gms | German Medical Science

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.