A Real‐World Multicentre Retrospective Study of Paclitaxel‐Bevacizumab and Maintenance Therapy as First‐Line for HER2‐Negative Metastatic Breast Cancer

Abstract

Bevacizumab in combination with taxanes in HER2‐negative metastatic breast cancer (MBC) patients has shown improved progression‐free survival (PFS), despite the lack of clear overall survival (OS) benefit. We performed a retrospective analysis to evaluate the impact of paclitaxel‐bevacizumab and of maintenance therapy with bevacizumab (BM) and endocrine therapy (ET) in the real‐world practice. We identified 314 HER2‐negative MBC patients treated in 12 cancer centers. Overall, the median PFS and OS were 14 and 40 months, respectively. Among the 254 patients potentially eligible for BM, 183 received BM after paclitaxel discontinuation until progression/toxicity. PFS and OS were improved in patients who had received BM in comparison with those potentially eligible but who did not receive BM (P< 0.0001 and P = 0.001, respectively). Results were confirmed when adjusting for propensity score. Among the 216 hormone‐receptor positive patients eligible for BM, a more favorable PFS and OS were observed when maintenance ET was administered (P < 0.0001). Multivariate analysis showed that PS, BM, number of disease sites and maintenance ET were related to PFS, while response and maintenance ET were related to OS. In hormone‐receptor positive patients, BM produced a significant PFS and a trend towards OS benefit only in absence of maintenance ET (P = 0.0007 and P = 0.06, respectively). In the triple‐negative subgroup, we observed a trend towards a better OS for patients who received BM (P = 0.06), without differences in PFS (P = 0.21). Our results confirmed the efficacy of first‐line paclitaxel‐bevacizumab in real‐world practice; both BM and maintenance ET significantly improved PFS and OS compared to no maintenance therapies. J. Cell. Physiol. 232: 1571–1578, 2017. © 2016 Wiley Periodicals, Inc.

Long-term response to first-line bevacizumab-based therapy in patients with metastatic breast cancer: results of the observational &ldquo;LORENA&rdquo; study

“… 32 Furthermore, several real-world studies have shown that MHT in combination with maintenance bevacizumab is associated with either improved PFS, 33 or improved PFS and OS. 27 , 31 These findings, in conjunction with the findings of the present study, suggest that the addition of hormonal therapy to maintenance bevacizumab after first-line bevacizumab-based therapy is a promising treatment option for patients with hormone receptor-positive MBC.…”

“… 23 In real-world studies, the median PFS and OS ranged from 8 to 14 months and from 21 to 40 months, respectively. 19 , 24 – 27 Furthermore, the ORR was also higher in the present study than in other real-world studies (60%–70%), 26 , 27 as well as in the long-term treatment subgroup in the ATHENA study (68%). 23 …”

Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab

“…This patient subgroup originated from a larger cohort, whose treatment outcomes had been addressed in previous work. 7 In the present manuscript, data where analyzed to assess the impact of BMI on treatment outcomes. In the overall patient cohort, stratification by BMI did not affect ORR or DCR, neither did we observe any effect in the luminal type subgroup.…”

“…The methods applied were extensively reported elsewhere. 7 Briefly, in the main study, HER2-negative MBC patients were identified and recruited from 12 Italian cancer centres. Treatment administration was compliant with the most updated indications and recommendations.…”

“…5,6 We have previously addressed treatment outcomes in a larger cohort of HER2-negative MBC patients treated with bevacizumab and paclitaxel in first-line chemotherapy. 7 In light of the evidence emerged from recent literature and within our previously established research pipeline on the role of anthropometric and metabolic determinants of treatment efficacy in breast and ovarian cancer, we have now focused on a more restricted subgroup of patients from the original cohort with available data on body mass index (BMI) values at baseline assessment. [8][9][10][11][12][13][14][15] In this patient subgroup, data on several patient-and disease-related features were also analyzed and reinterpreted in light of the evidence emerging from the BMIrelated analysis.…”