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Finale 2014 Trial Plus Prednisone Significantly
The series finale of the groundbreaking television comedy The Office is aired. Here, we present the final analysis of an early-access protocol trial that. Background: In the final analysis of the phase 3 COU-AA-301 study, abiraterone acetate plus prednisone significantly prolonged overall survival compared with prednisone alone in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy.
As discussed inWant to know whether you favourite casino accepts Mastercard, Visa or Paypal The Final Fantasy Realm Reborn Duty Roulette Trials page will give you all the information you need, including details about alternative payment methods.Patients ⩾18 years received oral sunitinib 50 mg per day on a 4-weeks-on–2-weeks-off schedule. Innocence Project, Facts on Post-Conviction DNA Exonerations, INNOCENCEPROJECT.ORG (last visited Sept. A review of post-conviction DNA exonerations found that at least 40 of cases in which the defendant was exonerated as a result of DNA evidence involved cross-racial eyewitness identifications.
Median progression-free survival (PFS) and overall survival (OS) were 9.4 months (95% CI: 8.8–10.0) and 18.7 months (95% CI: 17.5–19.5). Objective response rate was 16% (95% confidence interval (CI): 15–17). Median treatment duration and follow-up were 7.5 and 13.6 months. Results:A total of 4543 patients received sunitinib. Tumour measurements were scheduled per local practice.
Efficacy and safety findings were consistent with previous results.Sunitinib is an orally administered multitargeted inhibitor of vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors, and other receptor tyrosine kinases ( Abrams et al, 2003 Mendel et al, 2003 O’Farrell et al, 2003). Conclusion:Final analysis of the sunitinib expanded-access trial provided a good opportunity to evaluate the long-term side effects of a tyrosine kinase inhibitor used worldwide in mRCC. The most common grade 3/4 treatment-related adverse events were thrombocytopenia (10%), fatigue (9%), and asthenia, neutropenia, and hand–foot syndrome (each 7%). OS was strongly associated with the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model ( n=4065).
Finale 2014 Trial Registration Trial Of
Initial results from this expanded-access programme confirmed the activity of sunitinib in a broader ‘real-world’ population ( Gore et al, 2009).Here we report final results with extended follow-up of the 4543 patients treated in the expanded-access trial. Given the lack of active agents available in 2005 to treat advanced RCC, a global, expanded-access trial was implemented to provide sunitinib to patients in countries where its approval had not yet been granted and to those ineligible for registration-directed trials. In a subsequent pivotal phase III registration trial of treatment-naive patients with metastatic RCC (mRCC), sunitinib demonstrated a significant improvement in progression-free survival (PFS) compared with interferon-alfa (median PFS 11 vs 5 months hazard ratio (HR): 0.42, P<0.001) and in objective response rate (ORR 31% vs 6%, P<0.001 Motzer et al, 2007) in addition, overall survival (OS) was longer with sunitinib (median 26.4 vs 21.8 months HR: 0.821, P=0.051 Motzer et al, 2009).
Finale 2014 Trial Full Details For
Study design and treatmentThis was an international, open-label, expanded-access trial of sunitinib (SUTENT Pfizer Inc., New York, NY, USA) that treated patients from participating centres in 50 countries. All patients gave written, informed consent. Full details for eligibility criteria have been previously reported ( Gore et al, 2009). Any Eastern Cooperative Oncology Group (ECOG) performance status and asymptomatic brain metastases were permitted. Other requirements were as follows: resolution of prior treatment toxicities, adequate organ function, no major comorbidities, the potential to derive clinical benefit from sunitinib as judged by the treating physician, and ineligibility for other sunitinib studies.
Objective response rate was defined as the number of confirmed complete plus partial responses according to RECIST ( Therasse et al, 2000). Assessments were performed as per the local standard of care for mRCC, with data on tumour response, PFS, and OS collected when possible. Monitoring safety was mandatory at regular intervals (on days 1, 14, and 28 of cycle 1, and days 1 and 28 of subsequent cycles, until a protocol amendment (May 2006) removed the day 28 assessment in cycles ⩾3) by physical examination, ECOG performance status, haematology and biochemistry tests and cardiac function (12-lead electrocardiogram), and by recording and grading all adverse events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (Cancer Therapy Evaluation Program, 2006).No specific schedule was dictated by the protocol however, tumour measurement was assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0 ( Therasse et al, 2000). Study assessmentsScreening evaluations included disease assessment, physical examination, biochemistry and haematology tests, and a record of concomitant medications.
Statistical analysisBecause of the nature of this study, there was no pre-determined sample size nor were inferential analyses preplanned or any pre-specified hypotheses tested. Patients who were not known to be dead at the time of analysis or on the data cutoff date (September 2008) were censored on the date that they were last known to be alive. OS was defined as the time from start of therapy to death from any cause. Only deaths that occurred within 28 days of the last dose were counted as PFS events however, disease progression was not restricted to the treatment period plus the 28-day follow-up period.
Median follow-up (the time from the start of therapy until the patient was censored for survival or died, whichever occurred first) was 13.6 months (range: <1–71.3 months), and was similar for those who previously had or had not received cytokine therapy. All P-values were considered exploratory.Patients received a median of six cycles (range: 1–57), with median treatment duration of 7.5 months (95% CI: 6.9–7.8). In addition, a Cox multivariate analysis was used to explore the association between OS and the IMDC prognostic factors. Adverse factors were ECOG performance status >1, time from diagnosis to study treatment upper limit of normal (ULN), neutrophil count >ULN, and platelet count >ULN. The Kaplan–Meier method was used to estimate PFS and OS, with 95% CI calculated for the median.In an exploratory analysis, patients were grouped into favourable (0 adverse factors), intermediate (1–2 adverse factors), and poor ( ⩾3 adverse factors) risk categories according to the IMDC model ( Heng et al, 2009, 2013), with median OS for each group estimated by the Kaplan–Meier method and compared by the log-rank test. Objective response rate was calculated with corresponding exact 95% two-sided confidence interval (CI) using standard methods based on the binomial distribution.
SafetyApproximately 95% of patients reported treatment-related AEs of any grade, the most frequent of which were diarrhoea (47%), fatigue (40%), nausea (36%), and decreased appetite (31% Table 2). (Seventy patients (2%) were assigned to and received 37.5 mg per day on a continuous daily dosing schedule.) Dose reductions of sunitinib occurred at a higher frequency in patients who received prior cytokine treatment for advanced RCC, compared with those who had not received cytokines (51% vs 47%). The dose was reduced to 37.5 mg per day in 34% of patients, to 25 mg per day in 15% of patients, and to 12.5 mg per day in <1% of patients. Overall, 49% of patients required a dose reduction of sunitinib. Among these patients, the most common reasons for stopping therapy were lack of efficacy (39%), death (21%), AE (16%), consent withdrawn (9%), and lost to follow-up (3%).
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