Kümmel S, et al. - The GENEVIEVE study was designed to compare the pathological complete response (pCR) rate (ypT0/is ypN0/+) in patients with operable human epidermal growth factor receptor 2 (HER2)–negative breast cancer (BC) treated with either cabazitaxel or paclitaxel. Findings of this study indicated no short-term effect of cabazitaxel in triple-negative or luminal B/HER2-negative primary BC, while there seemed to be no differences in drug exposure and patient compliance between the two arms.

Methods

• A comparison was performed of the efficacy and the safety of four 3-weekly cycles cabazitaxel versus 12 weeks of paclitaxel given as neoadjuvant treatment in GENEVIEVE that was a prospective, multicentre, randomised, open-label, phase II study.
• For this study, primary end-point included the pCR rate defined as the complete absence of invasive carcinoma on histological examination of the breast irrespective of lymph node involvement (ypT0/is, ypN0/+) after the taxane treatment.
• An anthracycline-based therapy might be administered to patients thereafter.

Results

• Overall, randomization of 333 patients was performed and treatment was initiated.
• 74.7% and 83.2% of patients completed treatment in the cabazitaxel and paclitaxel arms, respectively.
• Patients in cabazitaxel arm indicated a markedly lower pCR rate compared to the paclitaxel arm (1.2% versus 10.8%; p = 0.001).
• At least one serious adverse event was evident in a total of 42 (25.3%) patients in the cabazitaxel arm and 17 (10.2%) in the paclitaxel arm (p < 0.001).
• In 9.6% patients in the cabazitaxel arm, dose reductions were observed compared to 11.4% in the paclitaxel arm (p = 0.721).
• Main reason for dose reductions included non-haematological toxicities in 3.0% versus 7.8% (p = 0.087), respectively.