Abstract | PURPOSE: METHODS: This was a prospective, multi-center, single-arm phase II study. Patients with non-squamous NSCLC who had experienced progression after cytotoxic chemotherapy were enrolled. Oral S-1 was administered on days 1-14 of a 21-day cycle, and bevacizumab (15 mg/kg) was given intravenously on day 1. Patients received S-1 adjusted on the basis of their creatinine clearance and body surface area. The primary endpoint was response rate (RR); secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. RESULTS: We enrolled 30 patients. One patient had never received platinum-based therapy. Five patients had activating mutations of the epidermal growth factor receptor gene, of whom four had received tyrosine kinase inhibitors before this study. The RR was 6.7% [95% confidence interval (CI) 1.8-21.3%], and the disease control rate (DCR) was 80% (95% CI 62.7-90.5%). Median PFS was 4.8 months (95% CI 2.7-6.4 months], and median OS was 13.8 months (95% CI 8.4 months-not applicable). Patients did not experience any Grade 4 toxicity or treatment-related death. Grade 3 hematologic toxicity ( anemia) occurred in one patient (3.3%). The main Grade 3 non-hematologic toxicities were anorexia (10%), infection (10%), and diarrhea (6.7%). CONCLUSION: The addition of bevacizumab to S-1 was tolerable, but not beneficial for patients with previously treated non-squamous NSCLC. We do not recommend further study of this regimen.
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Authors | Yu Nishijima-Futami, Seigo Minami, Shinji Futami, Taro Koba, Masayoshi Higashiguchi, Motohiro Tamiya, Hidekazu Suzuki, Tomonori Hirashima, Kiyoshi Komuta, Takashi Kijima |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 79
Issue 6
Pg. 1215-1220
(Jun 2017)
ISSN: 1432-0843 [Electronic] Germany |
PMID | 28455584
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- Angiogenesis Inhibitors
- Drug Combinations
- S 1 (combination)
- Tegafur
- Bevacizumab
- Oxonic Acid
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Topics |
- Adult
- Aged
- Angiogenesis Inhibitors
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects, therapeutic use)
- Bevacizumab
(administration & dosage)
- Carcinoma, Non-Small-Cell Lung
(drug therapy)
- Disease-Free Survival
- Drug Combinations
- Female
- Humans
- Lung Neoplasms
(drug therapy)
- Male
- Middle Aged
- Oxonic Acid
(administration & dosage)
- Prospective Studies
- Tegafur
(administration & dosage)
- Treatment Outcome
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