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Mistelsymposium München 2008
Brustkrebstherapie mit einem standardisiertem
Mistelextrakt (Studie I) : Am Scientific Research Oncological Institut, St.
Petersburg, Russland, wurde eine doppelblind und
randomisierte und Placebo kontrollierte Studie
durchgeführt an der 272 Patientinnen teilnahmen,
die unter einem operablen Brustkrebs litten.
Die Kranken erhielten in den Wochen 1 bis 15
entweder eine Standard-Chemotherapie (CMF-Protokoll)
plus einem Scheinmedikament (Placebo) oder aber
anstelle des Scheinmedikaments eine von drei
unterschiedlichen Konzentrationen eines
standardisierten Mistelextrakts (Lektinol
®). Die
Patientinnen beurteilten zu mehreren Zeitpunkten
anhand standardisierter visueller Verfahren
(GLQ-8 und Spitzer-Uniscale) ihre
Lebensqualität.
Die Auswertung der Antworten ergab für die
mittlere Lektinol-Konzentration eine statistisch
siognifikante Verbesserung der
Lebensqualitäts-Scores.
Der Mistelextrakt PS76A2 wurde gut vertragen und
die beobachteten Nebenwirkungen waren milde.
zur zweiten Studie
hier
Die vollständige englischsprachige
Kurzversion dieser Studie (sog. MEDLINE
Abstract) finden Sie
hier
und
hier
Anticancer Res. 2004
Mar-Apr;24(2C):1293-302.
The standardised mistletoe extract PS76A2
improves QoL in patients with breast cancer
receiving adjuvant CMF chemotherapy: a
randomised, placebo-controlled, double-blind,
multicentre clinical trial.
Semiglasov VF, Stepula VV, Dudov A, Lehmacher W,
Mengs U.
Scientific Research Oncological Institute, St.
Petersburg, Russia.
Patients with breast cancer receiving adjuvant
chemotherapy frequently suffer from a restricted
quality of life (QoL) due to the side-effects of
chemotherapy and the consequences of coping with
the diagnosis. Therefore, the objective of this
clinical study was to investigate the impact of
PS76A2, an aqueous mistletoe extract
standardised to the galactoside-specific
mistletoe lectin, on QoL by performing a
placebo-controlled trial.
Overall, 272 patients with breast cancer
receiving adjuvant CMF chemotherapy (cyclophosphamide-methotrexate-fluorouracil)
were enrolled and randomised to groups receiving
placebo or PS76A2 at concentrations of 10, 30 or
70 ng mistletoe lectin (ML) per ml. The patients
received 0.5 ml study medication twice weekly
subcutaneously for 15 consecutive weeks (4 CMF
cycles).
Primary variables were the self-assessment QoL
scores GLQ-8 (Global Life Quality) and Spitzer's
uniscale.
As a result, statistically significant
effects on QoL were obtained with the medium
dose (15 ng ML/0.5 ml). The treatment difference
between the medium dose and placebo with regard
to the GLQ-8 sum was 60.8 mm (95% confidence
interval: 19.3 to 102.0 mm). The treatment
effect for Spitzer's uniscale between the medium
dose and placebo was 16.4 mm (95% confidence
interval: 6.3 to 26.6 mm).
The results on QoL were supported by an increase
of T helper lymphocytes (CD4+) and the CD4+/CD8+
ratio (p<0.05). Overall, PS76A2 was well
tolerated. Local reactions at the injection
sites occurred dose-dependently, but were mild
at the low and medium dose levels.
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