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S Kümmel

Publications and source records attributed to S Kümmel.

12 recordsLinked to original sources
PubMed2006

Randomised trial: survival benefit and safety of adjuvant dose-dense chemotherapy for node-positive breast cancer.

We evaluated the survival benefit, safety, feasibility, and tolerability of dose-dense (DD) adjuvant chemotherapy with epirubicin and paclitaxel for women with node-positive primary breast cancer. Randomised patients (n=216) received DD or conventional-schedule (CS) chemotherapy. Dose-dense regimen patients (n=108) received epirubicin 90 mg m-2 plus paclitaxel 175 mg m-2 in four 14-day cycles, then cyclophosphamide 600 mg m-2, methotrexate 40 mg m-2, and fluorouracil 600 mg m-2 (CMF 600/40/600) in three 14-day cycles, plus filgrastim 5 microg kg day-1 as growth support in every cycle. Conventional-schedule regimen patients (n=108) received epirubicin 90 mg m-2 plus cyclophosphamide 600 mg m-2 in four 21-day cycles, then CMF 600/40/600 in three 21-day cycles, plus filgrastim if required. After a median follow-up of 38.4 months, 71 patients (33%) relapsed or died: DD, 33 patients (15 deaths); CS, 38 patients (22 deaths). Dose dense showed a trend for improved disease-free survival (DFS) and overall survival (OS). Four-year rates of DFS and OS were 64 and 85% for DD, and 58 and 75% for CS. All seven cycles were administered to 208 patients (96%). Rates of cycle delay, discontinuation, dose reduction, and adverse events were similar in both groups. Dose-dense sequential chemotherapy with epirubicin/paclitaxel then CMF, supported by filgrastim, is safe and improves survival for patients with node-positive breast cancer.

Adult↗
PubMed2006

Real-time elastography--an advanced method of ultrasound: First results in 108 patients with breast lesions.

OBJECTIVES: To evaluate whether real-time elastography, a new, non-invasive method for the diagnosis of breast cancer, improves the differentiation and characterization of benign and malignant breast lesions. METHODS: Real-time elastography was carried out in 108 potential breast tumor patients with cytologically or histologically confirmed focal breast lesions (59 benign, 49 malignant; median age, 53.9 years; range, 16-84 years). Tumor and healthy tissue were differentiated by measurement of elasticity based on the correlation between tissue properties and elasticity modulus. Evaluation was performed using the three-dimensional (3D) finite element method, in which the information is color-coded and superimposed on the B-mode ultrasound image. A second observer evaluated the elastography images, in order to improve the objectivity of the method. The results of B-mode scan and elastography were compared with those of histology and previous sonographic findings. Sensitivities and specificities were calculated, taking histology as the gold standard. RESULTS: B-mode ultrasound had a sensitivity of 91.8% and a specificity of 78%, compared with sensitivities of 77.6% and 79.6% and specificities of 91.5% and 84.7%, respectively, for the two observers evaluating elastography. Agreement between B-mode ultrasound and elastography was good, yielding a weighted kappa of 0.67. CONCLUSIONS: Our initial clinical results suggest that real-time elastography improves the specificity of breast lesion diagnosis and is a promising new approach for the diagnosis of breast cancer. Elastography provides additional information for differentiating malignant BI-RADS (breast imaging reporting and data system) category IV lesions.

Adolescent↗
PubMed2005

Primary chemotherapy with gemcitabine as prolonged infusion, non-pegylated liposomal doxorubicin and docetaxel in patients with early breast cancer: final results of a phase II trial.

BACKGROUND: Combinations of anthracyclines, taxanes and gemcitabine have shown high activity in breast cancer. This trial was designed to evaluate a modified combination regimen as primary chemotherapy. Non-pegylated liposomal doxorubicin (NPLD) was used instead of conventional doxorubicin to improve cardiac safety. Gemcitabine was given 72 h after NPLD and docetaxel as a prolonged infusion over 4 h in order to optimize synergistic effects and accumulation of active metabolites. PATIENTS AND METHODS: Forty-four patients with histologically confirmed stage II or III breast cancer were treated with NPLD (60 mg/m(2)) and docetaxel (75 mg/m(2)) on day 1 and gemcitabine as 4-h infusion (350 mg/m(2)) on day 4. Treatment was repeated every 3 weeks for a maximum of six cycles. All patients received prophylactically recombinant granulocyte colony-stimulating factor. Patients with axillary lymph node involvement after primary chemotherapy received adjuvant treatment with cyclophosphamide, methotrexate and fluorouracil. RESULTS: The clinical response rate was 80%, and complete remissions of the primary tumor occurred in 10 patients (25%). Breast conservation surgery was performed in 19 out of 20 patients (95%) with an initial tumor size of less than 3 cm and in 14 patients (70%) with a tumor size <or=3 cm. Seven patients had histologically confirmed complete responses accounting for a pCR rate of 17.5%. Expression of Ki--67 was the most important predictive parameter for response with high 38.9% breast pCR rate in patients with elevated Ki--67 expression. Although the predominant toxicity was myelosuppression with grade 3/4 neutropenia in 61% of patients few neutropenic complications resulted. Non-hematological toxicity was generally moderate with grade 3 or 4 toxicity in 10.0% of cycles. Most common non-hematologic toxicities were nausea, vomiting, alopecia, mucositis, asthenia and elevation of liver enzymes. CONCLUSION: The evaluated schedule provides a safe and highly effective combination treatment for patients with early breast cancer, which is suitable for phase III studies.

Adult↗
PubMed2003

Adjuvant treatment of breast cancer patients with 1-3 positive lymph nodes: vinorelbine plus epirubicin; vinorelbine plus epirubicin sequential followed up by paclitaxel; epirubicin plus cyclophosphamide; epirubicin plus cyclophosphamide sequential followed up by paclitaxel. A phase II study.

PURPOSE: The efficacy of anthracyclin-containing adjuvant chemotherapy of node-positive breast cancer can be further improved by adding sequential paclitaxel (T). There is also clinical evidence that replacing cyclophosphamide (C) with vinorelbin (V) might further reduce toxicity. In order to assess the safety of these options, we initiated a clinical cohort study of epirubicin/cyclophoshamide and epirubicin/vinorelbine with or without sequential paclitaxel. METHOD: Patients with node-positive (1-3) breast cancer were assigned to open-label epirubicin/vinorelbine (EV), epirubicin/vino-relbine and sequential paclitaxel (EV/T), epirubicin/cyclophosphamide (EC) or epirubicin/cyclophosphamide plus sequential paclitaxel (EC/T) therapy. RESULTS: Fifty four outpatients received a total of 304 chemotherapy cycles. There were significant differences in grade III/IV anemia only between the EV/T and EC/T groups, in favor of the EC/T group (P=0.002). CONCLUSIONS: The safety of paclitaxel is not impaired when given sequentially after administration of the two anthracyclin-containing regimens. The exchange of cyclophosphamide against vinorelbine leads to deteriorating safety of the EC/T regimen.

Adult↗
PubMed2000

Prognostic value of microscopic peritoneal dissemination: comparison between colon and gastric cancer.

PURPOSE: We evaluated the incidence and prognostic relevance of microscopic intraperitoneal tumor cell dissemination of colon cancer in comparison with dissemination of gastric cancer as a rational for additive intraperitoneal therapy. METHODS: Peritoneal washouts of 90 patients with colon and 111 patients with gastric cancer were investigated prospectively. Sixty patients with benign diseases and 8 patients with histologically proven gross visible peritoneal carcinomatosis served as controls. Intraoperatively, 100 ml of warm NaCl 0.9 percent were instilled and 20 ml were reaspirated. In all patients hematoxylin and eosin staining (conventional cytology) was performed. Additionally, in 36 patients with colon cancer and 47 patients with gastric cancer, immunostaining with the HEA-125 antibody (immunocytology) was prepared. The results of cytology were assessed for an association with TNM category and cancer grade, based on all patients, and with patient survival, among the R0 resected patients. RESULTS: In conventional cytology 35.5 percent (32/90) of patients with colon cancer and 42.3 percent (47/111) of patients with gastric cancer had a positive cytology. In immunocytology 47.2 percent (17/36) of patients with colon cancer and 46.8 percent (22/47) of patients with gastric cancer were positive. In colon cancer, positive conventional cytology was associated with pT and M category (P = 0.044 and P = 0.0002), whereas immunocytology was only associated with M category (P = 0.007). No association was found between nodal status and immunocytology in colon cancer and with the grading. There was a statistically significant correlation between pT M category and conventional and immunocytology in gastric cancer (P < 0.0015/P = 0.007 and P < 0.001/P = 0.009, respectively). Positive immunocytology was additionally associated with pN category (P = 0.05). In a univariate analysis of R0 resected patients (no residual tumor), positive immunocytology was significantly related to an unfavorable prognosis in patients with gastric cancer only (n = 30). Mean survival time was significantly increased in patients with gastric cancer with negative cytology compared with positive cytology (1,205 (standard error of the mean, 91) vs. 771 (standard error of the mean, 147) days; P = 0.007) but not in patients with colon cancer (1,215 (standard error of the mean, 95) vs. 1,346 (standard error of the mean, 106) days; P = 0.55). CONCLUSIONS: Because microscopic peritoneal dissemination influences survival time after R0 resections only in patients with gastric but not with colon cancer, our results may provide a basis for a decision on additive, prophylactic (intraperitoneal) therapy in gastric but not colon cancer.

Analysis of Variance↗
PubMed2000

[Dose intensified adjuvant chemotherapy in high risk breast carcinoma with 4-9 positive lymph nodes].

OBJECTIVE: Taxanes and anthracyclines represent the two most active groups of agents for the treatment of breast cancer. We evaluated this combination in patients with more than 3 positive lymph nodes in an adjuvant, dose-intensive, sequential therapy in comparison with the standard chemotherapy regimen epirubicin/cyclophosphamide in relation to toxicities. MATERIAL AND METHODS: Since 9/96 127 patients with 4-9/over 9 positive lymph nodes have been recruited from 21 participating centers in an ongoing trial. 67 patients were prospectively randomised for first-line chemotherapy to treatment group A (epirubicin 90 mg/m2-paclitaxel 175 mg/m2; 4 cycles bi-weekly, supported by G-CSF 5 micrograms/kg day 5-13 and 3 sequential cycles of CMF 600/40/600 mg/m2 at 2-weeks interval) and 60 patients to treatment group B (epirubicin 90 mg/m2-cyclophosphamide 600 mg/m2, 4 cycles tri-weekly, and 3 sequential cycles of CMF 600/40/600 mg/m2 at 3-weeks interval). RESULTS: Preliminary safety and toxicity data are evaluable for 679 cycles. Data about response rate and disease-free-survival and overall survival will be delivered later. For the hematological toxicity the main grade 3 and 4 adverse events for A vs. B were: leucopenia 9.8% vs. 8.4%, febrile neutropenia 1.6% vs. 0.8%--anemia (< 5.9 mmol/l), 0.4% vs. 0.2%--thrombopenia 0% vs. 0%. Non-hematological toxicity occurred more frequently in group A (grade 2, 3, 4):--neuropathy 4.4% vs. 0%,--nausea/emesis 27.8% vs. 19.3%,--fatigue 14.6% vs. 3.4% and mucositis 2.8% vs. 0.3%.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1999

Immunocytology improves prognostic impact of peritoneal tumour cell detection compared to conventional cytology in gastric cancer.

AIMS: Studies on the value of peritoneal tumour cell dissemination for prognosis in gastric cancer using various methods to detect tumour cells have produced conflicting conclusions. We studied the incidence and prognostic relevance of microscopic intraperitoneal tumour cell dissemination in gastric cancer, comparing conventional and immunocytological detection. METHODS: Peritoneal wash-outs of 111 consecutive gastric patients without overt peritoneal carcinomatosis, including 75 curatively resected patients, were studied. Sixty patients with benign disorders served as controls. 100 ml of warm NaCl 0.9% was instilled intraoperatively and 20 ml was reaspirated. The specimens were stained peri-operatively with H&E. In the last 47 patients (30 of whom were curatively resected) additional immunostaining with the HEA-125 antibody was performed. The results of cytology were correlated with the TNM categories and with post-operative follow-up. RESULTS: Of the patients, 42.3% and 48.9% were positive when conventional and immunocytological staining were employed, respectively. Conventional cytology was significantly associated with the pT and M categories. Immunocytology was significantly associated with the pT, pN and M caterogies. In four of 30 curatively resected patients (13.3%), the results of conventional and immunocytology were different. Three patients with positive immunocytology but negative conventional cytology died during follow-up (median follow-up 45.3 months), whereas one patient with positive conventional but negative immunocytology is still alive. In an univariate analysis 4 years post-surgery, positive immunocytology was significantly associated with an unfavourable prognosis in patients with curatively resected gastric cancer. While only 28.6% (six of 21) of the patients with negative immunocytology had died, this proportion increased to 77.8% (seven of nine) with positive immunocytology (P=0.018). The mean survival of negative vs positive patients amounted to 1205+/-91 vs 772+/-147 days (P=0.007). In contrast, in conventional cytology we found no significantly different survival time between negative and positive patients. CONCLUSIONS: Immunocytology seems to be superior to conventional cytology and should be preferred.

Case-Control Studies↗
PubMed1998

[Functional outcome and quality of life after coloanal or colonic pouch-anal anastomosis--a prosepctive randomized study].

Functional variables after coloanal anastomosis or anastomosis with J pouch were investigated in 40 patients in a prospective randomized study. Continence for liquids and gas control were superior after J pouch anastomosis compared with coloanal reconstruction. The neorectal capacity was higher after J pouch anastomosis. The perception threshold for stool filling was higher in patients with J pouch resembling those values observed preoperatively. Quality of life was improved in subjects with with J pouch, although differences did not reach a significant level.

Adult↗
PubMed1997

[Dynamic and static MRI using superparamagnetic MRI contrast medium Resovist for visualizing primary and secondary liver tumors].

PURPOSE: To analyse characteristics of benign and malignant liver tumours in dynamic and static MR imaging with the superparamagnetic MR contrast medium Resovist. MATERIAL AND METHODS: All 30 patients were examined on a 1.5 Tesla MR unit (Magnetom 63 SP, Siemens AG, Erlangen, Germany) using proton density (PD) weighted (w), T2-weighted-spin-echo, a T1-weighted SE, and a T1-weighted FLASH-2 D gradient echo (GRE) sequence before, during and after the application of Resovist. Dynamic imaging was performed using a T2-weighted GRE-sequence (TurboFLASH; TR/TE = 11/30; flip angle = 10 degrees; Tl = 600 ms). Histopathology revealed benign liver lesions in 8 patients and malignant lesions in 22 patients. RESULTS: Dynamic T2-weighted sequence revealed an early loss of signal intensity in normal liver parenchyma (percentage signal intensity loss (PSIL) = 40.0 +/- 12.2% by 4 mumol Fe/kg, 47.2 +/- 18.8% by 8 mumol Fe/kg and 62.7 +/- 13.0% by 16 mumol Fe/kg), in the spleen, as well as in FNH (PSIL = 49.5 +/- 7.3% by 8 mumol Fe/kg), and regenerating nodules in the first minute after application of Resovist. In two of 4 cases with HCC a short drop in signal intensity was immediately observed after the application, whereas signal intensity remained unchanged in all other malignant liver tumours. Enhanced PDw and T2-weighted SE-sequences revealed an improved detection and delineation of malignant liver lesions versus plain MR imaging. 17 liver lesions of a size lower 10 mm were additionally detected in postcontrast T2-weighted SE-sequences in 4 patients. CONCLUSION: Dynamic and static versus plain MR imaging of primary and secondary liver lesions is markedly improved by the superparamagnetic contrast material Resovist, especially in case of intravenous bolus application of this liver-specific contrast medium.

Adult↗
PubMed1996

Magnetic resonance imaging of focal liver lesions. Comparison of the superparamagnetic iron oxide resovist versus gadolinium-DTPA in the same patient.

RATIONALE AND OBJECTIVES: The authors assess the efficacy of static and dynamic magnetic resonance (MR) imaging using the superparamagnetic iron oxide SHU-555A (Resovist) versus standard dose of gadolinium (Gd)-DTPA in patients with focal liver lesions. METHODS: Magnetic resonance imaging was performed in 30 patients suffering from histopathologically verified malignant (n = 22) and benign (n = 8) liver lesions. T2-weighted conventional and fat-suppressed as well as T1-weighted sequences were used before, during, and after fast intravenous administration of Resovist (1 mL/minute) at three doses of 4, 8, and 16 mumol/kg body weight. One week before the Resovist-enhanced MR imaging study 20 patients underwent Gd-DTPA-enhanced MR imaging. RESULTS: Detection rate was improved for metastatic lesions revealing 36 lesions unenhanced versus 53 focal lesions using Resovist-enhanced MR imaging. Gadolinium-DTPA-enhanced scans showed no additional lesion versus unenhanced and Resovist-enhanced MR imaging. Static and dynamic imaging demonstrated no measurable percentage signal intensity loss (PSIL) using Resovist-enhanced MR imaging versus a percentage enhancement of 79.7% in Gd-DTPA enhanced scans. In the dynamic T2-weighted sequences, hepatocellular carcinoma nodules (n = 4) showed a rapid decrease in signal intensity starting at 44 seconds. Postinfusion of Resovist followed by a low, constant increase in signal intensity. Gadolinium-DTPA enhanced scans showed a percentage enhancement of 73.4 focal nodular hyperplasia (FNH) and hemangioma revealed a strong and early dose-dependent PSIL 44 to 60 seconds postinfusion with a prolonged signal loss for the FNH in the late study. Statistical evaluation revealed a statistically significant superiority of Resovist-enhanced MR imaging concerning the detection and delineation of focal liver lesions compared with unenhanced and Gd-DTPA enhanced scans (P < 0.05). CONCLUSIONS: The fast infusion of the new superparamagnetic contrast agent Resovist shows advantages for dynamic and static MR imaging of focal liver lesions.

Carcinoma, Hepatocellular↗
PubMed1996

Liver tumors: comparison of MR imaging with Gd-EOB-DTPA and Gd-DTPA.

PURPOSE: To compare the usefulness of gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid (Gd-EOB-DTPA) and gadolinium diethylenetriaminepentaacetic acid (Gd-DTPA) in the diagnosis of focal liver lesions. MATERIALS AND METHODS: Thirty-one patients with focal liver lesions underwent T2- and T1-weighted spin-echo magnetic resonance (MR) imaging and fast low-angle shot two-dimensional MR imaging before, during, and after intravenous administration of three different doses of Gd-EOB-DTPA (12.5, 25, and 50 mumol per kilogram body weight). Gd-DTPA-enhanced imaging (dose, 0.1 mmol per kilogram body weight) was performed in the same patients within 1 week of Gd-EOB-DTPA imaging. RESULTS: During the perfusion phase (the 3 minutes after injection of contrast material), the dynamic enhancement characteristics seen after injection of 25 and 50 mumol of Gd-EOB-DTPA were similar to those seen with Gd-DTPA. At the lowest dose of Gd-EOB-DTPA (12.5 mumol), the dynamic enhancement characteristics were not comparable to those seen with Gd-DTPA. During the hepatobiliary phase (1.5 minutes to 4 hours after injection), Gd-EOB-DTPA-enhanced images yielded a dose-independent, statistically significant improvement in the detection rate of additional metastases, hepatocellular carcinomas, and hemangiomas compared with unenhanced and Gd-DTPA-enhanced images (P < .05). CONCLUSION: Gd-EOB-DTPA-enhanced MR imaging enables improved detection of hepatic lesions over Gd-DTPA-enhanced MR imaging while providing comparable differential diagnostic information.

Adult↗