The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial.

Malignant ascites is a common manifestation of advanced cancers, and treatment options are limited. The trifunctional antibody catumaxomab (anti-epithelial cell-adhesion molecule x anti-CD3) represents a targeted immunotherapy for the intraperitoneal (i.p.) treatment of malignant ascites secondary to epithelial cancers. In this phase II/III trial (EudraCT 2004-000723-15; NCT00836654), cancer patients (n = 258) with recurrent symptomatic malignant ascites resistant to conventional chemotherapy were randomized to paracentesis plus catumaxomab (catumaxomab) or paracentesis alone (control) and stratified by cancer type (129 ovarian and 129 nonovarian). Catumaxomab was administered as an i.p. infusion on Days 0, 3, 7 and 10 at doses of 10, 20, 50 and 150 mug, respectively. The primary efficacy endpoint was puncture-free survival. Secondary efficacy parameters included time to next paracentesis, ascites signs and symptoms and overall survival (OS). Puncture-free survival was significantly longer in the catumaxomab group (median 46 days) than the control group (median 11 days) (hazard ratio = 0.254: p < 0.0001) as was median time to next paracentesis (77 versus 13 days; p < 0.0001). In addition, catumaxomab patients had fewer signs and symptoms of ascites than control patients. OS showed a positive trend for the catumaxomab group and, in a prospectively planned analysis, was significantly prolonged in patients with gastric cancer (n = 66; 71 versus 44 days; p = 0.0313). Although adverse events associated with catumaxomab were frequent, they were manageable, generally reversible and mainly related to its immunologic mode of action. Catumaxomab showed a clear clinical benefit in patients with malignant ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile.

[Treatment results of Hodgkin's lymphoma]. / Hodzkino limfomos gydymo rezultatai.

During last decades, there are strengthening attitudes to optimize the treatment of Hodgkin's lymphoma considering prognostic groups and risk factors. Based on the data of Vilnius University Clinics, a retrospective study was carried out, and treatment methods and outcomes of the patients treated during 1999-2004 were analyzed. Medical histories of 114 patients younger than 60 years were reviewed. Median age was 28 years. In 83% of cases, classic nodular sclerotic Hodgkin's lymphoma was diagnosed. Advanced-, intermediate-, and early-stage disease was diagnosed in 55%, 38%, and 7% of cases, respectively. The patients with early-stage disease underwent four ABVD chemotherapy courses; 88% of them underwent radiotherapy afterwards. The patients with intermediate-stage disease underwent 4-6 courses of ABVD or in minor cases (12% of patients with intermediate-stage disease) - 4 standard BEACOPP chemotherapy courses. After this treatment, 88% of patients with intermediate-stage disease underwent radiotherapy. Patients with advanced-stage disease underwent 8 escalate (44%) or standard BEACOPP (29%) chemotherapy courses. More than half of these patients (71%) underwent radiotherapy after chemotherapy. Patient follow-up median was 65 months. One hundred seven patients (94%) after primary treatment achieved complete remission, in 7 patients (6%) primary progression was observed, 12 patients (11%) relapsed, and 8 patients died. Overall survival and event-free survival in patients with early-stage disease was 100%. Overall survival in patients with early/intermediate- and advanced-stage disease was 95.1% and 84.0%, respectively. Event-free survival in patients with early/intermediate- and advanced-stage disease was 91.7% and 76.2%, respectively. In the groups of intermediate- and advanced-stage disease, the results of treatment were worse in the subgroup, which underwent extended-field radiotherapy (P<0.05). Overall survival in the group of patients with advanced-stage disease was the best who underwent ABVD scheme, but the event-free survival (70.6%) and disease-free survival (81.3%) in ABVD subgroup were worse compared to BEACOPP subgroup. According to our results, there was no statistically significant difference in survival of patients with advanced-stage disease who underwent or did not radiotherapy (P>0.05).

Time trends of incidence, mortality, and relative survival of invasive skin melanoma in Lithuania.

The aim of this study was to provide insights into the descriptive epidemiology of invasive skin melanoma in Lithuania by analyzing population-based incidence (1978-2002) and mortality (1990-2002) time trends, and relative survival based on 3485 skin melanoma. We calculated age-standardized incidence and mortality rates (cases per 100,000) using the European Standard Population and calculated period estimates of relative survival. The incidence rates increased from 1978 (men: 1.7, women: 2.3) to 2002 (men: 5.0, women: 7.0). The incidence increase over time is accompanied by cohort effects among both men and women. Mortality rates increased from 1990 (men: 1.2, women: 1.7) to 2002 (men: 2.3, women: 2.2). Relative 5-year survival rates among men were 10% lower than among women. The overall difference in survival was mainly due to a more favourable survival among women aged 60-74 years. Overall prognosis was less favourable among men, most likely due to diagnoses at later stages.

[Technology for tablets with herbal extracts and evaluation of its quality]. / Tableciu su augaliniais ekstraktais technologijos kurimas ir kokybes ivertinimas.

The article deals with the development of technology for production of tablets containing dry herbal extracts. Dry herbal extracts of two different compositions were produced by spray drying using BUCHI 190 apparatus. The quality of dry extracts was evaluated by determination the loss of extract mass during the drying process, and estimation of the amount of biologically active combinations. The tableting methods for dry herbal extracts--direct compression and also employing granulation--were used. The quality of the produced tablets was determined by examining their appearance, resistance to abrasion, crushing strength, mass uniformity, disintegration time. Contents of biologically active compounds in tablets were evaluated by the quantitative methods.

[Cervical cancer: recent trends of incidence and mortality in Lithuania]. / Gimdos kaklelio vezys. Sergamumo bei mirtingumo pokyciai Lietuvoje.

Time trends of the cervical cancer in Lithuanian population were analysed. Changes in age standardised cancer incidence rates (World standard) in Lithuania were analysed between 1978 and 1999. Incidence rates were calculated by periods--1978-1982, 1983-1987, 1988-1992, 1993-1997 and 1998-1999. Incidence was analysed among 15-34, 35-49, 50-64, 65-74 and 75+ age groups. From 1978-1982 cervical cancer incidence decreased from 15.4 to 12.9 per 100,000 in 1993-1997. Increase was observed from 1993-1997 up to 17.4 per 100,000 in 1998-1999. In 1998-1999 only 49.2 of all cervical cancer cases were diagnosed at stages I and II. During 1978-1992 cervical cancer mortality rates were not decreasing despite the reduction of incidence (6.8, 7.0 and 6.8 cases per 100,000 in 1978-1982, 1983-1987 and 1988-1992 respectively). Starting from 1993 the increasing number of new incidence cases is being registered, but mortality rates are not subjected to changes (7.6 and 7.7 cases per 100,000 in 1993-1997 and 1998-1999 metais respectively). The higher increasing rates in incidence and mortality were observed among women below 50 years. The causes of increase of cervical cancer incidence are demanding detailed studies. The incidence and mortality of cervical cancer can be reduced by the implementation of national-wide screening program for cervical cancer.