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 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.

CONCLUSION:

A combination of weekly docetaxel and FDR gemcitabine showed promising antitumor activity and tolerability in previously treated, metastatic esophageal SCC.

• Authors: 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
• Journal: World journal of gastroenterology (World J Gastroenterol) Vol. 21 Issue 14 Pg. 4268-74 (Apr 14 2015) ISSN: 2219-2840 [Electronic] United States
• PMID: 25892878 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Taxoids
• Deoxycytidine
• Docetaxel
• Gemcitabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Carcinoma, Squamous Cell (drug therapy, mortality, secondary)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Disease Progression
• Disease-Free Survival
• Docetaxel
• Drug Administration Schedule
• Esophageal Neoplasms (drug therapy, mortality, pathology)
• Esophageal Squamous Cell Carcinoma
• Female
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Prospective Studies
• Republic of Korea
• Taxoids (administration & dosage, adverse effects)
• Time Factors
• Treatment Outcome
• Gemcitabine