Perspectives on Drug Development for the Treatment of Chronic Myeloid Leukemia in Pregnant Patients and Patients Who Are Breastfeeding.

Tyrosine kinase inhibitors (TKI) have improved the outcome and life expectancy of patients with chronic myeloid leukemia (CML). Patients are diagnosed with CML at younger ages, and patients treated for CML may become pregnant or choose to breastfeed. The information available to date on the safety of TKIs during pregnancy and lactation and the optimal management of these patients is largely anecdotal, based on personal or small-group experience, and heterogeneous.

Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy.

Cancers affecting pregnant women include breast cancer, melanoma, thyroid cancer, cervical cancer, lymphomas, and leukemias. The medical management of cancer during pregnancy with molecularly targeted oncology drugs remains quite challenging, with knowledge gaps about the drugs' safety and efficacy due to exclusion of pregnant women from cancer clinical trials, discontinuation of individuals who become pregnant during clinical trials, and limited information on appropriate dosing of molecularly targeted oncology drugs during pregnancy. Physiological changes occur during pregnancy and may result in alterations in the absorption, distribution, metabolism, and excretion of drugs used in pregnant women.

Systemic Chemotherapies Retain Antitumor Activity in Desmoid Tumors Independent of Specific Mutations in CTNNB1 or APC: A Multi-institutional Retrospective Study.

Purpose: Determine whether specific CTNNB1 or APC mutations in patients with desmoid tumor were associated with differences in clinical responses to systemic treatments.

Experimental Design: We established a multi-institutional dataset of previously treated patients with desmoid tumor across four U.S.

Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury-TRICOM vaccine in patients with advanced cancer.

Background: MVA-BN-brachyury-TRICOM is a recombinant vector-based therapeutic cancer vaccine designed to induce an immune response against brachyury. Brachyury, a transcription factor overexpressed in advanced cancers, has been associated with treatment resistance, epithelial-to-mesenchymal transition, and metastatic potential. MVA-BN-brachyury-TRICOM has demonstrated immunogenicity and safety in previous clinical trials of subcutaneously administered vaccine.

Randomized, Double-Blind, Placebo-Controlled Phase II Study of Yeast-Brachyury Vaccine (GI-6301) in Combination with Standard-of-Care Radiotherapy in Locally Advanced, Unresectable Chordoma.

Background: Brachyury is a transcription factor overexpressed in chordoma and is associated with chemotherapy resistance and epithelial-to-mesenchymal transition. GI-6301 is a recombinant, heat-killed Saccharomyces cerevisiae yeast-based vaccine targeting brachyury. A previous phase I trial of GI-6301 demonstrated a signal of clinical activity in chordomas.

Cancer Vaccines.

Cancer vaccines are a promising strategic approach within the rapidly growing field of immuno-oncology. Therapeutic cancer vaccines are distinct from prophylactic vaccines and vary by both target antigen and vaccine platform. There are currently 3 FDA-approved therapeutic cancer vaccines: intravesical BCG live, sipuleucel-T, and T-VEC.

Social connectedness and life satisfaction: Comparing mean levels for 2 undergraduate samples and testing for improvement based on brief counseling.

Objectives: Comparing the mean levels of social connectedness and life satisfaction, and analyzing their relationship for 2 undergraduate samples, and testing for an increase in their means for a brief counseling sample.

Participants: Between October 2013 and May 2015, 3 samples were collected: not-in-counseling (NIC; n = 941), initial counseling session (ICS; ie, triage session only; n = 168), and brief counseling (BC; ie, median of 4 additional counseling sessions; n = 28).

Methods: Online surveys measuring demographic and background control variables, social connectedness, and life satisfaction.

Prevention of venous thrombotic events in brain injury: review of current practices.

Venous thromboembolic event after traumatic brain injury represents a unique clinical challenge. Physicians must balance appropriate timing of chemoprophylaxis with risk of increased cerebral hemorrhage. Despite an increase in the literature since the 1990s, there are clear disparities in treatment strategies.

Using buprenorphine to treat opioid-dependent university students: opportunities, successes, and challenges.

Objective: : The objective of this study was to characterize a population of opioid-dependent university students who were treated with buprenorphine, describe their treatment outcome, and discuss challenges the authors faced in working with this population in the setting of a university counseling center.

Methods: : We conducted a retrospective chart review of 27 opioid-dependent university students treated with buprenorphine at the university's counseling center.

Results: : Students were predominantly white (85%, n = 23), male (63%, n = 17), average age of 22 years with an average of 33.

The implementation of buprenorphine/naloxone in college health practice.

Opiate abuse and dependence have become important concerns for college healthcare providers. The passage of the Drug Addiction Treatment Act of 2000 and the approval of the combination buprenorphine/naloxone for office-based treatment of opiate dependence have increased the options available for college students and their healthcare providers. The authors review the pharmacology of buprenorphine/naloxone and discuss how it can be implemented in college health practice.

A functional prodynorphin promoter polymorphism and opioid dependence.

Objectives: The prodynorphin gene (PDYN) promoter has a repeat polymorphism that is functionally important in association with substance abuse. We examined this polymorphism for association in our sample of 168 opioid-dependent patients and 122 ethnically and geographically matched controls.

Methods: Patients were selected from university-affiliated residential and non-residential addiction treatment programs in the Philadelphia area.

Novel exonic mu-opioid receptor gene (OPRM1) polymorphisms not associated with opioid dependence.

The mu-opioid receptor (MOR) mediates reward and dependence associated with opioids and other commonly abused substances. Variability in the MOR gene, OPRM1, may influence risk for opioid dependence. In this study, associations between two single nucleotide polymorphisms (SNPs), dbSNP rs540825 and dbSNP rs562859, and opioid dependence were investigated.

A genetic association study of the mu opioid receptor and severe opioid dependence.

Objectives: Twin, family and adoption studies have suggested that vulnerability to opioid dependence may be a partially inherited trait (Cadoret et al., 1986; Merikangas et al., 1998; Tsuang et al.

Methadone maintenance treatment.

Preview Substance abuse, particularly injecting drug use, is receiving increased attention because of its role in the spread of AIDS. Methadone maintenance treatment programs help curb the spread by decreasing injecting drug abuse and by offering HIV testing, counseling, and referral for care of infected patients. Drs DeMaria and Weinstein explain how methadone programs work and what primary care physicians need to know to refer their opiate-dependent patients.