A meta-analysis of overall survival data from three randomized trials of bevacizumab (BV) and first-line chemotherapy as treatment for patients with metastatic breast cancer (MBC).

Salvage treatment in metastatic breast cancer with weekly paclitaxel and bevacizumab

“…The reported results from three large randomized studies [11,20,23] combining B with chemotherapy showed improvement in PFS but not OS, and this was also confirmed in a recently presented pooled analysis of these three studies [12] and has led to a more critical re-evaluation of the added therapeutic value of B in MBC. The role of B in pre-treated metastatic disease has been evaluated in a few studies [10,25,26] with no effect on overall survival.…”

“…The regimen was very well tolerated with a remarkably low incidence of febrile neutropenia (<1% overall). In a recently presented meta-analysis of three randomized trials in patients with MBC evaluating B plus first-line chemotherapy regimens (taxane-, anthracycline-, or capecitabine-based), median PFS improved from 6.7 to 9.2 months (p<0.0001) in the B arms; however, OS showed no statistically significant difference between the arms (p=0.56) [12].…”

Combining Emerging Agents in Advanced Breast Cancer

“…In a prospective, randomized, but not blinded phase III trial in the first-line treatment of MBC patients, the combination of bevacizumab and paclitaxel led to a significantly longer PFS interval than with paclitaxel alone (median, 11. A meta-analysis of OS from the phase III randomized trial evaluating bevacizumab in combination with paclitaxel (E2100) and the AVADO and RIBBON-1 trials (a total of 2,447 patients) confirmed the significant PFS benefit for bevacizumab in combination with chemotherapy, compared with chemotherapy alone for the first-line treatment of MBC patients (median, 9.2 months versus 6.7 months; HR, 0.64; p Ͻ .0001) [50]. Although the OS time was not significantly different between treatment arms (median, 26.7 months versus 26.4 months; HR, 0.97; 95% CI, 0.86 -1.08; p ϭ .56), the 1-year survival rate was greater for bevacizumab in combination with chemotherapy than for chemotherapy alone (81.6% versus 76.5%; p ϭ .003), suggesting an early benefit at 1 year.…”

Anti-VEGF Therapies in the Clinic

“…These results may also have been affected by variation in study conduct, limited maturity of survival data, access to bevacizumab off protocol, and the amount of treatment and relatively long time patients survived after protocol-defined treatment. Interesting, 50% of patients on the control arms and 40% of patients in the bevacizumab arms of these studies received bevacizumab as some component of their postprotocol therapy (O'Shaughnessy et al 2010). Regardless of these potential confounders, these improvements in PFS taken as a whole were considered sufficiently modest that the FDA has recommended removing bevacizumab's approval for the treatment of metastatic breast cancer (FDA 2010).…”