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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Munemoto, Yoshinori Kanda, Mitsuro Ishibashi, Keiichiro Hata, Taishi Kobayashi, Michiya Hasegawa, Junichi Fukunaga, Mutsumi Takagane, Akinori Otsuji, Toshio Miyake, Yasuhiro Nagase, Michitaka Sakamoto, Junichi Matsuoka, Masaki Oba, Koji Mishima, Hideyuki |
| Abstract | Background Although number of elderly patients with metastatic colorectal cancer (mCRC) is rapidly increasing, this population is often underrepresented in clinical trials. Recently, a phase II trial demonstrated that capecitabine and oxaliplatin (XELOX) combined with bevacizumab XELOX plus bevacizumab was effective and well tolerated by elderly patients with mCRC who reside in Western countries. The aim of this study was to evaluate the safety and efficacy of XELOX plus bevacizumab for Japanese patients aged ≥75 years with mCRC. Methods This prospective, open-label phase II trial recruited patients aged ≥75 years with previously untreated mCRC between March 2010 and January 2012. Treatment consisted of 7.5 mg/kg of intravenous bevacizumab and 130 mg/m2 of oxaliplatin on day 1 of each cycle combined with 2000 mg/m2 of oral capecitabine per day on days 1–14 of each cycle. Treatment was repeated every 3 weeks until disease progression or termination of the study. The primary endpoint was progression-free survival; the secondary endpoints were toxicity, overall response rate, time-to-treatment failure, and overall survival. Results Thirty-six patients (male 58 %; median age 78 years; colon cancer 67 %) met all eligibility criteria and received at least one course of the planned treatment. The median time-to-treatment failure was 7.0 months. Twelve patients (33.3 %) experienced adverse effects (AEs) ≥ grade 3 and frequent AEs ≥ grade 3, including neutropenia (22.2 %) and neuropathy (13.9 %). Hypertension was the most frequent AE ≥ grade 3 associated with bevacizumab (11.1 %). Low baseline creatinine clearance associated significantly with the incidence of AEs ≥ grade 3. Response and disease control rates were 55.6 and 91.7 %, respectively. Median progression-free and overall survival times were 11.7 months (95 % confidence interval, 8.0–13.4 months) and 22.9 months, respectively. Conclusion XELOX combined with bevacizumab was well tolerated by selected Japanese patients aged ≥75 years with mCRC patients, and controlled clinical trials are now required to determine the survival benefit. |
| Related Links | https://bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-015-1712-0.pdf |
| Ending Page | 10 |
| Page Count | 10 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 14712407 |
| DOI | 10.1186/s12885-015-1712-0 |
| Journal | BMC Cancer |
| Issue Number | 1 |
| Volume Number | 15 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2015-10-24 |
| Access Restriction | Open |
| Subject Keyword | Cancer Research Oncology Surgical Oncology Health Promotion and Disease Prevention Biomedicine Medicine Public Health Colorectal cancer Elderly Bevacizumab XELOX Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Cancer Research Oncology Genetics |
| Journal Impact Factor | 3.4/2023 |
| 5-Year Journal Impact Factor | 3.8/2023 |
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