title: Weekly docetaxel and gemcitabine in previously treated metastatic esophageal squamous cell carcinoma.
abstract: OBJECTIVE
  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 II 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.
  
  
  CONCLUSIONS
  A combination of weekly docetaxel and FDR gemcitabine showed promising antitumor activity and tolerability in previously treated, metastatic esophageal SCC.
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Min-Young
authors.initials: MY
authors.lastname: Lee
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Ki Sun
authors.initials: KS
authors.lastname: Jung
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Hae Su
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Ji Yun
authors.initials: JY
authors.lastname: Lee
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Sung Hee
authors.initials: SH
authors.lastname: Lim
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Moonjin
authors.initials: M
authors.lastname: Kim
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Hyun Ae
authors.initials: HA
authors.lastname: Jung
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Sung Min
authors.initials: SM
authors.lastname: Kim
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Jong Mu
authors.initials: JM
authors.lastname: Sun
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Myung-Ju
authors.initials: MJ
authors.lastname: Ahn
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Jeeyun
authors.initials: J
authors.lastname: Lee
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Seong Yoon
authors.initials: SY
authors.lastname: Yi
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: In Gyu
authors.initials: IG
authors.lastname: Hwang
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Lee
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Hee Kyung
authors.initials: HK
authors.lastname: Ahn
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Do Hyoung
authors.initials: DH
authors.lastname: Lim
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Soon Il
authors.initials: SI
authors.lastname: Lee
authors.affiliation: Min-Young Lee, Ki Sun Jung, Hae Su Kim, Ji Yun Lee, Sung Hee Lim, Moonjin Kim, Hyun Ae Jung, Sung Min Kim, Jong Mu Sun, Myung-Ju Ahn, Jeeyun Lee, Se Hoon Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
authors.forename: Keon Woo
authors.initials: KW
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D056910:Republic of Korea; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine
keywords: Carcinoma, Esophageal neoplasm; Chemotherapy; Clinical trial; Docetaxel; Gemcitabine; Phase II; Squamous cell