First results of TURANDOT Trial

Comparing two bevacizumab-containing regimens as first-line therapy for HER2 negative metastatic breast cancer

Professor Christoph Zielinski from the Comprehensive Cancer Centre, Vienna, Austria, presented the first efficacy results from the phase 3 study run by the Central European Cooperative Oncology Group (CECOG). The presentation was entitled the ‘capeciTabine and bevacizUmab Randomised Against avastiN anD taxOl Trial’ (TURANDOT). The study compared two bevacizumab-containing regimens as first-line therapy for HER2 negative metastatic breast cancer.

Prof. Zielinski reported results from a preplanned analysis of data at 19 months from this phase 3 trial of bevacizumab plus either paclitaxel or capecitabine as first-line therapy for patients with HER2 negative breast cancer. The primary objective was to demonstrate non-inferior overall survival with bevacizumab/capecitabine vs bevacizumab/paclitaxel. Interim and final overall survival analyses were planned after 175 and 389 deaths, respectively, in the per-protocol population to reject the null hypothesis of inferiority (hazard ratio [HR] ≥1.33) with 80% power and overall α = 0.025. Secondary endpoints included response rate, progression-free survival, safety and quality of life.

In TURANDOT study, chemotherapy naive patients were randomized to placebo or one of two bevacizumab regimens; 10 mg/kg d1 bevacizumab plus 90 mg/m2 d1 paclitaxel four times weekly or 15 mg/kg d1 bevacizumab plus 1000 mg/m2 bid capecitabine three times per week until disease progression or unacceptable toxicity occurred. Patients’ baseline characteristics were similar in both arms.

The trial’s primary endpoint, non-inferiority in overall survival was not met at the level of statistical significance. The pre-planned interim analysis done at a median of 19 months post-treatment showed one year overall survival rates of 81% in 285 patients treated with bevacizumab plus paclitaxel and 79% in 279 patients receiving the bevacizumab/capecitabine combination hazard ratio 1.04 (−∞ to 1.69); p = 0.0593. The response rate was 44% and 27%, in the two arms, respectively (p = 0.0001). Progression-free survival in the bevacizumab/paclitaxel and bevacizumab/capecitabine arms was median 11 months and 8.1 months, respectively (p = 0.0052).

No safety issues were raised; adverse events were consistent with the known safety profiles of all three drugs. The most common adverse events of grade ≥3 were neutropenia (18%), peripheral neuropathy (14%) and leucopenia (7%) in patients receiving bevacizumab plus paclitaxel while hand-foot syndrome (16%), hypertension (6%) and diarrhoea (5%) occurred with bevacizumab/capecitabine.

Final results from this trial are anticipated in 2014.

Professor Zielinski, commented “While seeing a significantly better progression free survival and overall response rate with paclitaxel + bevacizumab regimens in this randomised controlled trial, the interim analysis shows that overall survival was most probably not compromised by the use of capecitabine + bevacizumab as compared to the other regimen. This is particularly remarkable, as overall survival and its comparison between the two study arms was the primary end point of the study.” 

First results of TURANDOT Trial
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