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A Real-World Retrospective Cohort Study of Combined Therapy with Bevacizumab and Paclitaxel in Japanese Patients with Metastatic Breast Cancer
1Department of Surgery, Sekishindo Hospital, Saitama, Japan
2Division of Breast Oncology, Saitama Cancer Center, Saitama, Japan
3Department of Breast Surgery, Nippon Medical School, Tokyo, Japan
4Department of Breast and Endocrine Surgery, Saitama Medical Center, Saitama, Japan
5Department of Breast Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan
6Division of Breast Surgery, Ninomiya Hospital, Saitama, Japan
7Division of Surgery, JCHO Saitama Medical Center, Saitama, Japan
8Department of Surgery, Saitama Sekishinkai Hospital, Saitama, Japan
9Department of Breast Surgery, Kasukabe Medical Center, Saitama, Japan
10Breast Center, Mitsui Hospital, Saitama, Japan
11Shintoshin Ladies' Mammo Clinic, Saitama, Japan
12Department of Pathology, Saitama Cancer Center, Saitama, Japan
13The Saitama Breast Cancer Clinical Study Group
Objective: Combined therapy with bevacizumab and paclitaxel (BP regimen) as a first-line treatment has proven highly effective with good tolerance for patients with metastatic breast cancer (MBC). The objective of this study was to examine the efficacy and safety of the BP regimen for Japanese patients with MBC in real-world clinical settings.
Methods: From June 2012 through May 2014, we recruited 94 patients at 10 medical institutions. The primary endpoint was time to treatment failure (TTF), and the secondary endpoints were overall survival (OS) and safety. Objective response was assessed according to the Response Evaluation Criteria in Solid Tumors. Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0-Japan Clinical Oncology Group.
Results: Nighty patients with MBC (mean 58 years, range: 34-80 years) were enrolled, and 60 (66.6%) and 52 (57.7%) had undergone prior chemotherapy as adjuvant treatment and treatment for MBC, respectively. Median TTF was 6.2 months (95% confidence interval [CI], 4.2-8.3 months), and median OS was 15.4 months (95% CI, 12.0-18.9 months). The overall response rate was 67.8% (95% CI: 57.1-77.2%). A total of 28 patients (31.1%) required a dose reduction of paclitaxel. Forty-five, 42, and 3 patients received the initial doses of 90, 80, and 60 mg/m2, respectively. Among patients who received the initial doses of 90 mg/m2, 13 patients (28.9%) unexpectedly required a dose reduction of ≥20 mg/m2. The BP regimen was discontinued for 66 (73.3%) of the 90 patients, 52 (57.7%) of whom experienced"disease progression."Grade 3/4 hematologic AEs developed in 51 patients (56.6%), with leukopenia and neutropenia in 16 patients (17.8%) and 21 patients (23.3%), respectively. Grade 3 nonhematologic AEs developed in 8 patients (8.9%), with the most common nonhematologic AE of peripheral neuropathy in 4 patients (4.4%). No Grade 4 nonhematologic AEs developed. Peripheral neuropathy [56 patients (62.2%)], nail discoloration [53 patients (58.9%)], and fatigue [51 patients (56.7%)] were the most predominant AEs-the known AEs of paclitaxel.
Conclusions: The BP regimen was active and well tolerated in the real-world clinical settings. As many as 28.9% of patients who received the initial dose of 90 mg/m2 required a dose reduction of paclitaxel by 20 mg/m2. Therefore, there is a need to find a therapeutic regimen that is less likely to result in dose reductions for patients with MBC who undergo a BP regimen using the initial paclitaxel dose of 90 mg/m2.
J Nippon Med Sch 2017; 84: 215-223
Keywords
metastatic breast cancer, bevacizumab, paclitaxel, combined therapy, cohort study
Correspondence to
Kenichi Inoue, MD, PhD, Division of Breast Oncology, Saitama Cancer Center, 780 Komuro, Ina-machi, Kita-adachi-gun, Saitama 362-0806, Japan
ino.bad.ken@gmail.com
Received, February 9, 2017
Accepted, August 4, 2017
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