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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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