gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Impact of PS76A2, a standardised mistletoe extract, on quality of life in breast cancer patients during chemotherapy and follow-up: a randomised, placebo-controlled, double-blind, multicentre clinical trial

Meeting Abstract

  • corresponding author presenting/speaker Marc Azemar - Klinik für Tumorbiologie, Freiburg, Deutschland
  • Viktor F. Semiglazov - Petrov Research Institute of Oncology, St. Petersburg, Russia
  • Jörg Schnitker - Institut für Angewandte Statistik, Bielefeld
  • Ulrich Mengs - MADAUS GmbH, Köln

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO544

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dkk2006/06dkk654.shtml

Veröffentlicht: 20. März 2006

© 2006 Azemar et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

The objective of this clinical trial was to investigate the impact of PS76A2, an aqueous mistletoe extract standardised to mistletoe lectins (Lektinol®) on quality of life (QoL) of breast cancer patients during chemotherapy and follow-up. A total of 352 patients were randomly allocated to two groups receiving PS76A2 (15ng mistletoe lectin/0.5 mL) or matching placebo 2times per week for 4to 6cycles of CMF chemotherapy followed by 2 months follow-up. The primary efficacy endpoint was the change from baseline of 3subscales (physical, emotional and functional well-being) of FACT-G. Secondary measures included GLQ-8 (8linear analogue self assessment scales), Spitzer's uniscale, and haematological efficacy variables. Main variables of safety analysis were adverse events including injection site-reactions and clinical laboratory tests. As a result, physical, emotional and functional well-being was improved upon PS76A2, but deteriorated following placebo. The treatment differences were statistically significant for the three subscales as well as for the summary score FACT-G which was analysed as O'Brien's rank sum of its three subscales (p<0.0001). The GLQ-8 sum of 8LASA scales was analysed as summary score of GLQ-5 and GLQ-3 sum. GLQ-5 characterised typical aspects of QoL while GLQ-3 consisted of 3side-effects of CMF (feeling sick, numbness or pins and needless, loss of hair). GLQ-5 improved upon PS76A2, but decreased upon placebo (p<0.0001). GLQ-3 deteriorated in both groups, but the differences in favour of PS76A2 were nevertheless statistically significant (p=0.0007). The total score GLQ-8 and Spitzer`s uniscale improved after PS76A2 and deteriorated after placebo (p<0.0001). After a follow-up period of 2 months without chemotherapy, a significant treatment difference in favour of PS76A2 was determined in the level of QoL measured by means of FACT-G, GLQ-8, and Spitzer's uniscale, too. PS76A2 was well tolerated in this trial and local site-reactions were the only predominant events. In conclusion, PS76A2 was shown to be safe and effective in improving QoL in breast cancer patients during chemotherapy and follow-up.