Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head: A Phase II Randomized Clinical Trial.

PURPOSE: NRG/RTOG 0848 was designed to determine whether adjuvant radiation with fluoropyrimidine sensitization improved survival following gemcitabine-based adjuvant chemotherapy for patients with resected pancreatic head adenocarcinoma. In step 1 of this protocol, patients were randomized to adjuvant gemcitabine versus the combination of gemcitabine and erlotinib. This manuscript reports the final analysis of these step 1 data. METHODS: Eligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180. Gemcitabine arm-6 cycles of gemcitabine. Gemcitabine+erlotinib arm-gemcitabine and erlotinib 100 mg/d. Two hundred deaths provided 90% power (1-sided α=0.15) to detect the hypothesized OS signal (hazard ratio=0.72) in favor of the arm 2. RESULTS: From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2. Median age was 63 (39 to 86) years. CA19-9 ≤90 in 93%. Arm 1: 32 patients (20%) grade 4 and 2 (1%) grade 5 adverse events; arm 2, 27 (17%) grade 4 and 3 (2%) grade 5. GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22). The median follow-up (surviving patients) was 42.5 months (min-max: <1 to 75). With 203 deaths, the median and 3-year OS (95% confidence interval) are 29.9 months (21.7, 33.4) and 39% (30, 45) for arm 1 and 28.1 months (20.7, 30.9) and 39% (31, 47) for arm 2 (log-rank P=0.62). Hazard ratio (95% confidence interval) comparing OS of arm 2 to arm 1 is 1.04 (0.79, 1.38). CONCLUSIONS: The addition of adjuvant erlotinib to gemcitabine did not provide a signal for increased OS in this trial.

Bullying climate and school engagement in ninth-grade students.

BACKGROUND: Many authorities agree that bullying has a widespread impact on school climate, affecting bystanders as well as victims. This study tested the contention that a climate of bullying can have a schoolwide impact on student engagement in school. METHODS: Hierarchical linear modeling assessed the relations between student perception of bullying climate and student engagement at the individual and school level in a statewide sample of 7058 ninth graders randomly selected from 289 schools participating in the Virginia High School Safety Study. Student engagement was assessed by self-report scales measuring commitment to school and involvement in school activities. RESULTS: Individual differences in perception of school climate characterized by bullying were associated with lower commitment to school, but not less involvement in school activities. School-level differences in student perceptions of bullying climate were associated with both lower commitment to school and less involvement in school activities, after controlling for the effects of gender, race, school size, proportion of ethnic minority students in the school, and individual-level perception of bullying climate. CONCLUSION: Efforts to improve student engagement should consider the schoolwide impact of bullying on all students.

Palliative chemotherapy for pancreatic malignancies.

Metastatic pancreatic cancer is often one of the most challenging malignancies a medical oncologist faces. Although the primary endpoint of many studies remains overall survival, palliation and quality of life are now more commonly being addressed. The author discusses the most common chemotherapeutic modalities for the treatment of metastatic pancreatic cancer, such as single agent chemotherapy, combination therapy, targeted therapy, and second line treatment.