Prospective Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 14, 2015; 21(14): 4268-4274
Published online Apr 14, 2015. doi: 10.3748/wjg.v21.i14.4268
Weekly docetaxel and gemcitabine in previously treated metastatic esophageal squamous cell carcinoma
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, Seong Yoon Yi, In Gyu Hwang, Sang-Cheol Lee, Hee Kyung Ahn, Do Hyoung Lim, Soon Il Lee, Keon Woo Park
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
Seong Yoon Yi, Division of Hematology-Oncology, Department of Internal Medicine, Inje University Ilsan-Paik Hospital, Goyang 411-706, South Korea
In Gyu Hwang, Division of Hematology-Oncology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul 156-755, South Korea
Sang-Cheol Lee, Division of Hematology-Oncology, Department of Internal Medicine, Soonchunhyang University Hospital, Cheonan 330-721, South Korea
Hee Kyung Ahn, Division of Hematology-Oncology, Department of Internal Medicine, Gachon University Gil Hospital, Incheon 405-760, South Korea
Do Hyoung Lim, Soon Il Lee, Keon Woo Park, Division of Hematology-Oncology, Department of Internal Medicine, Dankook University College of Medicine, Cheonan 330-715, South Korea
Author contributions: Park SH, Park KW and Lee J designed the study and were also involved in editing the manuscript; Yi SY, Hwang IG, Lee SC, Ahn HK, Lim DH and Lee SI designed and performed the study; Sun JM and Ahn MJ consulted our study; Jung KS, Kim HS, Lee JY, Lim SH, Kim M, Jung HA and Kim SM organized patient data; Lee MY collected data and drafted the manuscript.
Supported by Dong-A ST (Seoul, Korea) for kindly provided the study drug (gemcitabine).
Ethics approval: This study was reviewed and approved by the Samsung Medical Center Institutional Review Board.
Clinical trial registration: This study is registered at http://clinicaltrials.gov/show/NCT01469598. The registration identification number is NCT01469598.
Informed consent: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest: The authors made no disclosures.
Data sharing: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Keon Woo Park, MD, Division of Hematology-Oncology, Department of Internal Medicine, Dankook University College of Medicine, 16-5 Anseo-Dong, Dongnam-Gu, Cheonan 330-715, South Korea. pkw800041@naver.com
Telephone: +82-41-5509360 Fax: +82-41-5507058
Received: September 17, 2014
Peer-review started: September 19, 2014
First decision: October 29, 2014
Revised: January 2, 2015
Accepted: January 21, 2015
Article in press: January 21, 2015
Published online: April 14, 2015
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 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/m2 and gemcitabine 1000 mg/m2 iv at a FDR (10 mg/m2 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.

Keywords: Clinical trial, Phase II, Chemotherapy, Carcinoma, Esophageal neoplasm, Squamous cell, Docetaxel, Gemcitabine

Core tip: Esophageal squamous cell carcinoma (SCC) is a lethal disease with a poor prognosis. Currently, there is no standard chemotherapy regimen for metastatic esophageal SCC patients who have failed platinum and fluoropyrimidine combination chemotherapy. In this multi-center, prospective phase II study, we demonstrated that the combination of weekly docetaxel and a fixed-dose rate of gemcitabine is active and well tolerated as a salvage chemotherapy in patients with previously treated metastatic esophageal SCC.