ABSTRACT
Randomized controlled clinical trials (RCTs) in oncology enroll patients who meet strict protocol-specified criteria. Many of these criteria overlap across multiple RCTs. A vast proportion of patients with metastatic cancer do not meet such criteria. Hence, patient populations encountered in clinical practice are essentially different from RCT-populations, questioning the representativeness of these trials. A real-world evidence approach, using data from clinical practice, is increasingly employed to complement the information on drug safety and efficacy obtained from traditional clinical trials.
ABSTRACT
A high incidence of Clostridium difficile and multiresistant organisms and increasing consumption of cephalosporins and quinolones have required an antibiotic stewardship programme, and antibiotic audits with feedback, revised guidelines and stringent prescription rules have been successful. The hospital intervention was managed by an antibiotic team combined with contact persons in all departments, a pocket edition of the guideline was available, and monthly commented reports about antibiotic consumption in each department were presented on the intranet. Significant declining use of restricted antibiotics was observed.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Antimicrobial Stewardship , Drug Prescriptions , Anti-Bacterial Agents/therapeutic use , Cephalosporins/administration & dosage , Cephalosporins/therapeutic use , Clostridium Infections/epidemiology , Clostridium Infections/prevention & control , Cross Infection/prevention & control , Drug Prescriptions/standards , Drug Prescriptions/statistics & numerical data , Drug Utilization Review , Hospitals/standards , Humans , Medical Audit , Practice Guidelines as Topic , Practice Patterns, Physicians' , Quinolones/administration & dosage , Quinolones/therapeutic useSubject(s)
Antimetabolites, Antineoplastic/adverse effects , Central Nervous System Diseases/chemically induced , Deoxycytidine/analogs & derivatives , Deoxycytidine/adverse effects , Lung Neoplasms/drug therapy , Ovarian Neoplasms/drug therapy , Urinary Bladder Neoplasms/drug therapy , Aged , Antimetabolites, Antineoplastic/therapeutic use , Confusion/chemically induced , Deoxycytidine/therapeutic use , Female , Headache/chemically induced , Humans , Male , Middle Aged , Seizures/chemically induced , GemcitabineABSTRACT
In advanced ovarian cancer, gemcitabine is a candidate for combination chemotherapy due to its unique mechanism of action, favorable toxicity profile, and proven activity. Gemcitabine, paclitaxel, and platinum have demonstrated a response rate of 100% in patients with relapsed ovarian cancer. The median time to progression was 10 months and the median survival was more than 27 months. Two trials with gemcitabine, paclitaxel, and carboplatin in previously untreated patients, including 24 and 13 evaluable patients, respectively, have both demonstrated 100% response rates. A complete remission (CR) rate of 60% has been described in one trial, and the median time to progression in this trial was 16 months. The median survival has not been reached but is more than 30 months. In conclusion, gemcitabine, paclitaxel, and carboplatin is a very active combination in previously untreated patients with advanced ovarian cancer. Ongoing and future randomized trials will show whether or not this finding translates into improved survival.
