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First-line bevacizumab (B) plus paclitaxel (P) in HER2-negative (HER2-ve) metastatic breast cancer (mBC): Efficacy and safety in an Italian multicenter retrospective study.

e11502 Background: The combination of B with P as first-line treatment for patients (pts) with HER2-ve mBC showed clinical benefits in terms of progression-free survival (PFS) and objective response rate (ORR) without an effect on overall survival (OS). This Italian multicenter retrospective study wanted to evaluate the first-line B plus P in term of efficacy and safety in routine oncology practice.


METHODS
A total of 96 female pts with HER2-ve mBC, Eastern Cooperative Oncology Group performance status of 0 to 1, received B 10 mg/Kg every 2 weeks or 15 mg/Kg every 3 weeks combined with P. PFS and OS were estimated using the Kaplan-Meier method and compared with log-rank test. Chi-square test was employed for comparison of proportion.


RESULTS
Pts characteristics included: median age 56.8 years; ≥3 sites of lesion 11.5%; previous (neo)adjuvant chemotherapy (CT) 83.4% (taxane-based CT 27.1%). After a median follow-up of 9.6 months, 51 pts progressed and 17 died. 46 pts (48.9% of evaluable pts) attained a disease response: 13 complete responses and 33 partial responses. Median PFS and OS were 9.5 and 22.7 months, respectively. ≥3 sites of lesion were associated with a significant worse PFS (p=0.02) and OS (p=0.03). No associations were found with clinical end-points based on biological variables (ER, Ki-67) stratification. Previous treatment in neo(adjuvant) setting with taxane-based regimens had a significant less chance to obtain disease response (p=0.002), and worse PFS (p=0.009) and OS (p=0.04). The majority of adverse events (AEs) were mild or moderate. Grade ≥3 AEs included hypertension (2.1%), neutropenia (1.0%), thromboembolic events (1.0%) and gastrointestinal perforation (1.0%). The occurrence of hypertension (all grades) was significantly associated with better ORR (76.5% vs 42.8%; p=0.01) and with a trend (not significant) of better PFS (p=0.08).


CONCLUSIONS
The efficacy and safety data of B plus P collected in this study were consistent with results from first-line trials. Pre-treatment in (neo)adjuvant setting with taxane was associated with a worse prognosis. We also confirmed hypertension as significant predictor of B activity.