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  • 1
    ISSN: 1432-1440
    Keywords: Metastatic breast cancer ; Corynebacterium parvum ; Comparison of different times and routes
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary From January 1978 to December 1980, 222 patients with metastatic breast cancer were included into a prospective multicenter trial. All patients were treated once a month with six cycles of VAC- (vincristine, adriamycin, cyclophosphamide) chemotherapy, followed by FMC (5-fluor-ouracil, methotrexate, cyclophosphamide) until progression was documented. By random assignment, the patients received immunostimulation with Corynebacterium parvum (CP) by one of four methods: subcutaneous (SC) on either day 1 or day 14, intravenous (IV) on either day 1 or day 14. The 214 evaluable patients were equally distributed to the four arms. The rates of complete or partial response to VAC/FMC plus CP did not differ significantly between the treatment groups. Of our patients, 22–33% were definite treatment failures. The Kaplan-Meier curves of duration of remission (medians 14 vs. 9 vs. 13 vs. 11 months) did not differ significantly. Only small differences in survival were noted among the four study groups (medians 15.4 vs. 17.5 vs. 17.2 vs. 13.0 months). However, complete and partial responders lived significantly longer (Log rank testP=0.008), when CP was given on day 14 by the SC rather than IV route (29+ vs. 14.3 months). Patients in the four study groups were treated with virtually identical doses of VAC/FMC chemotherapy. Patients receiving CP intravenously on day 14 experienced significantly lower mean leukocyte counts than patients in the other groups. Many patients suffered from high temperature (requiring treatment with antipyretics) and severe gastrointestinal toxicity, particularly when CP was given IV on day 1 together with the chemotherapy. Sixteen patients developed skin ulcers following repeated SC injections of CP. They showed a 4-month longer median survival than patients without these local reactions. Taken together, the results suggest that adding CP in the ways tested to monthly VAC/FMC chemotherapy is of no benefit to patients with metastatic breast cancer.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1432-1440
    Keywords: Corynebacterium parvum ; Chemotherapy ; Metastatic breast cancer ; Corynebacterium parvum ; Chemotherapie ; metastasierendes Mammakarzinom
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Zusammenfassung Seit September 1975 haben wir 156 Patientinnen mit metastasierenden Mammakarzinomen in eine prospektive multizentrische Studie aufgenommen. Alle Patientinnen erhielten 6 Zyklen Vincristin, Adriamycin und Cyclophosphamid (VAC) und anschließend weiterhin monatlich einmal 5-Fluorouracil, Methotrexat und Cyclophosphamid (FMC), bis eine Tumorprogression dokumentiert wurde. Auf Grund randomisierter Zuweisung erhielt etwa die Hälfte der Patientinnen zusätzlich subkutan Injektionen von Corynebacterium parvum jeweils am Tag 1 eines Chemotherapiezyklus (VAC/FMC). Bei den 150 auswertbaren Patientinnen fanden sich 33 von 76 (45%) bzw. 36 von 74 (49%) komplette oder partielle Remissionen unter Chemotherapie ohne bzw. mit Zusatz von Corynebacterium parvum. Die Kaplan-Maier-Kurven für die Dauer der Remissionen und des Überlebens waren bei beiden Kollektiven fast identisch (mediane Remissionsdauer 14,5 bzw. 12,1 Monate und mediane Überlebenszeit 22,2 bzw. 21,1 Monate). Die hämatologischen und gastrointestinalen Nebenwirkungen waren bei beiden Gruppen ebenfalls ähnlich. Auffällig war jedoch, daß 19 von 74 (26%) Patientinnen als Folge der wiederholten subkutanen Injektionen von Corynebacterium parvum Hautulcera entwickelten. Diese Patientinnen zeigten die längste Überlebenszeit (p=0.002, log rank test). Diese Ergebnisse lassen vermuten, daß eine unspezifische Immunstimulation mit Corynebacterium parvum am Tag 1 der heute üblichen Polychemotherapie den meisten Patientinnen mit metastasierenden Mammakarzinomen nichts nützt, sondern eine „immunreaktive“ Untergruppe mit gesteigerter lokaler Toxizität und Überlebenszeit selektioniert.
    Notes: Summary A total of 156 patients with metastatic breast cancer were entered into a prospective multicenter trial in September 1975. All patients were treated monthly with vincristine, adriamycin and cyclophosphamide (VAC) six times, followed by 5-fluorouracil, methotrexate and cyclophosphamide (FMC) until progression was documented. By random assignment, the patients received 5 mg/m2 Corynebacterium parvum (CP) subcutaneously on day 1, in addition to VAC/FMC. Of the 150 evaluable patients, 33 of 76 (45%) and 36 of 74 (49%) had complete or partial response to VAC/FMC plus CP, respectively. The Kaplan-Maier curves of duration of remission and survival were almost identical (medians 14.5 vs 12.1 months and 22.2 vs 21.1 months, respectively). The hematologic and gastrointestinal toxicity were also similar in the two study groups. However, 19 of 74 (26%) patients developed skin ulcers after repeated injections of CP. These patients showed prolonged survival (P=0.002, log rank test). These results suggest that adding nonspecific immunostimulation with CP to currently available chemotherapy on day 1 is of no benefit to most patients with metastatic breast cancer, but may select an ‘immunoreactive’ subgroup with increased local toxicity and survival.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1573-5117
    Keywords: water quality ; assessment criteria ; biological hierarchy ; reference conditions ; MuLFA ; Austria ; Europe
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology
    Notes: Abstract We propose a multi-level concept for fish-based assessment (MuLFA) of the ecological integrity of running waters. This concept is designed for large-scale monitoring programmes such as required for the proposed Water Framework Directive of the EU. Out of five different biological organisation levels (fauna, community, guild, population and individual), we propose seven criteria: River-type-specific species, species with self-sustaining populations, fish region, number of guilds, guild composition, population size and population age structure. The principle of the MuLFA is based on assessing the deviation from undisturbed reference conditions. Reference conditions have to be compiled for every distinct river type using historical fish and abiotic data, present river-type-specific reference sites and reference models. The final assessment procedure is done by comparing the assessment reach with the reference conditions using a 5-tiered normative scheme and assigning that reach to the level of highest coincidence. The benefit of the MuLFA is its potential for consistent sensitivity to low- and high-dose human alterations, and due to its general character, its adaptability to all river types.
    Type of Medium: Electronic Resource
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