Three long-term phase III oncology studies analysed by 4Pharma published recently

Marko Suojanen (marko.suojanen a, Jan 11th 2010

In FinXX study 1500 women with early breast cancer were followed up for a median time of 3 years before the present interim analysis. The analysis showed that integration of capecitabine into anthracycline-/taxane-based adjuvant therapy had significantly better efficacy compared with schedule of standard agents. The rate of breast cancer recurrence was reduced by 34% with a manageable toxicity profile. Link to the abstract:

In Finher study 1010 women with early breast cancer, including a subset of 232 women with HER2-positive disease were followed up for a median time of 5 years. The results of the interim analysis have been published earlier (Joensuu et al., N Engl J Med 2006). The final analysis confirmed that adjuvant treatment with docetaxel improves distant disease-free survival compared with vinorelbine. Furthermore, the final analysis suggested that among the HER2-positive women a brief course of trastuzumab administered concomitantly with docetaxel is safe and effective and warrants further evaluation. Link to the abstract:

In GAD study 237 women with advanced breast cancer were followed up for 2 years. The women were randomised to receive either docetaxel cycles or docetaxel cycles alternating with gemcitabine cycles until treatment failure as first-line chemotherapy. There was no significant difference in time to treatment failure between the two arms. However, the alternating treatment arm was associated with fewer severe adverse effects when the safety data was evaluated per cycle. Link to the abstract: