Title |
A phase II study of carboplatin plus weekly paclitaxel with bevacizumab for elderly patients with non-squamous non-small-cell lung cancer (NEJ016)
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Published in |
Investigational New Drugs, February 2017
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DOI | 10.1007/s10637-017-0436-1 |
Pubmed ID | |
Authors |
Satoru Miura, Makoto Maemondo, Akira Iwashima, Toshiyuki Harada, Shunichi Sugawara, Kunihiko Kobayashi, Akira Inoue, Taku Nakagawa, Yuichi Takiguchi, Hiroshi Watanabe, Takashi Ishida, Masaki Terada, Hiroshi Kagamu, Akihiko Gemma, Hirohisa Yoshizawa |
Abstract |
Background The efficacy and safety of bevacizumab in elderly patients with non-small cell lung cancer remain controversial. This study focused on both selecting fit elderly patients and overcoming interpatient variability with respect to pharmacodynamics. Methods Elderly (age: ≥70 years) patients with advanced non-squamous non-small cell lung cancer were enrolled. Patients with uncontrolled congestive heart failure and uncontrolled diabetes were excluded. The treatment regimen comprised carboplatin at an area under the curve of 5 mg/ml/min on day 1, paclitaxel at 90 mg/m(2) on days 1 and 8, and bevacizumab at 15 mg/kg on day 1 every 21 days for up to 4 cycles, followed by maintenance bevacizumab. Dose reduction due to side effects was performed, with a wide range of doses of paclitaxel from 23 mg/m(2)/week to 60 mg/m(2)/week. Results Of the 36 patients entered, 38.9% required a dose reduction or cancellation of paclitaxel administration on day 8, and 75% patients were able to complete 4 cycles of triplet therapy. The response rate, primary endpoint, was 69.4% (95% confidence interval [CI]: 51.9-83.7). The median progression free survival and overall survival were 8.4 months and 29.2 months, respectively. The most common adverse events included neutropenia, hypertension, anemia, and infection. Although Grade ≥ 3 adverse events were observed in 24 patients (66.7%), there were no deaths due to toxicity. Conclusion Carboplatin plus weekly paclitaxel with bevacizumab is a feasible, effective first-line regimen for elderly non-small cell lung cancer patients. (UMIN00006622). |
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Country | Count | As % |
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Unknown | 32 | 100% |
Demographic breakdown
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Other | 4 | 13% |
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Student > Bachelor | 2 | 6% |
Other | 8 | 25% |
Unknown | 5 | 16% |
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