Erlotinib and bevacizumab versus cisplatin, gemcitabine and bevacizumab in unselected nonsquamous nonsmall cell lung cancer.

Erlotinib with bevacizumab showed promising activity in recurrent nonsquamous (NS) nonsmall cell lung cancer (NSCLC). The INNOVATIONS study was designed to assess in first-line treatment of unselected cisplatin-eligible patients this combination compared to cisplatin, gemcitabine and bevacizumab. Stage IIIB/IV patients with NS-NSCLC were randomised on erlotinib (150 mg daily) and bevacizumab (15 mg·kg(-1) on day 1, every 3 weeks) (EB) until progression, or cisplatin (80 mg·m(-2) on day 1, every 3 weeks) and gemcitabine (1250 mg·m(-2) on days 1 and 8, every 3 weeks) up to six cycles and bevacizumab (15 mg·kg(-1) on day 1, every 3 weeks) (PGB) until progression. 224 patients were randomised (EB n=111, PGB n=113). The response rate (12% versus 36%; p<0.0001), progression-free survival (median 3.5 versus 6.9 months; hazard ratio (HR) 1.85, 95% CI 1.39-2.45; p<0.0001) and overall survival (median 12.6 versus 17.8 months; HR 1.41, 95% CI 1.01-1.97; p=0.04) clearly favoured PGB. In patients with epidermal growth factor receptor mutations (n=32), response rate, progression-free survival and overall survival were not superior with EB. Platinum-based combination chemotherapy remains the standard of care in first-line treatment of unselected NS-NSCLC. Molecular targeted approaches strongly mandate appropriate testing and patient selection.

Implementation of guidelines for the treatment of acute ST-elevation myocardial infarction: the Cologne Infarction Model Registry.

BACKGROUND: The aim of the Köln (Cologne) Infarction Model is to examine the feasibility of obligatory treatment of ST-segment-elevation myocardial infarction (STEMI) by first-line percutaneous coronary intervention. METHODS AND RESULTS: The study was performed in Cologne with >1 million citizens, 5 coronary intervention centers, and 11 primary care hospitals. Twelve-lead ECG was available for all emergency medical service (EMS) teams. Partners guaranteed direct transfer of STEMI patients to a catheterization laboratory. A total of 519 patients treated within KIM in 2006 were included in the study. Of these, 24% presented at a primary care hospital, 11% presented directly at a coronary intervention center, 5% were transferred by EMS to primary care hospitals, and 60% were directly transferred by EMS to a catheterization laboratory. In 91% of cases, the catheterization laboratory was notified of the patient's arrival in advance. False-positive ECG diagnosis of STEMI by EMS accounted for 6%. Median treatment times were as follows: from the start of symptoms to first medical contact, 120 minutes; phone to balloon, 70 minutes; and door to balloon, 49 minutes. Of all patients, 93% underwent angiography; 409 patients were treated by coronary intervention, and 24 underwent emergency coronary artery bypass graft. Thrombolysis in Myocardial Infarction grade 3 flow was obtained in 89%. In the hospitals, deaths and new myocardial infarctions were observed in 12.1% and in 1.9% of all patients, respectively. CONCLUSIONS: The Cologne Infarction Model provides evidence for the feasibility of obligatory treatment of STEMI by primary coronary intervention in a metropolitan setting. Acceptance of treatment pathways allowed nearly all STEMI patients to undergo coronary angiography. ECG competence of EMS was excellent. Treatment times were within postulated limits. Results, including mortality, were within a high quality range.