Quelle: Medline Abstract
Mistelsymposium
München 2008
Brustkrebstherapie mit einem standardisiertem
Mistelextrakt (Studie II): Am Scientific Research
Oncological Institut, St. Petersburg, Russland, nahmen 352 Brustkrebs-Patientinnen
an einer prospektiven, randomisierten und placebo-kontrollierten
(Placebo=Scheinmedikament) Studie teil.
Ziel der Untersuchung war es herauszufinden, ob sich die von den
Patientinnen selbst beurteilte Lebensqualität im Verlauf der Chemotherapie
(CMF-Protokoll) unter der Gabe des standardisierten Mistelextrakts
PS76A2 (Lektinol ®) im Vergleich zur Gabe eines Scheinmedikaments
statistisch eindeutig bessert.
Die
Auswertung der mit den bewährten Testverfahren FACT-G , Spitzer-Uniscale
und GLQ-8) erzielten Resultate zeigte, dass der Mistelextrakt
die subjektiv erlebte Lebensqualität im Vergleich zur Anwendung
des Scheinmedikaments deutlich verbesserte. Diese Verbesserungen
konnten nicht nur während der Chemotherapie beobachtet werden,
sondern auch in der Zeit nach Beendigung der Standard-Krebstherapie.
zur zweiten Studie
hier
Die
vollständige englischsprachige Kurzversion dieser Studie (sog.
MEDLINE Abstract) finden Sie
hier und
hier
Anticancer
Res. 2006 Mar-Apr;26(2B):1519-29.
Quality
of life is improved in breast cancer patients by Standardised
Mistletoe Extract PS76A2 during chemotherapy and follow-up: a
randomised, placebo-controlled, double-blind, multicentre clinical
trial.
Semiglazov VF, Stepula VV, Dudov A, Schnitker J, Mengs U.
Petrov Research Institute of Oncology, St. Petersburg, Russia.
The objective of this randomised, multicentre, double-blind
clinical trial was to investigate the impact of PS76A2, an aqueous
mistletoe extract standardised to mistletoe lectins, on quality
of life (QoL) in breast cancer patients.
A total of 352 patients were randomly allocated to 2 groups
receiving PS76A2 (15 ng mistletoe lectin/0.5 ml) or matching placebo
twice weekly for 4 to 6 cycles of CMF (cyclophosphamide, methotrexate,
fluorouracil) chemotherapy followed by 2 months follow-up.
The
primary efficacy end-point was the change from baseline of 3 FACT-G
subscales (physical, emotional and functional well-being) during
the fourth CMF cycle. Secondary measures included GLQ-8 (8 linear
analogue self-assessment scales), Spitzer's uniscale and haematological
variables.
The main variables of safety analysis were adverse events, including
injection site reactions and clinical laboratory tests.
The results showed that physical, emotional and functional
well-being improved upon PS76A2, but deteriorated following
placebo. The treatment differences were statistically significant
for the 3 subscales as well as for the summary score FACT-G, which
was analysed as O'Brien's rank sum of its 3 subscales: The total
score increased by 4.40 +/- 11.28, indicating a higher QoL after
PS76A2, but decreased by 5.11 +/- 11.77 with placebo (p<0.0001).
The GLQ-8 sum of 8 LASA scales was analysed as a summary score
of GLQ-5 (sum of item nos. 1, 5, 6, 7, 8) and GLQ-3 (sum of item
nos. 2, 3, 4). GLQ-5 characterises typical aspects of QoL, while
GLQ-3 consists of 3 side-effects of CMF (feeling sick, numbness
or pins and needles, loss of hair). GLQ-5 decreased by 42.9 +/-
125.0 upon PS76A2, indicating an improvement in QoL, but increased
by 60.3 +/- 94.0 upon placebo (p<0.0001).
GLQ-3 deteriorated in both groups (PS76A2: 13.9 +/- 52.4; placebo:
34.5 +/- 57.0), but the differences in favour of PS76A2 were,
nevertheless, statistically significant (p=0.0007). The total
score GLQ-8 improved by 28.9 +/- 154.6 after PS76A2 and deteriorated
by 94.8 +/- 141.1 after placebo (p<0.0001). Spitzer's uniscale
improved by 12.2 +/- 30.7 upon PS76A2 and deteriorated by 10.8
+/- 26.1 with placebo (p<0.0001).
After follow-up without chemotherapy, a significant treatment
difference in favour of PS76A2 was determined by means of FACT-G,
GLQ-8 and Spitzer's uniscale. PS76A2 was well tolerated in this
trial, with the exception of slight local reactions in 17.6% of
the PS76A2 group. In conclusion, PS76A2 (15 ng mistletoe lectin/0.5
ml twice weekly) was shown to be safe and effective in improving
QoL in breast cancer patients during chemotherapy and follow-up.
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