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• W2149117308 abstract "We would like to thank Tomao et al for their comments regarding our report of the AURELIA randomized phase III trial evaluating the addition of bevacizumab to single-agent chemotherapy in patients with platinum-resistant ovarian cancer. We agree with Tomao et al that the risk of fatal adverse events with bevacizumab does not appear to be affected by the bevacizumab regimen or administration schedule. For this reason, we chose a pragmatic bevacizumab schedule when combined with chemotherapy with the aim of minimizing inconvenience and preserving patients’ quality of life, that is, 15 mg/kg every 3 weeks if chemotherapy was administered every 3 weeks or 10 mg/kg every 2 weeks if chemotherapy was delivered on days 1, 8, and 15 every 4 weeks, to avoid bevacizumab administration during the chemotherapy-free week. Tomao et al question the inclusion of a weekly paclitaxel-based cohort in addition to pegylated liposomal doxorubicin (PLD) and topotecan in AURELIA. They comment that paclitaxel may be less active in patients previously treated with a paclitaxel-based regimen and that the weekly paclitaxel-bevacizumab combination may be more toxic than other single-agent chemotherapies combined with bevacizumab. This view is in contrast to several reports suggesting that weekly paclitaxel is a highly active and well-tolerated regimen in relapsed ovarian cancer, inducing significant response rates in patients whose tumors are resistant to paclitaxel administered once every 3 weeks. Indeed, the weekly paclitaxel regimen is being adopted increasingly for the treatment of platinum-resistant ovarian cancer and is widely used as the control arm in current clinical research with molecular targeted agents in this setting. In line with these data, exploratory analyses in predefined subgroups (based on stratification factors) in AURELIA showed that weekly paclitaxel was associated with a high response rate (29% with paclitaxel alone) and long median progression-free survival (3.9 months [95% CI, 3.5 to 5.6]) compared with PLD or topotecan. None of the deaths in the bevacizumab plus chemotherapy combination arm occurred in the weekly paclitaxel cohort. A numerical increase in the overall incidence of peripheral sensory neuropathy was detected, but may be explained by the longer duration of chemotherapy exposure associated with the strikingly prolonged progression-free survival when bevacizumab was combined with weekly paclitaxel. Globally, the AURELIA results provide convincing evidence for the addition of bevacizumab to all three chemotherapy agents evaluated. This is important, considering that many patients may not be candidates for taxane therapy. Furthermore, no increase in fatal adverse events is observed when bevacizumab is combined with weekly paclitaxel, and efficacy data strongly support the use of the paclitaxelbevacizumab combination. These results should reassure Tomao et al and encourage the use of weekly paclitaxel and bevacizumab in selected patients with platinum-resistant ovarian cancer." @default.
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• W2149117308 date "2014-11-01" @default.
• W2149117308 modified "2023-10-14" @default.
• W2149117308 title "Reply to F. Tomao et al" @default.
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• W2149117308 doi "https://doi.org/10.1200/jco.2014.57.7379" @default.
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