Weekly docetaxel and gemcitabine in previously treated metastatic esophageal squamous cell carcinoma
- Authors
- Lee, Min-Young; Jung, Ki Sun; Kim, Hae Su; Lee, Ji Yun; Lim, Sung Hee; Kim, Moonjin; Jung, Hyun Ae; Kim, Sung Min; Sun, Jong Mu; Ahn, Myung-Ju; Lee, Jeeyun; Park, Se Hoon; Yi, Seong Yoon; Hwang, In Gyu; Lee, Sang-Cheol; Ahn, Hee Kyung; Lim, Do Hyoung; Il Lee, Soon; Park, Keon Woo
- Issue Date
- 14-Apr-2015
- Publisher
- BAISHIDENG PUBLISHING GROUP INC
- Keywords
- Clinical trial; Phase II; Chemotherapy; Carcinoma, Esophageal neoplasm; Squamous cell; Docetaxel; Gemcitabine
- Citation
- WORLD JOURNAL OF GASTROENTEROLOGY, v.21, no.14, pp.4268 - 4274
- Journal Title
- WORLD JOURNAL OF GASTROENTEROLOGY
- Volume
- 21
- Number
- 14
- Start Page
- 4268
- End Page
- 4274
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/10607
- DOI
- 10.3748/wjg.v21.i14.4268
- ISSN
- 1007-9327
- 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.
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