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  • 1
    Abstract: Networking of medical institutions by means of a capable data infrastructure has the potential to open up vast amounts of routine data to translational cancer research. However, the secondary use of information collected independently in several institutions is a challenging task of data integration. In this review, we discuss the requirements and common challenges involved in the establishment of such a platform. We present methods and tools from the field of medical informatics as solutions to semantic and technical heterogeneity, questions of data protection and record linkage, as well as issues of trust and data ownership. We also describe the architecture of an existing cancer research network as an exemplary application of these methods.
    Type of Publication: Journal article epub ahead of print
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  • 2
  • 3
    Keywords: SURVIVAL ; COMBINATION ; evaluation ; Germany ; THERAPY ; FOLLOW-UP ; SURGERY ; TIME ; PATIENT ; primary ; CYCLE ; treatment ; ALPHA ; TRIAL ; DIFFERENCE ; METASTASIS ; chemotherapy ; MELANOMA ; PROGNOSTIC-FACTORS ; HIGH-RISK ; PROGNOSTIC FACTORS ; IMMUNOTHERAPY ; FOLLOW-UP TIME ; MALIGNANT-MELANOMA ; INTERFERON ; CENTERS ; MELANOMA PATIENTS ; CUTANEOUS MELANOMA ; RANDOMIZED TRIAL ; ADJUVANT ; DACARBAZINE ; DOSE BOLUS INTERLEUKIN-2 ; IL-2 ; PROGNOSTIC FACTOR ; RANDOMIZED-TRIAL ; RECOMBINANT INTERLEUKIN-2 ; relapse
    Abstract: Purpose: Low-dose interferon alfa (IFNalpha) has been shown to have limited effects in the adjuvant treatment of patients with intermediate- and high-risk primary melanoma. We hypothesized that a combination regimen with low-dose interleukin-2 (IL-2) may improve survival prospects in these patients. Patients and Methods: After wide excision of primary melanoma without clinically detectable lymph node metastasis (pT3 to 4, cN0, M0), 225 patients from 10 participating centers were randomly assigned to receive either subcutaneous low-dose 1FNalpha2b (3 million international units [MU]/m(2)/d, days 1 to 7, week 1; three times weekly, weeks 3 to 6, repeated all 6 weeks) plus IL-2 (9 MU/m(2)/d, days 1 to 4, week 2 of each cycle) for 48 weeks, or observation alone. The primary end point was prolongation of a relapse-free interval. Results: Of the 225 enrolled patients, 223 were found to be eligible. Median follow-up time was 79 months. All evaluated prognostic factors were well balanced between the two arms of the study. Relapses were noticed in 36 of 113 patients treated with IFNalpha2b plus IL-2 and in 34 of 110 patients with observation alone. Five-year disease-free survival of those who had routine surgery supplemented by IFNalpha2b and IL-2 treatment was 70.1% (95% confidence interval [CI], 61.3% to 78.9%), compared with 69.9% in those receiving surgery and observation alone (95% CI, 60.7% to 79.1%) in the intention-to-treat analysis. Evaluation of the overall survival did not show any difference between treated and untreated melanoma patients (P = .93). Conclusion: Adjuvant treatment of intermediate- and high-risk melanoma patients with low-dose IFNalpha2b and IL-2 is safe and well tolerated by most patients, but it does not improve disease-free or overall survival
    Type of Publication: Journal article published
    PubMed ID: 12885805
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  • 4
    Keywords: CANCER ; SURVIVAL ; carcinoma ; Germany ; LUNG ; TOXICITY ; lung cancer ; LUNG-CANCER ; DISEASE ; TIME ; PATIENT ; primary ; QUALITY ; treatment ; STAGE ; DIFFERENCE ; CLINICAL-TRIALS ; RATES ; chemotherapy ; ELDERLY-PATIENTS ; PHASE-III ; MULTICENTER TRIAL ; PLUS VINORELBINE ; QUALITY-OF-LIFE ; SINGLE-AGENT GEMCITABINE
    Abstract: Purpose To evaluate whether cisplatin-based chemotherapy (gemcitabine, vinorelbine, and cisplatin [GVP]) prolongs overall survival in comparison to cisplatin-free chemotherapy (gemcitabine and vinorelbine [GV]) as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods Between September 1999 and June 2001, 300 patients with NSCLC stage 11113 with malignant pleural effusion or stage IV disease were randomly assigned to receive GV (gemcitabine 1000 mg/m(2) + vinorelbine 25 mg/m(2) on days 1 and 8 every 3 weeks) or GVP (gemcitabine 1000 mg/m(2) + vinorelbine 25 mg/m(2) on days I and 8 + cisplatin 75 mg/m(2) on day 2 every 3 weeks). Primary end point of the study was overall survival. Results Two hundred eighty-seven patients (GV, 143 patients; GVP, 144 patients) were eligible for analysis. At the time of analysis, April 15, 2002, 209 patients (GV, 103 patients; GVP, 106 patients) of 287 patients had died (73%). No statistically significant difference was observed for overall survival (P =.73; median survival, 35.9 versus 32.4 weeks; 1-year survival rate, 33.6% versus 27.5%) as well as for event-free survival (P =.35; median time-to-event, 19.3 versus 22.3 weeks) between GV and GVP. Two hundred fourteen patients were assessable for best response. The overall response rates were 13.0% for GV versus 28.3% for GVP (P =.004; complete responders, 0% versus 3.8%; partial responders, 13.0% versus 24.5%). Hematologic and nonhematologic toxicity was significantly lower in the GV treatment arm compared with GVP. No statistically significant difference in quality of life was observed. Conclusion In this phase III study, the cisplatin-based GVP regimen showed no survival benefit as first-line chemotherapy in advanced NSCLC when compared with the cisplatin-free GV regimen, which was substantially better tolerated. (C) 2004 by American Society of Clinical Oncology
    Type of Publication: Journal article published
    PubMed ID: 15197195
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  • 5
    Keywords: SURVIVAL ; Germany ; THERAPY ; PATIENT ; IMPACT ; TRANSPLANTATION ; BINDING ; treatment ; chromosome ; NO ; TRIAL ; EXPERIENCE ; DIFFERENCE ; AGE ; meta-analysis ; chemotherapy ; leukemia ; PROGNOSTIC-FACTORS ; allogeneic ; PROGNOSTIC FACTORS ; ALLOGENEIC TRANSPLANTATION ; PROGNOSTIC FACTOR ; relapse ; COMPLETE REMISSION ; Y-CHROMOSOME ; acute myeloid leukemia ; INTENSIVE CHEMOTHERAPY ; POSTREMISSION THERAPY ; AUTOLOGOUS TRANSPLANTATION ; ONCOLOGY ; ADULT ; ADULTS ; overall survival ; REMISSION DURATION ; METAANALYSIS ; ACUTE MYELOBLASTIC-LEUKEMIA ; ADULT PATIENTS ; CHROMOSOME-ABNORMALITIES ; DE-NOVO AML ; HIGH-DOSE CYTARABINE ; REPETITIVE CYCLES ; STANDARD CYTOGENETICS
    Abstract: Purpose To evaluate prognostic factors for relapse-free survival (RFS) and overall survival (OS) and to assess the impact of different postremission therapies in adult patients with core binding factor (CBF) acute myeloid leukemias (AML). Patients and Methods Individual patient data-based meta-analysis was performed on 392 adults (median age, 42 years; range, 16 to 60 years) with CBF AML (t(8;21), n = 191; inv(1 6), n = 201) treated between 1993 and 2002 in prospective German AML treatment trials. Results RFS was 60% and 58% and OS was 65% and 74% in the t(8;21) and inv(16) groups after 3 years, respectively. For postremission therapy, intention-to-treat analysis revealed no difference between intensive chemotherapy and autologous transplantation in the t(8;21) group and between chemotherapy, autologous, and allogeneic transplantation in the inv(16) group. In the t(8;21) group, significant prognostic variables for longer RFS and OS were lower WBC and higher platelet counts; loss of the Y chromosome in male patients was prognostic for shorter OS. In the inv(16) group, trisomy 22 was a significant prognostic variable for longer RFS. For patients who experienced relapse, second complete remission rate was significantly lower in patients with t(8;21), resulting in a significantly inferior survival duration after relapse compared with patients with inv(16). Conclusion We provide novel prognostic factors for CBF AML and show that patients with t(8;21) who experience relapse have an inferior survival duration. (C) 2004 by American Society of Clinical Oncology
    Type of Publication: Journal article published
    PubMed ID: 15289486
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  • 6
    Keywords: brain ; CELLS ; EXPRESSION ; SURVIVAL ; tumor ; TUMOR-CELLS ; BLOOD ; CELL ; Germany ; THERAPY ; DISEASE ; LONG-TERM ; TUMORS ; TIME ; PATIENT ; INFECTION ; prognosis ; SKIN ; T cell ; T cells ; T-CELL ; T-CELLS ; cell culture ; culture ; MEMORY ; virus ; NERVOUS-SYSTEM ; NO ; immunohistochemistry ; ASSAY ; NUMBER ; VACCINE ; SAFETY ; CD8(+) ; immune response ; IMMUNE-RESPONSE ; IMMUNITY ; T-LYMPHOCYTES ; vaccination ; T lymphocyte ; side effects ; NEWCASTLE-DISEASE VIRUS ; ESTABLISHMENT ; TUMOR CELLS ; LONG-TERM SURVIVORS ; GLIOMAS ; T lymphocytes ; IMMUNIZATION ; ONCOLOGY ; AUTOLOGOUS TUMOR ; overall survival ; NEWCASTLE-DISEASE-VIRUS ; SURVIVORS
    Abstract: Purpose Prognosis of patients with glioblastoma is poor. Therefore, in glioblastoma patients, we analyzed whether antitumor vaccination with a virus-modified autologous tumor cell vaccine is feasible and safe. Also, we determined the influence on progression-free survival and overall survival and on vaccination-induced antitumor reactivity. Patients and Methods In a nonrandomized study, 23 patients were vaccinated and compared with nonvaccinated controls (n = 87). Vaccine was prepared from patient's tumor cell cultures by infection of the cells with Newcastle Disease Virus, followed by gamma-irradiation, and applied up to eight times. Antitumor immune reactivity was determined in skin, blood, and relapsed tumor by delayed-type hypersensitivity skin reaction, ELISPOT assay, and immunohistochemistry, respectively. Results Establishment of tumor cell cultures was successful in approximately 90% of patients. After vaccination, we observed no severe side effects. The median progression-free survival of vaccinated patients was 40 weeks (v 26 weeks in controls; log-rank test, P =.024), and the median overall survival of vaccinated patients was 100 weeks (v 49 weeks in controls; log-rank test, P 〈.001). Forty-five percent of the controls survived 1 year, 11% survived 2 years, and there were no long-term survivors (greater than or equal to3 years). Ninety-one percent of vaccinated 39% survived 2 years, and 4% were long-term survivors. In the patients survived I year, vaccinated group, immune monitoring revealed significant increases of delayed-type hypersensitivity reactivity, numbers of tumor-reactive memory T cells, and numbers of CD8(+) tumor-infiltrating T-lymphocytes in secondary tumors. Conclusion Postoperative vaccination with virus-modified autologous tumor cells seems to be feasible and safe and to improve the prognosis of patients with gliobiastomas. This could be substantiated by the observed antitumor immune response. (C) 2004 by American Society of Clinical Oncology
    Type of Publication: Journal article published
    PubMed ID: 15452186
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  • 7
    Keywords: CANCER ; BLOOD ; MODEL ; MODELS ; FOLLOW-UP ; NETWORKS ; TOOL ; DISEASE ; PROTEIN ; PATIENT ; BIOMARKERS ; BREAST-CANCER ; IDENTIFICATION ; PROGRESSION ; PATTERNS ; ASSAY ; PROSTATE-CANCER ; metastases ; mass spectrometry ; MELANOMA ; RECURRENCE ; MASS-SPECTROMETRY ; TIME-OF-FLIGHT ; MALIGNANT-MELANOMA ; STAGE-I ; MASSES ; SERUM ; molecular ; RE ; IV ; AMERICAN JOINT COMMITTEE ; MALDI ; biomarker ; CHIP ; DISEASE PROGRESSION ; predictive value ; protein chip ; INHIBITING ACTIVITY
    Abstract: Purpose Currently known serum biomarkers do not predict clinical outcome in melanoma. S100-beta is widely established as a reliable prognostic indicator in patients with advanced metastatic disease but is of limited predictive value in tumor-free patients. This study was aimed to determine whether molecular profiling of the serum proteome could discriminate between early- and late-stage melanoma and predict disease progression. Patients and Methods Two hundred five serum samples from 101 early-stage (American Joint Committee on Cancer [AJCC] stage I) and 104 advanced stage (AJCC stage IV) melanoma patients were analyzed by matrix-assisted laser desorption/ionisation (MALDI) time-of-flight (ToF; MALDI-ToF) mass spectrometry utilizing protein chip technology and artificial neural networks (ANN). Serum samples from 55 additional patients after complete dissection of regional lymph node metastases (AJCC stage III), with 28 of 55 patients relapsing within the first year of follow-up, were analyzed in an attempt to predict disease recurrence. Serum S100-beta was measured using a sandwich immunoluminometric assay. Results Analysis of 205 stage I/IV serum samples, utilizing a training set of 94 of 205 and a test set of 15 of 205 samples for 32 different ANN models, revealed correct stage assignment in 84 (88%) of 96 of a blind set of 96 of 205 serum samples. Forty-four (80%) of 55 stage III serum samples could be correctly assigned as progressors or nonprogressors using random sample cross-validation statistical methodologies. Twenty-three (82%) of 28 stage III progressors were correctly identified by MALDI-ToF combined with ANN, whereas only six (21%) of 28 could be detected by S100-beta. Conclusion Validation of these findings may enable proteomic profiling to become a valuable tool for identifying high-risk melanoma patients eligible for adjuvant therapeutic interventions
    Type of Publication: Journal article published
    PubMed ID: 16051955
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  • 8
    Keywords: CANCER ; Germany ; human ; PROSTATE ; ALGORITHM ; ALGORITHMS ; DIAGNOSIS ; COHORT ; RISK ; GENE ; GENES ; TIME ; PATIENT ; FAMILY ; treatment ; ASSOCIATION ; MALIGNANCIES ; AGE ; MUTATION ; REPAIR ; colorectal cancer ; COLORECTAL-CANCER ; prostate cancer ; PROSTATE-CANCER ; COLON-CANCER ; HEREDITARY ; MISMATCH REPAIR ; MUTATIONS ; CANCER-PATIENTS ; UNITED-STATES ; INDIVIDUALS ; CANCER PATIENTS ; GASTRIC-CANCER ; germline mutations ; NONPOLYPOSIS COLORECTAL-CANCER ; GENE-MUTATIONS ; RECTAL-CANCER ; MALIGNANCY ; ONCOLOGY ; FAMILIES ; MUTATION CARRIERS ; HNPCC ; gastric cancer ; MLH1 ; analysis ; methods ; MISMATCH-REPAIR ; correlation ; Male ; CANCERS ; colorectal ; hereditary nonpolyposis colorectal cancer ; MISMATCH-REPAIR-GENE ; PROSTATE CANCERS ; DNA-MISMATCH-REPAIR ; MUIR-TORRE-SYNDROME ; SYNDROME-II ; TUMOR SPECTRUM
    Abstract: Purpose Lynch syndrome is linked to germline mutations in mismatch repair genes. We analyzed the genotype-phenotype correlations in the largest cohort so far reported. Patients and Methods Following standard algorithms, we identified 281 of 574 unrelated families with deleterious germline mutations in MLH1 (n = 124) or MSH2 (n = 157). A total of 988 patients with 1,381 cancers were included in this analysis. Results We identified 181 and 259 individuals with proven or obligatory and 254 and 294 with assumed MLH1 and MSH2 mutations, respectively. Age at diagnosis was younger both in regard to first cancer (40 v 43 years; P 〈.009) and to first colorectal cancer (CRC; 41 v 44 years; P =.004) in MLH1 (n = 435) versus MSH2 (n = 553) mutation carriers. In both groups, rectal cancers were remarkably frequent, and the time span between first and second CRC was smaller if the first primary occurred left sided. Gastric cancer was the third most frequent malignancy occurring without a similarly affected relative in most cases. All prostate cancers occurred in MSH2 mutation carriers. Conclusion The proportion of rectal cancers and shorter time span to metachronous cancers indicates the need for a defined treatment strategy for primary rectal cancers in hereditary nonpolyposis colorectal cancer patients. Male MLH1 mutation carriers require earlier colonoscopy beginning at age 20 years. We propose regular gastric surveillance starting at age 35 years, regardless of the familial occurrence of this cancer. The association of prostate cancer with MSH2 mutations should be taken into consideration both for clinical and genetic counseling practice
    Type of Publication: Journal article published
    PubMed ID: 16908935
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  • 9
    Keywords: EXPRESSION ; SURVIVAL ; tumor ; Germany ; MODEL ; CLASSIFICATION ; DIAGNOSIS ; SYSTEM ; SYSTEMS ; COHORT ; DISEASE ; RISK ; DISTINCT ; GENE ; GENE-EXPRESSION ; microarray ; ACCURACY ; validation ; PATIENT ; BREAST-CANCER ; STAGE ; TRIAL ; TRIALS ; gene expression ; microarrays ; DELETIONS ; HIGH-RISK ; PROBES ; UNITED-STATES ; PREDICTION ; pathology ; CHILDREN ; DIFFERENTIAL EXPRESSION ; neuroblastoma ; INTEGRATION ; REGRESSION ; SIGNATURE ; PREDICTOR ; SPECIMENS ; SUBGROUPS ; PREDICTS ; SET ; CLINICAL COURSE ; 11Q
    Abstract: Purpose To develop a gene expression - based classifier for neuroblastoma patients that reliably predicts courses of the disease. Patients and Methods Two hundred fifty-one neuroblastoma specimens were analyzed using a customized oligonucleotide microarray comprising 10,163 probes for transcripts with differential expression in clinical subgroups of the disease. Subsequently, the prediction analysis for microarrays (PAM) was applied to a first set of patients with maximally divergent clinical courses ( n = 77). The classification accuracy was estimated by a complete 10-times-repeated 10-fold cross validation, and a 144-gene predictor was constructed from this set. This classifier's predictive power was evaluated in an independent second set ( n = 174) by comparing results of the gene expression based classification with those of risk stratification systems of current trials from Germany, Japan, and the United States. Results The first set of patients was accurately predicted by PAM (cross-validated accuracy, 99%). Within the second set, the PAM classifier significantly separated cohorts with distinct courses (3-year event-free survival [EFS] 0.86 +/- 0.03 [ favorable; n = 115] v 0.52 +/- 0.07 [ unfavorable; n = 59] and 3-year overall survival 0.99 +/- 0.01 v 0.84 +/- 0.05; both P 〈.0001) and separated risk groups of current neuroblastoma trials into subgroups with divergent outcome (NB2004: low-risk 3-year EFS 0.86 +/- 0.04 v 0.25 +/- 0.15, P 〈.0001; intermediate-risk 1.00 v 0.57 +/- 0.19, P =.018; high-risk 0.81 +/- 0.10 v 0.56 +/- 0.08, P =.06). In a multivariate Cox regression model, the PAM predictor classified patients of the second set more accurately than risk stratification of current trials from Germany, Japan, and the United States ( P 〈.001; hazard ratio, 4.756 [95% CI, 2.544 to 8.893]). Conclusion Integration of gene expression - based class prediction of neuroblastoma patients may improve risk estimation of current neuroblastoma trials
    Type of Publication: Journal article published
    PubMed ID: 17075126
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  • 10
    Keywords: CANCER ; tumor ; Germany ; human ; neoplasms ; DIAGNOSIS ; INFORMATION ; DISEASE ; incidence ; MORTALITY ; RISK ; RISKS ; SITE ; meningioma ; TUMORS ; TIME ; PATIENT ; primary ; SUSCEPTIBILITY ; LYMPHOMA ; MALIGNANCIES ; PATTERNS ; NUMBER ; AGE ; chemotherapy ; MODULATION ; DAMAGE ; DATABASE ; 2ND PRIMARY CANCERS ; RELATIVE RISK ; SKIN-CANCER ; ONCOLOGY ; CHILDHOOD ; RE ; SOLID TUMORS ; SURVIVORS ; methods ; PRIMARY NEOPLASMS ; USA ; CANCERS ; quantitative ; QUANTITATIVE DATA ; VA ; neoplasm ; SWEDISH ; subsequent cancer ; BRITISH COHORT
    Abstract: Purpose Quantitative data on subsequent cancers after primary cancers provide information on treatment-related risks on second cancers, with implications for therapeutic adverse effects and human susceptibility in general. Quantitative data on solid tumors are limited. We focus on survivors of non-Hodgkin's lymphoma (NHL) because the disease is diagnosed at a wide range of ages and treated uniformly primarily with chemotherapy. Patients and Methods The nationwide Swedish Family-Cancer Database included 11.5 million individuals whose cancers were retrieved from the Swedish Cancer Registry. Standardized incidence ratios (SIRs) were calculated for subsequent neoplasms among 28,131 patients with NHL. Results The SIR for solid tumors after NHL was 1.65 (2,290 patients) and that for lymphohematopoietic neoplasms was 5.36 (369 patients). Among the 25 most common solid tumors, the SIRs were increased for all but nine sites; the highest SIR (40.8) was observed for spinal meningioma. The SIRs for solid tumors declined in an age-dependent manner from 4.52 in diagnostic age younger than 20 years to 1.12 in diagnostic age 70 +/- years. In the most common patient groups, the SIRs for solid tumors increased up to 30 years after NHL diagnosis. Because of the high incidence of solid tumors in these age groups, they contributed the largest numbers of therapy-related cases. Conclusion These data indicate that age at treatment determines both the magnitude of the initial relative risk and the time-dependent modulation of the response. Therapy-related damage persists at least 30 years and its toll of solid tumors is largest 21 to 30 years after diagnosis
    Type of Publication: Journal article published
    PubMed ID: 18347006
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