A total of 44 patients with previously untreated Stage IV squamous cell carcinomas of the head and neck were treated with a combination of cis-platinum (100 mg/sq m) and 96-hour infusion of 5-fluorouracil (5-FU) (1,000 mg/sq m/day) in two courses or with cis-platinum (100 mg/sq m) and 120-hour infusion of 5-FU (1,000 mg/sq m/day) in three courses. In the 26 patients receiving the two course regimen, the tumor response rate was 88.5%. In five of the 26 patients complete disappearance of the tumor was achieved; partial remission was obtained in 18 of 26 patients. The main side effects were nausea and vomiting (70%), leukopenia (27%), and mild-to-moderate renal toxicity (27%). In the 18 patients who received the three course regimen of 5-FU and cis-platinum, there were 11 (61%) complete responses, 6 (33%) partial responses, and 1 (6%) minimal response. The incidence of complete response was increased with each course given. No added toxicity was observed with surgery or radiotherapy.

Adult↗

PubMedDate not supplied

Proto-chemotherapy in advanced head and neck cancer.

Induction (proto) chemotherapy consisting of 3 courses of cisplatin and 120-hour 5-fluorouracil infusion was administered to 88 patients who had locally advanced, previously untreated head and neck cancer. The majority (81%) of these patients were classified as stage IV, and 17% had second primary carcinomas of the upper aerodigestive tract. An overall response rate of 94% was observed, with a 54% incidence of complete clinical response. The toxicity of the chemotherapy was judged acceptable, and no life-threatening or fatal drug-related side effects occurred. Twenty-four percent of the patients failed to comply with recommended standard treatment. In patients achieving a complete clinical response, 47% refused recommended surgery. Any response less than a complete clinical response to induction chemotherapy was not associated with any survival advantage. We conclude that future research efforts should be directed toward the identification of chemotherapeutic regimins that maximize the incidence of complete clinical response. In addition, any large-scale chemotherapy trial in patients with resectable disease should avoid the use of an induction sequence to minimize compliance problems with standard treatment.

Antineoplastic Combined Chemotherapy Protocols↗

PubMedDate not supplied

Comparison of the efficacy and safety of oxaprozin and nabumetone in the treatment of patients with osteoarthritis of the knee.

This multicenter, 6-week, double-blind, placebo-controlled, parallel-group study compared the efficacy and safety of oxaprozin 1200 mg once daily with that of nabumetone 1000 mg once daily in patients with moderate-to-severe osteoarthritis (OA) of the knee. To be eligible, patients had to experience a flare of OA within 2 weeks of discontinuing their usual OA medication (nonsteroidal anti-inflammatory drug or analgesic). Eligible patients were assessed at baseline and then randomized to receive oxaprozin (n = 109), nabumetone (n = 110), or placebo (n = 109). Efficacy assessments were performed at weeks 1, 2, 4, and 6. Primary efficacy variables included knee pain on weight bearing, knee pain on motion, and patient's and physician's global assessments of OA. Secondary efficacy variables included pain intensity, time to walk 50 feet, and duration of morning stiffness. Safety was evaluated by use of routine laboratory analyses; physical examination at screening, baseline, and week 6 (or study termination); assessment of symptoms at baseline and at each visit; and testing stools for occult blood at screening and between week 4 and the final visit. Adverse events were monitored throughout the study. Between-group differences in efficacy variables were evident by week 1. The mean change in improvement from baseline with oxaprozin compared with placebo was statistically significant in favor of oxaprozin at weeks 1, 2, 4, and 6 for all primary efficacy variables. The mean change in improvement from baseline with nabumetone compared with placebo, however, was statistically significant only at week 1 for knee pain on motion, patient's global assessment, and physician's global assessment. The mean change in improvement from baseline was statistically significant (P < or = 0.035) in favor of oxaprozin versus nabumetone at weeks 2 and 6 for all four primary efficacy variables and also at week 4 for knee pain on motion. The incidence of adverse clinical events between treatment groups was not statistically significant. However, nine oxaprozin-treated patients had asymptomatic liver enzyme elevations reported as adverse events. Four of these patients had reversible elevations of aspartate aminotransferase and alanine aminotransferase greater than three times the upper limit of normal range (P < 0.05); two of these patients were taking other medications known to induce liver enzyme abnormalities. The study showed that oxaprozin 1200 mg once daily was statistically significantly more efficacious than nabumetone 1000 mg once daily for the treatment of patients with moderate-to-severe OA of the knee. Both drugs were clinically well tolerated.

Aged↗

PubMedDate not supplied

The efficacy, tolerability, and safety of 1200 mg/d of oxaprozin and 1500 mg/d of nabumetone in the treatment of patients with osteoarthritis of the knee.

This 6-week, multicenter, double-masked, placebo-controlled study compared the efficacy, tolerability, and safety of the recommended starting dose of oxaprozin (1200 mg/d) and a 1500-mg/d dose of nabumetone in the treatment of patients with moderate-to-severe osteoarthritis (OA) of the knee. A total of 347 patients with a mean age of 61.1 years were randomized to receive oxaprozin (116 patients), nabumetone (115 patients), or placebo (116 patients). Adults of either sex who were older than 18 years of age were eligible for entry into the study, if they had had OA of the knee for at least 6 months. Efficacy variables included knee pain on weight bearing, knee pain on motion, patients' and physicians' global assessments of OA, pain intensity as measured on a visual analog scale, and time to walk 50 feet as quickly as possible. Efficacy variables were assessed at baseline and at weeks 1, 2, 4, and 6. Between-group differences in efficacy variables were evident by week 1. Mean improvements were significantly greater with oxaprozin than with placebo for all efficacy variables at all time periods, except knee pain on motion at weeks 2 and 4 and time to walk 50 feet at weeks 1, 2, and 4. Mean improvements were significantly greater with nabumetone than with placebo for all efficacy variables at all time periods, except the following: knee pain on weight bearing at weeks 2, 4 and 6; knee pain on motion at weeks 2 and 4; patients' global assessment at week 4; and pain intensity as measured on a visual analog scale at weeks 2 and 4. There were, however, no significant differences between oxaprozin and nabumetone in any of these efficacy variables. Adverse events were reported by 83 (71.6%) patients who took oxaprozin, by 80 (69.6%) patients who took nabumetone, and by 57 (49.1%) patients who took placebo. Adverse events were reported for significantly more patients taking oxaprozin or nabumetone than placebo. However, adverse events tended to be mild or moderate and rarely resulted in patients withdrawing from the study. Combined with the results of an earlier study, the results of this study showed that a 1500-mg/d dose of nabumetone, which is higher than the recommended starting dose of 1000 mg/d, is required for efficacy equivalent to that of the recommended starting dose of oxaprozin, 1200 mg/d, in relieving the symptoms of OA. Thus nabumetone may require dosage titration from the recommended starting dose. Oxaprozin and nabumetone were found to have similar tolerability profiles, as shown by adverse-event monitoring and withdrawal rates, as well as clinically similar safety profiles, as demonstrated by physical examinations, hematologic and biochemical laboratory testing, hemoccult testing, and adverse-event monitoring and symptom assessment.

Adult↗

PubMedDate not supplied

Laparoscopic splenectomy: reduction of hospital charges.

Laparoscopic splenectomy has become our procedure of choice for the surgical management of immune thrombocytopenic purpura. Hospital charges for this procedure were analyzed for 24 consecutive patients undergoing laparoscopic splenectomy. Total charges have decreased over time and average a $233 decrease per patient treated. The decreased charges are related to decreased operating room charges. Furthermore, charges are shown to be related to the length of postoperative stay. Choice of instrumentation has kept intraoperative charges for disposables stable.

Arizona↗