EVITA-a double-blind, vehicle-controlled, randomized phase II trial of vitamin K1 cream as prophylaxis for cetuximab-induced skin toxicity.

Background: Acne-like skin rash is a frequently occurring adverse event associated with drugs against the epidermal growth factor receptor. This randomized vehicle-controlled study investigated the addition of vitamin K1 cream to doxycycline in patients with metastatic colorectal cancer treated with cetuximab. Patients and methods: Patients receiving first-line cetuximab + FOLFIRI were randomly assigned to prophylactic treatment with doxycylin and vitamin K1 cream or doxycycline and the vehicle. The primary end point of the study was the incidence of grade ≥ 2 skin rash (NCI CTCAE version 4.02) during 8 weeks of skin treatment. Secondary end points comprised skin rash according to a more thorough tripartite skin toxicity score (WoMo), quality of life, efficacy, and compliance. The study had 80% power to show a 20% reduction of the incidence of grade ≥ 2 skin rash. Results: A total of 126 patients were analyzed. The incidence of skin rash grade ≥ 2 was comparable between the arms. Likewise, no difference was seen in the WoMo score with respect to the percentage of skin affected. However, starting in week 5 and increasing over time patients treated with vitamin K1 cream had less severe rash and fewer fissures. Quality of life as well as efficacy and compliance with study medication and anticancer treatment was comparable in both arms. Conclusion: The primary end point of decreasing grade ≥ 2 skin rash was not met. However, using vitamin K1 cream as part of prophylactic treatment decreased the severity of acne-like skin rash according to WoMo, an alternative and more thorough skin toxicity scoring tool.

Excellent long-term survival of 170 patients with Waldenström's macroglobulinemia treated in private oncology practices and a university hospital.

The purpose of this study was to compare treatment and outcome of patients with Waldenström's macroglobulinemia (WM) in four private oncology practices (PP) and a university hospital (UH) in southwest Germany. We retrospectively reviewed the charts of all patients with WM of the last two decades of four PP in Mannheim, Heidelberg, Karlsruhe, and Speyer and the Department of Hematology of the University of Heidelberg. One hundred seventy patients could be identified, 74 from PP, 96 from the UH. Median age was 63.3 years. Patients from PP were older (median 65.3 vs. 62.5 years, p = 0.01). Only 54 % of patients from PP have received treatment during the observation time, as compared to 78.1 % of the UH (p < 0.001). In PP, 35 % of treated patients have received rituximab, as compared to 62.6 % of the patients of the UH (p < 0.001). Sixty percent of treated patients of PP have received bendamustine, as compared to only 8 % of the patients of the UH (p < 0.001). Time to first treatment was significantly shorter in patients from the UH compared to PP (median 13.7 vs. 52.9 months, p = 0.05). A trend towards a better overall survival was observed for patients treated with a rituximab-containing first-line regimen. The International Prognostic Scoring System for WM had significant prognostic value. Median overall survival was 25.0 years and did not differ between PP and UH. Despite different treatment strategies between PP and UH today overall survival of patients with WM is excellent, and better than previously reported.

[Workflow improvement and efficiency gain with near total digitalization of a radiology department]. / Workflowverbesserung und Effizienzsteigerungsaspekte durch nahezu vollständige Digitalisierung einer Röntgenabteilung.

PURPOSE: To determine the temporal changes of the workflow caused by digitalization of the radiology department after installation of digital luminescence-radiography (DLR), a radiology information system (RIS) and picture archiving and communication system (PACS) at the Missionsärztliche Klinik in April 2000. MATERIALS AND METHODS: In a comparative study, a workflow analysis by manual registration of different work steps was performed before (1999) and after (2001) digitalization of a radiology department. RESULTS: The digitalization shortened the examination time for patients from a mean of 8 min to 5 min. The time the patient is absent from the emergency room did not change. Reporting radiographic examinations including comparison with previous studies begins earlier from a mean of 2 h 37 min to 17 min. Using PACS, 85.9 % of all cases could be interpreted on the day of the examination (without PACS 41.2 %) and 87.2 % of the reports were completed the day after the examination (without PACS 64.5 %). No time differences were found between reading conventional studies on the monitor or as soft-copy. CONCLUSION: Compared to conventional film-screen systems, complete digitalization of a radiology department is time saving at nearly all steps of the workflow, with expected positive effects on the workflow quality of the entire hospital.

[Complications following colostomy closure --resection or extraperitoneal closure?]. / Komplikationen nach Colostomieverschluss--Resektion oder extraperitonealer Verschluss?

At the Surgical Clinic of the University Erlangen-Nürnberg 213 colostomies in the period between 1961 and 1971 have been closed. In 88 patients an extraperitoneal procedure and in 125 patients a resection was performed. We recommend resection, because complications (first of all leakage) have been observed less often than in the extraperitoneal method.

[Colostomy continence achieved with an implanted circular magnet (author's transl)]. / Kontinente Kolostomie durch Magnetverschluss

A new method of providing a colostomy continent for faeces and gas is described. It consists of the subcutaneous implantation of a magnetic ring which is led outside through the lumen of the colon and sutured to the skin. The colostomy is closed with a magnetic cover. The procedure has been used in 17 patients with a permanent colostomy after rectal excision and has been highly successful.

[Abdominal surgery in the elderly--a retrospective analysis over 11 years]. / Abdominalchirurgie im Alter--eine retrospektive Analyse über 11 Jahre.

Particular problems of abdominal surgery in geriatric patients were analyzed in a retrospective study of 1569 surgical procedures of the abdomen carried out in 1420 patients aged 70 years or more. Emergency procedures were necessary in 357 (22.8%) cases with a lethality of 25.5% compared to 8.8% in the elective group. Morbidity was also visibly different in both groups (59.3% vs. 40.2%). While the average time of hospitalisation was 22.4 days, almost 80% of our patients could be released and 12.6% died in hospital.

[Continence of anus praeter -- a problem solved? Erlangen magnetic stoma seal (author's transl)]. / Der kontinente Kunstafter -- ein gelöstes Problem? Der Erlanger Magnetverschluss.

Primary or secondary implantation of the Erlangen magnetic stoma seal in case of colostomy or ileostomy is technically simple, although it requires a critical selection of patients and careful surgical technique. The best follow-up of the operated cases should be in the special protological clinics in the hands of stoma therapists. About 15% of the cases meet local complications and therefore the magnet-ring is explanted. An ideal continence is not always achieved. We hope that these patients can be better helped with magnetic stoma seal through further development.

Acute abdominal rhabdomyolysis after body building exercise: is there a "rectus abdominus syndrome?".

Report of a 19-year-old man who was admitted to the hospital after vigorous exercise with signs of the "acute abdomen" syndrome. Since intestinal reasons for the complaints were excluded, a myocardial infarction was considered. However, the excessively increased serum CK levels indicated a disorder of the voluntary muscles. A biopsy taken from the rectus abdominis revealed typical features of acute rhabdomyolysis, which was obviously restricted to the rectus abdominis. Together with a somewhat later observed autopsy case of a young male with acute abdominal rhabdomyolysis, also restricted to the rectus abdominis, this case gives rise to discuss, whether there exists a "rectus abdominis syndrome" analogous to the anterior tibial syndrome.

[Injuries to the rectum in diagnostic and therapeutic measures (author's transl)]. / Verletzungen des Enddarmes bei diagnostischen und therapeutischen Massnahmen

From 1955 to 1973, 28 anus praeter or rectal perforations were observed in the Chirurgische Universitätsklinik Erlangen. Ten of these patients died. The perforation of the intestine was already noted at the time of injury in 14, in 14 it deteriorated until a peritonitis at the end of three days on the average required laparotomy. The perforations arose mainly through rectoscopy or enemas. Such everday measures need care, in particular to stop the manipulation when the patient complains of pain. If there is the slightest suspicion, visualize the point of injury with a water soluble contrast medium.

[Continent colostomy through magnetic closure in animal experiments on dogs]. / Kontinente Kolostomie durch Magnetverschluss - eine experimentelle Studie an Hunden

In dog experiments a continent colostomy be means of magnetic occlusion has been developed. Around a terminal anus praeter a silicon-coated ringmagnet was placed between muscular fascia and subcutaneous fascia. The colon was pulled through the lumen of the ring and sutured to the skin. There has been a primary wound healing. There was no leakage of gas and faeces beneath the magnetic cap, thus providing an excellent closure of the colostomy. After removal of the cap spontaneous defecation took place.

Combined isodose curves of high-dose rate interstitial brachytherapy with external-beam radiation therapy in pancreatic carcinoma.

From September 1989 until March 1992 nine patients with unresectable, though localized carcinoma of the pancreas were treated by a multimodality therapy consisting of palliative surgery, interstitial conformal brachytherapy in high-dose rate mode (HDRBT) with iridium-192 up to 30 Gy and external-beam radiation therapy (EBRT) of about 52 Gy. Four patients simultaneously received two cycles of chemotherapy consisting of 5-FU and Leucovorin. Since high radiation doses are applied which are not tolerated in adjacent healthy tissues, doses to tumor and critical areas need to be known precisely and are to be adjusted before treatment. A three-dimensional imaging system is required. A self developed method combines the data of simulation radiographs and those of CT scans. The prescribed minimum target absorbed dose in HDRBT is adjusted to the target volume sparing organs at risk. The specialized quality assurance is adapted to this method. Differences between measured and calculated doses do not exceed 5%. The addition of isodoses of HDRBT and EBRT on CT scans is demonstrated. Due to patients' selection the treatment concept did not reveal any positive effects on survival. However, excellent palliative results were obtained without severe side-effects.

Paramagnetic changes in pulmonary tumors.

Electron spin resonance studies on healthy and tumorous human lung samples have been conducted in order to determine possible differences in free radical concentration and shaped of the spectra between the different sections of the lung. It could be shown that in healthy lung tissue the signal caused by the semidehydroascorbate (SDA) radical is not prominent because of the prevailing high partial oxygen pressure. On formation of a tumor, the spin concentration increases, possibly due to the higher metabolic rate; here, the SDA peak is also more pronounced which indicates alterations in the interaction between cell constituents and ascorbic acid. Within the tumor, the spin concentration is considerably reduced which is probably caused by a still higher concentration of ascorbic acid. Addition of ascorbic acid to the different lung specimens enhanced the just described effect while oxidizing substances, such as H2O2, reversed it.

[3D-Ct-planned interstitial HDR brachytherapy + percutaneous irradiation and chemotherapy in inoperable pancreatic carcinoma. Methods and clinical outcome]. / 3D-CT-geplante interstitielle HDR-Brachytherapie + perkutane Bestrahlung und Chemotherapie bei inoperablen Pankreaskarzinomen. Methodik und klinische Ergebnisse.

PURPOSE: Clinical experiences in interstitial 192-iridium HDR brachytherapy for the treatment of unresectable pancreatic carcinoma are presented. Brachytherapy has been used as boost irradiation in a multimodality treatment concept together with external radiotherapy and simultaneous chemotherapy. Practicability during clinical routine, tolerability and toxicity of treatment are investigated. PATIENTS AND METHODS: Nineteen patients (9 female, 10 male, median age 67 years) with unresectable carcinoma of the pancreas have been treated with interstitial brachytherapy. Distribution according to UICC stages showed 4, 10 and 5 patients in stage II to IV respectively. In all cases afterloading technique with 192-iridium in HDR-modus was used. A total dose of 10 to 34 Gy to the reference isodose was delivered (single dose 1.88 to 5 Gy, median 2.5 Gy). Brachytherapy was followed by external radiotherapy, delivering an additional dose of 40 to 58 Gy. Nine patients received simultaneous chemotherapy (5-fluorouracil, leucovorin). Treatment planning was performed based on CT scans, allowing spatial correlation of isodose curves to the patient's anatomy. RESULTS: Median survival time was 6 months. A trend of lower survival rates with advanced stage of disease (median survival stage IV 4 months, stage II and III 6.5 months) was seen. Local control rate was 70%. Brachytherapy treatment was well tolerated, severe acute side effects were not observed. One patient developed pancreatic fistulae 4 months and 1 patient a gastric ulcer 7 months after treatment. Pain release was achieved in all patients. CONCLUSIONS: 192-iridium HDR-brachytherapy is an effective tool in the treatment of unresectable pancreatic carcinoma with a high rate of local control and a low rate of side effects and is comparable IORT or seed implantation.