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U Creutzig

Publications and source records attributed to U Creutzig.

131 records · Page 8Linked to original sources

[Prognosis of children with chronic myeloid leukemia: a retrospective analysis of 75 patients].

UNLABELLED: As the probability of survival of patients with chronic myelocytic leukemia (CML) gradually decreases over a period of 10 years, long-term follow-up is mandatory. Between 1977 and 1994, 68 children and adolescents between 1.0 and 18 years of age with CML in chronic phase and 7 presenting with blast crisis at diagnosis were reported to the study center in Münster. The Philadelphia-chromosome and/or BCR/ABL rearrangement could be detected in 66 children. The 4 Philadelphia-negative patients and 5 patients without karyotyping fulfilled the morphological criteria of CML. Clinical symptoms and hematological findings at presentations were similar to adult patients. THERAPY: Until 1985 chemotherapy consisted predominantly in busulfan (BU), later in hydroxyurea (HU) or a combination of both and since 1987 increasingly in HU plus interferon-alpha. 47 patients (6 in blast crisis) were allografted once or twice (n = 4) (27 HLA-identical, 16 unrelated, 4 haplo-identical) within 2.3-135 months (median 12 months) after diagnosis. RESULTS: 38 of 75 patients (3 in blast crisis at diagnosis) were alive after a median follow-up of 5.5 years. The probability of 12 years survival was 27%, SE 9% for patients in chronic phase. All deaths (n = 19) were leukemia-related in the 27 non-transplanted children. A comparison of survival for patients with or without bone-marrow transplantation (BMT) showed a significant difference in favour of the BMT-group (42%, SE 13% vs. 10%, SE 8%, p log-rank 0.003). The probability of survival increased to 62%, SE 10%, if patients transplanted later than 3 years after diagnosis were excluded. Only few patients (4/39 with information about the cause of death = 10%) died due to recurrent CML after BMT. CONCLUSION: Our data confirm the unfavourable outcome of CML in pediatric patients if treated with chemotherapy alone. With early BMT high cure rates can be achieved. If transplant-related mortality which in our patient group was 21% (8/39) can be reduced, even a higher cure rate appear realistic for the future.

Adolescent↗

[Treatment of chronic myeloid leukemia in children and adolescents--concept of the multicenter pilot study CML-ped].

CML is a rare malignancy in childhood not yet being treated by an established protocol of the Society of Pediatric Oncology and Hematology (GPOH). Up to now only allogeneic bone marrow transplantation (BMT) offers a curative treatment option. After being enrolled into the study "CML-päd" patients with a matched sibling donor should undergo BMT within six months after diagnosis and within one year if an unrelated donor can be identified. Progress in palliative therapy results from the experience in adult patients: Hydroxyurea in combination with interferon alpha (IFN) is the treatment of choice. One aim of the study is to monitor quantitatively in bone marrow aspirates the activity of the disease in all patients on treatment every three months by performing cytogenetics and molecular analysis. As a pilot protocol intensification of treatment by idarubicine and cytarabine is scheduled one year after diagnosis for those patients not undergoing BMT and exhibiting after IFN treatment less than partial response. After progress to the accelerated phase of the disease a decision has to be made on an individual basis whether the patient should undergo new experimental treatment approaches.

Adolescent↗

[Acute myeloid leukemia in children with Down syndrome].

Forty-four children, aged between 0.4 and 16.2 years (median 2.0 years) with Down's syndrome and acute myelogenous leukemia (AML) including subacute megakaryoblastic leukemia (M7) were diagnosed between 1980 and 1986 (group 1, n = 16) or between 1987 and 1992 (group 2, n = 28). The leukemic blasts from Down's syndrome patients often proved difficult to classify. In group 1 the most frequent diagnoses were FAB M5 (6 pts.), M6 (3 pts.), in 3 patients the morphological diagnosis of M7 can retrospectively be assumed. In group 2, 15 of 28 patients were classified as M7, in 3 patients based on morphology alone, and in the other 12 patients confirmed by immunophenotyping or biopsy. The other children in group 2 were classified as: FAB M0 (3 pts.), M1 (1 pt.), M4 (2 pts.), M5 (2 pts.), M6 (4 pts.), M6/M7 (1 pt.). Initially, the latter and 10 of the patients with M7 presented with < 30% of blasts in the bone marrow. Karyotyping in 12 of 13 children frequently revealed numeric abnormalities, particularly trisomies involving chromosomes 8 (n = 6), 11 (n = 3), 21 (n = 3) and 14 (n = 1) in addition to the constitutional + 21c. Six patients in group 1 received no specific treatment, while 10 children were treated according to the protocols AML-BFM-78 or -83. Four of them are still alive for more than 5 years, two others died from infections in remission after 1.0 and 3.8 years. Fourteen of the 28 patients in group 2 did not receive any chemotherapy (10 with M7), and subsequently died.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

[Recommendation for studies of optimizing therapy protocols].

Guidelines to establish the principles for the standard of Good Clinical Practice (GCP) for trials on medicinal products in human beings were coming into operation in the European Community in 1991. These recommendations are more extensive than those of the German drug regulatory act (AMG). Included are outlines for the protection of the patient, the responsibilities of the investigator, for biometrics and the quality assurance. Although most of the studies in pediatric oncology optimizing treatment schedules do not belong to the studies as defined by the AMG, certain rules and regulations are strictly adhered to, e.g. the Declaration of Helsinki for the protection of human rights, medical justification of involved risks, adequate and freely obtained informed consent of the patient and the parents. Furthermore, the approval of Ethics Committees must be requested.

Child↗

[Establishment of a uniform common data set for pediatric oncology. Applied Informatics Study Group of the GPOH (Society of Pediatric Oncology and Hematology)].

Large multicenter trials have made a major contribution to the improvement of treatment results in childhood malignancies. Coordination and central documentation ensure the quality of treatment and permit clinical and scientific investigations. This kind of cooperation requires a vast amount of documentation, which by itself has become a critical factor in answering important medical questions. The problems result from non-standardized documentation systems in different studies, from insufficient integration of clinical work and documentation and from a lack of application of modern computer based data management systems. The working group "Applied Informatics" of the German "Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH)" has started a project to create an uniform basic data set for the German pediatric oncology group. Relevant initial diagnostic data, information about planned and realized treatment as well as data concerning negative event had to be standardized. A minimal common data set with a substantially reduced documentation, which is applicable for all patients and trials, would have failed to fulfil the clinical as well as the research needs. The data set presented here is a detailed information structure introduced as a basic tool for the improvement of data management in the German pediatric oncology group. This first version of the basic data set will need further development, since some of the problems still need to be resolved and the requirements for such data pools are changing. Based on this data set new computer software and clinical information systems have to be developed to enable documentation and processing of all clinical and study related data.

Child↗