Weekly docetaxel and gemcitabine in previously treated metastatic esophageal squamous cell carcinoma
- Abstract
- AIM: To assess the efficacy and safety of weekly docetaxel plus a fixed-dose rate (FDR) of gemcitabine in metastatic esophageal squamous cell carcinoma (SCC). METHODS: A multi-center, open-label, prospective phase. study was designed. Thirty-three esophageal SCC patients with documented progression after fluoropyrimidine/platinum-based first-line chemotherapy were enrolled and treated with docetaxel 35 mg/m(2) and gemcitabine 1000 mg/m(2) iv at a FDR (10 mg/m(2) per minute) on days 1 and 8. Treatment was repeated every twenty-one days until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was response rate (RR), and secondary endpoints were safety, progression-free survival (PFS) and overall survival (OS). RESULTS: Combination of weekly docetaxel and FDR gemcitabine was well tolerated: the most common treatment-related adverse events were anemia (97%), fatigue (64%) and neutropenia (55%). One patient with multiple lung and lymph node metastases died of respiratory failure after receiving four cycles of chemotherapy, and the possibility of drug-induced pneumonitis could not be completely excluded. Disease control (objective response plus stable disease) in the ITT population was achieved in 88% of patients, and the overall RR was 30% (95% CI: 15%-46%). The median PFS and OS were 4.0 (95% CI: 3.4-4.6) and 8.8 mo (95% CI: 7.8-9.8 mo), respectively. CONCLUSION: A combination of weekly docetaxel and FDR gemcitabine showed promising antitumor activity and tolerability in previously treated, metastatic esophageal SCC.
- All Author(s)
- M. Y. Lee
; K. S. Jung
; H. S. Kim
; J. Y. Lee
; S. H. Lim
; M. Kim
; H. A. Jung
; S. M. Kim
; J. M. Sun
; M. J. Ahn
; J. Lee
; S. H. Park
; S. Y. Yi
; I. G. Hwang
; S. C. Lee
; H. K. Ahn
; D. H. Lim
; S. I. Lee
; K. W. Park
- Issued Date
- 2015
- Type
- Article
- Keyword
- Clinical trial; Phase II; Chemotherapy; Carcinoma, Esophageal neoplasm; Squamous cell; Docetaxel; Gemcitabine
- Publisher
- Baishideng Publishing Group
- ISSN
- 1007-9327
; 2219-2840
- Citation Title
- World journal of gastroenterology
- Citation Volume
- 21
- Citation Number
- 14
- Citation Start Page
- 4268
- Citation End Page
- 4274
- Language(ISO)
- eng
- DOI
- 10.3748/wjg.v21.i14.4268
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/816
- 공개 및 라이선스
-
- 파일 목록
-
Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.