Treatment of bendamustine and prednisone in patients with newly diagnosed multiple myeloma results in superior complete response rate, prolonged time to treatment failure and improved quality of life compared to treatment with melphalan and prednisone--a randomized phase III study of the East German Study Group of Hematology and Oncology (OSHO).

PURPOSE: This randomized phase III study compared bendamustine and prednisone (BP) to standard melphalan and prednisone (MP) treatment in previously untreated patients with multiple Myeloma (MM). PATIENTS AND METHODS: To be included, patients had to have histologically and cytologically proven stage II with progressive diseases or stage III MM. They were randomly assigned to receive BP (n=68) or MP (n=63). The primary endpoint was the time to treatment failure (TTF). Secondary endpoints included survival, remission rate, toxicity and quality of life. RESULTS: The overall response rate was 75% in the BP and 70% in the MP group. A significantly higher number of patients treated with BP achieved a complete remission than did patients receiving MP (32 vs. 13%; P=0.007), and the maximum response was achieved more rapidly in patients treated with BP compared to those receiving MP (6.8 vs. 8.7 cycles; P<0.02). TTF and remission duration were significantly longer in the BP group. Patients receiving BP had higher QoL scores and reported pain less frequently than patients receiving MP. CONCLUSION: BP is superior to MP with respect to complete remission rate, TTF, cycles needed to achieve maximum remission and quality of life and should be considered the new standard in first-line treatment of MM patients not eligible for transplantation.

Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-Hodgkin's lymphoma and mantle cell lymphoma: results of a randomised phase III trial (OSHO# 19).

PURPOSE: The purpose of this study was to compare the efficacy and toxicity of bendamustine, vincristine + prednisone (BOP) with a standard regimen of cyclophosphamide, vincristine + prednisone (COP) in patients with previously untreated advanced indolent non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma. METHODS: A total of 164 patients with follicular lymphoma (grade 1/2), mantle cell lymphoma or lymphoplasmacytic lymphoma (immunocytoma) was randomised to treatment with vincristine 2 mg (day 1) and prednisone 100 mg/m2 (days 1-5) + bendamustine 60 mg/m2 (days 1-5) or + cyclophosphamide 400 mg/m2 (days 1-5) for a total of eight 21-day cycles. RESULTS: The rate of complete remission was 22% with BOP and 20% with COP. The projected 5-year survival rate was 61% with BOP and 46% with COP. The BOP-associated 5-year survival advantage almost reached significance in the subgroup of patients who responded to therapy (74% vs. 56%; P = 0.05), and did reach significance in responders who did not receive interferon maintenance therapy (70% vs. 47%; P = 0.03). Toxicity was acceptable in both treatment groups, although alopecia and leucopenia were more severe with COP. CONCLUSIONS: Bendamustine can efficaciously and safely replace cyclophosphamide, as used in standard COP therapy, for the treatment of patients with indolent NHL and mantle cell lymphoma. Long-term survival data suggest a clinically significant benefit for patients treated with BOP.

Chemotherapy for mobilisation of Ph-negative progenitor cells from patients with CML: impact of different mobilisation regimens.

Mobilised peripheral blood stem cells are widely used for autografting in patients with chronic myeloid leukaemia (CML) and it is generally thought that a high proportion of Ph-negative progenitor cells in the graft is desirable. We report here the results of 91 stem cell mobilisations performed with various chemotherapy regimens followed by G-CSF. We show that mobilisation of Ph-negative cells is possible after diagnosis as well as in advanced stages of the disease. The yield of Ph-negative cells is highly dependent on the chemotherapy regimen: while the combination of idarubicin and cytarabin for 3-5 days (IC3-5) mobilised Ph-negative cells in most patients, high-dose cyclophosphamide was ineffective. Mobilisation of Ph-negative progenitor cells after IC3 was at least as effective as after IC5; however, less apheresis sessions were required, and toxicity was much reduced after IC3. Compared to historical controls, IC was equally effective as the widely used ICE/miniICE (idarubicin, cytarabin, etoposide) protocol. No correlation was found between graft quality and the cytogenetic response to subsequent treatment with interferon-alpha. We conclude that IC3 is an effective and well-tolerated regimen for mobilising Ph-negative cells that compares well with more aggressive approaches such as IC5 and ICE/miniICE.

[Sonography of the thyroid]. / Die Sonographie der Schilddrüse.

The thyroid gland provides ideal anatomic conditions for sonographic investigations. Apart from the scintigraphy the sonography of the thyroid gland, therefore, stands in the first place as imaging procedure. After a short description of the investigation method and its ability of statement typical sonographic findings are demonstrated. The differentiation into diffuse or nodous strumata, the proof of typical focal findings such as autonomous adenomas or tumours or an increased vascularization in the region of the thyroid gland present an essential enlargement of the spectre of the modern diagnostics of the thyroid gland.

[Changes of the gallbladder wall in the sonogram]. / Gallenblasenwandveränderungen im Sonogramm.

In the diagnostics of the changes of the gallbladder wall the sonography occupies a leading role. In acute cholecystitis on the basis of the criteria mentioned the making of a diagnosis is possible. Polypoid or plane-like infiltrating changes of the wall of the gallbladder are ambiguous and with the exception of the cholesterol polyps they are sonographically not always to be differentiated with sufficient certainty as benign (adenomas) or malignant (carcinomas) formations. When there is the least doubt about the dignity of the lesion of the gallbladder wall the continuing diagnostics (ERCP, CT) or the cholecystectomy is to be demanded.

[Ultrasonic diagnosis in aneurysm of the abdominal aorta]. / Sonographie beim Bauchaortenaneurysma.

The sonographic diagnostics of an aneurysm of the abdominal aorta has obtained a high value on account of the high reliability and the rapid availability of the investigation in connection with the absolute safety of the method. Form, extension, calcification, haemodynamics, thrombosis and dissection of an aneurysm of the aorta can sonographically be demonstrated and measured by longitudinal and transversal sections. As non-invasive approach the ultrasound tomography in the order of the graduated diagnostic method stands before the computed tomography which is not always at once available and before the angiography which have their qualification in the case of a planned operative approach above all for the purpose of the exact topographic differentiation between suprarenal and infrarenal extension.

[Ultrasound study of the spleen]. / Die Ultraschalluntersuchung der Milz.

The sonography is the method of choice for the determination of the size of the spleen. Normally, this has, represented from the left flank, a size of 12 x 5 cm (length and thickness) and a regular structural pattern. Splenomegalies with diffusely changed echo-structure are found in infections, congestion spleens as well as haemoblastoses. Focal lesions are typical for cysts, abscesses and haematomas of the spleen. The sonography of the spleen plays a particular role in the staging of malignant lymphomas, whereas metastatic changes of the spleen may more infrequently be stated sonographically. The authors deal with the great importance of the sonography of the spleen in abdominal traumas.

[Differential diagnosis problems in the assessment of pulmonary coin lesions]. / Differentialdiagnostische Probleme bei der Abklärung eines pulmonalen Rundherdes.

Cause for the publication was a primary hepatocellular carcinoma, the clarification of which was performed on an unusual diagnostic way. The consequence of a circular focus near the pleura were differential-diagnostic considerations. By an aimed biopsy and thoracoscopy a malignant tumour could be ascertained, in which case the histologic investigation resulted in the solitary metastasis of a hepatocellular carcinoma. The authors enter the problems of the diagnosis of pulmonary circular foci and of the hepatocellular carcinoma.

[Treatment of a Morgagni-Adams-Stokes attack in hyperthyroidism by means of temporary electrostimulation]. / Behandlung eines Morgagni-Adams-Stokes-Anfalls bei Hypothyreose durch temporäre Elektrostimulation.

The authors report on a 74-year-old female patient who revealed Adams-Stokes attacks and was supplied by an R-wave triggered external pacemaker. The patient showed intermittent total AV-block. A frequency of 26 beats was observed. Hypothyroidism was recognized as the cause of this disturbance of cardiac rhythm. After treatment with triiodothyronine the bradycardia disappeared and the external pacemaker could be removed. This case is reported for demonstrating a disturbance of the rhythm caused by hypothyroidism and which is successfully treated by temporary pacemaker and specific drug therapy.

[Changes in the munber of 60-year old and older internal patients during a period of 10 years]. / Veränderungen im krankengut bei 60jährigen and älteren internistichen Patienten im Laufe von 10 Jahren

In 273 persons, of them 76 with ischaemic heart disease, 46 with non-coronary heart diseases (vitia, hypertension, chronic cor pulmonale, cardiomyopathy) and a control group of 115 healthy persons, during and after submaximal load under bicycle ergometry the ECG after work was recorded, in which case indication and contraindications of the WHO were taken into consideration. Especially investigated were the degree and the morphology of the ST-T-changes in differential-diagnostic respect in ischaemic heart disease and functional disturbances of the repolarisation. Apart from this the disturbances of rhythm and conduction system were analysed, which appeared under stress. The highest diagnostic evidence was under a load of 400-600 kmp/min and a pulse rate of 130-150/mim.