Progression-free survival, overall survival and quality of life: What is their medicoeconomic importance in oncology?

Medico-economic evaluations estimate, for a given health technology, the added cost and the clinical benefit compared to a reference strategy. The objective here is to analyze the criteria used to measure clinical benefit as the basis for market access and reimbursement decisions for drugs in oncology both in France and in Europe. Prolonged overall survival is the criterion of choice to demonstrate the benefit of an anticancer drug; a survival gain of 2 to 3 months or more would be considered as relevant for a new product versus the comparator. In the absence of survival benefit or mature data on survival, progression-free survival or symptom-free survival and the availability of alternative curative treatments, decrease in drug toxicity and quality of life improvement may be considered. Differences in clinical benefit assessment between regulatory agencies and payers are not specific to France. Case studies show that it is difficult to find a consistency in reimbursement and pricing decisions and to identify factors that may fully explain reimbursement decisions when survival benefit is not demonstrated.

Epidemiology, management, and prognosis of secondary non-postoperative peritonitis: a French prospective observational multicenter study.

BACKGROUND: Despite improvements in treatment, secondary peritonitis still is associated with high morbidity and mortality rates. Better knowledge of real-life clinical practice might improve management. METHODS: Prospective, observational study (January-June 2005) of 841 patients with non-postoperative secondary peritonitis. RESULTS: Peritonitis originated in the colon (32% of patients), appendix (31%), stomach/duodenum (18%), small bowel (13%), or biliary tract (6%). Most patients (78%) presented with generalized peritonitis and 26% with severe peritonitis (Simplified Acute Physiology Score [SAPS] II score>38). Among the 841 patients, 27.3% underwent laparoscopy alone; 11% underwent repeat surgery, percutaneous drainage, or both. A SAPS II score>38 and the presence of Enterococcus spp. were predictive of abdominal and non-surgical infections (odds ratio [OR]=1.84; p=0.013 and OR=2.93; p<0.0001, respectively). A SAPS II score>38 also was predictive of death (OR=10.5; p<0.0001). The overall mortality rate was high (15%). Patients receiving inappropriate initial antimicrobial therapy had significantly higher morbidity and mortality rates than patients receiving appropriate therapy (44 vs. 30%; p=0.004 and 23% vs. 14%; p=0.015, respectively). The SAPS II score and rates of severe peritonitis, morbidity, and mortality were significantly lower in patients with appendiceal peritonitis. CONCLUSIONS: Patients with non-postoperative peritonitis should be considered high risk and should receive appropriate initial therapy. The presence of Enterococcus spp. in peritoneal cultures significantly increased morbidity but not the mortality rate. Appendiceal peritonitis that was less severe and had a better prognosis than peritonitis originating in other sites should be considered a special case in future studies.

Determination of free ertapenem in plasma and bronchoalveolar lavage by high-performance liquid chromatography with ultraviolet detection.

A sensitive assay for the determination of unbound ertapenem in human plasma and bronchoalveolar lavage (BAL) was developed using ultrafiltration of plasma and BAL samples. A rapid HPLC method was used with ultraviolet detection set at a wavelength of 305 nm and a separation on a Prontosil AQ C18 column, with imipenem used as internal standard. This assay was linear over the concentration range of 0.5-100 microg/mL and 0.25-50 microg/mL in plasma and BAL, respectively. Limits of detection and quantitation were respectively 0.05 and 0.25 microg/mL. Validation data for accuracy and precision were CV<2.48 and 8.25%, accuracy in the range 98.1-104.2% and 102.2-108.4%, respectively, for intra and inter-day.