Distinctive inhibitors of PI3K may possibly im pair VM formation and lessen MT1

In addition, patients in arms I and II self monitored BP bid at home prior to axitinib dosing and were instructed to contact their physicians for fur ther evaluation of systolic BP 150 mmHg or diastolic BP 100 mmHg. Patient reported outcomes were evaluated, using the M. D. Anderson Symptom Inventory questionnaire on days 1 and 8 of each chemo therapy cycle and on day 1 AP24534 943319-70-8 of each axitinib maintenance cycle. MDSAI is a 19 item, validated self reported ques tionnaire consisting of two scales that assess symptom se verity and interference with different aspects of patients life. Mean change in the MDASI score 0. 98 point was defined as clinically meaningful. Statistical analysis The primary purpose of this study was to assess the effi cacy of axitinib in combination with pemetrexed cisplatin versus pemetrexed cisplatin alone in patients with non squamous NSCLC in the randomized phase II study.<br><br> The sample size estimates were based on separate comparisons of the axitinib containing arms I and II versus arm III. Fifty patients were required in each arm and 70 events for each comparison AT-406 cell in vivo in vitro for a two sample log rank test to have an overall one sided significance level of 0. 20 and power of 0. 80. This assumed a 50% improvement in median PFS from 5. 0 months in arm III to 7. 5 months in arm I or II, and 12 month accrual time and 6 month follow up. The hazard ratio and its 95% CI were estimated. A stratified log rank test was used to compare PFS between the treatment arms, however, the P values were for reference only. Secondary endpoints included OS, ORR, duration of tumor response, PROs, and safety.<br><br> ORR between treatment arms was compared using Cochran Mantel Haenszel akt1 阻害剤 test stratified by baseline ECOG PS and gender. Descriptive summary statistics of the MDASI items were reported. Safety was analyzed in patients who received at least one dose of study drug, and the results from only the randomized phase II portion were presented here. The efficacy and safety analyses were originally con ducted based on the data obtained as of March 1, 2011, while the study was still ongoing. PFS and overall safety were later updated using a data cutoff date of December axitinib maintenance therapy. By the completion of the study, all patients discontinued the study, mostly due to death. Efficacy The investigator assessed median PFS was 8. 0, 7. 9, and 7.<br><br> 1 months in arms I, II, and III, respectively. The hazard ratio was 0. 89 for arm I 21, 2011, which are presented here. It should be noted that median PFS in each arm were very similar between the two analyses. The final analysis for OS, duration of tumor response among responders, number of deaths, and serious AEs was conducted after the database lock on May 18, 2012. For each endpoint, the most up to date results are presented in this manuscript. Results Patient characteristics Between January 19, 2009 and April 21, 2010, a total of 170 patients were randomly assigned among three treat ment arms, arm I, arm II, and arm III. All patients were treated with assigned drugs, except two patients in arm III who did not receive pemetrexed cisplatin.