Postoperative Tamoxifen for ductal carcinoma in situ: Cochrane systematic review and meta-analysis.

This review aimed to assess the effects of postoperative Tamoxifen following surgical resection of ductal carcinoma in situ (DCIS). Data on local DCIS recurrence, new invasive carcinoma, distant disease, mortality and adverse effects were extracted from randomised controlled trials (RCTs) comparing Tamoxifen after surgery for DCIS (regardless of oestrogen receptor (ER) status), with or without adjuvant radiotherapy. Meta-analysis was performed using the fixed-effect model and the results expressed as relative risks (RRs) or hazard ratios (HRs) with 95% confidence intervals (CIs). Two RCTs which recruited 3375 women were included. Tamoxifen after surgery for DCIS reduced recurrence of ipsilateral DCIS (HR 0.75; 95% CI 0.61-0.92) and contralateral DCIS (RR 0.50; 95% CI 0.28-0.87). Contralateral invasive cancer was reduced (RR 0.57; 95% CI 0.39-0.83), and there was a trend towards decreased ipsilateral invasive cancer (HR 0.79; 95% CI 0.62-1.01). The number needed to treat in order for Tamoxifen to have a protective effect against all breast events is 15. There was no evidence of a difference in all-cause mortality (RR 1.11; 95% CI 0.89-1.39). Only one trial involving 1799 participants followed-up for 163 months (median) reported on adverse events with no significant difference in event rate between Tamoxifen and placebo groups, but there was a non-significant trend towards more endometrial cancer in the Tamoxifen group. This review concludes that while Tamoxifen after local excision for DCIS, with or without adjuvant radiotherapy, reduced the risk of recurrent DCIS, it did not reduce the risk of all-cause mortality.

The Hall-Findlay mammaplasty pattern for skin-sparing mastectomy: case report.

We present an application of the Hall-Findlay mammaplasty skin pattern for skin-sparing mastectomy (SSM). This is a simplified vertical reduction mammaplasty. Vertical reduction mammaplasty is the procedure advised for patients with moderator or large ptotic breasts, who wish to have a simultaneous contra-lateral breast reduction/mastopexy at the time of SSM for cancer or prophylactic mastectomy. It is particularly suitable for breast reconstruction with autologous tissue in the form of free transverse rectus abdominis myocutaneous (TRAM), deep inferior epigastric artery perforator (DIEP) and extended latissimus dorsi (ELD) flaps.

Randomized, double-blind study of short-course (5 day) grepafloxacin versus 10 day clarithromycin in patients with acute bacterial exacerbations of chronic bronchitis.

The efficacy and safety of grepafloxacin were compared with clarithromycin in a randomized, double-blind, multicentre clinical trial of 805 patients with acute bacterial exacerbations of chronic bronchitis (ABECB). Patients were randomized to receive grepafloxacin 400 mg od for either 5 (n = 273) or 10 days (n = 268) or clarithromycin 250 mg bd for 10 days (n = 261). Patients were assessed pre-treatment, 3-5 days during treatment, 1-3 days post-treatment and at follow-up (21-28 days post-treatment). The clinical success rates for the evaluable patients were 91% in the 5 day grepafloxacin group, 95% in the 10 day grepafloxacin group and 86% in the clarithromycin group. At follow-up, respective rates were 72%, 81% and 73%. A total of 513 pathogens were isolated from the pre-treatment sputum specimens of 400 (49%) patients. The primary pathogens were Haemophilus influenzae (36% of isolates), Haemophilus parainfluenzae (27%), Moraxella catarrhalis (12%), Streptococcus pneumoniae (11%) and Staphylococcus aureus (3%). Pathogens were eradicated or presumed eradicated at post-treatment in 85%, 91% and 58% of evaluable patients treated with grepafloxacin for 5 days, grepafloxacin 10 days and clarithromycin 10 days, respectively. The eradication rates in both grepafloxacin groups were significantly greater than the clarithromycin group (P<0.001). All treatments were well tolerated and incidence of drug-related adverse events in each group was comparable. This study demonstrates that both a 5 and a 10 day regimen of grepafloxacin 400 mg od are as clinically and bacteriologically effective as in the treatment of ABECB clarithromycin 250 mg bd. for 10 days.

A multicenter study of grepafloxacin and clarithromycin in the treatment of patients with community-acquired pneumonia.

STUDY OBJECTIVES: To compare the efficacies of 10-day regimens of grepafloxacin (GFX) (Raxar or Vaxar; Glaxo Wellcome; Greenford, UK), 600 qd, and clarithromycin (CLA) (Klacid, Biaxin, or Klaracid; Abbott Laboratories; Chicago, IL), 500 mg bid, in patients with community-acquired pneumonia (CAP), on the basis of clinical response, including radiographic evidence, and bacteriologic efficacy. DESIGN: Phase IIIb, double-blind, double-dummy, randomized, prospective, parallel-group, comparative study conducted at 58 centers in 11 countries. PATIENTS AND SETTING: Adult patients with signs and symptoms of CAP that was confirmed by radiographic evidence and who did not require parenteral therapy were included in the study. ASSESSMENTS: Patients were assessed before treatment, during treatment, after treatment, and at follow-up (28 to 35 days after treatment completion). Clinical response was evaluated. Blood and sputum samples were cultured for bacterial pathogens, and serology testing was performed to detect atypical pneumonia. RESULTS: A total of 504 patients were enrolled into the trial: 251 were randomly assigned to receive GFX and 253 to receive CLA. In patients able to be clinically evaluated, clinical success rates at follow-up were 147 of 163 patients (90%) in the GFX group and 148 of 167 patients (89%) in the CLA group (95% confidence interval, -6% to 9%). Pretreatment pathogens were confirmed in 131 of 504 patients (26%), either by culture or serology testing, the primary pathogens being Streptococcus pneumoniae (22%), Haemophilus influenzae (17%), Mycoplasma pneumoniae (25%), and Chlamydia pneumoniae (11%). For patients able to be evaluated who had typical pathogens, bacteriologic success was achieved in 92% of the patients in each treatment group. For patients able to be evaluated who had atypical pathogens, 18 of 18 patients (100%) in the GFX and 23 of 26 patients (88%) in the CLA group had a successful clinical outcome. There were similar rates of adverse events in each group, resulting in

Short-course cefuroxime axetil therapy in the treatment of acute exacerbations of chronic bronchitis.

The efficacy and safety of a five-day course of cefuroxime axetil (250 mg b.d.) and a seven-day course of clarithromycin (250 mg b.d.) were compared in a large double-blind, randomised, multinational study involving 684 patients with acute exacerbations of chronic bronchitis. In an intent-to-treat analysis, the post-treatment clinical responses to each treatment were comparable (82%) and rates at follow-up were similar: 64% on cefuroxime axetil and 61% on clarithromycin. Pre-treatment pathogens were isolated from a total of 192 patients, Haemophilus influenzae being the most common. Overall pathogen eradication rates were similar for both treatments. Both treatments were well tolerated. In conclusion, a five-day course of cefuroxime axetil is clinically equivalent to a seven-day course of clarithromycin in the treatment of acute exacerbations of chronic bronchitis, and may have potential socioeconomic benefits.

Short course therapy with cefuroxime axetil for group A streptococcal tonsillopharyngitis in children.

BACKGROUND: Tonsillopharyngitis caused by group A beta-hemolytic streptococci (GABHS) is common in pediatric clinical practice. Standard penicillin therapy may be associated with poor compliance, penicillin tolerance in GABHS and microbial copathogenicity. Alternative treatments are available (e.g. oral cephalosporins), and data suggest that shorter courses of these agents may be effective. OBJECTIVE: This open, randomized, multicenter study compared a conventional 10-day course of the broad spectrum oral cephalosporin, cefuroxime axetil, with a shorter 5-day course. METHODS: Cefuroxime axetil suspension, 10 mg/kg, was given twice daily to children (ages 3 to 13 years) screened for GABHS tonsillopharyngitis. Patients were assessed clinically and bacteriologically 4 to 7 days after completing the course and followed up at 21 to 28 days. Among 651 patients recruited 520 had throat cultures positive for GABHS and were randomized to treatment. RESULTS: In the 406 patients with microbiologically confirmed GABHS infection, eradication of the initial pathogen was recorded in 177 of 201 (88%) and 189 of 205 (92%) of patients in the 5- and 10-day groups, respectively, at posttreatment. At follow-up, 137 of 162 (85%) of patients in the 5-day group and 145 of 167 (87%) in the 10-day group maintained bacteriologic eradication. All posttreatment isolates of GABHS were susceptible to cefuroxime, and reinfection with a different serotype of GABHS was rare (< or =2%) in both groups. The rates of recurrence of the pretreatment serotype were 10 and 7% in the 5- and 10-day groups, respectively. CONCLUSIONS: Short course therapy with cefuroxime axetil suspension may offer an effective alternative treatment to conventional regimens, with potential for better compliance and reduced costs.

Cefuroxime axetil versus clarithromycin in the treatment of acute maxillary sinusitis.

Acute maxillary sinusitis is a common condition requiring broad-spectrum therapy to prevent development of chronic disease. A randomised, double-blind, multicentre study was performed to compare the efficacy and safety of cefuroxime axetil 250 mg twice daily (n = 185) and clarithromycin 250 mg twice daily (n = 185), both administered for 10 days, in the treatment of patients with acute sinusitis. Efficacy was determined by assessment of clinical response at post-treatment and follow-up, and by radiological assessment at pre-treatment and follow-up. Assessment of days absent from work due to illness was also made. In the cefuroxime axetil group, 169/185 (91%) patients were cured/improved at post-treatment, as were 172/185 (93%) patients receiving clarithromycin and, of these, 137/169 (81%) and 143/172 (83%) maintained their response at follow-up. Follow-up radiography showed a reduction in incidence of air fluid level and/or opacification from 96% to 15% (cefuroxime axetil) and from 96% to 11% (clarithromycin), and a decrease in frequency of mucosal thickening from 58% to 28% (cefuroxime axetil) and from 56% to 29% (clarithromycin). Only 10% of patients in either group experienced adverse events and days absent from work were comparable. This study demonstrated clinical equivalence between twice-daily cefuroxime axetil and clarithromycin, both treatments being effective and well tolerated.

Sequential therapy with cefuroxime followed by cefuroxime axetil in community-acquired pneumonia.

STUDY OBJECTIVES: To compare the efficacy of two sequential therapy regimens of IV cefuroxime followed by oral cefuroxime axetil for the treatment of community-acquired pneumonia (CAP). DESIGN: Prospective, multicenter, randomized, open-label, parallel-group study. SETTING: Sixty-six centers in 11 countries (Belgium, Canada, Czech Republic, Germany, Hungary, Ireland, Israel, Poland, Portugal, South Africa, and the United Kingdom). PATIENTS: Six hundred thirty-six adults with CAP requiring hospitalization and initial IV antibiotic treatment. INTERVENTIONS: Cefuroxime, 1.5 g IV tid or bid for 48 to 72 h followed by oral cefuroxime axetil, 500 mg bid for 7 days. MEASUREMENTS AND RESULTS: For clinically evaluable patients, the clinical response rates were equivalent for cefuroxime tid and bid groups posttreatment (cure/improvement, 79% and 84%, respectively) and at follow-up (maintained cure, 87% and 82%, respectively). All signs and symptoms of pneumonia showed improvement at the time of switch from IV to oral therapy. A total of 111 pathogens were isolated, the most common being Streptococcus pneumoniae (23%), Haemophilus influenzae (18%), and Enterobacteriaceae (15%). Bacteriologic clearance was obtained posttreatment in 47 of 49 and 36 of 42 of bacteriologically evaluable patients in the cefuroxime tid and bid groups, respectively. Both regimens were well tolerated with a low incidence of drug-related adverse events, the most common being GI. CONCLUSIONS: Twice daily IV cefuroxime followed by oral cefuroxime axetil is a simple and effective sequential therapy regimen for the treatment of CAP. It offers potential cost savings and can replace the current tid regimen in this indication.

Sequential therapy with cefuroxime followed by cefuroxime axetil in acute exacerbations of chronic bronchitis.

A prospective, multicentre, randomized, open-label, parallel group study compared the efficacy, safety and tolerability of cefuroxime 750 mg iv administered either twice daily (bd) or three times daily (tds) for 48-72 h, followed by oral cefuroxime axetil 500 mg bd for 5-7 days in a sequential therapy regimen for the treatment of acute exacerbations of chronic bronchitis. A total of 628 adult patients entered the study; 323 in the cefuroxime tds group and 305 in the cefuroxime bd group. For clinically evaluable patients, the post-treatment clinical response rate was 86% and 88% in the cefuroxime tds and bd groups, respectively. Cure was maintained at follow-up (14-28 days after treatment completion) in 85% of the cefuroxime tds group and 84% of patients in the cefuroxime bd group. A total of 189 pathogens was isolated, the most common being Haemophilus influenzae (17%), other Haemophilus spp. (15%), Streptococcus pneumoniae (15%) and Enterobacteriaceae (23%). At the post-treatment assessment, 66% and 70% of pathogens were cleared in the cefuroxime tds and bd groups, respectively. Both treatment regimens were well tolerated. The incidence of drug-related adverse events was 7% in the cefuroxime tds group and 6% in the cefuroxime bd group; the most common side-effects were gastrointestinal. Qualitative and quantitative markers were used to determine the optimal time to switch from iv to oral therapy and, of these, peak expiratory flow rate was shown to be the most useful in the present study. In conclusion, the findings of this study support the use of a bd dosing schedule of cefuroxime in a sequential therapy regimen with oral cefuroxime axetil, demonstrating it to be clinically equivalent to the standard tds dosage currently used, as well as being simpler and more convenient to administer at a lower cost.

Is penicillin the appropriate treatment for recurrent tonsillopharyngitis? Results from a comparative randomized blind study of cefuroxime axetil and phenoxymethylpenicillin in children. The Swedish Study Group.

The efficacy of cefuroxime axetil compared with phenoxymethylpenicillin (PcV) was studied in group A beta-haemolytic streptococci (GAS) culture-proven tonsillitis in children aged 3-12 years with a history of at least 1 episode of tonsillopharyngitis requiring antibiotic therapy during the previous 3 months. This was a comparative, randomized, investigator-blind, multicentre study. A total of 236 children received either cefuroxime axetil suspension or PcV syrup. Inclusion criteria were a positive, rapid, group A strep test verified by bacteriological culture and clinical signs and symptoms of tonsillopharyngitis. Cefuroxime axetil treatment gave a significantly higher bacteriological eradication rate and clinical cure rate than PcV. At day 2-5 post treatment the eradication rates were 99/114 (87%) for cefuroxime axetil vs 61/109 (56%) for PcV (p < 0.001). The clinical cure rates were 98/114 (86%) and 73/109 (67%) respectively (p < 0.01). Up to 21-28 days post-treatment, 9/114 (8%) cefuroxime axetil patients and 37/109 (34%) PcV patients were treatment failures or had recurrence/reinfection of GAS tonsillopharyngitis (p < 0.001). More than 90% of the patients who experienced bacteriological treatment failure at either the first or second follow-up had the same serotype isolated pre- and post-treatment. During the study period, 21/114 (18%) patients in the cefuroxime axetil group and 50/109 (46%) patients in the PcV group received additional antibiotics (p < 0.001). No serious adverse events were noted and the mild adverse events were equally distributed among the patients in the 2 study groups: 15% for cefuroxime axetil and 14% for PcV.