Based on in vitro studies that have demonstrated synergy between 5-fluorouracil (5-FU), leucovorin (LV), and cisplatin (CDDP) against human colon cancer cell lines, a clinical trial was initiated to determine the effects of this combination in patients with advanced unresectable colorectal carcinoma. Fifty-nine patients were enrolled in the study and 12 of them had received prior conventional 5-FU chemotherapy. Treatment consisted of 4 weekly courses of high-dose LV (200 mg/m2) administered by intravenous (IV) bolus, followed by 5-FU (550 mg/m2) and CDDP (20 mg/m2) each administered as a 2-hour infusion on 4 consecutive days. After a median of 5.5 treatment cycles, objective tumor response was seen in 20 of 59 patients (34%) (this included 3 complete remissions). The response rate in the 47 previously untreated patients was 38% (95% confidence limits, 26% to 53%). Stable disease occurred in 16 (27%) patients, whereas the tumor progressed in 23 (39%) patients. The median survival time was 11.5 months, with 15% of the patients alive at 2 years. The regimen was well tolerated and the primary side effects were mild and reversible gastrointestinal symptoms and myelosuppression. There was no episode of life-threatening toxicity. Eastern Cooperative Oncology Group (ECOG) Grade III adverse reactions that required 25% dose reductions occurred in only 14% of the patients. The results of this trial suggest that 5-FU, LV, and CDDP is an active, safe, and well-tolerated combination regimen in patients with advanced colorectal cancer.
In this randomised prospective study we investigated whether treatment results of maximal androgen blockade (MAB) in patients with metastatic prostatic cancer can be further improved by additional Methotrexate therapy (MTX). A total number of 61 patients (stage T1 or '1"2) have been included and 31 were randomised to arm A receiving MAB, i.e. orchiectemy + flutamide (3x250 rag/d). In group B 30 patients were treated with MAB + 50 mg{m 2 MTX (once weekly for 4 months). 53 patients are evahiable for response criteria.
Seventeen years after detection of Helicobacter pylori as the pathogenetic factor in a variety of gastroduodenal diseases, current treatment options are about 90% effective in eradicating the bacteria and thereby curing the affiliated disorders. In 1987 successful therapy has been shown to reduce relapse rates of duodenal and gastric ulcers dramatically and clinicians all over the world started to perform a still ongoing vast number of trials searching for the most effective first--and in case of failure, second line-treatment options. The results of these trials led to strictly evidence based and generally accepted guidelines formulated by Consensus Reports. The main questions "who to treat" and "how to treat" can be answered by using the categories "strongly recommended indications", "advisable indications" that leave some space for individual decisions, and consideration of first and second time eradication therapies together as a package. Treatment has become simple: three drugs, twice daily for one week. All available protone pump inhibitors (PPI) have been shown to be effective and presently there is only a few antibiotic agents used in combination and defined dose, proven to ensure treatment success. The future will encounter clinicians with problems concerning patient compliance, antibiotic resistance and more effective second and even third line therapies. This paper will focus on two subjects: indications ("who to treat") and evidence-based eradication regimens ("how to treat") in a reasonable setting close to everyday clinical practice.
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