),
2
–
4
or an increased dose of an inhaled glucocorticoid.
2
Current guidelines of the National Asthma Education and Prevention Program favor the last two options.
2
In recent communications, however, the Food and Drug Administration (FDA)
5
and asthma experts
6
,
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have questioned the safety of LABA therapy and suggested strategies to minimize the use of these drugs. Because of such concerns and the heterogeneity of patients with . . .
Journal Article
Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer
Women with metastatic breast cancer that had progressed during treatment with trastuzumab plus a taxane were assigned to lapatinib plus capecitabine or to trastuzumab emtansine. The response rate and survival were significantly better with trastuzumab emtansine.
Amplification of human epidermal growth factor receptor 2 (HER2, also called ErbB2) occurs in approximately 20% of breast cancers and is associated with shortened survival.
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–
3
Combining HER2-targeted agents with standard chemotherapy is an effective therapeutic approach for patients with HER2-positive metastatic breast cancer. When combined with first-line chemotherapy, trastuzumab increases the time to progression and overall survival among patients with metastatic disease.
4
,
5
The addition of lapatinib to capecitabine increases the time to progression in patients previously treated with trastuzumab, an anthracycline, and a taxane,
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and this combination is a standard option for disease progression with trastuzumab.
Trastuzumab emtansine . . .
Journal Article
Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD
An important goal in the treatment of COPD is the prevention of exacerbations. In this trial, the investigators found that treatment with tiotropium, as compared with salmeterol, prolonged the time to the first exacerbation of COPD and decreased the number of exacerbations.
Chronic obstructive pulmonary disease (COPD) is a leading cause of disability and death worldwide.
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–
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Exacerbations of COPD indicate instability or worsening of the patient's clinical status and progression of the disease and have been associated with the development of complications, an increased risk of subsequent exacerbations, a worsening of coexisting conditions, reduced health status and physical activity, deterioration of lung function, and an increased risk of death.
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–
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The prevention of exacerbations therefore constitutes a major goal of treatment.
1
,
2
Therapy with a long-acting anticholinergic drug or a long-acting β
2
-agonist is recommended as first-line maintenance therapy in . . .
Journal Article
A 4-Year Trial of Tiotropium in Chronic Obstructive Pulmonary Disease
In this large, randomized trial, the investigators compared outcomes in patients with chronic obstructive pulmonary disease (COPD) treated with once-daily inhalation of tiotropium or placebo. There was no benefit of treatment on the rate of loss of lung function over time, although benefits were observed in some secondary end points.
These investigators compared outcomes in patients with chronic obstructive pulmonary disease treated with once-daily inhalation of tiotropium or placebo. There was no benefit of treatment on the rate of loss of lung function over time, although benefits were observed in some secondary end points.
Prospective studies testing effects on the progression of chronic obstructive pulmonary disease (COPD) through the evaluation of the slope of the forced expiratory volume in 1 second (FEV
1
) have not shown that inhaled short-acting anticholinergic drugs, inhaled corticosteroids, or
N
-acetylcysteine alter this marker of disease progression.
1
–
7
To date, only smoking cessation has prospectively been shown to alter the rate of decline of FEV
1
in patients with COPD.
2
Tiotropium is a once-daily, inhaled anticholinergic drug that provides at least 24-hour improvements in airflow and hyperinflation in patients with COPD.
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–
10
Clinical trials lasting 6 weeks to . . .
Journal Article