Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer.

PURPOSE: To compare the efficacy of pegylated liposomal doxorubicin (PLD) with that of a common salvage regimen (comparator) in patients with taxane-refractory advanced breast cancer. PATIENTS AND METHODS: Following failure of a first- or second-line taxane-containing regimen for metastatic disease, 301 women were randomly assigned to receive PLD (50 mg/m(2) every 28 days); or comparator-vinorelbine (30 mg/m(2) weekly) or mitomycin C (10 mg/m(2) day 1 and every 28 days) plus vinblastine (5 mg/m(2) day 1, day 14, day 28, and day 42) every 6 to 8 weeks. Patients were stratified before random assignment based on number of previous chemotherapy regimens for metastatic disease and presence of bone metastases only. RESULTS: Progression-free survival (PFS) and overall survival (OS) were similar for PLD and comparator (PFS: hazard ratio [HR], 1.26; 95% CI, 0.98 to 1.62; P =.11; median, 2.9 months [PLD] and 2.5 months [comparator]; OS: HR, 1.05; 95% CI, 0.82 to 1.33; P =.71; median, 11.0 months [PLD] and 9.0 months [comparator]). In anthracycline-na?ve patients, PFS was somewhat longer with PLD, relative to the comparator (n = 44; median PFS, 5.8 v 2.1 months; HR, 2.40; 95% CI, 1.16 to 4.95; P =.01). Most frequently reported adverse events were nausea (23% to 31%), vomiting (17% to 20%), and fatigue (9% to 20%) and were similar among treatment groups. PLD-treated patients experienced more palmar-plantar erythrodysesthesia (37%; 18% grade 3, 1 patient grade 4) and stomatitis (22%; 5% grades 3/4). Neuropathy (11%), constipation (16%), and neutropenia (14%) were more common with vinorelbine. Alopecia was low in both the PLD and vinorelbine groups (3% and 5%). CONCLUSION: PLD has efficacy comparable to that of common salvage regimens in patients with taxane-refractory metastatic breast cancer, thereby representing a useful therapeutic option.     

Risk factors and psychosocial consequences in depression of octo- and nonagenerians: results of an epidemiological study

In a two-wave community study in Munich, Germany, a representative sample of 402 people older than 85 years was restudied 1 year later. In the first cross section a total of 358 (89.1%) subjects were interviewed. One year later 263 (73.5%) subjects were reexamined. Several diagnostic systems were used. The probands showed a high prevalence of depression — nearly one quarter of the interviewees. In this extreme age group gender differences in depression were minimal. Depressives were distinctly impaired in daily life. Depressive probands were more often found in institutions than in private households. Depressives were high users of the medical care system, but very rarely treated by specialists. Need for care and certain specific especially threatening life events were identified as risk factors for depression.     

A binocular indirect ophthalmomicroscope (BIOM) for non-contact wide-angle vitreous surgery

The binocular indirect ophthalmomicroscope (BIOM) incorporates the principles of indirect ophthalmoscopy in the operating microscope. When used with an image inverting system, it enables noncontact 70°–90° wide-angle observation of the fundus during vitreous microsurgery.     

Suicidality, bipolar disorders, and pharmacotherapy.

Although the existence of mood disorders was identified centuries ago, the present state of knowledge is unsatisfactory. This special issue of Archives of Suicide Research (ASR), the official journal of the International Academy for Suicide Research, presents the state of the science and collects new empirical data. Different aspects of suicidality in bipolar and bipolar spectrum disorders are outlined and the prophylactic aspects of pharmacotherapy are noted, especially the anti-suicide effect of lithium. A call for further study is, however, necessary.     

Epinephrine‐supplemented local anesthetics for ear and nose surgery: Clinical use without complications in more than 10,000 surgical procedures

Introduction: Local anesthetics supplemented with epinephrine are generally regarded as contraindicated for surgical procedures involving the fingers, toes, penis, outer ear and the tip of the nose [ 1 ], but epinephrine is essential if automated tumescence local anesthesia (Auto‐TLA) is used. Materials and methods: Infiltration anesthesia supplemented with 1 : 200,000 epinephrine was used from 1985 – 1997 in our department, while Auto‐TLA supplemented with 1 : 1.000,000 epinephrine was introduced in 1997 for all surgical procedures involving the ear or nose. During this period, 10,201 patients underwent surgery at these locations. In addition, dermal blood flow was analyzed by acral photoplethysmography (APPG) and laser Doppler flowmetry (LDF) in the right ear lobe of five normal volunteers and during epinephrine supplemented Auto‐TLA. Results: Epinephrine‐induced complications were not observed in a single patient. Cosmetic skin flap surgery was performed in 4,953 of these patients. Even in patients with extended surgical procedures that took up to one to two hours and that included extensive skin flaps or skin grafts, we observed no increase in complications when compared to procedures performed either under general anesthesia or local anesthesia without epinephrine supplementation. Measuring blood perfusion of the earlobe showed a 69 % reduction of LDF and a 42 % reduction of arterial inflow (APPG) immediately following anesthesia. Conclusion: Epinephrine supplementation of local anesthetics does not block blood perfusion in the ear and did not induce organ, tissue or flap necrosis. Local anesthesia with epinephrine supplementation is therefore safe for acral areas such as the ear or nose. Despite the relatively small influence on blood perfusion, epinephrine supplementation results in a relatively bloodless operating field and longer effectiveness of local anesthesia. The relative absence of blood in the operating field of the ear and nose significantly reduces the duration of surgery and increases the healing rate, as less electrocautery is needed.