| Tsai DJ |
------>authors3_c= ------>paper_class1=2 ------>Impact_Factor=None ------>paper_class3=0 ------>paper_class2=0 ------>vol= ------>confirm_bywho=None ------>insert_bywho=djtsai ------>Jurnal_Rank=None ------>authors4_c= ------>comm_author= ------>patent_EDate=None ------>authors5_c= ------>publish_day=21 ------>paper_class2Letter=None ------>page2= ------>medlineContent= ------>unit=000 ------>insert_date=20070507 ------>iam=1 ------>update_date=None ------>author=??? ------>change_event=1 ------>ISSN= ------>authors_c=??? ------>score=-64 ------>journal_name=??V-10?????????????? ------>paper_name=?????????????????V-10 ------>confirm_date=None ------>tch_id=092086 ------>pmid=19917841 ------>page1= ------>fullAbstract=PURPOSE: This phase II/III double-blind study assessed efficacy and safety of cediranib with standard chemotherapy as initial therapy for advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Paclitaxel (200 mg/m(2)) and carboplatin (area under the serum concentration-time curve 6) were given every 3 weeks, with daily oral cediranib or placebo at 30 mg (first 45 patients received 45 mg). Progression-free survival (PFS) was the primary outcome of the phase II interim analysis; phase III would proceed if the hazard ratio (HR) for PFS </= 0.77 and toxicity were acceptable. RESULTS: A total of 296 patients were enrolled, 251 to the 30-mg cohort. The phase II interim analysis demonstrated a significantly higher response rate (RR) for cediranib than for placebo, HR of 0.77 for PFS, no excess hemoptysis, and a similar number of deaths in each arm. The study was halted to review imbalances in assigned causes of death. In the primary phase II analysis (30-mg cohort), the adjusted HR for PFS was 0.77 (95% CI, 0.56 to 1.08) with a higher RR for cediranib than for placebo (38% v 16%; P < .0001). Cediranib patients had more hypertension, hypothyroidism, hand-foot syndrome, and GI toxicity. Hypoalbuminemia, age >/= 65 years, and female sex predicted increased toxicity. Survival update (N = 296) 10 months after study unblinding favored cediranib over placebo (median of 10.5 months v 10.1 months; HR, 0.78; 95% CI, 0.57 to 1.06; P = .11). Causes of death in the cediranib 30-mg cohort were NSCLC (81%), protocol toxicity +/- NSCLC (13%), and other (6%); for the placebo group, they were 98%, 0%, and 2%, respectively. CONCLUSION: The addition of cediranib to carboplatin/paclitaxel results in improved response and PFS, but does not appear tolerable at a 30-mg dose. Consequently, the National Cancer Institute of Canada Clinical Trials Group and the Australasian Lung Cancer Trials Group initiated a randomized, double-blind, placebo-controlled trial of cediranib 20 mg with carboplatin and paclitaxel in advanced NSCLC. ------>tmu_sno=None ------>sno=15701 ------>authors2= ------>authors3= ------>authors4= ------>authors5= ------>authors6= ------>authors6_c= ------>authors=Tsai DJ ------>delete_flag=0 ------>SCI_JNo=None ------>authors2_c= ------>publish_area=1 ------>updateTitle=Randomized, Double-Blind Trial of Carboplatin and Paclitaxel With Either Daily Oral Cediranib or Placebo in Advanced Non-Small-Cell Lung Cancer: NCIC Clinical Trials Group BR24 Study. ------>language=1 ------>check_flag=None ------>submit_date=None ------>country=NULL ------>no= ------>patent_SDate=None ------>update_bywho=None ------>publish_year=2003 ------>submit_flag=None ------>publish_month=9 |