PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study: BrUOG 244.

PURPOSE: Efficacy signals but substantial myelosuppression were demonstrated in a single arm phase II study of paclitaxel poliglumex (PPX) in combination with temozolomide (TMZ) and radiation therapy (RT) for first-line treatment of glioblastoma. The objective of this randomized phase II trial was to assess the efficacy and safety of single-agent PPX with RT (PPX/RT) versus TMZ with RT (TMZ/RT) for glioblastoma without O-methylguanine-DNA methyltransferase (MGMT) methylation. MATERIALS AND METHODS: Patients with glioblastoma with unmethylated MGMT without prior chemotherapy or RT were eligible. Patients were randomly assigned 2:1 to PPX, 50 mg/m/wk for 6 weeks, or standard TMZ, with concurrent 60.0 Gy RT. One month after completion of chemoradiation all patients received standard maintenance TMZ. The primary endpoint was progression-free survival (PFS). RESULTS: Of the 164 patients enrolled, 86 were MGMT unmethylated. Of these, 63 patients were randomized (42 to PPX/RT and 21 to TMZ/RT). Fifty-nine patients could be analyzed. The median PFS was 9 months in the PPX/RT group and 9.5 months in the TMZ/RT group (hazard ratio in the PPX/RT group, 1.10; 95% confidence interval, 0.79-2.08; P=0.75). Median overall survival was 16 versus 14.8 months for PPX/RT and TMZ/RT groups, respectively (hazard ratio, 1.44; 95% confidence interval, 0.75-2.77; P=0.27). In the PPX and TMZ groups 44% versus 22% of patients, respectively, experienced one or more grade 3 or higher toxicities during chemoradiation. CONCLUSIONS: PPX/RT did not improve PFS or overall survival. This study provides an effective trial design for screening RT sensitizers in glioblastoma.

Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.

BACKGROUND: Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. METHODS: We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. RESULTS: Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38). CONCLUSIONS: Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups. TRIAL REGISTRATION: Clinicaltrials.gov NCT01772511.

Predictors of exclusive breastfeeding at least 8 weeks among Asian and Native Hawaiian or other Pacific Islander race subgroups in Hawaii, 2004-2008.

Breastfeeding is nurturing, cost-effective, and beneficial for the health of mother and child. Babies receiving formula are sick more often and are at higher risk for childhood obesity, diabetes, asthma, and other conditions compared with breastfed children. National and international organizations recommend exclusive breastfeeding for 6 months. Exclusive breastfeeding in Asian and Native Hawaiian or Other Pacific Islander (NHOPI) subgroups is not well characterized. Data from the 2004-2008 Hawaii Pregnancy Risk Assessment Monitoring System, a population-based surveillance system on maternal behaviors and experiences before, during, and after pregnancy, were analyzed for 8,508 mothers with a recent live birth. We examined exclusive breastfeeding status for at least 8 weeks. We calculated prevalence risk ratios across maternal race groups accounting for maternal and socio-demographic characteristics. The overall estimate of exclusive breastfeeding for at least 8 weeks was 36.3%. After adjusting for maternal age, pre-pregnancy weight, cesarean delivery, return to work/school, and self-reported postpartum depressive symptoms, the racial differences in prevalence ratios for exclusive breastfeeding for each ethnic group compared to Whites were: Samoan (aPR = 0.54; 95% CI 0.43-0.69), Filipino (aPR = 0.58; 95% CI 0.53-0.63), Japanese (aPR = 0.58; 95% CI 0.52-0.65), Chinese (aPR = 0.64; 95% CI 0.58-0.70), Native Hawaiian (aPR = 0.67; 95% CI 0.61-0.72), Korean (aPR = 0.72; 95% CI 0.64-0.82), and Black (aPR = 0.79; 95% CI 0.65-0.96) compared to white mothers. Providers and community groups should be aware that just over one-third of mothers breastfeed exclusively at least 8 weeks with lower rates among Asian, NHOPI, and Black mothers. Culturally appropriate efforts to promote exclusive breastfeeding are recommended particularly among Asian subgroups that have high breastfeeding initiation rates that do not translate into high exclusivity rates.