Article ; Online: Paclitaxel, bevacizumab, and everolimus/placebo as first-line treatment for patients with metastatic HER2-negative breast cancer: a randomized placebo-controlled phase II trial of the Sarah Cannon Research Institute.
Breast cancer research and treatment
2015 Volume 154, Issue 1, Page(s) 89–97
Abstract: Amplified PI3K/Akt/mTOR signaling is common in metastatic breast cancer (MBC). The mTOR inhibitor everolimus improves progression-free survival (PFS) when added to steroidal aromatase inhibitor therapy. This randomized phase II trial compares the ... ...
| Abstract | Amplified PI3K/Akt/mTOR signaling is common in metastatic breast cancer (MBC). The mTOR inhibitor everolimus improves progression-free survival (PFS) when added to steroidal aromatase inhibitor therapy. This randomized phase II trial compares the efficacy of paclitaxel/bevacizumab/everolimus and paclitaxel/bevacizumab/placebo as first-line treatment for MBC. Patients with untreated HER2-negative MBC were randomized (1:1) to receive 28-day cycles of paclitaxel 90 mg/m(2) IV (days 1, 8, and 15) and bevacizumab 10 mg/kg IV (days 1, 15) with either everolimus 10 mg (Arm 1) or placebo (Arm 2) daily. Treatment continued (evaluation every 8 weeks) until progression or unacceptable toxicity. Treatment of 110 patients allowed detection of an improvement in median PFS from 11 to 16 months (70 % power, α = 0.10). Between August 2009 and June 2011, 113 patients (median age 58 years; 88 % ER or PR positive) were randomized (Arm 1, 56; Arm 2, 57). Patients in both arms received a median of six treatment cycles. Median PFS (95 % CI) was 9.1 months (6.8-18.8) for Arm 1, and 7.1 months (5.6-10.8) for Arm 2 (p = 0.89). Comparisons of other efficacy endpoints were also similar in the two treatment arms. Patients receiving everolimus had more anemia, stomatitis, diarrhea, rash, and arthralgia/myalgia, although the overall incidence of severe (grade 3/4) toxicity was similar. The addition of everolimus did not improve the efficacy of weekly paclitaxel/bevacizumab as first-line treatment for patients with HER2-negative MBC. These results contrast with the demonstrated efficacy of adding everolimus to either hormonal or HER2-targeted therapy in previously treated patients. |
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| MeSH term(s) | Adult ; Aged ; Bevacizumab/administration & dosage ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Breast Neoplasms/pathology ; Disease-Free Survival ; Everolimus/administration & dosage ; Female ; Humans ; Middle Aged ; Neoplasm Metastasis ; Paclitaxel/administration & dosage ; Receptor, ErbB-2/genetics |
| Chemical Substances | Bevacizumab (2S9ZZM9Q9V) ; Everolimus (9HW64Q8G6G) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Paclitaxel (P88XT4IS4D) |
| Language | English |
| Publishing date | 2015-11 |
| Publishing country | Netherlands |
| Document type | Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 604563-7 |
| ISSN | 1573-7217 ; 0167-6806 |
| ISSN (online) | 1573-7217 |
| ISSN | 0167-6806 |
| DOI | 10.1007/s10549-015-3599-5 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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