Phase II study of gemcitabine and oxaliplatin in combination with bevacizumab in patients with advanced hepatocellular carcinoma.

PURPOSE: Hepatocellular carcinoma (HCC) is a vascular tumor with poor prognosis. Given the reported activity of gemcitabine and oxaliplatin (GEMOX) in HCC and the potential benefits of targeting the vascular endothelial growth factor pathway with bevacizumab (B), a phase II study of GEMOX-B was undertaken to define efficacy and toxicity profiles in HCC patients. PATIENTS AND METHODS: Eligible patients had pathologically proven measurable unresectable or metastatic HCC. For cycle 1 (14 days), bevacizumab 10 mg/kg was administered alone intravenously on day 1. For cycle 2 and beyond (28 days/cycle), bevacizumab 10 mg/kg was administered on days 1 and 15, gemcitabine 1,000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16. RESULTS: Thirty-three patients were enrolled and 30 patients were assessable for efficacy. The objective response rate was 20%, and 27% of patients had stable disease. Median overall survival was 9.6 months (95% CI, 8.0 months to not available) and median progression-free survival (PFS) was 5.3 months (95% CI, 3.7 to 8.7 months); the PFS rate at 3 and 6 months was 70% (95% CI, 54% to 85%) and 48% (95% CI, 31% to 65%), respectively. The most common treatment-related grade 3 to 4 toxicities included leukopenia/neutropenia, transient elevation of aminotransferases, hypertension, and fatigue. CONCLUSION: GEMOX-B could be safely administered with close monitoring and had moderate antitumor activity for patients with advanced HCC. The high 6-month PFS rate is encouraging, and this regimen is worthy of further investigation.

Effects of low stereo acuity on performance, presence and sickness within a virtual environment.

To examine the effect of stereo vision on performance, presence and oculomotor disturbances within a virtual environment (VE), two groups of 23 participants (good stereo acuity/low stereo acuity) were evaluated. Groups were matched in terms of gender, age and VE design factors (the latter were accounted for to ensure a similar VE experience between groups). Participants were immersed in a VE maze for up to 1h during which time they interacted with the environment while performing a number of stationary and movement-based tasks. Individuals with low stereo acuity traveled further to complete two tasks in the VE, yet performance time on these tasks was comparable to participants with good stereo acuity. Although participants with impaired stereo vision likely did not fully benefit from a stereoscopic view of the scene, they may have received sufficient depth information from movement-based cues to efficiently accomplish these tasks in a comparable amount of time. Overall performance, based on both the number of tasks completed and the total translational distance moved (based on input device movement) within the VE was not hindered for those with low stereo acuity. In addition, the expected increase in oculomotor disturbances for this group was not evident in this study, and both groups reported comparable amounts of presence from VE exposure. These results suggest that when head tracking is included as part of the VE experience (i.e., motion parallax cues exist), participants with low stereo acuity can be expected to perform comparable to normal sighted individuals, experience a comparable sense of presence, and report no increase in adverse effects when viewing scenes via stereoscopic displays. Thus, motion parallax cues may adequately provide a sense of depth within a VE, and alleviate theorized performance decrements for individuals with low stereo acuity. The results of this study have implications for those designing entertainment simulations or other such applications open to the general public, where people with low stereo acuity may routinely participate.

What to expect from immersive virtual environment exposure: influences of gender, body mass index, and past experience.

For those interested in using head-coupled PC-based immersive virtual environment (VE) technology to train, entertain, or inform, it is essential to understand the effects this technology has on its users. This study investigated potential adverse effects, including the sickness associated with exposure and extreme responses (emesis, flashbacks). Participants were exposed to a VE for 15 to 60 min, with either complete or streamlined navigational control and simple or complex scenes, after which time measures of sickness were obtained. More than 80% of participants experienced nausea, oculomotor disturbances, and/or disorientation, with disorientation potentially lasting > 24 hr. Of the participants, 12.9% prematurely ended their exposure because of adverse effects; of these, 9.2% experienced an emetic response, whereas only 1.2% of all participants experienced emesis. The results indicate that designers may be able to reduce these rates by limiting exposure duration and reducing the degrees of freedom of the user's navigational control. Results from gender, body mass, and past experience comparisons indicated it may be possible to identify those who will experience adverse effects attributable to exposure and warn such individuals. Applications for this research include military, entertainment, and any other interactive systems for which designers seek to avoid adverse effects associated with exposure.

Associations between health risk behaviors and opposite-, same-, and both-sex sexual partners in representative samples of vermont and massachusetts high school students.

OBJECTIVE: To examine associations between health risk behaviors and sexual experience with opposite-, same-, or both-sex partners in representative samples of high school students. DESIGN: We used 1995 and 1997 data from the Vermont and Massachusetts Youth Risk Behavior Surveys. Logistic regression and multiple regression analyses were used to compare health risk behaviors among students who reported sex with opposite-sex partners only (opposite-sex students), with same-sex partners only (same-sex students), and with both male and female sexual partners (both-sex students). SETTING: Public high schools in Vermont and Massachusetts. PARTICIPANTS: Representative, population-based samples of high school students. The combined samples had 14 623 Vermont students and 8141 Massachusetts students. MAIN OUTCOME MEASURE: Violence, harassment, suicidal behavior, alcohol and other drug use, and unhealthy weight control practices. RESULTS: In both states, both-sex students were significantly more likely to report health risk behaviors than were opposite-sex students. For example, both-sex students had odds 3 to 6 times greater than opposite-sex students of being threatened or injured with a weapon at school, making a suicide attempt requiring medical attention, using cocaine, or vomiting or using laxatives to control their weight. In both states, same-sex students were as likely as opposite-sex students to report most health risk behaviors. CONCLUSION: Relative to opposite- and same-sex students, both-sex students may be at elevated risk of injury, disease, and death by experiencing serious harassment and engaging in violence, suicidal behavior, alcohol and other drug use, and unhealthy weight control practices.