It has been followed by ABC-02, a randomised phase III study, also run under the auspices of the UK-NCRN, comparing the same two treatment arms but powered to detect a survival advantage as the primary end point.
Ledermann, J. et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial.
A randomised phase 3 trial by the German CONKO-study group (Pelzer et al, 2011) reported a median survival of 2.3 months in patients receiving best supportive care after front-line gemcitabine-based therapy, with a OS3-month of ∼35%.
In a randomised phase II study by Tempero et al (2003) comparing gemcitabine treatment as a standard 30 min infusion to administration at an FDR of 10 mg m−2 min−1 over 150 min, the 1- to 2- and even 3-year survival rates were in favour of the FDR.
The trial by Falkson and Falkson (1996), which was a randomised phase II study, was excluded.
In a randomised phase III trial conducted by Schadendorf et al. [ 83], patients received autologous peptide-loaded DC vaccination or DTIC (850 mg/m) at 4-week intervals.
However, the only individual randomised trial included in this meta-analysis that demonstrated significant improvements in recurrence and progression with the addition of chemotherapy to BCG was a randomised phase II trial reported by Di Stasi and colleagues [ 14].
The function of PCI in patients with ED-SCLC after chemotherapy has recently been investigated in a randomised Phase III trial conducted by the EORTC lung group (Slotman et al, 2007).
It has been developed by the German Cancer Research Center and been used before in a randomised phase II trial (Manegold et al, 2005).
Among them, Abraxane has been approved for metastatic breast cancer by the Food and Drug Administration in the USA based on the results of a randomised phase 3 trial.
